R0:
EDITOR:
The reviewers agree that your manuscript addresses an important topic. They have also raised a number of well-justified concerns and points requiring clarification. I hope that you see these as opportunities to further improve your manuscript such that it may be accepted for publication.
Review Comments to the Author
Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)
Reviewer #1: The author wrote this manuscript quite well. However, there are some suggestions for improving it better including,
Abstract: The abstract is written well. However, the results showed about self-stigma representing at 49% so this result should be suggested in conclusion as well.
Introduction: The introduction is organised and written well. However, there are some suggestions about referencing that should be revised along with Vancouver style and the journal format, such as (6)(7)(8), should be (6-8) or (Mbuthia et al., 2020) should be a number of reference. Another point, the abbreviation of drug-resistant TB (DR-TB) should be the same with DRTB in table 2 (page 10). Moreover, in terms of objective of the study, it should be written clearly. The author stated in line 98-100 (page 3), but it seems like expected outcomes rather than its objectives.
Methodology: Ethics statement: It is a clear statement, however, the date of approval should be presented as well to ensure the data were collected after approval.
Study population: The author stated that the target population comprised people with TB who were on treatment and were 15 years and above. However, the results showed that there were some participants aged under 15 years (0-14) as well. Thus, the author should revise and make it correct.
Sampling procedures: The author stated that the data were collected in 12 regions, however there were only 11 regions stated in line 139-140.
Sample size: The author showed some details of sample size calculation that met 421 persons (line 147). However, there were only 367 participants recruited to this study which is less than the appropriate sample size calculated. So, the author needs to explain more details about the sample size. It should be 421 as the result of calculation with the appropriate formula. Moreover, if there are sources of the number used to calculate, the reference needed to be stated as well.
Eligibility criteria: In terms of inclusion and exclusion criteria, the author stated that all people with TB aged 15 years and older would be recruited to the research and all people who were below the age of 15 years were excluded. This is the main point that needs to be clarified because in the results, there are some participants aged 0-14 years as stated before. Moreover, in terms of ethics, participants aged less than 18 years cannot sign the consent form by themselves, their parents should sign the consent form. So, the author needs to revise and clarify further.
Data collection tools and procedures: There is no information about the questionnaire well. The questionnaire should be clarified the details, especially the items used to categorise into "no stigma and stigma (binary). If you use only one item, it should not be appropriate to categorise. This is an important point of this study that needs to be explained. As well as, if the questionnaire was conducted by previous researchers, it should be cited correctly. Moreover, the author stated in this part that stigma was assessed using a set of standardised questions rated on a five-point Likert scale (0 = Strongly disagree to 4 = Strongly agree), while, in page 6, the author used (1 = Strongly agree to 5 = Strongly disagree) as well as the data were categorised in to 5 groups staring from 1.00 - 5.00. Please check the details again.
Data analysis: The Cronbach's alpha value needs to be presented with the exact value instead of >=0.70 that it will present the reliability of tools better. Moreover, the author stated in line 181 and table 2 "TB type" but in the conclusion, the author used "treatment type". So, this point needs to be the same. For the binary classification, the author needs to explain more details about how to categorise into 2 groups: no stigma and stigma. In terms of inferential statistics, the binary logistic regression and multiple logistic regression were not used and shown in the results. So, the author needs to revise about this point again.
Results: The sum of percentage, the details in Table 1 & 2 showed the percentage of each variable, which is good. However, the author needs to check the sum of each variable should be 100%. The author may use two decimal points for presenting the percentage. Moreover, some sub-variables which there is no data (0) does not need to present in the table. Please find the details in the attached file.
In table 2, inferential statistics, the author stated in data analysis that binary logistic regression and multiple logistic regression would be used to analyse to identify the predictors. However, in the results, there is no any results based on these statistics. So, the author needs to revise about the statistics stated in data analysis. Moreover, about chi-square, the author needs to check the assumption of chi-square because No cell should have an expected frequency < 1, and at least 80% of cells should have expected frequencies of 5 or more. So, if it does not meet the assumption, its results might be wrong.
Aged 0-14, the author stated in the methodology that the participants need to be 15 years or over. So, please check the data again.
Some words should be changed for example in line 213 from prevented to obstructed. Moreover, about abbreviation "DSTB and DRTB", for DSTB, the author did not state before so it needs to be mentioned in previous part first before using in this part. As well as, DRTB, the author used DR-TB in line 79 so it needs to be the same, with or without -.
Discussion: The author wrote this part quite well, however, the author needs to check about the number of percentage presented in this part again. Moreover, citation should be revise and rewrite following the format.
References: In terms of references, the author should check the format of Vancouver style referencing in both in-cited and references part again. As well as, the author needs to check the format along with the journal format. For example, (xx) to [xx]. Please revise and rewrite following the formats.
Reviewer #2: Please see my report. I think the manuscript transition from a dissertation to a paper is incomplete. Please review my report for details. I raise concerns regarding the sampling, statistical analysis and the conclusions made regarding the results.
Reviewer #3: This cross-sectional study tackles an important global health problem, TB-related stigma among people with TB. This study has significant merits including 367 people living with tuberculosis sampled over one year; and captures various contexts, specifically 180 health facilities across 11counties aiming for a nationally representative survey of TB-related stigma in Kenya. Two hundred and twenty-eight patients provided information regarding TB-related stigma, of whom 24 reported experiencing TB-related stigma.
Several areas remain unclear to me and require further clarification, elaboration or consideration for reformatting.
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The referencing style used is inconsistent. e.g. introduction section lines 60-61(Mbuthia et al. 2020), whereas other areas have a different style that is numbered. Consider reformatting for consistency.
