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.

Exploring the relationships between sexual violence, mental health and perpetrator identity: a cross-sectional Australian primary care study.

BACKGROUND: Research supports the association between adult sexual violence (SV) and poor mental health. However, most studies focus on rape and physical sexual assault. Little is known about how more subtle forms of SV affect women's well-being. Furthermore, evidence for the impact of the perpetrator's identity is mixed. There is also little data from clinical populations to help health practitioners identify SV. This paper addresses these gaps by exploring the associations between different types of adult SV, perpetrator identity, and women's mental health in the Australian primary care setting. METHODS: We conducted a descriptive, cross-sectional study in general practice clinics. Adult women completed an anonymous survey while waiting for the doctor. Measures included PHQ-9 (depression), GAD-7 (anxiety) and PCL-C (post-traumatic stress disorder). SV was measured using items from the National Intimate Partner and Sexual Violence Survey and categorised into three groups (rape/sexual assault; coercive behaviours and/or reproductive control; and unwanted sexual contact). RESULTS: We found significant associations between rape/sexual assault and poor mental health, and between coercion and/or reproductive control and higher PTSD and anxiety scores, compared to women with no SV experiences. SV perpetrated by an intimate partner was associated with significantly higher mean PTSD scores than SV perpetrated by a stranger, and significantly higher depression scores than SV perpetrated by another known person. CONCLUSION: Findings suggest that associations between SV and mental health are mediated by type of SV and perpetrator identity. Health practitioners should enquire about different types of SV beyond stranger rape as a cause of poor mental health, and about perpetrator identity to inform them about the likelihood of ongoing symptoms.

Acupuncture for chronic knee pain: a randomized clinical trial.

IMPORTANCE: There is debate about benefits of acupuncture for knee pain. OBJECTIVE: To determine the efficacy of laser and needle acupuncture for chronic knee pain. DESIGN, SETTING, AND PARTICIPANTS: Zelen-design clinical trial (randomization occurred before informed consent), in Victoria, Australia (February 2010-December 2012). Community volunteers (282 patients aged ≥50 years with chronic knee pain) were treated by family physician acupuncturists. INTERVENTIONS: No acupuncture (control group, n = 71) and needle (n = 70), laser (n = 71), and sham laser (n = 70) acupuncture. Treatments were delivered for 12 weeks. Participants and acupuncturists were blinded to laser and sham laser acupuncture. Control participants were unaware of the trial. MAIN OUTCOMES AND MEASURES: Primary outcomes were average knee pain (numeric rating scale, 0 [no pain] to 10 [worst pain possible]; minimal clinically important difference [MCID], 1.8 units) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index, 0 [no difficulty] to 68 [extreme difficulty]; MCID, 6 units) at 12 weeks. Secondary outcomes included other pain and function measures, quality of life, global change, and 1-year follow-up. Analyses were by intention-to-treat using multiple imputation for missing outcome data. RESULTS: At 12 weeks and 1 year, 26 (9%) and 50 (18%) participants were lost to follow-up, respectively. Analyses showed neither needle nor laser acupuncture significantly improved pain (mean difference; -0.4 units; 95% CI, -1.2 to 0.4, and -0.1; 95% CI, -0.9 to 0.7, respectively) or function (-1.7; 95% CI, -6.1 to 2.6, and 0.5; 95% CI, -3.4 to 4.4, respectively) compared with sham at 12 weeks. Compared with control, needle and laser acupuncture resulted in modest improvements in pain (-1.1; 95% CI, -1.8 to -0.4, and -0.8; 95% CI, -1.5 to -0.1, respectively) at 12 weeks, but not at 1 year. Needle acupuncture resulted in modest improvement in function compared with control at 12 weeks (-3.9; 95% CI, -7.7 to -0.2) but was not significantly different from sham (-1.7; 95% CI, -6.1 to 2.6) and was not maintained at 1 year. There were no differences for most secondary outcomes and no serious adverse events. CONCLUSIONS AND RELEVANCE: In patients older than 50 years with moderate or severe chronic knee pain, neither laser nor needle acupuncture conferred benefit over sham for pain or function. Our findings do not support acupuncture for these patients. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12609001001280.

