ABSTRACT
Background
Informed consent is a cornerstone of modern medicine, yet the extent to which patients truly understand surgical information in the perioperative setting remains uncertain, particularly among older and vulnerable populations. Orthopaedic surgery represents a particularly challenging context, as trauma pathways are often characterized by urgency, pain, and emotional stress, whereas elective procedures allow greater opportunity for structured communication.
Aims
To assess real‐time patient comprehension of surgical informed consent immediately before orthopaedic surgery and to compare understanding between elective and trauma pathways.
Methods
We conducted a prospective observational study at a single tertiary referral hospital in Northern Italy between January 2023 and December 2024. Approximately 870 adult orthopaedic surgical patients were screened for eligibility. After exclusion of patients with cognitive impairment, severe psychiatric illness, language barriers, refusal to participate, or incomplete questionnaires, 750 consecutive patients were included in the final analysis (460 elective, 290 trauma). All patients had received standard preoperative explanations and completed institutional informed consent procedures. In routine clinical practice, consent discussions generally involved both an orthopaedic resident and the supervising attending surgeon. Comprehension was assessed immediately before transfer to the operating room using a brief standardized four‐item tool evaluating understanding of the planned procedure, risks, benefits, and therapeutic alternatives. Responses were independently categorized as absent, vague/partial, or adequate.
Results
Overall, 488 patients (65.1%) demonstrated absent comprehension, 188 (25.1%) vague or partial comprehension, and only 74 (9.9%) adequate comprehension. Trauma patients showed significantly lower overall comprehension than elective patients, with fewer patients demonstrating at least partial comprehension (28.3% vs. 39.1%; p = 0.003). Adequate comprehension remained low in both groups (8.3% vs. 10.9%; p = 0.30). Older age and lower educational attainment were associated with poorer comprehension in exploratory analyses. Mean questionnaire completion time was 3.5 ± 1.2 min.
Discussion
Despite repeated explanations and signed consent forms, most patients entered the operating room without meaningful understanding of the planned procedure, risks, benefits, or alternatives. The observed deficit was present in both elective and trauma settings, suggesting a systemic limitation of routine consent processes rather than solely a physician‐specific communication issue.
Conclusions
Informed consent in orthopaedic surgery frequently fails to ensure patient comprehension. Consent should be reframed as a dynamic verification process rather than a purely administrative requirement, incorporating structured communication pathways, simplified language, and teach‐back–based strategies tailored to both elective and trauma settings.
Keywords: informed consent, orthopaedic surgery, patient comprehension, shared decision‐making, trauma surgery
1. Introduction
Informed consent is intended to protect patient autonomy and support shared decision‐making, and represents a fundamental component of ethical clinical practice [1, 2]. In principle, the consent process should enable patients to understand the nature of the proposed intervention, its expected benefits, potential risks, and available alternatives, thereby allowing them to make an informed and voluntary decision. However, in routine clinical practice, informed consent may become primarily a procedural or administrative requirement rather than a verified process of patient understanding [3, 4, 5].
Previous studies have shown that many surgical patients have limited comprehension or recall of essential information related to their planned procedure, even after formal consent documentation has been completed. Deficits in comprehension may involve not only technical details of the operation, but also higher‐order elements of consent, such as risks, expected outcomes, and treatment alternatives [6, 7, 8]. These limitations appear particularly relevant among older adults, patients with lower educational attainment or limited health literacy, and individuals exposed to stressful or time‐sensitive clinical circumstances [7, 8, 9].
Orthopaedic surgery represents a particularly relevant setting in which to examine the quality of informed consent. Elective procedures usually allow time for preoperative counselling, repeated discussion, and patient reflection. By contrast, trauma surgery often occurs in a context of acute pain, anxiety, emotional distress, hospitalization, and urgency, all of which may impair information processing and recall [9, 10]. Nevertheless, even in elective pathways, repeated exposure to information does not necessarily ensure meaningful understanding unless comprehension is actively assessed. Therefore, the key limitation of routine consent may not be only whether information has been provided, but whether the patient has actually understood it.
