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A multinational assessment of complications in type 1 diabetes: the DiaMond substudy of complications (DiaComp) level 1.

The objectives of this study were to describe the global geographic variation of microvascular and macrovascular complications in childhood onset type 1 diabetes (T1D) and to relate any such variation to diabetes care activities such as self blood glucose monitoring and intensive insulin therapy. The DiaComp study is a multinational (17 countries) cross-sectional study of complications in T1D (n=2,657). All participants were diagnosed at < 15 years of age and had a diabetes duration of 5-24 years when surveyed. Complications were assessed by self-report of physician diagnosis. Twenty-two centres in 17 countries achieved at least a 67% response rate and are included in the analyses. Central European centres exhibited high rates of retinopathy (Lithuania=31.6%, Romania=24.2%), laser treatment (Lithuania=25.4%) and neuropathy (Lithuania=29.9%, Romania=12.4%) in those with short duration of diabetes (5-15 years), as did Cuba for neuropathy (15.4%). For retinopathy the geographic variation in the short-duration group was also pronounced, ranging from 1.6% in Italy to 41.6% in Lithuania, and from 0% in Brazil, Italy and Australia, to 29.9% in Lithuania for laser treatment. Variation was less dramatic for the prevalence of complications in the long-duration group (15-25 years). Hypertension and duration were strong consistent predictors of all complications, while women had higher prevalence for half the complications (retinopathy, laser treatment and renal disease). Intensive insulin therapy and self-monitoring of blood glucose showed little association with prevalence of complications. In conclusion, this first population-based account of the geographic variation of T1D complications has demonstrated substantial variation. However, the healthcare practice variables that were measured contributed little toward explaining this variation.

Adolescent↗

Insights from the diabetes control and complications trial/epidemiology of diabetes interventions and complications study on the use of intensive glycemic treatment to reduce the risk of complications of type 1 diabetes.

OBJECTIVE: To analyze the long-term effects of early implementation of intensive glycemic treatment in patients with type 1 diabetes. METHODS: Data from the Diabetes Control and Complications Trial (DCCT) and the Epidemiology of Diabetes Interventions and Complications (EDIC) followup study are reviewed, particularly in terms of reduction of diabetes-related complications. RESULTS: In the DCCT, intensive intervention resulted in a 63% reduction in retinopathy progression, a 47% decrease in development of severe nonproliferative diabetic retinopathy, a 39% and 54% reduction in microalbuminuria and macroalbuminuria, respectively, and a 60% reduction in clinical neuropathy at 5 years. Aggressive early intervention before the manifestation of complications yielded the best results. In both intensive and conventional treatment groups in the DCCT, there was approximately a 40% reduction in risk of progression of retinopathy for each 10% proportional reduction in hemoglobin A1c (HbA1c). At the conclusion of the DCCT, participants learned about the results, and all were encouraged and helped to adopt intensive treatment. Thereafter, the HbA1c levels of the two groups rapidly approached each other and have not been significantly different for the past 5 years of the EDIC study. CONCLUSION: The findings in the DCCT and the EDIC follow-up study support early intensive treatment in patients with type 1 diabetes, with the goal of maintaining HbA1c levels as close to normal as is safely possible, to achieve long-term beneficial effects on the risk of complications.

Aging↗

Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group.

The Diabetes Control and Complications Trial has demonstrated that intensive diabetes treatment delays the onset and slows the progression of diabetic complications in subjects with insulin-dependent diabetes mellitus from 13 to 39 years of age. We examined whether the effects of such treatment also occurred in the subset of young diabetic subjects (13 to 17 years of age at entry) in the Diabetes Control and Complications Trial. One hundred twenty-five adolescent subjects with insulin-dependent diabetes mellitus but with no retinopathy at baseline (primary prevention cohort) and 70 adolescent subjects with mild retinopathy (secondary intervention cohort) were randomly assigned to receive either (1) intensive therapy with an external insulin pump or at least three daily insulin injections, together with frequent daily blood-glucose monitoring, or (2) conventional therapy with one or two daily insulin injections and once-daily monitoring. Subjects were followed for a mean of 7.4 years (4 to 9 years). In the primary prevention cohort, intensive therapy decreased the risk of having retinopathy by 53% (95% confidence interval: 1% to 78%; p = 0.048) in comparison with conventional therapy. In the secondary intervention cohort, intensive therapy decreased the risk of retinopathy progression by 70% (95% confidence interval: 25% to 88%; p = 0.010) and the occurrence of microalbuminuria by 55% (95% confidence interval: 3% to 79%; p = 0.042). Motor and sensory nerve conduction velocities were faster in intensively treated subjects. The major adverse event with intensive therapy was a nearly threefold increase of severe hypoglycemia. We conclude that intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy and nephropathy when initiated in adolescent subjects; the benefits outweigh the increased risk of hypoglycemia that accompanies such treatment.

