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Background: Diabetes distress is underrecognized and associated with poor outcomes. This study tested whether a 12-month collaborative, goal-setting, and behavioral telehealth intervention reduced diabetes distress levels. Methods: This is a secondary analysis of the Healthy Outcomes through Patient Empowerment (HOPE) study that included individuals (N = 225) with uncontrolled diabetes and depression living at least 20 miles from a Veteran's Affairs medical center. Participants were randomized to HOPE (intervention) or Enhanced Usual Care (EUC) with education. We evaluated diabetes distress levels as measured by the Problem Areas in Diabetes (PAID) Questionnaire and its four subscales (emotional, diabetes management, social, and treatment distress) at baseline, 6, and 12 months. Results: Between-group analysis revealed greater improvements in HOPE versus EUC for: 6-month PAID total score (p = 0.04), emotional (p = 0.03), and social (p = 0.04) subscales; 12-month PAID total score (p = 0.07) and emotional subscale (p = 0.07). Within-group comparisons showed larger effect sizes for HOPE compared with EUC: 12-month PAID total scores (0.82 vs. 0.54), 6-month emotional burden (0.54 vs. 0.31), and 6-month (0.32 vs. 0.08) and 12-month (0.41 vs. 0.12) social burdens. Repeated-measures analysis evaluating treatment group and time trended toward improvement in PAID overall for HOPE compared with EUC participants, but was not statistically significant (β = 6.96; SE = 4.35; p = 0.13). Discussion: Clinically meaningful reductions in PAID overall and the emotional and social subscales were observed in HOPE compared with EUC participants. Conclusion: Further evaluation of diabetes telehealth interventions that include other facets related to diabetes distress, including treatment, diabetes management, social, and emotional burdens, is warranted. Clinical Trial Number. NCT01572389; Clinical Trial Registry. https://clinicaltrials.gov/ct2/show/NCT01572389.

Objective The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012. Methods A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured. Results ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores. Conclusions Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up.

Background: The vast majority of individuals diagnosed with diabetes are low/middle income and may have access to only three of the 11 oral hypoglycemic medications (OHMs) due to cost: metformin intermediate release (IR) or extended release (ER), sulfonylureas (glimepiride, glipizide, glyburide), and pioglitazone. Sulfonylureas and pioglitazone have had significant controversy related to potential adverse events, but it remains unclear whether these negative outcomes are class, drug, or dose-related. Objective: We conducted a narrative review of low-cost OHMs. Results: We evaluated the maximum recommended (MAX) compared to the most effective (EFF) daily dose, time-to-peak change in HbA1c levels, and adverse events of low-cost oral hypoglycemic medications. Results: We found that the MAX was often greater than the EFF: metformin IR/ER (MAX: 2,550/2,000 mg, EFF: 1,500–2,000/1,500–2,000 mg), glipizide IR/ER (MAX: 40/20 mg, EFF: 20/5 mg), glyburide (MAX: 20 mg, EFF: 2.5–5.0 mg), pioglitazone (MAX: 45 mg, EFF: 45 mg). Time-to-peak change in HbA1c levels occurred at weeks 12–20 (sulfonylureas), 25–39 (metformin), and 25 (pioglitazone). Glimepiride was not associated with weight gain, hypoglycemia, or negative cardiovascular events relative to other sulfonylureas. Cardiovascular event rates did not increase with lower glyburide doses (p Conclusion: Metformin, glimepiride, and pioglitazone are safe and efficacious OHMs. Prescribing at the EFF rather than the MAX may avoid negative dose-related outcomes. OHMs should be evaluated as individual drugs, not generalized as a class, due to different dosing and adverse-event profiles; Glimepiride is the preferred sulfonylurea since it is not associated with the adverse events as others in its class.

