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PubMed2001

High and low serum potassium associated with cardiovascular events in diuretic-treated patients.

OBJECTIVE: To determine the relationship of moderately high and low concentrations of serum potassium with cardiovascular disease events among treated hypertensive patients. DESIGN: An observational cohort study with prospectively collected data. SETTING: A worksite treatment program for mild hypertension. PATIENTS: All program participants with baseline and at least one annual follow-up measure of serum potassium; 7,653 individuals with 6.7 years mean follow-up met these criteria. MAIN OUTCOME MEASURES: Outcome events were admissions to hospital because of cardiovascular disease, and deaths. The research question regarding serum potassium categories was formulated after data collection. The serum potassium concentration (mean +/- 2SD) of the study population was used to define low (3.0-3.5 mmol/l), high (5.1-5.9 mmol/l) and middle (3.6-5.0 mmol/l) categories. RESULTS: Individuals with low (n = 146) and high (n = 226) serum potassium had significantly greater risk for cardiovascular disease events than those in the middle category (n = 7,281). Multivariate adjusted hazard ratios from Cox models were 2.6 [95% confidence intervals (CI) 1.5-4.4] for the low potassium group and 1.7 (95% CI 1.0-2.7) for the high potassium group, with the middle group as reference. Among 1,679 individuals who regularly took diuretics, hazard ratios were 4.3 (95% CI 2.4-7.9) for the low potassium group and 6.7 (95% CI 2.8-15.9) for the high group. Neither low nor high potassium was significantly associated with outcome events for those not regularly using diuretics. CONCLUSIONS: These data confirm an association of mild hypokalemia with increased cardiovascular events among diuretic-treated hypertensive patients. In addition, we have found a similar increased cardiovascular risk associated with modest hyperkalemia among these patients. Whether modification of these serum potassium concentrations would alter that risk remains to be determined.

Cardiovascular Diseases↗

PubMed1999

Multi-slice helical CT: scan and reconstruction.

The multi-slice CT scanner refers to a special CT system equipped with a multiple-row detector array to simultaneously collect data at different slice locations. The multi-slice CT scanner has the capability of rapidly scanning large longitudinal (z) volume with high z-axis resolution. It also presents new challenges and new characteristics. In this paper, we study the scan and reconstruction principles of the multi-slice helical CT in general and the 4-slice helical CT in particular. The multi-slice helical computed tomography consists of the following three key components: the preferred helical pitches for efficient z sampling in data collection and better artifact control; the new helical interpolation algorithms to correct for fast simultaneous patient translation; and the z-filtering reconstruction for providing multiple tradeoffs of the slice thickness, image noise and artifacts to suit for different application requirements. The concept of the preferred helical pitch is discussed with a newly proposed z sampling analysis. New helical reconstruction algorithms and z-filtering reconstruction are developed for multi-slice CT in general. Furthermore, the theoretical models of slice profile and image noise are established for multi-slice helical CT. For 4-slice helical CT in particular, preferred helical pitches are discussed. Special reconstruction algorithms are developed. Slice profiles, image noises, and artifacts of 4-slice helical CT are studied and compared with single slice helical CT. The results show that the slice profile, image artifacts, and noise exhibit performance peaks or valleys at certain helical pitches in the multi-slice CT, whereas in the single-slice CT the image noise remains unchanged and the slice profile and image artifacts steadily deteriorate with helical pitch. The study indicates that the 4-slice helical CT can provide equivalent image quality at 2 to 3 times the volume coverage speed of the single slice helical CT.

Algorithms↗

PubMed2005

Schoolwide food practices are associated with body mass index in middle school students.

OBJECTIVE: To examine the association between body mass index in young adolescents and schoolwide food practices such as foods used in school fundraising and in the classroom as incentives and rewards. DESIGN: Using a cross-sectional study design, we collected data from both the schools and the students. School administrators provided information on schoolwide food policies and practices. Eighth-grade students provided self-reported heights and weights. SETTING: Sixteen middle schools in the Minneapolis-St Paul metropolitan area. PARTICIPANTS: The study included 3088 eighth-grade students. Students were participants in a school-based dietary intervention study. MAIN OUTCOME MEASURES: Body mass index was calculated from self-reported height and weight data. A 7-item schoolwide food practices scale (Cronbach alpha = 0.83) was created using data collected from school administrators. RESULTS: The mean number of food practices permitted by a school was 3 (range, 0-7). The most prevalent food practices were the use of food as incentives and rewards (69%) and in classroom fundraising (56%). Body mass index (BMI) [corrected] of the students increased a 0.10 BMI unit [corrected] for every additional food practice permitted in their school (P<.03). CONCLUSIONS: Schoolwide food practices that supported frequent snacking and the consumption of foods and beverages high in calories and low in nutrients by students throughout the school day were common and adversely associated with body mass index of the students. Prevention of overweight in childhood must include attention to the nutrition integrity of schools, and school nutrition policies that consistently support and promote healthy dietary practices among young adolescents are urgently needed.

