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Research Article
Revised

Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily

[version 4; peer review: 2 approved, 1 approved with reservations]
PUBLISHED 15 Jul 2020
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

Abstract

Background: The Institute for Healthcare Improvement (IHI) has proposed a new method, the Global Trigger Tool (IHI GTT), to detect and monitor adverse events (AEs) and provide information to implement improvement. In 2015, the Sicilian Health System adopted IHI GTT to assess the number, types and severity levels of AEs. The GTT was implemented in 44 of 73 Sicilian public hospitals and 18,008 clinical records (CRs) were examined. Here we present the standardized application of the GTT and the preliminary results of 14,706 reviews of CRs.
Methods: IHI GTT was adapted, developed and implemented to the local context. Reviews of CRs were conducted by 199 professionals divided into 71 review teams consisting of three individuals: two of whom had clinical knowledge and expertise, and a physician to authenticate the AE. The reviewers entered data into a dedicated IT-platform. All 44 of the public hospitals were included, with approximately 300,000 yearly inpatient admissions out of a population of approximately 5 million. In total, 14,706 randomized CRs of inpatients from medicine, surgery, obstetric and ICU wards, from June 2015 to June 2018 were reviewed.
Results: In 975 (6.6%) CRs at least one AE was found. Approximately 20,000 patients of the 300,000 discharged each year in Sicily have at least one AE. In 5,574 (37.9%) CRs at least one trigger was found. A total of 1,542 AEs were found. The analysis of ROC curve shows that the presence of two triggers in a CR indicates with high probability the presence of an AE. The most frequent type of AE was in-hospital related infection.
Conclusions: The GTT is an efficient method to identify AEs and to track improvement of care. The analysis and monitoring of some triggers is important to prevent AEs. However, it is a labor-intensive method, particularly if the CRs are paper-based.

Keywords

Global Trigger Tool, patient safety, adverse events detections, quality of care, medical errors, harm

Revised Amendments from Version 3

We verified and adjusted some typos and added more clarification as suggested by Professor Donev. These include adjustments to the Figure 1  title and Tables 3 and 4 legend.

See the authors' detailed response to the review by Brent C. James
See the authors' detailed response to the review by Doncho Donev
See the authors' detailed response to the review by James M. Naessens

Introduction

Safety is one of the domains of quality in healthcare. Improving the safety of patients is a political priority worldwide, as studies on the safety of patients have drawn attention to the high rates of health care-related harm13. Improving patient safety requires effective and reliable methods to identify and monitor adverse events (AEs) so that learning can take place and improvements can be made.

Even though several methods to detect AEs are available, there is no universally recognized method that reliably provides a comprehensive overview of the extent of the problem. These methods include incident reporting, clinical records (CRs) review and automated extraction using hospital administrative data, for example Patient Safety Indicators (PSI) as developed by the Agency for Healthcare Research and Quality (AHRQ). Incident reporting is the most commonly used method to detect AEs in hospitals, but is based on voluntary reporting. Despite considerable efforts by local hospitals, reporting systems only detect a limited number of AEs4. The effectiveness of automated extraction using hospital administrative data for detecting AEs depends on the accuracy of data compilation. CRs review, as used in the Harvard Medical Practice Study, is very labor intensive, thereby limiting its use4. As a result, health services, governments and researchers have focused on developing harm detection tools.

This paper is one of the first to report the findings of the application of the Global Trigger Tool, developed by the Institute for Healthcare Improvement (IHI), across the whole health system in Sicily. In 2015, the Sicilian Health System adopted IHI GTT5 to assess the number, types and severity levels of AEs.

Methods

IHI GTT

The measurement instrument used in our study is the Italian version of the IHI GTT6. The Italian version was adapted to be appropriate to the regional context7. The triggers are grouped into the same seven categories as the original version (care, medication, surgical, intensive care, obstetric, pediatrics and emergency care); however, changes to some triggers have been introduced. We did not consider triggers and AEs that were present on admission and we added three new triggers: change in procedure anesthesia, duration of surgery greater than 6 hours, and hospital stay greater than five days after delivery7.

