Comparison of the use of a foot pump with the use of low-molecular-weight heparin for the prevention of deep-vein thrombosis after total hip replacement. A prospective, randomized trial

We conducted a prospective, randomized trial to compare the safety and effectiveness of the A-V Impulse System foot pump with that of low-molecular-weight heparin for reducing the prevalence of deep-vein thrombosis after total hip replacement. Of 290 patients who were to have a primary total hip replacement, 143 were randomized to receive enoxaparin (forty milligrams daily) for seven days after the operation and 147, to use the foot pump for seven days. The primary outcome measure was the prevalence of deep-vein thrombosis, as determined by venography on the sixth, seventh, or eighth postoperative day. Secondary outcome measures included transfusion requirements, intraoperative blood loss, postoperative drainage, blood-loss index, appearance of the site of the wound according to a subjective visual-analog scale, and swelling of the thigh. The patients' compliance with the regimen for use of the foot pump was monitored with an internal timing device, and their acceptance of the device was assessed with a questionnaire. Symptoms consistent with pulmonary embolism were investigated with ventilation-perfusion scanning. The patients were contacted later for detection of symptoms of venous thromboembolism that may have occurred during the first three months after discharge from the hospital. Venography was performed on 274 patients: 136 who used the foot pump and 138 who received enoxaparin. Deep-vein thrombosis was detected in twenty-four (18 per cent) of the patients who used the foot pump compared with eighteen patients (13 per cent) who received enoxaparin (95 per cent confidence interval for the difference in proportions, -3.9 to +13.0 per cent). Thrombosis in the calf was found in seven patients (5 per cent) in the former group compared with six patients (4 per cent) in the latter (95 per cent confidence interval for the difference, -4.2 to +5.8 per cent), and proximal thrombosis was observed in seventeen patients (13 per cent) in the former group compared with twelve patients (9 per cent) in the latter (95 per cent confidence interval for the difference, -3.5 to +11.1 per cent). None of these differences was significant. No patient in either group had major proximal deep-vein thrombosis; all proximal thrombi were isolated entities involving the femoral valve cusp and were of unknown importance. One patient who used the foot pump had a non-fatal pulmonary embolism. One patient who received enoxaparin had a symptomatic deep-vein thrombosis during hospitalization. Two patients (one from each group [0.7 per cent]) were readmitted to the hospital because of a symptomatic deep-vein thrombosis despite normal venographic findings at the time of discharge. There was no difference in the transfusion requirements or the intraoperative blood loss between the two groups. There were more soft-tissue side effects in the patients who received enoxaparin than in those who used the foot pump: there was more bruising of the thigh and oozing of the wound (p < 0.001 for each), postoperative drainage (578 compared with 492 milliliters; p = 0.014), and swelling of the thigh (twenty compared with ten millimeters; p = 0.03). Of 124 patients who used the foot pump and were asked about the acceptability of the device, fourteen (11 per cent) said that it was uncomfortable, twenty-one (17 per cent) reported sleep disturbance, and four (3 per cent) stated that they had stopped using the device. Conversely, ten (8 per cent) found it relaxing. We concluded that the foot pump is a suitable alternative to low-molecular-weight heparin for prophylaxis against thromboembolism after total hip replacement and that it produces fewer soft-tissue side effects. Tolerance of the device is a problem for some patients.     

A randomised controlled trial of strategies to prompt attendance for a Pap smear

OBJECTIVE: To assess the comparative efficacy, by randomised controlled trial, of three interventions designed to encourage "at risk" women to have a Pap smear: an educational pamphlet; letters inviting attendance at a women's health clinic; and letters from physicians. METHODS: Subjects at risk for cervical cancer who had not been adequately screened were identified by a random community survey and randomly allocated to one of the intervention groups or a control group. Six months after intervention implementation, a follow up survey assessed subsequent screening attendance. Self report was validated by comparison with a national screening data base. RESULTS: A significantly greater proportion of women (36.9%) within the group receiving a physician letter reported screening at follow up than in any other group (P = 0.012). The variables most strongly predicting screening attendance were: age, perceived frequency of screening required, use of oral contraceptives, and allocation to receive the physician letter intervention. CONCLUSIONS: The relative efficacy of the GP letter in prompting screening attendance shows that this strategy is worthy of further investigation. There remains a need to examine the barriers to screening for older women, and to develop tailored strategies for this population.     

