Sex and age differences in the achievement of control targets in patients with type 2 diabetes: results from a population-based study in a South European region.

BACKGROUND: We aimed to determine the degree to which control targets of glycaemia and cardiovascular risk factors were achieved among patients with type 2 diabetes and to investigate sex- and age-related differences in this population. METHODS: This cross-sectional, population-based study was conducted in Spain. Glycated hemoglobin (HbA1c), blood pressure, LDL-c, HDL-c, triglycerides, BMI, and smoking history were obtained from electronic clinical primary care records (n = 32,638 cases). The proportions of patients who met control targets were determined according to sex and age groups. Comparisons between groups were conducted with t-tests for continuous variables, tests for trends in proportions for categorical and ordinal variables, and Pearson's chi-square tests and binary logistic regression models for categorical variables. RESULTS: The overall proportions of patients with type 2 diabetes who met the target objectives for HbA1c (<7 %, 53 mmol/mol), blood pressure (130/80 mmHg), and LDL-cholesterol (100 mg/dl) were 60, 40 and 41 %, respectively. Women were less likely than men to meet the control targets of HbA1c (59 vs 61 %), LDL (35 vs 45 %), and HDL (58 vs 78 %). Patients under 65 years of age presented poorer control than older age groups. Only a minority of patients with type 2 diabetes met the composite target objectives for glycemic control, blood pressure, and LDL. CONCLUSIONS: There are differential gaps in the control results of female patients and younger patients, which should prompt improvements in case management and care. There is room for further improvement in the cardiometabolic control of patients with type 2 diabetes.

Herniation of the temporomandibular joint into the external auditory canal: Our review of 13 cases.

UNLABELLED: Symptomatic dehiscence of the anterior wall of the external auditory canal is only occasionally encountered during otologic surgery. OBJECTIVE: To propose a technical answer for the reconstruction of anterior wall defects based on the size of the dehiscence. MATERIAL AND METHODS: Retrospective study of 13 cases of dehiscence of the anterior wall (9 male and 4 female patients between 30 and 66 years) operated between 1998 and 2010. The pathologies at the cause of the dehiscence were cholesteatoma (2 cases), chronic otitis externa (3 cases), congenital dehiscence (1 case), 5 cases which appeared after a surgery mainly for exostosis (3 of them previously operated in another center) and 2 cases of accidental breach during canal calibration. The size of the defect measured during surgery was "small" (< 4 mm diameter) in 2 cases, "medium" (between 4 and 8 mm) in 8 cases and "large" in 3 (> 8 mm). The reconstruction was performed in 7 cases through the EAC and in 6 cases an anterior approach of the anterior wall of the EAC was used. In all cases, we could insert a graft anteriorly and this was held in place by the pressure exerted by the temporomandibular joint. Bone paté and temporalis fascia with in most cases a piece of cortical bone graft was used in all cases. RESULTS: The follow up period ranged from 6 to 24 months. In 10 cases the anatomical result was perfect (in 3 cases we encountered some minor complications but with no clinical consequences). In the other three cases there was one with persistent inflammation of the external auditory canal, one case of recurrence of the lateralization of the tympanic membrane and one case which required a revision surgery. CONCLUSION: The reconstruction and the approach are done according to the size of the defect, whether small, medium or large. Complications and revision surgeries have been minimal.

Total knee replacement; minimal clinically important differences and responders.

OBJECTIVE: To provide new data on minimally clinical important difference (MCID) and percentages of responders on pain and functional dimensions of Western Ontario and McMaster Osteoarthritis Index (WOMAC) in patients who have undergone total knee replacement (TKR). METHODS: 1-year prospective multicentre study with two different cohorts. Consecutive patients on the waiting list were recruited. There were 415 and 497 patients included. Pain and function were collected by the reverse scoring option of the WOMAC (0-100, worst to best). Transition items (five point scale) were collected at 1-year and MCID was calculated through mean change in patients somewhat better, Receiver Operating Characteristic (ROC) and two other questions about satisfaction. Analysis was performed in the whole sample and by tertiles of baseline severity. Likewise were calculated the percentages of patients who attained cut-off values. RESULTS: Global MCID for pain were about 30 in both cohorts and 32 for. By ROC these values were about 20 and 24 respectively. According to the other two transitional questions these values were for pain 27 and 20 for function. By tertiles the worst the baseline score the higher the cut-off values. Percentage of responders does not change when comparing responders to the global MCID with their own tertile MCID and were about 61% for pain and 50% for function. CONCLUSION: Due to the wide variations, MCID estimates should be calculated and used according to the baseline severity score.

Patient acceptable symptom state and OMERACT-OARSI set of responder criteria in joint replacement. Identification of cut-off values.

