Near infrared spectroscopy for rapid determination of Mankin score components : a potential tool for quantitative characterization of articular cartilage at surgery

PURPOSE The purpose of this study was to demonstrate the potential of near infrared (NIR) spectroscopy for characterizing the health and degenerative state of articular cartilage based on the components of the Mankin score. METHODS Three models of osteoarthritic degeneration induced in laboratory rats by anterior cruciate ligament (ACL) transection, meniscectomy (MSX), and intra-articular injection of monoiodoacetate (1 mg) (MIA) were used in this study. Degeneration was induced in the right knee joint; each model group consisted of 12 rats (N = 36). After 8 weeks, the animals were euthanized and knee joints were collected. A custom-made diffuse reflectance NIR probe of 5-mm diameter was placed on the tibial and femoral surfaces, and spectral data were acquired from each specimen in the wave number range of 4,000 to 12,500 cm(-1). After spectral data acquisition, the specimens were fixed and safranin O staining (SOS) was performed to assess disease severity based on the Mankin scoring system. Using multivariate statistical analysis, with spectral preprocessing and wavelength selection technique, the spectral data were then correlated to the structural integrity (SI), cellularity (CEL), and matrix staining (SOS) components of the Mankin score for all the samples tested. RESULTS ACL models showed mild cartilage degeneration, MSX models had moderate degeneration, and MIA models showed severe cartilage degenerative changes both morphologically and histologically. Our results reveal significant linear correlations between the NIR absorption spectra and SI (R(2) = 94.78%), CEL (R(2) = 88.03%), and SOS (R(2) = 96.39%) parameters of all samples in the models. In addition, clustering of the samples according to their level of degeneration, with respect to the Mankin components, was also observed. CONCLUSIONS NIR spectroscopic probing of articular cartilage can potentially provide critical information about the health of articular cartilage matrix in early and advanced stages of osteoarthritis (OA). CLINICAL RELEVANCE This rapid nondestructive method can facilitate clinical appraisal of articular cartilage integrity during arthroscopic surgery.

Improving treatment for obese women with early stage cancer of the uterus : rationale and design of the levonorgestrel intrauterine device ±Metformin ±weight loss in endometrial cancer (feMME) trial

Purpose Endometrial adenocarcinoma (EC) is the most common gynaecologic cancer. Up to 90% of EC patients are obese which poses a health threat to patients post-treatment. Standard treatment for EC includes hysterectomy, although this has significant side effects for obese women at high risk of surgical complications and for women of childbearing age. This trial investigates the effectiveness of non-surgical or conservative treatment options for obese women with early stage EC. The primary aim is to determine the efficacy of: levonorgestrel intrauterine device (LNG-IUD); with or without metformin (an antidiabetic drug); and with or without a weight loss intervention to achieve a pathological complete response (pCR) in EC at six months from study treatment initiation. The secondary aim is to enhance understanding of the molecular processes and to predict a treatment response by investigating EC biomarkers. Methods An open label, three-armed, randomised, phase-II, multi-centre trial of LNG-IUD ± metformin ± weight loss intervention. 165 participants from 28 centres are randomly assigned in a 3:3:5 ratio to the treatment arms. Clinical, quality of life and health behavioural data will be collected at baseline, six weeks, three and six months. EC biomarkers will be assessed at baseline, three and six months. Conclusions There is limited prospective evidence for conservative treatment for EC. Trial results could benefit patients and reduce health system costs through a reduction in hospitalisations and through lower incidence of adverse events currently observed with standard treatment.

The effect of the addition of hip strengthening exercises to a lumbopelvic exercise programme for the treatment of non-specific low back pain : a randomized controlled trial

Objectives To compare the efficacy of two exercise programs in reducing pain and disability for individuals with non-specific low back pain and to examine the underlying mechanical factors related to pain and disability for individuals with NSLBP. Design A single-blind, randomized controlled trial. Methods: Eighty participants were recruited from eleven community-based general medical practices and randomized into two groups completing either a lumbopelvic motor control or a combined lumbopelvic motor control and progressive hip strengthening exercise therapy program. All participants received an education session, 6 rehabilitation sessions including real time ultrasound training, and a home based exercise program manual and log book. The primary outcomes were pain (0-100mm visual analogue scale), and disability (Oswestry Disability Index V2). The secondary outcomes were hip strength (N/kg) and two-dimensional frontal plane biomechanics (°) measure during the static Trendelenburg test and while walking. All outcomes were measured at baseline and at 6-week follow up. Results There was no statistical difference in the change in pain (xˉ = -4.0mm, t= -1.07, p =0.29, 95%CI -11.5, 3.5) or disability (xˉ = -0.3%, t= -0.19, p =0.85, 95%CI -3.5, 2.8) between groups. Within group comparisons revealed clinically meaningful reductions in pain for both Group One (xˉ =-20.9mm, 95%CI -25.7, -16.1) and Group Two (xˉ =-24.9, 95%CI -30.8, -19.0). Conclusion Both exercise programs had similar efficacy in reducing pain. The addition of hip strengthening exercises to a motor control exercise program does not appear to result in improved clinical outcome for pain for individuals with non-specific low back pain.