Adolescent↗

PubMed2006

Psychopathology in young people with intellectual disability.

CONTEXT: Comorbid severe mental health problems complicating intellectual disability are a common and costly public health problem. Although these problems are known to begin in early childhood, little is known of how they evolve over time or whether they continue into adulthood. OBJECTIVE: To study the course of psychopathology in a representative population of children and adolescents with intellectual disability. DESIGN, SETTING, AND PARTICIPANTS: The participants of the Australian Child to Adult Development Study, an epidemiological cohort of 578 children and adolescents recruited in 1991 from health, education, and family agencies that provided services to children with intellectual disability aged 5 to 19.5 years in 6 rural and urban census regions in Australia, were followed up for 14 years with 4 time waves of data collection. Data were obtained from 507 participants, with 84% of wave 1 (1991-1992) participants being followed up at wave 4 (2002-2003). MAIN OUTCOME MEASURES: The Developmental Behaviour Checklist (DBC), a validated measure of psychopathology in young people with intellectual disability, completed by parents or other caregivers. Changes over time in the Total Behaviour Problem Score and 5 subscale scores of the DBC scores were modeled using growth curve analysis. RESULTS: High initial levels of behavioral and emotional disturbance decreased only slowly over time, remaining high into young adulthood, declining by 1.05 per year on the DBC Total Behaviour Problem Score. Overall severity of psychopathology was similar across mild to severe ranges of intellectual disability (with mean Total Behaviour Problem Scores of approximately 44). Psychopathology decreased more in boys than girls over time (boys starting with scores 2.61 points higher at baseline and ending with scores 2.57 points lower at wave 4), and more so in participants with mild intellectual disability compared with those with severe or profound intellectual disability who diverged from having scores 0.53 points lower at study commencement increasing to a difference of 6.98 points below severely affected children by wave 4. This trend was observed in each of the subscales, except the social-relating disturbance subscale, which increased over time. Prevalence of participants meeting criteria for major psychopathology or definite psychiatric disorder decreased from 41% at wave 1 to 31% at wave 4. Few of the participants (10%) with psychopathology received mental health interventions during the study period. CONCLUSION: These results provide evidence that the problem of psychopathology comorbid with intellectual disability is both substantial and persistent and suggest the need for effective mental health interventions.

Adolescent↗

PubMed1999

Motion correction with PROPELLER MRI: application to head motion and free-breathing cardiac imaging.

A method for motion correction, involving both data collection and reconstruction, is presented. The PROPELLER MRI method collects data in concentric rectangular strips rotated about the k-space origin. The central region of k-space is sampled for every strip, which (a) allows one to correct spatial inconsistencies in position, rotation, and phase between strips, (b) allows one to reject data based on a correlation measure indicating through-plane motion, and (c) further decreases motion artifacts through an averaging effect for low spatial frequencies. Results are shown in which PROPELLER MRI is used to correct for bulk motion in head images and respiratory motion in nongated cardiac images. Magn Reson Med 42:963-969, 1999.

Artifacts↗

PubMed2000

Hyperventilation therapy for acute traumatic brain injury.

BACKGROUND: Because hyperventilation is often associated with a rapid fall in intracranial pressure, it has been assumed to be effective in the treatment of severe head injury. Hyperventilation reduces raised intracranial pressure by causing cerebral vasoconstriction and a reduction in cerebral blood flow. Whether reduced cerebral blood flow improves neurological outcome however, is unclear. OBJECTIVES: To quantify the effect of hyperventilation on death and neurological disability following head injury. SEARCH STRATEGY: The search strategy drew on that of the Injuries Group as a whole. The reference lists of all relevant articles identified were checked and the first author of reports was contacted to ask for assistance in identifying any further trials. Most recent search was done in September 1999. SELECTION CRITERIA: All randomised trials of hyperventilation, in which study participants had a clinically defined acute traumatic head injury of any severity. There were no language restrictions. DATA COLLECTION AND ANALYSIS: We collected data on the participants, the timing and duration of the intervention, duration of follow up, neurological disability and death. Relative risks (RR) and 95% confidence intervals were calculated for each trial on an intention to treat basis. Timing, degree and duration of hyperventilation were identified a-priori as potential sources of heterogeneity between trials. MAIN RESULTS: One trial of 113 participants was identified. Hyperventilation alone, as well as in conjunction with the buffer THAM showed a beneficial effect on mortality at one year after injury, although the effect measure was imprecise (RR=0.73; 95% CI 0.36;1.49 and RR=0.89; 95% CI 0.47;1.72 respectively). This improvement in outcome was not supported by an improvement in neurological recovery. For hyperventilation alone, the RR for death or severe disability was 1. 14 (95% CI 0.82;1.58). The RR for death or severe disability in the hyperventilation plus THAM group, was 0.87 (95% CI 0.58;1.28). REVIEWER'S CONCLUSIONS: The data available are inadequate to assess any potential benefit or harm that might result from hyperventilation in severe head injury. Randomised controlled trials to assess the effectiveness of hyperventilation therapy following severe head injury are needed.

