ARTICLE INFO

Article Type

Descriptive & Survey Study

Authors

Hatami   B. (1)
Davari   F. (*2)
Mohammad Alizadeh   A.H. (1)
Alimohammadi   A.M. (3)






(*2) Forensic Medicine Department, , Medical Faculty, Shahid Beheshti University of Medical Sciences, Tehran, Iran
(1) Gastrointestinal & Liver Diseases Research Center, , Shahid Beheshti University of Medical Sciences, Tehran, Iran
(3) Tehran Forensics General Office, Tehran, Iran

Correspondence

Address: Monitoring & Accreditation Management, Shahid Beheshti University of Medical Sciences, Hafez Street, Tehran, Iran. Postal Code: 1134845764
Phone: +98 (21) 66761126
Fax: +98 (21) 66703641
far95779@yahoo.com

Article History

Received:  January  30, 2019
Accepted:  June 2, 2019
ePublished:  June 20, 2019

BRIEF TEXT


Considering that ERCP is one of the most difficult and high risk activity fields of gastroenterologists, it is expected that a great percentage of complaints exist in this area.

... [1]. The patient's complaint about the therapist often is for dissatisfaction and this does not necessarily mean injury or abuse [2]. Although not all dissatisfactions lead to complaint, the medical error rates are increasing in health centers [3, 4]. Gastrointestinal specialists, like all physicians, are involved in medical malpractice lawsuits. Data on endoscopy-related complaints are scarce and often relate to more common endoscopic procedures. Information on the overall number and causes of Endoscopic Retrograde Cholangiopancreatography (ERCP)-related medical complaints is also scarcer [5–13].

The aim of this study was to investigate the ERCP-related medical complaints referred to the forensic medicine department of Tehran over six years (2011-2016).

This study was conducted by descriptive-analytical and retrospective method.

First, the statistics of the recorded complaints in the forensic medicine department of Tehran province against gastroenterology subspecialist or subspecialist assistants were extracted over six years (2011-2016).



In each case, a form including patient, disease and physician information and treatment was completed (no name was mentioned). Statistical analysis was performed by SPSS 17 software using chi-square test.

The total ERCP-related complaints were recorded during 2011 to 2016 were 35 cases, the highest rate in 2015 and 2015 (9 and 8 cases, respectively) and the least in 2011 (3 cases). Of the 35 patients who had complained of ERCP during these six years, 3 cases were 30 years old and younger, 17 cases were between 31 and 60 years and 15 cases were over 60 years, of whom 21 patients (0.60%) were male and 14 patients (40.0%) were female. Half of them had been urgently referred for ERCP and the other half had an active ERCP (in one case the patient referral was not recorded in the clinic), of whom15 cases were in public educational hospitals, 7 cases were in non-educational public hospitals 12 cases in private hospitals, and one cases was recorded in a private clinic. Of the physicians complained of, 20 subjects were faculty members and 15 cases were non-faculty members. Of the total number of cases reviewed, 34 cases (97.1%) had correct and scientific indication for ERCP and only one case did not have indication. The most common indication for performing ERCP was common bile duct stones (58.8%). The most common complication was pancreatitis after ERCP (8 cases, 22.9%) and intestinal perforation (7 cases, 20%). Other complications were bleeding, cholangitis and cardiopulmonary complications. In 26 cases (74.2%) the ERCP-related complication was diagnosed on time and was appropriately treated. Of the 35 patients, 17 patients had recovered and 18 patients had died. In 32 cases (91.4%), the informed consent was obtained before the procedure. The interval between ERCP and injury was less than one day in 20% of the cases, one to two days in 48.6% of the cases, and in 31.4% of cases, three days or more. In 10 cases (28.6%) the medical commission found medical malpractice and 25 cases (71.4%) resulted in acquittal. Of the 10 medical malpractice cases, 5 cases (14.3%) were due to imprudence, 4 cases (11.4%) due to careless and one case (2.9%) was due to the physician’s knowledge. The percentage of medical malpractice was less than 5% in 5 cases (50.0%), 6-10% in 3 cases (30.0%), and in 10 cases (20.0%) it was above 10%. Of these, 13 cases protested against the original commission vote, and the second commission in five cases changed the primary decision. The incidence of post-ERCP complication was not significantly correlated with the status of the physician (being a faculty member or not) (p = 0.064), however there was a significant relationship between timely diagnosis and appropriate and principled treatment of the complication and the medical status of the physician (p = 0.049). In the review of complaints, 89.5% of physicians (faculty members) timely identified and treated the complication. In contrast, the physicians who were not faculty members only diagnosed the complication in 60% of cases on time. In addition, in 80% of the complaints about physicians, the resulted complication was a known complication for the disease or treatment and the malpractice was not due to imprudence, careless and lack of knowledge of the physician. However, physicians who were not faculty members were reported for malpractice in more than half of the complaints, which included 26.7% for imprudence, 20% for careless, and 6.7% for lack of knowledge. Finally, there was a significant relationship between the final verdict and the medical status of the physician (p = 0.005). Physician who were faculty members were acquitted in 90% of complaints. In contrast, physicians who were not faculty members were acquitted in only about half of the cases (46.7%) and in 53.3% of the cases were guilty.

Medical malpractice includes cases where the medical treatment provided to the patient by the health system (hospital, physician, dentist, nurse, midwife, etc.) is not based on the standard level and may result in patient injury [11]. Whenever no diagnosis or no response to treatment complies with scientific and technical standards, it is not a medical malpractice [14-16]. When a person does not provide the tasks he is in charge of, and causes harm to another person, then it is called malpractice and in medical setting, if the person is a medical practitioner, a medical malpractice has occurred. … [17-18].

It is recommended that the study be conducted over a longer period.

One of the limitations of this study was the limited number of cases in the six-year period.

The selection of the patients based on the correct indication for ERCP operation and examination the patients after operation of the procedure in order to diagnose the probable side effects and its proper treatment have a significant role in reducing the number of complaints.

We would like to sincerely thank the staff of the Tehran General administration of the Legal Medicine Organization for their assistance in collecting information for this study.

None declared.

This study was approved by the Research Council and the Research Center of the Iran Legal Medicine Organization.

This study was funded by the Research Center of the Legal Medicine Organization.


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