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Autonomous artificial intelligence increases screening and follow-up for diabetic retinopathy in youth: the ACCESS randomized control trial.
Wolf, RM, Channa, R, Liu, TYA, Zehra, A, Bromberger, L, Patel, D, Ananthakrishnan, A, Brown, EA, Prichett, L, Lehmann, HP, et al
Nature communications. 2024;(1):421
Abstract
Diabetic retinopathy can be prevented with screening and early detection. We hypothesized that autonomous artificial intelligence (AI) diabetic eye exams at the point-of-care would increase diabetic eye exam completion rates in a racially and ethnically diverse youth population. AI for Children's diabetiC Eye ExamS (NCT05131451) is a parallel randomized controlled trial that randomized youth (ages 8-21 years) with type 1 and type 2 diabetes to intervention (autonomous artificial intelligence diabetic eye exam at the point of care), or control (scripted eye care provider referral and education) in an academic pediatric diabetes center. The primary outcome was diabetic eye exam completion rate within 6 months. The secondary outcome was the proportion of participants who completed follow-through with an eye care provider if deemed appropriate. Diabetic eye exam completion rate was significantly higher (100%, 95%CI: 95.5%, 100%) in the intervention group (n = 81) than the control group (n = 83) (22%, 95%CI: 14.2%, 32.4%)(p < 0.001). In the intervention arm, 25/81 participants had an abnormal result, of whom 64% (16/25) completed follow-through with an eye care provider, compared to 22% in the control arm (p < 0.001). Autonomous AI increases diabetic eye exam completion rates in youth with diabetes.
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High amplitude propagated contractions with Glycerin versus Bisacodyl: A within-subject comparison in children undergoing colonic manometry.
Mansi, S, Bahia, G, Patel, D, Dorfman, L, El-Chammas, K, Fei, L, Liu, C, Santucci, NR, Graham, K, Kaul, A
Neurogastroenterology and motility. 2023;(5):e14544
Abstract
BACKGROUND The presence of high amplitude propagated contractions (HAPCs) measured by colonic manometry (CM) reflect an intact neuromuscular function of the colon. Bisacodyl and Glycerin are colonic stimulants that induce HAPCs and are used for the treatment of constipation. HAPCs characteristics with each drug have not been compared before. We aimed to compare the HAPC characteristics with Bisacodyl and Glycerin in children undergoing CM for constipation. METHODS This is a prospective single-center cross-over study of children aged 2-18 years undergoing CM. All patients received both Glycerin and Bisacodyl during CM. They were randomized to group A with Bisacodyl first (n = 22) and group B with Glycerin first (n = 23), with 1.5 hours in between each dose. Differences in patient and HAPC characteristics between groups were summarized using descriptive statistics and compared using Chi-square test or Wilcoxon rank sum test as appropriate. KEY RESULTS A total of 45 patients were included. HAPCs post Bisacodyl had a longer duration of action (median of 40 vs 21.5 min, p < 0.0001), longer propagation (median of 70 vs 60 cm, p = 0.02), and more HAPCs (median of 10 vs 5, p < 0.0001) compared Glycerin. No differences were found in the HAPC amplitude and onset of action between both medications.
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Glycemic Index Versus Wheat Fiber on Arterial Wall Damage in Diabetes: A Randomized Controlled Trial.
Jenkins, DJA, Chiavaroli, L, Mirrahimi, A, Mitchell, S, Faulkner, D, Sahye-Pudaruth, S, Paquette, M, Coveney, J, Olowoyeye, O, Patel, D, et al
Diabetes care. 2022;(12):2862-2870
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OBJECTIVE High cereal fiber and low-glycemic index (GI) diets are associated with reduced cardiovascular disease (CVD) risk in cohort studies. Clinical trial evidence on event incidence is lacking. Therefore, to make trial outcomes more directly relevant to CVD, we compared the effect on carotid plaque development in diabetes of a low-GI diet versus a whole-grain wheat-fiber diet. RESEARCH DESIGN AND METHODS The study randomized 169 men and women with well-controlled type 2 diabetes to counseling on a low GI-diet or whole-grain wheat-fiber diet for 3 years. Change in carotid vessel wall volume (VWV) (prespecified primary end point) was assessed by MRI as an indication of arterial damage. RESULTS Of 169 randomized participants, 134 completed the study. No treatment differences were seen in VWV. However, on the whole-grain wheat-fiber diet, VWV increased significantly from baseline, 23 mm3 (95% CI 4, 41; P = 0.016), but not on the low-GI diet, 8 mm3 (95% CI -10, 26; P = 0.381). The low-GI diet resulted in preservation of renal function, as estimated glomerular filtration rate, compared with the reduction following the wheat-fiber diet. HbA1c was modestly reduced over the first 9 months in the intention-to-treat analysis and extended with greater compliance to 15 months in the per-protocol analysis. CONCLUSIONS Since the low-GI diet was similar to the whole-grain wheat-fiber diet recommended for cardiovascular risk reduction, the low-GI diet may also be effective for CVD risk reduction.
