The Uptake and Effectiveness of a Multidisciplinary Online Program for Managing Chronic Pain before and During the COVID-19 Pandemic.

OBJECTIVES: Societal and health system pressures associated with the coronavirus disease 2019 (COVID-19) pandemic exacerbated the burden of chronic pain and limited access to pain management services for many. Online multidisciplinary pain programs offer an effective and scalable treatment option, but have not been evaluated within the context of COVID-19. This study aimed to investigate the uptake and effectiveness of the Reboot Online chronic pain program before and during the first year of the COVID-19 pandemic. METHODS: Retrospective cohort analyses were conducted on routine service users of the Reboot Online program, comparing those who commenced the program during the COVID-19 pandemic (March 2020-March 2021), to those prior to the pandemic (April 2017-March 2020). Outcomes included the number of course registrations; commencements; completion rates; and measures of pain severity, interference, self-efficacy, pain-related disability, and distress. RESULTS: Data from 2,585 course users were included (n = 1138 pre-COVID-19 and n = 1,447 during-COVID-19). There was a 287% increase in monthly course registrations during COVID-19, relative to previously. Users were younger, and more likely to reside in a metropolitan area during COVID-19, but initial symptom severity was comparable. Course adherence and effectiveness were similar before and during COVID-19, with moderate effect size improvements in clinical outcomes post-treatment (g = 0.23-0.55). DISCUSSION: Uptake of an online chronic pain management program substantially increased during the COVID-19 pandemic. Program adherence and effectiveness were similar pre- and during-COVID. These findings support the effectiveness and scalability of online chronic pain management programs to meet increasing demand.

The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial.

BACKGROUND: Internet-based treatment programs present a solution for providing access to pain management for those unable to access clinic-based multidisciplinary pain programs. Attrition from internet interventions is a common issue. Clinician-supported guidance can be an important feature in web-based interventions; however, the optimal level of therapist guidance and expertise required to improve adherence remains unclear. OBJECTIVE: The aim of this study is to evaluate whether augmenting the existing Reboot Online program with telephone support by a clinician improves program adherence and effectiveness compared with the web-based program alone. METHODS: A 2-armed, CONSORT (Consolidated Standards of Reporting Trials)-compliant, registered randomized controlled trial with one-to-one group allocation was conducted. It compared a web-based multidisciplinary pain management program, Reboot Online, combined with telephone support (n=44) with Reboot Online alone (n=45) as the control group. Participants were recruited through web-based social media and the This Way Up service provider network. The primary outcome for this study was adherence to the Reboot Online program. Adherence was quantified through three metrics: completion of the program, the number of participants who enrolled into the program, and the number of participants who commenced the program. Data on adherence were collected automatically through the This Way Up platform. Secondary measures of clinical effectiveness were also collected. RESULTS: Reboot Online combined with telephone support had a positive effect on enrollment and commencement of the program compared with Reboot Online without telephone support. Significantly more participants from the Reboot Online plus telephone support group enrolled (41/44, 93%) into the course than those from the control group (35/45, 78%; χ21=4.2; P=.04). Furthermore, more participants from the intervention group commenced the course than those from the control group (40/44, 91% vs 27/45, 60%, respectively; χ21=11.4; P=.001). Of the participants enrolled in the intervention group, 43% (19/44) completed the course, and of those in the control group, 31% (14/45) completed the course. When considering the subgroup of those who commenced the program, there was no significant difference between the proportions of people who completed all 8 lessons in the intervention (19/40, 48%) and control groups (14/27, 52%; χ21=1.3; P=.24). The treatment efficacy on clinical outcome measures did not differ between the intervention and control groups. CONCLUSIONS: Telephone support improves participants' registration, program commencement, and engagement in the early phase of the internet intervention; however, it did not seem to have an impact on overall course completion or efficacy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001076167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001076167.

COVID-19 related differences in the uptake and effects of internet-based cognitive behavioural therapy for symptoms of obsessive-compulsive disorder.

