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Biomedical subjects

F Bunn

Publications and source records attributed to F Bunn.

At least 19 recordsLinked to original sources
PubMed2006

Nutritional support for head-injured patients.

BACKGROUND: Head injury increases the body's metabolic responses, and therefore nutritional demands. Provision of an adequate supply of nutrients is associated with improved outcome. The best route for administering nutrition (parenterally (TPN) or enterally (EN)), and the best timing of administration (for example, early versus late) of nutrients needs to be established. OBJECTIVES: To quantify the effect on mortality and morbidity of alternative strategies of providing nutritional support following head injury. SEARCH STRATEGY: Trials were identified by computerised searches of the Cochrane Injuries Group specialised register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, National Research Register, Web of Science and other electronic trials registers. Reference lists of trials and review articles were checked. The searches were last updated in July 2006. SELECTION CRITERIA: Randomised controlled trials of timing or route of nutritional support following acute traumatic brain injury. DATA COLLECTION AND ANALYSIS: Two authors independently abstracted data and assessed trial quality. Information was collected on death, disability, and incidence of infection. If trial quality was unclear, or if there were missing outcome data, trialists were contacted in an attempt to get further information. MAIN RESULTS: A total of 11 trials were included. Seven trials addressed the timing of support (early versus delayed), data on mortality were obtained for all seven trials (284 participants). The relative risk (RR) for death with early nutritional support was 0.67 (95% CI 0.41 to 1.07). Data on disability were available for three trials. The RR for death or disability at the end of follow-up was 0.75 (95% CI 0.50 to 1.11). Seven trials compared parenteral versus enteral nutrition. Because early support often involves parenteral nutrition, three of the trials are also included in the previous analyses. Five trials (207 participants) reported mortality. The RR for mortality at the end of follow-up period was 0.66 (0.41 to 1.07). Two trials provided data on death and disability. The RR was 0.69 (95% Cl 0.40 to 1.19). One trial compared gastric versus jejunal enteral nutrition, there were no deaths and the RR was not estimable. AUTHORS' CONCLUSIONS: This review suggests that early feeding may be associated with a trend towards better outcomes in terms of survival and disability. Further trials are required. These trials should report not only nutritional outcomes but also the effect on death and disability.

Craniocerebral Trauma↗
PubMed2006

Prophylactic antibiotics to prevent surgical site infection after breast cancer surgery.

BACKGROUND: Surgery has been used as part of breast cancer treatment for centuries; however any surgical procedure has the potential risk of infection. Infection rates for surgical treatment of breast cancer are documented at between three and 15%, higher than average for a clean surgical procedure. Pre and peri-operative antibiotics have been found to be useful in lowering infection rates in other surgical groups, yet there is no current consensus on prophylactic antibiotic use in breast cancer surgery. OBJECTIVES: To determine the effects of prophylactic antibiotics on the incidence of surgical site infection after breast cancer surgery. SEARCH STRATEGY: We searched the Cochrane Wounds and Breast Cancer Groups Specialised Registers, the Cochrane Central Register of Controlled Trials (CENTRAL) issue 1 2006. MEDLINE 2002-2005, EMBASE 1980-2005, NRR issue 1 2005, CINAHL 1982-2004 and SIGLE 1976-2004. Companies and experts in the field were contacted and reference lists were checked. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials of pre and peri-operative antibiotics for patients undergoing surgery for breast cancer were included. Primary outcomes were, incidence of breast wound infection and adverse reactions to treatment. DATA COLLECTION AND ANALYSIS: Two authors independently examined the title and abstracts of all studies identified by the search strategy, then assessed study quality and extracted data from those that met the inclusion criteria. MAIN RESULTS: Six studies met the inclusion criteria. All six evaluated pre-operative antibiotic compared with no antibiotic or placebo. Pooling of the results demonstrated that prophylactic antibiotics significantly reduce the incidence of surgical site infection for patients undergoing breast cancer surgery without reconstruction (pooled RR 0.66, 95% CI, 0.48 to 0.89). No studies presented separate data for patients who underwent reconstructive surgery at the time of removal of the breast tumour. AUTHORS' CONCLUSIONS: Prophylactic antibiotics reduce the risk of surgical site infection in patients undergoing surgery for breast cancer. The potential morbidity caused by infection, such as delays in wound healing or adjuvant cancer treatments must be balanced against the cost of treatment and potential adverse effects such as drug reactions or increased bacterial resistance. Further studies of patients undergoing immediate breast reconstruction would be useful as studies have identified this group as being at higher risk of infection than those who do not undergo immediate breast reconstruction.

