Informed consent for obstetric anesthesia research: factors that influence parturients' decisions to participate

Patients who are approached to participate in clinical studies just before delivery may have insufficient time to make an informed decision and/or may feel pressured into participation. This study was designed to examine factors that influence parturients to consent or decline participation in an anesthesia study related to their delivery. Parturients who had been approached to participate in a continuing clinical obstetric anesthesia study were subsequently given a questionnaire that documented their reasons for consenting or declining participation. There were no demographic differences among the consenters (n = 166) and nonconsenters (n = 109). The most important factors in the patient's decision to consent were related to their understanding and perceived importance of the study and the potential benefit to other women. Forty-one (40. 6%) nonconsenters strongly considered their pain/discomfort a factor in declining participation. Only one patient felt some pressure to consent, suggesting that the overall environment was noncoercive. Logistic regression analysis demonstrated that patients who read the consent form completely, those who had participated in a previous research study, and those who were less anxious about participating were more likely to consent. Implications: Obtaining informed consent for obstetric anesthesia studies presents a challenge to the anesthesiologist. Results from this study suggest that the environment in which consent for obstetric studies is sought is not coercive. However, it is important that the anesthesiologist ensures that the patient fully understands the study and develops a rapport with the patient to allay any anxiety associated with her participation as a potential research subject.     

Chronic sleep loss disrupts blood–testis and blood–epididymis barriers,and reduces male fertility

Sleep loss increases blood–brain barrier permeability. As the blood–brain barrier and the blood–tissue barriers in the reproductive tract (blood–testis and blood–epididymis barriers) share common characteristics, we hypothesized that sleep restriction may also modify their barrier function. Previous reports showed that sleep loss decreased sperm viability and progressive fast mobility, which may be a consequence of altered blood–testis and blood–epididymis barrier. Therefore, we quantified changes in blood–testis and blood–epididymis barrier after sleep loss and related them to male fertility. Adult male Wistar rats were sleep restricted using the multiple‐platform technique in a protocol of 20 hr daily sleep deprivation plus 4 hr of sleep recovery in the home‐cage. At the 10th day, barrier permeability assays were performed with Na‐fluorescein, 10 kDa Cascade blue‐dextrans and Evans blue, and the expression of tight junction proteins, actin and androgen receptor was quantified. At the 10th day of sleep restriction and after sleep recovery days 1–7, males were placed with sexually receptive females, sexual behaviour was tested, and the percentage of pregnancies was calculated. Sleep restriction increased the barrier permeability to low‐ and high‐molecular‐weight tracers, and decreased the expression of tight junction proteins, actin and androgen receptor. Concomitantly, sleep restriction reduced the percentage of ejaculating males and the number of pregnancies. Sleep recovery for 2–3 days progressively re‐established fertility, as indicated by a higher percentage of ejaculating males and impregnated females. In conclusion, chronic sleep loss alters fertility concomitantly with the disruption of the blood–tissue barriers at the reproductive tract, the mechanism involves androgen signalling.     

Endoscopic management of variceal bleeding

For the primary prophilaxis of the variceal bleeding, non selective beta-blockers (propanolol, nadolol) are still the mainstay of treatment but endoscopic ligation are becoming more popular Thanks to modern control procedures the acute bleeding mortality has been reduced. Endoscopic ligation is the prefered method for esophageal varices and the cyanoacrylate injection is the better method for fundic varices. Pharmacological therapy with octreotide or terlipresine seems to be effective, specially if endoscopic treatment is not available. TIPS is a good salvage option in case of endoscopic or pharmacologic failure. Endoscopic ligation seems to be the prefered method for secondary prophylaxis, specially compared with sclerotherapy. Some drugs that reduce portal hypertension are a good alternative. It is still very necessary to define technique and criteria of endoscopic variceal eradication to reduce the great variability reported in published trials.     

The treatment of intranodal tachycardias with intracavitary fulguration]

The electrical ablation of the His bundle with proximal intracardiac shocks of low energy was performed through an electrical catheter, to 14 patients with AV nodal reentry tachycardias refractory to pharmacological therapy, to whom at least 3 antiarrhythmic drugs were previously administered. The electrical energy applied oscillated between 10 to 150 Joules (114 average). 11 patients (72%) recovered the normal atrioventricular conduction and in the electrophysiological evaluation was found: 1--Increase in the duration of the AH interval. 2--No existence of two AV nodal pathways. 3--Absence of retrograde conduction. 4--Impossibility to induce tachycardia. The PR interval was prolonged (60 ms average) after the electrical shocks. These criteria defined the total effectiveness of the procedure. In the 3 remaining patients (28%) a permanent atrioventricular complete block was induced and the implantation of the permanent pacemaker was required. It was concluded that the electrical fulguration of the atrioventricular junction with low energy is an effective technique as curative treatment for intranodal reentry tachycardias, which can be applied without induction of permanent cardiac block.     

