Randomized Controlled Trials Methodology Research Articles

Laser land leveling technology for paddy production in Vietnam: impact on efficient irrigation and water conservation.

This research investigates the empirical effects of the laser land leveling (LLL) adoption on irrigation water and water efficiency in paddy production in the Mekong Delta region (MDR), using the randomized controlled trial (RCT) approach incorporated into input demand function models. The descriptive analysis highlights the potential for water reuse through farmers' drainage practices. However, the dependence on experiential methods for applying technology in paddy production poses challenges that could compromise long-term sustainability. The regression results indicate that the LLL treatment leads to savings of 1975 m3ha-1 and 1299.35 m3ha-1 in irrigation water and net water use in paddy production, respectively, compared to the control. These savings account for 20.52% of total irrigation water use and 28.64% of net water use. The projected savings on average are 375.51 and 247.05 million m3, respectively, for irrigation water and net water use with 5% implementation of the technology in the MDR. The research highlights the environmental benefits of the LLL technology and underscores the need for its promotion to achieve water conservation in paddy production, offering policymakers insights to enhance sustainable agriculture amid climate change and water scarcity. The study addresses significant gaps in the existing literature by providing an in-depth analysis of LLL technology's impact on irrigation water and efficiency by extending the drainage performance within the paddy mono-cropping context and employing RCT methodology combined with input demand function models to comprehensively evaluate its impact on irrigation water usage.

An Overview of Randomized Controlled Trials Examining Prescription and Nonprescription Pharmacological Interventions for Moderate to Severe Traumatic Brain Injury

Objective: To characterize randomized controlled trials (RCTs) of pharmacological interventions (prescription medications, nonprescription medications, and supplements) for the management of moderate to severe traumatic brain injury (MSTBI). Data sources: Systematic searches were conducted in MEDLINE, PubMed, Scopus, CINAHL, EMBASE, and PsycINFO for RCTs up to December 2022 inclusive in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Study selection and data extraction: Inclusion criteria were RCT study design; participants’ mean age ≥ 18 years and ≥ 50% had MSTBI; examined ≥ 1 pharmacological intervention(s), either alone or in combination with other interventions. Two independent reviewers conducted Cochrane risk of bias assessment. Data synthesis: Three hundred thirteen RCTs (1978-2022) met inclusion criteria. A total of 146 unique pharmacotherapies and supplements were studied. The most frequently studied intervention was mannitol ( n = 20 RCTs). Mean sample size was 230.4 (4-12 737) and 195 studies (62.3%) were conducted in the acute phase post-MSTBI. Four hundred thirty-five unique outcome measures (OMs) were studied; the most common OMs used were Glasgow Outcome Scale (GOS) (29.4%), mortality (25.2%), and intracranial pressure (25.2%), Glasgow Coma Scale (GCS) (19.5%), and mean arterial pressure (17.3%), and heart rate (10%). Of the included studies, only 7% ( n = 22) had low risk of bias. Conclusion: The paucity of high-quality studies, variability in RCT methodology, sample sizes, and OMs utilization, as well as the low number of RCTs conducted in the subacute- and chronic-phase after injury pose a challenge for conducting meta-analyses to provide strong recommendations for informed decision-making in clinical practice.

Interpreting modern randomized controlled trials of medical therapy in inflammatory bowel disease.

Treatment options for the medical management of inflammatory bowel disease (IBD) have expanded substantially over the past decade. Multiple classes of advanced therapies, including both monoclonal antibodies and novel oral small molecules, are now available for the treatment of moderately-to-severely active Crohn's disease and ulcerative colitis, highlighted by the approvals of the first IL23p19 antagonists, selective Janus kinase inhibitors and sphingosine-1-phosphate receptor modulators. These advances have been accompanied by the identification of novel targets and the rapid growth in both the number and size of IBD clinical trials. Over a dozen landmark randomized controlled trials (RCTs) have been completed in the past 5 years, including the first head-to-head biologic trials, the first combination biologic studies, and multiple phase III registrational trials of novel compounds with new co-primary and composite end points that will change the treatment landscape for years to come. Importantly, the methodology of RCTs in IBD has evolved substantially, with new trial designs, evaluation of unique patient populations, and different types of efficacy and safety end points being key innovations. In this Review, we provide a comprehensive evaluation of how modern RCTs of IBD medical therapies have evolved and the implications for their appraisal that will help guide the application of these data to clinical practice.

