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Results for “Randomized controlled trials”

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PubMed2002

Intracytoplasmic sperm injection versus in vitro fertilization: a randomized controlled trial and a meta-analysis of the literature.

OBJECTIVE: To compare ICSI with IVF using two insemination concentrations in moderate male infertility and to compare these data with other randomized controlled trials (RCTs). DESIGN: Prospective, randomized, controlled trial and meta-analysis. SETTING: University-based tertiary referral center. PATIENT(S): Seventy-three couples undergoing ART. INTERVENTION(S): In one IVF group a standard insemination concentration of 0.2 x 10(6)/mL was used, whereas in the other group a high insemination concentration (HIC) of 0.8 x 10(6)/mL was used. Each protocol was compared with ICSI on sibling oocytes. MAIN OUTCOME MEASURE(S): Fertilization, fertilization failure, and embryonic development. RESULT(S): The overall fertilization rate was significantly lower after standard IVF than after ICSI: 37.4% vs. 64.3%. Where HIC IVF was used, the overall fertilization rate was not significantly different from that after ICSI: 59.6% vs. 67.6%. Eight randomized controlled trials were selected and reviewed together with the present randomized controlled trial by meta-analysis. The risk ratio for an oocyte to become fertilized was 1.9 (95% confidence interval of 1.4 to 2.5) in favor of ICSI, and 3.1 ICSI cycles may be needed to avoid one complete fertilization failure after conventional IVF (95% CI of 1.7 to 12.4). CONCLUSION(S): The data from this study and the meta-analysis show that ICSI is a more efficient technique in terms of fertilization, but not in comparison with HIC IVF.

Adult↗

PubMedDate not supplied

Assessment of bias in methodology for randomized controlled trials published on implant dentistry.

PURPOSE: The purpose of this study was to assess randomized controlled trials (RCTs) published on implant dentistry over a 10-year period (1991 to 2000), based on the reporting of control of potential sources of bias in the design methodology. MATERIALS AND METHODS: A MEDLINE search was conducted for RCTs using keywords dental implant and publication type randomized controlled trial. Three areas of trial methodology were assessed: (1) adequate reporting of randomization procedure, (2) blinding in assessment of outcomes, and (3) handling of subject withdrawals in data analysis. A score of 1 or 0 was assigned for each of the three potential sources of bias. Thus, the maximum quality score for an RCT is 3 and the minimum is 0. RESULTS: Forty-three articles met criteria for classification as RCTs. Method of randomization was explicit in 51% of the RCTs, but only 12% incorporated blinding in the assessment of outcome. Ninety-eight percent accounted for all subjects at the end of the study. Looking at overall quality scores, only 2% of RCTs adequately reported on control of bias in the three areas examined, 56% were deficient in one area, and 42% were deficient in two areas. CONCLUSION: Reporting of randomization procedures and blinding in outcomes assessment for most implant RCTs was inadequate. Subject retention and documentation of subject withdrawals were adequately reported.

Bias↗

PubMed2000

Are randomized controlled trials sufficient evidence to guide clinical practice in type II (non-insulin-dependent) diabetes mellitus?

Randomized controlled trials (RCTs) are often considered the standard for defining the practice of evidence-based medicine. Taken alone, they are, however, often insufficient to guide clinical care. Randomized controlled trials are clearly the best method to determine whether interventions are efficacious. They have, however, numerous limitations which make them difficult to carry out or limit applicability to routine clinical practice. Although observational studies also have inherent limitations, they provide data which can help to further explain the results of randomized controlled trials. The use of observational studies to frame randomized trials can allow better application of randomized controlled trial results to individual patients and can thus help to optimize delivery of care, inform clinical practice and determine the need for further such trials.

Diabetes Mellitus, Type 2↗

PubMedDate not supplied

Efficacy of pneumococcal vaccination in adults. A meta-analysis of randomized controlled trials.

