Public Health Wales Research and Development 2013/14 Purpose of Document: The following table contains all research and development projects which have already concluded, or are still on-going in the 2013/14 financial year. This document will be updated on a quarterly basis throughout the financial year. Date Updated: August 2013 1 Public Health Wales – PUBLIC HEALTH SERVICES # 1 Project Title Biomarkers in Baseline HPV 2009 v1.0 2 SUPERLY Pro-Ex 3 FH02 Mammographic sureveillance in women aged 35 to 39 years at Lay Summary Human Papillomavirus (HPV) is a very common viral infection and most women will be infected at some point in their lives. This is a study to see if carrying out new tests for HPV status on cervical screening samples could identify women at a higher risk of cervical disease development. Occasionally, HPV can cause abnormal cell growth by interfering with the normal cell controls. The tests will start to look for possible changes in the virus status that could be the cause of this loss of control. This study will be performed on stored residual smear material (80°C) that has been previously collected as part of a pseudoanonymous study and will not affect patient treatment and will not require additional samples. HR HPV positive samples will be tested further with for viral integration status. The results of these tests will be compared with available smear and biopsy results collected pseudoanonymously over 2 rounds of screening (up to 6 higher risk of cervical disease development. This is a study of two additional tests to be carried out on cervical screening samples, in order to find out if it might be possible to safely reduce the number of women referred to hospital as a result of having abnormal smears. Taking part in the study will not involve having any extra samples taken or any change of treatment. Women will be invited to take part if they have been referred to colposcopy clinic after having had at least two abnormal smears. If they consent to being included in the study, their most recent smear will be tested with the new test (ProExC) and for human papillomavirus (HPV). The results of these tests will be compared with the results of the biopsies taken in colposcopy as part of routine practice and then with the result of any subsequent smear tests or biopsies taken as part of their normal clinical care over the next two years. Women with a family history of breast cancer are at increased risk of developing the disease themselves and this risk is particularly increased at younger ages. Only 1 in 200 people develop breast cancer before age 40, but 2 Lead Organisation Cardiff University Public Health Wales Investigator Dr Sam Hibbitts (Senior Lecturer, Cardiff University) hibbittssj@cf.ac.uk Cardiff University Dr Amanda Tristam (Senior Lecturer and Honorary Consultant in Gynaecological Oncology, University Hospital of Wales. Honorary Contract with Public Health Wales.) tristamaj@cf.ac.uk Central Manchester and Manchester Dr Rosemary Fox (Director of Screening Division, Public Health Wales) enhanced familial risk of breast Cancer 4 Understanding healthcare utilisation of responders and non-responders to the bowel screening programme in Wales (NAEDI) 5 Exploring attitudes to HPV self-sampling among a socially-stratified sample of Welsh women 6 Bangor Mycolic Acid study 2011 – Development of women at high and moderate risk due to family history at this very young age have a risk between 1 in 10 and 1 in 60. The benefits of an annual mammography in terms of early diagnosis and potential lives saved needs to be balanced against the risks such as earlier radiation exposure and false positive tests that may lead to unnecessary surgery. This trial will inform the NHS as to whether mammographic surveillance will be cost effective in terms in the likelihood of saving lives and whether whether there is an adequate trade off between these benefits and the attendant risks In order to be effective at a population level, national screening programmes need to achieve a high uptake. The bowel screening programme in Wales has been established for two years and its uptake is about 58%. Unlike other cancer screening tests, the sample is taken at home and does not require a visit to a clinician. Little is known about the characteristics of non-responders to understand why they do not access the opportunity for prevention or early detection of bowel cancer and whether there may be opportunities to improve uptake through opportunistic contact with health care professionals. Previous work on non-responders to other screening programmes has focussed on socio-demographic and adaptive factors. The role of co-morbidities, and hence opportunities for intervention at other points of contact with healthcare services, has not been examined. The introduction of HPV self-sampling is being discussed however as yet, no policy has been set. Self-sampling is a method where a woman can collect a sample of her own cells for HPV DNA testing. HPV self-sampling has been shown to have similar specificity and sensitivity to clinician sampling, is more sensitive than cytology and potentially avoids embarrassment and discomfort concerns associated with smear testing. This doctoral research aims to investigate women’s attitudes towards HPV self-sampling by incorporating the theoretical framework of the Extended Health Belief Model (EHBM) and particularly focusing on the concept of self-efficacy. Children’s University Hospital Rosemary.fox@wales.nhs.u k Cardiff University Dr Rosemary Fox (Director of Screening Division, Public Health Wales) Rosemary.fox@wales.nhs.u k Cardiff University Dr Sharon Hillier (Deputy Director of Screening, Public Health Wales) Sharon.hillier@wales.nhs.u k We have shown that synthetic antigens related to components of tuberculosis cells are recognized by antibodies present in the serum of Bangor University Dr Michael Ruddy (Consultant Microbiologist, 3 point of care TB diagnostic assay 7 Validation and application of cryptosporidium oral fluid immunoglobulin assays 8 Blood Stream Infections focus on outcomes Phase 1 patients infected with tuberculosis. In a population with high endemic tb levels we can distinguish TB positive from TB negative in laboratory assays to the standards of