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.

Comparison of pharmacist managed anticoagulation with usual medical care in a family medicine clinic.

BACKGROUND: The beneficial outcomes of oral anticoagulation therapy are dependent upon achieving and maintaining an optimal INR therapeutic range. There is growing evidence that better outcomes are achieved when anticoagulation is managed by a pharmacist with expertise in anticoagulation management rather than usual care by family physicians. This study compared a pharmacist managed anticoagulation program (PC) to usual physician care (UC) in a family medicine clinic. METHODS: A retrospective cohort study was carried out in a family medicine clinic which included a clinical pharmacist. In 2006, the pharmacist assumed anticoagulation management. For a 17-month period, the PC group (n = 112) of patients on warfarin were compared to the UC patients (n = 81) for a similar period prior to 2006. The primary outcome was the percentage of time patients' INR was in the therapeutic range (TTR). Secondary outcomes were the percentage of time in therapeutic range within ± 0.3 units of the recommended range (expanded TTR) and percentage of time the INR was >5.0 or <1.5. RESULTS: The baseline characteristics were similar between the groups. Fifty-five percent of the PC group was male with a mean age of 67 years; 51% of the UC group was male with a mean age of 71 years. The most common indications for warfarin in both groups were atrial fibrillation, mechanical heart valves and deep vein thrombosis. The TTR was 73% for PC and 65% for UC (p < 0.0001). The expanded TTR for PC was 91% and 85% for UC (p < 0.0001). The percentage of time INR values were <1.5 was 0.7% for PC patients and 1.9% for UC patients (p < 0.0001), and >5 were 0.3% for PC patients and 0.1% for UC (p < 0.0001). CONCLUSION: The pharmacist-managed anticoagulation program within a family practice clinic compared to usual care by the physicians achieved significantly better INR control as measured by the percentage of time patients' INR values were kept in both the therapeutic and expanded range. Based on the results of this study, a collaborative family practice clinic using pharmacists and physicians may be an effective model for anticoagulation management with these results verified in future prospective randomized studies.

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.

Patients' and physicians' satisfaction with a pharmacist managed anticoagulation program in a family medicine clinic.

BACKGROUND: A pharmacist managed anticoagulation service was initiated in a multi-physician family medicine clinic in December 2006. In order to determine the patient and physician satisfaction with the service, a study was designed to describe the patients' satisfaction with the warfarin education and management they received from the pharmacist, and to describe the physicians' satisfaction with the level of care provided by the pharmacist for patients taking warfarin. A self-administered survey was completed by both eligible patients receiving warfarin and physicians prescribing warfarin between December 2006 and May 2008. The patient survey collected information on patient demographics, satisfaction with warfarin education and daily warfarin management. The physician survey collected data about the satisfaction with patient education and daily anticoagulation management by the pharmacist. RESULTS: Seventy-six of 94 (81%) patients completed the survey. Fifty-nine percent were male with a mean age of 65 years (range 24-90). Ninety-six percent agreed/strongly agreed the pharmacist did a good job teaching the importance of warfarin adherence, the necessity of INR testing and the risks of bleeding. Eighty-five percent agreed/strongly agreed the risk of blood clots was well explained, 79% felt the pharmacist did a good job teaching about dietary considerations and 77% agreed/strongly agreed the pharmacist explained when to see a doctor. All patients felt the pharmacist gave clear instructions on warfarin dosing and INR testing. Four of nine physicians (44%) completed the survey. All agreed/strongly agreed the pharmacist was competent in the care provided, were confident in the care their patients received, would like the pharmacist to continue the service, and would recommend this program to other clinics. CONCLUSIONS: Patients and family physicians were satisfied with the pharmacist managed anticoagulation program and recommended continuation of the program. These results support the role of the pharmacist in the management of anticoagulation in a multi-physician family medicine clinic.

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.