A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women

Using annual bite-wing radiographs, the incidence and progression of approximal caries (4d-7m) were assessed longitudinally in teenagers and adolescents whose treatment had been based on remineralizing rather than restorative strategies. A closed cohort of 536 children initially was followed from 11 to 22 years of age. The scoring system was: 0 = no visible radiolucency; 1-2 = radiolucency in the enamel up to the enamel-dentin border; 3 = radiolucency with a broken enamel-dentin border but with no obvious progression in the dentin; 4 = radiolucency with obvious spread in the outer half of the dentin, and 5 = radiolucency in the inner half of the dentin. Caries rates were estimated as the number of new lesions/100 tooth surface-years, and the Kaplan-Meier estimate was used to calculate the cumulative survival time of each approximal surface. Three events were used: the transitions from states 0 to 2, 2 to 4 and 3 to 4. The results showed a considerable variation between the surfaces in both caries rates and survival time. For all surfaces combined, the median caries rate from state 0 to 2 was 3.9 new lesions/100 tooth surface-years; from state 2 to 4, the rate was 5.4, and from state 3 to 4 it was 20.3. Of the sound surfaces (state 0), 75% survived 6.3 years without reaching state 2. Given state 2, 75% survived 4.8 years without reaching the outer half of the dentin (state 4), while given a lesion at the enamel-dentin border (state 3), 75% survived 1.3 years without doing the same. The median survival time of lesions from state 3 to 4 was 3.1 years. The group with DMFSappr>1 at the age of 11-12 years had a risk of new approximal enamel lesions (state 0-2) that was 2.5 times greater than that of the group with DMFSappr = 0-1.     

The effect of octreotide on gastric emptying at a dosage used to prevent complications after pancreatic surgery: a randomised, placebo controlled study in volunteers

BACKGROUND: Octreotide is used in many centres to prevent complications after pancreatic surgery. Delayed gastric emptying is a another complication occurring in around 30% of patients after pancreatoduodenectomy (PD) and causes prolonged hospital stay. The influence of octreotide on this complication is doubtful. AIMS: To assess the effect of octreotide, at the clinical dosage used after pancreatic surgery, on gastric emptying in healthy volunteers. SUBJECTS AND METHODS: Eight healthy male volunteers (mean age 22.5 years) participated in this double blind, placebo controlled study. On day 1 subjects received 100 micrograms of octreotide or placebo subcutaneously, three times daily and on day 2, one hour after the fourth injection, gastric emptying, postprandial cholecystokinin (CCK) release, and mouth to caecum transit time (MCTT) were measured. This protocol was repeated after one week, in a crossover design. On the test day subjects received a liquid test meal (1.57 MJ/300 ml) and gastric emptying measurements were performed with applied potential tomography, an non-invasive, validated technique which measures gastric emptying through impedance differences. From the gastric emptying curves, lag time, t50, and postlag emptying rate were measured. MCTT was measured using the hydrogen breath test. RESULTS: Lag time decreased from 29.6 (6.3) (mean (SEM)) to 12.2 (4.6) minutes (p < 0.05) during octretide treatment; t50 decreased from 87.8 (12.0) to 47.5 (8.2) minutes (p < 0.02) and there was a trend towards an increased postlag emptying rate (0.8 to 1.6% per minute; p = 0.07). MCTT increased from 150 (12.7) to 229 (17.9) minutes during octreotide treatment (p < 0.01). Octreotide suppressed postprandial CCK release (p < 0.05). CONCLUSIONS: MCTT was delayed by octreotide, suggesting impairment of small bowl treatment. Octreotide administered at the clinical dosage for pancreatic surgery accelerates gastric emptying, mainly by shortening the lag time. Suppression of postprandial CCK release may be involved in this process. Octreotide administration is therefore not a contributing factor in the pathogenesis of delayed postoperative gastric emptying after PD and might even play a role in preventing this complication.     

