PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)"

Transcription

1 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (see an example) and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. Some articles will have been accepted based in part or entirely on reviews undertaken for other BMJ Group journals. These will be reproduced where possible. ARTICLE DETAILS TITLE (PROVISIONAL) AUTHORS Assessing the efficacy of the electronic patient record system EDeR: Implementation study - Study protocol Bachmann, Lucas; Job, Oliver; Schmid, Martin; Thiel, Michael; Ivic, Sandra VERSION 1 - REVIEW REVIEWER REVIEW RETURNED MILopez Galvez IOBA University of Valladolid, Valladolid,Spain 16-Dec-2012 RESULTS & CONCLUSIONS The article only includes the protocol not the results. It is not enough GENERAL COMMENTS I suggest to publish it with the results with thw analysis included There is no conlcusion The article is incomplete REVIEWER REVIEW RETURNED Frank Larkin, Consultant ophthalmologist, Moorfields Eye Hospital, London, UK. I have no competing interests. 31-Dec-2012 THE STUDY GENERAL COMMENTS 1. It may be inappropriate to evaluate clinician performance using the electronic record before any necessary learning time using the software has elapsed. I realise that the planned second analysis at one year would probably identify any such effect due to inexperience. 2. Refs #3-5, 8, 9 are incomplete (year of publication). This manuscript describes the design of a prospective simulated study to examine the factors associated with improved performance using an electronic clinical record versus paper records. They term this a randomised vignette study. The design is based on specific clinical decision points in consultations in a range of ophthalmology sub-specialties. While ophthalmology is itself a small specialty, it does lend itself to electronic patient record keeping better than many others for a number of reasons, including the high proportion of images which are used as diagrams or digital photographs in records (for example fundoscopy findings). My opinion is that the findings in this type of study would be of broad interest in clinical medicine more generally.

2 Specific comments. 1. Having indicated my support for this study, it would be of much higher value if the results were included. I encourage the authors to add their findings and discuss these. The manuscript is short as submitted. 2. As the authors indicate, there has been little research previously published in this field. More critical analysis of those previous reports which they cite would improve the manuscript. 2. Methods & design, P9 line 7: Is it valid to assume standard distribution of any differences in responses to matched vignette pairs? 3. Time of data collection, P9 line 22: If the authors have not set out to examine for any clinician learning effect with software, why not assess competence with software before the first comparative analysis? REVIEWER REVIEW RETURNED Prof. Dr. med. Jürgen Stausberg Ludwig-Maximilians-Universität München Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE) Germany 16-Jan-2013 GENERAL COMMENTS The authors present a well-thought-out study protocol to assess the electronic patient record system EDeR to be implemented in their ophthalmological department. Main focus of this study is to explore differences in speed and accuracy when searching clinical information using the paper based patient record or the EDeR. The authors also talk about patient s safety, which should be improved by an electronic medical record (EMR), and the possible barriers for a successful use of the EMR. As far as the reviewer understands, the plan is as follows. Patient vignettes are the observational units. The study measures the time needed to solve tasks related to those vignettes. The reviewer assumes that tasks and vignettes are related 1 to 1. Otherwise, if a patient vignette is used for several tasks, the tasks become observational unit. Time is the outcome variable. Intervention is the EMR that is compared with the paper-based patient record. Therefore, the study implements a two group design. The authors assume that the intervention saves 60 seconds time in the mean with a standard deviation of 45 seconds. Instead of randomly assigning vignettes to the groups, the study implements a crossover design in randomly assigning the sequence (EMR first, paper second vs. paper first EMR second) to vignettes. That design is underpinned by a formal correct sample size calculation leading to 7 observational units needed. To make it more complex, the authors include subgroups as well as several observers for each measurement. They include 5 subgroups for clinical specialties related to the patient vignettes and 2 subgroups of level of expertise related to the observers. At least, they will have 2 x 5 x 5 (five tasks each clinical subspecialty) x 2 (EMR and paper) = 500 measurements. To address less reliability having only one observer

3 in each subgroup (experts and beginners) the authors intend to recruit more than the two for the study. To make it more serious, the vignettes are slightly modified according to the group. So if an observer checks the same vignette a second time (e. g. in the EMR), he must read the content again, because the answer is different to the first time (e. g. in the paper-based version). The material for the paper-based-group comes from real patients records; the material for the EMR-group is entered into the EMR specifically for the study. This long description makes clear that the proposed study protocol characterizes a complex study design. Unfortunately, the complexity is not well addressed in the text. Furthermore, it is unclear whether the design is really appropriate to answer the research question. Therefore I recommend 1) to improve the readability of the text by clarifying the points made above on the one hand and 2) to rethink the study design according to the research question on the other hand. It would be helpful if the authors refer 3) to an established schema for study design rather than to describe the details in own words. However, the study idea of the authors in assessing the efficacy of EDeR is essential and a current and important topic that must be discussed. It offers a good basis to explore other essential usability and efficacy questions regarding the use of EMRs. General essential recommendations 4) As long as the time needed to fulfill the tasks is the only measurement, the study is solely related to efficacy as the authors denote time saving. Then, the study does not measure accuracy. Consequently, accuracy should be deleted a study goal. 5) A figure should be added to explain the several entities in the study (vignettes, tasks, sub-specialties, user groups). 6) A major concern with the study design is a potential bias introduced by the unblinded recording of the vignettes into the EMR. The reviewer assumes that the result is an optimized representation of the vignettes in the EMR. This optimized representation will be different from the information available in the EMR in routine use. Comparing the optimized representation of the vignettes in the EMR with an ordinary representation in a paper-based-record is unfair. Addressing this potential bias in the study design is mandatory. Specific essential recommendations 7) The authors should clarify whether the participants of the study will be trained or not in the implemented EDeR prior to the assessment.