BackgroundMany individuals with diabetes live in low- or middle-income settings. Glycemic control is challenging, particularly in resource-limited areas that face numerous healthcare barriers.ObjectiveTo compare HbA1c outcomes for individuals randomized to TIME, aTelehealth-supported,Integrated care with CHWs (Community Health Workers), andMEdication-access program (intervention) versus usual care (wait-list control).DesignRandomized clinical trial.ParticipantsLow-income Latino(a) adults with type 2 diabetes.InterventionsTIME consisted of (1) CHW-participant telehealth communication via mobile health (mHealth) for 12 months, (2) CHW-led monthly group visits for 6 months, and (3) weekly CHW-physician diabetes training and support via telehealth (video conferencing).Main MeasuresInvestigators compared TIME versus control participant baseline to month 6 changes of HbA1c (primary outcome), blood pressure, body mass index (BMI), weight, and adherence to seven American Diabetes Association (ADA) standards of care. CHW assistance in identifying barriers to healthcare in the intervention group were measured at the end of mHealth communication (12 months).Key ResultsA total of 89 individuals participated. TIME individuals compared to control participants had significant HbA1c decreases (9.02 to 7.59% (− 1.43%) vs. 8.71 to 8.26% (− 0.45%), respectively,p = 0.002), blood pressure changes (systolic: − 6.89 mmHg vs. 0.03 mmHg,p = 0.023; diastolic: − 3.36 mmHg vs. 0.2 mmHg, respectively,p = 0.046), and ADA guideline adherence (p > 0.50% HbA1c reductions (88.57% vs. 43.75%,p > 1 barrier to care, of whom 91.7% had medication issues. CHWs identified the majority (87.5%) of barriers.ConclusionsTIME participants resulted in improved outcomes including HbA1c. CHWs are uniquely positioned to identify barriers to care particularly related to medications that may have gone unrecognized otherwise. Larger trials are needed to determine the scalability and sustainability of the intervention.Clinical TrialNCT03394456, accessed athttps://clinicaltrials.gov/ct2/show/NCT03394456

Background: Community health workers (CHWs) are a well-established source to improve patient health care, yet their training and support remain suboptimal. This limits program expansion and potentially compromises patient safety. The objective of the study was to evaluate the feasibility and acceptability of weekly training and support by telemedicine (videoconferencing). Materials and Methods: CHWs (n = 6) who led diabetes group visits for low-income Latinos met weekly with a health care professional for training and support. Feasibility and acceptability outcome measures included telemedicine usability, knowledge of diabetes (baseline to 6 months), and program satisfaction. Results: Telemedicine training and support were found to be feasible and acceptable as measured by usability (Telehealth Usability Questionnaire: average 4.7/5.0, ±0.4), knowledge (Diabetes Knowledge Test: pretest 15.8 ± 1.3, posttest 21.8 ± 1.2, p

To review the factors contributing to underutilization of guideline-directed therapies, identify strategies to alleviate these factors, and apply these strategies for effective and timely dissemination of novel cardioprotective glucose-lowering agents.Recent analyses demonstrate underutilization of cardioprotective glucose lowering agents despite guideline recommendations for their use. Major contributors to underutilization of guideline-directed therapies include therapeutic inertia, perceptions about side effects, and factors found at the level of the clinicians, patients, and the healthcare system. The recent emergence of several novel therapies, such as sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists, for use in cardiovascular disease provides a unique avenue to improve patient outcomes. To effectively utilize novel cardioprotective glucose lowering agents to improve cardiovascular outcomes, clinicians must recognize and learn from prior barriers to application of guideline-directed therapies. Further endeavors are prudent to ensure uptake of novel agents.

IntroductionCommunity clinics often face pragmatic barriers, hindering program initiation and replication of controlled research trial results. Mentoring is a potential strategy to overcome these barriers. We piloted an in-person and telehealth mentoring strategy to implement the Telehealth-supported, Integrated Community Health Workers (CHWs), Medication-access, group visit Education (TIME) program in a community clinic.Research design and methodsParticipants (n=55) were low-income Latino(a)s with type 2 diabetes. The study occurred in two, 6-month phases. Phase I provided proof-of-concept and an observational experience for the clinic team; participants (n=37) were randomized to the intervention (TIME) or control (usual care), and the research team conducted TIME while the clinic team observed. Phase II provided mentorship to implement TIME, and the research team mentored the clinic team as they conducted TIME for a new single-arm cohort of participants (n=18) with no previous exposure to the program. Analyses included baseline to 6-month comparisons of diabetes outcomes (primary outcome: hemoglobin A1c (HbA1c)): phase I intervention versus control, phase II (within group), and research-run (phase I intervention) versus clinic-run (phase II) arms. We also evaluated baseline to 6-month CHW knowledge changes.ResultsPhase I: compared with the control, intervention participants had superior baseline to 6-month improvements for HbA1c (mean change: intervention: −0.73% vs control: 0.08%, p=0.016), weight (p=0.044), target HbA1c (p=0.035), hypoglycemia (p=0.021), medication non-adherence (p=0.0003), and five of six American Diabetes Association (ADA) measures (pConclusionsA novel, mentored approach to implement TIME into a community clinic resulted in improved diabetes outcomes. Larger studies of longer duration are needed to fully evaluate the potential of mentoring community clinics.

