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This randomized, double-blind, controlled trial investigates whether prompting patients facing elective cataract surgery to articulate their specific conditions for choosing surgery (a structured self-reflection intervention commonly used in Shared Decision-Making) affects their subsequent decision to undergo the procedure. Eligible cataract patients who have been informed of surgical indications at an outpatient visit will be randomly assigned 1:1 to an intervention group (structured writing about personal conditions for accepting surgery) or a control group (no writing task). Both groups read the same standardized information about cataract diagnosis and treatment, and both complete the same set of follow-up questionnaire items. Three treating physicians independently rate their degree of surgical recommendation for each patient; these ratings along with baseline clinical measures are included as covariates in the analysis. The primary outcome is whether participants register for cataract surgery within 6 months of their initial outpatient consultation. Secondary outcomes include self-reported understanding of the condition, clarity of treatment plan, condition-related anxiety, perceived urgency, perceived helpfulness of the consultation, semantic analysis of written responses, and patient experience measures.
Shared Decision-Making (SDM) tools for elective surgery often include exercises that ask patients to clarify under what conditions they would choose surgery. While such prompts have been effective for promoting medication adherence and vaccination, elective surgery is a higher-stakes decision involving pain, recovery, and cost concerns. A preliminary study of 60 patients found that 16.7% of controls versus 0% of intervention participants registered for surgery within 4 months, raising the hypothesis that structured self-reflection may inadvertently reduce surgical uptake by heightening patients' concerns.
Both groups first read a standardized paragraph explaining their cataract diagnosis and the availability of phacoemulsification surgery. The intervention group then receives a structured prompt asking them to write in detail about the specific conditions under which they would feel confident choosing surgery (e.g., "When I can confirm post-operative care from family for 3 days, I would be willing to proceed"). The control group does not receive a writing task and proceeds directly to the follow-up questionnaire items, which are identical across groups.
Three treating physicians each recruit from their own outpatient clinics within the same hospital. Each physician provides standardized, non-directive explanations of the condition and treatment options, and independently rates their degree of surgical recommendation for each of their patients based on their clinical judgment of surgical appropriateness. These physician recommendation ratings are included as covariates in the analysis. Baseline ophthalmic clinical measures - including visual acuity, best corrected visual acuity (BCVA), presence of fundus pathology or other ocular comorbidities, BCVA of the contralateral eye, cataract type and grade, and intraocular pressure - are also recorded and may be included as covariates.
After questionnaire completion, research assistants will track whether each participant registers for surgery within 6 months. Following surgery or the 6-month endpoint (whichever is earlier), participants will be fully debriefed and asked for informed consent. Data from participants who decline consent will be destroyed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured Self-Reflection (Intervention) | Experimental | Participants receive a structured prompt via an online questionnaire asking them to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept elective cataract surgery. For example: "When I can confirm that my children will be available for 3 days post-surgery, I would be willing to undergo the operation." This intervention guides participants to actively define a personal pathway toward the surgical decision |
|
| No Writing Task (Control) | No Intervention | After reading the same standardized introductory paragraph about cataract diagnosis and treatment as the intervention group, control participants proceed directly to the follow-up questionnaire items without any writing task. All subsequent questionnaire items are identical to those completed by the intervention group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Surgical Planning Self-Reflection | Behavioral | Participants are guided through an online structured writing exercise that prompts them to articulate the specific personal conditions under which they would choose to undergo elective cataract surgery. The prompt is embedded within an online questionnaire presented under the cover story of a comprehensive clinical assessment. It asks participants to think carefully and write down the specific conditions or circumstances under which they would feel confident and willing to accept the surgery, considering factors such as physical readiness, work, family, finances, timing, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Surgical