scholarly journals Post-trial follow-up methodology in large randomised controlled trials: a systematic review

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Rebecca Llewellyn-Bennett ◽  
Danielle Edwards ◽  
Nia Roberts ◽  
Atticus H. Hainsworth ◽  
Richard Bulbulia ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Controlled Trials ◽  
Post Trial ◽  
Randomised Controlled

scholarly journals Potential impact on estimated treatment effects of information lost to follow-up in randomised controlled trials (LOST-IT): systematic review

BMJ ◽  
2012 ◽  
Vol 344 (may18 1) ◽  
pp. e2809-e2809 ◽  
Author(s):  
E. A. Akl ◽  
M. Briel ◽  
J. J. You ◽  
X. Sun ◽  
B. C. Johnston ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Treatment Effects ◽  
Controlled Trials ◽  
Potential Impact ◽  
Randomised Controlled ◽  
Lost To Follow Up

scholarly journals Partially randomised patient preference trials as an alternative design to randomised controlled trials: systematic review and meta-analyses

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031151 ◽  
Author(s):  
Karin A Wasmann ◽  
Pieta Wijsman ◽  
Susan van Dieren ◽  
Willem Bemelman ◽  
Christianne Buskens
Keyword(s):  
Systematic Review ◽  
External Validity ◽  
Randomised Controlled Trials ◽  
Primary Outcome ◽  
Internal Validity ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Meta Analyses ◽  
Lost To Follow Up

ObjectiveRandomised controlled trials (RCT) are the gold standard to provide unbiased data. However, when patients have a treatment preference, randomisation may influence participation and outcomes (eg, external and internal validity). The aim of this study was to assess the influence of patients’ preference in RCTs by analysing partially randomised patient preference trials (RPPT); an RCT and preference cohort combined.DesignSystematic review and meta-analyses.Data sourcesMEDLINE, Embase, PsycINFO and the Cochrane Library.Eligibility criteria for selecting studiesRPPTs published between January 2005 and October 2018 reporting on allocation of patients to randomised and preference cohorts were included.Data extraction and synthesisTwo independent reviewers extracted data. The main outcomes were the difference in external validity (participation and baseline characteristics) and internal validity (lost to follow-up, crossover and the primary outcome) between the randomised and the preference cohort within each RPPT, compared in a meta-regression using a Wald test. Risk of bias was not assessed, as no quality assessment for RPPTs has yet been developed.ResultsIn total, 117 of 3734 identified articles met screening criteria and 44 were eligible (24 873 patients). The participation rate in RPPTs was >95% in 14 trials (range: 48%–100%) and the randomisation refusal rate was >50% in 26 trials (range: 19%–99%). Higher education, female, older age, race and prior experience with one treatment arm were characteristics of patients declining randomisation. The lost to follow-up and cross-over rate were significantly higher in the randomised cohort compared with the preference cohort. Following the meta-analysis, the reported primary outcomes were comparable between both cohorts of the RPPTs, mean difference 0.093 (95% CI −0.178 to 0.364, p=0.502).ConclusionsPatients’ preference led to a substantial proportion of a specific patient group refusing randomisation, while it did not influence the primary outcome within an RPPT. Therefore, RPPTs could increase external validity without compromising the internal validity compared with RCTs.PROSPERO registration numberCRD42019094438.

scholarly journals Which treatment is most effective for patients with Achilles tendinopathy? A living systematic review with network meta-analysis of 29 randomised controlled trials

2020 ◽  
pp. bjsports-2019-101872 ◽  
Author(s):  
Arco C van der Vlist ◽  
Marinus Winters ◽  
Adam Weir ◽  
Clare L Ardern ◽  
Nicky J Welton ◽  
...  
Keyword(s):  
Systematic Review ◽  
Exercise Therapy ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Achilles Tendinopathy ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Wait And See ◽  
Randomised Controlled

