A randomized controlled trial to compare the effects of time-restricted eating versus Mediterranean diet on symptoms and quality of life in bipolar disorder.

BACKGROUND: The primary objective of this randomized controlled trial (RCT) is to establish the effectiveness of time-restricted eating (TRE) compared with the Mediterranean diet for people with bipolar disorder (BD) who have symptoms of sleep disorders or circadian rhythm sleep-wake disruption. This work builds on the growing evidence that TRE has benefits for improving circadian rhythms. TRE and Mediterranean diet guidance will be offered remotely using self-help materials and an app, with coaching support. METHODS: This study is an international RCT to compare the effectiveness of TRE and the Mediterranean diet. Three hundred participants will be recruited primarily via social media. Main inclusion criteria are: receiving treatment for a diagnosis of BD I or II (confirmed via DIAMOND structured diagnostic interview), endorsement of sleep or circadian problems, self-reported eating window of ≥ 12 h, and no current mood episode, acute suicidality, eating disorder, psychosis, alcohol or substance use disorder, or other health conditions that would interfere with or limit the safety of following the dietary guidance. Participants will be asked to complete baseline daily food logging for two weeks and then will be randomly allocated to follow TRE or the Mediterranean diet for 8 weeks, during which time, they will continue to complete daily food logging. Intervention content will be delivered via an app. Symptom severity interviews will be conducted at baseline; mid-intervention (4 weeks after the intervention begins); end of intervention; and at 6, 9, and 15 months post-baseline by phone or videoconference. Self-rated symptom severity and quality of life data will be gathered at those timepoints, as well as at 16 weeks post baseline. To provide a more refined index of whether TRE successfully decreases emotional lability and improves sleep, participants will be asked to complete a sleep diary (core CSD) each morning and complete six mood assessments per day for eight days at baseline and again at mid-intervention. DISCUSSION: The planned research will provide novel and important information on whether TRE is more beneficial than the Mediterranean diet for reducing mood symptoms and improving quality of life in individuals with BD who also experience sleep or circadian problems. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT06188754.

Contemporary outcomes of operations for tricuspid valve infective endocarditis.

BACKGROUND: Tricuspid valve infective endocarditis (TVIE) is uncommon. Patients are traditionally treated with antibiotics alone, and indications for operation are not clearly established. We report our operative single-center experience. METHODS: We retrospectively reviewed 56 patients who underwent operations for TVIE between January 2002 and December 2012. RESULTS: Methicillin-resistant Staphylococcus aureus was present in 41% of patients, septic pulmonary emboli in 63%, moderate/severe tricuspid regurgitation in 66%, and 86% were intravenous drug abusers. Patients underwent early operation if there was concomitant left-sided endocarditis with indications for operation (n = 18), atrial septal defect (n = 6), infected pacemaker lead (n = 4), or prosthetic TVIE (n = 1). The remaining 27 patients were treated with intravenous antibiotics. Five patients completed a 6-week course of intravenous antibiotics before requiring an operation for symptomatic severe tricuspid regurgitation or persistent bacteremia. Twenty-two patients did not complete the antibiotic therapy and underwent operation for symptomatic severe tricuspid regurgitation (n = 15), persistent fevers/bacteremia (n = 3), or patient-specific factors (n = 4). Valve repair was successful in 57% of patients. Overall operative mortality was 7.1%. No operative deaths occurred in patients with isolated native TVIE. Recurrent TVIE was diagnosed in 21% (5 of 24) of the replacement group and in 0% (0 of 32) in the repair group. Use of repair was strongly protective against recurrent TVIE (p < 0.01). CONCLUSIONS: In contrast to previously published reports of high operative mortality with TVIE, this experience demonstrates improved outcomes with low morbidity and mortality, particularly for native isolated TVIE. Future prospective comparisons between surgically and medically treated patients may help to further define indications and timing for operation for patients with TVIE.

Collaborating across multiple health care institutions in an urban colorectal cancer screening program.

BACKGROUND: Maryland, excluding Baltimore City, began public health screening for colorectal cancer in 2000. Initiating colorectal cancer screening in Baltimore City was an objective in the Maryland Comprehensive Cancer Control Plan. The Centers for Disease Control and Prevention's (CDC's) funding announcement for the "Colorectal Cancer Screening Demonstration Program" (CRCSDP) was seen as a potential opportunity for Maryland to begin screening in Baltimore City. METHODS: The Maryland Department of Health and Mental Hygiene (DHMH), the American Cancer Society, and five Baltimore City Hospitals collaborated to develop the funding application and model for the Baltimore City CRCSDP. After receipt of funding, between 2005 and September 2009, screening sites collaborated with the DHMH to implement the multi-site colorectal cancer screening program in Baltimore City. RESULTS: Close collaboration across organizational boundaries enabled the funding, formation, and implementation of the CRCSDP in Baltimore City. The Baltimore City CRCSDP illustrates the complexity of establishing a functional public health screening program. The program overcame expected and unexpected fiscal, programmatic, and clinical challenges to successfully perform 709 colonoscopies screening cycles among 696 people and detect three cancers during the 38 months of screening. CONCLUSIONS: Partnerships among the state and local health department, the American Cancer Society, and hospitals in Baltimore City enabled the implementation of this successful program. Lessons learned from the collaborative planning process and the program implementation may facilitate similar collaborations in other geographic areas.

Comprehensive cancer control programs and coalitions: partnering to launch successful colorectal cancer screening initiatives.

Colorectal cancer control has long been a focus area for Comprehensive Cancer Control programs and their coalitions, given the high burden of disease and the availability of effective screening interventions. Colorectal cancer control has been a growing priority at the national, state, territorial, tribal, and local level. This paper summarizes several national initiatives and features several Comprehensive Cancer Control Program colorectal cancer control successes.