Who is this guidance for? .uk



Using CRP testing to support clinical decisions in primary careThis brief guidance has been prepared by an expert group (a sub-group of the Antimicrobial Delivery Plan task and finish group Delivery Theme 2: Optimising prescribing practice) Appendix 3: Membership of the group Who is this guidance for?All GP practices in Wales, GP cluster leads, Local Medical Committees, Pharmacy Leads, Directors of Primary Care, Point of Care Testing Leads, Laboratory Clinical Leads, Health Board Antimicrobial Stewardship Groups.The technologyC reactive protein (CRP) testing is now available as a point of care test (CRP POCT) that can be used in primary care in certain defined clinical settings. NICE recommends its use in the diagnosis and appropriate management of lower respiratory tract infections in adults. The technical and clinical governance aspects of this technology are covered in detail in the Welsh Scientific Advisory Committee (WSAC) Policy on the management of POCT, what, when and how? March 20164 available on NHS Wales website nww.poctmatters.wales.nhs.uk and gpone.wales.nhs.uk.Should you and your practice consider investing in CRP POCT technology?The main role that CRP POCT is likely to have in general practice is in guiding antibiotic prescribing decisions. Its use may help improve clinical decision making and may make an important contribution to antimicrobial stewardship within your practice. CRP POCT can potentially help with patient education and managing expectations for an antibiotic.As a starting point, it is important for your practice to have a clear picture of your antibiotic prescribing and how this compares to models of good practice. Prescribing data show that there is considerable variation in the amount, class and duration of antibiotics prescribed across primary care practices in Wales. GPs can access their prescribing data (CASPA) from the Shared Services Partnership Primary Care Services online application: . Measuring CRP is one of many approaches that have been shown to help primary care prescribers reduce antibiotic prescribing for common infections. Communication skills to help manage patient expectations and deal with patient concerns without prescribing, are a really important and effective way of improving use of antibiotics. Indeed, research has shown that communication skills training and use of CRP POCT are likely to be complementary, and most effective when used in combination.1 In practices with existing low levels of antibiotic prescribing, the addition of CRP POCT testing may have little impact on practice level prescribing rates.2 Further information on relevant training, including e-learning modules for clinicians and information for patients is freely available via the RCGP TARGET program at public facing information (leaflets and posters) are available in Welsh and English from: decision as a practice as to whether investing in this technology is warranted must thus be based on an understanding of your overall antibiotic stewardship, the case mix of your population and the instances of uncertainty you face regarding bacterial infections within your daily practiceHow might a CRP POCT help support clinical decision making?C-reactive protein (CRP) is an acute phase protein that rises in the blood stream non-specifically in response to inflammation. Liver failure can impair the production of CRP and chronic inflammatory conditions can result in persistently elevated levels. CRP levels can become elevated in response to viral infections, but generally rise to higher levels in bacterial infections, especially severe bacterial infections. CRP POCT use can therefore help to guide decision making, but is not a replacement for clinical decision making and results should be interpreted in the context of the clinical assessment. In general, it will not add much to clinical decision making in situations where the pre-test probability of bacterial infection is very low or very high, but may help resolve uncertainty where there is an intermediate, or uncertain, risk of bacterial infection. It can also be used as a tool to help you in the dialogue you have with your patient around the need for antibiotics. Some patients in studies of using CRP POCT have indicated that they like the reassurance that a test provides, however some patients see it as a tool for the doctor, and don’t find that it helps with communication around antibiotic use5. You should also be aware that use of a CRP POCT may lead to ‘medicalisation’, where patients who would not normally consult feel that they need to see the doctor in order to have the test that can tell