A pilot trial of mobile, patient-performed teledermoscopy

BACKGROUND Early detection by skin self-examination (SSE) could improve outcomes from melanoma. Mobile teledermoscopy may aid this process. OBJECTIVES To establish clinical accuracy of SSE plus mobile teledermoscopy compared to clinical skin examination (CSE) and test whether providing people with detailed SSE instructions improves accuracy. METHODS Men and women 50-64 years (n=58) performed SSE plus mobile teledermoscopy in their homes between May and November 2013 and were given technical instructions plus detailed SSE instructions (intervention) or technical instructions only (control). Within three months, they underwent a CSE. Outcome measures included: a) body sites examined, lesions photographed, and missed; b) sensitivityof SSE plus mobile teledermoscopy compared to in-person CSE using either patients or lesions as denominator, and; c) concordance of telediagnosis with CSE. RESULTS: 49 of 58 randomised participants completed the study, and submitted 309 lesions to the teledermatologist (156 intervention; 153 control group). Intervention group participants were more likely to submit lesions from their legs compared to control (p=0.03), no other differences between groups in number or site of missed lesions.11 participants (22%) did not photograph 14 pigmented lesions the dermatologist considered worthwhile photographing or requiring clinical monitoring. Sensitivity of SSE plus mobile teledermoscopy was 81.8% (95% confidence interval 64.5-93.0) using the patient as the denominator and 41.9 (27.6-56.2) using the lesion as denominator.-There was substantial agreement between telediagnosis and CSE (Kappa =0.90) accounting for differential diagnoses. CONCLUSIONS SSE plus mobile teledermoscopy is promising for surveillance of particular lesions even without provision of detailed SSE instructions, but in the format tested in this study, consumers may overlook lesions and send many non-pigmented lesions. This investigation demonstrates that high quality dermoscopic images can be taken by patients at home and for those sent, telediagnosis is highly accurate.

Nutritional support in chronic obstructive Pulmonary Disease (COPD) a randomised trial

Rationale Nutritional support is effective in managing malnutrition in COPD (Collins et al., 2012) leading to functional improvements (Collins et al., 2013). However, comparative trials of first line interventions are lacking. This randomised trial compared the effectiveness of individualised dietary advice by a dietitian (DA) versus oral nutritional supplements (ONS). Methods A target sample of 200 stable COPD outpatients at risk of malnutrition (‘MUST’; medium + high risk) were randomised to either a 12-week intervention of ONS (ONS: ~400 kcal/d, ~40 g/d protein) or DA with supportive written advice. The primary outcome was quality of life (QoL) measured using St George’s Respiratory Questionnaire with secondary outcomes including handgrip strength, body weight and nutritional intake. Both the change from baseline and the differences between groups was analysed using SPSS version 20. Results 84 outpatients were recruited (ONS: 41 vs. DA: 43), 72 completed the intervention (ONS: 33 vs. DA: 39). Mean BMI was 18.2 SD 1.6 kg/m2, age 72.6 SD 10 years, FEV1% predicted 36 SD 15% (severe COPD). In comparison to the DA group, the ONS group experienced significantly greater improvements in protein intakes above baseline values at both week 6 (+21.0 SEM 4.3 g/d vs. +0.52 SEM 4.3 g/d; p < 0.001) and week 12 (+19.0 SEM 5.0 g/d vs. +1.0 SEM 3.6 g/d; p = 0.033;ANOVA). QoL and secondary outcomes remained stable at 12 weeks in both groups with slight improvements in the ONS group but no differences between groups. Conclusion In outpatients at risk of malnutrition with severe COPD, nutritional support involving either ONS or DA appears to maintain in tritional status, functional capacity and QoL. However, larger trials, and earlier, multi-modal nutritional interventions for an extended duration should be explored.