Although informed consent has been widely studied, important methodological limitations remain. Many previous investigations have relied on postoperative recall, patient satisfaction, or documentation‐based assessments, whereas fewer studies have evaluated comprehension immediately before surgery, after completion of the standard consent pathway and at the moment when consent becomes clinically operative [6, 8, 11]. In addition, limited evidence is available comparing elective and trauma orthopaedic patients within the same institutional framework and under routine real‐world conditions.
The present prospective observational study was therefore designed to evaluate patients' actual comprehension of surgical informed consent immediately before orthopaedic surgery, after routine explanations and formal consent documentation had already been completed. The primary aim was to compare comprehension between elective and trauma pathways. Secondary exploratory aims were to assess whether demographic and procedural factors were associated with poorer understanding. We hypothesized that a substantial proportion of patients would demonstrate limited comprehension despite standard consent procedures, with lower comprehension expected among trauma patients and vulnerable subgroups.
2. Materials and Methods
2.1. Design and Setting
This prospective observational study was conducted at a single tertiary referral hospital in Northern Italy between January 2023 and December 2024. The Department of Orthopaedics and Traumatology performs a high volume of both elective and trauma procedures. The study was designed to evaluate real‐world patient comprehension of surgical informed consent under routine institutional conditions, without modifying the standard consent pathway, surgical indication, timing of surgery, or perioperative workflow. The reporting of the study was guided by principles for observational research reporting [12].
2.2. Population, Eligibility and Patient Flow
During the study period, approximately 870 adult orthopaedic surgical patients were screened for eligibility, and 750 were included in the final analysis. Exclusion criteria included documented cognitive impairment, severe psychiatric illness, language barriers preventing reliable assessment, refusal to participate, inability to complete the questionnaire, or incomplete questionnaire data. The exact distribution of exclusions across these categories was not prospectively recorded and is acknowledged as a methodological limitation.
To minimize response bias, consecutive screening was used throughout the 24‐month recruitment period. Patients were assessed under routine clinical conditions immediately before surgery, without selection according to procedure type, surgeon, clinical pathway, or expected level of comprehension.
The final cohort was stratified into two groups: the elective group, including patients undergoing procedures scheduled in advance such as total hip and knee arthroplasties, arthroscopic interventions, and corrective osteotomies; and the trauma group, including patients undergoing urgent or emergency surgery for acute injuries such as proximal femur, distal radius, or shoulder fractures.
Given the exploratory and observational nature of the study, no formal a priori sample size calculation was performed. Instead, a pragmatic consecutive sampling strategy was adopted, including all eligible patients over a predefined 24‐month recruitment period. This approach was chosen to maximize representativeness, provide adequate precision for estimating comprehension levels, and allow exploratory comparison between elective and trauma pathways.
2.3. Inclusion and Exclusion Criteria
Inclusion criteria were age ≥ 18 years, ability to communicate in Italian, and prior completion of the standard institutional written informed consent form for the planned surgical procedure.
Exclusion criteria were documented cognitive impairment, severe psychiatric illness, language barriers preventing reliable assessment, inability or unwillingness to complete the questionnaire, refusal to participate, and incomplete questionnaire data.
2.4. Consent Pathway and Timing of Assessment
All patients had already received routine preoperative explanations and had signed the standard institutional surgical informed consent form before inclusion in the study.
In routine clinical practice, information regarding the planned procedure was provided by both an orthopaedic resident and the supervising attending surgeon. The attending surgeon was responsible for final confirmation of the surgical indication and completion of the consent documentation. Trauma patients received information during Emergency Department evaluation at the time of admission and again during hospitalization before surgery. Elective patients received information during the pre‐admission pathway and again at hospital admission before surgery.
The comprehension assessment was performed immediately before transfer to the operating room, after completion of all routine consent procedures. This timing was chosen to evaluate patient understanding at the final moment before surgery, when consent becomes clinically operative. Educational level was extracted from available clinical or administrative records when documented.