Brain Injuries↗

PubMed2004

Human albumin solution for resuscitation and volume expansion in critically ill patients.

BACKGROUND: Human albumin solutions are used in a range of medical and surgical problems. Licensed indications are the emergency treatment of shock and other conditions where restoration of blood volume is urgent, burns, and hypoproteinaemia. Human albumin solutions are more expensive than other colloids and crystalloids. OBJECTIVES: To quantify the effect on mortality of human albumin and plasma protein fraction (PPF) administration in the management of critically ill patients. SEARCH STRATEGY: We searched the Cochrane Injuries Group trials register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and BIDS Index to Scientific and Technical Proceedings. Reference lists of trials and review articles were checked, and authors of identified trials were contacted. The search was last updated in August 2004. SELECTION CRITERIA: Randomised controlled trials comparing albumin/PPF with no albumin/PPF, or with a crystalloid solution, in critically ill patients with hypovolaemia, burns or hypoalbuminaemia. DATA COLLECTION AND ANALYSIS: We collected data on the participants, albumin solution used, mortality at the end of follow up, and quality of allocation concealment. Analysis was stratified according to patient type. MAIN RESULTS: We found 32 trials meeting the inclusion criteria and reporting death as an outcome. There were 1632 deaths among 8452 trial participants. For hypovolaemia, the relative risk of death following albumin administration was 1.01 (95% confidence interval 0.92, 1.10). This estimate was heavily influenced by the results of the SAFE trial which contributed 91% of the information (based on the weights in the meta-analysis). For burns, the relative risk was 2.40 (1.11, 5.19) and for hypoalbuminaemia the relative risk was 1.38 (0.94, 2.03). There was no substantial heterogeneity between the trials in the various categories (chi-square = 21.86, df = 25, p =0.64). The pooled relative risk of death with albumin administration was 1.04 (0.95, 1.13). REVIEWERS' CONCLUSIONS: For patients with hypovolaemia there is no evidence that albumin reduces mortality when compared with cheaper alternatives such as saline. There is no evidence that albumin reduces mortality in critically ill patients with burns and hypoalbuminaemia. The possibility that there may be highly selected populations of critically ill patients in which albumin may be indicated remains open to question. However, in view of the absence of evidence of a mortality benefit from albumin and the increased cost of albumin compared to alternatives such as saline, it would seem reasonable that albumin should only be used within the context of well concealed and adequately powered randomised controlled trial.

Blood Proteins↗

PubMed2000

Botulinum toxin type A in the treatment of lower limb spasticity in cerebral palsy.

OBJECTIVES: To determine whether botulinum toxin (BtA) is an effective and safe treatment for lower limb spasticity in children with cerebral palsy. Functional outcomes are of particular interest. SEARCH STRATEGY: Studies for inclusion in the review were identified using the Movement Disorders Review Group trials register, the Cochrane Controlled Trials Register, MEDLINE, pharmaceutical company databases, communication with other researchers in the field and reference lists of papers found using above search strategies. SELECTION CRITERIA: Studies were considered eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of leg spasticity in children with cerebral palsy. They must have been randomised and include a concurrent control group receiving another intervention. DATA COLLECTION AND ANALYSIS: A paper pro forma was used to collect data from the included studies using double extraction by two independent reviewers. Each trial was assessed for internal validity by each of the two reviewers. Meta-analysis was not possible because results were presented in an incompatable form. A Peto odds ratio was calculated where this was appropriate, otherwise a descriptive summary of the results of the individual studies was compiled. MAIN RESULTS: Three eligible studies were found each with small numbers of subjects. They were short term, used single injection sessions with follow-up of between 4 and 26 weeks. One study (Koman), of twelve ambulant children, compared BtA with injection of a placebo and found non-significant improvements in gait in the BtA group compared to the placebo group. Two studies (Corry, Flett) compared BtA with the use of casts. Each included 20 ambulant children and found improvements in gait, range of ankle movement and muscle tone in both the BtA and cast groups. However there were no significant differences between the groups in either trial. One of these trials (Flett) also assessed motor function using the gross motor function measure (GMFM) (Russell, 1989) and found significant improvements in each group compared to baseline but no significant differences between the groups. The other trial (Corry) performed 3D gait analysis on those children able to co-operate. Maximal plantar flexion and maximal dorsiflexion during walking were both found to be significantly greater in the BtA group compared to the cast group. In all other dimensions there were no significant differences between the groups. REVIEWER'S CONCLUSIONS: This systematic review has not revealed strong controlled evidence to support or refute the use of BtA for the treatment of leg spasticity in cerebral palsy. Ongoing randomised controlled trials are likely to provide useful data on the short term effects of BtA for leg spasticity. Future research should also assess the longer term use of BtA. Ideally studies should be pragmatic in their approach to dose and distribution of toxin to reflect practise. Outcome measures assessing function and disability would give the most useful information.

