PEER REVIEW HISTORY ARTICLE DETAILS

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1 PEER REVIEW HISTORY BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form ( and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. TITLE (PROVISIONAL) AUTHORS REVIEWER REVIEW RETURNED GENERAL COMMENTS ARTICLE DETAILS Community pharmacists services for women during pregnancy and breastfeeding in Kuwait: A cross-sectional study Albassam, Abdullah; Awad, Abdelmoneim VERSION 1 REVIEW Dr. Ahmed Awaisu College of Pharmacy, Qatar University, Doha, Qatar 27-Aug-2017 These investigators report about community pharmacists services and views regarding self-care in pregnancy and lactation and their ability to recommend treatment for pregnancy and breastfeedingrelated conditions in Kuwait. Overall, there is paucity of data regarding community pharmacists competencies, practices, and training needs, especially from the context of Middle Eastern countries. Therefore, the study merits investigation. The findings of the study and the reporting was interesting and suitable for the scope of BMJ Open. The reporting complies very well with STROBE checklist. This reviewer recommends the publication of this paper in the journal subject to minor revision. General comments The manuscript is very well-written. Contrary to most reviewers of studies from that part of the world, I feel that the paper does not require any professional language editing, but rather needs careful proofreading by the authors for syntax improvement and misspelling in few places. I congratulate the authors for a job welldone. Keywords Please add lactation and feto-maternal to the list of key words. Abstract - The abstract is well-written, except the need for syntax improvement in some places. - Design: Please use a more elaborate description by adding the term questionnaire-based before survey. - Participants: Please do not begin a sentence with a number; therefore, express 192 in words. - Results: Add the symbol % after the 83.4 in parenthesis. - Results: Regarding the sentence that begins with Recommendations on medication use were occasionally inappropriate in terms of unneeded drug therapy..

2 The study objectives did not indicate that you studied pharmacists competencies or abilities to recommend therapies. - Conclusion: Please be specific about the intervention which you recommended. Strengths and limitations of this study - I feel that the first limitation can be better paraphrased and that the limitations should also include potential for social desirability bias. - In the last bullet, the word ailment was wrongly spelled as aliments. INTRODUCTION - The Introduction is appropriately presented with sufficient review of pertinent literature. The authors have presented what is known about the subject and the gap in the existing body of literature. Furthermore, the rationale and the objectives of the study are very clearly articulated. - However, I strongly suggest that paragraph 3 of the Introduction (that begins with Previous studies have evaluated the role. can be made more concise to avoid redundancies and its monotone nature. - In addition, the authors indicated in the Introduction and the Discussions that there are no published studies in the Middle East. But I would like to point the authors to the following study so as to tone down the language a bit: Bains S, Kitutu FE, Rahhal A, Samaha RA, Wilby KJ, Rowe H. Comparison of pharmacist knowledge, perceptions and training opportunities regarding maternal-feral medicine in Canada, Qatar, and Uganda. Canadian Pharmacists Journal 2014;147(6): Paragraph 4 (page 5), line 41 I suggest changing necessary to need or something more appropriate. METHODS - The Methods section is very detailed to allow replication of the study. The investigators did a great job in presenting all the necessary elements of the methodology. - The statistical analyses are very appropriate and robust. - For the study design, please use a better description such as a cross-sectional descriptive study using a pre-validated questionnaire or a cross-sectional descriptive questionnairebased study etc - Is the data on the population of Kuwait (2011) the most up-todate? - Paragraph 1 (page 6), line 41: I suggest replacing were with comprised of - Paragraph 2 (page 6), line 18: Change among to across. - Page 7, line 50 and throughout the manuscript: Please avoid the use of the term medicine dispensation. It should be something around dispensing medicine. - Page 8, line 8 18: The sentence that begins with In addition to three questions to determine the pharmacists need for continuing education about self-care in pregnancy is a hanging sentence and I am sure something is missing. What about if you add were asked at the end of the sentence (line 18 after the word lactation ). - Page 8, line 22 24: About SPSS manufacturer/owner s city. I think it is no longer Chicago IL. Please double check.

