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Surgical care checklists to optimize patient care following postoperative complications Philip H. Pucher, M.D., Ph.D., M.R.C.S.a,*, Rajesh Aggarwal, M.B.B.S., M.A., Ph.D., F.R.C.S.b,c, Mark H. Almond, M.D., M.Sc., M.R.C.P.d, Ara Darzi, M.D., F.R.C.S., F.A.C.S., K.B.E.a a
Department of Surgery and Cancer, St Mary’s Hospital, Imperial College London, London, UK; Department of Surgery, Faculty of Medicine and cArnold & Blema Steinberg Medical Simulation Centre, Faculty of Medicine, McGill University, Montreal, QC, Canada; dDepartment of Respiratory Medicine and Allergy, St Mary’s Hospital, Imperial College London, London, UK
b
KEYWORDS: Checklist; Surgery; Postoperative; Complications; Failure to rescue; Ward-based care
Abstract BACKGROUND: Postoperative complications are common. Inconsistency in the care of complications is reflected in variable rates of failure to rescue. This study aims to develop and validate checklists for treatment of common postoperative complications. METHODS: Initial checklists were based on best evidence, with expert clinician review. Casenote review was performed, comparing checklist item completion with outcomes. Logistic regression was performed for risk of further morbidity, considering American Society of Anesthesiology grade, age, sex, and checklist compliance. Checklists were finalized through end user multidisciplinary review. RESULTS: Evidence-based checklists were developed. Retrospective casenote review revealed management of 86% (31/37) of these complications to be noncompliant with checklist-mandated care. This resulted in delays and errors in 65% (24/37) of cases, with median treatment delay of 6 hours (interquartile range 5.4 hours). Regression analysis revealed poor checklist compliance to be to only significant factor (odds ratio 6.75, 95% confidence interval 1.11 to 41.00, P 5 .038) for developing further morbidity. CONCLUSIONS: Management of complications is highly variable, with failure to adhere to best practice principles significantly associated with an increased risk of further morbidity. This study presents an evidence-based framework for the development of checklists to standardize care. Ó 2015 Elsevier Inc. All rights reserved.
No funding was received for this body of work. Rajesh Aggarwal is a consultant for Applied Medical. All other authors declare no conflicts of interest. * Corresponding author. Tel.: 144-203-312-6666; fax: 144-203-3126309. E-mail address: [email protected] Manuscript received November 18, 2014; revised manuscript February 27, 2015 0002-9610/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2015.03.018
Despite continuing advances in surgical care, postoperative complications remain a common and accepted risk of surgery. Morbidity rates of up to 50% following major gastrointestinal surgical procedures are reported.1,2 The effective identification and amelioration of adverse events in the postoperative phase is vital to the successful recovery of patients who suffer complications. Unfortunately, this is
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not always the case, with the quality of management of complications shown to vary greatly between institutions, as reflected by differing rates of death following the development of complications, that is, failure to rescue.3,4 Investigation of the factors underlying this variability has identified certain structural factors, such as nurse:patient staffing ratios.5 However, this has accounted only for a small proportion of clinical variability seen. In a recent survey of 7,906 American surgeons, over 70% of respondents attributed witnessed medical errors to individual-level factors (ie, process), rather than system-level (structural) factors.6 Studies of error and patient safety have indicated that the majority of such process errors may be classified as errors of omission,7–9 defined as mental lapses or attentional failures,10 rather than active errors of commission, resulting in deviation from ideal practice and placing patients at risk of harm. The reduction and mitigation of such failures, experts such as James Reason suggest,10 are best addressed through checklists or protocols. Functioning as mental aids or prompts, checklists can be effective in the structuring of both crisis management as well as routine care, with widespread use of checklists in other high-complexity industries such as aviation.11 In these industries, checklists exist to guide the management of specific crises, such as engine flameouts or a failure to deploy landing gear. Thus far, checklists in surgery have been most widely employed as preoperative checklists12 or to guide patient postoperative care in best case models of recovery. In this form, the effectiveness of checklists to promote adherence to best practice, and reduce variation in care, is well established with enhanced recovery protocols.13 Care outcomes have been shown to improve significantly in relation to levels of compliance with care protocols defining best practice care.14 Diagnosis-specific checklists have been more recently introduced for the management of operating room crises.15,16
The standardized management of critical events such as operating room fires, or a failed airway, was significantly improved with the introduction of crisis checklists in a recent study reported by Arriaga et al.15 However, although intraoperative crises are, fortunately, rare (with an incidence of ,1.5%),17 this stands in stark contrast to the high incidence of postoperative complications which may affect as many as half of the patients following major surgery. The variability in the management of postoperative complications occurs despite established, evidence-based guidelines for the treatment of many of the most common complication types, such as catheter-associated urinary tract infections.18 It therefore stands to reason that a similar approach may be effective for postoperative crises also. We hypothesized that the development of checklists for common gastrointestinal surgical complications might therefore have a significant impact on reducing error and standardizing management of these conditions. This study sought to identify the most common complications occurring after complex gastrointestinal surgical procedures, and presents a structured development and validation of treatment checklists for patient management.
Figure 1
Methods We adopted a multiphase, iterative design process. This was based in part on previously published checklist design methodologies, and involved initial literature review, followed by expert assessment, casenote-based validation, and end user feedback (Fig. 1).16,19,20
Literature review An online search of recently published literature was performed. The PubMed online database was searched for
Iterative checklist development process.
P.H. Pucher et al.
Type and incidence rate of most frequently reported postoperative complications Morbidity rate (%) Wound infection
Study
Data source
Procedure
n
Overall
Kwaan, 2013 (USA) Molena, 2013 (USA) Yasunaga, 2013 (Japan) Merkow, 2012 (USA) Cone, 2012 (USA) Grant, 2012 (USA) Total Overall complication rate (%) Proportion of all reported complications (%) Mean complication rank
NSQIP NIS National database NSQIP NSQIP NSQIP
Colectomy Esophagectomy Gastrectomy or colectomy Esophagectomy Colectomy Pancreatectomy
4,875 18,966 30,765
17 n/r 15.5
7
1,600 24,730 1,030 81,936
43 n/r n/r
IA sepsis
HAP
Sepsis
2.3 18.25 2.3
4.3 5.92 1.2
2.8
20 6 9
30 3
26 4
9.92
3.59
18
1.4
5.1
UTI
Cardiac
Renal
Bleed
PE
.4 1.46 2.2
.7 6.19 .1
.4 3.75
.7
1.7
2.9 5.92 .9
7 2 6
3 1.8
2.7
4.63
2.49
1.75
1.58
26.8
15.1
6.5
11.2
2.6
3.2
4
4.6
.3
1.8
1.9
.74
.15
.04
4.9
6.0
3.7
.7
5.75
6
6.3
6.3
Checklists for postoperative complications
Table 1
Only most commonly reported complications shown, therefore percentages of all reported complications do not sum to 100%. HAP 5 hospital-acquired pneumonia; IA sepsis 5 intra-abdominal sepsis; NIS 5 National Inpatient Sample; n/r 5 not reported; NSQIP 5 National Surgical Quality Improvement Project; PE 5 pulmonary embolism; UTI 5 urinary tract infection.
