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PubMed2005

The effect of autologous fibrin tissue adhesive on postoperative cerebrospinal fluid leak in spinal cord surgery: a randomized controlled trial.

STUDY DESIGN: A prospective randomized study evaluating the efficacy of autologous fibrin tissue adhesive for decreasing postoperative cerebrospinal fluid (CSF) leak in spinal cord surgery. OBJECTIVE: To compare postoperative CSF leak in 3 groups (i.e., autologous fibrin tissue adhesive used, commercial fibrin glue used, and no fibrin tissue adhesive used) of patients undergoing spinal surgery who needed dural incision. SUMMARY OF BACKGROUND DATA: Spinal cord operations, particularly when dural incision is inevitable, sometimes involve postoperative CSF leak. Because CSF leak is a serious complication, countermeasure is necessary to prevent it after dural suture. Commercial fibrin tissue adhesive was formerly used. Because the possibility of prion infection was widely noticed, commercial fibrin tissue adhesive containing animal components has been used less often. METHODS: In 13 of 39 cases in which dural incision would be made, 400 mL whole blood was drawn, and autologous fibrin tissue adhesive was made of plasma. Cases were divided into 3 groups: (1) dural closure alone, (2) use of autologous fibrin tissue adhesive after dural closure, and (3) use of commercial fibrin tissue adhesive after dural closure. The primary outcome measure was determined as postoperative (3 days) volume of drainage fluid, and results were analyzed using the analysis of variance. The secondary outcome measure was general blood test, coagulation assay, and plasma fibrinogen, and these were analyzed also using the analysis of variance. RESULTS: There was a significant difference in the primary outcome between the autologous and control groups. No complications such as infection or continuous CSF leak were observed in any case. The mean volume of drainage fluid was 586.2 mL in the group with autologous fibrin tissue adhesive and 1026.1 mL in the group without fibrin tissue adhesive. The volume of drainage fluid was significantly lower in the former group than that in the latter group. There was no statistical difference between the volumes of the group with autologous adhesive and with commercial adhesive (639.2 mL). CONCLUSIONS: We used autologous fibrin tissue adhesive as a new sealant after dural closure instead of commercial fibrin tissue adhesive. No definitive CSF leak was observed, and the volume of drainage fluid was significantly lower in the group with autologous fibrin tissue adhesive than that in the group without fibrin tissue adhesive. The use of autologous fibrin tissue adhesive was superior to that of commercial fibrin tissue adhesive in cost.

Adult↗

PubMed1992

Effect of routine weekly cervical examinations at term on premature rupture of the membranes: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to determine whether routine antepartum cervical examinations at term are associated with premature rupture of membranes (PROM). METHODS: This was a randomized controlled trial conducted at a health maintenance organization in metropolitan Denver. The subjects were 604 term gravidas randomized to a no examination or examination group. Exclusions included preterm labor, third-trimester bleeding, cerclage, multiple pregnancy, history of PROM (rupture before the onset of labor), and planned induction or cesarean. In the no examination group, routine examinations (without clinical indication) were not performed. In the examination group, weekly examinations were performed from 37 weeks until delivery. RESULTS: No statistically significant difference in PROM or prolonged PROM (more than 6 hours) was observed between those unexposed and those exposed to routine cervical examinations at term. In addition, there were no differences between the groups in other relevant outcomes including cesarean delivery, induction, augmentation, chorioaminionitis, or neonatal infectious morbidity. CONCLUSION: In our population, there is no association between routine weekly antepartum cervical examinations at term and PROM or other study end points.

Cervix Uteri↗

PubMed2000

A randomized controlled trial of chiropractic spinal manipulative therapy for migraine.

