Abstract
Background
Informed consent supports voluntary surgical decision-making, yet patients’ routine perceptions of consent communication remain insufficiently described. In China, where family involvement and time-pressured care are common, understanding how patients retrospectively perceive written and oral consent communication is important.
Methods
We conducted a cross-sectional survey of 627 consecutive adult patients undergoing elective general surgery in a tertiary general hospital in Fuzhou, Fujian Province, China. Participants were interviewed face-to-face on postoperative days 2–7 using a structured questionnaire adapted from a validated instrument. Items were categorical (dichotomous, ordinal, or single/multiple-response). The survey assessed postoperative reports of written consent form handling, perceived understanding, oral explanation content, and the influence of information on decision-making. Multivariable logistic regression examined factors associated with self-reported careful reading, perceived full understanding of the written form, and reported discussion of surgical alternatives and non-treatment consequences, adjusting for sociodemographic and consent-process variables.
Results
Of 627 participants, 94.6% reported receiving a written consent form. Among recipients, self-reported careful reading (89.4%) and perceived full understanding (91.3%) were high, although 15.6% received the form only shortly before surgery and family involvement in signing was frequent. Most respondents also received oral explanations, commonly perceived as complete and understandable. Retrospectively, oral discussions focused on diagnosis (89.0%) and planned procedures (83.3%), whereas alternatives (27.7%) and non-treatment consequences (36.2%) were discussed less frequently. In multivariable models, explanation of the form at delivery was strongly associated with careful reading (adjusted odds ratio [aOR] 30.69, 95% CI 6.67–141.31, p<0.001) and perceived full understanding (aOR 41.55, 95% CI 4.77–361.55, p=0.001); college-level education was associated with reported discussion of alternatives (aOR 3.88, 95% CI 1.91–7.86, p<0.001) and non-treatment consequences (aOR 3.60, 95% CI 1.87–6.92, p<0.001), whereas receiving the form closer to surgery and from a non-surgeon were associated with lower odds of these disclosures. Several estimates had wide confidence intervals and should be interpreted cautiously.
Conclusion
Most postoperative patients reported receiving written and oral consent information and perceived both as understandable. However, alternatives and non-treatment consequences were reported less frequently, indicating gaps in the discussed information scope. These findings reflect retrospective, patient-reported perceptions of the consent process among clinically stable elective surgery patients, rather than objective understanding or an audit of overall informed consent quality.
Keywords: patient-reported perceptions, consent communication, surgical quality, perioperative communication, shared decision-making
Background
Informed consent (IC) is widely recognized as a cornerstone of ethical medical practice and a fundamental legal requirement in surgery.1 However, valid consent is more than obtaining a signature on a form. It requires that the patient receive information relevant to the decision, understand that information to a reasonable degree, and make a voluntary choice.2 In recent years, informed consent has increasingly been understood as an element of shared decision-making rather than a one-time administrative event.3,4 From this perspective, the purpose of consent is not only to authorize a proposed procedure, but also to support patients in comparing options in light of their own values, preferences, and tolerance of risk.5 Official guidance has moved in this direction. In China, the Physician Law requires clinicians to explain the patient’s condition, the proposed measures, medical risks, and alternative options, and to obtain explicit consent before surgery or other special interventions.6 Similarly, the UK General Medical Council emphasizes that consent should involve discussion of benefits, harms, reasonable alternatives, and the option of taking no action.7
A gap often remains, however, between normative standards and bedside practice. Many procedural and surgical consent forms are lengthy, linguistically complex, and difficult to read, and substantial variation exists across institutions in both disclosure content and wording, making it difficult to ensure that patients receive consistent and decision-relevant information.8,9 Studies in vascular surgery have shown that, when assessed objectively, patients often have limited understanding of key information such as diagnosis, risks, benefits, and alternatives, and that poorer comprehension is associated with factors including frailty.10 Qualitative evidence further suggests that patients value a consent process in which they can ask questions, seek clarification, and feel heard; this process-oriented model may be weakened by time pressure and document-centred practice.11 Within a shared decision-making framework, surgeons are therefore expected not only to recommend a treatment option, but also to discuss the relative benefits and harms of available alternatives and to incorporate patients’ values and preferences into the decision.12 Written consent materials and oral communication should thus be regarded as complementary rather than interchangeable: the document provides a standardized, traceable minimum set of information, while dialogue allows individualized explanation, clarification of misunderstanding, and assessment of whether the patient has truly understood.
Health literacy is a key social determinant of patients’ understanding of and participation in informed consent.13 Empirical studies in Chinese hospitals suggest that limited functional health literacy can reduce inpatients’ comprehension of consent forms and weaken their participation in the consent process, making merely formal consent more common.14 In this context, improving the readability of consent documents and the quality of communication is fundamentally a matter of institutional responsibility for quality and equity, rather than simply a matter of individual patient capacity.15
In the Chinese clinical context, informed consent is also strongly shaped by patterns of family involvement. Recent studies show that young physicians often face ethical dilemmas within a “doctor–family–patient” model: when disclosing serious diagnoses, many report informing family members first, and some delay or withhold information from patients at the family’s request.16 Qualitative research further suggests that so-called family-oriented informed consent in China cannot be explained solely as a matter of cultural preference; patients, family members, and health professionals differ in their views on its benefits, harms, and legitimacy, and social factors such as the risk of medical violence and financial pressure may also contribute to its persistence.17 When evaluating the quality of informed consent, it is therefore important to recognize the supportive role that family involvement may play, while remaining alert to the risk that it may be used to substitute for patient autonomy.
