Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial

Lauri Raittio; Antti P. Launonen; Teemu Hevonkorpi; Toni Luokkala; Juha Kukkonen; Aleksi Reito; Minna K. Laitinen; Ville M. Mattila

doi:10.1371/journal.pone.0232153

Peer Review History

Original SubmissionAugust 26, 2019
27 Oct 2019 Decision Letter - Iratxe Puebla, Editor Transfer Alert This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present. PONE-D-19-23143 Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial PLOS ONE Dear Mr Raittio, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. The manuscript has been assessed by two reviewers, their comments are available below. The reviewers are positive about the study but they have requested some clarifications about aspects of the methodology and additional information on the analyses completed. 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Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: No ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: No ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: well done study statistical methodology sound addresses a contemporary question now that so many of these fractures are treated operatively This reviewer has little critique with your overall methodology nor conclusions Reviewer #2: This investigation is well and completely reported and discussed. The English language is poor, even unclear, in parts (e.g., section ‘PCS’ in the appendix) and needs to be revised by a native speaker or other competent person. I have only minor comments and suggestions: 1. Please state the randomisation block size. According to the stated stratification factors, there seem to have been 2x3x2 = 12 strata, which for planned 57 patients per group would seem to lead to very numbers in each stratum. 2. The statistics software used for data analysis should be stated. 3. Detail of the multiple imputation procedure used should be given in the appendix. 4. Please state which outcome variables were collected at baseline, and the time-point of the outcome. In Table 2, only PCS is given at baseline. Further, which ‘difference’ is meant in the sentence beginning ‘The primary outcome measure was the difference…’, p.5? I understand that the PRWE was not measured at baseline, so presumably you mean the difference between the treatment groups? Generally, an ‘outcome’ should be defined on the individual patient. 5. I assumed that all localised outcome measures refer to the injured wrist, but on p.8 we are informed about the correlation with grip strength of the uninjured limb – please clarify. 6. When were the radiograph examinations and assessments performed, and were the assessors blinded to treatment group? 7. I suggest displaying the distribution of primary (and possibly important secondary) outcome values graphically, for instance using box-plots or scatter plots comparing the treatment groups. 8. Were subgroup analyses per site performed and if so, were any differences found? In such a surgery study, where physician-specific effects may be expected, it would be important to look for site subgroup differences in the primary treatment comparison. 9. On p.13 (discussion) a cast change rate per patient of 260% is referred to – does this mean multiple changes in some patients? ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes: Jeremy Franklin [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files to be viewed.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email us at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0232153.r001
Revision 1
7 Nov 2019 Author Response Rebuttal letter We would like to take this opportunity to thank the Reviewers for their constructive criticism of our manuscript. We have strived to revise the manuscript in accordance with the valuable criticism received from the Reviewers. We feel that the quality of our manuscript has improved as a result. The comments of the Reviewers are followed by our answers and a description of the corrections/changes that we have made to the manuscript (marked in italics). Reviewers' comments: 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: No We have now verified the policies of our Regional Ethical Committee on data sharing. In order to ensure the anonymization of the dat. Hence, the exact day and month of the recruitment has been removed and study centers are only referred to as numbers one, two, and three. Due to the common nature of distal radius fracture, we feel these changes enable the required anonymization of the data. The data will be submitted in the supplementary file alongside the manuscript. 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: No 5. Review Comments to the Author Reviewer #1: well done study statistical methodology sound addresses a contemporary question now that so many of these fractures are treated operatively. This reviewer has little critique with your overall methodology nor conclusions. The authors thank the reviewer for the positive comments. Reviewer #2: This investigation is well and completely reported and discussed. The English language is poor, even unclear, in parts (e.g., section ‘PCS’ in the appendix) and needs to be revised by a native speaker or other competent person. I have only minor comments and suggestions: The authors thank the reviewer for the positive comments. The material in the supplementary files has now been revised by a native speaker of English. 