The physician administering the questionnaire had not obtained the patient's informed consent and was not involved in the planned surgical procedure. Verbatim responses were subsequently evaluated independently by two physicians who had not conducted the original consent discussion. This separation between consent delivery and comprehension assessment was intended to reduce observer bias and avoid overlap between the physicians providing information and the physicians evaluating patient understanding.
Because the study was designed to evaluate real‐world comprehension under standard institutional conditions, the physicians involved in the consent process were not artificially standardized. Consent discussions occurred across ward and emergency settings and involved different members of the orthopaedic team according to routine clinical workflow. The identity and specific communication style of the physicians involved in each consent discussion were not recorded as study variables. Therefore, provider‐level effects, clustering by physician, and differences in individual communication style could not be formally assessed. Because no multivariable regression model including provider‐related variables was performed, multicollinearity between provider characteristics and clinical pathway was not statistically evaluated.
2.5. Comprehension Tool and Scoring
Patients were invited to complete a brief standardized four‐item verbal questionnaire designed to assess comprehension of the essential elements of informed consent. The questionnaire evaluated understanding of the planned surgical procedure, main risks or complications, expected benefits, and therapeutic alternatives.
A study‐specific tool was used because the objective was to assess essential, real‐time comprehension immediately before surgery in both elective and trauma settings. Many established comprehension instruments are lengthy, procedure‐specific, or designed for research contexts that may be difficult to apply in the immediate perioperative workflow, particularly in urgent trauma cases. The aim was therefore not to replace validated psychometric instruments, but to provide a pragmatic, low‐burden assessment of the core domains of informed consent under real‐world clinical conditions. These domains were selected because they correspond to the essential elements commonly required for informed surgical decision‐making: understanding the nature of the intervention, its risks, expected benefits, and available alternatives [1, 2, 3, 11].
All interviews were conducted by the same orthopaedic physician from the study team using a standardized verbal format. This approach was chosen to ensure consistency in questionnaire administration and reduce variability related to interviewer technique. Patients' answers were recorded verbatim and subsequently evaluated independently by two physicians according to predefined scoring criteria. Any disagreement in classification was resolved through consensus discussion.
The study‐specific questionnaire and predefined scoring criteria are summarized in Table 1. The mean time required for questionnaire completion was 3.5 ± 1.2 min.
Table 1.
Study‐specific questionnaire and scoring criteria.
| Domain | Question | Adequate | Vague/Partial | Absent |
|---|---|---|---|---|
| Procedure | What surgical procedure are you undergoing today? | Correct and specific answer | Generic or partially correct answer | Incorrect answer or “I don't know” |
| Risks | What are the main risks or complications of this procedure? | ≥ 2 appropriate risks identified | 1 generic risk identified | Incorrect answer or “I don't know” |
| Benefits | What are the expected benefits of this surgery? | Specific and correct answer | Generic or partially correct answer | Incorrect answer or “I don't know” |
| Alternatives | What alternatives were explained to you? | ≥ 1 realistic therapeutic alternative identified | Incomplete or vague answer | “None” or incorrect answer |
Global comprehension was classified as follows: absent comprehension was assigned when all responses were incorrect, irrelevant, or “I don't know”; vague or partial comprehension was assigned when one or two responses were partially correct but lacked essential detail; adequate comprehension was assigned when at least three responses were correct and complete.
2.6. Inter‐Rater Agreement
Because the questionnaire was developed specifically for this study and had not undergone formal psychometric validation, patients' verbatim responses were independently reviewed by two physicians according to predefined scoring criteria. Disagreements were resolved through consensus discussion. This approach was adopted to improve classification consistency and partially mitigate the limitations related to the use of a study‐specific comprehension tool.
Formal inter‐rater reliability statistics, including Cohen's kappa, were not prospectively planned. Therefore, the number of initial disagreements and Cohen's kappa were not available for the present analysis [13]. This is acknowledged as a methodological limitation, particularly because the tool was self‐developed and lacks formal validation.
2.7. Statistical Analysis
Descriptive statistics were expressed as frequencies and percentages. Ninety‐five percent confidence intervals were calculated using the Clopper–Pearson exact method [14]. Comparisons between elective and trauma groups were performed using the chi‐square test. A p‐value < 0.05 was considered statistically significant.
