The Importance Of Open Disclosure In Medical Misadventures

Discuss about the Medical Or Clinical Misadventure In Medical Treatment.

Introduction to Medical Misadventures

Medical or clinical misadventure is an adverse reaction or injury as a result of any form of medical treatment. Most of these cases are not intentional but may result as a result of negligence or not having adequate knowledge about potential risk factors that any method of treatment carries. An example of this is chronic carbamazepine overdose when managing a child who has been epileptic for more than 5 years. In this instance, adverse effects of the drug will manifest in many systems. They include seizures, coma, respiratory distress, hepatic injury and urinary retention. Other forms of clinical misadventures include infections, surgical mistakes and postoperative complications.

Because of the increasing cases of medical misadventures, lawsuits are increasing. According to a book by Jackson, (2016), many patients and their care givers are becoming more aware of their rights as patients and that their health care providers are answerable to any mistake that arises in their course of treatment. In countries like Japan, media coverage of iatrogenic complications sparked public interest in appraising the medical profession (Leflar, 2011). Open disclosure has become a popular subject among both law firms and in the health sector as an avenue for managing medical misadventures.

Open disclosure (OD) encompasses an open discussion with the patient regarding incidents that might result to harm to them in their treatment course at a health facility. This process is discussed with the patient, their family and any other support persons with the patient ("Open disclosure | Safety and Quality", 2017).  The practice is backed up by the Hippocratic Oath that was developed around the 4^th century to ensure moral standards are upheld in the medical profession. OD is important and should be in cooperated into the medical practice. A successful open disclosure involves establishing a good rapport, informed consent, proper and timely communication.

Studies have been conducted by Jane Feinmann on the importance of open disclosure. She uses Brownie’s story of how she died in the hospital, and the staff did not disclose the risks she developed after a surgery (Wallace, 2011). With open disclosure, Feinmann acknowledges that health care staff will reoccurrence of same mistakes since the next of kins would not be deprived of their right to know what happened.  A survey by Medical Protection Society (Wallace, 2011). also shows that 90% of respondents agreed that patients who receive apology from the doctor are less likely to sue the doctor and that only two thirds of doctors are willing to open up to their patients when something goes wrong.

Increasing Lawsuits and Need for Open Disclosure

Importance of open disclosure to health care staff includes helping them gain confidence in communicating when something goes wrong, feeling satisfied and supported when they want to disclose an event, gain more understanding on the topic, feeling of improved relationship with their patients and that the lessons learnt are helpful in preventing similar occurrence( Okuyama, Wagner& Bijnen, 2014).  For the patient or the support person, open disclosure ensures that they get meaningful apology, have a feeling that their concerns are acknowledged and that they can ask questions any time on what happened. It also helps them get reassured and have a greater respect and trust for the institution. Many medical practitioners fear litigation should they disclose unintended harm that occurred to the patient. There is no conclusive scientific evidence that disclosure increase or reduce litigation (Fisch, Gelbach, & Klick, 2016).  The importance of open disclosure is emphasized by current literature that if a patient is told about the harm, they may be less inclined to pursue legal action.

Open disclosure should be mandatory. It is intended to protect the public from unnecessary harm. It also aims at improving the quality of health service provision. Open disclosure is enshrined in the National Safety and Quality Health Service Standards (NSQHS). This operates under the principle of governance for safety and enhancing quality health care services in organizations ("Open Disclosure Policy", 2014). To reduce the litigation processes, to protect the institution’s image, to ensure that patient safety is upheld and medical legal issues are taken into account, the process of open disclosure should be mandatory.

Open disclosure process involves honesty, empathy and timely discussions between the health care provider and the patient after an incident. When done effectively, it ensures more confidence and trust in the health facility by the community, Koller et al., (2016). Before initiating the process, one must ensure that there is a trained expertise for the job, all staff must be aware of the commitment the organization has to disclose information and timely information should be provided to the staff participating in the process. The process, as shown by the Australian open disclosure framework includes a framework of eight guiding principles. They are:

• Open and timely communication after the incident.
• Acknowledging that the event occurred.
• Apologizing to the patient or the caregiver or expressing regrets.
• Supporting and meeting the expectations and needs of the patient, family and caregivers.
• Supporting and meeting the needs of those providing care in the facility.
• Good governance.
• Confidentiality in one’s self.

In summary, the elements of an open disclosure include apology, acknowledgement of compromised patient safety, active listening and responding to patient and their support person, discussing the consequences of the incident, proving room for patient and their support persons to ask questions, explaining the steps taken in managing the incident and proving support for the patient and their caregivers to manage the physical and psychological consequences, Wu et al., (2017)

What is Open Disclosure?

