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Measuring postoperative complications in general surgery patients using an outcomes-based strategy: comparison with complications presented at morbidity and mortality rounds.

BACKGROUND: This study was undertaken to compare the incidence of adverse postoperative outcomes recorded in a prospective general surgery database with that identified through weekly morbidity and mortality (M&M) rounds and to measure the impact of feedback of information to the providers of care. METHODS: Data were collected on patients admitted to one general surgery service between October 1, 1995, and May 15, 1996, and recorded in a computer database. Postoperative complications were graded in severity from I (minor) to IV (mortality). RESULTS: Of 479 admissions entered into the database during the study period, 325 (311 patients) led to operations and were further analyzed. Admissions resulting in complications were associated with longer hospital stays, regardless of complication grade, compared to uncomplicated admissions (p < 0.01). A total of 29 of 106 patients with postoperative complications were presented at M&Ms (27.4%). Whereas 15.4% of database patients with grade I complications were presented at M&Ms, this proportion increased to 22.2% for grade IIa, 34.8% for grade IIb, 33.3% for grade III, and 87.5% for grade IV. (p < 0.05 for grade I, IIa, and IIb compared to grade IV). A total of 58 of 142 patients in the first part of the study period developed complications (40.8%), compared to 53 of 183 patients in the second part of the study (29%, p = 0.034). CONCLUSIONS: Although most severe complications are recorded at M&M rounds, a large proportion of complications remain unreported. Monitoring of outcomes may contribute to improvements in quality of care.

Databases as Topic↗

Complications of transrectal ultrasound-guided systematic sextant biopsies of the prostate: evaluation of complication rates and risk factors within a population-based screening program.

OBJECTIVES: Screening for prostate cancer to reduce the mortality and morbidity from this disease has become an important issue in recent years. Of all procedures used to diagnose prostate cancer, biopsy of the prostate is the cause of most complications. To evaluate the safety of the screening procedure, we have studied the complications and risk factors for complications within the screened population of the European Randomized Study of Screening for Prostate Cancer (ERSPC), Rotterdam section. METHODS: Between June 1994 and July 1996, 1687 transrectal ultrasound-guided systematic sextant biopsies were performed after screening 6198 men through prostate-specific antigen level, digital rectal examination, and transrectal ultrasonography. RESULTS: From these 1687 biopsies, 302 cases of prostate cancer were diagnosed. Mild complications such as hematuria and hematospermia were reported frequently with rates of 23.6% and 45.3%, respectively. More severe complications were far less frequently seen. Fever, usually of low grade, was seen after 4.2% of biopsies. Seven men (0.4%) were admitted to a hospital after biopsy. Risk factors for complications could not be identified. CONCLUSIONS: Review of the literature concerning transrectal biopsies of the prostate shows that the complication rates within this screened population are comparable to those reported within referred patients. The admittance rate is slightly lower. Transrectal ultrasound-guided systematic sextant biopsy of the prostate is a safe procedure for the diagnosis of prostate cancer within the general population; however, identification of risk factors for complications might further improve the safety of the screening procedure.

Age Factors↗

Comparative analysis of the eye function and complications after removal of complicated cataract due to uveitis and senile cataract.

