Contents

Introduction

The issue of informed consent has become increasingly important in medical fields in recent times. Partially due to increase in legal action and partially due to the increase in quality improvement being undertaken by professions and institutions.

 In 1998 the Physiotherapy Department was involved in the Evaluation and Quality Improvement Program (Equip) at Orange Base Hospital. While considering its own performance the issue of informed consent was assessed and considered an opportunity for improvement.

In 1999, I participated in Action Research on Web and used the informed consent issue as a basis for my study. This paper tells the story of my journey from our initial interpretation of informed consent, the associated literature, a new understanding of the issue and our redefinition of the term “ informed consent “. That is, from a paternalistic, medical model to a process, which involves on-going dialogue and collaborative decision making between the patient and the therapist.

It also demonstrates the process undertaken by the physiotherapy department to address this issue. The use of Total Quality Management (TQM) and reflective practice to evaluate the process and outcomes.

The Journey

 The Equip Program and also my participation in Action Research on the Web (AROW) have stimulated this journey. AROW is a unit of study through the Web and email offered by University of Sydney. Its offered to graduate students, continuing professional education and research students to help them engage in research and action to improve their professional practice in organisations or social situations.

 Action Research is a non-traditional form of research which is often community based and carried out by a practitioner in the field (Stringer, 1996)

There are a number of characteristics, which distinguish Action Research from other sorts of research. Collaboration between researcher and practitioner, solution of practical problems, change in practice: theory development and publishing the results of the inquiry (Holter& Schwartz-Barcott, 1993; Zuberr & Skerritt, 1992)

Action research proceeds through planning, action, evaluation of the action and reflection (Hatten et al, 1996) The cycle is repeated creating a spiralling effect. Reflective practice, action learning, participatory research, action learning and continuous quality improvement are activities which share some, but not all features of action research. (Hughes, 1997)

Equip is a tool developed by the Australian Council of HealthCare Standards to help health care organisations to continuously improve their ability to identify areas of achievement and improvement. Outcome standards which state what is to be achieved and how it has to be achieved, by whom and when are set. It is also cyclic.

Self-assessment is the first step in the Equip process. Standard 1.2.5 states “Informed consent is obtained by the health professional responsible for the care of the patient/client.”

The physiotherapists at the Equip planning meeting felt that the issue of “informed consent” was an opportunity for improvement. The issue identified was “Do we obtain informed consent?” While involved in AROW I used its framework to research and hopefully improve our professional practice.

Cycle 1 - A review of the literature on informed consent.

Consent has been described as “the procedure whereby patients consent to or refuse a medical intervention based on information provided, regarding the nature and potential consequences of the proposed intervention.” Coy (1989)  Vines (1996) and Purtilo (1984) cover the legal background for informed consent. The traditional cause of action for a medical practitioner is trespass. Trespass is based on the notion of interference with bodily integrity and the common form of trespass is battery. Battery is the act of offensive touching that is done without the consent of the person touched. In recent times negligence has become the dominant cause of action. In a negligence action, the plaintiff patient has to prove that the defendant practitioner owed a duty of care to the plaintiff breached that duty of care in some way and that breach of the duty caused the injury suffered by the plaintiff.“ A person in whom another person has placed special trust or confidence is required to act in good faith and in the interests of that person” Purtilo (1984). This duty of care and the right to self-determination are Purtilo’s ethical basis of informed consent. Self-determination is a legal doctrine stating that every competent person has a right to be involved in what will happen to him or her

Disclosure is the means of ensuring self-determination. Beauchamp and Childress (1979) also consider self-determination and disclosure. They break informed consent in two areas; the informational and the consent element. The informational element involves disclosing the relevant information and comprehension of that information. The amount of information disclosed is open to debate and a matter of judgement but if the information is not understood disclosure is ineffectual.

The consent element involves competence and voluntariness. That is a patient’s inherent capacity to make rational, autonomous decisions without coercion or undue influence.

According to Department of Health guidelines for health care providers, informed choice involves the exchange and understanding of relevant information so that an informed, reasoned and unpressured decision can be made. Informed choice is a pre-condition of informed consent. Department of Health (1991)

It becomes apparent that the most important issue and the legal emphasis lie on the word informed. “Unless consent is informed it is not regarded as true consent.” Vines (1996)

Haswell (1996) summaries the issue well when she states:

“ Autonomy enhancing informed consent is probably achieved through an ongoing dialogue between the patient and the physiotherapist. Rather than being a single debatable event that occurs whenever a decision must be made because of potentially harmful consequences, autonomy enhancing informed consent would usually involve effective and continuous communication with the patient about their needs and wants.”