Adolescent↗

Effect of pregnancy on microvascular complications in the diabetes control and complications trial. The Diabetes Control and Complications Trial Research Group.

OBJECTIVE: To assess the effect of pregnancy on the development and progression of retinopathy and microalbuminuria in type 1 diabetes. RESEARCH DESIGN AND METHODS: We conducted longitudinal analyses of the Diabetes Control and Complications Trial (DCCT), a multicenter controlled clinical trial that compared intensive treatment with conventional diabetes therapy and studied 180 women who had 270 pregnancies and 500 women who did not become pregnant during an average of 6.5 years of follow-up. Women assigned to the conventional treatment group were changed to intensive therapy if they were planning pregnancy or as soon as possible after conception. Fundus photography was performed every 6 months, and the urinary albumin excretion rate (AER) was measured annually. RESULTS: Compared with nonpregnant women, pregnant women had a 1.63-fold greater risk of any worsening of retinopathy from before to during pregnancy (P < 0.05) in the intensive treatment group; the risk was 2.48-fold greater for pregnant vs. not pregnant women in the conventional group (P < 0.001). In the conventional group, the odds of > or =3-step progression from the baseline retinopathy level was >2.9-fold among pregnant vs. not pregnant women (P = 0.003). The odds ratio (OR) peaked during the second trimester (OR = 4.26, P = 0.001) and persisted as long as 12 months postpregnancy (OR = 2.87, P = 0.005). The level of AER during pregnancy in the intensive group, but not in the conventional group, was significantly elevated from the level at baseline, albeit in the normal range. Although individual patients had transient worsening of retinopathy during pregnancy, even to the proliferative level, at the end of the DCCT, mean levels of retinopathy and albuminuria in subjects who had become pregnant were similar to those in subjects who had not become pregnant within each treatment group. CONCLUSIONS: Pregnancy in type 1 diabetes induces a transient increase in the risk of retinopathy; increased ophthalmologic surveillance is needed during pregnancy and the first year postpartum. The long-term risk of progression of early retinopathy and albumin excretion, however, does not appear to be increased by pregnancy.

Adolescent↗

[Complicated cataract: Part II: complicated cataract in glaucoma. Part II: Complicated cataract in retinal degenerative disorders].

The paper shows pathognomonique cases of complicated cataracts concerning the prognostic aspects of surgical treatment. The article presents surgical methods of treating patients with secondary cataract in high myopia and glaucoma. Modern diagnostic methods are discussed, how to choose the safest surgical technique and to reach the desired postoperative refraction. More effective ways of cataract surgery in patients with glaucoma and in high myopia are suggested.

Cataract↗

Clustering of long-term complications in families with diabetes in the diabetes control and complications trial. The Diabetes Control and Complications Trial Research Group.

