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Results for “Randomized controlled trials”

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PubMed2006

Improved compliance and self-care in patients with periodontitis--a randomized control trial.

UNLABELLED: The present study was a randomized control trial to test an intervention emanating from the Client Self-care Commitment Model (CSCCM), to encourage patients to increase their responsibility for their oral self-care. MATERIALS AND METHODS: A total of 75 individuals were re-examined 1-2 years after their initial therapy at the Department of Periodontology, Uppsala County Council, Sweden. Patients who exhibited insufficient compliance, 37 individuals, were included in a randomized single-blind control trial to test an intervention based on the CSCCM. Patients were examined at baseline and 3 months after hygiene treatment. RESULTS: The results demonstrated that patients in the intervention (IV) group increased their interdental cleaning and reduced their plaque index significantly compared with the control group. The former also reduced the number of periodontal pockets >4 mm significantly from baseline until after the hygiene treatment. The majority of the individuals in the IV group reported that the written commitment had influenced on their oral self-care habits in a positive direction. CONCLUSIONS: The CSCCM enhanced the client participation in the treatment process and improved the compliance and oral self-care behaviours. In addition, the model contributed to a reduction in periodontal pockets.

Adult↗

PubMed2002

Breastfeeding peer support: maternal and volunteer perceptions from a randomized controlled trial.

BACKGROUND: Several studies have demonstrated the positive effects of peer support on various breastfeeding outcomes, but no study has assessed women's and peer volunteers' views on, or the nature and intensity of, the supportive intervention. The objective of this study was to describe maternal and peer volunteer perceptions of their experience while participating in a breastfeeding peer support trial. METHODS: A randomized controlled trial was conducted to evaluate the effect of telephone-based peer (mother-to-mother) support on breastfeeding duration. Two hundred and fifty-six primiparous breastfeeding women were randomly allocated to receive either conventional care or conventional care plus peer support. Three primary outcome measures were peer volunteer activity logs, maternal perceptions of peer support, and evaluations of the peer volunteer experience. RESULTS: Questionnaires were completed by 98.5 percent (n=130) of the mothers in the peer support group. Mothers reported their peer volunteers were available when difficulties were experienced, increased their confidence, decreased their concerns, and assisted them in reaching their breastfeeding goals. These supportive interactions resulted in 81.5 percent of mothers (n=106) being satisfied with their peer support experience and suggesting that every new mother should be offered this intervention. Similarly, all the peer volunteers interviewed (n=30) viewed their experience positively. They suggested some intervention modifications as follows: ensure that mothers enrolled in the program want peer support; provide peer volunteers with ongoing educational sessions and opportunities to "socialize" with other volunteers; and disseminate the results of peer support efforts. CONCLUSIONS: Both mothers and peer volunteers perceived their intervention experiences positively. Whereas maternal satisfaction was related to the number and duration of peer volunteer contacts, peer volunteers enjoyed their training session and the opportunity to assist mothers for a variety of reasons. Specific intervention modifications should be implemented to enhance peer volunteer satisfaction and retention.

Adult↗

PubMed1999

Meta-analyses of randomized controlled trials of laparoscopic vs conventional inguinal hernia repairs.

BACKGROUND: Despite randomized controlled trials, the merits of laparoscopic hernia repair remain poorly defined. A meta-analysis may provide a timely overview. METHODS: An electronic MEDLINE search, supplemented by a manual search, yielded 14 randomized controlled trials with usable statistical data, involving 2,471 patients. The trials were grouped for separate meta-analyses according to the control operation, either a tension-free or sutured repair, used for comparison. The effect sizes for operating time, postoperative pain, return to normal activity, and early recurrence were calculated, using a random-effects model when the effect sizes were heterogeneous and without subcategories. RESULTS: In all meta-analyses, the laparoscopic operation was significantly longer. When compared with tension-free repairs, the laparoscopic operation showed no advantage in terms of postoperative pain, but resulted in a shorter recovery (marginal significance). As compared with sutured repair, both postoperative pain and recovery were in favor of the laparoscopic operation. When all 14 trials were analyzed together, laparoscopic repairs still had moderately reduced postoperative pain and recovery time. CONCLUSIONS: Laparoscopic hernia repair has a modest advantage over conventional repairs. This advantage is more apparent when laparoscopic repairs are compared with sutured repairs rather than tension-free repairs.

