Impact of a Patient Support Program on time to discontinuation of adalimumab in Australian adult patients with immune-mediated inflammatory diseases-an observational study.

This observational study evaluated the impact of a sponsor company-provided Patient Support Program (PSP) on discontinuation of adalimumab in adult Australian patients eligible for Pharmaceutical Benefit Scheme (PBS)-reimbursed adalimumab for Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD), Ulcerative Colitis (UC), or Hidradenitis Suppurativa (HS). Patients initiating adalimumab between May 2018 and September 2019 were enrolled into two prospective cohorts based on their decision to opt for or decline the PSP (PSP or non-PSP cohorts). In addition, a historical, retrospective Non-PSP cohort was established from the Services Australia 10% PBS dataset by extracting data of patients initiating adalimumab prior to the introduction of adalimumab PSPs and based on adalimumab PBS listing dates (AS: April 2007 to March 2009; PsA/RA: January 2007 to December 2008; CD: January 2009 to December 2010; HS and UC indications not included). Follow-up for all cohorts was 12 months. The primary endpoint was the time to discontinuation, compared between the prospective PSP cohort and the prospective or retrospective Non-PSP cohort. Inverse probability of treatment weighting was used to balance the cohorts. A Cox proportional hazards model indicated no difference in time to discontinuation between the prospective PSP (n = 162) and non-PSP (n = 65) cohorts (HR [95% CI] = 1.256 [0.616-2.563], p = 0.5304). The 12-month adalimumab persistence rates (95% CI) were 78% (69%, 84%) and 82% (67%, 90%), respectively. In contrast, discontinuation was less likely in the prospective PSP (n = 151) compared with the retrospective non-PSP (n = 297) cohort (HR [95% CI] = 0.44 [0.28-0.68], p<0.001). The 12-month persistence rates (95% CI) were 81% (76%, 90%) and 61% (56%, 67%), respectively. Overall, this study suggests that optimal adalimumab persistence can be achieved with either a structured PSP or healthcare support from other sources, but this was not the case more than a decade ago.

Measuring effectiveness of the cervical cancer vaccine in an Australian setting (the VACCINE study).

BACKGROUND: The quadrivalent human papillomavirus vaccine has been provided in Australia through the National Human Papillomavirus Vaccination Program since April 2007. National registry data demonstrates good coverage of the vaccine, with 73% of school-aged girls having received all three doses. To evaluate the effectiveness of the program, we propose a two-pronged approach. In one (sub study A), the prevalence of the vaccine-targeted human papillomavirus genotypes in a population cohort is being estimated, and will be analysed in relation to vaccination status, cervical cytology screening status, demographic, social, behavioural, medical and clinical factors. In sub study B, the distribution of human papillomavirus genotypes detected in high grade cervical intraepithelial neoplastic lesions from vaccine eligible women is being assessed. METHODS/DESIGN: Sub Study A involves the recruitment of 1569 women aged 18-25, residing in Victoria, Australia, through Facebook advertising. Women who are sexually active are being asked to provide a self-collected vaginal swab, collected at home and posted into the study centre, where human papillomavirus DNA detection and genotyping is performed. Participants also complete an online questionnaire regarding sexual history, experience with, knowledge of, and attitudes towards human papillomavirus, the human papillomavirus vaccine, and cervical screening.Sub Study B will involve the collection of 500 cervical biopsies, positively identified as containing high grade cervical intraepithelial neoplastic lesions and/or adenocarcinoma in situ. Five serial sections are being taken from each case: sections 1 and 5 are being assessed to confirm the presence of the high grade cervical intraepithelial neoplastic lesions or adenocarcinoma in situ; human papillomavirus genotyping is performed on sections 2 and 3; single lesions are excised from section 4 using laser capture microdissection to specifically define causality of a human papillomavirus genotyping of each specific lesion. DISCUSSION: Australia is well placed to gain a clear and early insight into the effectiveness of the human papillomavirus vaccine in reducing the prevalence of human papillomavirus infection in young women, and any subsequent reduction in the prevalence of pre-cancerous cervical lesions, specifically high grade cervical intraepithelial neoplasia lesions, particularly of vaccine related types. The findings of a successful population based human papillomavirus program will have wide-reaching translational benefits across the globe.