BACKGROUND: The impacts of COVID-19 for people with obsessive-compulsive disorder (OCD) may be considerable. Online cognitive behavioural therapy (iCBT) programmes provide scalable access to psychological interventions, although the effectiveness of iCBT for OCD during COVID-19 has not been evaluated. AIM: This study investigated the uptake and effectiveness of iCBT for OCD (both self- and clinician-guided courses) during the first 8 months of the pandemic in Australia (March to October 2020) and compared outcomes with the previous year. METHOD: 1,343 adults (824/1343 (61.4%) female, mean age 33.54 years, SD = 12.00) commenced iCBT for OCD (1061 during the pandemic and 282 in the year before) and completed measures of OCD (Dimensional Obsessive-Compulsive Scale) and depression (Patient Health Questionaire-9) symptom severity, psychological distress (Kessler-10), and disability (WHO Disability Assessment Schedule) pre- and post-treatment. RESULTS: During COVID-19, there was a 522% increase in monthly course registrations compared with the previous year, with peak uptake observed between April and June 2020 (a 1191% increase compared with April to June 2019). OCD and depression symptom severity were similar for the COVID and pre-COVID groups, although COVID-19 participants were more likely to enrol in self-guided courses (versus clinician-guided). In both pre- and during-COVID groups, the OCD iCBT course was associated with medium effect size reductions in OCD (g = 0.65-0.68) and depression symptom severity (g = 0.56-0.65), medium to large reductions in psychological distress (g = 0.77-0.83) and small reductions in disability (g = 0.35-.50). CONCLUSION: Results demonstrate the considerable uptake of online psychological services for those experiencing symptoms of OCD during COVID-19 and highlight the scalability of effective digital mental health services.

The uptake and outcomes of Internet-based cognitive behavioural therapy for health anxiety symptoms during the COVID-19 pandemic.

BACKGROUND: Internet cognitive behavioural therapy (iCBT) for health anxiety has demonstrated efficacy but has not been evaluated during the COVID-19 pandemic. This study presents the first evaluation of the uptake and outcomes of iCBT for health anxiety during the COVID-19 pandemic. METHODS: THIS WAY UP is an Australian digital mental health service which delivers iCBT interventions to community members. We compared the uptake of THIS WAY UP's iCBT course for health anxiety in an Australian adult sample who started the course before the pandemic (12th September 2019-11 th March 2020) to during the pandemic (12th March to 11th June 2020). The course was accessible to Australian adults over 18 years old, with no inclusion criteria. Outcomes included course registrations and commencements, lesson and course completion, and self-reported health anxiety (Short Health Anxiety Inventory), depression (Patient Health Questionnaire 9-item) and distress (Kessler-10). RESULTS: From March to June 2020, we observed significant increases in course registrations (N = 238 vs N = 1057); and course commencements (N = 126 vs. N = 778). Large, significant improvements in health anxiety (g = 0.89), and distress (K10: g = 0.91), and medium improvements in depression (g = 0.55) were found. Course completion during COVID was 30.5%. CONCLUSIONS: iCBT improved health anxiety during the COVID-19 pandemic, and provides scalable intervention that can address increased demands for mental health services in the community.

A tale of two countries: Increased uptake of digital mental health services during the COVID-19 pandemic in Australia and New Zealand.

BACKGROUND: Digital mental health services (DMHS) provide highly accessible psychological supports and interventions that can supplement existing mental health services. Concerns about the mental health impact of the COVID-19 pandemic have been widespread and provide a unique impetus to examine the utility and responsivity of DMHS. This study examined the service utilisation and user characteristics of two DMHS (THIS WAY UP and Just a Thought) in Australia and New Zealand before and during the early pandemic period in these countries (March to June 2020). METHODS: Service use indices (website visits, course registrations and prescriptions, clinician registrations) were compared across different time periods before (12, 6 and 3 months) and during the pandemic in Australia and New Zealand. The demographic and clinical characteristics of course registrants (anxiety and depression symptom severity and psychological distress) were also compared across the pre- and during-COVID periods. RESULTS: Comparing pre-COVID to during-COVID time periods, we observed substantial increases across all service use indices in both DMHS (increases of >100% on the majority of service use indices). For example, in the 3 months prior to the pandemic, 2806 people registered for a THIS WAY UP course and 1907 people registered for a Just a Thought course, whereas 21,872 and 5442 registered for a THIS WAY UP and Just a Thought course, respectively, during the first 3 months of the COVID pandemic. Slight differences in the demographic and clinical profiles of course registrants were found between pre- and during-COVID time periods, with limited evidence of elevated anxiety and depression symptom severity in the COVID period. CONCLUSIONS: Following the outbreak of COVID-19 in Australia and New Zealand, the volume of users accessing DMHS increased yet the demographic and clinical characteristics of course registrants remained stable. Results underscore how nimble and scalable DMHS can be during periods of high demand.