Hernia, Inguinal↗

PubMed2004

Willingness of dialysis patients to participate in a randomized controlled trial of daily dialysis.

BACKGROUND: The National Institutes of Health (NIH) has proposed conducting randomized controlled trials comparing short, daily, in-center hemodialysis with conventional hemodialysis. However, there is concern that difficulties recruiting patients may prevent the successful completion of such trials if patients believe the inconveniences of daily dialysis outweigh any potential health benefits. METHODS: To gauge willingness to participate in a daily dialysis trial, we described a hypothetical, randomized controlled trial comparing conventional to daily hemodialysis to 209 chronic hemodialysis patients, and assessed their motivations for and concerns about participating. RESULTS: We found that 85 patients (41%) of 209 patients who agreed to be interviewed expressed some willingness to participate in the hypothetical trial. Patients who expressed greater willingness to participate were younger (OR for participating = 0.96 per year, 95% CI = 0.94 to 0.98, P= 0.001), less likely to smoke (OR = 0.38, 95% CI = 0.17 to 0.84, P= 0.017), more likely to have been hospitalized during the last 12 months (OR = 2.8, 95% CI = 1.5 to 5.5, P= 0.002), less likely to have reactive airway disease (OR = 0.21, 95% CI = 0.06 to 0.69, P= 0.01) or coronary artery disease (OR = 0.20, 95% CI = 0.08 to 0.53, P= 0.001), and less likely to be on the waiting list for a kidney transplant (OR = 0.23, 95% CI = 0.10 to 0.50, P < 0.0001). CONCLUSION: The study suggests that less than half of eligible patients would be willing to participate in the randomized controlled trial. Differing willingness to participate across patient subgroups suggests that certain subgroups (i.e., older patients and those with coronary artery disease) will need to be targeted to ensure that results are generalizable to most hemodialysis patients.

Adult↗

PubMed1999

Might stopping smoking reduce injury death risks? A meta-analysis of randomized, controlled trials.

BACKGROUND: Smokers have excesses of injuries. Randomized, controlled trials (RCT) could assess whether cigarette smoking (smoking) causes (and smoking cessation (cessation) prevents) those injuries. We analyzed injury, accident, suicide, and homicide deaths as secondary endpoints in RCT that induced cessation. METHODS: RCT were sought via MEDLINE, bibliographies, the CDC Smoking and Health database, and the GLOBALink Tobacco listserver. RCT were included if (1) net (intervention minus control) cessation totaled over 10% of all intervention smokers and (2) injury data were available. Relative risks (RR) were summarized by fixed effects modeling. RESULTS: Three trials were located (the Lung Health Study, MRFIT, and Whitehall RCT). In-trial annual point prevalence cessation averaged 41, 46, and 59% in the intervention group smokers versus 17, 22, and 28% in the respective controls. Intervention (cessation) was associated with pooled injury RR of 0.65 within the trials (95% confidence interval (CI) 0.36-1.19) and 0.68 (95% CI 0.43-1.09) with additional follow-up in the Lung Health and MRFIT populations. CONCLUSIONS: The smoking/injury death association is of borderline statistical significance in currently available RCT data. It modestly supports the significant forensic, cohort, case-control, cross-sectional, challenge-rechallenge, in vitro, and animal data suggesting that smoking may cause injury. Direct tests of the hypothesis could strengthen this inference.

Accidents↗

PubMed2007

Indomethacin prophylaxis for preterm infants: the impact of 2 multicentered randomized controlled trials on clinical practice.

OBJECTIVES: Two multicenter randomized controlled trials (RCTs) in premature infants (Ment et al, 1994 and TIPP, 2001) found beneficial effects of indomethacin prophylaxis on the incidences of patent ductus arteriosus (PDA), PDA ligation, and severe intracranial hemorrhage (ICH). The Ment trial recommended the use of indomethacin prophylaxis. The TIPP trial failed to find a benefit in its primary outcome (improved survival/neurodevelopmental outcome); this negative result may have discouraged indomethacin prophylaxis use. STUDY DESIGN: We used the National Institute of Child Health and Development's Neonatal Network Registry to determine the association between the 2 trials and the use of indomethacin prophylaxis. We also statistically assessed the assumptions that led to the TIPP trial's negative results. RESULTS: Use of indomethacin prophylaxis among network clinicians increased after publication of the Ment trial and decreased after the TIPP trial. Analysis of the TIPP trial showed that the primary outcome's anticipated effect size (> or = 20%) was too large; a smaller effect size (< 3%) would have been more appropriate based on the incidence of ICH in their population and its association with neurodevelopmental outcome. CONCLUSIONS: Two multicenter RCTs were associated with changes in indomethacin prophylaxis. After the Ment trial, the use of indomethacin prophylaxis increased. After the TIPP trial, which reported negative results based on an excessively large anticipated effect size, its use decreased.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1981

A method for assessing the quality of a randomized control trial.

