Integrated Medical Education Resources: 110330P - ASSESSING KNOWLEDGE, ATTITUDES, And PRACTICES REGARDING INFORMED CONSENT TO PATIENT TREATMENT IN THE KINGDOM OF SAUDI ARABIA

A research proposal by Prof. Omar Hasan Kasule

1.0 INTRODUCTION

We hear from anecdotes and read in some published reports that patients sign consent forms without understanding what they are doing. This is a serious issue that needs investigation and correction if true. This project will assess current practices and will propose corrective action

2.0 BACKGROUND

No medical procedures can be carried out without informed consent of the patient except in cases of legal incompetence. Informed consent means that the patient understands what he or she is consenting to. Consent is an autonomy right that is a basic human right. The patient has the purest intentions in decisions in the best interests of his or her life. Others may have bias in their decision-making. As part of his/her autonomy rights, the patient is free to make decisions regarding the choice of physicians and treatments. Consent can be direct and immediate or can be prospective by use of proxies, a living will, or power of attorney delegating decision making to someone else. The process of informed consent has several elements: disclosure by the physician, understanding by the patient, voluntariness of the decision, legal competence of the patient, explanation of all alternatives, and recommendation of the physician on the best course of action, decision by the patient, and authorization by the patient to carry out the procedures.

The patient must be free and capable of giving informed consent. The term competence or capacity is used to indicate capability to consent. A patient who is incapable of consenting is called incompetent or incapacitous. There are specific ways of testing that the patient is competent or capacitous.

3.0 LITERATURE REVIEW

A preliminary literature review has been made from international journals. Once the project is approved, a more extensive search will be made of problems and issues in informed consent. A specific search will be made of writings on informed consent in Saudi Arabia both published and unpublished.

4.0 OBJECTIVES OF THE STUDY

1.1 The first Phase: (a) Assessing institutional written policies on informed consent and comparing them with international standards. (b) assessing a sample of consent forms for completeness and appropriateness

1.2 The Second Phase: Assessing KAP regarding consent of physicians, nurses, medical students, and residents making sure to separate knowledge and attitudes on one hand from practice on the other hand

1.3 The Third Phase: (a) Assessing patient understanding and perceptions of consent, their understanding and retention of information given, the continuity of their consent, and what factors affect consent such as age, sex, etc (b) Assessing public understanding of informed consent by questionnaires given to visitors to the hospital

5.0 METHODOLOGY

5.1 QUESTIONNAIRE DESIGN: A questionnaire will be designed to cover the main issues of informed consent.

5.1.1 Informed consent for competent adults

forms of consent (oral, written, or body language).
explicit/express consent (spoken or written) and implicit consent (taking off clothes for examination)
purposes of getting informed consent (autonomy rights & protect the physician).
adults are presumed to be competent unless otherwise proved
irrational decisions by a competent person are binding.
consent in terms of duration (if time relapses new consent should be sought) and the extent of the procedure (only what was consented to is done).
consent does not force a physician to carry out a procedure he things is inappropriate eg amputation of a healthy limb, sex change operation.
autonomous right of a patient to be treated by a physician of his choice.
ethico-legal issues that arise if the physician and the patient are of opposite genders.
consent as a process and not a one-off event.
conditions for validity of consent (understand nature and purpose of the intervention, sufficient information, believe info and be able to weigh it in balance to reach a decision, voluntary and free from pressure, be aware that can refuse).
who should seek informed consent.
type of information to be provided to the patient (diagnosis, prognosis, proposed treatment and alternatives with explanation of benefits, risks, and costs of each procedure, name of doctor who will carry out the procedure, reminding the patient that he has the right to refuse or change his mind
situations in which it would be appropriate to withhold some information from the patient.
if the patient refuses to receive information.
procedures for which consent must be obtained in writing (complex risky procedures, research).
global and specific competence (patient may be competent to make some decisions and not others).
tests for capacity / competence (understand the intervention and its purpose; understand the benefits, risks, and alternatives; understand the consequences of not receiving the treatment; be able to retain the information long enough to make a decision; be able to weigh the information).
methods of enhancing capacity (non threatening venue, treatment of stressful symptoms, talk with patients when side effects of medication are minimal, break down the decision concept of informed refusal and its documentation.
patient rejects a cheap intervention in favor of a more expensive one.
ethico-legal issues in informed refusal of admission and treatment

5.1.2 Informed consent for the incompetent

a physician treating an incompetent patient without consent (best interests /benefit of the patient, necessity).
situations in which physicians can treat patients without consent (emergencies, compulsory treatment of mental patients).
legal guidelines of consent for preventive procedures (screening, immunization).
considerations in detaining or restraining patient movements (freedom to move, protection of the patient and others from harm).
main provisions of the mental health act regarding treatment of mental patients and describe the committal procedure.
involvement / role of the family in the consent process for the incompetent
ways in which a proxy decision maker can reach a decision (preferences of the patient, best interests of the patient).
an advance statement is a form of prospective autonomy d. Describe advantages of advance statements
disadvantages of advance statements
the format of an advance statement.
conditions in which a physician must seek a second opinion or court review if the patient in incapacitous (detention and restraint, sterilization or impairing fertility, pregnancy termination, withdrawing or withholding artificial nutrition and hydration, organ donation).