The primary comparison was comprehension between elective and trauma patients. Secondary analyses according to age, educational level, procedure type, and questionnaire domain were considered exploratory and hypothesis‐generating. No formal adjustment for multiple comparisons was applied to these secondary analyses. Therefore, subgroup p‐values were interpreted cautiously and were not considered confirmatory.
No multivariable regression model was performed because the study was designed as a pragmatic observational assessment of real‐world comprehension rather than as a predictive modelling study. In addition, provider‐level variables were not systematically collected, and adjustment for clustering by physician or provider‐related multicollinearity was therefore not possible.
2.8. Ethical Considerations
The study was purely observational and non‐interventional. It consisted solely of a brief verbal questionnaire administered immediately before surgery, without any influence on clinical decisions, surgical indication, timing of surgery, workflow, or patient management.
No identifiable personal data were collected, and all responses were fully anonymized. Participation was voluntary, and verbal consent to complete the questionnaire was obtained from each participant before inclusion.
According to institutional policy, the study protocol was reviewed and classified as exempt from formal ethics committee approval because of its minimal‐risk, fully anonymized, non‐interventional nature. The study adhered to the principles of the Declaration of Helsinki and complied with European data protection regulations [15].
3. Results
3.1. Patient Flow and Study Population
During the study period, approximately 870 adult orthopaedic surgical patients were screened for eligibility. After exclusion of patients with documented cognitive impairment, severe psychiatric illness, language barriers preventing reliable assessment, refusal to participate, inability to complete the questionnaire, or incomplete questionnaire data, 750 patients were included in the final analysis.
The final study population consisted of 460 elective patients and 290 trauma patients. No patient included in the final analysis had missing comprehension data.
3.2. Overall Comprehension
Overall comprehension of informed consent was low. Among the 750 patients evaluated, 488 patients demonstrated absent comprehension, corresponding to 65.1% of the cohort (95% CI 61.6–68.5). A further 188 patients showed vague or partial comprehension, corresponding to 25.1% (95% CI 22.0–28.5), whereas 74 patients achieved adequate comprehension, corresponding to 9.9% (95% CI 7.9–12.4). Overall comprehension levels are summarized in Table 2.
Table 2.
Overall comprehension levels in the study population, n = 750.
| Comprehension level | n (%) | 95% CI |
|---|---|---|
| Absent | 488 (65.1%) | 61.6–68.5 |
| Vague/Partial | 188 (25.1%) | 22.0–28.5 |
| Adequate | 74 (9.9%) | 7.9–12.4 |
Thus, fewer than one in ten patients demonstrated adequate understanding of the planned procedure, its risks, expected benefits, and available alternatives immediately before surgery.
3.3. Elective Versus Trauma Patients
When stratified by surgical setting, comprehension was limited in both groups but was lower among trauma patients. In the elective group, 280 of 460 patients (60.9%) showed absent comprehension, 130 (28.3%) showed vague or partial comprehension, and 50 (10.9%) achieved adequate comprehension. In the trauma group, 208 of 290 patients (71.7%) showed absent comprehension, 58 (20.0%) showed vague or partial comprehension, and 24 (8.3%) achieved adequate comprehension.
The overall distribution of comprehension categories differed significantly between elective and trauma patients (p = 0.010). Patients undergoing elective surgery were more likely to demonstrate at least partial comprehension than trauma patients (180/460, 39.1% vs. 82/290, 28.3%; p = 0.003). Adequate comprehension remained low in both groups and was numerically higher in elective patients than in trauma patients (50/460, 10.9% vs. 24/290, 8.3%; p = 0.30). Comprehension levels by surgical setting are summarized in Table 3.
Table 3.
