National Public Health Service for Wales Vascular risk assessment by community pharmacists Rapid review of the evidence for the role of community pharmacists in vascular risk assessment Author: Dr M Webb, Public Health Practitioner Date: 16 February 2016 Version: 1 Status: Final Intended Audience: Pharmaceutical Public Health Team Purpose and Summary of Document: Brief review of the evidence and information on the role of community pharmacists in vascular risk assessment. There is some evidence supporting a role for community pharmacists in the provision of vascular risk assessment. Publication/Distribution: Publication in NPHS Document Database (Pharmaceutical Public Health) © 2009 National Public Health Service for Wales Material contained in this document may be reproduced without prior permission provided it is done so accurately and is not used in a misleading context. Acknowledgement to the National Public Health Service for Wales to be stated. Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 1 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists Contents PAGE NUMBER Executive summary 3 1. Introduction 4 2. Aims 5 3. Research Question 5 4. 5 Methods identifying existing ongoing research and 5 6 4.1i Literature searching 5. Results 7 6. 10 7. Discussion and conclusions 17 8. References 18 Appendix 1 Main search strategy 22 Appendix 2 High level search strategy 24 Appendix 3 Evidence levels 25 Appendix 4 Evidence table 26 Appendix 5 33 Summary of evidence from Wolpert et al 20 Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 2 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists Executive summary National guidance from the Department of Health and the National Screening Committee has recommended the implementation of a vascular risk assessment (VRA) programme in the United Kingdom (UK). The programme commenced in England in April 2009 and all subjects between the ages of 40 to 74 years will be offered a risk assessment. Initially this will use GP based records to identify individuals for screening. In Wales, the Welsh Assembly Government has set up a group to investigate the optimum method for VRA and the Pharmaceutical Public Health Team from the National Public Health Service (NPHS) has been asked to participate. The published guidance suggests that there is a potential role for community pharmacists (CPs) in VRA programmes and the pharmacy specialist national organisations have produced guidance on how they could be involved, quality assurance and clinical governance arrangements. Some primary care trusts (PCTs) have already commissioned a service from CPs that has tended to use the opportunistic approach, but it has been suggested that a targeted approach may be more feasible. The programme is usually commissioned as a local enhanced service. The aim of the present document was to perform a rapid review of the evidence for the role of CPs in VRA, using previously validated methods. There was a lack of high quality (Level 1 and Level 2) evidence from the UK on the effectiveness or cost effectiveness of the involvement of CPs in VRA programmes. There was Level 1 and 2 evidence with methodological problems from the United States, Canada and Australia on risk assessment in patients with heart disease which indicated a role for CPs. Evidence for diabetes risk assessment was stronger. Observational evidence (Level 3) from UK case studies revealed that there were a number of initiatives that involved CPs. Evaluations of the programmes were scarce, but where performed showed a positive effect for the outcomes measured. Alternatives to CP provision of VRA included GP practices, dental practices and workplace initiatives. There was good evidence that GPs are well placed to perform VRAs, but often time constraints limit their ability to perform the assessment effectively. There was some evidence from a systematic review for the role of dentists, but no evidence for workplace initiatives, although two work-based schemes have commenced in Wales. Definitive evidence was lacking for the most appropriate method and risk score/tool to use was lacking. GP practice records, patient medication records in pharmacies, mail shots and telephone contact have all been investigated. Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 3 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists A survey of pharmacy customers showed good acceptability of VRAs performed by CPs, but concerns were expressed about the lack of privacy in some chemist premises, confidentiality and expertise. There was some evidence to indicate that CPs are effective in targeting people from groups that are at increased risk of vascular disease, who often do not access appropriate healthcare. Robust cost effectiveness data from the UK specific to CPs performing VRAs was lacking 1. Introduction Vascular disease (coronary heart disease, diabetes, stroke and renal disease) affects a large number of the population of the UK and in 2006 deaths from the disease in Wales were 11, 300.1 People from deprived communities and ethnic minorities are selectively affected and vascular disease accounts for a large part of population health inequalities. Various initiatives such as the national service frameworks and clinical guidelines have led to some improvement in the treatment of vascular disease. There is however, increasing emphasis on prevention and the clinical case for vascular risk assessments (VRAs) is described in international and UK guidelines. 2 3 45 The UK National Screening Committee (NSC) has published 6 guidance for VRA in March 2008 to inform and support a more structured approach for screening for vascular disease. In April 2009 the NHS Health Check Service, a VRA programme formerly known as the vascular check programme, commenced in England and all men and women between the ages of 40 to 74 years will be offered screening. 7 The VRA programme is a de facto screening programme, the details of which are shown in Appendix 1. Unlike other national screening programmes the design and implementation of the programme is not completely pre-determined and this allows local health boards/primary care trusts (LHBs/PCTs) to explore how this programme may best be delivered for the community. 8 Identifying individuals who are eligible for a health check is the first stage of the programme and initially general practice (GP) records will be used as the basis of a local call and recall system.9 It is crucial however, that VRAs are available in a variety of settings so that the programme reaches the widest range of people and includes subjects known to be difficult to include in health service provision. The pharmacy White Paper 10 highlighted the role of CP in the provision of VRA and as the VRA programme develops, the Government will discuss with stakeholders, including pharmacies, what delivery arrangements best support implementation in order to ensure wide availability of this service as soon as possible. Pharmacy-based approaches for VRA have many advantages, such as high street locations, commercial marketing experience, and long opening hours. The Government is already working with the Pharmaceutical Services Negotiating Committee (PSNC) and NHS Employers to develop a national template for a service Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 4 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists specification for VRA and management, as a locally commissioned enhanced service and the PSNC has information for local pharmaceutical committees on its website11 The NSC’s handbook 6 explains where pharmacy-based screening can fit into overall VRA and management, sets out the role of pharmacists and gives practical advice on how pharmacy can support an individual’s self-assessment of risk. The NSC also emphasises that it is important that pharmacy’s work is placed in the context of a risk assessment and management programme and that pharmacies have clear guidelines about how to move individuals onto whatever stage of support or treatment is indicated for that individual. In Wales the Minister for Health and Social Services announced in December 2008 1 that a group of clinicians will review current provision of vascular risk management and assessment in Wales and recommend a future model to reduce the number of people developing the disease. As part of the Welsh Assembly Government project looking at vascular risk management, the NPHS were asked to review the evidence for the role of CPs in VRA. 2. Aims The aim of the present document is to report the results of a rapid review of the evidence on the effectiveness of CPs performing VRAs. Information was specifically sought on: 3. Assessment – location and methods Outcomes Population reached/targeted Value for money Public acceptability Subsequent referral/treatment of subjects identified as high risk Safety/clinical governance e.g. equipment calibration and test quality assurance Research question With special reference to CPs what are the most effective and cost-effective methods of identifying people aged 16 years and over at increased risk of developing vascular disease, or who already have vascular disease? 