whether they need antibiotics. NICE guidelines on diagnosis and management of pneumonia in adults3 recommend that POCT CRP should be considered for people with symptoms of lower respiratory tract infection in primary care if a diagnosis is unclear after clinical assessment. The following vignettes provide some examples of scenarios in which CRP testing may play a role:A previously well adult with a one-week history of new cough, green sputum production, fever and feeling generally unwell. The patient has a mild tachycardia (pulse = 102), a temperature of 38.1, and on chest auscultation there are some diffuse coarse crackles but no evidence of consolidation. You do not suspect pneumonia, but feel that it is not clear whether antibiotics are likely to be beneficial or not.An adult patient with type 2 diabetes presents with a chesty cough that has been present for 2 weeks and is not getting better. The patient tells you that they have been feeling hot and cold and have no energy, and that they always need antibiotics when they get a chest infection. The clinical examination is unremarkable apart from a few wheezes on chest auscultation. You do not feel that the patient has pneumonia, but are aware that their diabetes places them at slightly higher risk, and that they have expressed a desire for antibiotics.CRP measurement may also have a role in guiding antibiotic prescribing decisions for other infections, but the evidence is less clear at present. The guidance therefore focuses on lower respiratory tract infections in adults. Research is currently being undertaken to understand the role of CRP POCT in the management of acute exacerbations of COPD. As the results of this, and other, studies become available, the role of CRP POCT may expand.Interpreting the results CRP POCT devices can provide results that are comparable with recommended thresholds for action, however not all devices have the same accuracy and precision and before a device is purchased it is advisable to seek advice from your local POCT Department. It is also important that the CRP POCT device results does not replace clinical decision making. The NICE guidelines on diagnosis and management of pneumonia in adults3 indicate that if the CRP level in a patient with a lower respiratory tract infection is more than 100 mg/l then the patient should generally be prescribed immediate antibiotics and an assessment of severity and the need for hospitalisation should be undertaken, and in patients with a CRP level less than 20 mg/l antibiotics should generally be avoided. However, in patients with a CRP level in the intermediate range (20 – 100 mg/l) the test is less helpful, and current NICE suggest that a delayed (back up) prescription can be useful in these circumstances. However, all test results should be considered in the clinical municating the results to your patientThe majority of patients will have a low (less than 20 mg/l) CRP level and can be reassured that the risk of serious infection, and the chance of having an infection that will benefit from antibiotic treatment, are minimal. Patients with high CRP values that are being managed in the community should be informed that their blood test indicates that their body is responding to something, and that this is likely to be a bacterial infection. They should be treated with antibiotics and given safety-netting information, including what should prompt them to seek a further assessment. Patients with a CRP value in the intermediate range need to be assessed and a decision made about antibiotic treatment. It is important to inform the patient that although you have not identified any clear indicator of pneumonia, their blood test shows that their body is responding to something, and that this could be a bacterial infection. It is important to give them good safety-netting advice, and if you decide to give them a delayed (back-up) prescription then it is important to give clear advice about what should prompt them to collect and use the prescription. This is not a replacement for safety-netting advice, as people with features of more severe illness should be re-assessed rather than just starting to take antibiotics. It is important to ensure that the patient is supported in this and leaflets such as “treating your infection” may help.What are the benefits to your patient?Patients who do not have evidence of bacterial infection should not be prescribed antibiotics; reducing the risk of side effects and serious complications such as Clostridium difficile infection, and reducing development of antibiotic resistance. The former may be particular important for elderly patients for whom