Antibiotic Prophylaxis↗
PubMed2004

Colloids versus crystalloids for fluid resuscitation in critically ill patients.

BACKGROUND: Colloid solutions are widely used in fluid resuscitation of critically ill patients. There are several choices of colloid and there is ongoing debate about the relative effectiveness of colloids compared to crystalloid fluids. OBJECTIVES: To assess the effects on mortality of colloids compared to crystalloids for fluid resuscitation in critically ill patients. SEARCH STRATEGY: We searched the Injuries Group specialised register, Cochrane Controlled Trials Register, MEDLINE, EMBASE and BIDS Index to Scientific and Technical Proceedings, and checked reference lists of trials and review articles. SELECTION CRITERIA: All randomised and quasi-randomised trials of colloids compared to crystalloids, in patients requiring volume replacement. Cross-over trials and trials in pregnant women and neonates were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and rated quality of allocation concealment. Trials with a 'double-intervention', such as those comparing colloid in hypertonic crystalloid to isotonic crystalloid, were analysed separately. The analysis was stratified according to colloid type and quality of allocation concealment. MAIN RESULTS: Colloids compared to crystalloidsAlbumin or plasma protein fraction. Nineteen trials reported data on mortality, including a total of 7576 patients. The pooled relative risk (RR) from these trials was 1.02 (95% confidence interval [95% CI] 0.93 to 1.11). When the trial with poor quality allocation concealment was excluded, pooled RR was 1.01 (95% CI 0.92 to 1.10). Hydroxyethyl starch. Ten trials compared hydroxyethyl starch with crystalloids, including a total of 374 randomised participants. The pooled RR was 1.16 (95% CI 0.68 to 1.96). Modified gelatin. Seven trials compared modified gelatin with crystalloid, including a total of 346 randomised participants. The pooled RR was 0.54 (95% CI 0.16 to 1.85). Dextran. Nine trials compared dextran with a crystalloid, including a total of 834 randomised participants. The pooled relative risk was RR 1.24 (95% CI 0.94 to 1.65). Colloids in hypertonic crystalloid compared to isotonic crystalloidEight trials compared dextran in hypertonic crystalloid with isotonic crystalloid, including 1283 randomised participants. Pooled RR was 0.88 (95% CI 0.74 to 1.05). REVIEWERS' CONCLUSIONS: There is no evidence from randomised controlled trials that resuscitation with colloids reduces the risk of death, compared to resuscitation with crystalloids, in patients with trauma, burns or following surgery. As colloids are not associated with an improvement in survival, and as they are more expensive than crystalloids, it is hard to see how their continued use in these patients can be justified outside the context of randomised controlled trials.

Colloids↗
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↗
PubMed2004

Telephone consultation and triage: effects on health care use and patient satisfaction.

BACKGROUND: Telephone consultation is the process where calls are received, assessed and managed by giving advice or by referral to a more appropriate service. In recent years there has been a growth in telephone consultation developed, in part, as a response to increased demand for General Practitioner (GP) and Accident and Emergency (A&E) department care. OBJECTIVES: To assess the effects of telephone consultation on safety, service usage and patient satisfaction and to compare telephone consultation by different health care professionals. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials, the specialised register of the Cochrane Effective Practice and Organisation of Care (EPOC) group, Pubmed, EMBASE, CINAHL, SIGLE, and the National Research Register. We checked reference lists of identified studies and review articles and contacted experts in the field. The search was not restricted by language or publication status. SELECTION CRITERIA: Randomised controlled trials (RCTs), controlled studies, controlled before/after studies (CBAs) and interrupted time series (ITSs) of telephone consultation or triage in a general health care setting. Disease specific phone lines were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened studies for inclusion in the review, extracted data and assessed study quality. Data were collected on adverse events, service usage, cost and patient satisfaction. Due to heterogeneity we did not pool studies in a meta-analysis and instead present a narrative summary of the findings. MAIN RESULTS: Nine studies met our inclusion criteria, five RCTs, one CCT and three ITSs. Six studies compared telephone consultation versus normal care; four by a doctor, one by a nurse and one by a clinic clerk. Three studies compared telephone consultation by different types of health care workers; two compared nurses with doctors and one compared health assistants with doctors or nurses. Three of five studies found a decrease in visits to GP's but two found a significant increase in return consultations. In general at least 50% of calls were handled by telephone advice alone. Seven studies looked at accident and emergency department visits, six showed no difference between the groups and one, of nurse telephone consultation, found an increase in visits. Two studies reported deaths and found no difference between nurse telephone triage and normal care. REVIEWERS' CONCLUSIONS: Telephone consultation appears to reduce the number of surgery contacts and out-of-hours visits by general practitioners. However, questions remain about its affect on service use and further rigorous evaluation is needed with emphasis on service use, safety, cost and patient satisfaction.