4. Methods The research question in section 3 was converted to structured questions for searching using the Population, Intervention, Comparison and Outcome (PICO)12 format. 4.1 Identifying existing and ongoing research Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 5 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 4.1i Vascular risk assessment by community pharmacists Literature searching Systematic searching: As per the protocol contained in The Evidence Checklist 13 a scoping search was initially performed to identify major papers on published evidence and refine the final search strategy. For the present overview, search terms contained in the search strategies were used from published reviews and they were kept broad to maximise retrieval of references. The basic search strategy is shown in Appendix 2. The type of literature on vascular risk screening in CPs necessitated the use of a pragmatic approach to searching for evidence in order to achieve production of the review, within the short timescales for delivery. It is clear that there had to be a balance between timeliness and rigour and high quality evidence and systematic reviews, meta-analyses, randomised controlled trials (RCTs), health technology assessments and clinical guidelines were identified first. It should be emphasised that the review is not a systematic review of primary studies. High level searching: It is well known that the classical databases for medical literature, such as Medline, do not adequately index all relevant literature. The reviewer used previously described validated methods that involved the use of metasearch engines and other databases for ‘high level’ searching to quickly identify relevant evidence. For critical appraisal, the tables recommended for use in the National Institute for Health and Clinical Excellence Guideline Development Methods 1 manual were modified to accept the type of studies identified for community pharmacy/ies/ists and vascular risk screening interventions. The quality of the evidence was graded using the NICE hierarchy of evidence and the quality checklists. Evidence was rejected if graded as poor quality, apart from where it was of Level 1 type (see Appendix 3 for explanation of evidence grading system) and was highly relevant to the question. The data relevant to the research question was entered into an evidence table. (Appendix 4) Due to practical limitations a single reviewer performed the final selection, critical appraisal and data extraction. Inclusion Criteria Search period January 1996 - April 2009 Papers in English, German, French or Spanish Papers relating to the effectiveness of interventions for VRA performed in community pharmacies/by community pharmacists. Randomised controlled trials Systematic reviews Meta-analyses 1 Available at http://www.nice.org.uk Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 6 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists Guidelines Observational studies (where higher quality evidence was not available) Throughout the document the term vascular risk (VR) is used to include CHD, stroke, transient ischaemic attack, type 2 diabetes mellitus peripheral arterial disease and chronic kidney disease. 5. Results Overall there was little high level (Level 1 and Level 2) research identified that investigated the effectiveness and cost effectiveness of VRA by CPs. The scoping search revealed several up to date comprehensive reviews that provided evidence for the role of CPs in improving public health that included VRA and national guidelines on prevention of vascular disease. These secondary sources were used extensively to inform this review. The results of the systematic search are shown in Appendix 2, the large number of results necessitated application of date and article type filters. High level searching indicated several relevant documents that were not indexed in the classical databases such as Medline and Embase and illustrate the problems with retrieval of evidence. 5.1 Assessment The NICE public health guidance on identifying people at risk to die prematurely contains useful information of relevance to VRA. 5 Although the VRA is being implemented in the UK and hence in a population with very high levels of registration with GP practices, recall through practices is not necessarily the only screening strategy worth considering. The Department of Health (DH) document Vascular Checks – Next Steps for PCTs 9 emphasised that consideration should be given to different approaches targeting different groups, for example black and minority ethnic groups, men and women, people with disabilities (physical and mental) and people of different ages. Several of the current pilots of the VRA are using other methods e.g. outreach approaches in an attempt to target difficult to reach groups. A systematic review, commissioned by the North East London Cardiac and Stroke Network 14 to assist in the implementation of the Health Check programme examined the evidence for the effectiveness of different strategies or interventions to recruit or enrol community dwelling adults into any screening programme. The main outcome measure was uptake. There were 27 reports of cardiovascular disease (CVD) risk factor screening programmes or pilots, of which 5 were RCTs, 2 non- randomised trials, 3 cohort studies, 13 cross sectional studies, 3 qualitative and 1 questionnaire study. Only one of the included studies concerned a pharmacy intervention, the Birmingham Life Expectancy programme, described in UK initiatives section. The authors of the report suggested that the main options for local organisation of the VRA programme appear to be:I. opportunistic screening of unscheduled and scheduled attenders at GP practices II. letter-based recall by GP practices III. telephone-based recall by GP practices IV. a combination of II and III Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 7 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists V. opportunistic screening by pharmacists VI. initial “walk-in” outreach by nurses or healthcare assistants in community based settings e.g. mobile clinics, halls, workplaces, churches, mosques, temples and shopping centres. VII. combination of I, V and/or VI coupled social marketing approaches e.g. targeting areas with a high expected prevalence of vascular risk with leaflets or announcements. A mapping study 15 was performed for the production of the NICE guidance 5 on interventions that reduce the rates of premature death in disadvantaged areas through proactive case finding, retention and improvement of access to services. The review provided examples of the different approaches that are currently being used to identify target populations. Several different approaches to identifying those at risk from CVD were identified ranging, from city-wide proactive case finding across practice populations, to interventions targeted at practices in disadvantaged areas, or combinations of practice and community-based proactive approaches targeted at specific groups. Pharmacies are among the options for community-based proactive case finding. Practice-based approaches to identifying target populations are those related to better performance against the Quality and Outcomes Framework (QOF) and NSF standards and those which build on practice registers to develop proactive approaches to case finding. 