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Table 2 Summary of consensus status for individual questioning items

From: Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study

Items rated Consensus status
Section A
General questions about AEs Round 2 Round 3
 Explicit question about change in health (e.g. ‘Have you observed any change or new complaint since your last visit/in the past x days [trial-specific time scale]?’) Optimal  
 Question implying causality (e.g. ‘Did your child experience any side effect from the drug since your last visit/in the past x days [trial-specific time scale]?’)   Not optimal
 General question about feeling (e.g. ‘How have you [has your child] been feeling since your last visit/in the past x days [trial-specific time scale]?)   No consensus
 General question about past adverse reactions to treatments (e.g. ‘Have you ever reacted badly to a drug or vaccine’)   No consensus
 General question about rating any change in health (e.g. ‘How do you rate your state of health after taking the study medicine?’)   No consensus
Structured questions about body parts, systems or function (e.g. ‘Have you experienced a problem with your head, chest, breathing….?’ or ‘Have you experienced fever, headache, rash….?’) Round 2 Round 3
Nose   Optimal
Lungs/breathing   Optimal
Head   Optimal
Ears   No consensus
Throat   No consensus
Eyes   No consensus
Chest   No consensus
Heart   No consensus
Lymphatic system   No consensus
Nervous system   No consensus
Tiredness/fatigue/weakness/lethargy   Optimal
Muscle pain   Optimal
Joint pain   Optimal
Abdominal pain   Optimal
Mood/behavioural change   Optimal
Allergic skin rash (e.g. some forms of urticaria)   Optimal
Skin abnormalities   Optimal
Dizziness   Optimal
Vision/sight problem   Optimal
Change in urine colour   Optimal
Palpitations   Optimal
Confusion   Optimal
Jaundice/icterus   Optimal
Oculogyric crisis   Not optimal
Photosensitivity (sensitivity to light)   Optimal
Spontaneous bleeding   Optimal
Constipation   Optimal
Blisters (on skin or mucous membrane)   Optimal
Hallucinations   Optimal
Headache Optimal  
Fever Optimal  
Cough Optimal  
Loss of appetite Optimal  
Vomiting Optimal  
Nausea Optimal  
Diarrhoea Optimal  
Itching (no rash) Optimal  
Peeling skin Optimal  
Tinnitus (ringing in the ears)/hearing problem Optimal  
Sleep disturbance/nightmares Optimal  
Involuntary movements (e.g. rigors/convulsions/seizures) Optimal  
Wheezing/difficulty breathing Optimal  
Non-allergic skin rash (e.g. scabies)   No consensus
Posturing   No consensus
Pallor   No consensus
Change in walking (gait disturbance)   No consensus
In infants   
Eating/drinking/feeding less than normal Optimal  
Irritable   Optimal
Abnormal sucking, if breastfed   Optimal
Crying more than normal   Optimal
Difficult to arouse Optimal  
In pregnant women   
Baby movements less than normal   Optimal
Vaginal bleeding   Optimal
Increased uterine contractions, more than normal Optimal  
Pictorial questioning tools about AEs Round 2 Round 3
Using photographs, drawings or pictures of the following signs and symptoms   
Mucous membrane blisters   Optimal
Skin rash   Optimal
Headache   No consensus
Fever   No consensus
Loss of appetite   No consensus
Diarrhoea   No consensus
Jaundice/icterus   No consensus
Joint pain   No consensus
Pruritus   No consensus
Using photographs, drawings or pictures of the following body parts
Respiratory system   No consensus
Gastrointestinal tract   No consensus
Central nervous system   No consensus
Skin   No consensus
Other Round 2 Round 3
Whole body outline   No consensus
Collecting AE reports using mobile phones   Optimal
Collecting AE reports using patient diaries   Optimal
Using an archive of visual analogue scales from day 0 throughout all the follow-ups to measure potential AEs and any change in the occurrence of these events   Optimal
Openly engaging participants to discuss any concerns they have   Optimal
Keeping an archive of digital photographs of AEs Optimal  
Collecting AE reports using group discussions   No consensus
Using flip charts, with a picture on one side for the participant and a written question for the investigator on the reverse side (to reduce investigator variability)   No consensus
Using video footage on smartphones or tablets to show how some AEs which are difficult to depict on still images may manifest e.g. seizure activity   No consensus
Section B   
General questions about previous or concomitant medication (non-study druG) Round 2 Round 3
General questions about the use of non-study medications (e.g. ‘Have you taken any medications since your last visit/in the past x days [trial-specific time scale]?’). Optimal  
Structured questions about previous or concomitant medication (non-study drug) Round 2 Round 3
Questions about the source of medicines (e.g. ‘Have you received any medication from a traditional healer since you were last seen here?’):   
Medicine obtained from another health facility Optimal  
Medicine obtained from a drug shop, pharmacy, chemical seller, the market (or equivalent) Optimal  
Medicine obtained from a traditional healer, informal doctor (or equivalent) Optimal  
Medicines already available in the home (from previous treatment courses). Optimal  
Medicines obtained from family and/or friends   Optimal
Collecting and using naturally occurring herbs/remedies Optimal  
Structured questions about treatment class or specified indication   
Analgesics/anti-inflammatory drug   Optimal
Antibiotics   Optimal
Antihistamines   Optimal
Anti-malarial   Optimal
Vitamins   No consensus
Other Round 2 Round 3
Asking about individual treatments by name according to what is known to be locally relevant   Optimal
Pictorial and/or other physical tools to question about previous or concomitant medication (non-study druG) Round 2 Round 3
Showing photographs or drawings of commonly used drugs or drug packets   Optimal
Showing samples of commonly used drugs or drug packets   Optimal
Showing photographs or drawings of commonly used herbs/traditional remedies   Optimal
Asking participants to bring any non-study medication they may have taken before and/or during the trial/study to scheduled visits for a physical inspection   Optimal
Showing samples of commonly used herbs/traditional remedies   No consensus
  1. Summary of consensus status for individual questioning items rated for relevance, importance and feasibility for asking participants in uncomplicated malaria clinical trials/studies about adverse events and non-study medication