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4 Table 2
Results of casenote review
n Age (years) Male:Female ratio Checklist compliance (%) 100% compliance achieved Delays to treatment (hours)
37 73 (58–82) 24:13 60 (48–72) 16% (6/37) 6 (3.3–8.7)
Results reported as median (interquartile range).
studies published in the last 2 years (2012 to 2013) reporting postoperative outcomes for gastrointestinal surgical procedures using the following search terms: (‘‘postoperative outcome’’ or ‘‘complications’’) and ‘‘surgery’’ and (‘‘esophagectomy’’ or ‘‘gastrectomy’’ or ‘‘colectomy’’ or ‘‘pancreat*’’). Both benign and neoplastic resections were considered, with studies reporting at least 1,000 cases or more included for final analysis. Data on incidence of postoperative complications were extracted from included publications. Reported complications were ranked in order of incidence, rather than using absolute complication rates, to control for the variable risks of morbidity for different surgical procedures. Mean of ranks across all included studies were calculated, with the most common (ie, highest ranked) complications selected for checklist development.
Checklist development Initial checklists were drafted for the management of each identified complication based on best published evidence. This was located through online searching of electronic databases (PubMed, Google Scholar), as well as grey literature and guidelines published by national and international specialist associations. A formal literature review was not conducted, as treatment was based on specialist associations’ recommendations and endorsed publications, such as the Society for Antimicrobial Therapy’s Working Party Group on Hospital-Acquired Pneumonia.21
Table 3
These were then combined with local protocols, where applicable (eg, local antibiotic prescribing guidelines).
Clinical expert review Each checklist was subsequently reviewed by a panel of clinical experts, who were asked to comment on checklist usability, content, and practical applicability to their personal practice. In addition, they were asked to identify any common clinical errors they felt were not addressed by the checklist, which might merit inclusion. Finally, they were asked whether they would want their residents using the checklists in the management of patients under their care. Feedback gained from the expert panel resulted in revision and second iteration of the checklists.
Casenote review and clinical validation To assess relevance of the checklists to current clinical practice, and estimate the improvement in clinical performance which might be achieved with full implementation thereof, a retrospective casenote analysis was performed. If, for example, all checklist-included items were already being completed, there would have been little point in their development or introduction to clinical practice. The last 40 consecutive postoperative complications to which the checklists applied were identified from a prospectively maintained database of gastrointestinal surgery patients at our institutiondan urban tertiary academic center in London, UK. Occurrence of a complication was defined on an intention-to-treat basis as recorded by the clinical team. Patient casenotes were retrieved and management of complications compared with checklist items. Completion of checklist items was recorded, as well as any delays or process errors occurring in the management of complications, by a clinician researcher experienced in casenote review. Errors were defined as any action which failed to achieve its aims, or an incorrect action for a given aim. Delays were defined as failures of prescribed actions or treatments to take place at the intended time, or when
Delays and adverse events in management of common surgical complications
Event
n (%)
Example(s)
Relevance to checklist
Process error
9 (37)
Prescribing error
9 (37)
Catheter removal where possible in cases of suspected UTI. Antibiotics to be given early, with blood cultures first if pyrexial Evidence- and local protocol-based guidance on diagnosis-specific antibiotic prescribing
Communication failure
6 (25)
Catheter-associated UTI treated with catheter change, delay to administration of antibiotics Incorrect antibiotic regimen prescribed, later corrected Failure to prescribe stat dose on commencing antibiotics Suspected diagnosis made by specialist nurse, interns advised, but waited to speak to senior residents before starting treatment
UTI 5 urinary tract infection.
Checklist, endorsed by seniors, flattens hierarchy and allows initiation of treatment by any member of the clinical team
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immediately intended actions (such as administration of ‘‘stat’’ dose antibiotics) were not accomplished within an hour. A second clinician independently reviewed 30% of cases, with inter-rater reliability calculated using Cohen’s kappa. The relationship between quality of management of complications, as measured by the number of checklist items completed, and subsequent patient outcomes was analyzed. Logistic regression analysis, using a forward logistic model, was performed for the risk of developing further complications, with checklist compliance, age, American Society of Anesthesiology grade, and sex considered as independent variables (IBM SPSS Statistics 21; IBM Corp, Armonk, NY). The assessed cohort size was considered too small for any impact on morbidity or mortality to be seendthis was not assessed. For all analyses, a P value of less than .05 was considered statistically significant.
5 complications each made up less than 1% of all reported morbidity and were thus not further considered.
Checklist development A search of published peer-reviewed and grey literature was conducted,18,21–27 and combined with local prescribing and treatment protocols in the development of the first iteration of Post-Operative Surgical Checklist for Hospital care (POSCH), for each of the 6 complications.
Clinical expert review
Following clinical validation, a penultimate version of the checklists was presented to a multidisciplinary group of end users, comprised of residents, interns, and nursing staff. They were asked to review the format, readability, and practicability of use. They were asked to identify any desired changes or errors, and whether they would use checklists in their own clinical practice. This feedback was taken into account and a final iteration of checklists completed.
A group of 5 clinical experts in surgery (n 5 3) and critical care and anesthesia (n 5 2) were consulted on the use of the POSCH checklists in clinical practice. All (5/5, 100%) agreed that the checklists were useful and relevant in the management of postoperative complications, and would encourage their trainees to use them. The expert panel also recommended minor modifications which were incorporated in the second iteration of the checklists. For example, experts identified a common clinical errordthe delay to initiation of treatment when antibiotics were initiated, but no loading dose prescribed. Relevant checklist items were changed to include the prescription of loading doses to address this. In addition, minor changes were made to phrasing and formatting (ie, informing of a senior member of team, previously recommended, made mandatory).
Results
Casenote review and clinical validation
Literature review
Of the 40 identified cases, 3 clinical records could not be retrieved, resulting in a total of 37 casenotes undergoing review (Table 2). Thirty percent (11/37) was reviewed by an independent second clinician reviewer, with very good inter-rater reliability (Cohen’s kappa 5 .775, P , .001). Overall checklist compliance was median 60% (interquartile range 40% to 72%), with full compliance (100% of checklist items met) seen in only 16% (6/37) of the cases. Sixty-five percent (24/37) of the cases were associated with delay or error in treatment (Table 3). Thirty-seven percent (9/24) of the errors were related to general process error, such as failure to remove a urinary catheter associated with infection. Errors relating specifically to prescription errors, generally relating to a failure to comply with local antibiotic guidelines, were seen in a further 37% (9/24). In 25% (6/24), errors were related to communication failures, such as where a suspected diagnosis was made but not acted upon because of delays in communicating to an appropriate member of the clinical team. These errors resulted in a median 6-hour (interquartile range 3.3 to 8.7 hours, range 1 to 36 hours) delay to the patient receiving appropriate treatment. All documented errors were considered preventable with the appropriate use of the developed checklists.
