Cited by 46Patient Safety and Medication ErrorsPharmacovigilance and Adverse Drug ReactionsHospital Admissions and Outcomes

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Effectiveness of routine reporting to identify minor and serious adverse outcomes in surgical patients

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Marang-van de Mheen, P J·2005·Quality and Safety in Health Care

DOI 10.1136/qshc.2004.013250PMC PMC1744069

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Abstract

OBJECTIVE: To assess the effectiveness of routine reporting to identify surgical adverse outcomes in comparison with retrospective medical record review. DESIGN: Independent assessment of two methods applied to one sample. Surgeons and surgical residents routinely reported all adverse outcomes for patients in their care during admission. A trained research assistant, blinded to the surgeons' reporting data, retrospectively reviewed the medical records of selected patients and registered all adverse outcomes identified from paper or electronic patient records. SETTING: Dutch university hospital. STUDY SAMPLE: A 5% sample of patients (N = 150) discharged in 2002 was taken; oversampling of patients undergoing reoperations, sick patients (ASA >or=3), and those undergoing technically complex surgery was done to increase the yield of adverse outcomes. MAIN OUTCOME MEASURES: The number of adverse outcomes identified by each method was compared with the total number identified by either method. This was done both for all adverse outcomes and for serious adverse outcomes. RESULTS: Routine reporting identified fewer adverse outcomes than medical record review (62.5% v 78.2%). Complete agreement was achieved in only 40.7% of adverse outcomes. Routine reporting identified slightly more serious adverse outcomes (84.8% v 79.5% of the total), but this difference was not statistically significant. Extrapolating these results to the total number of admissions in 2002, routine reporting underestimated the annual adverse outcome incidence by 1.8% (increasing from 14.5% to 16.3%) and the incidence of serious adverse outcomes by 0.3% (increasing from 6.9% to 7.2%). CONCLUSIONS: Neither method identified all adverse outcomes. Routine reporting underestimated the incidence of minor events but was as accurate as record review in identifying serious adverse outcomes.