5.1.1 Community pharmacy-based interventions The new contract for community pharmacy (nPhS) implemented in 2005, provides greater flexibility for commissioning services from pharmacies. There are two tiers of services commissioned nationally: essential services provided by all pharmacies; and advanced services which require the pharmacist to be accredited and the pharmacy to have a private consultation area. A third tier of services, enhanced services, are commissioned locally by LHBs/PCTs. It has been stated pharmacists are probably the biggest untapped resource for health improvement. 16 The nPhS contract reflects the potential contribution of CPs to public health, for example through the provision of opportunistic health promotion advice to patients presenting prescriptions, and for self care. In the present review evidence was found indicating the increasing recognition of the role of CPs in improving public health, including smoking cessation, weight management, VRA and managing long term conditions.17 It is accepted that whilst screening for vascular disease by GPs/primary care is an effective method that with their time constraints it is not possible to screen all patients with a potential risk for vascular disease. 18 Initiatives by CPs were started over 25 years ago but progress has been slow, however as mentioned previously the new pharmacy contract has facilitated the development of new initiatives for case finding by pharmacists. Furthermore research in UK practice has shown a lack of professional action in the presence of e.g. high BP readings. 19 The NICE guidance 5 suggested that routine screening of those who are frequent clinic attenders is not as valuable as targeting those who are rarely seen 20 21 and it is this sort of subject for whom a VRA programme performed at a CP could therefore be effective. Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 8 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists International evidence Expanding the roles of CPs was the subject of a Cochrane review published in 2000. The authors concluded that there was some evidence to support the role of CPs in health management and counselling, but that this evidence was of poor quality and limited generalisability. 22 In the present review problems were encountered finding studies where the primary aim and outcome of the intervention was case finding or risk assessment. A review of the literature from 1990-2007 23 on the contribution of CPs to improving the public’s health indicated that there was Level 1 evidence from single RCTs to demonstrate that using pharmacy medication records to identify clients at ‘high risk’ of coronary heart disease (CHD) is effective and can be used for instigating health promotion measures. These trials, mostly from Canada, were however small and have a risk of confounding and bias. 24 25 The RCT Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP) was performed at 54 CPs to assess the effectiveness of a CP led intervention for cholesterol management in patients who were at high risk for CHD. Pharmacists classified potential study participants as high-risk for CHD if they had atherosclerosis related vascular disease, including myocardial infarction, stable or unstable angina, bypass surgery for coronary revascularization, cerebral or peripheral vascular disease or diabetes with one CHD risk factor. A total of 675 individuals were recruited and randomised to the intervention (n = 344) or usual care control (n = 331) groups. The pharmacists evaluated patient CHD risk via interview and measurement of total cholesterol and provided patient education. The study was terminated early because preliminary data analyses from the first 400 patients found strong evidence of an improvement in the intervention group when compared with the control group. Yamada et al. 26 evaluated the effectiveness of a pharmacist intervention on lipid control among individuals identified as being at very high risk of cardiovascular events one year after the end of the intervention. This study, the second Study of Cardiovascular Risk Intervention by Pharmacists (SCRIP-plus), randomised 419 patients into intervention and control groups. The intervention group participated in face-to-face visits with a pharmacist at baseline, and three- and six-month follow-ups. Pharmacists assessed lipid levels, provided patient education and provided physicians with recommendations regarding medication management. Pharmacists also contacted patients by telephone two and four weeks after the initial visit to monitor progress. The control group received usual care. At six-month follow-up, the intervention group had a significant reduction in average LDL-C level from 135.2 mg/dl to 116.0 mg/dl (p < 0.0001). A total of 162/359 patients who completed the final six-month follow-up in SCRIP-plus visited their CP and had their fasting LDL-C levels measured at one-year follow-up. The results indicated that 38 per cent of the patients were at the target LDL-C level of less than 96.7 mg/dl. A systematic review included 13 trials and found evidence of effectiveness of pharmacist input in significantly reducing systolic blood pressure.27 A RCT controlled trial in one CP tested an intervention comprising an individualised plan for action in relation to diet, physical activity, obesity and alcohol intake. 28 Blood pressure control improved significantly in the intervention group. A controlled study showed that blood pressure control improved in the intervention arm of a CP-based health promotion programme.29 Computer software was used to flag study patients and prompt Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 9 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists pharmacists to intervene. So few interventions were recorded by the pharmacists that the researchers hypothesised that simply measuring blood pressure in the pharmacy may have an effect on control. The identified evidence for diabetes was stronger and a systematic review 30 with meta-analysis of data from 2247 patients in 16 studies found a significant reduction in HbA1c levels in the pharmacists’ intervention group (1.00 ± 0.28%; P < 0.001) but not in controls (0.28 ± 0.29%; P = 0.335). Pharmacy-based screening for undiagnosed diabetes was the subject of three studies (Australia, the US and Switzerland). The Australian and US studies used simple risk factor assessment as a filter prior to diabetes screening and involved testing of 1286 and 888 people respectively. 31 32 The Swiss paper reported findings from a national screening campaign in which 93,258 people were tested. 33 Follow up to identify subsequent diagnoses was conducted only in the Australian study, where 1.7% of those tested were diagnosed as having diabetes. In the US study 81% of those screened were referred, 15% of whom had blood glucose measurements outside the defined range. In the Swiss campaign 6.9% of those tested were classed as possible diabetes. UK initiatives The mapping exercise for England 15 revealed that a number of PCTs have initiatives in place (or planned) to involve pharmacies. In North Tyneside, for example, men over 50 can access a service provided by local pharmacists in disadvantaged areas of North Tyneside. Patients with a CVD risk of over 20% are referred to the GP for further management. In Knowsley PCT, in 2006, following collaboration with the local pharmaceutical committee, eight pharmacies took part in a pilot of free health checks in men aged 50-65 years who had not had any health check via their GP or practice nurse in the last 12 months. The pharmacy health check involved a 25-30 minute assessment, including cholesterol measurement and smoking status. Lifestyle advice (verbal and written) was provided. It was operated with a combination of pre-booked appointments and drop-ins. The PCT provided equipment as well as