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Results for “Randomized controlled trials”

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PubMed1999

Occlusal treatments in temporomandibular disorders: a qualitative systematic review of randomized controlled trials.

Occlusal treatments (occlusal splints and occlusal adjustment) are controversial but widely used treatment methods for temporomandibular disorders (TMD). To investigate whether studies are in agreement with current clinical practices, a systematic review of randomized controlled trials (RCTs) of occlusal treatment studies from the period 1966 to March 1999 was undertaken. Eighteen studies met the inclusion criteria, 14 on splint therapy, and 4 on occlusal adjustment. The trials were scored using the quality scale presented by Antczak et al., 1986a (A.A. Antczak, J. Tang, T.C. Chalmers, Quality assessment of randomized control trials in dental research. I. Methods, J. Periodontal Res. 1986a;21:305-314). The overall quality of the trials was fairly low, the mean quality score was 0.43/1.00 (range 0.12-0.78). The most obvious methodological shortcomings were inadequate blinding, small sample sizes, short follow-up times, great diversity of outcome measures and numerous control treatments, some of unknown effectiveness. Splint therapy was found superior to 3, and comparable to 12 control treatments, and superior or comparable to 4 passive controls, respectively. Occlusal adjustment was found comparable to 2 and inferior to one control treatment and comparable to passive control in one study. Because of the methodological problems, only suggestive conclusions can be drawn. The use of occlusal splints may be of some benefit in the treatment of TMD. Evidence for the use of occlusal adjustment is lacking. There is an obvious need for well designed controlled studies to analyse the current clinical practices.

Humans↗

PubMedDate not supplied

Complementary and alternative medicine (CAM) in reproductive-age women: a review of randomized controlled trials.

PURPOSE: Complementary and alternative medicine (CAM) therapies are widely used in the general population. This paper reviews randomized controlled trials of CAM therapies for obstetrical and gynecologic conditions and presents therapies that are likely to be used by women of reproductive age and by pregnant women. DATA SOURCES: Sources included English-language papers in MEDLINE 1966-2002 and AMED (1985-2000) and the authors' extensive holdings. STUDY SELECTION: Randomized controlled clinical trials of CAM therapies for obstetric and gynecologic conditions. DATA EXTRACTION: Clinical information was extracted from the articles and summarized in tabular form or in the text. DATA SYNTHESIS: Ninety-three trials were identified, 45 of which were for pregnancy-related conditions, 33 of which were for premenstrual syndrome, and 13 of which were for dysmenorrhea. Data support the use of acupressure for nausea of pregnancy and calcium for PMS. Preliminary studies indicate a role for further research on Vitamin B6 or ginger for nausea and vomiting of pregnancy; calcium, magnesium, Vitamin B6, or chaste-tree berry extract for PMS; and a low-fat diet, exercise, or fish oil supplementation for dysmenorrhea. CONCLUSIONS: Limited evidence supports the efficacy of some CAM therapies. Exposure of women of reproductive age to these therapies can be expected.

Adult↗

PubMed2006

Fluoroquinolones vs beta-lactams for empirical treatment of immunocompetent patients with skin and soft tissue infections: a meta-analysis of randomized controlled trials.

OBJECTIVE: To compare the effectiveness and safety of fluoroquinolones with beta-lactams in the treatment of patients with skin and soft tissue infections (SSTIs). METHODS: We searched the PubMed database, Cochrane Database of Controlled Trials, and references of relevant articles for study reports published between January 1980 and February 2006. RESULTS: Twenty randomized controlled trials that enrolled 4817 patients were included in the analysis. Fluoroquinolones as empirical treatment of patients with SSTIs were more effective than beta-lactams for the clinically evaluable patients (90.4% vs 88.2%; odds ratio [OR], 1.29; 95% confidence interval [CI], 1.00-1.66). This was also true in subset analyses of randomized controlled trials that studied ciprofloxacin (OR, 2.49; 95% CI, 1.45-4.26) and for patients with mild to moderate infections (OR, 1.83; 95% CI, 1.13-2.96). In contrast, no difference was found between the compared regimens for patients with moderate to severe infections (OR, 1.12; 95% CI, 0.80-1.55), for patients who did not receive third-generation cephalosporins as the comparator antibiotic (OR, 0.99; 95% CI, 0.73-1.34), or for the microbiologically evaluable patients (OR, 1.19; 95% CI, 0.89-1.59). Fluoroquinolones were also associated with more adverse effects (19.2% vs 15.2%; OR, 1.33; 95% CI, 1.13-1.57). CONCLUSION: The high proportion of successfully treated patients in the compared groups of antibiotics and the development of more adverse effects associated with fluoroquinolone use suggest that these antibiotics do not have substantial advantages compared with beta-lactams for empirical treatment of patients with SSTIs.