OBJECTIVE There is mounting evidence regarding the cardiovascular benefits of sodium–glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA) among patients with atherosclerotic cardiovascular disease (ASCVD) and type 2 diabetes mellitus (T2DM). There is paucity of data assessing real-world practice patterns for these drug classes. We aimed to assess utilization rates of these drug classes and facility-level variation in their use. RESEARCH DESIGN AND METHODS We used the nationwide Veterans Affairs (VA) health care system data set from 1 January 2020 to 31 December 2020 and included patients with established ASCVD and T2DM. Among these patients, we assessed the use of SGLT2i and GLP-1 RA and the facility-level variation in their use. Facility-level variation was computed using median rate ratios (MRR), a measure of likelihood that two random facilities differ in use of SGLT2i and GLP-1 RA in patients with ASCVD and T2DM. RESULTS Among 537,980 patients with ASCVD and T2DM across 130 VA facilities, 11.2% of patients received an SGLT2i while 8.0% of patients received a GLP-1 RA. Patients receiving these cardioprotective glucose-lowering drug classes were on average younger and had a higher proportion of non-Hispanic Whites. Overall, median (10th–90th percentile) facility-level rates were 14.92% (9.31–22.50) for SGLT2i and 10.88% (4.44–17.07) for GLP-1 RA. There was significant facility-level variation among SGLT2i use—MRRunadjusted: 1.41 (95% CI 1.35–1.47) and MRRadjusted: 1.55 (95% CI 1.46 –1.63). Similar facility-level variation was observed for use of GLP-1 RA—MRRunadjusted: 1.34 (95% CI 1.29–1.38) and MRRadjusted: 1.78 (95% CI 1.65–1.90). CONCLUSIONS Overall utilization rates of SGLT2i and GLP-1 RA among eligible patients are low, with significantly higher residual facility-level variation in the use of these drug classes. Our results suggest opportunities to optimize their use to prevent future adverse cardiovascular events among these patients.

We previously found that a 6-month multidimensional diabetes program, TIME (Telehealth-Supported, Integrated Community Health Workers, Medication-Access) resulted in improved clinical outcomes.To follow TIME participant clinical outcomes for 24 months PARTICIPANTS: Low-income Latino(a)s with type 2 diabetes DESIGN AND INTERVENTION: We collected post-intervention clinical data for five cohorts (n = 101, mean n = 20/cohort) who participated in TIME programs from 2018 to 2020 in Houston, Texas.We gathered HbA1c (primary outcome), weight, body mass index (BMI), and blood pressure data at baseline, 6 months (intervention end), and semiannually thereafter until 24 months after baseline to assess sustainability. We also evaluated participant loss to follow-up until 24 months.Participants decreased HbA1c levels during the intervention (p0.0001) and maintained these improvements at each timepoint from baseline to 24 months (p range:0.0001 to 0.015). Participants reduced blood pressure levels during TIME and maintained these changes at each timepoint from baseline until 18 months (systolic p range0.0001 to 0.0005, diastolic p range:0.0001 to 0.008) but not at 24 months (systolic: p = 0.065; diastolic: p = 0.85). There were no significant weight changes during TIME or post-intervention: weight (p range = 0.07 to 0.77), BMI (p range = 0.11 to 0.71). Attrition rates (loss to follow-up during the post-intervention period) were 5.9% (6 months), 24.8% (12 months), 35.6% (18 months), and 41.8% (24 months).It is possible for vulnerable populations to maintain long-term glycemic and blood pressure improvements using a multiple dimensional intervention. Attrition rates rose over time but show promise given the majority of post-intervention timepoints occurred during the COVID-19 pandemic when low-income populations were most susceptible to suboptimal healthcare access. Future studies are needed to evaluate longitudinal outcomes of diabetes interventions conducted by local clinics rather than research teams.

