Immediate postoperative oral hydration after caesarean section. Randomised controlled trial comparing oral and intravenous rehydration therapy in children with diarrhoea. Management of meningitis in children with oral fluid restriction or intravenous fluid at maintenance volumes: a randomised trial. Modifying dyspepsia management in primary care: a cluster randomised controlled trial of educational outreach compared with passive guideline dissemination. A randomized trial of increased intravenous hydration in labor when oral fluid is unrestricted. Oral versus intravenous rehydration of moderately dehydrated children: a randomized, controlled trial. The effect of pre-operative oral fluids on morbidity following anaesthesia for minor surgery. Randomised trial of educational visits to enhance use of systematic reviews in 25 obstetric units. Factors associated with failure to publish large randomized trials presented at an oncology meeting.
A study was carried out to assess the effects of immediate postoperative oral rehydration in 51 unpremedicated women undergoing caesarean section under epidural anesthesia. The patients were randomly assigned to 2 groups: group 1 (n = 22)--fasting at least until 24 hours after the end of the operation, and group 2 (n = 29)--receiving immediate oral intake of fluids (water, tea or coffee with sugar) without limitation of quantity. The 2 groups were compared for the occurrence of postoperative nausea and vomiting, onset of peristalsis, rectal gas emission, first bowel movement, and possible complications. The results demonstrate no significant differences between the parturients who drank immediately postoperatively as compared to those in whom oral fluid intake was delayed for 24 hours or more. It is concluded that immediate postoperative oral rehydration had no harmful effect upon peristalsis post-caesarean section. To determine the effectiveness of oral rehydration in children with moderate dehydration caused by gastroenteritis, and to compare the complications of oral and intravenous treatment.
                Randomised controlled trial.
                Emergency department and infectious diseases ward in a large urban teaching hospital.
                111 children aged 3-36 months who had been previously healthy, had had diarrhoea for seven days or less, had clinical signs of dehydration, and were not in shock. Six children were withdrawn because the diagnosis was incorrect (four in oral group, two in intravenous group) and one (oral group) was withdrawn at her parents' request.
                Oral rehydration fluid was given by mouth or nasogastric tube, or both to 52 children. The remaining 52 received intravenous rehydration fluids but were allowed to drink.
                Success or failure of rehydration. Number of times child vomited or passed stool after starting treatment. Time taken to rehydrate.
                Oral treatment failed in two children (failure rate 3.8%, upper 95% confidence limit 11.6%) and intravenous treatment in none. Vomiting was more common in the oral group (p less than 0.01): 26 of 50 children (52%) in the oral group and 11 of 50 (22%) in the intravenous group vomited during rehydration. There was no significant difference between the two treatment groups in the number of stools passed during rehydration (p = 0.09). None of the children had serious complications of treatment.
                Rehydration by mouth or nasogastric tube is a safe and effective treatment for moderately dehydrated children with gastroenteritis. A multi-centre randomised open trial was done to determine whether moderate oral fluid restriction or intravenous fluid at full maintenance volumes would result in a better outcome for children with bacterial meningitis in Papua New Guinea, and what clinical signs could guide fluid management. Children with clinical signs and cerebrospinal fluid suggestive of bacterial meningitis received either breast milk by nasogastric tube at 60% of normal maintenance volumes (n = 172) or intravenous half-normal saline and 5% dextrose at 100% of normal maintenance volumes (n = 174) for the 1st 48 hrs of treatment. An adverse outcome was death or severe neurological sequelae, and a good outcome was defined as intact survival or survival with at worst mild-to-moderate neurological sequelae. The probability of an adverse outcome was 24.7% in the intravenous group and 33.1% in the oral-restricted group, but the difference was not statistically significant (RR 0.75, 0.53-1.04, p = 0.08). Sunken eyes or reduced skin turgor at presentation were risk factors for an adverse outcome (OR 5.70, 95% CI 2.87-11.29) and were most strongly associated with adverse outcome in the fluid-restricted group. Eyelid oedema during treatment was also a risk factor for an adverse outcome (OR 2.54, 95% CI 1.36-4.75) and eyelid oedema was much more common in the intravenous group (26%) than in the restricted group (5%). For many children with bacterial meningitis in less developed countries, moderate fluid restriction is unnecessary and will be harmful; a normal state of hydration should be achieved but over-hydration should be avoided. Giving 100% of normal maintenance fluids, especially with intravenous hypotonic fluid, will lead to oedema in up to one quarter of children with bacterial meningitis. If additional intravenous fluids are required for children with meningitis, an isotonic solution should be used. Quality improvement initiatives in health services rely upon the effective introduction of clinical practice guidelines. However, even well constructed guidelines have little effect unless supported by dissemination and implementation strategies.
                To test the effectiveness of 'educational outreach' as a strategy for facilitating the uptake of dyspepsia management guidelines in primary care.
