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• W1973133775 abstract "Editor's Capsule Summary for Ferre et al1Ferre R.M. Wasielewski J.N. Strout T.D. et al.Tamsulosin for uretal stones in the emergency department: a randomized, controlled trial.Ann Emerg Med. 2009; 54: 432-439Abstract Full Text Full Text PDF PubMed Scopus (40) Google ScholarWhat is already known on this topicPatients with ureteral calculi are often prescribed adjunctive treatment with an α-blocking agent to enhance spontaneous stone passage. This practice has not been validated in emergency department (ED) patients.What question this study addressedDoes the addition of a 10-day course of tamsulosin to standard therapy after discharge from the ED increase the rate of passage of distal ureteral stones?What this study adds to our knowledgeIn this randomized trial of 80 patients, most of whom had stones of 4 mm or less, time to stone passage was similar in tamsulosin and control patients.How this might change clinical practiceThis study does not support the routine use of tamsulosin in ED patients, though it is possible that it would be beneficial in patients with larger stones. Editor's Capsule Summary for Ferre et al1Ferre R.M. Wasielewski J.N. Strout T.D. et al.Tamsulosin for uretal stones in the emergency department: a randomized, controlled trial.Ann Emerg Med. 2009; 54: 432-439Abstract Full Text Full Text PDF PubMed Scopus (40) Google Scholar Patients with ureteral calculi are often prescribed adjunctive treatment with an α-blocking agent to enhance spontaneous stone passage. This practice has not been validated in emergency department (ED) patients. Does the addition of a 10-day course of tamsulosin to standard therapy after discharge from the ED increase the rate of passage of distal ureteral stones? In this randomized trial of 80 patients, most of whom had stones of 4 mm or less, time to stone passage was similar in tamsulosin and control patients. This study does not support the routine use of tamsulosin in ED patients, though it is possible that it would be beneficial in patients with larger stones. SEE RELATED ARTICLE, P. 432.Discussion Points1A well-designed clinical trial will be meaningless if the outcome measure is inappropriate, irrelevant, or unhelpful.A. What are the qualities of an ideal outcome measure?B. There are multiple types of outcome measures in clinical trials, including biomarkers, surrogate (aka intermediate) endpoints, and clinical (aka patient-centered) endpoints. Discuss the benefits and limitations of each of these outcome measures. Can you identify a recent high-profile case in which a drug with successful surrogate marker trials failed to demonstrate success when clinical endpoints were measured?C. In this small, randomized, controlled trial (RCT) of tamsulosin for the treatment of distal ureterolithiasis, the authors chose to study the primary outcome of successful spontaneous passage of renal calculi by 14 days. Is this a reasonable outcome measure to evaluate tamsulosin's efficacy? How might a patient's failure to recognize stone passage affect the results? Postulate why the authors used the passage of calculi by 14 days rather than time to passage as the primary outcome.D. Large clinical trials often use a composite outcome measurement. For example, a new heart failure trial might measure a composite outcome of death, emergency department visit, and/or unplanned hospitalization within 30 days. What are the advantages of using a composite endpoint? How might a composite outcome affect the trial's conclusions?E. This small trial also examines many secondary outcomes such as days of work missed, time to stone passage, adverse events, number of pain episodes, amount of pain medication used, and the number of return visits. What are the benefits of secondary outcomes, and what does a lack of a clinically important change in secondary outcomes usually mean?2Clarke et al2Clarke M. Sally Hopewell S. Chalmers I. Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report.J R Soc Med. 2007; 100: 187-190Crossref PubMed Scopus (99) Google Scholar have argued that every published RCT should begin with a systematic review of previous studies and conclude with a revised systematic review that shows how the RCT changes our belief about the topic. They suggest that this structure would foster the conduct of meaningful research.A. Speculate why the editors deemed this study sufficiently important to warrant publication in Annals.B. How did the ED-based study population and the other methodology factors discussed in answer 2a affect this study's results compared with previous studies?3In this study the authors randomized patients to a 10-day course of standard analgesic therapy or tamsulosin plus standard therapy. Study participants were not blinded to their treatment assignment because the investigators elected not to administer placebo tablets to patients randomized to the standard analgesic-only arm.A. It goes without saying that randomization is a central issue in the conduct of randomized clinical trials. Discuss the pros and cons of the following randomization techniques: simple randomization, prerandomization, block randomization, and stratified block randomization. What randomization technique did these authors select? How might a different randomization strategy have influenced the study results?B. Do you feel that the lack of placebo tablet in this trial altered the results? What if the primary outcome were patient ratings of their pain? Do you think it would have been more or less important to blind patients to their treatment assignment through the use of a placebo tablet?C. Imagine you are designing a placebo-controlled