Publications by authors named "E S Connolly"

912 Publications

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial.

Trials 2021 Sep 16;22(1):630. Epub 2021 Sep 16.

RAND Corporation, Santa Monica, CA, USA.

Background: Malawi is a low-income country in sub-Saharan Africa that has limited resources to address a significant burden of disease-including HIV/AIDS. Additionally, depression is a leading cause of disability in the country but largely remains undiagnosed and untreated. The lack of cost-effective, scalable solutions is a fundamental barrier to expanding depression treatment. Against this backdrop, one major success has been the scale-up of a network of more than 700 HIV clinics, with over half a million patients enrolled in antiretroviral therapy (ART). As a chronic care system with dedicated human resources and infrastructure, this presents a strategic platform for integrating depression care and responds to a robust evidence base outlining the bi-directionality of depression and HIV outcomes.

Methods: We will evaluate a stepped model of depression care that combines group-based Problem Management Plus (group PM+) with antidepressant therapy (ADT) for 420 adults with moderate/severe depression in Neno District, Malawi, as measured by the Patient Health Questionnaire-9 (PHQ-9) and Mini-International Neuropsychiatric Interview (MINI). Roll-out will follow a stepped-wedge cluster randomized design in which 14 health facilities are randomized to implement the model in five steps over a 15-month period. Primary outcomes (depression symptoms, functional impairment, and overall health) and secondary outcomes (e.g., HIV: viral load, ART adherence; diabetes: A1C levels, treatment adherence; hypertension: systolic blood pressure, treatment adherence) will be measured every 3 months through 12-month follow-up. We will also evaluate the model's cost-effectiveness, quantified as an incremental cost-effectiveness ratio (ICER) compared to baseline chronic care services in the absence of the intervention model.

Discussion: This study will conduct a stepped-wedge cluster randomized trial to compare the effects of an evidence-based depression care model versus usual care on depression symptom remediation as well as physical health outcomes for chronic care conditions. If determined to be cost-effective, this study will provide a model for integrating depression care into HIV clinics in additional districts of Malawi and other low-resource settings with high HIV prevalence.

Trial Registration: ClinicalTrials.gov NCT04777006 . Registered on 1 March, 2021.
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http://dx.doi.org/10.1186/s13063-021-05601-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8444539PMC
September 2021

Real world outcomes of neoadjuvant chemotherapy and radiotherapy for borderline resectable pancreatic cancer: A multicentre observational study.

ANZ J Surg 2021 Aug 23. Epub 2021 Aug 23.

Department of Medical Oncology, Chris O'Brien Lifehouse, Sydney, New South Wales, Australia.

Background: Neoadjuvant therapy may increase the likelihood of complete (R0) resection for borderline resectable pancreatic cancer. The optimal approach is unknown and differs amongst treatment centres.

Methods: We identified patients with biopsy-proven borderline resectable pancreatic adenocarcinoma who commenced neoadjuvant therapy between January 2012 and June 2019 at three centres in Sydney, Australia. Patterns of care and outcomes of varying approaches were examined.

Results: Forty-eight patients were identified. Median age was 66 years (range: 41-84). Staging included endoscopic ultrasound in 98%, PET-CT scan in 77%, laparoscopy in 46%. Neoadjuvant regimens used were a combination of chemotherapy and chemo-radiation (58%), chemotherapy alone (13%) and chemoradiation alone (29%). Radiologic complete or partial response occurred in 33% and progression in 25%. Complete macroscopic surgical resection was achieved in 50%, and R0 resection in 38%. At median follow-up of 15 months, the 1-year and 2-year overall survival was 75% and 63% respectively, and the 1-year and 2-year progression-free survival was 50% and 29% respectively. Significant predictors of macroscopic resectability were radiologic response (p = 0.005) but not addition of radiotherapy to chemotherapy (OR 0.87, p = 0.81). Predictors of overall survival included baseline Ca19.9 level (p = 0.04) and a trend to the use of systemic chemotherapy (HR 0.51, p = 0.07), but not use of radiotherapy (HR 0.70, p = 0.47).