End user review
The literature search as described returned 6 publications (Table 1). These described postoperative outcomes for 81,936 patients following colectomy, esophagectomy, gastrectomy, and pancreatectomy, with an overall complication rate of 17% to 43%. All data were sourced from large-scale, well-validated national databases; we accepted each database’s own criteria for the included complications. Calculating the mean ranked incidence of all complications, wound infection, hospital-acquired pneumonia, sepsis, intra-abdominal sepsis/anastomotic leak, and urinary tract infection was identified as the 5 most common postoperative complications, and considered for checklist development. Cardiac and renal failures were the sixth and seventh most common complications, but were excluded as these descriptions covered a potentially broad range of underlying pathologies, each requiring different treatment. Surgical bleeding, as the next most common type of morbidity, was included. The 6 complications selected for checklist development (wound infection, pneumonia, sepsis, anastomotic leak, urinary tract infection, and bleeding) accounted for 92.2% of all reported morbidity. Pulmonary embolus and all other reported postoperative
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The relationship between checklist compliance and outcomes were analyzed. Logistic regression modeling, considering checklist compliance, American Society of Anesthesiology grade, age, and sex for the risk of developing further (multiple) morbidity revealed checklist compliance of less than 50% to be to only significant determining factor (odds ratio 6.75, 95% confidence interval 1.11 to 41.00, P 5 .038).
study, their true incidence is likely to be have been higher still. The prevalence of communication errors in surgical care, and their relation to adverse events, is well documented.29,30 Increasingly, however, evidence suggests that the improvement in communication is one of the primary mechanisms through which checklists can affect change, by improving awareness of protocols and patient safety.31 These gains are over and above those reported by studies which have sought to modify communication protocols alone and have reported improved information transfer,32 but where little evidence supporting any improvement in outcomes exists.33 By mandating a set care pathway to be followed by clinical staff, studies have shown checklists capable of flattening clinical hierarchies and improving safety attitudes as they improve outcomes.34 Implementation of POSCH checklists could be expected to exert a similar effect. Despite their previous successes, it must be noted that checklists alone cannot be considered a clinical cure-all. A recent report has suggested that large-scale checklist interventions such as the Michigan Keystone project, which includes perioperative care processes and a systematic program of safety improvement, have not significantly altered outcomes.35 Other studies have assessed barriers to the successful adoption of interventions such as the World Health Organization (WHO) Safer Surgery Checklist have included a lack of understanding of their use and purpose, highlighting also the need for training in their use before introduction.36 Urbach et al,37 recent report on the introduction of the WHO checklist across the province of Ontario, Canada, is a poignant reflection of this. Despite over 98% of hospitals introducing the checklist within the timeframe of the study, no significant differences in morbidity or mortality were seen. Previous studies of the WHO checklist have reported on the poor outcomes which result without appropriate implementation and localization strategies.38,39 Accordingly, subsequent commentary has implicated a lack of localization, training, and education as the reason for the failures suggested by Urbach et al,40 wherein the majority of entries reported no assessment of local needs, provision of training, or implementation support. One strength of the POSCH checklist development process presented in this study is the inclusion of local care protocols and clinicians in the finalization of the checklists. In this manner, applicability to local practice and buy-in from staff could be assured. These elements, as described in the present development framework for POSCH checklists, are crucial to success. Equally important is the selection of items for inclusion in a checklist. In line with Reason’s argument that checklists should function as mental aides, to function as useful prompts, checklists must seek to include processes that are often missed (as otherwise checklists would be superfluous), yet may potentially still affect outcomes (as otherwise they would be ineffective). The process described here ensured this through audit of current
End user review A group representing potential end users (n 5 10) of the checklist, comprised of residents (n 5 4), interns (n 5 3), and nurses (n 5 3), reviewed the checklists. All (10/10, 100%) responded positively to the checklists and indicated that they would be willing to use them in their own practice. Minor changes to formatting and layout were made to improve usability and readability in a final revision of the checklists (Appendix). In addition to printed reference panels, they were designed as adhesive stickers to be entered into the written medical record upon use. No content changes were deemed necessary.
Comments The incidence of postoperative morbidity following major surgery remains high in current practice. Optimal management of complications requires appropriate treatment to maximize the patient’s chance of recovery and prevention of further deterioration, or death (failure to rescue). However, variations in care quality and the unavoidable nature of human error mean that the management of postoperative complications remains inconsistent.28 To reduce error and enhance standardization of care, we describe the development and validity evidence of checklists for common gastrointestinal surgical morbidity, with the 6 developed checklists encompassing over 92% of reported postoperative complications. By integrating evidence-based care processes with local procedures and culture, involving end users and clinical experts in the development process, this study presents a process for the optimization and standardization of an important aspect of postoperative care. Errors in management place patients at risk of receiving inappropriate treatment and delays, which may negatively affect outcomes. In this study, we report that failure to adhere to best practice principles is significantly associated with an increased risk of further morbidity. Analysis of current practice through casenote review revealed a potential to improve care in accordance with the checklists in 84% of cases. However, not all errors in care are related to omission errors directly amenable to correction through inclusion as a specific checklist item. A significant proportion of delays resulted from communication errors. Furthermore, as only those explicitly documented in the medical record could be recorded in this
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practice in historical casenotes, demonstrating the potential for significant impact on practice if checklists were to be adhered to, despite the apparent simplicity of some items. Additionally, it also demonstrated the potential for significant improvement in outcomes, which better adherence might achieve. A recent trial of operative crisis checklists piloted their use in a simulated setting,15 with the use of simulation for the training and certification of proficiency for technical skills already well established.41,42 The introduction of POSCH checklists would be amenable to a similar approach, involving high-fidelity ward simulation43 to ensure staff understanding of, and proficiency in, their use. Dissemination of POSCH checklists to other centers would also need to be adapted to local needs through a similar process as described in this study to take into account local policies and resources (eg, integration into electronic records systems), as the focus of process- and quality-improvement initiatives to improve care and outcomes. The results of this study must be considered in the context of several limitations. The initial literature search was nonexhaustive, and limited to recent, large cohort studies only. However, this was intended to reflect current practice, and across these publications, there was broad agreement in the type of complications reported, regardless of procedure. One limitation of this is that the classification of complications remained broad. Although this was desired in