Investigating the Adequacy of Intervention Descriptions in Recent Speech-Language Pathology Literature: Is Evidence From Randomized Trials Useable?

2017 ◽  
Vol 26 (2) ◽  
pp. 443-455 ◽  
Author(s):  
Arabella Ludemann ◽  
Emma Power ◽  
Tammy C. Hoffmann
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Speech Language Pathology ◽  
Consecutive Sample ◽  
Randomized Controlled ◽  
Session Duration ◽  
Language Pathology ◽  
Intervention Description ◽  
Poor Reporting

Purpose To evaluate the completeness of intervention descriptions in recent randomized controlled trials of speech-language pathology treatments. Method A consecutive sample of entries on the speechBITE database yielded 129 articles and 162 interventions. Interventions were rated using the Template for Intervention Description and Replication (TIDieR) checklist. Rating occurred at 3 stages: interventions as published in the primary article, secondary locations referred to by the article (e.g., protocol papers, websites), and contact with corresponding authors. Results No interventions were completely described in primary publications or after analyzing information from secondary locations. After information was added from correspondence with authors, a total of 28% of interventions was rated as complete. The intervention elements with the most information missing in the primary publications were tailoring and modification of interventions (in 25% and 13% of articles, respectively) and intervention materials and where they could be accessed (18%). Elements that were adequately described in most articles were intervention names (in 100% of articles); rationale (96%); and details of the frequency, session duration, and length of interventions (69%). Conclusions Clinicians and researchers are restricted in the usability of evidence from speech-language pathology randomized trials because of poor reporting of elements essential to the replication of interventions.

scholarly journals High-cited favorable studies for COVID-19 treatments ineffective in large trials

2022 ◽  
Author(s):  
John P.A. Ioannidis
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Clinical Studies ◽  
Observational Studies ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Wide Dissemination ◽  
Highly Cited Articles ◽  
Highly Cited

Importance. COVID-19 has resulted in massive production, publication and wide dissemination of clinical studies trying to identify effective treatments. However, several widely touted treatments failed to show effectiveness in large well-done randomized controlled trials (RCTs). Objective. To evaluate for COVID-19 treatments that showed no benefits in subsequent large RCTs how many of their most-cited clinical studies had declared favorable results for these interventions. Methods. Scopus (last update December 23, 2021) identified articles on lopinavir-ritonavir, hydroxycholoroquine/azithromycin, remdesivir, convalescent plasma, colchicine or interferon (index interventions) that represented clinical trials and that had received >150 citations. Their conclusions were assessed and correlated with study design features. The ten most recent citations for the most-cited article on each index intervention were examined on whether they were critical to the highly-cited study. Altmetric scores were also obtained. Findings. 40 articles of clinical studies on these index interventions had received >150 citations (7 exceeded 1,000 citations). 20/40 (50%) had favorable conclusions and 4 were equivocal. Highly-cited articles with favorable conclusions were rarely RCTs while those without favorable conclusions were mostly RCTs (3/20 vs 15/20, p=0.0003). Only 1 RCT with favorable conclusions had sample size >160. Citation counts correlated strongly with Altmetric scores, in particular news items. Only 9 (15%) of 60 recent citations to the most highly-cited studies with favorable or equivocal conclusions were critical to the highly-cited study. Conclusion. Many clinical studies with favorable conclusions for largely ineffective COVID-19 treatments are uncritically heavily cited and disseminated. Early observational studies and small randomized trials may cause spurious claims of effectiveness that get perpetuated.

scholarly journals Can musical intervention improve memory in Alzheimer’s patients? Evidence from a systematic review

2018 ◽  
Vol 12 (2) ◽  
pp. 133-142 ◽  
Author(s):  
Shirlene Vianna Moreira ◽  
Francis Ricardo dos Reis Justi ◽  
Marcos Moreira
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Positive Outcome ◽  
Memory Deficit ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Exclusion Criteria ◽  
Randomized Controlled

ABSTRACT Treatment with music has shown effectiveness in the treatment of general behavioural and cognitive symptoms of patients with various types of dementia. Objective: To assess the effectiveness of treatment with music on the memory of patients with Alzheimer’s disease (AD). Methods: A systematic search was performed on PubMed (Medline), Cochrane Library, PsycINFO and Lilacs databases up to June 2017 and included all randomized controlled trials that assessed memory using musical interventions in patients with AD. Results: Forty-two studies were identified, and 24 studies were selected. After applying the exclusion criteria, four studies involving 179 patients were included. These studies showed the benefits of using music to treat memory deficit in patients with AD. Conclusion: To the best of our knowledge, this is the first systematic review focusing on randomized trials found in the literature that analysed the role of musical interventions specifically in the memory of patients with AD. Despite the positive outcome of this review, the available evidence remains inconsistent due to the small number of randomized controlled trials.

