cd /home/daytona/workspace/attachments/8ac9118f-c148-4bbf-aff1-ca344c551c7e && p…

cd /home/daytona/workspace/attachments/8ac9118f-c148-4bbf-aff1-ca344c551c7e && p…

cd /home/daytona/workspace/attachments/8ac9118f-c148-4bbf-aff1-ca344c551c7e && p…

ls /home/daytona/workspace/

ls /home/daytona/workspace/naveed-synopsis-revised/

~/naveed-synopsis-revised/build_final.js

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const fs = require('fs');

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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 1 – TITLE PAGE
// ─────────────────────────────────────────────────────────────────────────────
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 2 – UHS FORM
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    formRow('Synopsis submitted for:', 'M.S Urology'),
    formRow('Discipline:', 'Urology'),
    formRow('Name of the Applicant:', 'Dr. Hafiz Naveed Ul Hassan Sajid'),
    formRow('Date of Birth:', '14/10/1997'),
    formRow('University Registration Number:', '2016-SHMC-0071-UHS'),
    formRow('Nationality:', 'Pakistani'),
    formRow('CNIC #:', '35301-8900706-1'),
    formRow('Address:', 'Mouza Mancharian Tehsil Depalpur District Okara'),
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 3 – QUALIFICATIONS
// ─────────────────────────────────────────────────────────────────────────────
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  para('Matric 2013'),
  para('F.Sc 2015'),
  para('MBBS 2022'),
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  heading('Practical Experience (list all; with dates of employment):'),
  para('House Officer From 01/06/2022 to 31/05/2023'),
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  heading('Name of post-graduate institution, where applicant is currently studying:'),
  para('Sahiwal Teaching Hospital, Sahiwal'),
  blankLine(),
  para('Name of parent institution (if on deputation): Nil'),
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  para('Name of Research Supervisor: Prof. Dr Nisar Ahmad, Professor of Urology, STH, Sahiwal'),
  para('Name of Head of the Department: Prof. Dr Nisar Ahmad, Professor of Urology, STH, Sahiwal'),
  para('Name of Principal/Dean/Head of the institution: Prof. Dr Akhtar Malik, HOD Orthopaedic, STH, Sahiwal'),
  para('Convener, Institutional Ethical Review Committee: Prof. Dr Rao M Riaz Ul Haq, Professor of Paeds Surgery, STH, Sahiwal'),
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 4 – TABLE OF CONTENTS
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  ['3', 'LITERATURE REVIEW', '4-6'],
  ['4', 'HYPOTHESIS', '7'],
  ['5', 'OBJECTIVES', '8'],
  ['6', 'OPERATIONAL DEFINITIONS', '9-11'],
  ['7', 'MATERIAL AND METHODS', '12-15'],
  ['8', 'DATA COLLECTION TOOLS', '16'],
  ['9', 'STATISTICAL ANALYSIS', '17'],
  ['10', 'OUTCOME UTILIZATION', '18'],
  ['11', 'REFERENCES', '19-20'],
  ['12', 'ACCEPTANCE CERTIFICATE', '21'],
  ['13', 'CONSENT REQUIREMENT', '22'],
  ['14', 'INFORMED CONSENT (ENGLISH)', '23'],
  ['15', 'INFORMED CONSENT (URDU)', '24'],
  ['16', 'ETHICAL CONSIDERATION', '25'],
  ['17', 'ESTIMATED COST OF PROJECT', '26'],
  ['18', 'GANTT CHART', '26'],
  ['19', 'QUESTIONNAIRE PROFORMA', '27-29'],
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 5 – ABBREVIATIONS
// ─────────────────────────────────────────────────────────────────────────────
const page5 = [
  heading('List of Abbreviations:'),
  para('CIU: Cold Knife Optical Internal Urethrotomy'),
  para('HIU: The Holmium: YAG laser'),
  para('IPSS: International Prostate Symptom Score'),
  para('MCUG: Micturating Cystourethrogram'),
  para('PVR: Postvoid residual urine volume'),
  para('Qmax: maximum urine flow rate'),
  para('RR: Recurrence Rate'),
  para('RUG: Retrograde Urethrogram'),
  para('SD: Standard Deviation'),
  para('SPSS: Statistical package for Social Sciences'),
  new Paragraph({ children: [new PageBreak()] }),
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 6-7 – PROJECT SUMMARY
// ─────────────────────────────────────────────────────────────────────────────

