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In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed.
BACKGROUND: Public interest in herbal medicines has generated an increasing number of trials evaluating their efficacy. Trials with poor methodologic quality have exaggerated estimates of treatment effect, and incomplete reporting of trials causes difficulties in assessing trial methodologic quality. The objective of this project was to examine the quality of reporting of randomized controlled intervention trials of herbal medicine. METHODS: MEDLINE (1966 to September 2003) was searched for randomized controlled trials of 10 herbal medicines. Two individuals (J. G. and J. D.) independently assessed trials using the Consolidated Standard of Reporting Trials checklist. Disagreements were resolved by consensus. The mean number of checklist items reported across all and for individual herbal medicines was calculated. The influence of decade of publication and species of herbal medicine tested was explored using an analysis of variance. RESULTS: A total of 206 randomized controlled trials of herbal medicine were included. Interrater reliability on reporting quality assessment was high. A total of 45% of items were reported across all trials. The quality of reporting improved across decades from the 1970s to the 2000s. Individual herbal species differed in the total number of items reported, with echinacea, ginkgo, St. John's wort, and kava trials reporting the most items. CONCLUSIONS: Important methodologic components of randomized controlled trials of herbal medicines are incompletely reported including allocation concealment, method used to generate the allocation sequence, and whether an intention-to-treat analysis was used. Also, key information unique to these trials may be missing, such as percentage of active constituents and type or form of the herbal medicine preparation. We suggest trialists consult a recent extension of the Consolidated Standard of Reporting Trials statement specific to herbal medicine trials when designing and reporting randomized controlled intervention trials of herbal medicines.
A randomized controlled study in a family practice setting was conducted on the use of hypnosis in helping people quit smoking. In the hypnosis group 21 percent of patients quit smoking by the three month follow-up compared with 6 percent in the control group. By six months there were no significant differences between the two groups, and at one year 22 percent in the hypnosis group and 20 percent in the control group had quit. The only significant predictor of success with quitting was having a college education.
PURPOSE: The purpose of this study was to evaluate the sensitivity, specificity, and precision of MEDLINE search strategies for detecting randomized controlled trials (RCTs) in prosthodontics. MATERIALS AND METHODS: A list of RCTs was obtained by hand-searching the International Journal of Prosthodontics, Journal of Prosthetic Dentistry, and Journal of Prosthodontics published between 1988 and 1997. RCTs identified served as the "gold standard" with which different MEDLINE search strategies were compared. Subject headings, keywords, MEDLINE checktags, publication types, and combinations thereof were used, and their results were compared with the "gold standard". RESULTS: Sensitivity ranged from 9% to 67%, specificity was at least 96% for all searches, and precision ranged from 22% to 59%. The most productive searches were by publication type clinical trial and publication type randomized controlled trial. Combining search terms did not improve sensitivity for detecting RCTs published in prosthodontic journals (p > .10). CONCLUSION: These findings support the need for more detailed reporting of trial methodologies to facilitate accurate indexing of prosthodontic articles in MEDLINE.
In recent years, several large randomized trials have clarified the role of various interventions in acute myocardial infarction. There is clear evidence that thrombolytic therapy, aspirin, and beta-blockers reduce mortality. Both aspirin and beta-blockers also reduce reinfarction and stroke. Of the thrombolytic agents, comparative trials have established that tissue plasminogen activator and streptokinase have similar effects on mortality, morbidity, and left ventricular function. There appears to be an increased risk of cerebral hemorrhage with tissue plasminogen activator. The benefits of heparin in conjunction with aspirin and a thrombolytic agent are unclear and, at best, are likely to be modest. Heparin increases the risk of hemorrhagic complications twofold. Although trials of vasodilators conducted before the widespread use of thrombolytic therapy and aspirin have been promising, newer trials are needed to evaluate their effects among patients receiving these agents. The aggregate of all trials of the routine use of calcium antagonists or antiarrhythmic agents indicates that these agents do not improve survival.
