The prototype of a preference-based index of weight-related quality of life: demonstrating the possibilities.

PURPOSE: Evidence for comparative and cost-effectiveness of weight-loss interventions is lacking as there are no obesity-specific measures fit for this purpose. This study aimed to estimate the extent to which a prototype of a brief, multi-dimensional obesity-specific Preference-Based Index of Weight-Related Quality of Life (PBI-WRQL) could fill this gap. METHODS: Longitudinal data from a Canadian bariatric cohort was used. Forty-eight items from the IWQoL-Lite, EQ-5D-3L, and SF-12V2 were mapped onto the WHO ICF domains, and one item was chosen for the dimension based on fit to the Rasch model. Individuals' health ratings (0-100) were regressed on each dimension, and the regression coefficients for the response options were used as weights to generate a total score. Generalized estimation equations were used to compare measure parameters across groups and levels of converging constructs. RESULTS: Pre-surgery data were available on 201 people (Women: 82%; BMI: 48.8 ± 6.7 kg/m2; age: 43 ± 9.0 years) and on 125 (62%) at 6 months post-bariatric surgery. Seven dimensions with three response options formed the PB-WRQL prototype: Mobility/Physical Function, Pain, Depression, Participation, Energy, Peripheral Edema, and Dyspnea. The prototype showed substantial change (mean + 40) with bariatric surgery, higher than the EQ-5D (mean + 11.5). The prototype showed the strongest relationship with BMI at baseline (t = - 3.68) and was the most sensitive to change in BMI (t = - 3.42). CONCLUSION: This study demonstrates that a brief, 7-dimension index weighted by health impact performed as well as the 31-item IWQoL-Lite and better than the EQ-5D-3L. These findings demonstrate the potential value of the brief PB-WRQL prototype index and support its further development using preference weights to reflect the current generation's needs and concerns.

Maternal history of asthma modifies the risk of childhood persistent asthma associated with maternal age at birth: Results from a large prospective cohort in Canada.

BACKGROUND: Asthma is a prevalent disease that affects many Canadians. Persistent asthma can affect quality of life, and has multiple health implications. Maternal age at birth has been associated with many adverse health outcomes in children. Conflicting study results exist regarding maternal age at birth and childhood asthma. The association between maternal age at birth and persistent asthma in children is still unknown. OBJECTIVE: To investigate the relationship between maternal age at birth and persistent asthma in children at ten years of age. METHODS: This is a prospective cohort study including all children aged 0-2 years who took part in the first cycle of the National Longitudinal Survey of Children and Youths (NLSCY) and were followed every two years until eight to ten years of age in Cycle 5. An interaction term between maternal age at birth and maternal asthma history was introduced in a multivariate model to examine modification effects of maternal asthma history on the association. RESULTS: Multivariate logistic regression demonstrated that older maternal age at birth was significantly associated with an increased risk of childhood persistent asthma in mothers with a history of asthma (OR = 1.20, 95% CI: 1.04-1.40, p = .016). No relationship was found in mothers without a history of asthma. CONCLUSION: Maternal history of asthma has an impact on the association between maternal age at birth and childhood persistent asthma in children by age ten. The finding may help explain the inconsistent results in the literature regarding the risk of asthma associated with maternal age at birth.

Diabetes and the occurrence of infection in primary care: a matched cohort study.

BACKGROUND: People with diabetes may be at higher risk for acquiring infections through both glucose-dependent and biologic pathways independent of glycemic control. Our aim was to estimate the association between diabetes and infections occurring in primary care. METHODS: Using the Newfoundland and Labrador Sentinel of the Canadian Primary Care Sentinel Surveillance Network, patients with diabetes ≥18 years between 1 January 2008 and 31 March 2013 were included with at least 1-year of follow-up. We randomly matched each patient with diabetes on the date of study entry with up to 8 controls without diabetes. Primary outcome was the occurrence of ≥1 primary care physician visits for any infectious disease. Secondary outcomes included primary visits for head & neck, respiratory, gastrointestinal, genitourinary, skin and soft tissue, musculoskeletal, and viral infections. Using multivariable conditional logistic regression analysis, we measured the independent association between diabetes and the occurrence of infections. RESULTS: We identified 1779 patients with diabetes who were matched to 11,066 patients without diabetes. Patients with diabetes were older, had a higher prevalence of comorbidities, and were more often referred to specialists. After adjusting for potential confounders, patients with diabetes had an increased risk of any infection compared to patients without diabetes (adjusted odds ratio = 1.21, 95% confidence interval 1.07-1.37). Skin and soft tissue infections had the strongest association, followed by genitourinary, gastrointestinal, and respiratory infections. Diabetes was not associated with head and neck, musculoskeletal, or viral infections. CONCLUSION: Patients with diabetes appear to have an increased risk of certain infections compared to patients without diabetes.

The usefulness and costs of routine contrast studies after laparoscopic sleeve gastrectomy for detecting staple line leaks.

BACKGROUND: Although laparoscopic sleeve gastrectomy (LSG) has been shown to be a safe and effective treatment for severe obesity (body mass index ≥ 35), staple line leaks remain a major complication and account for a substantial portion of the procedure's morbidity and mortality. Many centres performing LSG routinely obtain contrast studies on postoperative day 1 for early detection of staple line leaks. We examined the usefulness of Gastrografin swallow as an early detection test for staple line leaks on postoperative day 1 after LSG as well as the associated costs. METHODS: We conducted a retrospective review of a prospectively collected database that included 200 patients who underwent LSG for severe obesity between 2011 and 2014. Primary outcome measures were the incidence of staple line leaks and the results of Gastrografin swallow tests. We obtained imaging costs from appropriate hospital departments. RESULTS: Gastrografin swallow was obtained on postoperative day 1 for all 200 patients who underwent LSG. Three patients (1.5%) were found to have staple line leaks. Gastrograffin swallows yielded 1 true positive result and 2 false negatives. The false negatives were subsequently diagnosed on computed tomography (CT) scan. The sensitivity of Gastrografin swallow in this study was 33%. For 200 patients, the total direct cost of the Gastrografin swallows was $35 000. CONCLUSION: The use of routine upper gastrointestinal contrast studies for early detection of staple line leaks has low sensitivity and is costly. We recommend selective use of CT instead.

CONTEXTE: Même si la gastrectomie longitudinale par laparoscopie (GLL) s'est révélée sûre et efficace pour le traitement de l'obésité sévère (indice de masse corporelle ≥ 35), les fuites survenant à la ligne d'agrafes demeurent une complication majeure et sont responsables d'une bonne partie des complications et des décès associés à cette chirurgie. Plusieurs des centres effectuant des GLL procèdent au dépistage systématique des fuites à la ligne d'agrafes en réalisant des tests avec des agents de contraste le jour suivant la chirurgie. Nous avons évalué l'utilité du test à la gastrografine comme méthode de dépistage précoce des fuites à la ligne d'agrafes au jour 1, ainsi que les coûts qui y sont associés. MÉTHODES: Nous avons mené une étude rétrospective à partir d'une base de données créée de façon prospective qui portait sur 200 patients ayant subi une GLL entre 2011 et 2014 en raison d'une obésité sévère. Les principaux indicateurs de résultats étaient l'incidence de fuites à la ligne d'agrafes et les résultats obtenus aux tests à la gastrografine. Les renseignements sur le coût des tests d'imagerie nous ont été fournis par les départements appropriés des hôpitaux. RÉSULTATS: Selon les résultats des tests à la gastrografine au jour 1 obtenus pour les 200 patients ayant subi une GLL, 3 patients (1,5 %) présentaient des fuites à la ligne d'agrafes. Il s'agissait en réalité d'un vrai positif et 2 faux négatifs. Le diagnostic des faux négatifs a ensuite été effectué par tomographie par ordinateur. La sensibilité du test à la gastrografine était donc de 33 % au cours de cette étude. Le coût total de ce test, pour les 200 patients, était de 35 000 $. CONCLUSION: Le recours à des examens systématiques du tractus gastro-intestinal supérieur au moyen d'agents de contraste pour le dépistage précoce des fuites à la ligne d'agrafes a une faible sensibilité et est associé à des coûts élevés. Nous recommandons plutôt l'utilisation sélective de la tomographie par ordinateur.

Safety and Efficacy of Incretin-Based Therapies in Patients With Type 2 Diabetes Mellitus and CKD: A Systematic Review and Meta-analysis.