Sample selection

89 of medicine, surgery, obstetrics and intensive care wards has participated in the study. Some of these has participated from June 2015 to June 2018, while others did not continue to the end of the observation period. Others were added during the study. Some departments participated in the study from June 2015 to June 2018, while others did not continue until the end of the observation period. Others were added during the study.

We used a random method of records selection, as recommended by the IHI GTT. In each ward, 10 inpatient CRs were randomly and monthly selected, one every ten. (Table 1) From the ordered sequence of the numbering of the CRs of the period under evaluation, a CR was selected every 10 (ie 10th, 20th, 30th, 40th, 50th, etc). In the case in which the number of patients discharged during that month was less than 100, we proceded to remove the previously selected CRs and to select another CR in the same way (one CR every 10). Eligibility criteria were an admission lasting more than 24 hours, and all the administrative data completed. In the Intensive Care Unit (ICU), all patient CRs, discharged during the reference period, were reviewed.

Table 1. Distribution of CRs per clinical area.

MedicineSurgeryObstetricICUTotal
CRs examined, n (%)4571 (31.1)4826 (32.8)3336 (22.7)1973 (13.4)14706 (100)
CRs with triggers per CRs examined, n (%)1571 (34.3)1709 (35.4)676 (20.2)1672 (84.7)5574 (37.9)
CRs with isolated trigger CRs examined, n (%)930 (20.3)1085 (22.5)491 (14.7)272 (13.7)2778 (18.9)
CRs with AEs, n (%)191 (19.5)128 (14.2)57 (5.8)599 (61.5)975 (100)
AEs, n (%)210 (13.5)138 (9.0)61 (3.9)1133 (73.5)1542 (100)
CRs with AEs/CRs examined, (%)4.22.71.730.46.6
CRs with AEs/CRs with triggers, (%)11.18.48.435.917.5

CRs, clinical records; ICU, intensive care unit; AES, adverse events

Review team

As per the IHI protocol, each review team was composed of three individuals: two with clinical knowledge and expertise on patient clinical documentation, and a physician whose role was to authenticate the findings and the severity rating of the AEs.

The total number of the reviewers was 199 divided into a 71 team. Where possible, the review team remained consistent over time.

Review process

We excluded triggers and/or events that took place outside the time of the patient admission to the hospital and we considered only triggers and AEs that occurred during hospitalization. The two clinical reviewers audited all the CRs on their own, independently. We used five worksheets: general care, medication, surgical, obstetric and intensive care, with some changes in accordance with the IHI GTT. The third reviewer was always a physician. The physician did not review the CRs, but had to authenticate the consensus of the two primary record reviewers. The physician authenticated the findings of the adverse events, the rating of severity and provided answers to questions of the record reviewers about findings in a specific record. We have used the IHI GTT definition of an adverse event: unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment or hospitalization, or that results in death.

Triggers and AEs present at the time of hospitalization were excluded in this study.

The CRs were examined following the order of the sections described in the IHI GTT. The revison time should have been no longer than 20 minutes. The “20-minute rule” was applied to all records regardless their size5. The reviewers entered data into a specially developed dedicated IT-platform, developed by our IT team (based on Jawascript HTML and PHP)8

Statistical analysis

For the statistical analysis we used the software SPSS ver. 20. We used it also to develop the Receiver Operating Characteristic (ROC) curve analysis.

Results

From June 2015 to June 2018, 18,008 CRs from 105 wards of 44 Sicilian public hospitals were examined. In this study, we analyzed just 14,706 CRs relating to patients discharged from 89 medicine, surgery, obstetrics and intensive care wards, without including the CRs of the emergency and pediatric wards. In 5,574 (37.9%) CRs at least one trigger in each patient was found. In 7 CRs, the reading of the discharge diagnosis aroused interest by reviewers and an AE was detected and the triggers were not looked for. AEs were determined in 1,542 CRs (Table 1). The identification of triggers allowed us to identify corresponding AEs (Table 2).

Table 2. Distribution of general care triggers and AEs.

TriggerDescriptionNumber
of times
detected,
n (%)
Number
of times
associated,
with AEs,
n (%)
TriggerDescriptionNumber
of times
detected,
n (%)
Number
of times
associated,
with AEs,
n (%)
C01Blood products use2002 (26.7)958 (15.7)S01Return to surgery64 (20)47 (31.8)
C02Emergency and
rescue
719 (9.6)617 (10.1)S02-AChange in procedure: surgery57 (18)8 (5.4)
C03Acute dialysis279 (3.7)438 (7.2)S02-BChange in procedure: anesthesia6 (1.8)0 (0)
C04Positive blood culture291 (3.9)485 (7.9)S03Admission to ICU31 (9.6)13 (8.8)
C05X-ray or Doppler
studies for emboli or
DVT
435 (5.8)112 (1.8)S04Intubation/reintubation/BiPap in
PACU
10 (3.1)7 (4.7)
C06Decrease of Hb or Ht
>25%
1433 (19.1)896 (14.7)S05X-ray intraoperative or in PACU4 (1.2)0 (0)
C07Patient fall29 (0.4)20 (0.3)S06Intraoperative or postoperative
death
9 (2.8)2 (1.4)
C08Pressure ulcers254 (3.4)449 (7.4)S07Mechanical ventilation
>24 hours post-op
18 (5.6)9 (6.1)
C09Readmission within
30 days
294 (3.9)115 (1.9)S08Intraoperative epinephrine,
norepinephrine, naloxone, or
flumazenil
7 (2.2)2 (1.4)
C10Restraint use260 (3.5)38 (0.6)S09Postoperative troponin level
>1.5 ng/mL
19 (5.9)3 (2.0)
C11Health care–
associated infection
504 (6.7)894 (14.6)S10Injury, repair, or removal of organ13 (4.0)9 (6.1)
C12In-hospital stroke35 (0.5)78 (1.3)S11Any operative complication60 (19)41 (27.7)
C13Transfer to higher
level of care
678 (9.0)595 (9.7)S12Duration of surgery > 6h25 (7.7)7 (4.7)
C14Any procedure
complication
284 (3.8)408 (6.7)TOTAL323 (100)148 (100)
TOTAL7.497 (100)6.103 (100)P013rd- or 4th-degree lacerations13 (2.6)7(10.9)
M01Clostridium difficile–
positive stool
28 (1.0)21 (1.4)P02Platelet count less than 50,0002 (0.4)0 (0)
M02PTT >100 seconds99 (3.4)122 (8.0)P03Estimated blood loss >500 mL
(vaginal) or >1000 mL (C-section)
27 (5.5)13 (20.3)
M03INR > 648 (1.7)33 (2.2)P04Specialty consult96 (19.5)11 (17.2)
M04Glucose < 50 mg/dl225 (7.8)238 (15.6)P05Administrate prostaglandins
postpartum
97 (19.7)8 (12.5)
M05Rising BUN or serum
creatinine >2 times
baseline
1194 (41.5)718 (47.1)P06Instrumented delivery101 (20.5)7 (10.9)
M06Vitamin K
administration
231 (8.0)155 (10.2)P07General anesthesia75 (15.2)10 (15.6)
M07Anti-allergic use145 (5.0)49 (3.2)P08Hospital stay> more than 5 days81 (16.5)8(12.5)
M08Flumazenil use37 (1.3)24 (1.6)TOTAL492 (100)64 (100)
M09Naloxone use7 (0.2)6 (0.4)I01Pneumonia onset193 (10.6)380 (19.8)
M10Anti-emetic use843 (29.3)133 (8.7)I02Readmission ICU59 (3.2)125 (6.5)
M11Over-sedation21 (0.7)26 (1.7)I03In-unit procedure761 (41.9)679 (35.3)
TOTAL2,878 (100)1,525 (100)I04Intubation/reintubation804 (44.2)740 (38.5)
TOTAL1,817 (100)1,924 (100)

AEs, adverse events; ICU, Intensive Care Unit; PACU, Post Anesthesia Care; Hb, Hemoglobin; Ht, hematocrit; DVT, deep venous thrombosis; PTT, Partial Thromboplastin Time; INR, International Normalized Ratio; BUN, Blood Urea Nitrogen.

In this study, 37.9% (n=5,574) of all CRs examined had at least 1 positive trigger. Of those, 2,778 CRs had a single positive trigger (49.8% of all CRs with positive triggers) while 2,796 CRs had more than one positive trigger (51.2% of all CRs with positive triggers).

