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.

Roxadustat (FG-4592) Versus Epoetin Alfa for Anemia in Patients Receiving Maintenance Hemodialysis: A Phase 2, Randomized, 6- to 19-Week, Open-Label, Active-Comparator, Dose-Ranging, Safety and Exploratory Efficacy Study.

BACKGROUND: Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. STUDY DESIGN: Phase 2, randomized (3:1), open-label, active-comparator, safety and efficacy study. SETTING & PARTICIPANTS: Patients with stable end-stage renal disease treated with hemodialysis who previously had hemoglobin (Hb) levels maintained with epoetin alfa. INTERVENTION: Part 1: 6-week dose-ranging study in 54 individuals of thrice-weekly oral roxadustat doses versus continuation of intravenous epoetin alfa. Part 2: 19-week treatment in 90 individuals in 6 cohorts with various starting doses and adjustment rules (1.0-2.0mg/kg or tiered weight based) in individuals with a range of epoetin alfa responsiveness. Intravenous iron was prohibited. OUTCOMES: Primary end point was Hb level response, defined as end-of-treatment Hb level change (ΔHb) of -0.5g/dL or greater from baseline (part 1) and as mean Hb level ≥ 11.0g/dL during the last 4 treatment weeks (part 2). MEASUREMENTS: Hepcidin, iron parameters, cholesterol, and plasma erythropoietin (the latter in a subset). RESULTS: Baseline epoetin alfa doses were 138.3±51.3 (SD) and 136.3±47.7U/kg/wk in part 1 and 152.8±80.6 and 173.4±83.7U/kg/wk in part 2, in individuals randomly assigned to roxadustat and epoetin alfa, respectively. Hb level responder rates in part 1 were 79% in pooled roxadustat 1.5 to 2.0mg/kg compared to 33% in the epoetin alfa control arm (P=0.03). Hepcidin level reduction was greater at roxadustat 2.0mg/kg versus epoetin alfa (P<0.05). In part 2, the average roxadustat dose requirement for Hb level maintenance was ∼1.7mg/kg. The least-squares-mean ΔHb in roxadustat-treated individuals was comparable to that in epoetin alfa-treated individuals (about -0.5g/dL) and the least-squares-mean difference in ΔHb between both treatment arms was -0.03 (95% CI, -0.39 to 0.33) g/dL (mixed effect model-repeated measure). Roxadustat significantly reduced mean total cholesterol levels, not observed with epoetin alfa. No safety concerns were raised. LIMITATIONS: Short treatment duration and small sample size. CONCLUSIONS: In this phase 2 study of anemia therapy in patients with end-stage renal disease on maintenance hemodialysis therapy, roxadustat was well tolerated and effectively maintained Hb levels.

Trauma surgeon-performed peripheral arterial repairs are associated with equivalent outcomes when compared with vascular surgeons.

BACKGROUND: Civilian extremity trauma with vascular injury carries a significant risk of morbidity, limb loss, and mortality. We aim to describe the trends in extremity vascular injury repair and compare outcomes between trauma and vascular surgeons. METHODS: We performed a single-center retrospective review of patients 18 years or older with extremity vascular injury requiring surgical intervention between January 2009 and December 2019. Demographics, injury characteristics, operative course, and hospital course were analyzed. Descriptive statistics were used to examine management trends, and outcomes were compared for arterial repairs. Multivariate regression was used to evaluate surgeon specialty as a predictor of complications, readmission, vascular outcomes, and mortality. RESULTS: A total of 231 patients met our inclusion criteria; 80% were male with a median age of 29 years. The femoral vessels were most commonly injured (39.4%), followed by the popliteal vessels (26.8%). Trauma surgeons performed the majority of femoral artery repairs (82%), while vascular surgeons repaired the majority of popliteal artery injuries (84%). Both had a similar share of brachial artery repairs (36% vs. 39%, respectively). There were no differences in complications, readmission, vascular outcomes, and mortality. Median time from arrival to operating room was significantly shorter for trauma surgeons. There was a significant downward trend between 2009 and 2017 in the proportion of total and femoral vascular procedures performed by trauma surgeons. On multivariate regression, surgical specialty was not a significant predictor of need for vascular reintervention, prophylactic or delayed fasciotomies, postoperative complications, or readmissions. CONCLUSION: Traumas surgeons arrived quicker to the operating and had no difference in short-term clinical outcomes of brachial and femoral artery repairs compared with patients treated by vascular surgeons. Over the last decade, there has been a significant decline in the number of open vascular repairs done by trauma surgeons. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level IV.

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).

Chemoprevention: A new concept for cancer prevention in primary care

Background: Prevention of cancer in primary care has focused on modifying behaviours associated with increased risk of cancer (primary prevention) or increasing participation in national cancer screening programs (secondary prevention). On the basis of metaanalyses of large prevention trials, a new paradigm in primary prevention ­ chemoprevention ­ is beginning to enter the realms of primary care for specific populations. Objectives: In this article, we discuss two examples of cancer chemoprevention relevant to general practice: low-dose aspirin for the prevention of colorectal cancer in people aged 50­70 years, and selective oestrogen receptor modulators (SERMs) for women at increased risk of breast cancer. We present new expected frequency trees that show the absolute benefits and harms of taking these medications in specific populations. Discussion: These expected frequency trees can serve as risk-communication aids to support shared decision making and the implementation of new chemoprevention guidelines in general practice.

Direct Telephonic Communication in a Heart Failure Transitional Care Program: An observational study.

BACKGROUND: This study investigated the trend of phone calls in the Banner Good Samaritan Medical Center (BGSMC) Heart Failure Transitional Care Program (HFTCP). The primary goal of the HFTCP is to reduce 30-Day readmissions for heart failure patients by using a multi-pronged approach. METHODS: This study included 104 patients in the HFTCP discharged over a 51-week period who had around-the-clock telephone access to the Transitionalist. Cellular phone records were reviewed. This study evaluated the length and timing of calls. RESULTS: A total of 4398 telephone calls were recorded of which 39% were inbound and 61% were outbound. This averaged to 86 calls per week. During the "Weekday Daytime" period, Eighty-five percent of the totals calls were made. There were 229 calls during the "Weekday Nights" period with 1.5 inbound calls per week. The "Total Weekend" calls were 10.2% of the total calls which equated to a weekly average of 8.8. CONCLUSIONS: Our experience is that direct, physician-patient telephone contact is feasible with a panel of around 100 HF patients for one provider. If the proper financial reimbursements are provided, physicians may be apt to participate in similar transitional care programs. Likewise, third party payers will benefit from the reduction in unnecessary emergency room visits and hospitalizations.