Anti-Infective Agents↗

PubMed2003

Safety of oral use of nimesulide in children: systematic review of randomized controlled trials.

BACKGROUND: Nimesulide has been widely used to treat fever in children. Due to reports of adverse drug reactions, discontinuation or modification of its use has been suggested. OBJECTIVE: To evaluate the safety of oral use of nimesulide in children. DESIGN: Systematic review of published randomized controlled trials. SEARCH STRATEGY: Electronic searches of databases (PubMed, Cochrane, Toxnet) for relevant trials upto January 2003 using specified key words. The studies were also identified by searching the references of available meta-analyses and review articles, and bibliography of pertinent references. INCLUSION CRITERIA: Randomized controlled trials in children (less than or equal to 18 years of age) comparing the use of oral nimesulide with placebo or other antipyretic, anti-inflammatory or analgesic agents. OUTCOME: The primary outcome variable included the commonly encountered adverse effects of nimesulide therapy, i.e., hypothermia, abdominal symptoms, gastrointestinal bleeding, and elevated liver enzymes. DATA COLLECTION AND ANALYSIS: One of the authors developed a questionnaire and independently extracted data on methods, type of participants, interventions and outcomes. The meta-analysis was conducted using pooled relative risk with 95% confidence intervals, with random effects model assumption. RESULTS: We identified 16 trials that fulfilled the inclusion criteria. These included 1254 subjects, with mean age between 22 -140 months. Nimesulide was primarily used for its antipyretic (10 trials) or anti-inflammatory and analgesic activity (4 trials). One study each evaluated the symptomatic improvement in ARI and bronchial asthma. The control group included administration of placebo (3 studies), paracetamol (9 studies), and ketoprofen, naproxen, mefanemic acid and aspirin in one study each. The pooled effect sizes of various adverse events as compared between nimesulide and different control groups were: hypothermia (RR: 1.055; 95% CI: 0.184 - 6.047; P = 0.952), abdominal symptoms (RR: 0.464; 95% CI: 0.264 - 0.816; P = 0.008), gastrointestinal bleeding (RR: 0.914; 95% CI: 0.236 - 3.543; P = 0.896), and asymptomatic liver enzyme elevation (RR: 2.678; 95% CI, 0.558-12.853; P = 0.218). Cutaneous and renal adverse effects were not seen in any of the included studies. CONCLUSION: Oral nimesulide is as safe or unsafe as other analgesics-antipyretics for short-term use (less than or equal to 10 d) in children. The drug is best avoided in known or suspected liver disease; caution is warranted while prescribing nimesulide concomitantly with other hepatotoxic drugs. There is limited data for drawing concrete inferences below the age of six months.

Administration, Oral↗

PubMed2004

Acupressure and fatigue in patients with end-stage renal disease-a randomized controlled trial.

The purpose of the study is to investigate the effectiveness of acupressure on fatigue in patients with end-stage renal-disease (ESRD). The study was a randomized control trial; qualified patients were randomly assigned into acupressure group, sham group or control group. A total of 106 participants were included in the study. The measures included the revised Piper Fatigue Scale (PFS), VAS of Fatigue, the Pittsburgh Sleep Quality Index and the Beck Depression Inventory. Data of fatigue measures were collected at pretreatment and a week following treatment. Sleep quality and depression were collected during post-test only. The statistical methods included the descriptive statistics, one-way ANOVA, ANCOVA, and repeated-measures ANOVA. ANCOVA that adjusted for differences in baseline fatigue scores (PFS), post-test of depression and sleep quality, result was significant, F(2,100)=3.99, p=0.02. Post-hoc tests revealed that patients in the acupressure group were significantly having lower scores of fatigue than patients in the control group. ANCOVA results also significant for VAS of Fatigue among groups, F(2,100)=5.63, p=0.003. Comparisons indicated that there were significant differences between the acupressure group and the control group (p=0.01) and between the sham group and control group (p=0.003). Predialysis fatigue was assessed routinely by using a rating of 0-10. Repeated-measures ANOVA results demonstrate the group main effect was significant in the perceived fatigue (F(2,88)=19.46, p<0.001). Follow-up tests indicated there were significant differences between the acupressure group and the control group (p<0.001) and between the sham group and control group (p<0.001). The study provided an alternative method for health care providers to managing ESRD patients with fatigue.

