Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

BACKGROUND: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. METHOD: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. RESULTS: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. CONCLUSION: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.

Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: protocol for a systematic review.

INTRODUCTION: Decisions regarding the optimal vascular access for haemodialysis patients are becoming increasingly complex, and the provision of vascular access is open to variations in systems of care as well as surgical experience and practice. Two main surgical options are recognised: arteriovenous fistula and arteriovenous graft (AVG). All recommendations regarding AVG are based on a limited number of randomised controlled trials (RCTs). It is essential that when considering an RCT of a surgical procedure, an appropriate definition of quality assurance (QA) is made for both the new approach and the comparator, otherwise replication of results or implementation into clinical practice may differ from published results. The aim of this systematic review will be to assess the methodological quality of RCT involving AVG, and the QA measures implemented in delivering interventions in these trials. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify relevant literature. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Data collected will pertain to generic measures of QA, credentialing of investigators, procedural standardisation and performance monitoring. Trial methodology will be compared against a standardised template developed by a multinational, multispecialty review body with experience in vascular access. A narrative approach will be taken to synthesise and report data. ETHICS AND DISSEMINATION: Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations, with the ultimate aim of providing recommendations for future RCT of AVG design.

Recruitment into randomised trials of arteriovenous grafts: A systematic review.

Although randomised controlled trials (RCT) are considered the optimal form of evidence, there are relatively few in surgery. Surgical RCT are particularly likely to be discontinued with poor recruitment cited as a leading reason. Surgical RCT present challenges over and above those seen in drug trials as the treatment under study may vary between procedures, between surgeons in one unit, and between units in multi-centred RCT. The most contentious and debated area of vascular access remains the role of arteriovenous grafts, and thus the quality of the data that is used to support opinions, guidelines and recommendations is critical. The aim of this review was to determine the extent of variation in the planning and recruitment in all RCT involving AVG. The findings of this are stark: there have been only 31 RCT performed in 31 years, the vast majority of which exhibited major limitations severe enough to undermine the results. This underlines the need for better quality RCT and data, and further inform the design of future studies. Perhaps most fundamental is the planning for a RCT that accounts for the intended population, the uptake of a RCT and the attrition for the significant co-morbidity in this population.

Enablers and barriers to non-dispensing pharmacist integration into the primary health care teams of Aboriginal community-controlled health services.

BACKGROUND: The primary health care management of chronic disease affecting Aboriginal and Torres Strait Islander peoples requires healthcare quality and equity demands to be met, and systems that foster better team-based care. Non-dispensing pharmacists (NDPs) integrated within primary healthcare settings can enhance the quality of patient care, although factors that enable or challenge integration within these settings need to be better understood. OBJECTIVES: To investigate enabling factors and barriers influencing integration of NDPs within Aboriginal community-controlled health services delivering primary health care. This was achieved through qualitative evaluation of the Integrating Pharmacists within Aboriginal Community Controlled Health Services (IPAC) Trial exploring the perceptions of NDPs, community pharmacists, healthcare staff, managers, and Aboriginal and Torres Strait Islander patients of these services. METHODS: NDPs were employed across twenty urban, rural, and remote services in three Australian states and provided pre-defined medication-related roles to adult Aboriginal and Torres Strait Islander patients. Perceptions were elicited from online surveys, interviews, and focus groups. Transcripts were thematically analyzed using the constant comparison method to identify, compare, and refine emerging themes. RESULTS: One hundred and four participants informed the findings, including 24 NDPs, 13 general practitioners, 12 service managers, 10 community pharmacists, 17 health service staff, and 17 patients. Enablers of integration included: personal (previous experience with Aboriginal and Torres Strait Islander peoples, cultural awareness, skills, individual attributes); health service-related (induction programs, Aboriginal Health Worker support, team-building initiatives); and community-related factors (engaged community elders, leaders, cultural mentors, community pharmacy champions). Barriers to NDP integration included a lack of systems supports for patients and staff to adapt to NDP roles, health service factors, travel requirements, a lack of community linkages, and time and budget constraints. CONCLUSIONS: NDP integration within primary health care services has potential to enhance medication-related services to Aboriginal and Torres Strait Islander peoples if enabling factors are supported and health systems and adequate resources facilitate the integration of pharmacists within these settings.

