2. Research recommendations based on a gap in the evidence on antihistamines as an adjunct to topical nasal steroids for intermittent and persistent allergic rhinitis in children.

Core elements	Issues to consider	Status of research for this review
Evidence (E)	What is the current state of evidence	A systematic review with one small and high risk of bias RCT
Population (P)	Diagnosis, disease stage, comorbidity, risk factor, sex, age, ethnic group, specific inclusion or exclusion criteria, clinical setting	Children under the age of 18 with a history of allergic rhinitis, with or without allergic conjunctivitis or asthma, in whom topical nasal steroids are being used. The diagnosis will have been confirmed by the clinical history or the allergen will have been identified and the sensitivity proven by positive skin prick test or high circulating levels of allergen‐specific IgE antibody, detected by radioallergosorbent test (RAST). Children with different age groups, ethnicity or sex should be preferably reported separately. Variations in pollen seasons and environmental co‐factors should be also taken into consideration
Intervention (I)	Type, frequency, dose, duration, prognostic factor	All participants will receive topical nasal steroids (any topical nasal steroid preparation prescribed for allergic rhinitis, at any dosage, over any period of time) and the active interventions studied: oral or topical antihistamine preparations at any dosage over any time period
Comparison (C)	Type, frequency, dose, duration, prognostic factor	The control group will receive topical nasal steroids with type, dosage and over a period of time similar to the intervention group plus placebo (looking, smelling and tasting similar to the antihistamine)
Outcome (O)	Which clinical or patient related outcomes will the researcher need to measure, improve, influence or accomplish? Which methods of measurement should be used?	Primary outcomes: Improvement of global symptoms. Recorded in validated daily or weekly diaries and any scores from validated visual analogue scales. Individual symptom scores may include any appropriate measures of nasal obstruction, runny nose, sneezing, itching and eye symptoms. Depending on the age of the child, parent‐rated rhinitis symptom scores will be acceptable but all scores must be confirmed and investigator rated. Adverse events. Any specific adverse effects, systemic or local, and any clinically diagnosed hypersensitivity or other adverse reactions to the topical nasal steroid medications. Secondary outcomes: Nasal assessment scores of inspiratory peak flow levels Rhinomanometry or other objective measurement of nasal airflow Assessment of allergen sensitivity in either the eye or nose Measurement of serum IgE antibody In addition we will consider any outcomes which have utilised quality of life instruments to measure any of the following domains; performance at school, absenteeism, social behaviour, emotional well‐being and social relationships We would recommend that the trialists use validated disease specific quality of life instruments for children and their parents, e.g. Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) or Parents Questionnaire: the effects of Rhinopharyngitis and/or otitis of the child upon family life (PAR‐ENT‐QoL)
Time Stamp (T)	Date of literature search or recommendation	September 2009
Study Type	What is the most appropriate study design to address the proposed question?	Randomised controlled trial (parallel, cross‐over, N‐of‐1 trial) Methods: concealment clear Blindness: preferably patients and their parents, therapist, trialists, outcomes assessors blind, data analysts (at least patient and their parents and the outcome assessor should be blinded) Setting: primary care or outpatient care with follow up If a cross‐over design is used, the trialists should ensure that there is a sufficiently long wash‐out period between intervention and placebo. If in the cross‐over trials children with seasonal allergic rhinitis are included, trialists should be careful about the variations in pollen seasons as it might further complicate the interpretation of data due to environmental co‐factors.