maintaining healthy gut flora is very important. What are the wider benefits to the people of Wales?Reduced antibiotic prescribing and improved antimicrobial stewardship will contribute to a reduction in antimicrobial resistance in Wales, and is likely to have an important impact on Clostridium difficile infection rates across Wales.Quality Management SystemsIt is essential the POCT CRP undergoes the appropriate level of quality assurance. This will require collaboration with your local hospital POCT department for advice on the most appropriate device, developing operating protocols on how the test is used, and ensuring all users are trained and have documented competency. This will extend to ensuring records of internal quality control, External Quality Assurance (EQA), clinical audit and electronic storage of results in patient records. These requirements and processes are covered in detail in the Welsh Scientific Advisory Committee (WSAC) Policy on the management of POCT4 and at HYPERLINK "file:///\\\\rytvpsrvfil0002\\shared\\PHTOP\\CCDC\\AMR%20programme\\CRP\\nww.poctmatters.wales.nhs.uk"nww.poctmatters.wales.nhs.ukCost considerationsCapital, revenue, professional and implementation costs should be assessed. A resource should be identified for a POCT service and incorporated into a Service Level Agreement (SLA) with the local laboratory. The SLA should define the level of service provided and the responsibilities of all parties and include all additional costs incurred as per Welsh Scientific Advisory Committee (WSAC) Policy on the management of POCT4 and at nww.poctmatters.wales.nhs.ukTime costs to clinical staff, following initial training, within a GP practice will be around 10 minutes per patient. The benefit from using the machine in the context of a high prescribing practice may be considerable, however this may be less so where prescribing rates are already low.Appendix 2: Real costs incurred in the introduction of CRP POCT in primary care in North WalesWhat training and support do I and my practice need to actually use the CRP POCT?Training in use of CRP POCT will be provided by arrangement with your local hospital POCT department and manufacturer. Through your local POCT lead you will have access to a laboratory clinical lead. Details of the relevant contacts and requirements will be available via: nww.poctmatters.wales.nhs.ukLocal implementation and evaluation of impact of CRP in primary care It is recommended that the Health Board Antimicrobial Stewardship Group maintains oversight of the introduction and impact of CRP in primary care. A target of 50% reduction in inappropriate antimicrobial prescribing has been set for 2020. It is expected that a primary care lead is nominated for all AMR Stewardship Groups and Point of Care Groups for all Health Boards. These individuals will work closely with the local POCT lead and provide assurance to the Board that prudent prescribing initiatives implemented locally are effective. A national CRP co-ordinator will be nominated who will monitor the introduction and impact of CRP on clinical practice and antimicrobial prescribing.If you have any questions regarding this issue your local point of care lead is:......................................................Maximising impact of introduction of CRPWhat training and interventions are likely to support and enhance any benefit from CRP POCT?An understanding of how to communicate potentially complex information to patients regarding antibiotic prescribing will help support your clinical practices. Your clinical decision may run contrary to patient expectations and an understanding of how to communicate issues relating to antibiotics may benefit you. We recommend the leaflets for patients available via the RCGP TARGET program: components of the RGCP TARGET toolkit are freely available however there is clearly a time and/or resource investment required for implementation. The TARGET toolkit recommends all steps are implemented as they complement each other, however you may wish to use specific components relevant to your needs.How do the potential interventions available, and outlined in the TARGET Toolkit, compare in terms of resource commitment?Providing information for patients: Leaflets and posters are available (in Welsh and in English) as downloads for printing on local printers or can be purchased pre-printed. The cost incurred will reflect local demand and printing options, and the time taken to explain leaflets to patients.Improved communication skills for clinicians and training resources for GPs: ?Free e learning modules are available. These will require time (duration depending