APA issues revised pre-manipulation guidelines

[Physiobase]

Finally it seems that the APA are acknowledging that cervical spine manipulation and the risks associated with it require careful pre-application and signed, informed and understood concent before a procedure is carried out. Why? Because it is a hig risk technique, it does cause harm (shown especially in the younger age group <45)

Statement of Concern to the Canadian Public from Canadian Neurologists: 2002 - A recent study by the Institute of Clinical Evaluative Sciences (ICES Ontario) indicates that patients with posterior circulation strokes under the age of 45 are 5 times more likely than controls to have visited a chiropractor within one week of the event

Physiobase welcomes the revised guidelines even though they put a dampener on one's clinical practise. Afterall in a technique where you need a client to remain relaxed this can't be you first thought: "Oh by the way their is a risk of stroke and death when I perform this technique - please sign here to say it is OK." Hmmm, maybe not.

I tend to agree that there is a lot written about the incidence of symptoms post cervical manipulation. Yet when I see my osteopath or chiropractor they never mention the risks to me and they never ask me to sign off on any informed concent. Is this because it could fundementally destroy their business? Or is it because their insurance premiums match the risk. We should be careful that we don't recommend at a national association level clinical guidelines that really relate to the risk of malpractice injury claims and the insurers ability to cover that risk. In some cases the right thing to do is increase the insurance premium for cervical manipulators, something that matches that of a chiropractor in Australia. Unfortunately this is about 5 times that of a physiotherapist and that perhaps makes some policies non-competitive. Swings and round abouts here but what it best for the profession, and the patient? Please have your say..

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[MrPhysio+]

Interesting topic. Comparing different professions use of manipulation pre test warnings to patients based upon the level of insurance cover raises many questions. If an insurer could prove that a therapist did not give correct warning to a patient regarding informed consent, the insurer could be within their rights to deny a claim by the therapist when a negative patient incident occurred, regardless of the perceived insurance cover.
The onus then falls upon the therapist to: 1. Ensure the manipulation technique performed was valid for the patient 2. The patient understood the risks involved. 3. Signing a waiver against a high risk procedure when their are insufficient valid statistics, plus ensuring patient understanding of the information within the waiver - could be a minefield in court. The therapist may find themselves completely at risk.
Check out the site www.quackwatch.com (chiropractic section) for a debate on manipulation. Even U.S. chiropractors cannot agree on the validity of manipulation / adjustments.
MrPhysio

[Physiobase]

Thanks MrPhysio for your input. Any chance of ellaborating on point 3?

[DMITSCH]

I'd agree with much of what MrPhysio says on this one.

Informed consent shouldn't be viewed as a risk management / payout reduction tool. It's about fully informing patients about all the risks involved in treatment and then allowing patients to make an informed decision based on that information.

Insurance on the other hand is intended to protect against medical 'negligence'. Practitioners doing something that they shouldn't have or not doing something that they should have (like fully informing patients about known risks). Fully informing patients does have the effect of reducing claims and payouts because it's good practice.

Naturally, there is vigorous debate about how much information is too much or not enough. Much of this debate gets resolved in a court of law. One might argue that when a court issues a large payout, they're saying that the community standard is much higher than that applied by the practitioner. If you accept the argument that courts reflect community standards, we're hearing that large payout = you need to more to better inform the client of the risks.

Another issue is that client populations don't have an homogenous level of risk adversity. I scuba dive - it's mildly risky from my perspective. I've got friends who will never dive as it's too risky for them. We each get to make that decision based on our risk perception. In the clinical setting, we shouldn't assume patients have homogenous views on risk or that practitioners 'know best'. For some people, even mild risks are too much.

www.physiotherapy.asn.au/pba

[MrPhysio+]

Hi,
Sorry for the delay in responding re point 3. I have moved into my new purpose built house and clinic this weekend, with many dramas over the last 4+ months. Still unpacking with patients starting to attend tomorrow.
Anyway re point 3. There is an ongoing debate regarding risk to patient, how much training a therapist should have prior to manip, the validity of pre-tersting to adequately screen for risks anyway, and how much insurance cover is valid anyway.
Damian makes a good point regarding different patient groups and their understanding of and willingness to accept risk. We all make these types of decisions everyday, even to the level of crossing the road. Some of us get it wrong and get run over by a vehicle, despite previous experience indicating it was safe.
Some of my patients have received chiropractic treatments for years, and expect me to give them the same treatment despite the fact that contraindications to manip of the cervical spine are obvious. (I do not manip!)

