Real World Studies of Psoriasis and Mental Illness in Newfoundland and Labrador.

BACKGROUND: Psoriasis is a chronic, immune-mediated inflammatory disease with an implied connection to psychiatric disorders. OBJECTIVE: This study aims to illustrate an association between psoriasis and psychiatric disorders using real world data gathered from the Newfoundland and Labrador population. METHODS: Data on 15,100 patients with psoriasis and 75,500 controls (1:5) was collected from the Newfoundland and Labrador Centre for Health Information's Electronic Health Records. The cases and controls were matched for age, sex, and geography. Indicators for psychiatric disorders include diagnosis of mental illnesses from physician's visits and hospitalization records (all coded for mental health using ICD-9 and ICD-10 codes). RESULTS: 9,991 (66.2%) cases were identified to have at least one visit with a diagnostic code for mental illness compared to 42,276 (56.0%), P < .0001 in the control group. The percentage of people coded for anxiety was 36.50% compared to 28.95%, P < .0001; depression was 37.04% compared to 30.19%, P < .0001; and adjustment disorder was 6.89% versus 5.48%, P < .0001, among those with and without psoriasis, respectively. The greatest risk for anxiety [OR 1.4 (1.20, 1.67)] and depression [OR 1.65 (1.36, 2.00)] among psoriasis patients was between the 0 to 20 age group. Women with psoriasis are more likely to have anxiety [OR 1.08 (1.03, 1.13)], depression [OR 1.04 (1.01, 1.09)] and adjustment disorder [OR 1.07 (0.98, 1.17)] compared to female controls. CONCLUSION: Our result shows that patients with psoriasis have an increased prevalence of mental illness. Using real world data to carry out further investigations will better elucidate this association and provide an increased understanding of the association between psoriasis and mental disorders.

Laying the foundation for Real-world evidence studies: a case study from Newfoundland and Labrador.

The Janssen and Newfoundland and Labrador Health Innovation Partnership (JANL-HIP) was established to carry out Real-World Evidence (RWE) projects to generate evidence about disease pathways, healthcare delivery, the effects of clinical interventions. Doing so will support and influence clinical decision-making in Newfoundland and Labrador (NL). This case study describes the foundational elements necessary for a real-world evidence generation project in NL and may provide learning for the effective execution of real-world studies in other jurisdictions. It uses an ongoing project in psoriatic disease in NL to illustrate the partnership and the benefits of RWE studies. Ultimately, the JANL-HIP RWE project aims to inform decisions that will drive improvements in health outcomes, system delivery, and policy mutually beneficial to health ecosystem stakeholders.

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.

Pre-operative and post-operative changes in CRP and other biomarkers sensitive to inflammatory status in patients with severe obesity undergoing laparoscopic sleeve gastrectomy.

INTRODUCTION: C-reactive protein (CRP) is often elevated in patients living with severe obesity (BMI≥35kg/m2). However, there is limited information on how CRP, and other inflammation responsive biomarkers, change in response to weight loss following laparoscopic sleeve gastrectomy (LSG). We studied how CRP, ferritin and albumin change following LSG surgery in relation to obesity, metabolic syndrome (MetS) ATPIII risk components and diabetes mellitus (DM). METHODS: Laboratory parameters (including CRP) were examined in 197 patients prior to LSG, and at 6, 12, 18 and 24months. Changes in laboratory parameters, and laboratory investigations, were also examined in a 125 patient subgroup at both pre-LSG and at the 12month follow-up visit. RESULTS: All patients had BMI≥35kg/m2. CRP levels positively correlated with BMI (r=0.171, p=0.016) and alkaline phosphatase (ALP; r=0.309; P<0.001), but negatively correlated with alanine aminotransferase (ALT; r=-0.260; P<0.001) and albumin (r=-0.358; P<0.001). LSG significantly reduced CRP and ferritin, which were maintained for at least 24months. At 12months post-LSG there was a significant decrease in weight (kgs) (p<0.001), CRP (p<0.001), ferritin (p=0.004), and various MetS risk components (p<0.001) but not albumin (p=0.057). Changes in CRP also correlated with changes in weight (r=0.233, p=0.018) and ALP (r=0.208, p=0.034) but not albumin (r=-0.186, p=0.058) or ferritin (r=0.160, p=0.113) after LSG. CONCLUSION: The negative correlation between CRP and albumin levels in obesity may indicate a low grade inflammatory process affecting both. LSG related weight loss decreased CRP and ferritin, likely explained by improvement in inflammatory status.

Morbidity and health-related quality of life of patients accessing laparoscopic sleeve gastrectomy: a single-centre cross-sectional study in one province of Canada.