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Effect of High-Dose Zinc and Ascorbic Acid Supplementation vs Usual Care on Symptom Length and Reduction Among Ambulatory Patients With SARS-CoV-2 Infection: The COVID A to Z Randomized Clinical Trial.
Thomas, S, Patel, D, Bittel, B, Wolski, K, Wang, Q, Kumar, A, Il'Giovine, ZJ, Mehra, R, McWilliams, C, Nissen, SE, et al
JAMA network open. 2021;(2):e210369
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IMPORTANCE There is limited evidence regarding early treatment of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression. OBJECTIVE To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020. INTERVENTION Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care. OUTCOMES The primary end point was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements. RESULTS A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups. CONCLUSIONS AND RELEVANCE In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04342728.
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PGAxBSA composite versus PASI: Comparison across disease severities and as therapeutic response measure for Cal/BD foam in plaque psoriasis.
Gold, LS, Hansen, JB, Patel, D, Veverka, KA, Strober, B
Journal of the American Academy of Dermatology. 2020;(1):131-138
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BACKGROUND The product of the Physician Global Assessment and body surface area (PGA×BSA) is simpler to use than the Psoriasis Area and Severity Index (PASI), which lacks sensitivity in patients with mild psoriasis. OBJECTIVE To compare the PGA×BSA versus the modified PASI (mPASI) for assessing disease severity and therapeutic response to calcipotriol/betamethasone dipropionate (Cal/BD) foam. METHODS This post hoc analysis evaluated the efficacy of Cal/BD foam in mild, moderate, and severe psoriasis, as assessed by the PGA×BSA and mPASI, using data from 3 randomized controlled trials (NCT01536886, NCT01866163, NCT02132936). Spearman correlation and Bland-Altman plots were used to compare the PGA×BSA with the mPASI. RESULTS Proportions of patients receiving Cal/BD foam achieving 75% response for PGA×BSA and mPASI at weeks 1, 2, and 4 were similar and significantly greater than with vehicle (P ≤ .002 at all timepoints); at week 4, mean improvements were 51.0% and 50.7%, respectively. Spearman correlations for mild, moderate, and severe psoriasis were moderate to high between PGA×BSA and mPASI at baseline (r = .51, .72, and .86, respectively; n = 126, 465, and 58, respectively) and high at week 4 (r = .80, .81, and .89, respectively; n = 121, 452, and 58, respectively) (P < .001). LIMITATIONS Pooled data from different trials were not prespecified for post hoc analysis. Interrater reliability was not assessed. CONCLUSION Pooled data analysis showed that the PGA×BSA and mPASI correlation was higher with increasing psoriasis severity.
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Pain Control Interventions in Preterm Neonates: A Randomized Controlled Trial.
Shukla, VV, Bansal, S, Nimbalkar, A, Chapla, A, Phatak, A, Patel, D, Nimbalkar, S
Indian pediatrics. 2018;(4):292-296
Abstract
OBJECTIVE To compare individual efficacy and additive effects of pain control interventions in preterm neonates. DESIGN Randomized controlled trial. SETTING Level-3 University affiliated neonatal intensive care unit. PARTICIPANTS 200 neonates (26-36 wk gestational age) requiring heel-prick for bedside glucose assessment. Exclusion criteria were neurologic impairment and critical illness precluding study interventions. INTERVENTION Neonates were randomly assigned to Kangaroo mother care with Music therapy, Music therapy, Kangaroo Mother care or Control (no additional intervention) groups. All groups received expressed breast milk with cup and spoon as a baseline pain control intervention. MAIN OUTCOME MEASURES Assessment of pain using Premature Infant Pain Profile (PIPP) score on recorded videos. RESULTS The mean (SD) birth weight and gestational age of the neonates was 1.9 (0.3) kg and 34 (2.3) wk, respectively. Analysis of variance showed significant difference in total PIPP score across groups (P<0.001). Post-hoc comparisons using Sheffe's test revealed that the mean (SD) total PIPP score was significantly lower in Kangaroo mother care group [7.7 (3.9) vs. 11.5 (3.4), 95% CI(-5.9, -1.7), P<0.001] as well as Kangaroo mother care with Music therapy group [8.5 (3.2) vs. 11.5 (3.4), 95%CI (-5.1, -0.9), P=0.001] as compared to Control group. PIPP score was not significantly different between Control group and Music therapy group. CONCLUSIONS Kangaroo mother care with and without Music therapy (with expressed breast milk) significantly reduces pain on heel-prick as compared to expressed breast milk alone. Kangaroo mother care with expressed breast milk should be the first choice as a method for pain control in preterm neonates.