3 REVIEWER REVIEW RETURNED GENERAL COMMENTS RESULTS - Very comprehensive and covers all the aspects and objectives of the study. - Page 11, line 34: Please avoid medicine dispensation and use dispensing medicine. DISCUSSION - Page 14, line 26 33: Please revisit the claim about lack of studies in the Middle East by referring to the reference I previously shared: Bains S et al. Comparison of pharmacist knowledge, perceptions and training opportunities regarding maternal-feral medicine in Canada, Qatar, and Uganda. Canadian Pharmacists Journal 2014;147(6): Page 14, line 49: Replace that with those. - Page 14, line 59: Again change that to those. - Page 16, line 17: Kindly change medicine dispensation with an appropriate terminology. Lisa Amir Judith Lumley Centre La Trobe University Australia 06-Sep-2017 This is a survey of community pharmacists in Kuwait investigating pharmacists attitudes towards medication for pregnant and breastfeeding, and reporting their advice to women. Abstract Objectives this is described as a descriptive study, which is fair enough. It does not make sense then to calculate the sample size on a difference between gender of pharmacists and their advice. Outcomes services offered by pharmacists doesn t sound quite right. Perhaps the outcomes are the proportions of pharmacists offering particular advice for health conditions in pregnancy and lactation. Results, line 47. agreed better to say indicated or similar. The pregnant or breastfeeding women needs to come earlier in the sentence so readers can understand the percentages. Conclusion: different approaches different to what? Strengths and limitations, line 24 proper sample size adequate would be better. Last dot point doesn t make sense: one point in time is appropriate for this study design. Introduction 2nd para. You can round off the percentages. The last sentence in this paragraph is a new topic and should be a new paragraph. Does this document refer to pregnancy and lactation? 3rd para. This paragraph needs revising. Most of the earlier studies have been inquiring whether pharmacists ask women if they are pregnant or breastfeeding they aren t about pharmacists advice. The paragraph goes on the next page to list the various studies. This is tedious to read. You need to synthesise the findings. Just point out the main findings. p. 5, 2nd para. The justification for this study goes on too long. Methods Ethics approval was the study given a number? or say the date when approval was given.

4 The sample size calculation based on comparing male and female respondents responses and expecting a 20% difference in proportion of what? comes out of nowhere. I suggest rethinking this. p. 6, line 51. gathered anonymously needs rewording. Obviously if the form was collected in person, they are not anonymous. Did they put the form in an envelope or something, so the collector could not see the answers? offered written consent does this mean they signed a consent form? p. 7, line 36. the options were presented in the results section I would prefer to see the options in the Methods section. p. 8, first para. You shouldn t be referring to the results figures and tables in the Methods section. p. 8, 2nd para. I m not sure if you need to test for internal consistency about pharmacists views. What is the justification? The results of the testing should be moved to the Results section (if justified, otherwise removed). p. 8, last para. The study is described as descriptive, but you plan to compare pharmacists characteristics against the various outcome measures. I think this needs to be justified. You would only do this if you had a hypothesis, say that female pharmacists had different attitudes to male pharmacists, or more experienced pharmacists behaved differently to less experienced pharmacists. It is not acceptable to say that you will just look at everything. Results p. 10, 1st para. How many agreed to participate but didn t actually complete the questionnaire? Can you compare your participants with all pharmacists in Kuwait? p nd para. The sentence starting moreover is not clear and needs rewriting. p nd para specific symptoms in breastfeeding add women. p. 12, last para. The sentence describing incorrect advice is rather long and could be improved. Perhaps just give a few examples of incorrect advice and explain to the reader why this might be a problem. Many readers won t be familiar with every medication mentioned. p. 13, 2nd para. I don t understand the sentence In the second dimension about safety. The last sentence claims a difference between genders, but the 95% CI includes 1. p. 13, last line. It is better to give previse p-values (not just > 0.05), the reader wants to know if it is 0.06 or 0.6, for example. Discussion, p. 14, 2nd para. number of women attending this is just a guess by the pharmacists, isn t it? It shouldn t be presented as actual data. p. 15, 2nd line study population change to participants. p This discussion repeats too much detail from the results section, and is not so interesting to read. It could be condensed and the important points mentioned and compared to other studies, where there is a clear point to make. Not every finding needs to be discussed. References - Check #25. Authors names? - #29. How many authors before et al? - #30. Is this complete? Table 1 - Age: years is a large group can you present 20-29, separately? - What does Pharm D mean? Figure 1 the colours are not clear in black and white.

