Table 2 Summary of consensus status for individual questioning items

 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

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

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

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

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

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

Asking about individual treatments by name according to what is known to be locally relevant

Optimal

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