Despite these normative expectations, relatively little is known about how patients in Chinese tertiary hospitals actually perceive routine surgical consent communication, and in particular whether the breadth of information they recall being discussed extends beyond diagnosis and the planned procedure to alternatives and the consequences of non-treatment. Elective general surgery is a particularly informative setting in which to examine this question: procedures are scheduled rather than emergent, so there is, in principle, time for structured pre-operative discussion; patients are generally clinically stable and able to participate; and general surgery encompasses a high volume and wide range of interventions for which meaningful treatment alternatives frequently exist. This study therefore aimed to describe postoperative patients’ perceptions of the informed consent process in elective general surgery at a tertiary general hospital in China. Specifically, we examined how patients retrospectively reported receiving, reading, and signing written consent forms; how they perceived the clarity, completeness, and content of oral communication; and how they perceived the relevance of consent-related information to their decision-making. The study does not objectively assess the content or legal validity of written consent forms, nor does it directly measure patients’ actual understanding. Rather, it focuses on patient-reported perceptions of the information and communication received during the consent process, including perceived comprehensibility, completeness, and participation in decision-making.
Methods
Study Design and Setting
This was a single-centre, cross-sectional survey examining postoperative patients’ perceptions of the informed consent process. The study was conducted in the Department of General Surgery of a tertiary (Grade A) general hospital in Fuzhou, Fujian Province, in south-eastern China, a high-volume surgical centre typical of the tertiary level of the Chinese public healthcare system. The department performs a broad range of elective general-surgical procedures, spanning benign and oncological indications and both major and minor complexity. The study period was January 2026 to March 2026. This design complies with the principles of the Declaration of Helsinki. Reporting follows the STROBE recommendations for cross-sectional studies.
Participants and Recruitment
Eligible participants were adult patients (aged >18 years) admitted to the Department of General Surgery who had undergone an elective surgical procedure. Exclusion criteria were: (1) patients under 18 years of age; (2) patients admitted to the Intensive Care Unit or requiring a second emergency operation due to complications, whose clinical condition might impair participation; and (3) patients with cognitive impairment or inability to communicate in Mandarin or the local dialect. During the study period, all consecutive patients meeting the eligibility criteria were approached, giving a consecutive-sampling design. Eligible patients were identified from ward admission and operating-schedule records by trained research staff who were independent of the surgical team; these staff approached patients at the bedside, explained the study, and invited them to participate. Participation was voluntary and involved no incentive.
This approach ensured that participants were clinically stable enough to complete the interview, but it also means that the study did not include patient groups in whom consent-related difficulties may be especially pronounced, such as critically ill, emergency, cognitively impaired, or communication-limited patients.
Sample Size
The target sample size was informed by the precision required to estimate population proportions. Using the formula for a single proportion and a conservative expected proportion of 50%, a 95% confidence level, and an absolute precision of ±4%, approximately 600 participants would be required. We therefore considered the final sample of 627 consecutive patients adequate for the primary descriptive aim.
Data Collection Instrument
Data were collected using a structured questionnaire adapted from the validated instrument developed by Agozzino et al.18 The questionnaire comprised four sections: (1) socio-demographic characteristics; (2) reports on the receipt, timing, delivery, signing, reading, and perceived understanding of the written informed consent form; (3) perceptions of oral explanations and the information discussed during consent-related communication; and (4) retrospective reports on the perceived influence of consent-related information on decision-making and emotional response. Items were closed-ended and categorical: dichotomous (e.g, receipt of the form: yes/no), single-choice ordinal or nominal categories (e.g, timing of receipt; perceived clarity rated as fully/partially/not understandable), and one multiple-response item on the content domains discussed during oral communication. The instrument was translated into Chinese and culturally adapted through forward translation and expert review by the study team (comprising clinical and health-management researchers) to ensure that item wording was appropriate to the Chinese surgical context; it was pilot-tested with a small number of postoperative patients before the main survey, and minor wording adjustments were made to improve clarity. No changes were made to the response structure after piloting.
Data Collection Procedure
The questionnaire was administered through face-to-face interviews conducted by trained researchers who were independent of the surgical team, in order to minimize social-desirability and response bias. Interviews took place in a private setting at the patient’s bedside between the second and seventh postoperative day, once patients had recovered sufficiently from anaesthesia to communicate effectively. For patients with lower literacy, researchers read the questions aloud and recorded responses faithfully. Written informed consent for study participation was obtained from each patient before the interview. No directly identifiable personal data were collected; responses were recorded on paper case-report forms, entered into a password-protected electronic database accessible only to the research team, and analysed in aggregate form. Because interviews were conducted after surgery, the data reflect patients’ retrospective self-reports of their consent experience rather than direct observation of the consent encounter or objective testing of comprehension.
Statistical Analysis
Analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Categorical variables were summarized as frequencies and percentages; denominators reflect survey skip patterns and item-level valid responses and are reported for each indicator.