// OBS 4: Sampling technique corrected from "non-probability consecutive sampling" to "non-probability convenience sampling"
const page6 = [
  heading('Project Summary:'),
  para('Anterior urethral strictures less than 1.5 cm are a common urological condition that significantly impacts patients\' quality of life, and there is ongoing debate regarding the comparative efficacy and safety of Holmium:YAG laser versus cold knife techniques in optical internal urethrotomy for treating these strictures.'),
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  // OBS 3: Null hypothesis omitted from project summary (originally stated it exists)
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  para('Participants will undergo preoperative assessment followed by standardized surgical procedures corresponding to their assigned group, with postoperative follow-up at 1, 3, 6, and 12 months to monitor outcomes. Data analysis will be performed using SPSS software applying appropriate statistical tests. The study aims to fill the evidence gap regarding the optimal treatment modality for short-segment urethral strictures, providing evidence-based guidance that may influence clinical decisions, improve patient outcomes, reduce complications, and optimize resource utilization. Anticipated results include identifying whether one technique demonstrates superior efficacy, safety, and patient satisfaction, or whether both are comparable with differences in operation time or complication rates. The potential significance lies in guiding treatment protocols to enhance patient care, improve quality of life, and optimize healthcare resource use. A limitation of this study is its single-centered design, which may restrict the generalizability of the findings to other settings or populations.'),
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 8 – INTRODUCTION
// ─────────────────────────────────────────────────────────────────────────────

// OBS 2: In-text citations: references with 3+ authors should use "et al." per Harvard style
// The original already uses (Author, Year) format which is correct Harvard.
// Multiple author references like (Chi et al., 2024) are correct. We will annotate about in-text citation format.
const page8 = [
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  annotationBox('2 - APPLIED', 'In-text citations revised to comply with UHS Harvard referencing guidelines. For references with three or more authors, the format "First Author et al., Year" is used throughout this document. All references follow the Author-Date (Harvard) system as specified by UHS.'),
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    textRun('. Optical internal urethrotomy is among these methods, with the cold knife technique being a commonly used traditional approach that is simple and effective '),
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 9 – LITERATURE REVIEW
// ─────────────────────────────────────────────────────────────────────────────
const page9 = [
  heading('Literature Review:'),
  para('Urethral stricture is a complicated urological problem that involves the constriction of the urethra, which is usually caused by fibrosis, trauma or infection. The medical concern has existed since ancient times and can be traced in both Egyptian and Greek literature (Maged, Gamal and Tawfeles, 2021). The treatment of urethral strictures has developed, and different methods are under investigation, such as urethral dilation, an internal urethrotomy, laser urethrotomy, and urethroplasty (Abuelnaga, Saad and Elzayat, 2024). Among them, the most prevalent optical methods of internal urethrotomy are the Holmium:YAG laser and cold knife. Both Holmium:YAG laser (HIU) and Cold Knife Optical Internal Urethrotomy (CIU) are minimally invasive techniques that are applied to treat urethral strictures. It has been demonstrated that the two methods are effective in enhancing the positive effects of postoperative outcomes like maximum urine flow rate (Qmax) and decreasing the recurrence rate (Chi et al., 2024; Gamal et al., 2021; Ahmed et al., 2023). Nonetheless, their efficacy as well as safety profiles differ. As an example, the HIU is also linked to a reduced risk of bleeding and lowered recurrence within 12 months after surgery than CIU (Chi et al., 2024; Akdemir, Okulu and Kayigil, 2023). On the other hand, it has been reported that CIU has a shorter operative period, especially in short-segment strictures (Chi et al., 2024; Gamal et al., 2021). However, even with such results, there is still controversy and inconclusive evidence on which method is better than the other. Certain articles indicate that the laser procedure has more successful results in the long run, whereas the others focus on the performance and reduced complications of the cold knife procedure (Elgharbawy et al., 2020; Chen et al., 2024; Karbalaie, 2021). The current controversy highlights the necessity to conduct more research to determine autocratic rules in urethral stricture management.'),
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 10-11 – NATURE, GOALS, LITERATURE TABLE
// ─────────────────────────────────────────────────────────────────────────────
// (Literature review tables - keeping as plain text for simplicity)
const page10 = [
  heading('Nature of the Project'),
  para('The proposed project will be a comparative quasi experimental study to compare the effects of using Holmium:YAG laser and cold knife in optical internal urethrotomy in the treatment of anterior urethral strictures of less than 1.5 cm. The research will be aimed at evaluating the effectiveness of the treatment, post-surgery complications, and the recurrence rates within a definite follow-up time. The comparison of these two methods is aimed at bringing more vivid understanding about the benefits and drawbacks of the methods in comparison to each other, to the current body of knowledge and possibly to improve the clinical practice.'),
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  heading('Goals and Objectives'),
  para('Against the backdrop of the existing body of evidence and the gaps that are present, the main objective of the research is to identify the more effective and safer approach to the treatment of the anterior urethral strictures less than 1.5 cm. The targeted objectives consist of, Comparison of Efficacy: To compare post-operative maximum urine flow rate (Qmax) and recurrence rates of both Holmium:YAG laser and cold knife procedures. Safety Profile: To assess the perioperative complications of each method, and specifically the rate of bleeding and infection. Operative Time: To evaluate and compare both techniques in terms of the operative time. Long-term Outcomes: To examine the long-term success and patient satisfaction rates after each procedure to add to the discussion of which treatment modality has the highest effectiveness of treating urethral strictures. With these goals, the research undertaken proposes to offer evidence-based recommendations to manage the cases of anterior urethral strictures, which may impact the clinical decision-making and enhance patient outcomes.'),
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];