The uptake and effectiveness of online cognitive behaviour therapy for symptoms of anxiety and depression during COVID-19.

BACKGROUND: The mental health impacts of COVID-19 have been considerable with many individuals experiencing significant anxiety and depression. Online cognitive behavioural therapy (iCBT) programs provide scalable access to psychological interventions, however the effectiveness of these programs during the pandemic has not been investigated. This study examined the uptake and effectiveness of iCBT for symptoms of anxiety and depression during the first eight months of the pandemic in Australia (March- October 2020) and compared outcomes to the 12 months prior to COVID-19. METHODS: 6,132 adults commenced iCBT (5,074 during the pandemic and 1,058 in the year before) and completed measures of anxiety and depression symptom severity, and psychological distress pre- and post-treatment. RESULTS: In the COVID-19 period, we observed a 504% increase in the number of monthly course registrations compared to the year prior (with a peak increase of 1,138% between April and June 2020). Baseline anxiety and depression symptom severity were similar for the COVID and pre-COVID groups. Prior to and during the pandemic, the iCBT course was associated with large effect size reductions in anxiety (g = 0.94-1.18) and depression (g = 0.92-1.12) symptom severity, as well as psychological distress (g = 1.08-1.35). LIMITATIONS: lack of control group and long-term follow-up, as well as lack of detailed information about course users (e.g., health status and life context). CONCLUSION: Results indicate the considerable increase in demand for psychological support during the COVID-19 pandemic in Australia and demonstrate the effectiveness and scalability of iCBT for symptoms of anxiety and depression.

Comorbid personality difficulties are not associated with poorer outcomes for online cognitive behaviour therapy for symptoms of anxiety and depression.

Little is known about the prevalence and impact on treatment of comorbid personality disorders for adults undertaking online cognitive behaviour therapy (internet-delivered or internet-based cognitive behaviour therapy (iCBT)) for anxiety and depressive disorders. This study explored how common comorbid personality difficulties were in a large sample of consecutive patients (N = 1 132) seeking iCBT for their symptoms of anxiety and depression in routine care settings. Patients completed the Standardized Assessment of Personality-abbreviated Scale Self-Report prior to commencing an iCBT programme, as well as completing assessments of anxiety and depression symptom severity and psychological distress pre-iCBT and post-iCBT. Consistent with previous studies, a high proportion of the sample (62.6%) reported experiencing comorbid personality difficulties. However, comorbid personality difficulties were not significantly associated with poorer treatment adherence or higher post-treatment symptom severity or psychological distress (controlling for baseline symptom severity, demographic characteristics and treatment variables). Current findings support an inclusive approach to iCBT provision where comorbid personality difficulties do not appear to be a contraindication for treatment. © 2021 John Wiley & Sons, Ltd.

Evaluating Real-World Adherence and Effectiveness of the "Reboot Online" Program for the Management of Chronic Pain in Routine Care.