We investigated familial clustering of diabetic retinopathy and nephropathy in the families of 372 subjects from the Diabetes Control and Complications Trial (DCCT). These subjects had 467 first-degree relatives with IDDM or NIDDM. Family sizes ranged from two to six. A complete data set was obtained from 241 relatives of 217 DCCT subjects. Among the DCCT subjects, 53% were in the intensive treatment group and 47% were in the conventional group; 44% were from the primary prevention cohort (no retinopathy or microalbuminuria at the DCCT baseline) and 56% were from the secondary intervention cohort (mild-to-moderate nonproliferative retinopathy and <200 mg/24 h albumin excretion rate [AER] at baseline). Retinopathy and nephropathy were assessed with seven-field stereo fundus photography and timed urinary AER measurements. Retinopathy was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale. ETDRS scores and AERs were adjusted for the DCCT treatment group and for significant covariates from among sex, age, diabetes duration, HbA1c value, and body weight. Familial associations were assessed by comparing the prevalence of retinopathy and nephropathy in diabetic relatives of the respective positive versus negative DCCT subjects. To determine family clustering of the severity of retinopathy or nephropathy, the intraclass (familial) correlation was computed from the log-adjusted retinopathy and nephropathy scores of DCCT subjects and their relatives for all family members and sib-sib relationships. For parent-offspring, mother-child, and father-child relationships, the pairwise estimate of the correlations was computed. A correlation of 0.2 was considered to be biologically meaningful a priori. Among families of patients in the intensive and conventional groups combined, there was an increased risk of severe retinopathy (an ETDRS score > or =47, clinically significant macular edema, or laser treatment in either eye) among relatives of retinopathy-positive vs. retinopathy-negative DCCT subjects in the secondary intervention cohort (odds ratio [OR], 3.1; 95% CI 1.2-7.8; P < 0.05). There was no increase in the risk of retinopathy of any severity (microaneurysms or worse) in the relatives of retinopathy-positive vs. retinopathy-negative DCCT subjects of the primary prevention cohort. There was an increased risk of nephropathy (AER >40 mg/24 h) in relatives of nephropathy-positive versus nephropathy-negative DCCT subjects of the secondary intervention cohort (OR, 5.4; 95% CI 2.2-13.7; P < 0.001). The risk of severe retinopathy in the relatives of positive versus negative subjects from the conventional treatment group alone (OR, 4.3; 95% CI 1.01-18.6; P < 0.05) was statistically significant and somewhat greater than that among relatives of the subjects in intensive treatment group (OR, 2.4; 95% CI 0.7-8.1), which was not significant. Correlations for the severity of retinopathy were 0.187 (all family members), 0.327 (parent-offspring), 0.249 (father-child), 0.391 (mother-child), and 0.060 (sib-sib), using the combined treatment group families. All these correlations were statistically significant (P < 0.05), except for sib-sib. The results showed similar trends when the families from the conventional and intensive treatment groups were analyzed separately. Correlations for nephropathy in the combined treatment group families were 0.063 (all family members), 0.138 (parent-offspring), 0.170 (father-child), 0.103 (mother-child), and 0.107 (sib-sib). None of these correlations is statistically significant. The lack of significant correlation for the severity of nephropathy may reflect the relatively short duration of diabetes in the offspring of these families and the known high intrasubject variability of AERs. These data provide the first available evidence that the severity of diabetic retinopathy is influenced by familial (possibly genetic) factors and confirmatory evidence that such factors influence the development

Adult↗

Assessment of complications of distal radius fractures and development of a complication checklist.

The purposes of this study were to determine the overall incidence of distal radius fracture (DRF) complications, determine the incidence and types of DRF complications in a consecutive cohort of 250 patients with DRFs, describe DRF complications reported by patients compared with those reported by physicians, and formulate a DRF complication checklist to improve recording of DRF complications. We found that the overall complication rates vary widely (6% to 80%). Physician-reported complication data were collected for 236 patients, and a physician-reported complication rate of 27% was determined. A patient-reported complication rate of 21% was found for 207 patients whose patient-reported data were collected. We also noted that patients and physicians assess DRF complications differently: patients are more focused on symptoms than diagnoses. A DRF complication checklist was developed to improve prospective data collection. The checklist includes a classification for all DRF complications and allows for assessment of severity of each complication.

Adult↗

Presentation and management of major complications of midurethral slings: Are complications under-reported?

AIMS: Midurethral slings have become the mainstay of stress urinary incontinence (SUI) treatment due to their efficacy and low complication rates. The purpose of this study was to report the presentation and treatment of major complications from these minimally invasive treatments presented to a tertiary referral practice and to highlight a discrepancy in major complications between literature and the food and drug administration (FDA) device failure database. METHODS: From 2001 through 2005, we reviewed all cases of midurethral sling complications that presented to our institution. A literature review of all complications due to midurethral slings during the same time period was performed as was the FDA manufacturer and user facility device experience (MAUDE) database queried for self-reported complications. RESULTS: A total of 26 patients referred to UCLA with voiding dysfunction after sling placement was found to have mesh in the urethra or bladder. Treatments required a combination of urethrolysis with mesh removal, urethral reconstruction with graft, and bladder excision. These were compared to major complications reported in the world literature of <1%. The MAUDE database contained 161 major complications out of a total of 928 complications reported for suburethral slings. There was significantly more major complications reported in MAUDE than in published literature. CONCLUSIONS: Although rare, major complications of midurethral slings are more common than appear in literature. Devastating complications involving urethral and bladder perforations can present with mild urinary symptoms and thus are likely under-diagnosed and under-reported. Most of these cases need to be managed with additional reconstructive surgery.