drug trial to treat renal colic in the ED. What practical considerations about the inclusion of the placebo do you need to weigh during the trial design? How might the study's conclusions be affected if the participants or the investigators measuring the outcome can differentiate active drug from placebo? How might investigators measure whether study participants are truly blinded to whether the treatment is active or placebo?4In this study the investigators performed an interim analysis and found no issues prompting early stoppage of the trial.A. What are the reasons that investigators perform interim analyses and why might a trial be stopped? How do planned interim analyses affect the study sample size? Why is it important to specify planned interim analyses in a clinical trial that is using a classic statistical analysis?B. The Bayesian statistical approach provides an alternative, and many would argue more robust, strategy for trial design and analysis. Describe the major differences between the Bayesian statistical approach and the more commonly used frequentist statistical approach with regard to hypothesis testing, interim analyses, analyzing the data, and interpreting the study's results. SEE RELATED ARTICLE, P. 432. Discussion Points1A well-designed clinical trial will be meaningless if the outcome measure is inappropriate, irrelevant, or unhelpful.A. What are the qualities of an ideal outcome measure?B. There are multiple types of outcome measures in clinical trials, including biomarkers, surrogate (aka intermediate) endpoints, and clinical (aka patient-centered) endpoints. Discuss the benefits and limitations of each of these outcome measures. Can you identify a recent high-profile case in which a drug with successful surrogate marker trials failed to demonstrate success when clinical endpoints were measured?C. In this small, randomized, controlled trial (RCT) of tamsulosin for the treatment of distal ureterolithiasis, the authors chose to study the primary outcome of successful spontaneous passage of renal calculi by 14 days. Is this a reasonable outcome measure to evaluate tamsulosin's efficacy? How might a patient's failure to recognize stone passage affect the results? Postulate why the authors used the passage of calculi by 14 days rather than time to passage as the primary outcome.D. Large clinical trials often use a composite outcome measurement. For example, a new heart failure trial might measure a composite outcome of death, emergency department visit, and/or unplanned hospitalization within 30 days. What are the advantages of using a composite endpoint? How might a composite outcome affect the trial's conclusions?E. This small trial also examines many secondary outcomes such as days of work missed, time to stone passage, adverse events, number of pain episodes, amount of pain medication used, and the number of return visits. What are the benefits of secondary outcomes, and what does a lack of a clinically important change in secondary outcomes usually mean?2Clarke et al2Clarke M. Sally Hopewell S. Chalmers I. Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report.J R Soc Med. 2007; 100: 187-190Crossref PubMed Scopus (99) Google Scholar have argued that every published RCT should begin with a systematic review of previous studies and conclude with a revised systematic review that shows how the RCT changes our belief about the topic. They suggest that this structure would foster the conduct of meaningful research.A. Speculate why the editors deemed this study sufficiently important to warrant publication in Annals.B. How did the ED-based study population and the other methodology factors discussed in answer 2a affect this study's results compared with previous studies?3In this study the authors randomized patients to a 10-day course of standard analgesic therapy or tamsulosin plus standard therapy. Study participants were not blinded to their treatment assignment because the investigators elected not to administer placebo tablets to patients randomized to the standard analgesic-only arm.A. It goes without saying that randomization is a central issue in the conduct of randomized clinical trials. Discuss the pros and cons of the following randomization techniques: simple randomization, prerandomization, block randomization, and stratified block randomization. What randomization technique did these authors select? How might a different randomization strategy have influenced the study results?B. Do you feel that the lack of placebo tablet in this trial altered the results? What if the primary outcome were patient ratings of their pain? Do you think it would have been more or less important to blind patients to their treatment assignment through the use of a placebo tablet?C. Imagine you are designing a placebo-controlled drug trial to treat renal colic in the ED. What practical considerations about the inclusion of the placebo do you need to weigh during the trial design? How might the study's conclusions be affected if the participants or the investigators measuring the outcome can differentiate active drug from placebo? How might investigators measure whether study participants are truly blinded to whether the treatment is active or placebo?4In this study the investigators performed an interim analysis and found no issues prompting early stoppage of the trial.A. What are the reasons that investigators perform interim analyses and why might a trial be stopped? How do planned interim analyses affect the study sample size? Why is it important to specify planned interim analyses in a clinical trial that is using a classic statistical analysis?B. The Bayesian statistical approach provides an alternative, and many would argue more robust, strategy for trial design and analysis. Describe the major differences between the Bayesian statistical approach and the more commonly used frequentist statistical approach with regard to hypothesis testing, interim analyses, analyzing the data, and interpreting the study's results. 