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- The rise of defensive medicine
- A burden to the health system
- Medical responsibility
- Ethical aspects of defensive medicine
- Are there possible solutions to prevent medical errors?
- Improving health care quality
- Authors’ contributions
Error in medicine and medical liability has a long history dating back to Antiquity. During the 19th Century, most lawsuits related to errors in treating surgical problems were settled. However, in the first half of the 20th Century, lawsuits claimed that mistakes were related to the doctor's action: the doctor made something wrong (errors of commission). In Brazil, medical error is defined as inappropriate conduct, including negligence and recklessness, that causes harm to the patient. The physician's fear of being suited is the reason for some practice named defensive Medicine (D.M.), defined as ordering unnecessary tests and procedures or avoiding treatments for patients considered at high-risk. Thus, this narrative review aims to analyze and describe the relationship between medical errors, medical negligence, and the practice of D.M. So, the authors propose procedures and attitudes to avoid medical errors and the approach of D.M.: a national focus to create leadership and research tools to enhance the knowledge base about patient safety; a reporting system that would help to identify and learn from errors; the use of a computer-based protocol reminder; some technological devices to help the medical practice (electronic prescribing and information technology systems); creating risk management programs in hospitals. Therefore, the authors conclude that the most critical attitude to avoid medical liability is a good and ethical medical practice with the proper use of technology, based on knowledge of scientific evidence and ethical principles of medicine - for the benefit of patients.
Error in medicine and questions about medical liability has a long history dating back to Antiquity. In Mesopotamia, there was already the Code of Hammurabi (1792‒1750 BC). This code dealt with the mistakes made by doctors in the exercise of their profession. One of the first reports of errors in medicine was made by British legal scholar Sir William Blackstone. In 1765, he published a compendium of legal principles entitled Commentaries on the Laws of England. He refers to “Mala Praxis”, which he defines as “neglect or unskillful management of a physician or surgeon”. The modern word “malpractice” is derived 1 from this term. Since then, in 1794, “the first recorded medical malpractice lawsuit in the U.S. takes place in Connecticut where a patient died of a surgical complication”. 2 De Ville 3 stated, “in 1871 the Medical and Surgical Report recounted a daring solution to a malpractice charge”. One patient told his surgeon that he would sue him due to a poorly healed fracture. The surgeon offered to correct the defect and resolve the problem. The patient refused, so the surgeon immobilized him and successfully operated. The patient then decided to drop all charges. According to De Ville 3 “it might be characterized as an early case of defensive medicine”.
The problem evolved during the 19 th Century through lawyers who acted aggressively, with most lawsuits related to errors in treating fractures, dislocations, and amputations. 1
Lawsuits for alleged medical errors continued during the first half of the 20 th Century. Most of them claimed that mistakes were related to the doctor's action: the doctor made something wrong, so-called errors of commission, “such as causing injuries due to too much radiation (during radiographs examination), complications of surgical treatment, and diagnostic failures”. 1 , 4 From the 1950s onwards, there was a transition from errors of action to errors of omission. The doctor failed to do what was correct for that particular case. For example, from the early 1970s to the late 1980s, the number of lawsuits in the U.S. alleging failure to diagnose cancer increased by 50%. 3 Berlin1 stated that “a 1991 study disclosed that 75% of all adverse events due to negligence committed in New York hospitals in the late 1980s involved diagnostic mishaps, usually the result of a physician's failure to do something”. In the meantime, “malpractice claims dramatically increased between the 1960s and 1980s reaching 15 claims out of 100 physicians in a given year, with a doubling in payouts”. 5
At this point, someone can argue: what really is a medical error?
Some authors define a medical error as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim”. 6 In Brazil, medical error is defined as inappropriate conduct due to negligence, recklessness, or malpractice that causes harm to the patient. It is a sign of the evolution of the “error concept”, which encompasses all aspects of behavior capable of causing damage to the patient.
In summary, allegations of negligence against physicians suffered a transformation over the last decades: in the beginning, patients sued them for doing something wrong; now, the doctors began being sued for failing to do something right.
As a result, contingency plans “often arise within a clinician when faced with thoughts of shame, or embarrassment” 1 , 5 following an accusation of wrongdoing by patients or family, medical errors, and other lapses in judgment. Also, there has been a tendency to react with overdiagnosis, and unnecessary surgeries, which may be harmful to patients. 1 , 5 This approach to extreme care is psychologically soothing. But it also can be profit-motivated. And worst: medical students and residents can observe this practice (e.g., so-called defensive medicine) in their training, perpetuating the problem.
Thus, this narrative review aims to analyze and describe the relationship between medical errors, medical negligence, and defensive medicine and propose some procedures and attitudes to avoid the mistakes and the practice of defensive medicine.
An extensive search query was utilized, analyzing results from journal articles regarding medical error, medical negligence, and defensive medicine. A MEDLINE, PubMed, and Cochrane Library literature search were conducted with search terms “defensive medicine” AND “medical malpractice” OR “medical errors”. All articles were analyzed for this narrative review, but the authors chose 34 of them that we believed were essential to explaining the authors’ point of view.
Physicians are accustomed to operating within multi-level guidelines, but errors can arise in planning actions or executing them. According to Oyebode, 6 errors include “improper transfusions, surgical injuries, wrong-site surgeries, suicides, restraint-related injuries or death, falls, burns, pressure ulcers, and mistaken patient identities”. The most affected settings where these errors occur are intensive care units, operating rooms, and emergency departments. 6 Medication error is the most common and preventable cause of patient injury, and “the rates of medication errors in pediatric settings appear to be up to three times the rates in adult settings, mainly due to parental drug administration”. 6
It is important to note that “there are two models of human error causation, namely the person approach and the systems approach”. 6 The person approach calls attention to individual action, including forgetfulness, inattention, or moral failure. On the other hand, the system approach regards the work's conditions as the source of errors, aiming to understand “the origin of errors and building defenses to prevent them or mitigate their effects”. 6 It is crucial to know that both systems are complementary and that human rather than technical failures are the sources of most medical errors. They represent a severe threat to potentially hazardous systems. 7
Oyebode 6 remarks that the “most common systems failure identified as underlying clinical errors are failures in the dissemination of drug knowledge and inadequate availability of patient information such as test results necessary for safe treatment”. Other causes reported are the disregard of guidelines and policies, unavailability of equipment, “production pressure and hectic schedules”. 8 Fatigue is a non-negligible factor that needs to be taken into account. Shift work of 24h or more “was more likely to be associated with medical errors than shorter shifts”. 6 , 9
In this scenario, some pathways are intended to prevent error by negligence, primarily by surgeons, in the 21 st Century. First, they began to use a type of conduct called “Defensive Medicine” (D.M.). As stated by Hellinger and Encinosa, 10 “the most damaging attribute of our medical malpractice system is not that it fails to compensate victims or to deter poor performance but that it promotes the practice of “defensive medicine”. Borgan et al. 11 defined defensive medicine as “the routine medical care to avoid or reduce the risk of real or perceived future legal consequences”. Frati P et al. 12 stated that “D.M. has been defined as ordering tests, procedures, and visits or avoiding treatments for patients considered at high-risk, to prevent malpractice claims”.
The American Medical Association (AMA) has defined defensive medicine as the “performance of diagnostic tests and treatments which, but for the treat of a malpractice action would not have been done”. 3
In the last decades, the culture of practice of D.M. spread worldwide due to an increasing number of lawsuits against physicians in all medical specialties. As a result, the physicians used D.M. “to lessen their exposure to medical malpractice litigation” or “by fear of malpractice litigation”. 12 , 13
The specialties most affected by claims are in the U.S and Brazil. were Plastic Surgery, General Surgery, Gynecology, and Dermatology. 14 , 15 In Brazil, in a study carried out in Santa Catarina, in 2005‒2009, the medical specialties with the highest number of litigation in court for medical errors were gynecology, anesthesiology, and general surgery. 14 In general, in Brazil, “lawsuits against physicians have increased by 1,600%, compared with that in the previous decade, and this is a crucial concern”. 15
Otherwise, Frati P et al. 12 pointed out that “several studies have highlighted how lawsuits negatively impact physicians, causing them stress, thereby jeopardizing their future performance”. In addition, it creates a “significant pressure on health professionals, particularly in some specialized branches more exposed to this risk”. De Ville 3 observes that “physicians are likely to look to the law first, not afterward, and are often preoccupied with maintaining the safest legal procedure possible”. In turn, Frati P et al. 12 emphasize that “there is no evidence in the literature that a fear of being sued is useful for reducing the medical error rate”.
As far as the authors know, D.M. has two primary forms. An active form, also called “positive”, is when the physician orders extra tests and procedures. The other is “passive or negative” when avoiding high-risk patients and methods. Someone can also categorize defensive practices into two distinct patterns: “assurance practices that unnecessary over-investigate lower-risk patients, and avoidance practices that aim to avoid intervention in the care of higher-risk patients”. 13 Finally, Baungaart et al. 14 note that there are other forms different from fear of litigation, which is applied by “self-protective motives”, and they can be grouped in “four categories: fear of patient dissatisfaction; fear of overlooking a severe diagnosis; fear of negative publicity and unconscious defensive medicine”.
In this perspective, exposure to lawsuits has made physicians more careful in their actions and procedures to prevent medical claims, “rather than to promote the patient's best interest”, disregarding medical ethics. 13 As adequately stated by Hermer & Brody, 17 “while perhaps not 'unnecessary' care, defensive medicine is meant more to offer economical and psychological benefit to the physician than to the patient”. Again, this disregards medical ethics and the benefit of the patients.
Another problem is that D.M. is not innocuous or harmless. As physicians involved in any surgery may be sued when executing surgical treatment or preoperative activities, the result is the request for unnecessary tests before the procedures with consequent enhancement of the entire process.
In a universal public health system, as in England or Brazil, this means considerable resources, burdening the whole system and harming many other patients who may be left without care. Furthermore, Garattini, Padula & Mannucci 18 stated in 2020, that “the broad impact of defensive medicine” also includes indirect costs induced by physician's stress, time, and reputation loss. In addition, the authors say that “redundant D.M. practices induced by the threat of medical liability are expected to increase total health care expenditures”. In a developing country like Brazil, with scarce public resources destinated for the health system, it becomes a severe problem affecting all the Community. 16
The essential principle of ethical behavior in medical practice is to act to the patient's benefit. But it also includes the use of all communities, that is, public health ethics focusing on collective aspects, such as sharing risks and benefits. 13 Thus, beyond the individual indirect costs, there is a high cost to all the patients that are hampered by the scarcity of public resources.