                A pragmatic, cluster-randomised controlled trial of guideline introduction, comparing educational outreach with postal guideline dissemination alone.
                One-hundred and fourteen general practices (233 general practitioners) in the Salford and Trafford Health authority catchment area in the northwest of England.
                All practices received guidelines by post in July 1997. The intervention group practices began to receive educational outreach three months later. This consisted of practice-based seminars with hospital specialists at which guideline recommendations were appraised, and implementation plans formulated. Seminars were followed up with 'reinforcement' visits after a further 12 weeks. Outcome measures were: (a) the appropriateness of referral for; and (b) findings at, open access upper gastrointestinal endoscopy; (c) costs of GP prescriptions for acid-suppressing drugs, and (d) the use of laboratory-based serological tests for Helicobacter pylori. Data were collected for seven months before and/or after the intervention and analysed by intention-to-treat.
                (a) The proportion of appropriate referrals was higher in the intervention group in the six-month post-intervention period (practice medians: control = 50.0%, intervention = 63.9%, P < 0.05); (b) the proportion of major findings at endoscopy did not alter significantly; (c) there was a greater rise in overall expenditure on acid-suppressing drugs in the intervention as compared with the control group (+8% versus +2%, P = 0.005); and (d) the median testing rate per practice for H pylori in the post-intervention period was significantly greater in the intervention group (four versus O, P < 0.001).
                This study suggests that educational outreach may be more effective than passive guideline dissemination in changing clinical behaviour. It also demonstrates that unpredictable and unanticipated outcomes may emerge. Increased intravenous (IV) hydration is associated with decreased labor duration and oxytocin augmentation in nulliparous women when oral fluid is restricted. The objective of this study was to determine the effect of increased IV hydration on the duration of labor when access to oral fluid was unrestricted.
                Term, nulliparous women with uncomplicated singleton pregnancies were randomly assigned to receive lactated ringers at 250 ml per hour (IV fluid group) throughout active labor or usual care. All women were allowed unrestricted access to oral fluids.
                Eighty women completed the study, 37 in the IV fluid group and 43 in the usual care group. There was no difference in the primary outcome of total duration of labor (9.5 versus 9.4 hours) or in the secondary outcomes of duration of the first stage (7.9 versus 8.0 hours), duration of second stage (1.6 versus 1.4 hours), or rate of oxytocin augmentation (51% versus 44%).
                Increased IV hydration does not decrease labor duration in nulliparous women when access to oral fluid is unrestricted. Dehydration from viral gastroenteritis is a significant pediatric health problem. Oral rehydration therapy (ORT) is recommended as first-line therapy for both mildly and moderately dehydrated children; however, three quarters of pediatric emergency medicine physicians who are very familiar with the American Academy of Pediatrics recommendations for ORT still use intravenous fluid therapy (IVF) for moderately dehydrated children.
                To test the hypothesis that the failure rate of ORT would not be >5% greater than the failure rate of IVF. Secondary hypotheses were that patients in the ORT group will (1) require less time initiating therapy, (2) show more improvement after 2 hours of therapy, (3) have fewer hospitalizations, and (4) prefer ORT for future episodes of dehydration.
                A randomized, controlled clinical trial (noninferiority study design) was performed in the emergency department of an urban children's hospital from December 2001 to April 2003. Children 8 weeks to 3 years old were eligible if they were moderately dehydrated, based on a validated 10-point score, from viral gastroenteritis. Patients were randomized to receive either ORT or IVF during the 4-hour study. Treating physicians were masked and assessed all patients before randomization at 2 and 4 hours of therapy. Successful rehydration at 4 hours was defined as resolution of moderate dehydration, production of urine, weight gain, and the absence severe emesis (> or =5 mL/kg).
                Seventy-three patients were enrolled in the study: 36 were randomized to ORT and 37 were randomized to IVF. Baseline dehydration scores and the number of prior episodes of emesis and diarrhea were similar in the 2 groups. ORT demonstrated noninferiority for the main outcome measure and was found to be favorable with secondary outcomes. Half of both the ORT and IVF groups were rehydrated successfully at 4 hours (difference: -1.2%; 95% confidence interval [CI]: -24.0% to 21.6%). The time required to initiate therapy was less in the ORT group at 19.9 minutes from randomization, compared with 41.2 minutes for the IVF group (difference: -21.2 minutes; 95% CI: -10.3 to -32.1 minutes). There was no difference in the improvement of the dehydration score at 2 hours between the 2 groups (78.8% ORT vs 80% IVF; difference: -1.2%; 95% CI: -20.5% to 18%). Less than one third of the ORT group required hospitalization, whereas almost half of the IVF group was hospitalized (30.6% vs 48.7%, respectively; difference: -18.1%; 95% CI: -40.1% to 4.0%). Patients who received ORT were as likely as those who received IVF to prefer the same therapy for the next episode of gastroenteritis (61.3% vs 51.4%, respectively; difference: 9.9%; 95% CI: -14% to 33.7%).
