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Year : 2019  |  Volume : 32  |  Issue : 4  |  Page : 1173-1176

The role of root cause analysis in the prevention of venous thromboembolism in intensive care patients

1 Department of Anesthesia and ICU, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Anesthesia and ICU, Critical Care at Sharq El-Madina Specialized Center Hospital, Sidi Beshr Bahary, Alexandria, Egypt

Date of Submission11-Nov-2018
Date of Decision24-Dec-2018
Date of Acceptance30-Dec-2018
Date of Web Publication31-Dec-2019

Correspondence Address:
Mohamed H Younis
Sidi Bishr, Elmontaza District, Alexandria
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/mmj.mmj_356_18

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To review the role of root cause analysis (RCA) in the prevention of venous thromboembolism (VTE) in intensive care patients.
Data sources
A systematic search of MEDLINE (PubMed, Medscape, Science Direct, and EMF-Portal) and internet was conducted on all articles published from 2003 to 2017.
Study selection
English-language reports of the indications of revision sinus surge were included.
Data extraction
Articles not reporting on the role of RCA in the prevention of VTE in intensive care patients were not included. Three independent investigators extracted data on methods, health outcome, and prevention protocols.
Data synthesis
Comparisons were made by structured review, with the results tabulated. Four authors studied the role of RCA in the prevention of VTE. There were 11 studies on VTE risk assessment protocols and eight studies emphasized different methods of VTE prophylaxis.
Analysis of the avoidable events showed that lack of the VTE risk assessment in the first place was the main factor for their occurrence.
Organizations are required to investigate all inpatient venous thromboembolic events using RCA methodology, where specific questions can be asked in relation to VTE risk assessment and prophylaxis; this eventually allows them to learn from VTE incidents and improve patient safety.

Keywords: risk assessment tool, root causes analysis, venous thromboembolism

How to cite this article:
EL Sharkawy OA, Rayan AA, Younis MH. The role of root cause analysis in the prevention of venous thromboembolism in intensive care patients. Menoufia Med J 2019;32:1173-6

How to cite this URL:
EL Sharkawy OA, Rayan AA, Younis MH. The role of root cause analysis in the prevention of venous thromboembolism in intensive care patients. Menoufia Med J [serial online] 2019 [cited 2020 Oct 28];32:1173-6. Available from: http://www.mmj.eg.net/text.asp?2019/32/4/1173/274263

  Introduction Top

Venous thromboembolism (VTE) in the form of deep venous thrombosis and pulmonary embolism is a leading cause of hospital-related deaths worldwide with range between 10 and 30% and associated with additional morbidity and mortality [1]. With the increase in the awareness of the VTE problem, a number of reports, guidelines, and initiatives have been published to help increase the number of patients assessed on admission to hospital and ensure receiving appropriate prophylaxis when identified as being at risk of VTE [2]. All health service providing organizations are required to have a VTE prevention protocol, which consists of risk assessment model linked to a menu of appropriate prophylaxis options for each level of risk, and this will provide a guidance for management of each patient regarding the selection of the prophylaxis methods [3], and also the assessment of bleeding risk and the time of using prophylaxis should be a part of such protocol [4]. There are two models for risk assessment: qualitative and quantitative risk models. The qualitative model ascribes groups of patients to broad risk categories or 'buckets' of risk that are linked to appropriate prophylaxis options for each group without going through individualized point scoring [5]. Quantitative model includes a scoring system with several sets of risk factors, for example, Caprini scoring system, which was pioneered an individualized quantitative risk assessment model for both medical and surgical patients. In this system, one set is scored as 1 point for each risk factor, the second as 2 points, the third as 3 points, and the fourth as 5 points, and then each set is scored to produce a subtotal, and the four subtotals are summed to yield the total risk factor score and recommended prophylaxis [6]. The second part of the prevention protocol is applying the prophylaxis method according to each patient condition; there are two methods of prophylaxis:

  1. Mechanical methods include early mobilization, intermittent pneumatic leg compression, and inferior vena cava filters [7]
  2. Pharmacological agents: anticoagulation agents are used in both prevention and treatment according to either the dose or the duration of the agent used. When deciding to use pharmacologic prophylaxis, risk of bleeding should be considered and weighed against the risk of developing a VTE in each individual patient [8].

