Correction to: Trials
https://doi.org/10.1186/s13063-019-3255-1
After publication of our article [1] the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study. These changes were made after the recruitment of participants and after approval by the Institutional Review Board, and registration at clinicaltrials.gov (study identifier), but before cleaning and closing of the database.
The Postoperative Quality of Recovery Scale (PQRS), an outcome used in the IPPCollapse II study, is a five–dimensional ordinal scale designed to estimate patients’ recovery in the postoperative period [2]. Each patient is scored at predefined time points and is classified as either ‘recovered’ if the score reaches at least the predetermined baseline score or ‘not recovered’ if otherwise. The five dimensions are then combined in an ‘overall score’ – a patient is classified as ‘overall recovered’ if ‘recovered’ in every domain and as ‘overall not recovered’ if ‘not recovered’ in any of the five domains.
Outcome variables that are repeatedly assessed over time in the same study patients are to be treated as ‘repeated measures’ or ‘longitudinal data’ [3]. Common statistical techniques applied on cross-sectional data assume independence between observations [4]. This crucial assumption is not fulfilled by ‘repeated measures’ or ‘longitudinal data’. Ignoring this correlation can lead to biased estimates, invalid P values and confidence intervals, as well as loss of statistical power [5, 6].
We incorrectly detailed how the PQRS score was to be analysed. We suggested to treat the scores at the four different time points as individual outcomes. From hindsight we feel that this approach does not consider the conceptual underlying model (i.e., between patients’ variability) and the temporal design. Furthermore, we also imperfectly reported our primary outcome since we did not specified which domain of the scale was analyzed as primary endpoint although we did report which one we used (i.e. physiologic score) in the sample size calculation. We therefore changed the primary and secondary outcomes as follows:
The primary outcome of the IPPCollapse II study is the recovery of the ‘physiologic’ component of the PQRS score over the assessed time points;
The other domains, i.e., the ‘nociceptive’, ‘emotional’, ‘cognitive’, and ‘functional’ components, as well as the ‘overall score’ are used as secondary outcomes;
Association between group assignment and recovery of PQRS score in each domain is assessed by a mixed logistic regression, introducing patients as random factors, and age, weight, BMI and sex as covariables;
The originally reported analysis (i.e. ordinal regression) is still carried out, however only as a sensitivity analysis.
References
1. Diaz-Cambronero, et al. An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study. Trials; 2019; 20, 190.[COI: 1:STN:280:DC%2BB3M%2FhtlOitw%3D%3D] [DOI: https://dx.doi.org/10.1186/s13063-019-3255-1] [PubMed: https://www.ncbi.nlm.nih.gov/pubmed/30944044][PubMedCentral: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6446296]
2. Royse, CF; Newman, S; Chung, F; Stygall, J; McKay, RE; Boldt, J et al. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology.; 2010; 113,
3. Schober, P; Vetter, TR. Repeated measures designs and analysis of longitudinal data: if at first you do not succeed—try, try again. Anesth Analg; 2018; 127, pp. 569-575. [DOI: https://dx.doi.org/10.1213/ANE.0000000000003511]
4. Verbeke, G; Fieuw, S; Molenberghs, G; Davidian, M. The analysis of multivariate longitudinal data: a review. Stat Methods Med Res; 2014; 23, pp. 42-59. [DOI: https://dx.doi.org/10.1177/0962280212445834]
5. Ma, Y; Mazumdar, M; Memtsoudis, SG. Beyond repeated-measures analysis of variance data in anesthesia research. Reg Anesth Pain Med; 2012; 37, pp. 99-105. [DOI: https://dx.doi.org/10.1097/AAP.0b013e31823ebc74]
6. Windt, J; Ardern, CL; Gabbett, TJ; Khan, KM; Cook, CE; Sporer, BC et al. Getting the most out of intensive longitudinal data: A methodological review of workload-injury studies. BMJ Open; 2018; 8, pp. 1-17. [DOI: https://dx.doi.org/10.1136/bmjopen-2018-022626]
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Abstract
After publication of our article [1] the authors have notified us that there are changes in the primary outcome and the statistical analysis plan of the study.
You have requested "on-the-fly" machine translation of selected content from our databases. This functionality is provided solely for your convenience and is in no way intended to replace human translation. Show full disclaimer
Neither ProQuest nor its licensors make any representations or warranties with respect to the translations. The translations are automatically generated "AS IS" and "AS AVAILABLE" and are not retained in our systems. PROQUEST AND ITS LICENSORS SPECIFICALLY DISCLAIM ANY AND ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES FOR AVAILABILITY, ACCURACY, TIMELINESS, COMPLETENESS, NON-INFRINGMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Your use of the translations is subject to all use restrictions contained in your Electronic Products License Agreement and by using the translation functionality you agree to forgo any and all claims against ProQuest or its licensors for your use of the translation functionality and any output derived there from. Hide full disclaimer
Details
1 Hospital Universitari i Politècnic La Fe, Department of Anaesthesiology, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602); Instituto de Investigación Sanitaria La Fe (IIS laFe), Perioperative Medicine Research Group, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602); SCReN-IIS La Fe, PT17/0017/0035, Spanish Clinical Research Network (SCReN), Valencia, Spain (GRID:grid.476458.c)
2 Instituto de Investigación Sanitaria La Fe (IIS laFe), Perioperative Medicine Research Group, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602); Hospital Universitari i Politecnic la Fe, Department of Anaesthesiology, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602)
3 Consorcio Hospital General Universitario de Valencia, Department of Anaesthesiology, Valencia, Spain (GRID:grid.106023.6) (ISNI:0000 0004 1770 977X)
4 Academic Medical Center, Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology (L·E·I·C·A), Amsterdam, The Netherlands (GRID:grid.5650.6) (ISNI:0000000404654431); Mahidol University, Mahidol Oxford Tropical Medicine Research Unit (MORU), Bangkok, Thailand (GRID:grid.10223.32) (ISNI:0000 0004 1937 0490)
5 Hospital Universitari i Politècnic La Fe, Department of Colorectal Surgery, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602)
6 Hospital Universitari i Politècnic La Fe, Department of Anaesthesiology, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602); Instituto de Investigación Sanitaria La Fe (IIS laFe), Perioperative Medicine Research Group, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602)
7 Hospital General Universitario de Castellón, Department of Anaesthesiology, Castellón, Spain (GRID:grid.470634.2)
8 Hospital General Universitario Gregorio Marañón, Department of Anaesthesiology, Madrid, Spain (GRID:grid.410526.4) (ISNI:0000 0001 0277 7938)
9 Hospital Universitario Virgen Macarena, Department of Anaesthesiology, Sevilla, Spain (GRID:grid.411375.5) (ISNI:0000 0004 1768 164X)
10 Instituto de Investigación Sanitaria La Fe (IIS laFe), Perioperative Medicine Research Group, Valencia, Spain (GRID:grid.84393.35) (ISNI:0000 0001 0360 9602)