OBJECTIVE: To assess the efficacy of chiropractic spinal manipulative therapy (SMT) in the treatment of migraine. DESIGN: A randomized controlled trial of 6 months' duration. The trial consisted of 3 stages: 2 months of data collection (before treatment), 2 months of treatment, and a further 2 months of data collection (after treatment). Comparison of outcomes to the initial baseline factors was made at the end of the 6 months for both an SMT group and a control group. SETTING: Chiropractic Research Center of Macquarie University. PARTICIPANTS: One hundred twenty-seven volunteers between the ages of 10 and 70 years were recruited through media advertising. The diagnosis of migraine was made on the basis of the International Headache Society standard, with a minimum of at least one migraine per month. INTERVENTIONS: Two months of chiropractic SMT (diversified technique) at vertebral fixations determined by the practitioner (maximum of 16 treatments). MAIN OUTCOME MEASURES: Participants completed standard headache diaries during the entire trial noting the frequency, intensity (visual analogue score), duration, disability, associated symptoms, and use of medication for each migraine episode. RESULTS: The average response of the treatment group (n = 83) showed statistically significant improvement in migraine frequency (P < .005), duration (P < .01), disability (P < .05), and medication use (P< .001) when compared with the control group (n = 40). Four persons failed to complete the trial because of a variety of causes, including change in residence, a motor vehicle accident, and increased migraine frequency. Expressed in other terms, 22% of participants reported more than a 90% reduction of migraines as a consequence of the 2 months of SMT. Approximately 50% more participants reported significant improvement in the morbidity of each episode. CONCLUSION: The results of this study support previous results showing that some people report significant improvement in migraines after chiropractic SMT. A high percentage (>80%) of participants reported stress as a major factor for their migraines. It appears probable that chiropractic care has an effect on the physical conditions related to stress and that in these people the effects of the migraine are reduced.

Adolescent↗

PubMed2003

Treatment of calcifying tendinitis of the shoulder by acetic acid iontophoresis: a double-blind randomized controlled trial.

OBJECTIVE: To assess the effects of acetic acid iontophoresis on the treatment of calcifying tendinitis of the shoulder. DESIGN: Double-blind randomized controlled trial. SETTING: Ambulatory academic hospital in Quebec, Canada. PARTICIPANTS: Thirty-six subjects with a calcifying tendinitis of the shoulder. INTERVENTIONS: Subjects were randomized into 1 of 2 groups: physiotherapy during 6 weeks (10 sessions) plus acetic acid iontophoresis for the treatment group (n=18) and sham acetic acid iontophoresis for the control group (n=18). MAIN OUTCOME MEASURES: The Shoulder Pain and Disability Index (SPADI), shoulder range of motion (ROM); and radiologic evaluation of shoulder calcifications. RESULTS: Nine patients dropped out, leaving 27 assessable subjects for analysis. Interim analysis showed that, in both groups, treatment led to improvement, as measured by the SPADI score (P=.004), ROM of the shoulder for abduction (P<.001), internal rotation (P=.001), external rotation (P<.001), and the mean number of calcifications per subject (P=.010). Although no formal significant intervention effects (P=.13) were found for the primary endpoint (SPADI), exploratory analyses suggest a greater improvement in the treatment group (P=.001) than in the control group (P=.33). CONCLUSIONS: Despite a trend toward greater improvement in the SPADI score in the treatment group, the use of acetic acid iontophoresis and physiotherapy for the treatment of calcifying tendinitis of the shoulder did not result in better clinical and radiologic effects than those observed in subjects treated by physiotherapyalone.

Acetic Acid↗

PubMed1996

Risks and benefits of aerosolized pentamidine and cotrimoxazole in primary prophylaxis of Pneumocystis carinii pneumonia in HIV-1-infected patients: a two-year Italian multicentric randomized controlled trial. The Italian PCP Study Group.

We randomized 220 HIV-1-infected subjects to receive aerosolized pentamidine (300 mg/4 weeks) or orally trimethoprim-sulfamethoxazole (320-1600 mg/day) for primary prophylaxis of Pneumocystis carinii pneumonia (PCP), and evaluated PCP and toxoplasmic encephalitis (TE) occurrence and survival. Patients developing toxicity switched to the other regimen. Analysis was on intention-to-treat. At 1 year of study, we observed in the pentamidine group a non-significant excess of PCP (4 vs. 1) and TE (7 vs. 3), and a significant increased death rate (15 vs. 2). After 2 years, no significant differences were observed: adjusted RR estimates for pentamidine vs. cotrimoxazole were 1.20 (95% CI, 0.33-4.37) for PCP (6 cases vs. 5), 1.23 (95% CI, 0.46-3.29) for TE (10 vs. 8) and 1.52 (95% CI, 0.83-2.79) for death (30 vs. 18). Crossovers were more frequent in the cotrimoxazole group (41 vs. 4, P < 0.001). Aerosolized pentamidine and cotrimoxazole were equally effective in preventing PCP, and no major differences were observed in TE occurrence and survival after 2 years follow-up.