4 8) Study population: How big the study population is or will be? For instance, how many ophthalmologists are found in the eye clinic of the cantonal hospital Lucerne? How many junior and senior ophthalmologists are there? How many ophthalmologists already voluntarily agreed to participate in the study? What is the expectation of the recruitment rate? Experimental design: 9) For each out of five different ophthalmologic sub-specialties, the authors will create five tasks based on a patient example. Did some literature lead the choice of these five task types? Or how did the authors come to the definition of the task types? What motivated this choice? The authors should specify if these five tasks are the main consultation s tasks in their ophthalmology department or if these tasks are generally error-prone when using the paper-based form. 10) Each physician from each division has to solve all of the tasks. So, a physician from a specific division will have to solve <5 or 25?> tasks using paper-based records and <5 or 25?> tasks using the EDeR in a randomized sequence. Please specify if the physicians will have to solve all <10 or 50?> tasks at once, that is without break. 11) The evaluation will take place at two time points; immediately after implementation of EDeR and one year after. Please specify if the physicians are already trained in EDeR at the first time point. What about the second time point (one year after)? Also specify if the physicians will be using EDeR during that year or would you keep training them to prepare them to the second evaluation? Detailed research plan: 12) At the assessment/the role of the assessor. Let s suppose a technical problem occurs after a physician has already performed 8 tasks. This problem unfortunately forces the break of the assessment. Shall the physician start all tasks from the beginning at another time point or may he perform only the last tasks later? Sample size calculation: 13) Please check, if the sample size estimation holds true in view of the several subgroups as well as the issue of multiple testing introduced with the subgroups. 14) Having 20 minutes time for a whole consultation, 60 seconds time reduction with a single task seems unrealistic. Please clarify how the total time reduction for a whole consultation is estimated by observing small tasks. Discussion: We presume that the implementation of the electronic medical record software EDeR will have a positive impact on the efficiency of

5 the doctors, which will result in an increase of consultations per day. 15) Good and fine, but what is more important: the increase of consultations per day (through decrease of consultation time: 1 min gained) or the improvement of patients healthcare (improved quality of consultation, patient safety)? Further recommendations 16) Abstract Introduction: replace the second sentence with Critics, however, claim that they are hard to read, because of illegible handwriting, and uncomfortable to use. 17) Abstract Methods and Analysis: there is an 'e' too much in the first sentence. Background: second paragraph, last sentence: As a result of these problems should be As a solution to these problems. 18) Background: third paragraph, last sentence: the second word 'understanding' should be 'understand'. 19) Last paragraph, first sentence: there is an 'e' too much in the first sentence (In this protocol we describe e a study exploring ). 20) Methods/Design Study population, first sentence: change in in into. 21) Methods/Design Data collection Point of time of data collection: Second part of the second sentence should be rewritten. Did you mean: with the help of a medical record? 22) Even if there is just one table provided in the paper, the authors should give it a number when referencing to it. 23) References related to the evaluation of medical informatics interventiones is misssing. 24) The selection of references according to the research question is arbitrary. 25) It is unclear whether a conflict of interest exists due to the involvement of the authors in the development of the EMR-system. Please include a statement related to the involvement of the authors.

6 VERSION 1 AUTHOR RESPONSE # Reviewer: M.I. Lopez Galvez Our reply 1 The article only includes the protocol not the results. It is not enough Thank you. This is the protocol for a study that will be still executed. BMJ open offers publication of protocols and we think that this is very useful to share and discuss methods of studies before their execution. 2 I suggest to publish it with the results with the analysis included There is no conclusion Reviewer: Frank Larkin, Please see our reply to query 1 Our reply 1 It may be inappropriate to evaluate clinician performance using the electronic record before any necessary learning time using the software has elapsed. I realise that the planned second analysis at one year would probably identify any such effect due to inexperience. Thank you for the favorable assessment of our proposal. 2 Refs #3-5, 8, 9 are incomplete (year of publication). Thank you the references have been revised. 3 This manuscript describes the design of a prospective simulated study to examine the factors associated with improved performance using an electronic clinical record versus paper records. They term this a randomised vignette study. The design is based on specific clinical decision points in consultations in a range of ophthalmology subspecialties. While ophthalmology is itself a small specialty, it does lend itself to electronic patient record keeping better than many others for a number of reasons, including the high proportion of images which are used as diagrams or digital photographs in records (for example fundoscopy findings). My opinion is that the findings in this type of study would be of broad interest in clinical medicine more generally. 4 Having indicated my support for this study, it would be of much higher value if the results were included. I encourage the authors to add their findings and discuss these. The manuscript is short as submitted. 5 As the authors indicate, there has been little research previously published in this field. More critical analysis of those previous reports which they cite would improve the manuscript. Thank you! No reply required. Thank you. We would like to refer to our reply to query number 1 of Dr. Lopez Galvez Thank you no reply required.

7 6 Methods & design, P9 line 7: Is it valid to assume standard distribution of any differences in responses to matched vignette pairs? 7 Time of data collection, P9 line 22: If the authors have not set out to examine for any clinician learning effect with software, why not assess competence with software before the first comparative analysis? Thank you. We checked again with our statistician and he confirmed the adequacy of our approach. Thank you for this important query. We fully agree and clarified this point in the revised paper. (p.8, 1 st para) Prior to the examination baseline data will be collected of each participant.

8 Reviewer Jürgen Stausberg Our reply 1 The authors present a well-thought-out study protocol to assess the electronic patient record system EDeR to be implemented in their ophthalmological department. Main focus of this study is to explore differences in speed and accuracy when searching clinical information using the paper based patient record or the EDeR. The authors also talk about patient s safety, which should be improved by an electronic medical record (EMR), and the possible barriers for a successful use of the EMR. 2 As far as the reviewer understands, the plan is as follows. Patient vignettes are the observational units. The study measures the time needed to solve tasks related to those vignettes. The reviewer assumes that tasks and vignettes are related 1 to 1. Otherwise, if a patient vignette is used for several tasks, the tasks become observational unit. Time is the outcome variable. Intervention is the EMR that is compared with the paper-based patient record. Therefore, the study implements a two group design. The authors assume that the intervention saves 60 seconds time in the mean with a standard deviation of 45 seconds. Instead of randomly assigning vignettes to the groups, the study implements a crossover design in randomly assigning the sequence (EMR first, paper second vs. paper first EMR second) to vignettes. That design is underpinned by a formal correct sample size calculation leading to 7 observational units needed. To make it more complex, the authors include subgroups as well as several observers for each measurement. They include 5 subgroups for clinical specialties related to the patient vignettes and 2 subgroups of level of expertise related to the observers. At least, they will have 2 x 5 x 5 (five tasks each clinical subspecialty) x 2 (EMR and paper) = 500 measurements. To address less reliability having only one observer in each subgroup (experts and beginners) the authors intend to recruit more than the two for the study. To make it more serious, the vignettes are slightly modified according to the group. So if an observer checks the same vignette a second time (e. g. in the EMR), he must read the content again, because the answer is different to the first time (e. g. in the paper-based version). The material for the paper-based-group comes from real patients records; the material for the EMR-group is entered into the EMR specifically for the study. Thank you for the favorable assessment of our protocol. No reply required. This is an excellent analysis of the proposed method. Thank you no reply required.

