Finding My Way: results of a multicentre RCT evaluating a web-based self-guided psychosocial intervention for newly diagnosed cancer survivors.

PURPOSE: This multicentre randomised controlled trial examined the efficacy of Finding My Way (FMW), a 6-week/6-module online self-guided psychotherapeutic intervention for newly diagnosed curatively treated cancer survivors, in reducing cancer-related distress and improving quality of life compared to an online attention control. METHODS: Participants were randomised on a 1:1 ratio using a gender-stratified block design to intervention (n = 94) or attention control (n = 97), and were blinded to condition. Assessments were completed at baseline (T0), post-intervention (T1), 3 months (T2), and 6 months (T3) post-intervention. Mixed model repeated measures analyses examined differences between groups for cancer-specific distress (primary outcome) and general distress, quality of life (QoL), coping, and health service utilisation (secondary outcomes). RESULTS: While both groups reported reduced cancer-specific and general distress over time, between-group differences were not significant. Intervention participants reported lower total health service utilisation and supportive care utilisation post-intervention than controls (total HS use: between-group mean difference = - 1.07 (- 1.85 to - 0.28); supportive care use: between-group mean difference = - 0.64 (- 1.21 to - 0.06)) and significantly higher emotional functioning at 3 months (between-group mean difference = 7.04 (0.15 to 13.9)). At 6 months, the supportive care utilisation finding reversed (between-group mean difference = 0.78 points (0.19 to 1.37). Across remaining QoL and coping outcomes, no significant group differences emerged. CONCLUSIONS: While both groups experienced reductions in distress, between-group differences were not significant. This contrasts with the significantly improved emotional functioning observed in FMW participants at 3 months and the short-term reductions in health service utilisation. Long-term increases in supportive care service utilisation suggest FMW only met needs while being actively used. TRIAL REGISTRATION: ACTRN12613000001796;  http://www.ANZCTR.org.au/ACTRN12613000001796.aspx.

Comparison of implementation strategies to influence adherence to the clinical pathway for screening, assessment and management of anxiety and depression in adult cancer patients (ADAPT CP): study protocol of a cluster randomised controlled trial.

BACKGROUND: Health service change is difficult to achieve. One strategy to facilitate such change is the clinical pathway, a guide for clinicians containing a defined set of evidence-based interventions for a specific condition. However, optimal strategies for implementing clinical pathways are not well understood. Building on a strong evidence-base, the Psycho-Oncology Co-operative Research Group (PoCoG) in Australia developed an evidence and consensus-based clinical pathway for screening, assessing and managing cancer-related anxiety and depression (ADAPT CP) and web-based resources to support it - staff training, patient education, cognitive-behavioural therapy and a management system (ADAPT Portal). The ADAPT Portal manages patient screening and prompts staff to follow the recommendations of the ADAPT CP. This study compares the clinical and cost effectiveness of two implementation strategies (varying in resource intensiveness), designed to encourage adherence to the ADAPT CP over a 12-month period. METHODS: This cluster randomised controlled trial will recruit 12 cancer service sites, stratified by size (large versus small), and randomised at site level to a standard (Core) versus supported (Enhanced) implementation strategy. After a 3-month period of site engagement, staff training and site tailoring of the ADAPT CP and Portal, each site will "Go-live", implementing the ADAPT CP for 12 months. During the implementation phase, all eligible patients will be introduced to the ADAPT CP as routine care. Patient participants will be registered on the ADAPT Portal to complete screening for anxiety and depression. Staff will be responsible for responding to prompts to follow the ADAPT CP. The primary outcome will be adherence to the ADAPT CP. Secondary outcomes include staff attitudes to and experiences of following the ADAPT CP, using the ADAPT Portal and being exposed to ADAPT implementation strategies, collected using quantitative and qualitative methods. Data will be collected at T0 (baseline, after site engagement), T1 (6 months post Go-live) and T2 (12 months post Go-live). DISCUSSION: This will be the first cluster randomised trial to establish optimal levels of implementation effort and associated costs to achieve successful uptake of a clinical pathway within cancer care. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347.