Comprehension levels by surgical setting.
| Group | n | Absent | Vague/Partial | Adequate |
|---|---|---|---|---|
| Elective | 460 | 280 (60.9%) | 130 (28.3%) | 50 (10.9%) |
| Trauma | 290 | 208 (71.7%) | 58 (20.0%) | 24 (8.3%) |
| Total | 750 | 488 (65.1%) | 188 (25.1%) | 74 (9.9%) |
3.4. Subgroup and Exploratory Analyses
Secondary exploratory analyses suggested lower comprehension among older patients and among patients with lower educational attainment. Adequate comprehension was observed in 47 of 380 patients aged < 70 years (12.4%) and in 27 of 370 patients aged ≥ 70 years (7.3%; p = 0.02).
Educational level was also associated with comprehension. Among patients with university or higher education, adequate comprehension was observed in 36 of 210 patients (17.1%), compared with 38 of 540 patients with lower educational attainment (7.0%; p < 0.001).
In the elective cohort, adequate comprehension varied according to procedure type. Adequate comprehension was observed in 19 of 240 arthroplasty patients (7.9%) and in 31 of 220 patients undergoing arthroscopy, osteotomy, or day‐surgery procedures (14.1%; p = 0.048). In the trauma cohort, adequate comprehension was observed in 24 of 290 patients (8.3%), with no major variation across the main fracture categories.
Because these subgroup analyses were exploratory and were not adjusted for multiple comparisons, their findings should be interpreted cautiously.
3.5. Domain‐Specific Comprehension
Domain‐specific analysis showed that the planned procedure was the most frequently understood component of informed consent, with adequate responses in 240 of 750 patients (32.0%). By contrast, risks and therapeutic alternatives were the least frequently understood domains, with adequate responses in 83 of 750 patients (11.1%) and 45 of 750 patients (6.0%), respectively. Expected benefits were adequately understood by 113 of 750 patients (15.1%). Subgroup and domain‐specific findings are summarized in Table 4.
Table 4.
Subgroup and domain‐specific findings.
| Variable | n | Adequate comprehension, n (%) | p‐value |
|---|---|---|---|
| Age < 70 years | 380 | 47 (12.4%) | 0.02 |
| Age ≥ 70 years | 370 | 27 (7.3%) | |
| Higher education | 210 | 36 (17.1%) | < 0.001 |
| Low education | 540 | 38 (7.0%) | |
| Elective—arthroplasty | 240 | 19 (7.9%) | 0.048 |
| Elective—arthroscopy/osteotomy | 220 | 31 (14.1%) | |
| Trauma—fractures | 290 | 24 (8.3%) | NS |
| Question 1: procedure | 750 | 240 (32.0%) | — |
| Question 2: risks | 750 | 83 (11.1%) | — |
| Question 3: benefits | 750 | 113 (15.1%) | — |
| Question 4: alternatives | 750 | 45 (6.0%) | — |
This pattern indicated that patients were more likely to recall the name or type of procedure than to understand more complex elements of informed consent, such as complications, expected benefits, and alternative treatment options.
3.6. Summary of Findings
In this prospective cohort of 750 orthopaedic surgical patients, comprehension of informed consent immediately before surgery was limited. Approximately two thirds of patients demonstrated absent comprehension, and fewer than one in ten achieved adequate comprehension. Trauma setting, older age, and lower educational attainment were associated with poorer comprehension in exploratory analyses. Across domains, patients more frequently understood the planned procedure than risks, expected benefits, or alternatives.
4. Discussion
This prospective observational study demonstrates a marked discrepancy between the formal completion of informed consent and patients' actual comprehension immediately before orthopaedic surgery. Although all included patients had received routine preoperative explanations and had signed the institutional consent form, approximately two thirds demonstrated absent comprehension, and fewer than one in ten achieved adequate understanding of the planned procedure, its risks, expected benefits, and available alternatives. These findings suggest that the main weakness of routine informed consent may not be the absence of information delivery, but the lack of systematic verification that information has been understood.
The timing of the assessment represents one of the most relevant aspects of this study. Patients were interviewed immediately before transfer to the operating room, after completion of the standard consent pathway and at the moment when consent becomes clinically operative. This approach differs from studies based on postoperative recall, satisfaction surveys, or documentation review, and provides a real‐time estimate of patient understanding at the final point before surgery. From this perspective, the results highlight a clinically important gap between procedural consent and meaningful informed decision‐making. A signed form may document that information was provided, but it does not necessarily demonstrate that the patient has understood the nature of the intervention or the decision being made [1, 2, 3, 5, 7].