OBJECTIVE We reevaluated the Action for Health in Diabetes (Look AHEAD) intervention, incorporating diabetes subgroups, to identify whether intensive lifestyle intervention (ILI) is associated with differential risk for cardiovascular disease (CVD) by diabetes subgroup. RESEARCH DESIGN AND METHODS In the Look AHEAD trial, 5,145 participants, aged 45–76 years, with type 2 diabetes (T2D) and overweight or obesity were randomly assigned to 10 years of ILI or a control condition of diabetes support and education. The ILI focused on weight loss through decreased caloric intake and increased physical activity. To characterize diabetes subgroups, we applied k-means clustering to data on age of diabetes diagnosis, BMI, waist circumference, and glycated hemoglobin. We examined whether relative intervention effects on the trial’s prespecified CVD outcomes varied among diabetes subgroups. RESULTS We characterized four subgroups related to older age at diabetes onset (42% of sample), poor glucose control (14%), severe obesity (24%), and younger age at diabetes onset (20%). We observed interactions (all P < 0.05) between intervention and diabetes subgroups for three separate composite cardiovascular outcomes. Randomization to ILI was associated with increased risk for each cardiovascular outcome only among the poor-glucose-control subgroup (hazard ratio >1.32). Among the three other diabetes subgroups, ILI was not associated with increased risk for CVD. CONCLUSIONS Among overweight and obese adults with T2D, a lifestyle intervention was associated with differential risk for CVD that was dependent on diabetes subgroup. Diabetes subgroups may be important to identify the patients who would achieve benefit and avoid harm from an ILI.

Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

Background/objectives Type 2 diabetes mellitus and obesity are sometimes described as conditions that accelerate aging. Multidomain lifestyle interventions have shown promise to slow the accumulation of age-related diseases, a hallmark of aging. However, they have not been assessed among at-risk individuals with these two conditions. We examined the relative impact of 8 years of a multidomain lifestyle intervention on an index of multimorbidity. Design Randomized controlled clinical trial comparing an intensive lifestyle intervention (ILI) that targeted weight loss through caloric restriction and increased physical activity with a control condition of diabetes support and education (DSE). Setting Sixteen U.S. academic centers. Participants A total of 5,145 volunteers, aged 45 to 76, with established type 2 diabetes mellitus and overweight or obesity who met eligibility criteria for a randomized controlled clinical trial. Measurements A multimorbidity index that included nine age-related chronic diseases and death was tracked over 8 years of intervention delivery. Results Among individuals assigned to DSE, the multimorbidity index scores increased by an average of .98 (95% confidence interval [CI] = .94-1.02) over 8 years, compared with .89 (95% CI = .85-.93) among those in the multidomain ILI, which was a 9% difference (P = .003). Relative intervention effects were similar among individuals grouped by baseline body mass index, age, and sex, and they were greater for those with lower levels of multimorbidity index scores at baseline. Conclusions Increases in multimorbidity over time among adults with overweight or obesity and type 2 diabetes mellitus may be slowed by multidomain ILI. J Am Geriatr Soc 68:2249-2256, 2020.