1. Please state the randomisation block size. According to the stated stratification factors, there seem to have been 2x3x2 = 12 strata, which for planned 57 patients per group would seem to lead to very numbers in each stratum. In the randomization process, we had two stratification variables, age and extra- or intra-articular fracture line, with two blocks in each variable. Thus, there were 4 stratification factors (lines 116-7). 2. The statistics software used for data analysis should be stated. The statistical software used for the data analysis was SPSS v. 25 (lines 147-8). 3. Detail of the multiple imputation procedure used should be given in the appendix. The variables used for the multiple imputation were age, sex, cast position (treatment allocation), the PRWE at 3 and 12 months, the PCS at 3 and 12 months, the VAS for pain at 3 and 12 months, and the Quick-DASH at 3 and 12 months. This has now been explained in more detail in appendix S4. 4. Please state which outcome variables were collected at baseline, and the time-point of the outcome. In Table 2, only PCS is given at baseline. Further, which ‘difference’ is meant in the sentence beginning ‘The primary outcome measure was the difference…’, p.5? I understand that the PRWE was not measured at baseline, so presumably you mean the difference between the treatment groups? Generally, an ‘outcome’ should be defined on the individual patient. The mean difference between study groups at 12 months was the primary outcome. This has now been stated more clearly (lines 126-7). 5. I assumed that all localised outcome measures refer to the injured wrist, but on p.8 we are informed about the correlation with grip strength of the uninjured limb – please clarify. The reviewer is indeed correct that we have reported the correlation with the grip strength of the uninjured limb to the PRWE score in order to find an association, if any, between the physical strength of the upper arms and the primary outcome. 6. When were the radiograph examinations and assessments performed, and were the assessors blinded to treatment group? The radiograph examinations were performed before and after the closed reduction, 1, 2, and 5 weeks after fracture. The radiographic assessments were performed by authors who were blinded to the treatment allocation at the time of assessments (lines 133-4). 7. I suggest displaying the distribution of primary (and possibly important secondary) outcome values graphically, for instance using box-plots or scatter plots comparing the treatment groups. The authors fully agree with the usefulness of the graphical reporting of the main results. We have now added a box-plot graph that contains the results of the PRWE, the Quick-DASH, and VAS for pain in appendix S4. 8. Were subgroup analyses per site performed and if so, were any differences found? In such a surgery study, where physician-specific effects may be expected, it would be important to look for site subgroup differences in the primary treatment comparison. In each study center, recruitment to the study and the closed reduction of the fracture was performed by various on-call physicians in the emergency departments. Therefore, each physician only recruited and treated a few patients in the study. The subgroup analysis of radiograph parameters for the internal validation of the allocated treatment showed no difference between study centers. 9. On p.13 (discussion) a cast change rate per patient of 260% is referred to – does this mean multiple changes in some patients? This rate of cast changes has been referred to in a paper published by Anzarut et a.l (ref 26 in the manuscript) who reported in Table 1 of the article the mean of 2.6 and the median of 2 cast changes in the study population. However, we are not confident in this reported number and we have therefore changed the sentence: “Studies investigating cast immobilization methods have not routinely reported on cast changes, but studies have reported various rates of cast changes” (lines 270-1). Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0232153.r002
9 Apr 2020 Decision Letter - Jesse Bernard Jupiter, Editor Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial PONE-D-19-23143R1 Dear Dr. Raittio, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. 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With kind regards, Jesse Bernard Jupiter, MD Guest Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: (No Response) ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: (No Response) ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: (No Response) ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: no further comments. The authors have fully complied with the suggests made by the reviewers and improved the overall clarity Reviewer #2: (No Response) ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes: Jeremy Franklin https://doi.org/10.1371/journal.pone.0232153.r003
Formally Accepted
27 Apr 2020 Acceptance Letter - Jesse Bernard Jupiter, Editor PONE-D-19-23143R1 Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial Dear Dr. Raittio: I am pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. PLOS Manuscript Reassignment Staff Editor PLOS ONE https://doi.org/10.1371/journal.pone.0232153.r004

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