Acarbose for the prevention of Type 2 diabetes, hypertension and cardiovascular disease in subjects with impaired glucose tolerance: facts and interpretations concerning the critical analysis of the STOP-NIDDM Trial data.
Research Centre, Centre hospitalier de l'Université de Montréal-Hôtel-Dieu, Department of Medicine, University of Montreal, 3850 St. Urbain Street, Rm 8-202, Montreal, Quebec H2W 1T7, Canada. email@example.com
The STOP-NIDDM Trial has shown that acarbose treatment in subjects with impaired glucose tolerance is associated with a significant risk reduction in the development of diabetes, hypertension and cardiovascular complications. Kaiser and Sawicki have accused the investigators of the STOP-NIDDM Trial of major biases in the conduct of the study, of manipulating the data and of conflict of interest. The aim of this paper is to present data and explanations refuting these allegations. In the STOP-NIDDM Trial, 61 subjects were excluded from the efficacy analysis before unblinding for legitimate reasons: failure to satisfy major entry criteria (n=17) and lack of post-randomisation data (n=44). Blinding and randomisation were carried out by an independent biostatistician. Titration of placebo/acarbose is well described in the protocol and in the study design paper. Of the study population, 9.3% had a fasting plasma glucose of > or =7.0 mmol/l at screening and could have been diabetic according to the new diagnostic criteria. However, even if these subjects are excluded, patients having acarbose treatment still saw a significant risk reduction in the development of diabetes (p=0.0027). The changes in weight are consistent in different publications and are related to different times of follow-up and assessment. Weight change does have an effect on the development of diabetes, but acarbose treatment is still effective even after adjusting for this (p=0.0063). The cardiovascular endpoints were a clearly designated assessment in the original protocol, and only those defined in the protocol and ascertained by the independent Cardiovascular Event Adjudication Committee were used in the analysis. Hypertension was defined according to the most recent diagnostic criteria. The STOP-NIDDM Trial results are scientifically sound and credible. The investigators stand strongly behind these results demonstrating that acarbose treatment is associated with a delay in the development of diabetes, hypertension and cardiovascular complications in a high-risk population with IGT.
There is scarce information in literature about the decisions made by ethics committees concerning the clinical studies they have reviewed. A retrospective, detailed review of 666 applications, their amendments and the ethics committees' statements was undertaken. All protrocols of clinical studies on medicinal products submitted to and reviewed by the ethics committees of two university hospitals during the years 1992, 1994, 1996 and 1998 were investigated. Most of the studies were international (50%), multicenter (71%), phase III trials (41%) on a new clinical entity, (38%). Validity of the clinical drug study applications was acceptable in more than half of the cases (364; 55%), while 91 (14%) were approved with advisory comments, 153 (23%) had to be amended, 35 (5%) were left pending and 23 (3%) were rejected. Most of the questions pertained to informed consent and the study protcol. In accordance with precious results, our findings support the opinion that the submitted documents need to be improved, especially with regard to informed consent and study protocols, in order to gain better Good Clinical Practice (GCP) compliance. Well-defined, documented operating procedures of the ethics committees would have facilitated the practical issues in the review process.
Review the evidence regarding methods to prevent wrong site operations and present a framework that healthcare organizations can use to evaluate whether they have reduced the probability of wrong site, wrong procedure, and wrong patient operations.
Operations involving the wrong site, patient, and procedure continue despite national efforts by regulators and professional organizations. Little is known about effective policies to reduce these "never events," and healthcare professional's knowledge or appropriate use of these policies to mitigate events.
A literature review of the evidence was performed using PubMed and Google; key words used were wrong site surgery, wrong side surgery, wrong patient surgery, and wrong procedure surgery. The framework to evaluate safety includes assessing if a behaviorally specific policy or procedure exists, whether staff knows about the policy, and whether the policy is being used appropriately.
Higher-level policies or programs have been implemented by the American Academy of Orthopaedic Surgery, Joint Commission on Accreditation of Healthcare Organizations, Veteran's Health Administration, Canadian Orthopaedic, and the North American Spine Society Associations to reduce wrong site surgery. No scientific evidence is available to guide hospitals in evaluating whether they have an effective policy, and whether staff know of the policy and appropriately use the policy to prevent "never events."
There is limited evidence of behavioral interventions to reduce wrong site, patient, and surgical procedures. We have outlined a framework of measures that healthcare organizations can use to start evaluating whether they have reduced adverse events in operations.
Action plans are recommended for most patients with persistent asthma to reduce the morbidity associated with this chronic disease. Unfortunately, despite these recommendations, this tool remains underused.
The authors conducted a descriptive study at the asthma clinic of a tertiary care centre to determine the number of asthmatic patients presenting to a respiratory physician (new reference or follow-up visit) who possessed an individualized, written action plan, and to evaluate the patients' level of confidence and perceived efficacy toward their plans. In addition, for all patients in the study, the level of confidence in and the perceived efficacy of three different action plans (two traditional tools versus a simplified tool) were compared.
A total of 92 asthmatic patients were included in the study. Overall, 46% of the patients possessed an action plan. The patients' average level of confidence and perceived efficacy toward their action plans were high (4.1 out of five and 3.3 out of four, respectively). When the three different action plans were compared, the level of confidence in and perceived efficacy of the traditional tools were similar, both being superior to the simplified tool.
The number of asthmatic patients who presented to the asthma clinic and who possessed an action plan was higher than the reported Canadian mean of 10%; however, most of the patients were treated by specialized respiratory physicians, which may explain this improvement. Considering that most patients with persistent asthma should have an individualized, written action plan, the present study confirms that this tool is still not used for all asthmatic patients.