1A well-designed clinical trial will be meaningless if the outcome measure is inappropriate, irrelevant, or unhelpful.A. What are the qualities of an ideal outcome measure?B. There are multiple types of outcome measures in clinical trials, including biomarkers, surrogate (aka intermediate) endpoints, and clinical (aka patient-centered) endpoints. Discuss the benefits and limitations of each of these outcome measures. Can you identify a recent high-profile case in which a drug with successful surrogate marker trials failed to demonstrate success when clinical endpoints were measured?C. In this small, randomized, controlled trial (RCT) of tamsulosin for the treatment of distal ureterolithiasis, the authors chose to study the primary outcome of successful spontaneous passage of renal calculi by 14 days. Is this a reasonable outcome measure to evaluate tamsulosin's efficacy? How might a patient's failure to recognize stone passage affect the results? Postulate why the authors used the passage of calculi by 14 days rather than time to passage as the primary outcome.D. Large clinical trials often use a composite outcome measurement. For example, a new heart failure trial might measure a composite outcome of death, emergency department visit, and/or unplanned hospitalization within 30 days. What are the advantages of using a composite endpoint? How might a composite outcome affect the trial's conclusions?E. This small trial also examines many secondary outcomes such as days of work missed, time to stone passage, adverse events, number of pain episodes, amount of pain medication used, and the number of return visits. What are the benefits of secondary outcomes, and what does a lack of a clinically important change in secondary outcomes usually mean?2Clarke et al2Clarke M. Sally Hopewell S. Chalmers I. Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report.J R Soc Med. 2007; 100: 187-190Crossref PubMed Scopus (99) Google Scholar have argued that every published RCT should begin with a systematic review of previous studies and conclude with a revised systematic review that shows how the RCT changes our belief about the topic. They suggest that this structure would foster the conduct of meaningful research.A. Speculate why the editors deemed this study sufficiently important to warrant publication in Annals.B. How did the ED-based study population and the other methodology factors discussed in answer 2a affect this study's results compared with previous studies?3In this study the authors randomized patients to a 10-day course of standard analgesic therapy or tamsulosin plus standard therapy. Study participants were not blinded to their treatment assignment because the investigators elected not to administer placebo tablets to patients randomized to the standard analgesic-only arm.A. It goes without saying that randomization is a central issue in the conduct of randomized clinical trials. Discuss the pros and cons of the following randomization techniques: simple randomization, prerandomization, block randomization, and stratified block randomization. What randomization technique did these authors select? How might a different randomization strategy have influenced the study results?B. Do you feel that the lack of placebo tablet in this trial altered the results? What if the primary outcome were patient ratings of their pain? Do you think it would have been more or less important to blind patients to their treatment assignment through the use of a placebo tablet?C. Imagine you are designing a placebo-controlled drug trial to treat renal colic in the ED. What practical considerations about the inclusion of the placebo do you need to weigh during the trial design? How might the study's conclusions be affected if the participants or the investigators measuring the outcome can differentiate active drug from placebo? How might investigators measure whether study participants are truly blinded to whether the treatment is active or placebo?4In this study the investigators performed an interim analysis and found no issues prompting early stoppage of the trial.A. What are the reasons that investigators perform interim analyses and why might a trial be stopped? How do planned interim analyses affect the study sample size? Why is it important to specify planned interim analyses in a clinical trial that is using a classic statistical analysis?B. The Bayesian statistical approach provides an alternative, and many would argue more robust, strategy for trial design and analysis. Describe the major differences between the Bayesian statistical approach and the more commonly used frequentist statistical approach with regard to hypothesis testing, interim analyses, analyzing the data, and interpreting the study's results. Tamsulosin for Ureteral Stones in the Emergency Department: A Randomized, Controlled TrialAnnals of Emergency MedicineVol. 54Issue 3PreviewThe α-adrenergic antagonist tamsulosin hydrochloride has become an increasingly common adjunct in the treatment of ureteral calculi; however, its efficacy in a general emergency department (ED) population has not been investigated. Full-Text PDF" @default.
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• W1973133775 title "Journal Club: Outcome Measures, Interim Analyses, and Bayesian Approaches to Randomized Trials" @default.
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