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103 PATIENT CONSENT IN SEVEN MEDICAL-CARE INSTITUTIONS NOREEN M. CLARK, Ph.D., ESTELLE S. GROSS, M.P.H., and JUDITH BARKEL, M.P.H. Department of Health Behavior and Health Education. University of Michigan. School of Public Health. Ann Arbor. Michigan ABSTRACT An exploratory study of the patient consent process was conducted in seven large medical-surgical institutions. Analysis of the most recent literature on consent and of data provided by knowledgeable persons in each facility led to the conclusions that (I) the primary intent of obtaining patient consent is to legally protect the hospi- tal and the physician, (2) legal and educational objec- tives are confused and entangled in the consent process, (3) legal objectives are not adequately met in any facil- ity, and (4) the potential for sophisticated patient edu- cation is dim given existing procedures. INTRODUCTION Recent articles in Patient Counselling and Health Education'< and elsewherev-" have focused on patient consent. It is generally agreed that informed consent is a process culminating in the patient's disagreement of agreement to a recommended course of action. All evi- dence suggests, however, that forms by which patients are asked to give their consent may not be comprehensi- ble. In addition, studies suggest that the intent of the patient-physician encounter, of which forms are part, is rarely clear to patients. This lack of clarity extends to the literature, where informed consent is primarily dis- cussed as one process with several objectives: legal, informational, and educational. We collected data that enabled us to describe patient consent procedures in seven medical-care institutions, to determine the hospital's primary intent in obtaining in- formed consent, and to assess the adequacy of the pro- cess given these intentions. The results of our analysis led us to postulate ways that obtaining informed consent might be made a more effective process for patients, physicians, and hospitals. VOLUME 4INUMBER 2 BACKGROUND An important reason generally given for the lack of effectiveness of patient consent is inappropriate read- ability of both the consent form and related educational materials. Doak and colleagues" found the average readability of patient education materials at a Public Health Service hospital to be at the tenth grade level, with a renge from fourth grade to graduate school. The patients reported a mean educational attainment of 10.5 grades, and only 46% had completed high school. Using the SMOG test, Freimurhv found that pamphlets gener- ally used for patient information required a reading ability ranging from the 11th grade level through senior year of college. Consent forms frequently require reading skills as high or higher. Grunder's" analysis of the readability of five surgical consent forms revealed that all were off the graph according to the Fry Scale. Four were judged to be at the level of a scientific journal according to the Flesch formula. Morrow 's'" analysis of 60 consent forms revealed an average score equivalent to the level of a professional journal. As one might expect, patients rarely understand con- sent forms. Doak and associates," using the Cloze test, found that 45% of the patients sampled understood material presented at reading levels between the fifth and tenth grades, but 25% needed extensive help to understand materials presented at the fifth grade level. Cassileth and associates.P in a study of 200 patients, found that persons with less than a high school educa- tion had significantly poorer understanding or recall of information related to consent. Bergler and col- leagues;" in a study of 75 Veterans Administration hospital patients, found no correlation between patients' education level and accuracy of recall of information on a form. The investigators attributed the effectiveness of that particular form to its simplicity, the highly personal process comprising its use, and the fact that patients were left alone for up to 15 minutes to study the form. In another investigation of 108 VA hospital patients, however, Eaton and Holloway-? concluded that a basic ingredient of comprehension was reading skill. Still other criticisms of consent forms have been levied. Moore" contended that consent forms can be more harmful than beneficial to patients, physicians,

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PATIENT CONSENT IN SEVENMEDICAL-CARE INSTITUTIONS

NOREEN M. CLARK, Ph.D.,ESTELLE S. GROSS, M.P.H.,and JUDITH BARKEL, M.P.H.

Department of Health Behaviorand Health Education.University of Michigan.School of Public Health.Ann Arbor. Michigan

ABSTRACT

An exploratory study of the patient consent process wasconducted in seven large medical-surgical institutions.Analysis of the most recent literature on consent and ofdata provided by knowledgeable persons in each facilityled to the conclusions that (I) the primary intent ofobtaining patient consent is to legally protect the hospi­tal and the physician, (2) legal and educational objec­tives are confused and entangled in the consent process,(3) legal objectives are not adequately met in any facil­ity, and (4) the potential for sophisticated patient edu­cation is dim given existing procedures.