AIDS-Related Opportunistic Infections↗

PubMed1992

Randomized controlled trial of dexamethasone treatment in very-low-birth-weight infants with ventilator-dependent chronic lung disease.

This randomized controlled trial was designed to answer the question: does administration of dexamethasone to neonates with bronchopulmonary dysplasia decrease the need for assisted ventilation? Twenty-five infants with a birth weight < 1501 g, requiring mechanical ventilation and FiO2 of > or = 0.30 at 21-35 days of age, were randomized to treatment with iv dexamethasone or to sham injections for 12 days. The primary outcome criterion was extubation within seven days after study entry. Treatment (n = 12) and control (n = 13) groups were well matched at entry. Dexamethasone facilitated weaning from assisted ventilation (p = 0.0154). There was no increased incidence of infection. Dexamethasone treatment resulted in a significant increase in glucosuria (p = 0.0002) and in systolic blood pressure (p = 0.0034). There was a significant decrease in heart rate (p = 0.0001) and a significant weight loss (p = 0.0002) following dexamethasone treatment. Dexamethasone treatment facilitated weaning from assisted ventilation but several systemic effects were noted that deserve further evaluation before dexamethasone becomes routine treatment.

Blood Pressure↗

PubMed2005

Effect of a low-allergen maternal diet on colic among breastfed infants: a randomized, controlled trial.

BACKGROUND: There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants. METHODS: A randomized, controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic. In the active arm, mothers excluded cow's milk, eggs, peanuts, tree nuts, wheat, soy, and fish from their diet; mothers in the control group continued to consume these foods. Outcomes were assessed after 7 days, as the change in cry/fuss duration over 48 hours, with validated charts. The primary end point was a reduction in cry/fuss duration of > or =25% from baseline. Mothers also assessed the responses to diet with categorical and visual analog scales. RESULTS: Of 107 infants, 90 completed the trial (mean age: 5.7 weeks; range: 2.9-8.6 weeks; 54 male infants). Infants in both groups presented with significant distress (geometric mean: low-allergen group: 690 minutes per 48 hours; control group: 631 minutes per 48 hours). In follow-up assessments on days 8 and 9, there were significantly more responders in the low-allergen group (74% vs 37%), ie, an absolute risk reduction of 37% (95% confidence interval: 18-56%). Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group; the adjusted geometric mean ratio was 0.79 (95% confidence interval: 0.63-0.97), ie, an average reduction of 21% (95% confidence interval: 3-37%). Mothers' subjective assessments of the responses to diet indicated little difference between the groups. CONCLUSION: Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life.

Allergens↗

PubMed1993

Does low-dose acetylsalicylic acid prevent stroke after carotid surgery? A double-blind, placebo-controlled randomized trial.

BACKGROUND AND PURPOSE: The aim of this randomized double-blind, placebo-controlled trial was to evaluate whether neurological deficits could be prevented with low-dose acetylsalicylic acid (ASA) as an adjunct to carotid endarterectomy. METHODS: A total of 232 patients were randomized to two groups, 75 mg/d ASA starting preoperatively and continued for 6 months (n = 117) or placebo (identical tablets) (n = 115). The patients were followed up regularly for 1 year. RESULTS: The groups were well matched regarding laboratory data and indication for operation. The number of patients with intraoperative or postoperative stroke without complete recovery within 1 week were 0 and 2 at 30 days and 6 months, respectively, in the ASA group, compared with 7 and 11 in the placebo group (P = .01). Including all neurological events within 6 months, this was found in 15 patients in the ASA group compared with 24 in the placebo group (P = .12). Mortality was 0.8% and 3.4% at 30 days and 6 months, respectively, in the ASA group. In the placebo group, the corresponding figures were 4.3% and 6.0%, respectively (P = .12). The intraoperative bleeding did not differ between the groups nor did the number of reoperations due to bleeding or other complications related to pharmacology. CONCLUSIONS: This study indicates that low-dose ASA (75 mg/d) reduces the number of postoperative strokes without complete recovery within 1 week. Overall neurological events are insignificantly reduced, as also mortality. The use of low-dose ASA (75 mg) seems safe and effective in reducing cerebrovascular events after carotid endarterectomy.