5.2 STUDY POPULATION

5.2.1 The study will be piloted in the male surgical ward and the obstetric department of KFMC. Depending on findings it will be modified and adapted for a random sample of hospitals in all 13 regions of the Kingdom (private, MOH, and military) and at various levels of sophistication (tertiary, secondary) and teaching as well as non-teaching.

5.2.2 The study sample will be selected randomly from patients requiring intervention procedures with duration of 10 minutes or more. The pilot study in the surgical and obstetric wards will involve 20 patients. The definitive study will attempt to recruit 150 patients from each hospital with representation of a wide range of departments.

5.2.3 Sampling will be based primarily on patient charts. Interviews will be carried out with physicians and nurses who handled that patient

5.3 DATA COLLECTION

5.3.1 Chart Review will use a check list to assess whether proper procedures and documentation were followed. The check list will be developed after extensive literature review

5.3.2 Questionnaire survey of physicians and nurses will seek to assess knowledge of various aspects of informed consent, attitudes / opinions on its role and importance and establishing what healthcare givers do in actual practice.

5.3.3 Questionnaire survey of patients and relatives will assess their knowledge of their rights of autonomy and whether they were given enough information to give an informed consent.

5.3.4 Direct observation of the consent process will assess the efficacy or physician-patient communication regarding consent; assess how physicians test for capacity, and how they resolve consent issues for incapacitous patients.

5.3.5 Focus Group discussions will be used to probe attitudes and opinions that cannot be studied well using a questionnaire

5.4 DATA MANAGEMENT AND ANALYSIS

5.3.1 Data collection will be by excel data sheets and will be analyzed using SPSS version 15

5.3.2 Simple descriptive analysis will be carried out: means -/+ standard error & proportions with variance and 95% confidence limits

5.3.3 Group comparisons will be carried out using the t or F test statistics and the chi square test statistic.

6.0 FINAL REPORT AND RECOMMENDATIONS

6.1 Extensive tabulations and cross tabulations of the data will be made accompanied by an executive summary. The data will eventually be published as a journal article.

6.2 Recommendations will be made on improvements

7.0 STRENGTHS AND LIMITATIONS OF THE STUDY

7.1 The main strength of the study will be primary data collection from physicians, nurses, and patients involved in specific types of cases so that it will be possible to relate study findings to specific and clearly defined problems

7.2 A weakness of the study is that information on opinions and attitudes is basically qualitative and may not be well represented in a quantitative questionnaire.

8.0 RESEARCHERS

Dr Abdulaziz al Kaabba Principal researcher

Prof Abdurahman al Mazrou Co-researcher

Prof Omar Hasan Kasule Co-researcher

Others from MOH (to be selected by Dr Qahtani)

9.0 TIME TABLE

Research Activity

May

'11

Jun

'11

Jul

'11

Aug

'11

Sep

'11

Oct

'11

Nov

'11

Dec '11

Jan

'12

Feb

'12

Mar

'12

Apr

'12

May

'12

Jun

'12

Literature survey

Study protocol and questionnaire

Pilot study

Assembling the study sample

Data collection – phase 1

Data collection – phase 2

Data collection – phase 3

Data management analysis

Final report and presentation

10.0 BUDGET

10.1 Phase 1: (a) Assessing institutional written policies on informed consent and comparing them with international standards. (b) assessing a sample of consent forms for completeness and appropriateness

Category	Task	Justification	Total
Research Assistants / medical secretary	Chart review and form review
Research Assistant / data clerk	Data entry and management
Main researcher	Supervision of all research activities
3 co-researchers	Supervision of all research activities
Administrative assistants	Coordination
Transport and accommodation	Visit hospitals for study purposes
Total			100,000

10.2 The Second Phase: Assessing KAP regarding consent of physicians, nurses, medical students, and residents making sure to separate knowledge and attitudes on one hand from practice on the other hand.

Category	Task	Justification	Total
Research Assistants / nurses	Questionnaire administration
Research Assistant / data clerk	data entry and management
Main researcher	Supervision of all research activities
3 co-researchers	Supervision of all research activities
Administrative assistants	Coordination
Transport and accommodation	Visit hospitals for study purposes
Total			200,000

10.3 The Third Phase: (a) Assessing patient understanding and perceptions of consent, their understanding and retention of information given, the continuity of their consent, and what factors affect consent such as age, sex, etc (b) Assessing public understanding of informed consent by questionnaires given to visitors to the hospital.