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Surgical stress can influence oncological outcome and survival. The enhanced recovery after surgery (ERAS) protocol is designed to reduce perioperative stress and has been shown to reduce postoperative morbidity. We studied if adherence to ERAS is associated with increased long-term survival.
Between the years 2002 and 2007, 911 consecutive patients, operated with major colorectal cancer surgery at Ersta Hospital, Stockholm, Sweden were analyzed. The histopathological reports of the resected specimen, date, and cause of death of the patients as well as postoperative CRP levels were obtained. The relation between the rate of adherence to the ERAS protocol at the time of surgery, and the short-term outcomes in relation to 5-year overall and colorectal cancer-specific survival was determined in this retrospective cohort study.
In patients with =70 % adherence to ERAS interventions (N = 273,), the risk of 5-year cancer-specific death was lowered by 42 %, HR 0.58 (0.39-0.88, cox regression) compared to all other patients (
Sentinel lymph node biopsy (SLNB) has been unevenly adopted into practice in Canada. In this qualitative study, the authors explored individual, institutional, and policy factors that may have influenced SLNB adoption. This information will guide interventions to improve SLNB implementation.
Qualitative methodology was used to examine factors influencing SLNB adoption. Grounded theory guided data collection and analysis. Semistructured interviews were based on Roger's diffusion of innovation theory. Purposive and snowball sampling was used to identify participants. Semistructured telephone interviews were conducted with urban, rural, academic, and community health care providers and administrators to ensure all perspectives and motivations were explored. Two individuals independently analyzed data and achieved consensus on emerging themes and their relationship.
A total of 43 interviews were completed with 21 surgeons, 5 pathologists, 7 nuclear medicine physicians, and 10 administrators. Generated themes included awareness of SLNB with the exception of some administrators, acknowledged advantage of SLNB, SLNB compatibility with beliefs regarding axillary staging, acknowledgment that SLNB was a complex innovation to adopt, extensive trialing of SLNB prior to adoption, observable benefits with SLNB, acknowledgment that hospital-level administrative support enabled adoption, desire for a provincial policy supporting SLNB to assist in hospital-level adoption, requirement of a local high-volume breast surgery champion who communicated extensively with team to facilitate local adoption, and need for credentialing of SLNB to ensure quality.
SLNB is a complex innovation to adopt. Successful adoption was assisted by a high-volume breast cancer surgical champion, interprofessional communication, and administrative support.
Treating severe childhood obesity has proven difficult with inconsistent treatment results. This study reports the results of the implementation of a childhood obesity chronic care treatment protocol.
Patients aged 5 to 18 years with a body mass index (BMI) above the 99th percentile for sex and age were eligible for inclusion. At baseline patients' height, weight, and tanner stages were measured, as well as parents' socioeconomic status (SES) and family structure. Parental weight and height were self-reported. An individualised treatment plan including numerous advices was developed in collaboration with the patient and the family. Patients' height and weight were measured at subsequent visits. There were no exclusion criteria.
Three-hundred-thirteen (141 boys) were seen in the clinic in the period of February 2010 to March 2013. At inclusion, the median age of patients was 11.1 years and the median BMI standard deviation score (SDS) was 3.24 in boys and 2.85 in girls. After 1 year of treatment, the mean BMI SDS difference was -0.30 (95% CI: -0.39; -0.21, p
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Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.
Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method 'affect school with script analysis' and the mind-body therapy 'basic body awareness treatment' will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality.
Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration =62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18-59 years; and diabetes duration =1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed using self-report instruments. HbA1c concentration, midnight salivary cortisol concentration, blood pressure, serum lipid concentrations and anthropometrics are measured. Data are collected from computerized medical records and the Swedish national diabetes and causes of death registers.
Whether the "affect school with script analysis" will reduce psychological symptoms, increase emotional awareness and improve diabetes related factors will be tried, and compared to "basic body awareness treatment" and treatment as usual.
Trauma patients frequently require transport from the hospital to which they are admitted initially to a trauma unit for further assessment and management. Canada's geography and demography provide unique challenges when transporting the severely injured patient by air or land. The author describes and compares air and land transport for the trauma patient. These complementary modes of transport are an integral part of a comprehensive trauma system.
Though airway management methods during out-of-hospital cardiac arrest (OHCA) remain controversial, no studies on the topic from Finland have examined adherence to OHCA recommendations in real life. In response, the aim of this study was to document the interventions, success rates, and adverse events in airway management processes in OHCA, as well as to analyse survival at hospital discharge and at follow-up a year later.
During a 6-month study period in 2010, data regarding all patients with OHCA and attempted resuscitation in southern and eastern Finland were prospectively collected. Emergency medical services (EMS) documented the airway techniques used and all adverse events related to the process. Study endpoints included the frequency of different techniques used, their success rates, methods used to verify the correct placement of the endotracheal tube, overall adverse events, and survival at hospital discharge and at follow-up a year later.
A total of 614 patients were included in the study. The incidence of EMS-attempted resuscitation was determined to be 51/100,000 inhabitants per year. The final airway technique was endotracheal intubation (ETI) in 413 patients (67.3%) and supraglottic airway device (SAD) in 188 patients (30.2%). The overall success rate of ETI was 92.5%, whereas that of SAD was 85.0%. Adverse events were reported in 167 of the patients (27.2%). Having a prehospital EMS physician on the scene (p?