Acupressure↗

PubMed2006

Pediatricians' clinical decision making: results of 2 randomized controlled trials of test performance characteristics.

OBJECTIVE: To determine whether presenting test performance characteristics influences clinical management. DESIGN: Two questionnaire-based, randomized controlled trials. SETTING: Mailed surveys with 2 clinical vignettes. PARTICIPANTS: Randomly selected US pediatricians (N=1502). INTERVENTION: Vignette-specific, randomly assigned test information: no additional information (control), test characteristics (TC), or TC defined. In the pertussis vignette, the TC group received the direct fluorescent antibody test's sensitivity and specificity, and the TC defined group received the same information with definitions. In the urinalysis vignette, the TC group received the false-positive rate of persistent microhematuria in predicting renal disease, and the TC defined group received a definition of this information. MAIN OUTCOME MEASURES: In the pertussis vignette, diagnostic test choice and management of erythromycin therapy and hospital discharge plans. In the urinalysis vignette, serum laboratory testing and nephrology referral plans. RESULTS: Six hundred fifty-three participants (49.5% of those eligible) returned completed surveys. In the pertussis vignette, significantly more of the TC (73%) and TC defined (71%) groups ordered the best-performing test than did controls (21%) (P<.001 for both comparisons). Receiving test characteristics did not significantly affect erythromycin therapy or hospital discharge plans (P>or=.40). In the urinalysis vignette, the TC defined group referred to nephrology (30%) and checked laboratory tests (88%) significantly more often than did controls (19%, P=.01; 78%, P=.01, respectively), but the TC and control groups' testing and referral plans did not differ significantly (22% vs 19%, P=.36; 75% vs 78%, P=.48, respectively). CONCLUSION: Providing test performance characteristics influenced certain clinical decisions, sometimes in unexpected ways.

Adult↗

PubMed2004

Mental health first aid training in a workplace setting: a randomized controlled trial [ISRCTN13249129].

BACKGROUND: The Mental Health First Aid training course was favorably evaluated in an uncontrolled trial in 2002 showing improvements in participants' mental health literacy, including knowledge, stigmatizing attitudes, confidence and help provided to others. This article reports the first randomized controlled trial of this course. METHODS: Data are reported on 301 participants randomized to either participate immediately in a course or to be wait-listed for 5 months before undertaking the training. The participants were employees in two large government departments in Canberra, Australia, where the courses were conducted during participants' work time. Data were analyzed according to an intention-to-treat approach. RESULTS: The trial found a number of benefits from this training course, including greater confidence in providing help to others, greater likelihood of advising people to seek professional help, improved concordance with health professionals about treatments, and decreased stigmatizing attitudes. An additional unexpected but exciting finding was an improvement in the mental health of the participants themselves. CONCLUSIONS: The Mental Health First Aid training has shown itself to be not only an effective way to improve participants' mental health literacy but also to improve their own mental health. It is a course that has high applicability across the community.

Adolescent↗

PubMed2004

Rationale and design of a multicenter randomized controlled trial on a 'minimal intervention' in Dutch army personnel with nonspecific low back pain [ISRCTN19334317].