PURPOSE: retrospective, comparative analysis of the effectiveness of the results among patients who underwent removal of complicated cataract due to uveitis and senile cataract. MATERIAL AND METHODS: Patients with cataract enrolled in this study were divided into two groups. Group 1 comprised 30 eyes with complicated cataract due to uveitis. The main causes of uveitis were: rheumatoid arthritis in 8 eyes, ankylosing spondylitis in 7, Reiter syndrome in 3, psoriatic arthritis in 3, systemic sarcoidosis in 2, post-traumatic uveitis in 1. In 6 patients (6 eyes) the etiology of uveitis was unknown. Group 2 comprised 30 eyes with senile cataract. In 5 patients in each group there were coexisting glaucoma. In both groups phacoemulsification or phacoaspiration and foldable three piece IOL implantation were performed. The follow-up period was 12 months. Best corrected visual acuity and intra and postoperative complications were taken into consideration. RESULTS: There were no differences in gender and cataract hardness between the two groups. Significantly younger patients were in group 1 p< 0.01. Mean preop./ postop. visual acuity was better in group 2 as compared with group 1: 0.4/ 0.8 and 0.2/ 0.5, respectively, p < 0.01. In both groups however, the preoperative visual acuity was significantly lowest in patients with coexisting glaucoma: group 1, 0.1 p < 0.01 and in group 2: 0.25 p < 0.001. Significantly more frequent intraoperative complications were observed in group 1 as compared with group 2 e.g., corneal burn 10% and 6.6%, local sphincter damage 10% and 0%, zonular rupture 10% and 3.3% respectively. Similarly, in the late postoperative period more frequent complications were observed in group 1 than in group 2 e.g.: secondary cataract 50% and 13.3%, IOL decentration 40% and 6.6%, capsule contraction 80% and 10%, glaucoma 10% and 3.3% respectively. Recurrence of uveitis was observed in 30% of eyes in group 1. CONCLUSIONS: Although the modern microsurgical technology and IOL implantation have led to more effective treatment of senile cataract, the surgery of complicated cataract due to uveitis is still not free from complications. Future surgical strategy of complicated cataract owing to uveitis has to comprise the most adequate qualification criteria e.g. choice of the optimal period for surgery and the most convenient surgical technique as well as the most effective perioperative anti-inflammatory treatment.

Adult↗

Ropinirole versus bromocriptine for levodopa-induced complications in Parkinson's disease.

BACKGROUND: Long-term levodopa therapy for Parkinson's disease is complicated by the development of motor fluctuations and abnormal involuntary movements. One approach is to add a dopamine agonist at this stage of the disease to reduce the time the patient spends immobile or off and to reduce the dose of levodopa in the hope of reducing such problems in the future. OBJECTIVES: To compare the efficacy and safety of adjuvant ropinirole therapy with bromocriptine in patients with Parkinson's disease already established on levodopa therapy and suffering from motor complications. SEARCH STRATEGY: Electronic searches of MEDLINE, EMBASE and the Cochrane Controlled Trials Register. Handsearching of the neurology literature as part of the Cochrane Movement Disorders Group's strategy. Examination of the reference lists of identified studies and other reviews. Contact with SmithKline Beecham. SELECTION CRITERIA: Randomised controlled trials of ropinirole versus bromocriptine in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy. DATA COLLECTION AND ANALYSIS: Data was abstracted independently by the authors and differences settled by discussion. The outcome measures used included Parkinson's disease rating scales, levodopa dosage, 'off' time measurements and the frequency of withdrawals and adverse events. MAIN RESULTS: No significant differences between ropinirole and bromocriptine were found in off time reduction, dyskinesia as an adverse event, motor impairment and disability, or levodopa dose reduction. Withdrawal rates and adverse event frequency were similar with the two agents apart from significantly less nausea with ropinirole (odds ratio 0.50; 0.29, 0. 84 95% CI; p =0.01). REVIEWER'S CONCLUSIONS: Ropinirole is at least as good as bromocriptine in patients with Parkinson's disease with motor complications in terms of improving off time and reducing levodopa dose, without increasing adverse events including dyskinesia. However, these comparitor studies may have been underpowered to detect clinically meaningful differences between the agonists. Further, much larger, phase IV studies are required to examine the efficacy, effectiveness, and safety of all of the dopamine agonists as adjuvant therapy in Parkinson's disease.

Antiparkinson Agents↗

Delayed ocular complications of mustard gas poisoning and the relationship with respiratory and cutaneous complications.