Emergency Service, Hospital↗
PubMed2004

Hypertonic versus near isotonic crystalloid for fluid resuscitation in critically ill patients.

BACKGROUND: Hypertonic solutions are considered to have a greater ability to expand blood volume and thus elevate blood pressure and can be administered as a small volume infusion over a short time period. On the other hand, the use of hypertonic solutions for volume replacement may also have important disadvantages. OBJECTIVES: To determine whether hypertonic crystalloid decreases mortality in patients with hypovolaemia. SEARCH STRATEGY: We searched MEDLINE, EMBASE, The Cochrane Controlled Trials Register and the specialised register of the Cochrane Injuries Group. We checked reference lists of all articles identified and searched the National Research Register. SELECTION CRITERIA: Randomised trials comparing hypertonic to isotonic and near isotonic crystalloid in patients with trauma, burns or undergoing surgery. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data and assessed the quality of the trials. MAIN RESULTS: Fourteen trials with a total of 956 participants are included in the meta-analysis. The pooled relative risk (RR) for death in trauma patients was 0.84 (95% confidence interval [CI] 0.69-1.04); in patients with burns 1.49 (95% CI 0.56-3.95); and in patients undergoing surgery 0.51 (95% CI 0.09, 2.73). In the one trial that gave data on disability using the Glasgow outcome scale, the relative risk for a poor outcome was 1.00 (95% CI 0.82, 1.22). REVIEWERS' CONCLUSIONS: This review does not give us enough data to be able to say whether hypertonic crystalloid is better than isotonic and near isotonic crystalloid for the resuscitation of patients with trauma, burns, or those undergoing surgery. However, the confidence intervals are wide and do not exclude clinically significant differences. Further trials which clearly state the type and amount of fluid used and that are large enough to detect a clinically important difference are needed.

Critical Illness↗
PubMed2003

Area-wide traffic calming for preventing traffic related injuries.

BACKGROUND: It is estimated that by 2020 road traffic crashes will have moved from ninth to third in the world disease burden ranking, as measured in disability adjusted life years, and second in developing countries. The identification of effective strategies for the prevention of traffic related injuries is of global health importance. Area-wide traffic calming schemes that discourage through traffic on residential roads is one such strategy. OBJECTIVES: To evaluate the effectiveness of area-wide traffic calming in preventing traffic related crashes, injuries, and deaths. SEARCH STRATEGY: We searched the following electronic databases: Cochrane Injuries Group's Specialised Register, Cochrane Controlled Trials Register, MEDLINE, EMBASE and TRANSPORT (NTIS, TRIS, TRANSDOC). We searched the web sites of road safety organisations, handsearched conference proceedings, checked reference lists of relevant papers and contacted experts in the area. The search was not restricted by language or publication status. SELECTION CRITERIA: Randomised controlled trials, and controlled before-after studies of area-wide traffic calming schemes. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data on type of study, characteristics of intervention and control areas, and length of data collection periods. Before and after data were collected on the total number of road traffic crashes, all road user deaths and injuries, pedestrian-motor vehicle collisions and road user deaths. The statistical package STATA was used to calculate rate ratios for each study, which were then pooled to give an overall estimate using a random effects model. MAIN RESULTS: We found no randomised controlled trials, but 16 controlled before-after trials met our inclusion criteria. Seven studies were done in Germany, six in the UK, two in Australia and one in the Netherlands. There were no studies in low or middle income countries. Eight trials reported the number of road traffic crashes resulting in deaths. The pooled rate ratio was 0.63 (0.14, 2.59 95% CI). Sixteen studies reported the number of road traffic crashes resulting in injuries (fatal and non fatal). The pooled rate ratio was 0.89 (0.80, 1.00 95% CI). Nine studies reported the total number of road traffic crashes. The pooled rate ratio was 0.95 (0.81, 1.11 95% CI). Thirteen trials reported the number of pedestrian-motor vehicle collisions. The pooled rate ratio was 1.00 (0.84, 1.18). There was significant heterogeneity for the total number of crashes and deaths and injuries. REVIEWER'S CONCLUSIONS: The results from this review suggest that area-wide traffic calming in towns and cities may be a promising intervention for reducing the number of road traffic injuries, and deaths. However, further rigorous evaluations of this intervention are needed.