The effectiveness of small group education of general practitioners in the management of asthma was evaluated by randomized controlled trial. The outcome measure was the asthma morbidity of the general practitioners' own patients. Following random selection from the list of one family practitioner committee in suburban London, the 27 participating general practitioners were allocated randomly to one of two educational groups or to a control group. The educational intervention comprised eight meetings at which the management of chronic asthma was discussed and attempts made to devise agreed strategies for care. The two educational groups devised different strategies. Asthma morbidity was assessed by postal questionnaires to patients before the intervention and on five further occasions at six-monthly intervals over two and a half years. Of 454 patients who entered the study 338 completed the sixth and final assessment. The degree of morbidity experienced by the patients and their reported use of asthma specific drugs was considerable and was notably constant over the period of study. There was no difference in morbidity between the three groups at the outset and no effect of the intervention could be demonstrated. In this educational intervention the participating general practitioners were not informed about the morbidity and drug use reported by their patients. This information may be crucial if small groups are to be used to design and implement effective strategies for care. It would appear that small group education of general practitioners in the form reported here is not effective in reducing morbidity from chronic asthma.
BACKGROUND: Current clinical practice guidelines recommend that no particular type of peritoneal dialysis (PD) catheter has been proved superior to another. However, a recent Cochrane review recommended the need for a large, well-designed, randomized, controlled trial of straight versus coiled PD catheters because of the paucity and suboptimal quality of previously performed trials. METHODS: A randomized controlled trial was undertaken at 2 metropolitan teaching hospitals comparing the effects of straight versus coiled PD catheters on time to catheter malposition (primary outcome), catheter-associated infection, technique failure, and all-cause mortality. RESULTS: One hundred thirty-two PD patients were enrolled and randomly assigned to insertion of a coiled (n = 62) or straight catheter (n = 70). There was no significant difference in time to laparoscopic reposition between the 2 cohorts (log-rank score, 0.41; P = 0.52). However, median technique survival was significantly worse for coiled catheters (1.5 years; 95% confidence interval [CI], 1.2 to 1.8) compared with straight catheters (2.1 years; 95% CI, 1.8 to 2.5; P < 0.05), primarily because of increased risk for inadequate dialytic clearance with the former. On univariate Cox proportional hazards model analysis, insertion of a coiled PD catheter was associated significantly with a greater risk for technique failure (unadjusted hazard ratio, 1.86; 95% CI, 1.03 to 3.36). No difference was observed between the 2 groups with respect to catheter-associated infections or overall patient survival. CONCLUSION: Coiled catheters do not influence the risk for drainage failure caused by catheter malposition compared with straight catheters, but are associated with significantly increased risk for PD technique failure, primarily because of inadequate dialytic clearance.
The aim of this randomized controlled trial was to assess the efficacy of interferon alfa-2b (IFN) for the treatment of advanced hepatocellular carcinoma (HCC). Fifty-eight patients with HCC who were not suitable for resection, transplantation, ethanol injection, or arterial embolization were stratified according to their Okuda stage and randomized to receive IFN (3 x 10(6), 3 times a week, for 1 year) (n = 30) or symptomatic treatment (n = 28). Both groups were identical in terms of age, sex, performance status, presence of constitutional syndrome, Child-Pugh class, Okuda stage, multinodularity, portal thrombosis, and extrahepatic spread. Adhesion to IFN treatment was adequate in 27 patients, with a mean duration of treatment of 8 +/- 3 months. However, IFN treatment was associated with side effects in 23 patients, leading to treatment discontinuation in 13 patients. Two of the 30 patients (6.6%) presented a partial response with greater than 50% size reduction and normalization of alpha-fetoprotein levels. The survival at 1 and 2 years according to intention to treat was not different between the 2 groups (58% and 38% vs. 36% and 12%, respectively, Breslow P =. 19, log rank P =.14) and the absence of difference was maintained when dividing patients according to their Okuda stage. The probability of presenting tumor progression (P =.17), or deterioration of Child-Pugh class (P =.37), performance status (P =. 07), or Okuda stage (P =.44) was not modified by IFN treatment. These results indicate that IFN is not properly tolerated in patients with cirrhosis and advanced HCC and that its administration prompts no benefit in terms of tumor progression rate and survival.