9 3 This long description makes clear that the proposed study protocol characterizes a complex study design. Unfortunately, the complexity is not well addressed in the text. Furthermore, it is unclear whether the design is really appropriate to answer the research question. Therefore I recommend to improve the readability of the text by clarifying the points made above on the one hand and to rethink the study design according to the research question on the other hand. 4 It would be helpful if the authors refer to an established schema for study design rather than to describe the details in own words. 5 However, the study idea of the authors in assessing the efficacy of EDeR is essential and a current and important topic that must be discussed. It offers a good basis to explore other essential usability and efficacy questions regarding the use of EMRs. Thank you for this query we agree that the description was too brief. We amended the protocol as follows lending substantially from Prof Stausberg s excellent summary in point 2: (p 8, last. para.) Design Matrix Summary This is a two group (EDeR vs. paper based) cross-over (randomly assigning the sequence electronic vs. paper-based per task) study. Time (primary endpoint) and accuracy (secondary endpoint) are the two outcome variables. Intervention is the EDeR that is compared with the paper-based patient record. We assess tasks within 5 clinical subgroups (without examining subgroup effects) and perform the experiment in two groups with different ophthalmologic expertise (junior doctors vs. senior doctors). Each assessor will complete 50 tasks (i.e. 25 tasks based on the electronic patient record and 25 based on the paper patient record). Electronic and paper-based vignettes are slightly different for each task. If an assessor checks the same vignette a second time (e. g. in the electronic version), he or she must read the content again, because the answer is different to the first time (e. g. in the paper-based version). The material for the paperbased-group comes from real patients records and the tasks were selected based on clinical relevance. Thank you we are unaware of a similar application and would be grateful, if you could indicate a paper covering the same topic and applying a similar method. Thank you, no reply required.

10 6 As long as the time needed to fulfill the tasks is the only measurement, the study is solely related to efficacy as the authors denote time saving. Then, the study does not measure accuracy. Consequently, accuracy should be deleted a study goal. 7 A figure should be added to explain the several entities in the study (vignettes, tasks, subspecialties, user groups). 8 A major concern with the study design is a potential bias introduced by the unblinded recording of the vignettes into the EMR. The reviewer assumes that the result is an optimized representation of the vignettes in the EMR. This optimized representation will be different from the information available in the EMR in routine use. Comparing the optimized representation of the vignettes in the EMR with an ordinary representation in a paper-based-record is unfair. Addressing this potential bias in the study design is mandatory. 9 The authors should clarify whether the participants of the study will be trained or not in the implemented EDeR prior to the assessment. We fully agree that the protocol did not clearly specify that accuracy was a secondary outcome of this study. We amended the protocol as follows. (p para.) Primary outcome Gain in speed, when performing the task using the EDeR system Secondary outcome Accuracy of replies given using the EDeR system vs. the paper record We agree with the Reviewer and added a figure to the amended manuscript. Thank you. The Reviewer raises an important issue. Data managers at the Hospital will enter the complete available patient record into EDeR. Thus, the content will be identical in both exposures. We agree that this aspect was not clearly stated in the initial submission. We therefore revised the paper as follows: (p. 7, 2. para) The patient model will come from original paper forms to assure that cases are comparable to the real life situation. The full patient record, containing a slight modification for the contrast examined in a specific task, will be transferred from paper into the electronic patient record system. Thank you. We fully agree and amended the protocol as follows: (p.6, 5 para) Ophthalmologist of the cantonal hospital Lucerne eye clinic who voluntarily agreed to participate in the study will be included. Each participant will receive a general introduction on the usage of the EDeR of half an hour prior to the assessment.

11 10 Study population: How big the study population is or will be? For instance, how many ophthalmologists are found in the eye clinic of the cantonal hospital Lucerne? How many junior and senior ophthalmologists are there? How many ophthalmologists already voluntarily agreed to participate in the study? What is the expectation of the recruitment rate? 11 For each out of five different ophthalmologic subspecialties, the authors will create five tasks based on a patient example. Did some literature lead the choice of these five task types? Or how did the authors come to the definition of the task types? What motivated this choice? The authors should specify if these five tasks are the main consultation s tasks in their ophthalmology department or if these tasks are generally errorprone when using the paper-based form. 12 Each physician from each division has to solve all of the tasks. So, a physician from a specific division will have to solve <5 or 25?> tasks using paper-based records and <5 or 25?> tasks using the EDeR in a randomized sequence. Please specify if the physicians will have to solve all <10 or 50?> tasks at once, that is without break. Thank you for this query. We provide some information in the revised paper. (p.6. 2 nd para) The study is planned to take place at the cantonal hospital of Lucerne in the clinic of ophthalmology. The Eye clinic is run by six consultant ophthalmologists, 12 senior physicians, and 14 junior doctors. And (p. 9, 3 rd para) At the time of writing this protocol 10 senior physicians and 9 junior doctors were willing to participate in the study. Thank you again for this important query. We specified the selection of topics in the amended manuscript as follows: (p.7, 1 st para) The tasks are chosen on the basis of the relevance in clinical practice. Thank you. We clarified this as follows: (p.8, 3 rd para) We will design a reply form into which each participant enters his or her response to the task. This reply form will be handed over to the assessor after completion. Time will be taken by the assessor after completing each entry into this form. In total, each participant will go through 25 pairs of tasks.

12 13 The evaluation will take place at two time points; immediately after implementation of EDeR and one year after. Please specify if the physicians are already trained in EDeR at the first time point. What about the second time point (one year after)? Also specify if the physicians will be using EDeR during that year or would you keep training them to prepare them to the second evaluation? 14 At the assessment/the role of the assessor. Let s suppose a technical problem occurs after a physician has already performed 8 tasks. This problem unfortunately forces the break of the assessment. Shall the physician start all tasks from the beginning at another time point or may he perform only the last tasks later? 15 Please check, if the sample size estimation holds true in view of the several subgroups as well as the issue of multiple testing introduced with the subgroups. Please see our reply to your query 9. Before the first exposure, only a general introduction on the usage of EDeR will be provided that will last about 30 minutes. The training will cover aspects of data collection and saving very briefly. The training will be such, that the basic functions are known. We amended the paper as follows. (p. 6, 3 rd para.) The training will cover aspects of data collection and saving very briefly. The training will be such, that the basic functions of the EDeR are known. On page 10, 3 rd para we also revised as follows: At the second time point, one year after the first assessment, the experiment will be repeated using the same protocol. In the interval between the two measurements, all physicians will be mainly working with the EDeR system. Thank you very much for this important query. We fully agree and added this statement on p.9 1 st para: In case of a technical problem with the electronic system, the assessment will be suspended and the remaining tasks will be completed after restoration of the system. We will only make statistical comparisons on the main effect. Subgroup analyses will be performed in exploratory analyses. Any subgroup result will be marked in the paper as such and the issue of power will be discussed.