Adult↗

PubMed2000

[Thirty years of coronary revascularization in stable angina pectoris. Results of randomized controlled trials].

From a survey of randomized studies we wanted to elucidate the therapeutic gain and the risk of complications with coronary artery bypass grafting (CABG) and percutaneous transluminal angioplasty (PTCA) in stable angina pectoris. The following main conclusions emerged: Invasive revascularization was associated with increased survival (reduced frequency of cardiac death or myocardial infarction) exclusively in patients with three-vessel disease and/or left main lesion accompanied by a decreased left ventricular function. This group accounted for less than 10% of treated patients. With regard to survival, patients with one- and two-vessel disease were better off with conservative treatment. Relief of angina was achieved for a number of years in the majority of patients. Angina recurred earlier following PTCA than CABG. PTCA is considered less traumatic, but a ten times higher need of additional revascularization seems to eliminate this advantage. The frequency of serious complications (including the higher risk at re-revascularization) was > or = 10% after PTCA and > or = 7% after CABG.

Angina Pectoris↗

PubMed2005

Remifentanil compared with morphine for postoperative patient-controlled analgesia after major abdominal surgery: a randomized controlled trial.

BACKGROUND AND OBJECTIVE: This randomized, double-blinded clinical study was designed to compare the efficacy and safety of remifentanil and morphine administered using intravenous (i.v.) patient-controlled analgesia (PCA) for postoperative analgesia after major abdominal surgery during the first 24 postoperative hours. METHODS: Sixty-nine patients were randomly allocated into two groups, each receiving remifentanil or morphine. The first group received i.v. remifentanil PCA with a loading dose of 45 microg, a maintenance dose of 1 microg min(-1), a bolus dose of 15 microg and a lockout interval of 10 min during the first 24 postoperative hours. The second group received i.v. morphine PCA with a loading dose of 5 mg, a maintenance dose of 0.3 mg h(-1), a bolus dose of 1 mg and a lockout interval of 15 min. Age, weight, sex, history of general anaesthesia, duration of surgery and time spent in the post-anaesthesia care unit were recorded. Preoperative pulse rate, systolic and diastolic blood pressures (BP), respiration rate and arterial blood gases were collected. Pulmonary function was tested before induction of anaesthesia, as well as at 4 and 26 h after operation. Pulse rate, systolic and diastolic BP, respiration rate, arterial blood gases, sedation and visual analogue scores, and presence of side-effects in the recovery room and on the ward for 24 h were recorded at 0, 1, 2, 4, 6, 12, 18 and 24 h after operation. Total drug use, number of boluses delivered, number of boluses demanded and delivery/demand ratio were collected. RESULTS: Sixty patients were evaluated. The groups did not differ in age, weight, sex, history of general anaesthesia, duration of surgery or time spent in the recovery unit. There were also no clinically relevant differences between the groups with regard to haemodynamic and respiratory parameters as well as sedation and visual analogue scores (P > 0.05). More bolus doses were demanded and delivered and the delivery/demand ratio was significantly higher in the remifentanil group (P < 0.05). There was no finding suggesting acute opioid tolerance during remifentanil or morphine PCA. CONCLUSION: The i.v. remifentanil PCA with the chosen dosage regimen after abdominal surgery produces postoperative analgesia and has cardiovascular side-effects similar to those achieved with i.v. morphine. Special attention must be given to respiratory depression during establishment of PCA with remifentanil.

Abdomen↗

PubMed1988

A randomized, controlled trial to determine the effectiveness of fascial infiltration of bupivacaine in preventing respiratory complications after elective abdominal surgery.