Four pre-specified, patient-reported binary outcomes served as dependent variables in separate multivariable logistic regression models: (1) careful reading of the written informed consent form; (2) perceived full understanding of the written form; (3) reported discussion of alternatives to surgery; and (4) reported discussion of the consequences of non-treatment. Models 1 and 2 were restricted to patients who reported receiving a written form; models 3 and 4 were restricted to patients who reported receiving oral communication. The independent variables (covariates) were selected a priori on the basis of conceptual relevance to the consent process and comprised sex, age group, education level, signer of the consent form, timing of receipt of the form, who delivered the form, whether the form was explained at delivery, and whether the patient had an opportunity to ask questions; self-reported careful reading was additionally entered in the model for perceived full understanding. Age and education were modelled using multiple categories to reduce information loss.
Adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were reported, using complete-case analysis. Multicollinearity was assessed using variance inflation factors, and model performance was evaluated using the area under the receiver-operating-characteristic curve and the Hosmer–Lemeshow goodness-of-fit test. A two-sided p value <0.05 was considered statistically significant. Because several outcomes had low event counts, the resulting estimates—particularly those with wide confidence intervals—are interpreted as exploratory rather than confirmatory.
Results
Study Population and Demographics
A total of 627 patients completed the survey. Socio-demographic characteristics are shown in Table 1. The sample was approximately balanced by sex (48.8% male, 51.2% female) and distributed across age groups, with 28.4% aged 18–30 years, 21.4% aged 31–45 years, 24.6% aged 46–60 years, and 25.7% aged 61 years or older. Most participants were Han Chinese (96.0%) and married (64.9%). Educational attainment was heterogeneous: 23.8% had primary education or below and 22.7% junior high school, whereas 24.4% held an undergraduate degree and 4.0% a master’s degree or above. The most common occupational groups were farmers (27.8%) and civil servants or public-institution employees (16.4%), and most participants were covered by urban medical insurance (44.5%) or the New Rural Cooperative Medical Scheme (33.5%).
Table 1.
Socio-Demographic Characteristics of the Study Population (n = 627)
| Characteristic | Category | n | % |
|---|---|---|---|
| Gender | Male | 306 | 48.80 |
| Female | 321 | 51.20 | |
| Age group | 18–30 | 178 | 28.39 |
| 31–45 | 134 | 21.37 | |
| 46–60 | 154 | 24.56 | |
| ≥61 | 161 | 25.68 | |
| Ethnicity | Han Chinese | 602 | 96.01 |
| Ethnic minority | 25 | 3.99 | |
| Marital status | Unmarried | 177 | 28.23 |
| Married | 407 | 64.91 | |
| Divorced | 16 | 2.55 | |
| Widowed | 27 | 4.31 | |
| Education level | Primary school and below | 149 | 23.76 |
| Junior high school | 142 | 22.65 | |
| High school | 78 | 12.44 | |
| Associate degree | 80 | 12.76 | |
| Undergraduate | 153 | 24.40 | |
| Master’s degree and above | 25 | 3.99 | |
| Occupation | Farmers | 174 | 27.75 |
| Worker | 88 | 14.04 | |
| Employees of private/foreign enterprises | 59 | 9.41 | |
| Civil servants/public institution staff | 103 | 16.43 | |
| Student | 67 | 10.69 | |
| Retired | 27 | 4.31 | |
| Other | 109 | 17.38 | |
| Medical insurance type | Personal self-funded | 102 | 16.27 |
| New Rural Cooperative Medical Scheme | 210 | 33.49 | |
| Urban medical insurance | 279 | 44.50 | |
| Public-funded medical care | 21 | 3.35 | |
| Commercial medical insurance | 15 | 2.39 |
Notes: Bold text in the first column denotes the characteristic (variable) headings and does not indicate statistical significance.
Written Informed Consent: Receipt, Signing, Reading, and Clarity
Overall, 94.6% (593/627) of participants reported receiving a written surgical informed consent form, while 0.6% reported not receiving it and 4.8% did not remember (Table 2). Among recipients (n=593), signing was commonly shared: 39.8% signed together with a family member, 31.2% reported that a family member signed, and 28.7% signed themselves. Reading was high: 89.4% (530/593) reported reading the form carefully and 7.9% skimmed it. Among respondents who provided clarity ratings (n=577), 91.3% (527/577) reported the content was fully understandable and 8.3% reported partial understanding. Regarding timing (n=577), most participants received the form one day before surgery (67.1%) or more than one day before (14.2%), but 15.6% received it only a few hours before, or immediately before, surgery. The form was most often delivered by another department physician (43.2%) or the attending surgeon (40.9%).
Table 2.
