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Lead-I ECG for detecting atrial fibrillation in patients attending primary care with an irregular pulse using single-time point testing: A systematic review and economic evaluation


Autoři: Rui Duarte aff001;  Angela Stainthorpe aff001;  James Mahon aff003;  Janette Greenhalgh aff001;  Marty Richardson aff001;  Sarah Nevitt aff001;  Eleanor Kotas aff001;  Angela Boland aff001;  Howard Thom aff005;  Tom Marshall aff006;  Mark Hall aff007;  Yemisi Takwoingi aff006
Působiště autorů: Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, United Kingdom aff001;  Health Economics and Outcomes Research Ltd, Cardiff, United Kingdom aff002;  Coldingham Analytical Services, Berwickshire, United Kingdom aff003;  York Health Economics Consortium, University of York, York, United Kingdom aff004;  Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, United Kingdom aff005;  Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom aff006;  Liverpool Heart and Chest Hospital, Liverpool, United Kingdom aff007;  NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, United Kingdom aff008
Vyšlo v časopise: PLoS ONE 14(12)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0226671

Souhrn

Background

Atrial fibrillation (AF) is the most common type of cardiac arrhythmia and is associated with increased risk of stroke and congestive heart failure. Lead-I electrocardiogram (ECG) devices are handheld instruments that can detect AF at a single-time point.

Purpose

To assess the diagnostic test accuracy, clinical impact and cost effectiveness of single-time point lead-I ECG devices compared with manual pulse palpation (MPP) followed by a 12-lead ECG for the detection of AF in symptomatic primary care patients with an irregular pulse.

Methods

Electronic databases (MEDLINE, MEDLINE Epub Ahead of Print and MEDLINE In-Process, EMBASE, PubMed and Cochrane Databases of Systematic Reviews, Cochrane Central Database of Controlled Trials, Database of Abstracts of Reviews of Effects, Health Technology Assessment Database) were searched to March 2018. Two reviewers screened the search results, extracted data and assessed study quality. Summary estimates of diagnostic accuracy were calculated using bivariate models. Cost-effectiveness was evaluated using an economic model consisting of a decision tree and two cohort Markov models.

Results

Diagnostic accuracy

The diagnostic accuracy (13 publications reporting on nine studies) and clinical impact (24 publications reporting on 19 studies) results are derived from an asymptomatic population (used as a proxy for people with signs or symptoms of AF). The summary sensitivity of lead-I ECG devices was 93.9% (95% confidence interval [CI]: 86.2% to 97.4%) and summary specificity was 96.5% (95% CI: 90.4% to 98.8%).

Cost effectiveness

The de novo economic model yielded incremental cost effectiveness ratios (ICERs) per quality adjusted life year (QALY) gained. The results of the pairwise analysis show that all lead-I ECG devices generate ICERs per QALY gained below the £20,000-£30,000 threshold. Kardia Mobile is the most cost effective option in a full incremental analysis. Lead-I ECG tests may identify more AF cases than the standard diagnostic pathway. This comes at a higher cost but with greater patient benefit in terms of mortality and quality of life.

Limitations

No published data evaluating the diagnostic accuracy, clinical impact or cost effectiveness of lead-I ECG devices for the target population are available.

Conclusions

The use of single-time point lead-I ECG devices in primary care for the detection of AF in people with signs or symptoms of AF and an irregular pulse appears to be a cost effective use of NHS resources compared with MPP followed by a 12-lead ECG, given the assumptions used in the base case model.

Registration

The protocol for this review is registered on PROSPERO as CRD42018090375.

Klíčová slova:

Atrial fibrillation – Cost-effectiveness analysis – Database searching – Diagnostic medicine – Electrocardiography – Medical devices and equipment – Primary care


Zdroje

1. National Institute for Health and Care Excellence (NICE). Clinical knowledge summaries: atrial fibrillation. 2015. Available from: https://cks.nice.org.uk/atrial-fibrillation#!topicsummary [accessed January 2018].

2. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37:2893–62. doi: 10.1093/eurheartj/ehw210 27567408

3. Public Health England. Atrial fibrillation prevalence estimates in England: application of recent population estimates of AF in Sweden. 2017. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/644869/atrial_fibrillation_AF_briefing.pdf [accessed January 2018].

4. Duarte R, Stainthorpe A, Greenhalgh J, Richardson M, Marshall T, Hall M, et al. The clinical and cost effectiveness of lead-I electrocardiogram (ECG) devices for detecting atrial fibrillation using single-time point testing in primary care—Protocol 2018. Available from: https://www.nice.org.uk/guidance/dg35/documents/final-protocol.

5. National Institute for Health and Care Excellence (NICE). Atrial fibrillation: management. clinical guideline CG180. 2014. Available from: https://www.nice.org.uk/guidance/cg180/chapter/Introduction [accessed January 2018].

