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BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2009

Open Access 01-12-2009 | Research article

Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary intervention

Authors: Morgane Ethgen, lsabelle Boutron, Philippe Gabriel Steg, Carine Roy, Philippe Ravaud

Published in: BMC Medical Research Methodology | Issue 1/2009

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Abstract

Background

Stents are commonly used to treat patients with coronary artery disease. However, the quality of reporting internal and external validity data in published reports of randomised controlled trials (RCTs) of stents has never been assessed.
The objective of our study was to evaluate the quality of reporting internal and external validity data in published reports of RCTs assessing the stents for percutaneous coronary interventions.

Methods

A systematic literature review was conducted. Reports of RCTs assessing stents for percutaneous coronary interventions indexed in MEDLINE and the Cochrane Central Register of Controlled Trials and published between January 2003 and September 2008 were selected. A standardized abstraction form was used to extract data. All analyses were adjusted for the effect of clustering articles by journal.

Results

132 articles were analyzed. The generation of the allocation sequence was adequate in 58.3% of the reports; treatment allocation was concealed in 34.8%. Adequate blinding was reported in one-fifth of the reports. An intention-to-treat analysis was described in 79.5%. The main outcome was a surrogate angiographic endpoint in 47.0%. The volume of interventions per center was described in two reports. Operator expertise was described in five (3.8%) reports. The quality of reporting was better in journals with high impact factors and in journals endorsing the CONSORT statement.