OBJECTIVE: Chronic pain is a prevalent and disabling condition. Reboot Online was developed as a multidisciplinary and widely accessible online treatment program for chronic pain. It has been shown to be effective in clinical trials, but the effectiveness of this program in routine care settings remains unknown. This study aimed to examine program adherence and effectiveness in a real-world sample of participants completing Reboot Online in the community. DESIGN AND SUBJECTS: A retrospective cohort study was conducted using real-world data from participants referred the Reboot Online program by clinicians as part of their routine care, from April 2017 to April 2019. METHODS: Routinely collected data on program adherence, participant demography and clinical outcomes were included in the analyses. Measures included the Pain Self Efficacy Questionnaire, Brief Pain Inventory, Tampa Scale of Kinesiophobia, Pain-Disability Index, and Patient Health Questionnaire 9-item (depression). Logistic regression was used to investigate whether certain factors predict program adherence (completion versus noncompletion), and linear mixed models were used to examine effectiveness. RESULTS: In total, 867 participants were included in the analyses, and 583 engaged with at least one Reboot Online lesson. Of these, 42% (n = 247) completed the course in its entirety, with rurality and lower Tampa scores being significant predictors of adherence. Completers demonstrated significant improvements across all outcome measures (effect sizes ranging from 0.22 to 0.51). CONCLUSIONS: Reboot Online is an effective treatment for chronic pain in the routine care setting. Adherence was variable (overall 42%), and could be predicted by rurality and less fear of movement at baseline.

The effectiveness of internet-delivered cognitive behavioural therapy for health anxiety in routine care.

INTRODUCTION: Randomised controlled trials have shown that internet-delivered cognitive behavioural treatment (iCBT) is an effective treatment for health anxiety, but the effectiveness of these programs in routine care has not been investigated. This study examined the effectiveness of iCBT for health anxiety symptoms in routine care settings in the community. METHODS: Using an open-trial design, we investigated adherence to, and effectiveness of a 6-lesson iCBT program for health anxiety symptoms amongst individuals (n = 391, mean age 41 years, 64% female) who enrolled in the program either self-guided (n = 312) or under the supervision of community clinicians (general practitioners, psychologists and other allied health professionals) (n = 79). Primary outcome was health anxiety severity on the Short Health Anxiety Inventory (SHAI), and secondary outcomes were depression severity on the Patient Health Questionnaire 9-item (PHQ-9) (depression) and distress (Kessler-10: K-10). RESULTS: Adherence to the iCBT program was modest (45.6% in the clinician-supervised group, 33.0% in the unguided group), but within-subjects effect sizes were large (SHAI: g = 1.66, 95%CI: 1.45-1.88; PHQ-9: g = 1.12, 95%CI: 0.92-1.32; K-10: g = 1.35, 95%CI: 1.15-1.56). LIMITATIONS: No control group, lack of follow-up data. CONCLUSIONS: iCBT is an effective treatment for health anxiety symptoms in routine care, but methods to increase adherence are needed to optimise benefits to participants. Randomised controlled effectiveness trials with long-term follow-up are needed.

User Involvement in Developing the MYPLAN Mobile Phone Safety Plan App for People in Suicidal Crisis: Case Study.

BACKGROUND: The effect of safety planning for people in suicidal crisis is not yet determined, but using safety plans to mitigate acute psychological crisis is regarded as best practice. Between 2016 and 2017, Australian and Danish stakeholders were involved in revising and updating the Danish MYPLAN mobile phone safety plan and translating the app into a culturally appropriate version for Australia. OBJECTIVE: The objective of this study was to examine the negotiation of stakeholders' suggestions and contributions to the design, function, and content of the MYPLAN app and to characterize significant developments in the emerging user-involving processes. METHODS: We utilized a case study design where 4 focus groups and 5 user-involving workshops in Denmark and Australia were subjected to thematic analysis. RESULTS: The analyses identified 3 consecutive phases in the extensive development of the app: from phase 1, Suggesting core functions, through phase 2, Refining functions, to phase 3, Negotiating the finish. The user-involving processes continued to prevent closure and challenged researchers and software developers to repeatedly reconsider the app's basic user interface and functionality. It was a limitation that the analysis did not include potentially determinative backstage dimensions of the decision-making process. CONCLUSIONS: The extended user involvement prolonged the development process, but it also allowed for an extensive exploration of different user perspectives and needs.

A randomized controlled trial of 'MUMentum Pregnancy': Internet-delivered cognitive behavioral therapy program for antenatal anxiety and depression.