A system has been constructed to evaluate the design, implementation, and analysis of randomized control trials (RCT). The degree of quadruple blinding (the randomization process, the physicians and patients as to therapy, and the physicians as to ongoing results) is considered to be the most important aspect of any trial. The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies. Description of the patient and treatment materials and the measurement of various controls of quality have less weight. An index of quality of a RCT is proposed with its pros and cons. If published papers were to approximate these principles, there would be a marked improvement in the quality of randomized control trials. Finally, a reasonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.

Clinical Trials as Topic↗

PubMed1998

Shortcomings of the randomized controlled trial: a view from the boondocks.

The randomized controlled trial (RCT), despite its well-known limitations, continues to be regarded as a gold standard in determining whether an intervention does more harm than good. Some recent evidence suggests that it tends to overvalue the modalities it tests. Moreover, the accuracy with which the disorder under consideration is diagnosed can be critical to the performance of a new intervention designed for it. When technological progress allows us to diagnose milder instances, some therapies, possibly useful in dire circumstances, will appear ineffective if most of a trial population is at low risk. Human individuality makes it impossible to duplicate a RCT. As a result, Popper's criterion of falsifiability may not be met and so the carrying out of a large-scale therapeutic experiment may not be a scientific activity. Finally, it is doubtful whether group probabilities derived from RCTs can be safely applied to individuals. These and other reservations concerning the applicability of the RCT to clinical practice are discussed.

Evidence-Based Medicine↗

PubMed2006

Randomized controlled trials in pediatric urology: room for improvement.

PURPOSE: The primary purpose of this study was to ascertain what proportion of the body of published literature in pediatric urology is represented by randomized controlled trials. The secondary purpose was to assess the quality of these trials. MATERIALS AND METHODS: Using a predefined strategy, we conducted systematic computerized searches of the MEDLINE (years 1966 to 2004) and EMBASE (1980 to 2004) databases to identify all English language randomized controlled trials related to pediatric urology. Full text versions of identified studies were reviewed in blinded fashion for key demographic, methodological and statistical characteristics. Trial quality was assessed with the previously validated Jadad tool. RESULTS: The 77 identified randomized controlled trials represented only 0.4% to 0.9% of the indexed pediatric urology literature. The origins of these trials were Europe (40%), North America (26%) and a variety of other geographic centers (34%). A primarily surgical focus was present in 43% of the studies. Trials with negative results represented only 19% of the total randomized controlled trials. Generally, the trials were of low to fair quality (median Jadad score 3), with substandard methodological reporting and planning. There was not a significant trend toward improved quality in recent years. Trials from North America and Europe had higher quality (p = 0.007), as did those reporting negative results (p = 0.0001). CONCLUSIONS: Randomized controlled trials in pediatric urology constitute only a small proportion of the body of published literature in the field. High quality studies are uncommon. Efforts should be made to increase the number of well designed, randomized controlled trials in pediatric urology.

Bibliometrics↗

PubMed2004

Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials.

OBJECTIVE: Studies investigating means of recruiting participants to randomized controlled trials (RCTs) are sparse. We investigated the effects of telephone reminders as a recruitment strategy. STUDY DESIGN AND SETTING: Sick-listed employees received a written invitation to participate in a study comparing standard treatments with a solution-focused follow-up and were randomly allocated to an intervention or control group (n=703). Those who did not respond within 2 weeks received either 'no reminder' (n=242) or 'attempted telephone reminder' (n=256). Outcome was enrollment to the RCT. RESULTS: An intention to recruit analysis revealed no significant differences between the groups (P=.229). An intention to phone analysis among nonresponders revealed significant differences between 'no reminder' (recruited 4.5%) and 'attempted telephone reminder' (recruited 12.1%) (P=.003, odds ratio 2.89, 95% confidence interval [CI] 1.42-5.90). An analysis of numbers needed to phone showed that to recruit one more person in this group of nonresponders, we needed to phone 13 persons (95% CI=8-33). CONCLUSION: Systematic use of telephone calls can increase the recruitment rate among nonresponders in RCTs.