A randomised controlled trial of a dietary advice program for relatives of heart attack victims

OBJECTIVE: To compare two interventions for reducing dietary fat intake in first degree relatives of recent heart attack victims. DESIGN: A randomised controlled trial comparing a low cost mail-out advice program; referral to a general practitioner (GP); and no intervention (control group). PARTICIPANTS: Adult children or siblings, aged less than 70 years, of survivors of definite or suspected heart attack who had been admitted to hospitals in the Lower Hunter Region of New South Wales. MAIN OUTCOME MEASURES: Dietary fat intake (evaluated with a validated short questionnaire) and measurement of blood cholesterol levels at six months. RESULTS: Of the 342 relatives who participated (36% of those invited), 109, 120 and 113, respectively, were randomly assigned to receive a mail-out intervention, advice from their GP or to be part of a control group. The six-month follow-up questionnaire was completed by only 59% of those in the mail-out intervention group compared with 71% of the GP group and 77% of the control group. Younger participants, cigarette smokers and children (compared with siblings) were less likely to return a follow-up questionnaire. The mail-out group showed a statistically significant 20% reduction in self-reported dietary fat intake, but this was not seen in either the GP group or the controls. The low response rate meant the study had insufficient power to detect hypothesised changes in blood cholesterol. CONCLUSION: Because of the poor response rate and possible biases from a differential response to follow-up, we conclude that this low intensity intervention for relatives of people with recent heart attack produces only a modest improvement in reported dietary fat intake. Alternative strategies may be more effective in reducing the risk of heart disease.     

The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: A randomized controlled trial.

The present study examined the impact of a brief version of an acceptance-based treatment (acceptance and commitment therapy; ACT) that teaches patients to accept unavoidable private events; to identify and focus on actions directed toward valued goals; and to defuse from odd cognition, just noticing thoughts rather than treating them as either true or false. Eighty inpatient participants with positive psychotic symptoms were randomly assigned to treatment as usual (TAU) or to 4 sessions of ACT plus TAU. ACT participants showed significantly higher symptom reporting and lower symptom believability and a rate of rehospitalization half that of TAU participants over a 4-month follow-up period. The same basic pattern of results was seen with all participant subgroups except delusional participants who denied symptoms. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Effect of community based management in failure to thrive: randomised controlled trial

OBJECTIVE: To evaluate the effectiveness of a health visitor led intervention for failure to thrive in children under 2 years old. DESIGN: Controlled trial, randomised by primary care practice. SETTING: Newcastle upon Tyne health district. INTERVENTION: Structured health visitor management, with dietetic, paediatric, and social work input as required. SUBJECTS: 229 children (120 in intervention practices and 109 in control practices) were identified as failing to thrive by population screening during the first 2 years of life. Follow up was by home visit of a research nurse and review of the childrens' records at age 3 years. MAIN OUTCOME MEASURES: Follow up weight and height and number of routinely collected weights. RESULTS: 95 of the 97 families offered intervention completed at least the initial assessment. At follow up, 187 (82%) records were reviewed, and these suggested that 15 (16%) controls were lost to follow up immediately after the screening weight was taken compared with only one child in the intervention group. In the 134 (58%) families who consented to home visits, children in the intervention group were significantly heavier and taller and were reported to have better appetites than childen in the control group, although both groups were equally satisfied by the services they had received. When the children were last weighed, 91 (76%) in the intervention group had recovered from their failure to thrive compared with 60 (55%) in the control group (P<0.001). CONCLUSION: In failure to thrive, health visitor intervention, with limited specialist support, can significantly improve growth compared with conventional management.     