this case, as the aim of this study was to develop generic checklists for a general gastrointestinal surgical unit, future checklist development (particularly in subspecialty centers or units) might wish to confine their selection to specialist domains and more specific types of morbidity, or be based on local site-specific data. The validation of the checklists was a single-center, retrospective casenote review, representing a source of selection bias. To limit this, we selected consecutive patients receiving treatment in a tertiary academic center, rated as one of the top 5 centers in England according to standardized hospital mortality indicators.44 Any bias is therefore likely to have been positivedwith levels of adherence to best practice in other centers therefore lower still. It is important to note that the treatment initiated through the checklists is not intended to be definitive. Depending on the site of leak, severity of infection, or stability of the patient, in many cases further intervention may often be required, and seeking senior support is included as an item on each. The aim of these checklists, rather, is to initiate immediate measures to begin the process of resuscitation and recovery without further delay. Through use of checklists, the first appropriate and available member of the clinical team is able to initiate treatment independently, and nursing staff are empowered to query treatment according to checklist-recommended items if any are missed. As the treatment items are intentionally noninvasive, where diagnostic uncertainty exists, it may in some cases be appropriate to initiate selected appropriate items
7 from one or even multiple checklists simultaneously. Noted champions of checklists, such as James Reason, have stressed the fact that checklists are intended to function as mental aides, rather than mandates, and clinicians must interpret each case in context.10 Without such guidance, however, the casenote review has demonstrated the treatment delays which may result. These delays were associated with an increased risk of further morbidity and were likely to have resulted in a prolonged length of stay, preventable patient suffering, and excess healthcare expendituredall of which, our analysis has suggested, could have been prevented with use of the checklists. Finally, although we discuss implementation and training strategies, a lack of in vivo clinical data means that there may be obstructions to effective clinical use that we have not yet encountered. However, checklists represent an amenable intervention, whose effectiveness in other areas of care has been thoroughly and well documented.12,15,34,45 Prominent advocates of surgical checklists, such as Gawande’s ‘‘Project Check’’ and their ‘‘checklist for checklists,’’46 have stressed the importance of an iterative development process such as is presented here, and the need for checklists to be adapted and suited to needs on a local basis. Accordingly, the use of these checklists in other centers should seek further adaptation through a similar process as described, incorporating end users in the process, to ensure relevance to local processes and practice culture, maximizing staff buy-in and the likelihood of success. Future clinical trials must be pursued to assess the impact of checklist implementation and compliance rates on outcomes such as morbidity and mortality. With a predefined and thorough strategy to promote successful implementation, there can be little doubt that improvement in clinical care, in line with accepted international guidelines, can improve care.
Conclusions This study presents a development and validation of checklists to guide management of complications following gastrointestinal surgery for the improvement of postoperative care. It presents 6 initial checklists for management of the most commonly reported types of morbidity, based on best evidence and adaptable to local practice and clinical culture, with a framework for the development of similar checklists to be adapted for other complications, specialties, and centers. This is the first study to assess patterns of error in the management of these same common complications, suggesting broad scope for improvement even in a tertiary academic center, and validating the applicability of checklists in this context. Future research to assess feasibility, clinical implementation, and effect on patient outcomes is required. With excellent feedback from staff suggesting few barriers to wider uptake, there is great potential for these checklists to improve and standardize care, ensuring
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optimal patient management and the best chance for recovery of patients who suffer postoperative complications.
19. Soong C, Daub S, Lee J, et al. Development of a checklist of safe discharge practices for hospital patients. J Hosp Med 2013;8:444–9. 20. Hales B, Terblanche M, Fowler R, et al. Development of medical checklists for improved quality of patient care. Int J Qual Health Care 2008;20:22–30. 21. Masterton RG, Galloway A, French G, et al. Guidelines for the management of hospital-acquired pneumonia in the UK: report of the working party on hospital-acquired pneumonia of the British Society for Antimicrobial Chemotherapy. J Antimicrob Chemother 2008;62: 5–34. 22. American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med 2005;171:388–416. 23. Ferrer R, Artigas A, Levy MM, et al. Improvement in process of care and outcome after a multicenter severe sepsis educational program in Spain. JAMA 2008;299:2294–303. 24. Phitayakorn R, Delaney CP, Reynolds HL, et al. Standardized algorithms for management of anastomotic leaks and related abdominal and pelvic abscesses after colorectal surgery. World J Surg 2008;32:1147–56. 25. Gould CV, Umscheid CA, Agarwal RK, et al. Guideline for prevention of catheter-associated urinary tract infections 2009. Infect Control Hosp Epidemiol 2010;31:319–26. 26. Dagi TF. The management of postoperative bleeding. Surg Clin North Am 2005;85:1191–213. x. 27. National Institute for Health and Care Excellence. Prevention and Treatment of Surgical Site Infection CG74. London: National Institute for Health and Care Excellence; 2008. 28. Reason J. Human error: models and management. BMJ 2000;320: 768–70. 29. Symons NR, Almoudaris AM, Nagpal K, et al. An observational study of the frequency, severity, and etiology of failures in postoperative care after major elective general surgery. Ann Surg 2013;257:1–5. 30. Nagpal K, Vats A, Lamb B, et al. Information transfer and communication in surgery: a systematic review. Ann Surg 2010;252:225–39. 31. Russ S, Rout S, Sevdalis N, et al. Do safety checklists improve teamwork and communication in the operating room? A systematic review. Ann Surg 2013;258:856–71. 32. Van Eaton EG, Horvath KD, Lober WB, et al. Organizing the transfer of patient care information: the development of a computerized resident sign-out system. Surgery 2004;136:5–13. 33. Pucher PH, Johnston MJ, Aggarwal R, et al. Effectiveness of interventions to improve patient handover in surgery: a systematic review. Surgery; 2015 [epub ahead of print]. 34. Haynes AB, Weiser TG, Berry WR, et al. Changes in safety attitude and relationship to decreased postoperative morbidity and mortality following implementation of a checklist-based surgical safety intervention. BMJ Qual Saf 2011;20:102–7. 35. Reames BN, Krell RW, Campbell Jr DA, et al. A checklist-based intervention to improve surgical outcomes in Michigan: evaluation of the Keystone Surgery program. JAMA Surg 2015;150:208–15. 36. Fourcade A, Blache JL, Grenier C, et al. Barriers to staff adoption of a surgical safety checklist. BMJ Qual Saf 2012;21:191–7. 37. Urbach DR, Govindarajan A, Saskin R, et al. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med 2014;370: 1029–38. 38. Borchard A, Schwappach DL, Barbir A, et al. A systematic review of the effectiveness, compliance, and critical factors for implementation of safety checklists in surgery. Ann Surg 2012;256:925–33. 39. Russ SJ, Sevdalis N, Moorthy K, et al. A qualitative evaluation of the barriers and facilitators toward implementation of the WHO surgical safety checklist across hospitals in England: lessons from the ‘‘Surgical Checklist Implementation Project’’. Ann Surg 2015;26:81–91. 40. Leape LL. The checklist conundrum. N Engl J Med 2014;370:1063–4. 41. Orzech N, Palter VN, Reznick RK, et al. A comparison of 2 ex vivo training curricula for advanced laparoscopic skills: a randomized controlled trial. Ann Surg 2012;255:833–9.
Supplementary data Supplementary data related to this article can be found at http://dx.doi.org/10.1016/j.amjsurg.2015.03.018.