OBJECTIVE: To identify new cut-off values beyond which patients can be considered as satisfied or as responders through patient acceptable symptom state (PASS) and OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) set of responder criteria in total joint replacement. METHODS: Secondary analysis of a 1-year prospective multicenter study of 861 patients, 510 with total knee replacement (TKR) and 351 with total hip prosthesis (THR). Pain and function data were collected by the reverse scoring option of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). PASS values were identified with the 25th centile estimation using an anchoring question about satisfaction with actual symptoms. OMERACT-OARSI set of responder criteria was based on a combination of absolute and relative change of pain, function and global patient's assessment. Receiver operating characteristic (ROC) analysis was used as a complementary approach. RESULTS: The values for PASS were about 80 and 69 for pain and function in THR, while these values were 80 and 68 when using OMERACT-OARSI criteria. Regarding TKR, PASS values were about 75 and 67 in pain and function with both criteria. ROC values were slightly lower in all cases. PASS and OMERACT-OARSI values varied moderately across tertiles of baseline severity. CONCLUSION: With the provided data we can establish when a patient can be considered as satisfied/responder in joint replacement. The scores achieved at 1 year were very similar according to both criteria.

Central sleep apnea is associated with increased risk of ischemic stroke in the elderly.

OBJECTIVES: Sleep apnea/hypopnea syndrome is a well-recognized independent risk factor for stroke in middle-aged population, but controversy remains in older subjects. We examined the possible association between different respiratory parameters and risk of stroke in a prospective population-based cohort of 394 stroke-free elderly subjects. MATERIAL AND METHODS: Fully overnight polysomnography was performed at baseline. Over the 6 year follow-up period, 20 ischemic strokes occurred. Differences in stroke-free survival between subjects according to central apnea index (CAI) were assessed. RESULTS: We just observed association with incident ischemic stroke on central sleep apnea (CSA) episodes. Obstructive sleep apnea, time passed under 90% oxygen saturation, or arousal index were not associated. The event-free survival was lowest in the highest CAI group. This association was independent of any other vascular risk factors. CONCLUSIONS: CSA is the specific respiratory event associated with stroke in the elderly. Additionally, CSA could be a marker of silent brain ischemia, as a sign of disturbed regulation of central respiratory mechanisms, tentatively of ischemic origin.

Total knee replacement: Are there any baseline factors that have influence in patient reported outcomes?

BACKGROUND: There is conflicting evidence about what factors influence outcomes after total knee replacement (TKR). The objective is to identify baseline factors that differentiate patients who achieve both, minimal clinically important difference (MCID) and a patient acceptable symptom state (PASS) in pain and function, measured by WOMAC, after TKR from those who do not attain scores above the cutoff in either of these dimensions. METHODS: One-year prospective multicentre study. Patients completed WOMAC, SF-12, EQ-5D, expectations, other joint problems and sociodemographic data while in the waiting list, and 1-year post-TKR. Dependent variable was a combination of MCID and PASS in both dimensions (yes/no). Univariate analysis was performed to identify variables associated. Exploratory factor analysis (EFA) was performed to study how these variables grouped into different factors. RESULTS: Total sample comprised 492 patients. Mean (SD) age was 71.3 (6.9), and there were a 69.7% of women. Of the total, 106 patients did not attain either MCID or PASS in either dimension, and 230 exceeded both thresholds in both dimensions. In the univariate analysis, 13 variables were associated with belonging to one group or another. These 13 variables were included in EFA; 3 factors were extracted: expectations, mental health, and other joints problems. The percentage of variance explained by the 3 factors was 80.4%. CONCLUSION: We have found 2 modifiable baseline factors, expectations and mental health, that should be properly managed by different specialist. Indication of TKR should take into account these modifiable factors for improving outcomes after TKR.

Tobacco smoking and bipolar disorder.

BACKGROUND: We sought to determine whether tobacco smoking is associated with bipolar disorder. METHOD: This case-control study carried out in Alava, in the north of Spain, included patients with a DSM-III-R diagnosis of bipolar disorder type I (N = 51) and a representative sample of the normal population (N = 517). Smoking history of bipolar patients was assessed with the Fagerstrom Test for Nicotine Dependence and was verified by family members of the patients. RESULTS: The frequencies of ever smoking and current daily smoking were, respectively, 63% (32/51) and 51% (26/51) for the bipolar patients and 45% (235/517) and 33% (169/517) for the control group (respective odds ratios [ORs] and 95% confidence intervals [CIs] were OR = 2.0, 95% CI = 1.1 to 3.8 and OR = 2.1, 95% CI = 1.2 to 4.0). The differences were significant (p = .03 and p = .042, respectively) for bipolar versus control males. Bipolar disorder (in both genders) was also significantly associated (OR = 4.4, 95% CI = 1.7 to 11.9, p = .0015) with heavy smoking (more than 1 pack per day). CONCLUSION: Despite its small sample size, this study suggests that smoking may be more prevalent in bipolar patients than in the normal population. Since most patients started to smoke before the onset of illness, vulnerability to bipolar illness may make subjects vulnerable to become tobacco smokers.