a software programme to record details. Pharmacy contractors received £25.00 for each health check carried out to the standard specified in the service level agreement. The total expenditure (including equipment, software and training) was £30,000 and 159 health checks were carried out. An evaluation showed that this service was popular with clients as it was convenient and local. Pharmacists were successful in identifying undiagnosed conditions and signposting other services. The service was mainstreamed and approximately half the CPs in Knowsley now offer free health checks. It has now been extended to women and the age range broadened from 4075. By the end of February 2007, 440 health checks had been carried out. The PCT has now made a commitment to continue funding the health checks as part of an enhanced CP service. A further initiative has been developed in Birmingham with Lloyds Pharmacy, which is piloting an opportunistic screening service (Heart MOT) for men aged over 40 at risk of heart disease in the most deprived areas and in areas of highest CVD mortality. The new Heart MOT measures cholesterol, blood pressure, blood glucose and BMI, Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 10 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists as well as providing a full lifestyle assessment. The customer receives a percentage score of developing heart disease, with a personal action plan and summary of the test results. For high-risk customers a support pack will be supplied. This service integrates the services of fitness staff, healthcare professionals, pharmacists and technicians to provide advice and support. A range of methods have been used to reach the target populations in the city, including door to door leaflets delivered across key areas of Birmingham according to health need, and local advertising directly from pharmacies and practices. The service is delivered by trained health care assistants and pharmacists. The Heart MOT measures and communicates the risk of developing CVD over the next 10 years and takes into consideration multiple risk factors including age, gender, ethnicity, total and HDL cholesterol, blood pressure, blood glucose, Body Mass Index (BMI) and waist circumference. Information on family history of CVD, medical history and lifestyle history including smoking status is also obtained. All results are recorded on a secure IT programme. The pharmacist discusses the results with the customer and prints two copies; one for the customer to keep and a second copy for the customer to give to the GP. From April 2007 to June 2008, Lloyds Pharmacy tested 868 people in 14 pharmacies across the city. Overall, there was a high level of uptake in deprived areas. Results of the evaluation in 2008 showed that of those who attended the service: 57% were male; 49% were referred to their GP practice due to a variety of factors, including elevated blood pressure and elevated TC:HDL ratio; 27% were found to be at high CVD risk (> 20%) and referred to their GP. The initial results confirmed the need and value of the service and the role CP can play in helping to reduce health inequalities. The Pembrokeshire Coronary Heart Health Project 34 is a community heart health project based around GP practices and pharmacists in Pembroke, Pembroke Dock and the rural north of the county, the aim of which is to provide primary prevention initiatives to reduce the risk of developing coronary heart disease. The project targeted deprived communities and supported established community groups by providing training, resources and expertise. During 2002 – 2008 the results of the evaluation were: the project successfully delivered screening clinics through 8 GP Practices and 4 pharmacies. These screening clinics have delivered 11,859 sessions to 5,652 individuals, 32% of which reduced their overall CHD risk. All individuals have received a screening for coronary heart disease risk, been given appropriate lifestyle advice and have been sign posted to local support systems to enable them to make changes to improve their health. individual risk factors were also reduced in that 43% of those identified as having high blood pressure at their first visit had reduced it to below acceptable levels by their last visit. 72% (1,043) were identified as being at risk through having raised cholesterol levels. CHD registers and screening clinics established at eight GP Practices, increased provision of outreach screening requested by communities. Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 11 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists introduction of ‘out of hours’ clinics improved access to some groups of the population. .CPs involved in the Healthy North Ayrshire project performed 1513 health checks in 19 pharmacies between April 2006 and March 2008. In total 19% of men and 6% of women were found to have a 10 year CV risk of >20%. Small numbers of participants were referred to their GPs. CPs were positive about the project but the evaluation report highlighted some challenges including limited engagement by larger multiple pharmacies, a lack of feedback from GPs on referrals and problems with communicating sensitive health matters. 35 In two small UK studies, a single community pharmacy worked in collaboration with local GPs. In one study, GP records were used to identify people who were likely to be ‘at risk’ and were invited to have an assessment in the pharmacy. 36 This appears to be the first programme to have targeted people in collaboration with the support of local doctors. Approximately 50% of the people assessed were found to need referral back to the GP and the remainder received lifestyle advice. In around half of those assessed, changes in medication were recommended and implemented or initiation of new treatment was recommended and started. No data were reported on outcomes of the lifestyle advice provided. Another study in a single community pharmacy used risk assessment software with referral to the GP where needed. 37 For those clients advised by the pharmacist, there was a significant improvement in risk score at three months, but this was not sustained at six months. Many pharmacies already carry out diabetes testing and the Vascular Risk Assessment handbook 6 describes the FINDRISC diabetes risk tool that people can complete with the support of their pharmacist. There were reports of the involvement of CPs in screening for renal disease. 38 5.1.2 Alternatives to CP provision of VRA Primary care/GP practices The most recent guidance on VRA 8 states that in the absence of national guidelines the question of who performs the check and provides lifestyle management advice is one for local commissioners. The JBS guidelines 3 suggest that the preferred site for screening is in general practice as it identifies high risk patients and provides the behavioural and educational services that can mitigate risk. One review of the literature concluded that there is good evidence (Level 1 and 2) that GP practice is an excellent place for screening and risk assessment. 21 Reports on the uptake of risk screening projects for CVD in primary care using postal invitations generally reported a poor result of between 29% and 47%. 14 39 It is very likely that as in cancer screening there will be socioeconomic and ethnic gradients in uptake for VRA in deprived areas and it is recommended that whilst other providers such as pharmacies should be commissioned to further increase uptake the services should be mainstreamed as soon as possible and all data incorporated into GP computer systems to identify non attenders. Although the check itself is not covered in the QOF, there are a number of entries that do relate to work performed during the Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 12 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists NHS Health Check. Policy from the DH suggests that GPs and primary care teams should develop a register of CVD patients through which they can review medication, offer advice on diet and lifestyle and maintain the necessary contact with patients most at risk of developing repeat cardiac problems. 