Country house poetry of the English Civil war: a metaphorical exploration of contemporary debates in UK child and adolescent psychoanalytic psychotherapy research and an update on TIGA-CUB

ABSTRACT Using the country house poetry of the English Civil War as a metaphor, this article traces some of the key debates in child and adolescent psychoanalytic psychotherapy (CAPPT) research over the last 25 years. It identifies three main trends: initial confidence that child and adolescent psychoanalytic psychotherapists (CAPPTs) could apply their existing theoretical methods to empirical research; recognition of the need to use qualitative methodology and to engage with quantitative approaches; and a period of retrenchment, with particular questioning of the use of randomised controlled trial (RCT) methodology. The article also reports the results of a service evaluation undertaken subsequent to the feasibility Trial on Inter-Generational Attachment and Children Undergoing Behaviour problems (TIGA-CUB) to determine whether to proceed to a large-scale, definitive trial, and the inclusion of TIGA-CUB in an on-going, innovative research project on RCT methodology. The article concludes that, if CAPPTs want RCT methodology more appropriate to their ways of working, the profession and the Association of Child Psychotherapists (ACP) will need to develop a more pro-research environment, as well as career pathways which combine clinical work and publicly funded research.

Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platform

BackgroundGerm Defence (www.germdefence.org) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly.MethodsWith NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics.ResultsGerm Defence was used 310,731 times. The average website satisfaction score was 7.52 (0–10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list.ConclusionsWhile the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment.Trial registrationThis trial was registered in the ISRCTN registry (14602359) on 12 August 2020.

Methodology reporting improved over time in 176,469 randomized controlled trials

ObjectivesTo describe randomized controlled trial (RCT) methodology reporting over time. Study Design and SettingWe used a deep learning-based sentence classification model based on the Consolidated Standards of Reporting Trials (CONSORT) statement, considered minimum requirements for reporting RCTs. We included 176,469 RCT reports published between 1966 and 2018. We analyzed the reporting trends over 5-year time periods, grouping trials from 1966 to 1990 in a single stratum. We also explored the effect of journal impact factor (JIF) and medical discipline. ResultsPopulation, Intervention, Comparator, Outcome (PICO) items were commonly reported during each period, and reporting increased over time (e.g., interventions: 79.1% during 1966–1990 to 87.5% during 2010–2018). Reporting of some methods information has increased, although there is room for improvement (e.g., sequence generation: 10.8–41.8%). Some items are reported infrequently (e.g., allocation concealment: 5.1–19.3%). The number of items reported and JIF are weakly correlated (Pearson's r (162,702) = 0.16, P < 0.001). The differences in the proportion of items reported between disciplines are small (<10%). ConclusionOur analysis provides large-scale quantitative support for the hypothesis that RCT methodology reporting has improved over time. Extending these models to all CONSORT items could facilitate compliance checking during manuscript authoring and peer review, and support metaresearch.

Mild matters: trial learnings and importance of community engagement in research for early identified bilateral mild hearing loss.

Early identification of mild hearing loss has resulted in early hearing amplification without adequate evidence of effectiveness. This paper describes learnings from a pilot trial, combined with a qualitative study, to highlight the importance of community engagement in designing research studies to determine whether early amplification benefits young children with bilateral mild hearing loss. PART 1 of the study is a proof-of-concept non-blinded multi-centre randomised controlled trial (RCT) of hearing device fitting vs. no fitting aimed to gather preliminary data and determine its acceptability/feasibility in children <2 years old with bilateral mild hearing loss. PART 2 is a qualitative study to understand the barriers/enablers to RCT participation. Of 40 potentially eligible families, nine (23%) declined, three were uncontactable (7%), 26 (65%) ineligible: of these, nine (35%) did not meet hearing threshold inclusion criteria, 11 (42%) were already fitted or had made decisions on fitting hearing device, two (7%) had conductive loss and four (16%) were ineligible for other reasons. Two of 11 (18%) eligible families were randomised. With the limited sample size, outcome measures were not compared between groups. Both participants completed the trial, reported the RCT to be acceptable, and neither changed group post-enrolment. Whilst recruitment uptake could potentially be increased by altering the eligibility criteria, better communication with and reimbursement of clinicians as recruiters, and improving awareness of the study amongst external stakeholders, the RCT methodology does not conform to family-centred practice, and potentially raises ethical concerns regarding potential adverse consequences of not offering early amplification. Parental perception of losing control over choice of management due to randomisation is not an easily modifiable factor. Alternative methodological approaches without randomisation are required to determine whether hearing amplification benefits infants with mild hearing loss.Clinical Trial Registration: identifier [ACTRN12618001608257].

