Peer Review History
Original SubmissionJune 19, 2019 |
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PONE-D-19-17368 Using evidence when planning for trial recruitment: An international perspective from time-poor trial recruiters and designers PLOS ONE Dear Dr Gardner, 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. ============================== In particular, the reviewers would like further information to justify the study, with some background on recruitment models, and discussion on the potential risk of bias that may occur with recruitment difficulties. Further information on the possible sources of uncertainty in recruitment would also benefit readers. Please also carefully address the comment on the risk of disclosure of identity from some comments, further details are below. ============================== We would appreciate receiving your revised manuscript by Oct 24 2019 11:59PM. When you are ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. To enhance the reproducibility of your results, we recommend that if applicable you deposit your laboratory protocols in protocols.io, where a protocol can be assigned its own identifier (DOI) such that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols Please include the following items when submitting your revised manuscript:
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Please include a copy of the interview guide used in the study, in both the original language and English, as Supporting Information, or include a citation if it has been published previously. 2. Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical. 3. Please amend your manuscript to include your abstract after the title page. Additional Editor Comments (if provided): Thank you for submitting your manuscript for review. This is an interesting topic, and as such, I encourage you to consider the extensive feedback provided from the reviewers below. [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: Partly 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: Yes ********** 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: Yes ********** 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: This manuscript describes interviews with individuals involved with clinical trial recruitment - the planning and design phase. The rationale provided is a bit weak. It does not reference recruitment models. The methods are adequately described; missing is the typical length of the interview. Results are presented with sufficient supportive quotes provided. The discussion is wide ranging and includes areas not addressed within the interviews/data/results. It sounds a bit 'preachy' in places and reads as if the authors had conclusions in mind (e.g. use of evidence to inform selected strategies; its time we create a culture change). The discussion includes items that might better be presented in results and could be significantly shortened. A typo in the Results section: The encompass should be They encompass Reviewer #2: This manuscript presents the results of a qualitative study of professionals who run clinical trial recruitment efforts. There were 23 interviews conducted. The interviews were semi-structured, in-depth interviews. The results were analyzed using the Framework method. Topics addresssed include: who is responsible for planning recruitment, detailed planning procedures, using empirical evidence, barriers to planning, and stress on those responsible for recruitment. Each topic is addressed with quotations from those who were interviewed. In general, a lack of resources (especially time) make it difficult for those planning recruitment to have sufficiently detailed plans to respond to issues in recruitment. Recruitment often lags behind expected results. Recruiters respond with ad hoc solutions, but the work is stressful as a result. This paper presents interesting results. It raises important questions about how clinicial trials are typically run. I am a survey methodologist by training. As such, it is hard for me to evaluate this paper with respect to other papers on a similar topic. However, as a survey methodologist, I see a number of points of overlap with concerns in our field. There are also some differences. Expanding the paper in several areas would reinforce the importance of the results. Major Comments 1. As with recruitment to clinical trials, surveys are facing rising nonresponse rates. This has been true since the 1990s and an area of concern. This manuscript argues that the major threat is to the power of studies. Clinical trials with recruitment difficulties might not meet their recruitment targets and, therefore, would be underpowered for drawing conclusions about treatment effectiveness. While this certainly is a risk, in the survey context, we have become more concerned with how this difficulty might lead to bias in estimates. This manuscript doesn't really discuss the potential for bias. It would be useful to review the pertinent literature on this question for clinical trials. I found this citation: Hofer, A., M. Hummer, R. Huber, M. Kurz, T. Walch and W. W. Fleischhacker (2000). "Selection Bias in Clinical Trials with Antipsychotics." Journal of Clinical Psychopharmacology 20(6): 699-702. As I am not an expert on the risk of bias in recruitment to clinical trials, I would like to hear more about this from a clinical trial perspective. This raised a larger question that the field of survey methodology has been confronting for several years: what is quality in this context? The authors seem to suggest that meeting targets is the sole measure of quality. Are there other relevant measures? In survey methodology, we have developed measures related to the risk of nonresponse bias, but clinical trials might require other measures. This issue may be larger than this paper. 2. A second area of overlap between the two fields is the problem of uncertainty in the design. In surveys, the ability to predict how survey production will go has been greatly hampered by the general trend of declining response rates. What are the reasons for the uncertainty in recruitment to clinical trials? The paper quotes one of the interviewees as saying "the number of cases promised in any clinical study must be divided by a factor of at least 10." Is this due to a changing environment or is it because the designs in proposals to funders are overly optimistic? Some description of the sources of this uncertainty would be helpful. In surveys, a technique known as responsive survey design was developed that planned for uncertainty. It's akin to risk management. Design changes are pre-planned and then triggered when indicators (such as response rates) meet (or don't meet) specified targets. I provide a key citation: Groves, R. M. and S. G. Heeringa (2006). "Responsive design for household surveys: tools for actively controlling survey errors and costs." Journal of the Royal Statistical Society: Series A (Statistics in Society) 169(3): 439-457. 3. As an outsider, it seems that an important question for this field is how to systematize a body of knowledge. Should there be more academic research in the area of methods of recruitment to clinical trials? Could new journals be organized? Is there sufficient professional training available? Do people working in this area have conferences where they can share their knowledge? All of these would be useful and might help stimulate more systematic research on this topic and adoption of new techniques in practice. The conclusion of the paper makes some very general suggestions. "Trial Forge" is mentioned as one program aimed at improving design and implementation of studies. It would be helpful to make some more specific recommendations. Survey methodology does have a fair amount of published research on recruitment methods and data quality. This research is clustered in a few journals that are associated with the profession (e.g. Public Opinion Quarterly). The role of questionnaire length is one such topic. The use of incentives is the subject of a huge amount of research. Some of this might be helpful for persons running recruitment to clinical trials. 4. General comment on disclosure risk. You have a relatively small sample. I worry that the information in Table 1, plus the comments with descriptive tag lines, could lead to identification of some of the participants. I can't say for sure, but wonder if someone in this community could identify colleagues and determine which quotes were theirs. For example, in Table 1, I can see that there is one person from a particular location. With that knowledge, and knowing who works there, could I figure out who some of the quotes were from? Minor Comments 1.Sample size. I'm not convinced by a concept of "data saturation" stated in such a general way. I think the sample size should be a function of the thing being studied. For this research, I'm not very worried about justifying the sample size. 2.Organization of paper. The heads and subheads are confusing. It's difficult to see which sections are embedded in which. ********** 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: James Wagner [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. |
Revision 1 |
Using evidence when planning for trial recruitment: An international perspective from time-poor trialists PONE-D-19-17368R1 Dear Dr. Gardner, 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. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and no later than 48 hours after receiving the formal acceptance. 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. With kind regards, Kathleen Finlayson Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: |
Formally Accepted |
PONE-D-19-17368R1 Using evidence when planning for trial recruitment: An international perspective from time-poor trialists Dear Dr. Gardner: 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. Kathleen Finlayson Academic Editor PLOS ONE |
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