Databases, Factual↗

Complications of diagnostic cardiac catheterisation: results from a confidential inquiry into cardiac catheter complications.

OBJECTIVES: To estimate the frequency and nature of complications in patients undergoing diagnostic cardiac catheterisation and to assess time trends in complications since the introduction of a voluntary cooperative audit. METHODS: Cardiac centres undertaking diagnostic cardiac catheterisation in England and Wales during the 10 years 1990-9 were invited to join the study. Each participating centre reported numbers of patients catheterised each month and details of complications and deaths as they occurred. Complication rates were calculated for the main diagnostic procedures and for each participating hospital and time trends in complications were examined. RESULTS: 41 cardiac centres contributed. 211 645 diagnostic procedures in adults and 7582 paediatric procedures were registered. The majority (87%) of diagnostic catheter studies in adults were left heart studies with coronary arteriography. The overall complication rate for adult procedures was 7.4/1000, with mortality at 0.7/1000; for paediatric procedures the complication rate was similar but mortality rather higher. Complication rates varied between centres but there was little association with caseload. Time trends across the decade showed both complication and mortality decreasing; from 9.5 to 5.8/1000 and from 1.4 to 0.4/1000, respectively. CONCLUSION: Complication rates of diagnostic catheterisation are low but neither negligible nor irreducible. While voluntary audit of cardiac catheter complications is useful and inexpensive, there is a clear need to establish a formal reporting system in all cardiac catheter laboratories, with clear definitions of reportable complications.

Adult↗

Survival and complication rates in 300 horses undergoing surgical treatment of colic. Part 2: Short-term complications.

REASONS FOR PERFORMING STUDY: Few studies have assessed short- and long-term complication rates of horses following surgical treatment of colic, a potentially fatal condition. Complications can lead to patient discomfort and increased costs; knowledge of predisposing factors may help to reduce complication rates. OBJECTIVES: To document and analyse short-term complications in 300 horses undergoing colic surgery, and to assess some of the possible predisposing factors. METHODS: History, clinical findings, surgical findings and procedures, and post operative treatments of 300 consecutive surgical colic cases (1994-2001) were reviewed. Comparisons among groups of discrete data were made using chi-squared or Student's t tests as appropriate. RESULTS: Short-term complications in 227 horses following a single laparotomy included colic/pain (28.2%), incisional drainage or infection (26.9%), post operative ileus (13.7%), severe endotoxaemic shock (12.3%), jugular thrombophlebitis (7.5%), septic peritonitis (3.1%) and colitis/diarrhoea (2.2%). Horses with small bowel obstruction had a higher rate of post operative ileus than those with large bowel obstruction. Rates of post operative pain and shock were higher in horses with small colon rather than large colon obstruction, and in those that had an ischaemic rather than a simple obstruction. The rate of wound complications increased with increasing total plasma protein concentration at admission. Horses that had a repeat laparotomy had a higher rate of wound complications compared to those that had a single laparotomy. Application of a stent bandage was associated with a higher rate of wound complications than if no stent was applied; however, application of an incise drape over the wound for recovery was associated with a lower rate of wound complications than for horses that had no protective covering of the wound. CONCLUSIONS: The most common short-term post operative complications following colic surgery were pain, incisional drainage, ileus, endotoxaemiac shock and jugular thrombophlebitis. Some factors that appeared to predispose to these complications were identified. Although many of these factors related to the underlying disease process, a number of factors, including surgical techniques, were identified that might be amenable to modification. POTENTIAL RELEVANCE: Prospective studies to assess the effects of modifying these factors on survival rates should be performed.

Animals↗

Intestinal and extraintestinal complications of Crohn's disease: predictors and cumulative probability of complications.

