Randomized Control Trial Research Research Articles

Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records.

Real-world evidence (RWE) and randomized control trial (RCT) data are considered mutually complementary. However, compared with RCT, the outcomes of RWE continue to be assigned lower credibility. It must be emphasized that RWE research is a real-world practice that does not need to be executed as RCT research for it to be reliable. The advantages and disadvantages of RWE must be discerned clearly, and then the proper protocol can be planned from the beginning of the research to secure as many samples as possible. Attention must be paid to privacy protection. Moreover, bias can be reduced meaningfully by reducing the number of dropouts through detailed and meticulous data quality management. RCT research, characterized as having the highest reliability, and RWE research, which reflects the actual clinical aspects, can have a mutually supplementary relationship. Indeed, once this is proven, the two could comprise the most powerful evidence-based research method in medicine.

Is sham acupuncture a real placebo: Skeptical for sham acupuncture

Since acupuncture came to western countries, research has been done to try and prove whether or not it is effective. Current Acupuncture research is most often based on the sham needle which was first designed by K Streitberger and J Kleinhenz in 1998. The sham acupuncture needles are developed for the control group and do not penetrate the skin. Sham acupuncture has been used in randomized controlled trial (RCT) for diseases which normally benefit from acupuncture treatment. The sham needle is not the best placebo needle though. Because of the use of sham acupuncture, the result of those research shows acupuncture having no effect or it shows there is no significant difference between real acupuncture (verum) and sham acupuncture (placebo). However, a detailed introduction of the Nine Classical Needles (ancient) and the Nine Modern Needles (SHI's nine needles) shows that the use of sham acupuncture in RCT research is flawed by design. This then casts doubt on the findings and conclusions reached by using sham acupuncture in RCT acupuncture research.

What qualitative research can contribute to a randomized controlled trial of a complex community intervention

Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

Safety Planning for Military (SAFE MIL): Rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients

Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). To date, few evidence-based suicide prevention programs have been developed for delivery to military personnel and family members admitted for psychiatric inpatient care due to suicidal self-directed violence. This paper describes the rationale and detailed methodology for a study called Safety Planning for Military (SAFE MIL) which involves a randomized controlled trial (RCT) at the largest military treatment facility in the United States. The purpose of this study is to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning Intervention (Stanley and Brown, 2012). Primary outcomes, measured by blinded assessors at one and six months following psychiatric discharge, include suicide ideation, suicide-related coping, and attitudes toward help seeking. Additionally, given the study's focus on a highly vulnerable patient population, a description of safety considerations for human subjects' participation is provided. Based on this research team's experience, the implementation of an infrastructure in support of RCT research within DoD settings and the processing of regulatory approvals for a clinical trial with high risk suicidal patients are expected to take up to 18–24months. Recommendations for expediting the advancement of clinical trials research within the DoD are provided in order to maximize cost efficacy and minimize the research to practice gap.

Adherence reporting in randomized controlled trials

Treatment adherence may influence the therapeutic effect that is observed in a randomized controlled trial (RCT). Adherence may also be an indicator of research quality and treatment acceptance by participants. Despite the importance of adherence in RCT research, little is known about current practices for its measurement and reporting. The objective of this study was to determine and evaluate adherence measurement and reporting practices in RCTs involving oral pharmacologic interventions published in high impact factor journals. We conducted a systematic review of RCTs involving oral pharmacotherapy published during 2010 in 10 high-impact general medicine and subspecialty journals. Two investigators independently abstracted data regarding trial characteristics, adherence monitoring, and adherence reporting. Differences were reconciled in conference. Descriptive statistics were calculated, statistical comparisons were made using chi-square analysis, and associations assessed using Spearman's rank correlation coefficient. Of 111 RCT manuscripts included in the sample, 51 (45.9%) reported study-drug adherence among participants. Studies that reported adherence results were more likely to report negative findings (i.e., no significant treatment effect in a superiority trial, non-equivalence in an equivalence trial) (p = 0.032). The most common method for adherence monitoring was pill count-back on returned bottles. Among the studies that reported adherence, the median adherence was 88.4% (range: 48%-100%), and trials with longer follow-up time reported lower adherence (r = -0.45; p = 0.0015). A minority of the 51 studies described a strategy for calculating adherence that accounted for participants who were lost to follow-up (11/51 studies; 21.6%), discontinued the study medication temporarily (6/51 studies; 11.8%), or discontinued the study drug permanently (1/51 study; 2%). This study is limited by the inclusion of a small set of journals with the highest impact factors in specific fields of clinical medicine, including general medicine. Although the analysis pertains to studies published in 2010, no new guidelines in the field since the last Consolidated Standards of Reporting Trials (CONSORT) statement have been issued that would be expected to change practices for adherence monitoring, analysis, and reporting. Adherence measurement methodology and results are underreported in published RCTs. In the minority of RCTs that provided adherence information, there was substantial heterogeneity in how adherence was defined, analyzed, and reported. Improved reporting of adherence may enhance the interpretation of study quality and results.

