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BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2010

Open Access 01-12-2010 | Research article

Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials

Authors: Lorena P Rios, Chenglin Ye, Lehana Thabane

Published in: BMC Medical Research Methodology | Issue 1/2010

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Abstract

Background

Experts recommend formulating a structured research question to guide the research design. However, the basis for this recommendation has not been formally evaluated. The aim of this study was to examine if a structured research question using the PICOT (Population, Intervention, Comparator, Outcome, Time-frame) format is associated with a better reporting quality of randomized controlled trials (RCTs).

Methods

We evaluated 89 RCTs reports published in three endocrinology journals in 2005 and 2006, the quality of reporting of which was assessed in a previous study. We examined whether the reports stated each of the five elements of a structured research question: population, intervention, comparator, outcome and time-frame. A PICOT score was created with a possible score between 0 and 5. Outcomes were: 1) a 14-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials; and 2) a 3-point key score (KS), based on allocation concealment, blinding and use of intention-to-treat analysis. We conducted multivariable regression analyses using generalized estimating equations to determine if a higher PICOT score or the use of a structured research question were independently associated with a better reporting quality. Journal of publication, funding source and sample size were identified as factors associated with OQS in our previous report on this dataset, and therefore included in the model.

Results

A higher PICOT score was independently associated with OQS (incidence rate ratio (IRR) = 1.021, 95% CI: 1.012 to 1.029) and KS (IRR = 1.142, 95% CI: 1.079 to 1.210). A structured research question was present in 33.7% of the reports and it was associated with a better OQS (IRR = 1.095, 95% CI 1.059-1.132) and KS (IRR = 1.530, 95% CI 1.311-1.786).

Conclusions

Better framing of the research question using the PICOT format is independently associated with better overall reporting quality - although the effect is small - and better reporting of key methodologies.
Appendix
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Literature
1.
Rios LP, Odueyungbo A, Moitri MO, Rahman MO, Thabane L: Quality of reporting of randomized controlled trials in general endocrinology literature. J Clin Endocrinol Metab. 2008, 93: 3810-3816. 10.1210/jc.2008-0817.CrossRefPubMed
2.
3.
Balasubramanian SP, Wiener M, Alshameeri Z, Tiruvoipati R, Elbourne D, Reed MW: Standards of reporting of randomized controlled trials in general surgery: can we do better?. Ann Surg. 2006, 244: 663-667. 10.1097/01.sla.0000217640.11224.05.CrossRefPubMedPubMedCentral
4.
Dias S, McNamee R, Vail A: Evidence of improving quality of reporting of randomized controlled trials in subfertility. Hum Reprod. 2006, 21: 2617-2627. 10.1093/humrep/del236.CrossRefPubMed
5.
Mills E, Loke YK, Wu P, Montori VM, Perri D, Moher D, Guyatt G: Determining the reporting quality of RCTs in clinical pharmacology. Br J Clin Pharmacol. 2004, 58: 61-65. 10.1111/j.1365-2125.2004.2092.x.CrossRefPubMedPubMedCentral
6.
Scales CD, Norris RD, Keitz SA, Peterson BL, Preminger GM, Vieweg J, Dahm P: A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature. J Urol. 2007, 177: 1090-1094. 10.1016/j.juro.2006.10.027.CrossRefPubMed
7.
Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T, Consort G: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001, 134: 663-694.CrossRefPubMed
8.
Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF: Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996, 276: 637-639. 10.1001/jama.276.8.637.CrossRefPubMed
9.
Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001, 134: 657-662.CrossRefPubMed
10.
Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury I: Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust. 2006, 185: 263-267.PubMed
11.
Haynes R: Forming research questions. Clinical Epidemiology: How to do Clinical Practice Research. Edited by: Haynes R, Sacket D, Guyatt G, Tugwell P. 2006, Philadelphia, PA: Lippincott Williams & Wilkins, 3-14. 3
12.
Clouse RE: Proposing a good research question: a simple formula for success. Gastrointest Endosc. 2005, 61: 279-280. 10.1016/S0016-5107(04)02579-9.CrossRefPubMed
13.
Thabane L, Thomas T, Ye C, Paul J: Posing the research question: not so simple. Can J Anesth. 2009, 56: 71-79. 10.1007/s12630-008-9007-4.CrossRefPubMed
14.
15.
Stone P: Deciding upon and refining a research question. Palliat Med. 2002, 16: 265-267. 10.1191/0269216302pm562xx.CrossRefPubMed
16.
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: 609-613. 10.1016/S0140-6736(98)01085-X.CrossRefPubMed
17.
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: 408-412. 10.1001/jama.273.5.408.CrossRefPubMed
18.
19.
20.
Landis JR, Koch GG: The measurement of observer agreement for categorical data. Biometrics. 1977, 33: 159-174. 10.2307/2529310.CrossRefPubMed
21.
Zeger SL, Liang KY, Albert PS: Models for longitudinal data: A generalized estimating equation approach. Biometrics. 1988, 44: 1049-1060. 10.2307/2531734.CrossRefPubMed
22.
Haynes B: Forming research questions. J Clin Epidemiol. 2006, 59: 881-886. 10.1016/j.jclinepi.2006.06.006.CrossRef
23.
O'Connor D, Green S, Higgins JPT: Defining the review question and developing criteria for including studies. Cochrane handbook for systematic reviews of interventions. Edited by: Higgins JPT, Green S. 2008, Chichester: John Wiley & Sons Ltd, 83-94.
24.
Devereaux PJ, Choi PT, El-Dika S, Bhandari M, Montori VM, Schunemann HJ, Garg AX, Busse JW, Heels-Ansdell D, Ghali WA, Manns BJ, Guyatt G: An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods. J Clin Epidemiol. 2004, 57: 1232-1236. 10.1016/j.jclinepi.2004.03.017.CrossRefPubMed
25.
Pildal J, Chan AW, Hrobjartsson A, Forfang E, Altman DG, Gotzsche PC: Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study. BMJ. 2005, 330: 1049-10.1136/bmj.38414.422650.8F.CrossRefPubMedPubMedCentral
26.
Olivo SA, Macedo LG, Gadotti IC, Fuentes J, Stanton T, Magee DJ: Scales to Assess the Quality of Randomized Controlled Trials: A Systematic Review. Phys Ther. 2008, 88: 156-175.CrossRefPubMed
27.
Juni P, Witschi A, Bloch R, Egger M: The hazards of scoring the quality of clinical trials for meta-analysis. JAMA. 1999, 282: 1054-1060. 10.1001/jama.282.11.1054.CrossRefPubMed
28.
Juni P, Altman DG, Egger M: Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001, 323: 42-46. 10.1136/bmj.323.7303.42.CrossRefPubMedPubMedCentral
29.
Whiting P, Harbord R, Kleijnen J: No role for quality scores in systematic reviews of diagnostic accuracy studies. BMC Med Res Methodol. 2005, 5: 19-10.1186/1471-2288-5-19.CrossRefPubMedPubMedCentral
30.
Juni P, Egger M: Scoring the quality of clinical trials. JAMA. 2000, 283: 1422-1423.
31.
Herbison P, Hay-Smith J, Gillespie WJ: Adjustment of meta-analyses on the basis of quality scores should be abandoned. J Clin Epidemiol. 2006, 59: 1249-1256. 10.1016/j.jclinepi.2006.03.008.CrossRefPubMed
Metadata
Title
Association between framing of the research question using the PICOT format and reporting quality of randomized controlled trials
Authors
Lorena P Rios
Chenglin Ye
Lehana Thabane
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2010
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-10-11

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