BACKGROUND: The pharmacokinetics and pharmacodynamics of antidiabetic therapies for patients with type 2 diabetes are often altered in the context of chronic kidney disease (CKD). STUDY DESIGN: Systematic review and meta-analysis. SETTING & POPULATION: Patients with type 2 diabetes and CKD. SELECTION CRITERIA FOR STUDIES: 2 reviewers independently screened studies identified through bibliographic databases (Cochrane Library, PubMed, Embase, International Pharmaceutical Abstracts), clinical trial registries, and references from pertinent articles and clinical practice guidelines. Eligible studies included randomized controlled trials evaluating incretin-based therapy in adults with type 2 diabetes and estimated glomerular filtration rates < 60mL/min/1.73m2. INTERVENTIONS: Incretin-based therapies (dipeptidyl peptidase 4 inhibitors and glucagon-like peptide 1 receptor agonists) compared to placebo or active antidiabetic therapies. OUTCOMES: Changes in glycated hemoglobin (HbA1c), hypoglycemia, mortality, change in fasting plasma glucose, cardiovascular events, and end-stage renal disease. RESULTS: Of 1,619 nonduplicate records screened, 13 studies were included. Compared to placebo, incretin-based therapies significantly reduced HbA1c levels (n = 9; weighted mean difference, -0.64; 95% CI, -0.79 to -0.48; I2 = 43%); however, compared with active comparators, they did not (n = 4; weighted mean difference, -0.07; 95% CI, -0.25 to 0.12; I2 = 38%). Incretin-based therapies significantly increased the risk for hypoglycemia compared to placebo (n = 7; relative risk [RR], 1.38; 95% CI, 1.01-1.89; I2 = 0%) but no effect was observed versus active comparators (n = 4; RR, 0.24; 95% CI, 0.03-1.94; I2 = 52%). Limited evidence exists for all-cause mortality (placebo: n = 7 [RR, 1.21; 95% CI, 0.64-2.29; I2 = 0%]; active comparators: n = 3 [RR, 0.70; 95% CI, 0.32-1.54; I2 = 0%]). LIMITATIONS: Variation among interventions, small number of studies, heterogeneity between studies, and high risk for attrition bias in 7 of the selected studies. CONCLUSIONS: In patients with moderate or severe CKD, incretin-based therapies are effective in reducing HbA1c levels. Hypoglycemic events are rare, and wide CIs for the association preclude any definitive conclusions. Likewise, wide CIs were observed for mortality, cardiovascular events, and end-stage renal disease.

The Newfoundland and Labrador Bariatric Surgery Cohort Study: Rational and Study Protocol.

BACKGROUND: In Canada, there has been a disproportionate increase in adults with Class II (BMI 35.0-39.9 kg/m2) or Class III obesity (BMI ≥ 40 kg/m2) affecting 9 % of Canadians with increases projected. Individuals affected by severe obesity (BMI ≥ 35) are at increased risk of high blood pressure, cardiovascular disease, diabetes, cancer, impaired quality of life, and premature mortality. Bariatric surgery is the most effective treatment for severe obesity. Laparoscopic sleeve gastrectomy (LSG), a relatively new type of bariatric surgery, is growing in popularity as a treatment. The global prevalence of LSG increased from 0 to 37.0 % between 2003 and 2013. In Canada and the US, between 2011 and 2013, the number of LSG surgeries increased by 244 % and LSG now comprises 43 % of all bariatric surgeries. Since 2011, Eastern Health, the largest regional health authority in Newfoundland and Labrador (NL), Canada has performed approximately 100 LSG surgeries annually. METHODS: A population-based prospective cohort study with pre and post surgical assessments at 1, 3, 6, 12, 18, 24 months and annually thereafter of patients undergoing LSG. This study will report on short - to mid-term (2-4 years) outcomes. Patients (n = 200) followed by the Provincial Bariatric Surgery Program between 19 and 70 years of age, with a BMI between 35.0 and 39.9 kg/m2 and an obesity-related comorbidity or with a BMI ≥ 40 kg/m2 are enrolled. The study is assessing the following outcomes: 1) complications of surgery including impact on nutritional status 2) weight loss/regain 3) improvement/resolution of comorbid conditions and a reduction in prescribed medications 4) patient reported outcomes using validated quality of life tools, and 5) impact of surgery on health services use and costs. We hypothesize a low complication rate, a marked reduction in weight, improvement/resolution of comorbid conditions, a reduction in related medications, improvement in quality of life, and a decrease in direct healthcare use and costs and indirect costs compared to pre-surgery. DISCUSSION: Limited data on the impact of LSG as a stand-alone procedure on a number of outcomes exist. The findings from this study will help to inform evidence-based practice, clinical decision-making, and the development of health policy.

High rates of International Code violations: a cross-sectional study in a region of Canada with low breastfeeding rates.