Reflection

Having reflected on the literature it became evident that that our original interpretation of informed consent was weighted towards the medical model of an informed consent form and paternalistic. That is with little consideration given to the exchange and understanding of information. The therapist determines treatment choices because “physician knows best”.

After consideration the reviewed issue was “ Do we communicate with our patients and keep them informed throughout the assessment and treatment. ” 

The physiotherapists at Orange Base Hospital felt they did keep their patients/clients informed. Areas of information the physiotherapists felt they covered were: explanation of the assessment procedure, diagnosis of the condition with underlying anatomy and physiology, the treatment options, warnings associated with treatment techniques and the responsibilities of the therapist and patient. On reflection, it became apparent these were therapist centred perceptions. Does this cover what the patient wants to know? 

Cycle 2 - What are the informational needs of Physiotherapy patients.

 A review of the literature on the informational needs, perceptions and attitudes in relation to physiotherapy revealed disenchantment with physiotherapy. Johnson (1993) investigated disabled people’s perceptions of physiotherapy. Some of the reasons for disenchantment cited were failure to ensure understanding and involvement in treatment and arrogance in stifling individual autonomy. Physiotherapy was perceived as “problem-centred” rather than “client-centred”.

Trede (1999) while investigating the educational component of physiotherapy found physiotherapists educated patients about aetiology, anatomy, pathophysiology and biomechanics in order to gain patients trust and respect and confidence. She felt this was a therapist centred approach where the therapist exclusively determined treatment management. 

On questioning the patients, patients stated they wanted themselves rather than the techniques to be the centre of concern. Personal communication was more valued by patients than the provision of scientific facts.

When looking at the research that has been done on the informational needs of patients in the other health areas eg post surgical, following myocardial infarct and in intensive care. Ziemmer(1983) and Noon and Devero (1987) found patient satisfaction and recovery were linked to the amount of information a patient received. Retas and Forrester (1995) qualify “ the information takes its precise contents from the needs, concerns and circumstances of the patient.”

Turton (1998) compared the self-perceived informational needs of post myocardial infarct patients with the perceptions of nursing staff. Like Trede, Turton found there was a difference between what the nurses felt was important information and what the patient required. Duryee (1992) when discussing the post –Myocardial infarction education, states the process must be determined by the individual interests and concerns of the patients, rather then those of the nursing staff and medical staff.

Jensen and Lorish (1994) researched the barriers experienced in implementing exercise programs in clinical practice. They suggest cooperation in implementing an exercise program is mediated by the patients belief system and requires a therapeutic process of mutual inquiry, problem solving and negotiation between the therapist and patient.

The Journey So Far

The journey has undertaken two cycles of identifying an issue, investigating the literature and reflecting on the findings. The reflection has then reframed the initial issue initiating another cycle of inquiry.

We have gone from “ Do we obtain informed consent?“ through “ Do we communicate with our patients and keep them informed? ” to “ What are the informational needs of our patients.” 

In this project we are still in the Plan phase. We’ve formulated an area for improvement but we are still determining what data is necessary in the process. Although the process is part of a TQM program I feel it better reflects the practices of action inquiry and particularly reflective practice. There has been a plan, act, describe, and reflect process in which reflection has been the conscious attempt to evaluate the process and outcomes. The reflection has occurred after the action and the description of the action has been the description of the Enquirer’s experience. No ideas or changes have been implemented or trialed and therefore no monitoring or evaluation. In effect no action or research has been undertaken.

 We can align our actions with Schon (1991) definition of reflective practice:

“ The initial enquiry is triggered by a problem which is initially set according to the observation at the moment. Comparison of this problem frame with knowing-in-action produces new phenomena or reframing of the initial problem. Awareness of feedback from the milieu stimulates reflection, which causes the individual to continue to reframe, experiment, transform knowledge schema and create new insights. This cycle is on-going.”

 The initial problem “ Do we obtain informed consent?” triggered inquiry and a literature review of informed consent. The knowledge gained reframed the initial problem to “ Do we communicate with our patients and keep them informed?” Reflection was stimulated and there has been continuing reframing, experimentation and transformation of knowledge to create new insights. ie Informed consent requires autonomy, information, effective communication and the information must reflect the needs and wants of the patient.