The OnTrack Diabetes web-based program for type 2 diabetes and dysphoria self-management: A randomized controlled trial protocol

Background: The prevalence of type 2 diabetes is rising with the majority of patients practicing inadequate disease self-management. Depression, anxiety, and diabetes-specific distress present motivational challenges to adequate self-care. Health systems globally struggle to deliver routine services that are accessible to the entire population, in particular in rural areas. Web-based diabetes self-management interventions can provide frequent, accessible support regardless of time and location Objective: This paper describes the protocol of an Australian national randomized controlled trial (RCT) of the OnTrack Diabetes program, an automated, interactive, self-guided Web program aimed to improve glycemic control, diabetes self-care, and dysphoria symptoms in type 2 diabetes patients. Methods: A small pilot trial is conducted that primarily tests program functionality, efficacy, and user acceptability and satisfaction. This is followed by the main RCT, which compares 3 treatments: (1) delayed program access: usual diabetes care for 3 months postbaseline followed by access to the full OnTrack Diabetes program; (2) immediate program: full access to the self-guided program from baseline onward; and (3) immediate program plus therapist support via Functional Imagery Training (FIT). Measures are administered at baseline and at 3, 6, and 12 months postbaseline. Primary outcomes are diabetes self-care behaviors (physical activity participation, diet, medication adherence, and blood glucose monitoring), glycated hemoglobin A1c (HbA1c) level, and diabetes-specific distress. Secondary outcomes are depression, anxiety, self-efficacy and adherence, and quality of life. Exposure data in terms of program uptake, use, time on each page, and program completion, as well as implementation feasibility will be conducted. Results: This trial is currently underway with funding support from the Wesley Research Institute in Brisbane, Australia. Conclusions: This is the first known trial of an automated, self-guided, Web-based support program that uses a holistic approach in targeting both type 2 diabetes self-management and dysphoria. Findings will inform the feasibility of implementing such a program on an ongoing basis, including in rural and regional locations.

Can skin cancer prevention and early detection be improved via mobile phone text messaging? a randomised, attention-control trial.

Objective. To test the impact of a theory-based, SMS (text message)-delivered behavioural intervention (Healthy Text) targeting sun protection or skin self-examination behaviours compared to attention-control. Method. Overall, 546 participants aged 18–42 years were randomised using a computer-generated number list to the skin self-examination (N = 176), sun protection (N = 187), or attention-control (N = 183) text messages group. Each group received 21 text messages about their assigned topic over 12 months (12 weekly messages for three months, then monthly messages for the next nine months). Data was collected via telephone survey at baseline, three-, and 12-months across Queensland from January 2012 to August 2013. Results. One year after baseline, the sun protection (mean change 0.12; P = 0.030) and skin self-examination groups (mean change 0.12; P = 0.035) had significantly greater improvement in their sun protection habits (SPH) index compared to the attention-control group (reference mean change 0.02). The increase in the proportion of participants who reported any skin self-examination from baseline to 12 months was significantly greater in the skin self-examination intervention group (103/163; 63%; P < 0.001) than the sun protection (83/173; 48%), or attention-control (65/165; 36%) groups. There was no significant effect of the intervention for participants who self-reported whole-body skin self-examination, sun tanning behaviour, or sunburn behaviours. Conclusion. The Healthy Text intervention was effective in inducing significant improvements in sun protection and any type of skin self-examination behaviours.

Depressive symptoms and adverse outcomes from hospitalization in older adults : secondary outcomes of a trial of falls prevention education

Depression is common in older people and symptoms of depression are known to substantially increase during hospitalization. There is little known about predictors of depressive symptoms in older adults or impact of common interventions during hospitalization. This study aimed to describe the magnitude of depressive symptoms, shift of depressive symptoms and the impact of the symptoms of depression among older hospital patients during hospital admission and identify whether exposure to falls prevention education affected symptoms of depression. Participants (n = 1206) were older adults admitted within two Australian hospitals, the majority of participants completed the Geriatric Depression Scale – Short Form (GDS) at admission (n = 1168). Participants’ mean age was 74.7 (±SD 11) years and 47% (n = 551) were male. At admission 53% (619 out of 1168) of participants had symptoms of clinical depression and symptoms remained at the same level at discharge for 55% (543 out of 987). Those exposed to the low intensity education program had higher GDS scores at discharge than those in the control group (low intensity vs control n = 652, adjusted regression coefficient (95% CI) = 0.24 (0.02, 0.45), p = 0.03). The only factor other than admission level of depression that affected depressive symptoms change was if the participant was worried about falling. Older patients frequently present with symptoms of clinical depression on admission to hospital. Future research should consider these factors, whether these are modifiable and whether treatment may influence outcomes.

Telephone-delivered health coaching improves anxiety outcomes after myocardial infarction: The 'ProActive Heart' trial

