Feasibility, acceptability and validation of wearable devices for climate change and health research in the low-resource contexts of Burkina Faso and Kenya: Study protocol

Sandra Barteit; Valentin Boudo; Aristide Ouedraogo; Pascal Zabré; Lucienne Ouremi; Ali Sié; Stephen Munga; David Obor; Daniel Kwaro; Sophie Huhn; Aditi Bunker; Rainer Sauerborn; Hanns-Christian Gunga; Martina A. Maggioni; Till Bärnighausen

doi:10.1371/journal.pone.0257170

Peer Review History

Original SubmissionJune 2, 2021
14 Jul 2021 Decision Letter - Manuela Cabiati, Editor PONE-D-21-17308 Feasibility, acceptability and validation of wearable devices for climate change and health research in the low-resource contexts of Burkina Faso and Kenya: Study protocol PLOS ONE Dear Dr Barteit I apologize for the delay, we have received the response of the second reviewer. 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 accordance to the other colleagues, your manuscript need of minor revisions and should be modified as suggested. best regards manuela cabiati ============================== Please submit your revised manuscript by Aug 28 2021 11:59PM. 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If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Yes Reviewer #2: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes Reviewer #2: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 ****** 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: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: This is an interesting manuscript that comprises a study protocol for the purpose of conducting a climate change and health research in low-resource areas using wearable devices. Overall, the protocol looks fine and the expected results would be valuable. I don’t have major objections to the manuscript. I do have the following small issues for the authors to consider: 1. I suggest the authors to consider is it necessary to monitor all the devices to see if some are not working properly (e.g., if some of them are under direct sunshine and the battery got burned) and what to do if malfunctions do occur. 2. I’m not sure if (regular) incentives are necessary to provide to the participants to finish the study. 3. I’m not sure if the data would be enough for the authors to use deep learning models for analysis. Reviewer #2: This manuscript presents the study protocol to investigate the acceptability, feasibility and validity of some wearable devices to study a sub-Saharan Africa population subjected to heat stress. The presentation of the protocol is well described and the number of subjects who will be enrolled seems to be compatible with significant statistical power for the subsequent analysis. The issue is certainly important considering the problem of climate change that we are experiencing in this era. Perhaps it would be appropriate to specify the method of sterilization of the instrumentation supplied in the study also in light of the problems of Covid 19. A likely critical point within the various physiological parameters that will be monitored is the measurement of blood pressure, which is only foreseen at the time of the meeting with the nurse. This parameter will certainly not give information on the relative trend of blood pressure so it could be useful if a measurement within 24 hours of the subjects enrolled could be useful to be related to the environmental climatic characteristics. Considering also a possible purpose of the study which could be to evaluate the cardiovascular response to heat stress, it is also asked to specify how the environmental climatic parameters will be detected during the enrollment period of the subjects. ****** 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:** Lorenza Pratali [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.] 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 PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0257170.r001
Revision 1
22 Jul 2021 Author Response resp. 1. We have revised the submitted manuscript according to the PLOS ONE’s style requirements and I hope that we have adhered to all style requirements now in our revised manuscript. resp. 2. I have uploaded all research ethics committee approval letters (Heidelberg University Hospital, SERU Kenya, CRSN Burkina Faso, Charité Berlin, uploaded in the Editorial Manager on May 28th, 2021). As per our study protocol (CP1) we collaborate with sub-project P4 as part of this research unit, as we compare the consumer-grade wearable devices that are part of sub-project CP1 with the gold standard sensors of sub-project P4 (Charité). The Charité ethical approval is not a necessary element for the study protocol of CP1, as we have ethical approval from Heidelberg University, the CRSN in Burkina Faso and the SERU in Kenya. With regards to the SERU ethical approval: The SERU in Kenya has approved all sub-projects that are part of this research unit in one approval of the complete DFG research unit "Climate Change and Health in Sub-Saharan