Kapp 19 pointed out that D.M. “constitutes bad medical practice, drives up health care costs, depends on medical specialty and a physician's own prior experience as a malpractice defendant”. Although he stated that D.M. is a “rational response to actual legal risks confronting physicians”, he also assumed that D.M. “varies depending on a jurisdiction's particular tort law climate”. 19
The legal culture in each country towards medical errors and medical responsibility affects how and how D.M. is practiced. In Brazil, for example, it must be clear that medical responsibility is subjective; the doctor should care for the patient but not cure. Moreover, the cure depends on several other individual and collective factors, not just on the doctor's performance. Therefore, it is necessary to characterize the existence of fault on the part of the professional to confirm the presence of an error in medical practice. And guilt, in turn, is manifested by inappropriate medical conduct based on negligence, recklessness, or malpractice. The proof of error is made through the expert examination requested by the judge, who will decide based on this expert analysis.
But, as far as the authors know, in the U.S. and other countries, the medical responsibility is objective; there is a compromise with cure and with a good result – independently of any factor strange to the doctor-patient relationship. Moreover, their legal system “is based on the premise of trial advocacy, which relies on the adversarial arrangement of opposing parties, a judge, and potentially a jury. The jury serves as the decider of fact, whereas the judges decide all questions of law”. 20
In Brazilian Criminal Law, the doctor can also be called upon in articles 129 (bodily injury) and 121 (to kill someone if the patient dies) of the Penal Code. Whether the doctor has a “non-observance of the professional technical rule” in both cases will be observed. If so, the penalty will be increased. It is essential to point out that “non-observance of professional technical rule” means that the doctor did not follow the protocols and guidelines recommended for each case. Of course, the procedures and protocols are built on the best available scientific evidence.
Defensive medicine is a medical, legal, and moral problem. 20–22 Someone could contest the power of the state to interfere in medical practice, 21 furthermore in front of the Criminal Law. But It must be clear that “it is morally permitted for governments to enforce contracts that citizens record as binding among them”. 20 As Engelhardt 20 says, “currently, there are no questions that the practice of medicine is controlled through law and regulation”.
However, somebody should view bioethical principles in a relational way. 23 Respect “principle of beneficence”, for example, must be applied in favor of the individual and regarding the social benefits of all communities.
It is important to note that D.M. in positive (when additional procedures are performed without proven necessity) or negative (when high-risk patients and methods are avoided) form is firmly questioned morally and ethically. Frierson and Joshi 24 remark that “the duty in medical practice begins when a doctor-patient relationship is established”. In the case of a psychiatrist-patient relationship, for example, when the doctor predicts the possibility of being sued, its improper termination could constitute abandonment. It is unethical behavior and a kind of D.M.
The authors pointed out above that physicians in the U.S. and other countries, in the past decades, “have long believed that they must practice defensive medicine to diminish litigation risk”. 17 The focus of these physicians is centered on themselves and not on their patients. In other words, they are not acting to benefit the patients, disregarding basic principles like do not cause harm to them or respecting their autonomy. 23 , 24 , 25 They do not listen to their patients but convince them that unnecessary exams are “necessary”. It is a kind of fraud. In summary, from this point of view, D.M. is unethical since it disregards actions for the benefit of the patients, adds avoidable risks to patients, and increases costs to society and public health.
Besides, the practice of D.M. does not have the strength to prevent a lawsuit. For example, since defensive medicine became part of medical malpractice 45-years ago, medical errors have increased1; D.M. is not a solution for posterior medical litigation. As stated by Williams et al., 26 “This practice (D.M.) does not necessarily prevent malpractice claims and more importantly, neither does it equate to good medical practice, with some leading to poor outcomes”. Unnecessary exams and tests imply overdiagnosis and overtreatment. It is “a new kind of error of Commission”. 1 Errors of omission (failure to diagnose) declined because of the use of D.M. On the other hand, unfortunately, errors of commission, overdiagnosis, and overtreatment appear on the rise.
Committing an error has devastating consequences for the physician, personally and professionally. To be suspended from practice, convicted, or increased surveillance about his professional performance are some of the worst effects. Colleagues may regard him as incompetent or careless. Hospitals may suspend him to practice. Thus, the fear of being perceived “as a lesser-quality physician” supports the survival of D.M. 1
First of all, to answer this question, the authors have to pay attention to other correlated questions, such as individual motivation to perform at the best level of his capacity, professional culture, and social constraints within the workplace. The staff and gestures are really committed to making changes that could prevent errors? If so, are they interested in proscribing procedures of D.M. in their environment? Are they committed to improving health care quality?
Oyebode 6 states that “there are numerous proposed strategies for reducing the incidence of clinical errors”. The authors can cite a “national focus to create leadership and research tools to enhance the knowledge base about patient safety”. The authors must create a reporting system “that would help identify and learn from errors”, 6 that would help to ensure that root-cause analysis, hidden during malpractice litigation, will be discovered and prevented. Although reporting systems should be controversial, and "there is little good evidence that errors identification systems are of much use in teaching residents”, 6 it is evident that a change of culture is more than necessary nowadays. It is also essential to create work teams to improve patient safety, especially in emergency settings.
Since McDonald 27 proposed the use of computer-based protocol reminders in the mid-1970s, and it proved to be effective in reducing errors, irrespective of the seniority of the clinician, some practical measures can be adopted, such as the use of voice-recognition technology for radiology reports. 28 In addition, electronic prescribing and information technology systems are methods for reducing prescribing errors that might be effective, 29 including in intensive care units. 30
It is essential to note that many studies of malpractice deterrence suggest that a “higher risk of malpractice liability is not significantly associated with improved health care quality”. 31 In other words, the risk of liability can be itself an adverse event, perpetuating the practices of D.M.
In turn, the authors think that some actions must be taken. As the authors pointed out above, we must act to improve technologies to avoid risks to the patients or build strategies to improve the doctor-patient relationship. It is important to note that “some errors involve momentary or inadvertent lapses at the individual clinician level”. 32 , 33
The authors must invest in creating risk management programs in the study's hospitals. As Kohn et al. 32 state, “Originating with the increase in liability risk in the mid-1970s, hospital risk management programs have long been associated with reducing institutional liability and financial loss control”. It includes the identification of risks before the events and containing them after. In this perspective, the education of staff and patients is also essential. “Educational efforts tend to focus on reviewing state statutes on informed consent, presentations by the hospital's defense counsel, and programs on medical and legal topics for physicians”. 32
On the other hand, two problems can be avoided in preventing to use of D.M. First: as Mello et al. 31 pointed out, “hospitals might be able to implement systems to identify some such errors before they cause harm, but other errors are not amenable to the kind of conscious precaution taking (at either the hospital or the physician level) on which the deterrence model relies”. The other is uncertainty about aspects involving medical responsibility. Many physicians “complain that they do not know what negligence is – i.e., precisely what the law requires in a given situation”. 31 That is the way the education of the staff is essential. If a physician does not know what negligence is, D.M. seems to him an easy shortcut to avoid it.
Kohn et al. 32 add that “although effort has been made to move toward ‘primary’ risk management that would focus on preventing adverse events from occurring, risk management is still focused largely on loss control”. Someone could argue that it is a matter of perspective. In other words, where should I put my efforts and my focus?
Kohn et al. 32 also say that “incident reporting systems are intended to include major events such as surgical mishaps”, and minor incidents have been underreported, mainly because “largely slips, falls, and medication errors that may have little consequence”. 31 Otherwise, “although risk management committees include a medical staff member, risk management has not been embraced at the organizational leadership level in its broadest sense of patient safety ‒ protecting patients from any accidental injury”. That is, the authors must change the culture within the organizations that control hospitals and other clinics.
In the case of adverse events or errors, Morris et al. 34 suggest that “we must create a safety culture within a culture of quality”. The authors also build a series of practical points that must be implemented, such as “create a culture that rewards event reporting as a valued task, a culture that holds the reporter blameless for the report, but individuals accountable for the event”. They propose that “we must change our systems and redesign our work” at the institutional level. They reinforce the necessity of moving professionals to the bedside and minimizing nonclinical distractions. In addition, they add: “We must create a workplace that allows the professional to evolve from an individual who records medical information to an individual who processes medical information. We must rapidly integrate new technology that provides bedside electronic data capture and order entry. We must develop the software and systems that predict and prevent adverse events before they occur”.
Another necessary action regarding avoiding medical liability is the performance of an autopsy in the cases of the suspect of medical error. In Brazil, that procedure is made by the Medico-Legal Institute (IML), and they are called “suspicious death”. Kohn et al. 32 state that “unexpected findings at autopsy are an excellent way to refine clinical judgment and identify misdiagnosis. Lundberg cites a 40 percent discrepancy between antemortem and postmortem diagnoses”. The authors say that “when autopsies are completed, their value in improving care depends on reports reaching clinicians promptly. Yet, many hospitals report long delays (several weeks or more) before clinicians receive autopsy reports. In general, rapid improvement requires shortening the cycle time between investigation and feedback to caregivers and managers. Timeliness in autopsy reporting is representative of all data gathering activities intended for quality improvement and reduction of errors”.
Finally, from the authors’ point of view, the most important solution to prevent medical litigation and the use of D.M. is a good and ethical medical practice with the proper use of technology. A medical practice based on knowledge of scientific evidence and ethical principles of medicine ‒ for the benefit of patients. Nonetheless, “the factors that predict that a patient will resort to litigation include a prior poor relationship with the clinician and the feeling that the patient is not being kept informed”. 6 On the other hand, the authors must encourage a more open physician-patient relationship, with better communication and respect, with physicians listening to their patients before trying to convince them. It is not a new or innovative proposal but is more than efficient. After all, the places are different, but the patients are the same everywhere.
Medical errors have several causes, mainly disregarding guidelines and protocols of safety, failures in the dissemination of drug knowledge and inadequate availability of patient information, unavailability of equipment, production pressure and hectic schedules, and physician fatigue. These errors are capable of leading a medical liability. On the other hand, the fear of penalties induces the use of procedures of defensive medicine, which are, by nature, unethical and increase the costs of medical practice. Besides, its use does not prevent future litigation.