Written Informed Consent: Delivery, Signing, Reading, Clarity, and Timing
| Indicator (Denominator) | Category | n | % |
|---|---|---|---|
| Receipt of written IC (N=627) | Yes, received | 593 | 94.58 |
| No | 4 | 0.64 | |
| Do not remember | 30 | 4.78 | |
| Signer of IC (n=593) | Patient | 170 | 28.67 |
| Family member | 185 | 31.20 | |
| Patient and family together | 236 | 39.80 | |
| Do not remember | 2 | 0.34 | |
| Reading of IC (n=593) | Read carefully | 530 | 89.38 |
| Skimmed | 47 | 7.93 | |
| Did not read (did not want to) | 10 | 1.69 | |
| Did not read (no time) | 6 | 1.01 | |
| Perceived clarity (n=577) | Fully understandable | 527 | 91.33 |
| Partially understandable | 48 | 8.32 | |
| Not understandable | 2 | 0.35 | |
| Time of receipt before surgery (n=577) | Immediately before surgery | 56 | 9.71 |
| A few hours before | 34 | 5.89 | |
| One day before | 387 | 67.07 | |
| >1 day before | 82 | 14.21 | |
| Do not remember | 18 | 3.12 | |
| Delivered by (n=577) | Attending surgeon | 236 | 40.90 |
| Other department physician | 249 | 43.15 | |
| Nurse | 42 | 7.28 | |
| Anesthesiologist | 23 | 3.99 | |
| Do not remember | 27 | 4.68 |
Note: Denominators reflect survey skip patterns and item-level valid responses.
Abbreviation: IC, informed consent.
Oral Communication: Explanation, Completeness, and Content
Among those who rated whether staff explained the written consent at delivery (n=577), 96.7% reported receiving an explanation and 1.9% a partial explanation (Table 3). In addition, 95.7% (600/627) reported that physicians communicated about the condition and provided oral disclosure to the patient and/or family beyond the written form. Among respondents who received oral information (n=600), 85.0% considered it “very complete” and 15.0% “basically complete but could be more detailed”; 85.0% reported the oral explanation was very easy to understand, while 14.7% reported that some medical jargon limited comprehension. Regarding content domains (multiple responses allowed; n=600), diagnosis/condition (89.0%) and the name/type of the planned surgery (83.3%) were most frequently discussed, followed by potential benefits (65.7%) and risks/complications (63.0%). However, alternatives (27.7%) and consequences of non-treatment (36.2%) were reported far less frequently, indicating potential gaps in the breadth of decision-relevant information (Table 3).
Table 3.
Oral Communication During the Consent Process: Explanation, Completeness, Comprehensibility, and Content Domains Discussed
| Indicator (Denominator) | Category | n | % |
|---|---|---|---|
| Explanation of written IC at delivery (n=577) | Yes, explained | 558 | 96.71 |
| Partly explained | 11 | 1.91 | |
| Not explained | 1 | 0.17 | |
| Do not remember | 7 | 1.21 | |
| Additional oral communication beyond the form (N=627) | Yes | 600 | 95.69 |
| No | 3 | 0.48 | |
| Do not remember | 24 | 3.83 | |
| Perceived completeness of oral information (n=600) | Very complete | 510 | 85.00 |
| Basically complete but could be more detailed | 90 | 15.00 | |
| Incomplete | 0 | 0.00 | |
| Perceived comprehensibility of oral information (n=600) | Very easy to understand | 510 | 85.00 |
| Basically understandable but with some jargon | 88 | 14.67 | |
| Difficult to understand | 2 | 0.33 | |
| Content domains reported as discussed during oral communication (multiple responses allowed; n=600) | |||
| Diagnosis/condition | 534 | 89.00 | |
| Name and type of planned surgery | 500 | 83.33 | |
| Potential benefits | 394 | 65.67 | |
| Risks/complications | 378 | 63.00 | |
| Chance of success | 329 | 54.83 | |
| Prognosis | 306 | 51.00 | |
| Postoperative recovery process | 313 | 52.17 | |
| Consequences of non-treatment | 217 | 36.17 | |
| Alternative treatments | 166 | 27.67 | |
Note: Percentages for content domains are of respondents who received oral communication (n=600) and sum to more than 100% because multiple responses were permitted.
Abbreviation: IC, informed consent.
Decision-Making Influence, Opportunities to Ask Questions, and Emotional Response
More than half of participants reported that the information received (written and/or oral) had a large influence on their decision to undergo surgery (53.6%), while 15.6% reported no influence because they had already decided (Table 4). Among respondents who reported at least some influence (n=529), oral explanation was most frequently identified as the stronger influence (70.9%), compared with the written form alone (5.1%) or both equally (20.6%). Most participants reported having an opportunity to ask questions and receiving satisfactory answers (87.7%); a small proportion reported unsatisfactory answers (3.8%) or that they wanted to ask but had no opportunity (0.8%). After receiving information, 88.8% reported feeling reassured or more confident, whereas 2.4% reported increased anxiety.
Table 4.
Perceived Influence on Decision-Making and Communication Process
| Indicator (Denominator) | Category | n | % |
|---|---|---|---|
| Extent to which information influenced the decision (N=627) | Large influence | 336 | 53.59 |
| Some influence | 158 | 25.20 | |
| Little influence | 35 | 5.58 | |
| No influence (decision already made) | 98 | 15.63 | |
| Which channel had greater influence (n=529)* | Oral explanation | 375 | 70.89 |
| Written consent form | 27 | 5.10 | |
| Both about the same | 109 | 20.60 | |
| Unclear | 18 | 3.40 | |
| Opportunity to ask questions (N=627) | Yes, and answers were satisfactory | 550 | 87.72 |
| Yes, but answers were unsatisfactory | 24 | 3.83 | |
| Did not ask questions | 48 | 7.66 | |
| Wanted to ask but had no opportunity | 5 | 0.80 | |
| Emotional response after receiving information (N=627) | Reassured/more confident | 557 | 88.84 |
| No particular feeling | 55 | 8.77 | |
| More anxious/tense | 15 | 2.39 |
Note: *This item was answered by respondents who reported that the information had at least some influence on their decision (n=529).