INTRODUCTION

Recent articles in Patient Counselling and HealthEducation'< and elsewherev-" have focused on patientconsent. It is generally agreed that informed consent is aprocess culminating in the patient's disagreement ofagreement to a recommended course of action. All evi­dence suggests, however, that forms by which patientsare asked to give their consent may not be comprehensi­ble. In addition, studies suggest that the intent of thepatient-physician encounter, of which forms are part, israrely clear to patients. This lack of clarity extends tothe literature, where informed consent is primarily dis­cussed as one process with several objectives: legal,informational, and educational.

We collected data that enabled us to describe patientconsent procedures in seven medical-care institutions, todetermine the hospital's primary intent in obtaining in­formed consent, and to assess the adequacy of the pro­cess given these intentions. The results of our analysisled us to postulate ways that obtaining informed consentmight be made a more effective process for patients,physicians, and hospitals.

VOLUME 4INUMBER 2

BACKGROUND

An important reason generally given for the lack ofeffectiveness of patient consent is inappropriate read­ability of both the consent form and related educationalmaterials. Doak and colleagues" found the averagereadability of patient education materials at a PublicHealth Service hospital to be at the tenth grade level,with a renge from fourth grade to graduate school. Thepatients reported a mean educational attainment of 10.5grades, and only 46% had completed high school. Usingthe SMOG test, Freimurhv found that pamphlets gener­ally used for patient information required a readingability ranging from the 11th grade level through senioryear of college.

Consent forms frequently require reading skills ashigh or higher. Grunder's" analysis of the readability offive surgical consent forms revealed that all were off thegraph according to the Fry Scale. Four were judged tobe at the level of a scientific journal according to theFlesch formula. Morrow 's'" analysis of 60 consentforms revealed an average score equivalent to the levelof a professional journal.

As one might expect, patients rarely understand con­sent forms. Doak and associates," using the Cloze test,found that 45% of the patients sampled understoodmaterial presented at reading levels between the fifthand tenth grades, but 25% needed extensive help tounderstand materials presented at the fifth grade level.Cassileth and associates.P in a study of 200 patients,found that persons with less than a high school educa­tion had significantly poorer understanding or recall ofinformation related to consent. Bergler and col­leagues;" in a study of 75 Veterans Administrationhospital patients, found no correlation between patients'education level and accuracy of recall of information ona form. The investigators attributed the effectiveness ofthat particular form to its simplicity, the highly personalprocess comprising its use, and the fact that patientswere left alone for up to 15 minutes to study the form.In another investigation of 108 VA hospital patients,however, Eaton and Holloway-? concluded that a basicingredient of comprehension was reading skill.

Still other criticisms of consent forms have beenlevied. Moore" contended that consent forms can bemore harmful than beneficial to patients, physicians,

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and hospitals. Inadequate forms used inconsistently ac­tually may be legal evidence of the fact that a patientwas not properly informed . Moore also suggested thatproof of informed consent is legally ambiguous whenforms are written in such a way as to appear to existprimarily for physicians' protection. In the Cassileth"study, three fourths of the patients surveyed reportedthat they believed consent forms were legal documentsto protect the rights of physicians; however, 78% feltthat the forms were important to patients for decisionmaking.

The way in which consent is obtained may havepsychological effects on the patient. Legal terminologyin a form presented on the eve of surgery, for example ,may have a negative effect. 29 When used in such a way,the extent to which the patient is truly informed may becalled into question."

A few studies have considered explanations given topatients by physicians as part of the consent pro­cess.25 .31-33 Most of these investigations have shownlow levels of patient understanding of the condition , therecommended course of action , and the meaning of pa­tient consent. The amount of information to be dis­closed by the physician has also been a subject for dis­cussion, particularly the extent to which nonlegalinformation is provided. Faden and collaborators'"reported that patients and parents of patients wanted farmore detailed information than physicians offered .Furthermore, physicians were unlikely to provide muchinformation about alternatives to the suggested clinicalprocedures . Both Faden 's study and that of Brittain"posit that the patient who is better informed is sub­sequently less likely to be surprised or become angryabout the course of action .