Therefore, the authors conclude that the essential attitude to avoid medical liability is a good and ethical medical practice with the proper use of technology, based on knowledge of scientific evidence and ethical principles of medicine ‒ for the benefit of patients.
Ivan Dieb Miziara and Carmen Silvia Molleis Galego Miziara: These authors contributed equally to this work.
ORCID ID: Ivan Dieb Miziara: 0000-0001-7180-8873
ORCID ID: Carmen Silvia Molleis Galego Miziara: 0000-0002-4266-0117
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- Indian J Urol
- v.25(3); Jul-Sep 2009
Medical negligence: Coverage of the profession, duties, ethics, case law, and enlightened defense - A legal perspective
M. s. pandit.
Corporate Advocates, D- 29, 5 th Floor, Mantri Kishore Park, Bhosale Nagar, Pune 411 007, India
A patient approaching a doctor expects medical treatment with all the knowledge and skill that the doctor possesses to bring relief to his medical problem. The relationship takes the shape of a contract retaining the essential elements of tort. A doctor owes certain duties to his patient and a breach of any of these duties gives a cause of action for negligence against the doctor. The doctor has a duty to obtain prior informed consent from the patient before carrying out diagnostic tests and therapeutic management. The services of the doctors are covered under the provisions of the Consumer Protection Act, 1986 and a patient can seek redressal of grievances from the Consumer Courts. Case laws are an important source of law in adjudicating various issues of negligence arising out of medical treatment.
WHAT IS MEDICAL NEGLIGENCE?
The medical profession is considered a noble profession because it helps in preserving life. We believe life is God given. Thus, a doctor figures in the scheme of God as he stands to carry out His command. A patient generally approaches a doctor/hospital based on his/its reputation. Expectations of a patient are two-fold: doctors and hospitals are expected to provide medical treatment with all the knowledge and skill at their command and secondly they will not do anything to harm the patient in any manner either because of their negligence, carelessness, or reckless attitude of their staff. Though a doctor may not be in a position to save his patient's life at all times, he is expected to use his special knowledge and skill in the most appropriate manner keeping in mind the interest of the patient who has entrusted his life to him. Therefore, it is expected that a doctor carry out necessary investigation or seeks a report from the patient. Furthermore, unless it is an emergency, he obtains informed consent of the patient before proceeding with any major treatment, surgical operation, or even invasive investigation. Failure of a doctor and hospital to discharge this obligation is essentially a tortious liability. A tort is a civil wrong ( right in rem ) as against a contractual obligation ( right in personam ) – a breach that attracts judicial intervention by way of awarding damages. Thus, a patient's right to receive medical attention from doctors and hospitals is essentially a civil right. The relationship takes the shape of a contract to some extent because of informed consent, payment of fee, and performance of surgery/providing treatment, etc. while retaining essential elements of tort.
In the case of Dr. Laxman Balkrishna Joshi vs . Dr. Trimbark Babu Godbole and Anr., AIR 1969 SC 128 and A.S.Mittal v. State of U.P., AIR 1989 SC 1570, it was laid down that when a doctor is consulted by a patient, the doctor owes to his patient certain duties which are: (a) duty of care in deciding whether to undertake the case, (b) duty of care in deciding what treatment to give, and (c) duty of care in the administration of that treatment. A breach of any of the above duties may give a cause of action for negligence and the patient may on that basis recover damages from his doctor. In the aforementioned case, the apex court interalia observed that negligence has many manifestations – it may be active negligence, collateral negligence, comparative negligence, concurrent negligence, continued negligence, criminal negligence, gross negligence, hazardous negligence, active and passive negligence, willful or reckless negligence, or negligence per se. Black's Law Dictionary defines negligence per se as “conduct, whether of action or omission, which may be declared and treated as negligence without any argument or proof as to the particular surrounding circumstances, either because it is in violation of statute or valid Municipal ordinance or because it is so palpably opposed to the dictates of common prudence that it can be said without hesitation or doubt that no careful person would have been guilty of it. As a general rule, the violation of a public duty, enjoined by law for the protection of person or property, so constitutes.”
Negligence per se
While deliberating on the absence of basic qualifications of a homeopathic doctor to practice allopathy in Poonam Verma vs . Ashwin Patel and Ors. (1996) 4 SCC 322, the Supreme Court held that a person who does not have knowledge of a particular system of medicine but practices in that system is a quack. Where a person is guilty of negligence per se, no further proof is needed.
Duty on the part of a hospital and doctor to obtain prior consent of a patient
There exists a duty to obtain prior consent (with respect to living patients) for the purpose of diagnosis, treatment, organ transplant, research purposes, disclosure of medical records, and teaching and medico-legal purposes. With respect to the dead in regard to pathological post mortem, medico-legal post mortem, organ transplant (for legal heirs), and for disclosure of medical record, it is important that informed consent of the patient is obtained. Consent can be given in the following ways:
- Express Consent: It may be oral or in writing. Though both these categories of consents are of equal value, written consent can be considered as superior because of its evidential value.
- Implied Consent: Implied consent may be implied by patient's conduct.
- Tacit Consent: Tacit consent means implied consent understood without being stated.
- Surrogate consent: This consent is given by family members. Generally, courts have held that consent of family members with the written approval of 2 physicians sufficiently protects a patient's interest.
- Advance consent, proxy consent, and presumed consent are also used. While the term advance consent is the consent given by patient in advance, proxy consent indicates consent given by an authorized person. As mentioned earlier, informed consent obtained after explaining all possible risks and side effects is superior to all other forms of consent.
The importance of obtaining informed consent
In the case of Samira Kohli vs . Dr. Prabha Manchanda and Ors. I (2008) CPJ 56 (SC), the apex court held that consent given for diagnostic and operative laparoscopy and “laporotomy if needed” does not amount to consent for a total hysterectomy with bilateral salpingo opherectomy. The appellant was neither a minor nor mentally challenged or incapacitated. As the patient was a competent adult, there was no question of someone else giving consent on her behalf. The appellant was temporarily unconscious under anesthesia, and as there was no emergency. The respondent should have waited until the appellant regained consciousness and gave proper consent. The question of taking the patient's mother's consent does not arise in the absence of emergency. Consent given by her mother is not a valid or real consent. The question was not about the correctness of the decision to remove reproductive organs but failure to obtain consent for removal of the reproductive organs as performance of surgery without taking consent amounts to an unauthorized invasion and interference with the appellant's body. The respondent was denied the entire fee charged for the surgery and was directed to pay Rs. 25000/- as compensation for the unauthorized surgery.
Coverage of doctors and hospitals under CPA
In the case of the Indian Medical Association vs . V.P. Shanta and Ors., III (1995) CPJ 1 (SC), the Supreme Court finally decided on the issue of coverage of medical profession within the ambit of the Consumer Protection Act, 1986 so that all ambiguity on the subject was cleared. With this epoch making decision, doctors and hospitals became aware of the fact that as long as they have paid patients, all patients are consumers even if treatment is given free of charge. While the above mentioned apex court decision recognizes that a small percentage of patients may not respond to treatment, medical literature speaks of such failures despite all the proper care and proper treatment given by doctors and hospitals. Failure of family planning operations is a classic example. The apex court does not favor saddling medical men with ex gratia awards. Similarly, a in a few landmark decisions of the National Commission dealing with hospital death, the National Commission has recognized the possibility of hospital death despite there being no negligence.
WHERE COMPENSATION WAS AWARDED
In this context, it may be recalled that in the case of the State of Haryana and Ors v. Smt. Santra, I (2000) CPJ 53 (SC) (by S. Saghir Ahmad and D.P.Wadhwa, JJ.), the Supreme Court in a Special Leave Petition upheld the claim for compensation where incomplete sterilization (family planning operation) was held to be defective in service. Smt Santra underwent a family planning operation related only to the right fallopian tube and the left fallopian tube was not touched, which indicates that complete sterilization operation was not performed. A poor laborer woman, who already had many children and had opted for sterilization, became pregnant and ultimately gave birth to a female child in spite of a sterilization operation that had obviously failed.
Claim for damages was based on the principle that if a person has committed civil wrong, he must pay compensation by way of damages to the person wronged. The apex court held: “Maintenance” would obviously include provision for food, clothing, residence, education of the children and medical attendance or treatment. The obligation to maintain besides being statutory in nature is also personal in the sense that it arises from the very existence of the relationship between a parent and the child. Claim for damages, on the contrary, is based on the principle that if a person has committed civil wrong, he must pay compensation by way of damages to the person wronged.
While elaborating on medical negligence, the apex court observed as follows (abridged): Negligence is a ‘tort’. Every doctor who enters into the medical profession has a duty to act with a reasonable degree of care and skill. This is what is known as ‘implied undertaking’ by a member of the medical profession that he would use a fair, reasonable and competent degree of skill. In the case of Bolam V. Friern Hospital Management Committee, (1957) 2 All ER 118, McNair, J. summed up the law as the following:
“The test is the standard of the ordinary skilled man exercising and professing to have that special skill. A man need not possess the highest expert skill: It is well established law that it is sufficient if he exercises the ordinary skill of an ordinary competent man exercising that particular art. In the case of a medical man, negligence means failure to act in accordance with the standards of reasonably competent medical men at the time. There may be one or more perfectly proper standards, and if he confirms with one of these proper standards, then he is not negligent.”
In the case of Spring Meadows Hospital and Anr. v Harjol Ahluwalia, 1998 4 SCC 39, a compensation of Rs. 5 lacs was awarded because of mental anguish caused to the parents of a child who became totally incapacitated for life in addition to a compensation of Rs. 12 lacs approx. awarded to the child. While the amount of Rs. 12 lacs was to be paid by insurer, the balance amount was to be paid by the hospital. Though the insurance company took a stand since the nurse who administered the adult dose of inj. Lariago to the child was not qualified, the apex court did not go into this issue while adjudicating negligence related proceeding. Therefore, it is important to keep in mind that doctors and hospitals should not only obtain a Professional Indemnity Insurance Policy, but also take care that nurses and other hospitals staff engaged by it are qualified.