5 Reviewer #1: VERSION 1 AUTHOR RESPONSE Kindly note that the changes in the revised version of the manuscript are highlighted using the track changes mode. 1. The manuscript is very well-written. Contrary to most reviewers of studies from that part of the world, I feel that the paper does not require any professional language editing, but rather needs careful proofreading by the authors for syntax improvement and misspelling in few places. I congratulate the authors for a job well-done. Response: Thank you for your valuable comments that have been very helpful and significantly improved the quality and impact of our manuscript. The proof reading of the paper was done as recommended. 2. Keywords Please add lactation and feto-maternal to the list of key words. Response: The words lactation and feto-maternal were added to the list of keywords (page 3, paragraph 2). Abstract 3. Design: Please use a more elaborate description by adding the term questionnaire based before survey. Response: The term questionnaire based was added before survey (page 2, paragraph 2). 4. Participants: Please do not begin a sentence with a number; therefore, express 192 in words. Response: The number 192 was expressed in words One hundred and ninety-two (page 2, paragraph 4, line 2). 5. Results: Add the symbol % after the 83.4 in parenthesis. Response: The symbol % was added after the 83.4 in parenthesis (page 2, paragraph 6, line 2). 6. Regarding the sentence that begins with Recommendations on medication use were occasionally inappropriate in terms of unneeded drug therapy.. The study objectives did not indicate that you studied pharmacists competencies or abilities to recommend therapies. Response: We agree that it was not clearly stated in the objectives; however, this finding was reported as a consequence of the findings related to the objective to determine the pharmacists recommendations for treatment of pregnancy and breastfeeding related ailments. 7. Conclusion: Please be specific about the intervention which you recommended. Response: The conclusion was revised to include specific interventions and not to exceed the max. 300 words limit of the abstract (page 3, paragraph 1).

6 Strengths and limitations of this study 8. I feel that the first limitation can be better paraphrased and that the limitations should also include potential for social desirability bias. In the last bullet, the word ailment was wrongly spelled as aliments. Response: The first limitation was revised as being recommended. The last limitation was deleted as recommended by the second reviewer and replaced by the social desirability bias (page 3). INTRODUCTION 9. The Introduction is appropriately presented with sufficient review of pertinent literature. The authors have presented what is known about the subject and the gap in the existing body of literature. Furthermore, the rationale and the objectives of the study are very clearly articulated. - However, I strongly suggest that paragraph 3 of the Introduction can be made more concise to avoid redundancies and its monotone nature. Response: The paragraph about the previous studies was revised and made more concise as recommended (Page 4, paragraph 4 and page 5, paragraph1). 10. In addition, the authors indicated in the Introduction and the Discussions that there are no published studies in the Middle East. But I would like to point the authors to the following study so as to tone down the language a bit: Bains S, Kitutu FE, Rahhal A, Samaha RA, Wilby KJ, Rowe H. Comparison of pharmacist knowledge, perceptions and training opportunities regarding maternal-fetal medicine in Canada, Qatar, and Uganda. Canadian Pharmacists Journal 2014;147(6): Response: The reference was included (ref.18) on page 5 (paragraphs 1, line 1 and paragraph 2, lines 3-5). In the discussion, the sentence was changed to To our knowledge, this is the first study to be performed in Kuwait, and the second in the Middle Eastern area,.. (page 13, paragraph 1, line 1). 11. Paragraph 4 (page 5), line 41 I suggest changing necessary to need or something more appropriate. Response: It was changed as recommended (page 5, paragraph 2, line 2). METHODS 12. The Methods section is very detailed to allow replication of the study. The investigators did a great job in presenting all the necessary elements of the methodology. - The statistical analyses are very appropriate and robust. - For the study design, please use a better description such as a crosssectional descriptive study using a pre-validated questionnaire or a cross-sectional descriptive questionnaire-based study etc Response: It was changed as recommended (page 5, paragraph 3, line 1). 13. Is the data on the population of Kuwait (2011) the most up-to-date? Response: Yes, it is the last published data.