CRs with triggers (n=5,574) are significantly present in surgery wards (n=1,709; 35.4%), medicine wards (n=1,517; 34.3%) and ICU (n=1,672; 84.7%). while CRs with triggers in obstetrics wards are significantly less frequent (n=676; 20.3%). CRs with isolated triggers are more common in medical wards (n=1,085; 23.7%) and rarer in ICU (n=272; 13.7%) (Table 1).

We detected 1542 AEs in 975 CRs (i.e. patients) with AEs. In 652 patients (66.8%) a single AE was present. In the remaining 323 (33.2%) were more than one AEs.

This analysis allowed us to highlight how isolated triggers are not always a good indicator of AEs. A Receiver Operating Characteristic (ROC) curve analysis demonstrates that the presence of two triggers in a CR has a high probability that an AE having occurred (Figure 1). In CRs with a high frequency of triggers, a corresponding number of AEs was not always detected. As indicated in Table 3, on the contrary, some triggers were associated with a large number of AEs. For example, the trigger C11 Health care–associated Infection was detected in 504 CRs. However, often, a single CR with trigger C11, presented more than one AE.

4883c1bd-f9b7-4a24-b6f7-ae5b01ba6794_figure1.gif

Figure 1. ROC analysis of two random triggers.

ROC curve shows that the presence of two triggers in clinical records indicates an adverse event with a high probability.

Table 3. Distribution of triggers and AEs.

TriggerTriggers
with AEs (n)
AEs with
trigger (n)
C11Health care–associated
Infection
504894
C04Positive blood culture291485
C14Any procedure
complication
284408
C03Acute dialysis279438
C08Pressure ulcers254449
M04Glucose < 50 mg/dl225238
I01Pneumonia onset193380
M02PTT >100 seconds99122
I02Readmission ICU59125
C12In-hospital stroke3578
M11Over-sedation2126

AEs, adverse events; ICU, Intensive Care Unit; PTT, Partial Thromboplastin Time.

Triggers and AEs were analyzed when isolated triggers were identified (Table 4). For example, the isolated trigger C01 (Blood products use) was present in 483 cases, but identified only two AEs, and the trigger M05 (Rising BUN or serum creatinine >2 times the baseline) did not identify any AEs. AEs were classified using the 2009 edition of the WHO International Classification for Patient Safety (ICPS)9, and a clinical classification developed by our group (Table 5).

Table 4. Distribution of isolated triggers and AEs.

TriggerDescriptionnumber
of times
detected
isolated,
n (%)
number of times
associated with
AEs, n (%)
TriggerDescriptionnumber
of times
detected
isolated,
n (%)
number of times
associated with
AEs, n (%)
C01Blood products use483 (33.7)2 (2.5)S01Return to surgery12 (15.0)5 (41.7)
C02Emergency and rescue91 (6.4)4 (5.0)S02-AChange in procedure: surgery32 (40.0)1 (8.3)
C03Acute dialysis6 (0.4)4 (5.0)S02-BChange in procedure: anesthesia3 (3.8)0 (0)
C04Positive blood culture26 (1.8)11 (13.8)S03Admission to ICU5 (6.3)0 (0)
C05X-ray or Doppler studies for
emboli or DVT
186 (13.0)0 (0)S04Intubation/reintubation/BiPap in PACU1 (1.3)0 (0)
C06Decrease of Hb or Ht >25%190 (13.3)0 (0)S05X-ray intraoperative or in PACU2 (2.5)0 (0)
C07Patient fall9 (0.6)4 (5.0)S06Intraoperative or postoperative death1 (1.3)0 (0)
C08Pressure ulcers23 (1.6)15 (18.8)S07Mechanical ventilation
>24 hours post-op
1 (1.3)0 (0)
C09Readmission within 30 days114 (8.0)9 (11.3)S08Intraoperative epinephrine,
norepinephrine, naloxone, or flumazenil
0 (0)0 (0)
C10Restraint use115 (8.0)2 (2.5)S09Postoperative troponin level >1.5 ng/mL2 (2.5)0 (0)
C11Health care–associated infection32 (2.2)17 (21.3)S10Injury, repair, or removal of organ4 (5.0)1 (0)
C12In-hospital stroke3 (0.2)0 (0)S11Any operative complication16 (20.0)5 (41.7)
C13Transfer to higher level of care97 (6.8)1 (1.3)S12Duration of surgery > 6h1 (1.3)0 (0)
C14Any procedure complication58 (4)11 (13.8)TOTAL80 (100)12 (0)
TOTAL1433 (100)80 (100)P013rd- or 4th-degree lacerations9 (3.3)4 (36.4)
M01Clostridium difficile–positive stool7 (0.7)1 (5.6)P02Platelet count less than 50,0001 (0.4)0 (0)
M02PTT >100 seconds13 (1.4)0 (0)P03Estimated blood loss >500 mL (vaginal)
or >1000 mL (C-section)
5 (1.9)3 (27.3)
M03INR >65 (0.5)0 (0)P04Specialty consult52 (19.3)0 (0)
M04Glucose < 50 mg/dl53 (5.6)4 (22.2)P05Administrate prostaglandins postpartum48 (17.8)0 (0)
M05Rising BUN or serum creatinine
>2 times baseline
263 (27.7)0 (0)P06Instrumented delivery77 (28.6)2 (18.2)
M06Vitamin K administration31 (3.3)2 (11.1)P07General anesthesia35 (13.0)2 (18.2)
M07Anti-allergic use60 (6.3)7 (38.9)P08Hospital stay > 5 days after delivery42 (15.6)0 (0)
M08Flumazenil use10 (1.1)0 (0)TOTAL269 (100)11 (100)
M09Naloxone use1 (0.1)0 (0)I01Pneumonia onset8 (17.4)0 (0)
M10Anti-emetic use504 (53.1)4 (22.2)I02Readmission ICU1 (2.2)0 (0)
M11Over-sedation3 (0.3)0 (0)I03In-unit procedure15 (32.6)0 (0)
TOTAL950 (100)18 (100)I04Intubation/reintubation22 (47.8)1 (100)
TOTAL46(100)1(100)

AEs, adverse events; ICU, Intensive Care Unit; PACU, Post Anesthesia Care; Hb, Hemoglobin; Ht, hematocrit; DVT, deep venous thrombosis; PTT, Partial Thromboplastin Time; INR, International Normalized Ratio; BUN, Blood Urea Nitrogen.

Table 5. Categorization of adverse events.

International Classification for Patient Safety
(ICPS) - WHO ed. 2009
Clinical classification
INCIDENT TYPEAEs, N (%)INCIDENT TYPEAEs, N (%)
Healthcare Associated
Infection
742 (48.1)Healthcare Associated
Infection
742 (48.1)
Clinical Process/Procedure697 (45.2)Surgical complications175 (11.3)
Medication/IV Fluids89 (5.7)Pressure ulcers172 (11.2)
Patient Accidents12 (0.1)Acute kidney injury133 (8.6)
Blood/Blood Products2 (0.1)Procedure complications*109 (7.1)
TOTAL1542 (100)Hypoglycemia62 (4.0)
Delivery complications47 (3.0)
In-hospital Stroke18 (1.2)
Anesthetic complications17 (1.1)
Hemorrhage5 (0.3)
Various62 (4.0)
TOTAL1542 (100)

AEs, adverse events.

* Endoscopic procedures, central catheterization, urinary catheterization, orotracheal intubation.

The most frequent type of AEs observed: in-hospital related infections; surgical complications; pressure ulcers; acute kidney injury; and procedure complications.

Discussion

The evaluation of the quality and safety of health systems is difficult, but has become a priority of healthcare funders and organizations. Outcome, management and patient satisfaction indicators are available to measure the different dimensions of health care quality, but reliable measurements of safety have been elusive. Many methodologies and indicators, such as the PSI developed by AHRQ, the review of health documentation incident reporting and prospective clinical surveillance methodology are currently used.

The documentation and study of AEs, i.e. where they occur, and the type and degree of harm, is essential to promote specific opportunities for interventions improvement and to evaluate effectiveness of any intervention over time.