Psoriasis and Vitamin D: A Systematic Review and Meta-Analysis.

Psoriasis is a chronic immune-dysregulated inflammatory disease and hypovitaminosis D is considered a risk factor. We conducted an online database search to review and meta-analyze the relationship between vitamin D, other bone metabolism parameters, and psoriasis. The efficacy of oral vitamin D supplementation in improving Psoriasis Area and Severity Index (PASI) was also evaluated. Non-original articles, case reports, and animal studies were excluded. Bias risk was assessed according to the Cochrane Collaboration's tool and the Newcastle-Ottawa scale in randomized controlled trials (RCTs) and case-control studies, respectively. Unstandardized mean differences were used for data synthesis. Twenty-three studies reported serum 25 hydroxyvitamin D (25(OH)D) levels in 1876 psoriasis patients and 7532 controls. Psoriasis patients had significantly lower 25(OH)D levels than controls (21.0 ± 8.3 vs. 27.3 ± 9.8, p < 0.00001). Conversely, 450 psoriasis patients had lower levels of parathormone than 417 controls (38.7 ± 12.8 vs. 43.7 ± 16.5, p = 0.015). Four RCTs examined the effect of oral vitamin D supplementation on psoriasis for 173 patients and 160 patients were treated with placebo. No significant differences were found in PASI after 3, 6, and 12 months of supplementation. It is shown that 25(OH)D serum levels are significantly lower in psoriasis, but, although the granularity of RCT methodology may have influenced the pooled analysis, vitamin D supplementation did not seem to improve clinical manifestations.

A Randomized-Controlled Trial of EMDR Flash Technique on Traumatic Symptoms, Depression, Anxiety, Stress, and Life of Quality With Individuals Who Have Experienced a Traffic Accident.

The Flash Technique of Eye Movement Desensitization and Reprocessing (EMDR) is widely recognized for its effectiveness in reducing the effects of emotional responses associated with traumatic memories. Using a randomized-controlled trial methodology, this study attempts to establish the efficacy of the EMDR Flash Technique. This study’s sample includes volunteers who were involved in traffic accidents and were given the randomized EMDR Flash Technique and Improving Mental Health Training for Primary Care Residents (mhGAP) Stress management module. The participants were given a socio-demographic data form, the Depression-Anxiety-Stress 21 scale (DASS-21), the Impact of Event Scale-Revised (IES-R), and the WHOQOL Quality of Life scale. Participants were evaluated using measurements taken before and after the application, as well as a one-month follow-up. The mean age of the participants was 36.20 (11.41) years and 82.1% (n = 32) were female. The DASS-21 Anxiety (η2 = 0.085), IES-R Intrusion (η2 = 0.101), Avoidance (η2 = 0.124), Total (η2 = 0.147), and WHOQOL-BREF Psychological (η2 = 0.106) score improvements of the EMDR Flash Technique group were shown to be statistically significant when compared to the mhGAP group. However, no statistically significant difference in the DASS-21 Depression, Stress, Impact of Event Scale-Revised Hyperarousal WHOQOL-BREF General Health, Physical, Social Relationships, and Environment component scores was reported between the two groups. The present study’s findings clearly demonstrate that the EMDR Flash technique, when applied to persons involved in traffic accidents, is successful in improving anxiety, intrusion, avoidance, total traumatic stress, and mental quality of life symptoms for at least 1 month. We believe that these findings will improve the reliability and applicability of the EMDR Flash Technique, which was tested for the first time in a clinical randomized-controlled trial (RCT).

Commentary on “Promising careers? A critical analysis of a randomised control trial in community health worker recruitment in Zambia,” by James Wintrup

“Promising careers? A critical analysis of a randomised control trial in community health worker recruitment in Zambia” (Wintrup, 2021) raises important questions about the uses of randomized controlled trials (RCTs) and uses our RCT embedded in Zambia's National Community Health Assistant (CHA) Program (Ashraf et al., 2020a) as a case study to illustrate the pitfalls of the RCT methodology and especially its potential to do harm. This commentary clarifies the misunderstandings at the heart of Wintrup (2021)'s critique.