Registration Within 6 Months | Proportion of participants who register (sign up) for cataract surgery at the Shanghai General Hospital Ophthalmology Clinical Center within 6 months of their initial outpatient consultation at which they were informed of surgical indications. Determined by cross-referencing surgery registration lists with study participant records. | 6 months from initial outpatient consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Understanding of Cataract Condition (3-point scale, 1 = not at all, 3 = very much) | Patient-reported level of understanding of their cataract condition following the outpatient consultation, measured via a single-item self-assessment in the online questionnaire. | At time of questionnaire completion (Within 48 hours post-initial outpatient consultation) |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Surgical Recommendation Rating (5-point scale, 1 = very weak, 3 = very strong) | Each of the three treating physicians independently rates their degree of recommendation for surgery for each patient they see, based on their clinical judgment of surgical appropriateness. These ratings serve as covariates to control for between-patient variation in clinical indication severity and between-physician variation in recommendation tendencies. Time Frame: At time of initial outpatient consultation |
Inclusion Criteria:
1. Diagnosed with one of the following: age-related cataract, complicated cataract, traumatic cataract, metabolic cataract, or congenital cataract 2. Age 18+ years 3. Baseline intraocular pressure (IOP) ≤ 21 mmHg 4. Axial length 20-30 mm 5. No intraocular surgery within the past 3 months 6. Meets at least ONE of the following functional criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Y. Charles Zhang | Contact | +86 13262886498 | yizi@tongji.edu.cn |
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all the primary, secondery, and other outcome measures.
Starting 12 months after publication
all information can be requested by emailing Charles Zhang
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Participants are not informed of the study's true hypothesis or the existence of the other study arm. Outcome assessors (research assistants tracking surgical registration) are blinded to group assignment. The three treating physicians provide standardized information and are blinded to each patient's group allocation. Randomization is acheived through the survey platform.
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| Clarity of Treatment Plan (3-point scale, 1 = not at all, 3 = very much) | Patient-reported sense of having a clear plan regarding subsequent treatment for their eye condition, measured via a single-item self-assessment. | At time of questionnaire completion (Within 48 hours post-initial outpatient consultation) |
| Condition-Related Anxiety (3-point scale, 1 = not at all, 3 = very much) | Patient-reported level of anxiety about their current cataract condition, measured via a single-item self-assessment. | At time of questionnaire completion (Within 48 hours post-initial outpatient consultation) |
| Perceived Urgency to Act (3-point scale, 1 = not at all, 3 = very much) | Patient-reported perceived urgency of taking the next step for their cataract condition, measured via a single-item self-assessment. | At time of questionnaire completion (Within 48 hours post-initial outpatient consultation) |
| Perceived Helpfulness of Consultation (3-point scale, 1 = not at all, 3 = very much) | Patient-reported overall assessment of how helpful the outpatient visit was, measured via a single-item self-assessment. | At time of questionnaire completion (Within 48 hours post-initial outpatient consultation) |
| Semantic Content Analysis of Written Responses | Qualitative and quantitative analysis of the text written by intervention-group participants in the structured self-reflection task, examining themes, specificity, emotional valence, and their correlation with surgical uptake. | At time of questionnaire completion (Within 48 hours post-initial outpatient consultation) |
| within 24 hours of initial outpatient consultation |
| Presenting Visual Acuity (Study Eye) | logMAR of the presenting visual acuity of the study eye measured using a standardized chart. | Baseline (initial outpatient consultation) |
| Best Corrected Visual Acuity (Study Eye) | logMAR of the best corrected visual acuity of the study eye following refraction. | Baseline (initial outpatient consultation) |
| Best Corrected Visual Acuity (Contralateral Eye) | logMAR of the corrected visual acuity of the non-study eye measured using a standardized chart. | Baseline (initial outpatient consultation) |
| Intraocular Pressure (Study Eye) | mmHg of the intraocular pressure measured using tonometry. | Baseline (initial outpatient consultation) |
| Presence of fundus pathology or other ocular comorbidities as assessed during clinical examination. | Proportion of participants with ≥1 comorbidity (%) | Baseline |
| Cataract Morphological Type | Classification of cataract type (e.g., nuclear, cortical, posterior subcapsular). | Baseline |
| Cataract Severity Grade | Cataract severity graded using LOCS III. | Baseline |