sensitivity and selectivity required by the WHO and we are developing point of care diagnostic devices. The method we employ has the capacity to identify and compensate for population variations and in principle to identify other mycobacterial infections. The aim of this study is to show that this method also works in a population with a low TB burden and to provide proof of concept that we can provide a simple and efficient device for point-of-care diagnosis and monitoring the effect of treatment. Options for assessing whether an individuals or groups of people have had recent exposure to the parasite Cryptosporidium, a major cause of gastrointestinal illness, are limited. For individuals, diagnosis of ensuing illness by testing stool samples for the parasite is usual. However, routine laboratory tests are not very sensitive for detection of the parasite, and not everyone will become sick and seek diagnosis. To study groups of people, blood samples can be tested for antibodies (specifically immunoglobulin G) which develop following infection. However, this is invasive, and not desirable for children who are of special interest as they are at high risk of infection. Newly-published methods for detecting antibodies in oral fluid involve a non-invasive, convenient sample collection process but the assays need further evaluation and validation as indicators of recent infection. If proven successful, the assays will be of great benefit for outbreak investigations and population exposure and risk studies into Cryptosporidium. Infection is a major concern in British hospitals and it is estimated that there are around 90100,000 cases of Blood Stream Infections (BSI) every year. The death rate from these infections can be very high 10-30% and for certain organisms can reach 50%. Blood stream infections with Methicillin resistant Staphylococcus aureus, Pseudomonas aeruginosa, extended spectrum Blactamase producing E.coli or Klebsiella spp and Candida spp. have been particularly associated with high levels of mortality following infection. A number of factors are thought to play a role in poor outcome, in particular underlying disease and the site and severity of infection. In contrast, timely appropriate use of antibiotics and removal of infected prosthetic materials 4 Public Health Wales) Michael.ruddy@wales.nhs. uk Public Health Wales NHS Trust Dr Rachel Chalmers (Clinical Scientist, Public Health Wales Health Protection) Rachel.chalmers@wales.nh s.uk Bristol University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk 9 Probiotics for Antibiotic Associated Diarrhoea (including C.Diff) in Care Homes (PAAD ) Phase 2 10 Diagnosis of Urinary Tract Infection in Young Children (DUTY) 11 Giardia Typing Pilot Study are thought to be beneficial from small single centre studies. Ward staffing levels are also thought to have a role. All these factors will be examined in more depth in this multicentre study to see what effect they have and how they can be changed to improve patient care and outcome of disease following a BSI. The results of the study will then be fed back into the NHS to modify practice to improve patient care and outcome. Phase 1: Phase 1 is a prospective observational study that aims to collect data (e.g. amount and type of antibiotics used, episodes of Antibiotic Associated Diarrhoea (AAD) and Clostridium difficile associated diarrhoea (CDAD) and outcome) for 12 months in a purposive sample of care homes. 270 Service users’ in nine care homes in South Wales will be recruited. An optional baseline stool sample will be taken to assess C.difficile carriage. Should the service user develop diarrhoea either during the course of antibiotics or within eight weeks from stopping the antibiotic, a stool sample will be collected. This phase will provided reliable incidence data and confirm the basis of our sample size calculation for the randomised controlled trial (RCT) (Phase 2). Research procedures, including administering the probiotic, for Phase 2 will be piloted. Family focus groups around the issues of consent and assent will be conducted. Additional interviews will be conducted with study participants capable of consent. Urinary Tract Infection (UTI) is one of the most common bacterial infections in children. UTIs in young children can cause acute morbidity and recurrent symptoms and a delayed or missed diagnosis may lead to rare but serious complications. In our study we want to establish the best way to diagnose UTI in children under the age of five who present to primary care with an acute illness of less than or equal to 28 days duration. This study will provide novel, clinically important information on the epidemiology and presentation of childhood UTI that will be used to develop a feasible and cost-effective clinical tool to help primary care clinicians in the UK and worldwide improve the efficiency of diagnosing UTI in young children. This will help minimise acute suffering and may help prevent serious long-term complications. Up to 200 cases of the gastrointestinal illness giardiasis, caused by the 5 Cardiff University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk Cardiff University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk Public Health Dr Rachel Chalmers 12 Chromatic Reasoning In Treating Infectious Conditions (CRITIC) protozoan parasite Giardia duodenalis (syn. lamblia), are reported in Wales each year. Some cases are acquired abroad but outbreaks have occurred here, especially in institutional settings resulting in exclusion and ensuing impact on carers. Clusters of cases are reported in Wales among people who have not been abroad, but it is often unclear what links, if any, there are between them. Current methods of detection rely on microscopical examination of stools to observe the presence of the parasite. However, due to the organism’s invariant morphology, this does not differentiate between “strains” (assemblages). Differentiation of assemblages may assist investigations into case relatedness, and source identification, as has been demonstrated during outbreak investigations abroad. Although two assemblages are found in humans, it is suspected that assemblage A contains more subtypes originating from animals and that assemblage B may be