The ideal VTE prevention protocol would have the following characteristics:

  1. Accurately detect all patients at risk of developing deep vein thrombosis
  2. Reliably exclude patients who would be unlikely to develop deep venous thrombosis, and minimizing inappropriate over-prophylaxis in those at lower risk
  3. Provide an actionable recommendation for permutations of VTE and bleeding risk
  4. Be simple to use in routine clinical practice, with minimal need for laboratory investigations or complex calculations
  5. Have predictors of VTE risk available to ordering provider at the point of care
  6. Provide decision support regarding those who would benefit from combination mechanical and anticoagulant prophylaxis
  7. Integrate into clinical practice results in a way that decreases hospital-associated VTE without any increase in bleeding
  8. Lend itself to automation, and to dynamic ongoing re-evaluations [9].

Although this looks good on paper and theoretically will prevent VTE events, what will happen if the patient developed VTE events? This question will lead to the investigation of what went wrong in the patient's prevention protocol and hence comes the role of root cause analysis (RCA) method. RCA is simply application of well-known common sense techniques that can produce systematic quantified and documented approach to identification, understanding, and resolution of a problem [10].

Root cause is defined as the most basic reason for undesirable condition or problem, which, if eliminated or corrected, would have prevented this problem from existing. So RCA refers to the process to identifying these casual factors. RCA initially was developed to analyze industrial accidents, and now in medicine, RCA is widely deployed as a cause analysis tool in health care [11]. RCA will explore the how, the what, and most importantly the whyof patient safety incidents to happen. The technique uses a structured process to move beyond identifying what went wrong and helps identify the contributory factors and root causes of patient safety incidents using a number of tools and techniques [12].

Comprehensive RCA can be time and resource consuming, so organizations should establish local triggers to establish which events prompt a RCA. The following are some suggested triggers for RCA in VTE events:

  1. Patient presenting with a VTE within 3 months of previous admission
  2. Inpatients developing a VTE
  3. Diagnosis of VTE by radiological, ultrasound, or other imaging investigations
  4. Complaints identifying VTE as an issue
  5. Sudden death of a patient, suspected of suffering a VTE during hospital admission
  6. Sudden death of a patient within 3 months of admission, suspected to be related to a VTE
  7. VTE reported in a postmortem
  8. Pregnant women or women up to 6 weeks following delivery, presenting with or dying from a VTE [13].

There are two levels of investigation: a 'single RCA', which is for a patient who presented with or died of a VTE (within 3 months of a hospital admission), and an 'aggregate RCA,' which is for multiple VTE events, in which we will investigate a number of previously uninvestigated similar incidents, to determine the root causes and develop an action plan to address these issues. In the investigation process, we will ask three questions: 'what happened?' with establishing the timeline; 'how it happened?' with examination of the problem, and 'why it happened?' with scrutinizing of the problem. The studies show low levels of VTE knowledge existed throughout the system as no one felt directly responsible for VTE risk assessment or for putting an action plan based on the risk assessment. Here comes the role of RCA. By applying RCA, it will highlight the importance of continuous training, risk assessment to prevent VTE, and to understand the significance of the procedure to ensure that VTE preventative measures are administered; it is also essential that medical staff acknowledge that VTE prevention is the responsibility of everyone involved in a patient's care. The aim of this work was to review the usage of RCA to investigate the preventable VTE events in ICU patients.

  Materials and Methods Top

Data sources

A systemic search of the role of RCA in the prevention of VTE in intensive care patients using MEDLINE (PubMed, Medscape, Science Direct, EMF-Portal) and internet was conducted on all articles published from 2003 to 2017. During research, the focus was on risk assessment protocols/methods of prophylaxis/items of RCA program. Additional records were identified by reference lists in retrieved articles. The search was established in the electronic databases from 2003 to 2017.

