How do hospital professionals involved in a randomised controlled trial perceive the value of genotyping vs. PCR-ribotyping for control of hospital acquired C. difficile infections?

BMC Infectious Diseases

Peter M Hawkey¹  Savita Gossain¹  Helen Parsons⁴  Nigel Stallard⁴  Katherine Hardy¹  Susan Manzoor²  Ala Szczepura³ 

[1] Public Health Laboratory Birmingham, Public Health England, Heart of England NHS Foundation Trust, Birmingham B9 5SS, UK;Research and Development, Heart of England NHS Foundation Trust, Birmingham B9 5SS, UK;Faculty of Health and Life Sciences, University of Coventry, Coventry, UK;Warwick Medical School, University of Warwick, Coventry, UK

关键词: Staff attitudes;    Value of test information;    MLVA sub-typing;    Ribotyping;    C. difficile tests;    Hospital infection control;   

Others  :  1134301
DOI  :  10.1186/1471-2334-14-154

 received in 2012-12-05, accepted in 2014-01-27,  发布年份 2014

【 摘 要 】

Background

Despite scientific advances in typing of C. difficile strains very little is known about how hospital staff use typing results during periods of increased incidence (PIIs). This qualitative study, undertaken alongside a randomised controlled trial (RCT), explored this issue. The trial compared ribotyping versus more rapid genotyping (MLVA or multilocus variable repeat analysis) and found no significant difference in post 48 hour cases (C difficile transmissions).

Methods

In-depth qualitative interviews with senior staff in 11/16 hospital trusts in the trial (5 MLVA and 6 Ribotyping). Semi-structured interviews were conducted at end of the trial period. Transcripts were content analysed using framework analysis supported by NVivo-8 software. Common sub-themes were extracted by two researchers independently. These were compared and organised into over-arching categories or ‘super-ordinate themes’.

Results

The trial recorded that 45% of typing tests had some impact on infection control (IC) activities. Interviews indicated that tests had little impact on initial IC decisions. These were driven by hospital protocols and automatically triggered when a PII was identified. To influence decision-making, a laboratory turnaround time < 3 days (ideally 24 hours) was suggested; MLVA turnaround time was 5.3 days. Typing results were predominantly used to modify initiated IC activities such as ward cleaning, audits of practice or staff training; major decisions (e.g. ward closure) were unaffected. Organisational factors could limit utilisation of MLVA results. Results were twice as likely to be reported as ‘aiding management’ (indirect benefit) than impacting on IC activities (direct effect). Some interviewees considered test results provided reassurance about earlier IC decisions; others identified secondary benefits on organisational culture. An underlying benefit of improved discrimination provided by MLVA typing was the ability to explore epidemiology associated with CDI cases in a hospital more thoroughly.

Conclusions

Ribotyping and MLVA are both valued by users. MLVA had little additional direct impact on initial infection control decisions. This would require reduced turnaround time. The major impact is adjustments to earlier IC measures and retrospective reassurance. For this, turnaround time is less important than discriminatory power. The potential remains for wider use of genotyping to examine transmission routes.