7 14. Paragraph 1 (page 6), line 41: I suggest replacing were with comprised of Response: It was changed as recommended (page 5, paragraph 3, line 4). 15. Paragraph 2 (page 6), line 18: Change among to across. Response: It was changed as recommended (page 6, paragraph 1, line 8). 16. Page 7, line 50 and throughout the manuscript: Please avoid the use of the term medicine dispensation. It should be something around dispensing medicine. Response: It was changed as recommended (page 7, paragraph 1, line 11). 17. Page 8, line 8 18: The sentence that begins with In addition to three questions to determine the pharmacists need for continuing education about self-care in pregnancy is a hanging sentence and I am sure something is missing. What about if you add were asked at the end of the sentence (line 18 after the word lactation ). Response: It was changed as recommended (page 7, paragraph 1, last line). 18. Page 8, line 22 24: About SPSS manufacturer/owner s city. I think it is no longer Chicago IL. Please double check. Response: It was revised and changed to (IBM SPSS Statistics for Windows, version 23, Armonk, NY: IBM Corp) (page 7, paragraph 2, lines 1-2). RESULTS 19. Very comprehensive and covers all the aspects and objectives of the study. - Page 11, line 34: Please avoid medicine dispensation and use dispensing medicine. Response: It was changed as recommended (page 9, paragraph 3, last line). DISCUSSION 20. Page 14, line 26 33: Please revisit the claim about lack of studies in the Middle East by referring to the reference I previously shared: Bains S et al. Comparison of pharmacist knowledge, perceptions and training opportunities regarding maternalferal medicine in Canada, Qatar, and Uganda. Canadian Pharmacists Journal 2014;147(6): Response: It was changed to To our knowledge, this is the first study to be performed in Kuwait, and the second in the Middle Eastern area,.. (page 13, paragraph 1, line 1). 21. Page 14, line 49: Replace that with those. - Page 14, line 59: Again change that to those. Response: The first one was deleted based on the second reviewer s comment. The second was changed as recommended (page 13, paragraph 2, line 3). 22. Page 16, line 17: Kindly change medicine dispensation with an appropriate terminology.

8 Response: It was deleted based on the second reviewer s comment (page 14, paragraph 2). Reviewer #2: Kindly note that the changes in the revised version of the manuscript are highlighted using the track changes mode. Abstract 1. Objectives this is described as a descriptive study, which is fair enough. It does not make sense then to calculate the sample size on a difference between gender of pharmacists and their advice. Response: Thank you to the reviewer. We do agree that the study has extended toward being analytical than just descriptive in nature, especially from statistical viewpoint. To improve the clarity for the study design and sample size calculation, the word descriptive was deleted from the study design (page 1 and page 5, paragraph 3 line 1). Also, the study has secondary objectives that are included in the introduction (page 5, paragraph 2, last 3 lines). Secondary objectives were to determine factors associated with pharmacists (a) recommendations for treatment of pregnancy and lactation related ailments, (b) views about self-care of pregnant and breast-feeding women, and (c) need for continuing education. The secondary objectives were not included in the abstract due to the word limitation (max. 300 words). These factors were the independent variables (age, gender, experience, and location of the pharmacy). 2. Outcomes services offered by pharmacists doesn t sound quite right. Perhaps the outcomes are the proportions of pharmacists offering particular advice for health conditions in pregnancy and lactation. Response: This was changed as recommended by the reviewer (page 2, paragraph 5, lines 1-2). 3. Results, line 47. agreed better to say indicated or similar. The pregnant or breastfeeding women needs to come earlier in the sentence so readers can understand the percentages. Response: It was changed as recommended (page 2, paragraph 6, line 3, and lines 8-10). 4. Conclusion: different approaches different to what? Response: The word approaches was deleted and the sentence was modified to improve clarity (page 3, paragraph 1). 5. Strengths and limitations, line 24 proper sample size adequate would be better. Last dot point doesn t make sense: one point in time is appropriate for this study design. Response: The authors concur with the reviewer proper sample size was changed to adequate sample size. The last point about the cross-sectional study design was deleted (page 3). Introduction 6. 2nd para. You can round off the percentages. The last sentence in this paragraph is a new topic and should be a new paragraph. Does this document refer to pregnancy and lactation?