Does stress increase risk of breast cancer? A 15-year prospective study.

OBJECTIVE: The possible impact of stress on cancer incidence remains controversial. We prospectively evaluated associations between life event stressors, social support, personality characteristics (optimism, anger control, antiemotionality), and risk of developing primary breast cancer (BCa), in women at increased familial risk of BCa. METHODS: A prospective cohort, repeated measures design was used. Recruitment was through the Kathleen Cuningham Foundation Consortium for Research into Familial Breast Cancer, which collects genetic, epidemiological, and clinical data from Australasian families with multiple BCa cases. Acute and chronic stressors for the prior 3 years and psychosocial, clinical, and epidemiological variables were measured at cohort entry and at 3-yearly intervals. Cox proportional hazard regression analysis controlling for BCa risk factors and familial clustering was undertaken. The primary outcome was histopathologically confirmed BCa (invasive or ductal carcinoma in situ, including occult cases diagnosed during risk-reducing mastectomy). RESULTS: Of 3595 consecutive women invited to participate, 3054 (85.0%) consented. Of these, 2739 (89.7%) from 990 families (range 1-16 per family) completed at least 1 assessment point. During the study, 103 women were diagnosed with BCa. No stressor or psychosocial variable or interaction between them was significantly associated with BCa in unadjusted or adjusted models (total acute stressors HR = 1.03 [0.99-1.08], P = .19; total chronic stressors HR = 1.0 [0.90-1.11], P = .98). CONCLUSIONS: This study did not demonstrate an association between acute and chronic stressors, social support, optimism, antiemotionality or anger control, and BCa risk. Women should focus on proven methods of BCa risk reduction.

Exploring the communication of oncologists, patients and family members in cancer consultations: development and application of a coding system capturing family-relevant behaviours (KINcode).

BACKGROUND: Family members (FMs) regularly attend oncology consultations. However, limited studies have assessed actual behaviours of oncologists, patients and FMs - particularly during decision-making. The current study aimed the following: (i) to rigorously develop a family (kin) interaction coding system (KINcode) capturing communication and decision-making behaviours of FMs and family-relevant behaviours of oncologists and patients and (ii) to apply KINcode to initial oncology consultations. METHODS: The 80-item KINcode system was developed and applied to 72 transcripts of audiotaped medical/radiation oncology consultations including an FM, collected as part of two previous studies. RESULTS: The role of the FM varied considerably within the one encounter, with 33% of FMs assuming three or more roles across the four consultation stages. Whilst most FMs asked treatment decision questions (71%), a minority engaged in other behaviours such as prompting patient questions (4%) or providing information relevant to the decision to the oncologist (18%). Although oncologists rarely initiated interaction with FMs such as in rapport building (18%) or asking FMs questions (25%), they were typically fully responsive to FM questions (90%). Many patients asked their FM a question (42%), but few elicited the FM's decision preferences (4%). CONCLUSIONS: This study provides novel insights into the complex nature of family involvement. The findings highlight potentially positive FM-focused consultation behaviours such as oncologist responsiveness to family questions and potential areas for improvement such as rapport building, invitation of questions and validation of the family's role. Family-specific communication skills training should be considered in medical student and professional education settings. Copyright © 2015 John Wiley & Sons, Ltd.

Association between patient activation and patient-assessed quality of care in type 2 diabetes: results of a longitudinal study.