13 16 Having 20 minutes time for a whole consultation, 60 seconds time reduction with a single task seems unrealistic. Please clarify how the total time reduction for a whole consultation is estimated by observing small tasks. 17 We presume that the implementation of the electronic medical record software EDeR will have a positive impact on the efficiency of the doctors, which will result in an increase of consultations per day. Good and fine, but what is more important: the increase of consultations per day (through decrease of consultation time: 1 min gained) or the improvement of patients healthcare (improved quality of consultation, patient safety)? 18 Abstract Introduction: replace the second sentence with Critics, however, claim that they are hard to read, because of illegible handwriting, and uncomfortable to use. 19 Abstract Methods and Analysis: there is an 'e' too much in the first sentence. 20 Background: second paragraph, last sentence: As a result of these problems should be As a solution to these problems. 21 Background: third paragraph, last sentence: the second word 'understanding' should be 'understand'. 22 Last paragraph, first sentence: there is an 'e' too much in the first sentence (In this protocol we describe e a study exploring ). 23 Methods/Design Study population, first sentence: change in in into. 24 Methods/Design Data collection Point of time of data collection: Second part of the second sentence should be rewritten. Did you mean: with the help of a medical record? The reviewer raises an interesting question. We performed a small survey among the senior staff at our institution and there was a consensus that a meaningful difference should be at least 1 Minute / Patient. Therefore, this delta was chosen. We do agree that the advantage in terms of speed will not necessarily come from one single task in clinical practice. But still this could be the case for example when checking the number of interventions a patient received over a longer period of time combined with a judgment of treatment effect. Arguably, there is no strong basis for our statistical assumptions but they seem rational to us. Therefore, we would like to keep the paper unchanged on this point. Please also see our reply to your query 6. We agree, therefore accuracy is assessed as a secondary outcome in this study. We realize that accuracy is only an indirect measure of improved quality of consultation and patient safety and will design further studies investigating this more directly, once this study showed a superiority of EDeR. We kept the manuscript unchanged. Thank you. We revised the Abstract accordingly. Well spotted thank you! Thank you we revised the paper accordingly. Thank you we revised the paper accordingly. Thank you we revised the paper accordingly. Thank you we revised the paper accordingly. Thank you we revised the paper accordingly.

14 25 Even if there is just one table provided in the paper, the authors should give it a number when referencing to it. 26 References related to the evaluation of medical informatics interventions are missing. 27 The selection of references according to the research question is arbitrary. 28 It is unclear whether a conflict of interest exists due to the involvement of the authors in the development of the EMR-system. Please include a statement related to the involvement of the authors. Thank you we revised the paper accordingly. Thank you we checked again and added the reference of your excellent 2008 Systematic Review published in J Biomed Inform. to the background section. We also added some additional references to underpin our statements better. Please see our reply to your query 26 Thank you we fully agree and amended the paper accordingly. We declare to have no conflict of interest. (p.13, last para) VERSION 2 REVIEW REVIEWER REVIEW RETURNED Prof. Dr. med. Jürgen Stausberg Ludwig-Maximilians-Universität München Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE) Germany 05-Mar-2013 GENERAL COMMENTS The authors submitted a revised manuscript of their study protocol that takes into account the majority of the reviewer s concerns. Only a few points remain. The authors may or may not change their study protocol according to those points or may or may not comment on those points in their manuscript. A) The reviewer expects a bias favoring EDeR due to the following reasons: 1) The authors compare real-world paper-based records with artificial electronic records. Therefore, the artificial electronic records will be more complete, plausible and unambiguous than the paperbased ones. However, competing study designs suffer also from weaknesses due to the impossibility to create a double-blind setting for that type of analysis. 2) Voluntarily participants for technological studies tend to prefer the technological alternative. 3) Training in EDeR will be a relevant confounder in this study, maybe in the opposite direction at the first time point. B) There is some literature about the methodology of evaluating medical informatics technologies, e. g. Nykänen P, Brender J, Talmon J, de Keizer N, Rigby M, Beuscart- Zephir MC, Ammenwerth E. Guideline for good evaluation practice in health informatics (GEP-HI). Int J Med Inform. 2011; 80: Brender J. Handbook of Evaluation Methods for Health Informatics. Elsevier, Friedman CP, Wyatt JC. Evaluation Methods in Biomedical

15 Informatics. Springer, Wyatt JC. Clinical data systems, Part 3: Development and evaluation. Lancet ; 344: C) Figure 1 is not helpful because it does not appropriately represent the flow of the study. For example, the box patient model from original paperforms describes something that should be available before the first time point, but it is palced in the middle of the 12 months. There should be an unambiguous flowchart presenting the timeline and the logic of the study. VERSION 2 AUTHOR RESPONSE # Query Our reply 1 The authors submitted a revised manuscript of their study protocol that takes into account the majority of the reviewer s concerns. Only a few points remain. The authors may or may not change their study protocol according to those points or may or may not comment on those points in their manuscript. 2 A) The reviewer expects a bias favoring EDeR due to the following reasons: 1) The authors compare real-world paper-based records with artificial electronic records. Therefore, the artificial electronic records will be more complete, plausible and unambiguous than the paper-based ones. However, competing study designs suffer also from weaknesses due to the impossibility to create a double-blind setting for that type of analysis. 2) Voluntarily participants for technological studies tend to prefer the technological alternative. 3) Training in EDeR will be a relevant confounder in this study, maybe in the opposite direction at the first time point. Thank you for your additional queries. We are grateful for the comments and will address those in a point-to-point manner and revise the paper accordingly. The reviewer addresses an important issue related to the planned study: We understand the concern but do not fully agree with point 1: We are not creating artificial electronic records but exact representations of an existing paper-based record. Thus, the content of each pair of paper and electronic record is identical. The only difference is one little contrast that is changed for a specific task. We realize that this was not made fully clear and amended the protocol as follows (p.8, 1. para): The electronic records are exact representations of an existing paperbased record. Patient records differ only in respect to one contrast that is changed for a specific task. Thus, besides that task-specific detail, the remaining content of each pair of patient records is identical. Concerning 2: we fully agree and added this to the discussion section (p.12, 2. para): It can be argued that choosing volunteers for this study could lead to exaggerated results. Nevertheless we believe that the results of our study will provide a rational basis to quantify the added value of an electronic medical