Data extraction

Articles not reporting on the role of RCA in the prevention of VTE in intensive care patients were not included. Three independent investigators extracted data on methods, health outcome, and prevention protocols.

The analyzed publications were evaluated according to evidence-based medicine criteria using the classification of the US Preventive Services Task Force and UK National Health Service protocol for evidence-based medicine in addition to the Evidence Pyramid.

US Preventive Services Task Force classification was as follows

  1. Level I: evidence obtained from at least one properly designed randomized controlled trial
  2. Level II-1: evidence obtained from well-designed controlled trials without randomization
  3. Level II-2: evidence obtained from well-designed cohort or case–control analytic studies, preferably from more than one center or research group
  4. Level II-3: evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence
  5. Level III: opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees [14].

Study quality assessment

Quality of all the studies was assessed. Important factors included study design, ethical approval, calculation of evidence power, specified eligibility criteria, appropriate controls, adequate information, and specified assessment measures.

It was expected that confounding factors would be reported and controlled for and appropriate data analysis made in addition to an explanation of missing data.

Data synthesis

A structured systematic review was done with the results tabulated. Three authors studied the indications of RCA in the prevention of VTE. There were 11 studies about VTE risk assessment protocols, and eight studies emphasized different methods of VTE prophylaxis.

  Results Top

Study selection and characteristics

In total, 35 potentially relevant publications were identified. Moreover, 28 articles were excluded as they differed from our inclusion criteria. Seven studies were reviewed as they met the inclusion criteria. Three studies showed the importance of formulating a risk assessment protocol for VTE, and four studies showed the importance of investigating all cases of ICU patients who developed VTE by RCA. The results were tabled [Table 1].
Table 1: Root cause analysis for venous thromboembolism events

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  Discussion Top

The incidence of VTE varies among heterogeneous ICU population and depends upon the reason for admission, and there is lack of data about VTE prophylaxis in developing countries as showed in ENDORSE study [15]. Other studies showed the need of VTE risk assessment program in health organization. After conducting RCA for VTE events, it was found that they can be attributed to inadequate prophylaxis in 51 (32.5%), contraindication to chemical prophylaxis in 23 (14.6%), contraindication to all prophylaxis in 11 (7.0), prophylaxis failure in 43 (27.4%), line associated in 20 (12.7%), and was considered unexpected in nine (5.7%) patients without any risk factors for VTE. Inadequate prophylaxis resulted from failure to prescribe in 17 (33.3%), unexplained delay in initiation in eight (15.7%), unexplained missed doses in seven (13.7%), inadequate duration of prophylaxis in five (9.8%), or inferior agent or dose in nine (17.6%) cases, with a combination of all these in five (9.8%) cases. This was reported by Roberts et al. [16]. Shlebak et al. [17] found that VTE was attributed to absence of risk assessment protocol in the first place. Benjamin and Warwick [18] reported that if patients develop VTEs despite the use of such guidelines, then the reasons are that the guidelines were (a) followed but the VTE occurred anyway and (b) not implemented appropriately.

In another study, a systemic analysis of the 94 incidents has identified as potential contributing factors to the development of hospital-associated VTE. There were 45 (47.9%) cases where there was insufficient information to determine the underlying contributing factor. Five (33.3%) cases had inconclusive information to determine if the VTE was preventable or not, six (40%) cases had appropriate precautions observed (unpreventable), and in four (26.7%) cases, the patient death may have been avoidable had appropriate VTE prophylaxis been in place (preventable). This was reported by Malone and George [19].