BACKGROUND: Previous research using cross-sectional data has shown a positive relationship between patient activation and quality of care. The quantitative relationships in the same patients over time, however, remain undefined. OBJECTIVE: To examine the relationship between changes in activation over time and patient-assessed quality of chronic illness care. DESIGN: Prospective cohort study. PARTICIPANTS: The study used data reported annually from 2008 (N = 3761) to 2010 (N = 3040), using self-report survey questionnaires, completed by patients with type 2 diabetes in a population-based cohort in Queensland, Australia. MAIN MEASURES: Principal measures were the 13-item Patient Activation Measure (PAM), and the 20-item Patient Assessment of Chronic Illness Care (PACIC) instrument. METHODS: Nonparametric anova was used to determine the association between patient activation and patient-assessed quality of care in low and high patient activation groups at baseline (2008), and in 2009 and 2010, when patients had changed group membership. The Wilcoxon signed ranks test was used to compare the PACIC scores between baseline and each follow-up survey for the same patient activation level. RESULTS: Patient activation was positively associated with the median PACIC score within each survey year and within each of the groups defined at baseline (high- and low-activation groups; P < 0.001). CONCLUSIONS: Patient activation and the PACIC change in the same direction and should be considered together in the interpretation of patient care assessment. This can be carried out by interpreting PACIC scores within strata of PAM.

Influence of patient-assessed quality of chronic illness care and patient activation on health-related quality of life.

OBJECTIVE: To examine the association of the Patient Assessment of Chronic Illness Care (PACIC) with health-related quality of life (HRQoL) and the modulating effect of patient activation on this association. DESIGN AND PARTICIPANTS: A population-based prospective cohort study of people with Type 2 diabetes in Queensland, Australia, using data from self-report questionnaires, collected annually from 2008 (n = 3761) to 2010 (n = 3040). MAIN OUTCOME MEASURES: Predictors were the 20-item PACIC (dichotomized at the score of 3), and the 13-item Patient Activation Measure (PAM), dichotomized into activation Levels 1 and 2 versus Levels 3 and 4. Analyses were restricted to participants whose PACIC and PAM categories did not change over 2 years of follow-up. Outcome variables were EQ-5D index and EQ VAS dichotomized at the uppermost quartile, and EQ-5D index also dichotomized at the median. STATISTICAL ANALYSES: An inverse probability weighted Poisson regression with a log-link function and a binary response variable for each outcome was used to obtain risk ratios (RRs), and the interaction between PACIC and PAM was statistically modelled, taking into consideration patient characteristics and the respective baseline outcome variable. RESULTS: The positive association between the PACIC and EQ VAS was seen only in participants with low activation (adjusted RR: 3.91; 95% CI: 1.40-10.95; P = 0.009), and not in those with high activation, indicating the non-synergistic interaction effect of the PACIC and PAM. This association was not found with EQ-5D index. CONCLUSIONS: Chronic care received consistently over time can positively affect health status, and benefit patients with low activation.

The impact of concordant and discordant comorbidities on patient-assessed quality of diabetes care.

OBJECTIVE: To examine the impact of concordant and discordant comorbidities on patients' assessments of providers' adherence to diabetes-specific care guidelines and quality of chronic illness care. RESEARCH DESIGN AND METHODS: A population-based survey of 3761 adults with type 2 diabetes, living in Queensland, Australia was conducted in 2008. Based on self-reports, participants were grouped into four mutually exclusive comorbid categories: none, concordant only, discordant only and both concordant and discordant. Outcome measures included patient-reported providers' adherence to guideline-recommended care and the Patient Assessment of Chronic Illness Care (PACIC), which measures care according to the Chronic Care Model. Analyses using the former measure included logistic regressions, and the latter measure included univariate analysis of variance, both unadjusted and adjusted for sampling region, gender, age, educational attainment, diabetes duration and treatment status. RESULTS: Having concordant comorbidities increased the odds of patient-reported providers' adherence for 7 of the 11 guideline-recommended care activities in unadjusted analyses. However, the effect remained significant for only two provider activities (reviews of medication and/or complications and blood pressure examinations) when adjusted. A similar pattern was found for the both concordant and discordant comorbidity category. The presence of discordant comorbidities influenced only one provider activity (blood pressure examinations). No association between comorbidity type and the overall PACIC score was found. CONCLUSIONS: Comorbidity type is associated with diabetes-specific care, but does not seem to influence broader aspects of chronic illness care directly. Providers need to place more emphasis on care activities which are not comorbidity-specific and thus transferable across different chronic conditions.

