Tools for Enhancement and Quality Improvement of Peer Assessment and Clinical Care in Endocrinology and Metabolism.

Members of the College of Physicians and Surgeons of Ontario Endocrinology and Metabolism Peer Review Network have been involved in a quality improvement project to help standardize the peer assessment of physicians practicing in endocrinology and metabolism. This has included developing state-of-the-art summaries of common endocrine problems by Canadian experts in endocrinology and metabolism. These tools have been developed in response to the educational needs, as identified by peer reviewers, of practicing endocrinologists in Ontario. These pedagogical tools aim not only to standardize the documentation of the clinical performance of endocrinologists but also to make the process more transparent and to improve the quality of patient care in Ontario. This article summarizes the project and also provides the tools developed for the endocrinology and metabolism section of the College of Physicians and Surgeons of Ontario.

Finding the Optimal volume and intensity of Resistance Training Exercise for Type 2 Diabetes: The FORTE Study, a Randomized Trial.

AIM: To compare different volumes and intensities of resistance training (RT) combined with aerobic training (AT) for improvements in glycemic control and cardiovascular health for persons with type 2 diabetes (T2DM). METHODS: Participants with T2DM were stratified by HbA1c and randomized: "usual care" (RT1), which consisted of moderate intensity (50% 1-repetition maximum [1-RM]), low volumeRT (initiated half-way through program); higher intensity (75% 1-RM) and higher volume (initiated at program onset) RT (RT2); or moderate intensity but higher volume RT (RT3). RT sets and repetitions were adjusted to maintain similar work and volume between RT2 and RT3. Walking or cycling (60-80% aerobic capacity)was prescribed 5 times/week, and RT was prescribed 2 times/week. An ANCOVA, adjusted for baseline and gender, assessed changes post-6months in glycemic control (HbA1c- primary outcome), aerobic capacity and anthropometrics. RESULTS: Sixty-two participants (52.3±1.2years, 48% female) were randomized (RT1, n=20; RT2, n=20; RT3, n=22). Only post-training fasting glucose, without significant HbA1c change, was different between groups (RT1-RT3=-1.7mmol/L, p=0.046). Pre-post differences were found in pooled HbA1c (7.4±0.2%[57±2.2mmol/mol] vs. 6.7±0.2%[50±2.2mmol/mol], p<0.001), aerobic capacity (21.5±0.8vs. 25.2±0.8ml/kg/min, p<0.001), body mass (84.0±2.7vs. 83.0±2.7kg, p=0.022[DXA]), body mass index (30.8±0.9vs. 30.3±0.8kg/m2, p=0.02) and body fat (32.3±1.1vs. 31.3±1.2%, p<0.001). The trial was discontinued early; no HbA1c advantage was found with either RT2 or RT3 over RT1. CONCLUSIONS: Combined AT+RT exercise improved glycemic control, cardiovascular risk factors and body composition after 6months for participants with T2DM, but differential effects between the prescribed intensities and volumes of RT were not found to effect HbA1c.

Crying, oral contraceptive use and the menstrual cycle.

BACKGROUND: Crying, a complex neurobiological behavior with psychosocial and communication features, has been little studied in relationship to the menstrual cycle. METHODS: In the Mood and Daily Life study (MiDL), a community sample of Canadian women aged 18-43 years, n=76, recorded crying proneness and crying frequency daily for six months along with menstrual cycle phase information. RESULTS: Crying proneness was most likely during the premenstruum, a little less likely during menses and least likely during the mid-cycle phase, with statistically significant differences although the magnitude of these differences were small. By contrast, actual crying did not differ between the three menstrual cycle phases. Oral contraceptive use did not alter the relationship between menstrual cycle phase and either crying variable. A wide range of menstrual cycle phase - crying proneness patterns were seen with visual inspection of the individual women's line graphs. LIMITATIONS: timing of ovulation was not ascertained. Using a three phase menstrual cycle division precluded separate late follicular and early luteal data analysis. The sample size was inadequate for a robust statistical test of actual crying. CONCLUSIONS: reproductive aged women as a group report feeling more like crying premenstrually but may not actually cry more during this menstrual cycle phase. Individual patterns vary substantially. Oral contraceptive use did not affect these relationships. Suggestions for future research are included.

Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial.