7 8 9 21 One systematic review 40 included 1 RCT and 3 observational studies of practice based initiatives, only 1 of which was from the UK. The moderate quality RCT 41 found postal prompts to patients following an acute coronary event and to their GPs, improved monitoring of patients’ risk. The 3 case studies 42 43 44 investigated the effectiveness of inviting specific population groups for screening: Of the 159 patients participating in the screening, 52(32%) were identified as having undiagnosed hypertension and 42 (26%) patients were identified as having a risk factor of over 30% over the next 10 years. A further 101 (63%) had a risk factor of <15% and a follow-up appointment was made for 1 year. The actual participation rate with the screening was unclear. Dental practices A review of information regarding the prevention, diagnosis, or treatment of CVD revealed that dental care providers can have an important role in screening healthy patients for CVD risk factors, monitoring conditions that could lead to the development of CVD or deterioration of existing CVD and providing education to patients regarding CVD. 45 Most individuals visit their doctors only when they are sick but visit the dentist when they are healthy, thereby providing oral healthcare providers an opportunity to target primary prevention of CVD in relatively healthy patients. According to the author, a complete medical history that includes age, smoking habits, family history of CVD and diabetes, presence of hypertension, serum glucose levels and presence of diabetes, serum cholesterol levels, weight, height and physical activity should be obtained from all patients visiting the dentist to enable the detection of risk factors for CVD. Oral healthcare professionals should not diagnose CVD in their patients; their important role is to screen for risk factors, determine the presence or risk of disease and provide a referral to an appropriately qualified medical professional. Workplace One systematic review found no data on workplace interventions for VRA.21 One small study of 265 subjects reported a pharmacist managed health screening programme. Two local unions of plumbers and electricians contracted with a CP to provide health screening services for union workers and their dependents. Using the Framingham score pharmacists provided intermediate and high risk participants with guideline based recommendations. 46 In Wales a major screening programme aimed at reducing morbidity and mortality in Carmarthenshire was launched in April 2009. Prosiect Sir Gar will see workers over the age of 40 in the county’s three biggest employers screened for CVD and type 2 diabetes. The programme is the first of its kind in Wales and will run over 10 years, targeting those most at risk to reduce the impact on individual health and NHS resources. It is a partnership between the Carmarthenshire Local Public Health Team of the NPHS, Carmarthenshire LHB, Carmarthenshire County Council, Hywel Dda Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 13 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists NHS Trust, Corus, Swansea University School of Medicine and local voluntary organisations. 47 The Heart Smart 48 project was established to raise awareness of CHD in workplace settings as a joint venture between Bridgend LHB, Bro Morgannwg NHS Trust and businesses and organisations throughout the Bridgend area. The Heart Smart project ran from 2003 to 2008 and provided a confidential work place screening programme for coronary heart disease. The project was particularly aimed at individuals who did not regularly visit their GP/Primary Health Care Team and adopted a coaching style approach to help its clients question and modify their risk factors, empowering them to make healthy lifestyle choices. Businesses were offered the opportunity to allow their employees to attend a visiting mobile clinic for a free assessment. Attendees who were over 35 years and had 3 or more risk factors were offered a full CHD assessment including point of care blood tests. 5.2 Methods of VRA 5.2.1 Community pharmacy patient medication records Vascular checks in CPs will usually be based on straightforward questions (age, gender, smoking, family history, medicines), measurements (height, weight, blood pressure) and a routine blood test for lipids and other factors when indicated. Then, depending on the results, a range of options would be deployed. These would range from offering general lifestyle advice for those assessed as being at low risk, through specific programmes such as weight management and stopping smoking for those at higher risk, to advise to consult a GP without delay for those at the highest levels of risk. In a systematic review of CP methods for risk screening, the authors distinguished between the terms ‘screening’ and ‘case finding’ in a pharmacy setting. 49 The terms used are based on the definitions adopted by the UK National Screening Committee. 50 Screening = a health service in which members of a defined population, who do not necessarily perceive they are at risk of a disease or its complications, are asked a question or offered a test, to identify those individuals who are more likely to be helped than harmed by further tests or treatment. Case-finding = actively trying to diagnose probands for cascade screening (systematic identification and testing of members in a proband’s family). Some of the published papers included in the review used the term ‘screening’ to describe the disease detection services that are, or might be, provided from CPs. In practice however, most CP based services are in fact case finding, where targeted groups identified from an analysis of patient medication records are invited to attend for testing. The results of the review indicated that there was limited published evidence (1 US RCT and 1 observational study) on pharmacy-based case finding in heart disease prevention, but the available evidence did demonstrate that pharmacy medication records are a valuable tool. Further reviews confirmed that CPs can use patient medication records to identify clients at high risk of CHD, by for example, searching for a range of drugs that would Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 14 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists indicate heart disease. Studies in the US 51 Canada,52 and Australia 53 indicated that the use of such data to target patients with risk factors for CHD appears to be effective in identifying those at risk. Importantly the authors of one report concluded that it was unclear whether or not pharmacists can play an effective part in screening activities, such as blood pressure measurement, without further research and training and that currently available evidence suggested that CP based screening services are unlikely to be successful unless they are part of a co-ordinated, funded activity. 54 One small RCT 55 assessed mail and telephone methods for inviting patients to attend cardiovascular health awareness sessions. A group of 235 community-based patients aged 65 years and older were recruited from one family physician practice in Canada and randomised to the mail invitation group (n = 119) or the telephone invitation group (n = 116). All participants were invited to attend one of five blood pressure monitoring sessions held at five pharmacies in the same area during a 10day period. Overall attendance at the cardiovascular health awareness sessions was 58 per cent. . Of these, 44 per cent of patients invited by mail and 72 per cent of those invited by telephone attended (OR = 3.3; 95 per cent CI 1.9–5.7; p < 0.001). The difference in the cost per person between the mail and telephone invitation groups was small (US$2.18 by mail versus US$2.02 by telephone). Some pharmacies provide blood pressure testing, cholesterol testing or computerised ‘lifestyle assessments’. They may promote these through a range of mechanisms, including window displays, leaflets and the national or local media. While such services can help identify unrecognised illness, it is important to appreciate that oneoff measurements, for example of blood pressure or cholesterol, can sometimes be misleading. People may worry, and visit their GP unnecessarily. Such testing should, therefore, be in accordance with relevant national screening guidelines, where they exist, and in line with local LHB/PCT programmes for prevention and management of risk factors and with robust quality assurance processes. 