6. Centre for Reviews and Dissemination. Systematic reviews: CRD's guidance for undertaking systematic reviews in health care. 2009. Available from: http://www.york.ac.uk/inst/crd/SysRev/!SSL!/WebHelp/SysRev3.htm [accessed January 2018].

7. National Institute for Health and Care Excellence (NICE). Diagnostic assessment programme manual [Internet] 2011. Available from: http://www.nice.org.uk/media/A0B/97/DAPManualFINAL.pdf [accessed January 2018].

8. Cochrane Diagnostic Test Accuracy Working Group. Handbook for DTA reviews. 2009. Available from: http://srdta.cochrane.org/handbook-dta-reviews [accessed January 2018].

9. McInnes MDF, Moher D, Thombs BD, McGrath TA, Bossuyt PM, Clifford T, et al. Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies: The PRISMA-DTA Statement. Jama. 2018;319(4):388–96. Epub 2018/01/25. doi: 10.1001/jama.2017.19163 29362800.

10. Whiting PF, Rutjes AW, Westwood ME, Mallett S, Deeks JJ, Reitsma JB, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Annals of Internal Medicine. 2011;155:529–36. doi: 10.7326/0003-4819-155-8-201110180-00009 22007046

11. Herzog R, Alvarez-Pasquin MJ, Diaz C, Del Barrio JL, Estrada JM, Gil A. Are healthcare workers' intentions to vaccinate related to their knowledge, beliefs and attitudes? A systematic review. BMC public health. 2013;13:154. Epub 2013/02/21. doi: 10.1186/1471-2458-13-154 23421987; PubMed Central PMCID: PMC3602084.

12. Wells G, Shea B, O'Connell D, Peterson J, Welch V, Losos M, et al. The Newcastle-Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. Ottawa Hospital Research Institute: 2012.

13. Chu H, Cole SR. Bivariate meta-analysis of sensitivity and specificity with sparse data: a generalized linear mixed model approach. J Clin Epidemiol. 2006;59 (12):1331–2; author reply 2–3. Epub 2006/11/14. doi: 10.1016/j.jclinepi.2006.06.011 17098577.

14. Takwoingi Y, Guo B, Riley RD, Deeks JJ. Performance of methods for meta-analysis of diagnostic test accuracy with few studies or sparse data. Stat Methods Med Res. 2017;26(4):1896–911. Epub 2015/06/28. doi: 10.1177/0962280215592269 26116616; PubMed Central PMCID: PMC5564999.

15. Adderley NJ, Ryan R, Nirantharakumar K, Marshall T. Prevalence and treatment of atrial fibrillation in UK general practice from 2000 to 2016. Heart. 2018. doi: 10.1136/heartjnl-2018-312977

16. Piccini JP, Simon DN, Steinberg BA, et al. Differences in clinical and functional outcomes of atrial fibrillation in women and men: two-year results from the orbit-af registry. JAMA Cardiology. 2016;1(3):282–91. doi: 10.1001/jamacardio.2016.0529 27438106

17. Welton NJ, McAleenan A, Thom HH, Davies P, Hollingworth W, Higgins JP, et al. Screening strategies for atrial fibrillation: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2017;21(29):1–236. Epub 2017/06/21. doi: 10.3310/hta21290 28629510.

18. Engdahl J, Andersson L, Mirskaya M, Rosenqvist M. Stepwise screening of atrial fibrillation in a 75-year-old population: implications for stroke prevention. Circulation. 2013;127(8):930–7. Epub 2013/01/25. doi: 10.1161/CIRCULATIONAHA.112.126656 23343564.

19. Aronsson M, Svennberg E, Rosenqvist M, Engdahl J, Al-Khalili F, Friberg L, et al. Cost-effectiveness of mass screening for untreated atrial fibrillation using intermittent ECG recording. Europace. 2015;17(7):1023–9. Epub 2015/04/15. doi: 10.1093/europace/euv083 25868469.

20. Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015;131(25):2176–84. Epub 2015/04/26. doi: 10.1161/CIRCULATIONAHA.114.014343 25910800.

21. NHS Digital. Quality and outcomes framework (QOF) - 2016–2017. 2017. Available from: https://digital.nhs.uk/catalogue/PUB30124 [accessed January 2018].

22. Mathisen SM, Dalen I, Larsen JP, Kurz M. Long-Term Mortality and Its Risk Factors in Stroke Survivors. Journal of stroke and cerebrovascular diseases: the official journal of National Stroke Association. 2016;25(3):635–41. Epub 2016/01/08. doi: 10.1016/j.jstrokecerebrovasdis.2015.11.039 26738815.