BACKGROUND: Exposure to marketing and promotion of commercial milk formula is associated with an increased likelihood of formula-feeding. In 1981, the International Code (IC) of Marketing of Breastmilk Substitutes was adopted by the 34th World Health Assembly to restrict the promotion, marketing and advertising of commercial milk formula and protect breastfeeding. RESEARCH AIM: The current study examines mothers' exposure to violations of the IC in Newfoundland and Labrador, a province of Canada with low breastfeeding rates. METHODS: A cross-sectional online survey measured exposure to IC violations (e.g., marketing, advertising and promotion of commercial milk formula) by mothers of infants less than two years old (n = 119). Data were collected on type, frequency, and location of violation. RESULTS: Most participants (87%, n = 104/119) reported exposure to at least one IC violation. Of this group (n = 104): 94% received coupons or discount codes for the purchase of commercial milk formula; 88% received free samples of commercial milk formula from manufacturers, and 79% were contacted directly by commercial milk formula companies via email, text message, mail or phone for advertising purposes. One-third (n = 28/104, 27%) observed commercial milk formula promotional materials in health care facilities. The most frequent locations were violations occurred were doctors' offices (79%), supermarkets(75%), and pharmacies (71%). CONCLUSION: The majority of mothers of young infants were exposed to violations of the IC involving the marketing, advertising and promotion of commercial milk formula. Companies producing commercial milk formula reached out directly to new mothers to offer unsolicited promotions and free samples of commercial milk formula.

A cross-sectional study of breastfed infants referred for tongue tie assessment and frenotomy in one Canadian health region.

Importance: Tongue tie (TT) is a condition that can cause infant feeding difficulties due to restricted tongue movement. When TT presents as a significant barrier to breastfeeding, a frenotomy may be recommended. Universally accepted diagnostic criteria for TT are lacking and wide prevalence estimates are reported. New referral processes and a Frenotomy Assessment Tool were implemented in one Canadian health region to connect breastfeeding dyads with a provider for TT evaluation and frenotomy. Objective: To determine the proportion of babies with TT as well as the frequency of frenotomy. Methods: This cross-sectional study included infants who initiated breastfeeding at birth and were referred for TT evaluation over a 14-month period. Data were collected retrospectively by chart review and analyzed using SPSS. Factors associated with frenotomy were examined using logistic regression. Results: Two hundred and forty-one babies were referred. Ninety-two percent (n = 222) were diagnosed with TT and 66.0% (n = 159) underwent frenotomy. In the multivariate model, nipple pain/trauma, inability to latch, inability to elevate tongue, and dimpling of tongue on extension were associated with frenotomy (P < 0.05). Most referrals in our region resulted in a diagnosis of TT; however, the number of referrals was lower than expected, and of these two-thirds underwent frenotomy. Interpretation: TT is a relatively common finding among breastfed infants. Future research should examine whether a simplified assessment tool containing the four items associated with frenotomy in our multivariate model can identify breastfed infants with TT who require frenotomy.

Patients' perceptions of waiting for bariatric surgery: a qualitative study.

BACKGROUND: In Canada waiting lists for bariatric surgery are common, with wait times on average > 5 years. The meaning of waiting for bariatric surgery from the patients' perspective must be understood if health care providers are to act as facilitators in promoting satisfaction with care and quality care outcomes. The aims of this study were to explore patients' perceptions of waiting for bariatric surgery, the meaning and experience of waiting, the psychosocial and behavioral impact of waiting for treatment and identify health care provider and health system supportive measures that could potentially improve the waiting experience. METHODS: Twenty-one women and six men engaged in in-depth interviews that were digitally recorded, transcribed verbatim and analysed using a grounded theory approach to data collection and analysis between June 2011 and April 2012. The data were subjected to re-analysis to identify perceived health care provider and health system barriers to accessing bariatric surgery. RESULTS: Thematic analysis identified inequity as a barrier to accessing bariatric surgery. Three areas of perceived inequity were identified from participants' accounts: socioeconomic inequity, regional inequity, and inequity related to waitlist prioritization. Although excited about their acceptance as candidates for surgery, the waiting period was described as stressful, anxiety provoking, and frustrating. Anger was expressed towards the health care system for the long waiting times. Participants identified the importance of health care provider and health system supports during the waiting period. Recommendations on how to improve the waiting experience included periodic updates from the surgeon's office about their position on the wait list; a counselor who specializes in helping people going through this surgery, dietitian support and further information on what to expect after surgery, among others. CONCLUSION: Patients' perceptions of accessing and waiting for bariatric surgery are shaped by perceived and experienced socioeconomic, regional, and waitlist prioritization inequities. A system addressing these inequities must be developed. Waiting for surgery is inherent in publicly funded health care systems; however, ensuring equitable access to treatment should be a health system priority. Supports and resources are required to ensure the waiting experience is as positive as possible.

Obesity prevalence estimates in a Canadian regional population of preschool children using variant growth references.