on scope and modules completed). The likely benefit is improved dialogue with patients and increased confidence in prescribing decisions.Audit toolkits, self assessment: Undertaking the process of auditing and assessing of your practice will require time input, however the benefits may be significant.Prescribing guidelines: Applying your health board’s primary care empiric antibiotic treatment guidelines to clinical practice can be a quick and accurate way to improve antibiotic stewardship. Delayed prescriptions: Delayed prescriptions have a role to play in prudent antimicrobial prescribing and Task and Finish Group 2 of the AMR Delivery Plan – Prudent Prescribing – is developing guidance to support thisReferencesLittle et al. 2013. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial controlled trial. Lancet 2013; 382: 1175-82Minnaard MC, van de Pol AC, Hopstaken RM, van Delft S, Broekhuizen BD, Verheij TJ, de Wit NJ.C-reactive protein point-of-care testing and associated antibiotic prescribing. Fam Pract. 2016 (4):408-13. doi: 10.1093/fampra/cmw039. Epub 2016 May 26NICE guidelines on diagnosis and management of pneumonia in adults Clinical guideline [CG191] Published date: December 2014WSAC Policy of the Management of POCT, what, When and how? March 2016 (current draft; lead author Annette Thomas)Tonkin-Crine, S. K. G., Anthierens, S., Francis, N. A., Brugman, C., Fernandez-Vandellos, P., Krawczyk, J., et al. (2014). Exploring patients' views of primary care consultations with contrasting interventions for acute cough: a six-country European qualitative study. NPJ Primary Care Respiratory Medicine, 24, 14026. 1CRP testing in primary care; evidence summaryNICE guidanceThe NICE clinical guideline [CG191] Pneumonia in adults: diagnosis and management recommend’s that for people presenting with symptoms of lower respiratory tract infection in primary care, to consider a CRP-POCT if after clinical assessment a diagnosis of pneumonia has not been made and it is not clear whether antibiotics should be prescribed, and to use the results to guide antibiotic prescribing in these patients. There are two recently published (September 2016) medical technology innovation briefings relevant to CRP testing in primary care. These are MB 78 and MB 81 addressing the QuickRead go and AlereAfinion CRP point of care tests. The guidance addresses the use of CRP with people with lower respiratory tract infection. The medical briefings suggest for both technologies that using the technology could contribute to fulfilling antibiotic stewardship programs. Efficacy and effectivenessReview level evidence is provided by the key Cochrane Review (2014) Biomarkers as point of care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care (Cochrane database 2014:11). This review Included studies up to January 2014.The authors concluded that a point-of-care biomarker (e.g. C-reactive protein) can guide antibiotic treatment of acute respiratory infections in primary care and can reduce antibiotic use, although the degree of reduction remains uncertain. Used as an adjunct to a doctor's clinical examination this reduction in antibiotic use did not affect patient-reported outcomes, including recovery from and duration of illness. However, a possible increase in hospitalisations was of concern. A more precise effect estimate is needed to assess the costs of the intervention and compare the use of a point-of-care biomarker to other antibiotic-saving strategies. The largest study analysed within the Cochrane review was a multi country cluster randomise control trial (RCT) (Little et al 2013). This looked at the effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections. This trial was carried out across wide range of settings (6 EU countries). Practices were randomised to CRP-POCT with training, internet based interactive training in enhanced communication skills targeted at prescribers, usual care, and a combination of CRP training and communication training. However several practices were excluded before and after randomisation because of recruitment issues. A meaningful effect size impact on antibiotic prescribing was seen for all interventions with the greatest effect in the combined intervention (CRP-POCT alone 33% vs 48% ARR 0.54 95%CI 0.42-0.69, Communications training 36% vs 45% ARR 0.69 95%CI 0.54-0.87). The RCT provided support for CRP-POCT however greatest benefit was as part of training package. A similar effect size was seen with communication training alone. In both scenarios effect size was meaningful (15%).Harms were however identified: slightly lengthened symptom duration with communication training and