MEDICAL ETHICS AND THE TREATMENT OF ACCIDENT VICTIMS
In the case of Pravat Kumar Mukherjee vs . Ruby General Hospital and Ors, II(2005)CPJ35(NC), the National Commission delivered a landmark decision concerning treatment of an accident victim by the hospital. The brief facts of the case are as follows: the complainants are the parents of the deceased boy. They approached the National Commission for compensation and adequate relief. The case involves the unfortunate death of a young boy, Shri Sumanta Mukherjee, a student of second year B. Tech., Electrical Engineering. At Netaji Subhash Chandra Bose Engineering College on January 14, 2001 a bus from Calcutta Tramway Corporation crashed with the motorcycle driven by the deceased. Sumanta was conscious after the accident and was taken to the hospital about 1 km from the site of the accident. He was insured for Rs. 65,000/- under a Mediclaim Policy issued by the New India Assurance Co. Ltd. When he reached the hospital, the deceased was conscious and showed the Mediclaim certificate he was carrying in his wallet. He also assured that charges for treatment would be paid and treatment should be started. Acting on this promise, the hospital started treatment in its emergency room by giving moist oxygen, starting suction, and by administering injection Driphylline, Injection Lycotinx, and titanous toxoid. The respondents demanded an immediate payment of Rs. 15000/- and discontinued treatment as the amount was not deposited immediately though an assurance to pay the amount was made by the accompanying persons from the general public. Actually, the crowd collected Rs. 2000/- and the amount with the motorcycle of the patient and insurance receipt was offered. As the hospital was adamant and discontinued treatment after giving treatment for 45 minutes, the people from the crowd present were forced to take the patient to National Calcutta Medical College, which is about 7-8 km from the current hospital. The patient died on the way and was declared dead upon arrival at the National Calcutta Medical College.
The National Commission allowed the complaint and the Opponent Ruby Hospital was directed to pay Rs. 10 lakhs to the Complainant for mental pain agony. The Commission observed as follows: “This may serve the purpose of bringing about a qualitative change in the attitude of the hospitals of providing service to human beings as human beings. A human touch is necessary; that is their code of conduct; that is their duty and that is what is required to be implemented. In emergency or critical cases, let them discharge their duty/social obligation of rendering service without waiting for fee or for consent”. However, it remains to be seen whether the above award has brought in any attitudinal change in the medical fraternity.
An award was given on the following basis/grounds. While dealing with the contention that ‘no consideration paid’, ‘deceased or complainant not consumer’ National Commission observed as follows (abridged): “Not acceptable. Persons belonging to the poor class who are provided service free of charge are beneficiaries of service which is hired or availed of by the paying class. The status of an emergency or critically ill patient would be the same as people belonging to the poor class since both are not in a position to pay. Free services would also be services and the recipient would be the consumer under the Act. Since doctors started treatment on the deceased due to an emergency, that itself is availing of services, may it be free of cost or promised deferred payment. Expert evidence pointed out that discontinuance of treatment hastened the death of the patient, which itself is deficiency in service. Serious negligence and laxity on the part of the hospital by refusing admission and treatment facility to the youth who was almost in dying condition, defying all medical ethics and a gross violation of the Clinical Establishment rules and Act of 1950 as amended in 1998. How was a patient who was advised admission at ITU was allowed to leave the hospital for treatment elsewhere without signing any document or risk bond not shown? Withdrawal of treatment can not be justified on any ground. Deficiency is writ large.
Secondly, while dealing with the contention that there was no consent for treatment, the National Commission observed as follows (abridged): “Since emergency treatment is required to be given to a patient who was brought in seriously injured condition there was no question of waiting for consent. Consent is implicit in such cases. On the contrary, a surgeon who fails to perform an emergency operation must prove that the patient refused to undergo an operation not only at the initial stage but even after he was informed about the dangerous consequences of not undergoing the operation. Waiting for consent of a patient or a passer-by who brought the patient to the hospital is nothing but absurd and is apparent failure of duty on the part of doctor. Deficiency in service was proved and compensation was granted.
Maintainability of a consumer case when a Motor Accident Claims Tribunal (MACT) case is pending: The National Commission held that the MACT case is no bar to complaint under CP Act. Two causes are different and required to be decided by separate tribunals/forums. While the cause of action before MACT was rash and negligent driving, due to which the accident was caused, the cause of action against doctors and hospitals is for deficiency in rendering service – emergency treatment by the doctors or the hospital. Since both causes are separate and distinct, complaint is maintainable.
THE IMPORTANCE OF CASE LAW
Jurisprudential principle of ‘stare decisis’ is based on a Latin phrase meaning to stand by decided cases; to uphold precedents; to maintain the positions laid down by higher courts earlier. One of the important characteristics of a good law is that the law should be definite, lucid, and unambiguous with the flexibility to relate to different situations, facts, and circumstances and that justice is done in accordance with law. Latin maxim ‘Stare decisis, et non quieta movere’ means it is best to adhere to decisions and not to disturb questions put at rest. The objective is to avoid confusion in the minds of the citizens as to what the law of the land is. As laid down in u.a 141 of the constitution of India, the law declared by the Supreme Court is binding in all courts. Furthermore, the Constitution of India provides that both the Supreme Court and High Courts of States are the courts of records. So far as the case law laid down by the National Commission and State Commission is concerned, they are followed by lower fora as a binding precedent though no specific provision has been made in the Consumer Protection Act, 1986. It is generally accepted that when a point of law is settled by a decision of a superior authority, it is not to be departed from. Change of a judge shall not affect the settled legal position. A new judge is not supposed to pronounce a new law but is expected to maintain and expound the old one. While this appears to restrict the elbow room of new judges to interpret the law when there is a settled legal position laid down by his predecessor, this restriction is substantially lifted when the law undergoes amendment. There is considerable criticism that Consumer Fora have not scrupulously followed the principle laid down by superior fora, that is State Commissions of the state and the National Commission and also that even superior fora have often not maintained settled positions laid down by their predecessors. The decisions of the National Commission and State Commissions are reported. However, there may not be uniformity with all such decisions. Furthermore, there may be conflicting decisions of various State Commissions and National Commissions. Consequently, while some legal experts have called for express provision to that effect, others feel that the principle being followed in respect of the Supreme Court and High Courts (since an appeal to Supreme Court is provided, High Courts are generally not expected to entertain consumer related writs though there is no such bar in the Act) may be generally followed even in respect of the decisions of State and National Commission subject to the interpretations if any of High Courts and the final legal position as laid down by Supreme Court.
Clear case of medical negligence (similar to res ipsa loquitor?)
An appellant doctor was found by the State Commission to be responsible for leaving ribbon gauze in the right side of the nose after a septoplasty resulting in several complications. The complainant suffered and had to be under treatment all the while the National Commission confirmed the order and observed that it has no option but to deduce that it was a clear case of medical negligence on the part of the appellant. The National Commission in the case of Dr. Ravishankar vs . Jery K. Thomas and Anr, II (2006) CPJ 138 (NC) held that based on the facts and circumstances, the obvious deduction is that the appellant doctor is responsible for leaving behind ribbon gauze resulting in complications. Medical negligence was proved.
The brief facts of the case are as follows. The complainant was having some nasal and breathing problems. He approached the appellant doctor who upon examination advised a septoplasty, which was carried out on August 18, 1999 in second Respondent's hospital. It is the case of the complainant that after the operation, the pain aggravated and the breathing problem persisted. After examination, the complainant was advised to take some antibiotics for major nasal infection. Despite taking these medicines, the complainant was not getting any relief so he was taken to St. John's Hospital. A computed tomography (CT) scan showed that there was a deposit inside the nasal cavity for which an endoscopy was performed at St. John's hospital. Cotton gauze was removed from the nasal section on November 28, 2000. It was in these circumstances alleging medical negligence on the part of appellant and second respondent a complaint was filed before the State Commission. After hearing perusal of evidence and other material on record, the State Commission held the second respondent guilty of medical negligence and directed him to pay a compensation of Rs. 1 lac with interest @ 6% p.a from the date of complaint along with the cost of Rs. 5000/-. Aggrieved by this order, the Appellant doctor filed this appeal.
Held: heard the counsel for the appellant. As held by the State Commission, it is neither the surgery nor the procedure adopted that is under challenge. What is being challenged is the leaving behind of cotton gauze after surgery and the non removal of it by the appellant doctor. After going through the record maintained at St. John's hospital, Dr. Balasubramanium opined that after the CT scan a soft tissue mass ( gauze piece ) was found retained in the right nasal cavity that was removed under local anesthesia.
In these circumstances, deduction is obvious that it was the appellant who was responsible for leaving behind ribbon gauze in the right side of the nose after the septoplasty performed by him on August 18, 1999 resulting in several complications. Because of this, the complainant suffered and had to be under treatment leaving us with no option but to deduce that it was a clear case of medical negligence on the part of the appellant.
MEDICO LEGAL – SOME IMPORTANT ISSUES
The death of a patient while undergoing treatment does not amount to medical negligence.
In the case of Dr. Ganesh Prasad and Anr. V. Lal Janamajay Nath Shahdeo, I (2006) CPJ 117 (NC), the National Commission (Order: Per Mrs. Rajalaxmi Rao, Member) reiterated the principle that where proper treatment is given, death occurring due to process of disease and its complication, it can not be held that doctors and hospitals are negligent and orders of lower fora do not uphold the claim and award a compensation. In this case, a 4 ½ year old child suffering from cerebral malaria was admitted to the hospital. A life-saving injection was given. As opined by the child specialist, doses were safe and the treatment was proper. Though the death of the child is unfortunate, it can not be said that there was negligence on the part of the doctor.
The opinion based on teachings of one school of thought may not amount to medical negligence when there are two responsible schools of thought. Observations of the National Commission in the case of Dr. Subramanyam and Anr. vs . Dr. B. Krishna Rao and Anr., II (1996) CPJ 233 (NC) on the question of medical negligence are most illuminating as it involved a complaint by a well-qualified doctor against a fellow professional who treated his wife for an endoscopic sclerotherapy. It is relevant to note that in this case the complainant doctor alleged that the moment the patient was admitted to the Nursing Home, there was total mismanagement to the extent of virtually throwing her into the jaws of death solely because of negligence and improper rather wrong treatment given to her by the first opposite party, Dr. Rao. The complainants submitted that the slipshod, callous, and negligent way in which the patient was treated led to her death. Hon'ble Commission observed as follows: “The principles regarding medical negligence are well settled. A doctor can be held guilty of medical negligence only when he falls short of the standard of reasonable medical care. A doctor can not be found negligent merely because in a matter of opinion he made an error of judgment. It is also well settled that when there are genuinely two responsible schools of thought about management of a clinical situation the court could do no greater disservice to the community or advancement of medical science than to place the hallmark of legality upon one form of treatment.”
