Evaluation of ‘spin’ in the abstracts and articles of randomized controlled trials in pain literature and general anesthesia

2021 ◽  
Vol 11 (1) ◽  
pp. 23-28
Author(s):  
Jaime W Thompson ◽  
Ross Tanzer ◽  
Tate Triska ◽  
Jay Thompson ◽  
Trevor Bright ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trials ◽  
General Anesthesia ◽  
A Priori ◽  
Controlled Trials ◽  
End Points ◽  
Randomized Controlled ◽  
Pubmed Search ◽  
Clinical Consequences ◽  
Period Data

Aim: To evaluate the abstracts and articles of randomized controlled trials (RCTs) in pain literature and general anesthesia for the evidence of spin. Materials & methods: Following a priori protocol, we used a PubMed search for RCTs from a 2-year period. Data extracted using the Boutron spin definition for criteria. Results: A total of 163 articles were identified as RCTs with clear primary and secondary end points. A total of 33 trials were identified with nonsignificant primary end points. An 18/33 were found to have spin (54.5%). The spin was identified in the results, title and conclusion 12/18, 3/18 and 3/18, respectively. Conclusion: Spin was found in 54% of pain RCTs. With sensitive clinical concerns, such as chronic pain, any misrepresentation of validity could prove to have significant clinical consequences.

scholarly journals Total extraperitoneal (TEP) versus laparoscopic transabdominal preperitoneal (TAPP) hernioplasty: systematic review and trial sequential analysis of randomized controlled trials

Hernia ◽  
2021 ◽  
Author(s):  
Alberto Aiolfi ◽  
Marta Cavalli ◽  
Simona Del Ferraro ◽  
Livia Manfredini ◽  
Francesca Lombardo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Randomized Controlled Trials ◽  
Sequential Analysis ◽  
Hernia Recurrence ◽  
Trial Sequential Analysis ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Transabdominal Preperitoneal ◽  
Tapp Repair

Abstract Purpose To examine the updated evidence on safety, effectiveness, and outcomes of the totally extraperitoneal (TEP) versus the laparoscopic transabdominal preperitoneal (TAPP) repair and to explore the timely tendency variations favoring one treatment over another. Methods Systematic review and trial sequential analysis (TSA) of randomized controlled trials (RCTs). MEDLINE, Scopus, Web of Science, Cochrane Central Library, and ClinicalTrials.gov were consulted. Risk Ratio (RR), weighted mean difference (WMD), and 95% confidence intervals (CI) were used as pooled effect size measures. Results Fifteen RCTs were included (1359 patients). Of these, 702 (51.6%) underwent TAPP and 657 (48.4%) TEP repair. The age of the patients ranged from 18 to 92 years and 87.9% were males. The estimated pooled RR for hernia recurrence (RR = 0.83; 95% CI 0.35–1.96) and chronic pain (RR = 1.51; 95% CI 0.54–4.22) were similar for TEP vs. TAPP. The TSA shows a cumulative z-curve without crossing the monitoring boundaries line (Z = 1.96), thus supporting true negative results while the information size was calculated as adequate for both outcomes. No significant differences were found in term of early postoperative pain, operative time, wound-related complications, hospital length of stay, return to work/daily activities, and costs. Conclusions TEP and TAPP repair seems comparable in terms of postoperative hernia recurrence and chronic pain. The cumulative evidence and information size are sufficient to provide a conclusive evidence on recurrence and chronic pain. Similar trials or meta-analyses seem unlikely to show diverse results and should be discouraged.

RANDOMISED CONTROLLED TRIALS OF CHRONIC PAIN IN CHILDREN AND ADOLESCENTS: A SYSTEMATIC REVIEW

2015 ◽  
Vol 101 (1) ◽  
pp. e1.66-e1
Author(s):  
Rym Boulkedid ◽  
Armiya Yousouf Abdou ◽  
Emilie Desselas ◽  
Marlène Monegat ◽  
Corinne Alberti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Randomized Controlled Trials ◽  
Children And Adolescents ◽  
Methodological Quality ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Recurrent Pain ◽  
Pharmacological Agents ◽  
Randomized Controlled

