What constitutes clinical equipoise. Br J Neurosurg. Hewitt C. Adequacy and reporting of allocation concealment: review of recent trials published in four general medical journals. Higgins J, Green S. Cochrane handbook for systematic reviews of interventions version 5. Cochrane Collab. Designing clinical research, vol. Blinding of outcomes in trials of orthopaedic trauma: an opportunity to enhance the validity of clinical trials.
Blinding: who, what, when, why, how? Displaced intracapsular hip fractures in fit, older people: a randomised comparison of reduction and fixation, bipolar hemiarthroplasty and total hip arthroplasty.
Health Technol Assess. Kennedy A, Grant A. Subversion of allocation in a randomised controlled trial. Control Clin Trials. The role and interpretation of pilot studies in clinical research. J Psychiatr Res.
Type-II error rates beta errors of randomized trials in orthopaedic trauma. Sham surgery in orthopedics: a systematic review of the literature. Pain Med. Facts are more important than novelty: replication in the education sciences.
Educ Res. Randomized controlled clinical trials in orthopedics: difficulties and limitations. Rev Bras Ortop. Ethics in human research. Trop Parasitol. Contrasting medical and legal standards of evidence: a precision medicine case study. J Law Med Ethics. The ethics of sham surgery in clinical orthopaedic research. Misra S. Int J Surg. Design and execution of clinical trials in orthopaedic surgery. Bone Joint Res. Nissen T, Wynn R. The history of the case report: a selective review. JRSM Open.
Fluid lavage in patients with open fracture wounds FLOW : an international survey of surgeons. BMC Musculoskelet Disord. Safety and efficacy of long-term intraarticular steroid injections in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled trial.
Arthritis Rheum. The well-built clinical question: a key to evidence-based decisions. ACP J Club. Sample size calculation in clinical trials. Dtsch Arztebl Int. Am J Obstet Gynecol. Rothschild PC.
Social media use in sports and entertainment venues. Int J Event Festival Manag. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Although no study is likely on its own to prove causality, randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome. This is because the act of randomization balances participant characteristics both observed and unobserved between the groups allowing attribution of any differences in outcome to the study intervention.
This is not possible with any other study design. In designing an RCT, researchers must carefully select the population, the interventions to be compared and the outcomes of interest. Once these are defined, the number of participants needed to reliably determine if such a relationship exists is calculated power calculation. Participants are then recruited and randomly assigned to either the intervention or the comparator group.
This is often ensured by using automated randomization systems e. RCTs are often blinded so that participants and doctors, nurses or researchers do not know what treatment each participant is receiving, further minimizing bias. RCTs can be analyzed by intentionto-treat analysis ITT; subjects analyzed in the groups to which they were randomized , per protocol only participants who completed the treatment originally allocated are analyzed , or other variations, with ITT often regarded least biased.
All RCTs should have pre-specified primary outcomes, should be registered with a clinical trials database and should have appropriate ethical approvals. RCTs can have their drawbacks, including their high cost in terms of time and money, problems with generalisabilty participants that volunteer to participate might not be representative of the population being studied and loss to follow up.
There were no differences in the fetal outcomes between the 3 trial arms. In conclusion, this study demonstrates that a single IV iron infusion is an effective and safe option for treatment of IDA during pregnancy. FCM was more convenient than other treatments. Rapid parenteral iron repletion can improve iron stores, Hb levels and QoL in pregnant women, with ongoing benefits until delivery. Integration of IV iron for IDA in pregnancy can potentially improve pregnancy outcomes for the mother.
Update of guidelines to integrate the use of new IV iron preparations in pregnancy is warranted.
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