Error of judgment in diagnosis or failure to cure a disease does not necessarily mean medical negligence. In the case of Dr. Kunal Saha vs . Dr. Sukumar Mukherjee and Ors. III (2006) CPJ 142 (NC), the National Commission (per Mr. Justice M. B. Shah, President) considered the question of whether the Opponent doctors and hospital acted negligently in diagnosis of the disease suffered by the patient (wife of complainant doctor), administration of medicine (it was alleged that an overdose of steroids was prescribed), provision of facilities in hospital (absence of burn unit in hospital was alleged). A compensation of Rs. 77,76,73,500/- was claimed. The National Commission held that an error in medical diagnosis does not amount to deficiency in service. The National Commission further observed that the deceased (wife of Complainant) suffered from TEN (Toxic Epidermal Necrolysis), which is a rare disease and the mortality rate varies from 25% to 70% as per medical literature. The Commission also observed that considering the facts and circumstances of this case, the doctor can not be held liable for want of an exact diagnosis.
Role of expert opinion: in the case of Sethuraman Subramniam Iyer vs . Triveni Nursing Home and Anr. I (1998) CPJ 110 (NC), the National Commission dismissed the complaint holding that there was no expert evidence on behalf of the complainant. Similarly, in ABGP vs . Jog Hospital, the complaint was held to be not maintainable. In Farangi lal Mutneja vs . Shri Guru Harkishan Sahib Eye Hospital Sahana and Anr., IV (2006) CPJ 96, Union Territory Commission, Chandigarh dismissed the claim based on medical negligence with following observation: “The O.P. conducted an eye operation upon the complainant. The cornea was damaged subsequently, and visibility was lost. The complainant alleged that proper dilation of an eye was not done before conducting the cataract operation. Also it was alleged that the operation was done in a hurried manner. The Medical Council of India, after obtaining the expert opinion of two well known institutions, came to the conclusion that standard treatment protocol was followed and optimal procedures were carried out. Thus there was no negligence on the part of the O.P.”
Medical Literature: In the case of P. Venkata Lakshmi vs . Dr. Y. Savita Devi, II (2004) CPJ 14 (NC), the National Commission held that the State Commission ought to have considered the medical literature filed by the complainant and the State Commission had dismissed the complaint on the grounds that there was no expert evidence and remanded the matter.
Quantum of compensation: With regard to the quantum of compensation payable to an injured patient, the Supreme Court observed in the case of IMA vs . V.P. Shanta and Ors. III (1995) CPJ I (SC), as follows: “A patient who has been injured by an act of medical negligence has suffered in a way which is recognized by the law – and by the public at large as deserving compensation. This loss may be continuing and what may seem like an unduly large award may be little more than that sum which is required to compensate him for such matters as loss of future earnings and the future cost of medical or nursing care. To deny a legitimate claim or to restrict arbitrarily the size of an award would amount to substantial injustice. After all, there is no difference in legal theory between the plaintiff injured through medical negligence and the plaintiff injured in an industrial or motor accident.”
Engaging a specialist when available is obligatory. In the case of Prashanth S. Dhananka vs . Nizam Institute of Medical Science and Ors (1999) CPJ43 (NC), the National Commission deliberated on important issues such as what constitutes medical negligence, the duty of a hospital to engage a specialist when a specialist is available, vicarious liability of a hospital for omissions and commissions of doctors and staff, and compensation for mental and physical torture.
The National Commission on the question of whether compensation has to be awarded when doctors decide not to operate and the patient later dies. In the case of Narasimha Reddy and Ors. Vs . Rohini Hospital and Anr. I (2006) CPJ144 (NC), the National Commission held that when a patient could not be operated due to a critical condition, the doctor can not be held guilty of negligence if the proper course of practice is adopted and reasonable care is taken in administration of treatment. Consequently the Revision petition filed by the complainant was dismissed.
When a patient does not give a proper medical history, the doctor can not be blamed for the consequences. In the case of S. Tiwari vs . Dr. Pranav 1(1996) CPJ 301 (NC), it was alleged that a tooth was extracted without a proper test. When bleeding continued, the doctor administered a pain killer. Though the patient had a blood pressure of 130/90, he did not give the doctor his proper medical history. The National Commission upheld the findings of the State Commission and dismissed the complaint on the ground that the patient did not give a correct case history and follow-up when required.
Hospital is vicariously liable for any wrong claiming on the part of consultants. In the case of Ms Neha Kumari and Anr. V Apollo Hospital and Ors. 1 (2003) CPJ 145 (NC), the National Commission held that alleged medical negligence is not proved as the complainant suffered from complex birth defects of the spine and whole body as evidenced by a pre-operative CT scan. Two complaints were filed claiming a compensation of Rs. 26,90,000 alleging that while performing an operation (surgery) on the spinal canal, a rod was fitted inappropriately at the wrong level that resulted in the non functioning of the lower limbs. The Hon'ble commission held as follows:
“We do not find it is a case of medical negligence as alleged. Complaints have not denied that Neha Kumari was suffering from ailments from the very birth and that she was operated upon when she was only four years of age. On detailed investigations Neha Kumari was found to have multiple congenital complicated problems in Kiphoscoliotic deformity with weakness and wasting right upper limbs and (i) complex Khyphoscoliotic deformity of the mid dorsal spine with hemivertibrae of the D and D6 spinal levels and spinal bifida of the D and D7 vertebrae….Further filing of the appeal was delayed and no sufficient cause was shown to the satisfaction of Commission.
However, on the question of vicarious liability of the hospital for negligence on the part of the consultants, the Hon'ble Commission relying on the judgment in Basant Seth V Regency Hospital O P No.99 of 1994 rejected the contention of the hospital and held that the hospital is vicariously liable for any wrong claiming on the part of consultants.
Award of ex-gratia compensation against doctors and hospitals is not proper. The decision of the Supreme Court in the State of Punjab vs . Shiv Ram and Ors., IV (2005) CPJ 14 (SC) on a complaint alleging an unsuccessful family planning operation due to negligence of the doctor can be said to be an important milestone for many reasons. Firstly, the Supreme Court held that medical men and hospitals should not be saddled with damages unless they are found negligent. The apex court felt that awarding ex gratia compensation against doctors and hospitals without any findings on negligence is not proper. The court further held that there is a need for developing a welfare fund or insurance scheme. Failure of sterilization performed successfully is attributable to causes other than medical negligence and that the state government should think of devising and making provisions for a welfare fund or collaborating with insurance companies.
This judgment makes very pragmatic observations in the midst of several verdicts against medical professionals and hospitals especially when an award is made based on sympathetic considerations. It is heartening to note that the apex court looks at the issues relating to the medical profession and medical negligence in a holistic manner and with utmost consideration.
In a full bench decision dated August 25, 2005, Mr. Justice R.C. Lahoti, former C.J.I observed as follows: “Medical profession is one of the oldest professions of the world and is the most humanitarian one. There is no better service than to serve the suffering, wounded, and the sick. Inherent in the concept of any profession is a code of conduct, containing the basic ethics that underline the moral values that govern the professional practice and is aimed at upholding its dignity. Medical ethics underlines the values at the heart of the practitioner-client relationship. In the recent times, professionals are developing a tendency to forget that the self regulation which is at the heart of their profession is a privilege and not a right and the profession obtains this privilege in return for an implicit contract with society to provide good, competent and accountable service to the public. It must always be kept in mind that a doctor is a noble profession and the aim must be to serve humanity, otherwise the dignified profession will lose its true worth.”
The apex court further held that merely because a woman having undergone a sterilization operation became pregnant and delivered a child, the operating surgeon or his employer can not be held liable for payment of compensation on account of unwanted pregnancy or child. A claim in tort is sustainable only if there was negligence on the part of surgeon in performance of a surgery or the surgeon assured 100% exclusion of pregnancy after surgery. Proof of negligence will have to satisfy Bolam's test. Cause of failure of the sterilization operation may be obtained from laparoscopic inspection of the uterine tubes, by an X-ray examination, or by a pathological examination of the material removed at a subsequent operation of re-sterilization. The cause of action in the failed sterilization operation arises on account of negligence of the surgeon and not on account of child birth-failure due to natural causes.
The apex court reaffirmed the above observations in the State of Haryana and Ors. vs . Raj Rani IV (2005) CPJ28 (SC) and held as follows: “Doctors can be held liable only in cases where failure of operation is attributable to his negligence and not otherwise. Medical negligence recognized percentage of failure of sterilization operation due to natural causes depending on techniques chosen for performing surgery. The pregnancy can be for reasons de hors any negligence of the surgeon. A fallopian tube that is cut and sealed may reunite and the woman may conceive though a surgery is performed. Neither can the surgeons can be held liable to pay compensation nor can the state be held vicariously liable in such cases. However, payment made by the state will be held as ex gratia payment and the money paid to the poor will not be recovered.”
Source of Support: Nil
Conflict of Interest: None declared.
- Research article
- Open access
- Published: 25 April 2018
The struggle against perceived negligence. A qualitative study of patients’ experiences of adverse events in Norwegian hospitals
- Gunn Hågensen ORCID: orcid.org/0000-0002-8332-5083 1 ,
- Gudrun Nilsen 1 ,
- Grete Mehus 1 &
- Nils Henriksen 2
BMC Health Services Research volume 18 , Article number: 302 ( 2018 ) Cite this article
A Correction to this article was published on 14 March 2019
This article has been updated
Every year, 14 % of patients in Norwegian hospitals experience adverse events, which often have health-damaging consequences. The government, hospital management and health personnel attempt to minimize such events. Limited research on the first-hand experience of the patients affected is available. The aim of this study is to present patients’ perspectives of the occurrence of, disclosure of, and healthcare organizations’ responses to adverse events. Findings are discussed within a social constructivist framework and with reference to principles of open disclosure policy.
This qualitative study with an explorative descriptive design included fifteen in-depth interviews with former patients recruited by the Health and Social Services ombudsmen in the two northernmost counties of Norway. Inclusion criteria were as follows: 1) experience of adverse events in connection with surgical, orthopedic or medical treatment in general hospitals; 2) men and women; 3) aged 20–70; and 4) a minimum of one year since the event occurred. Transcribed audio-recorded interviews were analyzed through qualitative content analysis.
The analysis revealed three main topics regarding patients’ experiences of adverse events: 1) ignored concerns or signs of complications; 2) lack of responsibility and error correction; and 3) lack of support, loyalty and learning opportunities. Patients had to struggle to demonstrate the error that had occurred and to receive the necessary treatment and monitoring in the aftermath of the events.
Patient narratives reveal a lack of openness, care and responsibility in connection with adverse events. Conflicting power structures, attitudes and established procedures may inhibit prevention, learning and patient safety work in spite of major efforts and good intentions. Attitudes in day-to-day patient care and organizational procedures should be challenged to invite patients into open disclosure processes and include them in health and safety work to a greater extent. The study’s small sample of self-selected participants limits the generalizability of the findings, and future studies should include a larger number of patients as well as professional perspectives.
Peer Review reports
Illness and health problems shock people out of their natural rhythm by placing their life and health at risk [ 1 ]. People utilize health services to regain their health and welfare to the greatest extent possible and expect that their care will be performed in a safe and beneficial manner. Norway’s health service is considered high quality. However, calculations show that 13–14% of patients experience adverse events (AEs) from hospital treatments [ 2 ], and this value corresponds to international figures found in recent decades [ 3 ]. The World Health Organization (WHO) has defined an AE as “An injury related to medical management, in contrast to complications of disease. Medical management includes all aspects of care, including diagnosis and treatment, failure to diagnose or treat, and the systems and equipment used to deliver care” [ 4 ]. Patients are affected by AEs in two different ways: partly by the injury itself and partly by the hospital’s responses before, during and after the incident [ 5 , 6 ].
In line with increasing international focus on the issue of AEs, Norwegian public investigations and consultations have indicated the need to develop a culture guided by principles of open disclosure in the health service. Key elements of such a culture include care for patients and their families after an injury, documentation of organizational responsibility, registration and reporting systems, investigations of undesirable incidents, systems for measuring patient safety and risk, and the involvement of patients and their families [ 7 , 8 ]. Legislation has included internationally recognized principles of open disclosure [ 9 ] to ensure that injured patients receive information and help with follow-up care after incidents have occurred [ 10 ]. The Norwegian Ministry of Health and Care Services emphasizes the increasing need to account for patient perspectives in the planning and implementation of patient treatment as well as in systematic quality and safety activities [ 11 ].
Thus far, hospital responses to AEs have been deficient. An Australian study based on “100 patient stories” found a lack of open disclosure and follow-up after the occurrence of AEs [ 12 ]. These findings corroborate an American study of cancer patients’ views on apologies and open disclosure when an error occurs [ 13 ] and studies of injured patients from the UK [ 14 , 15 ]. All of these results suggest a lack of recognition of patients’ need for an explanation of the event that has occurred, acceptance of responsibility, corrective apologies and initiation of measures to prevent the occurrence of similar incidents in the future. This issue is identified as the “disclosure gap” [ 16 ] or the “disclosure dilemma” [ 17 ]. Research has suggested that clinicians often avoid openness to protect their professional integrity and prevent personal consequences of an emotional, career or legal nature [ 17 , 18 ]. A publication from the Harvard Medical Practice Study III concluded that “Medical-malpractice litigations infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care” [ 19 ].
To date, patient safety activities and research on AEs have largely followed a system-based and biomedical perspective [ 20 ], which has been subject to critique as a top-down approach that often excludes patient voices from patient safety research and programs [ 21 ]. Within the sociotechnical systems tradition, the Systems Engineering Initiative for Patient Safety represents a person-centered model that incorporates human factors and stands out as an alternative to more limited traditional approaches [ 22 ]. However, the authorities and health personnel appear to have prioritized clinical, efficiency-related, financial and legal perspectives [ 23 , 24 ].
Scholars have critiqued these perspectives for potentially obscuring a range of social processes that affect AEs [ 14 , 20 ], and have argued for closer investigation of the multiple perspectives and different versions of events that may exist [ 25 , 26 ]. Ocloo states that it is time to re-identify the challenges and recognize the experiences of harmed patients as essential to patient safety efforts [ 14 ].
Clinical practice evolve through developments in medical research and interactions and negotiations between people who act within specific organizational frames that shape through professional, scientific and political discourses and the enactment of power [ 27 , 28 , 29 , 30 ]. These discourses and processes define the context, content of and responses to AEs and patient injuries. Extended patient safety discourses should include how professional power and control affect the articulation of patient experiences [ 15 ].
Patients possess power in the form of knowledge of their own body and health issues. However, the balance of strength and power remain askew. From a social constructivist [ 31 ] and interactionist [ 32 ] perspective, the rules of situations and settings in which social practices unfold are frames that influence actors’ behaviors. How patients perceive and interpret these frames may contribute to a broader understanding of how encounters are constructed and how power is exercised in hospitals when AEs occur.
Patient perspectives have largely been investigated using survey questionnaires with predefined questions and limited opportunities for patients to provide detailed accounts of their experiences [ 33 ], while in-depth interviews, which provide more detailed knowledge, have rarely been used [ 12 , 13 , 14 ]. First-hand accounts can provide authentic perspectives that illustrate patients’ experiences. The aim of this article is to illuminate conditions surrounding AEs from the patient perspective. Key aspects include how patients perceive the occurrence of events and the responses from health personnel and the health service.
Study design and setting
This qualitative study with an explorative descriptive design is part of an independent Ph.D. project entitled Experiencing an Adverse Event and Life Afterwards . The researchers have a background in nurse education, nursing and healthcare research and sociology and are affiliated with the UiT, The Arctic University of Norway. Individual open-ended interviews were considered an appropriate method for collecting data to capture complementary thick descriptions from patients about their experiences of AEs. Explorative designs allow participants an opportunity to emphasize important issues narrated from their own perspectives [ 34 ]. An in–depth interview is a professional conversation that seeks deep information and understanding of lived experiences from the interviewee’s perspective [ 35 , 36 ].
Recruitment and the sample
In Norway, The Health and Social Services ombudsman in each county can support patients and clients who experience AEs or insufficient help for their needs. The ombudsmen in the two northernmost counties Troms and Finnmark receive approximately 430 complaints related to hospital care each year [ 37 ], and were asked to assist in recruitment of study participants. As a statistical generalization was not an issue, we instructed the ombudsmen to obtain a varied sample. They performed a non-random search in their archives using the following inclusion criteria: adults between 20 and 70 years; both male and female; experience of AEs attached to surgical, orthopedic or medical treatment at general hospitals; and at least one year had passed since the event, allowing sufficient time for participants to reflect on and process the event. For qualitative in-depth studies, 10–25 interviews are considered sufficient to provide adequate data related to the research question [ 34 ].
The ombudsmen posted sixty invitation letters that included information sheets and informed consent forms that were all prearranged by the first author. The researcher did not participate in the recruitment process until the informed consent forms arrived by mail. Participants were contacted via telephone, and interviews were arranged based on their preferences.
A total of 19 former patients responded to the invitation. Two of these patients chose not to participate because they had enough trouble caused by the event, one had moved to a different geographical area, and one was unable to focus on the event during the interview. Thus, the study included fifteen participants, nine females and six males, ranging from 43 to 70 years old (median = 61 years). The incidents had occurred across three local hospitals and one university clinic in Northern Norway and one national hospital and one private clinic in Southern Norway. The interviews were conducted one to ten years after the AE, with an average of four years (median = 4 years). A maximum time limit was not set, as such a limit was viewed as a potential obstacle to recruiting a satisfactory number of participants. At the time of the interview, some of the informants were still undergoing treatment. All participants had experienced an injury as patients and approached the Health and Social Services ombudsman but had not necessarily claimed compensation from the Norwegian System of Patient Injury Compensation (NPE) (Table 1 ).
The first author conducted individual interviews during the period from September 2013 to January 2014. Based on her experience with interview research and to position herself, she informed the participants that she had a background in nursing, that the study was independent and that she had no obligation toward the hospitals or to the Health and Social Services ombudsmen.
The conversations took place in the informants’ homes or in a desired meeting place. The first language of all participants was Norwegian, and the conversations were held in Norwegian. Each interview began with the open question: Please tell me what happened to you ..., and the participants were given an opportunity to speak as freely as possible to emphasize their own reflections and understandings. The researcher took a listening role and asked follow-up questions to increase the richness and depth of the stories [ 34 ]. A thematic interview guide formulated from findings of previous research [ 5 , 6 , 12 , 13 , 14 ] was used as a supporting document (see Additional file 1 ). ZxXThis guide served to ensure coverage of main themes across patient stories and to obtain more details about statements or topics if necessary [ 34 ]. Examples of follow-up questions include: What do you mean by that? Can you explain more about that? Side notes were written during the interviews. As no substantial new information appeared during the last interviews, the sample size was considered adequate for research purposes. The interviews lasted 45–150 min, were recorded as sound files and were transcribed to text by the first author. Expressions such as silences, sighs, laughter, crying, etc. were noted because they may influence the underlying meaning [ 38 ]. Eight of the participants released their discharge reports as supporting material.
Ethical considerations corresponding with the Helsinki declaration and national research regulations were made throughout the entire project [ 39 , 40 ]. After receiving oral and written information about the design and goals of the study, all participants provided their voluntary approval for participation and publication by signing an informed consent form. The participants were informed about their right to withdraw at any time, without stating a reason, and were guaranteed confidentiality and the anonymous presentation of findings. Fictitious names are used in the presentation of the results.
In qualitative research, analysis involves hermeneutic processes in which a pre-understanding derived from personal experience, former research and theoretical perspectives meets data and produces a deeper understanding and new concepts [ 38 , 41 ]. All text from the interviews (approximately 141,600 words) was subjected to the analysis, which was inspired by Graneheim and Lundman’s inductive model of qualitative content analysis [ 38 ] and supported by Malterud’s approach [ 34 ]. Our analysis addressed the manifest content aspects and describes the visible, obvious components in the texts as well as the latent underlying meaning based on interpretation. The texts were reread a number of times (GH and GN all interviews; NH 5 interviews) to gain an overall understanding and to generate preliminary categories.
