Development of a Health-Related Quality of Life Questionnaire (HRQL) for patients with Extremity Soft Tissue Infections (ESTI)

BACKGROUND: Past clinical trials of antimicrobial treatment in soft tissue infections have focused on non-standardized clinical and physiological outcome variables, and have not considered the subjective experience of patients. The objective of this study was to develop a health-related quality of life questionnaire (HRQL) for patients with extremity soft tissue infections (ESTI) for future use in clinical trials. METHODS: The design of this study followed published guidelines and included item generation, item reduction, and questionnaire preparation. Study subjects were consenting English-speaking adults with acute ESTI requiring prescription of at least two days of outpatient intravenous antibiotic therapy. RESULTS: A list of 49 items that adversely impact the quality of life of patients with ESTI was generated by literature review, informal health professional feedback, and semi-structured interviews with twenty patients. A listing of these items was then administered to 95 patients to determine their relative importance on quality of life. A questionnaire was prepared that included the twenty most important items with a 5-point Likert scale response. Questionnaire domains included physical symptoms, problems performing their activities of daily living, impairment of their emotional functioning, and difficulties in their social interactions as related to their ESTI. The final questionnaire was pre-tested on a further ten patients and was named the ESTI-Score. CONCLUSION: The ESTI-Score is a novel instrument designed to quantify the impact of ESTI on quality of life. Future study is required to determine its validity and responsiveness before use as an outcome measure in clinical trials

Guidelines for diagnosis and management of the cobalamin-related remethylation disorders cblC, cblD, cblE, cblF, cblG, cblJ and MTHFR deficiency

BACKGROUND: Remethylation defects are rare inherited disorders in which impaired remethylation of homocysteine to methionine leads to accumulation of homocysteine and perturbation of numerous methylation reactions. OBJECTIVE: To summarise clinical and biochemical characteristics of these severe disorders and to provide guidelines on diagnosis and management. DATA SOURCES: Review, evaluation and discussion of the medical literature (Medline, Cochrane databases) by a panel of experts on these rare diseases following the GRADE approach. KEY RECOMMENDATIONS: We strongly recommend measuring plasma total homocysteine in any patient presenting with the combination of neurological and/or visual and/or haematological symptoms, subacute spinal cord degeneration, atypical haemolytic uraemic syndrome or unexplained vascular thrombosis. We strongly recommend to initiate treatment with parenteral hydroxocobalamin without delay in any suspected remethylation disorder; it significantly improves survival and incidence of severe complications. We strongly recommend betaine treatment in individuals with MTHFR deficiency; it improves the outcome and prevents disease when given early

Canagliflozin and renal outcomes in type 2 diabetes and nephropathy

BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years

An Epidemic of Primary Tuberculosis in a Canadian Aboriginal Community

In 1987, an outbreak of primary tuberculosis occurred in a Canadian aboriginal community of 350 people. The source case was a young woman who had been symptomatic for four months with smear positive cavitary pulmonary tuberculosis. Her 17 siblings and their families were frequent close contacts. Among the 626 persons surveyed in the community and environs, 35 additional active cases of tuberculosis were identified. The mean age of cases was 13 years and the median age 10 years. The method of diagnosis was bacteriological in 20 and radiological in 16. There were 257 positive tuberculin reactors of whom 120 had no previous record of a positive skin test. Isoniazid prophylaxis was recommended to all new reactors, close household contacts, reactors under the age of 35 years and reactors with lung scars. One late case was identified at one year of follow-up in a contact who had refused prophylaxis. The rates of infection and disease were higher in the family (65% and 46%, respectively) than in the community and environs (19% and 5.6%, respectively). This report illustrates the nature of a point source epidemic of primary tuberculosis in a susceptible community with a predictable reservoir of infection. The delay in diagnosis of the source case allowed numerous new infections to occur. However, prompt aggressive contact follow-up was successful in containing the epidemic. To prevent future outbreaks, the reservoir of infected persons must be identified and administered chemoprophylaxis

Impact of antibiotic prophylaxis on wound infection after cesarean section in a situation of expected higher risk

Background: To measure rates of incisional surgical site infection (ISSI) after cesarean section (CS) and to assess risks for infection. Methods: Prospective surveillance for ISSI at a 540-bed hospital in Saudi Arabia by using Centers for Disease Control and Prevention definitions for infection and the National Nosocomial Infections Surveillance (NNIS) system risk index. Results: Seven hundred thirty-five CSs were studied from September 1998 to July 1999; 72% were emergency procedures, despite a 95% rate of antenatal care. The overall ISSI rate was 2.8% (95% confidence interval [CI], 1.7%-4.3%). The rate for NNIS risk category 0 was 2.4% (95% CI, 1.3%-4.2%; n = 536) and for category 1 was 4.1% (95% CI, 1.8%-8.6%; n = 170). In the multivariate analysis, the only independent risks for ISSI were duration of surgery (OR = 1.01; 95% CI, 1.00-1.03; P =.02) and no antibiotic prophylaxis (OR = 3.09; 95% CI, 1.10-9.11; P =.04). Antibiotic prophylaxis was inconsistently administered among both emergency and elective CS. Infection control procedures were inadequate in the obstetric suite operating room. Conclusions: Despite deficient infection control practices in the setting described, ISSI rates after CS were judged “acceptable” compared with NNIS benchmark rates. This was attributed to prescribing antibiotic prophylaxis for patients at low risk as well as high risk of infection. (AJIC Am J Infect Control 2001;29:85-8

Impact of antibiotic prophylaxis on wound infection after cesarean section in a situation of expected higher risk

Background: To measure rates of incisional surgical site infection (ISSI) after cesarean section (CS) and to assess risks for infection. Methods: Prospective surveillance for ISSI at a 540-bed hospital in Saudi Arabia by using Centers for Disease Control and Prevention definitions for infection and the National Nosocomial Infections Surveillance (NNIS) system risk index. Results: Seven hundred thirty-five CSs were studied from September 1998 to July 1999; 72% were emergency procedures, despite a 95% rate of antenatal care. The overall ISSI rate was 2.8% (95% confidence interval [CI], 1.7%-4.3%). The rate for NNIS risk category 0 was 2.4% (95% CI, 1.3%-4.2%; n = 536) and for category 1 was 4.1% (95% CI, 1.8%-8.6%; n = 170). In the multivariate analysis, the only independent risks for ISSI were duration of surgery (OR = 1.01; 95% CI, 1.00-1.03; P =.02) and no antibiotic prophylaxis (OR = 3.09; 95% CI, 1.10-9.11; P =.04). Antibiotic prophylaxis was inconsistently administered among both emergency and elective CS. Infection control procedures were inadequate in the obstetric suite operating room. Conclusions: Despite deficient infection control practices in the setting described, ISSI rates after CS were judged “acceptable” compared with NNIS benchmark rates. This was attributed to prescribing antibiotic prophylaxis for patients at low risk as well as high risk of infection. (AJIC Am J Infect Control 2001;29:85-8