【 授权许可】

   
2014 Szczepura et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Panel TDRDEE, Banoo S, Bell D, Bossuyt P, Herring A, Mabey D, Poole F, Smith PG, Sriram N, Wongsrichanalai C, Linke R, O'Brien R, Perkins M: Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 2008, 6(11 Suppl):S16-26.
• [2]Szczepura A, Kankaanpa\0308a J: Assessment of health care technologies: case studies, key concepts and strategic studies. Chichester: Wiley; 1996.
• [3]Diagnostics Assessment Programme manual [http://www.nice.org.uk/aboutnice/whatwedo/aboutdiagnosticsassessment/DiagnosticsAssessmentProgrammeManual.jsp webcite]
• [4]Testore GP, Pantosti A, Cerquetti M, Babudieri S, Panichi G, Gianfrilli PM: Evidence for cross-infection in an outbreak of Clostridium difficile-associated diarrhoea in a surgical unit. J Med Microbiol 1988, 26(2):125-128.
• [5]Kamthan AG, Bruckner HW, Hirschman SZ, Agus SG: Clostridium difficile diarrhea induced by cancer chemotherapy. Arch Intern Med 1992, 152(8):1715-1717.
• [6]Gerard M, Defresne N, Daneau D, Van der Auwera P, Delmee M, Bourguignon AM, Meunier F: Incidence and significance of Clostridium difficile in hospitalized cancer patients. Eur J Clin Microbiol Infect Dis 1988, 7(2):274-278.
• [7]Cumming AD, Thomson BJ, Sharp J, Poxton IR, Fraser A: Diarrhoea due to Clostridium difficile associated with antibiotic treatment in patients receiving dialysis: the role of cross infection. Br Med J (Clin Res Ed) 1986, 292(6515):238-239.
• [8]Kuijper EJ, Coignard B, Tull P: Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect 2006, 12(Suppl 6):2-18.
• [9]Bartlett JG: Clinical practice. Antibiotic-associated diarrhea. N Engl J Med 2002, 346(5):334-339.
• [10]Gerding DN, Johnson S, Peterson LR, Mulligan ME, Silva J Jr: Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol 1995, 16(8):459-477.
• [11]Department of Health: Colstridium difficile infection: How to deal with the problem. London: Department of Health; 2009.
• [12]Stubbs SL, Brazier JS, O'Neill GL, Duerden BI: PCR targeted to the 16S-23S rRNA gene intergenic spacer region of Clostridium difficile and construction of a library consisting of 116 different PCR ribotypes. J Clin Microbiol 1999, 37(2):461-463.
• [13]Health Protection Agency: Enhanced fingerprinting of Clostridium difficile. Clostridium difficile Ribotyping Network for England (CDRNE). London: Health Protection Agency; 2008.
• [14]Kuijper EJ, van den Berg RJ, Brazier JS: Comparison of molecular typing methods applied to Clostridium difficile. Methods Mol Biol 2009, 551:159-171.
• [15]Killgore G, Thompson A, Johnson S, Brazier J, Kuijper E, Pepin J, Frost EH, Savelkoul P, Nicholson B, van den Berg RJ, Kato H, Sambol SP, Zukowski W, Woods C, Limbago B, Gerding DN, McDonald LC: Comparison of seven techniques for typing international epidemic strains of Clostridium difficile: restriction endonuclease analysis, pulsed-field gel electrophoresis, PCR-ribotyping, multilocus sequence typing, multilocus variable-number tandem-repeat analysis, amplified fragment length polymorphism, and surface layer protein A gene sequence typing. J Clin Microbiol 2008, 46(2):431-437.
• [16]Warny M, Pepin J, Fang A, Killgore G, Thompson A, Brazier J, Frost E, McDonald LC: Toxin production by an emerging strain of Clostridium difficile associated with outbreaks of severe disease in North America and Europe. Lancet 2005, 366(9491):1079-1084.
• [17]Fawley WN, Freeman J, Smith C, Harmanus C, van den Berg RJ, Kuijper EJ, Wilcox MH: Use of highly discriminatory fingerprinting to analyze clusters of Clostridium difficile infection cases due to epidemic ribotype 027 strains. J Clin Microbiol 2008, 46(3):954-960.
• [18]Brazier JS, Raybould R, Patel B, Duckworth G, Pearson A, Charlett A, Duerden BI: Distribution and antimicrobial susceptibility patterns of Clostridium difficile PCR ribotypes in English hospitals, 2007-08. Euro Surveill 2008., 13(41) http://www.ncbi.nlm.nih.gov/pubmed/18926105 webcite