A randomised placebo controlled trial of oral misoprostol in the third stage of labour

OBJECTIVE: To compare oral misoprostol 400 microg with placebo in the routine management of the third stage of labour. DESIGN: A double-blind placebo controlled trial. Setting The labour ward of an academic hospital in Johannesburg, South Africa with 7000 deliveries per annum. PARTICIPANTS: Low-risk women expected to deliver vaginally. METHODS: Women in labour were randomly allocated to receive either misoprostol 400 microg orally or placebo after the birth. Conventional oxytocics were given immediately if blood loss was thought to be more than usual. Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan. Side effects were recorded. MAIN OUTCOME MEASURES: Measured blood loss > or = 1000 ml within the first hour after birth. Use of additional oxytocics. RESULTS: The groups were well matched. Measured blood loss > or = 1000 ml occurred in 15/250 (6%) after misoprostol and 23/250 (9%) after placebo (relative risk 0.65; 95% confidence interval 0.35-1.22). The difference may have been reduced by the greater use of conventional oxytocics in the placebo group, which was statistically significant for intravenous oxytocin infusion (2.8% vs 8.4%, relative risk 0.33, 95% confidence interval 0.14-0.77). Shivering was more common in the misoprostol group (19% vs 5%, relative risk 3.69; 95% confidence interval 2.05-6.64). CONCLUSIONS: Shivering has been shown in this study to be a specific side effect of misoprostol administered orally in the puerperium. No serious side effects were noted. Misoprostol shows promise as a method of preventing postpartum haemorrhage. Because of the potential benefits for childbearing women, particularly those in developing countries, further research to determine its effects with greater certainty should be expedited.     

Randomized controlled trial of an intervention to prevent adherence failure among HIV-infected patients initiating antiretroviral therapy.

Objective: Compare the efficacy of a multicomponent social support intervention to standard-of-care counseling on medication adherence among HIV-infected patients initiating antiretroviral therapy. Design: Randomized controlled trial. Generalized estimating equations tested for differences in the percentage of participants achieving 90% adherence. Main Outcome Measures: Pill-taking, electronically monitored over 6 consecutive months; plasma viral load (VL), assessed at 3 and 6 months following initiation of therapy. Results: Of 226 participants who were randomized and began the trial, 87 (38%) were lost to the study by 6 months. The proportion of adherent participants declined steadily over time, with no time by group interaction. Sustained adherence was associated with increased odds of achieving an undetectable VL (OR = 1.78; 95% CI = 1.01, 3.13). In intention-to-treat analyses, a larger proportion of the intervention group than the control group was adherent (40.15% vs. 27.59%, p = .02) and achieved an undetectable VL p = .04). However, the majority of participants who remained on study experienced some reduction in VL (≥ 1-log drop or undetectable), regardless of experimental condition. Conclusion: The multicomponent social support intervention significantly improved medication adherence over standard-of-care counseling; evidence for improved virologic outcomes was inconsistent. Early discontinuation of care and treatment may be a greater threat to the health of HIV patients than imperfect medication-taking. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Low molecular weight heparin and unfractionated heparin for prevention of thrombo-embolism in general surgery: a meta-analysis of randomised clinical trials

Low molecular weight heparin (LMWH), unfractionated heparin (UFH) and warfarin were compared with respect to efficacy and safety in the prevention of thrombo-embolism in general surgery. Meta-analysis (MA) with a priori definition of the MA protocol was used to combine the results from randomised trials with patients who underwent general surgery and deep-vein thrombosis (DVT) prophylaxis with LMWH, UFH or warfarin. Forty-four studies were identified for assessment and 33 were included, however, none for warfarin. For efficacy (DVT and pulmonary embolism) and major bleeding, no significant difference between the LMWH- and UFH-treated groups was demonstrated. The relative risk of minor bleedings for LMWH versus UFH was 0.75 (0.64-0.88; 95% confidence interval) and is significant (p < 0.05). Within the limitations of the MA, LMWH and UFH did not differ significantly in terms of prevention of thrombo-embolism, but LMWH had a significantly better safety profile. On this basis, LMWH may be preferable to UFH in the prevention of thrombo-embolism in general surgery.     

