Kidney function following nephrectomy: Similitude and discrepancies between kidney cancer and living donation

ObjectivesThe reported long-term safety of kidney donation is inconsistent with the impairment of kidney function observed following nephrectomy for renal cell cancer. We aimed to investigate if indication for nephrectomy (kidney cancer vs. living donation) was an independent risk factor for kidney function deterioration.Materials and methodsBetween 1985 and 2008, 124 patients with localized renal cell carcinoma who meet the criteria used for living donation, underwent radical nephrectomy (group 1) at our institution. Group 1 was retrospectively compared with 124 consecutive living donor nephrectomies (group 2) performed from 2004 to 2008. Kidney function evaluation was performed preoperatively and at 1, 2, 3, and 4 years postoperatively with calculation of estimated glomerular filtration rate through the Modification of Diet in Renal Disease (MDRD-eGFR) and the adjusted Cockroft and Gault (CG-eGFR) formula. Multivariate logistic regression included patients' characteristics and indication for nephrectomy as predictors of kidney function deterioration.ResultsMean decrease in MDRD-eGFR was 30.4% and 32.4% in groups 1 and 2 (P = 0.30). Prevalence of chronic kidney disease (CKD), defined by MDRD-eGFR < 60 mL/min/m², varied from 42.3% to 71% in group 1 and from 41.6% to 56% in group 2 at different time points (P = 0.073). Prevalence of CKD at 4 years defined by MDRD-eGFR < 45 mL/min/m² was significantly increased in group 1 compared with group 2 (16.2% and 5.3%, P < 0.005, respectively). Linear regression analysis showed only baseline kidney function and patient age predicted a significant decrease in postoperative kidney function (P < 0.001 and P = 0.04).ConclusionsRenal cell carcinoma is not an independent risk factor for kidney function impairment following nephrectomy. Selected kidney cancer patients with few morbidities face the same deterioration of meanly 30% of kidney function compared with living donors, but their lower baseline function results in an increased risk for CKD.     

Using GRADE methodology for the development of public health guidelines for the prevention and treatment of HIV and other STIs among men who have sex with men and transgender people

ABSTRACT: BACKGROUND: The World Health Organization (WHO) Department of HIV/AIDS led the development of public health guidelines for delivering an evidence-based, essential package of interventions for the prevention and treatment of HIV and other sexually transmitted infections (STIs) among men who have sex with men (MSM) and transgender people in the health sector in low- and middle-income countries. The objective of this paper is to review the methodological challenges faced and solutions applied during the development of the guidelines. METHODS: The development of the guidelines followed the WHO guideline development process, which utilizes the GRADE approach. We identified, categorized and labeled the challenges identified in the guidelines development process and described the solutions through an interactive process of in-person and electronic communication. RESULTS: We describe how we dealt with the following challenges: (1) heterogeneous and complex interventions; (2) paucity of trial data; (3) selecting outcomes of interest; (4) using indirect evidence; (5) integrating values and preferences; (6) considering resource use; (7) addressing social and legal barriers; (8) wording of recommendations; and (9) developing global guidelines. CONCLUSION: We were able to successfully apply the GRADE approach for developing recommendations for public health interventions. Applying the general principles of the approach while carefully considering specific challenges can enhance both the process and the outcome of guideline development.     

Immunogenicity and safety of a new meningococcal A conjugate vaccine in Indian children aged 2–10 years: A Phase II/III double-blind randomized controlled trial