BACKGROUND: Researchers from the Royal Netherlands Army are studying the potential of isolated lumbar extensor training in low back pain in their working population. Currently, a randomized controlled trial is carried out in five military health centers in The Netherlands and Germany, in which a 10-week program of not more than 2 training sessions (10-15 minutes) per week is studied in soldiers with nonspecific low back pain for more than 4 weeks. The purpose of the study is to investigate the efficacy of this 'minimal intervention program', compared to usual care. Moreover, attempts are made to identify subgroups of different responders to the intervention. METHODS: Besides a baseline measurement, follow-up data are gathered at two short-term intervals (5 and 10 weeks after randomization) and two long-term intervals (6 months and one year after the end of the intervention), respectively. At every test moment, participants fill out a compound questionnaire on a stand-alone PC, and they undergo an isometric back strength measurement on a lower back machine. Primary outcome measures in this study are: self-assessed degree of complaints and degree of handicap in daily activities due to back pain. In addition, our secondary measurements focus on: fear of movement/(re-) injury, mental and social health perception, individual back extension strength, and satisfaction of the patient with the treatment perceived. Finally, we assess a number of potential prognostic factors: demographic and job characteristics, overall health, the degree of physical activity, and the attitudes and beliefs of the physiotherapist towards chronic low back pain. DISCUSSION: Although a substantial number of trials have been conducted that included lumbar extension training in low back pain patients, hardly any study has emphasized a minimal intervention approach comparable to ours. For reasons of time efficiency and patient preferences, this minimal sports medicine approach of low back pain management is interesting for the population under study, and possibly for comparable working populations with physical demanding job activities.

Exercise Therapy↗

PubMed1996

Bedside charting of pain levels in hospitalized patients with cancer: a randomized controlled trial.

Despite advances in the technology of cancer pain assessment and control, cancer pain often remains undertreated even in hospital settings. To determine whether a graphical display of cancer patients' pain levels might improve their treatment, the investigators conducted a randomized controlled trial. Patients assigned to the intervention group (N = 40) had periodic pain assessments by study staff, who graphically recorded their reported pain-intensity levels on bedside wall charts. Control group patients (N = 38) had periodic pain assessments by study staff but did not have this information displayed. The results failed to show a significant beneficial effect of the intervention on pain control, sleep, cancer-related symptoms, or analgesic dosing, but confidence intervals were broad. More research is needed to improve the quality of care for inpatients with cancer-related pain.

Adolescent↗

PubMed1994

Prophylactic isradipine treatment after kidney transplantation: a prospective double-blind placebo-controlled randomized trial.

There is evidence that calcium antagonists may have a beneficial effect on cyclosporine-induced nephropathy after transplantation. We treated 50 consecutive non-diabetic patients receiving their first cadaveric transplant with isradipine, a dihydropyridine calcium antagonist, or placebo in a double-blind, randomized, placebo-controlled trial. There were no significant differences between the two groups as regards age, weight, sex, HLA matching and ischaemic periods. To achieve optimal vasodilation, treatment was started intravenously 2 h before the transplantation procedure, and continued orally afterwards for 3 months. The immunosuppressive treatment included rabbit antithymocyte globulin on day 0, and oral cyclosporine from day 5. In both groups 7 patients had primary non-functioning grafts, but the incidence of never functioning kidneys due to vascular and thrombotic complications was significantly higher in the placebo group (0 vs 4 patients, P < 0.05). Hypertension was treated with oral labetolol in combination with guanfacine if necessary. In the placebo group antihypertensive medication had to be prescribed significantly more often (67% vs 33% of patients, P < 0.05), but resulted in similar blood pressure recordings in the two study groups. Cyclosporin A (CsA) plasma concentrations were also comparable but in the isradipine group a significantly higher dose of CsA was needed to achieve adequate levels (8.0 +/- 0.5 vs 6.2 +/- 0.5 mg/kg per day, P < 0.01). However, in the isradipine-treated patients creatinine clearance was significantly higher (66.1 +/- 4.5 vs 55.6 +/- 6.2 ml/min, P < 0.05) after 3 months. We conclude that isradipine is an effective antihypertensive agent after kidney transplantation. Isradipine ameliorates CsA-induced nephropathy and seems to protect against early postoperative vascular complications.

Adult↗

PubMed2002

Estimating MEDLINE's identification of randomized control trials in pediatric dentistry.