Postoperative contamination after using vancomycin and gentamicin during phacoemulsification.

OBJECTIVE: To investigate if the addition of vancomycin and gentamicin to the irrigating solutions during phacoemulsification with lens implantation reduces the incidence of positive postoperative intraocular cultures. DESIGN: Two-part double-masked, placebo-controlled, randomized clinical trial. PATIENTS: In the preliminary study, intracameral antibiotic concentrations were measured immediately after surgery (in 10 eyes) and 2 hours after surgery (in 10 eyes) in patients treated with antibiotics. In the primary study, 120 eyes underwent uncomplicated surgery. The treatment group and the placebo group were composed of 60 eyes each. INTERVENTION: The treatment group received vancomycin, 20 micrograms/mL, and gentamicin, 8 micrograms/mL, in the irrigating fluid. The placebo group received only irrigating fluid. All patients in the primary study underwent anterior chamber aspiration following surgery, and culturing was performed 2 hours later. MAIN OUTCOME MEASURE: Identification and quantification of positive cultures in thioglycolate broth and chocolate agar. RESULTS: In the preliminary study, the half-life of both intraocular antibiotics was less than 2 hours. In the primary study, intraocular aspirates yielded positive cultures in 3 specimens (5.0%) in the antibiotic-treated group and in 7 specimens (12.0%) in the placebo group. CONCLUSIONS: Although we found a higher rate of positive postoperative cultures in the placebo group (odds ratio = 2.51), 2 hours of contact between the antibiotic solution and bacteria did not produce results that reached statistical significance (P =.18) to support adding vancomycin and gentamicin to the irrigating solutions during phacoemulsification. Further studies are needed to evaluate the clinical implications of using antibiotics in irrigating solutions.

[Validation study of a polygraphic screening device (BREAS SC20) in the diagnosis of sleep apnea-hypopnea syndrome]. / Estudio de validez de un equipo de poligrafía respiratoria (BREAS SC-20) para el diagnóstico del síndrome de apneas-hipopneas durante el sueño.

OBJECTIVE: To validate the BREAS SC20 (Breas Medical AB, Mölnlyke, Sweden) polygraphic screening device, comparing it with conventional polysomnography (PSG), in the diagnosis of sleep apnea-hypopnea syndrome. A validity study of the diagnostic test was carried out at the sleep clinic of a tertiary hospital. PATIENTS AND METHODS: Seventy patients clinically suspected of sleep apnea-hypopnea syndrome and treated at the sleep laboratory of the Hospital Txagorritxu, Vitoria, Spain, from November, 2001 until August, 2002 were consecutively enrolled in the study. Patient characteristics, comorbidities, and results on the Epworth sleepiness scale were recorded. The apneahypopnea index (AHI) per hour of sleep was determined by PSG; the respiratory events index (REI) per hour of screening was determined by the polygraphic screening device. RESULTS: Sixty studies were valid (77% were men; mean [SD] age: 51.6 [13.2]; body mass index: 30.3 [5]; AHI: 31.0 [27.6]). The intraclass correlation coefficient between the AHI by PSG and the manual REI was 0.92. The mean difference between the AHI and the manual REI was 2.92 (9.75). The area under the receiver operating characteristic curve was 0.924 for the cut point AHI >or =5. The optimal cut point for an AHI > or = 5 was 3.6 in the REI (98% sensitivity). The respiratory screening device correctly classified 90% to 95% of the patients. CONCLUSIONS: The BREAS SC20 is a valid system for identifying patients clinically suspected of sleep apnea-hypopnea syndrome.

Remifentanil versus placebo for analgesia during external cephalic version: a randomised clinical trial.

BACKGROUND: Breech presentation occurs in up to 3% of pregnancies at term and may be an indication for caesarean delivery. External cephalic version can be effective in repositioning the fetus in a cephalic presentation, but may be painful for the mother. Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version. METHODS: A randomized, double-blind, controlled trial that included women at 36-41 weeks of gestation with non-cephalic presentations was performed. Women were randomized to receive either a remifentanil infusion at 0.1 µg/kg/min and demand boluses of 0.1 µg/kg, or saline placebo. The primary outcome was the numerical rating pain score (0-10) after external cephalic version. RESULTS: Sixty women were recruited, 29 in the control group and 31 in the remifentanil group. There were significant differences in pain scores at the end of the procedure (control 6.5 ± 2.4 vs. remifentanil 4.7 ± 2.5, P = 0.005) but not 10 min later (P = 0.054). The overall success rate for external cephalic version was 49% with no significant differences between groups (remifentanil group 54.8% vs. control group 41.3%, P = 0.358). In the remifentanil group, there was one case of nausea and vomiting, one of drowsiness and three cases of fetal bradycardia. In the control group, there were three cases of nausea and vomiting, one of dizziness and nine cases of fetal bradycardia. CONCLUSION: Intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction. There were no additional adverse effects, and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia.

