Increasing bowel cancer screening using SMS in general practice: the SMARTscreen cluster randomised trial.

BACKGROUND: Australia has one of the highest incidences of colorectal cancer (CRC) worldwide. The Australian National Bowel Cancer Screening Program (NBCSP) is a best-practice, organised screening programme, but uptake is low (40.9%) and increasing participation could reduce morbidity and mortality associated with CRC. Endorsement by GPs is strongly associated with increasing screening uptake. AIM: This study (SMARTscreen) aimed to test whether a multi-intervention short message service (SMS) sent by general practices to 50-60-year-old patients who were due to receive the NBCSP kit would increase NBCSP uptake, by comparing it with usual care. DESIGN AND SETTING: A stratified cluster randomised controlled trial was undertaken, involving 21 Australian general practices in Western Victoria, Australia. METHOD: For intervention practices, people due to receive the NBCSP kit within a 6-month study period were sent an SMS just before receiving the kit. The SMS included a personalised message from the person's general practice endorsing the kit, a motivational narrative video, an instructional video, and a link to more information. Control practices continued with usual care, comprising at-home testing with a faecal immunochemical test (FIT) through the NBCSP. The primary outcome was the between-arm percentage difference in uptake of FIT screening within 12 months from randomisation, which was estimated using generalised linear model regression. RESULTS: In total, 39.2% (1143/2914) of people in 11 intervention practices and 23.0% (583/2537) of people in 10 control practices had a FIT result in their electronic health records - a difference of 16.5% (95% confidence interval = 2.02 to 30.9). CONCLUSION: The SMS intervention increased NBCSP kit return in 50-60-year-old patients in general practice. This finding informed a larger trial - SMARTERscreen - to test this intervention in a broader Australian population.

Modelling the Compaction Step of a Platform Direct Compression Process.

The ability to predict formulation behaviour at production scale during formulation design can reduce the time to market and decrease product development costs. However, it is challenging to extrapolate compaction settings for direct compression formulations between tablet press models during scale-up and transfer from R&D to commercial production. The aim of this study was to develop statistical process models to predict tablet tensile strength, porosity and disintegration time from compaction parameters (pre-compression and main compression force, and press speed), for three formulations, with differing deformation characteristics (plastic, brittle and elastic), on three tablet press models (one pilot-scale tablet press (KG RoTab) and two production-scale presses (Fette 1200i and GEA Modul P)). The deformation characteristics of yield pressure and elastic recovery were determined for the model placebo formulations investigated. To facilitate comparison of dwell time settings between tablet press models, the design of experiments (DoE) approach was 9 individual 16-run response surface DoEs (3 formulation × 3 press models), whose results were combined to create a polynomial regression model for each tablet property. These models predicted tablet tensile strength, porosity and disintegration time and enabled the construction of design spaces to produce tablets with specified target properties, for each formulation on each press. The models were successfully validated. This modelling approach provides an understanding of the compaction behaviour of formulations with varying deformation behaviour on development and commercial tablet press models. This understanding can be applied to inform achievable production rates at a commercial scale, during the formulation development.

The SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program.

BACKGROUND: Increasing participation in the Australian National Bowel Cancer Screening Program (NBCSP) is the most efficient and cost-effective way of reducing mortality associated with colorectal cancer by detecting and treating early-stage disease. Currently, only 44% of Australians aged 50-74 years complete the NBCSP. This efficacy trial aims to test whether this SMS intervention is an effective method for increasing participation in the NBCSP. Furthermore, a process evaluation will explore the barriers and facilitators to sending the SMS from general practice. METHODS: We will recruit 20 general practices in the western region of Victoria, Australia to participate in a cluster randomised controlled trial. General practices will be randomly allocated with a 1:1 ratio to either a control or intervention group. Established general practice software will be used to identify patients aged 50 to 60 years old who are due to receive a NBCSP kit in the next month. The SMS intervention includes GP endorsement and links to narrative messages about the benefits of and instructions on how to complete the NBCSP kit. It will be sent from intervention general practices to eligible patients prior to receiving the NBCSP kit. We require 1400 eligible patients to provide 80% power with a two-sided 5% significance level to detect a 10% increase in CRC screening participation in the intervention group compared to the control group. Our primary outcome is the difference in the proportion of eligible patients who completed a faecal occult blood test (FOBT) between the intervention and control group for up to 12 months after the SMS was sent, as recorded in their electronic medical record (EMR). A process evaluation using interview data collected from general practice staff (GP, practice managers, nurses) and patients will explore the feasibility and acceptability of sending and receiving a SMS to prompt completing a NBCSP kit. DISCUSSION: This efficacy trial will provide initial trial evidence of the utility of an SMS narrative intervention to increase participation in the NBCSP. The results will inform decisions about the need for and design of a larger, multi-state trial of this SMS intervention to determine its cost-effectiveness and future implementation. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620001020976 . Registered on 17 October 2020.

Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and Production Scale.

Optimizing processing conditions to achieve a critical quality attribute (CQA) is an integral part of pharmaceutical quality by design (QbD). It identifies combinations of material and processing parameters ensuring that processing conditions achieve a targeted CQA. Optimum processing conditions are formulation and equipment-dependent. Therefore, it is challenging to translate a process design between formulations, pilot-scale and production-scale equipment. In this study, an empirical model was developed to determine optimum processing conditions for direct compression formulations with varying flow properties, across pilot- and production-scale tablet presses. The CQA of interest was tablet weight variability, expressed as percentage relative standard deviation. An experimental design was executed for three model placebo blends with varying flow properties. These blends were compacted on one pilot-scale and two production-scale presses. The process model developed enabled the optimization of processing parameters for each formulation, on each press, with respect to a target tablet weight variability of <1%RSD. The model developed was successfully validated using data for additional placebo and active formulations. Validation formulations were benchmarked to formulations used for model development, employing permeability index values to indicate blend flow.

Facilitating hepatitis B clinical management in general practice: A qualitative investigation.

METHOD: Data from qualitative semi-structured interviews with 19 participants from primary care settings were thematically analysed. RESULTS: Critical elements in providing clinical care in primary care settings were identified at an organisational and provider level. A supportive organisational culture included leadership, a multidisciplinary team approach, community engagement and cultural competency, while provider-related issues included authorisation to prescribe, access to linguistic and cultural mediators and effective relationships with relevant specialist services. DISCUSSION: The research identified practice leadership, organisational culture and a patient focus supported hepatitis B clinical management transitioning from specialist to primary care services.

A survey of transfusion practitioners in international society of blood transfusion member countries.

BACKGROUND: Transfusion Practitioner (TP) is a term that describes activities undertaken by a variety of healthcare professionals who play a key role in supporting safe and appropriate blood management/transfusion care for patients. There is significant variation in staff specialty filling the role. To understand which countries have the TP role, and the variations that exist, an international survey was undertaken in 2017. METHODS: A survey was developed by the TP Forum Steering Committee (TPFSC) with input from the International Society of Blood Transfusion (ISBT) Clinical Transfusion Working Party. The survey was distributed by the ISBT Office to all ISBT members and promoted via newsletters and social media. RESULTS/DISCUSSION: Five hundred and eighty-two responses received from 84 different countries. The TP role exists in 67 countries, 10 countries do not have the TP role, one was unaware of the role, and respondents from six other countries did not answer this question. The most prevalent TP activities reported were policy and procedure development, education, participation in Transfusion Committees and audit activities. Eighty-eight respondents indicated they did not have a TP role, with the main barrier being financial, followed by lack of support for the role. Eight respondents indicated they previously had a TP, and this role was no longer in place due to lack of support for the role, cutbacks and other priorities. CONCLUSION: This survey provides insights as to where and how the TP functions and provides the TPFSC with valuable information to develop tools to support further development of the role.

To contemplate or not to contemplate evaluating a preliminary intervention proposal in an outpatient setting: the contemplation therapy group.