This randomized clinical trial compares the effectiveness of telephone-delivered collaborative goal setting and behavioral activation vs enhanced usual care for depression symptoms among US veterans with uncontrolled diabetes., Key Points Question Can a telephone-delivered, collaborative goal-setting intervention improve depression symptoms and glycemic control among high-risk, patients with comorbid diabetes identified using a population screening approach? Findings In this randomized clinical trial of 225 US veterans with uncontrolled diabetes and significant depression symptoms, a telephone-delivered intervention using collaborative goal setting and behavioral activation had mixed results compared with enhanced usual care. Secondary analyses found that a significantly higher proportion of intervention participants achieved and maintained clinically significant responses of depression symptoms at 12 months but did not find such improvements for glycemic levels at 12 months. Meaning A telephone-delivered, collaborative goal-setting approach can improve depression symptoms among high-risk patients with uncontrolled diabetes who maintain engagement for 12 months., Importance Depression symptoms are present in one-third of patients with diabetes, contributing to significant adverse consequences. Population screening of high-risk patients coupled with telephone delivery of evidence-based therapies for comorbid diabetes may address barriers to care. Objective To evaluate the effectiveness of proactive population screening plus telephone delivery of a collaborative goal-setting intervention among high-risk patients with uncontrolled diabetes and depression. Design, Setting, and Participants In this randomized clinical trial, 225 participants (intervention [n = 136] and control [n = 89]) were enrolled from a regional Veterans Healthcare System serving Southeast Texas from November 1, 2012, through June 24, 2016. Data were gathered at baseline and 6 and 12 months after intervention. Patients selected had uncontrolled diabetes (hemoglobin A1c [HbA1c] >7.5%]) and clinically significant depression (Patient Health Questionnaire–9 scores [PHQ-9] ≥10) and were living more than 20 miles from the Veterans Affairs medical center. Data collection was completed on December 6, 2016, and final analyses were completed by January 25, 2018. All analyses were intent to treat. Interventions Healthy Outcomes Through Patient Empowerment (HOPE) included 9 telephone sessions with 24 trained health care professionals using collaborative goal-setting and behavioral activation methods. The control group received enhanced usual care (EUC) and notification of high-risk status. Main Outcomes and Measures Change in depression symptoms using PHQ-9 and glycemic control using HbA1c from baseline to 6 months and to 12 months. Secondary analyses evaluated clinically significant responses for these measures. Results Among 225 participants, 202 (89.8%) were men, the mean (SD) age was 61.9 (8.3) years, 145 (64.4%) were married, and 156 (69.3%) had some education beyond high school. For the overall study, 38 participants (16.9%) were lost to follow-up or withdrew at 6 months and another 21 (9.3%) were lost to follow-up or withdrew at 12 months. Repeated-measures analysis with multiple imputation for missing data assessing the interaction of treatment group (HOPE vs EUC) and time (baseline, 6 months, and 12 months) found no significant improvement in PHQ-9 (β, 1.56; 95% CI, –0.68 to 3.81; P = .17) or HbA1c (β, –0.005; 95% CI, –0.73 to 0.72; P = .82). Analyses using t test for change from baseline to 12 months showed a HOPE vs EUC between-group mean difference for PHQ-9 of 2.14 (95% CI, 0.18 to 4.10; P = .03) and for HbA1c of –0.06% (95% CI, –0.61% to 0.50%; P = .83). A secondary analysis of patients experiencing a clinical response found that 52.1% of HOPE participants had clinically significant responses in PHQ-9 at 12 months vs 32.9% in EUC (difference, 0.19; 95% CI, 0.04-0.33; P = .01). Conclusions and Relevance Telephone-delivered, collaborative goal setting produced clinically significant reductions in depression symptoms but not glycemic control among patients who remained engaged at 12 months compared with EUC among a population screened sample of high-risk patients with diabetes and depression. Although the intervention created some lasting effect for depression, additional strategies are needed to maintain engagement of this high-risk population within an interprofessional team approach to primary care. Trial Registration ClinicalTrials.gov identifier: NCT01572389

Background: Prior studies have supported the efficacy of diabetes group visits. However, the benefit of diabetes group visits for low-income and underserved individuals is not clear. The purpose of this study was to conduct a narrative review in order to clarify the efficacy of diabetes group visits in low-income and underserved settings. Methods: The authors performed a narrative review, categorizing studies into nonrandomized and randomized. Results: A total of 14 studies were identified. Hemoglobin A1c was the most commonly measured outcome, which improved for the majority of group visit participants. Preventive care showed consistent improvement for intervention arms. There were several other study outcomes including metabolic (i.e., blood pressure), behavioral (i.e., exercise), functional (i.e., quality of life), and system-based (i.e., cost). Conclusion: Diabetes group visits for low-income and underserved individuals resulted in superior preventive care but the impact on glycemic control remains unclear.

Previous studies revealed that higher levels of acculturation are related to obesity in Hispanic adults. Conflicting findings exist regarding this relationship in children, and little is known about the impact of acculturation on children’s success in pediatric weight management programs. The purposes of the study were to (1) examine the relationship between acculturation and overweight/obese weight status and (2) determine the impact of acculturation on the changes in weight status among overweight/obese children 12 and 24 months after having participated in a weight management intervention. This is a secondary analysis of aggregated data from three randomized control trials that occurred between 2005 and 2009. Height, weight, and level of acculturation using the Child Short Scale for Hispanics (C-SASH) were measured in a sample of Hispanic children (n = 559). Logistic regression models were used to study phase 1 (n = 559) and phase 2 (n = 142), controlling for child and family characteristics. Children reporting high levels of acculturation had a 52 % lower odds of being overweight or obese. Among overweight/obese children who participated in the intervention, high levels of acculturation demonstrated greater reductions in standardized body mass index (zBMI) at 24 months. The results of this study indicate a need to tailor weight management programs for Hispanic children who have lower levels of acculturation.