Joint influence of Patient-Assessed Chronic Illness Care and patient activation on glycaemic control in type 2 diabetes.

OBJECTIVE: To examine the association of the Patient Assessment of Chronic Illness Care (PACIC) with glycaemic control and the modulating effect of patient activation on this association. DESIGN, SETTING AND PARTICIPANTS: A population-based prospective cohort study of people with type 2 diabetes in Queensland, Australia, using data from self-report questionnaires, collected annually from 2008 (N = 3761) to 2010 (N = 3040). MAIN MEASURES: Predictors were the 20-item PACIC (dichotomized at the score of 3), and the 13-item Patient Activation Measure (PAM), dichotomized into activation levels 1 and 2 versus levels 3 and 4. Analyses were restricted to participants whose PACIC and PAM categories did not change over 2 years of follow-up. Outcome variable was self-reported HbA1c of ≤ 7% (53 mmol/mol) versus >7%. STATISTICAL ANALYSES: An inverse probability-weighted Poisson regression with a log-link function and a binary response outcome variable (HbA1c) was used to obtain risk ratios (RRs), and the interaction between PACIC and PAM was statistically modelled, taking into consideration patient characteristics and baseline glycaemic status. RESULTS: The effect of the PACIC was not seen in the activated participants (adjusted RR: 1.1; 95% CI: 0.96-1.2; P = 0.20) but was strongly observed in participants with low activation (adjusted RR: 2.3; 95% CI: 1.6-3.1; P < 0.001). Similarly, there was a positive association between patient activation and glycaemic control when the PACIC was low (adjusted RR: 1.6; 95% CI: 1.3-2.0; P < 0.001). CONCLUSIONS: Better patient-assessed chronic care received consistently over time facilitates achievement of better glycaemic control in patients with low activation.

The muscle mass, omega-3, diet, exercise and lifestyle (MODEL) study - a randomised controlled trial for women who have completed breast cancer treatment.

BACKGROUND: Loss of lean body mass (LBM) is a common occurrence after treatment for breast cancer and is related to deleterious metabolic health outcomes [Clin Oncol, 22(4):281-288, 2010; Appl Physiol Nutr Metab, 34(5):950-956, 2009]. The aim of this research is to determine the effectiveness of long chain omega-3 fatty acids (LCn-3s) and exercise training alone, or in combination, in addressing LBM loss in breast cancer survivors. METHODS/DESIGN: A total of 153 women who have completed treatment for breast cancer in the last 12 months, with a Body Mass Index (BMI) of 20 to 35 kg/m2, will be randomly assigned to one of 3 groups: 3g/d LCn-3s (N-3), a 12-week nutrition and exercise education program plus olive oil (P-LC) or the education program plus LCn-3s (EX+N-3). Participants randomised to the education groups will be blinded to treatment, and will receive either olive oil placebo (OO+N-3) or LCn-3 provision, while the N-3 group will be open label. The education program includes nine 60-75 min sessions over 12 weeks that will involve breast cancer specific healthy eating advice, plus a supervised exercise session run as a resistance exercise circuit. They will also be advised to conduct the resistance training and aerobic training 5 to 7 days per week collectively. Outcome measures will be taken at baseline, 12-weeks and 24-weeks. The primary outcome is % change in LBM as measured by the air displacement plethysmograhy. Secondary outcomes include quality of life (FACT-B + 4) and inflammation (C-Reactive protein: CRP). Additional measures taken will be erythrocyte fatty acid analysis, fatigue, physical activity, menopausal symptoms, dietary intake, joint pain and function indices. DISCUSSION: This research will provide the first insight into the efficacy of LCn-3s alone or in combination with exercise in breast cancer survivors with regards to LBM and quality of life. In addition, this study is designed to improve evidence-based dietetic practice, and how specific dietary prescription may link with appropriate exercise interventions. TRIALS REGISTRATION: ACTRN12610001005044; and World Health Organisation Universal trial number: U1111-1116-8520.