23. Berg J, Lindgren P, Nieuwlaat R, Bouin O, Crijns H. Factors determining utility measured with the EQ-5D in patients with atrial fibrillation. Quality of life research: an international journal of quality of life aspects of treatment, care and rehabilitation. 2010;19(3):381–90. Epub 2010/01/29. doi: 10.1007/s11136-010-9591-y 20108048.

24. The EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990; 16(3):199–208. Epub 1990/11/05. doi: 10.1016/0168-8510(90)90421-9 10109801.

25. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339. doi: 10.1136/bmj.b2535

26. Desteghe L, Raymaekers Z, Vijgen J, Dilling-Boer D, Koopman P, Schurmans J, et al. Accuracy and cost-effectiveness of two handheld electrocardiogram recorders to screen for atrial fibrillation in a hospital setting. Eur Heart J. 2016;37 (Supplement 1):1265. http://dx.doi.org/10.1093/eurheartj/ehw434. 612285808.

27. Desteghe L, Raymaekers Z, Vijgen J, Dilling-Boer D, Koopman P, Schurmans J, et al. Accuracy and usability of handheld electrocardiogram recorders to detectatrial fibrillation in hospitalised patients. Europace. 2016;18 (Supplement 1):i177. http://dx.doi.org/10.1093/europace/euw158. 617786028.

28. Desteghe L, Raymaekers Z, Lutin M, Vijgen J, Dilling-Boer D, Koopman P, et al. Performance of handheld electrocardiogram devices to detect atrial fibrillation in a cardiology and geriatric ward setting. Europace. 2017;19(1):29–39. doi: 10.1093/europace/euw025 26893496.

29. Doliwa PS, Frykman V, Rosenqvist M. Short-term ECG for out of hospital detection of silent atrial fibrillation episodes. Scand Cardiovasc J. 2009;43(3):163–8. Epub 2008/12/20. doi: 10.1080/14017430802593435 19096977.

30. Haberman ZC, Jahn RT, Bose R, Tun H, Shinbane JS, Doshi RN, et al. Wireless smart phone equipped ECG enables large scale screening in diverse populations. Heart Rhythm. 2014;1):S312. http://dx.doi.org/10.1016/j.hrthm.2014.03.031. 71427925.

31. Haberman ZC, Jahn RT, Bose R, Tun H, Shinbane JS, Doshi RN, et al. Wireless smartphone ECG enables large-scale screening in diverse populations. J Cardiovasc Electrophysiol. 2015;26(5):520–6. doi: 10.1111/jce.12634 25651872.

32. Lau J, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway C, et al. Validation of an iphone ECG application suitable for community screening for silent atrial fibrillation: a novel way to prevent stroke. Circulation Conference: American Heart Association. 2012;126(21 SUPPL. 1). 70955633.

33. Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, et al. iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke. Int J Cardiol. 2013;165(1):193–4. Epub 2013/03/08. doi: 10.1016/j.ijcard.2013.01.220 23465249.

34. Tieleman RG, Plantinga Y, Rinkes D, Bartels GL, Posma JL, Cator R, et al. Validation and clinical use of a novel diagnostic device for screening of atrial fibrillation. Europace. 2014;16(9):1291–5. doi: 10.1093/europace/euu057 24825766.

35. Vaes B, Stalpaert S, Tavernier K, Thaels B, Lapeire D, Mullens W, et al. The diagnostic accuracy of the MyDiagnostick to detect atrial fibrillation in primary care. BMC family practice. 2014;15:113. doi: 10.1186/1471-2296-15-113 24913608.

36. Williams J, Pearce K, Benett I. The effectiveness of a mobile ECG device in identifying AF: sensitivity, specificity and predictive value. Br J Cardiol. 2015;22:70–2.

37. Crockford CJ, Ahmed O, Kaba R, Berry R. An analysis of the applicability of lead1 screening for cardiac arrhythmia in primary care settings using novel sensing technology & multiple commercial algorithms for automating detection to increase PPV of referrals for further investigation. Europace. 2013; 4):iv20. http://dx.doi.org/10.1093/europace/eut317. 71254381.

38. Koltowski L, Balsam P, Glowczynska R, Peller M, Maksym J, Blicharz L, et al. Comparison of kardia mobile (one lead ECGs records) with 12-lead ECGs in 100 consecutive patients with various cardiovascular disorders. Europace. 2017;19 (Supplement 3):iii353. 618768329.

39. Battipaglia I, Gilbert K, Hogarth AJ, Tayebjee MH. Screening for atrial fibrillation in the community using a novel ECG recorder. J Atr Fibrillation. 2016;9(2):1433. Epub 2016/12/03. doi: 10.4022/jafib.1433 27909536; PubMed Central PMCID: PMC5129689.