16 record system in an ophthalmologic environment. Concerning 3: We do not fully understand why confounding should occur. We are assessing differences in effects between the two time-points. This allows us examining differences in training on the relative efficacy of the electronic patient record. Therefore, we would like to keep the protocol unchanged. 3 B) There is some literature about the methodology of evaluating medical informatics technologies, e. g. Nykänen P, Brender J, Talmon J, de Keizer N, Rigby M, Beuscart-Zephir MC, Ammenwerth E. Guideline for good evaluation practice in health informatics (GEP-HI). Int J Med Inform. 2011; 80: Brender J. Handbook of Evaluation Methods for Health Informatics. Elsevier, Friedman CP, Wyatt JC. Evaluation Methods in Biomedical Informatics. Springer, Wyatt JC. Clinical data systems, Part 3: Development and evaluation. Lancet ; 344: C) Figure 1 is not helpful because it does not appropriately represent the flow of the study. For example, the box patient model from original paperforms describes something that should be available before the first time point, but it is placed in the middle of the 12 months. There should be an unambiguous flowchart presenting the timeline and the logic of the study. We would like to thank the reviewer very much for pointing at additional pertinent literature. We will study these references carefully and will set them into perspective when writing-up the paper based on our findings. We agree and revised the figure accordingly.

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS

PEER REVIEW HISTORY ARTICLE DETAILS PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Current reporting in published research

Current reporting in published research Current reporting in published research Doug Altman Centre for Statistics in Medicine, Oxford, UK and EQUATOR Network Research article A published research article is a permanent record that will be used

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Tatyana A Shamliyan. I do not have COI. 30-May-2012

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Tatyana A Shamliyan. I do not have COI. 30-May-2012 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (see an example) and are provided with free text boxes to

More information

Introducing Guidelines for Good Evaluation Practice in Health Informatics

Introducing Guidelines for Good Evaluation Practice in Health Informatics 958 Medical Informatics in a United and Healthy Europe K.-P. Adlassnig et al. (Eds.) IOS Press, 2009 2009 European Federation for Medical Informatics. All rights reserved. doi:10.3233/978-1-60750-044-5-958

More information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON DATA MONITORING COMMITTEES European Medicines Agency Pre-authorisation Evaluation of Medicines for Human Use London, 27 July 2005 Doc. Ref. EMEA/CHMP/EWP/5872/03 Corr COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE

More information

When Does it Make Sense to Perform a Meta-Analysis?

When Does it Make Sense to Perform a Meta-Analysis? CHAPTER 40 When Does it Make Sense to Perform a Meta-Analysis? Introduction Are the studies similar enough to combine? Can I combine studies with different designs? How many studies are enough to carry

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Avinesh Pillai Department of Statistics University of Auckland New Zealand 16-Jul-2015

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Avinesh Pillai Department of Statistics University of Auckland New Zealand 16-Jul-2015 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Course schedule (4 blocks) Room: N23/2622

Course schedule (4 blocks) Room: N23/2622 Universität Ulm 89069 Ulm Germany Medizinische Fakultät Institut für Epidemiologie und Medizinische Biometrie Leitung: Prof. Dr. D. Rothenbacher http://www.uni-ulm.de/med/epidemiologie-biometrie Gruppe

More information

What is Wrong with EMR?

What is Wrong with EMR? What is Wrong with EMR? James J. Cimino, M.D. Associate Professor, Department of Medical Informatics, Columbia University 161 Fort Washington Avenue, New York, New York 10032 USA Phone: (212) 305-8127

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Dingcheng Li Mayo Clinic, USA 20-Dec-2015

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Dingcheng Li Mayo Clinic, USA 20-Dec-2015 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

GLOSSARY OF EVALUATION TERMS

GLOSSARY OF EVALUATION TERMS Planning and Performance Management Unit Office of the Director of U.S. Foreign Assistance Final Version: March 25, 2009 INTRODUCTION This Glossary of Evaluation and Related Terms was jointly prepared

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Assessing MOHLTC Research Protocols Secondary Data Studies By: Tommy Tam, MSc

Assessing MOHLTC Research Protocols Secondary Data Studies By: Tommy Tam, MSc Assessing MOHLTC Research Protocols Secondary Data Studies By: Tommy Tam, MSc Definition of secondary data study: Secondary data studies use data source(s) collected by someone other than the user for

More information

computer methods and programs in biomedicine 100 (2010) 283 288 journal homepage: www.intl.elsevierhealth.com/journals/cmpb

computer methods and programs in biomedicine 100 (2010) 283 288 journal homepage: www.intl.elsevierhealth.com/journals/cmpb computer methods and programs in biomedicine 100 (2010) 283 288 journal homepage: www.intl.elsevierhealth.com/journals/cmpb Comparison of documentation time between an electronic and a paper-based record

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

CLINICAL INFORMATICS STUDY GUIDE MATERIALS EXAMINATION CONTENT OUTLINE OFFICE OF THE BOARD. 111 West Jackson, Suite 1340 Chicago, Illinois 60604

CLINICAL INFORMATICS STUDY GUIDE MATERIALS EXAMINATION CONTENT OUTLINE OFFICE OF THE BOARD. 111 West Jackson, Suite 1340 Chicago, Illinois 60604 STUDY GUIDE MATERIALS EXAMINATION CONTENT OUTLINE CLINICAL INFORMATICS OFFICE OF THE BOARD 111 West Jackson, Suite 1340 Chicago, Illinois 60604 (312) 939-ABPM [2276] Fax (312) 939-2218 E-mail: abpm@theabpm.org

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Legislation to encourage medical innovation a consultation. British Medical Association response. Executive Summary