The purpose of this study was to determine the number of randomized controlled trials in children from 1990-2000 in seven dental disciplines. Sensitive and specific MEDLINE search methodologies were used for upper and lower estimates, capture-recapture corrected those estimates, and hand evaluation refined the estimates. The data indicate that between 602 and 1737 trials were published, and the number per year doubled from 1990 to 2000. These results have implications for clinical decision making, the development of systematic reviews, insurance reimbursement, and teaching.

Child↗

PubMed1999

Inhaled budesonide in addition to oral corticosteroids to prevent asthma relapse following discharge from the emergency department: a randomized controlled trial.

CONTEXT: Relapses of acute asthma following emergency department (ED) discharge can be reduced with systemic corticosteroid treatment. However, whether inhaled corticosteroids (ICSs) provide additional benefit is not known. Objective To determine whether the addition of ICSs to oral corticosteroid treatment would reduce relapses in patients with acute asthma discharged from the ED. DESIGN AND SETTING: Placebo-controlled, double-blind, randomized clinical trial conducted in a community teaching hospital ED in Canada between November 1995 and September 1997, with a 21-day follow-up. PARTICIPANTS: A total of 1006 consecutive patients aged 16 to 60 years presented to the ED with acute asthma; after excluding those using oral and/or inhaled corticosteroids as well as those meeting other exclusion criteria, 188 were included in the study. INTERVENTIONS: Patients were discharged with a nontapering course of oral prednisone (50 mg/d) for 7 days. In a double-blind fashion, patients were randomly assigned to 1600 microg/d of inhaled budesonide (n = 94) or identical placebo (n = 94) for 21 days. MAIN OUTCOME MEASURES: Incidence of relapse, defined as an unscheduled visit for worsening asthma symptoms, in budesonide vs placebo groups. Secondary outcomes included response to the Asthma Quality of Life Questionnaire, beta2-agonist use, symptom score, global asthma improvement assessment, and pulmonary function. RESULTS: Five patients in the budesonide group and 3 in the placebo group either dropped out or were lost to follow-up but were included in primary analyses. After 21 days, 12 (12.8%) of 94 patients in the budesonide group experienced a relapse compared with 23 (24.5%) of 94 in the placebo group, a 48% relapse reduction (P=.049). Asthma Quality of Life Questionnaire scores were higher (better quality) in the budesonide group (P=.001), as well as for all domain scores (P=.001 to .01). Fewer beta2-agonist activations were used at the end of the trial by patients receiving budesonide (2.4/d vs 4.2/d; P=.01). Symptom scores (P=.001 to .004) and self-assessed asthma improvement scores (based on a 7-point Likert scale) (6.2 vs 5.2; P<.001) were higher (indicating fewer symptoms) for budesonide vs placebo. There were no differences in pulmonary function between the groups (peak expiratory flow rate: budesonide, 437 vs placebo, 453 L/min; P= .39) at 21 days. Using this approach, as few as 9 patients would require budesonide to prevent 1 relapse. CONCLUSIONS: Patients discharged from the ED following treatment for acute asthma benefit from added treatment with high-dose inhaled budesonide for 21 days compared with oral corticosteroids alone.

Acute Disease↗

PubMed2002

Interferon alfa therapy for malignant melanoma: a systematic review of randomized controlled trials.

PURPOSE: No standard systemic adjuvant therapy has been proven to increase overall survival in melanoma patients. The effect of interferon alfa (IFNalpha) as a single agent or in combination has been widely explored in clinical trials. The purpose of this study was to assess the benefit of IFNalpha therapy in malignant melanoma. METHODS: We performed a systematic review of randomized controlled trials comparing regimens with or without IFNalpha adjuvant therapy in melanoma patients. We assessed the effect of IFNalpha therapy on overall survival (OS), disease-free survival (DFS), melanoma recurrences, and toxicity. The quality of each trial was systematically evaluated. RESULTS: Nine randomized controlled trials (RCTs) of IFNalpha therapy in melanoma patients were identified. Eight were published and one was unpublished. Eight trials comprising 3,178 patients fulfilled our inclusion criteria and were analyzed. Quality assessment scores ranged from 22 to 71, with a mean score of 55.4 (95% confidence interval, 53.8 to 57.0). For OS, only one trial reported a statistically significant benefit for IFNalpha, but our analysis did not confirm it. Two trials reported statistically significant benefit in DFS for the patients treated with IFNalpha, but our analysis confirmed it in only one trial. There was a wide clinical heterogeneity between included trials, making meta-analysis inappropriate. CONCLUSION: In our review, results from included RCTs demonstrated no clear benefit of IFNalpha therapy on OS in melanoma patients. A large RCT is required to answer whether a full regimen of IFNalpha therapy is effective and to identify the subgroups of patients who might benefit from IFNalpha treatment.