The use of patient-controlled transcutaneous electronic nerve stimulation (TENS) to decrease the discomfort of regional anaesthesia in dentistry: a randomised controlled clinical trial

OBJECTIVE: To compare the use of topical anaesthesia and transcutaneous electronic nerve stimulation (TENS) as means of reducing the discomfort of inferior dental block injections. METHODS: One hundred adult dental patients received 2% lignocaine with 1:80,000 adrenaline for long buccal and inferior dental block anaesthesia. The long buccal injections were given first with no prior mucosal preparation. Patients received inferior dental blocks after one of the following mucosal preparations: (1) no pretreatment; (2) a 2 min application of 20% benzocaine topical anaesthetic; (3) application of patient-controlled TENS at the injection site. Patients scored injection discomfort after each administration on a 100 mm visual analogue scale. RESULTS: The discomfort of the long buccal injection did not differ between the three groups of patients (F2,97 = 1.0). There were significant differences in the pain scores for the inferior dental block injections (F2,97 = 5.3; p < 0.01). Injection discomfort following TENS was less than that following no pretreatment (p < 0.01) and after topical anaesthetic application (p < 0.05). The use of topical anaesthesia did not produce a significant change in injection discomfort compared with no pretreatment. CONCLUSION: The use of TENS reduces injection discomfort during inferior dental block anaesthesia.     

The management of elderly patients with femoral fractures. A randomised controlled trial of early intervention versus standard care

Retroperitoneal fibrosis is an uncommon collagen vascular disease. Back pain with no specific radiation pattern is a common finding. Evaluation usually begins with an abdominal CT scan or MRI. The finding of fibrous periaortic tissue in conjunction with an elevated erythrocyte sedimentation rate supports the diagnosis. A biopsy is necessary to confirm the diagnosis and exclude malignancy. Sometimes retroperitoneal fibrosis can progress to the point of causing bilateral ureteral obstruction leading to acute renal failure. Corticosteroids, in conjunction with surgery when needed, are the mainstay of therapy.     

Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women

OBJECTIVE: To assess the effectiveness of a home exercise programme of strength and balance retraining exercises in reducing falls and injuries in elderly women. DESIGN: Randomised controlled trial of an individually tailored programme of physical therapy in the home (exercise group, n = 116) compared with the usual care and an equal number of social visits (control group, n = 117). SETTING: 17 general practices in Dunedin, New Zealand. SUBJECTS: Women aged 80 years and older living in the community and registered with a general practice in Dunedin. MAIN OUTCOME MEASURES: Number of falls and injuries related to falls and time between falls during one year of follow up; changes in muscle strength and balance measures after six months. RESULTS: After one year there were 152 falls in the control group and 88 falls in the exercise group. The mean (SD) rate of falls was lower in the exercise than the control group (0.87 (1.29) v 1.34 (1.93) falls per year respectively; difference 0.47; 95% confidence interval 0.04 to 0.90). The relative hazard for the first four falls in the exercise group compared with the control group was 0.68 (0.52 to 0.90). The relative hazard for a first fall with injury in the exercise group compared with the control group was 0.61 (0.39 to 0.97). After six months, balance had improved in the exercise group (difference between groups in change in balance score 0.43 (0.21 to 0.65). CONCLUSIONS: An individual programme of strength and balance retraining exercises improved physical function and was effective in reducing falls and injuries in women 80 years and older.     

Clonidine for major vascular surgery in hypertensive patients: a double-blind, controlled, randomized study