BACKGROUND: This study was aimed to determine the correlation between ocular complications and respiratory or cutaneous complications in a group of 40 Iranian veterans with late complications of sulphur mustard (SM) poisoning. METHODS: Thorough ophthalmologic examination was performed on all severely SM-poisoned veterans in the province of Khorasan, Iran. Spirometric evaluation of pulmonary function, as well as estimation of the burned skin area, was performed for all the patients. The severities of ocular, respiratory and cutaneous complications were classified into four grades in each patient and were compared with each other, using Spearman's rank correlation test. RESULTS: Forty male patients (aged 43.8 +/- 9.8 years) with confirmed SM poisoning were studied 16-20 years after their initial exposure. Common symptoms were recorded as itching (42.5%), burning sensation (37.5%), photophobia (30%) and tearing (27.5%). Abnormal conjunctival and limbal findings were chronic conjunctivitis (17.5%), perilimbal hyperpigmentation (17.5%), vascular tortuosity (15%) and limbal ischaemia (12.5%). Abnormal corneal findings were subepithelial opacity (15%), corneal thinning (15%), diffuse corneal opacity (10%), neovascularization (7.5%) and epithelial defects (5%). A significant positive correlation was found between the severity of ocular and respiratory complications (r = 0.322, P = 0.043). Cutaneous complications revealed no significant correlation with either ocular or respiratory complications. CONCLUSIONS: SM causes delayed destructive lesions in the ocular surface and cornea, leading to progressive visual deterioration and ocular irritation. Late complications of SM poisoning in the eyes, respiratory system and skin are mainly due to SM's local irritant effects.

Adult↗

Medical complications of cocaine: changes in pattern of use and spectrum of complications.

We sought to determine whether changes in patterns of cocaine use, characterized by widespread abuse of cocaine alkaloid, have altered the nature and severity of medical complications over the past decade. Infectious complications, almost invariably associated with intravenous use, accounted for nearly all hospital admissions in the early 1980s. Cardiovascular, neurologic and psychiatric complications rose dramatically after 1987 both in absolute number and as a proportion of total complications. This rise parallelled increases in the absolute number and proportion of hospitalized patients smoking cocaine alkaloid or using intranasal cocaine, both disproportionately associated with non-infectious complications. While infectious complications were often local in nature, serious neurologic and cardiovascular sequelae were observed. These data indicate that changes in patterns of cocaine use have altered the nature and increased the severity of medical complications with a shift from infectious to cardiovascular, neurologic and psychiatric complications which may be life-threatening and associated with substantial morbidity.

Administration, Intranasal↗

Oral complications from cancer therapy: Part 1--Pathophysiology and secondary complications.

PURPOSE/OBJECTIVES: To review the pathophysiology of oral complications from cancer therapy and potential secondary complications. DATA SOURCES: Published articles, books, and monographs. DATA SYNTHESIS: Cancer, chemotherapy, and radiation therapy disturb the normal integrity and function of the oral cavity. This leads to ulcerations, bone changes, bleeding, infection, salivary gland dysfunction, and dental diseases. Secondary complications occur as consequences of existing oral complications and often result in life-threatening situations. CONCLUSIONS: Coordinating the efforts of nursing, medicine, and dentistry is critical to the prevention, management, and resolution of oral complications. Continued research is needed. IMPLICATIONS FOR NURSING PRACTICE: Understanding the pathophysiology of oral complications from cancer therapy enables nurses to identify significant changes and implement appropriate measures to prevent complications. By identifying patients who are at risk for developing secondary complications, nurses can provide detailed instructions to these patients and their significant others to aide them in reporting changes that require prompt medical attention.

Antineoplastic Agents↗

Markers of inflammation are cross-sectionally associated with microvascular complications and cardiovascular disease in type 1 diabetes--the EURODIAB Prospective Complications Study.

AIMS/HYPOTHESIS: The pathogenesis of vascular complications in type 1 diabetes is poorly understood, but may involve chronic, low-grade inflammation. We investigated the association of markers of inflammation with vascular complications in type 1 diabetes. METHODS: A cross-sectional nested case-control study of the follow-up data of the EURODIAB Prospective Complications Study. This study included 543 individuals (278 men) with type 1 diabetes diagnosed at <36 years of age. Cases (n=348) had complications of diabetes, controls (n=195) had no complications. RESULTS: C-reactive protein, interleukin-6 and tumour necrosis factor-alpha levels, which were combined in an inflammatory marker Z-score, were associated with albuminuria, retinopathy and cardiovascular disease. Calculated means (95% confidence intervals) of the marker Z-score were -0.15 (-0.22 to -0.07), 0.10 (-0.05 to 0.25), and 0.28 (0.15 to 0.41), p for trend <0.0001, in individuals with normo-, micro- and macroalbuminuria; -0.23 (-0.33 to -0.13), 0.14 (0.02 to 0.25) and 0.20 (0.07 to 0.32), p for trend <0.0001, in individuals with no, non-proliferative and proliferative retinopathy; and -0.28 (-0.39 to -0.18) and 0.06 (-0.08 to 0.20), p<0.001, in individuals without and with cardiovascular disease. Per 1 SD increase of the inflammatory marker Z-score, GFR decreased by -4.6 (-6.6 to -2.6) ml per min per 1.73 m(2) (p<0.001). CONCLUSIONS/INTERPRETATION: We have shown that markers of inflammation are strongly and independently associated with microvascular complications and cardiovascular disease in type 1 diabetes. These data suggest that strategies to decrease inflammatory activity may help to prevent the development of vascular complications in type 1 diabetes.

