Development and Validation of the Transition Readiness Assessment Instrument in Type 1 Diabetes "On TRAck".

OBJECTIVES: Transition to adult care is challenging for youth with type 1 diabetes (T1D) and their caregivers. We have developed the diabetes-specific "On TRAck" transition readiness scale, and in this study we assess its reliability and validity compared with TRANSITION-Q, a generic transition readiness questionnaire. METHODS: We systematically created 3 versions of On TRAck: adolescent, parent and health-care provider (HCP) versions (for case managers and physicians). Among adolescents 13 to 18 years of age with T1D at a single academic centre, we conducted an exploratory factor analysis and assessed interrater agreement, internal consistency and relationship with age; recent glycated hemoglobin (A1C); and recent diabetic ketoacidosis (DKA) with On TRAck and TRANSITION-Q. RESULTS: One hundred fifteen adolescents (aged 15.8±1.6 years and diabetes duration 6.7±4.1 years), their caregivers and diabetes HCPs participated. The final 24-item adolescent and parent scales (with 3 subscales: "Self-efficacy," "Autonomy" and "Support & maturity") and the 3-item HCP version had a Cronbach's alpha of 0.86 to 0.93. Adolescent scores correlated with parents (r=0.64), case managers (r=0.39) and physicians (r=0.28). Mean adolescent score was 190.3±27.1 points out of 240. Adolescent scores were 3.4 points higher per year of age (p=0.03) and 4.4 points higher for every 1% lower A1C (p=0.01), but were not associated with DKA. TRANSITION-Q was associated with age. On TRAck HCP scores were associated with adolescent's age, A1C and DKA. CONCLUSIONS: On TRAck represents a new psychometrically comprehensive diabetes-specific scale that can be used in adolescent diabetes clinics for measuring transition readiness. It is a multidimensional instrument with ease of use and high reliability scores.

Efficacy of Treatments for Polycystic Ovarian Syndrome Management in Adolescents.

Limited evidence on treatment options for polycystic ovarian syndrome (PCOS) has led to considerable variation in health care practices. We aimed to compare the effects of metformin and/or oral contraceptive pills (OCP) in combination with pioglitazone, spironolactone, flutamide, and lifestyle interventions among adolescents aged 11 to 19 years with PCOS. Literature searches were performed in Medline, Embase, and the Cochrane Central Register of Controlled Trials from database inception through December 2018, with no language restriction. Two reviewers screened titles and abstracts, assessed full text eligibility, and extracted information from eligible trials. Evidence was synthesized through network meta-analyses (NMA) using a Bayesian random-effects approach. We identified 37 randomized controlled trials, in which 2400 patients were randomized. NMA showed no statistically important difference among all interventions to improve menstrual regulation or body mass index. Moderate-quality evidence showed hirsutism scores were reduced by multiple interventions that included single and combination medications namely; lifestyle intervention, metformin, OCP, spironolactone, pioglitazone, metformin-OCP, metformin-spironolactone, and metformin-flutamide against placebo. Moderate-quality evidence showed OCP results in more dysglycemia compared to metformin (odds ratio, 2.98; 95% credible interval, 1.02-8.96), no intervention resulted in dysglycemia reduction. In conclusion, metformin and OCP as monotherapy or in combination with other interventions compared with placebo can reduce hirsutism scores, but none of these medications lead to effective menstrual cycle regulation or weight reduction. However, the use of OCP leads to worse cardiometabolic risk factors. Further research into new treatment options is urgently needed. PROSPERO REGISTRATION NUMBER: CRD42015016148.

The effect of adding metformin to insulin therapy for type 1 diabetes mellitus children: A systematic review and meta-analysis.

We aimed to assess the effectiveness of adding metformin to insulin in type 1 diabetes mellitus (T1DM) children for improving metabolic outcomes. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) conducted on children age 6 to 19 years who are diagnosed with T1DM, and examined the effect of adding Metformin to standard insulin therapy. We performed literature searches on Ovid Midline, Ovid Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) from the date of inception of the database to February 15, 2016. Two reviewers screened titles and abstracts independently, assessed full text eligibility, and extracted information from eligible trials. The primary outcome is glycated hemoglobin (HbA1c), and the secondary outcomes are health-related quality of life, body mass index (BMI), lipid profile, total insulin daily dose, hypoglycaemia, and diabetes ketoacidosis. We screened 736 studies, and included 6 RCTs with 325 patients. All RCTs were of low risk of bias, and included adolescents (mean age 15 years). The meta-analysis showed that the addition of Metformin resulted in decreased total insulin daily dose (TIDD) (unit/kg/d) (mean difference [MD] = -0.15, 95%CI, -0.24, -0.06), and reduced BMI kg/m2 (MD -1.46, 95%CI -2.54, 0.38), and BMI z-score (MD= - 0.11, 95%CI -0.21, -0.01), and similar HbA1c (%) (MD= - 0.05, 95%CI, -0.19, 0.29). The overall evidence quality was high to moderate. Current evidence does not support use of Metformin in T1DM adolescents to improve HbA1c. However, Metformin may provide modest reduction in TIDD and BMI.