Next, we made thematic categories and categorized the material in the texts that addressed the experiences related to the event itself. We then analyzed this material closely for the current paper. Statements related to the same central meaning were converted into condensed meaning units, which were coded and further interpreted and categorized as sub-topics and finally collected into main topics without use of qualitative software. The manifest content addressed the event that occurred, where and when it occurred, who was involved, how it was handled, and the patients’ perception of the event. Additionally, latent content, e.g. cover up , arose ‘unexpectedly’ or inductively from interview statements and was subject to interpretation. Coding and interpretations were checked against original transcripts. An example of this analysis is provided in Table 2 .
Trustworthiness of the data was achieved through reading the manuscripts multiple times and discussing themes in a series of meetings, and the three researchers’ independent generation of topics and themes. Discrepancies were resolved through several discussions until consensus was reached. The authors had different levels of experience with AEs from their professional and personal backgrounds. Reflexivity, practiced by noting biases and prior expectations, was an important piece of the analysis process to elicit the new understandings. The discharge reports were analyzed in light of whether the events were described and how they were presented. All the authors discussed the topics in light of relevant theory and achieved overall agreement. The following main topics emerged from the data (Table 3 ): ignored concerns or signs of complication; lack of responsibility and error correction; and lack of support, loyalty and learning. All study participants ( n = 15) reported experiences that related to each of the three themes.
Descriptions of events
The findings concern AEs in various stages of the treatment chain and cover a wide range of basic illnesses and degrees of severity at the time of the event. A common feature among the fifteen study participants was that they experienced that something or someone had failed. The accounts represent many common denominators with regard to the overall sequence of events; reaction patterns; and patients’ perceptions of health personnel, the system, the care provided, and follow-up afterwards. Failures and defects are found in medical treatment but also in communication, information and documentation. Six of the events were related to failures and defects before treatment began. In these cases, the patients received a delayed or incorrect cancer diagnosis, which postponed the start of cancer treatment.
Various forms of cancer were represented: breast, prostate, kidney and stomach/colon. The informants assessed the causes of the events as follows: incorrect medical assessment of clinical signs and symptoms, failure of diagnostic tests, notices of appointments that were sent incorrectly or were missing or test results/referrals that were put aside for later examination but were not assessed. According to the informants, the delays resulted in an increased spread of cancer; more severe complications, resulting in more complicated treatment regimens; and mental stress. The informants mentioned the stress involved in getting cancer but stated that the most difficult aspect was the perceived incorrect or deficient treatment, which they viewed as a sign that their lives and health were not sufficiently valued.
The other nine events represent experiences related to orthopedic conditions, such as hip or knee interventions; surgery on the cheek/neck; incorrect anesthesia; incorrect medication; radiation injury; and deficient stroke treatment.
The events include errors/failures that were discovered while the patient was in hospital as well as errors/serious complications that became evident after discharge. Several of the informants believed that medical assessments, test analyses or organizational/administrative systems did not function properly. According to the interviewee’s, the events resulted in functional impairment requiring further surgery or treatment, difficult rehabilitation, organs that failed, pain and a more complicated sequence of treatment.
Ignored concerns or signs of complications
All the informants understood that hospital treatment involves a certain degree of risk. They stated that information about operations, other treatments and delayed diagnosis was presented in a standardized and everyday manner. When an undesirable event occurred, the health personnel did not appear to relate to the event or come to grips with the problem that the patient experienced Health personnel were perceived as trivializing, rejecting, skeptical or doubtful.
Most of the respondents described a powerful inner concern that something was wrong but felt as though they were ignored or overlooked when they mentioned their concern. In the case of diagnostic errors, the concern was related to bodily symptoms or a long wait for or absence of further tests and treatment. A woman with a delayed diagnosis of breast cancer explained:
Eva: “ I didn’t like that lump, and I felt strongly that something wasn’t right ... The lump was visible and painful. I went to the doctor several times and tried to speak up ..., but mammography and tissue samples had been taken, and the specialist at the hospital had signed them as normal.”
It was later proven that an error had been committed with the samples and that the cancer had been discovered many months earlier. The test results had rested in a pile at the hospital for new assessment, but a review was not performed. Positive test results were found coincidentally.
The events that became evident during the hospital stay or after returning home concerned symptoms of errors or of complications assessed as normal issues or symptoms that would disappear over time.
Peter: “I asked how the operation had gone, and the doctor said that it had been a little more complicated than first envisioned, but everything had gone well. I had pains when discharged, but I could still manage to move my arm. At home, I suddenly could not hold my arm out. I contacted the doctor at the hospital; he said it was completely normal and I could relax. It would get better again. But it certainly did not: it got worse and worse. I spoke to the hospital again but got the same answer ...”
After a long struggle, neurological examinations found nerve damage that resulted in permanent pain, paralysis and loss of function.
When errors became visible, health personnel appeared unwilling to talk about the errors, support the patients during a difficult situation, or help with further follow-up and treatment.
Lack of responsibility and error correction
The informants reported their experiences of being in the middle of situations that were decisive for life and health. They had expectations that any damages and errors would be rapidly limited and corrected, but they were disappointed. Few of the informants received an apology or detailed explanation of the event that had occurred, and none of them had a meeting with those involved to clarify the situation afterwards. The two informants who received an apology and explanation viewed them as noncommittal because they were not invited to share their experiences with the staff in general. Most informants perceived that hospital staff denied responsibility by avoiding dialogue and not providing suggestions for correction and damage limitation. The informants clearly expressed their disappointment.
Kari: “The doctor held his head up and walked straight past me; I know he saw me - that was a really unpleasant feeling.” Tone: “I had gotten much worse, but the doctor just turned around and walked out. And that was that. It was this denial of responsibility; that you were not allowed to talk about it like ... it would have meant a lot to me to have a good discussion with someone...”
The accounts show that it was essentially the patients’ responsibility to prove the AE. They encountered a hospital culture that normalized and trivialized AEs by referring to the fact that current procedures and rules had been followed and/or that tests and examinations showed normal findings.
Bjørn: “Not very much I can do when the doctor says it looks fine. You have to be quite active and more or less healthy to be able to keep up with all this. I don’t know ... you feel almost like a scoundrel. Feel that you are being met with doubt the whole time.”
This was experienced as a challenge in that patients can refer to only unexpected symptoms and feelings. Patients experiencing pain, discomfort and vulnerability must struggle to ensure that their condition is re-assessed. In Camilla’s case, after a hip operation, the prosthesis came out of joint. She heard a click , which was followed by serious pains and mobility problems. The staff thought that the pains were normal postoperative pains, and the patient had to make a fuss to get a new X-ray, which confirmed the luxation. She then had to wait four painful days for reoperation, which revealed a splinter of bone that had remained in the hip joint. Other informants experienced similar difficulties with circumstantiation and clinicians who they perceived as rejecting and arrogant:
Nina: “I could see for myself that the muscle was just hanging, but they said it would get better.” “He (the doctor) said that everything was perfect without touching me. I couldn’t understand how ... he had just done perfect work.”
These deficiencies reinforced the informants’ feelings of discouragement, vulnerability, pain and bitterness. The interviewees perceived that those who were responsible did not wish to accept the consequences of their decisions and actions, while the patients had to struggle to receive further help and treatment. The informants felt that they were not prioritized and that the time between the discovery of the error and the start of treatment could be long.
Peter: “Everyone can be unlucky, but can’t they just be nice enough to say so. Say ‘we’ll help you’ -why can’t they do that?”
Responsibilities regarding follow-up appeared to be unclear, and the informants stated that they were placed on new waiting lists where they received little or no information about what was to be done and when.
Eva: “That was when the struggle began, and that was the worst. I was naive enough to think that once an error had been discovered then things would move quickly. Nothing could be done about what had happened, but they could come to grips with things quickly, but that didn’t happen ... I had to fight my way to treatment, pure and simple. I had to stay on the phone and ring, and ring, and ring ...”
Lack of support, loyalty and learning
All the informants felt alone with their problems. Admitted patients found that hospital personnel rarely noticed their need for physical or mental support.
Kari: “There has been no real follow-up with me as a person, and I don’t feel that I have had any support ...”
Nurses and other carers showed understanding related to the performance of concrete tasks such as pain relief, showering or toilet visits but were otherwise perceived to be silent and absent. However, there were references to nurses who expressed understanding and recommended that the patient seek help from the patient and services ombudsman or report the incident as a patient injury. Informants described physiotherapists as one professional group that was supportive and asked questions about the patients’ progress and if they could help in any way.
The informants described how errors and defects in case notes made the course of further treatment difficult. Hospital doctors, other health personnel and GPs did not have knowledge about earlier events or complications due to a lack of written documentation in patient records. Some of these professionals notice problems and support the patient, while others are more concerned about documentation in the medical records before they refer patients to new examinations, check-ups and rehabilitation. The released discharge reports confirm the lack of descriptions of events and complications. When new health professionals must refer to incomplete written records, it is difficult for the patient to gain acceptance of his or her version and participate in decision making that could correct the error or prevent a new error from occurring. Thus, reoperations or corrective treatments are viewed as new treatments without considering the situation as a whole. Informants perceived this view as problematic and expressed that clinicians and administrative systems should be aware of the event, facilitate better follow-up, and be more attentive to patient needs in the situation.
Several of the informants spoke of specialist assessments and second opinions that finally supported their assertion that an error had occurred. The feeling of being seen and cared for as a person was of great significance. Kari explained this when describing the surgeon who performed the reoperation.
Kari: “He has followed up, telephoned me and given me very good information. This is reassuring, and it is directed at me as a person, not just two knees.”
However, informants also found that verbal feedback did not necessarily correspond with written statements in the medical records.
Bjørn: “He actually saw what was wrong with me straight away. It was good to have it confirmed ... but he did not want to stab a colleague in his back, which is why the report is as it was. However, he would follow my case, and he was one hundred per cent behind me. Therefore, I imagine he has something of a bad conscience. This hierarchy is like nothing else in society. They can’t just sit and cover each other.” Mari: “The doctor I spoke to said that the first doctor had made an incorrect assessment but that the system then got involved. A cover-up begins, and there are rules about what they can say and what they can do. Anyway, I am glad he was honest enough to say that. It helps a little.”
The informants appeared to be strongly affected by the events and their impact on their lives. At the same time, they believed that health personnel and the health service at both the individual and system levels should learn from the events and prevent similar events in the future. They interpreted the experience of a lack of recognition, disclosure and understanding to imply that learning is hindered when events are trivialized to such an extent.