Early intensive behavioral intervention appears beneficial for young children with autism spectrum disorders

Reichow B, Barton EE, Boyd BA, Hume K. Early intensive behavioral intervention (EIBI) for young children with autism spectrum disorders (ASD). Cochrane Database Syst Rev 2012;10. Among children with autism spectrum disorder, what is the clinical efficacy of early intensive behavioral intervention (EIBI), compared with routine treatment, in lessening the impact of symptoms on children’s functioning? Systematic review of the treatment effect of EIBI. Clinic, school, or home based treatment. Children younger than 6 years of age with autism spectrum disorder. EIBI or treatment-as-usual. Primary outcomes: adaptive behavior, psychopathology (symptom severity), and deterioration on a primary measure (worsening). Secondary outcomes: intelligence, communication and language skills, social competence, and quality of life (for both children with autism spectrum disorder and their caregivers). One randomized controlled trial (RCT) and four non-RCTs with a total of 203 participants were included. All studies used a treatment-as-usual comparison group. The results of the four non-RCTs used a random-effects model of meta-analysis of the standardized mean differences. Positive effects in favor of the EIBI treatment group were found for all outcomes. The mean effect size for adaptive behavior was g (standardized mean difference) = 0.69 (95% CI: 0.38-1.01; P < .0001). The mean effect size for IQ was g = 0.76 (95% CI: 0.40-1.11; P < .0001). Three measures of communication and language skills all showed results in favor of EIBI: expressive language g = 0.50 (95% CI: 0.05-0.95; P = .03), receptive language g = 0.57 (95% CI: 0.20-0.94; P = .03), and daily communication skills g = 0.74 (95% CI: 0.30-1.18; P = .0009). The mean effect size for socialization was g = 0.42 (95% CI: 0.11-0.73; P = .0008), and for daily living skills was g = 0.55 (95% CI: 0.24-0.87; P =.0005). Quality of life and psychopathology effects were variable, depending on how they were measured. There is some evidence that EIBI is an effective behavioral treatment for some children with autism spectrum disorder. However, the current state of the evidence is limited because of the reliance on data from non-randomized control trials due to the lack of RCTs. Additional studies using RCT research designs are needed to make stronger conclusions about the effects of EIBI for children with autism spectrum disorder.

Efficacy and safety of laser therapy for acne vulgaris: a systematic evaluation

Objective To assess the efficacy and safety of various spectrum lasers in the treatment of acne vulgaris. Methods Based on the principles and methods of Cochrane systematic reviews, we searched the Cochrane Library (2009, 6 issues), PubMcd, Embase, China Biomedical Literature Database, China Journal Full Text Database, Chinese Scientific Journals Full Text Database. Retrieval time was up to June, 2009. Randomized controlled trials (RCTs) of lasers for acne vulgaris were included. Results Twelve RCTs totaling 367 patients were included. Because the lack of clinical homogeneity, only descriptive analysis was conducted. Acne lesion counts improved significantly with laser therapy. Adverse effects were limited to transient erythema and edema at treatment sites. Treatment-related pains were well tolerated. Conclusions Current evidence demonstrates that all type lasers in treating acne vulgaris is safe and efficacy. However, higher quality RCT research would be needed to verify the effects and status of lasers on acne vulgaris. Key words: Acne vulgaris; Lasers; Randomized controlled trials (RCT); Systematic review

Randomized Controlled Trials for loss prevention research: Process and problems

Retailers face difficult and expensive decisions regarding what loss prevention intervention they should use to reduce shrink. A Randomized Controlled Trial (RCT), based on the experimental research approach, can provide retailers with valuable information regarding the effectiveness of a loss prevention intervention. Implementing a RCT in the real world of retailing, however, presents several challenges to the validity of the results. This article, based on the experience of implementing several RCT projects for retailers, examines the threats to the validity of the results. It also provides practical recommendations for correcting the threats to validity. This article also recommends that researchers and retailers must collaborate to implement effective RCT research projects.

The Effectiveness of Distance Interventions for Increasing Physical Activity: A Review

Evaluate the effectiveness of distance physical activity interventions to establish intervention features that are key to success. Computerized searches for randomized controlled trials (RCTs) of distance physical activity interventions and visual scans of reference lists were performed between March 2004 and July 2006. Studies were included if they (1) employed a randomized controlled design, (2) encouraged physical activity in adults, and (3) had no face-to-face contact between participants and researchers or health educators. Twenty-two studies were found that met the inclusion criteria. Authors assessed the quality of the studies and coded articles according to key intervention features. This review is a systematic narrative review. Heterogeneity and poor study quality made formal meta-analysis inappropriate. Nevertheless, effect sizes were calculated for studies comparing intervention with control. Overall, distance interventions increased physical activity in the short term (between-group effect size range, -.2 to .45). Print medium plus telephone contact was the most effective delivery mode. Poor study quality prevented firm conclusions. However, distance interventions were found to promote physical activity in the short term for some populations. This review provided limited support for the efficacy of distance exercise interventions and revealed limitations of the extant literature. Expansion of RCT research into distance approaches to promoting physical activity is warranted.