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BMJ Open is an online, open access journal, dedicated to publishing medical research from all disciplines and therapeutic areas. The journal publishes all research study types, from study protocols to phase I trials to meta-analyses, including small or specialist studies. Publishing procedures are built around fully open peer review and continuous publication, publishing research online as soon as the article is ready.

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  • Please leave your comments for the authors below Please see the attached Word file for a better formatted version of the below comments.

    Thank you for the opportunity to review this revision. I congratulate the authors for making use of the feedback and improving their manuscript. I am largely satisfied with the changes and I feel that the majority of the issues have been addressed well. I have only minor issues that I would like the authors to address in their final version of the paper. Well done.

    Minor issues Page 4, Line 28 – “Red Book” Since the review, the 9th edition of the Red Book has been released. The authors may want to update the reference.

    Page 15, Lines 53-57 – Injuries and absenteeism I have commented on this in the previous review, and I note the author’s response. I would counter that injuries as seen in emergency departments do not translate to injuries seen in general practice. The majority of injuries seen in general practice would not be due to alcohol misuse. The context is very different – ED is not general practice. Also, although individuals with alcohol use disorders may have frequent work absenteeism, the reverse logic does not hold. The majority of individuals coming to see a GP for an illness certificate (repeat or otherwise) do so not because of alcohol use problems, but because of chronic illness (both physical and mental). The questionnaire did not ask GPs whether alcohol use disorders are associated with work absenteeism. Rather, it asked whether requests for frequent illness certificates would prompt questioning about alcohol, amongst a list of other scenarios. The updated language in this section of the paper has been improved, but in my view, the rationale underlying the statement “Injuries and work absenteeism are very common outcomes of harmful drinking,[23, 24] yet ‘suspicious or frequent injuries’ and ‘frequent requests for sickness certificates’ were ranked in the top three presentations by 20% or fewer of GPs in our survey” is weak. I agree with the overarching thesis of this section of the paper, that GPs use clinical judgements of individuals to identity risky drinking (and so they should!) and tend not to use more systematic or health screening approaches. The use of the results on injuries and work absenteeism, in my view, do not especially strengthen or support this idea. I do not consider this to be a critical issue, and the existing text is publishable. However, I feel this section would be improved and streamlined by simply removing the interpretation of results on injuries and work absenteeism as a noteworthy point.

    Page 17, Lines 41-43 – AUDIT-C and WHO I’m not sure it would be accurate to describe the AUDIT-C as a WHO developed modification of the AUDIT. My understanding is that the consumption items of the AUDIT was first tested as a brief screening tool by Bush and colleagues (who labelled it the “AUDIT-C”) in a Veteran Affairs Population: Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA, for the Ambulatory Care Quality Improvement Project (ACQUIP). The AUDIT Alcohol Consumption Questions (AUDIT-C): An Effective Brief Screening Test for Problem Drinking. Arch Intern Med. 1998;158(16):1789-1795. doi:10.1001/archinte.158.16.1789.

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  • Thank you for this detailed and well-written protocol. I have only a few comments:

    1) The design of the study is not sufficient to answer the question of whether ACT works. The reason is, as you might know, the lack of an appropriate control group. We may find that the functioning of those in the active treatment group is indeed improved compared to treatment-as-usual group after the intervention period. But we cannot know that the observed effect is not due to 'non-specific' factors of the active treatment rather than the theory-based factors. Particularly, we cannot tell if the effect is due to differing levels of therapist contact between the two groups, or differing expectations for the two treatments. I wouldn't ask that you redesign the study to include blinding of participants and an active control group (matched for expectancy and therapist contact, etc., but with no component based on ACT-theory) which would help answer whether the treatment works, but a simple wording change would be good. Could you remove the word 'controlled' from the title and 'RCT' from the manuscript? That way any results from the study will not misinterpreted as controlling for the non-specific effects of the treatment.

    2) The development of the PACT protocols, and the training and supervising of the physiotherapists, was carried out by a number of the authors. This is a competing interest and needs to be included in the 'Conflict of Interest' section.

    3) The Design section on page 5 says the trial is 'single-blind'. 'Single-blind' would usually refer to the participants being blind to which intervention they are receiving. I think you are referring to the blinding of the statistician doing the analysis rather than the participants or the researchers so it would be better to remove the phrase.