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Previous research on TB-related stigma measurement and its implications to TB related outcomes in the Kenyan context has not been highlighted.
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Ethics statement section could be aligned for consistent formatting with other text sections of the manuscript.
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The sample size calculation could be further clarified for the readers to judge its robustness. a. Is there a proportion of TB-related stigma assumed from a previous study? b. What is the rationale of a 90% response rate? – Lines 147 to 150. c. What was the actual response rate?
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From the manuscript, the sample size calculated was 421 TB patients, but only 367 are reported and 228 TB patients provide information related to TB stigma. These patients were sampled over one year from 180 health facilities across 11 counties in Kenya. a. Further clarification on the sampling frame is needed. b. How many patients were sampled per health facility? Was there any gender consideration per health facility? c. How were the 12 regions chosen and how do they relate to the current national or programmatic divisions? d. It is indicated that one county was chosen from the 12 regions but only 11 counties included.
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Elaborating on the tool and procedures used is needed for the readers to judge the robustness of the methodology used. This information is crucial in the methods section. Lines 164-165: “Stigma was assessed using a set of standardized questions rated on a five-point Likert scale (0 = Strongly Disagree to 4 = Strongly Agree).”
(i) What is the set of standardized questions? (ii) What tool was used? (iii) Has this tool been previously used in the literature? (iv) Has the tool been previously used in the Kenyan context? (v) Is this a validated tool? (vi) In what language/s were the questions asked? (vii) Who administered the survey? Provide relevant references.
These details are missing in the methods section; and need to be considered for inclusion in the main text and/or supplementary material based on journal guidelines.
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What do the authors think could be the implications of handling neutral scores as missing? Lines 189-190: ‘Responses with a "Neutral" score were treated as missing in the binary variable.’ Please elaborate and describe the possible limitation.
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Lines 192 to 194: “Variables with p-values <0.05 in bivariate analysis were entered into a multivariate logistic regression model to identify independent predictors of TB-related stigma” – Do the authors mean a multivariable logistic regression model?
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In the results section, 10 participants are aged 0-14 years however, one of the study inclusion criteria is that participants should be aged 15 years and above. Further clarification is needed.
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Are the age group categories shown in Table 1 meaningful? Would other summary descriptive statistics for age central tendency and dispersion be considered to provide more information about patient characteristics.
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The term “Pagan” in Table 1 may be considered derogatory – consider an alternative word.
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Several other participant characteristics would be important to understand TB-related stigma, including: a) the type of tuberculosis; b) the timing of treatment for the TB patient at which this survey was being performed; c) disclosure of a TB diagnosis; among others. There is existing global, regional and particularly Kenyan literature that supports the importance of these particular characteristics. Consider including these in Table 1.
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Lines 228-230: “Out of 367 participants, 228 individuals with TB shared their experiences regarding stigma. Among them, 24 (11%) reported experiencing TB-related stigma, while 204 (89%) did not. The remaining 139 participants did not provide an opinion and were excluded from the bivariate analysis.” a. Based on this statement, it is not clear what the procedures for study participation were. The study was to assess TB-related stigma, but 139 participants did not provide an opinion. Please elaborate the study procedures for the readers to gain clarity. b. What are the characteristics of the individuals of TB patients who did not share their experiences regarding stigma? c. Were they different from those who did?
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Clarification is needed regarding the proportions of stigma provided in different sections of the manuscript. TB-related stigma dimensions in Figure 2 report relatively high TB-related stigma levels (49% for self-stigma, 68% of community-level stigma); compared to the overall TB-related stigma reported as 11% and also shown in Table 2.
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Consider including whether the type of TB was pulmonary or not, in Table 2. This is not clear.
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Data analysis:
Lines 171-175: “Exploratory factor analysis (EFA) was conducted to test the internal consistency and construct validity of the stigma scale in the Kenyan context. Cronbach’s alpha was calculated to assess internal reliability, with values ≥0.7 indicating acceptable consistency. The principal components extraction method was used to identify underlying factors, with factor loadings ≥0.4 considered acceptable.”
- Although this section is included in the data analysis methods section, there is no data in the manuscript to support this. Please provide this information if it is available.
Lines 182-186: “Stigma-related responses covering domains such as guilt, fear, social avoidance, and disclosure concerns were numerically encoded (1 = Strongly Agree to 5 = Strongly Disagree). Scores were aggregated row-wise per participant to generate a mean stigma score, which was then categorized as follows: 1.00–1.49: Strongly Disagree, 1.50–2.49: Disagree, 2.50–3.49: Neutral, 3.50–4.49: Agree and 4.50–5.00: Strongly Agree.”
- Similarly, although this section is included in the data analysis methods section, there is no data in the manuscript to support this. Stigma is reported as a binary variable and not continuous. Please provide this information if it is available.
Lines 192-194: Variables with p-values <0.05 in bivariate analysis were entered into a multivariate logistic regression model to identify independent predictors of TB-related stigma. Outputs are presented in Table 1 and Table 2 of the Results section.
- Again, this section is included in the data analysis methods section, but there is no data in the manuscript to support this. No results are provided for multivariable logistic regression in Table 1 or Table 2. Please provide this information if it is available.
Was there a justification of including age group instead of age as a continuous variable instead in the data analyses models used?
Was the sample size calculated powered to determine the factors associated with TB-related stigma?
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Results, Discussion and Conclusion. The main confusion for me is around denominators and the respective proportions related to TB stigma that have been presented. Clarification on this is needed.
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Study limitations need to be acknowledged.