scholarly journals Issues in the statistical detection of data fabrication and data errors in the scientific literature: simulation study and reanalysis of Carlisle, 2017

2017 ◽  
Author(s):  
Scott W. Piraino
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Screening Tool ◽  
Scientific Literature ◽  
Controlled Trials ◽  
Large Set ◽  
Random Assignment ◽  
Data Errors ◽  
Randomized Controlled ◽  
Statistical Detection

AbstractBackgroundThe detection of fabrication or error within the scientific literature is an important and underappreciated problem. Retraction of scientific articles is rare, but retraction may also be conservative, leaving open the possiblity that many fabricated or erroneous findings remain in the literature as a result of lack of scrutiny. A recently statistical analysis of randomized controlled trials [1] has suggested that the reported statistics form these trials deviate substantially from expectation under truely random assignment, raising the possiblity of fraud or error. It has also been proposed that the method used could be implemented to prospectively screen research, for example by applying the method prior to publication.Methods and FindingsTo assess the properties of the method proposed in [1], I carry out both theoretical and empirical evaluations of the method. Simulations suggest that the method is sensitive to assumptions that could reasonably be violated in real randomized controlled trials. This suggests that deviation for expectation under this method can not be used to measure the extent of fraud or error within the literature, and raises questions about the utlity of the method for propsective screening. Empirically analysis of the results of the method on a large set of randomized trials suggests that important assumptions may plausibly be violated within this sample. Using retraction as a proxy for fraud or serious error, I show that the method faces serious challenges in terms of precision and sensitivity for the purposes of screening, and that the performance of the method as a screening tool may vary across journals and classes of retractions.ConclusionsThe results in [1] should not be interpreted as indicating large amount of fraud or error within the literature. The use of this method for screening of the literature should be undertaken with great caution, and should recognize critical challenges in interpreting the results of this method.

Hair Removal Policies in Clean Surgery: Systematic Review of Randomized, Controlled Trials

2005 ◽  
Vol 26 (12) ◽  
pp. 923-928 ◽  
Author(s):  
B. S. Niël-Weise ◽  
J. C. Wille ◽  
P. J. van den Broek
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Working Party ◽  
Surgical Site Infections ◽  
Hair Removal ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Preoperative Hair Removal

AbstractObjective:To determine whether certain hair removal policies are better than others to prevent surgical-site infections in patients undergoing clean surgery.Methods:Publications were retrieved by a systematic search of Medline, the Cochrane Library, and EMBASE up to February 2005. Additionally, the reference lists of all identified trials were examined. All randomized trials, quasi-randomized trials, and systematic reviews or meta-analyses of randomized or quasi-randomized trials comparing hair removal policies in clean surgery were selected. Trials involving patients undergoing cranial neurosurgery were excluded. Two reviewers independently assessed trial quality and extracted data. Disagreements were resolved by discussion with a third reviewer. Data from the original publications were used to calculate the relative risk or risk difference of surgical-site infection. Data for similar outcomes were combined in the analysis, where appropriate, with the use of a random effects model.Results:Four trials were included in the review. No eligible systematic review or meta-analysis of randomized or quasi-randomized trials was found. The quality of the trials and how they were reported were generally unsatisfactory. Evidence regarding whether preoperative hair removal has any effect was inconclusive. When hair removal was considered necessary, evidence about the best time for removal was inconclusive. There was some evidence that hair removal by clipper is superior to removal by razor.Conclusions:Because of insufficient evidence as a basis for recommendations, the practical consequences for ward management were essential when the Dutch Working Party on Infection Prevention formulated its recommendations for hair removal policies. Large randomized, controlled trials are needed to determine the optimal policy for preoperative hair removal.

scholarly journals Factors affecting enrollment in randomized controlled trials conducted for patients with metastatic breast cancer

2020 ◽  
Vol 50 (8) ◽  
pp. 873-881
Author(s):  
Shozo Ohsumi ◽  
Hirofumi Mukai ◽  
Masato Takahashi ◽  
Yasuo Hozumi ◽  
Hiromitsu Akabane ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Informed Consent ◽  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Metastatic Breast ◽  
Controlled Trials ◽  
Breast Cancer Patients ◽  
Factors Affecting ◽  
Randomized Controlled

Abstract Background It is critical to obtain informed consent from eligible patients to complete clinical trials. We investigated the factors that affect the participation rates of eligible patients. Patients and methods Patients with metastatic breast cancer who were eligible for SELECT BC or SELECT BC-CONFIRM trials, randomized controlled trials conducted for patients with chemotherapy-naive metastatic breast cancer were recruited to prospective studies, SELECT BC-FEEL and SELECT BC-FEEL II, respectively. SELECT BC FEEL and SELECT BC-FEEL II were conducted to identify the factors affecting the rates at which informed consent was obtained, using a self-administered questionnaire we developed. Results In total, 232 patients participated in the studies. The patients who agreed to take part in the randomized trials were more likely than the refusers to answer that they decided to participate because: ‘My doctor wanted me to participate in this trial’ (P = 0.00000), ‘ My family or friends wanted me to participate in this trial’ (P = 0.00000), ‘Both treatment regimens used in the trial are suitable to me’ (P = 0.00383), ‘I know that the trial is conducted to determine which is a better treatment’ (P = 0.01196), and ‘ I think that my participation in the trial will contribute to the benefit to future patients with the same disease’ (P = 0.00756). Conclusions To enhance the consent rate in randomized trials of metastatic breast cancer patients, concepts of the trials must be considered important and acceptable not only by patients but also by doctors and their families.

scholarly journals Antithrombotic Therapy in COVID-19: Systematic Summary of Ongoing or Completed Randomized Trials

2021 ◽  
Author(s):  
Azita H. Talasaz ◽  
Parham Sadeghipour ◽  
Hessam Kakavand ◽  
Maryam Aghakouchakzadeh ◽  
Elaheh Kordzadeh-Kermani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Controlled Trials ◽  
Critically Ill Patients ◽  
Antithrombotic Therapy ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Antithrombotic Agents ◽  
Randomized Controlled ◽  
Data Gaps ◽  
Medical Wards

ABSTRACTEndothelial injury and microvascular/macrovascular thrombosis are common pathophysiologic features of coronavirus disease-2019 (COVID-19). However, the optimal thromboprophylactic regimens remain unknown across the spectrum of illness severity of COVID-19. A variety of antithrombotic agents, doses and durations of therapy are being assessed in ongoing randomized controlled trials (RCTs) that focus on outpatients, hospitalized patients in medical wards, and critically-ill patients with COVID-19. This manuscript provides a perspective of the ongoing or completed RCTs related to antithrombotic strategies used in COVID-19, the opportunities and challenges for the clinical trial enterprise, and areas of existing knowledge, as well as data gaps that may motivate the design of future RCTs.

scholarly journals Effectiveness of Thermal Annular Procedures in Treating Discogenic Low Back Pain

2012 ◽  
Vol 3;15 (3;5) ◽  
pp. E279-E304
Author(s):  
Standiford Helm II
Keyword(s):  
Systematic Review ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Controlled Trials ◽  
Low Back ◽  
Discogenic Pain ◽  
Randomized Controlled ◽  
Discogenic Low Back Pain