BACKGROUND: Anxiety and depression are common during pregnancy and associated with adverse outcomes for the mother and infant if left untreated. Despite the need to improve treatment accessibility and uptake in this population, no studies have investigated internet-delivered cognitive behavioural therapy (iCBT) for antenatal anxiety and depression. In a randomised controlled trial, we examined the efficacy and acceptability of a brief, unguided iCBT intervention - the MUMentum Pregnancy program - in pregnant women with anxiety and/or depression. METHODS: Participants meeting clinical threshold on validated self-report measures of generalised anxiety and/or depression were recruited online and randomised to iCBT (n = 43) or a treatment as usual (TAU) control (n = 44). Outcomes were assessed at baseline, post-treatment and four-week follow-up; and included anxiety, depression, psychological distress, antenatal bonding, quality of life, and treatment acceptability. RESULTS: Of the 36 women who started iCBT, 26 completed all three lessons of treatment (76% adherence rate). iCBT produced moderate to large effect size reductions for anxiety on the GAD-7 (Hedges' g = 0.76) and psychological distress on the Kessler-10 (g = 0.88) that were superior to TAU. Only small nonsignificant differences were found for depression outcomes (g = < 0.35). Participants reported that iCBT was an acceptable treatment for antenatal anxiety and/or depression. LIMITATIONS: Lack of an active control condition and long-term postpartum follow-up. CONCLUSIONS: This is the first study to evaluate brief unguided iCBT for antenatal anxiety and depression. While our findings are promising, particularly for anxiety reduction, additional RCTs are required to establish treatment efficacy.

A systematic review of psychological treatments for clinical anxiety during the perinatal period.

Maternal anxiety is common during the perinatal period, and despite the negative outcomes of anxiety on the mother and infant, its treatment has received limited attention. This paper describes the first review of psychological interventions for clinical anxiety during the perinatal period. A systematic search was carried out of six electronic databases. Five studies which evaluated psychological interventions for clinical anxiety in perinatal women were identified. Of the five studies included, four were open trials and one was a randomised controlled trial. Three studies evaluated group-based interventions; one study evaluated an online-delivered intervention; and one study a combined pharmacologic-psychological intervention. All participants demonstrated significant reductions in anxiety symptom severity from pre- to post-treatment. However, this review was limited to published literature evaluating treatments for clinical anxiety in perinatal women, which may have excluded important intervention studies and prevention programs, and unpublished literature. This review identifies an area of research that needs urgent attention, as very few studies have evaluated psychological treatments for perinatal anxiety. The studies included in this review demonstrate that symptoms of anxiety during the perinatal period appear to improve during treatment. Future research is needed to establish the efficacy of perinatal anxiety interventions in randomised controlled trials, whether reductions persist long term and whether benefits extend to other outcomes for the mother, infant and family.

Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: study protocol for two randomised controlled trials.

BACKGROUND: We aimed to evaluate the acceptability and efficacy of two brief, Internet-delivered cognitive behavioural therapy interventions-MUMentum Pregnancy (study 1) and MUMentum Postnatal (study 2)-in reducing maternal symptoms of anxiety, depression and overall psychological distress compared to usual care in the perinatal period. METHODS/DESIGN: Women who are pregnant (study 1) or < 12 months postpartum (study 2) with current clinically elevated symptoms of anxiety and/or depression according to validated self-report measures, will be recruited via the research arm of a not-for-profit clinical and research unit in Australia and randomised to the intervention group or treatment as usual control group. The minimum sample size for each study (alpha 0.05; power 0.80 for a g of 0.80) was identified as 50 with at least 10% more to be recruited to account for expected attrition. The co-primary outcome measures are the Patient Health Questionnaire 9-item scale and Generalised Anxiety Disorder 7-item scale to measure depression and anxiety symptom severity, respectively, and will be administered at the following primary time-points: baseline; post treatment; and at one-month follow-up. Psychological distress will be measured according to the Kessler-10 psychological distress scale at each primary time-point and will also be completed before each lesson for those in the intervention group. The total trial period nine weeks for study 1 and 11 weeks for study 2. Program efficacy will be determined using intent-to-treat mixed models. Maintenance of gains will be assessed at one-month follow-up. DISCUSSION: The current randomised controlled trial seeks to extend the literature by evaluating the efficacy of a self-help intervention for women in the perinatal period. If efficacious, the MUMentum programs have the potential to be easily disseminated via https://thiswayup.org.au/ to large numbers of women across Australia as an intervention for women screening positive for anxiety, depressive or distress symptoms during pregnancy or postpartum. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616000560493 ; ACTRN12616000559415 . Registered on 2nd May 2016.