BackgroundApproximately 15 to 30% of children and adolescents suffer from daily pain persistent over more than 3 months and there is evidence supporting that the prevalence of chronic pain is steadily increasing in this population. Chronic pain is known to have a negative impact on children's development and social behaviour, leading often to severe psychological distress and physical disability. We reviewed medical literature to assess the characteristics and quality of randomized controlled trials (RCTs) on pharmacological and non-pharmacological therapies in chronic and recurrent pain in the paediatric population.MethodsWe performed a systematic search of PubMed, Embase and the Cochrane Library up to March 2014. Bibliographies of relevant articles were also hand-searched. We included all RCTs that involved children and adolescents (age 0 to 18 years) and evaluated the use of a pharmacological agent or a non-pharmacological approach in the context of chronic or recurrent pain. The latter was defined as pain persisting for more than 3 months. Methodological quality was evaluated using the Cochrane Risk of Bias Tool. Two reviewers independently assessed studies for inclusion and evaluated methodological quality.ResultsA total of 52 randomized controlled trials were selected and included in the analysis. The majority were conducted in single hospital institutions, with no information on study funding. Median sample size was 45 (34–57) participants. Almost 50% of the RCTs included both adults and children with a median age at inclusion of 13 years. Non-pharmacological approaches were more commonly tested whereas evaluation of pharmacological agents concerned less than 30% of RCTs. Abdominal pain and headache were the most common types of chronic pain experienced among trial participants. Overall, the methodological quality was poor and did not parallel the number of RCTs that increased over the years. The risk of bias was high or unclear in 70% of the trials.ConclusionsThis is the first systematic review of RCTs conducted to evaluate pharmacological and non-pharmacological therapies in chronic and recurrent pain in children and adolescents. Although, management of pain in adults has significantly improved over the years due to the evaluation of numerous analgesic therapies, our results highlight the existing knowledge gap with regards to children and adolescents. Therapeutic strategies, in particular pharmacological agents, applied to relieve chronic or recurrent pain in children and adolescents are not evaluated through high quality RCTs. The need to improve analgesic therapy in children and adolescents with chronic pain is still unmet. We discuss possible research constraints and challenges related to this fact as well as adequate methodologies to circumvent them.

scholarly journals Outcomes of older patients with follicular lymphoma using individual data from 5922 patients in 18 randomized controlled trials

2021 ◽  
Vol 5 (6) ◽  
pp. 1737-1745
Author(s):  
Carla Casulo ◽  
Jesse G. Dixon ◽  
Fang-Shu Ou ◽  
Eva Hoster ◽  
Bruce A. Peterson ◽  
...  
Keyword(s):  
Elderly Patients ◽  
Follicular Lymphoma ◽  
Randomized Controlled Trials ◽  
Age Groups ◽  
Progression Free Survival ◽  
Controlled Trials ◽  
Early Disease ◽  
End Points ◽  
Randomized Controlled ◽  
Disease Outcomes

Abstract Limited data exist to describe the clinical features and outcomes for elderly patients with follicular lymphoma (FL). The Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) group performed a prospectively planned pooled analysis of individual patient data from first-line randomized controlled trials (RCTs) and examined associations between age (≤70 vs >70 years), clinical characteristics, and FL outcomes. We identified 18 multicenter clinical RCTs in the FLASH database that enrolled elderly patients (>70 years). Primary end points were early disease outcomes, CR24 and CR30, and progression-free survival (PFS) at 24 months (PFS24). Secondary end points were PFS and overall survival (OS). We identified 5922 previously untreated FL patients from 18 RCTs. Patients age >70 years (vs ≤70 years) more commonly had elevated lactate dehydrogenase, hemoglobin <12 g/dL, ECOG PS ≥2, and elevated β2-microglobulin. Median follow-up was 5.6 years. Patients >70 years did not differ from patients ≤70 years in rates of CR24, CR30, or PFS24. With a median OS of 14.6 years for all patients, median OS was 7.4 and 15.7 years for patients >70 and ≤70 years of age, respectively (hazard ratio = 2.35; 95% confidence interval = 2.03-2.73; P < .001). Age >70 years was a significant predictor of OS and PFS due to higher rates of death without progression, but not PFS24, CR24, or CR30. FL patients >70 years treated on trials have similar early disease outcomes to younger patients. There is no disease-specific outcome difference between age groups. Age alone should not disqualify patients from standard treatments or RCTs.

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