Antineoplastic Agents↗

PubMed1998

A qualitative assessment of randomized controlled trials in otolaryngology.

In 1996 the CONSORT statement made recommendations on the strict reporting of randomized controlled trials (RCT). This will facilitate the future assessment of such trials and will highlight those trials that have been performed suboptimally and whose results may be biased. We have devised a scoring system, based on CONSORT, to assess RCT quality and by reading each original paper in full we have now assessed the quality of trials published from 1966 to 1995. The mean score for trials identified was 7.3 out of a maximum 12 points. No one journal was significantly better than the others. Trials in rhinology are reported better than head and neck oncology trials (mean scores 7.6 and 6.5 respectively). The past 30 years has not seen an improvement in the quality of the trials. The reporting of RCTs in the ENT literature is poor. CONSORT guidelines now exist and trialists are encouraged to adopt them when conducting future clinical trials.

Head and Neck Neoplasms↗

PubMed2006

Vitamin K and the prevention of fractures: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Observational and some experimental data suggest that low intake of vitamin K may be associated with an increased risk of fracture. OBJECTIVE: To assess whether oral vitamin K (phytonadione and menaquinone) supplementation can reduce bone loss and prevent fractures. DATA SOURCES: The search included the following electronic databases: MEDLINE (1966 to June 2005), EMBASE (1980 to June 2005), the Cochrane Library (issue 2, 2005), the ISI Web of Science (1945 to June 2005), the National Research Register (inception to the present), Current Controlled Trials, and the Medical Research Council Research Register. STUDY SELECTION: Randomized controlled trials that gave adult participants oral phytonadione and menaquinone supplements for longer than 6 months were included in this review. DATA EXTRACTION: Four authors extracted data on changes in bone density and type of fracture. All articles were double screened and double data extracted. DATA SYNTHESIS: Thirteen trials were identified with data on bone loss, and 7 reported fracture data. All studies but 1 showed an advantage of phytonadione and menaquinone in reducing bone loss. All 7 trials that reported fracture effects were Japanese and used menaquinone. Pooling the 7 trials with fracture data in a meta-analysis, we found an odds ratio (OR) favoring menaquinone of 0.40 (95% confidence interval [CI], 0.25-0.65) for vertebral fractures, an OR of 0.23 (95% CI, 0.12-0.47) for hip fractures, and an OR of 0.19 (95% CI, 0.11-0.35) for all nonvertebral fractures. CONCLUSIONS: This systematic review suggests that supplementation with phytonadione and menaquinone-4 reduces bone loss. In the case of the latter, there is a strong effect on incident fractures among Japanese patients.

Bone Density↗

PubMedDate not supplied

Postoperative patient-controlled analgesia: meta-analyses of initial randomized control trials.

STUDY OBJECTIVE: To compare outcomes during conventional analgesia (as-needed intramuscular dosing) and patient-controlled analgesia (PCA) in postoperative patients by analyzing data from published comparative trials. DESIGN: Meta-analyses of 15 randomized control trials. PATIENTS: Seven hundred eighty-seven adult patients (aged 16 to 65) undergoing various operative procedures. INTERVENTIONS: Either PCA or conventional analgesia for postoperative pain control. MEASUREMENTS AND MAIN RESULTS: Data were extracted on analgesic efficacy, analgesic use, patient satisfaction, length of hospital stay, and side effects. Meta-analyses of the data showed the following: (1) greater analgesic efficacy when PCA was used, with a mean additional benefit of 5.6 on a scale of 0 to 100 (SED, 2.2; p = 0.006); (2) a nonsignificant trend toward reduced analgesic use in PCA patients, based on a count of trials finding in one direction or the other (p = 0.092); (3) a 42% difference in the proportion of patients expressing satisfaction over dissatisfaction (SED, 20%; p = 0.02), with PCA being preferred; (4) a nonsignificant trend toward shortening of length of hospital stay with PCA use (mean, 0.15 days, SED, 0.13; p = 0.24); (5) no significant differences in the occurrence of any side effect. CONCLUSIONS: Patient preference strongly favors PCA over conventional analgesia. Patients using PCA also obtain better pain relief than those using conventional analgesia, without an increase in side effects. Favorable effect of PCA upon analgesic usage and length of hospital stay did not in the initial trials attain statistical significance. Nonetheless, the favorable trends in the mean effect sizes for both outcomes argue that further studies of both outcomes should be performed to determine whether the favorable impact of PCA upon either may become statistically significant if larger numbers of patients are enrolled.