Adult↗

Do tissue plasminogen activator-plasminogen activator inhibitor-1 complexes relate to the complications of insulin-dependent diabetes mellitus? Pittsburgh Epidemiology of Diabetes Complications Study.

The purpose of this study was to examine the potential relationship of tissue plasminogen activator-plasminogen activator inhibitor-1 (tPA-PAI-1) complexes and diabetic complications in individuals with insulin-dependent diabetes mellitus (IDDM). To address this issue, data from the third follow-up visit of participants in the Epidemiology of Diabetes Complications (EDC) study were examined. There were 454 participants, aged 32 +/- 8 years, with duration of IDDM of 23 +/- 8 years. Higher levels of tPA-PAI-1 complexes were seen for both men and women with IDDM complications. Specifically, statistically significant differences were seen in men with neuropathy (1.81 +/- 0.9 versus 1.42 +/- 0.8 ng/mL, p < 0.01), microalbuminuria (1.77 +/- 1.1 versus 1.35 +/- 0.6 ng/mL, p < 0.01), retinopathy (1.67 +/- 0.9 versus 1.43 +/- 0.8 ng/mL, p < 0.05), and lower extremity arterial disease (1.93 +/- 0.7 versus 1.50 +/- 0.9 ng/mL, p < 0.05) versus men without the particular complication. In women, higher complex levels were shown for those with retinopathy (1.51 +/- 0.8 versus 1.29 +/- 1.1 ng/mL, p < 0.01). Potential mechanisms for the relationship of higher complex levels and diabetic complications include an altered fibrinolytic response and/or insulin resistance. Because the results are cross sectional, it cannot be established whether the higher concentration of complexes is a result of the presence of complications or are antecedent. Prospective follow-up will be required to determine if tPA-PAI-1 complexes are predictive of the development of IDDM complications.

Adult↗

Antireflux surgery, highly selective vagotomy and duodenal switch procedure: post-operative evaluation in patients with complicated and non-complicated Barrett's esophagus.

Antireflux surgery, highly selective vagotomy (HSV) and Roux-en-Y duodenojejunostomy have been suggested for control of pathophysiological factors involved in patients with Barrett's esophagus (BE). The aim of this study was to evaluate prospectively the results of this technique in patients with complicated (n = 21) and noncomplicated (n=45) BE. Complete evaluation of esophageal function, endoscopic histologic and clinical control was carried out before and 2 years after surgery. Post-operative results show recurrence of ulcer in patients with complicated BE, but no recurrence in patients with non-complicated BE. Preoperative esophageal ulcer and stricture were present in 85.3% and 14.3%, respectively, of patients with complicated BE. In this group, recurrence of these complications was 38.1% and 9.5% respectively. The technique offers excellent results in patients with non-complicated BE. However, in patients with complicated BE, the recurrence rate is higher, mainly because of the persistence of acid reflux into the esophagus.

Adult↗

[Serious complications of injections--retrospective analysis of incidences, complication-management, prophylaxis and economic aspects].