A Comparison of Self-Reported and Objective Physical Activity Measures in Young Australian Women.

BACKGROUND: The evidence for beneficial effects of recommended levels of physical activity is overwhelming. However, 70% of Australians fail to meet these levels. In particular, physical activity participation by women falls sharply between ages 16 to 25 years. Further information about physical activity measures in young women is needed. Self-administered questionnaires are often used to measure physical activity given their ease of application, but known limitations, including recall bias, compromise the accuracy of data. Alternatives such as objective measures are commonly used to overcome this problem, but are more costly and time consuming. OBJECTIVE: To compare the output between the Modified Active Australia Survey (MAAS), the International Physical Activity Questionnaire (IPAQ), and an objective physical activity measure-the SenseWear Armband (SWA)-to evaluate the test-retest reliability of the MAAS and to determine the acceptability of the SWA among young women. METHODS: Young women from Victoria, Australia, aged 18 to 25 years who had participated in previous studies via Facebook advertising were recruited. Participants completed the two physical activity questionnaires online, immediately before and after wearing the armband for 7 consecutive days. Data from the SWA was blocked into 10-minute activity times. Follow-up IPAQ, MAAS, and SWA data were analyzed by comparing the total continuous and categorical activity scores, while concurrent validity of IPAQ and MAAS were analyzed by comparing follow-up scores. Test-retest reliability of MAAS was analyzed by comparing MAAS total physical activity scores at baseline and follow-up. Participants provided feedback in the follow-up questionnaire about their experience of wearing the armband to determine acceptability of the SWA. Data analyses included graphical (ie, Bland-Altman plot, scatterplot) and analytical (ie, canonical correlation, kappa statistic) methods to determine agreement between MAAS, IPAQ, and SWA data. RESULTS: A total of 58 participants returned complete data. Comparisons between the MAAS and IPAQ questionnaires (n=52) showed moderate agreement for both categorical (kappa=.48, P<.001) and continuous data (r=.69, P<.001). Overall, the IPAQ tended to give higher scores. No significant correlation was observed between SWA and IPAQ or MAAS continuous data, for both minute-by-minute and blocked SWA data. The SWA tended to record lower scores than the questionnaires, suggesting participants tended to overreport their amount of physical activity. The test-retest analysis of MAAS showed moderate agreement for continuous outcomes (r=.44, P=.001). However, poor agreement was seen for categorical outcomes. The acceptability of the SWA to participants was high. CONCLUSIONS: Moderate agreement between the MAAS and IPAQ and moderate reliability of the MAAS indicates that the MAAS may be a suitable alternative to the IPAQ to assess total physical activity in young women, due to its shorter length and consequently lower participant burden. The SWA, and likely other monitoring devices, have the advantage over questionnaires of avoiding overreporting of self-reported physical activity, while being highly acceptable to participants.

Simultaneous determination of delta33S(V-CDT) and delta34S(V-CDT) using masses 48, 49 and 50 on a continuous flow isotope ratio mass spectrometer.

A new, fast, continuous flow technique is described for the simultaneous determination of delta33S and delta34S using SO masses 48, 49 and 50. Analysis time is approximately 5 min/sample with measurement precision and accuracy better than +/-0.3 per thousand. This technique, which has been set up using IAEA Ag2S standards S-1, S-2 and S-3, allows for the fast determination of mass-dependent or mass-independent fractionation (MIF) effects in sulfide, organic sulfur samples and possibly sulfate. Small sample sizes can be analysed directly, without chemical pre-treatment. Robustness of the technique for natural versus artificial standards was demonstrated by analysis of a Canon Diablo troilite, which gave a delta33S of 0.04 per thousand and a delta34S of -0.06 per thousand compared to the values obtained for S-1 of 0.07 per thousand and -0.20 per thousand, respectively. Two pyrite samples from a banded-iron formation from the 3710 Ma Isua Greenstone Belt were analysed using this technique and yielded MIF (Delta33S of 2.45 and 3.31 per thousand) comparable to pyrite previously analysed by secondary ion probe.