A randomized, controlled trial was performed to determine whether infiltration of fascia with bupivacaine, a long-acting local anesthetic, at the time of closure after elective laparotomy, is effective in preventing postoperative respiratory complications. At the Toronto General Hospital 415 patients undergoing elective laparotomy were randomly allocated to receive bupivacaine 0.25% (2 ml/cm incision), infiltrated into the fascia evenly along both sides of the incision before wound closure (202 patients), or to have closure without infiltration (213 patients). Chest x-ray (CXR) films of all patients were obtained preoperatively and on the second postoperative day. Pulmonary function studies were performed preoperatively and for the first two consecutive days postoperatively. CXR films were scored by a blinded observer. Postoperatively, 64% of the treatment group and 56% of the control group had evidence of atelectasis on CXR films (p = NS, chi 2 test). Both groups had similar decrements in vital capacity and expiratory reserve volume on the first and second postoperative days. There was no significant difference in the amount of analgesic taken in the first 24 hours, although the time to first analgesic was significantly longer in the treatment group (2.2 vs 1.3 hours, p less than 0.055). We conclude that infiltration of the fascia with 0.25% bupivacaine at a dose of 2 ml/cm of incision is not effective in preventing postoperative atelectasis. It does not reduce use of an analgesic although it may delay its initial requirement.

Adult↗

PubMed1989

Results of randomized controlled trials of low-versus high-osmolality contrast media.

The authors reviewed 100 randomized controlled trials (RCTs) conducted in humans to compare safety or efficacy of new low-osmolality contrast media (LOM) with that of high-osmolality contrast media (HOM). Findings of the 43 RCTs judged to be of the highest quality suggest that the efficacy of LOM in imaging is equal or superior to that of HOM for all routes of administration. Heat sensation occurred less often with LOM for all routes and pain occurred less often with LOM for intraarterial routes. No differences were seen in nephrotoxicity or in frequency of nausea, vomiting, urticaria, bronchospasm, laboratory test abnormalities, or neurologic events. Greater cardiovascular changes were seen with HOM, including increased or decreased heart rate, increased left ventricular end-diastolic pressure, decreased systolic pressure, and QT prolongation, depending on route of administration. To demonstrate whether a reduction in clinically significant adverse outcomes truly occurs with LOM, trials will need to enlist larger numbers of patients and employ appropriate outcome measures. Future trials should stratify patients according to their risk of adverse reactions to provide better information about benefits of LOM in low- versus high-risk patients.

Clinical Trials as Topic↗

PubMed2004

Extractions as a form of interception in the developing dentition: a randomized controlled trial.

OBJECTIVE: To determine if the extractions of lower primary canines are an effective procedure to relieve crowding of the labial segment. STUDY DESIGN: randomized controlled trial. Subject sample: 83 cases were collected in clinics in Italy, Germany and Wales. The groups were followed over a 2-year period. METHODS: Subjects were randomly allocated to a primary canine non-extraction or extraction group. Dental casts of the patients were collected at the start and at the recall period of the trial. The outcome measures recorded were lower incisor crowding, arch length, intermolar width, overbite, overjet, lower clinical crown heights and lower incisor inclinations. STATISTICS: The Mann-Whitney test was used to compare the differences between the extraction and non-extraction groups. RESULTS: In both groups, crowding reduced 1.27 mm in the non-extraction group and 6.03 mm in the extraction group. The difference between the 2 groups was 4.76 mm (P<0.05). The arch perimeter decreased more in the extraction group by 2.73 mm (P<0.05). As the incisor inclination stayed essentially the same, the loss in arch length was attributed to the molars moving forward. The net gain from extracting deciduous canines was 2.03 mm. CONCLUSIONS: There was a reduction in lower incisor crowding as a result of lower primary canine extraction. However, arch perimeter decreased more in the extraction group leaving less space for the eruption of the lower secondary canines.

Child↗

PubMed1992

Treatment of acute cerebral hemorrhage with intravenous glycerol. A double-blind, placebo-controlled, randomized trial.