The methodology of randomized control trials (RCTs) of the primary treatment of early breast cancer has been reviewed using a quantitative method. Sixty-three RCTs comparing various treatment modalities tested on over 34,000 patients and reported in 119 papers were evaluated according to a standardized scoring system. A percentage score was developed to assess the internal validity of a study (referring to the quality of its design and execution) and its external validity (referring to presentation of information required to determine its generalizability). An overall score was also calculated as the combination of the two. The mean overall score for the 63 RCTs was 50% (95% confidence interval [CI] = 46% to 54%) with small and nonstatistically significant differences between types of trial. The most common methodologic deficiencies encountered in these studies were related to the randomization process (only 27 of the 63 RCTs adopted a truly blinded procedure), the handling of withdrawals (only 26 RCTs included all patients in the analyses), the description of the follow-up schedule (only 12 RCTs reported adequately), the report of side effects (adequate information given in 33 RCTs), and the description of the patient population (satisfactory in 29 RCTs). Telephone calls to the principal investigators improved the quality scores by seven points on a scale of 100, indicating that some of the deficiencies lay in reporting rather than performance. There was evidence that quality has improved over time and that the increasing tendency of involving a biostatistician in the research team was positively associated with the improvement of the internal validity but not with the external.
A randomized controlled trial of acellular diphtheria/pertussis/tetanus (ADPT) freeze-dried and liquid vaccines in infants was conducted in a peri-urban community (Ashaiman) in southern Ghana. Immunogenicity of the acellular vaccines, persistence of antibodies and adverse reactions were compared with those achieved with a whole-cell diphtheria-pertussis-tetanus (DPT) vaccine. The incidence of pertussis in the vaccine groups and prevalence of pertussis in children under 5 years of age in the study area were also determined. The acellular vaccines produced significantly fewer local and systemic reactions. Local reactions such as swelling and redness were observed in 2% (8/399) to 2.3% (9/385) of the acellular vaccine recipients as against 31% (122/394) in the whole-cell vaccine group. Fever ( > or = 37.5 degrees C) occurred in 7.27% (29/399) to 9.8% (38/385) in the acellular vaccine groups compared with 36.6% (145/394) in the whole-cell vaccine group. Geometric mean titres (GMTs), measured by ELISA, to pertussis toxin (PT) and filamentous haemagglutinin (FHA) were significantly higher in the acellular vaccine groups than in the whole-cell DPT (WCDPT) group. There were no significant differences in the GMTs of tetanus and diphtheria antitoxins between the two groups after each vaccination. Twelve months after primary vaccination, GMTs to PT in the freeze-dried, liquid ADPT groups and the WCDPT group have fallen from 56.23, 62.63 and 44.97 ELISA U/ml to 6.08, 6.18 and 11.30 ELISA U/ml, respectively. GMTs to FHA in all the vaccine groups also dropped during the same period from 49.94, 41.73 and 20.74 ELISA U/ml to 7.26, 7.72 and 5.91 ELISA U/ml, respectively. In this comparative controlled trial, the ADPT vaccines were more immunogenic, with less local and systemic reactions, than the WCDPT vaccine but there was a considerable drop in antibody titres in all the vaccine groups 12 months after primary vaccination. However, the levels of titres of anti-PT and anti-FHA antibodies in all the three vaccines that confer protection are not known. Further studies are necessary to provide this information in order to assess the need for subsequent booster doses after primary immunization with both ADPT and WCDPT vaccines.
BACKGROUND: In addition to well-established secondary prevention benefits for atherosclerotic coronary artery disease, 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are hypothesized to have short-term benefit in acute coronary syndrome (ACS), yet the data are inconsistent, with some trials underpowered to demonstrate therapeutic benefit. Our objective was to determine the effects of early, intensive statin therapy for ACS. DATA SOURCES: Studies found in the PubMed, MEDLINE, EMBASE, BIOSIS, SciSearch, PASCAL, and International Pharmaceutical Abstracts (IPA) databases and the Cochrane Controlled Trials Register published between January 1974 and May 2006. STUDY SELECTION: Randomized controlled trials of statins begun within 14 days of hospitalization for ACS were included. DATA EXTRACTION: Two investigators independently abstracted study quality, characteristics, and outcomes. DATA SYNTHESIS: Thirteen randomized controlled trials published before May 2006 were available, involving 17 963 adults (median number of patients, 135; median follow-up, 6 months). Early, intensive statin therapy for ACS decreased the rate of death and cardiovascular events over 2 years of follow-up (hazard ratio, 0.81 [95% confidence interval, 0.77-0.87]) (Q(3) = 58.54; P<.001; I(2) = 95%). Survival curves revealed that this benefit begins to occur between 4 and 12 months, achieving statistical significance by 12 months. There was no evidence of publication bias, and sensitivity analyses did not identify a dominating study or study characteristic. CONCLUSIONS: Early, intensive statin therapy reduces death and cardiovascular events after 4 months of treatment. The validity of this finding would be strengthened by an analysis of individual patient data.