Accident Prevention↗
PubMed2003

Post-licence driver education for the prevention of road traffic crashes.

BACKGROUND: Worldwide, each year over a million people are killed and some ten million people are permanently disabled in road traffic crashes. Post-licence driver education is used by many as a strategy to reduce traffic crashes. However, the effectiveness of post-licence driver education has yet to be ascertained. OBJECTIVES: To quantify the effectiveness of post-licence driver education in reducing road traffic crashes. SEARCH STRATEGY: We searched the following electronic databases: the Cochrane Injuries Group's Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, TRANSPORT (NTIS, TRIS, TRANSDOC, IRRD), Road Res (ARRB), ATRI, National Research Register, PsycInfo, ERIC, SPECTR, Zetoc, SIGLE, Science (and Social Science) Citation Index. We searched the Internet, checked reference lists of relevant papers and contacted appropriate organisations. The search was not restricted by language or publication status. SELECTION CRITERIA: Randomised controlled trials comparing post-licence driver education versus no education, or one form of post-licence driver education versus another. DATA COLLECTION AND ANALYSIS: Two reviewers independently screened search results, extracted data and assessed methodological trial quality. MAIN RESULTS: We found 24 trials of driver education, 23 conducted in the USA and one in Sweden. Twenty trials studied remedial driver education. The methodological quality of the trials was poor and three reported data unsuitable for meta-analysis. Nineteen trials reported traffic offences: pooled relative risk (RR) = 0.96, 95% confidence interval (95% CI) = 0.94, 0.98); trial heterogeneity was significant (p=<0.00001). Fifteen trials reported traffic crashes: pooled RR = 0.98 (95% CI 0.96, 1.01), trial heterogeneity was not significant (p=0.75). Four trials reported injury crashes: pooled RR = 1.12 (95% CI 0.88, 1.41), trial heterogeneity was significant (p=<0.00001). No one form of education (correspondence, group or individual) was found to be substantially more effective than another, nor was a significant difference found between advanced driver education and remedial driver education. Funnel plots indicated the presence of publication bias affecting the traffic offence and crash outcomes. REVIEWER'S CONCLUSIONS: This systematic review provides no evidence that post-licence driver education is effective in preventing road traffic injuries or crashes. Although the results are compatible with a small reduction in the occurrence of traffic offences, this may be due to selection biases or bias in the included trials. Because of the large number of participants included in the meta-analysis (close to 300,000 for some outcomes) we can exclude, with reasonable precision, the possibility of even modest benefits.

Accidents, Traffic↗
PubMed2003

Traffic calming for the prevention of road traffic injuries: systematic review and meta-analysis.

