Patient Education and Informed Consent
INTRODUCTION
A good outcome means both a good medical response to therapy and a satisfied patient. Patient satisfaction depends not so much on the technical success of the procedure as it does on the expectations held by the patient before the procedure. The best way to ensure a good outcome is to make sure that the expectations of the patient and the doctor are the same before beginning any treatment.
Patient education is an important first step. There are risks associated with every procedure and no procedure guarantees an excellent medical outcome every time. The patient must understand that medicine is not an exact science and that there is no guarantee that he or she will be satisfied with the improvement in his or her varicose/spider veins after treatment. To ensure consistency, a list of standard topics for discussion should be adopted. Each topic should be explained carefully, preferably with pictures, in such a way that the patient is able to understand. Each patient must have ample opportunity to ask any questions and to receive complete answers. One should not proceed with treatment until one feels comfortable with the patient’s understanding and expectations. It is difficult to establish the appropriate physician–patient relationship with patients who are unreasonable, overly demanding, or unable to comprehend the basics. These types of patients are also the most likely to complain about any or all aspects of their treatment.
TOPICS FOR DISCUSSION
Typical topics for discussion include reasonable patient expectations, underlying causes of venous disease, the medical and cosmetic benefits of treatment, the risks of unsuccessful treatment or of complications, the types of treatments available and the alternatives to treatment, the reasons for requiring a complete examination with testing where indicated, the solutions that may be used in treatment and their potential side effects, and any temporary problems that may arise during the course of treatment and the healing phase (Table 11-1). Only after such a discussion can an informed consent document reasonably be signed.
TABLE 11-1
Topics for Discussion with the Patient
Patient expectations
Causes of venous disease
Medical benefits of treatment
Cosmetic benefits of treatment
Risks of unsuccessful treatment
Risks of complications or side effects
Types of treatments available
Alternatives to treatment
Reasons for requiring a complete examination with vascular testing where indicated
Solutions that may be used in treatment and their potential side effects
Temporary problems that may arise during the course of treatment
What to expect during the healing phase
Patient Expectations
The patient expectations are listed below:
1. Improvement of pain and other symptoms if caused by abnormal veins;
2. Complete closure of any particular vein to be treated;
3. Eighty percent clearing of overall areas treated for cosmetic reasons: no promises of complete clearance;
4. Length of time for clearance: typically six months;
5. Only the veins will change—the underlying legs will remain the same;
6. Excellent cosmetic results, but not “perfect legs”;
7. Ability to wear shorts without embarrassment.
Causes of Varicose Veins and Spider Veins
The causes of varicose veins and spider veins are listed below:
1. High pressure converting normal veins into varicose veins;
2. Heredity resulting in weak vein walls or malformed vein valves;
3. Hormones making vein walls and valves more elastic;
4. Trauma injuring vein valves in a local area;
5. Occupations involving prolonged standing (if genetically susceptible).
Benefits of Treatment
The benefits of treatment are as follows:
1. Improves symptoms (if due to diseased veins);
2. Improves appearance;
3. Prevents worsening of and hopefully avoid ultimate non-healing stasis ulcers;
4. Prevents the spread of disease to other connected veins (high pressure effects).
Treatments Available and Techniques Used
The treatments available and the techniques used are as follows:
1. Watchful waiting—no treatment;
2. Compression stockings alone;
3. Sclerotherapy (with or without Duplex guidance);
4 Minimal surgery—ambulatory phlebectomy of varicose veins;
5. RF endovenous occlusion (Closure™; VNUS Medical Technologies, 5799 Fontanoso Way San Jose, CA) of varicose veins;
6. Endovenous laser ablation of varicose veins;
7. Cutaneous laser treatments for small vessels without underlying high pressure.
Need for Complete Examination and Possible Testing
The need for complete examination and possible testing is:
1. to make a correct diagnosis before considering treatment;
2. to identify any potentially correctable cause for vein problems;
3. to give a prognosis for recurrent or new vein problems after treatment;
4. to measure the severity of the problem quantitatively for later comparison;
5. to identify possible contraindications for treatment:
• Deep vein blockage by blood clots, malformation, or scarring
• Deep vein valve leakage
6. to develop an appropriate treatment plan for each individual patient.
Sclerotherapy Solutions Utilized
More than 30 different solutions are available for sclerotherapy, but in the United States today, only a few are considered truly safe and effective. Sodium morrhuate and ethanolamine oleate are U.S. Food and Drug Administration (FDA)-approved sclerosants but are rarely recommended because of a reportedly high incidence of serious side effects, including anaphylaxis and death. Sodium tetradecyl sulfate (Sotradecol®; Bioniche Pharma, USA LLC, Lake Forest, IL), polidocanol (Asclera®; Chemische Fabrik Kreussler & Co. GmbH 65203 Wiesbaden, Germany), hypertonic saline, hypertonic saline diluted with dextrose (HSD; Sclerodex®; OMEGA LABORATORIES LTD, Hamon Street Montreal, Quebec Canada, H3M 3E4), and glycerin are widely considered to be safe and effective sclerosing agents (see Chapter 14).