increased hospital admissions with CRP -POCT. A further paper based on the trial used a mixed method triangulation approach to better understand the study findings (Tonkin-Crine et al. 2016). The authors concluded that: the use of CRP tests did not appear to engage patients or influence illness perceptions and its effect was more centered on changing clinician behaviour. Communication skills and a patient booklet were relevant and useful for all patients and associated with increased patient satisfaction.A further Cochrane Review: Interventions that facilitate shared decisions between primary care clinicians and patients about antibiotic use for acute respiratory infections (Cochrane database 2015:11) provided some support for shared decision making; which would potentially be an important component of CRP testing. The authors concluded that Interventions that aim to facilitate shared decision making significantly reduce antibiotic prescribing for acute respiratory infections in primary care, without a decrease in patients’ satisfaction with the consultation, or an increase in repeat consultations for the same illness. However there was not enough information to decide whether shared decision making affects other clinically adverse secondary outcomes.A number of non-Cochrane reviews have looked at the evidence. Huang et al. 2013 carried out a systematic review and meta-analysis on papers published up to June 2013 (prior to the Cochrane review) and concluded that POCT-CRP testing significantly reduced antibiotic prescribing for respiratory tract infections (RTIs) (this was not limited to lower RTIs). A more recent expert review (Meili et al 2015) compared CRP-POCT tests with procalcitonin (PCT) testing and concluded biomarkers have shown promising results however they highlighted the need for a high quality trial to compare CRP-POCT and PCT-POCT testing in primary care. A narrative review of primary care point of care testing and antibacterial use in RTI published in 2015 concluded that CRP and procaltitonin were both clinically valuable and cost effective. Two of the authors declared conflicts of interest.Recent studies – postdating Cochrane reviewA recent observational study carried out in the Netherlands (Minnaard et al. 2016) enrolled 40 GPs to a study that instructed them to use CRP testing for patients presenting with acute cough. They concluded that CRP testing influenced GPs to change prescribing decisions; however CRP testing did not reduce overall antibiotic prescribing by GPs who have an already low antibiotic prescribing rate. A trial limited to children presenting with fever and/or respiratory symptoms reported no effect seen, however the study limited power to detect an effect (Rebnord et al. 2016).A small North Wales pilot of CRP-POCT testing for patients presenting at a practice with acute RTI demonstrated a reduction in prescribing of antibiotics during the study period compared to the same period in the previous year (Hughes et al. 2016). This reduction was significantly greater than that observed in other GP practices within the health board (21.4% vs. 10.6%). Whilst this is consistent with a real beneficial effect there are clearly potential uncontrolled confounders that may influence these findings.Trials in progressThe PACE Study: General Practitioner (GP) use of CRP-POCT to help target antibiotic prescribing to patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) who are most likely to benefit. NIHR HTA. Cost effectiveness studiesTwo cost effectiveness studies were carried out in contexts outside of the UK (Netherlands and Norway and Sweden), it is thus difficult to determine from these the likely situation in a scale up of CRP across Wales. A more recent study (Hunter 2015) looked at the cost effectiveness of CRP-POCT testing in England. This study compared with standard practice; CRP-POCT by GP, by practice nurse, and by GP with communication training for the GPs. The author concluded that the additional; cost per patient of the CRP-POCT test was outweighed by associated cost savings and a QUALY increment due to a reduction in infections in the long term (this is however based on findings from one study). The author declared a conflict of interest.Evidence for optimising implementation of CRP testingA qualitative study (Huddy et al. 2016) addressed barriers and facilitators for the adoption of CRP testing in primary care. The primary barrier was an absence of a UK funding and reimbursement model. Concerns were raised around the maintenance, stocking arrangements and quality assurance of test device and cartridges. Laboratories could take an active role in supporting