 Where to Now

 The plan after cycle 1 was to conduct an informational needs analysis of the physiotherapy patients attending the outpatient department at Orange Base Hospital. Participative action research involving patients, representatives, physiotherapists, quality manager, allied health manager and other allied health disciplines would have been conducted.

 However, the individual needs and wants of patients highlighted by the literature has led me to reflect that the need arises for a system or frame to implement into the clinical setting which stimulates a process whereby each, individual patient is involved in mutual inquiry, problem solving and treatment is negotiated between the physiotherapist and client.

Trede found physiotherapists primarily saw themselves as technicians and had difficulty with the education component of treatment.

Cycle 3 - What processes are available to promote mutual inquiry, problem solving and collaboration/negotiation between patient and client.

 The next cycle will investigate relationships between therapists and clients. Enhancing our understanding of collaboration and ways we can integrate a model of client and practitioner collaboration into the clinical setting

Conclusion

 Through the process of TQM, action inquiry and reflective practice Informed consent has been redefined as“ the ongoing dialogue between the patient and the physiotherapist that occurs whenever a decision must be made regarding the care of the client and involves effective and continuous communication with the patient about their needs and wants.” 

From a review of all the literature cited there is a clear need to redefine the way physiotherapists perceive their patients needs. Rather than having a problem or therapist centred approach we should have a patient centred approach if we are to confidently claim we have obtained “informed consent”.

References

Australian Council of HealthCare Standards (1996) Evaluation and Quality Improvement Program.

Beauchamp, T.L. & Chidress, J.F. (1979) Principles of biomedical ethics. Oxford University Press.

Coy J.A. (1989): Autonomy based informed consent: Ethical implications for patient non-compliance. Physical Therapy 69:826-833.

Department of Health (1991): Principles and guidelines for informed choice and consent: for all health care providers and planners. Wellington, New Zealand: Director General of Health, New Zealand Health Council.

Duryee R. (1992) The efficacy of inpatient education after myocardial infarction. Heart & Lung21 (3), 217-225.

Haswell, K. (1996) Informed choice and consent for cervical spine manipulation. Physiotherapy Vol 42, No 2: 149-155.

Hatten R, Knapp D & Salonga R. Action Research: comparison with the concepts of ‘ the reflective practitioner’ and ‘quality assurance’ 1997; AROW Reader http//www.cchs.usyd.edu.au/arow/reader/rdr.htm

Holter, I.M & Schwartz-Barcott, D. (1993) Action Research: What is it? How has it been used and how can it be used in nursing? Journal of Advanced Nursing.18, 298-304.

Hughes, I. (1997) Introduction to Action Research. AROW Electronic Reader http//www.cchs.usyd.edu.au/arow/reader/rintro.htm.

Jensen, GM (1994) Promoting patient co-operation with exercise programs linking research, theory and practice. Arthritis cares and Research. 7(4): 181-9,1994 Dec. (44 ref)

Johnson, R. (1993) Attitudes don’t just hang in the air…” Disabled people’s perceptions of physiotherapists. Physiotherapy. 79(9): 619-27, 1993 Sept. (33 ref)

Noon, B.E. & Davero, C.C. (1987) Ambulatory surgery: Patient satisfaction in a hospital based day surgery setting. AORN Journal, 46,306-312.

Purtilo R.B. (1984) Applying the Principles of Informed Consent to Patient care. Legal and Ethical considerations for Physical Therapy. Physical Therapy. Vol 64, No 6: 934-937.

Retas A & Forrester K (1995) Consent implications for Health care practitioners. Journal of Law and Medicine 2: 317-326.

Schon, D. (1991) The Reflective Practitioner: How Professionals think in Action. Avebury: Ashgate Publishing Ltd.

Stringer, E.T. (1996) Action Research – A Handbook for Practitioners. London: SAGE publications.

Trede, F. (1999) What do physiotherapists do when educating patients with low back pain. Unpublished Masters Thesis. New South Wales University.

Turton, J. (1998) Importance of information following myocardial infarction study of the self-perceived needs of patients and their spouse/partner compared with the perceptions of nursing staff. Advanced Nursing. Vol 27(4). April 1998:770-778.

Vines P. (1996) Informed Consent: From paternal benevolence to trust and mediated by truthfulness. Physiotherapy Vol 42, No 3: 245-246.

Zeimer, M. (1983) Effects of information on post-surgical coping. Nursing Research, 32,282-287.

Zuber-Skerritt, O. (1995) Models for Action Research. In S. Pinchen & R. Passfield. (Eds) Moving On: Creative applications of action learning and action research. (Pp3-29)