Consumers of medical services are entitled to information about open disclosure whenever an event happens. A study by Fein and fellow researchers found that six elements were needed for a satisfactory disclosure. They include:

• Admission that there was an error. This is said to the patient and their care giver. The process of error is communicated in a way that they can understand ("Open Disclosure Policy", 2014).
• Discussion of the event: this involves discussing the occurrence of the event containing the error. For example if it was a caesarian section that involved accidental tubal ligation. This is also explained in a clear manner ("Open Disclosure Policy", 2014).
• Linking the error to the proximate effect: The patient has to understand the consequences of the error and how it will affect their life ("Open Disclosure Policy", 2014).
• Proximate effect: the effect of the error has to be communicated to the patient. For instance that the tubal ligation will see that the patient becomes sub fertile if it was bilateral ("Open Disclosure Policy", 2014).
• Link to harm: if harm occurred during the error, this has to be communicated in a comprehensible way ("Open Disclosure Policy", 2014).
• Harm: if there was harm from the error, the communication concerning the harm must be relayed ("Open Disclosure Policy", 2014).

One of the duties of health service organizations include informing the patients, support persons and families about the expectation during their hospital stay. The information should cover what is expected normally and what to expect when something goes wrong. This should be done in a large framework that will ensure the information is provided to the patient during their episode of care (Piper, Iedema & Bower, 2014). Communication strategies may include information on the normal and what is expected during a misadventure via a brochure or hospital website, patient information booklet and through an open disclosure booklet.

Open disclosure can therefore be full, as discussed above or partial which include giving misleading statements and inadequate information. Apart from giving the information to clinical consumers, medical staff are also entitled to know the adverse event that occurred. This, however, should be done with a legal reason since disclosure requires consent and is an autonomous procedure ("Confidentiality - Disclosures without consent", 2014). However, if it is between the clinical consumers, sharing this information may be helpful in making decisions that may help in averting the harmful event ("Guidelines for Doctors on Disclosing Medical Records to Third Parties 2010", 2010).

Information regarding medical misadventures can be provided by electronic messages to staff, verbal reporting at staff meetings and discussions during shift handovers, replacing outdated policies immediately in information sources in every department, regular clinical meetings, giving newsletters, putting in the notice boards and using clinical risk handbooks.

Legal issues arise when there has to be a decision for an open closure, whenever there is an evidence of harm or no evidence of harm. The Australian law on open closure is widely used, although the process in Singapore would be similar. Different ethical principles underlie the practice of open disclosure include (Studdert & Richardson, 2010).

1. Privacy between what the patient and clinician discuss during the process (Studdert & Richardson, 2010).
2. Confidentiality to ensure that the information gets to only those who want to know (Studdert & Richardson, 2010)..
3. Veracity which includes truth, informed consent and autonomy in the clinician patient relationship (Studdert & Richardson, 2010)..
4. Fidelity involving loyalty (Studdert & Richardson, 2010).

In evidence of harm, open disclosure is mandatory. In a relationship perspective, it strengthens the patient doctor relationship. In the legal approach, it is the patient’s right, ensures increased transparency and ethically and legally right thing to do. If there is no evidence of harm, open disclosure is generally the right thing to do. This is according to a journal on ("Disclosure of harm following an adverse event", 2011).  A journal by the Canadian Medical Protective Association ("Disclosing harm from healthcare delivery", 2015) highlights a scenario for no harm and near miss incidences.

Importance of Open Disclosure

 At times, no harm is caused to the patient and can result from no harm incidents or near misses. The former occurs when the event reached the patient but there was no evidence of harm at that time or in the future, but harm might still manifest later. An example is when a surgical procedure is performed in a poorly sterilized environment. Viral infections may take time before ensuing. No harm incidents therefore require no disclosure ("Disclosing harm from healthcare delivery", 2015). Near miss incidents also do not need disclosure except in some circumstances when there is a similar and ongoing safety risk for the patient or if they know about the near miss and that an explanation will promote trust and alleviate the fears.

Open disclosure when no harm is present allows the patients to be active in their care, making them aware of potential signs and symptoms that they should watch out. This is important in delaying the patient’s concern about delays in their recovery process (Adler, McLean, & 2017). There are questions regarding whether disclosure is not required in case of a misadventure. In some cases, the timing can be delayed on the basis of patient’s ability to make decisions at that point. Flexibility in determining the appropriate time depend on factors like the patient condition and availability of support persons.

Clinicians have rights and responsibilities whenever an adverse event has occurred and an open disclosure process needs to be initiated (Watson, Angus, Gore & Farmer, 2015). These rights include

• Right and responsibility to seek for appropriate legal advice when an event occurs. The legal system protects both the patient and the clinician. This information should be disclosed to the legal team in a way that it ensures attraction of legal professional priviledge.
• A right undergo fair treatment by the institution involved and that to receive justice in a fair way.
• The right to evade defamation as this will reduce the trust in clinicians and the health institution.
• The right to seek suitable advice and guidance, and a contractual responsibility in some instances as a matter of enhancing medical defense organizations and guidance against indemnity.

However, there might be a situation when the staff members are concerned about being litigated or may be afraid of losing their reputation. In this circumstance, they should be encouraged to contact their medical defense team or an indemnifier from a professional body to clarify their position (Andrew & Brenner, 2015).  The process of open disclosure can be facilitated by a manager by organizing a meeting with the involved team or giving assistance with the disclosure interview.