Postoperative Outcomes and Discharge Information
Most participants reported a successful surgical outcome without complications (96.8%). The actual recovery trajectory was considered basically consistent with pre-operative information by 91.7%, while 0.6% reported that no pre-operative information about recovery had been provided. At discharge, 93.0% reported receiving clear discharge instructions and 6.2% wanted more detail. Among those who responded to adherence (n=622), 91.8% reported fully following discharge instructions (Table 5).
Table 5.
Postoperative Outcomes and Discharge Information
| Indicator (Denominator) | Category | n | % |
|---|---|---|---|
| Self-reported surgical outcome (N=627) | Successful, no complications | 607 | 96.81 |
| Some complications | 20 | 3.19 | |
| Coherence between expected and actual recovery (N=627) | Basically consistent | 575 | 91.71 |
| Better than expected | 43 | 6.86 | |
| Worse than expected | 5 | 0.80 | |
| No preoperative information provided | 4 | 0.64 | |
| Discharge instructions provided (N=627) | Yes, explained clearly | 583 | 92.98 |
| Yes, but wanted more details | 39 | 6.22 | |
| No | 5 | 0.80 | |
| Adherence to discharge instructions (n=622) | Fully adhered | 571 | 91.80 |
| Partly adhered | 50 | 8.04 | |
| Did not adhere | 1 | 0.16 |
Note: Denominators reflect item-level valid responses.
Multivariable Analyses of Written-Form Engagement and Reported Information Content
Among patients who reported receiving a written informed consent form and had complete data (n=552), self-reported careful reading was independently associated with explanation of the form at delivery (aOR 30.69, 95% CI 6.67–141.31, p<0.001) and with having an opportunity to ask questions (aOR 3.77, 95% CI 1.31–10.87, p=0.014), whereas demographic variables were not significant after adjustment (Table 6). Perceived full understanding was independently associated with careful reading (aOR 20.68, 95% CI 8.41–50.81, p<0.001) and explanation at delivery (aOR 41.55, 95% CI 4.77–361.55, p=0.001). Compared with patient self-signing, family-only signing (aOR 0.17, 95% CI 0.05–0.61, p=0.006) and joint signing by patient and family (aOR 0.23, 95% CI 0.06–0.82, p=0.023) were associated with lower odds of perceived full understanding. Some of these estimates were accompanied by wide confidence intervals, reflecting low cell counts, and should therefore be interpreted with caution.
Table 6.
Multivariable Logistic Regression for Self-Reported Careful Reading and Perceived Full Understanding of the Written Informed Consent Form
| Variable | Category | Careful Reading aOR (95% CI) |
p | Full Understanding aOR (95% CI) |
p |
|---|---|---|---|---|---|
| Sex | Male (ref) | — | — | ||
| Female | 0.75 (0.37–1.53) | 0.426 | 0.93 (0.43–2.03) | 0.865 | |
| Age group | 18–30 years (ref) | — | — | ||
| 31–45 years | 0.61 (0.18–2.01) | 0.413 | 1.58 (0.44–5.72) | 0.485 | |
| 46–60 years | 0.48 (0.15–1.60) | 0.233 | 1.17 (0.34–4.00) | 0.798 | |
| ≥61 years | 0.37 (0.11–1.30) | 0.122 | 0.66 (0.18–2.43) | 0.533 | |
| Education level | Primary school or below (ref) | — | — | ||
| Middle school | 0.49 (0.18–1.34) | 0.163 | 1.39 (0.45–4.23) | 0.567 | |
| High school/vocational | 0.59 (0.17–1.98) | 0.390 | 0.76 (0.22–2.62) | 0.660 | |
| College or above | 0.61 (0.20–1.88) | 0.393 | 1.23 (0.35–4.24) | 0.747 | |
| Signer of the written form | Patient self-signing (ref) | — | — | ||
| Family-only signing | 0.74 (0.29–1.93) | 0.542 | 0.17 (0.05–0.61) | 0.006 | |
| Patient and family jointly signing | 0.80 (0.32–2.01) | 0.629 | 0.23 (0.06–0.82) | 0.023 | |
| Timing of receipt of the form | >1 day before surgery (ref) | — | — | ||
| 1 day before surgery | 0.49 (0.13–1.91) | 0.305 | 0.64 (0.17–2.35) | 0.501 | |
| A few hours before surgery | 4.32 (0.21–90.41) | 0.346 | 1.12 (0.11–11.68) | 0.923 | |
| Immediately before surgery | 0.68 (0.10–4.74) | 0.695 | 0.61 (0.10–3.78) | 0.592 | |
| Who delivered the form | Surgeon (ref) | — | — | ||
| Other doctor in the department | 0.43 (0.18–1.02) | 0.056 | 1.02 (0.42–2.50) | 0.958 | |
| Other staff/did not remember† | 0.49 (0.15–1.62) | 0.243 | 0.40 (0.13–1.26) | 0.119 | |
| Written form explained at delivery | No/partly explained (ref) | — | — | ||
| Yes | 30.69 (6.67–141.31) | <0.001 | 41.55 (4.77–361.55) | 0.001 | |
| Opportunity to ask questions | No opportunity/did not ask (ref) | — | — | ||
| Had opportunity | 3.77 (1.31–10.87) | 0.014 | 2.87 (0.82–10.06) | 0.100 | |
| Self-reported careful reading | No (ref) | — | — | — | |
| Yes | — | — | 20.68 (8.41–50.81) | <0.001 |
Note: Population: patients who reported receiving a written informed consent form and had complete data for the multivariable models (n = 552). Bold text in the first column denotes the variable (predictor) headings and does not indicate statistical significance. †Other staff/did not remember includes nurses, anaesthesiologists, and respondents who did not remember who delivered the form.