Mental health issues decrease diabetes-specific quality of life independent of glycaemic control and complications: findings from Australia's living with diabetes cohort study.

BACKGROUND: While factors associated with health-related quality of life for people with chronic diseases including diabetes are well researched, far fewer studies have investigated measures of disease-specific quality of life. The purpose of this study is to assess the impact of complications and comorbidities on diabetes-specific quality of life in a large population-based cohort of type 2 diabetic patients. METHODS: The Living with Diabetes Study recruited participants from the National Diabetes Services Scheme in Australia. Data were collected via a mailed self-report questionnaire. Diabetes-specific quality of life was measured using the Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire. The analyses are for 3609 patients with type 2 diabetes. Regression models with adjustment for control variables investigated the association of complications and comorbidities with diabetes-specific quality of life. Next, the most parsimonious model for diabetes-specific quality of life after controlling for important covariates was examined. RESULTS: The expected associations with better diabetes-specific quality of life were evident, such as increased income, not on insulin, better glycaemic control and older age. However, being single and having been diagnosed with cancer were also associated with better ADDQoL. Additionally, poorer diabetes-specific quality of life was strongly sensitive to the presence of diabetes complications and mental health conditions such as depression, anxiety and schizophrenia. These relationships persisted after adjustment for gender, age, duration of diabetes, treatment regimen, sampling region and other treatment and socio-demographic variables. CONCLUSIONS: A greater appreciation of the complexities of diabetes-specific quality of life can help tailor disease management and self-care messages given to patients. Attention to mental health issues may be as important as focusing on glycaemic control and complications. Therefore clinicians' ability to identify and mange mental health issues and/or refer patients is critical to improving patients' diabetes-specific quality of life.

Patterns and Determinants of Complementary and Alternative Medicine Practitioner Use among Adults with Diabetes in Queensland, Australia.

There is evidence that complementary and alternative medicine (CAM) use is common among people with diabetes. The role of CAM in the treatment or management of diabetes is an emerging health issue given the potential side effects and benefits associated with the use of this kind of medicine. This paper examined patterns and determinants of CAM practitioner use in Queensland, Australia, using a large population-based sample of people with type 1 and type 2 diabetes. The study found that within a 12-month period, 7.7% of people with diabetes used the services of CAM practitioners alongside or as a complement to conventional health care service. Younger age, female gender, a higher education, having private health insurance, and engagement in preventive health behaviours are significant predictors of individuals who are more likely to visit a CAM practitioner. There was no significant difference in CAM practitioner use between people with type 1, type 2 insulin requiring, or type 2 noninsulin requiring diabetes. The findings highlight the need for further research on the role of CAM in the prevention and management of diabetes.

Waiting to vote safely: How Covid-19 safety measures shaped in-person voter wait times during the 2020 election.

Objective: The aim of this article is to assess the impact of Covid-19 safety measures on voter wait times during the 2020 U.S. election. Methods: Multinomial logistic regression models predicting voter wait times contingent on the presence of Covid safety measures: poll workers wearing face coverings, protective barriers separating voters and workers, voters and booths socially distanced, hand sanitizer, single-use ballot marking pens, and cleaning voting booths between voters, as well as an additive index of these measures. Results: Findings suggest Covid-safety measures significantly affected voter wait times. Effects vary by Covid safety feature, with face coverings, barriers, social distancing, and cleaning booths increasing voter wait times (typically around 10-30 min), single-use pens decreasing voter wait times, and hand sanitizer having no effect. Results are further confirmed using an additive index. Conclusion: Covid safety features likely increased voter wait times during the 2020 U.S. election, potentially accounting for a portion of the increased voter wait time, compared to previous elections.

Prevalence of abnormal ankle-brachial index among individuals with low or intermediate Framingham Risk Scores.