predominantly human in origin, but we do not know what the distribution is in Wales. Assemblage typing could be readily implemented by the national Cryptosporidium Reference Unit (CRU), Public Health Wales Microbiology ABM, where the technological platforms and proven scientific expertise in molecular parasitology are already in place for Cryptosporidium typing. In a one year pilot study, stool samples submitted for routine investigation of gastrointestinal illness in which Giardia is detected, will be blind coded and further tested by assemblage typing. The typing data will be added to patient exposure data which is collected as part of routine investigation and follow-up of cases, and analysed for trends and statistical associations to see if the additional information helps explain sources of infection and links between infections. If it is found to be of help, then Giardia typing can be considered for inclusion as part of Public Health Wales' service delivery. Around 80% of all antibiotics in the UK are prescribed in primary care. With the development of antibiotic resistance and few new antibiotics, the need for change is paramount. Point of care tests are considered to be a useful tool in helping GPs to make a decision as to whether to prescribe antibiotics or not. Though many point of care tests (POCTs) have been developed many are not used as they are not feasible for practical use in settings like GP 6 Wales NHS Trust (Clinical Scientist, Public Health Wales Health Protection) Rachel.chalmers@wales.nh s.uk Cardiff University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk 13 DURESS Study Cryptosporidium in Upland Hosts and Vectors surgeries. This is because they are often to complex, expensive or timely. This project focuses on the development of a potential new point of care test to guide GPs in prescribing antibiotics to patients with suspected urinary tract infection (UTI) or acute cough. The test uses a new technology called chromatic sensing. If successful this test would be inexpensive, easy to use without the need for reagents or laboratory equipment and produce results within minutes. Chromatic sensing uses current information technology such as laptop computers and mobile phone systems to capture and analyse images of samples. Images of urine (for UTI) or sputum (for acute cough) are analysed according to the red, blue and green (RBG) wavelengths of the image of the sample. The RBG signals are translated into effective signal strength, dominating wavelength and signal spread synonymous with the parameters of colour science. We hope to determine a difference between bacterial positive and bacterial negative urine and sputum samples according to these parameters. The aim of this study is to explore whether chromatic sensing can distinguish between bacterial positive or negative urine and/or sputum samples and be helpful in guiding clinicians in their decision to prescribe antibiotics. The primary objectives are to refine and optimise the setup for taking images of urine and sputum samples using either laptop and webcam system or a mobile phone and to determine whether chromatic sensing can distinguish between bacterial culture positive or negative urine and/or sputum samples. The protozoan parasite Cryptosporidium represents a major health concern associated with surface waters. Outbreaks of gastrointestinal illness have been linked to upland supplies. Unlike most waterborne pathogens, Cryptosporidium is not controlled by chlorination. Kill or removal from water requires expensive treatment technologies mainly applied in high income countries. Further, there are increased risks of exposure for people served by small, often private, water supplies. Cryptosporidium causes an acute gastroenteritis (cryptosporidiosis), with between 3000 and 6000 laboratory confirmed cases reported each year in the UK. Two species, C. parvum and C. hominis, account for most cases. Not all species of Cryptosporidium are infectious to humans and some species are more adapted to some hosts 7 Cardiff University Dr Rachel Chalmers (Clinical Scientist, Public Health Wales Health Protection) Rachel.chalmers@wales.nh s.uk 14 Children with Eczema Antibiotic Management Study (CREAM) 15 Point Of carE Testing for urinary tract Infection in primary Care (POETIC) (Stage 1 and Stage 2) than others. We know that farmed animals and sewage from septic tanks can be sources of contamination in upland rivers, but little is known about the possible role of aquatic animals in the transmission of Cryptosporidium as there is a limited amount of previous research in this topic area. It has been shown that some animals such as birds, flies and shellfish may act as transport vectors of human infectious Cryptosporidium species without becoming infected themselves. Birds can become infected but with different species. Nothing is known about whether other filter feeders, such as aquatic insect larvae, may also have a similar role in harbouring the parasite. We aim to find out whether insect larvae can harbour Cryptosporidium and to find out more about the role of insectivores, fish and birds in transmission of the parasite in upland catchments. CREAM is a doubleblind, randomised controlled trial based in general practices in Wales, Scotland, and the West of England. Children suitable for the study will be identified by General Practitioners. If the child’s parent/carer agrees, children will be randomly put into one of three treatment groups (for one week): 1. Oral antibiotic and placebo cream; 2. oral placebo and antibiotic cream; or 3. oral placebo and placebo cream. Children taking part will be followed-up over 12 months. A trained research nurse will visit each child during the first 4 weeks and use established questionnaires to assess the severity of eczema; effect on quality of life; healthcare consultations; impact on the family; and take swabs from the skin, nose and mouth. The child’s parent/carer will be asked to complete a diary during the first 4 weeks to record symptom severity and use of medication. At 3 and 12 months, the parent/carer will be asked to complete questionnaires and repeat swabs. These swabs will be used to assess impact of treatments on subsequent development of antibiotic resistance; and to