Managers should be involved in the process of open disclosure whenever a medical misadventure occurs. Managerial skills are needed in circumstances like taking an active role in the disclosure interview ("Open Disclosure Policy", 2014). This happens when a critical event has occurred and a manager’s participation may provide assurance to the patient and the family. In this case, the manager talks to both the patient and family in the view that the incident that has happened is being taken into serious consideration by the organization ("Open Disclosure Policy", 2014).  For example, when a patient being rehydrated is overhydrated without takin into account their heart failure, they can end up developing a complication like pulmonary edema. In this instance, the in charge can assure the patient and family of their intention to take stern action against the health care provider involved.

Elements of Open Disclosure

Another situation needing managerial involvement in open disclosure is when the senior clinician involved requires the manager’s support in explaining the event (KIM, Shroff, Vyas & Moerman, 2015). When ongoing investigations after a misadventure has revealed managerial issues, the manager is needed to explain the gaps in the system that led to the event. Managerial participation is also needed when there has been a breakdown in patient-healthcare team relationship.

The manager’s role in assisting implementation of open disclosure is important in ensuring patient trust in the organization. This creates an organizational network that prioritizes the patient before the colleges, themselves and the organization (Capell, Tzafrir, Enosh & Dolan, 2018).   The framework also looks at system improvement and not accusing induvial while providing a supportive environment for the staff in a case where they are involved in a misadventure. The manager also ensures that guidelines and policies that align with the open disclosure framework of the given country is developed and implemented.

Policies regarding open disclosure should be developed in Singapore, as other countries like Australia have done ("Open Disclosure Policy", 2014).The importance of this directive is to set minimum requirement for an open disclosure process that will be consistent with the public health services of Singapore.  This needs good will from many stakeholders like patients, consumers and their careers, clinicians and clinical organizations, health service organizations, health interest groups, government, private health funders, professional indemnity insurers and educational institutions. Policy development will require that surveys and researches are conducted on the incidences of medical misadventures in various health institutions across the country. ("Open Disclosure Policy", 2014). This should help come with scientific evidence for policy development and implementation. Face to face stakeholder forums should be conducted and written submissions sent to the stakeholders.

Mandatory requirements before ensuring policy development will include acknowledging patient safety incidences through extensive scientific research and political goodwill from both stakeholders including the government ("Open Disclosure Policy", 2014). Essentially, a multidisciplinary team should be involved. Other requirements will include truthful, clear and timely communication, providing an apology to patient, providing ongoing care and support to patients, support to health care staff and integrated approach to improving patient safety. A compliance to legal and ethical issues is also needed (Lehr, Kenneally & Bauer, 2015).

References

Adler, N. R., McLean, C. A., & Gin, D. (2017). The specimen that did not survive processing: Ethical considerations pertaining to open disclosure. Journal of the American Academy of Dermatology, 77(5), 988-990.

Andrew, L. B., & Brenner, B. E. (2015). Physician suicide. Medscape Drugs & Diseases.

Capell, B., Tzafrir, S. S., Enosh, G., & Dolan, S. L. (2018). Explaining sexual minorities’ disclosure: The role of trust embedded in organizational practices. Organization Studies, 39(7), 947-973.

Fisch, J. E., Gelbach, J. B., & Klick, J. (2016). After Halliburton: Event studies and their role in federal securities fraud litigation.

Jackson, E. (2016). Medical law: text, cases and materials (4th ed., pp. 40-135). Oxford, United Kingdom: Oxford University Press.

KIM, J. B., Shroff, P. K., Vyas, D. U., & Moerman, R. W. (2015). Active CDS trading and managers’ voluntary disclosure.

Koller, D., Rummens, A., Le Pouesard, M., Espin, S., Friedman, J., Coffey, M., & Kenneally, N. (2016). Patient disclosure of medical errors in paediatrics: A systematic literature review.Paediatrics & Child Health, 21(4), E32-E38. 10.1093/pch/21.4.e32

Leflar, R. (2011). The Law of Medical Misadventure in Japan (11th ed.). Japan: Chi-Kent-Lev.

Lehr, W., Kenneally, E., & Bauer, S. (2015). The Road to an Open Internet is Paved with Pragmatic Disclosure & Transparency Policies.

Okuyama, A., Wagner, C., & Bijnen, B. (2014). Speaking up for patient safety by hospital-based health care professionals: a literature review. BMC health services research, 14(1), 61.

Piper, D., Iedema, R., & Bower, K. (2014). Rural patients' experiences of the open disclosure of adverse events. Australian journal of rural health, 22(4), 197-203.

Studdert, D., & Richardson, M. (2010). Legal aspects of open disclosure: a review of Australian law. Medical Journal of Australia, 193(5), 273-276.

Wallace, M. (2011). Jane Feinmann on the importance of open disclosure. Patientstories, 45(23).

Watson, B. M., Angus, D., Gore, L., & Farmer, J. (2015). Communication in open disclosure conversations about adverse events in hospitals. Language & Communication, 41, 57-70.

Wu, A. W., McCay, L., Levinson, W., Iedema, R., Wallace, G., Boyle, D. J.. & Conway, J. B. (2017). Disclosing adverse events to patients: international norms and trends. Journal of patient safety, 13(1), 43-49.