Of 238 patients with Crohn's disease seen at our clinics from April 1973 to August 1988, 203 patients were selected for this study, since they fulfilled the following criteria: they had been followed up for more than 6 months as outpatients or had been treated as inpatients for more than 1 month. They were studied to elucidate: (a) the different types and incidence of various complications, (b) the factors related to complications present at the time of diagnosis, (c) predictors of new complications arising after diagnosis, and (d) the cumulative incidence of complications occurring during the course of the disease from the times of onset and diagnosis. Of the intestinal complications, perianal fistula was most common (33%), followed by strictures with dilatations of the proximal bowel (21%), and internal fistula (14%). Of the extraintestinal complications, menstrual disturbance was the most common (18% of the female patients), followed by arthritis (10%), and aphthous stomatitis (10%). As for the factors influencing complications present at the time of diagnosis, the pattern of bowel involvement was significantly correlated with the presence of intestinal stricture, while the erythrocyte sedimentation rate was significantly correlated with the presence of perianal fistula. A significant predictor of new complications arising after diagnosis was the general well-being of patients at the time of diagnosis. Patients who, at diagnosis, already have complications such as stricture, abdominal abscess, internal or external fistula, massive hemorrhage, and free perforation or anal lesions are more likely to develop new complications in addition to those present at diagnosis, compared with patients without any complications at diagnosis (P = 0.055).

Adult↗

Complications associated with the Nuss procedure: analysis of risk factors and suggested measures for prevention of complications.

PURPOSE: Because the Nuss procedure for the correction of pectus excavatum is in its early stage, there have been problems that need to be solved. The authors examined complications in a single-institute experience of the Nuss technique to develop possible solutions to prevent them. METHODS: A total of 335 consecutive patients who underwent the Nuss procedure between August 1999 and September 2002 were studied retrospectively. Median age was 8 years (range, 1 to 46). Two hundred sixty-four patients (78.8%) were in the pediatric group (age < or = 15) and 71 patients (21.2%) were in adult group (age > 15). One hundred ninety-three patients (57.6%) had symmetric and 142 patients (42.4%) had asymmetric pectus configurations. Risk factors predicting postoperative complications were analyzed using multivariate logistic regression. RESULTS: Postoperative complication rate was 16.1% (54 of 335) in total patients. Early complications (within a month) were pneumothorax (n = 23; 6.9%), wound seroma (n = 11; 3.3%), and bar displacement (n = 8; 2.4%). Late complications (after a month) were pericarditis and pericardial effusion (n = 5; 1.5%), bar displacement (n = 4; 1.2%), and hemothorax (n = 3; 0.9%). Techniques were modified to prevent complications especially in bar shaping and fixation, which led to decrease of complication rate in later experience (operation date 1, 29.4%; 15 of 51 v. operation date 2, 12.0%; 34 of 284; P =.004). Grand Canyon type (eccentric long canal type) showed a higher complication rate than other types (40%, 12 of 30 v. 12.1%, 37 of 305; P <.001). Risk factors were analyzed in each group. CONCLUSIONS: Major complications were related to severe eccentric type of pectus configuration (Grand Canyon type) and lack of surgeon's experience (earlier date of operation). Complication rate was reduced with accumulation of experience and advancement of surgical techniques. The Nuss procedure can be performed at a low risk of complications with the current technique.

Adolescent↗

Do complication screening programs detect complications present at admission?

BACKGROUND: A study was undertaken to verify the accuracy of computer algorithms on administrative data to identify hospital complications. The assessment was based on a medical records indicator that differentiated hospital-acquired conditions from preexisting comorbidities. METHODS: The indicators for identifying potential hospital complications were applied to all secondary diagnoses to distinguish hospital-acquired from preexisting conditions for all 1997-1998 discharges. RESULTS: Of the 95 defined complication types, cases were found with secondary diagnoses that met the criteria for 71 different complications. Sixty-nine of these complications had one or more cases with the trigger diagnosis coded as an acquired condition. Thirty-five complications had at least 30 cases with acquired conditions. Hospital complications add greatly to costs; for example, postoperative septicemia increased the hospital bill by more $25,000, added 13 hospital days to the stay, and increased hospital mortality by 16.6%. CONCLUSIONS: Current complication algorithms identify many cases where the condition was actually present on hospital admission. This fact, coupled with the known variability in coding between institutions, makes comparisons between hospitals on many of the complications problematic. Collection of the present-on-admission flag significantly reduces the noise in monitoring complication rates.