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

Background Australian guidelines recommend that all people aged 50-70 years old consider taking low-dose aspirin to reduce the risk of colorectal cancer (CRC). Aim To determine the effect of a consultation with a researcher in general practice using a decision aid about taking low-dose aspirin to prevent CRC on informed decision-making and low-dose aspirin uptake compared to a general CRC prevention brochure. Design and Setting Individually randomised controlled trial in six general practices in Victoria, Australia, from October 2020 to March 2021. Method Patients aged 50-70 years attending a general practitioner (GP) were recruited consecutively. The intervention was a consultation using a decision aid to discuss taking aspirin to reduce CRC risk; control consultations discussed reducing CRC risk generally. The self-reported co-primary outcomes were informed choices about taking aspirin at one month and low-dose aspirin uptake at six months. Results 261 participants (86% of eligible patients) were randomised into trial arms (129 intervention, 132 control). 17.7% (20/113) of intervention and 7.6% (9/118) control participants reported making an informed choice at one 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 using aspirin at six months were: 10.2% (12/118) intervention vs 13.8% (16/116) control (estimated between-arm difference: -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 has little effect on long-term regular use of aspirin to reduce CRC risk.

'Family court sucks out your soul': Australian general practitioners' experiences supporting domestic violence survivors through family court.

BACKGROUND: Domestic violence is a significant public health issue with survivors experiencing short- and long-term physical, sexual and psychological health issues. Given this, survivors of domestic violence use healthcare services at an increased rate compared to the general population. Therefore, general practitioners (GPs) are well placed to support survivors of domestic violence. However, many practitioners do not feel ready to address this complex issue of domestic violence. Further, there is no research exploring GPs' role in supporting families through family court in the context of domestic violence. METHODS: This study used qualitative methods. Fifteen GPs participated in individual in-depth interviews. The interviews were audio recorded with consent, transcribed verbatim and thematically analysed. RESULTS: The majority of participants were female GPs working in metropolitan settings. Four themes were generated from the data: on different planets, witnessing legal systems abuse, weaponizing mental health in family court and swinging allegiances. Participants had negative perceptions of family court and felt that it operated on a different paradigm to that of general practice which caused difficulties when supporting patients. Participants supported survivors through instances where the court was used by perpetrators to further their abusive behaviour or where the court acted abusively against survivors. In particular, perpetrators and the family court used survivors' mental health against them in court proceedings, which resulted in survivors being reluctant to receive treatment for their mental health. Participants struggled with their allegiances within their patient family and usually opted to support either the mother, the father, or the children. CONCLUSIONS: Implications of these findings for GP training are evident, including curriculum that discusses the intersection of mental health diagnoses and legal proceedings. There may also be a place for health justice partnerships within 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.

Efficacy of acupuncture for chronic knee pain: protocol for a randomised controlled trial using a Zelen design.

BACKGROUND: Chronic knee pain is a common and disabling condition in people over 50 years of age, with knee joint osteoarthritis being a major cause. Acupuncture is a popular form of complementary and alternative medicine for treating pain and dysfunction associated with musculoskeletal conditions. This pragmatic Zelen-design randomised controlled trial is investigating the efficacy and cost-effectiveness of needle and laser acupuncture, administered by medical practitioners, in people with chronic knee pain. METHODS/DESIGN: Two hundred and eighty two people aged over 50 years with chronic knee pain have been recruited from metropolitan Melbourne and regional Victoria, Australia. Participants originally consented to participate in a longitudinal natural history study but were then covertly randomised into one of four treatment groups. One group continued as originally consented (ie natural history group) and received no acupuncture treatment. The other three were treatment groups: i) laser acupuncture, ii) sham laser or, iii) needle acupuncture. Acupuncture treatments used a combined Western and Traditional Chinese Medicine style, were delivered by general practitioners and comprised 8-12 visits over 12 weeks. Follow-up is currently ongoing. The primary outcomes are pain measured by an 11-point numeric rating scale (NRS) and self-reported physical function measured by the Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index subscale at the completion of treatment at 12 weeks. Secondary outcomes include quality of life, global rating of change scores and additional measures of pain (other NRS and WOMAC subscale) and physical function (NRS). Additional parameters include a range of psychosocial measures in order to evaluate potential relationships with acupuncture treatment outcomes. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 months. DISCUSSION: The findings from this study will help determine whether laser and/or needle acupuncture is efficacious, and cost-effective, in the management of chronic knee pain in older people. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry reference: ACTRN12609001001280.