OBJECTIVE: To assess whether area-wide traffic calming schemes can reduce road crash related deaths and injuries. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Cochrane Injuries Group Specialised Register, Cochrane Central Register of Controlled Trials, Medline, EMBASE, Sociological Abstracts Science (and social science) citation index, National Technical Information service, Psychlit, Transport Research Information Service, International Road Research Documentation, and Transdoc, and web sites of road safety organisation were searched; experts were contacted, conference proceedings were handsearched, and relevant reference lists were checked. INCLUSION CRITERIA: Randomised controlled trials, and controlled before/after studies of area-wide traffic calming schemes designed to discourage and slow down through traffic on residential roads. METHODS: Data were collected on road user deaths, injuries, and traffic crashes. For each study rate ratios were calculated, the ratio of event rates before and after intervention in the traffic calmed area divided by the corresponding ratio of event rates in the control area, which were pooled to give an overall estimate using a random effects model. FINDINGS: Sixteen controlled before/after studies met our inclusion criteria. Eight studies reported the number of road user deaths: pooled rate ratio 0.63 (95% confidence interval (CI) 0.14 to 2.59). Sixteen studies reported the number of injuries (fatal and non-fatal): pooled rate ratio 0.89 (95% CI 0.80 to 1.00). All studies were in high income countries. CONCLUSION: Area-wide traffic calming in towns and cities has the potential to reduce road traffic injuries. However, further rigorous evaluations of this intervention are needed, especially in low and middle income countries.

Accidents, Traffic↗
PubMed2002

Safety education of pedestrians for injury prevention.

BACKGROUND: Each year about one million people die and about 10 million are seriously injured on the world's roads. Educational measures to teach pedestrians how to cope with the traffic environment are considered to be an essential component of any prevention strategy, and pedestrian education has been recommended in many countries. However, as resources available for road safety are limited, a key question concerns the relative effectiveness of different prevention strategies. OBJECTIVES: To quantify the effectiveness of pedestrian safety education programmes in preventing pedestrian-motor vehicle collisions. SEARCH STRATEGY: We searched the Injuries Group specialised register, Cochrane Controlled Trials Register, TRANSPORT, MEDLINE, EMBASE, ERIC, PSYCHLIT, SPECTR, and the WHO database on the Internet. We checked reference lists of relevant reviews and papers and contacted experts in the field. Most database searching was conducted in 1999. SELECTION CRITERIA: Randomised controlled trials of safety education programmes for pedestrians of all ages. DATA COLLECTION AND ANALYSIS: One reviewer screened records. Two reviewers independently extracted data and assessed methodological quality of trials. Because of differences in the types of interventions and outcome measures used in the trials, meta-analyses were not carried out. MAIN RESULTS: We found 15 randomised-controlled trials of pedestrian safety education programmes, conducted between 1976 and 1997. Methodological quality of the included trials was generally poor. Allocation concealment was adequate in three trials, outcome assessment was blinded in eight, and in most of the studies large numbers of participants were lost to follow-up. Study participants were children in 14 studies and institutionalised adults in one. Eight studies involved the direct education of participants, seven used parents as educators. No trials were conducted in a developing country and there were none of pedestrian safety training in the elderly. None of the included trials assessed the effect of pedestrian safety education on the occurrence of pedestrian injury but six trials assessed the effect on observed behaviour. Some of these trials showed evidence of behavioural change following pedestrian safety education but it is difficult to predict what effect this might have on pedestrian injury risk. REVIEWER'S CONCLUSIONS: Pedestrian safety education can result in improvement in children's knowledge and can change observed road crossing behaviour but whether this reduces the risk of pedestrian motor vehicle collision and injury occurrence is unknown. There is evidence that changes in safety knowledge and observed behaviour decline with time suggesting that safety education must be repeated at regular intervals.

Accidents, Traffic↗
PubMed2001

Timing and volume of fluid administration for patients with bleeding following trauma.