OBJECTIVE: Better Nights/Better Days, a distance intervention for insomnia in school-aged children (with and without attention-deficit/hyperactivity disorder [ADHD]), was evaluated to determine its effectiveness on children's sleep and psychosocial functioning. METHODS: A single center, parallel group design randomized controlled trial (stratified on ADHD diagnosis) was conducted. Parents were randomized to intervention (n = 31) or waitlist control (n = 30), and completed questionnaires administered over the phone at baseline, postintervention (2 months), and follow-up (6 months). Actigraphy was also collected. The intervention consisted of a five-session manual and weekly telephone coach support. RESULTS: The intervention group demonstrated a significant reduction in sleep problems and improved psychosocial functioning at postintervention and follow-up. Actigraphy results indicated improved sleep onset, but not sleep duration. Children with and without ADHD responded in a similar manner to this intervention. Parents provided high satisfaction ratings. CONCLUSIONS: This intervention holds promise as an accessible, sustainable, and effective program to address insomnia in school-aged children.

The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women.

BACKGROUND: Obesity in infertile women increases the costs of fertility treatments, reduces their effectiveness and increases significantly the risks of many complications of pregnancy and for the newborn. Studies suggest that even a modest loss of 5-10 % of body weight can restore ovulation. However, there are gaps in knowledge regarding the benefits and cost-effectiveness of a lifestyle modification program targeting obese infertile women and integrated into the fertility clinics. This study will evaluate clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women. We hypothesize that the intervention will: 1) improve fertility, efficacy of fertility treatments, and health of mothers and their children; and 2) reduce the cost per live birth, including costs of fertility treatments and pregnancy outcomes. METHODS/DESIGN: Obese infertile women (age: 18-40 years; BMI ≥30 kg/m(2) or ≥27 kg/m(2) with polycystic ovary syndrome) will be randomised to either a lifestyle intervention followed by standard fertility treatments after 6 months if no conception has been achieved (intervention group) or standard fertility treatments only (control group). The intervention and/or follow-up will last for a maximum of 18 months or up to the end of pregnancy. Evaluation visits will be planned every 6 months where different outcome measures will be assessed. The primary outcome will be live-birth rates at 18 months. The secondary outcomes will be sub-divided into four categories: lifestyle and anthropometric, fertility, pregnancy complications, and neonatal outcomes. Outcomes and costs will be also compared to similar women seen in three fertility clinics across Canada. Qualitative data will also be collected from both professionals and obese infertile women. DISCUSSION: This study will generate new knowledge about the implementation, impacts and costs of a lifestyle management program in obese infertile women. This information will be relevant for decision-makers and health care professionals, and should be generalizable to North American fertility clinics. TRIAL REGISTRATION: ClinicalTrials.gov NCT01483612. Registered 25 November 2011.

Sleep quality and the menstrual cycle.

OBJECTIVE: This study aimed to assess the temporal relationship of subjective sleep quality to menstrual cycle phase in a community (non help-seeking) sample of adult women over six months. Previous work has produced contradictory results and often used student samples. PATIENTS/METHODS: This was a cohort study, using daily electronic data collection in the Greater Toronto Area, Ontario, Canada; 76 women aged 18-42 years recruited by random digit telephone dialing, recorded mood, sleep quality, and other health variables on a daily basis for 24 weeks. RESULTS: Using linear mixed models, we assessed the relationship between subjective sleep quality and three menstrual cycle phases (menses, premenstrual and midcycle) over 395 cycles. Premenstrual sleep quality was poorer than during the rest of the cycle, with a mean difference of 1.32 between premenstrual and midcycle reference phase, on a 1-100 quality scale (higher score denotes poorer quality). This difference held when the independent variables of daily exercise and physical health were added to the model; it became non-significant when perceived stress and later, social support were also added to the model. CONCLUSIONS: Sleep quality in adult non-help seeking women is statistically poorer in the premenstruum but the size of the difference is of little clinical significance and was no longer statistically significant with inclusion of the potentially confounding variables, perceived stress and social support.

Mood and the menstrual cycle.