5.2.2 GP practice based methods Practice-based approaches to identifying target populations fall into two main areas, those related to better performance against the QOF and NSF standards; and those which build on practice registers to develop proactive approaches to case finding. A systematic, population-based approach for identifying those at risk of CVD, through GP at-risk registers, is a preferred option. Software development is key to identifying practice populations at risk, given current difficulties. The mapping review 15 found that the effectiveness of this approach depends partly on the progress being made by GP practices in this area, which appeared patchy and hampered by software problems and partly on an assessment of the extent to which those most at risk are likely to access GPs. There are many examples of practices achieving high QOF points in areas where non-elective admissions and CHD mortality remain high, leading to the development of additional targeted and proactive approaches. The mapping review and the PHAST study 14 identified many current initiatives to develop proactive case finding through GP population registers and a number are described below:Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 15 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists In Sandwell, CVD risk factor data are extracted from some GP electronic records on all patients in the relevant age groups (35 -74 years) and excluding those patients already on existing registers. Calculation of a ten-year CVD risk is based on age, gender, smoking status, blood pressure, cholesterol levels and diabetes data. Default values (from the Health Survey for England, based on national averages) were used where data were missing. This assigned a probable CVD risk to all patients. The patients with the highest risk were then invited for an assessment in descending order. Eligible patients were offered appropriate treatment, pharmacological and/or referral to a number of local lifestyle services, for example, stop smoking services, dietician or exercise referral programmes. The Salford Heart Strategy aims to encourage GPs to record BMI, blood pressure, lipids, glucose and abdominal circumference in all those over 45 (and also carry out an equity audit). It also advocates screening of those with risk factors to calculate their ten year CHD risk. Salford PCT will support preventive prescription of statins to those vulnerable to CVD, as well as registers to identify people at high risk of CVD. The strategy aimed for GP practices to achieve 80 per cent of CHD QOF points by March 2006 (and 90 per cent of QOF points by March 2007); it also plans structured case finding of those most at risk of CVD, which includes ranking patients aged between 35 and 74 years who are not currently on disease registers and then inviting then for a review. In Sedgefield, the model proposed is an incentive-based scheme to select patients at risk from all those over 40 who do not currently have heart disease (criteria based on the Framingham Tables, but ensuring the nGMS at-risk group, depending on BMI, smoking status and hypertension, were also identified). The at-risk group were invited to attend for a health check once every three years, and added to the risk register. In the process of identifying the population with a 15% risk of CHD over 10 years for this one-off personal health advice, the more serious group at 30% risk would also be identified and referred into treatment programmes. South Birmingham has developed an identification and screening programme for patients with a greater than 20 per cent risk of developing CVD within ten years. Practices will use the Framingham risk assessment tool (with the risk score uplifted by 1.5 for people of South Asian/Indian sub continent origin. In Croydon, pharmacy advisors advise the PCT IT team on the extraction of data from GP systems, for example, the analysis of MIQUEST data and the development of appropriate MIQUEST queries. They advise on the appropriate coding of patients which allows the practice to identify at risk patients. This strategy initially targeted patients with diabetes and hypertension, followed by those who smoke or are overweight. The authors of a report of a survey of 272 CPs, carried out between 2004 and 2005 17 commented that whilst most of those involved in the evaluation study thought the new pharmacy contract has the potential to increase integration of CP into primary care, in practice it has had very little effect on inter-professional working. More than 80% of CPs indicated that there had been no change in their contact with GPs since implementation of the new contract. Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 16 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 5.3 Vascular risk assessment by community pharmacists Choice of VRA tool/score There is much debate about the best risk assessment tool/score to use for VRA. The assessment of evidence for the effectiveness of the different risk assessment tools or scores is not however, within the remit of the present literature review. The types of tool were comprehensively reviewed for the NICE guidance 5 and In the NSC handbook.6 The latest JBS guidance and the NICE guidance use a modified Framingham method, but SIGN advocate using the ASSIGN Tool. There are a number of other risk assessment methods available and these include the New Zealand risk calculator, the Heart Score, the Sheffield Risk Table, the ETHRISK and others. The Heart Score is based on the SCORE project and has been adopted by the Joint European Society guidelines. It has the advantage of being based on European epidemiological studies, and also predicts CVD risk and not CHD risk alone. However, it can only predict fatal CVD and therefore underestimates the true burden of total CVD risk. A systematic review of published literature by Brindle et al. 56 found evidence that the accuracy of cardiovascular risk assessment using Framingham risk scores is highly variable and also found that there is little evidence that CVD risk assessment performed by a clinician improves health outcomes. Specifically, CVD risk was overestimated in people with low risk, leading to unnecessary treatment; moreover, CVD risk was underestimated in people with high risk, leading to inadequate treatment. The use of FINDRISC is being considered in Wales. This tool was designed to predict future diabetes mellitus (DM) risk and has proved to be a reasonably reliable method in identifying previously unrecognised DM. Using the risk cut-off of 11 (for the original version) it has a sensitivity of 66% in men and 70% in women. Furthermore it has also been shown to be strongly associated with the presence of CVD risk factors, the metabolic syndrome, and also as a future predictor of CHD, stroke and total mortality. 57 The FINDRISC has been tested in other populations. In a German study which compared the Dutch, Cambridge and American risk scores compared with the FINDRISC, the FINDRISC had the highest sensitivity (88%). 58 5.4 Outcomes Little evidence was found supporting or refuting the assumption that CVD assessment by clinicians improves health outcomes. The interventions showed no improvement in predicted absolute risk or in declared primary outcomes. 