BACKGROUND: Treatment of haemorrhagic shock involves maintaining blood pressure and tissue perfusion until bleeding is controlled. Different resuscitation strategies have been used to maintain the blood pressure in trauma patients until bleeding is controlled. However, while maintaining blood pressure may prevent shock, it may worsen bleeding. OBJECTIVES: To assess the effects of early versus delayed, and larger versus smaller volume of fluid administration in trauma patients with bleeding. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, the specialised register of the Injuries Group, MEDLINE, EMBASE, the National Research Register and the Science Citation Index. We checked reference lists of identified articles and contacted authors and experts in the field. SELECTION CRITERIA: Randomised trials of the timing and volume of intravenous fluid administration in trauma patients with bleeding. Trials in which different types of intravenous fluid were compared were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and assessed trial quality. MAIN RESULTS: We did not combine the results quantitatively because the interventions and patient populations were so diverse. Early versus delayed fluid administration: Three trials reported mortality and two coagulation data. In the first trial (n=598) relative risk (RR) for death with early fluid administration was 1.26 (95% confidence interval of 1.00-1.58). The weighted mean differences (WMD) for prothrombin time and partial thromboplastin time were 2.7 (95% CI 0.9-4.5) and 4.3 (95% CI 1.74-6.9) seconds respectively. In the second trial (n=50) RR for death with early blood transfusion was 5.4 (95% CI 0.3-107.1). The WMD for partial thromboplastin time was 7.0 (95% CI 6.0-8.0) seconds. In the third trial (n=1309) RR for death with early fluid administration was 1.06 (95% CI 0.77-1.47). Larger versus smaller volume of fluid administration: Three trials reported mortality and one coagulation data. In the first trial (n=36) RR for death with a larger volume of fluid resuscitation was 0.80 (95% CI 0.28-22.29). Prothrombin time and Partial thromboplastin time were 14.8 and 47.3 seconds in those who received a larger volume of fluid as compared to 13.9 and 35.1 seconds in the comparison group. In the second trial (n=99) RR for death with a high (100 mm Hg) compared to low (70 mm Hg) systolic blood pressure resuscitation target was 1.02 (95% CI 0.27-3.85). In the third trial (n=25) there were no deaths. REVIEWER'S CONCLUSIONS: We found no evidence from randomised controlled trials to support early or larger volume of intravenous fluid administration in uncontrolled haemorrhage. There is continuing uncertainty about the best fluid administration strategy in bleeding trauma patients. Further randomised controlled trials are needed to establish the most effective fluid resuscitation strategy.

Hemorrhage↗
PubMed2001

Spinal immobilisation for trauma patients.

BACKGROUND: Spinal immobilisation involves the use of a number of devices and strategies to stabilise the spinal column after injury and thus prevent spinal cord damage. The practice is widely recommended and widely used in trauma patients with suspected spinal cord injury in the pre-hospital setting. OBJECTIVES: To quantify the effect of different methods of spinal immobilisation (including immobilisation versus no immobilisation) on mortality, neurological disability, spinal stability and adverse effects in trauma patients. SEARCH STRATEGY: We searched the Cochrane Controlled Trial Register (CCTR), the specialised register of the Cochrane Injuries Group, MEDLINE, EMBASE, CINAHL, PubMed and the National Research Register. We checked reference lists of all articles and contacted experts in the field to identify eligible trials. Manufacturers of spinal immobilisation devices were also contacted for information. SELECTION CRITERIA: Randomised controlled trials comparing spinal immobilisation strategies in trauma patients with suspected spinal cord injury. Trials in healthy volunteers were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied eligibility criteria to trial reports and extracted data. MAIN RESULTS: We found no randomised controlled trials of spinal immobilisation strategies in trauma patients. REVIEWER'S CONCLUSIONS: We did not find any randomised controlled trials that met the inclusion criteria. The effect of spinal immobilisation on mortality, neurological injury, spinal stability and adverse effects in trauma patients remains uncertain. Because airway obstruction is a major cause of preventable death in trauma patients, and spinal immobilisation, particularly of the cervical spine, can contribute to airway compromise, the possibility that immobilisation may increase mortality and morbidity cannot be excluded. Large prospective studies are needed to validate the decision criteria for spinal immobilisation in trauma patients with high risk of spinal injury. Randomised controlled trials in trauma patients are required to establish the relative effectiveness of alternative strategies for spinal immobilisation.

Humans↗
PubMed2001

Advanced trauma life support training for ambulance crews.