Background: Recently, we found a telephone-delivered secondary prevention programme using health coaching (‘ProActive Heart’) to be effective in improving a range of key behavioural outcomes for myocardial infarction (MI) patients. What remains unclear, however, is the extent to which these treatment effects translate to important psychological outcomes such as depression and anxiety outcomes, an issue of clinical significance due to the substantial proportion of MI patients who experience depression and anxiety. The objective of the study was to investigate, as a secondary hypothesis of a larger trial, the effects of a telephone-delivered health coaching programme on depression and anxiety outcomes of MI patients. Design: Two-arm, parallel-group, randomized, controlled design with six-months outcomes. Methods: Patients admitted to one of two tertiary hospitals in Brisbane, Australia following MI were assessed for eligibility. Four hundred and thirty patients were recruited and randomly assigned to usual care or an intervention group comprising up to 10 telephone-delivered ‘health coaching’ sessions (ProActive Heart). Regression analysis compared Hospital Anxiety and Depression Scale scores of completing participants at six months (intervention: n = 141 versus usual care: n = 156). Results: The intervention yielded reductions in anxiety at follow-up (mean difference = −0.7, 95% confidence interval=−1.4,−0.02) compared with usual care. A similar pattern was observed in mean depression scores but was not statistically significant. Conclusions: The ProActive Heart programme effectively improves anxiety outcomes of patients following myocardial infarction. If combined with psychological-specific treatment, this programme could impact anxiety of greater intensity in a clinically meaningful way.

A randomised controlled trial of an online theory-based intervention to improve adult Australians' sun-protective behaviours

Objective. To evaluate the effectiveness of a single-session online theory of planned behaviour (TPB)-based intervention to improve sun-protective attitudes and behaviour among Australian adults. Methods. Australian adults (N = 534; 38.7% males; Mage = 39.3 years) from major cities (80.9%), regional (17.6%) and remote areas (1.5%)were recruited and randomly allocated to an intervention (N=265) and information only group (N = 267). The online intervention focused on fostering positive attitudes, perceptions of normative support, and control perceptions for sun protection. Participants completed questionnaires assessing standard TPB measures (attitude, subjective norm, perceived behavioural control, intention, behaviour) and extended TPB constructs of group norm (friends, family), personal norm, and image norm, pre-intervention (Time 1) and one week (Time 2) and one month post-intervention (Time 3). Repeated Measures Multivariate Analysis of Variance tested intervention effects across time. Results. Intervention participants reported more positive attitudes towards sun protection and used sunprotective measures more often in the subsequent month than participants receiving information only. The intervention effects on control perceptions and norms were non-significant. Conclusions. A theory-based online intervention fostering more favourable attitudes towards sun safety can increase sun protection attitudes and self-reported behaviour among Australian adults in the short term.

Facilitating lifestyle changes to manage menopausal symptoms in women with breast cancer: A randomized controlled pilot trial of The Pink Women’s Wellness Program

OBJECTIVE Women diagnosed as having breast cancer may experience difficulties with posttreatment effects such as menopausal symptoms. The aims of this pilot study were to (1) evaluate the impact of a multimodal lifestyle program on reducing menopausal symptoms in women with breast cancer and (2) examine the impact of the program on health-related quality of life (HRQoL) and adherence to lifestyle recommendations. METHODS Overall, 55 women aged 45 to 60 years with one moderate to severe menopausal symptom and a history of breast cancer were randomized into an intervention group (n = 26) or a control group (n = 29). Women in the intervention group received a lifestyle intervention (The Pink Women’s Wellness Program) that included clinical consultations and a tailored health education program. Measurements of menopausal symptoms (Greene Climacteric Scale), HRQoL (SF-12 and Functional Assessment of Cancer Therapy—Breast), and modifiable lifestyle factors (food intake, physical activity, smoking and alcohol use, and sleep disturbance) were taken at baseline and 12 weeks. RESULTS Women in the intervention group reported clinically significant reductions in many menopausal symptoms, specifically somatic symptoms (d = 0.52), vasomotor symptoms (d = 0.55), sexual dysfunction (d = .65), and overall menopausal symptoms (d = 0.54), at 12 weeks compared with the control group (d = 0.03, d = 0.24, d = 0.18, and d = 0.05, respectively). Women in the intervention group reported improvements in Functional Assessment of Cancer Therapy—Breast subscale scores, physical well-being and functional well-being, and Functional Assessment of Cancer Therapy—General total scores (intervention group: d = 0.54, d = 0.50, and d = 0.48, respectively; control group: d = 0.22, d = 0.11, and d = 0.05, respectively). CONCLUSIONS The Pink Women’s Wellness Program is effective in decreasing menopausal symptoms, thus improving HRQoL. This being a pilot study, further research is recommended to investigate the benefits of combining nonpharmacological interventions for women with breast cancer to reduce their treatment-related menopausal symptoms.

Exercise during chemotherapy for ovarian cancer (Echo) : study design features and outcomes of a Cancer Australia and Cancer Council Australia funded randomised, controlled trial

Ovarian cancer is the most common cause of gynaecological cancer death, with an overall 5-year relative survival of 43%. Impaired physical wellbeing and overall quality of life (QoL) represent major concerns for women during and following ovarian cancer treatment, predict survival and are amenable to change through interventions. Exercise, now considered an important part of overall management of a number of cancers, improves short-term outcomes (e.g., function, fatigue, QoL) during chemotherapy...