Background: Persistent low back pain refractory to conservative treatment is a common problem that leads to widespread impairment, resulting in significant costs to society. The intervertebral disc is a major source of persistent low back pain. Technologies developed to treat this problem, including various surgical instrumentation and fusion techniques, have not reliably provided satisfactory results in terms of either pain relief or increased function. Thermal annular procedures (TAPs) were first developed in the late 1990s in an attempt to treat discogenic pain. The hope was that they would provide greater value than fusion in terms of efficacy, morbidity, and cost. Three technologies have been developed to apply heat to the annulus: intradiscal electrothermal therapy (IDET), discTRODE, and biacuplasty. Since nerve ingrowth and tissue regeneration in the annulus is felt to be the source of pain in discogenic low back pain, when describing the 3 above techniques we use the term “thermal annular procedures” rather than “thermal intradiscal procedures.” We have specifically excluded studies treating the nucleus. TAPs have been the subject of significant controversy. Multiple reviews have been conducted resulting in varying conclusions. Study Design: A systematic review of TAPs for the treatment of discogenic low back pain. Objective: To evaluate the effectiveness of TAPs in treating discogenic low back pain and to assess complications associated with those procedures. Methods: The available literature on TAPs in treating discogenic low back pain was reviewed. The quality assessment and clinical relevance criteria utilized were the Cochrane Musculoskeletal Review Group criteria for interventional techniques for randomized trials, and the criteria developed by the Newcastle-Ottawa Scale criteria for observational studies. The level of evidence was classified as good, fair, or limited (or poor) based on the quality of evidence developed by the U.S. Preventive Services Task Force. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through December 2011, and manual searches of the bibliographies of known primary and review articles. Outcome Measures: The primary outcome measure was pain relief of at least 6 months. Secondary outcome measures were improvements in functional status. Results: For this systematic review, 43 studies were identified. Of these, 3 randomized controlled trials and one observational study met the inclusion criteria. Using current criteria for successful outcomes, the evidence is fair for IDET and limited (or poor) for discTRODE and biacuplasty procedures regarding whether they are effective in relieving discogenic low back pain. Since 2 randomized controlled trials are in progress on that procedure, assessment of biacuplasty may change upon publication of those studies. Limitations: The limitations of this systematic review include the paucity of literature and nonavailability of 2 randomized trials which are in progress for biacuplasty. Conclusion: In summary, the evidence is fair for IDET and limited (or poor) for discTRODE and biacuplasty is being evaluated in 2 ongoing randomized controlled trials. Key words: Spinal pain, chronic low back pain, discogenic pain, thermal procedures, annular procedures, IDET, biaculoplasty, disctrode

The role of an open-label non-intervention design versus a placebo-control arm in oncology randomized trials.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14099-e14099
Author(s):  
Igal Kushnir ◽  
Mark J. Clemons ◽  
Dean Fergusson ◽  
Dominick Bosse ◽  
M. Neil Reaume
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Placebo Control ◽  
Controlled Trials ◽  
Open Label ◽  
Investigational Agent ◽  
Randomized Controlled ◽  
Medical Oncologists ◽  
Metastatic Setting

e14099 Background: Randomized trials are considered the gold standard when assessing the efficacy of new therapeutic agents. In settings where there is no known effective agent available, a randomised study could compare the investigational agent with either a placebo arm or an open-label non-intervention arm (i.e. best supportive care). The use of placebo arm can result in additional inconvenience and time commitments for patients, as well as increased administrative and regulatory costs. We conducted a survey among Canadian medical oncologists to assess whether an open-label non-intervention arm would be an acceptable alternative control to placebo in randomized trials. Methods: Members of the Canadian Association of Medical Oncologists were invited to participate in an anonymous online survey. Standardized case scenarios were used to determine participants’ attitudes regarding the role of open-label randomized-controlled trials instead of a placebo. Results: Eighty-six medical oncologists and trainees responded (response rate was 27%). Eighty-one (94%) of respondents worked at university-affiliated centres and 41 (48%) had been in practice for at least 10 years. Fifty-one (59%) respondents believed that it is acceptable to use an open-label design instead of a placebo arm when assessing a therapeutic agent in the adjuvant setting. Thirty-eight (49%) felt it was acceptable to compare the investigational agent to an open-label arm instead of a placebo to assess overall survival in the metastatic setting. Twenty-eight (38%) of respondents felt using an open-label design when assessing quality of life endpoints was acceptable. Most physicians (75%) were unsure whether or not the US Food and Drug Administration requires a placebo-controlled arm in cancer clinical trials. Conclusions: We report disagreement and uncertainty among Canadian medical oncologists regarding the acceptability of an open-label design in randomized-controlled trials where no standard therapy is approved. Clearer guidance from regulatory bodies on the adequacy of different trial designs could help reduce this equipoise.

Year Up

2020 ◽  
pp. 139-158
Author(s):  
David Stoesz
Keyword(s):  
Inner City ◽  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Workforce Training ◽  
Controlled Trials ◽  
Innovative Strategy ◽  
Randomized Controlled ◽  
Training Initiative ◽  
Big Brother ◽  
Corporate Sponsors

Gerald Chertavian extrapolated from being a Big Brother by developing an internship program for minority, inner-city youth. Through socialization, training, and internships with corporate sponsors, Year Up demonstrates an innovative strategy for workforce training, which had come under review when conventional government training initiatives failed. Committed to documenting outcomes, Year Up embeds randomized controlled trials in organizational operations to continuously improve training. Another youth training initiative, Per Scholas, also integrates randomized trials in its operations.

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