40. Orchard J, Freedman SB, Lowres N, Peiris D, Neubeck L. iPhone ECG screening by practice nurses and receptionists for atrial fibrillation in general practice: the GP-SEARCH qualitative pilot study. Australian family physician. 2014;43(5):315–9. 24791776

41. Chan LL, Chan SC, Yan BP. Feasibility and acceptability of atrial fibrillation screening using a hand-held ECG device in general practice setting in Hong Kong. Value in Health. 2017;20 (9):A599. http://dx.doi.org/10.1016/j.jval.2017.08.1136. 619024614.

42. Chan NY, Choy CC. Community screening for atrial fibrillation in a Chinese population using a smartphone-based wireless single-lead ECG. J Am Coll Cardiol. 2015;1:A467. 71833524.

43. Chan NY, Choy CC. Screening for atrial fibrillation in 13 122 Hong Kong citizens with smartphone electrocardiogram. Heart. 2016a;12. http://dx.doi.org/10.1136/heartjnl-2016-309993. 613158288.

44. Chan PH, Wong CK, Poh YC, Pun L, Leung WW, Wong YF, et al. Diagnostic performance of a smartphone-based photoplethysmographic application for atrial fibrillation screening in a primary care setting. J Am Heart Assoc. 2016b;5(7). Epub 2016/07/23. doi: 10.1161/JAHA.116.003428 27444506; PubMed Central PMCID: PMC5015379.

45. Gibson J, Hanjari M, Watkins C, Chauhan U. Opportunistic detection of atrial fibrillation in primary care: a mixed methods evaluation of the introduction of new healthcare technology. Eur Stroke J. 2017;2 (1 Supplement 1):112. http://dx.doi.org/10.1177/2396987317705242. 616966470.

46. Hussain W, Thakrar D. The use of a handheld device in identifying atrial fibrillation patients during flu vaccination clinics. Europace. 2016;18 (Supplement 2):ii19. http://dx.doi.org/10.1093/europace/euw268. 617764330.

47. Kaasenbrood F, Hollander M, Rutten FH, Gerhards LJ, Hoes AW, Tieleman RG. Yield of screening for atrial fibrillation in primary care with a hand-held, single-lead electrocardiogram device during influenza vaccination. Europace. 2016;18(10):1514–20. doi: 10.1093/europace/euv426 26851813.

48. Lowres N, Neubeck L, Salkeld G, Krass I, McLachlan AJ, Redfern J, et al. Feasibility and cost-effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies. the SEARCH-AF study. Thromb Haemost. 2014;111(6):1167–76. Epub 2014/04/02. doi: 10.1160/TH14-03-0231 24687081.

49. Orchard J, Lowres N, Freedman SB, Ladak L, Lee W, Zwar N, et al. Screening for atrial fibrillation during influenza vaccinations by primary care nurses using a smartphone electrocardiograph (iECG): a feasibility study. Eur J Prev Cardiol. 2016;23(2_suppl):13–20. http://dx.doi.org/10.1177/2047487316670255. 613012263.

50. Reeves B. Preliminary evaluation of the viewing function of the imPulse ECG monitor. NR.

51. Waring O, Davidson N, Stout M, Pearce K. Detection of atrial fibrillation in community locations using novel technology's as a method of stroke prevention in the over 65's asymptomatic population—should it become standard practise? Europace Conference: heart rhythm congress 2016 United kingdom [Internet]. 2016; 18:[ii39 p.]. Available from: http://onlinelibrary.wiley.com/o/cochrane/clcentral/articles/744/CN-01406744/frame.html [Accessed June 2018].

52. Yan BPY, Chan LLY, Lee VWY, Freedman B. Medical outpatient clinics an ideal setting for atrial fibrillation screening using a handheld single-lead ECG with automated diagnosis. Eur Heart J. 2016;37 (Supplement 1):888. http://dx.doi.org/10.1093/eurheartj/ehw433. 612283606.

53. Duarte R, Stainthorpe A, Greenhalgh J, Richardson M, Nevitt S, Mahon J, et al. Lead-I ECG for detecting atrial fibrillation in patients with an irregular pulse using single time point testing: a systematic review and economic evaluation. Health Technol Assess. [in press].

54. Taggar JS, Coleman T, Lewis S, Heneghan C, Jones M. Accuracy of methods for detecting an irregular pulse and suspected atrial fibrillation: A systematic review and meta-analysis. Eur J Prev Cardiol. 2016;23(12):1330–8. Epub 2015/10/16. doi: 10.1177/2047487315611347 26464292; PubMed Central PMCID: PMC4952027.

55. Jacobs MS, Kaasenbrood F, Postma MJ, Van Hulst M, Tieleman RG. Cost-effectiveness of screening for atrial fibrillation in primary care with a handheld, single-lead electrocardiogram device in the Netherlands. Europace. 2018;20(1):12–8. doi: 10.1093/europace/euw285 27733465.


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