Top

Trials

Published in:

Open Access 01-12-2021 | Postoperative Pain Management | Review

Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review

Authors: Thea Nørgaard Rønsbo, Jens Laigaard, Casper Pedersen, Ole Mathiesen, Anders Peder Højer Karlsen

Published in: Trials | Issue 1/2021

Abstract

Background

The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve transparent reporting of randomised clinical trials. It comprises a participant flow diagram with the reporting of essential numbers for enrolment, allocation and analyses. We aimed to quantify the use of participant flow diagrams in randomised clinical trials on postoperative pain management after total hip and knee arthroplasty.

Methods

We searched PubMed, Embase and CENTRAL up till January 2020. The primary outcome was the proportion of trials with adequate reporting of participant flow diagrams, defined as reporting of number of participants screened for eligibility, randomised and included in the primary analysis. Secondary outcomes were recruitment (randomised:screened) and retention (analysed:randomised) rates, reporting of a statistical strategy, reasons for exclusion from the primary analysis and handling of missing outcome data. Trends over time were assessed with statistical process control.

Results

Of the 570 included trials, we found adequate reporting in 240 (42%). Reporting with participant flow diagram increased significantly over time. Median recruitment was 73% (IQR 44–91%), and retention was 97% (IQR 93–100%). These rates did not change over time. Trials with adequate reporting of participant flow were more likely to report a statistical strategy (41% vs 8%), reasons for post-randomisation exclusions (100% vs 55%) and handling of missing outcome data (14% vs 6%).

Conclusions

Adherence to participant flow diagrams for RCTs has increased significantly over time. Still, there is room for improvement of adequate reporting of flow diagrams, to increase transparency of trials details.

Available only for authorised users

Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. Jama. 1996;276(8):637–9. https://doi.org/10.1001/jama.276.8.637.CrossRefPubMed

Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672–7. https://doi.org/10.1016/j.ijsu.2011.09.004.CrossRefPubMed

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340(mar23 1):c869. https://doi.org/10.1136/bmj.c869.CrossRefPubMedPubMedCentral

Moher D, Jones A, Lepage L, Group ftC. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285(15):1992–5. https://doi.org/10.1001/jama.285.15.1992.CrossRefPubMed

Turner L, Shamseer L, Altman DG, Schulz KF, Moher D. Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review. Syst Rev. 2012;1(1):60. https://doi.org/10.1186/2046-4053-1-60.CrossRefPubMedPubMedCentral

Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust. 2006;185(5):263–7. https://doi.org/10.5694/j.1326-5377.2006.tb00557.x.CrossRefPubMed

Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet. 2005;365(9453):82–93. https://doi.org/10.1016/s0140-6736(04)17670-8.CrossRefPubMed

Gabriel SE, Normand SL. Getting the methods right--the foundation of patient-centered outcomes research. N Engl J Med. 2012;367(9):787–90. https://doi.org/10.1056/NEJMp1207437.CrossRefPubMed

Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: a systematic review. PLoS One. 2017;12(3):e0173107. https://doi.org/10.1371/journal.pone.0173107.CrossRefPubMedPubMedCentral

10.

Karlsen APH, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015;156(1):8–30. https://doi.org/10.1016/j.pain.0000000000000003.CrossRef

11.

Rennie D, Flanagin A. Research on peer review and biomedical publication: furthering the quest to improve the quality of reporting. Jama. 2014;311(10):1019–20. https://doi.org/10.1001/jama.2014.1362.CrossRefPubMed

12.

Moher D, Liberati A, Tetzlaff J, Altman DG, Group P. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol. 2009;62(10):1006–12. https://doi.org/10.1016/j.jclinepi.2009.06.005.CrossRefPubMed

13.

Laigaard J, Pedersen C, Ronsbo TN, Mathiesen O, Karlsen APH. Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review. Br J Anaesth. 2021. https://doi.org/10.1016/j.bja.2021.01.021.

14.

Anhoj J, Olesen AV. Run charts revisited: a simulation study of run chart rules for detection of non-random variation in health care processes. PLoS One. 2014;9(11):e113825. https://doi.org/10.1371/journal.pone.0113825.CrossRefPubMedPubMedCentral

15.

Schilling MF. The surprising predictability of long runs. Mathematical Assoc Am. 2012;85(2). https://doi.org/10.4169/amer.math.monthly.118.05.404.

16.

Chen Z. A note on the runs test. Model Assist Stat Appl. 2010;5(2):73–7. https://doi.org/10.3233/mas-2010-0142.CrossRef

17.

Jacob Anhoej. Qicharts2: quality improvement charts. R package version 0.2.1. 2017. URL https://CRAN.R-project.org/package=qicharts2. Accessed 05 May 2020.

18.

R Core Team. R: a language and environment for statistical computing. Foundation for Statistical computing, Vienna, Austria. 2017. URL https://www.R-project.org/. Accessed 05 May 2020.

19.

Moher D, Pham B, Jones A, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses? Lancet. 1998;352(9128):609–13. https://doi.org/10.1016/s0140-6736(98)01085-x.CrossRefPubMed

20.

Agha R, Cooper D, Muir G. The reporting quality of randomised controlled trials in surgery: a systematic review. Int J Surg. 2007;5(6):413–22. https://doi.org/10.1016/j.ijsu.2007.06.002.CrossRefPubMed

21.