References 1. Hii MW, Smithers BM, Gotley DC, et al. Impact of postoperative morbidity on long-term survival after oesophagectomy. Br J Surg 2013;100:95–104. 2. Ghaferi AA, Birkmeyer JD, Dimick JB. Hospital volume and failure to rescue with high-risk surgery. Med Care 2011;49:1076–81. 3. Ghaferi AA, Birkmeyer JD, Dimick JB. Variation in hospital mortality associated with inpatient surgery. N Engl J Med 2009;361:1368–75. 4. Ghaferi AA, Birkmeyer JD, Dimick JB. Complications, failure to rescue, and mortality with major inpatient surgery in medicare patients. Ann Surg 2009;250:1029–34. 5. Aiken LH, Cimiotti JP, Sloane DM, et al. Effects of nurse staffing and nurse education on patient deaths in hospitals with different nurse work environments. Med Care 2011;49:1047–53. 6. Shanafelt TD, Balch CM, Bechamps G, et al. Burnout and medical errors among American surgeons. Ann Surg 2010;251:995–1000. 7. Tam VC, Knowles SR, Cornish PL, et al. Frequency, type and clinical importance of medication history errors at admission to hospital: a systematic review. CMAJ 2005;173:510–5. 8. Pucher PH, Aggarwal R, Twaij A, et al. Identifying and addressing preventable process errors in trauma care. World J Surg 2013;37: 752–8. 9. Clarke JR, Spejewski B, Gertner AS, et al. An objective analysis of process errors in trauma resuscitations. Acad Emerg Med 2000;7: 1303–10. 10. Reason J. Combating omission errors through task analysis and good reminders. Qual Saf Health Care 2002;11:40–4. 11. Flin R, Martin L, Goeters K, et al. Development of the NOTECHS (non-technical skills) system for assessing pilots’ CRM skills. Hum Factors Aeorspace Saf 2003;3:97–119. 12. Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360:491–9. 13. Adamina M, Kehlet H, Tomlinson GA, et al. Enhanced recovery pathways optimize health outcomes and resource utilization: a metaanalysis of randomized controlled trials in colorectal surgery. Surgery 2011;149:830–40. 14. Gustafsson UO, Hausel J, Thorell A, et al. Adherence to the enhanced recovery after surgery protocol and outcomes after colorectal cancer surgery. Arch Surg 2011;146:571–7. 15. Arriaga AF, Bader AM, Wong JM, et al. Simulation-based trial of surgical-crisis checklists. N Engl J Med 2013;368:246–53. 16. Ziewacz JE, Arriaga AF, Bader AM, et al. Crisis checklists for the operating room: development and pilot testing. J Am Coll Surg 2011;213:212–217.e10. 17. Charuluxananan S, Punjasawadwong Y, Suraseranivongse S, et al. The Thai Anesthesia Incidents Study (THAI Study) of anesthetic outcomes: II. Anesthetic profiles and adverse events. J Med Assoc Thai 2005;88(Suppl 7):S14–29. 18. Hooton TM, Bradley SF, Cardenas DD, et al. Diagnosis, prevention, and treatment of catheter-associated urinary tract infection in adults: 2009 International Clinical Practice Guidelines from the Infectious Diseases Society of America. Clin Infect Dis 2010;50:625–63.
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42. Palter VN, Orzech N, Reznick RK, et al. Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial. Ann Surg 2013;257:224–30. 43. Pucher PH, Aggarwal R, Srisatkunam T, et al. Validation of the simulated ward environment for assessment of ward-based surgical care. Ann Surg 2014;259:215–21.
9 44. Health and Social Information Centre. Available at: https://indicators. ic.nhs.uk/webview/. Accessed November 8, 2013. 45. Weiser TG, Haynes AB, Dziekan G, et al. Effect of a 19-item surgical safety checklist during urgent operations in a global patient population. Ann Surg 2010;251:976–80. 46. Project Check. A Checklist for Checklists. Available at: http://www. projectcheck.org/checklist-for-checklists.html. Accessed November 8, 2014.
Surgical care checklists to optimize patient care following postoperative complications Philip H. Pucher, M.D., Ph.D., M.R.C.S.a,*, Rajesh Aggarwal, M.B.B.S., M.A., Ph.D., F.R.C.S.b,c, Mark H. Almond, M.D., M.Sc., M.R.C.P.d, Ara Darzi, M.D., F.R.C.S., F.A.C.S., K.B.E.a a
Department of Surgery and Cancer, St Mary’s Hospital, Imperial College London, London, UK; Department of Surgery, Faculty of Medicine and cArnold & Blema Steinberg Medical Simulation Centre, Faculty of Medicine, McGill University, Montreal, QC, Canada; dDepartment of Respiratory Medicine and Allergy, St Mary’s Hospital, Imperial College London, London, UK
b
KEYWORDS: Checklist; Surgery; Postoperative; Complications; Failure to rescue; Ward-based care
Abstract BACKGROUND: Postoperative complications are common. Inconsistency in the care of complications is reflected in variable rates of failure to rescue. This study aims to develop and validate checklists for treatment of common postoperative complications. METHODS: Initial checklists were based on best evidence, with expert clinician review. Casenote review was performed, comparing checklist item completion with outcomes. Logistic regression was performed for risk of further morbidity, considering American Society of Anesthesiology grade, age, sex, and checklist compliance. Checklists were finalized through end user multidisciplinary review. RESULTS: Evidence-based checklists were developed. Retrospective casenote review revealed management of 86% (31/37) of these complications to be noncompliant with checklist-mandated care. This resulted in delays and errors in 65% (24/37) of cases, with median treatment delay of 6 hours (interquartile range 5.4 hours). Regression analysis revealed poor checklist compliance to be to only significant factor (odds ratio 6.75, 95% confidence interval 1.11 to 41.00, P 5 .038) for developing further morbidity. CONCLUSIONS: Management of complications is highly variable, with failure to adhere to best practice principles significantly associated with an increased risk of further morbidity. This study presents an evidence-based framework for the development of checklists to standardize care. Ó 2015 Elsevier Inc. All rights reserved.