Conclusion: There is high variability in staging and neoadjuvant approaches for borderline resectable pancreas cancer. Despite aggressive neoadjuvant therapies, R0 resection and prolonged survival are uncommon. The incremental benefit of neoadjuvant radiotherapy after neoadjuvant chemotherapy was not demonstrated in this observational study.
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http://dx.doi.org/10.1111/ans.17151DOI Listing
August 2021

Complication Rates After IntraOperative Radiation Therapy: Do Applicator Size and Distance to Skin Matter?

J Surg Res 2021 Aug 17;268:440-444. Epub 2021 Aug 17.

Breast Surgery Division, Columbia University Medical Center, New York, New York. Electronic address:

Background: Intraoperative radiation therapy (IORT) has gained popularity for early stage breast cancer treatment. Few studies have examined the relationship between complications and both demographic and technical factors. The objective of the current study was to determine if applicator size or distances to the skin were significant risk factors for complications.

Methods: Data was prospectively collected on patients who underwent lumpectomy followed by IORT from November 1, 2013 to August 31, 2018. Exclusion criteria included any prior radiation exposure or personal history of breast cancer. Comorbid conditions such as body mass index, diabetes, and smoking as well as technical specifications such as applicator size and distances to the skin were included for investigation. Student's t-test, Fisher's exact test, and odds ratios were utilized for statistical analysis.

Results: The study was comprised of 219 patients. None developed Clavien-Dindo grade 2 or above complications. Of 21.0% (n = 46) had minor complications. The most common complication was a palpable breast seroma (n = 37). Diabetes was the only comorbid condition with increased risk for complications (OR 3.2; 95% CI1.3-7.5; P = 0.008). The applicator sizes and average skin distances were similar between groups. Surprisingly, the closest skin distance was not a significant risk factor for post-operative complications (1.4 +/- 1.6 versus 1.4 +/- 1.9 cm; P = 1.0).

Conclusion: Neither applicator size nor the closest skin distance were associated with increased complications. Traditionally described risk factors such as BMI and smoking were not predictive. This data provides support for potentially expanding the utilization for IORT without increasing complications.
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http://dx.doi.org/10.1016/j.jss.2021.06.078DOI Listing
August 2021

Vitamin K Intake and Atherosclerotic Cardiovascular Disease in the Danish Diet Cancer and Health Study.

J Am Heart Assoc 2021 Aug 7;10(16):e020551. Epub 2021 Aug 7.

Institute for Nutrition Research School of Medical and Health Sciences Edith Cowan University Perth Australia.

Background Dietary vitamin K (K and K) may reduce atherosclerotic cardiovascular disease (ASCVD) risk via several mechanisms. However, studies linking vitamin K intake with incident ASCVD are limited. We aimed to determine the relationship between dietary vitamin K intake and ASCVD hospitalizations. Methods and Results In this prospective cohort study, participants from the Danish Diet, Cancer, and Health Study, with no prior ASCVD, completed a food-frequency questionnaire at baseline and were followed up for hospital admissions of ASCVD; ischemic heart disease, ischemic stroke, or peripheral artery disease. Intakes of vitamin K and vitamin K were estimated from the food-frequency questionnaire, and their relationship with ASCVD hospitalizations was determined using Cox proportional hazards models. Among 53 372 Danish citizens with a median (interquartile range) age of 56 (52-60) years, 8726 individuals were hospitalized for any ASCVD during 21 (17-22) years of follow-up. Compared with participants with the lowest vitamin K intakes, participants with the highest intakes had a 21% lower risk of an ASCVD-related hospitalization (hazard ratio, 0.79; 95% CI: 0.74-0.84), after multivariable adjustments for relevant demographic covariates. Likewise for vitamin K, the risk of an ASCVD-related hospitalization for participants with the highest intakes was 14% lower than participants with the lowest vitamin K intake (hazard ratio, 0.86; 95% CI, 0.81-0.91). Conclusions Risk of ASCVD was inversely associated with diets high in vitamin K or K. The similar inverse associations with both vitamin K and K, despite very different dietary sources, highlight the potential importance of vitamin K for ASCVD prevention.
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http://dx.doi.org/10.1161/JAHA.120.020551DOI Listing
August 2021
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