In summary, several problems are evident in the pro­cess of obtaining informed consent. Some of the prob­lems are a function of forms themselves, which appearto convey little to patients. The literature, however,views informed consent as much more than a signatureon a form. It entails the encounter between physician orother representative of the institution and the patient ,and documentation that the entire process met certainstandards of quality , culminating in an educated andinformed patient. Findings from several studies, how­ever, suggest either that the basic purpose of thephysician-patient encounter in practice is unclear or thatpatients consider the communication insufficient orincomplete .

Is informed consent a legal process to documentagreements between the patient, the institution, and thephysician and to ensure at minimum that the patientknows what is going to happen? Is it an educationalprocess to enable the patient to assume a greater role indecision making? Analyses in recent research havetended to consider each of these objectives simulta-

neously and have centered on the general potential ofpatient consent to protect, to inform, and to educate.There has been little, if any, consideration of the effec­tiveness of the process in light of the specific intentionsof specific hospitals in using it. We believed it wasimportant to discover not only how but why facilitiesuse the consent form and procedures. We wanted toascertain their primary purpose and , given that objec­tive, to assess the effectiveness of a hospital's consentprocedure.. If the primary purpose is to obtain legal protection for

the facility and the physician by documenting that thepatient knew and agreed to the physician's decision,procedures might indeed be adequate. On the otherhand, they might be inadequate for other purposes, suchas educating patients to take part in decision making.For our study, we clearly distinguished legal and edu­cational objectives. We defined the legal objective asproviding information to ensure patient awareness andagreement to clinical decisions made by the physician.We defined the educational objective as a significantlygreater effort to educate the patient to play an activerole in selecting the clinical course . Education movesthe patient beyond being informed to collaborating indecision making.

Among the objectives of our study were to determineif hospitals distinguish legal from educational objectivesand to ascertain the hospitats' underlying purposes inobtaining informed consent. We then analyzed the ex­tent to which we might expect legal and educationalobjectives to be met, given the nature and quality of theprocedures that representatives of the institutions wereto follow routinely. We explored as well how the hos­pitals' procedures compared with criteria for the mini­mal elements for effective patient consent as discussedby the authors of the literature we reviewed. In the viewof these authors, meeting certain criteria theoreticallyensures that a patient is protected, informed, and edu­cated, as all these objectives are considered part of oneprocess.

METHOD

Data Collection

Seven hospitals agreed to participate in the study . Weselected hospitals that were general medical-surgical in­stitutions with 300 beds or more, were within the AnnArbor- Detroit vicinity , and represented diverse catch­ment areas, including urban and suburban communities.

We conducted extensive face-to-face interviews withtwo or three persons in each hospital who could beexpected to be knowledgeable about the consent processin that facility and who represented different perspec­tives, such as administration, nursing , and health edu­cation . Physicians were not interviewed because we

PATIENT COUNSELUNG AND HEALTH EDUCATION

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considered them too intimately involved in the processbeing studied . We interviewed six hospital adminis­trators or associate administrators, one attorney repre­senting administration , three head nurses, three healtheducators, and two admitting supervisors responsible foroverseeing consent on admission for elective surgicalprocedures. Interviews were conducted using a list ofopen-ended questions that inquired into the intent ofobtaining patient consent, specific hospital procedures,problems encountered, and personnel involved. Copiesof medical and surgical consent forms were obtainedfrom each facility and were discussed during the inter­views, as were written policies and procedures for ob­taining patient consent.

Data Analysis

The unit for analysis was the patient consent processitself as described by the representatives of each institu ­tion. While it would have been highly desirable to as­sess the extent to which the process yielded the resultsintended by each facility (such as legal protection inparticular cases or increased education of specific pa­tients), this objective was far beyond the scope of thestudy . Rather, the focus was the process, accepted atface value, as described by knowledgeable individuals.

The data describing patient consent forms and proce­dures were analyzed to determine the extent to whichthey could be expected to achieve what the institutionsintended. Criteria used for analysis were those pub­lished in 1981 by the Joint Commission on the Ac­creditation of Hospitals (lCAH) . These criteria are con­sidered minimum standards by the JCAH. They wereaugmented by eight criteria also discussed in the litera­ture as fundamental to the informed consent pro­cess.9 , l O,14 ,18 ,26 ,30 ,34 The readability of consent formsused at each institution was determined by using the Frytest formula.