Is Butter Back? A Systematic Review and Meta-Analysis of Butter Consumption and Risk of Cardiovascular Disease, Diabetes, and Total Mortality.

BACKGROUND: Dietary guidelines recommend avoiding foods high in saturated fat. Yet, emerging evidence suggests cardiometabolic benefits of dairy products and dairy fat. Evidence on the role of butter, with high saturated dairy fat content, for total mortality, cardiovascular disease, and type 2 diabetes remains unclear. We aimed to systematically review and meta-analyze the association of butter consumption with all-cause mortality, cardiovascular disease, and diabetes in general populations. METHODS AND FINDINGS: We searched 9 databases from inception to May 2015 without restriction on setting, or language, using keywords related to butter consumption and cardiometabolic outcomes. Prospective cohorts or randomized clinical trials providing estimates of effects of butter intake on mortality, cardiovascular disease including coronary heart disease and stroke, or diabetes in adult populations were included. One investigator screened titles and abstracts; and two reviewed full-text articles independently in duplicate, and extracted study and participant characteristics, exposure and outcome definitions and assessment methods, analysis methods, and adjusted effects and associated uncertainty, all independently in duplicate. Study quality was evaluated by a modified Newcastle-Ottawa score. Random and fixed effects meta-analysis pooled findings, with heterogeneity assessed using the I2 statistic and publication bias by Egger's test and visual inspection of funnel plots. We identified 9 publications including 15 country-specific cohorts, together reporting on 636,151 unique participants with 6.5 million person-years of follow-up and including 28,271 total deaths, 9,783 cases of incident cardiovascular disease, and 23,954 cases of incident diabetes. No RCTs were identified. Butter consumption was weakly associated with all-cause mortality (N = 9 country-specific cohorts; per 14g(1 tablespoon)/day: RR = 1.01, 95%CI = 1.00, 1.03, P = 0.045); was not significantly associated with any cardiovascular disease (N = 4; RR = 1.00, 95%CI = 0.98, 1.02; P = 0.704), coronary heart disease (N = 3; RR = 0.99, 95%CI = 0.96, 1.03; P = 0.537), or stroke (N = 3; RR = 1.01, 95%CI = 0.98, 1.03; P = 0.737), and was inversely associated with incidence of diabetes (N = 11; RR = 0.96, 95%CI = 0.93, 0.99; P = 0.021). We did not identify evidence for heterogeneity nor publication bias. CONCLUSIONS: This systematic review and meta-analysis suggests relatively small or neutral overall associations of butter with mortality, CVD, and diabetes. These findings do not support a need for major emphasis in dietary guidelines on either increasing or decreasing butter consumption, in comparison to other better established dietary priorities; while also highlighting the need for additional investigation of health and metabolic effects of butter and dairy fat.

High variation in manufacturer-declared serving size of packaged discretionary foods in Australia.

Despite the potential of declared serving size to encourage appropriate portion size consumption, most countries including Australia have not developed clear reference guidelines for serving size. The present study evaluated variability in manufacturer-declared serving size of discretionary food and beverage products in Australia, and how declared serving size compared with the 2013 Australian Dietary Guideline (ADG) standard serve (600 kJ). Serving sizes were obtained from the Nutrition Information Panel for 4466 packaged, discretionary products in 2013 at four large supermarkets in Sydney, Australia, and categorised into fifteen categories in line with the 2013 ADG. For unique products that were sold in multiple package sizes, the percentage difference between the minimum and the maximum serving size across different package sizes was calculated. A high variation in serving size was found within the majority of food and beverage categories - for example, among 347 non-alcoholic beverages (e.g. soft drinks), the median for serving size was 250 (interquartile range (IQR) 250, 355) ml (range 100-750 ml). Declared serving size for unique products that are available in multiple package sizes also showed high variation, particularly for chocolate-based confectionery, with median percentage difference between minimum and maximum serving size of 183 (IQR 150) %. Categories with a high proportion of products that exceeded the 600 kJ ADG standard serve included cakes and muffins, pastries and desserts (≥74 % for each). High variability in declared serving size may confound interpretation and understanding of consumers interested in standardising and controlling their portion selection. Future research is needed to assess if and how standardising declared serving size might affect consumer behaviour.