No funding was received for this body of work. Rajesh Aggarwal is a consultant for Applied Medical. All other authors declare no conflicts of interest. * Corresponding author. Tel.: 144-203-312-6666; fax: 144-203-3126309. E-mail address: [email protected] Manuscript received November 18, 2014; revised manuscript February 27, 2015 0002-9610/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2015.03.018
Despite continuing advances in surgical care, postoperative complications remain a common and accepted risk of surgery. Morbidity rates of up to 50% following major gastrointestinal surgical procedures are reported.1,2 The effective identification and amelioration of adverse events in the postoperative phase is vital to the successful recovery of patients who suffer complications. Unfortunately, this is
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not always the case, with the quality of management of complications shown to vary greatly between institutions, as reflected by differing rates of death following the development of complications, that is, failure to rescue.3,4 Investigation of the factors underlying this variability has identified certain structural factors, such as nurse:patient staffing ratios.5 However, this has accounted only for a small proportion of clinical variability seen. In a recent survey of 7,906 American surgeons, over 70% of respondents attributed witnessed medical errors to individual-level factors (ie, process), rather than system-level (structural) factors.6 Studies of error and patient safety have indicated that the majority of such process errors may be classified as errors of omission,7–9 defined as mental lapses or attentional failures,10 rather than active errors of commission, resulting in deviation from ideal practice and placing patients at risk of harm. The reduction and mitigation of such failures, experts such as James Reason suggest,10 are best addressed through checklists or protocols. Functioning as mental aids or prompts, checklists can be effective in the structuring of both crisis management as well as routine care, with widespread use of checklists in other high-complexity industries such as aviation.11 In these industries, checklists exist to guide the management of specific crises, such as engine flameouts or a failure to deploy landing gear. Thus far, checklists in surgery have been most widely employed as preoperative checklists12 or to guide patient postoperative care in best case models of recovery. In this form, the effectiveness of checklists to promote adherence to best practice, and reduce variation in care, is well established with enhanced recovery protocols.13 Care outcomes have been shown to improve significantly in relation to levels of compliance with care protocols defining best practice care.14 Diagnosis-specific checklists have been more recently introduced for the management of operating room crises.15,16
The standardized management of critical events such as operating room fires, or a failed airway, was significantly improved with the introduction of crisis checklists in a recent study reported by Arriaga et al.15 However, although intraoperative crises are, fortunately, rare (with an incidence of ,1.5%),17 this stands in stark contrast to the high incidence of postoperative complications which may affect as many as half of the patients following major surgery. The variability in the management of postoperative complications occurs despite established, evidence-based guidelines for the treatment of many of the most common complication types, such as catheter-associated urinary tract infections.18 It therefore stands to reason that a similar approach may be effective for postoperative crises also. We hypothesized that the development of checklists for common gastrointestinal surgical complications might therefore have a significant impact on reducing error and standardizing management of these conditions. This study sought to identify the most common complications occurring after complex gastrointestinal surgical procedures, and presents a structured development and validation of treatment checklists for patient management.
Figure 1
Methods We adopted a multiphase, iterative design process. This was based in part on previously published checklist design methodologies, and involved initial literature review, followed by expert assessment, casenote-based validation, and end user feedback (Fig. 1).16,19,20
Literature review An online search of recently published literature was performed. The PubMed online database was searched for
Iterative checklist development process.
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Type and incidence rate of most frequently reported postoperative complications Morbidity rate (%) Wound infection
Study
Data source
Procedure
n
Overall
Kwaan, 2013 (USA) Molena, 2013 (USA) Yasunaga, 2013 (Japan) Merkow, 2012 (USA) Cone, 2012 (USA) Grant, 2012 (USA) Total Overall complication rate (%) Proportion of all reported complications (%) Mean complication rank
NSQIP NIS National database NSQIP NSQIP NSQIP
Colectomy Esophagectomy Gastrectomy or colectomy Esophagectomy Colectomy Pancreatectomy
4,875 18,966 30,765
17 n/r 15.5
7
1,600 24,730 1,030 81,936
43 n/r n/r
IA sepsis
HAP
Sepsis
2.3 18.25 2.3
4.3 5.92 1.2
2.8
20 6 9
30 3
26 4
9.92
3.59
18
1.4
5.1
UTI
Cardiac
Renal
Bleed
PE
.4 1.46 2.2
.7 6.19 .1
.4 3.75
.7
1.7
2.9 5.92 .9
7 2 6
3 1.8
2.7
4.63
2.49
1.75
1.58
26.8
15.1
6.5
11.2
2.6
3.2
4
4.6
.3
1.8
1.9
.74
.15
.04
4.9
6.0
3.7
.7
5.75
6
6.3
6.3
Checklists for postoperative complications
Table 1
Only most commonly reported complications shown, therefore percentages of all reported complications do not sum to 100%. HAP 5 hospital-acquired pneumonia; IA sepsis 5 intra-abdominal sepsis; NIS 5 National Inpatient Sample; n/r 5 not reported; NSQIP 5 National Surgical Quality Improvement Project; PE 5 pulmonary embolism; UTI 5 urinary tract infection.
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4 Table 2
Results of casenote review
n Age (years) Male:Female ratio Checklist compliance (%) 100% compliance achieved Delays to treatment (hours)
37 73 (58–82) 24:13 60 (48–72) 16% (6/37) 6 (3.3–8.7)
Results reported as median (interquartile range).
studies published in the last 2 years (2012 to 2013) reporting postoperative outcomes for gastrointestinal surgical procedures using the following search terms: (‘‘postoperative outcome’’ or ‘‘complications’’) and ‘‘surgery’’ and (‘‘esophagectomy’’ or ‘‘gastrectomy’’ or ‘‘colectomy’’ or ‘‘pancreat*’’). Both benign and neoplastic resections were considered, with studies reporting at least 1,000 cases or more included for final analysis. Data on incidence of postoperative complications were extracted from included publications. Reported complications were ranked in order of incidence, rather than using absolute complication rates, to control for the variable risks of morbidity for different surgical procedures. Mean of ranks across all included studies were calculated, with the most common (ie, highest ranked) complications selected for checklist development.
Checklist development Initial checklists were drafted for the management of each identified complication based on best published evidence. This was located through online searching of electronic databases (PubMed, Google Scholar), as well as grey literature and guidelines published by national and international specialist associations. A formal literature review was not conducted, as treatment was based on specialist associations’ recommendations and endorsed publications, such as the Society for Antimicrobial Therapy’s Working Party Group on Hospital-Acquired Pneumonia.21
Table 3
These were then combined with local protocols, where applicable (eg, local antibiotic prescribing guidelines).
Clinical expert review Each checklist was subsequently reviewed by a panel of clinical experts, who were asked to comment on checklist usability, content, and practical applicability to their personal practice. In addition, they were asked to identify any common clinical errors they felt were not addressed by the checklist, which might merit inclusion. Finally, they were asked whether they would want their residents using the checklists in the management of patients under their care. Feedback gained from the expert panel resulted in revision and second iteration of the checklists.