SODIUM TETRADECYL SULFATE (SOTRADECOL®) Sotradecol® dates from the 1930s and was “grand fathered” by the FDA for approval as a sclerosant in 1946. Sotradecol® is safe and effective, and has a low incidence of problems such as anaphylaxis, ulceration and hyperpigmentation. Most specialists in the United States use Sotradecol® for larger vessels, and many use it for vessels of all sizes in the appropriate dilutions.
POLIDOCANOL (ASCLERA®) Polidocanol became FDA-approved for use in the United States in 2010, but has been the most popular sclerosant worldwide for years. It is believed by many specialists to be the safest agent with the least side effects. Originally developed in 1931 and sold as a local anesthetic agent, polidocanol has been used as a sclerosant for more than 50 years. It is used regularly for sclerotherapy by many vein specialists in the United States and worldwide, especially for small veins where a good cosmetic result is important.
HYPERTONIC SALINE Hypertonic saline is approved by the FDA for use as an abortifacient; so, its use in sclerotherapy is considered “off-label.” Its use was taught in vascular surgery and dermatology residencies for many years, and many older practitioners still use it regularly. Hypertonic saline is a relatively weak, but effective sclerosant that can be very painful on injection and can cause severe muscle cramps lasting some time after a treatment session. Hypertonic saline is not usually the best choice where cosmetic outcome is important because it can cause a very high incidence of ulceration and hyperpigmentation.
HYPERTONIC SALINE DILUTED WITH DEXTROSE (SCLERODEX®) HSD is a compounded mixture of dextrose 250 mg/ml, sodium chloride 100 mg/ml, propylene glycol 100 mg/ml, and phenethyl alcohol 8 mg/ml. HSD is a relatively weak sclerosant for local treatment of small vessels. Although a slight burning sensation occurs upon injection, pain and risk of ulceration is far less than with hypertonic saline.
GLYCERIN COMPOUND The creation of a specially compounded solution of 72 percent glycerin diluted with 1 percent lidocaine with epinephrine (1:100,000) in a (2:1) solution has been a tremendous advance in the treatment of telangiectasia. No cutaneous necrosis or anaphylaxis from glycerin has been reported in the phlebology literature. It also works very well in the treatment of cutaneous blushing (matting) that can occur as a side effect of sclerotherapy.
Potential Complications
The potential complications are as follows (see Chapter 24):
1. Poor results of sclerotherapy due to an undiagnosed venous insufficiency of deeper vessels;
2. Hyperpigmentation, especially where large veins have been present for a long time;
3. Swelling if foot, or sometimes ankle, is treated;
4. Skin ulceration and scar formation;
5. Telangiectatic matting (new tiny “blush” vessels, usually temporary);
6. Allergy to sclerosing solutions, tape, or stockings;
7. Vasovagal episodes from nervousness or discomfort;
8. Known risk of blood clots after vein surgery or sclerotherapy of large, deeper vessels
9. Theoretical (but unproven) increased risk of blood clots after sclerotherapy of small superficial vessels;
10. Risk of blood clots from untreated varicose veins;
11. Transient visual disturbances and headaches occur infrequently but are more common with foam sclerotherapy;
12. Rare transient ischemic attacks or small strokes reported with foam sclerotherapy;
13. Inadvertent arterial injection with skin necrosis and nerve injury.
Treatment Caveats
The cautions exercised while treatment of patients are as follows:
1. Areas treated with any agent may look temporarily inflamed, with tiny red “blush” vessels.
2. Temporary bruising will occur at treatment sites.
3. Trapped blood may cause local soreness until it is reabsorbed or released.
4. Results will not be usually visible until several treatments have been completed.
5. Some eventual recurrence or development of new veins is inevitable unless the cause can be removed.
Informed Consent
Obtaining informed consent before a procedure is a legal duty owed to the patient. Informed consent is usually obtained in writing. A written document offers many advantages for the physician. It is a way for the patient to demonstrate an informed willingness to accept the risks of treatment and to share in the responsibility for whatever outcome may follow. It is a way to identify an unrealistic patient who does not want to sign because he or she does not truly accept the intrinsic risks of treatment. An informed consent document is not a legal protection for the physician, but the absence of such a document can be an important deficiency in the defense against any future complaint. Appendix 11-A shows a sample consent document for patients who will undergo sclerotherapy for superficial venous insufficiency (see also Chapter 25).
SUMMARY
Patient education and informed consent are the most important way of enhancing overall patient satisfaction with a normal range of outcomes. Presentation of a standard list of topics followed by an open discussion will provide the best opportunity to fully understand a patient’s needs and wishes. Equally important is the opportunity to communicate a reasonable expectation of what can and cannot be achieved. Informed consent will not prevent a lawsuit, but the entire process of education and consent will diminish the overall likelihood of trivial lawsuits being filed or having adverse outcomes.
APPENDIX 11 – A
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