Africa". Prof. Dr. Dr. Rainer Sauerborn is the spokesperson of this research unit and has such is addressed in the SERU approval letter. I hope this can clarify on the respective ethical approvals. resp. 3. We have revised the funding information in the manuscript accordingly. resp. 4. We have moved the ethics statement to the Methods section. resp. 5. We revised the manuscript so all figures are referred to in the text. Furthermore, we have uploaded our two figures as included in this revised manuscript to PACE. resp. 6. We have added the following references to the revised manuscript: - we have added the following reference as we have added further examples of research that has already used wearable devices data correlated with weather data 28. Culp K, Tonelli S. Heat-Related Illness in Midwestern Hispanic Farmworkers: A Descriptive Analysis of Hydration Status and Reported Symptoms. Workplace Health Saf. 2019;67: 168–178. doi:10.1177/2165079918813380 - we have added the following reference as we have added further examples of research that has already used wearable devices data correlated with weather data 29. Lam CKC, Hang J, Zhang D, Wang Q, Ren M, Huang C. Effects of short-term physiological and psychological adaptation on summer thermal comfort of outdoor exercising people in China. Build Environ. 2021;198: 107877. doi:10.1016/j.buildenv.2021.107877 - we have added the following reference to complete the statement in the sentence in the manuscript (p.8): The study is conducted in the two African countries of Burkina Faso and Kenya, as both countries are located in SSA and have one of the highest burdens of climate-sensitive diseases, but differ in their climatic, socioeconomic and disease profile [2,39–41]. 41. Sewe M, Rocklöv J, Williamson J, Hamel M, Nyaguara A, Odhiambo F, et al. The association of weather variability and under five malaria mortality in KEMRI/CDC HDSS in Western Kenya 2003 to 2008: a time series analysis. Int J Environ Res Public Health. 2015;12: 1983–1997. - we have added further specifications in the Analysis section of the manuscript (p.22) and have accordingly added this reference to refer to the specified research: “This is a first exploration to investigate the feasibility of classifying common local activities like harvesting, fetching water and so on, using time-domain plots of wearable device data, as reported in other research [60].” 60. Liu Y, Nie L, Liu L, Rosenblum DS. From action to activity: Sensor-based activity recognition. Neurocomputing. 2016;181: 108–115. doi:10.1016/j.neucom.2015.08.096 We would like to thank the reviewers for their comments and helpful suggestions to our manuscript. Accordingly, we have made amendments to the manuscript and describe our amendments with respect to the reviewers’ comments in the following. Reviewer #1: This is an interesting manuscript that comprises a study protocol for the purpose of conducting a climate change and health research in low-resource areas using wearable devices. Overall, the protocol looks fine and the expected results would be valuable. I don’t have major objections to the manuscript. I do have the following small issues for the authors to consider: 1. I suggest the authors to consider is it necessary to monitor all the devices to see if some are not working properly (e.g., if some of them are under direct sunshine and the battery got burned) and what to do if malfunctions do occur. - Many thanks for this comment. We do take up hardware reliability as part of this study and have added the following section to the manuscript, which we hope clarifies this point a bit further, p.8: “We will investigate the feasibility and acceptability with a Likert-scaled questionnaire that covers also demographic items: 13 items addressing feasibility with a strong focus on hardware reliability (i.e., are the devices functioning well in the sub-Saharan climatic conditions), and 29 items addressing acceptance (see S1 File for the questionnaire). If the wearable devices fail or we have data outages, we shall keep track of them in order to gain a quantitative overview of the types of failures and sources of data disruptions.” 2. I’m not sure if (regular) incentives are necessary to provide to the participants to finish the study. - Indeed, study participants receive an adequate reimbursement (according to local standards). We have added on p.16 the following: “The study participants are reimbursed for their time commitment in the study and the type and scope are subject to local HDSS guidelines.” 