ObjectiveTo provide a consistently updated overview of the comparative effectiveness of treatments for Achilles tendinopathy.DesignLiving systematic review and network meta-analysis.Data sourcesMultiple databases including grey literature sources were searched up to February 2019.Study eligibility criteriaRandomised controlled trials examining the effectiveness of any treatment in patients with both insertional and/or midportion Achilles tendinopathy. We excluded trials with 10 or fewer participants per treatment arm or trials investigating tendon ruptures.Data extraction and synthesisReviewers independently extracted data and assessed the risk of bias. We used the Grading of Recommendations Assessment, Development and Evaluation to appraise the certainty of evidence.Primary outcome measureThe validated patient-reported Victorian Institute of Sport Assessment-Achilles questionnaire.Results29 trials investigating 42 different treatments were included. 22 trials (76%) were at high risk of bias and 7 (24%) had some concerns. Most trials included patients with midportion tendinopathy (86%). Any treatment class seemed superior to wait-and-see for midportion Achilles tendinopathy at 3 months (very low to low certainty of evidence). At 12 months, exercise therapy, exercise+injection therapy and exercise+night splint therapy were all comparable with injection therapy for midportion tendinopathy (very low to low certainty). No network meta-analysis could be performed for insertional Achilles tendinopathy.Summary/conclusionIn our living network meta-analysis no trials were at low risk of bias and there was large uncertainty in the comparative estimates. For midportion Achilles tendinopathy, wait-and-see is not recommended as all active treatments seemed superior at 3-month follow-up. There seems to be no clinically relevant difference in effectiveness between different active treatments at either 3-month or 12-month follow-up. As exercise therapy is easy to prescribe, can be of low cost and has few harms, clinicians could consider starting treatment with a calf-muscle exercise programme.PROSPERO registration numberCRD42018086467.

scholarly journals Perioperative liberal versus restrictive fluid strategies and postoperative outcomes: a systematic review and metanalysis on randomised-controlled trials in major abdominal elective surgery

Critical Care ◽  
2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Antonio Messina ◽  
Chiara Robba ◽  
Lorenzo Calabrò ◽  
Daniel Zambelli ◽  
Francesca Iannuzzi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Postoperative Complications ◽  
Randomised Controlled Trials ◽  
Elective Surgery ◽  
Fluid Management ◽  
Risk Difference ◽  
Controlled Trials ◽  
Perioperative Fluid Management ◽  
Liberal Approach ◽  
Randomised Controlled

Abstract Background Postoperative complications impact on early and long-term patients’ outcome. Appropriate perioperative fluid management is pivotal in this context; however, the most effective perioperative fluid management is still unclear. The enhanced recovery after surgery pathways recommend a perioperative zero-balance, whereas recent findings suggest a more liberal approach could be beneficial. We conducted this trial to address the impact of restrictive vs. liberal fluid approaches on overall postoperative complications and mortality. Methods Systematic review and meta-analysis, including randomised controlled trials (RCTs). We performed a systematic literature search using MEDLINE (via Ovid), EMBASE (via Ovid) and the Cochrane Controlled Clinical trials register databases, published from 1 January 2000 to 31 December 2019. We included RCTs enrolling adult patients undergoing elective abdominal surgery and comparing the use of restrictive/liberal approaches enrolling at least 15 patients in each subgroup. Studies involving cardiac, non-elective surgery, paediatric or obstetric surgeries were excluded. Results After full-text examination, the metanalysis finally included 18 studies and 5567 patients randomised to restrictive (2786 patients; 50.0%) or liberal approaches (2780 patients; 50.0%). We found no difference in the occurrence of severe postoperative complications between restrictive and liberal subgroups [risk difference (95% CI) = 0.009 (− 0.02; 0.04); p value = 0.62; I2 (95% CI) = 38.6% (0–66.9%)]. This result was confirmed also in the subgroup of five studies having a low overall risk of bias. The liberal approach was associated with lower overall renal major events, as compared to the restrictive [risk difference (95% CI) = 0.06 (0.02–0.09); p value  = 0.001]. We found no difference in either early (p value  = 0.33) or late (p value  = 0.22) postoperative mortality between restrictive and liberal subgroups Conclusions In major abdominal elective surgery perioperative, the choice between liberal or restrictive approach did not affect overall major postoperative complications or mortality. In a subgroup analysis, a liberal as compared to a restrictive perioperative fluid policy was associated with lower overall complication renal major events, as compared to the restrictive. Trial Registration CRD42020218059; Registration: February 2020, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=218059.

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