BACKGROUND: Childhood obesity is a public health problem in Canada. Accurate measurement of a health problem is crucial in defining its burden. The objective of this study is to compare the prevalence estimates of overweight and obesity in preschool children using three growth references. METHODS: Weights and heights were measured on 1026 preschool children born in Newfoundland and Labrador (NL), Canada, and body mass index calculated. The prevalence of overweight and obesity was determined and statistical comparisons conducted among the three growth references; the Centres for Disease Control (CDC), the International Obesity Task Force (IOTF) and the World Health Organization (WHO). RESULTS: CDC and IOTF produced similar estimates of the prevalence of overweight, 19.1% versus 18.2% while the WHO reported a higher prevalence 26.7% (p < .001). The CDC classified twice as many children as obese compared to the IOTF 16.6% versus 8.3% (p < .001) and a third more than the WHO 16.6% versus 11.3% (p < .01). There was variable level of agreement between methods. CONCLUSIONS: The CDC reported a much higher prevalence of obesity compared to the other references. The prevalence of childhood obesity is dependent on the growth reference used.

Evidence-Based Decision-Making 1: Critical Appraisal.

This chapter provides an introduction to the concept of Evidence-based Medicine (EBM) including its history, rooted in Canada and its important role in modern medicine. The chapter introduces EBM and explains the process of conducting EBM . The chapter starts with a description of the traditional hierarchy of evidence that exists in research with reference to the critical appraisal tools often used to assess the quality or credibility of individual studies. It includes a section on assessing risk of bias in randomized clinical trials and non-randomized studies and guidelines for reporting study findings now fully captured in the EQUATOR Network. In addition, a section on GRADE (Grades of Recommendation Assessment, Development and Evaluation) and the process used to determine the quality of evidence when guiding clinical decisions or developing clinical practice guidelines is included. In response to the substantial number of research syntheses being published, AMSTAR2, a tool used to critically appraise the quality and reporting of systematic reviews is described. The main focus of the chapter remains on how to critically appraise the medical literature, as one step in the EBM process. However, this process also includes an assessment of study bias and an understanding of reporting guidelines. At its basic level, critical appraisal requires an understanding of the strengths and weaknesses of study design and how these in turn impact the validity and applicability of research findings. Strong critical appraisal skills are critical to evidence-based decision-making .

Changing Health-Related Behaviors 1: Patient-Oriented Research and Patient Engagement in Health Research.

Engaging with patients and families is largely routine at the healthcare service or provision level. The concept of patient engagement in health research has a more recent history but is now often endorsed by leading journals and funders. Often described as research being done with patients, rather than "to" or "about" them, patient-oriented research is distinguished by patients serving as research partners rather than passive study subjects. It is generally accepted that patient engagement in health research is worthwhile and can contribute to better quality research. However, questions remain about how to do it, what values underlie it, and how patients can be engaged as partners in health research. In this chapter, we attempt to answer these questions and provide tangible examples of patient-oriented research in our province of Newfoundland and Labrador (NL), Canada. While there is no single approach to patient engagement in health research, we hope the examples provided herein help demonstrate how it might be done and assist research teams to better integrate and utilize patients' valuable input.

Nonsurgical weight loss interventions: A systematic review of systematic reviews and meta-analyses.

Access to bariatric surgery to treat obesity is limited and has long wait times. Many adults are seeking nonsurgical weight loss support. Our study objective was to conduct a systematic review of nonsurgical weight loss interventions. PubMed, EMBASE, CINAHL, PsycInfo, and the CochraneLibrary were searched. Inclusion criteria were adults 18 + with a BMI > 25 enrolled in minimum a 3-month nonsurgical weight loss intervention. Studies were independently extracted and assessed for quality using A MeaSurement Tool to Assess systematic Reviews 2 (AMSTAR2). Pooled analyses were extracted, graded for evidence quality, and summarized. A total of 1065 studies were assessed for eligibility; 815 screened and 236 full-texts assessed. Sixty-four meta-analyses met eligibility criteria: 1180 RCTs with 184,605 study participants. Studies were categorized as diets (n = 13), combination therapies (n = 10), alternative (n = 16), technology (n = 10), behavioral (n = 5), physical activity (n = 6), and pharmacotherapy (n = 3). In 80% of studies, significant weight losses were reported ranging from 0.34-8.73 k in favor of the intervention. The most effective nonsurgical weight loss interventions were diets, either low-carbohydrate or low-fat diets, followed for 6 months; combination therapy including meal replacements plus enhanced support; and pharmacotherapy followed for 12 months. Although significant weight losses were reported for other types of interventions such as physical activity and technology, the majority of studies reported weight losses less than 2 kgs.