Botulinum Toxins, Type A↗

PubMed2000

Epidural local anaesthetics versus opioid-based analgesic regimens on postoperative gastrointestinal paralysis, PONV and pain after abdominal surgery.

BACKGROUND: Gastrointestinal paralysis, nausea and vomiting, and pain, are major clinical problems following abdominal surgery. Anaesthetic and analgesic techniques that reduce pain and postoperative nausea and vomiting (PONV), and prevent or reduce postoperative ileus, may reduce postoperative morbidity, duration of hospitalisation and hospital costs. OBJECTIVES: To compare effects of postoperative epidural local anaesthetic with regimens based on systemic or epidural opioids, on postoperative gastrointestinal function, postoperative pain, PONV and surgical/anaesthetic complications. SEARCH STRATEGY: Trials were identified by computerised searches of the Cochrane Controlled Trials Register, MEDLINE, EMBASE and by checking the reference lists of trials and review articles. SELECTION CRITERIA: Randomised controlled trials comparing the effects of postoperative epidural local anaesthetic with systemic or epidural opioids. DATA COLLECTION AND ANALYSIS: Collected data included treatment in active (local anaesthetic) and control (opioid based) groups, time to first postoperative stool, time to first postoperative flatus, gastric emptying measured by the paracetamol absorption test, duration of the passage of barium sulphate, pain assessments, use of supplementary analgesics, nausea, vomiting and surgical/anaesthetic complications. MAIN RESULTS: Most studies in this review involved a small number of patients. Furthermore half of the studies indicated a poor level of methodology in particular regarding blinding and report of withdrawals. Heterogeneity of included studies was substantial. Results consistently showed reduced time to return of gastrointestinal function in the epidural local anaesthetic group compared with groups receiving systemic or epidural opioid (37 hours and 24 hours, respectively). Postoperative pain was comparable. Two studies compared the effect of epidural local anaesthetic with a combination of epidural local anaesthetic and opioid on gastrointestinal function. One study favoured epidural local anaesthetic and one study was indifferent. A meta analysis of five of eight studies comparing the effect of epidural local anaesthetic with a combination of epidural local anaesthetic and opioid on postoperative pain, yielded a reduction in VAS pain scores (0-100 mm) on the first postoperative day of 15 mm, in favour of the combination. No significant differences in PONV were observed between epidural local anaesthetic and opioid based regimens. REVIEWER'S CONCLUSIONS: Administration of epidural local anaesthetics to patients undergoing laparotomy reduce gastrointestinal paralysis compared with systemic or epidural opioids, with comparable postoperative pain relief. Addition of opioid to epidural local anaesthetic may provide superior postoperative analgesia compared with epidural local anaesthetics alone. The effect of additional epidural opioid on gastrointestinal function is so far unsettled. Randomized, controlled trials comparing the effect of combinations of epidural local anaesthetic and opioid with epidural local anaesthetic alone on postoperative gastrointestinal function and pain are warranted.

Abdomen↗

PubMed2000

Premedication for anxiety in adult day surgery.

BACKGROUND: Surgery is increasingly performed on a day-case basis. Many patients are anxious pre-operatively and might benefit from pharmacological anxiolysis. Drugs are sometimes not used, however, for fear of delaying discharge from hospital. OBJECTIVES: To asses the effect of anxiolytic premedication on time to discharge in adult patients undergoing day case surgery under general anaesthesia. SEARCH STRATEGY: Trials were identified by computerised searches of the Cochrane Controlled Trials Register, MEDLINE, EMBASE, by checking the reference lists of trials and review articles, by hand-searching three main anaesthesia journals and by contacting five researchers active in the field and the Product Information departments of the manufacturers of five commonly used premedicants. SELECTION CRITERIA: All randomised controlled trials comparing an anxiolytic drug(s) with placebo before general anaesthesia in adult day case surgical patients. DATA COLLECTION AND ANALYSIS: We collected data on anaesthetic drugs used, results of tests of psychomotor function where these were used to assess residual effect of premedication, and on times from end of anaesthesia to ability to walk unaided or readiness for discharge from hospital. Formal statistical synthesis of individual trials was not performed in view of the variety of drugs studied. MAIN RESULTS: Searching identified twenty-nine reports; fourteen studies, with data from a total of 1263 patients, were considered eligible for analysis. Only two studies specifically addressed the discharge question; both found no delay in premedicated patients. Three other studies used clinical criteria to assess fitness for discharge, though times were not given. Again, there was no difference from placebo. Four studies used both clinical measures and tests of psychomotor function as tests of recovery from anaesthesia. In none of these studies did the premedication appear to delay discharge, although performance on tests of psychomotor function was sometimes still impaired. Of the four studies which used tests of psychomotor function to assess recovery, three showed impaired recovery (after midazolam 7.5mg, midazolam 15mg or diazepam 15mg) which might possibly interfere with discharge from hospital. REVIEWER'S CONCLUSIONS: We have found no evidence of a difference in time to discharge from hospital in patients who received anxiolytic premedication. However, in view of the age and variety of anaesthetic techniques used, inferences for current day-case practice should be made with caution.