BACKGROUND: There is an increasing global burden of disease from injuries. Models of trauma care initially developed in high-income countries are also being adopted in low and middle-income countries (LMIC). Amongst these ambulance crews with Advanced Life Support (ALS) training are being promoted in LMIC as a strategy for improving outcomes for victims of trauma. However there is controversy as to the effectiveness of this health service intervention, and the evidence has yet to be rigorously appraised. OBJECTIVES: To quantify the effectiveness of ambulance crews with ALS training versus crews with any other level of training in reducing mortality and morbidity in trauma patients. SEARCH STRATEGY: We searched the Cochrane Controlled Trial Register (CCTR), the specialised register of the Cochrane Injuries Group, MEDLINE, EMBASE, CINAHL, PubMed and the National Research Register. We checked references of background papers and contacted authors to identify additional published or unpublished data. SELECTION CRITERIA: Randomised controlled trials, quasi-randomised controlled trials and controlled before-and-after studies comparing effectiveness of ambulance crews with ALS training versus crews with any other levels of training in reducing mortality and morbidity in trauma patients. Studies which compared crews staffed by physicians versus others were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied eligibility criteria to trial reports for inclusion and extracted data. MAIN RESULTS: We found one randomised controlled trial, which included 16 trauma cases. However, outcome data were added to the main non-randomised cohort in the analysis, and data on these 16 cases are not yet available. REVIEWER'S CONCLUSIONS: In the absence of evidence of the effectiveness of advanced life support, strong argument could be made that it should not be promoted outside the context of a properly concealed and otherwise rigorously conducted randomised controlled trial.

Controlled Clinical Trials as Topic↗
PubMed2000

Size and quality of randomised controlled trials in head injury: review of published studies.

OBJECTIVE: To assess whether trials in head injury are large enough to avoid moderate random errors and designed to avoid moderate biases. DESIGN: All randomised controlled trials on the treatment and rehabilitation of patients with head injury published before December 1998 were surveyed. Trials were identified from electronic databases, by hand searching journals and conference proceedings, and by contacting researchers. Data were extracted on the number of participants, quality of concealment of allocation, use of blinding, loss to follow up, and types of participants, interventions, and outcome measures. RESULTS: 279 reports were identified, containing information on 208 separate trials. The average number of participants per trial was 82, with no evidence of increasing size over time. The total number of randomised participants in the 203 trials in which size was reported was 16 613. No trials were large enough to detect reliably a 5% absolute reduction in the risk of death or disability, and only 4% were large enough to detect an absolute reduction of 10%. Concealment of allocation was adequate in 22 and inadequate or unclear in 25 of the 47 (23%) in which it was reported. Of 126 trials assessing disability, 111 reported the number of patients followed up, and average loss to follow up was 19%. Of trials measuring disability, 26 (21%) reported that outcome assessors were blinded. CONCLUSIONS: Randomised trials in head injury are too small and poorly designed to detect or refute reliably moderate but clinically important benefits or hazards of treatment. Limited funding for injury research and unfamiliarity with issues of consent may have been important obstacles.

Bias↗
PubMed2000

Colloids versus crystalloids for fluid resuscitation in critically ill patients.

BACKGROUND: Colloid solutions are widely used in fluid resuscitation of critically ill patients. There are several choices of colloid and there is ongoing debate about the relative effectiveness of colloids compared to crystalloid fluids. OBJECTIVES: To assess the effects on mortality of colloids compared to crystalloids for fluid resuscitation in critically ill patients. SEARCH STRATEGY: We searched the Injuries Group specialised register, Cochrane Controlled Trials Register, MEDLINE, EMBASE and BIDS Index to Scientific and Technical Proceedings and checked the reference lists of trials and review articles. SELECTION CRITERIA: All randomised and quasi-random trials of colloids compared to crystalloids, in patients requiring volume replacement. Cross-over trials and trials in pregnant women and neonates were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted data and rated quality of allocation concealment. Trials with a 'double-intervention' such as those, which compared colloid in hypertonic crystalloid to isotonic crystalloid, were analysed separately. The analysis was stratified according to colloid type and quality of allocation concealment. MAIN RESULTS: Colloids compared to crystalloids: Albumin or plasma protein fraction: Eighteen trials reported data on mortality, including a total of 641 patients. The pooled relative risk from these trials was 1.52 (95% confidence interval 1.08 to 2.13). The risk of death in the albumin treated group was 6% higher than in the crystalloid treated group (1% to 11%). When the trial with poor quality allocation concealment was excluded the pooled relative risk was 1.34 (0.95 to 1.89). Hydroxyethylstarch: Seven trials compared hydroxyethylstarch with crystalloids including a total of 197 randomised participants. The pooled relative risk was 1.16 (0.68 to 1.96). Modified gelatin: Four trials compared modified gelatin with crystalloid including a total of 95 randomised participants. The pooled relative risk was 0.50 (0. 08 to 3.03). Dextran: Eight trials compared dextran with a crystalloid including a total of 668 randomised participants. The pooled relative risk was 1.24 (0.94 to 1.65). Colloids in hypertonic crystalloid compared to isotonic crystalloid: Eight trials compared dextran in hypertonic crystalloid with isotonic crystalloid, including 1283 randomised participants. The pooled relative risk was 0.88 (0.74 to 1.05). REVIEWER'S CONCLUSIONS: There is no evidence from randomised controlled trials that resuscitation with colloids reduces the risk of death compared to crystalloids in patients with trauma, burns and following surgery. As colloids are not associated with an improvement in survival, and as they are more expensive than crystalloids, it is hard to see how their continued use in these patient types can be justified outside the context of randomised controlled trials.

