Exploring The Experiences And Expectations Of Surgical Informed Consent：from Patients’ And Doctors’ Perspective

Objectives:Focusing on patient-doctor communication during surgical informed consent, thisstudy aims to understand the status of the surgical informed consent, to find patient-doctorcommunication needs during surgical informed consent, as well as to explore both doctors’and patients’ real experiences and expectations during surgical informed consent.Suggestions were proposed in order to promote the process of surgical informed consentand to improve patient-doctor communication effectiveness, which may be helpful toreduce medical disputes and conflicts, and build harmonious patient-doctor relationship.Methods:1、Content analysis was used to analyze the content structure of surgical consentdocuments. The analysis category included the basic informations, surgery-relatedinformation, the patient’s informed choice, etc.2、A phenomenological methodology was adopted to explore the real experiences andexpectations of the surgical informed consent from both patients’ and doctors’ perspectives.Purposive sampling strategy and principle of maximum differentiation were adopted torecruit participants. Patients’ gender, age, education level, types of surgery, days aftersurgery, doctors’ gender, age, years of work were considered. Patients who had a surgery ortheir lineal relation who had participated in surgical informed consent and doctors withexperiences of surgical informed consent were selected. All of the participants came fromfour hospitals (2secondary and2tertiary hospitals) in Shanghai. A total of22patients and19doctors were interviewed. They were asked to tell their experiences and expectations ofthe surgical informed consent using semi-structured interview.3、A questionnaire survey was carried out to investigate the status and patient-doctorcommunication needs during surgical informed consent. Based on Theoretical Frameworkof Patient Participation in Patient Safety, the results of qualitative interviews and consentanalysis, two questionnaires were formed and revised by expert consultation andpre-investigation. Convenient sampling were applied to recruit participants from8secondary and tertiary hospitals in Shanghai,and a total of317patients and315doctorsparticipated. SPSS17.0statistical software was used to analyze the data. Results:1、Consent analysis of the surgical informed consent documents showed that：○1Only20.8%included the introduction of the forms，which introducing the information such asdiagnosis, patients’ condition, surgical procedures etc.;○2Patients’ demographiccharacteristics included name, diagnosis, age, gender and so on;○3Surgery relatedinformation mainly covered the risks and complications of the surgery operation;○4Patients’ preferences comprised the applications of surgery and power of attorney,declaration of refusal of surgery, patients’ informed consent, patients’ decision-making ofsurgery;○5All of the forms consisted of patients’ signatures, while doctors’ signaturesinvolved attending physicians、surgeons and those who conducted the surgical informedconsent.2、10core themes were drawn from qualitative study:（1）Patient-doctor experiencesof surgical informed consent:○1Some patients were not clear their rights for engaging insurgical informed consent rights was not strong;○2Doctors tended to choose the familiesto acquire surgical informed consent;○3Both patients and doctors reported that theprocess of surgical informed consent were not standardized;○4Both patients and doctorsagreed that surgical informed consent emphazied too much risks of surgery;○5Patient haddifferent opinions on the function of signature.（2）Patient-doctor expectations of surgicalinformed consent:○1Patients’ willingness to engage in the surgical informed consent werehigh;○2Doctors expected family members to be engaged in the surgical informed consentinterview;○3Both doctors and patients expected that there should be some criteria fordoctors who conduct surgical informed consent interview;○4Both doctors and patientsexpected to standardize the process of surgical informed consent;○5Both doctors andpatients expected to improve the quality and efficiency of surgical informed consentcommunication.3、The questionnaires of the status and communication needs of surgical informedconsent for doctors and for patients were formed. Each of them included the demographicdata, experiences of the surgical informed consent and expectations of the surgicalinformed consent.4、The results of survey:（1） the descriptive statistical analysis showed that:○1Family members were the main person who participated in surgical informed consent andsigned as decisions-makers. However, both doctors and patients expected that both patientsand family members should be engaged in surgical informed consent and enrolled as decisions-makers; both doctors and patients expected the doctor who conducted surgicalinformed consent interview should be experienced and skillful in communication, and bewell trained;○2Both doctors and patients expected that a private and quiet place, a rightand sufficient time and a variety of expressions should be provided during surgical informedconsent;○3Patients cared more about the outcome and the success rate of surgery andneglected the risks, while doctors focused on the possible risks of surgery;○4Patients didnot understand the contents of surgical informed consent well, which impaired the role ofthe written consent. Doctors and patients had different opinion on the role of surgicalinformed consent form;（2）There were significant differences in the realistic and expectedinterlocutors, interview place, the time-period and decision-maker from patients’ anddoctors’ perspectives;（3）Significant difference and o positive correlation were showedbetween patients’ satisfaction of surgery, communication satisfaction and trust of doctor,compared with patients’ understanding of the contents of surgical informed content.Conclusions:1、The consents and forms of the current surgical informed consent documents neededto be improved.2、The effects of the surgical informed consent was insufficient in current China.Participants attending the surgical informed consent interview, doctors’ qualification forconducting the surgical informed consent interview,the contents and process of thesurgical informed consent needed to be more standardized.3、Both doctors and patients expected that more standard training for the doctor whoconducting the patients’ surgical informed consent interview should be provided; Patientsshould be more encouraged for their right of engaging in surgical informed consent. A newpattern that patients, family members and doctors engaged together in the surgicalinformed consent should be set up. And, the contents and forms of surgical informedconsent needed to be enriched.