BACKGROUND: In Canada, severe obesity (BMI ≥ 35 kg/m2) affects 5% or 1.2 million adults. Bariatric surgery is the only effective treatment for severe obesity, but the demand for publicly funded procedures is high and capacity limited. Little is known in Canada about the types of patients undergoing these procedures, especially laparoscopic sleeve gastrectomy (LSG). The study objective is to examine the socio-demographic profile, morbidity and HRQoL of patients accessing LSG in one Canadian province. METHODS: Health status and HRQoL were examined in patients (n = 195) undergoing LSG. HRQoL was assessed using the EQ-5D-3L, SF-12v2 and the Impact of Weight on Quality of Life-lite questionnaire. RESULTS: Mean age and BMI were 44 and 49 kg/m2 and most were women (82%). Pre-surgery, comorbidities were sleep apnea (65%), dyslipidemia (48%), hypertension (47%) and osteoarthritis (44%). Patients reported impaired HRQoL with 44-67% reporting problems in mobility, usual activities, pain and anxiety/depression. Physical health was impaired more than mental health. There were few socio-demographic differences between women and men, but significant differences in comorbid conditions such as sleep apnea, dyslipidemia, hypertension and gout exist (p < .05). Women reported fewer problems with self-care (9.5% vs. 25.0%, p < .05), and better overall health (VAS 61.5 vs. 52.0, p < .05) and General Health (39.3 vs. 32.9, p < .05), but greater impairment in self-esteem (27.3 vs. 44.1, p < .01) and sexual life (49.2 vs. 63.6, p < .05). CONCLUSIONS: Before LSG, patients reported significant morbidity and impaired HRQoL. Although baseline characteristics were similar between men and women, gender specific differences were observed in comorbid profile and HRQoL.

The Relationship between Body Mass Index and the Severity of Coronary Artery Disease in Patients Referred for Coronary Angiography.

Background and Aim. Obesity is associated with an increased risk of cardiovascular disease and may be associated with more severe coronary artery disease (CAD); however, the relationship between body mass index [BMI (kg/m2)] and CAD severity is uncertain and debatable. The aim of this study was to examine the relationship between BMI and angiographic severity of CAD. Methods. Duke Jeopardy Score (DJS), a prognostic tool predictive of 1-year mortality in CAD, was assigned to angiographic data of patients ≥18 years of age (N = 8,079). Patients were grouped into 3 BMI categories: normal (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2), and obese (≥30 kg/m2); and multivariable adjusted hazard ratios for 1-year all-cause and cardiac-specific mortality were calculated. Results. Cardiac risk factor prevalence (e.g., diabetes, hypertension, and hyperlipidemia) significantly increased with increasing BMI. Unadjusted all-cause and cardiac-specific 1-year mortality tended to rise with incremental increases in DJS, with the exception of DJS 6 (p < 0.001). After adjusting for potential confounders, no significant association of BMI and all-cause (HR 0.70, 95% CI .48-1.02) or cardiac-specific (HR 1.11, 95% CI .64-1.92) mortality was found. Conclusions. This study failed to detect an association of BMI with 1-year all-cause or cardiac-specific mortality after adjustment for potential confounding variables.

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.

Impact of Body Mass Index on Short-Term Outcomes in Patients Undergoing Percutaneous Coronary Intervention in Newfoundland and Labrador, Canada.

Background and Aim. Obesity (BMI ≥ 30 kg/m(2)) is associated with advanced cardiovascular disease requiring procedures such as percutaneous coronary intervention (PCI). Studies report better outcomes in obese patients having these procedures but results are conflicting or inconsistent. Newfoundland and Labrador (NL) has the highest rate of obesity in Canada. The aim of the study was to examine the relationship between BMI and vascular and nonvascular complications in patients undergoing PCI in NL. Methods. We studied 6473 patients identified in the APPROACH-NL database who underwent PCI from May 2006 to December 2013. BMI categories included normal, 18.5 ≤ BMI < 25.0 (n = 1073); overweight, 25.0 ≤ BMI < 30 (n = 2608); and obese, BMI ≥ 30.0 (n = 2792). Results. Patients with obesity were younger and had a higher incidence of diabetes, hypertension, and family history of cardiac disease. Obese patients experienced less vascular complications (normal, overweight, and obese: 8.2%, 7.2%, and 5.3%, p = 0.001). No significant differences were observed for in-lab (4.0%, 3.3%, and 3.1%, p = 0.386) or postprocedural (1.0%, 0.8%, and 0.9%, p = 0.725) nonvascular complications. After adjusting for covariates, BMI was not a significant factor associated with adverse outcomes. Conclusion. Overweight and obesity were not independent correlates of short-term vascular and nonvascular complications among patients undergoing PCI.