Abbreviations: aOR, adjusted odds ratio; CI, confidence interval; ref, reference category.
Among patients who reported receiving oral communication (n=553), college education or above was positively associated with reported discussion of alternatives (aOR 3.88, 95% CI 1.91–7.86, p<0.001) and of the consequences of non-treatment (aOR 3.60, 95% CI 1.87–6.92, p<0.001) (Table 7). In contrast, receiving the consent form closer to the time of surgery was consistently associated with lower odds of reporting discussion of these two items. Compared with receipt more than one day before surgery, receipt one day before and immediately before surgery were associated with lower odds of reporting discussion of alternatives (aOR 0.56, 95% CI 0.32–0.98, p=0.044; and aOR 0.18, 95% CI 0.07–0.46, p<0.001, respectively), while receipt one day before, a few hours before, and immediately before surgery were associated with lower odds of reporting discussion of the consequences of non-treatment (aOR 0.44, 95% CI 0.25–0.75, p=0.003; aOR 0.19, 95% CI 0.07–0.52, p=0.001; and aOR 0.13, 95% CI 0.05–0.31, p<0.001, respectively). Receiving the form from another doctor rather than the surgeon was also associated with lower odds of reporting discussion of alternatives (aOR 0.33, 95% CI 0.20–0.53, p<0.001) and of the consequences of non-treatment (aOR 0.43, 95% CI 0.28–0.67, p<0.001) (Table 7).
Table 7.
Multivariable Logistic Regression for Reported Discussion of Alternatives to Surgery and Consequences of Non-Treatment During Oral Communication
| Variable | Category | Alternatives Discussed aOR (95% CI) |
p | Non-Treatment Consequences Discussed aOR (95% CI) |
p |
|---|---|---|---|---|---|
| Sex | Male (ref) | — | — | ||
| Female | 1.06 (0.69–1.60) | 0.798 | 0.82 (0.55–1.21) | 0.311 | |
| Age group | 18–30 years (ref) | — | — | ||
| 31–45 years | 1.48 (0.82–2.67) | 0.195 | 1.72 (0.97–3.03) | 0.063 | |
| 46–60 years | 1.29 (0.68–2.45) | 0.441 | 1.40 (0.76–2.58) | 0.273 | |
| ≥61 years | 2.07 (0.99–4.34) | 0.054 | 2.48 (1.24–4.98) | 0.010 | |
| Education level | Primary school or below (ref) | — | — | ||
| Middle school | 0.61 (0.29–1.29) | 0.192 | 0.80 (0.42–1.52) | 0.490 | |
| High school/vocational | 0.92 (0.39–2.16) | 0.845 | 0.89 (0.41–1.91) | 0.759 | |
| College or above | 3.88 (1.91–7.86) | <0.001 | 3.60 (1.87–6.92) | <0.001 | |
| Signer of the written form | Patient self-signing (ref) | — | — | ||
| Family-only signing | 0.98 (0.55–1.72) | 0.933 | 0.80 (0.47–1.35) | 0.403 | |
| Patient and family jointly signing | 1.27 (0.77–2.10) | 0.346 | 1.21 (0.76–1.93) | 0.428 | |
| Timing of receipt of the form | >1 day before surgery (ref) | — | — | ||
| 1 day before surgery | 0.56 (0.32–0.98) | 0.044 | 0.44 (0.25–0.75) | 0.003 | |
| A few hours before surgery | 0.47 (0.18–1.27) | 0.136 | 0.19 (0.07–0.52) | 0.001 | |
| Immediately before surgery | 0.18 (0.07–0.46) | <0.001 | 0.13 (0.05–0.31) | <0.001 | |
| Who delivered the form | Surgeon (ref) | — | — | ||
| Other doctor in the department | 0.33 (0.20–0.53) | <0.001 | 0.43 (0.28–0.67) | <0.001 | |
| Other staff/did not remember† | 0.58 (0.31–1.06) | 0.078 | 0.90 (0.51–1.61) | 0.729 | |
| Opportunity to ask questions | No opportunity/did not ask (ref) | — | — | ||
| Had opportunity | 1.80 (0.64–5.04) | 0.264 | 0.85 (0.37–1.92) | 0.691 |
Notes: Population: patients who reported receiving oral communication and had complete data for the multivariable models (n = 553). Bold text in the first column denotes the variable (predictor) headings and does not indicate statistical significance. †Other staff/did not remember includes nurses, anaesthesiologists, and respondents who did not remember who delivered the form.
Abbreviations: aOR, adjusted odds ratio; CI, confidence interval; ref, reference category.