measure the antibiotic sensitivity of bacteria found on the skin, nose and mouth. One approach to improving the management of women with symptomatic UTI is to use technologies that incorporate near patient culture techniques. One such technology is the Flexicult system, which is a novel point of care test. This POCT uses specific chromatogenic agar to identify bacteria, and 8 Cardiff University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk Cardiff University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk 16 A prospective randomised, multicentre trial to assess the impact of laboratory based RAPId Diagnosis on Outcome in patients with Blood Stream Infections (RAPIDO) can be impregnated with antibiotics of choice to identify any antibiotic resistant bacteria. The results of this test are available to the Clinician within 24 hours, enabling a more accurate diagnosis and better decisions about treatment regime. Timely identification of a bacterial pathogen, and its antibiotic resistance profile, in urine samples from women presenting with symptomatic UTI in primary care, could help reduce the overall use of antibiotics and help ensure that the most appropriate antibiotic is used for women who are likely to benefit from antibiotic treatment (avoiding the use of antibiotics where no bacterial infection is identified, and ensuring the narrowest spectrum antibiotic to which the infecting bacteria is sensitive to).This will not only improve the care of patients presenting with symptomatic UTI, it will also help reduce the selective pressure that comes from widespread unnecessary antibiotic use which is an important contributory mechanism in the development of antimicrobial resistance. The two stages described here will allow us to: 1. Assess the feasibility of integrating such a test into general practices as well as the acceptability for both prescribers and patients. 2. Assess the variation in current management that could be changed by utilising a new POCT. Both of these are required before a full scale implementation RCT of the test can be undertaken. Blood stream infections (BSI) are a major problem and about 8% of hospital inpatients have a BSI. Some will be admitted with a BSI and others will develop an infection during their hospital stay. Recent improvements in infection control have reduced the number of patients that acquire an infection during their hospital stay, but BSI still occur and there are currently around 90100,000 cases a year. In certain infections the death rate can be as high as 50% and every patient that contracts an infection has a longer hospital stay. BSI is diagnosed by taking a blood sample from patients with suspected infection. Antibiotic treatment is commenced within hours, but processing of blood cultures takes several days to reach a definitive diagnosis and identify the correct antibiotic. The initial antibiotic selected will be a broad spectrum antibiotic, based on the clinician's judgment of the clinical picture. However, until definitive bacterial analysis is performed it is 9 Bristol University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk 17 Laboratory Evaluation and Development of Rapid Diagnostic Tests for Urinary Tract Infection 18 Investigating Long-Term Health Effects of Cryptosporidium occurring unknown if the correct antibiotic has been selected and there can be a time lag of up to 35 days before patients receive appropriate antibiotic therapy for their BSI. Administration of the correct antibiotics has been shown to reduce death by up to 50% in some patient groups. This study will assess the impact of new technology designed to speed up laboratory diagnosis. The new technique should produce information within ½ hr of commencing laboratory processing of positive specimens. A five centre, randomised controlled trial design will be used and all patients with BSI will be randomised into two groups, one which will be subjected to the current diagnostic approach and the other group will have the current diagnostic approach plus the new rapid diagnostic technology as well. Outcome will be assessed by collecting the same set of clinical information on each patient in the study. Around 80% of all antibiotic's in the UK are prescribed in primary care. With the development of antibiotic resistance and few new antibiotics, the need for change is paramount. Point of care tests are considered to be a useful tool in helping GPs to make a decision as to whether to prescribe antibiotics or not. Though many point of care tests (POCTs) have been developed many are not used as they are not feasible for practical use in settings like GP surgeries. This is because they are often too complex, expensive or timely. This study focuses on the development and laboratory evaluation of new rapid diagnostic tests to aid the diagnosis of urinary tract infection (UTI). The aims of this study are to: • Evaluate the performance of UK Flexicult™ SSI urinary test in a laboratory setting; • Develop and evaluate a new technology, Chromatic sensing, for use as a future rapid diagnostic test for UTI; • Evaluate chromatic sensing as an improved alternative to user based interpretation of dipsticks for UTI The study will follow-up a group of people who were part of an outbreak of cryptosporidiosis occurring in the North of England and Scotland during May 2012. We will approach potential participants, seek informed consent, and 10 Cardiff University Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk Swansea University Dr Rhianwen Stiff (Specialty Registrar, Public Health Wales) in the 12 months following Acute Infection: an Outbreak Follow-Up Study 19 A pilot study on the risk factors for Toxoplasma Gondii infection in England and Wales 20 Long-term health sequelae of cryptosporidiosis ask them to complete a health related questionnaire at 3 months and again at 12 months after they were diagnosed with Cryptosporidium infection. Environmental Health Officers routinely conduct 'exposure' questionnaires with cases of Cryptosporidium at the time of their diagnosis. We will link data from exposure and follow-up study questionnaires. The outbreak follow-up study aims: To investigate those health sequelae of Cryptosporidium infection which occur after the acute infection