Legislation to encourage medical innovation a consultation. British Medical Association response. Executive Summary Legislation to encourage medical innovation a consultation British Medical Association response Executive Summary This consultation is about proposed primary legislation to liberate doctors from perceived

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (see an example) and are provided with free text boxes to

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

FOREIGN AFFAIRS PROGRAM EVALUATION GLOSSARY CORE TERMS

FOREIGN AFFAIRS PROGRAM EVALUATION GLOSSARY CORE TERMS Activity: A specific action or process undertaken over a specific period of time by an organization to convert resources to products or services to achieve results. Related term: Project. Appraisal: An

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Carrieri, Vicenzo University of Salerno 19-Jun-2013

Carrieri, Vicenzo University of Salerno 19-Jun-2013 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (see an example) and are provided with free text boxes to

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Biostat Methods STAT 5820/6910 Handout #6: Intro. to Clinical Trials (Matthews text)

Biostat Methods STAT 5820/6910 Handout #6: Intro. to Clinical Trials (Matthews text) Biostat Methods STAT 5820/6910 Handout #6: Intro. to Clinical Trials (Matthews text) Key features of RCT (randomized controlled trial) One group (treatment) receives its treatment at the same time another

More information

Improving reporting in randomised trials: CONSORT statement and extensions Doug Altman

Improving reporting in randomised trials: CONSORT statement and extensions Doug Altman Improving reporting in randomised trials: CONSORT statement and extensions Doug Altman Centre for Statistics in Medicine University of Oxford Whatever the outcome of a study, it is really hard for the

More information

If several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form.

If several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form. General Remarks This template of a data extraction form is intended to help you to start developing your own data extraction form, it certainly has to be adapted to your specific question. Delete unnecessary

More information

DEVELOPMENT AND EVALUATION OF A MONITORING SYSTEM TO ASSESS THE QUALITY OF HOSPITAL INFORMATION SYSTEMS

DEVELOPMENT AND EVALUATION OF A MONITORING SYSTEM TO ASSESS THE QUALITY OF HOSPITAL INFORMATION SYSTEMS DEVELOPMENT AND EVALUATION OF A MONITORING SYSTEM TO ASSESS THE QUALITY OF HOSPITAL INFORMATION SYSTEMS Elske Ammenwerth 1, Frauke Ehlers 1, Bernhard Hirsch 2, Katharina Christoph 1, Gordon Gratl 2 1 Research

More information

Journal Article Reporting Standards (JARS)

Journal Article Reporting Standards (JARS) APPENDIX Journal Article Reporting Standards (JARS), Meta-Analysis Reporting Standards (MARS), and Flow of Participants Through Each Stage of an Experiment or Quasi-Experiment 245 Journal Article Reporting

More information

Glossary of Methodologic Terms

Glossary of Methodologic Terms Glossary of Methodologic Terms Before-After Trial: Investigation of therapeutic alternatives in which individuals of 1 period and under a single treatment are compared with individuals at a subsequent

More information

DEVELOPING AN ANALYTICAL PLAN

DEVELOPING AN ANALYTICAL PLAN The Fundamentals of International Clinical Research Workshop February 2004 DEVELOPING AN ANALYTICAL PLAN Mario Chen, PhD. Family Health International 1 The Analysis Plan for a Study Summary Analysis Plan:

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Contents. Abstract...i. Committee Membership... iii. Foreword... vii. 1 Scope...1

Contents. Abstract...i. Committee Membership... iii. Foreword... vii. 1 Scope...1 ISBN 1-56238-584-4 Volume 25 Number 27 ISSN 0273-3099 Interference Testing in Clinical Chemistry; Approved Guideline Second Edition Robert J. McEnroe, PhD Mary F. Burritt, PhD Donald M. Powers, PhD Douglas

More information

Main Section. Overall Aim & Objectives

Main Section. Overall Aim & Objectives Main Section Overall Aim & Objectives The goals for this initiative are as follows: 1) Develop a partnership between two existing successful initiatives: the Million Hearts Initiative at the MedStar Health

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Yale University Open Data Access (YODA) Project Procedures to Guide External Investigator Access to Clinical Trial Data Last Updated August 2015

Yale University Open Data Access (YODA) Project Procedures to Guide External Investigator Access to Clinical Trial Data Last Updated August 2015 OVERVIEW Yale University Open Data Access (YODA) Project These procedures support the YODA Project Data Release Policy and more fully describe the process by which clinical trial data held by a third party,

More information

Checklist for Quasi-Experimental Studies (non-randomized experimental studies)

Checklist for Quasi-Experimental Studies (non-randomized experimental studies) The Joanna Briggs Institute Critical Appraisal tools for use in JBI Systematic Reviews Checklist for Quasi-Experimental Studies (non-randomized experimental studies) http://joannabriggs.org/research/critical-appraisal-tools.html

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Joel Lexchin York University Canada 14-Jul-2014

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Joel Lexchin York University Canada 14-Jul-2014 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

How to Work with a Statistician. Sandra Taylor, Ph.D. Clinical and Translational Science Center University of California, Davis 26 April 2012

How to Work with a Statistician. Sandra Taylor, Ph.D. Clinical and Translational Science Center University of California, Davis 26 April 2012 How to Work with a Statistician Sandra Taylor, Ph.D. Clinical and Translational Science Center University of California, Davis 26 April 2012 Overview Understand what statisticians can (and cannot) do for

More information

Submission of a clinical trial for access to ECRIN services Notice to the Applicant

Submission of a clinical trial for access to ECRIN services Notice to the Applicant Submission of a clinical trial for access to ECRIN services Notice to the Applicant BEFORE SUBMITTING YOUR PROTOCOL Please, contact the European Correspondent (EuCo) in your country. The list of EuCos

More information

Guidance for Peer Reviewers. The Journal of the American Osteopathic Association (JAOA)

Guidance for Peer Reviewers. The Journal of the American Osteopathic Association (JAOA) Guidance for Peer Reviewers The Journal of the American Osteopathic Association (JAOA) JAOA Editorial Staff This module is available online at http://jaoa.org/documentlibrary/prmodule.pdf Guidance for

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Cristina Botella Universitat Jaume I (Spain) 05-Mar-2016

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Cristina Botella Universitat Jaume I (Spain) 05-Mar-2016 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Managing & Validating Research Data

Managing & Validating Research Data Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical

More information

Organizing Your Approach to a Data Analysis

Organizing Your Approach to a Data Analysis Biost/Stat 578 B: Data Analysis Emerson, September 29, 2003 Handout #1 Organizing Your Approach to a Data Analysis The general theme should be to maximize thinking about the data analysis and to minimize

More information

Guidelines for AJO-DO submissions: Randomized Clinical Trials June 2015

Guidelines for AJO-DO submissions: Randomized Clinical Trials June 2015 Guidelines for AJO-DO submissions: Randomized Clinical Trials June 2015 Complete and transparent reporting allows for accurate assessment of the quality of trial and correct interpretation of the trial

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

APPENDIX B OASIS DATA ACCURACY

APPENDIX B OASIS DATA ACCURACY APPENDIX B OASIS DATA ACCURACY 1. DATA ACCURACY Medicare Home Health Care Conditions of Participation 484.20(b) Standard: Accuracy of Encoded OASIS Data stipulates that the encoded OASIS data must accurately

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Anna Sinaiko Harvard School of Public Health United States of America 20-Dec-2013

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Anna Sinaiko Harvard School of Public Health United States of America 20-Dec-2013 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (see an example) and are provided with free text boxes to

More information

The PCORI Methodology Report. Appendix A: Methodology Standards

The PCORI Methodology Report. Appendix A: Methodology Standards The Appendix A: Methodology Standards November 2013 4 INTRODUCTION This page intentionally left blank. APPENDIX A A-1 APPENDIX A: PCORI METHODOLOGY STANDARDS Cross-Cutting Standards for PCOR 1: Standards

More information

What are confidence intervals and p-values?

What are confidence intervals and p-values? What is...? series Second edition Statistics Supported by sanofi-aventis What are confidence intervals and p-values? Huw TO Davies PhD Professor of Health Care Policy and Management, University of St Andrews

More information

Writing for publication a guide for new authors

Writing for publication a guide for new authors International Journal for Quality in Health Care 2001; Volume 13, Number 5: pp. 417 421 Methodology Matters Writing for publication a guide for new authors NANCY DIXON Healthcare Quality Quest, Romsey,

More information

Journal Article Review

Journal Article Review Journal Article Review Janssen KW, van Mechelen W, Verhagen E. Bracing superior to neuromuscular training for the prevention of self-reported recurrent ankle sprains: a three-arm randomised controlled

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Guidance on NHS patients who wish to pay for additional private care

Guidance on NHS patients who wish to pay for additional private care Guidance on NHS patients who wish to pay for additional private care DH INFORMATION READER BOX Policy HR / Workforce Management Planning / Clinical Document Purpose Gateway Reference Title Author Publication

More information

Title:Nudging children towards whole wheat bread: a field experiment on the influence of appealing bread roll shape on consumption during breakfast

Title:Nudging children towards whole wheat bread: a field experiment on the influence of appealing bread roll shape on consumption during breakfast Reviewer's report Title:Nudging children towards whole wheat bread: a field experiment on the influence of appealing bread roll shape on consumption during breakfast Version:1Date:16 April 2014 Reviewer:Dana

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Helen Smith University of Manchester, UK 18-May-2015

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Helen Smith University of Manchester, UK 18-May-2015 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Critical Appraisal of a Randomized Trial

Critical Appraisal of a Randomized Trial Critical Appraisal of a Randomized Trial Presented by Brian S. Alper, MD, MSPH, FAAFP Founder of DynaMed; Vice President of Evidence-Based Medicine Research and Development, Quality and Standards Introduction

More information

Priority Program Translational Oncology Applicants' Guidelines

Priority Program Translational Oncology Applicants' Guidelines Stiftung Deutsche Krebshilfe Dr. h.c. Fritz Pleitgen Präsident Spendenkonto Kreissparkasse Köln IBAN DE65 3705 0299 0000 9191 91 BIC COKSDE33XXX Priority Program Translational Oncology Applicants' Guidelines

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies

Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies 26 September 2012 EMA/623947/2012 Patient Health Protection Guidance for the format and content of the protocol of non-interventional post-authorisation Introduction From 10 January 2013, marketing authorisation

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Rapid Critical Appraisal of Controlled Trials

Rapid Critical Appraisal of Controlled Trials Rapid Critical Appraisal of Controlled Trials Carl Heneghan Dept of Primary Health Care University of Oxford November 23rd 2009 Five steps in EBM 1. Formulate an answerable question 2. Track down the best

More information

Justifying the adequacy of samples in qualitative interview-based studies: Differences between and within journals

Justifying the adequacy of samples in qualitative interview-based studies: Differences between and within journals Justifying the adequacy of samples in qualitative interview-based studies: Differences between and within journals Prof Julie Barnett a, Konstantina Vasileiou a, Dr Susan Thorpe b, Prof Terry Young c a

More information

Open-EMR Usability Evaluation Report Clinical Reporting and Patient Portal

Open-EMR Usability Evaluation Report Clinical Reporting and Patient Portal Open-EMR Usability Evaluation Report Clinical Reporting and Patient Portal By Kollu Ravi And Michael Owino Spring 2013 Introduction Open-EMR is a freely available Electronic Medical Records software application

More information

GUIDE TO CONDUCTING AN EDUCATIONAL NEEDS ASSESSMENT: BEYOND THE LITERATURE REVIEW. Table of Contents. Overview. 1

GUIDE TO CONDUCTING AN EDUCATIONAL NEEDS ASSESSMENT: BEYOND THE LITERATURE REVIEW. Table of Contents. Overview. 1 GUIDE TO CONDUCTING AN EDUCATIONAL NEEDS ASSESSMENT: BEYOND THE LITERATURE REVIEW Table of Contents Overview. 1 Definition of educational needs assessment...1 Importance of educational needs assessment

More information

Quantifying the effects of electronic health record systems in hospitals

Quantifying the effects of electronic health record systems in hospitals Quantifying the effects of electronic health record systems in hospitals Prof Johanna Westbrook Health Informatics Research & Evaluation Unit The University of Sydney Approaches to answer four research

More information

Northern Ireland Waiting Time Statistics:

Northern Ireland Waiting Time Statistics: Northern Ireland Waiting Time Statistics: Inpatient Waiting Times Quarter Ending September 2014 Reader Information Purpose Authors This publication presents information on waiting times for inpatient treatment

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Jeffrey Sparks Brigham and Women's Hospital Harvard Medical School USA 25-Nov-2015