The comparison between elective and trauma pathways further supports this interpretation. Trauma patients showed poorer comprehension than elective patients, with a significantly higher proportion of absent comprehension and a lower rate of at least partial understanding. This finding is consistent with the clinical reality of trauma care, where acute pain, anxiety, emotional overload, hospitalization, and time‐sensitive decision‐making may reduce the patient's ability to process and retain information [8, 9]. However, the low comprehension observed among elective patients is equally relevant. Even in scheduled procedures, where patients usually have more time for counselling, repeated explanations, and preoperative reflection, adequate comprehension remained uncommon. This suggests that repetition alone is insufficient if communication remains primarily unidirectional and if patient understanding is not actively checked [10, 11].
The observed association between lower comprehension, older age, and lower educational attainment should be interpreted cautiously because these subgroup analyses were exploratory and not adjusted for multiple comparisons. Nevertheless, the pattern is clinically plausible and consistent with the broader literature on health literacy and surgical communication [6, 7, 8]. Informed consent often requires patients to understand complex concepts, including probabilistic risks, expected benefits, uncertainty, and alternatives. These elements may be particularly difficult to process for older patients, individuals with lower educational attainment, or patients experiencing pain, stress, or acute hospitalization. The findings therefore reinforce the need for consent strategies that are not only legally complete but also cognitively accessible.
A particularly important finding emerged from the domain‐specific analysis. Patients were more likely to identify the planned procedure than to describe risks, expected benefits, or alternatives. This suggests that basic procedural recall is easier to retain than the more complex decisional components of informed consent. Knowing the name or general type of operation does not necessarily imply that the patient understands the possible complications, the expected functional benefit, or the existence of reasonable alternatives. In this sense, informed consent should not be evaluated only by asking whether the patient knows “what operation” is planned, but also whether the patient can explain, in their own words, why the procedure is being performed, what could go wrong, what benefit is expected, and what other options exist [10, 13].
These results are consistent with previous evidence showing that patient comprehension after surgical consent is frequently incomplete. Prior studies and systematic reviews have reported limited understanding of procedural risks, benefits, and alternatives despite formal consent documentation [5, 6, 7]. The present study adds to this literature by focusing specifically on orthopaedic surgery, by comparing elective and trauma pathways within the same institutional setting, and by assessing comprehension immediately before surgery rather than after the event. This design allowed us to evaluate consent comprehension under real‐world perioperative conditions, where clinical workload, emotional stress, and institutional workflows may all influence the quality of communication.
From a practical perspective, these findings support a shift from information disclosure to comprehension verification. In elective orthopaedic surgery, this may include structured preoperative education, simplified written materials, visual aids, staged counselling, and opportunities for patients to revisit information before admission. In trauma surgery, where time and stress limit the possibility of extended counselling, consent strategies should be concise, focused on the most relevant information, and supported by rapid comprehension checks. In both settings, teach‐back methods may be particularly useful because they require patients to restate the essential elements of the decision in their own words, allowing clinicians to identify misunderstandings before surgery [16, 17, 18].
The brief four‐item questionnaire used in this study may represent a pragmatic model for integrating comprehension checks into perioperative workflows. The tool was not intended to replace validated psychometric instruments, and its self‐developed nature is an important limitation. However, its short completion time suggests that real‐time assessment of essential comprehension is feasible even in busy surgical environments. A structured check of understanding could be incorporated into preoperative routines or surgical safety processes, not as an additional bureaucratic requirement, but as a quality safeguard to ensure that consent is truly informed [19, 20].
The findings also have ethical, organizational, and medico‐legal implications. Ethically, informed consent should protect autonomy and support shared decision‐making. Organizationally, patient comprehension may be considered a measurable indicator of communication quality within perioperative care. Medico‐legally, documentation that understanding was actively verified may be more meaningful than reliance on the signed form alone. This is particularly relevant in orthopaedic surgery, where procedures are often invasive, technically complex, and associated with important functional consequences. In this context, improving consent comprehension may strengthen patient trust, reduce misunderstanding, and support a more transparent therapeutic alliance.