PURPOSE: To determine the prevalence of an abnormal ankle-brachial index (ABI) among subjects not considered to be at high risk for cardiovascular disease (CVD) based on the Framingham Risk Score (FRS). MATERIALS AND METHODS: Data from the Population-Based Examinations to Determine Ankle-brachiaL index (PEDAL) Study (2007-2009), a cross-sectional study at 23 U.S. sites, in conjunction with Legs for Life, a national ABI screening program, were analyzed. This study includes data from 822 participants (average age 64.3 years ± 11.6, 69.7% women, 89.7% non-Hispanic white) without known CVD or diabetes, who were screened for peripheral artery disease (PAD) with an ABI and for whom all FRS variables were available. Participants' 10-year coronary heart disease (CHD) risk was estimated from the FRS, and three risk categories were defined: low (< 10%), intermediate (10%-19%), and high (≥ 20%). ABI < 0.90 or > 1.4 in either leg was considered abnormal. RESULTS: The prevalence of abnormal ABI was 14.2% (95%confidence interval [CI] 11.9%-16.8%). According to the FRS, 463 (56.3%) participants were at low risk, 212 (25.8%) were at intermediate risk, and 147 (17.9%) were at high risk. Among participants with a low FRS (n = 463; without CVD or diabetes or both) and an intermediate FRS (n = 212; without CVD or diabetes or both), 12.3% and 12.2% had an abnormal ABI. CONCLUSIONS: The prevalence of abnormal ABI, a CHD equivalent, is high among individuals not identified as high risk by conventional Framingham-based risk assessment.

Bone mineral density in children with myelomeningocele.

The aim of the present study was to document bone mineral density (BMD) in children with myelomeningocele and to identify variables that contribute to reduced BMD. The study included 24 children with myelomeningocele (nine males, 15 females; age range 4-18y), who had varied levels of neurological impairment (thoracic/high-lumbar, n=6; mid-lumbar, n=9; sacral, n=9) and ambulatory status (non-ambulators, n=12; part-time ambulators n=2; full-time ambulators, n=10). BMD measurements of the femoral neck and whole body using dual energy X-ray absorptiometry assessments of dietary calcium intake, and serum markers of bone metabolism were obtained. BMD is presented as standardized scores (z-scores) which are age- and sex-matched to normally developing children. The mean femoral-neck z-score was -2.41. Femoral-neck z-scores differed significantly according to ambulatory status, with lower z-scores in children who were wheelchair-dependent (p=0.03). The mean z-score at the femoral neck demonstrated a trend toward lower z-scores in children with higher levels of lesions. Almost all children met their recommended daily intake of calcium. Markers of bone metabolism were normal in all patients. This study demonstrates that reduced BMD is a major complication in children with myelomeningocele. There is a significant relationship with low BMD in children who are wheelchair-dependent, a trend in those with higher neurological levels, and no relationship between fractures and reduced BMD.

Apolipoprotein E epsilon4 allele and outcomes of traumatic spinal cord injury.

BACKGROUND/OBJECTIVE: To test the hypothesis that apolipoprotein E (APOE) polymorphisms are associated with outcomes after spinal cord injury (SCI). METHODS: Retrospective cohort study, from rehabilitation admission to discharge. PARTICIPANTS: Convenience sample of 89 persons with cervical SCI (C3-C8) treated from 1995 through 2003. Median age was 30 years (range 14-70); 67 were male (75%) and 83 were white (93%). MAIN OUTCOME MEASURES: American Spinal Injury Association (ASIA) motor and sensory scores, ASIA Impairment Scale (AIS), time from injury to rehabilitation admission, and length of stay (LOS) in rehabilitation. RESULTS: Subjects with an APOE epsilon4 allele (n = 15; 17%) had significantly less motor recovery during rehabilitation than did individuals without an epsilon4 allele (median 3.0 vs 5.5; P < 0.05) and a longer rehabilitation LOS (median 106 vs 89 days; P = 0.04), but better sensory-pinprick recovery (median 5.0 vs 2.0; P= 0.03). There were no significant differences by APOE epsilon4 allele status in sensory-light touch recovery, likelihood of improving AIS Grade, or time from injury to rehabilitation admission. CONCLUSIONS: APOE epsilon4 allele was associated with differences in neurological recovery and longer rehabilitation LOS. Genetic factors may be among the determinants of outcome after SCI and warrant further study.