}'INDINGS

Analysis of the specific consent forms used by eachinstitution enabled us to discern the extent to which theform itself met accepted criteria as an instrument forrecording the steps of the consent process , that is ,whether completion of the forms would docsment theprocess as timely and appropriate and one in which thepatient could be expected to understand informationpresented. Documentation is to assure that the patientwas given certain basic information , that the form waskept as part of the clinical record , and that it was ad­ministered at the relevant time. To ensure that theserequirements are met, the JCAH suggests that the formitself contain the basic information that is presented tothe patient.

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105

Table I illustrates the extent to which each par­ticipating hospital met the criteria of documentation . Allbut the final criterion are those of the JCAH . Althoughmost hospitals had a stated policy , only one institutionrequired that clinical procedures be translated on theform into lay terms. Only one required that alternativetherapies to the recommended course of action be listed.Three institutions did not require that the physician whoobtained consent be identified on the form. Four of theseven hospitals did not require the physician to recordwhether attempts were made to verify the patient's un­derstanding of the information provided.

Analysis of interview data describing the proceduresfor the consent process in each facility provided a pro­file of the general routine for discussion with the patientthat led to reading and signing the consent form. Thepremise is that the physician-patient encounter must be

Table I. Extent to which forms meet accepted criteria fordocumentation.

Hospitals

Criteria A B C D E F G

I. Form available inmedical record x x x x x x x

2. Identity ofpatient recorded x x x x x x x

3. Date recorded x x x x x x x

4. Procedure inquestion specified x x x x x x x

5. Procedure describedin lay terms x

6. Name of individual whowill perform procedure ortreatment recorded x x x x x x

7. Alternative therapiesrecorded x

8. Risks and complica-tions recorded x x x x x x

9. Authorization for dis-posal of tissue included x x x x x x

10. Signature of patient!guardian required x x x x x x x

I I. Ident ification of prac-titioner who informs andobtains consent required x x x x

12. Photos , research,or studies authorizationrecorded x x x x

13. Understanding ofcontent of form verified x x x

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characterized by several elements to ensure the discus- Table II. Criteria for the consent procedure.sion is of a quality that will result in an informed pa- Hospitalstient. As a rule, the discussion is to provide more com-

Criteria A B C D E F Gplete information than is described on the form. Theinstitution asks the physician to follow certain proce- 1. Treatment anddures to ensure that important aspects related to the procedure explained x x x x x x xcondition are covered. JCAH suggests eight criteria for 2. Risks and sidethese procedures (l through 8 in Table II). Investigators effects explained x x x x x x xof the consent process suggested an additional eight 3. Problems related toprocedural criteria that they believe increase chances of recuperation explainedpatient understanding.

4. Probability of successTable II shows the extent to which participating hos- discussed xpitals met criteria for correct procedures in the

5. Voluntary, competent,physician-patient encounter. One sees that several im-portant steps were generally omitted. When consent was and understanding

obtained at admissions, hospitals proceeded on the as- consent sought x x x x x x x

sumption that the proper discussion had taken place 6. Information regarding

between patient and physician beforehand. No hospital alternatives given x x x x

attempted to verify the elements of these presumed dis- 7. Information regardingcussions. In no hospital, either at admission or before who is responsible forsurgery, for example, was discussion of problems re- authorizing and per-lated to recuperation mandated. Only one institution ex- forming procedures or

pected physicians to discuss the chances of success of a treatment given x * * x x x

specific course of action beyond the general disclaimer 8. Information about anyof guarantee that appears on virtually all consent forms. experiments or research/In three of the seven hospitals, physicians did not educational projects and

routinely provide information regarding alternatives to right to refuse to partici-pate given x * * *the recommended treatment. In two institutions physi-

cians were present for the signing of the form. In only 9. Form used consistentlyone, and there just in the Intensive Care Unit, was it for every case x x x x x x

required that family members be present during the dis- 10. Form signed incussion. In only one facility were other materials used physician's presence x xto aid in discussions leading to signing the form. In no 11. Family present (ICU)institution was there discussion of the consequences of during discussion xnot signing the form, nor were any methods used to 12. Teaching aids used inascertain whether or not patients understood the content conjunction with form xof the discussion. In only two hospitals were patient

13. Information obtainededucators involved in the informed consent process. In solely through physician x x x x x xall facilities, the choice of when and where to discuss