Colloids↗
PubMed2000

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

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 Controlled Trials Register, 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 November 1999. 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. We assessed publication bias using the regression test for funnel plot asymmetry. MAIN RESULTS: We found 30 trials meeting the inclusion criteria and reporting death as an outcome. There were 156 deaths among 1419 trial participants. For each patient category the risk of death in the albumin treated group was higher than in the comparison group. For hypovolaemia the relative risk of death following albumin administration was 1.46 (95% confidence interval 0.97 to 2.22), for burns the relative risk was 2.40 (1.11 to 5.19), and for hypoalbuminaemia the relative risk was 1.69 (1.07 to 2.67). The pooled relative risk of death with albumin administration was 1.68 (1.26 to 2.23). Overall, the risk of death in patients receiving albumin was 14% compared to 8% in the control groups, an increase in the risk of death of 6% (3% to 9%). These data suggest that for every 17 critically ill patients treated with albumin there is one additional death. REVIEWER'S CONCLUSIONS: There is no evidence that albumin administration reduces the risk of death in critically ill patients with hypovolaemia, burns or hypoalbuminaemia, and a strong suggestion that it may increase the risk of death. These data suggest that the use of human albumin in critically ill patients should be urgently reviewed and that it should not be used outside the context of a rigorously conducted randomised controlled trial.

Blood Proteins↗
PubMed2000

Colloid solutions for fluid resuscitation.

BACKGROUND: Colloids are widely used in the replacement of fluid volume, however doubts remain as to their benefits. Different colloids vary in their molecular weight and therefore in the length of time they remain in the circulatory system. Because of this and their other characteristics, they may differ in their safety and efficacy. OBJECTIVES: To compare the effects of different colloid solutions in patients thought to need volume replacement. SEARCH STRATEGY: The Cochrane Injuries Group specialised register, The Cochrane Controlled trials register (all years), MEDLINE (1994-98), EMBASE (1974-98) were searched. Bibliographies of trials retrieved were searched and drug companies manufacturing colloids were contacted for information. SELECTION CRITERIA: Randomised and quasi randomised trials comparing colloid solutions in critically ill and surgical patients thought to need volume replacement. The main outcomes measured were death, amount of whole blood transfused and incidence of adverse reactions. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data and assessed the quality of the trials. MAIN RESULTS: 46 trials met the inclusion criteria, with a total of 2884 participants. Many of the trials were small. In the majority of trials quality was poor or uncertain. Deaths were obtained from 27 trials. Twenty three trials recorded the amount of blood transfused, however quantitative analysis was not possible due to skewness and variable reporting. Thirteen trials recorded adverse reactions, but none occurred. For albumin or PPF versus hydroxyethyl starch (HES) 20 trials reported mortality. The pooled relative risk (RR) was 1.17 (95% CI 0.91, 1.50). For albumin or PPF versus gelatin 3 trials reported mortality. The RR was 0.99 (0.69, 1.42). For gelatin vs HES 3 trials reported mortality, RR was 0.97 (0.65, 1.44). RR was not estimable in the albumin vs dextran, gelatin vs dextran, and HES vs dextran groups. REVIEWER'S CONCLUSIONS: From this review, there is no evidence that one colloid solution is more effective or safe than any other, although the confidence intervals are wide and do not exclude clinically significant differences between colloids. Larger trials of fluid therapy are needed if clinically significant differences in mortality are to be detected or excluded.

Blood Proteins↗