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“18 Moreover, incident, AE and complaint rates closely resembled those in other studies.”
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“It was also shown that only 10% of these were captured by our routine reporting system, although it was higher for adverse outcomes requiring readmission (still only 25%), which has been shown to be effective in identifying in-hospital adverse outcomes.(12) Of the postdischarge adverse outcomes missed in the routine r…”
BackgroundInfluential
Adverse Physiological Events under Anaesthesia and Sedation: A Pilot Audit of Electronic Patient Records
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Method
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“37 This deﬁnition did not change during the study period.”
BackgroundMethod
Surgical adverse outcomes and patients' evaluation of quality of care: inherent risk or reduced quality of care?
de Mheen, P. J. M., van Duijn‐Bakker, N., & Kievit, J. (2007) · Postgraduate Medical Journal · doi:10.1136/qshc.2006.021071 · Cited by 19
The Association Between Complications, Incidents, and Patient Experience: Retrospective Linkage of Routine Patient Experience Surveys and Safety Data.
de Vos, M. D., Hamming, J., Boosman, H., & de Mheen, P. J. M.-V. (2019) · Journal of patient safety · doi:10.1097/pts.0000000000000581 · Cited by 12
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Effectiveness of a multifaceted quality improvement intervention to improve patient outcomes after total hip and knee arthroplasty: a registry nested cluster randomised controlled trial
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Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients
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“Routine reporting by physicians identified fewer events than medical record review[15].”
Background
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Schepers, A., Mieog, S., van de Burg, B. B., van Schaik, J., Liefers, G., & de Mheen, P. J. M. (2010) · Journal of Surgical Research · doi:10.1016/j.jss.2010.07.022 · Cited by 15
Effects of study methodology on adverse outcome occurrence and mortality
de Mheen, P. J. M., Hollander, E.-J. F., & Kievit, J. (2007) · International Journal for Quality in Health Care · doi:10.1093/intqhc/mzm039 · Cited by 15
Retrospective record review in proactive patient safety work – identification of no-harm incidents
Schildmeijer, K. G. I., Unbeck, M., Muren, O., Perk, J., Härenstam, K. P., & Nilsson, L. M. (2013) · BMC Health Services Research · doi:10.1186/1472-6963-13-282 · Cited by 14
“It is a frequently used method in healthcare practice to identify AEs [5,17,18], and in this respect superior to different incidentreporting systems [8,9,19-21].”
Method
How do we know that we are doing a good job – Can we measure the quality of our work?
Gisvold, S. E., & Fasting, S. (2011) · Best practice & research. Clinical anaesthesiology · doi:10.1016/j.bpa.2011.02.010 · Cited by 14
Nurse Reports of Adverse Events During Sedation Procedures at a Pediatric Hospital
Lightdale, J. R., Mahoney, L. B., Fredette, M. E., Valim, C., Wong, S., & DiNardo, J. A. (2009) · Journal of PeriAnesthesia Nursing · doi:10.1016/j.jopan.2009.07.004 · Cited by 13
Linking Patient-Reported Outcome Measure Scores to Adverse Event Data to Gain Insight into Overestimation of Postoperative Patient-Reported Outcome Measure Improvement After Total Hip Arthroplasty and Total Knee Arthroplasty Due to Selective Nonresponse
van Schie, P., van Bodegom‐Vos, L., Zijdeman, T. M., Gosens, T., Nelissen, R. G. H. H., & de Mheen, P. J. M. (2024) · The Journal of Arthroplasty · doi:10.1016/j.arth.2024.06.064 · Cited by 11
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van der Slegt, J., Flu, H. C., Veen, E. J., Ho, G. H., de Groot, H. G. W., Vos, L. D., & van der Laan, L. (2014) · Annals of Vascular Surgery · doi:10.1016/j.avsg.2014.10.022 · Cited by 10
“This definition was confirmed by the Association of Surgeons of the Netherlands (ASN) and has been chosen with the explicit aim of excluding subjective judgment on cause and effect, and right or wrong (12, 15-18).”
Method
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“A previous study has shown that such a routine reporting system is an effective method to identify adverse outcomes [ 11 ].”
Method
Quality of Care and Analyses of Surgical Complications
Visser, A., Ubbink, D. T., van Wijngaarden, A. K. S., Gouma, D. J., & Goslings, J. C. (2012) · Digestive Surgery · doi:10.1159/000344007 · Cited by 8
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“…primary outcome was nerve injury, de ﬁ ned as postoperative nerve impairment, which was reported by physicians as a postoperative complication during routine clinical practice, collected in the complication registry, which has previously been shown to be valid compared with record review [20,21] .”
Result
Patient safety events cause harm across a variety of veterinary care settings: a global retrospective analysis
Larson, M., Low, R. M., Adler, J. A., Schortz, L., Shaw, S. P., Blackie, K., Grace, K., Hsu, Y., & Wu, A. M. (2025) · Journal of the American Veterinary Medical Association · doi:10.2460/javma.24.08.0523 · Cited by 6
First Experience of a Novel Femorocrural Expanded Polytetrafluoroethylene Bypass Graft
Tuijp, S. J., Flu, H. C., Donker, J. M. W., Veen, E. J., Ho, G. H., de Groot, H. G., van der Waal, J. C., & van der Laan, L. (2013) · Annals of Vascular Surgery · doi:10.1016/j.avsg.2013.04.024 · Cited by 3
Detecting Adverse Events in Dermatologic Surgery
PINNEY, D., PEARCE, D. J., & Feldman, S. R. (2009) · Dermatologic Surgery · doi:10.1111/j.1524-4725.2009.01378.x · Cited by 3
“5% to 66% of events in a similar patient population.(10,11) Put differently, routine reporting failed to identify 38% of AEs.”
Background
Evaluation of retrospective patient record review as a method to identify patient safety and quality information in orthopaedic care
Unbeck, M. (2012) · Figshare · Cited by 3
Registration of catheter-related complications in adverse events reporting systems: a major underestimation of the real complication practice
Laan, B. J., Godfried, M. H., & Geerlings, S. E. (2021) · Journal of Infection Prevention · doi:10.1177/17571774211012455 · Cited by 2
“In contrast, the nationwide routine reporting of surgical adverse events in The Netherlands is integrated in daily clinical practice, which results in a registration of 85% of serious adverse events (Marang-van de Mheen et al, 2005).”
Background
Discrepancy in Reporting of Perioperative Complications
Gomes, N. V., Polutak, A., Schindler, C., Weber, W. P., Steiner, L. A., Rosenthal, R., & Dell‐Kuster, S. (2023) · Annals of Surgery · doi:10.1097/sla.0000000000005807 · Cited by 2
Patients’ willingness to complete written incident report forms in one UK tertiary cancer hospital
Doherty, C., Stavropoulou, C., & Dickinson, L. (2015) · Clinical Risk · doi:10.1177/1356262215616013 · Cited by 1
Morbilidad y mortalidad secundaria a complicaciones cardiológicas después de la revascularización de extremidad por isquemia crítica
Flu, H. C., Lardenoye, J.-W. H. P., Veen, E. J., Aquarius, A. E., Henegouwen, D. P. V. B., & Hamming, J. F. (2009) · Anales de Cirugía Vascular · doi:10.1016/j.acvsp.2009.11.018
“Clasificaci on de Fontaine(30,31) 0,257 III 49 (46) 36 (50) 13 (38) IV 57 (54) 36 (50) 21 (62) Clasificaci on TASC(1,2) Lesiones femoropopl ıteas 0,805 Tipo B 39 (37) 26 (36) 13 (38) Tipo C 16 (15) 12 (17) 4 (12) Tipo D 51 (48) 34 (47) 17 (50) Procedimientos primarios 106 (82) 72 (100) 34 (60) 0,817 ATP 39 (37) 26 (36…”
Morbidité et mortalité d'origine cardiaque après revascularisation pour ischémie critique
Flu, H. C., Lardenoye, J.-W. H. P., Veen, E. J., Aquarius, A. E., Henegouwen, D. P. V. B., & Hamming, J. F. (2009) · Annales de Chirurgie Vasculaire · doi:10.1016/j.acvfr.2010.02.014
Quality of Provided Care in Vascular Surgery
Hamming, J. F., & Flu, H. C. (2008)
Voluntary Incident Reporting in Health Care
Markes, A. R., & Diab, M. (2025) · Journal of Bone and Joint Surgery · doi:10.2106/jbjs.24.00880

