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Table 1 Responses to questionnaire on standard format package leaflet (oral contraceptives without placebo comparison)

From: Understanding adverse drug reactions in package leaflets – an exploratory survey among health care professionals

Extract of questionnaire
Common side effects (more than 1 in 100 people who take Lovelle® are affected):
  • Depression or mood disorder
  • Headache
  • Stomach problems, such as nausea
  • Breast problems, such as painful or tender breasts
  • Weight gain
Question 1: How often does the intake of this oral contraceptive cause (1) depression or mood disorder (2) weight gain?a
 Responses (No) None Lower frequency than listed in package leaflet Same frequency as listed in package leaflet Higher frequency than listed in package leaflet No response
 Format free text
 Group 1 (n = 22) Health science students (1): 0 (1): 0 (1): 22 (100 %) (1): 0 (1): 0
(2): 0 (2): 0 (2): 20 (91 %) (2): 0 (2): 2 (9 %)
Question 2: If 100 women take this oral contraceptive – in how many women does the intake of this oral contraceptive cause (1) depression or mood disorder (2) weight gain?b
 Responses (No) None Lower frequency than listed in package leaflet Same frequency as listed in package leaflet Higher frequency than listed in package leaflet No response
 Format free text
 Group 1 (n = 21) Health science students (1): 0 (1): 0 (1): 21 (100 %) (1): 0 (1): 0
(2): 0 (2): 0 (2): 21 (100 %) (2): 0 (2): 0
 Group 2 (n = 25) Health science students (1): 0 (1): 4 (16 %) (1): 10 (40 %) (1): 10 (40 %) (1): 1 (4 %)
(2): 0 (2): 3 (12 %) (2): 10 (40 %) (2): 11 (44 %) (2): 1 (4 %)
Question 3: If 100 women take this oral contraceptive – in how many women does the intake of this oral contraceptive cause (1) depression or mood disorder?b
 Responses (No) 0 1 >1 >10 No response
 Format multiple choice
 Group 3 (n = 80) Gynaecologists (1): 0 (1): 11 (14 %) (1): 56 (70 %) (1): 7 (9 %) (1): 6 (7 %)
Question 4: If 100 women do not take an oral contraceptive – in how many of them does (1) depression or mood disorder (2) weight gain occur?c
 Responses (No) None Lower frequency than listed in package leaflet Same frequency as listed in package leaflet Higher frequency than listed in package leaflet No response
 Format free text
 Group 1 (n = 21) Health science students (1): 0 (1): 12 (57 %) (1): 1 (5 %) (1): 1 (5 %) (1): 7 (33 %)
(2): 0 (2): 12 (57 %) (2): 1 (5 %) (2): 1 (5 %) (2): 7 (33 %)
  1. aPossible answers: Since the exact value cannot be known from the information provided, any value lower than given in the package leaflet would be accepted. The frequency given in the package leaflet or higher would definitely be wrong. Due to it being free text, missing responses were seen as a sign of non-participation
  2. bSince the exact value cannot be known from the information provided, any value lower than given in the package leaflet including no response would be accepted. The frequency given in the package leaflet or higher would definitely be wrong
  3. cPossible answers: Since the exact value cannot be known from the information provided, any value except “none” or higher values than listed in the package leaflet would be accepted. Due to it being free text, missing responses were seen as a sign of non-participation