Adult↗

PubMed2006

Beta lactam antibiotic monotherapy versus beta lactam-aminoglycoside antibiotic combination therapy for sepsis.

BACKGROUND: Optimal antibiotic treatment for sepsis is imperative. Combining a beta-lactam antibiotic with an aminoglycoside antibiotic may have certain advantages over beta-lactam monotherapy. OBJECTIVES: We compared clinical outcomes for beta lactam-aminoglycoside combination therapy versus beta lactam monotherapy for sepsis. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library, Issue 3, 2004); MEDLINE (1966 to July 2004); EMBASE (1980 to March 2003); LILACS (1982 to July 2004); and conference proceedings of the Interscience Conference of Antimicrobial Agents and Chemotherapy (1995 to 2003). We scanned citations of all identified studies and contacted all corresponding authors. SELECTION CRITERIA: We included randomized and quasi-randomized trials comparing any beta-lactam monotherapy to any combination of one beta-lactam and one aminoglycoside for sepsis. DATA COLLECTION AND ANALYSIS: The primary outcome was all-cause fatality. Secondary outcomes included treatment failure, superinfections, colonization, and adverse events. Two authors independently collected data. We pooled relative risks (RR) with their 95% confidence intervals (CI) using the fixed effect model. We extracted outcomes by intention-to-treat analysis whenever possible. MAIN RESULTS: We included 64 trials, randomizing 7586 patients. Twenty trials compared the same beta-lactam in both study arms, while the remaining compared different beta-lactams using a broader spectrum beta-lactam in the monotherapy arm. In studies comparing the same beta-lactam, we observed no difference between study groups with regard to all-cause fatality, RR 1.01 (95% CI 0.75-1.35) and clinical failure, RR 1.11 (95% CI 0.95-1.29). In studies comparing different beta-lactams, we observed an advantage to monotherapy: all cause fatality RR 0.85 (95% CI 0.71-1.01), clinical failure RR 0.77 (95% CI 0.69-0.86). No significant disparities emerged from subgroup and sensitivity analyses, including the assessment of patients with Gram-negative and Pseudomonas aeruginosa infections. We detected no differences in the rate of resistance development. Adverse events rates did not differ significantly between the study groups overall, although nephrotoxicity was significantly more frequent with combination therapy, RR 0.30 (95% CI 0.23-0.39). We found no heterogeneity for all comparisons. We included a small subset of studies addressing patients with Gram-positive infections, mainly endocarditis. We identified no difference between monotherapy and combination therapy in these studies. AUTHORS' CONCLUSIONS: The addition of an aminoglycoside to beta-lactams for sepsis should be discouraged. All-cause fatality rates are unchanged. Combination treatment carries a significant risk of nephrotoxicity.

Aminoglycosides↗

PubMed2006

Addition of drug/s to a chemotherapy regimen for metastatic breast cancer.

BACKGROUND: The addition of a chemotherapy drug or drugs to an established regimen is one method used to increase the dose and intensity of treatment for metastatic breast cancer. OBJECTIVES: To identify and review the randomised trial evidence in the first line management of women with metastatic breast cancer that evaluates the addition of one or more chemotherapy drugs to an established regimen. SEARCH STRATEGY: We searched the specialised register maintained by the Editorial Base of the Cochrane Breast Cancer Group on 3rd August 2004 (updated search on 2nd August 2005) using the codes for "advanced breast cancer" and "chemotherapy". Details of the search strategy applied by the Group to create the register, and the procedure used to code references, are described in the Group's module on the Cochrane Library. SELECTION CRITERIA: Randomised trials that evaluated a first line regimen of at least two chemotherapy drugs, and compared it to that same regimen plus the addition of one or more chemotherapy drugs in women with metastatic breast cancer. DATA COLLECTION AND ANALYSIS: We collected data from published trials and assessed studies for eligibility and quality. Two reviewers extracted data independently. We derived hazard ratios (HR) from time-to-event outcomes where possible, and a fixed effect model was used for meta-analysis. We analysed response rates as dichotomous variables and extracted toxicity data where available. MAIN RESULTS: We identified 17 trials reporting on 22 treatment comparisons (2674 patients randomised). Fifteen trials (20 treatment comparisons) reported results for tumour response and 11 trials (14 treatment comparisons) published time-to-event data for overall survival. There were 1532 deaths in 2116 women randomised to trials of the addition of a drug to the regimen and control (the regimen alone). There was no detectable difference in overall survival between these patients, with an overall HR of 0.96 (95% CI 0.87 to 1.07, P = 0.47) and no statistically significant heterogeneity. We found no difference in time to progression between these regimens, with an overall HR of 0.93 (95% CI 0.81 to 1.07, P = 0.31) and no statistically significant heterogeneity. Addition of a drug to the regimen was favourably associated with overall tumour response rates (OR 1.21, 95% CI 1.01 to 1.44, P = 0.04) although we observed statistically significant heterogeneity for this outcome across the trials. Where measured, acute toxicities such as alopecia, nausea and vomiting and leukopenia were more common with the addition of a drug. AUTHORS' CONCLUSIONS: The addition of one or more drugs to the regimen shows a statistically significant advantage for tumour response in women with metastatic breast cancer but the results suggest no difference in survival time or time to progression. The positive effect on tumour response observed with addition of a drug to the regimen was also associated with increased toxicity.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2005

Optimal timing for intravenous administration set replacement.