Casenote review and clinical validation To assess relevance of the checklists to current clinical practice, and estimate the improvement in clinical performance which might be achieved with full implementation thereof, a retrospective casenote analysis was performed. If, for example, all checklist-included items were already being completed, there would have been little point in their development or introduction to clinical practice. The last 40 consecutive postoperative complications to which the checklists applied were identified from a prospectively maintained database of gastrointestinal surgery patients at our institutiondan urban tertiary academic center in London, UK. Occurrence of a complication was defined on an intention-to-treat basis as recorded by the clinical team. Patient casenotes were retrieved and management of complications compared with checklist items. Completion of checklist items was recorded, as well as any delays or process errors occurring in the management of complications, by a clinician researcher experienced in casenote review. Errors were defined as any action which failed to achieve its aims, or an incorrect action for a given aim. Delays were defined as failures of prescribed actions or treatments to take place at the intended time, or when
Delays and adverse events in management of common surgical complications
Event
n (%)
Example(s)
Relevance to checklist
Process error
9 (37)
Prescribing error
9 (37)
Catheter removal where possible in cases of suspected UTI. Antibiotics to be given early, with blood cultures first if pyrexial Evidence- and local protocol-based guidance on diagnosis-specific antibiotic prescribing
Communication failure
6 (25)
Catheter-associated UTI treated with catheter change, delay to administration of antibiotics Incorrect antibiotic regimen prescribed, later corrected Failure to prescribe stat dose on commencing antibiotics Suspected diagnosis made by specialist nurse, interns advised, but waited to speak to senior residents before starting treatment
UTI 5 urinary tract infection.
Checklist, endorsed by seniors, flattens hierarchy and allows initiation of treatment by any member of the clinical team
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immediately intended actions (such as administration of ‘‘stat’’ dose antibiotics) were not accomplished within an hour. A second clinician independently reviewed 30% of cases, with inter-rater reliability calculated using Cohen’s kappa. The relationship between quality of management of complications, as measured by the number of checklist items completed, and subsequent patient outcomes was analyzed. Logistic regression analysis, using a forward logistic model, was performed for the risk of developing further complications, with checklist compliance, age, American Society of Anesthesiology grade, and sex considered as independent variables (IBM SPSS Statistics 21; IBM Corp, Armonk, NY). The assessed cohort size was considered too small for any impact on morbidity or mortality to be seendthis was not assessed. For all analyses, a P value of less than .05 was considered statistically significant.
5 complications each made up less than 1% of all reported morbidity and were thus not further considered.
Checklist development A search of published peer-reviewed and grey literature was conducted,18,21–27 and combined with local prescribing and treatment protocols in the development of the first iteration of Post-Operative Surgical Checklist for Hospital care (POSCH), for each of the 6 complications.
Clinical expert review
Following clinical validation, a penultimate version of the checklists was presented to a multidisciplinary group of end users, comprised of residents, interns, and nursing staff. They were asked to review the format, readability, and practicability of use. They were asked to identify any desired changes or errors, and whether they would use checklists in their own clinical practice. This feedback was taken into account and a final iteration of checklists completed.
A group of 5 clinical experts in surgery (n 5 3) and critical care and anesthesia (n 5 2) were consulted on the use of the POSCH checklists in clinical practice. All (5/5, 100%) agreed that the checklists were useful and relevant in the management of postoperative complications, and would encourage their trainees to use them. The expert panel also recommended minor modifications which were incorporated in the second iteration of the checklists. For example, experts identified a common clinical errordthe delay to initiation of treatment when antibiotics were initiated, but no loading dose prescribed. Relevant checklist items were changed to include the prescription of loading doses to address this. In addition, minor changes were made to phrasing and formatting (ie, informing of a senior member of team, previously recommended, made mandatory).
Results
Casenote review and clinical validation
Literature review
Of the 40 identified cases, 3 clinical records could not be retrieved, resulting in a total of 37 casenotes undergoing review (Table 2). Thirty percent (11/37) was reviewed by an independent second clinician reviewer, with very good inter-rater reliability (Cohen’s kappa 5 .775, P , .001). Overall checklist compliance was median 60% (interquartile range 40% to 72%), with full compliance (100% of checklist items met) seen in only 16% (6/37) of the cases. Sixty-five percent (24/37) of the cases were associated with delay or error in treatment (Table 3). Thirty-seven percent (9/24) of the errors were related to general process error, such as failure to remove a urinary catheter associated with infection. Errors relating specifically to prescription errors, generally relating to a failure to comply with local antibiotic guidelines, were seen in a further 37% (9/24). In 25% (6/24), errors were related to communication failures, such as where a suspected diagnosis was made but not acted upon because of delays in communicating to an appropriate member of the clinical team. These errors resulted in a median 6-hour (interquartile range 3.3 to 8.7 hours, range 1 to 36 hours) delay to the patient receiving appropriate treatment. All documented errors were considered preventable with the appropriate use of the developed checklists.
End user review
The literature search as described returned 6 publications (Table 1). These described postoperative outcomes for 81,936 patients following colectomy, esophagectomy, gastrectomy, and pancreatectomy, with an overall complication rate of 17% to 43%. All data were sourced from large-scale, well-validated national databases; we accepted each database’s own criteria for the included complications. Calculating the mean ranked incidence of all complications, wound infection, hospital-acquired pneumonia, sepsis, intra-abdominal sepsis/anastomotic leak, and urinary tract infection was identified as the 5 most common postoperative complications, and considered for checklist development. Cardiac and renal failures were the sixth and seventh most common complications, but were excluded as these descriptions covered a potentially broad range of underlying pathologies, each requiring different treatment. Surgical bleeding, as the next most common type of morbidity, was included. The 6 complications selected for checklist development (wound infection, pneumonia, sepsis, anastomotic leak, urinary tract infection, and bleeding) accounted for 92.2% of all reported morbidity. Pulmonary embolus and all other reported postoperative
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The relationship between checklist compliance and outcomes were analyzed. Logistic regression modeling, considering checklist compliance, American Society of Anesthesiology grade, age, and sex for the risk of developing further (multiple) morbidity revealed checklist compliance of less than 50% to be to only significant determining factor (odds ratio 6.75, 95% confidence interval 1.11 to 41.00, P 5 .038).
study, their true incidence is likely to be have been higher still. The prevalence of communication errors in surgical care, and their relation to adverse events, is well documented.29,30 Increasingly, however, evidence suggests that the improvement in communication is one of the primary mechanisms through which checklists can affect change, by improving awareness of protocols and patient safety.31 These gains are over and above those reported by studies which have sought to modify communication protocols alone and have reported improved information transfer,32 but where little evidence supporting any improvement in outcomes exists.33 By mandating a set care pathway to be followed by clinical staff, studies have shown checklists capable of flattening clinical hierarchies and improving safety attitudes as they improve outcomes.34 Implementation of POSCH checklists could be expected to exert a similar effect. Despite their previous successes, it must be noted that checklists alone cannot be considered a clinical cure-all. A recent report has suggested that large-scale checklist interventions such as the Michigan Keystone project, which includes perioperative care processes and a systematic program of safety improvement, have not significantly altered outcomes.35 Other studies have assessed barriers to the successful adoption of interventions such as the World Health Organization (WHO) Safer Surgery Checklist have included a lack of understanding of their use and purpose, highlighting also the need for training in their use before introduction.36 Urbach et al,37 recent report on the introduction of the WHO checklist across the province of Ontario, Canada, is a poignant reflection of this. Despite over 98% of hospitals introducing the checklist within the timeframe of the study, no significant differences in morbidity or mortality were seen. Previous studies of the WHO checklist have reported on the poor outcomes which result without appropriate implementation and localization strategies.38,39 Accordingly, subsequent commentary has implicated a lack of localization, training, and education as the reason for the failures suggested by Urbach et al,40 wherein the majority of entries reported no assessment of local needs, provision of training, or implementation support. One strength of the POSCH checklist development process presented in this study is the inclusion of local care protocols and clinicians in the finalization of the checklists. In this manner, applicability to local practice and buy-in from staff could be assured. These elements, as described in the present development framework for POSCH checklists, are crucial to success. Equally important is the selection of items for inclusion in a checklist. In line with Reason’s argument that checklists should function as mental aides, to function as useful prompts, checklists must seek to include processes that are often missed (as otherwise checklists would be superfluous), yet may potentially still affect outcomes (as otherwise they would be ineffective). The process described here ensured this through audit of current
End user review A group representing potential end users (n 5 10) of the checklist, comprised of residents (n 5 4), interns (n 5 3), and nurses (n 5 3), reviewed the checklists. All (10/10, 100%) responded positively to the checklists and indicated that they would be willing to use them in their own practice. Minor changes to formatting and layout were made to improve usability and readability in a final revision of the checklists (Appendix). In addition to printed reference panels, they were designed as adhesive stickers to be entered into the written medical record upon use. No content changes were deemed necessary.