CRP testing in test administration, quality control and training. The North Wales pilot (Hughes et al 2016) demonstrated the importance of considerable close support of the biochemistry laboratory service within the health board. This was required to ensure quality, comply with governance and to sort out problems with the testing process. An observational study from Sweden (Lindstr?m et al. 2015) provides insight on the physician’s view of CRP testing.ReferencesInterventions that facilitate shared decisions between primary care clinicians and patients about antibiotic use for acute respiratory infections (Cochrane database 2015:11)Little et al. 2013. effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial controlled trial. Lancet 2013; 382: 1175-82Yafang Huang, Rui Chen, Tao Wu, Xiaoming Wei, Aimin Guo Association between point-of-care CRP testing and antibiotic prescribing in respiratory tract infections: a systematic review and meta-analysis of primary care studies. Br J Gen Pract Nov 2013, 63 (616) e787-e794; DOI: 10.3399/bjgp13X674477 Rebnord et al. Out-of-Hours antibiotic prescription after screening with C reactive protein: a randomised controlled trial. BMJ Open 2016;6: e011231 Biomarkers as point of care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care (Cochrane database 2014:11)Raymond Oppong, Richard D Smith, Paul Little, Theo Verheij, Christopher C Butler, Herman Goossens, Samuel Coenen, Michael Moore, Joanna Coast. Cost effectiveness of amoxicillin for lower respiratory tract infections in primary care: an economic evaluation accounting for the cost of antimicrobial resistance. Br J Gen Pract Sep 2016, 66 (650) e633-e639; DOI: 10.3399/bjgp16X686533 Minnaard MC, van de Pol AC, Hopstaken RM, van Delft S, Broekhuizen BD, Verheij TJ, de Wit NJ.C-reactive protein point-of-care testing and associated antibiotic prescribing. Fam Pract. 2016 (4):408-13. doi: 10.1093/fampra/cmw039. Epub 2016 May 26Hughes A, Gwyn L, Harris S. Clark C. Evaluating point-of-care C-reactive protein testing in a general practice. Clinical Pharmacist 2016vol 8(10)309-318Huddy JR, Ni MZ, Barlow J, Majeed A, Hanna GB Point-of-care C reactive protein for the diagnosis of lower respiratory tract infection in NHS primary care: a qualitative study of barriers and facilitators to adoption. BMJ Open. 2016 Mar 3;6(3):e009959. doi: 10.1136/bmjopen-2015-009959.Hunter R. Cost-effectiveness of point of care C-reactive protein tests for respiratory tract infections in primary care in England. Adv Ther (2015); 32:69-85Lindstr?m J, Nordeman L, Hagstr?m B What a difference a CRP makes. A prospective observational study on how point-of-care C-reactive protein testing influences antibiotic prescription for respiratory tract infections in Swedish primary health care. Scand J Prim Health Care. 2015;33(4):275-82. doi: 10.3109/02813432.2015Appendix 2: Real costs incurred in the introduction of CRP POCT in primary care in North WalesSharman Harris, Principal Biochemist, BCUHB, November 2016CRP analyser costs (based on Alere Afinion)POCT itemCost (?)Afinion CRP Analyser (current quote from Alere)1500connectivity120Associated connectivity conworx costWaiting for informationPrinter250Scanner125Total analyser cost ( 1 analyser without VAT)1995Cartridge/reagent3.50 per testIQC 136/annualEQA (WEQAS)240/annualReagent cost per test (Afinion) – includes cartridge, IQC,EQA4.50Annual reagent cost ( 1 analyser) – projected from Amlwch study1692Reagent costs – 94 tests/ 3months from Amlwch study – projected to 376 tests/yearAnnual cost of CRP cartridges ?1316 for 1 GP practiceTotal reagent annual cost (cartridge/IQC/EQA) -= 1316 + 136 + 240 = ?1692To ensure value for money a framework for purchasing machines and reagents will be available for use on nww.poctmatters.wales.nhs.ukAppendix 3: Membership of expert groupC-Reactive Protein Point of Care Testing (CRP POCT)Expert Group - Reporting to TFG 2Annette ThomasDirector of WEQASChairChristine HopkinsPoC Testing Service Manager, ABMUDiane WilliamsPoC Coordinator, Aneurin BevanLinda TurnerPoC Coordinator, Aneurin BevanMark HenryPoC Testing Service Manager, Cwm TafMaggie HeginbothomPHW Senior Scientist AMR ProgrammeMarion LyonsPHW AMRDP LeadMeryl DaviesClinical Pharmacist, Hywel DdaNick FrancisGP, Cwm Taf -? PACE StudyNoel CrainePHW Research ScientistPaul Gimson1000 lives & Prudent Prescribing Implementation GroupRobin HowePHW AMR Programme Lead, Chair AWAGGSharman HarrisClinical Biochemist, BCUHBJulia WalshClinical Biochemist, Aneurin BevanSion JamesGP, Hywel DdaVivienne WilliamsPoC Testing Coordinator, Hywel Dda ................
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