  Conclusion Top

All health organizations are required to have a VTE risk assessment protocol consisting of VTE risk assessment linked to a menu of appropriate VTE prophylaxis options, with the establishment of local triggers to prompt a RCA in case of developing VTE events despite the presence of such protocol. The aim of this investigation is to prevent VTE events by correction of its root cause.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

  References Top

Geerts W, Cook D, Selby R, Etchells E. Venous thromboembolism and its prevention in critical care. J Crit Care 2002; 17:95–104.  Back to cited text no. 1
Rowswell HR, Nokes TJ. Significant reduction in hospital-acquired thrombosis: impact of national risk assessment and real-time feedback. Open Heart 2017; 4:e000653.  Back to cited text no. 2
Kirchner J, Obermann A, Stückradt S, Tüshaus C, Goltz J, Liermann D, et al. Lung infarction following pulmonary embolism: a comparative study on clinical conditions and CT findings to identify predisposing factors. Rofo 2015; 187:440–444.  Back to cited text no. 3
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Maynard G, Stein J. Designing and implementing effective venous thromboembolism prevention protocols: lessons from collaborative efforts. J Thromb Thrombolysis 2010; 29:159–166.  Back to cited text no. 5
Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med 2007; 146:278–288.  Back to cited text no. 6
Chana-Rodríguez F, Mañanes RP, Rojo-Manaute J, Haro JA, Vaquero-Martín J. Methods and guidelines for venous thromboembolism prevention in polytrauma patients with pelvic and acetabular fractures. Open Orthop J 2015; 9:313–320.  Back to cited text no. 7
Kahn SR, Lim W, Dunn AS, Cushman M, Dentali F, Akl EA, et al. Prevention of VTE in nonsurgical patients antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2 Suppl):e195S–e1226.  Back to cited text no. 8
Maynard G, Jenkins IH, Merli GJ. Venous thromboembolism prevention guidelines for medical inpatients: mind the (implementation) gap. J Hosp Med 2013; 8:582–588.  Back to cited text no. 9
Wu AW, Lipshutz AK, Pronovost PJ. Effectiveness and efficiency of root cause analysis in medicine. JAMA 2008; 299:685–687.  Back to cited text no. 10
Knudsen P, Herborg H, Mortensen AR, Knudsen M, Hellebek A. Preventing medication errors in community pharmacy: root-cause analysis of transcription errors. Qual Saf Health Care 2007; 16:285–290.  Back to cited text no. 11
House of Commons Health Committee Report. The prevention of venous thromboembolism in hospitalized patients. London: The Stationery Office; 2005.  Back to cited text no. 12
National Health Service (NHS). Venous thromboembolism (VTE) risk assessment. England: NHS; 2018.  Back to cited text no. 13
Guirguis J, Calonge N, Miller T, Siu A, Teutsch S, Whitlock E, et al. Current processes of the U.S. Preventive Services Task Force: refining evidence-based recommendation development. Ann Intern Med 2007; 147:117–122.  Back to cited text no. 14
Goubran HA, Sholkamy S, El-Haddad A, Mahmoud A, Rizkallah MA, Sobhy G. Venous thromboembolism risk and prophylaxis in the acute hospital care setting: report from the ENDORSE study in Egypt. Thromb J 2012; 10:20.  Back to cited text no. 15
Roberts LN, Patel RK, Bonner L, Arya R. Outcomes from root cause analysis of hospital-associated thrombosis over twelve months: a single centre experience. Blood 2011; 118:675.  Back to cited text no. 16
Shlebak A, Sandhu P, Ali V, Jones G, Baker C. The impact of the DoH commissioning for quality and innovation incentive on the success of venous thromboembolism risk assessment in hospitalised patients. A single institution experience in a quality outcome improvement over a 4-year cycle. JRSM Open 2016; 7:6.  Back to cited text no. 17
Benjamin S, Warwick D. Venous thromboembolism after total knee replacement or total hip replacement: what can be learnt from root-cause analysis? Ann R Coll Surg Engl 2016; 98:538–542.  Back to cited text no. 18
Malone C, George L. Incident Investigation and VTE. 2014. Available from: www.cec.health.nsw.gov.au/__data/assets/pdf_file/0004/259519/vte- prevention-launch-gaps-reporting-c.malone.pdf. [Accessed 2018 May 01].  Back to cited text no. 19


  [Table 1]


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