Algorithms↗

Psychosocial factors and complications of IDDM. The Pittsburgh Epidemiology of Diabetes Complications Study. VIII.

OBJECTIVE: To investigate whether psychosocial factors are associated with diabetic complications. RESEARCH DESIGN AND METHODS: Questionnaires on quality of life, depressive symptomatology, and personality type were completed and a clinical assessment was performed. The study population was an incident cohort of childhood-onset insulin-dependent diabetic (IDDM) subjects whose duration of IDDM was greater than or equal to 25 yr (n = 175). RESULTS: Patients with macrovascular disease (P less than 0.01) or nephropathy (P less than 0.05) reported significantly poorer quality of life compared with those who were free from all complications. Patients with macrovascular disease also reported greater depressive symptomatology (P less than 0.05). Quality of life significantly deteriorated according to the presence of multiple (greater than or equal to 4) complications (P less than 0.001). Higher depression symptom scores were also related to the presence of greater than or equal to 4 complications (P less than 0.001). Those with multiple complications reported less type A behavior than those without any complications (P less than 0.05). CONCLUSIONS: This study shows that psychosocial differences exist according to both the number and the type of diabetic complications present. Because poorer quality of life and symptoms of depression may both result form complications, prospective follow-up is needed to clarify their temporal interrelationships, and to determine whether type A personality affords any protection against complications or is diminished as a result of developing complications.

Adult↗

Vascular complications in adult patients after orthotopic liver transplantation: role of color duplex sonography in the diagnosis and management of vascular complications.

Vascular complications after orthotopic liver transplantation are one of the most serious problems in liver-grafted patients, and if undetected they may result in graft failure and death unless prompt revascularization or retransplantation is performed. As the outcome of treatment of vascular complications depends on an early diagnosis, the role of color-coded duplex sonography (CCD) for diagnosis and treatment was analyzed during a 17-month observation period. Altogether, 88 consecutive liver allografts in 77 adult patients were studied by serial CCD. Vascular complications occurred with an incidence of 12.9%. Hepatic artery complications represented the most frequent event with an incidence of 11.6%. CCD showed a sensitivity of 100%, a specificity of 97% and a positive predictive value of 0.84. With the use of CCD, vasculature and localization of the site of arterial complications can be directly visualized and the various types of complications can be differentiated, thus reducing the time needed for diagnosis. Early hepatic artery complications, occurring during the first 3 days after transplantation, which were immediately diagnosed by CCD examination and rapidly treated by revascularization had a good clinical outcome. In contrast, the outcome of vascular complications requiring retransplantation was found to be poor. As radiologic intervention offers an alternative to the treatment strategy of vascular complications in liver-grafted patients, CCD is the method of choice to noninvasively monitor the initial and follow-up examinations after intervention.

Adolescent↗

Complications in arthroscopy: the knee and other joints. Committee on Complications of the Arthroscopy Association of North America.

A questionnaire was sent to members of the Arthroscopy Association of North America surveying complications in arthroscopic surgery of the knee and other joints. There were 395,566 arthroscopies reported including 375,069 knee arthroscopies, 14,329 shoulder arthroscopies, 4,478 ankle arthroscopies, 1,569 elbow arthroscopies, and 121 wrist arthroscopies. There were 2,215 complications reported. The overall complication rate was 0.56%. Specific procedures were surveyed for the first time. The complication rate reported for meniscal repair was 2.4%. The complication rate in anterior cruciate ligament (ACL) procedures (repairs and reconstructions) was 1.8%. The procedure with the highest complication rate was the anterior staple capsulorrhaphy of the shoulder (5.3%). Surgery in the subacromial space resulted in a complication rate of 0.76%. None of these complication rates included failures. As newer procedures are instituted into clinical practice that involve various joints, and are more technically demanding, the complication rate is increasing.

Anesthesia↗

The absence of a glycemic threshold for the development of long-term complications: the perspective of the Diabetes Control and Complications Trial.