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Jeffrey Sparks Brigham and Women's Hospital Harvard Medical School USA 25-Nov-2015 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Comment Form: WHO Statement on Public Disclosure of Clinical Trial Results. Suggested Amendment

Comment Form: WHO Statement on Public Disclosure of Clinical Trial Results. Suggested Amendment Form: WHO Statement on Public Disclosure of Clinical Trial Results Page 1 of 6 as individual or on behalf of agency or institution?: Institution er's Name in Full, Title, Institution, City, Country, Tel.,

More information

A. Terms and Definitions Used by ABET

A. Terms and Definitions Used by ABET AMERICAN BOARD OF ENGINEERING AND TEACHNOLOGY ABET http://www.abet.org/pev-refresher-training-module4/# A. Terms and Definitions Used by ABET Unfortunately, there is no universally accepted set of terms

More information

INTERNATIONAL STANDARD ON AUDITING 230 AUDIT DOCUMENTATION CONTENTS

INTERNATIONAL STANDARD ON AUDITING 230 AUDIT DOCUMENTATION CONTENTS INTERNATIONAL STANDARD ON AUDITING 230 AUDIT DOCUMENTATION (Effective for audits of financial statements for periods beginning on or after December 15, 2009) CONTENTS Paragraph Introduction Scope of this

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Lepelletier Nantes University Hospital, Nantes, France 20-Jul-2015

PEER REVIEW HISTORY ARTICLE DETAILS VERSION 1 - REVIEW. Lepelletier Nantes University Hospital, Nantes, France 20-Jul-2015 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Introduction to the online training materials

Introduction to the online training materials Introduction to the online training materials These materials are intended for college staff who have been designated the role of facilitator for the Summative review stage of QAA's Integrated quality

More information

2011 CMIO and Physician IT Survey Report

2011 CMIO and Physician IT Survey Report 2011 CMIO and Physician IT Survey Report Facts, Salaries and Advice from Physician IT Leaders Factors Demanding Clinical IT Leadership Federal money and mandate tied to Meaningful Use Clinical automation

More information

Establishing a Regulatory Framework for Credentialing

Establishing a Regulatory Framework for Credentialing 18 March 2013 Strategy and Policy Board 5 For decision Establishing a Regulatory Framework for Credentialing Issue 1. In 2012 Council agreed that the GMC should develop a regulatory framework for introducing

More information

Removal of paper-based health records from Norwegian hospitals: Effects on clinical workflow

Removal of paper-based health records from Norwegian hospitals: Effects on clinical workflow Removal of paper-based health records from Norwegian hospitals: Effects on clinical workflow Jan Tore LIUM a,1 and Arild FAXVAAG b a Norwegian university of science and technology, Trondheim, Norway b

More information

Operational aspects of a clinical trial

Operational aspects of a clinical trial Operational aspects of a clinical trial Carlo Tomino Pharm.D. Coordinator Pre-authorization Department Head of Research and Clinical Trial Italian Medicines Agency Mwanza (Tanzania), June 11, 2012 1 Declaration

More information

PROTOCOL FILE APPROVALS

PROTOCOL FILE APPROVALS RESEARCH TRAINING ACCREDITATION APPROVALS PRELIMINARY REPORT EQUATOR CHECK UP DATA SHARING IMPLEMENTATION PROTOCOL FILE Evidence METHODOLOGICAL DESIGN Data collection Bias Clinician opinion Patients opinion

More information

X`PEER REVIEW HISTORY

X`PEER REVIEW HISTORY X`PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

Analysis Issues II. Mary Foulkes, PhD Johns Hopkins University

Analysis Issues II. Mary Foulkes, PhD Johns Hopkins University This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this

More information

A First Look at Attitudes Surrounding Telehealth:

A First Look at Attitudes Surrounding Telehealth: A First Look at Attitudes Surrounding Telehealth: Findings from a national survey taking a first look at attitudes, usage, and beliefs of family physicians in the U.S. towards telehealth. OVERVIEW Telehealth

More information

1. FORMULATING A RESEARCH QUESTION

1. FORMULATING A RESEARCH QUESTION W R I T I N G A R E S E A R C H G R A N T P R O P O S A L 1. FORMULATING A RESEARCH QUESTION 1.1. Identify a broad area of interest through literature searches, discussions with colleagues, policy makers

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Prepared by:jane Healey (Email: janie_healey@yahoo.com) 4 th year undergraduate occupational therapy student, University of Western Sydney

Prepared by:jane Healey (Email: janie_healey@yahoo.com) 4 th year undergraduate occupational therapy student, University of Western Sydney 1 There is fair (2b) level evidence that living skills training is effective at improving independence in food preparation, money management, personal possessions, and efficacy, in adults with persistent

More information

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL)

PEER REVIEW HISTORY ARTICLE DETAILS TITLE (PROVISIONAL) PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf)

More information

Critical Appraisal of the Medical Literature

Critical Appraisal of the Medical Literature Critical Appraisal of the Medical Literature James A. Hokanson, Ph.D. Department of Preventive Medicine and Community Health The University of Texas Medical Branch 2001 United States Crude Death Rates

More information

Overview of Medical Device Design Controls in the US. By Nandini Murthy, MS, RAC

Overview of Medical Device Design Controls in the US. By Nandini Murthy, MS, RAC Overview of Medical Device Controls in the US By Nandini Murthy, MS, RAC 18 controls are a regulatory requirement for medical devices. In the US, compliance with the design controls section of 21 Code

More information

Clinical pathway concept - a key to seamless care

Clinical pathway concept - a key to seamless care SECTION 5: PATIENT SAFETY AND QUALITY ASSURANCE 1 Clinical pathway concept - a key to seamless care Audrey Janoly-Dumenil, Hôpital Edouard Herriot, CHU Lyon Marie-Camille Chaumais, Hôpital Antoine Béclère,

More information

Pharmacotherapy/Psychotherapy Research: Psychotherapy Research T O P C O N F E R E N C E S H A N G H A I, C H I N A A L L A N T A S M A N, M. D.

Pharmacotherapy/Psychotherapy Research: Psychotherapy Research T O P C O N F E R E N C E S H A N G H A I, C H I N A A L L A N T A S M A N, M. D. Pharmacotherapy/Psychotherapy Research: Psychotherapy Research T O P C O N F E R E N C E S H A N G H A I, C H I N A A L L A N T A S M A N, M. D. Psychotherapy Research Research in psychiatry has expanded

More information