has resolved (postacute health sequelae) To investigate whether people who have had Cryptosporidium infection are at an increased risk of Developing symptoms consistent with post-infectious irritable bowel syndrome. Toxoplasma is a common single-celled parasite that infects about 5 in 1000 of the UK population each year. Once an individual is infected, the parasite forms cysts in heart and CNS tissues and can remain there for life. In otherwise healthy individuals Toxoplasma infection often passes unnoticed or causes only mild to moderate flu- or glandular fever-like symptoms that require no treatment. If the infection is acquired during pregnancy, however, this can be severe or life-threatening for the unborn child. Toxoplasma is acquired either by eating raw or undercooked meat from animals that are infected, or by inadvertently ingesting oocysts (microscopic parasite eggs) from the environment. Thus, infection may be food borne or may be associated with a wide range of occupational or social activities involving exposure to the environment. In the UK it is not known which of these routes is the most important and this information is critical in ensuring health protection advice is targeted towards the highest risk activities. The findings will also inform national strategy and policy on food safety. This study involves finding out, through a 30 minute telephone interview and questionnaire, what exposure to risk factors has been encountered by individuals recently infected with Toxoplasma. Relatively little is known about the spectrum of illness caused by Cryptosporidium, particularly long-term health consequences following acute infection. It is these consequences we would like to investigate using a combination of methods: 11 Rhianwen.stiff@nhs.wales. uk Health Protection Agency (HPA) Dr Edward Guy (Head of Toxoplasma Reference Unit, Public Health Wales) Edward.guy@wales.nhs.uk Public Health Wales Dr Rhianwen Stiff (Specialty Registrar, Public Health Wales) Rhianwen.stiff@nhs.wales. 21 Role of chronic urinary infection in the pathophysiology of overactive bladder syndrome (OAB and Infection) 1. Systematic review of the literature 2. Retrospective study - We will securely link anonymised laboratory results (diagnosis date, species found) with health record data 3. Prospective study - We will approach potential participants, seek informed consent, and ask them to complete a health related questionnaire at the time of diagnosed with Cryptosporidium, and also at 3 and 12 months afterwards. Overactive bladder (OAB)is characterised by urgency(a sudden compelling desire to pass urine which is difficult to defer), with or without urge incontinence (complaint of involuntary leakage accompanied by or immediately preceded by urgency), usually with frequency and nocturia (complaint that the individual has to wake at night one or more times to void).It effects 13% of the population and the incidence rises with age. It has significant adverse effect on quality of life; sleep quality and emotional wellbeing. OAB has been proposed to have a greater negative effect on the health related quality of life (HRQoL) than diabetes mellitus, hypertension, asthma or depression. Various hypotheses have explained the pathophysiology of OAB symptoms but no concrete evidence exists which supports these hypotheses. In recent years, subclinical urinary infection has been explored as an etiological factor for OAB symptoms, but robust data is still lacking. The aim of our study is to investigate whether women with OAB symptoms (and no evidence of overt clinical infection by conventional Mid Stream Urine for culture) have significant markers of subclinical infection when compared to individuals with no OAB symptoms. We aim to compare the urine samples of patients with OAB with healthy controls. We will be looking for the following markers of infection 1) microscopy of fresh urine for pus cells 2) culture of urine for bacterial growth 3) Detection of inflammatory biomarkers in the urine. 4)Molecular testing for bacterial DNA in the fourth sample. explained the pathophysiology of OAB symptoms but no concrete evidence exists which supports these hypotheses. In recent years, subclinical urinary infection has been explored as an etiological factor for OAB symptoms, but robust data is still lacking. The aim of our study is to investigate whether women with OAB 12 uk Abertawe Bro Morgannwg UHB Eugene Rees (Head of Bacteriology, Public Health Wales Swansea) 22 A prospective study of faecal parasite infections among children in Cambodia 23 Protecting the health of Europeans by improving methods for the detection of pathogens in drinking water and water used in food preparation: AQUALVALENS symptoms (and no evidence of overt clinical infection by conventional Mid Stream Urine for culture) have significant markers of subclinical infection when compared to individuals with no OAB symptoms. We aim to compare the urine samples of patients with OAB with healthy controls. We will be looking for the following markers of infection 1) microscopy of fresh urine for pus cells 2) culture of urine for bacterial growth 3) Detection of inflammatory biomarkers in the urine. 4)Molecular testing for bacterial DNA in the fourth sample. Cambodia has some of the poorest health indicators in Southeast Asia, with high rates of malnutrition. Just under a third of the population have access to improved sanitation facilities, and rainwater is the main source of water for most homes. It is therefore not surprising that infection with gut parasites is a common problem in children, causing detrimental effects on nutrition, growth and cognitive development and contributing substantially to childhood anaemia. The primary purpose of this study is to define the incidence and range of faecal parasites causing infections in Cambodian children presenting to hospitals; the R&D approval sought here is specifically for the work that will be undertaken at the national Cryptosporidium Reference Unit in Public Health Wales Microbiology Swansea: the analysis of DNA extracted from stools for the detection and characterisation of the Cryptosporidium parasite. The DNA will have already been extracted from stools at Liverpool University. AQUAVALENS is an EU funded collaborative project centered on the concept of developing suitable platforms that harness the advances in new molecular techniques to permit the routine detection of waterborne pathogens and improve the provision of hygienically safe water for drinking and food production. It is vital for improving risk assessment and risk management of water supplies that robust techniques are developed that can inform better our knowledge of the occurrence and abundance of waterborne pathogens presenting a threat to individual water supplies. Our work will centre on the applied parasitology aspects of AQUAVALENS for the detection, virulence assessment and subtyping of major waterborne protozoa: Cryptosporidium and Giardia. 