The case finding, proof of concept, service was provided between April and October 2015.
Fifteen community pharmacies across England recruited through the National Association of Primary Care’s Primary Innovation Network, and including Rowlands Pharmacy and an Independent pharmacy agreed to participate. Pharmacies were purposively recruited to ensure a wide geographical spread, a mix of pharmacy locations i.e. linked to GP practice or stand alone and from large multiple and independently managed companies. Participating pharmacies were asked to contact local GP practices to inform them of the study taking place.
Training and support
Participating pharmacists were expected to undertake an online module on recognising and managing coeliac disease from the Centre for Pharmacy Postgraduate Education, learning pharmacy website . Posters for raising awareness and information leaflets were supplied by Coeliac UK.
Senior pharmacists from the different companies were involved in the service design and trained by Tillotts Pharma Ltd on the use of the Simtomax® POCTs. These individuals then trained staff within the recruited pharmacies on the use of the POCTs, including how to identify, approach and recruit patients and provide feedback after testing. The majority of pharmacists also received in house training, direct from Tillotts Pharma Ltd.
Pharmacies received remuneration on commencement of training, half way through and at the end of the study.
All customers who met the inclusion criteria outlined below were given an information sheet which explained the purpose of the service and process.
Men and women aged 18 years and over receiving prescribed treatments, or requesting OTC treatments for either IBS and or iron, vitamin B12 or folate deficiency anaemia.
No previous diagnosis or investigation for coeliac disease.
Registered with a GP.
Those who subsequently expressed an interest were then given a short questionnaire to complete to enable any of the following exclusion criteria to be identified.
Adults on a gluten-free diet or people excluding gluten from their diets.
Adults with learning disabilities.
Adults who have a terminal illness.
Adults unable to give verbal consent.
Women receiving folate due to pregnancy.
Adults previously tested for coeliac disease with a negative result.
Symptoms and diagnoses of any associated conditions were recorded using categories provided within the bespoke pharmacy software which were based on NICE guidance  and verbal consent obtained before testing was undertaken.
Patients declining the test were asked to fill in a short questionnaire to capture their reasons for declining, provided with an information leaflet on coeliac disease, and signposted to their GP should any symptoms persist or re-appear.
The test, which measured both total immunoglobulin A (IgA) and IgA tissue transglutaminase antibodies (IgA tTGA), was provided for free to the patient and was undertaken in a consultation room within the pharmacy by a trained member of the pharmacy team. A finger prick blood sample was taken and inserted into the testing device as per standard operating procedure. In a pilot study the specificity and sensitivity of the POCT used were found to be consistent with current NHS laboratory tests for this disease .
Information provided in all patient leaflets highlighted the possibility of false positive or negative test results and outlined the need for further referral to confirm test results in line with national guidance. Leaflets were designed to ensure that participants were aware of the implications of the test result and could make fully informed decisions as to their future actions. On receipt of the result all participants were given a letter containing the results for their records and the opportunity to ask further questions.
Customers with negative results were given a patient leaflet, informed that the POCT indicated that they were unlikely to have coeliac disease but if problems persist to speak with their GP.
Customers with a positive result were provided with a description of the POCT, confirmation of the result, an information leaflet on coeliac disease, advised to see their GP and not to change their diet as a result of this screening test.
Sample size justification
A pragmatic approach was applied and each pharmacy was requested to carry out 40 POCTs during the study period, which after allowing for training and preparation for the service in each pharmacy, equated to 2 POCTs per week.
Assuming that 600 POCTs were performed if the detection rate was similar to that previously reported in an at risk population of 9.6 %  then this would provide a 95 % CI of ±2.4 %.
For each participant their age, gender, medication which triggered the approach for recruitment, present symptoms and outcome of the test result were recorded.
All service recipients were asked to complete a short satisfaction questionnaire which included a question on whether they would have been prepared to pay for the service and how much they would be willing to pay.
The pharmacy team also completed a baseline and end of study questionnaire to determine their experience of providing the service.
Interviews were undertaken with participating pharmacists, transcribed verbatim and anonymised by a representative from Coeliac UK. Analysis consisted of a framework approach . After familiarisation with the data a coding framework was developed and subsequently applied to the transcripts. Constant reference was made to the transcripts when abstracting themes and sub-themes from the data to ensure meaning and context were retained. Interpretation of the transcripts was checked by a second researcher.