Discussion
This study describes how postoperative patients recalled and perceived key elements of the surgical consent process, rather than providing an objective evaluation of its quality or validity. In this cross-sectional survey of elective general-surgery inpatients in a Chinese tertiary hospital, most participants reported receiving the written form, reading it carefully, and finding it understandable, and oral communication was almost universal and perceived as complete and easy to understand. The most notable pattern was uneven content breadth: clinicians most often covered diagnosis and the planned procedure, whereas alternatives and the consequences of non-treatment were reported much less frequently. In the multivariable analyses—which represent the main analytical contribution of the study—reported disclosure of alternatives and non-treatment consequences was higher among more highly educated patients but lower when the form was received close to surgery or delivered by a clinician other than the operating surgeon, and perceived understanding of the written form was strongly linked to whether it was explained at delivery. The distinction between perceived and actual understanding is important, because retrospective satisfaction may not correspond to comprehension or to the ethical adequacy of consent.
Selective Disclosure Appeared More Prominent Than the Absence of Consent-Related Communication
Within this selected sample, the salient finding was not the absence of consent-related communication but the apparently selective breadth of what patients recalled being discussed. Patients commonly reported that clinicians explained the diagnosis and the proposed operation, whereas disclosure of alternative options and the consequences of non-treatment was reported much less often. This pattern is ethically significant because disclosure of alternatives is central to autonomous authorization: a patient cannot make a meaningful treatment choice if the informational basis of the decision is restricted to the clinician’s preferred intervention.2 When discussion focuses primarily on what is recommended rather than on what may reasonably be chosen, informed consent risks becoming a procedural endorsement of medical advice rather than a process of deliberation among options.
This concern is consistent with a broader literature showing that surgical consent often remains formally complete while substantively incomplete. Written consent forms vary markedly in content and readability across institutions, and many are insufficiently designed to ensure access to consistent, decision-relevant information.8 Objective comprehension of diagnosis, risks, benefits, and alternatives is frequently limited even when consent has ostensibly been obtained.10 These comparisons should be interpreted with caution, however, because the cited evidence derives from different surgical contexts (for example, vascular surgery and research-consent settings) rather than from elective general surgery, and objective comprehension testing was not performed in the present study; the parallel is therefore conceptual rather than a direct, like-for-like comparison. From the perspective of medical ethics, the issue is not merely technical: the moral force of informed consent lies not in documentation alone but in whether the patient has been given the information needed to compare options in light of his or her own values, so that a process omitting alternatives or the likely consequences of non-treatment falls short both informationally and normatively.
The Greater Influence of Oral Communication is Both a Strength and a Source of Risk
Patients regarded oral communication as more influential for decision-making than the written form, a finding with dual significance. On the one hand, it reflects a strength of clinical dialogue: oral discussion allows clinicians to tailor explanation to the patient’s educational background, emotional state, and immediate concerns, and creates space for clarification, reassurance, and individualized framing of risk. This is consistent with prior work showing that patients value consent as an interactive communicative process rather than a purely documentary requirement,11 and that written forms alone are insufficient to meet patients’ informational and decisional needs.19
On the other hand, reliance on oral communication introduces ethical and practical risks. Verbal disclosure depends heavily on the communication style, habits, and time constraints of individual clinicians, and may generate inconsistency in risk disclosure, omission of key information, and inequity in understanding. Patients with higher education, greater confidence, or stronger family support may be more likely to elicit additional information, whereas patients with lower health literacy or greater anxiety may receive less effective disclosure despite formally undergoing the same process—an interpretation supported by the higher reported disclosure of alternatives and non-treatment consequences among more educated patients in our models. This strengthens the case for a systems approach in which standardized tools support, rather than replace, clinician–patient dialogue. A systematic review in surgery found that digital consent interventions improved early comprehension in many studies without reducing satisfaction or increasing anxiety;5 a randomized controlled trial in urological surgery reported that multimedia information provided before the consent consultation improved time efficiency while maintaining comparable satisfaction, anxiety, and information gain relative to paper-based consent;20 and randomized trials in Mohs surgery suggest that video-assisted consent can improve knowledge and may reduce physician time while maintaining or improving satisfaction.21 Together, these studies support the argument that, particularly in high-volume tertiary settings, improving consent quality should depend not on individual clinician style alone but on the institutional design of “standardized information plus structured conversation.”
Family Participation Should Be Interpreted as Support, Not Presumptive Substitution
Signatures were frequently shared with, or completed by, family members, consistent with the way perioperative decisions are often managed as a shared family responsibility in China, especially under time pressure and uncertainty. Most respondents also reported that doctors communicated orally with the patient or the family, indicating that real-world “being informed” is often mediated through conversation rather than the written document alone. Importantly, family involvement should not be interpreted only as substituting for the patient’s autonomy. In contexts where family ties are strong, family participation can function as a form of help-seeking—mobilizing support to understand complex information and cope with risk. An applied-ethics account notes that family bonds can provide support and improve the well-being of members who need help, even while acknowledging the potential to infringe on individual rights if family authority becomes coercive, and emphasizes that serious decisions are often shaped through dialogue with others.22 Framed this way, family presence in the consent encounter can be understood as a resource for comprehension and deliberation rather than as inherently paternalistic. In our context, family involvement may partly compensate for literacy and communication gaps; however, it may also amplify inequalities if only some families have the knowledge or confidence to ask questions. This supports a China-appropriate strategy: designing consent materials and conversations that explicitly include a supportive role for family members while safeguarding the patient’s agency—for example, through structured teach-back and standardized risk/alternative explanations.