Conclusion

The current reporting of results of RCTs testing stents needs to be improved to allow readers to appraise the risk of bias and the applicability of the results.
Appendix
Available only for authorised users
Literature
1.
Serruys PW, Kutryk MJ: The state of the stent: current practices, controversies, and future trends. The American journal of cardiology. 1996, 78 (3A): 4-7. 10.1016/S0002-9149(96)00485-7.CrossRefPubMed
2.
Schulz KF: Randomised trials, human nature, and reporting guidelines. Lancet. 1996, 348 (9027): 596-598. 10.1016/S0140-6736(96)01201-9.CrossRefPubMed
3.
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001, 134 (8): 663-694.CrossRefPubMed
4.
Hannan EL, Wu C, Walford G, King SB, Holmes DR, Ambrose JA, Sharma S, Katz S, Clark LT, Jones RH: Volume-outcome relationships for percutaneous coronary interventions in the stent era. Circulation. 2005, 112 (8): 1171-1179. 10.1161/CIRCULATIONAHA.104.528455.CrossRefPubMed
5.
Boutron I, Tubach F, Giraudeau B, Ravaud P: Methodological differences in clinical trials evaluating nonpharmacological and pharmacological treatments of hip and knee osteoarthritis. Jama. 2003, 290 (8): 1062-1070. 10.1001/jama.290.8.1062.CrossRefPubMed
6.
Boutron I, Tubach F, Giraudeau B, Ravaud P: Blinding was judged more difficult to achieve and maintain in non-pharmacological than pharmacological trials. J Clin Epidemiol. 2004, 57 (6): 543-550. 10.1016/j.jclinepi.2003.12.010.CrossRefPubMed
7.
Spaulding C, Morice MC, Lancelin B, El Haddad S, Lepage E, Bataille S, Tresca JP, Mouranche X, Fosse S, Monchi M, et al: Is the volume-outcome relation still an issue in the era of PCI with systematic stenting? Results of the greater Paris area PCI registry. Eur Heart J. 2006, 27 (9): 1054-1060. 10.1093/eurheartj/ehi843.CrossRefPubMed
8.
Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, et al: ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction–summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2002, 40 (7): 1366-1374. 10.1016/S0735-1097(02)02336-7.CrossRefPubMed
9.
Hill R, Bagust A, Bakhai A, Dickson R, Dundar Y, Haycox A, Mujica Mota R, Reaney A, Roberts D, Williamson P, et al: Coronary artery stents: a rapid systematic review and economic evaluation. Health Technol Assess. 2004, 8 (35): iii-iv. 1–242CrossRefPubMed
10.
Rothwell PM: External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005, 365 (9453): 82-93. 10.1016/S0140-6736(04)17670-8.CrossRefPubMed
11.
Steg PG, Lopez-Sendon J, Lopez de Sa E, Goodman SG, Gore JM, Anderson FA, Himbert D, Allegrone J, Werf Van de F: External validity of clinical trials in acute myocardial infarction. Arch Intern Med. 2007, 167 (1): 68-73. 10.1001/archinte.167.1.68.CrossRefPubMed
12.
Boutron I, Moher D, Tugwell P, Giraudeau B, Poiraudeau S, Nizard R, Ravaud P: A checklist to evaluate a report of a nonpharmacological trial (CLEAR NPT) was developed using consensus. J Clin Epidemiol. 2005, 58 (12): 1233-1240. 10.1016/j.jclinepi.2005.05.004.CrossRefPubMed
13.
14.
Lee KJ, Thompson SG: The use of random effects models to allow for clustering in individually randomized trials. Clin Trials. 2005, 2 (2): 163-173. 10.1191/1740774505cn082oa.CrossRefPubMed
15.
Prescott RJ, Counsell CE, Gillespie WJ, Grant AM, Russell IT, Kiauka S, Colthart IR, Ross S, Shepherd SM, Russell D: Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess. 1999, 3 (20): 1-143.PubMed
16.
Huwiler-Muntener K, Juni P, Junker C, Egger M: Quality of reporting of randomized trials as a measure of methodologic quality. Jama. 2002, 287 (21): 2801-2804. 10.1001/jama.287.21.2801.CrossRefPubMed
17.
Balk EM, Bonis PA, Moskowitz H, Schmid CH, Ioannidis JP, Wang C, Lau J: Correlation of quality measures with estimates of treatment effect in meta-analyses of randomized controlled trials. Jama. 2002, 287 (22): 2973-2982. 10.1001/jama.287.22.2973.CrossRefPubMed
18.
Tung R, Kaul S, Diamond GA, Shah PK: Narrative review: drug-eluting stents for the management of restenosis: a critical appraisal of the evidence. Ann Intern Med. 2006, 144 (12): 913-919.CrossRefPubMed
19.
Schulz KF, Chalmers I, Hayes RJ, Altman DG: Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Jama. 1995, 273 (5): 408-412. 10.1001/jama.273.5.408.CrossRefPubMed
20.
Topol EJ, Nissen SE: Our preoccupation with coronary luminology. The dissociation between clinical and angiographic findings in ischemic heart disease. Circulation. 1995, 92 (8): 2333-2342.CrossRefPubMed
21.
Ferreira-Gonzalez I, Busse JW, Heels-Ansdell D, Montori VM, Akl EA, Bryant DM, Alonso-Coello P, Alonso J, Worster A, Upadhye S, et al: Problems with use of composite end points in cardiovascular trials: systematic review of randomised controlled trials. Bmj. 2007, 334 (7597): 786-10.1136/bmj.39136.682083.AE.CrossRefPubMedPubMedCentral
22.
Neaton JD, Gray G, Zuckerman BD, Konstam MA: Key issues in end point selection for heart failure trials: composite end points. J Card Fail. 2005, 11 (8): 567-575. 10.1016/j.cardfail.2005.08.350.CrossRefPubMed
23.
Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C: Composite outcomes in randomized trials: greater precision but with greater uncertainty?. Jama. 2003, 289 (19): 2554-2559. 10.1001/jama.289.19.2554.CrossRefPubMed
24.
Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, et al: Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005, 26 (8): 804-847. 10.1093/eurheartj/ehi138.CrossRefPubMed
25.
Smith SC, Feldman TE, Hirshfeld JW, Jacobs AK, Kern MJ, King SB, Morrison DA, O'Neil WW, Schaff HV, Whitlow PL, et al: ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update 2001 Guidelines for Percutaneous Coronary Intervention). Circulation. 2006, 113 (7): e166-286. 10.1161/CIRCULATIONAHA.106.173220.CrossRefPubMed
26.
McGrath PD, Wennberg DE, Dickens JD, Siewers AE, Lucas FL, Malenka DJ, Kellett MA, Ryan TJ: Relation between operator and hospital volume and outcomes following percutaneous coronary interventions in the era of the coronary stent. Jama. 2000, 284 (24): 3139-3144. 10.1001/jama.284.24.3139.CrossRefPubMed
27.
Politi A, Galli M, Zerboni S, Michi R, De Marco F, Llambro M, Ferrari G: Operator volume and outcomes of primary angioplasty for acute myocardial infarction in a single high-volume centre. J Cardiovasc Med (Hagerstown). 2006, 7 (10): 761-767.CrossRef
28.
Tsuchihashi M, Tsutsui H, Tada H, Shihara M, Takeshita A, Kono S: Volume-outcome relation for hospitals performing angioplasty for acute myocardial infarction: results from the Nationwide Japanese Registry. Circ J. 2004, 68 (10): 887-891. 10.1253/circj.68.887.CrossRefPubMed
29.
Kastrati A, Neumann F-J, Schomig A: Operator volume and outcome of patients undergoing coronary stent placement. 1998, 32: 970-976.
30.
Bradley EH, Herrin J, Wang Y, Barton BA, Webster TR, Mattera JA, Roumanis SA, Curtis JP, Nallamothu BK, Magid DJ, et al: Strategies for Reducing the Door-to-Balloon Time in Acute Myocardial Infarction. 2006, 355: 2308-2320.
31.
Nallamothu BK, Wang Y, Magid DJ, McNamara RL, Herrin J, Bradley EH, Bates ER, Pollack CV, Krumholz HM: Relation between hospital specialization with primary percutaneous coronary intervention and clinical outcomes in ST-segment elevation myocardial infarction: National Registry of Myocardial Infarction-4 analysis. Circulation. 2006, 113 (2): 222-229. 10.1161/CIRCULATIONAHA.105.578195.CrossRefPubMed
32.
Devereaux PJ, Bhandari M, Clarke M, Montori VM, Cook DJ, Yusuf S, Sackett DL, Cina CS, Walter SD, Haynes B, et al: Need for expertise based randomised controlled trials. Bmj. 2005, 330 (7482): 88-10.1136/bmj.330.7482.88.CrossRefPubMedPubMedCentral
33.
Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P, Klassen TP: Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?. Lancet. 1998, 352 (9128): 609-613. 10.1016/S0140-6736(98)01085-X.CrossRefPubMed
Metadata
Title
Quality of reporting internal and external validity data from randomized controlled trials evaluating stents for percutaneous coronary intervention
Authors
Morgane Ethgen
lsabelle Boutron
Philippe Gabriel Steg
Carine Roy
Philippe Ravaud
Publication date
01-12-2009
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2009
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-9-24

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