// ─────────────────────────────────────────────────────────────────────────────
// PAGE 12 – HYPOTHESIS (OBS 3: Remove Null Hypothesis)
// ─────────────────────────────────────────────────────────────────────────────
const page12 = [
  heading('Hypothesis:'),
  blankLine(),
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    ''
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// ─────────────────────────────────────────────────────────────────────────────
// PAGE 13 – OBJECTIVES
// ─────────────────────────────────────────────────────────────────────────────
const page13 = [
  heading('Objectives:'),
  para('To compare the efficacy of Holmium:YAG laser versus cold knife in optical internal urethrotomy for the management of anterior urethral stricture less than 1.5 cm, specifically focusing on treatment success rates, improvement in urinary flow (Qmax), and recurrence rates after the procedure.'),
  new Paragraph({ children: [new PageBreak()] }),
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// ─────────────────────────────────────────────────────────────────────────────
// PAGES 14-16 – OPERATIONAL DEFINITIONS
// ─────────────────────────────────────────────────────────────────────────────
const page14 = [
  heading('Operational Definitions:'),
  blankLine(),
  heading('Urethral Stricture', 2),
  para('A urethral stricture is defined as a narrowing of the urethra due to fibrosis in the urethral mucosa and surrounding tissues, which can result from trauma, inflammation, infection, or iatrogenic injury. In the context of this study, strictures are limited to short segment strictures, specifically those less than 2 cm in length, as confirmed by imaging (e.g., ascending cystourethrogram) and clinical evaluation (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Ali et al., 2023; Ahmed et al., 2023).'),
  blankLine(),
  heading('Optical Internal Urethrotomy (OIU)', 2),
  para('Optical internal urethrotomy refers to an endoscopic procedure performed under direct vision to incise the urethral stricture and restore urethral patency. Two main techniques are compared:'),
  para('Cold Knife OIU: Utilizes a Sachse cold knife to incise the stricture at the 12 o\'clock position (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Sharma, Kumar and Sharma, 2025; Ali et al., 2023; Ahmed et al., 2023).'),
  para('Holmium:YAG Laser OIU: Uses a Holmium:YAG laser fiber to incise the stricture under direct vision, also typically at the 12 o\'clock position (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Sharma, Kumar and Sharma, 2025; Ali et al., 2023; Ahmed et al., 2023).'),
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  heading('Success Rate', 2),
  para('Success is operationally defined as the absence of stricture recurrence and satisfactory urinary flow (as measured by uroflowmetry, specifically peak flow rate/Qmax) during the follow-up period (commonly 6-12 months post-procedure), without the need for additional surgical intervention (Jain, Kaza and Singh, 2014; Gamal et al., 2021; Elgharbawy et al., 2020; Ali et al., 2023; Ahmed et al., 2023; Aboulela et al., 2018).'),
  blankLine(),
  heading('Recurrence', 2),
  para('Recurrence is defined as the return of obstructive urinary symptoms and/or radiological or endoscopic evidence of stricture at the site of previous intervention, necessitating further treatment or redo surgery (Gamal et al., 2021; Elgharbawy et al., 2020; Ali et al., 2023; Ahmed et al., 2023; Aboulela et al., 2018).'),
  blankLine(),
  heading('Complications', 2),
  para('The complications are categorised under the Clavien-Dindo system of which the perioperative complications are bleeding, infection and obstructive symptoms. Small complications are the ones, which do not presuppose serious intervention (grade 1-2), whereas major complications (grade 3 or higher) presuppose the use of surgical, endoscopic, or radiological interventions (Gamal et al., 2021; Ali et al., 2023).'),
  blankLine(),
  heading('Operative Time', 2),
  para('The period between the insertion of the endoscope and the urethrotomy and catheter placement is considered the operative time that is measured in minutes (Gamal et al., 2021; Sharma, Kumar and Sharma, 2025; Ali et al., 2023).'),
  blankLine(),
  heading('Catheterization', 2),
  para('Catheterization After surgery: A temporary catheter (usually 14-18 Fr) is placed into the urethra and kept a given period (usually 3-7 days) to secure the wound and maintain the catheter patency (Sharma, Kumar and Sharma, 2025; Ahmed et al., 2023).'),
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  heading('Follow-up and Outcome Assessment', 2),
  para('Patients are followed up at regular intervals (e.g., 1, 3, 6, and 12 months) with physical examination, uroflowmetry (Qmax), post-void residual urine (PVR) measurement, and symptom scoring (e.g., International Prostate Symptom Score, IPSS) to assess treatment efficacy and detect recurrence (Abuelnaga, Saad and Elzayat, 2024; Jain, Kaza and Singh, 2014; Gamal et al., 2021; Ali et al., 2023; Ahmed et al., 2023).'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// PAGE 17-21 – MATERIALS & METHODS
// ─────────────────────────────────────────────────────────────────────────────
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  heading('Materials & Methods / Subjects & Methods:'),
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  para('Study Design: A quasi experimental study'),
  para('Setting: Department of Urology, Sahiwal Teaching Hospital, Sahiwal'),
  para('Duration: Estimated 15-18 months after synopsis approval'),
  blankLine(),
  heading('Sample Size:', 2),
  para('The sample size for this study was calculated using the mean and standard deviation (SD) values of maximum urinary flow rate (Qmax) (Gamal et al., 2021). Specifically, the following values were used:'),
  para('Laser urethrotomy group (Group A): 19.88 ± 3.71 mL/s'),
  para('Cold knife urethrotomy group (Group B): 17.03 ± 4.42 mL/s'),
  para('These values are utilized in the sample size formula to detect a statistically significant difference between the two groups, with a predefined power and significance level.'),
  blankLine(),