BACKGROUND: Randomized controlled trials have demonstrated that fecal occult blood testing (FOBT) reduces colorectal cancer (CRC) mortality. However, patient compliance with FOBT is low and this is one of the major barriers to CRC screening. OBJECTIVE: To determine whether intensive patient education increases FOBT card return rates. DESIGN: Randomized controlled trial. SETTING: Department of Veterans Affairs primary care clinic. PARTICIPANTS: Seven hundred eighty-eight patients who were referred for FOBT. INTERVENTIONS: Patients were randomly allocated to receive either intensive (n=396) or standard (n=392) patient education. Patients in the intensive education group received a one-on-one educational session by primary care nurses on the importance of CRC screening, were instructed on how to properly collect stool specimens for FOBT, and were given a 2-page handout on CRC screening. Patients in the standard education group only received the FOBT cards and written instructions from the manufacturer on how to properly collect stool specimens for FOBT. RESULTS: Patients in the intensive education group were more likely to return the FOBT cards (65.9% vs 51.3%; P<.001) and called the clinic with additional questions less often (1.5% vs 5.9%; P=.001) than the standard education group. The median time to return the FOBT cards was significantly shorter in the intensive education group (36 vs 143 days; P<.001 by log-rank test). However, the proportion of patients who had a positive FOBT did not differ in the two groups (4.6% vs 6.0%; P=.51). CONCLUSIONS: Intensive patient education significantly improved patient compliance with FOBT. Future studies to evaluate additional educational strategies to further improve patient compliance with CRC screening are warranted.
This randomized controlled trial assessed which of three low-intensity ovulation induction protocols was associated with the highest rate of cycle completion among infertile women undergoing intrauterine insemination (IUI) with their husband's spermatozoa. Sixty-three women aged < or = 42 years with normospermic partners participated in the study. The primary diagnosis of infertility was unexplained in 89% of subjects, endometriosis in 6% and tubal factor in 5%. Women were assigned to three groups according to recombinant FSH dosage: group A received two ampoules (75 IU FSH per ampoule) on cycle day 4, and one ampoule on days 6 and 8 (total four ampoules); group B received two ampoules on days 4, 6 and 8 (total six ampoules); group C received two ampoules on days 4, 6, 8 and 10 (total eight ampoules). Daily ultrasound investigations began on cycle day 9-12 and human chorionic gonadotrophin (HCG) 5000 IU was administered when one or two follicles > or = 18 mm were seen. IUI was scheduled for the next day. HCG was given and/or ovulation shown to have occurred in 88 of 109 cycles attempted (81%) with no differences among the three dose groups. Two singleton pregnancies occurred (2.3% per ovulatory cycle and 1.8% per cycle start). There were no significant differences among the three regimes in terms of cycle parameters, suggesting that an individualized and more intensive approach to ovarian stimulation is necessary for many women with unexplained infertility.