Siddiq H, Pentapati KC, Acharya S. Adherence of randomized controlled trials to consolidated standards of reporting trials 2010 guidelines: a survey of randomized controlled trials published in 2011-2016 in 3 periodontology journals. J Evid Based Dent Pract. 2019;19(3):260–72. https://doi.org/10.1016/j.jebdp.2019.04.001.CrossRefPubMed

22.

Toerien M, Brookes ST, Metcalfe C, de Salis I, Tomlin Z, Peters TJ, et al. A review of reporting of participant recruitment and retention in RCTs in six major journals. Trials. 2009;10(1):52. https://doi.org/10.1186/1745-6215-10-52.CrossRefPubMedPubMedCentral

23.

Naidoo N, Nguyen VT, Ravaud P, Young B, Amiel P, Schanté D, et al. The research burden of randomized controlled trial participation: a systematic thematic synthesis of qualitative evidence. BMC Med. 2020;18(1):6. https://doi.org/10.1186/s12916-019-1476-5.CrossRefPubMedPubMedCentral

24.

Yelland LN, Kahan BC, Dent E, Lee KJ, Voysey M, Forbes AB, et al. Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: a systematic review. Clin Trials. 2018;15(3):278–85. https://doi.org/10.1177/1740774518761627.CrossRefPubMed

25.

Greenhalgh T, Howick J, Maskrey N. Evidence based medicine: a movement in crisis? Bmj. 2014;348(jun13 4):g3725. https://doi.org/10.1136/bmj.g3725.CrossRefPubMedPubMedCentral

26.

Glasgow RE, Huebschmann AG, Brownson RC. Expanding the CONSORT figure: increasing transparency in reporting on external validity. Am J Prev Med. 2018;55(3):422–30. https://doi.org/10.1016/j.amepre.2018.04.044.CrossRefPubMed

27.

Shapiro SH, Weijer C, Freedman B. Reporting the study populations of clinical trials. Clear transmission or static on the line? J Clin Epidemiol. 2000;53(10):973–9. https://doi.org/10.1016/s0895-4356(00)00227-4.CrossRefPubMed

28.

Kim ES, Bruinooge SS, Roberts S, Ison G, Lin NU, Gore L, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. J Clin Oncol. 2017;35(33):3737–44. https://doi.org/10.1200/jco.2017.73.7916.CrossRefPubMedPubMedCentral

29.

Pedersen C, Troensegaard H, Laigaard J, Koyuncu S, Schrøder HM, Overgaard S, et al. Differences in patient characteristics and external validity of randomized clinical trials on pain management following total hip and knee arthroplasty: a systematic review. Reg Anesth Pain Med. 2020;45(9):709–15. https://doi.org/10.1136/rapm-2020-101459.CrossRefPubMed

30.

Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162. https://doi.org/10.1186/s12874-017-0442-1.CrossRefPubMedPubMedCentral

31.

Fergusson D, Aaron SD, Guyatt G, Hébert P. Post-randomisation exclusions: the intention to treat principle and excluding patients from analysis. Bmj. 2002;325(7365):652–4. https://doi.org/10.1136/bmj.325.7365.652.CrossRefPubMedPubMedCentral

32.

Polit DF, Gillespie BM. Intention-to-treat in randomized controlled trials: recommendations for a total trial strategy. Res Nurs Health. 2010;33(4):355–68. https://doi.org/10.1002/nur.20386.CrossRefPubMed

33.

Montedori A, Bonacini MI, Casazza G, Luchetta ML, Duca P, Cozzolino F, et al. Modified versus standard intention-to-treat reporting: are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study. Trials. 2011;12(1):58. https://doi.org/10.1186/1745-6215-12-58.CrossRefPubMedPubMedCentral

34.

Shaikh AM, Mehta MM, Chawan VV. Evaluation of reporting of CONSORT flow diagrams in randomized controlled trials in a national and international pharmacology journal. Perspect Clin Res. 2019;10(4):168–71. https://doi.org/10.4103/picr.PICR_73_18.CrossRefPubMedPubMedCentral

35.

Jin Y, Sanger N, Shams I, Luo C, Shahid H, Li G, et al. Does the medical literature remain inadequately described despite having reporting guidelines for 21 years? - A systematic review of reviews: an update. J Multidiscip Healthc. 2018;11:495–510. https://doi.org/10.2147/jmdh.S155103.CrossRefPubMedPubMedCentral

36.

Peters JP, Hooft L, Grolman W, Stegeman I. Assessment of the quality of reporting of randomised controlled trials in otorhinolaryngologic literature - adherence to the CONSORT statement. PLoS One. 2015;10(3):e0122328. https://doi.org/10.1371/journal.pone.0122328.CrossRefPubMedPubMedCentral

Title: Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review
Authors: Thea Nørgaard Rønsbo
Jens Laigaard
Casper Pedersen
Ole Mathiesen
Anders Peder Højer Karlsen
Publication date: 01-12-2021
Publisher: BioMed Central
Keyword: Postoperative Pain Management
Published in: Trials / Issue 1/2021
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05233-5

At a glance: The STEP trials

Springer Medicine

Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review

Abstract

Background

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 1/2021

A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia

The UPTAKE study: implications for the future of COVID-19 vaccination trial recruitment in UK and beyond

Optimizing blood pressure control by an Information Communication Technology-supported case management (PIA study): study protocol for a cluster-randomized controlled trial of a delegation model for general practices

Effect of alkalized urine on renal calculi in patients with gout: a protocol for a placebo-controlled, double-blinded randomized controlled trial

Low-dose naltrexone for the treatment of fibromyalgia: protocol for a double-blind, randomized, placebo-controlled trial

In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable