Controlled clinical trials in complementary medicine - outcome, quality and the impact factor

2010 ◽  
Vol 2 (4) ◽  
pp. 195-195
Author(s):  
MH Pittler ◽  
NC Abbot ◽  
E Ernst
Cartilage ◽  
2017 ◽  
Vol 9 (4) ◽  
pp. 339-345 ◽  
Author(s):  
Florian Frehner ◽  
Jan P. Benthien

Objective This study is a literature review from 2010 to 2014 concerning the quality of evidence in clinical trials about microfracture in attempt to repair articular cartilage. We have decided to focus on microfracturing, since this seems to be the best documented technique. Interest in evaluation of publication quality has risen in orthopaedic sports medicine recently. Therefore, we think it is necessary to evaluate recent clinical trials being rated for their evidence-based medicine (EBM) quality. We also compared the mean impact factor of the journals publishing the different studies as an indicator of the study’s citation and evaluated for a change over the studied time frame. Design To measure the EBM level, we applied the modified Coleman Methodology Score (CMS) introduced by Jakobsen. The impact factor, which is a measurement of the yearly average number of citations of articles recently published in that journal, was evaluated according to self-reported values on the corresponding journal’s website. Results We found that the mean CMS has not changed between 2010 and 2014. The mean impact factor has also not changed between 2010 and 2014. The CMS variance was high, pointing to different qualities in the evaluated studies. There is no evidence that microfracturing is superior compared to other cartilage repair procedures. Conclusion Microfracture cannot be seen as an evidence based procedure. Further research needs to be done and a standardization of the operating method is desirable. There need to be more substantial studies on microfracturing alone without additional therapies.


Blood ◽  
2020 ◽  
Vol 136 (6) ◽  
pp. 755-759 ◽  
Author(s):  
Xinyi Xia ◽  
Kening Li ◽  
Lingxiang Wu ◽  
Zhihua Wang ◽  
Mengyan Zhu ◽  
...  

Two case series examining the impact of convalescent plasma on patients with COVID-19 suggest some clinical benefit from early administration and modest impact on parameters of inflammation. Further assessment of the impact of this intervention awaits controlled clinical trials.


2020 ◽  
Vol 49 (6) ◽  
pp. 708-712
Author(s):  
John A. Kellum

<b><i>Introduction:</i></b> Reports of consensus conferences are usually valued less than reports of clinical trials even when rigorous methodology is used. However, limited data are available comparing the impact of these 2 methods of shaping clinical practice. <b><i>Objective:</i></b> Compare the publication impact of consensus conferences and clinical trials. <b><i>Methods:</i></b> Consensus publications from the Acute Disease Quality Initiative (ADQI) from 2002 through 2017 were identified and classified by subject matter. Randomized trials were identified in the same publication year and subject in journals, starting with the highest impact factor. Both publication types were matched, and total citations were determined for each using Google Scholar. A secondary analysis compared total costs for each publication type. <b><i>Results and Conclusions:</i></b> Seventeen ADQI consensus conference reports and 17 randomized trials were identified. ADQI reports received a similar number of citations per paper (median, interquartile range) compared to randomized trials (132, 54–228; vs. 159, 60–340, <i>p</i> = ns). Similarly, 10 (58.8%) ADQI reports and 10 randomized trials were cited &#x3e;100 times. On average, ADQI reports appeared in journals with lower impact factors compared to clinical trials (5.4 ± 4.6 vs. 25.4 ± 27.1; <i>p</i> &#x3c; 0.01). The median cost per citation (USD 2017) for ADQI reports was USD 606.01 compared to almost twice this figure, USD 1,182.59, for clinical trials on the same topics (<i>p</i> = 0.09). Despite being published in lower impact factor journals, consensus reports on topics in critical care nephrology, received similar citations to randomized controlled trials published the same year.


2017 ◽  
Vol 27 (4) ◽  
pp. 813-818
Author(s):  
Gavin C.E. Stuart ◽  
Henry C. Kitchener ◽  
Jan B. Vermorken ◽  
Michael J. Quinn ◽  
William Small ◽  
...  

ObjectiveThe objective of this study was to demonstrate that the construction of the Gynecologic Cancer InterGroup (GCIG) has increased collaboration and accrual to high-quality phase 3 trials at a global level.Materials and MethodsThe GCIG is a collaboration of 29 international cooperative clinical trial groups committed to conduct of high-quality phase 3 trials among women with gynecologic cancer. A complete bibliography of the reported phase 3 trials has been developed and is available on the GCIG Web site http://www.gciggroup.com. A “GCIG trial” is a trial in which any 2 or more GCIG member groups are formally involved. We reviewed the output of the GCIG from 1997 to 2015 with respect to member participation and quality of publication (impact factor and citation index). The publications are considered in 3 cohorts, 1997 to 2002, 2003 to 2008, and 2009 to 2014, for the purposes of comparison and progress. A social network map has been developed for these publications to identify how the GCIG has increased capacity for clinical trials globally.ResultsUsing a global map, the number of member groups in the GCIG has increased in each of the 3 periods. The total annual number of publications and citations within the 1997 to 2015 period has increased significantly. The average number of citations per publication is demonstrated in each of the 3 periods. The steady increase in the number of citations is used as a proxy for the impact of the publications. The impact factor of the journal and the number of citations are reported for the 10 most highly cited publications. Finally, using a social networking methodology, networking has visibly and numerically increased in each of the 3 periods.ConclusionsEvidence supports that the construction of the GCIG has increased collaboration and accrual to high-quality phase 3 trials at a global level among women with gynecologic cancer.


Blood ◽  
2020 ◽  
Vol 136 (6) ◽  
pp. 759-762 ◽  
Author(s):  
Livia Hegerova ◽  
Ted A. Gooley ◽  
Kelly A. Sweerus ◽  
Cynthia Maree ◽  
Neil Bailey ◽  
...  

Two case series examining the impact of convalescent plasma on patients with COVID-19 suggest some clinical benefit from early administration and modest impact on parameters of inflammation. Further assessment of the impact of this intervention awaits controlled clinical trials.


Author(s):  
Luisa Collado-Garrido ◽  
Paula Parás-Bravo ◽  
Pilar Calvo-Martín ◽  
Miguel Santibáñez-Margüello

Cerebral palsy is one of the main causes of disability in childhood. Resistance therapy shows benefits in increasing strength and gait in these patients, but its impact on motor function is not yet clear. The objective was to analyze the impact of resistance therapy on the improvement in the motor function using a review and meta-analysis. A comprehensive literature research was conducted in Medline (PubMed), Institute for Scientific Information (ISI) Web of Knowledge, and Physiotherapy Evidence Database (PEDro) in relation to clinical trials in which resistance therapy was used and motor function was assessed. Twelve controlled clinical trials and three non-controlled clinical trials (only one intervention arm) studies were identified. In terms of pre–post difference, the overall intra-group effect was in favor of resistance therapy intervention: standardized mean difference (SMD) = 0.37, 95% confidence interval (CI) = 0.21 to 0.52, p < 0.001 (random-effects model), with moderate heterogeneity (I2 = 59.82%). SMDs were also positive by restricting to each of the analyzed scales: SMD = 0.37, 1.33, 0.10, and 0.36 for Gross Motor Function Measure (GMFM), Lateral Step Up (LSU), Time Up and Go (TUG), and Mobility Questionnaire (MobQue) scales, respectively. Regarding the difference between groups, the results showed a high heterogeneity (I2 < 99%), with the mean difference (MD) also favorable for the GMFM scale: MD = 1.73, 95% CI = 0.81 to 2.64, p < 0.001 (random-effects model). Our results support a positive impact of resistance therapy on motor function. Further studies should delve into the clinical relevance of these results.


Blood ◽  
1989 ◽  
Vol 73 (1) ◽  
pp. 47-56 ◽  
Author(s):  
M Tubiana ◽  
M Henry-Amar ◽  
P Carde ◽  
JM Burgers ◽  
M Hayat ◽  
...  

Abstract From 1964 to 1987, the EORTC Lymphoma Group conducted four consecutive controlled clinical trials on clinical stages I and II Hodgkin's disease in which 1,579 patients were entered. From the onset the main aim of these trials was to identify the subsets of patients who could be treated safely by regional radiotherapy (RT). Therefore, several prognostic indicators were prospectively registered and progressively used in the trial protocols for the delineation of the favorable and unfavorable subgroups as soon as they were recognized of high predictive value. In the H2 trial (1972 to 1976), the histologic subtype was the only variable taken into account for the therapeutic strategy and the staging laparotomy findings were found to be of prognostic value only in patients with favorable prognostic indicators. In the H5 trial (1977 to 1982), patients were subdivided into two subgroups according to six prognostic indicators. Patients with favorable features were submitted to a staging laparotomy (lap); lap negative patients were randomized between mantle field RT and mantle field plus paraaortic RT. Disease free survival (DFS) and total survival (S) were similar in the two arms. Among patients with unfavorable features, DFS and S were significantly higher in the arm treated by combination of mechlorethamine, vincristine, procarbazine, prednisone (MOPP) chemotherapy (CT) and RT than in the arm treated by total nodal irradiation. Nevertheless, in patients below the age of 40, the overall survival rates were equivalent in the two arms. In the H6 trial, the delineation of the favorable subgroup was based on (a) absence of systemic symptoms and elevated ESR, (b) no more than one or two lymph node areas involved. The aim of the study was to assess the impact on survival of a therapeutic strategy including staging laparotomy. At a 4-year follow-up, no difference in survival was evidenced. In patients with unfavorable prognostic indicators, 3 MOPP- RT-3 MOPP were compared with 3 ABVD-RT-3 ABVD. From H1 to H5 trials, the proportion of patients having received CT during the course of the disease gradually decreased; the data suggest that a further reduction in the proportion of patients aggressively treated is conceptually possible. On the basis of the prognostic factors identified, one can delineate three subsets of patients and modulate toxic cost of the initial treatment according to the characteristics of these subsets. In the most favorable subgroup, RT alone produces high survival and CT is not justified.(ABSTRACT TRUNCATED AT 400 WORDS)


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