I also have patients that visit a chiro the same day or day previous to consulting me, as they see the treatments as different. As vertebro-basilar complications can take time to develop after a manipulation, I could find myself in court defending a case despite doing nothing wrong based upon an incorrect patient assumption of guilt. I am likely to successfully defend the case, but would not wish to be placed in this situation!
Patients may believe they understand the risks following disclosure by a therapist, however if something goes wrong, they can later deny that they were informed or that they did not understand the complexity (how could they when it is being debated at a professional level), and furthermore if a good legal person becomes involved, the advice would be to sue the therapist.
Despite the fact that some valid procedures are high risk, it is my personal judgement that it is not economically or legally prudent for me to perform the procedure of cervical manipulation.
I have had a couple of patients that have had CVA problems post chiropractic manip, and others that have had lumbar discal disease worsened with prolapse etc due to improper treatments by other therapists.
The writing is on the wall for all of us.
To fully inform a patient of cervical manip risks would take a long time, and to ask a patient to sign a lengthy document of technical nature (which it would have to be given the inherent dangers), could be seen as a waste of time the moment a lawyer picked the document to pieces or the patient stated that they did not understand it. I do not believe that a person is allowed to sign away their rights, and that if they do so, the document could be thrown out of court. The APA pre manipulation testing document is prohibitive in actual application, as the amount of time required to comply would make it uneconomic to implement - and whilst other methods may not be quite as effective they are deemed to be safer and quicker.
Hope the above clarifies my thoughts on the matter.
MrPhysio+

[physiobob]

Well summarised MrP. I can only agree that what the APA have just issued plays into the hands of both a misinformed insurance world and an every growing litigous patient group. They are suggesting members do something that has no validity in it's action. The whole operationalisation fo the concept is flawed and should be pulled from the agenda.

I also do not manipulate the cervical spine. Why? Because I do not have the need to perform it often enough to make me any good at it. The infrequent use, therefore reduced skill, of the technique application might well be a bigger risk factor in complications than the actual technique itself (when applied by a skilled clinician). I do value the treatment option and that is why if I need one I send them next door to my osteopath, or in Australia, my chiropractor. They then send them back to me for continued rehabilitation.

In an organisation that is so into evidenced based practise, the mind does wonder if it's evidence...... when it suits

[dmitsch]

Bob,

These guidelines were externally compiled by:
1. Surveying a sample of members
2. A review of current literature
3. A review of current best practice
4. Review by an expert panel
5. Independent legal advice

They are based on evidence.

Is operationalisation as much of a problem for those physio's who's insurance doesn't have rigid requirements on written consent? Are they the misinformed insurers you're referring to?

[physiobob]

Bob,

These guidelines were externally compiled by:
1. Surveying a sample of members
2. A review of current literature
3. A review of current best practice
4. Review by an expert panel
5. Independent legal advice

They are based on evidence.

Is operationalisation as much of a problem for those physio's who's insurance doesn't have rigid requirements on written consent? Are they the misinformed insurers you're referring to?

A "literature review" as suggested above (as it's not much more than that) is not evidence, it is what is considered a review of normal common practise. Then again it was once normal to used TED stocking post op even though we now know (hoepfully) that they don't really work against gravity when standing and are only actually effective in lying. Yet on a survey of you above listed points 1-5 it might still be suggested that we still use them.

Where does it show in the evidence that informing a patient about the perceived risks of cervical manipulation, and indeed getting them to sign to the "informed concent", show that this reduces the incidence of trauma? I would suggest that this evidence does not exist as an outcome. Rather it might only result in the technique to be discarded as a treatment option and/or if it is used make it that much more difficult because of the psychological state that the client has just been put into when told that there is a risk of death when performing the technique. The guidelines as they are stated at present will either be disregarded by the majority as not really relevent in a legal sense or many will simply discontinue use of the technique.

Either way I still feel for my part that the APA is playing into the hands of the insurers and nothing more. Please do paste of attach any document of relevence that backs up the need for this guideline as something that when used reduces patient risk. I would love to have my opinion educated and even changed if the evidence shows otherwise....

[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?