This study compares the immunogenicity and safety of a single dose of a new meningococcal A conjugate vaccine (PsA-TT, MenAfriVac™, Serum Institute of India Ltd., Pune) against the meningococcal group A component of a licensed quadrivalent meningococcal polysaccharide vaccine (PsACWY, Mencevax ACWY^®, GSK, Belgium) 28 days after vaccination in Indian children. This double-blind, randomized, controlled study included 340 Indian children aged 2–10 years enrolled from August to October 2007; 169 children received a dose of PsA-TT while 171 children received a dose of PsACWY. Intention-to-treat analysis showed that 95.2% of children in PsA-TT group had a ≥4-fold response in serum bactericidal titers (rSBA) 28 days post vaccination as compared to 78.2% in the PsACWY group. A significantly higher rSBA GMT (11,209, 95%CI 9708–12,942) was noted in the PsA-TT group when compared to PsACWY group (2838, 95%CI 2368–3401). Almost all children in both vaccine groups had a ≥4-fold response in group A-specific IgG concentration but the IgG GMC was significantly greater in the PsA-TT group (89.1 μg/ml, 95%CI 75.5–105.0) when compared to the PsACWY group (15.3 μg/ml, 95%CI 12.3–19.2). Local and systemic reactions during the 4 days after immunization were similar for both vaccine groups except for tenderness (30.2% in PsA-TT group vs 12.3% in PsACWY group). None of the adverse events or serious adverse events was related to the study vaccines. We conclude that MenAfriVac™ is well tolerated and significantly more immunogenic when compared to a licensed polysaccharide vaccine, in 2-to-10-year-old Indian children.     

Intensive care unit admission in chronic obstructive pulmonary disease: patient information and the physician’s decision-making process

Introduction

ICU admission is required in more than 25% of patients with chronic obstructive pulmonary disease (COPD) at some time during the course of the disease. However, only limited information is available on how physicians communicate with COPD patients about ICU admission.

Methods

COPD patients and relatives from 19 French ICUs were interviewed at ICU discharge about their knowledge of COPD. French pulmonologists self-reported their practices for informing and discussing intensive care treatment preferences with COPD patients. Finally, pulmonologists and ICU physicians reported barriers and facilitators for transfer of COPD patients to the ICU and to propose invasive mechanical ventilation.

Results

Self-report questionnaires were filled in by 126 COPD patients and 102 relatives, and 173 pulmonologists and 135 ICU physicians were interviewed. For 41% (n = 39) of patients and 54% (n = 51) of relatives, ICU admission had never been expected prior to admission. One half of patients were not routinely informed by their pulmonologist about possible ICU admission at some time during the course of COPD. Moreover, treatment options (that is, non-invasive ventilation, intubation and mechanical ventilation or tracheotomy) were not explained to COPD patients during regular pulmonologist visits. Pulmonologists and ICU physician have different perceptions of the decision-making process pertaining to ICU admission and intubation.

Conclusions

The information provided by pulmonologists to patients and families concerning the prognosis of COPD, the risks of ICU admission and specific care could be improved in order to deliver ICU care in accordance with the patient’s personal values and preferences. Given the discrepancies in the decision-making process between pulmonologists and intensivists, a more collaborative approach should probably be discussed.     

Specific instructions for estimating unclearly reported blinding status in randomized trials were reliable and valid

ObjectiveTo test the reliability and validity of specific instructions to classify blinding, when unclearly reported in randomized trials, as “probably done” or “probably not done.”Study Design and SettingWe assessed blinding of patients, health care providers, data collectors, outcome adjudicators, and data analysts in 233 randomized trials in duplicate and independently using detailed instructions. The response options were “definitely yes,” “probably yes,” “probably no,” and “definitely no.” We contacted authors for data verification (46% response). For each of the five questions, we assessed reliability by calculating the agreement between the two reviewers and validity by calculating the agreement between reviewers’ consensus and verified data.ResultsThe percentage with unclear blinding status varied between 48.5% (patients) and 84.1% (data analysts). Reliability was moderate for blinding of outcome adjudicators (κ = 0.52) and data analysts (κ = 0.42) and substantial for blinding of patients (κ = 0.71), providers (κ = 0.68), and data collectors (κ = 0.65). The raw agreement between the consensus record and the author-verified record varied from 84.1% (blinding of data analysts) to 100% (blinding of health care providers).ConclusionWith the possible exception of blinding of data analysts, use of “probably yes” and “probably no” instead of “unclear” may enhance the assessment of blinding in trials.