Implications for Policy and Practice
The findings suggest three practical directions, which we present as implications for practice rather than as further interpretation of the data. First, at the level of content, institutions could define a minimum disclosure set for surgical consent—including, explicitly, reasonable alternatives and the consequences of non-treatment. Such a core disclosure framework would not eliminate the need for individualized explanation but would reduce the likelihood that ethically central information is omitted, directly addressing the disclosure gap observed here.
Second, at the procedural level, consent should be treated as a temporally ordered process rather than a last-minute formality, given that later receipt of the form was associated with lower reported disclosure of alternatives and non-treatment consequences. Patients need sufficient time to read, reflect, ask questions, and, where appropriate, discuss options with family before signing. Chinese quality-and-safety regulation already supports this orientation: the National Health Commission’s Core Medical Quality and Safety Systems specify that pre-operative discussion should be completed before surgical orders are issued and before the consent form is signed, and the 2025 monitoring indicators operationalize this by treating cases in which pre-operative discussion is completed after surgical orders or consent signing as non-compliant.23 These provisions provide a concrete regulatory basis for addressing “sign first, discuss later.”
Third, at the level of capacity-building and tools, consent quality could be strengthened through structured communication training and digital support. A proof-of-concept study in surgical informed consent found that teach-back improved knowledge-test performance and physician trust, although it increased interaction time by approximately 2.45 minutes,24 suggesting that it may be particularly valuable for high-risk procedures or patients with lower health literacy rather than being applied indiscriminately. Multimedia and digital platforms can assume responsibility for standardized baseline information and documentation, allowing clinicians to focus face-to-face discussion on patient-specific concerns. A combined model of standardized information delivery and structured, responsive dialogue therefore appears to be the most feasible direction for improving informed consent in busy tertiary hospitals.
Limitations
This study has several limitations. First, it was a single-centre, cross-sectional survey conducted in elective general surgery, which limits transferability to other specialties, hospital settings, or emergency contexts. Second, all measures of reading, understanding, completeness, and influence were based on postoperative patient self-report; the study captures retrospective perceptions of the consent process rather than direct observation of consent encounters, objective testing of comprehension, or formal evaluation of informed consent quality. Third, because interviews were conducted between postoperative days 2 and 7, responses may have been affected by recall bias, social-desirability bias, and the influence of a favourable postoperative course, all of which may inflate positive perceptions. Fourth, complete-case analysis was used, and several regression estimates had wide confidence intervals owing to low event counts, so the associations should be regarded as exploratory rather than causal. Finally, the questionnaire did not capture some potentially relevant constructs, such as overall satisfaction with care or objective surgical outcomes. These limitations should be borne in mind when interpreting the findings.
Conclusion
In this single-centre study of elective general surgery, most postoperative patients reported receiving written consent forms and retrospectively perceived both written and oral consent-related communication as understandable. However, alternatives and the consequences of non-treatment were reported far less frequently than diagnosis or the planned procedure, and reported disclosure of these elements was lower when the form was received close to surgery or delivered by a clinician other than the surgeon. Despite these positive perceptions, important gaps therefore remain in the breadth of decision-relevant information, such that high levels of reassurance and satisfaction coexisted with incomplete disclosure of options. Because these findings are based on retrospective patient self-report, they are subject to recall and social-desirability bias and should be interpreted as patient-reported perceptions of the consent communication process rather than as an objective assessment of understanding or of the overall quality of informed consent. Within these constraints, improving consent practice appears to require more than ensuring that forms are delivered and signed.
Acknowledgments
The authors thank all the participants and staff who helped in the completion of this study.
Funding Statement
This work was supported by the Nursing Humanities Research Center, Fujian Provincial University Research Base for Humanities and Social Sciences (ID: HLRW202506).
Declaration of AI-assisted writing
The authors used ChatGPT, an artificial intelligence tool, during manuscript preparation to assist with language editing and to provide suggestions for improving the abstract and overall manuscript presentation. The tool was not used to generate research data, conduct statistical analyses, or make scientific interpretations. All AI-assisted outputs were critically reviewed, verified, and edited by the authors. The authors take full responsibility for the accuracy, originality, integrity, and coherence of the manuscript, including all data, analyses, interpretations, and references. The authors confirm that they have reviewed the terms of use of the AI tool and that its use is suitable for publication.
Abbreviations
IC, informed consent; aOR, adjusted odds ratio; CI, confidence interval; STROBE, Strengthening the Reporting of Observational Studies in Epidemiology.
Data Sharing Statement
Data generated in this study are available from the corresponding author upon reasonable request.
Ethics Approval and Consent to Participate
This study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the Ethics Committee of Research and Clinical Technology Application, Ethics Committee of the First Affiliated Hospital of Fujian Medical University (ID: 2026[032]). All participants provided written informed consent prior to the interview. No identifiable personal data were collected, and all information was analysed in aggregated form.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
The authors declare that they have no competing interests in this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Data generated in this study are available from the corresponding author upon reasonable request.
