A rapid review of the evidence for the role of community pharmacists

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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
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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
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Vascular risk assessment by community
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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.
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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
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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
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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
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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
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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.
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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
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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,
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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.
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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
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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
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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
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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
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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.
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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
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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.
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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
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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.
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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
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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.
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Vascular risk assessment by community
pharmacists
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26
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42
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46 Liu Y et al. Community pharmacist assessment of 10-year risk of coronary heart
disease for union workers and their dependents. Journal American Pharmacists
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intervention in cholesterol risk management: an evaluation of the study of
cardiovascular risk intervention by pharmacists. Pharmacotherapy 2001; 21: 627–35.
Author: Webb, Public Health Practitioner
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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
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National Public Health Service for Wales
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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
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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
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National Public Health Service for Wales
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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
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Page: 30 of 30
DESIGN
EVIDENCE
LEVEL/
QUALITY
Status: Final
Intended Audience: Pharmaceutical
Public Health Team
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