Best practice guidelines on informed consent for weight loss surgery patients.
OBJECTIVE
To provide evidence-based guidelines on informed consent and the education that underlies it for legally competent, severely obese weight loss surgery (WLS) patients.


METHODS
We conducted a systematic review of the scientific literature published on MEDLINE between 1984 and 2004. Three articles focused on informed consent for WLS; none was based on empirical studies. We summarized each paper and assigned evidence categories according to a grading system derived from established evidence-based models. We also relied on informed consent and educational materials from six WLS programs in Massachusetts. All evidence is Category D. Recommendations were based on a review of the available literature, informed consent materials from WLS programs, and expert opinion.


RESULTS
This Task Group found that the informed consent process contributes to long-term outcome in multiple ways but is governed by limited legal requirements. We focused our report on the legal and ethical issues related to informed consent, i.e., disclosure vs. comprehension. Recommendations centered on the importance of assessing patient comprehension of informed consent materials, the content of those materials, and the use of active teaching/learning techniques to promote understanding.


CONCLUSIONS
Although demonstrated comprehension is not a legal requirement for informed consent in Massachusetts or other states, the members of this Task Group found that the best interests of WLS patients, providers, and facilities are served when clinicians engage patients in active learning and collaborative decision making.
Sabin
James
J
Harvard Pilgrim Health Care, Department of Psychiatry, 133 Brookline Avenue, Sixth Floor, Boston, MA 02215, USA. Jim_Sabin@harvard.pilgrim.org
Fanelli
Robert
R
Flaherty
Helen
H
Istfan
Nawfal
N
Mariner
Wendy
W
Barnes
Janet Nally
JN
Pratt
Janey S A
JS
Rossi
Laura
L
Samour
Patricia
P
D013505:Digestive System Surgical Procedures; D019317:Evidence-Based Medicine; D006801:Humans; D007258:Informed Consent; D016239:MEDLINE; D009765:Obesity / Q000601:surgery*; D010353:Patient Education as Topic; D017410:Practice Guidelines as Topic; D012307:Risk Factors; D015431:Weight Loss