Adolescent↗

PubMed2004

Treatment of diffuse proliferative lupus nephritis: a meta-analysis of randomized controlled trials.

BACKGROUND: In this systematic review of randomized controlled trials (RCTs), we assess the benefits and harm of current treatments for diffuse proliferative lupus nephritis (DPLN). METHODS: The Cochrane Controlled Trial Registry, MEDLINE, and EMBASE were searched for RCTs of treatment for DPLN. All available RCTs of patients with biopsy-proven DPLN were included, and data were extracted for overall mortality, end-stage renal disease, doubling of serum creatinine level, relapse, major infection, herpes zoster infection, ovarian failure, malignancy, and bladder toxicity. Treatment effects on these outcomes were summarized as relative risk (RR) with 95% confidence interval (CI) and pooled by using a random-effects model. RESULTS: Twenty-five of 920 articles identified were eligible RCTs and were included. The majority compared cyclophosphamide or azathioprine plus steroids versus steroids alone. Cyclophosphamide plus steroids reduced the risk for doubling of serum creatinine level (4 RCTs, 228 patients; RR, 0.59; 95% CI, 0.40 to 0.88) compared with steroids alone, but had no impact on overall mortality (5 RCTs, 226 patients; RR, 0.98; 95% CI, 0.53 to 1.82). However, risk for ovarian failure was increased significantly (3 RCTs, 147 patients; RR, 2.18; 95% CI, 1.10 to 4.34). In studies from the 1970s, azathioprine plus steroids reduced the risk for all-cause mortality compared with steroids alone (3 RCTs, 78 patients; RR, 0.60; 95% CI, 0.36 to 0.99), but had no effect on renal outcomes. Neither therapy was associated with increased risk for major infection. The addition of plasma exchange to these treatments offered no benefit, and information on other agents, including mycophenolate mofetil, was insufficient for analysis. CONCLUSION: Until future RCTs of newer agents are completed, the current use of cyclophosphamide combined with steroids remains the best option to preserve renal function in patients with DPLN. The smallest effective dose and shortest duration of treatment should be used to minimize gonadal toxicity without compromising efficacy.

Azathioprine↗

PubMed2003

[The Comprehensive Cohort Design as alternative to the randomized controlled trial in rehabilitation research: advantages, disadvantages, and implementation in the SARAH study].

In rehabilitation research new therapies have to be evaluated within randomized trials as the best choice for proving the efficacy. Randomized controlled trials are widely accepted as the definitive method for evaluating the efficacy of new therapies. The random assignment of patients to their treatment ensures the internal validity of the comparison of new treatments with controls. Often patients in a randomized trial only represent a small proportion of the patients who satisfy the inclusion criteria of the trial. This will especially be true in rehabilitation medicine because of strong preferences of the patients for one or the other therapy. An assessment of the external validity of trial results can best be achieved by comparing the study population to the population of patients who met the eligibility criteria but did not consent to randomization. The Comprehensive Cohort Design (CCD) is designed to have the opportunity of recruiting all patients fulfilling these eligibility criteria regardless of their consent to randomisation. Advantages and disadvantages of this study design will be discussed in detail and on the example of the SARAH-study.

Adult↗

PubMed2006

A randomized controlled trial of cognitive behavior therapy for borderline personality disorder: rationale for trial, method, and description of sample.

This paper describes the rationale for a randomized controlled trial, comparing cognitive behavior therapy in addition to treatment as usual with treatment as usual alone, for borderline personality disorder. Previous pioneering randomized controlled trials of psychotherapies have suffered from methodological weaknesses and have not always been reported clearly to allow adequate evaluation of either the individual study or comparisons across studies to be undertaken. We report on the recruitment and randomization, design, and conduct of an ongoing randomized controlled trial of one hundred and six patients with borderline personality disorder. Primary and secondary hypotheses and their planned analyses are stated. The baseline characteristics of 106 patients meeting diagnostic criteria for borderline personality disorder are described.