OBJECTIVE: To evaluate the quality of reporting of randomized controlled trials for pharmacologic interventions in long-term care residents with dementia. DATA SOURCES: We performed electronic searches of AMED, CINAHL, E-PSYCHE, Cochrane Controlled Trials Register, and MEDLINE. We also searched the reference lists of included studies and bibliographies of relevant review articles. STUDY SELECTION: All randomized controlled trials for pharmacologic interventions in patients with dementia residing in long-term care facilities. DATA ABSTRACTION: We abstracted data independently, in duplicate, using a data abstraction sheet and a quality checklist. DATA SYNTHESIS: Fifteen trials met inclusion criteria. Five trials lacked institutional ethical review, while two lacked informed consent. Eleven trials gave adequate description of withdrawals and 14 trials reported adverse events adequately. We found incomplete reporting of methods of randomization, allocation concealment, restriction, blinding, sample size estimation and intention-to-treat analysis. Sensitivity analysis indicated that reporting of allocation concealment was associated with increased quality of trial according to the quality scale (P = 0.007). CONCLUSIONS: Clinicians and the public do not have high-quality information to guide pharmacologic decision making for long-term care residents with dementia. The reporting quality is highly variable in the trials reviewed, and concerns exist surrounding the conduct of several trials.
This study was a randomized controlled trial of a smoking cessation intervention for pregnant smokers. Women who reported smoking at their first antenatal visit and satisfied the inclusion criteria were asked to participate in the trial. Analysis was restricted to 393 evaluable women in the control group (received usual antenatal care) and 339 women to the study group (received usual antenatal care plus the intervention). The primary hypotheses were that the intervention would result in a higher proportion of quitters and that the mean birth-weight of babies born to women receiving the intervention would be greater than that of babies born to women in the control group. The outcome measures were smoking status based on self-report combined with a urinary cotinine level of <115 ng/mL, and birth-weight. There was no significant difference in quit rate between women receiving the intervention and women in the control group (11.9% versus 9.8% p=0.41). Babies born to women receiving the intervention were on average 84 g heavier than babies born to controls (p=0.04). The factors that contribute to the lack of a significant increase in smoking cessation in the intervention group and the possible explanation for the changes in birth-weight are discussed.
The authors conducted a randomized controlled trial of functional disability screening in a hospital-based internal medicine group practice. They assigned 60 physicians and 497 of their patients to either an experimental or a control group. Every four months the patients in both groups completed a self-administered questionnaire measuring physical, psychological, and social function. The experimental group physicians received reports summarizing their patients' responses; the control group physicians received no report. At the end of one year the authors found no significant difference between the patients of the experimental and control group physicians on any measure of functional status. Functional disability screening alone does not improve patient function.
AIMS: To study in a randomized placebo-controlled design the efficacy of the antidepressant venlafaxine, a serotonin and a weak noradrenaline reuptake inhibitor, in the treatment of atypical facial pain (AFP). METHODS: The study was a randomized, double-blind, crossover comparison of venlafaxine and a placebo. It consisted of 2 treatment periods, each of 4 weeks' duration, separated by a 2-week washout period. Thirty patients suffering from chronic pain who had been diagnosed with AFP after a thorough clinical examination were recruited. Pain intensity and pain relief were registered at 6 visits. Anxiety, depression, and adverse effects were recorded. Venous blood samples were collected at the end of each treatment period for the determination of serum levels of venlafaxine and its metabolites. RESULTS: Twenty patients completed the trial. Eight patients discontinued because of adverse effects and 2 patients were excluded because of noncompliance. Two patients completed the trial but were excluded from the analysis because they experienced no pain at the baseline visit. There was no significant difference in pain intensity reduction between the maximum tolerated dose of venlafaxine (75 mg in most cases) and the placebo. Pain relief was significantly greater with venlafaxine than with the placebo treatment. Significantly more escape medication was consumed during the placebo period compared with the venlafaxine period. No significant correlation was found between the serum concentration of the drug and the response to treatment. Anxiety and depression scores did not differ between venlafaxine and placebo treatment. Adverse effects were equally common during both treatments. CONCLUSION: Venlafaxine was only modestly effective in the treatment of AFP.
A Department of Health leaflet suggests two treatment methods for head lice: mechanical removal by wet combing; and insecticide lotion/rinses. However, there are no reports in the literature comparing the effectiveness of these two treatment methods and well controlled clinical trials of insecticide treatments are sparse. A pilot randomized control trial of the effectiveness of a specific method of wet combing, 'Bug Busting', against a single application of a proprietary insecticide product is reported. The difficulties of designing a trial are discussed and modifications that would allow a definitive trial to take place are suggested. The pilot study included enzyme analysis of lice for insecticide resistance status assessment.