The IHI GTT is one methodology proposed to detect and monitor AEs and provide information to implement improvement. At present, compared to other methods, it may be the best methodology to use4. A systematic review reported the use of GTT methodology in 15 countries in 44 hospitals, with 79,004 clinical records examined10. The data are an underestimation, as the report did not include some comprehensive Swedish and Norwegian studies11. Recently, papers have been published in Italy, Austria, China and Russia1216. A critical appraisal of the studies and their results is difficult, as the methodologies use are heterogeneous, protocols are often locally adapted to the local context, the populations studied are different, and the skills of the reviewers vary. We adapted the IHI GTT to the local context in Sicily for this study and did not consider triggers and AEs identified at the admission of the patient as well as modifying some triggers. In this study, the triggers were analyzed both when associated with other triggers and when isolated. In both cases the correlation with AEs was analyzed.

Rates of triggers

In this study, 37.9% (n=5,574) of all CRs examined had at least 1 positive trigger. Of those, 2,778 CRs had a single, positive trigger (49.8% of all CRs with positive triggers) while 2,796 CRs had more than one positive trigger (51.2% of all CRs with positive triggers).

The connection between the number of CRs with triggers and the number of CRs examined is not always reported in the literature and when reported it is not always clear. Xu et al.17 report that during review of 240 clinical records, 51.0% triggers (26/51) were identified 206 times. Mortaro et al.12 report that during review of 1,320 clinical records, a total of 130 triggers were detected.

In our study, few AEs were identified by isolated triggers and many isolated triggers are not associated with AEs. Not very useful for identifying AEs, some triggers may be direct measures of "near misses". Today's trigger could be tomorrow's adverse event.

In general, it would appear that little attention is paid to triggers if they are not related to an AE. Instead, many triggers of the IHI GTT protocol could be considered to be a measure of near misses and potential AEs. These include, decrease of Hb or Ht >25%, readmission within 30 days, transfer to higher level of care, clostridium difficile–positive stool, PTT >100 seconds, INR > 6, glucose < 50 mg/dl, rising BUN or serum creatinine >2 times baseline, blood loss >500 mL (after vaginal delivery) or >1000 mL (Cesarean section), and readmission to ICU.

Rates of AEs

In a systematic review, de Vriess et al.18 reported that in 8 studies that included 74,485 CRs, the median overall incidence of in-hospital AEs was 9.2%. Another systematic review reported 44 hospitals with 79,004 CRs, had an incidence between 7 and 51%10. In the Sicilian public hospitals, 1,542 AEs were detected in 975 clinical records, corresponding to an incidence of 6.6% of CRs examined, and to 17.5% of CRs with triggers.

The results of this study are not comparable with other studies due to the diversity of detection protocols. This is also demonstrated by the wide frequency variability of AEs reported in the literature (7–51%)10.

In this study the most significant difference, compared to the other studies, is the exclusion of triggers and AEs present at the time of the patient admission in the hospital.

ICUs have the highest incidence of AEs, both with respect to CRs examined (30.4%) and those with triggers (35.9%) (Table 1). This could be due to patients being transferred to ICU and the cause of the AE was in another clinical setting. We analyzed the AEs comparing them to the triggers to allow for their identification:

  • Most AEs are associated with general care triggers (from C1 to C14) (n=6,103) (Table 2). If triggers are isolated, AEs are more frequently associated with care triggers (n=80) (Table 4).

  • The triggers related to general care have been identified 7,497 times, with an AE in 6,103 (81.4%).

  • Medications-related triggers (From M1 to M11) have been identified 2,878 times, with an AE in 1,525 (53%).

  • Surgery-related triggers (form S1 to S12) have been identified 323 times, with an AE in 148 (45.8%).

  • Obstetrics-related triggers (from P1 to P8) have been identified 492 times, with an AE in 61 (12.4%).

  • Intensive-care-related triggers (from I1 to I4) have been identified 1,817 times with an AE in 1,924 (i.e. it is very common for triggers to identify more AEs in the same patient) (Table 1 and Table 2).

However, if isolated triggers are considered, the intensive-care-related triggers were detected 46 times and they were correlated with only one AE (Table 4). This observation suggests that isolated triggers rarely allow to identify an AE and that the strength of the IHI’s GTT methodology is linked to the association of triggers. It is evident that the detection of many triggers in a CR is associated with a high probability of AEs. The analysis of the ROC curve (Figure 1) shows that it is sufficient to detect two triggers in a CR because it can be almost certain that in that CR there may be an AE.

