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abchoneytree Group

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Initial D: First Stage Episode 5



Measuring BSLs after the first three episodes of expressing, to ensure that the expressing is not causing hypoglycaemia (which can occur with breastfeeding).45 A consultant endocrinologist will advise the research team on maternal diabetes care as needed, and assist with interpretation of relevant outcomes.




Initial D: First Stage Episode 5


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Fetal well-being associated with expressing (assessed by CTG at initial then subsequent opportunistic CTG episodes); antenatal expression episodes, timing and volumes collected (intervention group only); time to lactogenesis II.


Data will be collected to meet the CONSORT guidelines for reporting of randomised trials,50 including data on eligible non-participants. The first stage of analysis will check the comparability of participants allocated to the two groups. The intervention group will be compared with the standard care group by intention to treat analysis. The primary outcome measure will be compared using χ2 tests and ORs. Comparison of means will be undertaken for continuous variables using t tests where data are normally distributed or Mann-Whitney U tests will compare medians otherwise. Ranked or Likert-type scales will be analysed using cumulative ORs. Where there are differences in baseline characteristics of the women in the two groups which might be associated with outcomes, an additional multivariate analysis will be carried out. Duration of breastfeeding will be compared using Kaplan-Meier statistics. Content analysis will be used to summarise open-ended comments.51


After the patients first sought care, the average time taken to diagnose and initiate DR-TB treatment was 87 days (IQR 17-202) for the entire cohort (data not shown in figure). Further analysis was undertaken to see the median difference in pathways of new and retreatment DR-TB patients ( Figure 2). The time taken from first care seeking to DR-TB diagnosis (p value = 0.041) and the total pathway duration (p value = 0.016) were significantly shorter for retreatment patients. However the duration from onset of symptoms to first care seeking was almost similar for the two groups, indicating that patients with a past episode of TB were not seeking care earlier compared to new patients. Patients were further split into those diagnosed with DR-TB at presentation and those diagnosed after a course of first line treatment ( Figure 3).


With respect to the entire cohort the median pathways after seeking first access to care was 86 days (IQR 14-202) which is relatively shorter than that reported in a multistate study (128 days, IQR 103-173) 6 but nevertheless long. Even though the study findings show certain significant differences in pathway durations of new and re-treatment DR-TB patients, we caution that in light of the small sample size, the observations currently be interpreted as indicative. The study throws light on patient related delay, seen specifically among retreatment patients who showed a similar time frame in accessing first care (20 days vs 27 days) on developing symptoms that were probably similar to their first disease episode. This could be due to patient denial of the disease and for lack of information/counseling received from their TB care providers in the past 5 .


The first paragraph of the results section is confusing: When you say that only 4 of 13 retreatment patients underwent drug susceptibility testing and only 2 of 10 new patients underwent drug susceptibility testing. But clearly 20 of 23 patients ultimately underwent drug susceptibility testing later in their clinical course to get diagnosed with DR TB based on what you say later. As such, I think what you mean to say in that first paragraph is that only 4 of 13 retreatment and 2 of 10 new patients underwent drug susceptibility testing upon their initial presentation with TB symptoms.


5. Response: The figure mentioned in the abstract (median 180 days) is the total pathway duration for only new patients (1 st episode) whereas median of 87 days mentioned in the results is from first point of care to treatment initiation for the entire cohort. Median of 86 days is from first point of care to diagnosis for the entire cohort (this does not come up in the discussion but is reflected in Figure 2). 041b061a72


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