PURPOSE: The concept for the contemplation group intervention was derived from motivational interviewing (MI) to support people suffering from an eating disorder who are reluctant to engage with treatment. This evaluation focuses on the contemplation group run by the eating disorder services in the Cardiff and Vale area between 2012 and 2016 to investigate the outcomes for participants and implications for working with people suffering from an eating disorder who are ambivalent about change. METHOD: Quantitative measures were used to assess eating disorder symptomatology, motivation to change and location within the stages of change model. A brief qualitative evaluation of client experiences was also included. RESULTS: While dropout was high, a number of patients displayed increased readiness for treatment at the end of the group or even started to engage in change-focussed therapy. Participants who completed the group described it as challenging but helpful. CONCLUSIONS: This evaluation shows that explorative contemplation of their ambivalence towards their eating disorder and treatment was helpful for the participants of the group and supported them in achieving more clarity and decisiveness regarding whether to engage in treatment or not. Further research is needed to evaluate long-term outcomes for patients who feel ambivalent towards treatment, and to explore what interventions can be used to help them. EVIDENCE LEVEL: Level IV: Evidence obtained from multiple time series with or without the intervention.

Increasing bowel cancer screening participation: integrating population-wide, primary care and more targeted approaches.

OBJECTIVES: Participation in the Australian National Bowel Cancer Screening Program (NBCSP) is suboptimal. Given the program's enormous potential to save lives, Cancer Council Victoria has prioritised increased screening participation as part of its strategic plan. This paper describes the implementation, and evaluation where available, of Cancer Council Victoria programs to increase participation, supported by a mix of own organisation and Victorian state health department funding. Type of programs: At the population level, Cancer Council Victoria has delivered television-led mass media campaigns to motivate age-eligible individuals to complete and return their NBCSP kit. It has also delivered targeted awareness and education programs for underscreened populations including Aboriginal and Torres Strait Islander people, people from culturally and linguistically diverse communities, and groups experiencing social disadvantage. Programs involving general practice have also been trialled to improve the knowledge and confidence of general practitioners (GPs) to discuss bowel screening with their patients, and to implement identification, reminder and follow-up systems to improve bowel screening participation. RESULTS: There is strong evidence to support the use of mass media public health campaigns, which have resulted in significant increases in screening kit return rates. Targeted education sessions with underscreened communities have led to increases in knowledge about bowel cancer screening, confidence to do the test and intention to participate in the NBCSP in communities where these sessions have been trialled. Early findings suggest that GP endorsement strategies are welcomed by patients and are an effective way to encourage NBCSP participation. System changes using patient information systems may be more challenging, given the inconsistent entry of NBCSP data. LESSONS LEARNT: Our work to date demonstrates that there is a strong case for regular, widespread mass media strategies to increase NBCSP participation. There is also evidence to support more tailored, complementary approaches with dedicated education programs for underscreened groups, and active and sustained engagement with underscreened communities and primary care providers to overcome personal, cultural and systems barriers to screening. Improved data capture capabilities are needed to better implement and evaluate the impact of future strategies to improve NBCSP participation.

Increased expression of the nicotinic acetylcholine receptor in stimulated muscle.

Chronic low-frequency stimulation has been used as a model for investigating responses of skeletal muscle fibres to enhanced neuromuscular activity under conditions of maximum activation. Fast-to-slow isoform shifting of markers of the sarcoplasmic reticulum and the contractile apparatus demonstrated successful fibre transitions prior to studying the effect of chronic electro-stimulation on the expression of the nicotinic acetylcholine receptor. Comparative immunoblotting revealed that the alpha- and delta-subunits of the receptor were increased in 10-78 day stimulated specimens, while an associated component of the surface utrophin-glycoprotein complex, beta-dystroglycan, was not drastically changed in stimulated fast skeletal muscle. Previous studies have shown that electro-stimulation induces degeneration of fast glycolytic fibres, trans-differentiation leading to fast-to-slow fibre transitions and activation of muscle precursor cells. In analogy, our results indicate a molecular modification of the central functional unit of the post-synaptic muscle surface within existing neuromuscular junctions and/or during remodelling of nerve-muscle contacts.