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.

An online healthy relationship tool and safety decision aid for women experiencing intimate partner violence (I-DECIDE): a randomised controlled trial.

BACKGROUND: Evidence for online interventions to help women experiencing intimate partner violence is scarce. We assessed whether an online interactive healthy relationship tool and safety decision aid (I-DECIDE) would increase women's self-efficacy and improve depressive symptoms compared with an intimate partner violence information website. METHODS: In this two-group pragmatic randomised controlled trial, we enrolled women who had screened positive for any form of intimate partner violence or fear of a partner in the 6 months before recruitment. Women aged 16-50 years currently residing in Australia, who had safe access to a computer and an internet connection, and who answered positively to one of the screening questions in English were eligible for inclusion. Participants were randomly assigned (1:1) by computer to receive either the intervention or control website. The intervention website consisted of modules on healthy relationships, abuse and safety, and relationship priority setting, and a tailored action plan. The control website was a static intimate partner violence information website. As the initial portion of the website containing the baseline questions was identical for both groups, there was no way for women to tell which group they had been allocated to, and the research team were also masked to participant allocation until after analysis of the 12-month data. Data were collected at baseline, immediately after completion of the website, at 6 months, and 12 months. Primary outcomes were mean general self-efficacy score (immediately after website completion, and at 6 months and 12 months) and mean depression score (at 6 months and 12 months). Data analyses were done according to intention-to-treat principles, accounting for missing data, and adjusted for outcome baseline scores. This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN 12614001306606. FINDINGS: Between Jan 16, and Aug 28, 2015, 584 patients registered for the study and were assessed for eligibility. 422 eligible participants were randomly allocated to the intervention group (227 patients) or control group (195 patients). 179 (79%) participants in the intervention group and 156 (80%) participants in the control group completed 12-month follow-up. Mean self-efficacy at 6 months and 12 months was lower for participants in the intervention group than for participants in the control group, although this did not meet the prespecified mean difference (6 months: 27·5 [SD 5·1] vs 28·1 [4·4], imputed mean difference 1·3 [95% CI 0·3 to 2·3]; 12 months: 27·8 [SD 5·4] vs 29·0 [5·0], imputed mean difference 1·6 [95% CI 0·5 to 2·7]). We found no difference between groups in depressive symptoms at 6 months or 12 months (6 months: 22·5 [SD 17·1] vs 24·2 [17·2], imputed mean difference -0·3 [95% CI -3·5 to 3·0]; 12 months: 21·9 [SD 19·3] vs 21·5 [19·3], imputed mean difference -1·9 [95% CI -5·6 to 1·7]). Qualitative findings indicated that participants found the intervention supportive and a motivation for action. INTERPRETATION: Our findings highlight the need for further research, development, and refinement of online interventions for women experiencing intimate partner violence, particularly into the duration needed for interventions. Although we detected no meaningful differences between groups, our qualitative results indicated that some women find an online tool a helpful source of motivation and support. FUNDING: Australian Research Council.

Sexual violence associated with poor mental health in women attending Australian general practices.

OBJECTIVE: Sexual violence (SV) against adult women is prevalent and associated with a range of mental health issues. General practitioners could potentially have a role in responding, however, there is little information to help guide them. Data around prevalence of all forms of adult SV (not just rape) is inconsistent, particularly in clinical samples, and the links between other forms of SV and mental health issues are not well supported. This study aimed to address these gaps in the knowledge base. METHODS: A descriptive, cross-sectional study was conducted in Australian general practice clinics. Two hundred and thirty adult women completed an anonymous iPad survey while waiting to see the doctor. RESULTS: More than half the sample had experienced at least one incident of adult SV. Most commonly, women reported public harassment or flashing, unwanted groping and being coerced into sex. Women who had experienced adult SV were more likely to experience anxiety than women who had not, even after controlling for other factors. Women who had experienced adult SV were more likely to feel down, depressed or hopeless than women who had not; however, this association disappeared after controlling for childhood sexual abuse. CONCLUSIONS: The findings support the association between SV and poor mental health, even when 'lesser' incidents have occurred. Implications for public health: General practitioners should consider an experience of SV as a possible factor in otherwise unexplained anxiety and depressive symptoms in female patients.