    4) The section on Blinding says that no hypothesis has been proposed to the participants as to the superiority of PACT over usual care, but there may be subtle transmission of the idea that it is effective in the Patient Information Sheet, and from the physios delivering the treatment.

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  • General comments: The protocol addresses an important topic relevant to clinicians, policy makers and methodologists. The authors have substantial expertise in the area. The publication of the protocol will allow the transparent evaluation of the methods employed in the development of the guidelines, and strengthen the final guidelines, and as such should be published.

    Major comments: While I am sympathetic to the idea that there are specific considerations when undertaking a systematic review in children’s health, I think the case for a paediatric specific reporting guideline would be strengthened by an example of how the use of PRISMA may fail researchers undertaking a review relevant to children. Are there particular challenges that the authors have experienced that would help to explain the value of a specific reporting guideline? There are no details from the as yet unpublished scoping review by the same authors, nor from the Toronto meeting. Some elucidation of the paediatric-specific items identified there may help to illustrate the need for the extension of PRISMA.

    The methods appear robust and clear. I would question the inclusion of the systematic review within the Phase III consensus process. Would this not be a part of the earlier Phase II literature review, as per the Moher paper cited?

    Minor comments: Page 2, line 39 “sough” should read “sought” Background: The references used to demonstrate the methodological limitations of systematic reviews seem somewhat arbitrary, and following a statement that ends “even…in high impact journals” cite research that was not published in high impact journals. Would it not make sense to use some of the evidence base which prompted the development of the PRISMA guidelines which the authors go on to describe?

    Final sentence of the background “improve the quantity” would presumably read better as “increase the quantity” if that is itself a worthwhile objective.

    Methods: In the systematic review process (page 7, line 40), does the ‘conventional approach’ not refer to the PRISMA approach? Similarly, line 47, the description of PRISMA as a ‘widely endorsed reporting guideline’ is unnecessary. PRISMA has already been introduced. Page 7, line 37, complied should be compiled. Page 9, line 9, will the systematic reviewers used to evaluate the extension have been involved in the Delphi or the Consensus meeting?

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  • This was a very straightforward study examining whether a simple text message could increase flu vaccination uptake. The trial was well designed and the write-up is crystal clear. The results show a small increase in uptake, but given the low costs this is a potentially useful intervention. The per protocol analysis showed a larger increase than the intention-to-treat, which suggests that the intervention might be more effective in more ideal circumstances.

    I have only minor comments: - The practices involved already used texting, so some set up costs have already been spent and the intervention may be slightly more expensive in non-texting practices. - It's a shame that the ethical complexities of studying pregnant women have excluded them from this study. - I assume the 5% significance level for the power calculation was two-sided? - page 11, line 14, it might be worth inserting 'observed' for 'intra-cluster correlation' as the previous page used an assumed one for the power calculation (and it's the closest I've ever seen between an a priori 0.024 and observed 0.029 ICC). - page 15, line 26, the important thing for significance testing is not whether the confidence intervals overlap, but whether the mean of one estimate is contained within the other interval. Given that, it does look like mornings are worse, although a formal interaction test would be preferable. - page 24, not every author appears in the contributions - Figure 2 does not add much information as there's no investigation of any geographical bias (plus the data are also in Table 1)

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    Zhang et. al. apply exploratory spatial data analysis and empirical Bayes smoothing technique to examine spatial patterns of county- level incidence rates of human brucellosis in mainland china from 2004-2010. The manuscript reads well and presents the results in a clear and concise manner. However, the reviewer could not identify any advancement in the methodology or knowledge presented in the manuscript compared to previous reports.

    Major concerns:

    The author retrieved the dataset from the internet-based disease- reporting system of the China Information System for Disease Control and Prevention and applied statistical analysis techniques similar to previously published studies (References 14-17). The reviewer could not identify any advancement in the analytical methodology compared to previously published studies.

    The same dataset analyzed in this manuscript and the main conclusion (high-risk cluster on counties) has been described in a previously published article cited by the authors (Reference 31). Although the authors discuss the differences between the two studies, the data presented and the overall conclusions are essentially the same.

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    • Shervin Assari (1,547 merit) | 2 years, 5 months ago

      The manuscript could have a better use of the very extensive literature, and also the conceptual models that explain the findings. Theory could be more emphasized. What is the difference between spatial analysis of infectious disease and spatial analysis of obesity? What s common and what is unique to human brucellosis? What would be the difference if the authors had looked at lifetime prevalence...