Integrating pharmacists into Aboriginal Community Controlled Health Services (IPAC project): Protocol for an interventional, non-randomised study to improve chronic disease outcomes.

BACKGROUND: Aboriginal and Torres Strait Islander peoples experience a higher burden of chronic disease yet have poorer access to needed medicines than other Australians. Adverse health outcomes from these illnesses can be minimised with improved prescribing quality. This project aims to improve quality of care outcomes for Aboriginal and Torres Strait Islander adult patients with chronic disease by integrating a pharmacist within primary health care teams in Aboriginal Community Controlled Health Services (ACCHSs). METHODOLOGY: This non-randomised, prospective, pre and post quasi-experimental study, will be pragmatic, community-based and participatory, comparing outcomes and costs using paired patient data. Pharmacists will be integrated at 22 sites for approximately 15 months to conduct patient-related and practice-related activities through 10 core roles: providing medication management reviews, assessing adherence and medication appropriateness, providing medicines information and education and training, collaborating with healthcare teams, delivering preventive care, liaising with stakeholders, providing trnsitional care, and undertaking a drug utilisation review. With patients' consent, de-identified client-level data will be extracted from clinical information systems and pharmacists will record deidentified activity in an electronic logbook. Primary expected outcomes include improvements in biometric indices (glycated haemoglobin, systolic and diastolic blood pressure, lipids, cardiovascular risk, albumin-creatinine ratio) from baseline to end of study. Expected secondary outcomes include improvements in estimated glomerular filtration rate, prescribing indices (appropriateness, overuse and underuse), medication adherence, self-assessed health, and health service utilisation indices. A qualitative assessment of stakeholder and patient perceptions and a cost-effectiveness analysis will be undertaken. DISCUSSION: Numerous inquiries have recommended evaluating the impact of pharmacists integrated within primary health care settings. This study is the first to explore this impact on the health of Aboriginal and Torres Strait Islander peoples who are medically underserved. Evaluation of innovative integrated workforce models is necessary to address the challenges of delivering quality care together with this population.

Protocol for a feasibility study of an Indigenous Medication Review Service (IMeRSe) in Australia.

INTRODUCTION: The age-adjusted rate of potentially preventable hospitalisations for Aboriginal and Torres Strait Islander people is almost five times the rate of other Australians. Quality use of medicines has an important role in alleviating these differences. This requires strengthening existing medication reviewing services through collaboration between community pharmacists and health workers, and ensuring services are culturally appropriate. This Indigenous Medication Review Service (IMeRSe) study aims to develop and evaluate the feasibility of a culturally appropriate medication management service delivered by community pharmacists in collaboration with Aboriginal health workers. METHODS AND ANALYSIS: This study will be conducted in nine Aboriginal health services (AHSs) and their associated community pharmacies in three Australian states over 12 months. Community pharmacists will be trained to improve their awareness and understanding of Indigenous health and cultural issues, to communicate the quality use of medicines effectively, and to strengthen interprofessional relationships with AHSs and their staff. Sixty consumers (with a chronic condition/pregnant/within 2 years post partum and at risk of medication-related problems (MRPs) per site will be recruited, with data collection at baseline and 6 months. The primary outcome is the difference in cumulative incidence of serious MRPs in the 6 months after IMeRSe introduction compared with the 6 months prior. Secondary outcomes include potentially preventable medication-related hospitalisations, medication adherence, total MRPs, psychological and social empowerment, beliefs about medication, treatment satisfaction and health expenditure. ETHICS AND DISSEMINATION: The protocol received approval from Griffith University (HREC/2018/251), Queensland Health Metro South (HREC/18/QPAH/109), Aboriginal Health and Medical Research Council of New South Wales (1381/18), Far North Queensland (HREC/18/QCH/86-1256) and the Central Australian HREC (CA-18-3090). Dissemination to Indigenous people and communities will be a priority. Results will be available on the Australian Sixth Community Pharmacy Agreement website and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12618000188235; Pre-results.