Vitamin D insufficiency common in newborns, children and pregnant women living in Newfoundland and Labrador, Canada.

Vitamin D deficiency is associated with poor bone health, colorectal cancer, type 1 diabetes and multiple sclerosis. Two national health-related societies in Canada have made recommendations for vitamin D supplementation, yet little research has been reported on the vitamin D status of Canadians. Lifestyle changes, such as sunscreen use, spending less time outdoors and insufficient intake of vitamin D-containing foods as well as northern latitude, may be affecting human vitamin D status. A cross-sectional analysis of 25-hydroxyvitamin D [25-(OH)D] was conducted in pregnant women, newborns (umbilical cord blood) and children. Samples were analysed by liquid chromatography mass spectrometry. Published ranges for 25-(OH)D were used to determine vitamin D status. The prevalence of 25-(OH)D deficiency for the three groups studied revealed most concentrations in the 25-(OH)D deficiency or insufficiency ranges. There were significant differences in all groups studied between seasons, with the exception of maternal blood and female cord blood samples. 25-(OH)D insufficiency was common in all groups for winter and summer, more so in winter. 25-(OH)D insufficiency was common in the three groups studied. The Newfoundland and Labrador population may be at increased risk for vitamin D insufficiency because of factors such as northern latitude and lifestyle issues. Further research on the vitamin D status of this population is important, considering the potential adverse health-related outcomes and the recommendations on supplementation being made.

Comparative Safety of Dipeptidyl Peptidase-4 Inhibitors Versus Sulfonylureas and Other Glucose-lowering Therapies for Three Acute Outcomes.

Although the glucose lowering effect of dipeptidyl peptidase-4 (DPP4) inhibitors is well established, several potential serious acute safety concerns have been raised including acute kidney injury, respiratory tract infections, and acute pancreatitis. Using the UK-based Clinical Practice Research Datalink (CPRD), we identified initiators (365-day washout period) of DPP4 inhibitors and relevant comparators including initiators of sulfonylureas, metformin, thiazolidinediones, and insulin between January 2007 and January 2016 to quantify the association between DPP4 inhibitors and three acute health events - acute kidney injury, respiratory tract infections, and acute pancreatitis. The associations between drug and study outcomes were estimated using Cox proportional hazard models adjusted for deciles of high-dimensional propensity scores and number of additional glucose lowering agents. After controlling for potential confounders, the risk was not significantly increased or decreased for initiators of DPP4 inhibitors compared to sulfonylureas (hazard ratio (HR) [95% confidence interval (CI)] for acute kidney injury: 0.81 [0.56-1.18]; HR for respiratory tract infections: 0.93 [0.84-1.04]; HR for acute pancreatitis 1.03 [0.42-2.52], metformin (HR for respiratory tract infection 0.91 [0.65-1.27]), thiazolidinediones (HR for acute kidney injury: 1.12 [0.60-2.10]; HR for respiratory tract infections: 1.02 [0.86-1.21]; HR for acute pancreatitis: 1.21 [0.25-5.72]), or insulin (HR for acute kidney injury: 1.40 [0.77-2.55]; HR for respiratory tract infections: 0.74 [0.60-0.92]; HR for acute pancreatitis: 1.01 [0.24-4.19]). Initiators of DPP4 inhibitors were associated with an increased risk of acute kidney injury when compared to metformin initiators (HR [95% CI] for acute kidney injury: 1.85 [1.10-3.12], although this association was attenuated when DPP4 inhibitor monotherapy was compared to metformin monotherapy exposure as a time-dependent variable (HR 1.39 [0.91-2.11]). Initiation of a DPP4 inhibitor was not associated with an increased risk of acute kidney injury, respiratory tract infections, or acute pancreatitis compared to sulfonylureas or other glucose-lowering therapies.

Examining the risk of depression or self-harm associated with incretin-based therapies used to manage hyperglycaemia in patients with type 2 diabetes: a cohort study using the UK Clinical Practice Research Datalink.