The Diabetes Control and Complications Trial (DCCT) demonstrated a reduction in the development and progression of the long-term complications of IDDM with intensive therapy aimed at achieving glycemic control as close to the nondiabetic range as possible. The DCCT subsequently showed that the total lifetime exposure to glycemia was the principal determinant of the risk of retinopathy and that there was a continuous nonlinear relationship between this risk and the mean level of HbA1c (DCCT Research Group, Diabetes 44:968-993, 1995). In contrast, other authors, based on a retrospective study (Krolewski et al., N Engl J Med 332:1251-1255, 1995), have suggested that a glycemic threshold for microabuminuria and for retinopathy exists at an HbA1c level of approximately 8%, below which there is no further appreciable reduction in risk. In this perspective, we examine whether the DCCT data demonstrate such a glycemic threshold for the development of retinopathy, nephropathy, or neuropathy. In the DCCT, 1,441 patients with IDDM were randomly assigned to intensive (n = 711) or conventional (n = 730) therapy and followed for a mean of 6.5 years. Retinopathy was assessed every 6 months by stereoscopic fundus photography; albumin excretion was measured annually in a 4-h collection; and neuropathy was assessed with a standardized protocol performed at baseline and at 5 years. Glycosylated hemoglobin was measured quarterly. Episodes of severe hypoglycemia were ascertained using standardized procedures. The risks (hazard rates) of retinopathy progression and of developing microalbuminuria and neuropathy were found to be continuous but nonlinear over the entire range of glycosylated hemoglobin values in the intensive, conventional, and combined treatment groups. These nonlinear relationships describe a constant relative risk gradient in which proportional reductions in HbA1c are accompanied by proportional reductions in the risk of complications. Although the magnitude of the absolute risk reduction declines with continuing proportional reductions in HbA1c, there are still meaningful further reductions in risk as the HbA1c is reduced toward the normal range. When the instantaneous risks for different complications associated with different HbA1c values are compounded over time, there are substantial differences in the cumulative incidence of patients experiencing a complication for patients with HbA1c values of 6 vs. 7 vs. 8% or higher. In fact, no HbA1c threshold could be identified, short of normal glycemia, below which there was no risk of the development or progression of these complications. Furthermore, as the HbA1c was reduced proportionately, the proportional rate of decline in the relative risk for each of these complications was similar for HbA1c levels < or = 8.0% and for levels > 8%. In contrast, although the absolute risk of severe hypoglycemia in the intensive treatment group increased as the HbA1c decreased, the relative risk gradients were significantly less for HbA1c levels < or = 8.0% than for levels > 8%. These extensive prospective DCCT data do not support the conjecture that a glycemic threshold for the development of complications exists at an HbA1c of 8% or that an HbA1c goal of 8% is maximally beneficial. In the DCCT, as HbA1c was reduced below 8% there were continuing relative reductions in the risk of complications, whereas there was a slower rate of increase in the risk of hypoglycemia. Therefore, the DCCT continues to recommend implementation of intensive therapy with the goal of achieving normal glycemia as early as possible in as many IDDM patients as is safely possible.

Albuminuria↗

Perioperative complications of surgery for genital prolapse: does concomitant anti-incontinence surgery increase complications?

OBJECTIVES: To establish whether the short-term risks of prolapse surgery are increased by a concomitant anti-incontinence procedure. METHODS: Using data from the past 4 years of the National Hospital Discharge Survey, we identified women admitted for surgery for pelvic organ prolapse (specifically, suspension of the vagina or obliteration of the cul-de-sac, with or without concomitant hysterectomy or vaginal repairs). We identified women diagnosed with complications (including infections, bleeding complications, surgical injuries, pulmonary complications, and cardiovascular complications). We used multiple logistic regression analysis to compare women with and without complications with respect to concurrent continence procedures, controlling for demographic characteristics, concurrent procedures, and medical comorbidity (using the Charlson index). RESULTS: Of the 1931 women who underwent prolapse surgery, concomitant anti-incontinence procedures were performed in 514 (26.6%). Complications were reported in 288 patients (14.9%) and were associated with medical comorbidity (odds ratio 11.2) and concomitant hysterectomy (odds ratio 1.5). Concomitant surgery for incontinence was not associated with an increased risk of complications. CONCLUSIONS: These data suggest that medical comorbidity is strongly associated with complications after surgery for pelvic organ prolapse. A concomitant anti-incontinence procedure did not significantly increase the immediate morbidity of prolapse surgery.

Aged↗