9 Response: The percentages were rounded in the second paragraph of the introduction as recommended (page 4, paragraph 2, lines 1-4). 4, paragraph 3). 7. 3rd para. This paragraph needs revising. Most of the earlier studies have been inquiring whether pharmacists ask women if they are pregnant or breastfeeding they aren t about pharmacists advice. The paragraph goes on the next page to list the various studies. This is tedious to read. You need to synthesise the findings. Just point out the main findings. Response: The paragraph about the previous studies was revised and made more concise as recommended per the reviewers recommendations being recommended (page 4, paragraph 4 and page 5, paragraph 1). 8. p. 5, 2nd para. The justification for this study goes on too long. Response: The justification for the study was revised and made concise (page 5, paragraph 2). Methods 9. Ethics approval was the study given a number? or say the date when approval was given. Response: Yes, the number and the date are included in the revised manuscript (page 5, paragraph 3, lines 5-6). 10. The sample size calculation based on comparing male and female respondents responses and expecting a 20% difference in proportion of what? comes out of nowhere. I suggest rethinking this. Response: Thank you to the reviewer for insightful comment. The secondary objectives included in the introduction (page 5, paragraph 2, last 3 lines) show that the responses are about the three dependent variables. We do believe that the sample size will be adequate even if we use other strategies used in descriptive questionnaire-based surveys. Unfortunately, we cannot redo the sample size estimation in retrospect. 11. p. 6, line 51. gathered anonymously needs rewording. Obviously if the form was collected in person, they are not anonymous. Did they put the form in an envelope or something, so the collector could not see the answers? offered written consent does this mean they signed a consent form? Response: The questionnaires were handed in and collected in envelopes. Yes, they signed the consent form. (page 6, paragraph 1, last two lines). 12. p. 7, line 36. the options were presented in the results section I would prefer to see the options in the Methods section. p. 8, first para. You shouldn t be referring to the results figures and tables in the Methods section. Response: The questionnaire was included as a supplementary file (Appendix 1) and this was indicated in the methods section (page 6, paragraph 3, line 1). The figures and tables were removed from the methods section (page 7, paragraph 1).

10 13. p. 8, 2nd para. I m not sure if you need to test for internal consistency about pharmacists views. What is the justification? The results of the testing should be moved to the Results section (if justified, otherwise removed). Response: The research team with the advice of a biostatistician felt that this was needed because this construct measures respondents attitude using an attitudinal scale with all the items measuring the issues of self-care. In addition, the results in table (2) are presented with the overall median scale 11, paragraph 3, lines 1-5). 14. p. 8, last para. The study is described as descriptive, but you plan to compare pharmacists characteristics against the various outcome measures. I think this needs to be justified. You would only do this if you had a hypothesis, say that female pharmacists had different attitudes to male pharmacists, or more experienced pharmacists behaved differently to less experienced pharmacists. It is not acceptable to say that you will just look at everything. Response: We agree with the reviewer that we might have wrongly used the term descriptive in our study design which also has implication on sample size determination strategy. As mentioned earlier to improve the clarity for the study design and sample size calculation, the word descriptive was deleted from the study design (page 1 and page 5, paragraph 3 line 1). The study has secondary objectives which are included in the introduction (page 5, paragraph 2, last 3 lines). Secondary objectives were to determine factors associated with pharmacists (a) recommendations for treatment of pregnancy and lactation related ailments, (b) views about self-care of pregnant and breast-feeding women, and (c) need for continuing education. These factors were the independent variables (age, gender, experience, and location of the pharmacy). 15. Results p. 10, 1st para. How many agreed to participate but didn t actually complete the questionnaire? Can you compare your participants with all pharmacists in Kuwait? Response:All pharmacists who agreed to participate in the study completed the questionnaire. An adequate sample size and sampling method were used in this study to produce a representative data regarding the study population; therefore, the present findings can be generalized at the community pharmacists level in Kuwait. Hence, we believe that there are no differences between the study participants and other community pharmacists in Kuwait. 16. p nd para. The sentence starting moreover is not clear and needs rewriting. Response: The sentence was revised to improve clarity (page 9, paragraph 2). 17. p nd para specific symptoms in breastfeeding add women. Response: The term was added as recommended (page 10, paragraph 3, line 2). 18. p. 12, last para. The sentence describing incorrect advice is rather long and could be improved. Perhaps just give a few examples of incorrect advice and explain to the reader why this might be a problem. Many readers won t be familiar with every medication mentioned. Response:It was explained as being recommended as follows However, the respondents recommendations on medicine use were sometimes inappropriate in terms of unneeded drug therapy, off-label use, and safety (page 11, paragraph 2, lines 4-5). The supplementary file shows all the generic names and the ingredients of the medications that the readers may not be familiar with.

