期刊论文详细信息
BMC Public Health
Mixed methods evaluation of targeted case finding for cardiovascular disease prevention using a stepped wedged cluster RCT
Kate Jolly1  Nicola Gale1  Paramjit Gill1  Karla Hemming1  Michael Caley2  Tom Marshall1 
[1] School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK;Warwickshire Primary Care Trust, Westgate House, Market Street, Warwick, CV34 4DE, UK
关键词: Cluster randomised controlled trial;    Risk factors;    Prevention;    Cardiovascular diseases;    Statinsm;   
Others  :  1162927
DOI  :  10.1186/1471-2458-12-908
 received in 2012-10-10, accepted in 2012-10-24,  发布年份 2012
PDF
【 摘 要 】

Background

A pilot project cardiovascular prevention was implemented in Sandwell (West Midlands, UK). This used electronic primary care records to identify untreated patients at high risk of cardiovascular disease then invited these high risk patients for assessment by a nurse in their own general practice. Those found to be eligible for treatment were offered treatment. During the pilot a higher proportion of high risk patients were started on treatment in the intervention practices than in control practices. Following the apparent success of the prevention project, it was intended to extend the service to all practices across the Sandwell area. However the pilot project was not a robust evaluation. There was a need for an efficient evaluation that would not disrupt the planned rollout of the project.

Methods/design

Project nurses will sequentially implement targeted cardiovascular case finding in a phased way across all general practices, with the sequence of general practices determined randomly. This is a stepped wedge randomised controlled trial design. The target population is patients aged 35 to 74, without diabetes or cardiovascular disease whose ten-year cardiovascular risk, (determined from data in their electronic records) is ≥20%. The primary outcome is the number of high risk patients started on treatment, because these data could be efficiently obtained from electronic primary care records. From this we can determine the effects of the case finding programme on the proportion of high risk patients started on treatment in practices before and after implementation of targeted case finding. Cost-effectiveness will be modelled from the predicted effects of treatments on cardiovascular events and associated health service costs. Alongside the implementation it is intended to interview clinical staff and patients who participated in the programme in order to determine acceptability to patients and clinicians. Practical considerations meant that 26 practices in Sandwell could be randomised, including about 6,250 patients at high risk of cardiovascular disease. This gives sufficient power for evaluation.

Discussion

It is possible to design a stepped wedge randomised controlled trial using routine data to determine the primary outcome to evaluate implementation of a cardiovascular prevention programme.

【 授权许可】

   
2012 Marshall et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20150413083724219.pdf 263KB PDF download
Figure 1. 43KB Image download
【 图 表 】

Figure 1.