Biosimilars in psoriasis: Clinical practice and regulatory perspectives in Latin America

Latin American countries view biosimilar agents as an effective approach to curtail health‐care expenditures while maintaining the safety and efficacy profile of their branded innovator comparators. To understand the complexities of the regulatory landscape and key therapeutic issues for use of biosimilars to treat moderate to severe psoriasis in Latin America, the International Psoriasis Council convened dermatology experts from Argentina, Brazil, Chile, Colombia and Mexico in October 2015 to review the definition, approval, marketing and future of biosimilars in each country and develop a consensus statement. The regulatory framework for marketing approval of biosimilars in Latin America is currently a mosaic of disparate, country‐specific, regulatory review processes, rules and standards, with considerable heterogeneity in clarity and specificity. Regulations in Argentina, Brazil, Chile and Mexico have undergone multiple refinements whereas Colombia is finalizing draft guidelines. Verification of the similarity in quality, safety and efficacy of biosimilars to the innovator biologic remains a key challenge for policy makers and regulatory authorities. Other key regulatory challenges include: naming of agents and traceability, pharmacovigilance, extrapolation of indications, and interchangeability and substitution. An urgent need exists for more Latin American countries to establish national psoriasis registries and to integrate their common components into a multinational psoriasis network, thereby enhancing their interpretative power and impact. A Latin American psoriasis network similar to PSONET in Europe would assist health‐care providers, pharmaceutical companies, regulators and patients to fully comprehend specific products being prescribed and dispensed and to identify potential regional trends or differences in safety or outcomes.     

Response to treatment during medium-term follow-up in a series of patients with neurocardiogenic syncope

BACKGROUND: Syncope is a common symptom that has different recurrence ratios. We hypothesized that an individualized treatment regimen including pharmacologic and nonpharmacologic measures considering kind of neurocardiogenic syncope (NCS) and basal characteristics of each patient could allow optimized therapy to avoid recurrences. METHODS: We conducted a prospective study to evaluate performance of diverse accepted treatments for NCS. Each patient received specific treatment including general measures such as an increase in salt and water intake, tilt training, specific pharmacologic treatment according to head-up tilt table test (HUTT) result, and patient basal blood pressure and heart rate measurements. RESULTS: We followed a group of 127 patients during a main period of 20.8 +/- 9 months (range, 6-38 months). Mean age was 47.8 +/- 19.2 years and 66.9% were females. We had six (4.7%) patients with recurrence of symptoms 4 +/- 0.9 months after diagnostic HUTT. Medications used were atenolol in 20 patients, pindolol in 17, dysopiramide in 50, and fluoxetine in 25. Two patients received fludrocortisone. Tilt training was not indicated initially for patients with recurrences but was indicated later; to date, these patients have not experienced further episodes. CONCLUSIONS: Increase in water and salt intake, as well as tilt training, showed great value in prevention of syncope recurrences in this specific set of patients. Pharmacologic treatment has an important role, but there is no single medication associated with significant improvement in symptom control.     

Detection of myocardial viability could be improved by rest GIK (glucose-insulin-potassium solution)-Tc 99m sestamibi compared with TL-201 reinjection, in post myocardial infarction patients

GIK solutions improve detection of myocardium viability after acute infarction because they could change the metabolic conditions, improving myocardial perfusion defects. METHODS AND RESULTS: Seventy four patients (52 men, 22 women, mean age 53.3.08 +/- 12.14 years) with previous myocardial infarction (evolution time, 4.2 +/- 3.1 months) underwent pharmacological stress (dipyridamole), rest redistribution and reinjection Tl-201 image as well rest/stress Tc-99m Sestamibi, after the intravenous administration of GIK (200 g glucose +/- 30 UI regular insuline +/- 40 mEq potassiumchloride/500 mL in continuous infusion during 3 hours), Group A (N = 22) or oral administration of 70 g of glucose+/- 40 mEq of potassium chloride taking in advantage the endogenous insulin secretion, to non-diabetic patients (group B = GB, N = 26) and group C (GC, diabetic patients N = 26). All of the 74 patients received 10 mg of sublingual Isorbide previous to 25 mCi of Tc99m Sestamibi administration in a different 2 days protocol. A total of 1,480 myocardial segments were assessed and numbered, and the severity of perfusion defects in the segments involved, were compared between Thallium 201 rest reinjection and GIK-MIBI as the main objective of the study. Involved territories number: 4.02 +/- 2.50 vs. 6.88 +/- 2.12, p = 0.005 for AD; 5.2 +/- 1.44 vs. 6.35 +/- 1.11, p = 0.05 for RC and 1.58 +/- 1.01 vs. 2.05 +/- 1.05, p = 0.05 Cx. For GIK-MIBI vs. Tl-201 reinjection respectively, and defect severity: 8.2 +/- 6.04 vs. 13.22 +/- 5.38, p = 0.01 for LAD; 11.72 +/- 5.08 vs. 15.13 +/- 4.42, p = 0.005 for RC and 2.66 +/- 2.09 vs. 4.69 +/- 3.58, p = 0.003 Cx . For GIK-MIBI vs. Tl-201 reinjection respectively, were found. CONCLUSION: Our data suggest that GIK-MIBI protocol is a safe and easy procedure which improves the detection of perfusion reversible defects compared with Tl-201 reinjection, obtaining better information regarding myocardial viability, with lower acquisition time and less cost.     

Kearns-Sayre syndromes an absolute indication for prophylactic implantation of definitive pacemaker?

Kearns-Sayre syndrome is a mitochondrial cytopathy characterized by chronic progressive external ophthalmoplegia, retinitis pigmentosa and heart block, the last of which determines the survival of these patients. The case of a 23 year old man with Kearns-Sayre syndrome, conduction disturbances and mitral valve prolapse is presented. The characteristics of this syndrome are described and the criteria for prophylactic installation of a pacemaker discussed.