The utility of clonidine for hypertensive patients presenting for major vascular procedures remains debatable. Twenty-one hypertensive patients presenting for aortic surgery were given clonidine (n = 11) or placebo (n = 10) in a double-blind, randomized manner. Clonidine was administered 6 micrograms/kg per os 120 min before induction of anesthesia and 3 micrograms/kg intravenously (i.v.) over 60 min from aortic declamping to skin closure. Anesthesia was induced with alfentanil 20 micrograms/kg, midazolam, and atracurium and maintained with nitrous oxide 70%, an alfentanil infusion (0.25 microgram.kg-1. min-1), and isoflurane. Anesthetic requirements, circulatory variables, interventions, and isoproterenol dose-response curves (pre- and postoperatively) were determined. Plasma concentrations of clonidine, alfentanil, and vasoactive hormones were measured. When the clonidine group was compared with the placebo group, (a) isoflurane, alfentanil, and midazolam requirements were reduced by 38%, 42%, and 41%, respectively (P = 0.04, 0.03, 0.0002, respectively); (b) supplemental circulatory and anesthetic adjustments were reduced by 51% (P = 0.0006); (c) interventions with vasopressors were not significantly increased (placebo: two; clonidine: five); (d) systolic and mean arterial pressures and heart rate were reduced; (e) increases in norepinephrine, epinephrine, and plasma renin activity were suppressed, whereas vasopressin surge was attenuated; and (f) chronotropic response to isoproterenol was unaffected. Clonidine was effective in reducing anesthetic requirements and in improving circulatory stability in hypertensive patients presenting for major vascular procedures.     

Current practice in the preoperative evaluation of patients undergoing major vascular surgery: a survey of cardiovascular anesthesiologists

Comparison was made of the masseter muscle reflexes evoked by tapping on osseointegrated single-tooth aluminum oxide implants, and on natural teeth in nine patients. Tapping on eight out of nine patients evoked an inhibitory masseter muscle reflex, whereas tapping on all of the natural teeth evoked an inhibitory reflex. The threshold for this reflex was clearly elevated in implants compared to natural teeth. The pathway for the impulses responsible for this reflex and the clinical implications of the elevated threshold are discussed.     

A practice-based randomised controlled trial of the efficacy of an electric and a manual toothbrush on gingival health in patients with fixed orthodontic appliances

Twenty-three specimens from immediately anteroinferior to the mental foramen were obtained from male and female, dentate and edentate, human mandibles. Planoparallel 80 microm thick sections were prepared from the mandibular specimens and computerized quantitative microradiography undertaken, which allowed the production of mineralization frequency distribution curves and mean mineralization. No differences in mean mineralization with age, sex, presence or absence of dentition were found, but mineralization distribution curves indicated differences between males and females. Within the age range and small sample size examined (40-90 years) there were no age-related differences. There was a lower level of mineralization distribution in the edentulous than the dentate mandible.     

A common mutation in the methylenetetrahydrofolate reductase gene (C677T) increases the risk for deep-vein thrombosis in patients with mutant factor V (factor V:Q506)

Hyperhomocysteinemia is a frequent risk factor for deep-vein thrombosis. A common mutation (C677T) in the gene encoding for methylenetetrahydrofolate reductase (MTHFR) is responsible, in the homozygous state, for decreased enzyme activity and mild hyperhomocysteinemia and is associated with increased risk for cardiovascular disease. We studied the prevalence of C677T MTHFR in 77 patients with deep-vein thrombosis and in 154 age- and sex-matched healthy control subjects. In the same individuals, we also evaluated the frequency of the coexistence of C677T MTHFR with mutant factor V:Q506, a common risk factor for deep-vein thrombosis. Sixteen patients (20.8%) and 35 control subjects (22.7%) were homozygous for the C677T MTHFR mutation (odds ratio [OR] = 0.8, 95% confidence interval [CI] = 0.4-2.0). Sixteen patients (20.8%) and 4 control subjects (2.6%) had factor V:Q506; of them, 10 patients and 3 control subjects had isolated factor V:Q506 (adjusted OR = 6.3, 95% CI = 1.6-25.3) and 6 patients and 1 control subject also had C677T MTHFR (adjusted OR = 17.3, 95% CI = 2.0-152.9). The OR for the coexistence of the two mutations was 65% to 75% higher than the expected joint effect calculated by either an additive (OR = 6.0) or multiplicative (OR = 4.4) model. The homozygous C677T mutation of MTHFR per se is not a risk factor for deep-vein thrombosis but increases the risk associated with factor V:Q506. Due to the high prevalence of C677T MTHFR, it is likely that previous studies, which did not look for this mutation, overestimated the relative risk of thrombosis associated with factor V:Q506 alone.