Category	Task	Justification	Total
Research Assistants / nurses	Questionnaire administration
Research Assistant / data clerk	data entry and management
Statistician	data analysis
Research assistant / medical secretary	Report writing
Main researcher	Supervision of all research activities
3 co-researchers	Supervision of all research activities
Administrative assistants	Coordination
Transport and accommodation	Visit hospitals for study purposes
Total			100,000

11.0 BIBLIOGRAPHY (Search on going)

Lansimies-Antikainen H et al (2007). Evaluation of Informed Consent: a pilot study. Journal of Advanced Nursing 59(2), 146-154

¹Easton, R. B., Graber, Mark A., Monnahan, J., Hughes, J., “Defining the Scope of Implied Consent in the Emergency Department,” The American Journal of Bioethics, Published on 2007, vol. 7 no. 12, pp. 35-38.

²Biros, M. H, “Research without Consent: Exception from and Waiver of Informed Consent in Resuscitation Research”, Science Eng. Ethics, Published online on July 28, 2007, Vol. 13, pp 361-369.

³Sumathipala, A., Siribaddana, S., Hewege. S., Lekamwattage, M., Athukorale, M., etc. “Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka”, BMC Medical Ethics, Published on February 11, 2008.

⁴“Commentary on Informed Consent”, TheAmerican Journal of Medicine, Publised on 2006, vol. 119, pp. 194-197.

⁵Jones, J. W., McCullough, L. B., Richman, B.W., “A Comprehensive Primer of Surgical Informed Consent”, Surgical Clinic of North America, Published on 2007, vol. 87, pp. 903–918.

⁶Moskop, J. C., “Informed Consentand Refusal of Treatment: Challenges for Emergency Physicians” Emergency Medical Clinic of North America, Published on 2006, vol. 26, pp. 605–618.

⁷McCullough, L. B., Chervenak, F. A., “Informed Consent”, Clinics in Perinatology 2007, vol. 34, pp. 275–285.

⁸Childers, R., Lipsett, P. A., Pawlik, T. M., “Informed Consent and the Surgeon” Published on April 2009, vol.208 No. 4.

⁹Ivashkov, Y., VanNorman, G. A., “Informed Consent and the Ethical Management of Older Patient”, Anesthesiology Clinic, published on 2009, vol. 27, pp. 569–580.

¹⁰Hull, S. C., Sharp, R. R., Botkin, J. R., Brown, M., Hughes, M., Sugarman, J., Schwinn, D., Sankar, P., etc. “Patients’ Views on Identifiability of Samples and Informed Consent for Genetic Research” The American Journal of Bioethics, published on 2008, vol.8 no. 10, pp. 62–70.

¹¹Ivashkov, Y., Van Norman, G. A., “Informed Consent and the Ethical Management of the Older Patient” Anesthesiology Clinics, vol. 27 Issue 3, published on september 2009.

¹²Bavdekar, SB., “Informed consent documents submitted for initial review: What do they state about compensation for injured research participants?”, vol. 63 issue 10, published on 2009, pp. 455-460.

¹³Luce, J. M., “Informed Consent for Clinical Research Involving Patients With Chest Disease in the United States” The American College of Chest Physicians, vol. 135 issue no.4, published on April, 2009.

¹⁴Mehlman, M. J., Berg, J. W., “Human Subjects Protections in Biomedical Enhancement Research: Assessing Risk and Benefit and Obtaining Informed Consent” Journal of law, medicine & ethics, Blackwell Publishing Limited, published on 2008, pp. 546-559.

¹⁵Kegley, J. A., “Challenges to informed consent: New developments in biomedical research and healthcare may mark the end of the traditional concept of informed consent” EUROPEAN MOLECULAR BIOLOGY ORGANIZATION, vol. 5 no. 4, published on 2004.

¹⁶LA¨NSIMIES-ANTIKAINENH, Pietila A. M., Laitinen T., Schwab U., Rauramaa R., & Lansimies E. “Evaluation of informed consent: A pilot study” Journal of Advanced Nursing, vol. 59 no. 2, pp. 146–154.

¹⁷Murphy, J. Scott, J. Kaufman, D., Geller, G., LeRoy, L., Hudson, K., “ Informed Perspective on Health: Public Perspective on Informed Consent for Biobanking” American Journal of Public Health, vol. 99 no. 12, published on December, 2009.

¹⁸Wasan, A. D., Taubenberger, S. P., Robinson, W. M. “Reasons for Participation in Pain Research:Can They Indicate a Lack of Informed Consent?” Pain Medicine, vol. 10, published Nov. 1, 2009.

¹⁹WENDLER, D. , GRADY, C., ” WHAT SHOULD RESEARCH PARTICIPANTS UNDERSTAND TO UNDERSTAND THEY ARE PARTICIPANTS IN RESEARCH?” The Authors. Journal Compilation, published on November 4, 2008, vol. 22, pp. 203-208.

²⁰Michalek, W.” When is Informed Consent Not Enough?” Journal of Cancer of Education, vol. 20 no. 1, published on 2005.