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Background: Health systems in Australia and worldwide are increasingly expected to conduct research and quality improvement activities in addition to delivering clinical care and training health professionals. This study aims to inform a research impact evaluation at a regional Australian Hospital and Health Service by developing a programme theory showing how research investment is expected to have impact.Methods: This qualitative study, representing the first phase of a larger mixed methods research impact evaluation at the Townsville Hospital and Health Service (THHS), adopts a realist-informed design involving the development of a programme theory. Data were obtained between February and May 2019 from strategic documentation and interviews with six current and former health service executives and senior employees. Inductive themes were integrated into a conceptual framework to visually represent the programme theory.Results: Research at THHS has developed organically as the service has matured into a regional tertiary referral service serving a diverse rural and remote population across northern Queensland. Throughout this journey, individual THHS leaders often adopted a research development mantle despite disincentives arising from a performance-driven reporting and activity-based funding service context. Impact expectations from research investment at THHS were identified in the categories of enhanced research activity and capacity among clinicians, and improved clinical practice, health workforce capability and stability, and patient and population health. Seven contextual factors were identified as potential enablers or obstacles to these impact expectations and ambitions.Conclusions: By identifying both relevant impact types and key contextual factors, this study offers programme theory to inform a planned research impact evaluation at THHS. The conceptual framework may be useful in other regionally based health service settings. More broadly, there are opportunities for future research to test and refine hybrid versions of linear and realist research impact evaluation models that combine resource-intensive, theory-driven approaches with policy practicality. [ABSTRACT FROM AUTHOR]

Background: Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy.Methods/design: A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes.Discussion: This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes.Trial Registration: ClinicalTrials.gov Identifier: NCT01788527 Registration Date: December 19, 2012. [ABSTRACT FROM AUTHOR]