BACKGROUND: Administration of intravenous therapy is a common occurrence within the hospital setting. Routine replacement of administration sets has been advocated to reduce intravenous infusion contamination. If decreasing the frequency of changing intravenous administration sets does not increase infection rates, a change in practice could result in considerable cost savings. OBJECTIVES: The objective of this review was to identify the optimal interval for the routine replacement of intravenous administration sets when infusate or parenteral nutrition (lipid and non-lipid) solutions are administered to people in hospital via central or peripheral venous catheters. SEARCH STRATEGY: We searched The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, CINAHL, EMBASE: all from inception to February 2004; reference lists of identified trials, and bibliographies of published reviews. We also contacted researchers in the field. We did not have a language restriction. SELECTION CRITERIA: We included all randomized or quasi-randomized controlled trials addressing the frequency of replacing intravenous administration sets when parenteral nutrition (lipid and non-lipid containing solutions) or infusions (excluding blood) were administered to people in hospital via a central or peripheral catheter. DATA COLLECTION AND ANALYSIS: Two authors assessed all potentially relevant studies. We resolved disagreements between the two authors by discussion with a third author. We collected data for the outcomes; infusate contamination; infusate-related bloodstream infection; catheter contamination; catheter-related bloodstream infection; all-cause bloodstream infection and all-cause mortality. MAIN RESULTS: We identified 23 references for review. We excluded eight of these studies; five because they did not fit the inclusion criteria and three because of inadequate data. We extracted data from the remaining 15 references (13 studies) with 4783 participants. We conclude that there is no evidence that changing intravenous administration sets more often than every 96 hours reduces the incidence of bloodstream infection. We do not know whether changing administration sets less often than every 96 hours affects the incidence of infection. In addition, we found that there were no differences between participants with central versus peripheral catheters; nor between participants who did and did not receive parenteral nutrition, or between children and adults. AUTHORS' CONCLUSIONS: It appears that administration sets that do not contain lipids, blood or blood products may be left in place for intervals of up to 96 hours without increasing the incidence of infection. There was no evidence to suggest that administration sets which contain lipids should not be changed every 24 hours as currently recommended.

Bacterial Infections↗

PubMed2003

Ibuprofen for Alzheimer's disease.

BACKGROUND: Non-steroidal antiinflammatory drugs such as ibuprofen may have a role in the treatment of conditions characterized by inflammatory processes. Ibuprofen may attenuate the effects of modulators of inflammation that have been implicated in the pathogenesis of Alzheimer's disease. OBJECTIVES: To investigate the efficacy of ibuprofen treatment for people with Alzheimer's disease. SEARCH STRATEGY: The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 10 December 2002 using the (many) terms listed in the main text of the review. The CDCIG Register is updated regularly and contains records from all major health care databases and many ongoing trials databases. In addition computerized databases and Internet sites pertaining to ibuprofen and Alzheimer's disease were systematically examined by two reviewers independently. Data on ongoing trials of ibuprofen for the treatment of people with AD were also sought. SELECTION CRITERIA: Eligibility for this review included all single or multi centre placebo-controlled randomized trials examining the efficacy of ibuprofen in the treatment of people diagnosed with Alzheimer's disease according to internationally accepted criteria. Inclusion and exclusion criteria were specified to ensure lack of bias in selection and methodological quality of selected trials. DATA COLLECTION AND ANALYSIS: The aim was for the two reviewers NT and HF to collect data independently. The data selected would reflect cognitive, behavioural, physical and psychological domains of AD. MAIN RESULTS: A systematic search of all available databases and other sources failed to identify any completed randomized, double-blind and placebo-controlled trials, assessing the efficacy of ibuprofen in AD eligible for inclusion in the review. One double-blind placebo-controlled trial investigating ibuprofen treatment for age-associated memory impairment has been identified, but is yet unfinished and no data are yet available. Other trials assessing the effect of ibuprofen on CSF beta amyloid in cognitively unimpaired individuals and the effect of other NSAIDs such as naproxen and rofecoxib for people with AD are currently under way. REVIEWER'S CONCLUSIONS: No evidence yet exists from randomized double-blind and placebo-controlled trials on whether ibuprofen is efficacious for patients diagnosed as having Alzheimer's disease. Ibuprofen, like other NSAIDs, has an identifiable and in some instances a significant side-effect profile which may include gastrointestinal bleeding. Therefore, it needs to be shown that the benefits of such a treatment outweighs the risk of side effects before ibuprofen can be recommended for people with Alzheimer's disease.