A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder.

OBJECTIVE: A pilot randomized controlled trial (RCT) of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) was conducted with children who had sensory modulation disorders (SMDs). This study evaluated the effectiveness of three treatment groups. In addition, sample size estimates for a large scale, multisite RCT were calculated. METHOD: Twenty-four children with SMD were randomly assigned to one of three treatment conditions; OT-SI, Activity Protocol, and No Treatment. Pretest and posttest measures of behavior, sensory and adaptive functioning, and physiology were administered. RESULTS: The OT-SI group, compared to the other two groups, made significant gains on goal attainment scaling and on the Attention subtest and the Cognitive/Social composite of the Leiter International Performance Scale-Revised. Compared to the control groups, OT-SI improvement trends on the Short Sensory Profile, Child Behavior Checklist, and electrodermal reactivity were in the hypothesized direction. CONCLUSION: Findings suggest that OT-SI may be effective in ameliorating difficulties of children with SMD.

Effect of intensive blood pressure control with valsartan on urinary albumin excretion in normotensive patients with type 2 diabetes.

BACKGROUND: Diabetes is the most common cause of renal failure in the United States, and data regarding the effects of aggressive blood pressure (BP) therapy in normotensive patients with type 2 diabetes are inadequate. METHODS: A total of 129 type 2 diabetic patients with a BP of <140/80 to 90 mm Hg without overt albuminuria were randomized to either intensive BP control (diastolic BP goal 75 mm Hg) using an angiotensin II receptor blocker, valsartan, versus moderate BP control (diastolic BP 80 to 90 mm Hg with placebo initially) to evaluate the effect on the change in urinary albumin excretion (UAE) from baseline. RESULTS: The mean entrance BP was 126 +/- 8.8/84 +/- 2.4 mm Hg. The mean follow-up period was 1.9 +/- 1.0 years. During the follow-up period, the mean BP was 118 +/- 10.9/75 +/- 5.7 for the intensive v 124 10.9/80 6.5 mm Hg for the moderate BP groups (P < .001). No difference was observed in change in creatinine clearance or serum creatinine from baseline between the two groups. An analysis of covariance model for change in log (UAE + 1), adjusting for age, HBA(1c), duration of diabetes, baseline log (UAE + 1), sex, and ethnicity resulted in a significant treatment difference at 2 years (P = .007) with intensive BP control reducing log (UAE+1) compared with moderate BP control. CONCLUSION: Intensive BP control with valsartan to <120/80 mm Hg in normotensive patients with type 2 diabetes and normo- or microalbuminuria significantly decreased the progression of UAE and in some cases caused regression of UAE.

A Decision Aid for Women Considering Neoadjuvant Systemic Therapy for Operable Invasive Breast Cancer: Development and Protocol of a Phase II Evaluation Study (ANZ1301 DOMINO).