Adult↗

PubMed1999

The effect of a Mensendieck exercise program as secondary prophylaxis for recurrent low back pain. A randomized, controlled trial with 12-month follow-up.

STUDY DESIGN: A prospective, randomized, controlled trial with a stratification block design in which a Mensendieck exercise program was compared with the experience of a control group. OBJECTIVE: To evaluate the effect of a Mensendieck program on the incidence of recurrent episodes of low back pain in patients with a history of the condition who currently are working. SUMMARY OF BACKGROUND DATA: One episode of low back pain increases the risk of further episodes of the condition. The Mensendieck approach combines education and exercise. This approach has been used for many years in Scandinavia and the Netherlands. However, the effects on low back pain have not been evaluated previously in a randomized, controlled trial. METHODS: A total of 77 men and women, mean age 39.6 years (range, 21.2-49.8 years), who had finished treatment for a low back pain episode, were stratified according to incidence of low back pain episodes and symptoms of sciatica over the preceding 3 years. The patients were assigned at random to either the Mensendieck program or a control group. The Mensendieck group received 20 group sessions of exercises and ergonomic education in 13 weeks. At 5- and 12-month follow-up examinations, the patients were assessed for recurrence of low back pain, days of sick leave, low back pain, and functional scores. RESULTS: After 12 months, there was a significant reduction in recurrent low back pain episodes in the Mensendieck group compared with the control group (P < 0.05). There was a trend toward fewer days of sick leave because of low back pain in the Mensendieck group, but no significant differences between the groups. There was reduction in pain and improvement in function in both groups, with no significant differences between the groups. CONCLUSIONS: A secondary prophylaxis Mensendieck exercise program of 20 group sessions significantly reduced the incidence of low back pain recurrences in a population with history of the condition. However, there were no differences between the groups with regard to days of sick leave, low back pain, and function.

Activities of Daily Living↗

PubMed2006

Exercise therapy as a treatment for psychopathologic conditions in obese and morbidly obese adolescents: a randomized, controlled trial.

OBJECTIVE: We conducted a proof-of-concept, randomized, controlled trial to investigate the effects of a supervised exercise therapy intervention on psychopathologic outcomes in obese adolescents. METHODS: The participant sample consisted of 81 adolescents (age: 11-16 years) who had been referred to a children's hospital for evaluation of obesity or who responded to a community advertisement. Participants were assigned randomly to exercise therapy, an equal-contact exercise placebo intervention, or usual care. Intervention participants attended 3 one-on-one sessions per week for 8 weeks and then completed a home program for another 6 weeks. Outcomes included self-perceptions (self-esteem), depression, affect, physical activity, aerobic fitness, and BMI. RESULTS: A total of 18 of 81 participants were categorized as morbidly obese (BMI SD score: > 3.5; adult equivalent BMI: > or = 40). At baseline, 30.3% of participants had a Children's Depression Inventory score of > or = 13, and 27% reported recent suicidal ideation. Repeated-measures mixed analysis of covariance (controlling for baseline scores) revealed significant changes in physical self-worth, associated measures of self-esteem, and physical activity over time, consistently favoring exercise therapy. There were no significant changes in BMI. CONCLUSIONS: Findings confirmed psychopathologic conditions as a serious health concern in obese and morbidly obese adolescents. Our study is the first randomized, controlled trial to demonstrate that a brief supervised exercise therapy intervention has the potential to improve psychopathologic outcomes significantly and to increase physical activity in obese adolescents, relative to usual care.

Adolescent↗

PubMed2005

The randomized controlled trial: gold standard, or merely standard?

The randomized controlled trial (RCT) is not a gold standard: it is a good experimental design in some circumstances, but that's all. Potential shortcomings in the design and implementation of RCTs are often mentioned in passing, yet most researchers consider that RCTs are always superior to all other types of evidence. This paper examines the limitations of RCTs and shows that some types of evidence commonly supposed to be inferior to all RCTs are actually superior to many. This has important consequences for research methodology, for quality of care in clinical medicine, and--especially--for research funding policy. Because every study design may have problems in particular applications, studies should be evaluated by appropriate criteria, and not primarily according to the simplistic RCT/non-RCT dichotomy promoted by some prominent advocates of the evidence-based medicine movement and by the research evaluation guidelines based on its principles.

Biomedical Research↗

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↗