13 Oxford University Professor Rachel Chalmers (Head of Cryptosporidium Reference Unit) Rachel.chalmers@wales.nh s.uk University of East Anglia Professor Rachel Chalmers (Head of Cryptosporidium Reference Unit) Rachel.chalmers@wales.nh s.uk 24 25 Validation of MALDI-TOF for identification of Neisseria Gonorrhea The purpose of this project is to determine which identification system is the most sensitive and specific for the identification of cultured N. Gonorrhoea from clinical specimens and also to determine which method will provide results within the time and budget constraints of the laboratory. The study also aims to evaluate the antibiotic susceptibility to Cephalosporins and Macrolides within these bacteria. Public Health Wales NHS Trust As new technology is being developed and entering clinical laboratories, it is important to determine if this technology will be of benefit to the Cardiff laboratory and not implemented because it is new. Also it is important to determine a method that will provide the laboratory with reproducible results in a timely manner, as well as providing the clinician with a confirmed positive or negative result which will ultimately help with treatment efficacy. Point Of carE Testing for Fifteen percent of community antibiotic prescriptions are for uncomplicated Cardiff University urinary tract Infection in urinary tract infections (UTI’s). Most women presenting with UTI symptoms primary Care: Study Stages 3 are prescribed an antibiotic agent. However, 34% 60% of patients treated & 4: Randomised controlled with an antibiotic do not have a microbiologically proven UTI and 25% of trial and those with a positive culture are not prescribed antibiotics. This is important post RCT in terms of improving outcomes for women with symptoms of UTI. observational study (POETIC Unnecessary use of antibiotics contributes to the development of resistant 3&4) bacteria, an important and increasing public health threat. We propose a two stage study (stages 3 & 4) that follows on from our previous study (POETIC: stages 1 & 2) that aims to improve the management of UTI in women through use of a novel point of care test (POCT), based on an overnight culture technique that is carried out within general practice and provides a diagnosis of bacterial UTI and resistance profiles of any identified pathogen, within 24 hours. Stage 3 will be an individual randomised controlled trial to assess the effectiveness of the device in targeting appropriate use of antibiotics (i.e. avoiding the use of antibiotics where no bacterial infection is identified, and ensuring the narrowest spectrum antibiotic to which the infecting bacteria is sensitive to is prescribed for women with proven UTI). The fourth stage will only be done if the POCT guided strategy is shown to be effective in stage 3. It will be a pragmatic 14 Paula Brookes (Operational ManagerBacteriology Public Health Wales Cardiff) Paula.brookes2@wales.nhs .uk Dr Robin Howe (Consultant Microbiologist, Public Health Wales) Robin.howe@wales.nhs.uk assessment of the uptake and use of the POCT when provided to general practices outside of trial conditions. For both stages participants will be adult women presenting in general practice with symptoms suggestive of UTI. Public Health Wales – PUBLIC HEALTH DEVELOPMENT 26 Pilot Blood and Tissue Bank for Patients with Chronic Fatigue Syndrome 27 Using the All Wales Clinical Governance Practice Self Assessment Tool for general medical practices – assessing the opinions of health care professionals The study intends to develop a bank of research participants, including at least 50 patients with Chronic Fatigue, and two groups of Control participants. Firstly, a group of 25 Household Controls, each of whom will share the home of a patient with Chronic Fatigue. Only one control participant will be recruited from any given household. Secondly, a group of 50 Community Controls, who will be drawn from the wider community.All participants will be asked to complete an initial screening questionnaire and provide an initial blood sample. They may then be asked to provide a blood sample, complete a questionnaire or undertake tests of physical function up to twice a year. Clinical governance is a framework for the improvement of patient care through commitment to high standards, reflective practice, risk management and personal and team development. The Clinical Governance Practice Self Assessment Tool (CGPSAT) for general medical practices is about monitoring outcomes, identifying errors, reviewing activity and continually learning and developing. It is about sharing knowledge and experience, both good and bad. This study proposes to develop a questionnaire-based evaluation tool that can be used by Public Health Wales to determine what benefits(or not) have been derived by health care professionals who have completed the CGPSAT. If Public Health Wales decide that the service tool develop as part of this study is fit for purpose they will adopt it and provide feedback to the researcher based on the responses they receive from the questionnaire. If the questionnaire is not adopted they will provide feedback as to why. The researcher will review the feedback and information receive from Public Health Wales to review the service evaluation tool and identify any further improvement that are required or can otherwise be made. 15 Cardiff University Dr Hugo Van Woerden (Director of Health and Healthcare Improvement, Public Health Wales) Hugo.vanWoerden@wales. nhs.uk Swansea University Dr Paul Myres (Professional