The parenteral drug application is a routinely used method in all medical disciplines. Intramuscular, intraarticular, intravenous injections and infusions can cause local complications such as abscesses, articular infections or paravasates. These local complications can lead to bacteraemia, sepsis and may lead to multiple organ failure associated with high morbidity and mortality. Although these complications are rare, they are sometimes disastrous and result in life threatening clinical conditions. During a retrospective analysis (review period 1998-2002) 24 patients were admitted and hospitalized in our department. Within this report we demonstrate 7 patients with fatal complications after injections. In the majority of cases minor patients' complaints were proceeding before major complications were present. A long and expensive treatment period with multiple surgical interventions ends up in functional disabilities and unsatisfactory aesthetic results. Instead of delayed surgical treatment immediate radical surgical care is crucial to prevent disastrous complications. In case of the inability of sufficient debridement, amputations are sometimes indicated in the sense of "life before limb". Besides the consequences for the patient these disastrous complications have a high socioeconomic impact and result in reduced reimbursement for the hospital stay.

Abscess↗

A multinational comparison of complications assessment in type 1 diabetes: the DiaMond substudy of complications (DiaComp) level 2.

OBJECTIVE: To describe the global geographic variation of micro- and macrovascular complications in childhood-onset type 1 diabetes assessed by both reported and measured disease and risk factors and relate any such variation to diabetes control and health care activities. RESEARCH DESIGN AND METHODS: The DiaComp study is a multinational (17 countries) cross-sectional study of complications in type 1 diabetes and is comprised of two levels (level 1 includes survey only and level 2 includes survey plus examination). This report concerns level 2, representing 12 countries (n = 892). All participants were diagnosed at <15 years of age and had a diabetes duration of 5-24 years when surveyed. All complications were assessed by self-report and for microalbuminuria by Micral II dipstick, neuropathy by the Michigan Neuropathy Screening Instrument exam, and hypertension using the Hypertension Detection and Follow-up Program (HDFP) protocol. HbA(1c) was determined by using the DCA analyzer. RESULTS: A wide variation in neuropathy, reported renal disease/proteinuria, and hypertension among those of short diabetes duration was noted, with central Europe (Romania and Lithuania) standing out for both self-reported renal disease and measured microalbuminuria and for both self-reported and examined neuropathy. The Caribbean (Puerto Rico) also had high rates of microalbuminuria and examined neuropathy. For those of long duration, variation was more moderate. We found generally good agreement between the reported and clinically determined measures for neuropathy (r = 0.5, P = 0.01) and hypertension (r = 0.61, P = 0.001) as demonstrated by the high overall correlation between examination and self-report for these two complications. However, the agreement between examination and self-report for renal disease/proteinuria was less, with low overall correlation (r = -0.05, P = 0.86) and incongruous centers (Slovakia and Finland). Geographic variation in prevalence was not consistently explained for all complications, even with strong independent prediction by systolic blood pressure, although the variation in microalbuminuria was largely accounted for by self-monitored blood glucose, which was significantly protective. CONCLUSIONS: This report has identified wide variation and geographic patterns in complication prevalence, with a further indication that self-report is generally in agreement with examined prevalence, though less for renal disease/proteinuria. However, this level of DiaComp, with more complete assessment of risk factors and health care practice, was still not able to completely explain the variation in complication prevalence, except for microalbuminuria.

Asia↗

Stage IB carcinoma of the cervix, the Norwegian Radium Hospital: results and complications. III. Urinary and gastrointestinal complications.

The combination of surgery and radiotherapy for early cases of cancer of the cervix has been accused of producing prohibitive complication rates. In a series of 612 patients with cancer of the cervix, Stage IB, the frequency of major complications from the urinary and gastrointestinal tract has been studied, and an attempt has been made in determining the most probable etiology of these complications. No significant increase in complications can be attributed to the use of preoperative intracavitary irradiation. In patients with pelvic lymph node metastases the combination of radical surgery and a full course of radiotherapy is associated with a high complication risk, as 12% of these patients developed major complications. Their 5-year survival, however, was high: 54%.

Brachytherapy↗

Identifying genetic susceptibilities to diabetes-related complications among individuals at low risk of complications: An application of tree-structured survival analysis.