The importance of the design of observational studies in comparative effectiveness research: Lessons from the GARFIELD-AF and ORBIT-AF registries

Randomized controlled trials (RCTs) are considered the gold standard for estimating the effectiveness of a treatment. However, in many instances they are impractical to conduct because of time limitations, cost restrictions, or ethical reasons. As a consequence, non-randomized observational studies have an important role in comparative effectiveness and safety research since they can address issues that would not be possible using conventional RCT methodology. Observational studies can be strategically designed to reduce the risk of potential sources of bias by emulating the design principles of an equivalent but ideal randomized trial - the target trial - that would answer the research question of interest. In this article, we review some of the necessary components of observational studies required for valid causal inference within the framework of target trial emulation, so as to avoid common methodological pitfalls of study design. We discuss the assumptions of consistency, time-zero specification, exchangeability and positivity. To illustrate these concepts in a context where existing knowledge is well-established through clinical trials, we evaluate and compare the treatment effects of vitamin K antagonists (VKA) against no VKA (No VKA) on the treatment of atrial fibrillation from two real-world observational studies, namely the GARFIELD-AF and ORBIT-AF registries. Results are compared with those of published RCTs.

Education of Students with Disabilities, Science, and Randomized Controlled Trials

The purpose of this article is to examine the application of randomized controlled trial (RCT) methodology for determining the efficacy of school-based interventions in general and special education. In education science, RCTs are widely acknowledged as the gold standard of efficacy research, with other methodologies relegated to a lower level of credibility. However, scholars from different disciplines have raised a variety of issues with RCT methodology, such as the utility of random assignment, external validity, and the challenges of applying the methodology for assessing complex service interventions, which are necessary for many students with disabilities. Also, scholars have noted that school-based RCT studies have largely generated low effect sizes, which indicate that the outcomes of the interventions do not differ substantially from services as usual. The criticisms of RCT studies as the primary methodology in school-based intervention research for students with disabilities are offered along with recommendations for extending the acceptability of a broader variety of research approaches.

Psychogenic nonepileptic seizures that remit when the diagnosis is given: Just good luck?

ObjectiveSome patients with psychogenic nonepileptic seizures (PNES) remit when given the diagnosis. It is not realistically possible to test this potential therapeutic effect in an Randomized Controlled Trial (RCT) so we aim to statistically demonstrate it using the temporal relationship between the communication of the diagnosis and the timing of remission. MethodRe-analysis of data from a study of PNES, where diagnosis was communicated, and outcomes recorded in 54 patients. Making conservative assumptions and using the binomial distribution, the Poisson distribution and the chi-squared test distribution, we calculated likelihoods of the null hypothesis: that communication of the diagnosis and remission of seizures had occurred in random temporal relationship. ResultsRemission occurred in the week following communication of the diagnosis in 15 out of 54 patients. The χ2 test assigned this result a p value of <0.00001. Binomial and Poisson distribution calculations also indicated that remission was highly unlikely to have occurred by chance and that, in a dataset similar to ours, was unlikely to be due to chance if occurring in more than 9 patients (16.7%). ConclusionsWe showed that the observed remissions were highly unlikely to be due to chance. Where an intervention is ‘short and sharp’ and the outcome can be measured with reasonable temporal acuity, then this type of method may provide an alternative to RCT methodology when the latter is impracticable.

Research priorities and potential methodologies to inform care in subsequent pregnancies following stillbirth: a web-based survey of healthcare professionals, researchers and advocates

ObjectivesTo identify research priorities and explore potential methodologies to inform care in subsequent pregnancies following a stillbirth.DesignWeb-based survey by invitation.ParticipantsMultidisciplinary panel of 79 individuals involved in stillbirth research, clinical practice...

Predictive Modeling of Hypoglycemia Risk with Basal Insulin Use in Type 2 Diabetes: Use of Machine Learning in the LIGHTNING Study.

IntroductionHypoglycemia remains a global burden and a limiting factor in the glycemic management of people with diabetes using basal insulins or oral antihyperglycemic drugs. Hypoglycemia data gleaned from randomized controlled trials (RCTs) have limited generalizability, as the strict RCT methodology and inclusion criteria do not fully reflect the real-world clinical picture. Therefore, real-world evidence, gathered from sources including electronic health records (EHR), is increasingly recognized as an important adjunct to RCTs.Aims and methodsThe LIGHTNING study applied advanced analytical methods, including machine learning (ML), to EHR data. The study aimed to predict hypoglycemic event rates in patients with type 2 diabetes (T2DM) receiving different basal insulin treatments to identify potential subgroups of patients who are at lower risk of hypoglycemia when treated with one basal insulin compared with another and to predict hypoglycemia-related cost savings in these subgroups. Here we provide an overview of the objectives, study design and methods, and validation approaches used in the LIGHTNING study.ConclusionIt is hoped that results of the LIGHTNING study will help facilitate real-world clinical decision-making in addition to providing a clinically relevant predictive model of hypoglycemia risk.FundingSanofi.