BACKGROUND: Because of the prevalence of pneumococcal pneumonia, the substantial morbidity and mortality associated with many pneumococcal infections, and an increase in the incidence of antibiotic resistance among pneumococcal isolates, considerable efforts for disease prevention have been made using a polyvalent polysaccharide pneumococcal vaccine. Despite numerous clinical trials of the vaccine, its efficacy in the prevention of pneumococcal infections and other clinically relevant medical outcomes in adults remains uncertain. METHODS: To assess quantitatively the efficacy of pneumococcal vaccination, a MEDLINE literature search, manual reviews of article bibliographies, and communications with pneumococcal vaccine investigators were used to identify randomized controlled trials of the pneumococcal vaccine. Independent review of 594 articles revealed nine randomized trials with 12 vaccine and control study groups that evaluated clinically relevant outcomes in adults. To estimate a summary effect size for all outcomes, Mantel-Haenszel odds ratios (ORs) and Dersimonian and Laird rate differences (RDs) and their associated 95% confidence intervals (CIs) were computed. RESULTS: Summary ORs demonstrated a statistically significant protective effect of the vaccine for four pneumococcal infection-related outcomes: definitive pneumococcal pneumonia (OR = 0.34; 95% CI = 0.24 to 0.48), definitive pneumococcal pneumonia for vaccine-containing pneumococcal antigen types only (vaccine types only) (OR = 0.17; 95% CI = 0.09 to 0.33), presumptive pneumococcal pneumonia (OR = 0.47; 95% CI = 0.35 to 0.63), and presumptive pneumococcal pneumonia (vaccine types only) (OR = 0.39; 95% CI = 0.26 to 0.59). The summary RDs, which account for heterogeneity among studies, confirmed a statistically significant protective effect for two of these same outcomes: definitive pneumococcal pneumonia (RD = 4/1000; 95% CI = 0/1000 to 7/1000) and definitive pneumococcal pneumonia (vaccine types only) (RD = 8/1000; 95% CI = 1/1000 to 16/1000). Summary ORs and RDs failed to demonstrate a protective effect for pneumonia (all causes), bronchitis, and mortality (all causes) or mortality due to pneumonia or pneumococcal infection. Subgroup analyses showed that for all four pneumococcal infection-related outcomes, vaccine efficacy differed for high- and low-risk subjects, demonstrating efficacy for low-risk subjects and lack of efficacy for high-risk subjects. CONCLUSIONS: Pneumococcal vaccination appears efficacious in reducing bacteremic pneumococcal pneumonia in low-risk adults. However, evidence from randomized controlled trials fails to demonstrate vaccine efficacy for pneumococcal infection-related or other medical outcomes in the heterogeneous group of subjects currently labeled as high risk.

Adult↗

PubMed2002

A randomized controlled trial of home telecare.

We have established a randomized controlled trial of home telecare. The intervention aims to address a growing problem in the National Health Service (NHS), that is, high admission rates of patients with exacerbations of chronic obstructive pulmonary disease (COPD). Equipment procurement for the trial has been difficult, as no single supplier was able to meet the project s full requirements. The fact that the service is provided by existing clinical NHS staff has advantages when considering the generalizability of the results within the NHS. However, there are also disadvantages, since existing staff have little research experience. Considerable time has been required to help staff familiarize themselves with the equipment and become comfortable with its use. This has posed a barrier to the implementation of the service.

Home Care Services↗

PubMed2002

Design and quality considerations for randomized controlled trials in systemic sclerosis.

OBJECTIVE: To appraise systematically randomized controlled trials (RCTs) on systemic sclerosis (SSc) in order to determine whether the parameter of study design and its quality may influence the reporting of efficacy for tested interventions. METHODS: Seventy RCTs were analyzed (1965-2000) in terms of design, patient characteristics, outcomes, and reported results. RESULTS: Median sample size was 28 patients. Fifty-nine trials were double blind, but only 16 mentioned the randomization mode and only 7 described allocation concealment. There was sufficient information on withdrawals in 37 trials. Larger trials with longer followup scored higher on quality characteristics, but had higher withdrawal rates. Only 8 trials had a followup of more than 1 year. Significant efficacy was less likely to be reported in double-blind studies (P = 0.029) and in studies with larger rates of withdrawal (P = 0.032). Specification of the following parameters improved over time: power calculations (P = 0.0003), outcomes (P = 0.001), and sample size per arm (P = 0.011). CONCLUSIONS: Several aspects of the quality of design and conduct of SSc RCTs can be improved. Adequately powered trials with longer followup and clear outcomes are needed.

Databases, Factual↗

PubMed2003

Physiotherapy, including quadriceps exercises and patellar taping, for knee osteoarthritis with predominant patello-femoral joint involvement: randomized controlled trial.

OBJECTIVE: To design and carry out a randomized controlled trial of a complex, physical therapy based intervention for patello-femoral joint (PFJ) osteoarthritis (OA) of the knee, examining medium to longterm outcomes. METHODS: The participants, who had knee pain and predominant PFJ OA, were recruited from a large population based study. The study design was a controlled trial using prerandomization and a blind observer, comparing the intervention package with standard nonphysiotherapy treatment. The physiotherapy intervention was delivered in local community health centers and clinics and comprised education, quadriceps and functional exercises, and patellar taping delivered by a single physiotherapist in nine 30-minute sessions over 10 weeks, with advice to continue thereafter. The outcome measures were pain in the worse knee by 100 mm visual analog scale score, the disability domain of the Western Ontario and McMaster University OA index (WOMAC), and quadriceps muscle strength by maximum voluntary contraction. RESULTS: Eighty-seven patients were recruited to the study, 43 were randomized to the treatment arm. At 5 months post-baseline (10 weeks post-treatment) the treatment group had a small decrease in pain and a significant increase in quadriceps strength of the index knee. After one year there were no significant differences in any outcome measure, most of which had returned towards pretreatment levels. CONCLUSION: The treatment package produced small improvements in knee pain scores and quadriceps muscle strength 10 weeks after the end of the treatment period. There was no difference between the 2 groups at 12 months.

Aged↗

PubMed2005

Reporting of harm in randomized, controlled trials of nonpharmacologic treatment for rheumatic disease.

BACKGROUND: Reports of clinical trials usually emphasize benefits and give less attention to harms. PURPOSE: To compare the reporting of harm in trials of pharmacologic and nonpharmacologic treatment. DATA SOURCES: MEDLINE and the Cochrane Central Register of Controlled Trials. STUDY SELECTION: Reports of randomized, controlled trials assessing treatment of rheumatic disease that were published between January 1999 and January 2005. DATA EXTRACTION: A standardized abstraction form was used to extract data. DATA SYNTHESIS: 193 articles were analyzed. After adjustment for medical area, sample size, funding source, and multicenter trials, data on harm were more often described in pharmacologic treatment reports than in nonpharmacologic treatment reports in reporting adverse events (odds ratio, 5.2 [95% CI, 2.1 to 12.9]), reporting withdrawals due to adverse events (odds ratio, 4.6 [CI, 2.0 to 10.9]), reporting severity (odds ratio, 3.7 [CI, 1.5 to 9.1]), and allocating space for describing harm (odds ratio, 1.6 [CI, 1.2 to 2.3]). LIMITATIONS: Extrapolating results to trials in areas other than rheumatic disease is questionable. CONCLUSIONS: The lack of reporting harm in trials assessing nonpharmacologic treatment in rheumatic disease is an important barrier to evaluating the benefit-harm balance of nonpharmacologic treatments.

Antirheumatic Agents↗

PubMed2005

Outcomes from the Moving Beyond Cancer psychoeducational, randomized, controlled trial with breast cancer patients.

PURPOSE: Evidence suggests that the re-entry phase (ie, early period after medical treatment completion) presents distinct challenges for cancer patients. To facilitate the transition to recovery, we conducted the Moving Beyond Cancer (MBC) trial, a multisite, randomized, controlled trial of psychoeducational interventions for breast cancer patients. METHODS: Breast cancer patients were registered within 6 weeks after surgery. After medical treatment, they completed baseline measures and were randomly assigned to standard National Cancer Institute print material (CTL); standard print material and peer-modeling videotape (VID); or standard print material, videotape, two sessions with a trained cancer educator, and informational workbook (EDU). Two primary end points were examined: energy/fatigue and cancer-specific distress. Secondary end points were depressive symptoms and post-traumatic growth. Perceived preparedness for re-entry was analyzed as a moderator of effects. RESULTS: Of 558 women randomly assigned to treatment, 418 completed the 6-month assessment and 399 completed the 12-month assessment. In analyses controlling for study site and baseline depressive symptoms, VID produced significant improvement in energy/fatigue at 6 months relative to CTL, particularly among women who felt less prepared for re-entry at baseline. No significant main effect of the interventions emerged on cancer-specific distress, but EDU prompted greater reduction in this outcome relative to CTL at 6 months for patients who felt more prepared for re-entry. Between-group differences in the primary outcomes were not significant at 12 months, and no significant effects emerged on the secondary end points. CONCLUSION: A peer-modeling videotape can accelerate the recovery of energy during the re-entry phase in women treated for breast cancer, particularly among those who feel less prepared for re-entry.

Adult↗

PubMed2006

Methodological quality of randomized controlled trials of spinal manipulation and mobilization in tension-type headache, migraine, and cervicogenic headache.

STUDY DESIGN: Literature review of quality of clinical trials. OBJECTIVE: To determine the methodological quality of published randomized controlled trials that used spinal manipulation and/or mobilization to treat patients with tension-type headache (TTH), cervicogenic headache (CeH), and migraine (M) in the last decade. BACKGROUND: TTH, CeH, and M are the most prevalent types of headaches seen in adults. Individuals who have headaches frequently use physical therapy, manual therapy, or chiropractic care. Randomized controlled trials are considered an optimal method with which to assess the efficacy of any intervention. METHODS: Computerized literature searches were performed in MEDLINE, EMBASE, COCHRANE, AMED, MANTIS, CINHAL, and PEDro databases. Randomized controlled trials in which spinal manipulation and/or mobilization had been used for TTH, CeH, and M published in a peer-reviewed journal as full text, and with at least 1 clinically relevant outcome measure (ie, headache intensity, duration, or frequency) were reviewed. The methodological quality of the studies was assessed independently by 2 reviewers using a set of predefined criteria. RESULTS: Only 8 studies met all the inclusion criteria. One clinical trial evaluated spinal manipulation and mobilization together, and the remaining 7 assessed spinal manipulative therapy. No controlled trials analyzing exclusively the effects of spinal mobilization were found. Methodological scores ranged from 35 to 56 points out of a theoretical maximum of 100 points, indicating an overall poor methodology of the studies. Only 2 studies obtained a high-quality score (greater than 50 points). No significant differences in quality scores were found based on the type of headache investigated. Methodological quality was not associated with the year of publication (before 2000, or later) nor with the results (positive, neutral, negative) reported in the studies. The most common flaws were a small sample size, the absence of a placebo control group, lack of blinded patients, and no description of the manipulative procedure. CONCLUSIONS: There are few published randomized controlled trials analyzing the effectiveness of spinal manipulation and/or mobilization for TTH, CeH, and M in the last decade. In addition, the methodological quality of these papers is typically low. Clearly, there is a need for high-quality randomized controlled trials assessing the effectiveness of these interventions in these headache disorders.

Headache Disorders↗

PubMed1993

Anterior versus posterior reconstruction after transhiatal oesophagectomy: a randomized controlled trial.

In a prospective randomized trial the clinical results after transhiatal oesophagectomy with reconstruction in the anterior mediastinum (51 patients) or posterior mediastinum (45 patients) were compared. There were no differences in age, preoperative risk factors, tumour stage and local (surgical) complications between the two groups. However, reconstruction in the posterior mediastinum was associated with significantly fewer days spent in the intensive therapy unit (9 versus 14), fewer cardiopulmonary complications (13 versus 25 per cent) and lower mortality (30-day mortality rate 2 versus 6 per cent; hospital mortality rate 4 versus 10 per cent). These data show superiority of reconstruction in the posterior mediastinum after transhiatal oesophagectomy. This route is strongly recommended, particularly for patients with cardiopulmonary risk factors.

Cardiac Output↗

PubMed2000

Eradication of Helicobacter pylori prevents recurrence of ulcer after simple closure of duodenal ulcer perforation: randomized controlled trial.