Rapid Reduction in Use of Antidiabetic Medication after Laparoscopic Sleeve Gastrectomy: The Newfoundland and Labrador Bariatric Surgery Cohort (BaSCo) Study.

BACKGROUND: Patients who have undergone bariatric surgery generally need fewer medications as they experience improvement in, or even resolution of, various medical conditions, including type 2 diabetes mellitus, hypertension, and dyslipidemia. Published data on changes in medication use after laparoscopic sleeve gastrectomy, a type of bariatric surgery that is growing in popularity, are limited. OBJECTIVE: To determine whether patients took fewer medications for management of type 2 diabetes, hypertension, and dyslipidemia after laparoscopic sleeve gastrectomy, relative to preprocedure medications. METHODS: In this prospective, single-centre cohort study, a nurse practitioner used standard medication reconciliation and study data-extraction forms to interview adult patients who had undergone laparoscopic sleeve gastrectomy and determine their medication use and pertinent demographic data. The data were analyzed using generalized estimating equations and standard statistical software. Outcome measures included changes in the use of antidiabetic, antihypertensive, and antilipemic medications at 1, 3, and 6 months after the surgery. RESULTS: A total of 65 patients who underwent laparoscopic sleeve gastrectomy between May 2011 and January 2014 met the study inclusion criteria. Before surgery, the 30 patients with type 2 diabetes were taking an average of 1.9 antidiabetic medications. One month after the procedure, 15 (50%) had discontinued all antidiabetic medications, with a further decline at 3 and 6 months (p < 0.001 at each time point). Among the patients who were taking antihypertensives (n = 48) and antilipemics (n = 33) before surgery, the decline in use occurred at a more modest rate, with 6 (12%) and 2 (6%), respectively, discontinuing these medication classes within 1 month, and 12 (25%) (p = 0.001) and 8 (24%) (p = 0.015) having discontinued by 6 months. CONCLUSIONS: These findings suggest that patients with a history of type 2 diabetes mellitus, hypertension, and/or dyslipidemia who undergo laparoscopic sleeve gastrectomy are less likely to require disease-specific medications shortly after surgery.

CONTEXTE: Les patients ayant subi une chirurgie bariatrique ont généralement besoin de moins en moins de médicaments au fur et à mesure qu'ils voient leurs différentes affections, notamment le diabète sucré de type 2, l'hypertension et la dyslipidémie, s'estomper ou même se résorber. Or, il existe peu d'études publiées sur les changements apportés à la pharmacothérapie des patients ayant subi une gastrectomie longitudinale laparoscopique, une chirurgie bariatrique de plus en plus utilisée. OBJECTIF: Déterminer si les patients prennent moins de médicaments pour le traitement du diabète de type 2, de l'hypertension et de la dyslipidémie après avoir subi une gastrectomie longitudinale laparoscopique comparativement à leur situation avant l'opération. MÉTHODES: Dans cette étude de cohorte prospective menée dans un seul centre, un membre du personnel infirmier praticien a utilisé des formulaires standards de bilan comparatif des médicaments et d'extraction de données d'étude afin d'interroger des patients adultes ayant subi une gastrectomie longitudinale laparoscopique, et ce, dans le but de connaître leur consommation de médicaments ainsi que de recueillir des données démographiques pertinentes. Les données ont été analysées à l'aide d'équations d'estimation généralisées et d'un logiciel statistique courant. Les critères de jugement incluaient l'adaptation du traitement antidiabétique, antihypertenseur et hypolipémiant, un mois, trois mois et six mois après la chirurgie. RÉSULTATS: Au total, 65 patients ayant subi l'intervention chirurgicale entre mai 2011 et janvier 2014 ont été admis dans l'étude. Avant l'opération, les 30 patients atteints du diabète de type 2 prenaient en moyenne 1,9 antidiabétique. Un mois après la chirurgie, 15 (50 %) d'entre eux ont cessé de prendre des antidiabétiques, un chiffre qui a augmenté après le troisième et le sixième mois (p < 0,001 à chaque point dans le temps). Parmi les patients qui prenaient des antihypertenseurs (n = 48) et des hypolipémiants (n = 33) avant l'intervention chirurgicale, un moins grand nombre a cessé de prendre ces médicaments. Seulement 6 (12 %) patients ont cessé les antihypertenseurs et 2 (6 %) patients ont cessé les hypolipémiants après un mois, puis 12 (25 %) (p = 0,001) et 8 (24 %) (p = 0,015) respectivement après six mois. CONCLUSIONS: Ces résultats laissent croire que les patients atteints du diabète sucré de type 2, d'hypertension ou de dyslipidémie qui subissent une gastrectomie longitudinale laparoscopique courent la chance de ne plus avoir besoin de médicaments pour traiter ces maladies, et ce, peu de temps après la chirurgie.