Analgesia↗

PubMed2005

Effect of augmented feedback on motor function of the affected upper extremity in rehabilitation patients: a systematic review of randomized controlled trials.

OBJECTIVE: Assessment of the available evidence regarding the effect of augmented feedback on motor function of the upper extremity in rehabilitation patients. METHODS: A systematic literature search was performed to identify randomized controlled trials that evaluated the effect of augmented feedback on motor function. Two reviewers systematically assessed the methodological quality of the trials. The reported effects were examined to evaluate the effect of therapeutic interventions using augmented feedback and to identify a possible relationship with patient characteristics, type of intervention, or methodological quality. RESULTS: Twenty-six randomized controlled trials were included, 9 of which reported a positive effect on arm function tests. Follow-up measurements were performed in 8 trials, 1 of which reported a positive effect. Different therapeutic interventions using augmented feedback, i.e. electromyographic biofeedback, kinetic feedback, kinematic feedback, or knowledge of results, show no difference in effectiveness. CONCLUSION: No firm evidence was found of effectiveness regarding the use of augmented feedback to improve motor function of the upper extremity in rehabilitation patients. Future studies should focus more on the content, form and timing of augmented feedback concerning the therapeutic intervention. It should be emphasized that motor learning effects can only be determined by re-examining the population after a follow-up period.

Arm↗

PubMed2005

Kangaroo mother care: a randomized controlled trial on effectiveness of early kangaroo mother care for the low birthweight infants in Addis Ababa, Ethiopia.

A randomized controlled trial was conducted over a 1-year period (November 2001-November 2002) in Addis Ababa to study the effectiveness of early Kangaroo mother care before stabilization of low birthweight infants as compared with the conventional method of care. There were 259 babies weighing less than 2000 g during the study period and a total of 123 (47.5 per cent) low birthweight infants were included in to the study. Sixty-two infants were enrolled as Kangaroo Mother Care (KMC) and the remaining 61 were Conventional Method of Care (CMC) cases. The demographic and socioeconomic characteristics for both groups were comparable. The mean age at the time of enrollment was 10 and 9.8 h for KMC and CMC, respectively (p>0.05 with 95 per cent confidence interval). The mean birthweight was 1514.8 g (range 1000-1900 g) for KMC and 1471.8 g (range 930-1900 g) for CMC (p>0.05 with 95 per cent CI) and the mean gestational age was 32.42 and 31.59 weeks for KMC and CMC cases, respectively. Fifty-eight per cent of KMC and 52 per cent of CMC cases were on i.v. fluid. Twenty-one of 62 (34 per cent) of KMC and 23/61 (37 per cent) of CMC babies were on oxygen through nasopharyngeal catheter. The mean age at exit from the study was 4.6 days for KMC and 5.4 days for CMC. Ninety-one per cent and 88 per cent of babies in KMC and CMC were discharged from the study in the first 7 days of life, respectively. The study showed that 14/62 (22.5 per cent) of KMC vs. 24/63 (38 per cent) CMC babies died during the study (p<0.05 and CI of 95 per cent.) The majority of deaths occurred during the first 12 h of life. Survival for the preterm low birthweight infants was remarkably better for the early kangaroo mother care group than the babies in the conventional method of care in the first 12 h and there after. More than 95 per cent of mothers reported that they were happy to care for their low birthweight babies using the early Kangaroo mother method. It was recommended to study the feasibility and effectiveness of Kangaroo mother care at the community level.

Ethiopia↗