We have classified the AEs using the ICPS 2009 classification and a clinical classification, developed by our group. In both classifications, hospital acquired infections are the most frequent AEs present (Table 5), observed in the ICU in 625 clinical records (84.3%). Surgical complications (n=175) were observed in 55.9% (n=99) in ICU, i.e. they were AEs in patients undergoing surgery and then transferred to ICU due to the onset of a complication. In 44.6% (n=80), the AEs are represented by hemorrhagic complications (intra- and post-operative hemorrhages or hematomas). Pressure ulcer lesions were detected in 172 cases, usually in the ICUs (n=112 - 65.1%). Also, the complications from procedures (n=109) were observed mainly in the ICU (n=78; 71.5%). In total, 33 complications from procedures are related to orotracheal intubation, 22 at central venous catheter, and 10 at childbirth analgesia. The complications of child birth (n= 47) were represented more frequently in 59.5% (n=28) by bleeding and in 29.8% (n=14) by lacerations.

Limitations

Our study has some several limitations. The first concerns the inter-rater reliability assessment of review teams that is not available. The second limitation is the underlying quality of CRs, which may have affected the results. However, all reviewers received the same training and each team followed the same protocols to ensure reliability. Another limitation was the limited number of hospital wards that were included in this study.

Conclusion

The Global Trigger Tool is an effective method to identify the risk of AEs and track improvement of care. It provides to clinical teams an understanding of the patient safety issues that are present in their clinical area, as well as opportunities to improve. With active involvement of clinical teams, it places patient safety in the centre of clinical activity and fosters a culture of safety. It also provides an effective way to assess the quality of the clinical records. The drawback is that the process is labor intensive, particularly if the clinical records are paper based. The introduction of electronic medical records would allow a quicker process with the automation of the identification of triggers and the possibility to link triggers together in the identification of adverse events and near misses, especially where there has been more than one trigger19,20. Finally, we conclude that the analysis and monitoring of some triggers, as potential indicators of near misses, is important to prevent adverse events. Today's trigger could be tomorrow's adverse event.

Ethical considerations

Since the data used in this study was gathered during routine practice and is used for analysis of hospital procedures, no ethical approval was obtained. Every patient gave written informed consent on admission to hospital for the use of their data for scientific research. This consent is the "Information on the processing of personal data" with reference to the Italian law n. 196/2003 and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (UE).

Data availability

Underlying data

Harvard Dataverse: Replication data for Developing and implementing the Global Trigger Tool methodology across a large health system in Sicily, https://doi.org/10.7910/DVN/YQNKCC21

Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

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Parrinello V, Grasso E, Saglimbeni G et al. Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily [version 4; peer review: 2 approved, 1 approved with reservations]. F1000Research 2020, 8:263 (https://doi.org/10.12688/f1000research.18025.4)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 3
VERSION 3
PUBLISHED 09 Oct 2019
Revised
Views
14
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Reviewer Report 17 Jun 2020
Doncho Donev, Institute of Social Medicine, Faculty of Medicine, Ss. Cyril and Methodius University of Skopje, Skopje, North Macedonia 
Approved
VIEWS 14
The paper presents an innovative method for detecting and monitoring triggers for adverse events (AEs) and serious adverse events (SAEs) in a systematic and comprehensive way. With some corrections and additions (Minor revision) the paper might be approved for indexing.
... Continue reading
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HOW TO CITE THIS REPORT
Donev D. Reviewer Report For: Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily [version 4; peer review: 2 approved, 1 approved with reservations]. F1000Research 2020, 8:263 (https://doi.org/10.5256/f1000research.22986.r65023)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 15 Jul 2020
    vincenzo parrinello, U.O. Quality management and patients safety - Azienda Ospedaliero-Universitaria Catania, Italy, Italy
    15 Jul 2020
    Author Response
    Dear Professor Donev, thank for your review and your suggestions. We verified and adjusted some typos and added more clarification as you suggested. Thank you for your time and consideration.