BACKGROUND AND PURPOSE: Hitherto, treatment of acute cerebral hemorrhage with intravenous glycerol has not been evaluated in rigorous clinical studies with sufficient patient numbers. METHODS: We undertook a double-blind, stratified and randomized, placebo-controlled clinical trial. Only patients with a first stroke admitted to the hospital within 24 hours after onset of symptoms were recruited, provided computed tomography confirmed hemorrhage and informed consent was obtained. After stratification into alert, semicoma, and coma subgroups using the Glasgow Coma Scale, 107 patients received active treatment (500 ml of 10% glycerol in saline by intravenous infusion over 4 hours on 6 consecutive days) and 109 were given corresponding saline treatment. Using a variety of objective scoring systems, patients were followed up for up to 6 months. RESULTS: At follow-up, all measures of outcome in the treated and control groups were very similar. At 6 months, respective mortality rates were 37 of 107 and 33 of 109. Corresponding mean +/- SD improvements in Scandinavian Stroke Study Group scores were 8.35 +/- 16.9 versus 11.55 +/- 15.6 (long-term) and 0.64 +/- 7.3 versus 2.40 +/- 6.9 (prognostic), and improvements in the Barthel Index ratings were 10.72 +/- 24.7 versus 13.95 +/- 23.3, respectively. Glasgow Coma Scale score improvements in the survivors were 0.81 +/- 1.5 and 1.16 +/- 1.7 in the treated and control groups, respectively. Hemolysis (generally subclinical) was the only adverse effect of glycerol noted. CONCLUSIONS: In the absence of any clinically or statistically significant difference in outcome between the treated and control groups, this trial provides no justification for glycerol therapy following acute cerebral hemorrhage.

Acute Disease↗

PubMed2000

Impact of ethics consultations in the intensive care setting: a randomized, controlled trial.

OBJECTIVE: To determine the following: a) whether ethics consultations in the intensive care setting reduce nonbeneficial treatments, defined as days in the intensive care unit (ICU) and treatments delivered to those patients who ultimately fail to survive to hospital discharge; and b) whether physicians, nurses, social workers, and patients/families agree that ethics consultations in the ICU are beneficial in addressing treatment conflicts. DESIGN: Prospective, randomized, controlled trial of ethics consultations. SETTING: Medical and pediatric ICUs in a university medical center. PATIENTS: Seventy-four patients in whom value-based treatment conflicts arose during the course of treatment. INTERVENTIONS: The patients were randomly assigned to an intervention (ethics consultation offered) or nonintervention (ethics consultation not offered) arm of the trial. MEASUREMENTS: Medical data and ICU hospital days were compared between the intervention and control groups before and after the randomization. Likert scale and commentary responses were recorded to structured and open-ended interviews with the responsible physicians, nurses, social workers, and families of patients assigned to the intervention arm within 1 month after the patient's death or hospital discharge. Interviewees were asked whether ethics consultations helped with the following: a) to identify ethical issues; b) to analyze ethical issues; c) to resolve ethical issues; d) to educate about ethical issues; and e) to present personal views. MAIN RESULTS: There were no differences in overall mortality between the control patients and patients receiving ethics consultations. However, ethics consultations were associated with reductions in ICU hospital days and life-sustaining treatments in those patients who ultimately failed to survive to discharge. Also, ethics consultations were regarded favorably by most participants. CONCLUSIONS: Ethics consultations seem to be useful in resolving conflicts that may be inappropriately prolonging futile or unwanted treatments and are perceived to be beneficial.

Attitude of Health Personnel↗

PubMed2007

Efficacy and feasibility of a novel tri-modal robust exercise prescription in a retirement community: a randomized, controlled trial.