4 One way of establishing whether VRA projects are working well is to track changes in premature mortality rates, although in the shorter term these are more likely to reflect the quality of secondary prevention and equitable access to investigation and treatment services. Other interventions may simply be evaluated in terms of monitoring the numbers accessing particular service developments, such as Heart MOTs or other outreach services. There appeared to be very little published evidence evaluating the outcomes of pharmacy based interventions for VRA. The lack of research on outcomes of community-based approaches to risk factors for CVD has been highlighted elsewhere. The comment is often made that practitioners have little time to write up or evaluate interventions, although there are many good practice networks which Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 17 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists share local information about effective interventions. The lack of evaluation is also partly because much of the relevant activity is considered part of mainstream service provision, rather than a separate initiative, and is therefore less likely to have been written up as a case study. Monitoring the implementation of a local enhanced service (LES) will allow uptake of an intervention by CPs to be evaluated and the effectiveness of different kinds of contract to be compared. It is important to consider that In relation to the prevention of CVD, opportunistic approaches, which are practice-based or which mainly attract those least in need of them, may lead to health inequalities being exacerbated. 5.5 Regulation/clinical governance Pharmacies are already performing screening for diabetes and the RPSGB has issued guidance for diabetes screening 59 and for a range of diagnostic testing and screening services. 60 The importance of quality assurance and regulation of initiatives under the heading of sporadic and opportunistic risk assessment activities such as those taking place in e.g. pharmacy and supermarket chains has been emphasised in the strategic document from the DH and NSC. The requirements for clinical governance are well documented in guidance from the RPSGB and all documents are available from their website. 61 In April 2009 the DH published best practice guidance for VRA, although the document does not specifically mention CPs.8 It is also essential that the standard operating procedure for referral, diagnosis, risk management and intervention are clearly defined and followed and the PSNC are in the process of developing these. 62 5.6 Public acceptability The issue of whether services should be open access and available on a walk-in basis to all, often argued to be the strength of CP setting versus a more targeted approach, remains unresolved. A survey conducted by the Patients Association 63 found that almost half of the respondents said they would be very happy to use a pharmacy for initial screening or diagnostics, while 25% said they would prefer the GP and 19% a nurse. The figures relating to regular monitoring tests showed slightly higher acceptance of pharmacy provision with 55% happy to use a pharmacy, 19% preferring the GP and 21% a nurse. Almost 60% agreed that pharmacists should be allowed and should receive resources to provide a much broader range of community healthcare advice and services, indicating broad support for a wider public health role for CP, with a quarter disagreeing. The concerns of the respondents were about privacy and confidentiality with only one in three agreeing that their local pharmacist always paid attention to these aspects. Respondents also expressed concern about whether the amount of space in their local pharmacy was sufficient to allow privacy. Patients were willing to seek a wider range of services, such as screening, from pharmacies but with the proviso that such services should be integrated with GP services. The authors also concluded that patients’ concerns about confidentiality, privacy and expertise may be discouraging fuller use of pharmacy services. Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 18 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 5.7 Vascular risk assessment by community pharmacists Target population There are different methods being developed for identifying and reaching target groups and areas. Financial incentives are being exploited in imaginative ways supported by the changes in the contracts for CPs and general medical services. A review performed for NICE 40 sought to find the evidence for what interventions PCTs could introduce to identify and reach people at increased risk of developing or with established CVD. For many of the papers (particularly for multiple-intervention studies) the primary purpose was not to examine the effectiveness of interventions to improve the identification of patients at cardiovascular risk. Whilst several interventions included patient referral for those at risk, studies did not always report the numbers referred or the referral outcomes. The few studies that attempted to measure referral outcomes were unsuccessful in the following up of all patients. A systematic review published in 2009 suggested that it is highly likely that, as in cancer screening, whilst large numbers of high risk individuals will be identified in deprived areas, there will be socioeconomic and ethnic gradients in uptake for the VRA as well. Planning for the VRA programme should address these issues from the outset. 14 5.8 Economic aspects For the Putting Prevention First programme the nationally predicted cost per basic VRA completed is £23.70 inclusive of laboratory tests. Additional costs of further investigations are nationally modelled at £9.80 per vascular assessment. These costs do not include lifestyle or medical interventions and delivery costs will need to be calculated for each locality. 64 Economic modelling by NICE 65also gives detailed costs for the use of a systematic strategy for primary prevention to identify people aged 40–74 who are likely to be at high risk of CVD. The authors concluded that the estimated additional costs of £13.4 million for systematic CVD risk assessments for adults at high risk of CVD. Because of the known predilection for vascular disease in socially deprived and minority communities considerable work has been performed on interventions for disadvantaged groups. 66 The latter report suggested that a disadvantaged group will have two cost components: a “treatment” cost, which will include standard costs of allowing the public access to the treatment, and an additional “finding” cost for ensuring similar access levels among the disadvantaged group in question, where “finding” includes the additional costs of maintaining contact and compliance. While the LES element of pharmacy and GP contracts can provide a vehicle for PCTs to target disadvantaged groups, more research on differential uptake is needed. There are also concerns that GP registers may under-record prevalence. The outcomes for cost effectiveness ideally are therefore:I. cost of treatment per QALY II. cost of finding per QALY III. total cost per QALY Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 19 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists For the general population, item II is defined as zero and thus for this population, items I and III are the same. For disadvantaged populations, it is assumed that item I has the same cost as for the general population and that there is an additional cost for item II. This assumption may not always hold, sometimes because disadvantaged groups have a greater extent of co-morbidities and sometimes (e.g. for smoking cessation) there are social reasons for the relative lack of success of an intervention among many disadvantaged groups. It is however, difficult to model a different treatment cost per QALY in the face of poor and sometimes contradictory evidence. Economic modelling 4 5 in an English primary care population showed that the most efficient strategy for identifying people at high risk of developing CVD is one which initially prioritises individuals based upon a prior estimate of their CVD risk using data already held in general practitioners’ electronic medical records compared to using age or random assessment. The cost-effectiveness results showed that using prior CVD information is the most cost-effective method of identifying those at risk of developing heart disease. Economic modelling performed by the DH indicates that vascular checks are likely to be cost effective and result in significant health improvements. The predicted cost per Quality Adjusted Life Year (QALY) is approximately £3000. The results of the initial modelling show that a national vascular check programme will per annum: prevent 9500 heart attacks and strokes save 2000 lives prevent 4000 people from developing diabetes provide earlier diagnosis of 25,000 cases of diabetes or kidney disease. There was a lack of cost effectiveness data directly relevant to the CP set up in the UK. A cost-effectiveness analysis was performed for 99 patients who had received the pharmacy-based diabetes service in the earlier of the two Australian trials. 