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Healthcare
Diabetes and Endocrinology

The analysis of plaque composition based on radio-frequency backscatter, so-called ‘virtual histology’, characterizes plaques as fibrotic, fibrofatty with or without a necrotic core, or calcific. Although the PROSPECT trial [ 243 ] provided new insights regarding indications for stent implantation, the role of tissue characterization for everyday practice remains to be established.

Optical coherence tomography (OCT) is a light-based modality of intravascular imaging with higher spatial resolution than IVUS (15 vs. 100 μm). Its penetration is lower than IVUS but it provides detailed imaging of the endoluminal borders. At present, OCT is a valuable research tool.

Although non-invasive stress imaging should be the gold standard for evaluation of patients with known or suspected CAD, many patients come to the catheterization laboratory without prior functional testing. When a non-invasive imaging stress test is unavailable, FFR can be useful, especially in the presence of MVD. The concept that avoiding unnecessary stenting actually improves outcome was demonstrated in the DEFER [ 15 ] and FAME [ 28 ] trials. FFR is a valuable tool to determine whether or not an intermediate stenotic segment can cause downstream ischaemia in stable and unstable patients with MVD, in-stent restenosis, LM stenosis, and post-MI.

Treatment of CAD patients often requires the combination of anti-platelet and antithrombotic therapies to prevent thrombosis from activation of both platelets and the coagulation system. The choice, initiation, and duration of antithrombotic strategies for myocardial revascularization depend on the clinical setting (elective, acute, or urgent intervention). To maximize the effectiveness of therapy and reduce the hazard of bleeding, ischaemic and bleeding risks should be evaluated on an individual basis. A well-validated score for estimating bleeding risk is eagerly awaited.

DAPT includes acetylsalicylic acid (ASA) 150–300 mg per os or 250 (−500) mg bolus i.v. followed by 75–100 mg per os daily for all patients plus clopidogrel 300 (600)-mg loading dose followed by 75 mg daily for all patients [ 55 ].

Since the vast majority of PCI procedures eventually conclude with stent implantation, every patient scheduled for PCI should be considered for pre-treatment with clopidogrel, regardless of whether stent implantation is intended or not. To ensure full antiplatelet activity, clopidogrel should be initiated at least 6h prior to the procedure with a loading dose of 300mg, ideally administered the day before a planned PCI. If this is not possible, a loading dose of 600mg should be administered at least 2 h before PCI. Of note, this pre-loading strategy was not shown to improve outcome. A 600-mg clopidogrel loading dose may be preferable because of greater platelet inhibition than with the 300-mg standard dose, even if this is given > 6 h before PCI. When diagnostic angiography is negative or no intervention is performed, clopidogrel can be stopped. When a 300-mg loading dose has been given and ad hoc PCI is performed, another 300-mg dose can be given. The use of a higher maintenance dose (150 mg) has been proposed in patients with high thrombotic risk (e.g. in diabetics, patients after recurrent MI, after early and late stent thrombosis, for complex lesions, or in life-threatening situations should occlusion occur). GPIIb-IIIa inhibitors should be used only in ‘bail-out’ situations (thrombus, slow flow, vessel closure, very complex lesions) [ 55 ]. Recent trials did not demonstrate additional benefit of GPIIb-IIIa inhibitors after a clopidogrel loading dose of 600mg.

The aim of this article, therefore, is to review briefly the main implications of adopting a cluster randomized design and to highlight the practical application of appropriate analytical techniques through the use of empirical data from a primary care-based case study.

1 + ( n -- 1 ) ρ

The ICC takes a value of between 0 and 1 and would be high if, for example, the management of patients within practices was very consistent; but, there was wide variation across different practices. A recent study of UK data sets relevant to implementation research showed that in primary care settings, the ICCs for process variables appear to be of an order of magnitude higher than those for outcome variables (estimates for process variables from primary care were of the order of 0.05–0.15), whereas ICCs for outcome variables were generally lower than 0.05. 9 As both the ICC and the cluster size influence the calculation, as shown by the equation for the design effect, even small values of ICC can have a substantial impact on power.