3. I’m not sure if the data would be enough for the authors to use deep learning models for analysis. - Again, many thanks for this comment. Indeed, this analysis is targeted for the subsequent one-year study that is planned to follow this study. We did not specify this well in the manuscript and after consideration have removed this paragraph, as it seems to be overburdening the current study protocol, which focus on feasibility, acceptability and validity. Reviewer #2: This manuscript presents the study protocol to investigate the acceptability, feasibility and validity of some wearable devices to study a sub-Saharan Africa population subjected to heat stress. The presentation of the protocol is well described and the number of subjects who will be enrolled seems to be compatible with significant statistical power for the subsequent analysis. The issue is certainly important considering the problem of climate change that we are experiencing in this era. Perhaps it would be appropriate to specify the method of sterilization of the instrumentation supplied in the study also in light of the problems of Covid 19. - Many thanks for this comment, which covers an important aspect. We have specified the sterilization in light of COVID-19 in the manuscript, p.10/11: “To decrease the likelihood to transmit infectious diseases like the Coronavirus disease (Covid-19), each study nurse and community field worker is equipped with a hygiene package comprising face masks, disinfectant spray, clean wipes and hand disinfectant. The wearable devices are first rinsed with water, then sprayed with disinfectant, and wiped clean. A protocol that details this process is handed out to each study nurse and field worker.” A likely critical point within the various physiological parameters that will be monitored is the measurement of blood pressure, which is only foreseen at the time of the meeting with the nurse. This parameter will certainly not give information on the relative trend of blood pressure so it could be useful if a measurement within 24 hours of the subjects enrolled could be useful to be related to the environmental climatic characteristics. - Yes, we agree that a 24hour measurement would be of great help to correlate this with weather characteristics. However, after consideration, we have removed the blood pressure measurement for this study, as we primarily want to focus on the feasibility, acceptability and reliability of the wearable devices and adding blood pressure at this point in time may only add further complications instead of insights. We will consider your remark for our one-year study that is to follow this study and we will aim for a 24-hour measurement to get higher granularity of individuals response to local weather events with regards to a blood pressure measurement. Considering also a possible purpose of the study which could be to evaluate the cardiovascular response to heat stress, it is also asked to specify how the environmental climatic parameters will be detected during the enrollment period of the subjects. - We have detailed specifics on the ten local weather stations that we have setup as part of this research unit in Kenya and Burkina Faso, p.8/9: “As part of this study, we have installed ten fully automated weather stations with the same configuration in the Nouna HDSS (5x) and in the Siaya HDSS (5x) that spatially cover the whole HDSS area. As a follow-up study to this feasibility, acceptability and validation study, it is planned to generate wearable measurements in a one-year study to account for seasonality and investigate whether weather (WBGT) has an effect on individual behavior and health (climate-sensitive disease, as available within the Nouna and Siaya HDSS). The local weather stations that have been setup as part of this research unit cover the continuous measurements of precipitation, wind speed, wind direction, radiation, temperature, and humidity, as well as WBGT. Seasonality has no bearing on the feasibility, acceptability, or validation of the wearable measurement in this study, hence it is not taken into consideration.” Attachments Attachment Submitted filename: Response_to_Reviewers.pdf https://doi.org/10.1371/journal.pone.0257170.r002
25 Aug 2021 Decision Letter - Manuela Cabiati, Editor Feasibility, acceptability and validation of wearable devices for climate change and health research in the low-resource contexts of Burkina Faso and Kenya: Study protocol PONE-D-21-17308R1 Dear Dr. Barteit, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. 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 help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- 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. Kind regards, Manuela Cabiati, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0257170.r003
Formally Accepted
3 Sep 2021 Acceptance Letter - Manuela Cabiati, Editor PONE-D-21-17308R1 Feasibility, acceptability and validation of wearable devices for climate change and health research in the low-resource contexts of Burkina Faso and Kenya: Study protocol Dear Dr. Barteit: I'm 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 let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, 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. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Manuela Cabiati Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0257170.r004

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