14. Consequences of notthe course of action and obtain consent was thephysician's. submitting to procedure

Table III presents the intent of each participating in-described

stitution in obtaining informed consent, the readability 15. Methods for evaluating

score for the consent form, and scores indicating how patient understanding used

the hospital met criteria for correct procedures and for 16. Patient education per-documentation of the patient consent process. It is evi- sonnel actively involved x xdent that all institutions but one regarded the form itself leu = intensive care unit.solely as a legal document and considered the primary *Provided on the consent form only.intent of the process to be legal protection of the physi-cian and the hospital. Six hospitals had secondary goals,which included education and what the hospitals termed Regardless of the intent of the institution, the level ofpatient awareness. One facility intended to educate pa- ability required for reading the consent forms probablytients as well as acquire legal protection. One viewed rendered them ineffective. No institution used an admis-legal protection as the sole purpose of both form and sion consent form with language simple enough to en-process. sure reaching the general adult population. Only one

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Table III. Intent, readability levels of consent forms, and criteria attainment scores of hospitals surveyed.

Procedure Scores Documentation Scores

Number Number Number NumberlCAH additional lCAH additional

Readability levels criteria criteria criteria criteriaIntentions Surgical Admissions met (8 met (8 met ( 12 met (I

Hospital Forms Process form form possible) possible) possible) possible)

A Legal Legal/education aTC College 6 4 10 0

B Legal Legal/patient aTC aTC 3 2 10 0awareness

C Legal Legal/patient aTC 12th grade 4 2 9 0awareness

D Legal/education Legal/education aTC aTC 6 3 9

E Legal Legal/patient aTC 4 3 8awareness

F Legal Legal/education aTC 10th grade 5 3 10 1

G Legal Legal aTC aTC * * 7 0

OTC = Off the scoring chart using the Fry formula: beyond the level of a professional-technical journal."Insufficient data.

used tenth grade level language, two ranged between12th grade and college, and the rest had readabilityscores that were off the scoring chart , that is, beyondthe professional-technical level.

No hospital met all the lCAH standards for informedconsent procedures or for documentation of the process .Indeed, only two came close to the desired procedures,meeting six of the possible eight criteria. No institutioncame close to meeting the eight possible additional pro­cedural criteria considered fundamental to ensuring pa­tient comprehension. Four was the highest score , andthis was achieved by only one facility. The hospitalsfared somewhat better in trying to document the pro­cess; three met ten of a possible 12 criteria.

DISCUSSION

This small exploratory study was limited in three im­portant ways. First, the sample comprised only sevenhospitals which may not represent other medical­surgical institutions. Second, respondents, while highlyfamiliar with the consent process in their facilities, didnot observe it regularly or systematically and reportedtheir view of what generally occurs. This limitation wasimpossible to overcome because none of the participat­ing hospitals consistently monitored the informed con­sent procedure. Third, the intended outcome of patientconsent was not assessed; rather, assessment was of theextent to which the process in each hospital met recog­nized criteria for reaching these outcomes.

Despite these limitations, the data provided an in­teresting and valuable profile of the consent process in

VOLUME 4/NUMBER 2

several large hospitals and enabled us to make somepreliminary determinations of the degree to which in­stitutions might actually have achieved their informedconsent intentions.

These seven institutions envisioned the consent pro­cess as a legal one. The purpose of discussion betweenphysician and patient is to enable the patient to agree tothe physician's decision. The physician and the institu­tion are protected by the patient's signature attesting tothis agreement. The consent, however, must be in­formed, that is, the patient's right to understand thecondition and the recommended therapeutic proceduremust be protected.

If we focus solely on the legal intent of thesefacilities in using the form and put aside the broadereducational goal that the patient be enabled to collabo­rate with the physician in making the decision, we mustsimply determine the extent to which patients hadenough information to agree or not to agree with thephysicians' decisions and verify that the process wasadequately documented. The data in this study suggestthat the processes used by participating hospitals to at­tain this legal protection were inadequate. The formscannot be considered either readable or comprehensibleby the general adult public. Fewer than half of the basiccriteria for ensuring required documentation of the pro­cess were met. Most criteria were not met for ensuringadequacy of the physician-patient discussion of detailsof the condition and the suggested course of action.

In analyzing the data, we assumed that patients werealert , interested, and not emotionally upset , that is, con­sent was obtained under the most desirable circum-

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stances for achieving its ends. It would, in fact, bedifficult for any institution in this study to demonstratethat patients were, in general, "informed' '; that in­forming patients is an institutional norm. Even morelegally alarming for physicians and institutions, no hos­pital in this study could demonstrate even in a generalway that it attempted to fully inform patients. Assuggested by Moore" regarding forms alone, the failureof hospitals to create systematic procedures that attemptto meet criteria for the consent process actually may bethe best proof that patients were uninformed.

It comes as little surprise that the consent process wasnot primarily intended to be educational in the sense ofempowering the patient to collaborate in making a deci­sion. It is even less of a surprise that the outlook is dimfor achieving such an educational goal with existingprocedures.

While patient consent is discussed in the literature asboth a legal and educational process, it appears from thestudy of these hospitals to be primarily a legal processto protect the facility and the physician. Few systematicattempts are made to ensure that patients understandwhat is going to happen to them. Thus the legal protec­tion afforded by the process is highly doubtful.

CONCLUSION

A better approach to informed consent may be to sepa­rate the legal and educational processes and to base thelegal process on the primary legal intent. The legal ob­jective would be to protect the patient, the physician,and the institution by obtaining consent to the physi­cian's elected course of action. The consent would beacquired by means of procedures that illustrate that theinstitution attempted in a conscientious and thoughtfulway to ensure the patient knew and agreed to what wasgoing to happen.

While such a blatant avoidance of education mayseem at first to serve only the interest of the health-careproviders, it actually affords greater protection to thepatient as well. The legal intent protects the institution'sright to proceed with consent and does not subvert theinterests of the patient precisely because inherent is thefact that the consent must be informed. Separating legalfrom educational goals does not diminish the impor­tance of either.. The more sophisticated educational goalis requisite for the institution and valid for the patientbecause the patient's active involvement in planning andcarrying out the most appropriate clinical course of ac­tion hastens and improves recovery. Satisfactory legaland educational procedures are fundamental to the qual­ity of care within the hospital. Both are the responsibil­ity of the physician and institution and both serve theinterests of the patients.

Current procedures, at least those used by the hospi­tals in our study, confuse the legal and educationalgoals. For example, most administrative, nursing, andmedical staff assume that the physician is the individualprimarily responsible for educating the patient and,therefore, for obtaining consent. We wonder if it isreasonable to expect the physician to be the one to ob­tain agreement to the recommended course of action.The physician has already decided what he or she be­lieves is best for the patient and has a vested interest inthe patient's agreement to the selected procedure. Theassumption that patient consent cannot be separatedfrom education leads to the practice of the physician­obtained consent. If, however, we assume that legal andeducational processes are separate, someone other thanthe physician might obtain consent.

The physician's responsibility to educate the patient,more and more frequently with assistance from nursesand health educators, is an inherent professional one.Education of the patient is a standard of medical prac­tice. Without education, the patient's response to illnessmay be more severe, and one's ability to regain healthmay be diminished or delayed. Education and counsel­ling of individual patients by the physician, embellishedby the nurse and the health educator, is essential toquality care.

Obtaining informed consent, however, is primarily alegal and administrative procedure. It is legal evidencethat the patient agreed to have specified proceduresperformed. When a patient is educated from the begin­ning of the hospital stay, giving consent simply may bean outgrowth of previous patient-physician decisions.If, on the other hand, the physician-patient relationshiphas been perfunctory and the patient has not beenappropriately educated from the outset, obtaining con­sent generally would entail more time and require provi­sion of more extensive information.

All parties might be better protected if a third personattended to ensuring their rights; that is the patient'sright to be informed and the physician's and institu­tions's right to proceed with consent. Fost? hassuggested that a surrogate for the patient discusshealth-care decisions with the physician. We propose,rather, that a third person, health educator, or om­budsman, someone not directly involved in the directdelivery of care, might better discuss with the patienthis or her condition and the physician's view of treat­ment options. The third person, during the consent dis­cussion, would adhere to and document along the waythe points outlined in the leAH criteria. Patient, physi­cian, and third person would then sign the documentedhistory of the discussion to serve as evidence of legalconsent. Separating legal and educational objectiveswould strengthen the legal by ensuring that the process

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of obtaining consent was an open exchange focused onthe wishes of the patient.