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Cross-sectional associations between dietary intake and carotid intima media thickness in type 2 diabetes: baseline data from a randomised trial.
Chiavaroli, L, Mirrahimi, A, Ireland, C, Mitchell, S, Sahye-Pudaruth, S, Coveney, J, Olowoyeye, O, Patel, D, de Souza, RJ, Augustin, LS, et al
BMJ open. 2017;(3):e015026
Abstract
OBJECTIVE To assess associations between dietary intake and carotid intima media thickness (CIMT) by carotid ultrasound (CUS), a surrogate marker of cardiovascular disease (CVD) risk, in those with type 2 diabetes. DESIGN Cross-sectional analysis of baseline data from 325 participants from three randomised controlled trials collected in the same way. SETTING Risk Factor Modification Centre, St. Michael's Hospital, Toronto, Canada. PARTICIPANTS 325 participants with type 2 diabetes, taking oral antidiabetic agents, with an HbA1c between 6.5% and 8.0% at screening, without a recent cardiovascular event. MAIN OUTCOME MEASURES CIMT by CUS and associations with dietary intake from 7-day food records, as well as anthropometric measures and fasting serum samples. RESULTS CIMT was significantly inversely associated with dietary pulse intake (β=-0.019, p=0.009), available carbohydrate (β=-0.004, p=0.008), glycaemic load (β=-0.001, p=0.007) and starch (β=-0.126, p=0.010), and directly associated with total (β=0.004, p=0.028) and saturated (β=0.012, p=0.006) fat intake in multivariate regression models adjusted for age, smoking, previous CVD event, blood pressure medication, antidiabetic medication and ultrasonographer. CONCLUSIONS Lower CIMT was significantly associated with greater consumption of dietary pulses and carbohydrates and lower total and saturated fat intake, suggesting a potential role for diet in CVD risk management in type 2 diabetes. Randomised controlled trials are anticipated to explore these associations further. TRIAL REGISTRATION NUMBER NCT01063374.
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Low-glycaemic index diet to improve glycaemic control and cardiovascular disease in type 2 diabetes: design and methods for a randomised, controlled, clinical trial.
Chiavaroli, L, Mirrahimi, A, Ireland, C, Mitchell, S, Sahye-Pudaruth, S, Coveney, J, Olowoyeye, O, Maraj, T, Patel, D, de Souza, RJ, et al
BMJ open. 2016;(7):e012220
Abstract
INTRODUCTION Type 2 diabetes (T2DM) produces macrovascular and microvascular damage, significantly increasing the risk of cardiovascular disease (CVD), renal failure and blindness. As rates of T2DM rise, the need for effective dietary and other lifestyle changes to improve diabetes management become more urgent. Low-glycaemic index (GI) diets may improve glycaemic control in diabetes in the short term; however, there is a lack of evidence on the long-term adherence to low-GI diets, as well as on the association with surrogate markers of CVD beyond traditional risk factors. Recently, advances have been made in measures of subclinical arterial disease through the use of MRI, which, along with standard measures from carotid ultrasound (CUS) scanning, have been associated with CVD events. We therefore designed a randomised, controlled, clinical trial to assess whether low-GI dietary advice can significantly improve surrogate markers of CVD and long-term glycaemic control in T2DM. METHODS AND ANALYSIS 169 otherwise healthy individuals with T2DM were recruited to receive intensive counselling on a low-GI or high-cereal fibre diet for 3 years. To assess macrovascular disease, MRI and CUS are used, and to assess microvascular disease, retinal photography and 24-hour urinary collections are taken at baseline and years 1 and 3. Risk factors for CVD are assessed every 3 months. ETHICS AND DISSEMINATION The study protocol and consent form have been approved by the research ethics board of St. Michael's Hospital. If the study shows a benefit, these data will support the use of low-GI and/or high-fibre foods in the management of T2DM and its complications. TRIAL REGISTRATION NUMBER NCT01063374; Pre-results.