Background: There are variable recommendations regarding initiating monotherapy or dual therapy in patients with newly diagnosed type 2 diabetes (T2D). Clear initial strategies are of particular importance in underserved settings where access to care and financial burdens are significant barriers. Objectives: To provide descriptive data of metabolic outcomes to therapy regimens for low-income individuals with newly diagnosed T2D placed on oral hypoglycemic agents (OAs). Methods: We conducted a retrospective chart review of low-income individuals with newly diagnosed T2D initiated on OAs. We provided descriptive data and then evaluated the effects of OA regimens (ie, mono-, dual-, transition [from mono to dual or vice versa] therapy) on hemoglobin A1c (A1c) (baseline to 12 months). Results: A total of 309 patients were included in the study. At 12 months, the mean decrease in A1c for the entire sample was −2.36% (9.37% to 7.01%). Patients prescribed dual therapy had a greater change of A1c compared to those taking monotherapy with metformin (−1.11%, P < .01). Patients who transitioned therapies did not differ in change of A1c compared to monotherapy. Conclusion: Initiation of dual therapy was superior to metformin monotherapy or transitioning therapies and may be preferred for low-income individuals with newly diagnosed T2D.

Laparoscopic cholecystectomy is commonly performed, and several factors increase the risk of open conversion, prolonging operating time and hospital stay. Preoperative stratification would improve consent, scheduling and identify appropriate training cases. The aim of this study was to develop a validated risk score for conversion for use in clinical practice.Preoperative patient and disease-related variables were identified from a prospective cholecystectomy database (CholeS) of 8820 patients, divided into main and validation sets. Preoperative predictors of conversion were identified by multivariable binary logistic regression. A risk score was developed and validated using a forward stepwise approach.Some 297 procedures (3.4%) were converted. The risk score was derived from six significant predictors: age (p = 0.005), sex (p 0.001), indication for surgery (p 0.001), ASA (p 0.001), thick-walled gallbladder (p = 0.040) and CBD diameter (p = 0.004). Testing the score on the validation set yielded an AUROC = 0.766 (p 0.001), and a score6 identified patients at high risk of conversion (7.1% vs. 1.2%).This validated risk score allows preoperative identification of patients at six-fold increased risk of conversion to open cholecystectomy.

IntroductionIn previous studies, it has been found that on average, children consistently gained weight during the summer months at an increased rate compared with the 9-month school year. This contributed to an increased prevalence of overweight and obesity in children. Several obesity-related interventions have occurred during or targeting the summer months. We propose to conduct a systematic review and meta-analysis of the impact of obesity prevention and treatment interventions for school-age children conducted during the summer or targeting the summer months when children are not in school on their body mass index (BMI), or weight-related behaviours.Methods and analysesA literature search will be conducted by the first author (JPM) using MEDLINE/PubMed, Cochrane Library, Scopus, CINAHL, PsycINFO, EMBASE and Proquest Dissertations and Theses databases from the date of inception to present. Studies must examine interventions that address the modification or promotion of weight-related behaviours (eg, dietary patterns, eating behaviours, physical activity (PA), sedentary behaviour or sleep) and target school-age children (ages 5–18). The primary outcomes will be changes from baseline to postintervention and/or the last available follow-up measurement in weight, BMI, BMI percentile, standardised BMI or per cent body fat. Secondary outcomes will include changes in dietary intake, PA, sedentary behaviour or sleep. Risk of bias will be assessed using the Cochrane risk of bias tool for randomised and non-randomised studies, as appropriate.Ethics and disseminationBecause this is a protocol for a systematic review, ethics approval will not be required. The findings will be disseminated via presentations at scientific conferences and published in a peer-reviewed journal. All amendments to the protocol will be documented and dated and reported in the PROSPERO trial registry.PROSPERO registration numberCRD42016041750