A Comparison of the Sodium Content of Supermarket Private-Label and Branded Foods in Australia.

Supermarket private-label products are perceived to be lower quality than their branded counterparts. Excess dietary sodium in foods contributes to high blood pressure and cardiovascular disease. Sodium concentrations in products are an important indicator of quality. We compared the sodium content of 15,680 supermarket private-label and branded products, available in four Australian supermarkets between 2011-2013, overall and for 15 food categories. Mean sodium values were compared for: (1) all products in 2013; (2) products in both 2011 and 2013; and (3) products only in 2013. Comparisons were made using paired and unpaired t tests. In each year the proportion of supermarket private-label products was 31%-32%, with overall mean sodium content 17% (12%-23%) lower than branded products in 2013 (p ≤ 0.001). For products available in both 2011 and 2013 there was a ≤2% (1%-3%) mean sodium reduction overall with no difference in reformulation between supermarket private-label and branded products (p = 0.73). New supermarket private-label products in 2013 were 11% lower in sodium than their branded counterparts (p = 0.02). Supermarket private-label products performed generally better than branded in terms of their sodium content. Lower sodium intake translates into lower blood pressure; some supermarket private-label products may be a good option for Australians needing to limit their sodium intake.

Assessing site performance in the Altair study, a multinational clinical trial.

BACKGROUND: Reviewing clinical trial site performance identifies strategies to control outcomes. Performance across 5 geographical regions (36 sites across Asia, Australia, Europe, North America and Latin America) was investigated in a study that randomised 322 HIV-infected individuals. METHODS: Regional performance was compared using descriptive analysis for time to site opening, recruitment, quality of data and laboratory samples. Follow-up consisted of 10 visits (96 weeks), electronic data collection (EDC) within 7 days of a visit and serious adverse events (SAEs) reported within 24 hours of site awareness. RESULTS: Median days to site opening was 250 (188 to 266), ranging from 177 (158 to 200) (Australia) to 265 (205 to 270) (Europe). Median days to ethics and regulatory approval was 182 (120 to 241) and 218 (182 to 341) days, respectively. Within regions, time to approval ranged from 187 (91 to 205) days (Australia) to 276 (175 to 384) days (Europe). Time to first randomisation ranged from 282 (250 to 313) days (Australia) to 426 (420 to 433) days (North America). Recruitment was lower than forecasted in Asia, Australia, Europe and North America at 89%, 77%, 91% and 43%, respectively. The converse was true in Latin America where despite ethics, regulatory and contractual delays, recruitment was 104% of predicted. Median days to EDC was 7 (3 to 16), ranging from 3 (1 to 16) (Asia) to 13 (8 to 14) days (North America). Median days for initial SAE submission to sponsor was 6 (2 to 20), ranging from 4 (2 to 18) (Latin America) to 24 (5 to 46) days (Australia). Sites took longer to submit final reports, overall median of 28 (7 to 91) days, ranging from 7 days (Australia) to 67 (23 to 103) days (Europe). CONCLUSIONS: Population availability and time to ethics and regulatory approvals influence recruitment; therefore accurate feasibility assessments are critical to site selection. Time to ethics and regulatory approval may not limit site inclusion if compensated by rapid recruitment. Identifying potential delays and methods for reduction can decrease time and costs for sponsors. TRIAL REGISTRATION: Clinical Trials.Gov identifier: NCT00335322. Date of registration: 8 June 2006.

Bone mineral density over 96 weeks in adults failing first-line therapy randomized to raltegravir/lopinavir/ritonavir compared with standard second-line therapy.