Comments The incidence of postoperative morbidity following major surgery remains high in current practice. Optimal management of complications requires appropriate treatment to maximize the patient’s chance of recovery and prevention of further deterioration, or death (failure to rescue). However, variations in care quality and the unavoidable nature of human error mean that the management of postoperative complications remains inconsistent.28 To reduce error and enhance standardization of care, we describe the development and validity evidence of checklists for common gastrointestinal surgical morbidity, with the 6 developed checklists encompassing over 92% of reported postoperative complications. By integrating evidence-based care processes with local procedures and culture, involving end users and clinical experts in the development process, this study presents a process for the optimization and standardization of an important aspect of postoperative care. Errors in management place patients at risk of receiving inappropriate treatment and delays, which may negatively affect outcomes. In this study, we report that failure to adhere to best practice principles is significantly associated with an increased risk of further morbidity. Analysis of current practice through casenote review revealed a potential to improve care in accordance with the checklists in 84% of cases. However, not all errors in care are related to omission errors directly amenable to correction through inclusion as a specific checklist item. A significant proportion of delays resulted from communication errors. Furthermore, as only those explicitly documented in the medical record could be recorded in this
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practice in historical casenotes, demonstrating the potential for significant impact on practice if checklists were to be adhered to, despite the apparent simplicity of some items. Additionally, it also demonstrated the potential for significant improvement in outcomes, which better adherence might achieve. A recent trial of operative crisis checklists piloted their use in a simulated setting,15 with the use of simulation for the training and certification of proficiency for technical skills already well established.41,42 The introduction of POSCH checklists would be amenable to a similar approach, involving high-fidelity ward simulation43 to ensure staff understanding of, and proficiency in, their use. Dissemination of POSCH checklists to other centers would also need to be adapted to local needs through a similar process as described in this study to take into account local policies and resources (eg, integration into electronic records systems), as the focus of process- and quality-improvement initiatives to improve care and outcomes. The results of this study must be considered in the context of several limitations. The initial literature search was nonexhaustive, and limited to recent, large cohort studies only. However, this was intended to reflect current practice, and across these publications, there was broad agreement in the type of complications reported, regardless of procedure. One limitation of this is that the classification of complications remained broad. Although this was desired in this case, as the aim of this study was to develop generic checklists for a general gastrointestinal surgical unit, future checklist development (particularly in subspecialty centers or units) might wish to confine their selection to specialist domains and more specific types of morbidity, or be based on local site-specific data. The validation of the checklists was a single-center, retrospective casenote review, representing a source of selection bias. To limit this, we selected consecutive patients receiving treatment in a tertiary academic center, rated as one of the top 5 centers in England according to standardized hospital mortality indicators.44 Any bias is therefore likely to have been positivedwith levels of adherence to best practice in other centers therefore lower still. It is important to note that the treatment initiated through the checklists is not intended to be definitive. Depending on the site of leak, severity of infection, or stability of the patient, in many cases further intervention may often be required, and seeking senior support is included as an item on each. The aim of these checklists, rather, is to initiate immediate measures to begin the process of resuscitation and recovery without further delay. Through use of checklists, the first appropriate and available member of the clinical team is able to initiate treatment independently, and nursing staff are empowered to query treatment according to checklist-recommended items if any are missed. As the treatment items are intentionally noninvasive, where diagnostic uncertainty exists, it may in some cases be appropriate to initiate selected appropriate items
7 from one or even multiple checklists simultaneously. Noted champions of checklists, such as James Reason, have stressed the fact that checklists are intended to function as mental aides, rather than mandates, and clinicians must interpret each case in context.10 Without such guidance, however, the casenote review has demonstrated the treatment delays which may result. These delays were associated with an increased risk of further morbidity and were likely to have resulted in a prolonged length of stay, preventable patient suffering, and excess healthcare expendituredall of which, our analysis has suggested, could have been prevented with use of the checklists. Finally, although we discuss implementation and training strategies, a lack of in vivo clinical data means that there may be obstructions to effective clinical use that we have not yet encountered. However, checklists represent an amenable intervention, whose effectiveness in other areas of care has been thoroughly and well documented.12,15,34,45 Prominent advocates of surgical checklists, such as Gawande’s ‘‘Project Check’’ and their ‘‘checklist for checklists,’’46 have stressed the importance of an iterative development process such as is presented here, and the need for checklists to be adapted and suited to needs on a local basis. Accordingly, the use of these checklists in other centers should seek further adaptation through a similar process as described, incorporating end users in the process, to ensure relevance to local processes and practice culture, maximizing staff buy-in and the likelihood of success. Future clinical trials must be pursued to assess the impact of checklist implementation and compliance rates on outcomes such as morbidity and mortality. With a predefined and thorough strategy to promote successful implementation, there can be little doubt that improvement in clinical care, in line with accepted international guidelines, can improve care.
Conclusions This study presents a development and validation of checklists to guide management of complications following gastrointestinal surgery for the improvement of postoperative care. It presents 6 initial checklists for management of the most commonly reported types of morbidity, based on best evidence and adaptable to local practice and clinical culture, with a framework for the development of similar checklists to be adapted for other complications, specialties, and centers. This is the first study to assess patterns of error in the management of these same common complications, suggesting broad scope for improvement even in a tertiary academic center, and validating the applicability of checklists in this context. Future research to assess feasibility, clinical implementation, and effect on patient outcomes is required. With excellent feedback from staff suggesting few barriers to wider uptake, there is great potential for these checklists to improve and standardize care, ensuring
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optimal patient management and the best chance for recovery of patients who suffer postoperative complications.
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Supplementary data Supplementary data related to this article can be found at http://dx.doi.org/10.1016/j.amjsurg.2015.03.018.
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