The authors hypothesized that genetic predisposition to diabetes complications would be more evident among low-risk individuals and aimed to identify genes related to developing complications (confirmed distal symmetric polyneuropathy, overt nephropathy, or coronary artery disease) in low-risk groups. Participants in the Pittsburgh, Pennsylvania, Epidemiology of Diabetes Complications Study of childhood-onset type 1 diabetes, first seen in 1986-1988 (mean age, 28 years; diabetes duration, 19 years), were reexamined biennially for 10 years. For each complication, subgroups with the lowest disease risk were identified by using tree-structured survival analysis, and 15 candidate genes were compared between subjects with and without complications. In the group with the lowest incidence of confirmed distal symmetric polyneuropathy (n = 123), confirmed distal symmetric polyneuropathy risk increased fivefold for those with the eNOS GG genotype (p < 0.05). In the group with the lowest risk of overt nephropathy (n = 340), the ACE D polymorphism increased overt nephropathy risk twofold (p = 0.05), whereas a protective effect was observed for the LIPC CC genotype (p < 0.05). In the group with the lowest incidence of coronary artery disease (n = 331), the MTHFR CC genotype increased coronary artery disease risk threefold (p < 0.05). Tree-structured survival analysis may help identify genetic predispositions among individuals who, despite low risk, develop diabetes-related complications.

Adult↗

Results and complications of temporary silicone oil tamponade in patients with complicated retinal detachments.

BACKGROUND: To assess the results and complications of temporary silicone oil tamponade in the treatment of complicated retinal detachments. METHODS: Fifty-eight consecutive eyes undergoing silicone oil removal were studied in a retrospective fashion. Forty-two eyes with proliferative vitreoretinopathy, nine eyes with giant tears, and seven traumatized eyes were included. In addition to anatomic and visual results, the following complications and their associated preoperative and intraoperative variables were assessed: glaucoma, hypotony, and keratopathy. RESULTS: Anatomic success was achieved in 81% of the eyes. Postoperative glaucoma was found in 12%, hypotony in 9%, and keratopathy in 7% of the eyes. Twenty-six (45%) of the 58 eyes had an increase in visual acuity of at least two Snellen lines after silicone oil removal. After multivariate logistic regression analysis for all variables versus the visual and anatomic results and versus the complications of glaucoma, hypotony, and keratopathy successively, a total of three or more operations (P < 0.05; odds ratio, 14.7) and the absence of an encircling band (P < 0.05; odds ratio, 29.9) were associated with redetachment, and a retinectomy size of more than 180 degrees was associated with hypotonia (P < 0.05; odds ratio, 67.5). CONCLUSIONS: Temporary silicone oil tamponade may be associated with a lower incidence of complications than recent studies have reported. Despite the acceptable risk of recurrent retinal detachment, the early removal of silicone oil may yield a lower rate of anterior segment complications and an increase in visual acuity in approximately half the eyes.

Adolescent↗

Survival and complication rates in 300 horses undergoing surgical treatment of colic. Part 3: Long-term complications and survival.

REASONS FOR PERFORMING STUDY: Few studies have evaluated long-term survival and complication rates in horses following surgical treatment of colic, making it difficult to offer realistic advice concerning long-term prognosis. OBJECTIVE: To review the complications occurring after discharge from hospital and survival to >12 months after surgery of 300 horses undergoing exploratory laparotomy for acute colic. Pre-, intra- and post operative factors that affected long-term complications and long-term survival were assessed. METHODS: History, clinical findings, surgical findings and procedures and post operative treatments of 300 consecutive surgical colic cases (1994-2001) were reviewed. Long-term follow-up information was retrieved from case records and telephone enquiries from owners. RESULTS: The long-term (>12 months) survival rate for 204 horses discharged after colic surgery and for which follow-up information was available was 84%. The most common complication after discharge was colic, affecting 35.1% of horses following a single laparotomy. Colic was most common in horses that had had small intestinal obstructions, bowel resection or post operative ileus. Abdominal adhesions were most common in horses that presented with severe colic due to strangulation of small intestine. Ventral hernia formation occurred in 8% of horses, and was most common in horses that had had post operative wound drainage or infection. CONCLUSIONS: This study identified various factors that appear to predispose horses to long-term complications after colic surgery. POTENTIAL RELEVANCE: Further evaluation of strategies that might reduce the incidence of such complications are needed; in particular, the value of intraperitoneal heparin should be evaluated, and procedures designed to reduce the rates of wound drainage and infection assessed.