Metformin or Oral Contraceptives for Adolescents With Polycystic Ovarian Syndrome: A Meta-analysis.

BACKGROUND: Polycystic ovarian syndrome (PCOS) is a common disease. There is limited evidence to support various treatment choices. This leads to variable treatment practices. OBJECTIVES: To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the use of metformin versus oral contraceptive pills (OCPs) for the treatment of PCOS in adolescents aged 11 to 19 years. DATA SOURCES: We performed literature searches through Ovid Medline, Ovid Embase, Cochrane Central Register of Controlled Trials, and gray literature resources, up to January 29, 2015. STUDY SELECTION AND DATA EXTRACTION: Two reviewers screened titles and abstracts of identified citations, assessed full text eligibility, and extracted information from eligible trials. RESULTS: Four RCTs met the inclusion and exclusion criteria. The reviewed evidence came from 170 patients. Overall, OCP treatment resulted in modest improvement in menstrual cycle frequency (weighted mean difference [WMD] = 0.27, P < .01, 95% confidence interval [CI] -0.33 to -0.21) and mild reduction of acne scores (WMD = 0.3, P = .02, 95% CI 0.05 to 0.55). While metformin resulted in greater BMI reduction (WMD = -4.02, P < .01, 95% CI -5.23 to -2.81) it was associated with decreased dysglycemia prevalence (risk ratio: 0.41, P = .02, 95% CI 0.19 to 0.86) and improved total cholesterol and low-density lipoprotein levels. Metformin and OCPs were similar in terms of impact on hirsutism. CONCLUSIONS AND LIMITATIONS: Current evidence is derived from very low to low quality evidence. Therefore, treatment choice should be guided by patient values and preferences while balancing potential side effects. Future high quality RCTs are needed to address several questions for the treatment of adolescents with PCOS.

Effect of serotonin modulating pharmacotherapies on body mass index and dysglycaemia among children and adolescents: a systematic review and network meta-analysis protocol.

INTRODUCTION: Serotonin-modulating medications are commonly prescribed for mental health issues. Currently, there is limited consensus on weight gain and dysglycaemia development among children using these medications. The objective of this study is to review and synthesise all the available evidence on serotonin-modulating medications and their effects on body mass index (BMI), weight and glycaemic control. METHODS AND ANALYSIS: We will conduct a systematic review of all randomised controlled trials evaluating the use of serotonin-modulating medications in the treatment of children 2-17 years with mental health conditions. The outcome measures are BMI, weight and dysglycaemia. We will perform literature searches through Ovid Medline, Ovid Embase, PsycINFO and grey literature resources. Two reviewers from the team will independently screen titles and abstracts, assess the eligibility of full-text trials, extract information from eligible trials and assess the risk of bias and quality of the evidence. Results of this review will be summarised narratively and quantitatively as appropriate. We will perform a multiple treatment comparison using network meta-analysis to estimate the pooled direct, indirect and network estimate for all serotonin-modulating medications on outcomes if adequate data are available. ETHICS AND DISSEMINATION: Serotonin-modulating medications are widely prescribed for children with mental health diseases and are also used off-label. This network meta-analysis will be the first to assess serotonin modulating antidepressants and their effects on weight and glycaemic control. We anticipate that our results will help physicians and patients make more informed choices while considering the side effect profile. We will disseminate the results of the systematic review and network meta-analysis through peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42015024367.

The effectiveness and safety of treatments used for polycystic ovarian syndrome management in adolescents: a systematic review and network meta-analysis protocol.

BACKGROUND: Polycystic ovarian syndrome (PCOS) is a common reproductive endocrine disease that is seen among adolescent women. Currently, there is limited evidence to support treatment options leading to considerable variation in practice among healthcare specialists. The objective of this study is to review and synthesize all the available evidence on treatment options for PCOS among adolescent women. METHODS/DESIGN: We will conduct a systematic review of all randomized controlled trials evaluating the use of metformin, oral contraceptive pills as monotherapy, or as combination with pioglitazone, spironolactone, flutamide, and lifestyle interventions in the treatment of PCOS in adolescent women ages 11 to 19 years. The primary outcome measures are menstrual regulation and change hirsutism scores. The secondary outcome measures include acne scores, prevalence of dysglycaemia, BMI, lipid profile, total testosterone level, and adverse events. We will perform literature searches through Ovid Medline, Ovid Embase, and Cochrane Central Register of Controlled Trials (CENTRAL), and gray literature resources. Two reviewers will independently screen titles and abstracts of identified citations, review the full texts of potentially eligible trials, extract information from eligible trials, and assess the risk of bias and quality of the evidence independently. Results of this review will be summarized narratively and quantitatively as appropriate. We will perform a multiple treatment comparison using network meta-analysis to estimate the pooled direct and indirect effects for all PCOS interventions on outcomes if adequate data is available. DISCUSSION: PCOS treatment poses a clinical challenge to the patients and physicians. This is the first systematic review and network meta-analysis for PCOS treatment in adolescents. We expect that our results will help improve patient care, unify the treatment approaches among specialists, and encourage research for other therapeutic options. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015016148.