【 参考文献 】
  • [1]National Institute for Clinical Excellence: Hypertension Management of hypertension in adults in primary care National Institute for Clinical Excellence. 2004. Clinical Guideline 18 www.nice.org.uk/CG018NICEguideline webcite Last accessed 26th July 2009
  • [2]National Institute for Health and Clinical Excellence: Cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. 2008. http://guidance.nice.org.uk/CG67 webcite] (Last accessed 26th July 2009)
  • [3]Heart UK, Primary Care Cardiovascular Society, The Stroke Association Prepared by: British Cardiac Society, British Hypertension Society, Diabetes UK, JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart 2005, 91:1-52.
  • [4]Scottish Intercollegiate: Guidelines Network SIGN 97 Risk estimation and the prevention of cardiovascular disease a national clinical guideline Scottish Intercollegiate Guidelines Network. 2007. http://www.sign.ac.uk/guidelines/fulltext/93-97/index.html webciteLast accessed 9th May 2012
  • [5]National Institute for Clinical Excellence: CG71 Familial hypercholesterolaemia: NICE guideline. 2008. http://publications.nice.org.uk/lipid-modification-cg71 webciteLast accessed 24th April 2012
  • [6]Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A, Antithrombotic Trialists' (ATT) Collaboration: Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009, 373(9678):1849-1860.
  • [7]Christian A, Millls T, Simpson S, Mosca L: Quality of Cardiovascular disease preventive care and physician/practice characteristics. J Gen Intern Med 2006, 21(3):231-237.
  • [8]Erhardt LR, Hobbs FD: A global survey of physicians' perceptions on cholesterol management: the From The Heart study. Int J Clin Pract 2007, 61(7):1078-1085.
  • [9]Roumie CL, Elasy TA, Wallston KA, Pratt S, Greevy RA, Liu X, Alvarez V, Dittus RS, Speroff T: Clinical inertia: a common barrier to changing provider prescribing behavior. Joint Comm J Qual Patient Saf 2007, 33(5):277-285.
  • [10]Arroll B, Jenkins S, North D, Kearns R: Management of hypertension and the core services guidelines: results from interviews with 100 Auckland general practitioners. New Zeal Med J 1995, 108:55-57.
  • [11]Backlund L, Skaner Y, Montgomery H, Bring J, Strender L: GPs’ decisions on drug treatment for patients with high cholesterol values: a think-aloud study. BMC Med Informat Decis Making 2004, 4:23. BioMed Central Full Text
  • [12]Midlöv P, Ekenbo R, Johansson L, Gerward S, Persson K, Nerbrand C, Hedblad B: Barriers to adherence to hypertension guidelines among GPs in south Sweden: A survey. Scand J of Prim Health Care 2008, 26(3):154-159.
  • [13]Roncaglioni MC, Avanzini F, Roccatagliata D, Monesi L, Tamayo-Benitez D, Tombesi M, Caimi V, Longoni P, Lauri D, Barlera S, Tognoni G, Collaborative Group Risk and Prevention Study: How general practitioners perceive and grade the cardiovascular risk of their patients. Eur J Cardiovasc Prev Rehabil 2004, 11(3):233-238.
  • [14]Vancheria F, Strender LE, Montgomery H, Skånér Y, Backlund LG: Coronary risk estimates and decisions on lipid-lowering treatment in primary prevention: Comparison between general practitioners, internists, and cardiologists. Eur J Intern Med 2009, 20(6):601-606.
  • [15]Montgomery AA, Fahey T, MacKintosh C, Sharp DJ, Peters TJ: Estimation of cardiovascular risk in hypertensive patients in primary care. Br J Gen Pract 2000, 451(2):127-128.
  • [16]The NHS Information Centre Health Survey for England: Trend tables Publication date: December 16, 2010. 2009. http://www.ic.nhs.uk/pubs/hse09trends webciteLast accessed 4th January 2012
  • [17]Department of Health: Putting prevention first: Vascular checks risk assessment and management - impact assessment. London: Department of Health; 2008.
  • [18]Department of Health: Economic Modelling for Vascular Checks. 2008. cited 3rd December 2009) Available from URL: http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_085917.pdf webcite
  • [19]Marshall T, Rouse A: Resource implications and health benefits of primary prevention strategies for cardiovascular disease in people aged 30 to 74: mathematical modelling study. Br Med J 2002, 325:197-199.
  • [20]Marshall T: The value of information: modelling the efficiency of strategies for identifying high-risk patients for primary prevention of cardiovascular disease. Informat Prim Care 2006, 14:85-92.
  • [21]Chamnan P, Simmons RK, Khaw KT, Wareham NJ, Griffin SJ: Estimating the population impact of screening strategies for identifying and treating people at high risk of cardiovascular disease: modelling study. BMJ 2010, 340:c1693.
  • [22]Marshall T, Westerby P, Chen J, Fairfield M, Harding J, Westerby R, Ahmad R, Middleton J: The Sandwell Project: a controlled evaluation of a programme of targeted screening for prevention of cardiovascular disease in primary care. BMC Publ Health 2008, 8:73. BioMed Central Full Text
  • [23]Brown CA, Lilford RJ: The stepped wedge trial design a systematic review. BMC Med Res Meth 2006, 6:54. BioMed Central Full Text
  • [24]Mdegea ND, Mana MS, Celia A, Taylor CA, Torgerson DJ: Systematic review of stepped wedge cluster randomized trials shows that design is particularly used to evaluate interventions during routine implementation. J Clin Epidemiol 2011, 64:936-948.
  • [25]Gambia Hepatitis Study Group: The Gambia Hepatitis Intervention Study. Canc Res 1987, 47:5782-7.
  • [26]MSD Informatics Clinical Managerhttp://www.msdinformatics.com/ClinMan.htm webciteLast accessed 4th January 2012
  • [27]Anderson KM, Odell PM, Wilson PW, Kannel WB: Cardiovascular disease risk profiles. Am Hear J 1991, 121(1 Pt 2):293-298.
  • [28]Marshall T: Identification of patients for clinical risk assessment by prediction of cardiovascular risk using default risk factor values. BMC Publ Health 2008, 8:25. BioMed Central Full Text
  • [29]British National Formulary BMJ Group and the Royal Pharmaceutical Society of Great Britain 2011. http://bnf.org/bnf/index.htm webciteLast accessed 5th January 2012
  • [30]Office of National Statistics: UK indices of multiple deprivation - a way to make comparisons across constituent countries easier. http://www.ons.gov.uk/ons/rel/hsq/health-statistics-quarterly/no--53--spring-2012/uk-indices-of-multiple-deprivation.html webciteLast accessed 2nd Sept 2012
  • [31]Campbell MJ, Donner A, Klar N: Developments in cluster randomised trial and Statistics in Medicine. Statistics in Medicine 2007, 26:2-19.
  • [32]Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ: Patterns of intra-cluster correlation from primary care research to inform study design and analysis. J Clin Epidemiol 2004, 57(8):785-794.
  • [33]Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ: Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol 2011, 11:102. BioMed Central Full Text
  • [34]Harper D: Talking about pictures: a case for photo elicitation. Vis Stud 2002, 17(1):13-26.
  • [35]Medical Research Council clinical trials series: Cluster randomised trials - Methodological and ethical considerations. 2002. http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002406 webciteLast accessed 1st February 2012
  • [36]Hussey MA, Hughes JP: Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials 2007, 28(2):182-191. Epub 2006 Jul 7
  文献评价指标  
  下载次数:13次 浏览次数:16次