Lead, Primary Medical Care Advisory Team, Public Health Wales) Paul.myres@wales.nhs.uk 28 29 Preventing alcohol misuse in young people. An exploratory trial of the Kids, Adults Together (KAT) Programme Randomised Controlled Trial of All-Wales Licensed Premises Intervention to Reduce Alcohol-Related Violence - Cardiff University Licensed Premises Intervention (CULPrIt) This study is developing and evaluating a school-based intervention – Kids, Adults Together (KAT), which draws on the Social Development Model and seeks to prevent alcohol use by strengthening pro-social communication in families. Cardiff University The KAT programme aims to prevent alcohol misuse by young people through integrating specially designed classroom activities with a family education evening and a DVD to promote pro-social communication. A recently completed formative evaluation of KAT demonstrated high levels of programme reach and acceptability, and impacts on pro-social communication in families - click here for further information. This Project examines the effectiveness of an intervention, delivered to pubs Cardiff and clubs, that is designed to reduce violence. Environmental Health Officers University (EHO) will deliver the intervention as they have a history of enforcement and partnership working and are trained to deliver interventions and advice to small and medium sized businesses. Furthermore, EHOs have available statutory powers, they can require entry to premises and are able to enforce change. The intervention itself is made up of four components. First, EHOs will host "Safety and Health Awareness Days" across Wales for Intervention premises. This will help engage those involved with premises operation and includes regional managers to serving staff. Second, they will audit premises to identify those areas where premises operation might increase the risk of violence (e.g. inappropriate alcohol promotions, which are associated with violence). Third, based on this audit, EHOs will formally require premises to make changes (where risks are covered by existing legislation), advise premises to make changes, and if appropriate refer premises to police and Local Authority licensing officers who are able to place conditions on premises licenses. Reducing known risks will reduce alcohol-related violence. Finally, EHOs will conduct a second audit one month later to assess whether premises have made the required changes and if not they will enforce as required. 16 Dr Jeremy Segrott (Research Fellow in Public Health, DECIPHer, Cardiff University) SegrottJ@cardiff.ac.uk Dr Simon Moore (Reader, School of Dentistry, Cardiff University) Mooresc2@cardiff.ac.uk 30 31 Fathers, Social Interventions and Children's Well-being Pilot Study of Alcohol Policy and Social Norms in Welsh Universities Social care and other helping services to engage with fathers is a relatively Cardiff recent innovation and not very much is yet known about the effectiveness of University different approaches. Three studies will contribute to the evidence base for more effective work with fathers and especially the impact of this work on the emotional well-being of children. Study 1 involves analysis of existing data on families and child health over time. It will examine which social factors, attitudes and behaviours in fathers are associated with children’s emotional well-being. (Note that ‘fathers’ here means all father figures, including biological fathers, step fathers and mothers’ boyfriends). Study 2 will try to identify which kinds of approaches and services are most commonly being used by practitioners who see themselves as working to engage fathers. Study 3 is a pilot study of two social interventions for fathers. The pilot study will explore the potential for future experimental research on outcomes for children of interventions with fathers, and in particular emotional health outcomes. Although originating in the USA, interest is growing in applying the social norms approach to reducing drinking behaviours in UK universities. This approach is based on the assumption that students perceptions of the norms of their peers are highly influential, but that these perceptions are often incorrect. That is, students often believe that their peers drink more, and experience more alcohol-related consequences, than they actually do. Social norms interventions therefore aim to correct these inaccurate perceptions, and in turn, to change behaviours. Earlier in 2011, a survey was conducted by the Cardiff Institute of Society and Health, in partnership with NUS Wales and Drinkaware to assess first year university students perceptions of peer drinking behaviour and consequences in four Welsh Universities. Data from this survey have informed the development of materials which aim to correct incorrect perceptions of drinking norms, which will be delivered through university 17 Cardiff University Professor Jonathan Scourfield (Professor of Social Sciences, Cardiff University) scourfield@cf.ac.uk Dr Simon Murphy (Senior Research Fellow, CISHE, Cardiff University) MurphyS7@cf.ac.uk halls of residence. 32 Randomised Control Trial of the Strengthening Families 10-14 UK programme (SP1014 UK) 33 Families Households and Health Improvement 34 The Role of Protozoa like Organisms in Respiratory Diseases 35 Barriers to Uptake of Smoking Cessation Services in Pregnant Women in Cwm Taf (BASICS) This study aims to examine the impact of these materials on first year students drinking and alcohol related consequences in four universities, and to establish the feasibility of a larger national trial. The use of alcohol, tobacco and illegal drugs by young people impacts on their health in the short and long term, and is also associated with antisocial behaviour, crime and dropping out of school. Many of the factors which protect young people from misusing drugs and alcohol, or put them at greater risk of doing so, are linked to family life and parenting. The Strengthening Families Programme 10-14 UK (SFP10-14 UK) aims to strengthen these protective factors (parenting, family communication, and young people’s resilience skills) and simultaneously reduce key risk factors that are located within families. The research will focus on how families negotiate roles and responsibilities for health through their interaction with each other and wider social structures. Families and households will be investigated through in-depth case study research. Individual and group interviews will be conducted with household members and activity diaries will be used to record relevant aspects of everyday life, relationships and behaviour. The findings will provide an insight into how health improvement messages and interventions can be better targeted and supported and should sensitize health care professionals to how families negotiate health decisions. 