0 The TARGET study Aims of the Study The TARGET study is investigating the clinical and microbiological factors influencing the prognosis of children presenting to primary care with a cough and respiratory tract infection (RTI). The study will develop a clinical rule, using children’s symptoms, signs, microbiology and demographics to help clinicians predict complications of RTI, principally hospitalisation with pneumonia, but also prolonged illness. This study will use data collection methods similar to the successful MRC funded DESCARTE study that recruited between 2007 and 2009. Sample size 8000 patients in total from the Bristol, London, Oxford and Southampton study centres. The Bristol centre will recruit 2300 children from the surrounding areas and across the South West within two years. Participating clinicians (GPs and/or practice nurses) will be invited to agree to recruit a set number of children (minimum 1 per week) during the study for which they will be reimbursed up to £60 per patient. Recruitment numbers will not be limited so successful clinicians can sign up for more. We will decide, together with the clinician, how and when to recruit in their consultations. Timeframe Study start date: August/September 2011 for two full years. What is involved for the practice?        Recruit children aged ≥3 months to <16 years whose parent/ carer has requested an appointment for an acute (≤28 days) cough (as the main presenting symptom) and RTI. Record children’s symptoms, signs and some demographic data on a web-based or paper based (single side of A4) Case Report Form (CRF). Record brief details for children/ parents that decline to participate and those eligible but missed (online or by postcard). Obtain a throat swab from the child, package in Royal Mail Safebox™ and send to the study laboratory for processing (results will not be routinely available). Give the parent/carer/child a symptom diary to record how long the child’s symptoms last at home (available for parents to use online or on paper, the Bristol study centre will provide support to help families do this). Allow a member of the research (or a member of your practice) team to review recruited children’s medical notes (for evidence of hospital admission in the 28 days post recruitment). Children can be managed according to your normal clinical practice. 2011 08 01 TARGET Clinician flyer Bristol centre v1.2 Page 1 of 2 Additional information    Prior to the start of recruitment, practices will be asked to:  Provide some basic information about the patient list (e.g. list size, list size of patients in ≥3 months to <16 years age range) and recruiting clinicians.  To nominate an administrative lead and a GP lead, whom the study team can occasionally contact for data verification or to communicate study updates. We require recruiting clinicians to be “lower” antibiotics prescribers, which means GP/nurses who would typically give an immediate prescription less than a third of the time to children with cough plus RTI (in this context, a delayed prescription is regarded as not prescribing). Using the web-based CRF has the added benefit of a cut-and-paste facility where the recruited child’s study data can be pasted into the child’s medical record. Funder National Institute for Health Research (NIHR) Programme Grant. UKCRN Portfolio adopted and supported by the PCRN. Service Support Costs £60 per successfully recruited child (inclusive of a throat swab sent to the lab). An additional £6 per completed notes review, if practices complete these themselves. Recruiting areas R&D approval obtained NHS Bristol South Gloucestershire PCT North Somerset PCT Somerset PCT Swindon PCT BANES (Bath & NE Somerset) NHS Dorset NHS Devon Cornwall & Isles of Scilly PCT R&D approval in progress NHS Gloucestershire If you would like further information about this study please do not hesitate to contact your local PCRN Research officer or a member of the TARGET team. Thank you for taking the time to consider this study. Contact the TARGET team Dr Niamh Redmond Programme Manager [email protected] Or [email protected] Tel: 0117 331 4523 Ms Isabel Richards TARGET Research Programme Assistant [email protected] Tel: 0117 928 7237 2011 08 01 TARGET Clinician flyer Bristol centre v1.2 Page 2 of 2