    Best ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 15 Jul 2020
    vincenzo parrinello, U.O. Quality management and patients safety - Azienda Ospedaliero-Universitaria Catania, Italy, Italy
    15 Jul 2020
    Author Response
    Dear Professor Donev, thank for your review and your suggestions. We verified and adjusted some typos and added more clarification as you suggested. Thank you for your time and consideration.


    Best ... Continue reading
Views
8
Cite
Reviewer Report 09 Oct 2019
James M. Naessens, Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA 
Approved
VIEWS 8
Revisions ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Naessens JM. Reviewer Report For: Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily [version 4; peer review: 2 approved, 1 approved with reservations]. F1000Research 2020, 8:263 (https://doi.org/10.5256/f1000research.22986.r54873)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 2
VERSION 2
PUBLISHED 11 Sep 2019
Revised
Views
10
Cite
Reviewer Report 19 Sep 2019
James M. Naessens, Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA 
Approved
VIEWS 10
I appreciate the revisions and responses that the authors have made. I believe that the manuscript is now more understandable. I have several editorial suggestions:
  • The heading for the fourth column of Table 2 is still
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Naessens JM. Reviewer Report For: Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily [version 4; peer review: 2 approved, 1 approved with reservations]. F1000Research 2020, 8:263 (https://doi.org/10.5256/f1000research.22544.r53740)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Version 1
VERSION 1
PUBLISHED 07 Mar 2019
Views
23
Cite
Reviewer Report 01 May 2019
Brent C. James, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA 
Approved with Reservations
VIEWS 23
General comments:

The Harvard Medical Practice Study (HMPS – cited by the authors) used post-discharge chart review to detect care-associated injuries (adverse events – AEs) that occurred during hospitalization. Under HMPS, trained nurses reviewed a random selection of ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
James BC. Reviewer Report For: Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily [version 4; peer review: 2 approved, 1 approved with reservations]. F1000Research 2020, 8:263 (https://doi.org/10.5256/f1000research.19713.r46773)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 28 May 2019
    vincenzo parrinello, U.O. Quality management and patients safety - Azienda Ospedaliero-Universitaria, Catania, Italy
    28 May 2019
    Author Response
    We appreciate the review by Professor Btrent of our paper, the accuracy of his observations and the relevance of his suggestions. We are honored that he considers our paper “useful ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 28 May 2019
    vincenzo parrinello, U.O. Quality management and patients safety - Azienda Ospedaliero-Universitaria, Catania, Italy
    28 May 2019
    Author Response
    We appreciate the review by Professor Btrent of our paper, the accuracy of his observations and the relevance of his suggestions. We are honored that he considers our paper “useful ... Continue reading
Views
47
Cite
Reviewer Report 28 Mar 2019
James M. Naessens, Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA 
Approved with Reservations
VIEWS 47
This paper by Parrinello et al., presents the experience of applying the Italian version of the Institute for Healthcare Improvement’s Global Trigger Tool (GTT) for screening for adverse events (AEs) to a random sample of medical records for hospital discharges ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Naessens JM. Reviewer Report For: Assessing the development and implementation of the Global Trigger Tool method across a large health system in Sicily [version 4; peer review: 2 approved, 1 approved with reservations]. F1000Research 2020, 8:263 (https://doi.org/10.5256/f1000research.19713.r45400)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
  • Author Response 11 Sep 2019
    vincenzo parrinello, Vincenzo Parrinello, U.O. Quality management and patients safety - Azienda Ospedaliero-Universitaria, Catania, Italy
    11 Sep 2019
    Author Response
    We appreciate the review by Professor Naessens of our paper, the accuracy of his observations and the relevance of his suggestions. We are honored that he considers our paper “a ... Continue reading
COMMENTS ON THIS REPORT
  • Author Response 11 Sep 2019
    vincenzo parrinello, Vincenzo Parrinello, U.O. Quality management and patients safety - Azienda Ospedaliero-Universitaria, Catania, Italy
    11 Sep 2019
    Author Response
    We appreciate the review by Professor Naessens of our paper, the accuracy of his observations and the relevance of his suggestions. We are honored that he considers our paper “a ... Continue reading

Comments on this article Comments (0)

Version 4
VERSION 4 PUBLISHED 07 Mar 2019
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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