OBJECTIVES: To compare population-based incidence rates of new-onset depression or self-harm in patients initiating incretin-based therapies with that of sulfonylureas (SU) and other glucose-lowering agents. DESIGN: Population-based cohort study. SETTING: Patients attending primary care practices registered with the UK-based Clinical Practice Research Datalink (CPRD). PARTICIPANTS: Using the UK-based CPRD, we identified two incretin-based therapies cohorts: (1) dipeptidyl peptidase-4 inhibitor (DPP-4i)-cohort, consisting of new users of DPP-4i and SU and (2) glucagon-like peptide-1 receptor agonists (GLP-1RA)-cohort, consisting of new users of GLP-1RA and SU, between January 2007 and January 2016. Patients with a prior history of depression, self-harm and other serious psychiatric conditions were excluded. MAIN OUTCOME MEASURES: The primary study outcome comprised a composite of new-onset depression or self-harm. Unadjusted and adjusted Cox proportional hazards regression was used to quantify the association between incretin-based therapies and depression or self-harm. Deciles of High-Dimensional Propensity Scores and concurrent number of glucose-lowering agents were used to adjust for potential confounding. RESULTS: We identified new users of 6206 DPP-4i and 22 128 SU in the DPP-4i-cohort, and 501 GLP-1RA and 16 409 SU new users in the GLP-1RA-cohort. The incidence of depression or self-harm was 8.2 vs 11.7 events/1000 person-years in the DPP-4i-cohort and 18.2 vs 13.6 events/1000 person-years in the GLP-1RA-cohort for incretin-based therapies versus SU, respectively. Incretin-based therapies were not associated with an increased or decreased incidence of depression or self-harm compared with SU (DPP-4i-cohort: unadjusted HR 0.70, 95% CI 0.51 to 0.96; adjusted HR 0.80, 95% CI 0.57 to 1.13; GLP-1RA-cohort: unadjusted HR 1.36, 95% CI 0.72 to 2.58; adjusted HR 1.25, 95% CI 0.63 to 2.50). Consistent results were observed for other glucose-lowering comparators including insulin and thiazolidinediones. CONCLUSIONS: Our findings suggest that the two incretin-based therapies are not associated with an increased or decreased risk of depression or self-harm.

The risk of fragility fractures in new users of dipeptidyl peptidase-4 inhibitors compared to sulfonylureas and other anti-diabetic drugs: A cohort study.

AIMS: Mixed evidence exists for the effect of incretin-based therapies on osteoporosis in type-2 diabetes. Therefore, we conducted a cohort study to determine the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and common osteoporotic "fragility fractures" (upper extremity, hip, spine). METHODS: The UK-based Clinical Practice Research Datalink was used to identify adults without prior fractures receiving a new anti-diabetic drug or a new type-2 diabetes diagnosis between 2007 and 2016. The primary aim was to compare new-users of DPP-4 inhibitors versus new-users of sulfonylureas (SU). The association between DPP-4 inhibitors and incident fractures was estimated using Cox proportional hazards models. Deciles of high-dimensional propensity scores and other anti-diabetic drugs were used as covariates. RESULTS: We identified 7993 and 26,636 new-users of DPP-4 inhibitors and SUs, respectively. At cohort entry, the mean age was 58.8, 40% were female, mean diabetes duration was 1.3 years, and 42% had A1c > 9%. Over 9 years (mean follow-up = 1.2 years), the incident rate of fragility fractures was lower among DPP-4 versus SU users (3.0/1000 vs. 5.2/1000 person-years; P-value = 0.007). After adjustment, there was no statistically significant difference in fracture risk (hazard ratio adjusted, aHR = 0.80, 95%CI 0.51-1.24; P-value = 0.3125). In a secondary analysis, DPP-4 inhibitors were not associated with a difference in fracture risk compared to insulin (aHR = 0.91, 95%CI 0.40-2.09); however were associated with a lower fracture risk versus thiazolidinediones (aHR = 0.47, 95%CI 0.26-0.83). Sensitivity analyses supported findings. CONCLUSIONS: DPP-4 inhibitors are not associated with an increased risk of fragility fractures compared with SUs or insulin; however, are associated with a lower risk versus thiazolidinediones.

Psychometric Assessment and Precision Remodeling of the Iowa Infant Feeding Attitude Scale to Improve Clinical Use and Efficacy Among Prenatal Women in Canada.