• [19]Department of Health: The Health and Social Care Act 2008. Code of Practice for the NHS on the prevention and control of healthcare associated infections and related guidance. London: DH Publications; 2009.
• [20]Goldenberg SD, French GL: Diagnostic testing for Clostridium difficile: a comprehensive survey of laboratories in England. J Hosp Infect 2011, 79(1):4-7.
• [21]Tanner HE, Hardy KJ, Hawkey PM: Coexistence of multiple multilocus variable-number tandem-repeat analysis subtypes of Clostridium difficile PCR ribotype 027 strains within fecal specimens. J Clin Microbiol 2010, 48(3):985-987.
• [22]Hardy K, Manzoor S, Marriott C, Parsons H, Waddington C, Gossain S, Szczepura A, Stallard N, Hawkey PM: Utilizing rapid multiple-locus variable-number tandem-repeat analysis typing to Aid control of hospital-acquired clostridium difficile infection: a multicenter study. J Clin Microbiol 2012, 50(10):3244-3248.
• [23]Strauss A, Corbin J: Basics of Qualitative Research: Grounded Theory Procedures and Techniques. Newbury Park, CA: Sage; 1990.
• [24]Bazeley P: Qualitative Data Analysis with NVivo. SAGE Publications Ltd; 2007.
• [25]Seale C: The Quality of Qualitative Research. Thousand Oaks, CA: Sage; 1999.
• [26]Quarterly Epidemiological Commentaries on MRSA and MSSA bacteraemia and C. difficile infection 2011. http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1259151891722 webcite
• [27]Fawley WN, Underwood S, Freeman J, Baines SD, Saxton K, Stephenson K, Owens RC Jr, Wilcox MH: Efficacy of hospital cleaning agents and germicides against epidemic Clostridium difficile strains. Infect Control Hosp Epidemiol 2007, 28(8):920-925.
• [28]Boyce JM: Environmental contamination makes an important contribution to hospital infection. J Hosp Infect 2007, 65(Suppl 2):50-54.
• [29]Alfa MJ, Lo E, Wald A, Dueck C, DeGagne P, Harding GK: Improved eradication of Clostridium difficile spores from toilets of hospitalized patients using an accelerated hydrogen peroxide as the cleaning agent. BMC Infect Dis 2010, 10:268. BioMed Central Full Text
• [30]ICNA Audit Tool for Monitoring Infection Control Standards in Community Settings http://www.nric.org.uk/integratedcrd.nsf/f0dd6212a5876e448025755c003f5d33/3395764df06ee7f9802571ca004c7d70?OpenDocument webcite
• [31]Tackling healthcare associated infections through effective policy action http://www.bma.org.uk/health_promotion_ethics/diseases/tacklinghcais.jsp webcite
• [32]Carroll KC: Tests for the diagnosis of Clostridium difficile infection: the next generation. Anaerobe 2011, 17(4):170-174.
• [33]Wilcox MH, Planche T, Fang FC, Gilligan P: What is the current role of algorithmic approaches for diagnosis of Clostridium difficile infection? J Clin Microbiol 2010, 48(12):4347-4353.
• [34]Health Protection Agency: Clostridium difficile Ribotyping Network (CDRN) for England and Northern Ireland. 2009/10 Report. London: Health Protection Agency; 2011.
• [35]National Audit Office: Reducing Healthcare Associated Infections in Hospitals in England. London: National Audit Office; 2009.
• [36]Lewin S, Glenton C, Oxman AD: Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study. BMJ 2009, 339:b3496.
• [37]Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P: Framework for design and evaluation of complex interventions to improve health. BMJ 2000, 321(7262):694-696.
• [38]Ferrante Di Ruffano L, Davenport C, Eisinga A, Hyde C, Deeks JJ: A capture-recapture analysis demonstrated that randomized controlled trials evaluating the impact of diagnostic tests on patient outcomes are rare. J Clin Epidemiol 2012, 65(3):282-287.
• [39]Ferrante Di Ruffano L, Hyde CJ, McCaffery KJ, Bossuyt PM, Deeks JJ: Assessing the value of diagnostic tests: a framework for designing and evaluating trials. BMJ 2012, 344:e686.
• [40]Dubberke ER, Wertheimer AI: Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol 2009, 30(1):57-66.