Animals↗

Respiratory complications after upper abdominal surgery. The incidence of chest X-ray abnormalities, arterial hypoxemia and clinically recorded pulmonary complications.

The incidence of postoperative chest X-ray abnormalities, arterial hypoxemia and clinically recorded pulmonary complications was studied in fifty-two 40-75-year-old men admitted for elective surgery for peptic ulcer or gallbladder disease. Twenty-eight (54%) patients had an abnormal chest X-ray and twenty-three (43%) arterial hypoxemia, whereas only four patients (8%) were identified with clinical signs and symptoms of respiratory complications. Forty-one patients (79%) were found with pulmonary complications by at least one of the three methods. Twelve patients had both an abnormal chest X-ray and arterial hypoxemia. Only two of these were identified with clinical signs indicating pulmonary complications. The great discrepancy between results based on clinical signs and symptoms noted in the patients' records and results based on postoperative chest X-ray and measurements of the arterial oxygen tension, respectively, should be of great importance when comparing the incidence of pulmonary complications after different forms of surgery and when assessing risk factors and clinical consequences of respiratory complications.

Adult↗

Ropinirole for levodopa-induced complications in Parkinson's disease.

BACKGROUND: Long-term levodopa therapy for Parkinson's disease is complicated by the development of motor fluctuations and abnormal involuntary movements. One approach is to add a dopamine agonist at this stage of the disease to reduce the time the patient spends immobile or off and to reduce the dose of levodopa in the hope of reducing such problems in the future. OBJECTIVES: To compare the efficacy and safety of adjuvant ropinirole therapy versus placebo in patients with Parkinson's disease already established on levodopa therapy and suffering from motor complications. SEARCH STRATEGY: Electronic searches of MEDLINE, EMBASE and the Cochrane Controlled Trials Register. Handsearching of the neurology literature as part of the Cochrane Movement Disorders Group's strategy. Examination of the reference lists of identified studies and other reviews. Contact with SmithKline Beecham. SELECTION CRITERIA: Randomised controlled trials of ropinirole versus placebo in patients with a clinical diagnosis of idiopathic Parkinson's disease and long-term complications of levodopa therapy. DATA COLLECTION AND ANALYSIS: Data was abstracted independently by the authors and differences settled by discussion. The outcome measures used included Parkinson's disease rating scales, levodopa dosage, 'off' time measurements and the frequency of withdrawals and adverse events. MAIN RESULTS: Three double-blind, parallel group, randomised, controlled trials have been conducted on 263 patients. The two phase II studies were relatively small, were conducted over the short term (12 weeks), and used relatively low doses of ropinirole. The other phase III study was medium term (26 weeks) and used ropinirole doses in line with the current UK licensed maximum. Additional data from the manufacturer showed that the difference in the reduction in off time was non-significantly greater with ropinirole than placebo (weighted mean difference [WMD] 0.19 hours; -0.63, 1.00 95% CI). As an adverse event, dyskinesia was significantly increased in those who received ropinirole (odds ratio [OR] 2.59; 1.35, 4.96 95% CI; p < 0.004). Measurements of motor impairments and disability were poor in these studies with incomplete information available. Levodopa dose could be reduced in two studies with a significantly larger reduction on ropinirole than on placebo (WMD 136.5mg/d; 74.5, 198.6 95% CI; p =0.00002). No significant differences in the frequency of adverse event reports were noted between ropinirole and placebo apart from the increase in dyskinesia with ropinirole. There was a trend towards fewer withdrawals from ropinirole but this did not reach statistical significance. REVIEWER'S CONCLUSIONS: Ropinirole therapy can reduce levodopa dose but at the expense of increased dyskinetic adverse events. No significant effect on off time reduction was found but this may have been due to under-powered trials and the low doses of ropinirole used in the phase II studies. Inadequate data on motor impairments and disability was collected to assess these outcomes. These conclusions apply to short and medium term treatment, up to 26 weeks. Further longer term trials are required, with measurements of effectiveness, and also studies to compare the newer with the older dopamine agonists.

Antiparkinson Agents↗