Physiological responses related to increased grain yield under drought in the first biotechnology-derived drought-tolerant maize.

Maize (Zea mays ssp. mays L.) is highly susceptible to drought stress. This work focused on whole-plant physiological mechanisms by which a biotechnology-derived maize event expressing bacterial cold shock protein B (CspB), MON 87460, increased grain yield under drought. Plants of MON 87460 and a conventional control (hereafter 'control') were tested in the field under well-watered (WW) and water-limited (WL) treatments imposed during mid-vegetative to mid-reproductive stages during 2009-2011. Across years, average grain yield increased by 6% in MON 87460 compared with control under WL conditions. This was associated with higher soil water content at 0.5 m depth during the treatment phase, increased ear growth, decreased leaf area, leaf dry weight and sap flow rate during silking, increased kernel number and harvest index in MON 87460 than the control. No consistent differences were observed under WW conditions. This indicates that MON 87460 acclimated better under WL conditions than the control by lowering leaf growth which decreased water use during silking, thereby eliciting lower stress under WL conditions. These physiological responses in MON 87460 under WL conditions resulted in increased ear growth during silking, which subsequently increased the kernel number, harvest index and grain yield compared to the control.

Brief report: development of the inflammatory bowel disease family responsibility questionnaire.

OBJECTIVE: To present psychometric data on youth and parent versions of the Inflammatory Bowel Disease-Family Responsibility Questionnaire (IBD-FRQ), a measure of family involvement in IBD management. METHODS: Fifty-eight adolescents with inflammatory bowel disease (IBD), along with 55 mothers and 26 fathers completed the IBD-FRQ, a demographics questionnaire, and a measure of family involvement in decision making in non-IBD domains. Medical information was obtained via chart review. RESULTS: Support for the internal consistency of the IBD-FRQ was obtained. Evidence of validity was documented via moderate to high intercorrelations among reporters. Youth involvement increased with youth age, while maternal and paternal involvement decreased with youth age. Across all reporters, maternal involvement was higher than paternal involvement. CONCLUSIONS: Preliminary analyses offer support for the measure's reliability and validity. The measure shows promise as a means of assessing family involvement in IBD condition management; however, further validation studies are needed.

Barriers to adherence among adolescents with inflammatory bowel disease.

BACKGROUND: The purpose of this study was to describe barriers to adherence among adolescents with inflammatory bowel disease (IBD) and to examine demographic, disease-related, and treatment regimen-related correlates of adherence barriers using a multimethod reporting strategy. A final goal was to examine relationships between the frequencies of barriers and levels of nonadherence. METHODS: In all, 64 adolescents (ages 11-18) participated, along with 61 mothers and 25 fathers. Barriers to adherence and ratings of medication adherence were assessed via patient and parent reports. Disease activity ratings were provided by pediatric gastroenterologists. RESULTS: Lack of time and medication side effects were commonly reported barriers across adolescent, mother, and father reports. Other adolescent-reported barriers included missing medication due to feeling well or discontinuing medication based on the belief that the medication was not working. The prevalence of adherence barriers was not consistently associated with adolescent age, sex, time since diagnosis, or disease activity. Adolescents whose regimen involved more than 1 daily medication administration had more adherence barriers based on adolescent and maternal report than did those whose regimen involved 1 or less than 1 daily medication administration. Finally, adherence barriers were significantly higher among families reporting imperfect adherence as compared to those reporting perfect adherence. CONCLUSIONS: Barriers to medication adherence do exist among adolescents with IBD and may have negative implications for medication adherence. Systematic assessment of barriers during routine medical appointments may help to identify and modify these barriers and ultimately improve adherence.