The separation may also improve patient education. Aseparation policy would imply to all parties that educa­tion entails a more continuous interaction between pa­tient and physician beyond the mere provision of infor­mation . Further, failure to provide education would be­come increasingly apparent as, theoretically , patientsgaining little in the interaction with their physicianswould require more attention at the time when consentwas to be obtained. Undereducated patients would havethe opportunity to pose questions to a third person ,who , in tum, may need additional consultation with thephysician. This practice might encourage physicians toeducate patients earlier and more fully to cut down onthe time required by consent and to avoid being knownas one who fails to educate patients .

Our suggestion assumes that it is possible for some­one other than the primary physician to adequatelycommunicate details of a condition and answer ques­tions asked by a patient. The third person and the physi­cian would have to discuss the patient 's situation andoptions beforehand. An open and timely (not on the eveof surgery) exchange between the patient and a thirdperson skilled in communication , using lay termsand a preformulated discussion outline, would ensue.This procedure might obviate the problem of a patient'stendency not to question the physician and the pressureon the physician to hedge, overprotect, or limitinformation .

It might appear that discussion by another person in­troduces a source of slippage of information betweenphysician and patient. In some extreme cases this maybe so . It is common, however, for institutions to desig­nate clerical personnel to obtain consent from the pa­tient on admission for elective procedures in the beliefthat such a person can present information. It is alsocommon for a busy attending physician to ask an internor a nurse to obtain consent at the last minute. (It wasalso a commonly held view of those we interviewed thatthis practice was inadequate. The inadequacy, however,was not because a third person was thought to be unableto assimilate the necessary facts about the patient andsituation , but was because patients were insufficientlyeducated, procedures were not systematic, and respon­sibility for consent was thrust on people who wereprimarily occupied with other dut ies or who did notview obtaining consent as their responsibility.)

The third person arrangement might appear to requireadditional personnel and initially increase costs forinstitutions . This is not necessarily the case , however.The savings associated with making more efficient andstreamlined a disorganized process, one that takes thetime of a variety of health providers, may offset the

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costs of the third person. Certainly the legal protectionafforded physicians and ho spitals would be muchstronger if the consent process could be demonstrated tobe timely, systematic, well-documented, and carried outby one other than the person directly delivering thecare. We assume there would be savings as well fromthe reduced incidence and threat of damage suits, for ,according to Faden ," the more educated and informedthe population, the greater the satisfaction with clinicalservices received. While the number of damage suitsbrought against hospitals is relatively small, it is on therise; and when hospitals lose these suits, the damagesare sizeable.

The recently issued lCAH guidelines on quality as­surance may spur institutions toward establishing morecomprehensive and systematic procedures for both pa­tient education and for informed consent. Many institu­tions have created offices of quality assurance, andclearly both education and informed consent are criticalelements in the quality of care .

In summary, this small study has illustrated that pa­tient consent processes in the hospitals studied are notadequate for reaching the institutional goal of legalprotection for the physician and hospital. The failure todevelop forms and minimal procedures, such as thoseproposed by the lCAH, is one reason. The failure todistinguish the process of obtaining consent and broadereducational efforts is another reason . Further, no evi­dence is available in any institution of a systematic hos­pitalwide attempt to move beyond information-givingregarding consent to a hospitalwide organized system ofpatient education. It is possible that a natural extensionof establishing and adhering closely to procedures thatattempt to truly inform patients would lead to the de­velopment of more effective and sophisticated patienteducation. We have distinguished education from in­formation as a broader attempt to involve patients in themangement of their illnesses and to provide opportunityfor more collaborative decision-making when selectingcourses of action. To enable patients to collaborate withphysicians with equanimity, patient education must becontinuous and comprehensive. Indeed, such educationis predicated on a shift in decision-making power fromhealth professional to patient. Education of this kind,however, seems far away given procedures currently thestandard in the medical-care inst itutions studied.

ACKNOWLEDGMENT

We would like to thank William C. McCaughrin , M.S.Ed. , M.P.H., Assistant Director, Greater Detroit AreaHospital Council , for his invaluable assistance duringthe conduction of this study and the preparation of thismanuscript.

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PATIENT COUNSELUNG AND HEALTH EDUCATION