We have encapsulated the chemotherapeutic agent doxorubicin into biodegradable polymer microspheres, and incorporated these microspheres into gelatin scaffolds, resulting in a controlled delivery system. Doxorubicin was encapsulated in poly(D,L-lactide-co-glycolide) (PLGA) using a double emulsion/solvent extraction method. Characterization of the microspheres including diameter, surface morphology, and in vitro drug release was determined. The release of doxorubicin up to 30 days in phosphate buffered solution was assessed by measuring the absorbance of the releasate solution. Gelatin scaffolds were crosslinked using glutaraldehyde and microspheres were added to gelatin during gelation. The murine mammary mouse tumor cell line, 4T1, was treated with various doses of doxorubicin. A propidium iodide assay was utilized to visualize dead cells. Using a Transwell basket assay, PLGA microspheres and gelatin constructs were suspended above 4T1 cells for 48 h. Viable cells were determined using the CyQUANT cell proliferation assay. Results indicate that the release was controlled by the incorporation of PLGA microspheres into gelatin constructs. A significant difference was seen in the cumulative release over days 5-16 (p < 0.05). The bioactivity of doxorubicin released from the microspheres and scaffolds was maintained as proven by significant reduction in viable cells after treatment with PLGA microspheres as well as with the gelatin constructs (p < 0.001). The drug-polymer conjugate can be used as a controlled drug delivery system in a biocompatible scaffold that could potentially promote preservation of soft tissue contour.

Aims Women are underrepresented in cardiovascular trials. We sought to explore the proportional representation of women in contemporary cardiovascular research and the factors (barriers and enablers) that affect their participation in cardiovascular studies. Methods and Results Multiple electronic databases were searched between January 2011 and September 2021 to identify papers that defined underrepresentation of women in cardiovascular research and/or reported sex-based differences in participating in cardiovascular research and/or barriers for women to participate in cardiovascular research. Data extraction was undertaken independently by two authors using a standardised data collection form. Results were summarised using descriptive statistics and narrative synthesis as appropriate. From 548 identified papers, 10 papers were included. Of those, four were conducted prospectively and six were retrospective studies. Five of the retrospective studies involved secondary analysis of trial data including over 780 trials in over 1.1 million participants. Overall, women were reported to be underrepresented in heart failure, coronary disease, myocardial infarction and arrhythmia trials, compared to men. Barriers to participation included lack of information and understanding of the research, trial-related procedures, the perceived health status of the participant and patient-specific factors including travel, childcare availability and cost. A significantly higher likelihood of research participation was reported by women following a patient educational intervention. Conclusions This review has highlighted the underrepresentation of women in a range of cardiovascular trials. Several barriers to women’s participation in cardiovascular studies were identified. Researchers could mitigate against these in future trial planning and delivery to increase women’s participation in cardiovascular research. Registration The protocol was published on the public Open Science Framework (OSF) platform on 13th August 2021 (no registration reference provided) and can be accessed at https://osf.io/ny4fd/.

Aim To describe a protocol for the pilot phase of a trial designed to test the effect of an mHealth intervention on representation and readmission after adult cardiac surgery. Design A multisite, parallel group, pilot randomized controlled trial (ethics approval: HREC2020.331‐RMH69278). Methods Adult patients scheduled to undergo elective cardiac surgery (coronary artery bypass grafting, valve surgery, or a combination of bypass grafting and valve surgery or aortic surgery) will be recruited from three metropolitan tertiary teaching hospitals. Patients allocated to the control group with receive usual care that is comprised of in‐patient discharge education and local paper‐based written discharge materials. Patients in the intervention group will be provided access to tailored ‘GoShare’ mHealth bundles preoperatively, in a week of hospital discharge and 30 days after surgery. The mHealth bundles are comprised of patient narrative videos, animations and links to reputable resources. Bundles can be accessed via a smartphone, tablet or computer. Bundles are evidence‐based and designed to improve patient self‐efficacy and self‐management behaviours, and to empower people to have a more active role in their healthcare. Computer‐generated permuted block randomization with an allocation ratio of 1:1 will be generated for each site. At the time of consent, and 30, 60 and 90 days after surgery quality of life and level of patient activation will be measured. In addition, rates of representation and readmission to hospital will be tracked and verified via data linkage 1 year after the date of surgery. Discussion Interventions using mHealth technologies have proven effectiveness for a range of cardiovascular conditions with limited testing in cardiac surgical populations. Impact This study provides an opportunity to improve patient outcome and experience for adults undergoing cardiac surgery by empowering patients as end‐users with strategies for self‐help. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000082808.