Alzheimer Disease↗

PubMed2005

Trypanocidal drugs for late stage, symptomatic Chagas disease (Trypanosoma cruzi infection).

BACKGROUND: People with Chagas disease (American Trypanosomiasis) may develop progressive and potentially lethal heart conditions. Drugs to eliminate the causative parasite, Trypanosoma cruzi, currently in use have limited therapeutic value and are used in early stages of the disease. Extending the use of these drugs to treat symptomatic chronic parasitism with chronic Chagasic cardiopathy (CCC) and progressive dilated cardiomyopathy has been proposed. OBJECTIVES: To assess the effects (harms and benefits) of nitrofurans and imidazolic trypanocidal drugs for treating late stage chronic Chagas disease and CCC. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 3, 2004), MEDLINE (1985-2004), EMBASE (1985-2004), BIREME (1985-2004), LILACS (1985-2004), ARTEMISA (1985-2004), SCIELO (1985-2004). Indexing terms in English and Spanish were used. References obtained were assessed for relevance by two reviewers independently. SELECTION CRITERIA: We included randomized controlled clinical trials (RCTs), single or double blind using trypanocidal drugs versus placebo or no treatment in CCC. DATA COLLECTION AND ANALYSIS: All articles retrieved were assessed using a predefined check list to determine if they met the inclusion criteria. Two independent reviewers collected data using a pre-designed form piloted on three articles before the review process started. Disagreements were resolved by a third reviewer. If the information was unavailable the articles were excluded. We planned a quantitative analysis of reduction of parasite load whether recorded as a categorical variable or the reduction of specific antibody titers. However insufficient data were available for quantitative analysis. We prepared a qualitative description of data identified. MAIN RESULTS: We found only one randomized double blind placebo controlled trial. We also found six uncontrolled or non-randomized studies which were of some relevance and were therefore described. We found insufficient evidence to define the effects of drug treatment for people with CCC. AUTHORS' CONCLUSIONS: There is insufficient evidence to support the efficacy of nitrofurans or imidazolic drugs as recommended treatment in CCC and chronic T.cruzi infections, specifically if overt heart disease is present. A well designed randomized controlled trial is necessary to establish if new drugs are suitable for treatment of cardiac patients with CCC.

Chagas Cardiomyopathy↗

PubMed2005

Botulinum toxin type A versus botulinum toxin type B for cervical dystonia.

Botulinum Toxins↗

PubMed2005

Botulinum toxin type B for cervical dystonia.