Worldwide trends in volume and quality of published protocols of randomized controlled trials

Background: Publishing protocols of randomized controlled trials (RCT) facilitates a detailed description of study rationale, design, and related ethical and safety issues. Little is known about how the practice of publishing protocols developed over time. Therefore, this study describes the worldwide trends in volume and methodological quality of RCT protocols. Methods: PubMed and EMBASE were searched, identifying 596 protocols published over a decade. Data were extracted on quality characteristics. Methodological quality was stated as high if adequate generation of allocation, concealment of allocation and intention-to-treat analysis were used. A comparison was made by publication period, geographical region and medical specialty. Results: The number of published RCT protocols increased from 69 in the first, to 390 in the third period (p<0.0001). Internal medicine and paediatrics were the most common topics. Whereas most protocols in the first period originated from North America (n=30, 44%), in the second and third this was Europe (respectively, n=65, 47% and n=190, 48%) (p=0.02). Quality of protocols was higher in Europe compared to North America. Surgical protocols had the highest quality among the three specialty topics used in this study (OR=1.94, CI=1.09-3.45, p=0.02). Conclusion: A five-fold increase in RCT protocol publication was observed. Although quality of protocols improved, it varied between geographical regions and across medical specialties. Improving training in RCT methodology is therefore important.

Research Review: The effects of mindfulness-based interventions on cognition and mental health in children and adolescents - a meta-analysis of randomized controlled trials.

BackgroundMindfulness based interventions (MBIs) are an increasingly popular way of attempting to improve the behavioural, cognitive and mental health outcomes of children and adolescents, though there is a suggestion that enthusiasm has moved ahead of the evidence base. Most evaluations of MBIs are either uncontrolled or nonrandomized trials. This meta‐analysis aims to establish the efficacy of MBIs for children and adolescents in studies that have adopted a randomized, controlled trial (RCT) design.MethodsA systematic literature search of RCTs of MBIs was conducted up to October 2017. Thirty‐three independent studies including 3,666 children and adolescents were included in random effects meta‐analyses with outcome measures categorized into cognitive, behavioural and emotional factors. Separate random effects meta‐analyses were completed for the seventeen studies (n = 1,762) that used an RCT design with an active control condition.ResultsAcross all RCTs we found significant positive effects of MBIs, relative to controls, for the outcome categories of Mindfulness, Executive Functioning, Attention, Depression, Anxiety/Stress and Negative Behaviours, with small effect sizes (Cohen's d), ranging from .16 to .30. However, when considering only those RCTs with active control groups, significant benefits of an MBI were restricted to the outcomes of Mindfulness (d = .42), Depression (d = .47) and Anxiety/Stress (d = .18) only.ConclusionsThis meta‐analysis reinforces the efficacy of using MBIs for improving the mental health and wellbeing of youth as assessed using the gold standard RCT methodology. Future RCT evaluations should incorporate scaled‐up definitive trial designs to further evaluate the robustness of MBIs in youth, with an embedded focus on mechanisms of action.

Psychological therapy for inpatients receiving acute mental health care: A systematic review and meta-analysis of controlled trials.

The effectiveness of psychological therapies for those receiving acute adult mental health inpatient care remains unclear, partly because of the difficulty in conducting randomized controlled trials (RCTs) in this setting. The aim of this meta-analysis was to synthesize evidence from all controlled trials of psychological therapy carried out with this group, to estimate its effects on a number of important outcomes and examine whether the presence of randomization and rater blinding moderated these estimates. A systematic review and meta-analysis of all controlled trials of psychological therapy delivered in acute inpatient settings was conducted, with a focus on psychotic symptoms, readmissions or emotional distress (anxiety and depression). Studies were identified through ASSIA, EMBASE, CINAHL, Cochrane, MEDLINE, and PsycINFO using a combination of the key terms 'inpatient', 'psychological therapy', and 'acute'. No restriction was placed on diagnosis. The moderating effect of the use of assessor-blind RCT methodology was examined via subgroup and sensitivity analyses. Overall, psychological therapy was associated with small-to-moderate improvements in psychotic symptoms at end of therapy but the effect was smaller and not significant at follow-up. Psychological therapy was also associated with reduced readmissions, depression, and anxiety. The use of single-blind randomized controlled trial methodology was associated with significantly reduced benefits on psychotic symptoms and was also associated with reduced benefits on readmission and depression; however, these reductions were not statistically significant. The provision of psychological therapy to acute psychiatric inpatients is associated with improvements; however, the use of single-blind RCT methodology was associated with reduced therapy-attributable improvements. Whether this is a consequence of increased internal validity or reduced external validity is unclear. Trials with both high internal and external validity are now required to establish what type, format, and intensity of brief psychological therapy is required to achieve sustained benefits. Clinical implications: This review provides the first meta-analytical synthesis of brief psychological therapy delivered in acute psychiatric inpatient settings. This review suggests that brief psychological therapy may be associated with reduced emotional distress and readmissions. The evidence in this review is of limited quality. The type, format, and intensity of brief psychological therapy required to achieve sustained benefits are yet to be established.