OBJECTIVE: In this randomized trial, the authors sought to determine whether eradication of Helicobacter pylori could reduce the risk of ulcer recurrence after simple closure of perforated duodenal ulcer. BACKGROUND DATA: Immediate acid-reduction surgery has been strongly advocated for perforated duodenal ulcers because of the high incidence of ulcer relapse after simple patch repair. Although H. pylori eradication is now the standard treatment of uncomplicated and bleeding peptic ulcers, its role in perforation remains controversial. Recently a high prevalence of H. pylori infection has been reported in patients with perforations of duodenal ulcer. It is unclear whether eradication of the bacterium confers prolonged ulcer remission after simple repair and hence obviates the need for an immediate definitive operation. METHODS: Of 129 patients with perforated duodenal ulcers, 104 (81%) were shown to be infected by H. pylori. Ninety-nine H. pylori-positive patients were randomized to receive either a course of quadruple anti-helicobacter therapy or a 4-week course of omeprazole alone. Follow-up endoscopy was performed 8 weeks, 16 weeks (if the ulcer did not heal at 8 weeks), and 1 year after hospital discharge for surveillance of ulcer healing and determination of H. pylori status. The endpoints were initial ulcer healing and ulcer relapse rate after 1 year. RESULTS: Fifty-one patients were assigned to the anti-Helicobacter therapy and 48 to omeprazole alone. Nine patients did not undergo the first follow-up endoscopy. Of the 90 patients who did undergo follow-up endoscopy, 43 of the 44 patients in the anti-Helicobacter group and 8 of the 46 in the omeprazole alone group had H. pylori eradicated; initial ulcer healing rates were similar in the two groups (82% vs. 87%). After 1 year, ulcer relapse was significantly less common in patients treated with anti-Helicobacter therapy than in those who received omeprazole alone (4.8% vs. 38.1%). CONCLUSIONS: Eradication of H. pylori prevents ulcer recurrence in patients with H. pylori-associated perforated duodenal ulcers. Immediate acid-reduction surgery in the presence of generalized peritonitis is unnecessary.

Anti-Bacterial Agents↗

PubMed2005

Amelioration of osteoporosis and hypovitaminosis D by sunlight exposure in hospitalized, elderly women with Alzheimer's disease: a randomized controlled trial.

UNLABELLED: In a random and prospective study, Alzheimer's disease (AD) patients were assigned to regular sunlight exposure (n = 132) or sunlight deprivation (n = 132) and followed for 1 year. Serum 25-OHD level increased by 2.2-fold in the sunlight-exposed group. Eleven patients sustained fractures in the sunlight-deprived group, and three fractures occurred among the sunlight-exposed group (p = 0.0362; odds ratio = 3.7). INTRODUCTION: A high incidence of fractures, particularly of the hip, represents an important problem in patients with Alzheimer's disease (AD), who are prone to falls and have osteoporosis. We previously showed that 25-hydroxyvitamin D (25-OHD) deficiency caused by sunlight deprivation with compensatory hyperparathyroidism causes reduced BMD in elderly women with AD. This study was undertaken to address the possibility that sunlight exposure with calcium supplementation may maintain BMD and reduce the incidence of nonvertebral fractures in elderly women with AD. MATERIALS AND METHODS: In a random and prospective study, AD patients were assigned to regular sunlight exposure (n = 132) or sunlight deprivation (n = 132) and followed for 1 year. BMD of the second metacarpal bone was measured using a computed X-ray densitometer (CXD). The CXD method measures BMD and cortical thickness at the middle of the second metacarpal bone on a radiogram of the hand and an aluminum step wedge as a standard (20 steps; 1 mm/step). Incidence of nonvertebral fractures in the two patient groups during the 1-year follow-up period was assessed. RESULTS AND CONCLUSION: At baseline, average hospitalization period was 1.7 years in both groups, and activity of daily living (ADL) was decreased. Patients of both groups showed vitamin D deficiency caused by sunlight deprivation and decreased dietary intake of vitamin D with compensatory hyperparathyroidism. The exposed group patients were exposed to sunlight (3615 minutes/year). BMD increased by 2.7% in the sunlight-exposed group and decreased by 5.6% in the sunlight-deprived group (p < 0.0001). Serum 25-OHD level increased from 24.0 to 52.2 nM in the sunlight-exposed group. Eleven patients sustained fractures in the sunlight-deprived group, and three fractures occurred among the sunlight-exposed group (p = 0.0362; odds ratio = 3.7). Sunlight exposure can increase the BMD of vitamin D-deficient bone by increasing 25-OHD concentration and lead to the prevention of nonvertebral fractures.

25-Hydroxyvitamin D 2↗

PubMed2006

The handsearching of 2 medical journals of Bahrain for reports of randomized controlled trials.