BACKGROUND: Premenstrual mood symptoms are considered common in women, but such prevailing attitudes are shaped by social expectations about gender, emotionality and hormonal influences. There are few prospective, community studies of women reporting mood data from all phases of the menstrual cycle (MC). We aimed (i) to analyze daily mood data over 6 months for MC phase cyclicity and (ii) to compare MC phase influences on a woman's daily mood with that attributable to key alternate explanatory variables (physical health, perceived stress and social support). METHOD: A random sample of Canadian women aged 18-40 years collected mood and health data daily over 6 months, using telemetry, producing 395 complete MCs for analysis. RESULTS: Only half the individual mood items showed any MC phase association; these links were either with the menses phase alone or the menses plus the premenstrual phase. With one exception, the association was not solely premenstrual. The menses-follicular-luteal MC division gave similar results. Less than 0.5% of the women's individual periodogram records for each mood item showed MC entrainment. Physical health, perceived stress and social support were much stronger predictors of mood (p < 0.0001 in each case) than MC phase. CONCLUSIONS: The results of this study do not support the widespread idea of specific premenstrual dysphoria in women. Daily physical health status, perceived stress and social support explain daily mood better than MC phase.

The association between the combined oral contraceptive pill and insulin resistance, dysglycemia and dyslipidemia in women with polycystic ovary syndrome: a systematic review and meta-analysis of observational studies.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common endocrine disorder of young women. First-line treatment is often the oral contraceptive pill (OC), but evidence suggests that OC may worsen metabolic outcomes in this population. We undertook this meta-analysis of observational studies and cohorts from within randomized controlled studies to investigate the association between OC use and dysglycemia, dyslipidemia and insulin resistance (IR) in women with PCOS. METHODS: We searched MEDLINE (1966-April 2010), EMBASE (1980-April 2010) and All EBM Reviews. We included prospective cohorts and RCTs that treated women, aged 13-44, with PCOS with OC for at least 3 months. Blinded quality assessment and data extraction were conducted on 35 included studies by two independent reviewers. We used random effects methods to calculate weighted mean differences as the effect size. We investigated heterogeneity using sequential removal of studies, subgroup analysis and meta-regression. RESULTS: OC use was significantly associated with an increase in high-density lipoprotein cholesterol (HDL-C) (P = 0.004) and triglycerides (P = 0.004). Significant heterogeneity was found in glucose, cholesterol, HDL-C, low-density lipoprotein cholesterol triglycerides, fasting glucose to insulin ratios and homeostatic model assessments-IR. Study characteristics such as mean BMI, mean age and duration of study could explain some of the heterogeneity. CONCLUSIONS: Use of OC was not associated with clinically significant adverse metabolic consequences. Because of limitations of the underlying studies, further research including rigorously designed randomized trials would more definitively confirm our findings.

Oligomenorrhoea in exercising women: a polycystic ovarian syndrome phenotype or distinct entity?

To date, the predominant mechanism underlying menstrual disturbances in exercising women supports an underlying energy deficiency-related aetiology, in which a failure to compensate dietary intake for the energy cost of exercise suppresses reproductive function. Increasing evidence demonstrates that energy deficiency plays a causal role in the induction of amenorrhoea in exercising women, and consistent with this mechanism are findings of glucoregulatory perturbations such as low triiodothyronine, reduced insulin secretion and elevated cortisol, growth hormone and ghrelin levels. The menstrual disturbance that may differ in its energetic characteristics and, perhaps in its androgenic and ovarian steroid environment, is oligomenorrhoea. We conducted a systematic review of the literature to begin to understand whether oligomenorrhoea in exercising women is a mild subclinical phenotype of polycystic ovarian syndrome (PCOS) in which exercise is conferring beneficial effects in protecting women from the classic PCOS phenotype, or whether oligomenorrhoea is part of the spectrum of menstrual disturbances caused by an energy deficiency that is often reported in exercising women with menstrual disturbances. We included observational, randomized controlled trials and cross-sectional studies that reported clinical, hormonal and metabolic profiles in exercising women with amenorrhoea or oligomenorrhoea and in women with PCOS. Previous studies examining the underlying mechanisms and consequences of exercise-associated menstrual disturbances have grouped exercising amenorrhoeic and oligomenorrhoeic women into a single group, and have relied primarily on self-reported menstrual history. Although scarce, the data available to date suggest that hyperandrogenism, such as that observed in PCOS, may likely be associated with oligomenorrhoea in exercising women, and may not always represent hypothalamic inhibition secondary to an energy deficiency. It is critical to closely examine the metabolic and endocrine status of women with menstrual disturbances because the treatment strategies for energy deficiency-related menstrual disturbances differ from that of disturbances traceable to hyperandrogenaemia. Further investigation is necessary to explore whether different endocrine aetiologies underly menstrual disturbances, particularly oligomenorrhoea, in physically active women.