OBJECTIVES: To test the feasibility and efficacy of current guidelines for multimodal exercise programs in older adults. DESIGN: Randomized, controlled trial. SETTING: Retirement village. PARTICIPANTS: Thirty-eight subjects (14 men and 24 women) aged 76.6 +/- 6.1. INTERVENTION: A wait list control or 10 weeks of supervised exercise consisting of high-intensity (80% of one-repetition maximum (1RM)) progressive resistance training (PRT) 3 days per week, moderate-intensity (rating of perceived exertion 11 to 14/20) aerobic training 2 days per week, and progressive balance training 1 day per week. MEASUREMENTS: Blinded assessments of dynamic muscle strength (1RM), balance, 6-minute walk, gait velocity, chair stand, stair climb, depressive symptoms, self-efficacy, and habitual physical activity level. RESULTS: Higher baseline strength and psychological well-being were associated with better functional performance. Strength gains over 10 weeks averaged 39+/-31% in exercise, versus 21+/-24% in controls (P=.10), with greater improvements in hip flexion (P=.01), hip abduction (P=.02), and chest press (P=.04) in the exercise group. Strength adaptations were greatest in exercises in which the intended continuous progressive overload was achieved. Stair climb power (12.3+/-15%, P=.002) and chair stand time (-7.1+/-15%, P=.006) improved significantly and similarly in both groups. Reduction in depressive symptoms was significantly related to compliance (attendance rate r=-0.568, P=.009, PRT progression in loading r=-0.587, P=.02, and total volume of aerobic training r=-0.541, P=.01), as well as improvements in muscle strength (r=-0.498, P=.002). CONCLUSION: Robust physical and psychological adaptations to exercise are linked, although volumes and intensities of multiple exercise modalities sufficient to cause significant adaptation appear difficult to prescribe and adhere to simultaneously in older adults.

Aged↗

PubMed2003

WBC-containing allogeneic blood transfusion and mortality: a meta-analysis of randomized controlled trials.

BACKGROUND: An association between allogeneic blood transfusion (ABT) and mortality was reported by one team of investigators from randomized controlled trials (RCTs) comparing recipients of non-WBC-reduced versus WBC-reduced RBCs in open-heart surgery. A meta-analysis was undertaken to examine whether this finding can be generalized across clinical settings and/or transfused RBC components. STUDY DESIGN AND METHODS: RCTs reporting on adverse immunomodulatory effects of ABT between January 1992 and August 2002 were retrieved. Fourteen studies had recorded mortality as a primary or secondary outcome and met all other criteria for meta-analysis. Summary ORs of mortality in a treatment arm receiving WBC-containing allogeneic RBCs versus a control arm receiving autologous or WBC-reduced allogeneic RBCs were calculated across studies, for groups of studies in which the hypothesis of homogeneity was not rejected. RESULTS: There was no association between ABT and mortality across 14 RCTs reporting on short-term mortality (summary OR, 1.20; 95% CI, 0.87-1.65) or across 3 RCTs reporting on long-term mortality (summary OR, 0.87; 95% CI, 0.64-1.19). In subgroup analyses, RCTs using autologous blood or conducted in abdominal or vascular surgery showed no difference in mortality, but short-term mortality differed across 3 RCTs conducted in open-heart surgery (summary OR, 2.26; 95% CI, 1.31-3.90; p < 0.05) and 7 RCTs comparing recipients of non-WBC-reduced versus WBC-reduced allogeneic RBCs filtered before storage (summary OR, 1.45; 95% CI, 1.00-2.11; p >/= 0.05). CONCLUSIONS: An association between ABT and either short-term or long-term mortality was not detected across clinical settings and transfused RBC components, but subgroup analyses suggest that an association between WBC-containing ABT and short-term mortality may exist in open-heart surgery and in settings where WBC-reduced allogeneic RBCs filtered before storage are administered.

Blood Component Removal↗

PubMed2005

Is advice to stop smoking from a midwife stressful for pregnant women who smoke? Data from a randomized controlled trial.

BACKGROUND: There are no randomized trials examining whether intensive advice to pregnant smokers is more stressful than standard care. METHOD: Nine hundred eighteen U.K. women currently smoking on commencing antenatal care were randomized into three arms. Women in Arm A received one episode of brief advice to stop smoking. Women in Arm B were assessed for stage of change and worked through an exercise in self-help manuals on three occasions. Women in Arm C used a 20-min interactive computer program three times in addition to the intervention women in Arm B received. Stress was assessed by the change in score on the Perceived Stress Scale (PSS) from baseline to 30 weeks gestation, the month before delivery, and 10 days postpartum. RESULTS: There were small and not significant differences in the changes in PSS between the arms at all outcome times. There was no evidence that the importance women attached to pleasing their midwife by stopping, having failed to quit, or nulliparity modified the effect of intensive advice on change in stress levels. CONCLUSIONS.: Intensive advice to stop smoking was not associated with increases in stress. Advice and support for pregnant women to stop smoking should be given without fear of causing stress.

Delivery of Health Care↗