The analysis of cluster randomized trials must also take into account the clustered nature of the data. Standard statistical techniques are no longer appropriate, unless an aggregated analysis is performed at the level of the cluster (see below), as they require data to be independent. If the clustering effect is ignored, many authors have highlighted that P -values will be artificially extreme, and confidence intervals will be over-narrow, increasing the chances of spuriously significant findings and misleading conclusions. 5 , 10

There are two main approaches to the analysis of cluster randomized trials: analysis at the cluster level or analysis at the patient level.

Traditionally, analysis has been focused at the cluster level; however, recent advances in statistics have led to the development of techniques which can incorporate the patient level data. Within each approach, simple analyses such as t -tests or more complex approaches such as regression analyses may be undertaken. Both allow the effect of the intervention to be tested; however, only complex analyses allow adjustment for potential covariates, such as baseline performance.

Analytical methods for each approach are described below, and worked examples using data from a particular primary care-based evaluation are presented. It should be noted that these methods are appropriate for completely randomized designs and P -values are quoted to increased levels of accuracy to highlight the differences between methods. Readers should refer to more detailed texts, e.g. Murray, 2 for discussion of the appropriate methods to analyse stratified or matched designs.

WRITTEN BY: Osama Hamdy, MD, PhD, FACE

Editor’s Note: This article was written by Dr. Osama Hamdy from the Joslin Diabetes Center , whichis the world’s largest diabetes research center, diabetes clinic, and provider of diabetes education. It was founded in 1952 and is located in Boston, Massachusetts, USA.

Editor’s Note:

What is hypoglycemia ?

Hypoglycemia is the state oflow blood sugarand is caused by too much insulin or too little sugar in the body. Itis defined as a blood sugar below 70 milligrams per deciliter (mg/dL), or 3.9 millimoles per liter (mmol/L). Untreated, it may result in seizures, unconsciousness and sometimes death.

You can go low if you miss a meal, don’t eat enough food for the amount of insulin you’ve taken or exercise a lot. It’s imperativeto monitor and treat low blood sugars immediately in order to prevent severe hypoglycemia and unconsciousness.

How do you treat it?

It’s important to know that treatment of hypoglycemia depends on the severity of the low blood sugar reading, and whether or not the person having a “hypo”is alert.

If person is awake… treat with simple carbohydrates (15 grams)

Blood glucose should be checked 15 minutes after treatment,and if blood glucose remains <70 mg/dl, another 15 grams of simple carbohydrates should be given.If you are sickat the time of a low, the number to consider a hypoglycemic event shouldbe higher(about 100 mg/dl.).

Ifperson is unconscious… treat with glucagon and call emergency

Glucagon is a hormone medicine used in emergencies when a diabetic is experiencing hypoglycemia and cannot take sugar orally. It comes in powder form and must be added to a solution in order to administer it. It is the opposite of insulin.

Consult with your endo

Recurrence of hypoglycemia is common,and you should make adjustments to your insulin regimen withyour doctor after a hypoglycemic event to avoid more lows.Endocrinologists willreview yourinsulin regimen and adjust basal or corrective bedtime insulin doses if you’re gettinglows while sleeping, or bolus and/or correctinsulin doses if you havehypoglycemia after meals (postprandial hypoglycemia).

BG spikes after a low

In about 20% of cases, rebound hyperglycemia (or blood sugar spikes) occur after a a low. Over-correction with carbohydrates is the main cause of rebound hyperglycemia. It is recommended to giveno more than 20 grams of carbohydrate for correction of blood glucose between 50-70 mg/dl (3-4 mmol/L) and as noted previously,to checkBG levels as needed in 15 minute increments, giving 15 grams more of carbs until levels rise.

Read How to Prevent Eye Complications with Type 1 Diabetes by the Joslin Center and read All About Glucagon .

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