Authors: Marang-van de Mheen, P. J.
Venue: Quality and Safety in Health Care
Publisher: BMJ
Published: 2005-10-01
Volume: 14
Issue: 5
Pages: 378-382
ISSN: 1475-3898 (ISSN-L)
1475-3901
DOI: 10.1136/qshc.2004.013250
PMC: PMC1744069
OpenAlex: W2123150039
Cited by: 46
References: 18
Citations by year: 2025: 2 · 2024: 1 · 2023: 2 · 2022: 2 · 2021: 1 · 2019: 2 · 2018: 1 · 2017: 2 · 2015: 4 · 2014: 2 · 2013: 2 · 2012: 3
FWCI: 3.37
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: BMJ Quality & Safety (publishedVersion)
Europe PMC (PubMed Central) (publishedVersion)
PubMed Central (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Patient Safety and Medication Errors
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Health Sciences › Nursing › Leadership and Management › Hospital Admissions and Outcomes
Keywords: adverse surgical outcomes, serious adverse events, outcome ascertainment, underreporting, surgical quality
MeSH terms: Adult, Age Factors, Aged, Female, Humans, Male, Medical Audit, Medical Records, Middle Aged, Netherlands, Reoperation, Retrospective Studies, Risk Factors, Risk Management, Surgery Department, Hospital, Surgical Procedures, Operative, Treatment Outcome, Outcome Assessment, Health Care

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Effectiveness of routine reporting to identify minor and serious adverse outcomes in surgical patients

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