                This trial demonstrated that ORT is as effective as IVF for rehydration of moderately dehydrated children due to gastroenteritis in the emergency department. ORT demonstrated noninferiority for successful rehydration at 4 hours and hospitalization rate. Additionally, therapy was initiated more quickly for ORT patients. ORT seems to be a preferred treatment option for patients with moderate dehydration from gastroenteritis. Postoperative morbidity and serum osmolality were studied in 46 patients who were encouraged to drink water until 3 h pre-operatively and 49 receiving the normal fasting regimen prior to minor surgery. There was significantly less thirst in the postoperative period in those patients allowed to drink and subjectively better recovery than after previous anaesthesia. There was no morbidity from ingestion of up to 11 of water 2.5 h pre-operatively. Although there was only a moderate improvement in postoperative recovery we feel that allowing patients to drink water pre-operatively improves patient comfort, especially since patients may have to fast for much longer than guidelines recommend, simply because of the traditional organisation of operating lists. To evaluate the effectiveness of an educational visit to help obstetricians and midwives select and use evidence from a Cochrane database containing 600 systematic reviews.
                Randomised single blind controlled trial with obstetric units allocated to an educational visit or control group.
                25 of the 26 district general obstetric units in two former NHS regions.
                The senior obstetrician and midwife from each intervention unit participated in educational visits. Clinical practices of all staff were assessed in 4508 pregnancies.
                Single informal educational visit by a respected obstetrician including discussion of evidence based obstetrics, guidance on implementation, and donation of Cochrane database and other materials.
                Rates of perineal suturing with polyglycolic acid, ventouse delivery, prophylactic antibiotics in caesarean section, and steroids in preterm delivery, before and 9 months after visits, and concordance of guidelines with review evidence for same marker practices before and after visits.
                Rates varied greatly, but the overall baseline mean of 43% (986/2312) increased to 54% (1189/2196) 9 months later. Rates of ventouse delivery increased significantly in intervention units but not in control units; there was no difference between the two types of units in uptake of other practices. Pooling rates from all 25 units, use of antibiotics in caesarean section and use of polyglycolic acid sutures increased significantly over the period, but use of steroids in preterm delivery was unchanged. Labour ward guidelines seldom agreed with evidence at baseline; this hardly improved after visits. Educational visits cost pound860 each (at 1995 prices).
                There was considerable uptake of evidence into practice in both control and intervention units between 1994 and 1995. Our educational visits added little to this, despite the informal setting, targeting of senior staff from two disciplines, and donation of educational materials. Further work is needed to define cost effective methods to enhance the uptake of evidence from systematic reviews and to clarify leadership and roles of senior obstetric staff in implementing the evidence. Large clinical trials are the criterion standard for making treatment decisions, and nonpublication of the results of such trials can lead to bias in the literature and contribute to inappropriate medical decisions.
                To determine the rate of full publication of large randomized trials presented at annual meetings of the American Society of Clinical Oncology (ASCO), quantify bias against publishing nonsignificant results, and identify factors associated with time to publication.
                Survey of 510 abstracts from large (sample size, > or =200), phase 3, randomized controlled trials presented at ASCO meetings between 1989 and 1998. Trial results were classified as significant (P< or =.05 for the primary outcome measure) or nonsignificant (P>.05 or not reported), and the type of presentation and sponsorship were identified. Subsequent full publication was identified using a search of MEDLINE and EMBASE, completed November 1, 2001; the search was updated in November 2002, using the Cochrane Register of Controlled Trials. Authors were contacted if the searches did not find evidence of publication.
                Publication rate at 5 years; time from presentation to full publication.
                Of 510 randomized trials, 26% were not published in full within 5 years after presentation at the meeting. Eighty-one percent of the studies with significant results had been published by this time compared with 68% of the studies with nonsignificant results (P<.001). Studies with oral or plenary presentation were published sooner than those not presented (P =.002), and studies with pharmaceutical sponsorship were published sooner than studies with cooperative group sponsorship or studies for which sponsorship was not specified (P =.02). These factors remained significant in a multivariable model. The most frequent reason cited by authors for not publishing was lack of time, funds, or other resources.
                A substantial number of large phase 3 trials presented at an international oncology meeting remain unpublished 5 years after presentation. Bias against publishing nonsignificant results is a problem even for large randomized trials. Nonpublication breaks the contract that investigators make with trial participants, funding agencies, and ethics boards.
There was no evidence from the limited randomised trials reviewed, to justify a policy of withholding oral fluids after uncomplicatedcaesarean section. Further research is justified.