OBJECTIVE: To compare bone mineral density (BMD) changes over 96 weeks in adults virologically failing standard first-line therapy, randomized to raltegravir plus lopinavir/ritonavir (RAL + LPV/r) or conventional 2-3 nucleoside/nucleotide reverse transcriptase inhibitors [N(t)RTIs] + LPV/r second-line therapy. METHODS: Participants underwent dual-energy x-ray absorptiometry at baseline and weeks 48 and 96 to measure total hip and lumbar spine BMD. Analyses were adjusted for gender, body mass index, and smoking. Linear regression was used to compare between-group differences, logistic regression for low BMD (hip or spine Z-score ≤ -2) incidence, and multivariate linear regression to determine predictors of BMD change. This work represents the extension and final results of the previously published initial 48 weeks of the study. RESULTS: The population included 210 adults from 5 middle-income countries: 52% females, 52% Asians, 43% Africans, mean age, 39 years (SD, 8 years). In the 2-3 N(t)RTI group (vs. RAL), BMD reduction was greater at the spine (mean change, -4.9% vs. -3.5%; adjusted difference, -1.9%; 95% confidence interval: -3.3 to -0.5%, P = 0.009) and hip (-4.1% vs. -2.2%; -1.9%; -3.4 to -0.4; P = 0.012). BMD decrease was greatest at 48 weeks with stabilization to week 96. Overall, low BMD occurred in 15 participants (7.9%), with no between-group differences. Independent predictors for bone loss included lower body mass index (regression coefficient: hip, -0.18% and spine, -0.26% per 1 kg/m), longer tenofovir exposure (hip, -0.74% and spine, -1.0% per year), greater change in CD4 to week 12 (hip, -5.11% per 10-fold higher), and higher baseline HIV-RNA (spine, -0.7% per 10-fold higher). CONCLUSIONS: Over 96 weeks, there was greater BMD decrease with 2-3 N(t)RTI + LPV/r compared with RAL + LPV/r; the relative decrease at the spine was greater than the hip. BMD decreases with second-line antiretroviral therapy largely occurred in the first 48 weeks with stabilization, but no recovery thereafter.

Hip structural parameters over 96 weeks in HIV-infected adults switching treatment to tenofovir-emtricitabine or abacavir-lamivudine.

BACKGROUND: Therapy with tenofovir is associated with lower bone mineral density (BMD), higher markers of bone turnover and increased fracture risk in HIV-infected adults. Bone structural parameters generated by hip structural analysis may represent a separate measure of bone strength, but have not been assessed in HIV. METHODS: Dual-energy X-ray absorptiometry (DXA) scans from 254 HIV-infected adults randomised to simplify their existing dual nucleoside analogue reverse transcriptase inhibitor therapy to coformulated tenofovir-emtricitabine or abacavir-lamivudine were analysed using DXA-derived hip structural analysis software. Hip structural parameters included femoral strength index, section modulus, cross-sectional area, and cross-sectional moment of inertia. We used one-way ANOVA to test the relationship between nucleoside analogue type at baseline and structural parameters, multivariable analysis to assess baseline covariates associated with femoral strength index, and t-tests to compare mean change in structural parameters over 96 weeks between randomised groups. RESULTS: Participants taking tenofovir at baseline had lower section modulus (-107.3 mm2, p = 0.001), lower cross-sectional area (-15.01 mm3, p = 0.001), and lower cross-sectional moment of inertia (-2,036.8 mm4, p = 0.007) than those receiving other nucleoside analogues. After adjustment for baseline risk factors, the association remained significant for section modulus (p = 0.008) and cross-sectional area (p = 0.002). Baseline covariates significantly associated with higher femoral strength index were higher spine T-score (p = 0.001), lower body fat mass (p<0.001), lower bone alkaline phosphatase (p = 0.025), and higher osteoprotegerin (p = 0.024). Hip structural parameters did not change significantly over 96 weeks and none was significantly affected by treatment simplification to tenofovir-emtricitabine or abacavir-lamivudine. CONCLUSION: In this population, tenofovir use was associated with reduced composite indices of bone strength as measured by hip structural analysis, but none of the structural parameters improved significantly over 96 weeks with tenofovir cessation. TRIAL REGISTRATION: ClinicalTrials.gov NCT00192634.