Review History


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Summary

  • The initial submission of this article was received on March 29th, 2017 and was peer-reviewed by 2 reviewers and the Academic Editor.
  • The Academic Editor made their initial decision on April 21st, 2017.
  • The first revision was submitted on June 13th, 2017 and was reviewed by the Academic Editor.
  • The article was Accepted by the Academic Editor on June 21st, 2017.

Version 0.2 (accepted)

· · Academic Editor

Accept

Thank you for your re-submission and carefully addressing the concerns raised by our expert reviewers. I am happy to accept your manuscript and recommend it for publication in PeerJ. Congratulations

Version 0.1 (original submission)

· · Academic Editor

Minor Revisions

Dear Dr. Rendell

Your manuscript has been reviewed by two expert reviewers in the field and I agree with the reviewers that this study will be of broad interest to the readers of PeerJ and scientific community at large. Thank you for this neat, well presented study. I am willing to Accept it once your have appropriately addressed the issues raised by the reviewers.

·

Basic reporting

1. The article is written using clear and unambiguous, professional English

2. Literature references, sufficient field background/context are provided.
Introduction: introduction is well written and very apt to the topic. I would recommend adding Incidence and prevalence rate of MDR-TB and HIV-TB in Mangolia in the second paragraph.
References: Relevant prior literature is appropriately referenced.However, authors should include the Mongolian NTP issued 2014 guidelines in the reference section along with all other references.

3. Professional article structure and tables. The structure of the article is in acceptable format.


4. This is a self-contained study that includes all results relevant to the hypotheses.

Experimental design

1. This is an original Interview based analysis within aims and scope of the journal. In this study, authors conducted semi-structured interviews with laboratory staff (N=8) and TB physicians (N=16) using an inductive-deductive approach to explore the specific challenges in implementation of the Xpert MTB/RIF test within Mongolia’s National Tuberculosis Program.

2. All the interview questions were relevant. The authors should have asked few more questions on sample collection, distance, transport conditions (especially temperature) and travel time for specimens, waste disposal system for cartridges

3. Rigorous investigation is performed to high technical & ethical standard.

4. Methods are described with sufficient detail information to replicate

Validity of the findings

No Comment

Comments for the author

Abstract: The abstract has accurately summarized the contents of the manuscript.

Introduction: introduction is well written and very apt to the topic. I would recommend adding Incidence and prevalence rate of MDR-TB and HIV-TB in Mangolia in the second paragraph.

Methods: All the interview questions were relevant. The authors should have asked few more questions on sample collection, distance and travel time for specimens, waste disposal system for cartridges etc

Results: 1. According to the Mongolian NTP guidelines 2014 the following specimens can be used for Xpert MTB/RIF testing: sputum, urine, stool, pleural fluid, ascites, gastric lavage, and surgical tissue samples. Have Mangolian NTP guidelines mentioned the proper protocols (as recommended by WHO guidelines) for other extra-pulmonary specimens especially urine, stool and gastric lavage? Did authors include extra-pulmonary specimens in total number of specimens tested (table 1 data)?
2. Poor sample quality - line 273, “‘Error results’ from Xpert MTB/RIF testing (i.e., notification of an error is displayed in the Check Status screen of the GeneXpert machine) were reported to occur occasionally.” Authors need to provide detailed analysis i.e. percentage for error results accompanied with their specific error codes.
3. Poor sample quality - line 276, “The quality of the sample (e.g. when patients did not collect sputum correctly) was reported as the most common reason for error” results experienced by participants when using Xpert MTB/RIF testing”. Here I would expect more information like how specimens were collected? Did proper instructions were given to patients? Please comment on distance, transport conditions (especially temperature) and travel time for transportation of these specimens.
4. The leading cause of error results observed in the present study was due to poor sample quality and improper equipment maintenance. Both these issues are easy to fix with proper precautions. As per my understanding, an ‘error’ result indicates that the Xpert MTB/RIF assay in a given test was aborted by internal quality control mechanisms including improper filling of the cartridge reaction tube, cartridge reagent probe integrity failure, cartridge internal pressure excess, or equipment malfunction. All ‘error’ results are accompanied by specific error codes that provide additional information as to the underlying cause of failure. Therefore, it is very important to find out whether the technical staff had enough knowledge & training to differentiate between these different error codes? Improper filling of the cartridge reaction tubes or internal pressure excess could be due to the very viscous sample quality, presence of food particles or air bubbles etc; and it can be avoided during sample processing step by proper liquefaction of the viscous sample with increased the incubation time, avoiding addition of food particles or air bubbles into the sample chamber. If there is an issue in sample quantity (less quantity) or quality (poor quality) one can expect false negative result rather than error. So authors need to reexamine technical staff with this regards.

Discussion: In this section, authors have properly discussed a range of potential factors that served as a barrier or enabler to the implementation of Xpert MTB/RIF testing and steps needed to improve the integration of GeneXpert MTB/RIF assay within the Mongolian NTP.

Conclusion: the authors accurately summarized the contents of the interview as well as specific lesson learned, in the conclusion.

References: I would recommend including the Mongolian NTP issued 2014 guidelines in the references.

·

Basic reporting

The authors provided a qualitative summary of possible barriers and enablers to Xpert MTB/RIF implementation in Mongolia based on a series of interviews with TB clinicians and laboratory staff. The overall approach and structure of the paper was well presented, with clear aims and goals.

Recommendations:
1. Line 55/56: Suggest adding "implementation" to the sentence "It is therefore of interest to explore the specific challenges with Xpert MTB/RIF (implementation) in Mongolia.

2. The paper summarizes some key findings from the focused interviews, but a comparison of the interview questions and paper content show there missing elements that should be expounded upon in the paper, particularly in the area of Communication systems (QA/QC for Xpert). Since the conclusions are based from current experiences using the Xpert MTB/RIF platform, additional information regarding current Quality management system activities and gaps should be addressed, as this is a crucial part of any platform implementation process.

3. The Tables provided should be strengthened to highlight key factors in a more definitive manner:
Table 2: Recommend expounding upon each area with key summary data to make this more comprehensive. Also suggest removing blank boxes to streamline the presentation.
Table 3: Add information regarding basis for MDR/XDR presumptions-this will provide more context for the additional details found in the 2nd column.

4. Line 209: What criteria was used to grade whether or not the cartridge supply was "well managed"? Suggest expounding upon this.

5. Lines 217-220: Equipment issues can be major problems for platform implementation, and in various settings where power fluctuations are common it is always recommended to install UPS systems to ensure non-interruptions of these processes. This section should be strengthened to detail other instances of "temporary problems" (Line 217) to provide additional background and help better understand current capacity.

6. Access to Experts (Line 241): It is recommended to define this in the context of expertise (clinical or technical) as well as type of guidance provided (installation, operations, troubleshooting, monitoring and evaluation).

7. The first paragraph of the discussion section should be updated to provide a more overall summary of findings, rather than just listing specific barriers/enablers that were identified.

Experimental design

1. How were methods used for this study based on specific guidelines used for reporting qualitative studies (Cochrane, COREQ, etc). This should be elaborated upon in the paper.

2. One missing population from those interviewed was from the Epi/TB Control perspective. What was the reason someone from this field was not included?

3. While this is a qualitative review, some of the findings would better supplemented with additional quantifiable results. Examples include increase in rates of TB detection after Xpert use, #'s and % of errors/indeterminate results from current Xpert platforms.

Validity of the findings

No comment

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