1. Can we use molecular techniques to identify the precise nature of the protozoa observed in the sputum of respiratory patients under light microscopy? 2. Are these protozoa also present in dust mite faeces? The study aims to identify ways to improve the support for pregnant women who wish to give up smoking in the region served by the Cwm Taf Health Board, South Wales. A questionnaire will be used to ascertain the views of recently pregnant mothers on the opportunities available to give up smoking 18 Cardiff University Professor Laurence Moore (Professor of Public Health Improvement, Cardiff University) Moorel1@cf.ac.uk Cardiff University Sarah MacDonald (Research Associate, CISHE, Cardiff University) macdonals@cf.ac.uk Public Health Wales NHS Trust Dr Hugo Van Woerdon (Director of Health and Healthcare Improvement, Public Health Wales) Hugo.vanWoerden@wales. nhs.uk Mrs Angela Jones (Consultant in Public Health, Public Health Wales) Glamorgan University during pregnancy. 36 (APP-cohol awareness)supporting people to drink less alcohol using a smart phone app and scratch card recorder Project objectives are to: Public Health a) identify appropriate target ‘user’ groups Wales NHS Trust b) determine how best to direct the target users to the app and scratch card c) determine what health messages should be used to support behaviour change by the users d) determine whether and to what extent the app and scratch card can effect behaviour change and reduce alcohol consumption. 37 Models for Access to Maternal Smoking Cessation Support (MAMMS Study) CWM Taf Addressing smoking in pregnancy is a high priority area for the NHS in Wales and the Welsh Government. Wales has higher rates of smoking in pregnancy than any other UK country, and levels before or during pregnancy is highest at 33% compared to 26% in England (Infant Feeding Survey, 2010). There is unequivocal evidence of the association between smoking and poor outcomes for mother and baby in the short, medium and long term. Uptake of NHS smoking cessation support in Wales is currently low and there is a requirement to review the current delivery model supporting pregnant women in order to improve the uptake of cessation support and achieve higher numbers of women successfully quitting. A review of the evidence (NICE), on the barriers to smoking cessation in pregnancy suggests that pregnant smokers are different to other adult smokers who are motivated to quit and self refer to smoking cessation services, and that a flexible approach is needed for pregnant women, particularly those who are disadvantaged, with the services being offered in a client centred way throughout pregnancy and following childbirth. This research aims to test the hypothesis that the uptake of evidence based smoking cessation services by pregnant women will increase, if flexible models of support are delivered by a Maternity Support Worker sited within the Midwifery team. A nonrandomised intervention approach will be 19 Cwm Taf Health Board Angela.jones26@wales.nhs .uk Dr Sarah Jones (Consultant in Environmental Health Protection, Public Health Wales) Sarah.jones27@wales.nhs. uk Margaret Munkley (Principal Public Health Specialist) Margaret.Munkley@wales. nhs.uk 38 Models for Access to Maternal Smoking Cessation Support (MAMMS Study) Comparison Analysis undertaken to establish the effectiveness compared to that provided by the usual care, i.e, existing Stop Smoking Wales service. Consistent data collection and analysis will be used to measure improvement in uptake of smoking cessation services by pregnant women, and subsequent smoking quit rates. Data will be extracted and analysed from the all Wales Maternity Record, Summary of Labour database and Stop Smoking Wales database. The study aims to compare the effectiveness of new models of service Public Health delivery for specialist smoking cessation services for pregnant women with Wales NHS Trust existing services delivered by Stop Smoking Wales. The new models of service delivery (pilots) will be implemented over a maximum 12 month period in selected sites across four health boards in Wales using an integrated approach between maternity services, local public health teams and stop smoking Wales. Core recommendations from NICE guidance will be implemented across pilot and usual care sites within the participating Health Boards. In usual care sites, stop smoking support for pregnant women will be delivered by the existing Stop Smoking Wales service. In pilot sites, support will be provided by a maternity support worker, a midwife or a dedicated Stop Smoking Wales advisor and will be delivered more flexibly than in usual care sites. Each health board has identified plot and usual care sites based on geographical areas or community midwife teams depending on how maternity care is organised in the Health Boards. Routine data collected by Health Board ,maternity team and Sop Smoking Wales for a cohort of women who participate in either a pilot or usual care service across the four Health Board areas will be extracted, linked and analysed for a maximum 12 month period. The primary outcome is engagement with specialist smoking cessation services defined by at least one face to face therapeutic contact. Secondary outcomes are pregnant smokers who set a quit date; pregnant smokers who quit at 4 weeks follow up (CO verified); smoking status of pregnant smokers during third trimester and birth outcomes (birth weight, gestational age). Process measures will assess fidelity to protocols, feasibility acceptability, maintenance and sustainability should the pilots be rolled out on a wider level. 20 Siobhan Jones (Consultant in Public Health) siobhan.jones2@wales.nhs .uk 21