The struggle against perceived negligence
The purpose of this study was to illuminate patients’ experiences of AEs as bottom-up inputs in patient safety work. Our sample represents a variety of diagnoses and conditions. The fact that all the “before treatment” cases in our study involved cancer, in contrast to only one of the during/after treatment cases, was somewhat surprising. This may be due to the sample composition. However, we are unable to evaluate this issue further at this time. One major finding concerns patients’ struggle against perceived negligence by clinicians and hospitals when they present their anxiety and concerns or point out errors and deficiencies. In summary, these reports describe the clinicians’ and health service’s avoidance or lack of response, signs of denial of responsibility and use of loyalty systems to largely support and protect each other. In these cases, patients are shocked by illness [ 1 ], and this shock may double due to injury or even triple due to the lack of adequate follow-up and treatment. The descriptions reveal potential barriers to openness and indicate that these patients were not invited into processes of open disclosure. This finding is in line with results reported by Iedema et al. [ 12 ], Ocloo [ 14 ] and Mazor et al. [ 13 ], who found that patients clearly expressed that a patient-centered and respectful dialogue to promote healing, learning and safety should follow the disclosure of an AE. In our study, informants’ descriptions also revealed a practice that was not in line with Norwegian governmental policy statements regarding the promotion of trust and openness in patient safety work [ 7 ].
However, some informants reported positive experiences of health personnel who acknowledged their experiences, offered help related to their condition and supported them in reporting the incident.
On the other hand, health personnel have been described as the second victims and also experience great stress from AEs; these factors must be taken into consideration [ 42 ]. Furthermore, individual clinicians may lack communication skills and may generally find it easier to avoid difficult conversations [ 18 ]. Several informants referred to their perceptions of doctors’ reluctance to criticize colleagues openly. This reluctance could connect to the Medical Associations’ ethical rules [ 43 ] of the handling of such events between colleagues but could also indicate that professional codes of collegiality and loyalty exist within the medical profession and potentially hamper an open disclosure process [ 17 , 18 ].
At a more general level, the breaches may represent more or less latent and unrecognized driving forces against defining errors and serious complications in hospitals. Hospitals work hard to avoid negative figures in reports and/or to maintain their reputation and income; paradoxically, such efforts may tend to counteract openness about undesirable circumstances [ 17 ]. However, we have no data to evaluate the extent to which hospitals used the errors narrated by study participants in learning processes to improve patient safety. Nevertheless, our findings may be interpreted as signs of professional and organizational cultures that do little to communicate errors to patients and to include them in learning processes at any organizational level, which potentially impedes open disclosure and even hampers learning from AEs as outlined in high-quality guidelines, e.g. guidelines from Harvard hospitals [ 9 ]. This could contribute to the understanding of why patients struggle to obtain evidence that recognizes the event and promotes further support.
The discursive power
The participants’ perception of being ignored and that the definition of events was not in line with the personal consequences that they experienced, was problematic. Our findings indicate that practitioners and hospitals have discursive power in the form of expert knowledge , which determines and limits the prevailing definition of the truth in the situation [ 27 ]. In general, professional knowledge and the hospital environment give health personnel an authority to assess the best course of action in any patient situation. Participants reported lack of acknowledgement of their condition in the encounter with the experts. This finding corroborate results from Eriksson and Svedlund who studied patients’ dissatisfaction with hospital care [ 44 ]. The results further shows that patients did not experience to be part of assessment processes or in the social construction of categories that defined what was considered normal in the patient’s situation. Sharpe and Faden argue that the definition of medical injury is overly one-sided and tends to reflect a narrow clinical understanding that excludes non-clinical perspectives and outcomes that the patients experience as damaging [ 45 ]. In this sense, the understanding of AEs may be selective and contribute to disciplinary actions and stigmatization [ 30 ]. Events described as foreseeable complications, misunderstandings, organizational failure etc. place the responsibility outside the potential control of the health personnel and attribute the events to chance, natural surgical risk or patient factors.
Some informants reported feeling uneasy when asking questions. Patients who speak up and ask questions may thus be perceived as extra concerned, having a negative attitude, being bothersome, difficult to treat etc. When problem descriptions take little account of patient perspectives, there is a risk that general intentions about increased patient involvement, empowerment, openness and AE reduction are not spread downwards through the organization and do not make contact with the prevailing values of the professional and organizational cultures. In practice, this may imply that a number of patients do not receive the treatment and follow-up that they need and begin a difficult process to ensure that their condition is acknowledged. The patients in our study were not involved in designing measures to avoid incidents, and to their knowledge, their experiences were not pursued for subsequent learning. Thus, intentions regarding patient-centered care and patient participation in the development of safety efforts appeared to be practiced to a limited extent in the reported cases.
Patient safety within fixed frames
Patterns of action that replicate many times in organizations like hospitals, become typified and institutionalized as permanent attitudes, actions and methods that tend to be taken as a given [ 31 , 32 ]. Within these frames, social practice unfolds. In this way, awareness in the everyday understanding of patient treatment has become routine. This issue not only applies to individual errors or deficiencies related to everyday performance, but may also represent practice cultures in which the exclusion of patients and events becomes routine and maintained by the prevailing knowledge regimes and professional hierarchies. Changing these regimes requires increased awareness, not only in terms of the authorities’ intentions to increase patient safety but also in terms of the inclusion of both personnel and patients at all levels of professional and organizational cultures [ 31 ].
Learning processes can be inhibited if the goal, in this case, the reduction of AEs and improved follow-up with patients, does not coincide with other goals, such as maintaining professional autonomy, promoting the individual clinician’s career opportunities or earning the status of the professional center or hospital with the fewest reported errors. Argyris and Schӧn [ 46 ] refer to this dilemma as the differences between espoused theory and theory-in-use , where ideals and reality do not concur. Changing fixed attitudes and patterns requires obtaining information that includes all relevant perspectives, weighing alternative knowledge-based actions, continuously assessing the consequences of the action taken and questioning whether the action is congruent with governing values [ 46 ].
The study results show that patient experiences may serve to identify barriers to patient safety work that are necessary to overcome to prevent future AEs.
Strengths and limitations
The data are from interviews with a small, selected group of patients who had the energy and resources to contact the Health and Social Services ombudsman for assistance. Thus, the findings cannot be generalized to the entire population of patients who experience AEs in Norwegian hospitals. Personal stories might also be selective, exposed to recall bias and affected by a wish to narrate only aspects that favor the quest for some kind of compensation following an AE. In addition, the relatively long time span between the incidents and the interview may have provided informants with new contexts of interpretation due to their personal biography and the increased public attention toward patient safety issues. On the other hand, an expanded time frame may contribute to greater richness in terms of reflections on the event. Overall, the patient stories bear significant similarities and appear to be consistent across all subject areas and diagnoses, across a wide range of institutional settings, and regardless of whether the persons had applied for or received compensation. This consistency should contribute to the trustworthiness of results and indicates that the stories reveal important aspects of a widespread deep structure within hospitals that inhibits the realization of principles of open disclosure. Another important limitation is that the study does not include clinicians or health service providers’ perspectives of the events. Some of the events may expose grey areas between complications and AEs. Nevertheless, experiences of a struggle against perceived negligence are present across all stories.
Patients are in need of emphatic and professional acceptance of responsibility when an error occurs. Health personnel must listen to the patient and bear in mind that communication and open dialogue have great implications for the person’s evaluation of the event and future life and health. This qualitative study may promote reflection among care providers irrespective of professional area, hospital management and government. Acknowledging that patients are co-producers with important knowledge about their health situation is essential to the development of safer treatment. Future research should include a larger number of patients as well as organizational and professional perspectives. The impact of AEs on the daily lives of patients and their families should also be studied.
This small-scale, qualitative study shows that some patients experience a lack of care, openness and acceptance of responsibility when AEs occur. They perceived that their perspective was largely ignored. We have no data to evaluate whether their cases are used as input for learning and development in patient safety work. However, open disclosure guidelines advocate for the inclusion of patients at early stages and throughout the process. Our results indicate that the full potential of such learning and development is not realized in hospital units. Considerable cultural and attitudinal changes in day-to-day patient care are necessary. Patients exposed to AEs should be invited into open disclosure processes and included as fellow architects of their own health and safety.
14 march 2019, abbreviations.
Norwegian System of Patient Injury Compensation
The Norwegian Social Science Data Services
Norwegian regulations for ethical research practice.
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We are grateful to all the participants who shared their accounts with us. We also thank the Health and Social Services ombudsmen for their recruitment efforts.
This study was funded by UiT, The Arctic University of Norway.
Availability of data and materials
The dataset supporting the conclusions of this article is not made available to secure participant confidentiality and because of the consistency of a large amount of qualitative interview transcripts in Norwegian.
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Department of Health and Care Sciences, UiT The Arctic University of Norway, Hammerfest, Norway
Gunn Hågensen, Gudrun Nilsen & Grete Mehus
Department of Health and Care Sciences, UiT The Arctic University of Norway, Tromsø, Norway
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GH was responsible for the conception and design of the study, the acquisition of data, the analysis and interpretation of data and the drafting of the manuscript. GN was involved with the design of the study, the analysis and interpretation of data, and the revision of the article. GM contributed to the refinement of the data analysis and the preparation of the manuscript. GM provided critical comments and suggestions for revisions. NH contributed to the conception and design of the study, the analysis of data, the incorporation of sociological theory, and the writing and critical revision of the manuscript. All authors read and approved the final version of the manuscript.
Correspondence to Gunn Hågensen .
Ethics approval and consent to participate.
The Norwegian Social Science Data Services (NSD) gave their approval (Reference number 34221), while the Regional Committee for Medical Research Ethics judged that the project did not require approval (REK North Reference number 2013/131), corresponding to the Norwegian regulations for ethical research practice and ethical principles stated in the Helsinki declaration. After receiving oral and written information about the design and goals of the study, all participants gave their voluntary approval for participation by signing an informed consent form.
The authors declare that they have no competing interests.
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Additional file 1:.
Interview guide. (DOCX 16 kb)
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Hågensen, G., Nilsen, G., Mehus, G. et al. The struggle against perceived negligence. A qualitative study of patients’ experiences of adverse events in Norwegian hospitals. BMC Health Serv Res 18 , 302 (2018). https://doi.org/10.1186/s12913-018-3101-2
Received : 06 May 2016
Accepted : 08 April 2018
Published : 25 April 2018
DOI : https://doi.org/10.1186/s12913-018-3101-2
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