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Randomised controlled trial of alternative messages to increase enrolment in a healthy food programme among individuals with diabetes.
Gopalan, A, Paramanund, J, Shaw, PA, Patel, D, Friedman, J, Brophy, C, Buttenheim, AM, Troxel, AB, Asch, DA, Volpp, KG
BMJ open. 2016;(11):e012009
Abstract
OBJECTIVES We compared the effectiveness of diabetes-focused messaging strategies at increasing enrolment in a healthy food programme among adults with diabetes. METHODS Vitality is a multifaceted wellness benefit available to members of Discovery Health, a South Africa-based health insurer. One of the largest Vitality programmes is HealthyFood (HF), an incentive-based programme designed to encourage healthier diets by providing up to 25% cashback on healthy food purchases. We randomised adults with type 2 diabetes to 1 of 5 arms: (1) control, (2) a diabetes-specific message, (3) a message with a recommendation of HF written from the perspective of a HF member with diabetes, (4) a message containing a physician's recommendation of HF, or (5) the diabetes-specific message from arm 2 paired with an 'enhanced active choice'(EAC). In an EAC, readers are asked to make an immediate choice (in this case, to enrol or not enrol); the pros and cons associated with the preferred and non-preferred options are highlighted. HF enrolment was assessed 1 month following the first emailed message. RESULTS We randomised 3906 members. After excluding those who enrolled in HF or departed from the Vitality programme before the first intervention email, 3665 (94%) were included in a modified intent-to-treat analysis. All 4 experimental arms had significantly higher HF enrolment rates compared with control (p<0.0001 for all comparisons). When comparing experimental arms, the diabetes-specific message with the EAC had a significantly higher enrolment rate (12.6%) than the diabetes-specific message alone (7.6%, p=0.0016). CONCLUSIONS Messages focused on diabetes were effective at increasing enrolment in a healthy food programme. The addition of a framed active choice to a message significantly raised enrolment rates in this population. These findings suggest that simple, low-cost interventions can enhance enrolment in health promoting programmes and also be pragmatically tested within those programmes. TRIAL REGISTRATION NUMBER NCT02462057.
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Can Iron Treatments Aggravate Epistaxis in Some Patients With Hereditary Hemorrhagic Telangiectasia?
Shovlin, CL, Gilson, C, Busbridge, M, Patel, D, Shi, C, Dina, R, Abdulla, FN, Awan, I
The Laryngoscope. 2016;(11):2468-2474
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OBJECTIVES/HYPOTHESIS To examine whether there is a rationale for iron treatments precipitating nosebleeds (epistaxis) in a subgroup of patients with hereditary hemorrhagic telangiectasia (HHT). STUDY DESIGN Survey evaluation of HHT patients, and a randomized control trial in healthy volunteers. METHODS Nosebleed severity in response to iron treatments and standard investigations were evaluated by unbiased surveys in patients with HHT. Serial blood samples from a randomized controlled trial of 18 healthy volunteers were used to examine responses to a single iron tablet (ferrous sulfate, 200 mg). RESULTS Iron tablet users were more likely to have daily nosebleeds than non-iron-users as adults, but there was no difference in the proportions reporting childhood or trauma-induced nosebleeds. Although iron and blood transfusions were commonly reported to improve nosebleeds, 35 of 732 (4.8%) iron tablet users, in addition to 17 of 261 (6.5%) iron infusion users, reported that their nosebleeds were exacerbated by the respective treatments. These rates were significantly higher than those reported for control investigations. Serum iron rose sharply in four of the volunteers ingesting ferrous sulfate (by 19.3-33.1 μmol/L in 2 hours), but not in 12 dietary controls (2-hour iron increment ranged from -2.2 to +5.0 μmol/L). High iron absorbers demonstrated greater increments in serum ferritin at 48 hours, but transient rises in circulating endothelial cells, an accepted marker of endothelial damage. CONCLUSIONS Iron supplementation is essential to treat or prevent iron deficiency, particularly in patients with pathological hemorrhagic iron losses. However, in a small subgroup of individuals, rapid changes in serum iron may provoke endothelial changes and hemorrhage. LEVEL OF EVIDENCE 4. Laryngoscope, 126:2468-2474, 2016.