BACKGROUND: Cervical dystonia is the most common form of focal dystonia. It is characterized by involuntary posturing of the head and frequently is associated with neck pain. Disability and social withdrawal are common. Most cases of cervical dystonia are idiopathic and generally it is a life-long disorder. In recent years, Botulinum toxin type A (BtA) has become the first line therapy. However, some patients become resistant to it. This problem led to the study of another Botulinum toxin (Bt) serotype, Bt type B (BtB) to address the issues of clinical efficacy, effect size, and safety of BtB in the treatment of cervical dystonia. OBJECTIVES: To determine whether botulinum toxin (BtB) is an effective and safe treatment for cervical dystonia. SEARCH STRATEGY: We identified studies for inclusion in the review using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE; and by handsearching the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, by communication with other researchers in the field, by searching reference lists of papers found using the above search strategies, and by contacting authors and drug manufacturers. SELECTION CRITERIA: We considered studies eligible for inclusion in the review if they evaluated the efficacy of BtB for the treatment of cervical dystonia in randomized, placebo-controlled trials. DATA COLLECTION AND ANALYSIS: We used a paper pro forma to collect data from the included studies with double extraction by two independent reviewers. Both reviewers assessed each trial for internal validity and settled differences by discussion. The outcome measures used included adverse events, improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, changes in pain scores, changes in quality of life assessments. MAIN RESULTS: Studies were short term (16 weeks) employing a single BtB injection session. All were multicentre and conducted in the US. All patients included had previously received BtA. The trials differed with respect to whether or not the patients were still responding to BtA but other entry criteria were similar. All studies used a dose of 10,000 Units of BtB in one group and the technique of administration was the same. Meta-analysis of three trials enrolling 308 participants showed statistically and clinically significant improvements in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score at week four with a Peto odds ratio (OR) for the number of patients who had at least a 20% improvement of 4.69 (95% CI 2.06 to 10.69) and a weighted mean difference of -5.92 (95% CI -9.61 to -2.23). Subjective rating scales (Patient Global Assessment of Change, Investigator Global Assessment of Change, and Patient Analog Pain Assessment) also improved. Adverse events clearly associated with the mechanism of action of BtB included dysphagia and dry mouth and the number of patients with any adverse event were more frequent in BtB treatment groups. Subgroup analyses showed a clear dose-response relationship for subjective and objective benefit, for frequency and severity of adverse events, and a greater benefit for BtA resistant patients than BtA responders in the primary outcome. The duration of effect was about 16 weeks. We found three eligible studies enrolling 308 participants. Studies were short term (16 weeks) employing a single BtB injection session. All were multicentre and conducted in the US. All patients included had previously received BtA. The trials differed with respect to whether or not the patients were still responding to BtA but other entry criteria were similar. Patient groups were appropriately selected and well matched. From the methodological point of view these trials were probably not subjected to important selection, performance or attrition bias and all studies used an intention-to-treat analysis.The dose varied significantly between studies although all used 10,000 Units of BtB in one group and the technique of administration was the same. The primary outcome in all trials was change in TWSTRS total score at week four and other efficacy outcomes were similar between studies. The number of dropouts was small and balanced in all trials. Reasons for withdrawals were given. One randomized double-blind placebo-controlled study was excluded because data couldn't be extracted for the outcomes. Meta-analysis showed statistically and clinically significant improvements with a Peto odds ratio (OR) of 20% in TWSTRS total score at week four (OR 4.69; 95% CI 2.06 to 10.69) and a weighted mean difference of -5.92 (95% CI -9.61 to -2.23). Subjective rating scales (Patient Global Assessment of Change, Investigator Global Assessment of Change, and Patient Analog Pain Assessment) also improved. The weighted mean difference for changes in these subjective scales varied between -13% to -21%. However, for many of the outcomes, we could not combine data from all studies. Only adverse events clearly associated with the mechanism of action of BtB were more frequent in the treatment group. These included dysphagia and dry mouth. The number of patients with any adverse event was more frequent with BtB. Subgroup analyses showed a clear dose-response relationship for subjective and objective benefit and for frequency and severity of adverse events. Subgroup analyses showed a greater benefit for the BtA resistant patients than BtA responders in the primary outcome. The duration of effect was about 16 weeks. These trials did not measure quality of life nor did they establish the long term duration of effect or immunogenicity AUTHORS' CONCLUSIONS: A single injection of BtB was effective and safe for treating cervical dystonia. Long-term uncontrolled studies suggested that further injection cycles continue to work for most patients. Future research should explore technical factors such as the optimum treatment intervals and use of image or electromyographic guidance for administration. Other issues include service delivery, quality of life, long-term efficacy and safety, and the relative indications for BtA, BtB and other treatments such as deep brain stimulation.

Botulinum Toxins↗

PubMed2005

Botulinum toxin type A therapy for blepharospasm.

BACKGROUND: Blepharospasm is a focal dystonia characterized by chronic intermittent or persistent involuntary eyelid closure due to spasmodic contractions of the orbicularis oculi muscles. Other facial and neck muscles are also frequently involved. Most cases are idiopathic and blepharospasm is generally a life-long disorder. Its severity can range from repeated frequent blinking to persistent forceful closure of the eyelids with functional blindness. Botulinum toxin type A (BtA) is the current first line therapy. OBJECTIVES: To determine whether botulinum toxin (BtA) is an effective and safe treatment for blepharospasm. SEARCH STRATEGY: We identified studies for inclusion in the review using the Cochrane Movement Disorders Group trials register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, handsearches of the Movement Disorders Journal and abstracts of international congresses on movement disorders and botulinum toxin, communication with other researchers in the field, reference lists of papers found using above search strategies, and contact with authors and drug manufacturers. SELECTION CRITERIA: Studies were eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of blepharospasm. They must have been randomised and placebo-controlled. DATA COLLECTION AND ANALYSIS: We used a paper pro-forma to collect data from the included studies using double extraction by two independent reviewers. The two reviewers separately assessed each trial for internal validity and they settled differences between them by discussion. The outcome measures used included adverse events, improvement in symptomatic rating scales, subjective evaluation by patients and clinicians, and changes in quality of life assessments. MAIN RESULTS: We found few controlled trials. They were of short duration and enrolled small numbers of patients. Because of their poor internal validity, the characteristics of the populations studied, and the types of interventions and outcomes, none of the trials fitted our criteria for inclusion. However, all these trials found BtA to be superior to placebo as did large case-control and cohort studies, which reported that around 90% of patients benefited. AUTHORS' CONCLUSIONS: There are no high quality, randomised, controlled efficacy data to support the use of Bt for blepharospasm. Despite this, other studies suggest that BtA is highly effective and safe for treating blepharospasm and support its use. The effect size (90% of patients benefit) seen in open studies makes it very difficult and probably unethical to perform new placebo-controlled trials of efficacy of BtA for blepharospasm. Future trials should explore technical factors such as the optimum treatment intervals, different injection techniques, doses, Bt types and formulations. Other issues include service delivery, quality of life, long-term efficacy, safety, and immunogenicity.

Blepharospasm↗