Dr Vladimarsson
(Thorleifsdottir 2012) |
29 March 2016; 18 April 2016; 21 April 2016 |
1. Did you have primary or secondary outcomes?
Reply: the primary prespecified endpoints in the RCT were reduction of the Psoriasis Area and Severity Index (PASI) and a coinciding decrease in the blood frequency of T lymphocytes that recognise auto‐antigens in the skin. These parameters, along with secondary outcome measures were compared to baseline values for each patient in the two groups. The key secondary endpoints included:
The change in validated health‐related quality of life scores; the Psoriasis Disability Index (PDI) and Psoriasis Life Stress Inventory (PLSI) at 12 and 24 months Correlation between the change in clinical status (PASI) and health‐related quality of life scores (PDI and PLSI) Proportion of patients who achieve ≥ 50% reduction in PASI from baseline (PASI 50) Proportion of participants who achieve PASI 75 and PASI 90 Changes in serum concentrations of cytokines after tonsillectomy Genetic and clinical profile that predicts best response to tonsillectomy
2. Could you give me more information concerning the results?
Time‐to‐resolution (time between inclusion and resolution), where resolution is defined as participants achieving clear or almost clear skin (Physician Global Assessment (PGA) 0 or 1 or Psoriasis Area and Severity Index (PASI) 90 or 100) Proportion of participants achieving a PASI 75 or PGA 1 to 2 in the short term (within 6 to 8 weeks) after randomisation
3 participants in Tonsillectomy group and none in no treated group achieved a PASI 75 or PGA 1 to 2 in the short term (within 6 to 8 weeks) after randomisation Time of 8‐week assessment1/15 (7%) patients achieved PASI 90 after 8 weeks. I cannot answer your first question better.
3. Did you have patients with secondary effects ?
Proportion of participants with adverse effects and serious adverse effects: None in both group. Reply: there were no major or serious adverse effects after the tonsillectomy. One patient had a minor post‐tonsillectomy bleed the day after, which resolved fast.
4. Concerning the relapse of participants:
4. How did you perform the sequence generation (table, computer)?
5. How did you perform the allocation concealment?
Reply:
Twenty‐nine patients met all inclusion criteria and were randomly allocated into tonsillectomy (TX) and control groups by means of a simple randomisation in a 1:1 ratio. A numerical code was used to identify patients and their specimens. All investigators except the study’s supervisor were unaware of the treatment allocation, which was concealed until the end of the study in order to reduce study bias. The study’s supervisor was responsible for the randomisation and only he had access to the numerical code. All included patients had strict instructions not to reveal their tonsil status to the investigator who did all the assessments.
6. What was the setting of the study ?
7. Did you perform throat swab before/during your study? If yes, what was the result?
Reply:
At study entry, 8/15 of the TX Group were colonised by Streptococci and 6/14 of the controls. I monitored sore throat symptoms closely during the follow‐up period of 24 months: The frequency of common cold and/or influenza was very similar in the 2 groups, 8/15 (53%) of the TX group and 4/14 (43%) of the controls. However, none of the tonsillectomised patients had Streptococcal pharyngitis during the 2‐year follow‐up, while 4/14 (29%) of the controls had a confirmed Streptococcal tonsillitis. The patients had instructions to observe and preferentially write down all episodes of sore throat and psoriasis flares. They also called me if they had pharyngitis, so that swabs could be taken. There were a few patients that reported a few episodes of sore throats and 2 patients in the TX group experienced psoriasis flare‐ups. However there were no Streptococcal throat infections. So during follow‐up, 0/15 of the TX Group had Streptococci and 4/14 of the Controls, which gives us a significant difference (P = 0.0421 with Fishers exact test)
8. Concerning the proportion of participants having at least one relapse at long‐term follow‐up (at least one year after the start of treatment) after randomisation: did you follow the control group or only the tonsillectomy Group?
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