Several limitations should be acknowledged. First, the study was conducted at a single tertiary referral hospital, which may limit generalizability to other institutions or healthcare systems. Second, although consecutive screening was used over a 24‐month recruitment period, the exact distribution of exclusions across categories, including refusal to participate, was not prospectively recorded. Residual selection or response bias therefore cannot be excluded. Third, the comprehension tool was specifically developed for pragmatic use in the immediate preoperative setting and has not undergone formal psychometric validation. Accordingly, the results should be interpreted as estimates of essential consent comprehension rather than as outcomes derived from a validated comprehension instrument.
Additional methodological limitations are relevant. Although questionnaire administration was standardized and performed by a physician who had not obtained the patient's consent and was not involved in the planned surgical procedure, the use of a single interviewer may have introduced interviewer‐related bias. Patients' responses were independently evaluated by two physicians who had not conducted the original consent discussion; however, formal inter‐rater reliability statistics, including Cohen's kappa, were not prospectively planned and were therefore unavailable [13]. Moreover, although routine consent involved both an orthopaedic resident and a supervising attending surgeon, the identity and communication style of the physicians obtaining consent were not systematically recorded. Provider‐level effects, clustering by physician, and the potential influence of individual communication styles could therefore not be assessed. Finally, subgroup analyses according to age, education, procedure type, and questionnaire domain were exploratory and not adjusted for multiple comparisons; these findings should therefore be considered hypothesis‐generating rather than confirmatory.
Despite these limitations, the study provides clinically relevant evidence that routine informed consent in orthopaedic surgery may succeed as a formal process while failing as a comprehension process. The central issue is not only whether information is delivered, but whether understanding is verified. Consent should therefore evolve from a signed document into a structured, patient‐centered dialogue. Elective pathways should incorporate clearer educational strategies and repeated opportunities for clarification, while trauma pathways require concise, adaptive, and stress‐sensitive communication. True informed consent is achieved not when a form is signed, but when the patient understands the treatment to which they agree.
5. Conclusions
This study demonstrates a substantial gap between the formal completion of informed consent and patients' actual comprehension immediately before orthopaedic surgery. Despite routine explanations and signed consent forms, most patients did not show adequate understanding of the planned procedure, its risks, expected benefits, or available alternatives.
These findings suggest that informed consent should not be regarded as a purely administrative or medico‐legal act, but as a dynamic communicative process requiring verification of understanding. In elective orthopaedic surgery, this requires structured discussions, simplified language, and supportive educational materials. In trauma settings, where urgency, pain, and stress may limit information processing, concise communication supported by rapid comprehension checks appears particularly important.
Ensuring that patients truly understand the treatment to which they consent is both an ethical obligation and a key component of safe, patient‐centered care. True informed consent is achieved not when a form is signed, but when understanding is verified.
Author Contributions
Filippo Raggini conceived and designed the study, administered the comprehension questionnaire, collected the data, analysed and interpreted the results, and drafted the manuscript. Alberto Vassallo independently reviewed the patients' verbatim responses together with Filippo Raggini according to the predefined scoring criteria, contributed to data interpretation, and critically revised the manuscript.
Both authors read and approved the final manuscript.
Funding
The authors have nothing to report.
Ethics Statement
The study was conducted in accordance with the Declaration of Helsinki. The study protocol was reviewed according to institutional policy and was deemed exempt from formal ethics committee approval because of its minimal‐risk, fully anonymized, non‐interventional nature.
All patients had provided standard written informed consent for the surgical procedure, as required by institutional practice. Participation in the comprehension assessment was voluntary, and verbal consent to complete the questionnaire was obtained immediately before administration. No identifiable personal data were collected.
Consent
The authors have nothing to report.
Conflicts of Interest
Filippo Raggini and Alberto Vassallo declare that they have no conflict of interest.
Data Availability Statement
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.
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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
The datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request.