BACKGROUND: Neoadjuvant systemic therapy is offered to selected women with large and/or highly proliferative operable breast cancers. This option adds further complexity to an already complex breast cancer treatment decision tree. Patient decision aids are an established method of increasing patient involvement and knowledge while decreasing decisional conflict. There is currently no decision aid available for women considering neoadjuvant systemic therapy. OBJECTIVE: We aimed to develop a decision aid for women diagnosed with operable breast cancer and considered suitable for neoadjuvant systemic therapy, and the protocol for a multicenter pre-post study evaluating the acceptability and feasibility of the decision aid. METHODS: The decision aid was developed through literature review, expert advisory panel, adherence to the International Patient Decision Aid Standards, and iterative review. The protocol for evaluation of the decision aid consists of the following: eligible women will undertake a series of questionnaires prior to and after using the decision aid. The primary endpoint is decision aid acceptability to patients and investigators and the feasibility of use. Secondary endpoints include change in decisional conflict, participant knowledge, and information involvement preference. Feasibility is defined as the proportion of eligible participants who use the decision aid to help inform their treatment decision. RESULTS: This study has recruited 29 out of a planned 50 participants at four Australian sites. A 12-month recruitment period is expected with a further 12-months follow-up. CONCLUSIONS: The decision aid has the potential to allow patients with operable breast cancer, who have been offered neoadjuvant systemic therapy, decreased decisional conflict, and greater involvement in the decision. If this study finds that an online decision aid is feasible and acceptable, it will be made widely available for routine clinical practice. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12614001267640; http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12614001267640&isBasic=True (Archived by WebCite at http://www.webcitation.org/6gh7BPZdG).

Patient Assessment of Chronic Illness Care (PACIC) in Type 2 Diabetes: A Longitudinal Study.

The Patient Assessment of Chronic Illness Care (PACIC) was designed to measure care congruent with several elements of the chronic care model (CCM), including self-management support and delivery system design. However, support for the a priori 5-subscale structure of the PACIC in previous research has been conflicting. Thus, we aim to investigate psychometric characteristics of the PACIC including the content and stability of its construct over time. A population-based prospective cohort study of patients with type 2 diabetes was conducted in Queensland, Australia, from 2008 (N = 3,761) to 2010 (N = 3,040). Participants completed annually the 20-item PACIC as well as measures of providers' adherence to guideline-recommended self-management support activities. We used exploratory factor analysis to determine its factor structure and examined internal consistency as well as agreement between the PACIC at baseline with repeated measurements at follow-up after 1 and 2 years. We also determined a criterion-related validity using multinomial logistic regression to explore PACIC's association with providers' self-management support. A one-factor structure was deemed optimal according to our findings. High internal consistency and moderate agreement within the scales over time were observed. Higher PACIC scores predicted better providers' self-management support. In conclusion, the PACIC is a reliable, valid, and reproducible instrument for assessment of diabetes care, and we recommend its promotion and use as a single scale rather than subscales as originally proposed.

Intensive blood pressure control reduces the risk of cardiovascular events in patients with peripheral arterial disease and type 2 diabetes.

BACKGROUND: Peripheral arterial disease (PAD) and diabetes are both associated with a high risk of ischemic events, but the role of intensive blood pressure control in PAD has not been established. METHODS AND RESULTS: The Appropriate Blood Pressure Control in Diabetes study followed 950 subjects with type 2 diabetes for 5 years; 480 of the subjects were normotensive (baseline diastolic blood pressure of 80 to 89 mm Hg). Patients randomized to placebo (moderate blood pressure control) had a mean blood pressure of 137+/-0.7/81+/-0.3 mm Hg over the last 4 years of treatment. In contrast, patients randomized to intensive treatment with enalapril or nisoldipine had a mean 4-year blood pressure of 128+/-0.8/75+/-0.3 mm Hg (P<0.0001 compared with moderate control). PAD, which is defined as an ankle-brachial index <0.90 at the baseline visit, was diagnosed in 53 patients. In patients with PAD, there were 3 cardiovascular events (13.6%) on intensive treatment compared with 12 events (38.7%) on moderate treatment (P=0.046). After adjustment for multiple cardiovascular risk factors, an inverse relationship between ankle-brachial index and cardiovascular events was observed with moderate treatment (P=0.009), but not with intensive treatment (P=0.91). Thus, with intensive blood pressure control, the risk of an event was not increased, even at the lowest ankle-brachial index values, and was the same as in a patient without PAD. CONCLUSIONS: In PAD patients with diabetes, intensive blood pressure lowering to a mean of 128/75 mm Hg resulted in a marked reduction in cardiovascular events.