APA issues revised pre-manipulation guidelines

[dmitsch]

Bob,

In my opinion:

Full disclosure of risk doesn't result in a reduction of those risks. Its purpose is to shift the decision making about what risks are acceptable back to the patient. Allowing patients to make an informed choice isn't just legally prudent, it's ethically and professionally responsible.

I'd be interested to see evidence that suggests patients as a broad group will refuse treatment on the basis of disclosure. The literature doesn't suggest this (see below) and I've not heard any physio's on the ground saying their patients have refused manipulation on the basis of disclosure.

In fact, these days society publishes graphic warnings on cigarette packages citing evidence that smoking causes cancer - people still smoke. People knowingly take risks every day and to suggest that patients knowing about the risks will result in a wholesale departure from physio is possibly an over reaction. The Clinical Guidelines make the point that the risk "appears to be less than that encountered in daily life" but given legal opinion it should be mentioned - so this is what I'd imagine clinicians are discussing with patients.

Secondly, The APA sought legal opinion. That legal opinion states that the remote risks should be mentioned. We would be remiss in our obligation to our members if we knew this and did not pass on this information.

Finally, a good literature review is drawing from secondary sources of evidence - it is a review of literature reporting primary sources of evidence.

Agre, Patricia, Robert C. Kurtz, and Beatrice J. Krauss. "A Randomized Trial Using Videotape to Present Consent Information for Colonoscopy." Gastrointestinal Endoscopy 40, no. 3 (1994): 271-76.

Increased understanding did not correlate with higher anxiety amongst patients

Agre, Patricia, Kathleen McKee, Nina Gargon et al. "Patient Satisfaction with an Informed Consent Process." Cancer Practice 5, no. 3 (1997): 162-67.

Research suggested that patients benefit from having background information before engaging in a substantive discussion with their physician


Alfidi, Ralph J. "Informed Consent: A Study of Patient Reaction."JAMA 216, no. 8 (1971): 1325-29.

Most patients reading consent forms that explicitly described the risks involved with angiography found the information to be useful and elected to
consent to the procedure

[physiobob]

Agre, Patricia, Robert C. Kurtz, and Beatrice J. Krauss. "A Randomized Trial Using Videotape to Present Consent Information for Colonoscopy." Gastrointestinal Endoscopy 40, no. 3 (1994): 271-76.

Increased understanding did not correlate with higher anxiety amongst patients

Agre, Patricia, Kathleen McKee, Nina Gargon et al. "Patient Satisfaction with an Informed Consent Process." Cancer Practice 5, no. 3 (1997): 162-67.

Research suggested that patients benefit from having background information before engaging in a substantive discussion with their physician


Alfidi, Ralph J. "Informed Consent: A Study of Patient Reaction."JAMA 216, no. 8 (1971): 1325-29.

Most patients reading consent forms that explicitly described the risks involved with angiography found the information to be useful and elected to consent to the procedure

Surely these studies do not in any way relate to informed concent about the risk of cervical spine manipulation. They are all related to investigate procedures and not a manual treatment of someone's neck.

Paiten groups like those above are more open to discussions about things that would (1) help the patient to make an informed decision, and (2) to do make that decision in a relaxed way. This cannot be compared to "I am about to manipulate you neck and there is a minimal risk of stroke or death." Of course I am being pedantic but the risk of sudden death during exercise testing to men in their early 20's is I think more prevalent than a cervical spine manipulation resulting in stroke or death.

In Houston (USA) in the first 4 months of the year:

Already this school year, three Houston-area teen athletes, ranging from 12 to 19 years old have died suddenly during or following athletic workouts. Though one was attributed to an aggressive form of meningitis, the other two were determined to be either from enlarged hearts or fatal arrhythmias. source: Understanding Sudden Death in teen athlete, Anissa Anderson Orr & Karen Krakower.

More than that, “Cardiac conditions with a predisposition to sudden death during or following exercise occur in about 5 of 100,000 participants and sudden death occurs in 0.5 of 100,000 people,” - Dr. Syam P. Rao, director of the Division of Pediatric Cardiology at UT Medical School

It seems that perceived risk and the perceived claim as a result of damage (when it doesn't result in death but perhaps disability) is being singled out more and more with the "lower risk" techniques yet we are not advised to inform about other more risky techniques that could have similar terminal risk outcomes. Should it not therefore be prudent to firstly create a guideline that forms a basis for risk assessment and comparison and there a guideline that perhaps suggests what is the industry standard as it relates to risk and therefore concent, and furthermore at what level of risk down signed, informed concent become essential.

I think that it is prudent to inform people of the risks and to discuss them at length. But when the risk is small its' significance may well be escalated above reality when asked to sign a waiver of some sort. Legal will always advise to gain signed and informed concent, that is there position and one that does not need asking. The bodies of the physiotherapy bodies around the world need to be diligent in standing up for what they believe to be the case, and normal practice as they provide the commentary in court for what is standard practice and therefore what might be considered as negligent.

We should be wary of insurers getting in the road and dictating what they think that should be. Next it might be the insurers telling us what treatments we can and cannot give - all of course based on the case mix results of a tired, under-staffed and under resourced public health sector.

Hopefully some other country members can provide some insights into this topic from there own local standards and legal percpectives.

[dmitsch]

Bob,

create a guideline that forms a basis for risk assessment and comparison and there a guideline that perhaps suggests what is the industry standard as it relates to risk and therefore concent, and furthermore at what level of risk down signed, informed concent become essential

I don't disagree and I certainly see your point. In a perfect world there would be an established framework for risk assesment, there'd be a cut off point and practitioners would let patients know that there are risks involved in treatment that are lower than that point and could give patients the choice to discuss what those risks are prior to treatment. Arguably, that point could be 'risk of daily living' and arguably, practitioners could currently manage consent in that way.

On the research front - I'd argue that the research is likely to translate to other patient cohorts as primarily consent is about informing patients about risk. I'd accept that procedure complexity may affect research outcomes however I have a suspicion that the moment a physiotherapist indicates that risks are lower than that encountered in daily living, patients are going to be entirely comfortable with the risks.

What do other people think?