[Primary hip replacement: first year results and predictive factors of poor outcome]. / Artroplastia primaria de cadera: resultados en el primer año y factores predictores de mala evolución.

OBJECTIVE: To evaluate the results of total hip arthroplasty in patients with osteoarthritis and to identify predictors of poor functional outcome. MATERIAL AND METHODS: A prospective observational study in patients operated on in 2006 with total hip arthroplasty in 4 hospitals in Guipúzcoa, followed up for 1 year. OUTCOME VARIABLES: pain, physical function, complications, mortality, quality of life by WOMAC and SF-12 (at 0, 3, 6 and 12 months) and «Poor functional outcome¼ at one year (last quartile of the WOMAC in function area). Logistic regression was performed to examine predictors of poor functional outcome. RESULTS: A total of 166 patients were followed up. The incidence of systemic and local complications was 6.3% and 14.5%, respectively, 4.3% readmissions and no deaths related to surgery. Close to 40 points improvement in pain, stiffness and WOMAC functional limitation, mainly in the first 3 months after surgery. A similar trend was seen, but lower in the physical and mental component of the SF12 (12 and 8 points, respectively). The previous score on the WOMAC function area and the physical component of SF-12, and the existence of any complications, are predictors of poor functional recovery. DISCUSSION: The improvement experienced after the surgery is already very important before the third month. The functional and physical status before surgery and possible complications of surgery are significant determinants of the results.

Explicit criteria for hospital admission in exacerbations of chronic obstructive pulmonary disease.

OBJECTIVE: To develop detailed, explicit criteria for determining the appropriateness of admission for patients with exacerbations of chronic obstructive pulmonary disease (COPD). DESIGN: Using a modified Delphi process, a panel of seven pneumologists and five emergency department (ED) physicians was assembled to establish the appropriateness of hospital admission for 896 distinct theoretical scenarios. To assess the reliability of the criteria, a second national panel of five pneumologists and five ED physicians was assembled. We examined the influence of all variables on the first panel score using linear regression models. The explicit criteria developed were summarised by classification and regression tree analysis. RESULTS: The appropriateness of the hospitalisation scenarios increased with the severity of COPD. The kappa of agreement between the two panels was 0.79. Predictors of appropriate hospitalisation were severity of current COPD exacerbation, response to previous treatment and expected adherence to treatment. The panel results were synthesised and presented in three decision trees. Misclassification error in the decision trees, as compared with the panel's original ratings, was 6.1%. CONCLUSIONS: These explicit criteria can be used to help determine the appropriateness of admission for patients with exacerbations of COPD.

D-dimer levels and 15-day outcome in acute pulmonary embolism. Findings from the RIETE Registry.

BACKGROUND: A number of variables have been evaluated for risk stratification in patients with acute pulmonary embolism (PE). Whereas increased D-dimer levels have been associated with mortality at 3 months, its role in predicting short-term outcome (the period of time during which any therapeutic decision has to be taken) remains unclear. METHODS: RIETE is an ongoing, prospective registry of consecutive patients with acute venous thromboembolism. We assessed the prognostic value of D-dimer levels at baseline, measured with an automated latex agglutination test (IL Test D-dimer), on the 15-day outcome in patients with acute PE. Overall mortality, fatal PE and major bleeding rates were compared by quartile. RESULTS: As of February 2008, 1707 patients with acute PE underwent D-dimer testing. Of these, 72 patients (4.2%) died during the first 15 days, 11 (0.6%) had recurrent PE, and 29 (1.7%) had major bleeding. Overall mortality increased with increasing D-dimer levels, from 2.7% in the first quartile (< 1050 ng mL(-1)) to 7.0% in the fourth quartile (>or= 4200 ng mL(-1)). The rates of fatal PE and major bleeding also increased. On multivariate analysis, patients with D-dimer levels in the fourth quartile had an increased risk for overall death (odds ratio, 1.8; 95% CI, 1.1-3.2), fatal PE (odds ratio, 2.0; 95% CI, 1.0-3.8) or major bleeding (odds ratio, 3.2; 95% CI, 1.5-7.0). CONCLUSIONS: PE patients with D-dimer levels in the fourth quartile had an increased incidence of overall death, fatal PE and major bleeding within 15 days both before and after multivariate adjustment.