67 Pharmacists were paid $40 (Australian dollars, approximately £18 in 2005) per hour. The mean cost of the intervention over nine months was $383 (Australian dollars, approximately £175) per patient. The cost-effectiveness of pharmacy-based risk assessment plus blood glucose testing (sequential screening) in generating a diagnosis of diabetes was compared with pharmacy-based risk assessment with referral to the GP for blood glucose testing in an Australian study. 31 The rates of diagnosis were 1.7% and 0.2% respectively. The sequential screening method resulted in fewer referrals to the GP, a higher uptake of referrals and was more cost effective. One Canadian study 68 calculated the costs of providing a CP-based risk reduction service. The 10-year Framingham risk decreased in the intervention group by 5.2% (from 17.3% to 16.4%) during the four-month study period. The costs to the pharmacy (in 2000) for providing the service were $22 (Canadian dollars) per patient and the costs to healthcare funders were $6.40. Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 20 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists 6. Conclusions Vascular risk assessment programmes are being implemented in the UK with the intention of reducing mortality from vascular disease. There were reports of a several CP programmes for VRA both in the UK and internationally, but good quality evidence for their effectiveness was lacking. The majority of the evidence came from studies of risk assessment in patients with heart disease and diabetes. Observational evidence indicated the potential for CPs to perform VRA, but further well designed trials with specified outcome measures are required. There are however issues relating to integration with general practice and these appear to be a key barrier to success. It should be recognised that while testing or risk assessment are important first steps, they are only part of the process and need to be positioned carefully within an integrated diagnosis, treatment and care plan. The major advantages and disadvantages of CP provision of VRA are shown in the Table:ADVANTAGES Recognised and trusted provider within the primary care setting, both by the LHB/PCT and the public. Well placed to provide services out-of hours and to those preferring less traditional environments. CPs have extensive marketing experience. Often located geographically closer to local communities than the GP surgery, in easily accessible areas i.e. retail areas and in deprived areas and can therefore help prevent a widening of the inequalities gap. Provide an opportunistic approach via the prescription process as people who are eligible for a screen can be highlighted on the printed prescription. Pharmacies with prescribing rights and use of near patient testing could offer a one-stop-shop approach. There is national guidance produced and under development by the pharmacy specialty organisations for VRA programmes. Author: Webb, Public Health Practitioner Version: 1 DISADVANTAGES Additional IM&T or other resource costs to ensure recoding of clinical data back onto GP practice databases. Patients requiring referral to their GP/ practice based pharmacist might be lost to follow up. Duplication of VRA provider may widen the inequalities gap, since the worried well attenders will be disproportionally represented. Some members of the public have misgivings about attending a CP for a VRA. Date 16/02/2016 Page: 21 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales 7. Vascular risk assessment by community pharmacists References 1 Welsh Assembly Government. New plans to improve prevention of vascular disease. 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Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 26 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists Appendix 1 Clinical overview for everyone in the population to have vascular disease risk managed appropriately 6 (Copyright permission applied for) . Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 27 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists Appendix 2 The following databases were searched. Ovid Medline, Embase, Cochrane Database of Systematic Reviews, ACP Journal Club EBM reviews; Database of Abstracts of Reviews of Effects; Cochrane Central Register of Controlled Trials; British Nursing Index and Cinahl, were searched. 1 2 3 4 5 SEARCHES pharmacists.mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] community pharmacy.mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] community pharmacy.mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] community pharmacy services.mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] pharmacies.mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] pharmaceutical services.mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] RESULTS 30440 3431 1810 11661 8326 6 7 8 9 10 11 12 13 14 15 ((#1 or#2 or#3 or #4 or #5) and health education).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (#1 or #2 or #3 or #4 or #5 health promotion).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (pharmac* and vascular risk).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] pharmac* and screening).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (pharmac* and smoking cessation).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (pharmac* and body weight).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (pharmac* and coronary heart disease).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (pharmac* and renal disease).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (pharmac* and stroke).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] (pharmac* and diabetes).mp. [mp=ti, ab, sh, hw, tn, ot, dm, mf, tc, id, nm] Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 28 of 30 14481 14579274 240 28672 4298 17936 2534 2479 8732 22258 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists Appendix 3 EVIDENCE LEVELS AND QUALITY GRADING (modified from NICE Guideline Methodology Manual) Level of Evidence Type of Evidence 1++ High-quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias Well-conducted meta-analyses, systematic reviews of RCTs,or RCTs with a low risk of bias Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias High-quality systematic reviews of case control or cohort studies. High-quality case-control or cohort studies with a very low risk of confounding, bias, or chance and a high probability that the relationship is causal Well-conducted case-control or cohort studies with a low risk of confounding, bias, or chance and a moderate probability that the relationship is causal Case-control or cohort studies with a high risk of confounding bias, or chance and a significant risk that the relationship is not causal Non-analytic studies (for example, case reports, case series) 1+ 12++ 2+ 2- 3 4 Expert opinion, formal consensus Quality grading ++ = good quality + = fair +/- = fair to poor - = poor Author: Webb, Public Health Practitioner Version: 1 Date 16/02/2016 Page: 29 of 30 Status: Final Intended Audience: Pharmaceutical Public Health Team National Public Health Service for Wales Vascular risk assessment by community pharmacists Appendix 4 Evidence table – to follow STUDY POPULATION/ INTERVENTION/AIM OUTCOMES RESULTS SETTING Author: Webb, Public Health Practitioner Version: 1 COMMENTS Italics= reviewers comments Date 16/02/2016 Page: 30 of 30 DESIGN EVIDENCE LEVEL/ QUALITY Status: Final Intended Audience: Pharmaceutical Public Health Team