OBJECTIVE: To identify reports of randomized trials by handsearching 2 Bahrain medical journals, which are indexed in the biomedical database EMBASE and to determine any added value of the handsearching by comparing the reports found by handsearching with what would have been found by searching EMBASE to examine (i) the precision and sensitivity of the EMBASE index term Randomized Controlled Trial (RCT) and (ii) The Cochrane Collaboration's systematic electronic search of EMBASE (which uses 4 index terms and 9 free-text terms). METHODS: All issues of the Bahrain Medical Bulletin (BMB) (1979-2004) and the Journal of the Bahrain Medical Society (JBMS) (1989-2004) were handsearched in February 2005 for reports of RCTs or Controlled Clinical Trials (CCTs), according to Cochrane eligibility criteria. RESULTS: Out of 395 articles in BMB we found reports of 12 RCTs and 4 CCTs. Distribution by country of corresponding author: Jordan (4 RCTs, one CCT), Bahrain (one RCT, one CCT), India (3 RCTs, one CCT), Kuwait (one CCT), Saudi Arabia (2 RCTs), USA/Bahrain (one RCT), and Oman (one RCT); and by specialty: Anesthesia (8), Surgery (1) Pediatrics (1), Radiotherapy (1), Community Medicine (1), Sports Medicine (1), Obstetrics/Gynecology (3). The Journal of the Bahrain Medical Society included reports of 14 RCTs and 3 CCTs, out of 97 articles. Distribution by country of corresponding author: Jordan (9 RCTs, 2 CCTs), Bahrain (3 RCTs), Egypt (one RCT), Kuwait (one RCT), and Saudi Arabia (one RCT); and by specialty: Anesthesia (7), General Surgery (3), Obstetrics/Gynecology (1), Radiotherapy (1), Pediatrics (1), Orthopaedic Surgery (1), Education (1) Ear Nose and Throat (1) Ophthalmology (1). Overall, of the 33 reports of trials found by handsearching both journals, only 23 were included in EMBASE of which only 6 had been indexed with the term RCT. Of the 23 reports of trials included in EMBASE, 16 had been identified in the Collaboration s systematic search of EMBASE. Two reports of trials could have been retrieved by this search but there was insufficient information in the title and abstract to code these as trials. The EMBASE records for the remaining 5 reports of trials did not contain terms currently used by The Cochrane Collaboration to identify reports of randomized trials in this database. CONCLUSION: The handsearching of these journals will help minimize publication bias by locating randomized trials not previously identified and, through their inclusion in the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, will ensure reports of randomized trials will not remain buried through indexing bias.

Bahrain↗

PubMed2004

Effect of raloxifene on urinary incontinence: a randomized controlled trial.

OBJECTIVE: To estimate the effect of 3 years of treatment with raloxifene on urinary incontinence in postmenopausal women. METHODS: We used measures of urinary incontinence severity, frequency, and type in the Multiple Outcomes of Raloxifene trial, a multicenter randomized, controlled trial of women who were at least 2 years postmenopausal with osteoporosis. At 10 U.S. sites of this trial, 963 women randomly assigned to raloxifene or placebo completed questionnaires about incontinence at baseline and 3 years later. We analyzed the odds of worsening severity and frequency of incontinence and type of incontinence after 3 years of treatment with raloxifene. RESULTS: The mean age of our subjects was 68.3 +/- 7 years. After 3 years of treatment, there was no significant difference between raloxifene and placebo groups in urinary incontinence severity (multivariable odds ratio [OR] 1.02; 95% [CI] 0.78, 1.34). The majority of the women (60%) had no change in urinary incontinence episodes from baseline to year 3. The odds of worsening urinary incontinence severity after 3 years of raloxifene treatment were 1.05 (95% CI 0.75, 1.48). Similarly, the odds of developing new onset incontinence were 0.95 (95% CI 0.59, 1.52). Finally, raloxifene did not effect the odds of having stress (OR 1.01; 95% CI 0.71, 1.43) or urge (OR 1.20; 95% CI 0.86, 1.68) incontinence after 3 years of use. CONCLUSION: In postmenopausal women with osteoporosis, 3 years of treatment with raloxifene had no effect on urinary incontinence. LEVEL OF EVIDENCE: I

Administration, Oral↗

PubMed2006

Effects of web-based supervisor training on job stressors and psychological distress among workers: a workplace-based randomized controlled trial.