11 19. p. 13, 2nd para. I don t understand the sentence In the second dimension about safety. The last sentence claims a difference between genders, but the 95% CI includes 1. Response: Safety of OTC medicines. The sentence was revised and the word safety was deleted (page 11, paragraph 3, last two lines). results up to 1 decimal. The results for this analysis were as follows: (p=0.043; OR = 2.107; 95% CI: ) and were presented in the manuscript as (p=0.04; OR = 2.1; 95% CI: ). It was changed to 1.1 (page 12, paragraph 1, last line). 20. p. 13, last line. It is better to give previse p-values (not just > 0.05), the reader wants to know if it is 0.06 or 0.6, for example. Response: Precise p-values are now included in the revised version of the manuscript (page 12, paragraph 2, lines 6-7). Discussion, 21. p. 14, 2nd para. number of women attending this is just a guess by the pharmacists, isn t it? It shouldn t be presented as actual data. Response: We agree that these numbers are approximate and not exact. The discussion about these numbers was deleted (page 13, paragraph 2). 22. p. 15, 2nd line study population change to participants. Response: It was changed as recommended (page 13, paragraph 2). 23. p This discussion repeats too much detail from the results section, and is not so interesting to read. It could be condensed and the important points mentioned and compared to other studies, where there is a clear point to make. Not every finding needs to be discussed. Response: The discussion was revised to avoid too much detail from the results. References 24. Check #25. Authors names? - #29. How many authors before et al? - #30. Is this complete? Response: The authors for ref.25 (now ref.26) was revised Bawazir SA. (page 20). Response:The number of authors in ref.29 (now ref.22) are five, three of them were included before et al. It was revised Boardman H, Lewis M, Croft P, et al. Three authors were included before et al. (page 20). Response: Reference 30 (now is ref.23) was revised BMJ Open 2013;3(4) pii: e (page 20). Table Age: years is a large group can you present 20-29, separately? - What does Pharm D mean?

12 Response: It was presented as being recommended (Table 1, page 21). Response: PharmD is the Doctor of Pharmacy degree (Table 1, page 21). 26. Figure 1 the colours are not clear in black and white. Response: The presentation of the figures was modified to ensure clarity in black and white (pages 22-24). REVIEWER REVIEW RETURNED GENERAL COMMENTS REVIEWER REVIEW RETURNED GENERAL COMMENTS VERSION 2 REVIEW Dr. Ahmed Awaisu Qatar University, College of Pharmacy, Doha, Qatar 26-Sep-2017 I have thoroughly reviewed all the changes made in the manuscript. The authors have adequately addressed all my concerns. I do believe that the article adds to the existing body of literature related to the role of pharmacists on feto-maternal health. I strongly recommend the publication of the article in the journal. Lisa Amir La Trobe University, Australia 04-Oct-2017 I am happy with the revisions made by the authors. No further comments. BMJ Open: first published as /bmjopen on 5 January Downloaded from on 21 March 2019 by guest. Protected by copyright.