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These six patients were included in the group of non-respondents and also in the discontinuation analysis.
To handle missing data as the result of premature discontinuation, analysis methods assumed similar event rates had the patient completed the study.
Of the 209 patients who had 24 months of data and attended all 9 visits, 202 patients had at least one documented RLAT injection recorded in the injection log and were included in the exposure and discontinuation analysis.
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Further, among all patients that were initiated on a biologic DMARD, 36% discontinued their index therapy in the 90-day discontinuation gap analysis, as opposed to the 46% identified using a 60-day treatment gap (results not reported).
As non-adherence is related to study discontinuation, the analysis was repeated on study completers and it was again shown that non-adherence significantly affected the level of improvement in CAARS:O-SV.
In addition, it was noted whether studies made explicit reference to theoretical frameworks underlying the implemented research, defined as a set of inter-related propositions (theoretical constructs) that constitute a framework for describing, explaining and predicting the behaviour (i.e. discontinuation) under analysis (Durand et al., 2008).
Reinitiate EVE at a lower dose Temporary dose interruption until recovery to grade ≤1 Consider reinitiating EVE at a lower dose If toxicity recurs at grade 3, consider discontinuation The analysis cut-off date was 15 December 2011 (median follow-up, 18 months).
Probability of first treatment discontinuation (Kaplan Meier analysis), number and causes of therapeutic switch were similar in both groups.
The low number of independent samples with data on reason of discontinuation mean this analysis lacked the power to detect a potentially important effect and further work could focus on discontinuation specifically due to adverse effects or lack of efficacy.
Fourth, for those individuals who stopped ARB or ACEI treatment but continued to have follow-up data after drug discontinuation, a sensitivity analysis censoring the follow-up 3 months after the last dose of ARB or ACEI was also conducted.
Additionally, as a supplemental sensitivity analysis, discontinuation was defined as the first occurrence of a treatment interruption of at least 90 consecutive days between the end of the drug supply (for a prescription of the index treatment) and the beginning of a next prescription (for the index treatment), or the end of the one-year study period, whichever occurred first.
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