Using workplaces as a unit for randomization, a randomized controlled trial was conducted to determine the effects of web-based supervisor training on the subject of worksite mental health on job stressors, supervisor support and psychological distress among subordinate workers. A total of eight workplaces of a sales and service company were randomly assigned to either training workplaces or non-training workplaces. Supervisors (n=23) at the training workplaces participated in web-based self-learning training on worksite mental health; supervisors (n=23) at the non-training workplaces did not. A total of 81 subordinate workers under the trained supervisors (the intervention group) and 108 subordinate workers under the non-trained supervisors (the control group) completed the Brief Job Stress Questionnaire (BJSQ) at baseline and at a three-month follow-up. No significant intervention effect was observed for any scale of the BJSQ measuring job stressors, supervisor or coworker support, or psychological distress among subordinate workers (p<0.05). The item score of work autonomy changed very little in the intervention group, while it decreased in the control group during the follow-up period, yielding a significant intervention effect (p=0.02). The item score for a friendly atmosphere in the workplace increased in the intervention group, while the score remained stable in the control group, yielding a significant intervention effect (p=0.02). While the present study failed to show any clear effect of the web-based training of supervisors on reduction of job stressors, it may be useful for maintaining worker autonomy and improving the friendliness of the worksite atmosphere.

Female↗

PubMed2006

Recent randomized controlled trials in pancreaticoduodenectomy.

OBJECTIVES: To analyze and summarize the recent randomized controlled trials (RCTs) investigating pancreaticoduodenectomy (PD). METHODS: A MEDLINE search was performed to identify prospective RCTs on PD published during the last decade. Eligible RCTs were analyzed using the following items: publication year, geographical area, study theme, sample size, and multicenter study. Moreover, the quality of each RCT was evaluated. RESULTS: Thirty-four articles were eligible for review. One to 6 RCTs have been carried out annually during the recent 10 years. Geographically, 15 trials were performed in Europe, 10 trials in North America, and 9 in Asia. Studies concerning postoperative complications in the early postoperative period such as pancreatic fistula and delayed gastric emptying have been most frequent. Randomized controlled trials comparing anastomotic procedures for the remnant pancreas, standard PD versus PD with extended lymphadenectomy, and PD versus pylorus-preserving PD follow in descending order. The average sample size has been 117, and 10 RCTs had sample size less than 50. The rate of multicenter studies among all RCTs is 21%, with the rate in the most recent 5 years having increased 2-fold compared with that in the earlier period. Concerning the quality of RCTs, calculation of sample size was described in only 14 RCTs and intention to treat analysis was performed in 26 RCTs. CONCLUSIONS: This study reviewed 34 RCTs on PD performed all over the world. Although the quality of every RCT was not satisfactory, high-grade evidence obtained by these RCTs should be applied in clinical settings to improve surgical quality and quality of life for each patient.

Evidence-Based Medicine↗

PubMed2002

A comparison of handsearching versus MEDLINE searching to identify reports of randomized controlled trials.

This study aims to compare handsearching to a basic MEDLINE search for the identification of reports of randomized trials in specialized health care journals. Twenty-two specialized health care journals, published in the U.K., were handsearched for all reports of controlled trials (as defined by the Cochrane Collaboration). The reports of trials, which were judged to be definitely randomized, were identified from a random sample of three years per journal and form one element of this study. A MEDLINE search using the publication type terms 'randomized controlled trial' and 'controlled clinical trial' was also performed for the same journal years. The reports of trials retrieved by handsearching were then compared against those retrieved from the MEDLINE search, to identify differences in retrieval between the two techniques. Reports of randomized trials identified by the MEDLINE search but not found by handsearching were individually assessed to see if they met the Cochrane eligibility criteria for a report of a randomized trial. A total of 714 reports of randomized trials were found by using a combination of both handsearching and MEDLINE searching. Of these, 369 (52 per cent) were identified only by handsearching and 32 (4 per cent) were identified only by MEDLINE searching. Of the reports identified only by handsearching, 252 had no MEDLINE record, of which 232 (92 per cent) were meeting abstracts or published in supplements; 117 (25 per cent) of the 462 reports of randomized trials which had a MEDLINE record were missed by the electronic search because they did not have either of the publication type terms 'randomized controlled trial' or 'controlled clinical trial'. This proportion varied depending on when the reports of randomized trials were published (that is, before or after the introduction of the MEDLINE publication type terms above). The highest additional yield from handsearching compared to MEDLINE searching was for reports of randomized trials published prior to 1991 and from handsearching the non-MEDLINE indexed parts of a journal. The results of this study suggest that a combination of MEDLINE and handsearching is required to identify adequately reports of randomized trials.

Information Storage and Retrieval↗