Why randomised controlled trials of psychological treatments are still essential

The movement towards evidence-based practice in psychotherapy has recently provoked a backlash. In the past few years, some authors have raised questions concerning the validity of randomised controlled trials (RCTs), which have long been regarded as a crucial linchpin for evidence-based practice. These critics have argued that data from RCTs should not be prioritised above data derived from alternative evidentiary sources, such as observational studies, uncontrolled case studies, and clinical experience. 1 Clay R More than one way to measure. Am Psychol. 2010; 41: 52 Google Scholar , 2 Guy A Thomas R Stephenson SL Loewenthal D NICE under scrutiny: the impact of the National Institute for Health and Clinical Excellence guidelines on the provision of psychotherapy in UK. J Psychol Therap Primary Care. 2012; 1: 77-102 Google Scholar Although many of the criticisms have been aimed at RCT methodology in general, some sceptics have extended them to raise questions concerning the role of RCTs in the evaluation of psychological treatments. Changing the topic does not change the facts – Authors' replyIn keeping with Rapoport's Rules of Argumentation,1 we acknowledge several points of agreement with Jonathan Shedler regarding our Comment.2 We concur that the treatments recommended in the post-traumatic stress disorder (PTSD) practice guidelines are not panaceas: even the best PTSD treatments leave many patients with clinically significant symptoms. Development of better interventions or improvement of existing ones to reach these remaining individuals is needed. Full-Text PDF Changing the topic does not change the factsIn a Comment published in The Lancet Psychiatry, Scott Lilienfeld and colleagues1 wrote that I encouraged psychotherapists to ignore new practice guidelines for post-traumatic stress disorder (PTSD) because they relied inordinately on randomised controlled trials (RCTs). I did not urge therapists to ignore the guidelines because they relied on RCTs; I urged them to ignore the guidelines because research studies—the same RCTs they laud—show that the recommended therapies do not work for most patients. Full-Text PDF

Adherence to CONSORT Items in Randomized Controlled Trials of Integrative Medicine for Colorectal Cancer Published in Chinese Journals

The majority of studies of integrative treatment for colorectal cancer (CRC) have been published in Chinese journals. These studies indicate potential benefits, but concerns have been raised over the quality of trials published in Chinese journals. The CONSORT statement provides a guide for study reporting that has been endorsed by more than 400 international journals. Previous studies have used the CONSORT checklist to assess the quality of randomized controlled trials (RCTs). This study focused on RCTs of integrative and traditional medicine for CRC published in Chinese journals and assessed: (1) the overall quality of reporting with a focus on methodological aspects; (2) change over time; and (3) the influence of study funding, level of institution conducting the trial, rank of the journal, and the length of the article. Searches of seven databases identified RCTs. Quality was assessed using CONSORT 2010 with adaptations to facilitate scoring. Additional codes were added for publication year, hospital rank, report length, and status of the journal. Scores of each checklist item, total scores, and scores for eight items associated with RCT methodology were calculated. Eighty-one studies were included in the main analyses. The RCT methodology subgroup scores were significantly higher in studies: with public funding, conducted by authors from university hospitals, published in higher ranked journals, and in longer articles. Few Chinese journals mention CONSORT in their author guidelines. In these RCTs on CRC better reporting of RCT methodology was associated with ranking of the journal as "core," public funding of the RCT, and first or correspondent author from a university hospital but the quality of reporting had not significantly improved in 15 years. As the volume of scientific information produced in China grows, it is imperative that there is growth in the quality of this information.