BACKGROUND: The 17-item Iowa Infant Feeding Attitude Scale (IIFAS) has been widely used to assess maternal attitudes toward infant feeding and to predict breastfeeding intention. The IIFAS has been validated among prenatal women located in Newfoundland and Labrador in Canada, although its length may prove challenging to complete in a clinical setting. Research aim: The authors aimed to reduce the number of items from the original 17-item IIFAS scale while maintaining reliability and validity. METHODS: A nonexperimental cross-sectional design was used among 1,283 women in their third trimester residing in Newfoundland and Labrador. Data were collected from August 2011 to June 2016. An exploratory factor analysis using principal component analysis was performed to explore the underlying structure of the IIFAS. The internal consistency of both the 17-item and reduced version was assessed using Cronbach's alpha and item-total correlation. The area under the curve and linear regression model were used to assess predictive validity of intention to breastfeed. RESULTS: Our findings revealed that a 13-item IIFAS (Cronbach's α = .870) had relatively similar internal consistency to the original IIFAS (Cronbach's α = .868). Three themes were extracted from the factor analysis, resulting in the removal of four items. The reduced scale demonstrated an excellent ability to predict breastfeeding intention (area under the curve = 0.914). CONCLUSION: The reduced 13-item version of the IIFAS is a psychometrically sound instrument that maintains its accuracy and validity when measuring maternal feeding attitudes during pregnancy and can be more time efficient in clinical settings compared with the 17-item IIFAS.

Determining Clinically Relevant Cutoff Scores for the Iowa Infant Feeding Attitude Scales Among Prenatal Women in Canada.

BACKGROUND: The original 17-item Iowa Infant Feeding Attitude Scale (IIFAS) has been validated and widely used to assess attitudes toward breastfeeding. A reduced 13-item version of the IIFAS was recently validated in a Canadian setting. However, cutoff scores for categorization of infant feeding attitudes on both scales have not yet been established. Research Aim: The aim of this study was to determine optimal cut-ff scores predicting infant feeding attitudes and outcomes for the original and reduced IIFASs. METHODS: A population-based prospective cohort study was undertaken in the Canadian province of Newfoundland and Labrador. A sample of 658 pregnant women were followed up to 1 month postpartum. The receiver operating curve and Youden index were assessed to identify the sensitivity and specificity of cutoff scores. The magnitude at which these scores predicted postpartum feeding outcomes was evaluated using linear regression. RESULTS: Scores of ≤60 (sensitivity = 0.81, specificity = 0.87) and ≤45 (sensitivity = 0.84, specificity = 0.83) for the 17-item and 13-item IIFASs, respectively, were found to be optimal cutoff scores for predicting negative breastfeeding attitudes. The cutoff score for the reduced IIFAS version maintained its ability to predict women who formula-fed at 1 month postpartum (adjusted odds ratio = 6.32, 95% confidence interval = 1.84-11.61) compared with the original scale (adjusted odds ratio = 4.62, 95% confidence interval = 2.42-16.52). CONCLUSION: The proposed cutoff scores for the original and reduced IIFASs have excellent predictive ability to determine infant feeding attitudes and outcomes. The classification of scores enhances the use and applicability of the IIFAS.

Preoperative and Postoperative Assessments of Biochemical Parameters in Patients with Severe Obesity Undergoing Laparoscopic Sleeve Gastrectomy.

BACKGROUND: The study aim was to determine the prevalence of abnormal serum biochemistries associated with micronutrient deficiencies before and after laparoscopic sleeve gastrectomy (LSG). METHODS: Two hundred and one patients had LSG surgery between May 2011 and May 2014. Using a prospective cohort study design, data were collected on ferritin, hemoglobin (Hgb), mean cell volume (MCV), calcium, albumin, 25-hydroxyvitamin D (25-OH-D), PTH, and vitamin B12 with follow-up of 75.6% (n = 152), 63.7% (n = 128), 52.7% (n = 106), and 40.3% (n = 81) at 6, 12, 18, and 24 months, respectively. RESULTS: Patients were female (81.6%) with mean ± SD, BMI (48.8 ± 6.8 kg/m2), weight (135.1 ± 23.6 kg), and age (44.0 ± 9.6 years). Mean values for all biochemical parameters pre- and post-LSG were within reference limits. After adjusting for age, weight, and supplement use, trend tests post-LSG were significant for mean differences in ferritin (p = 0.002), calcium (p = 0.017), and vitamin B12 (p = 0.034). Pre-LSG, the proportion of patients with values below reference limits included 25-OH-D (20.4%), ferritin (12.3%), and Hgb (10.0%), while the proportion above reference limits included PTH (29.1%) and ferritin (17.4%). After adjustment, hypoalbuminemia was more prevalent after 1 year; the proportion of patients with PTH levels in the upper reference limit was higher 6 months post-LSG (p < 0.05). Multivitamin use increased presurgery from 44 to 88% 2 years postsurgery. Vitamin B12 supplementation increased from 7% before surgery to 32% 2 years postsurgery. CONCLUSION: Abnormal serum biochemistries indicative of micronutrient deficiencies were prevalent before surgery; reduced abnormal values were observed after surgery, likely due to an increased use of multivitamins.