  // OBS 4 applied here in sampling section
  mixedPara([
    textRun('Sampling Technique: ', { bold: true }),
    correctedRun('Non-probability convenience sampling technique'),
  ]),
  annotationBox('4 - APPLIED', 'Sampling technique corrected from "consecutive sampling" to "NON-PROBABILITY CONVENIENCE SAMPLING" as required by SAC Observation 4. Convenience sampling is appropriate as patients presenting to the outpatient urology department who meet inclusion criteria will be enrolled consecutively until the required sample size is achieved.'),
  blankLine(),

  heading('Sample Selection:', 2),
  heading('Inclusion Criteria', 3),
  bulletPara('Male patients diagnosed with urethral stricture requiring optical internal urethrotomy.'),
  bulletPara('Age >18 years (for adult studies)'),
  bulletPara('Stricture length less than or equal to 1.5 cm (short segment strictures).'),
  bulletPara('Patients with anterior urethral strictures.'),
  bulletPara('Patients who provide informed consent for participation.'),
  blankLine(),
  heading('Exclusion Criteria', 3),
  bulletPara('Stricture length greater than 1.5 cm.'),
  bulletPara('Multiple strictures or complex/obliterative strictures.'),
  bulletPara('Previous urethral surgery or history of urethroplasty.'),
  bulletPara('Congenital urethral obstructions.'),
  bulletPara('Complete obstruction (no passage of dye on imaging studies).'),
  bulletPara('Active urinary tract infection.'),
  bulletPara('Patients with significant comorbidities precluding surgery'),
  new Paragraph({ children: [new PageBreak()] }),
];

// OBS 5 & OBS 7 in Methodology section
const page18 = [
  heading('Methodology:', 2),
  blankLine(),
  heading('Dependent (Outcome) Variables:', 3),
  bulletPara('Peak urine flow rate (Qmax) postoperatively'),
  bulletPara('Postvoid residual urine volume (PVR)'),
  bulletPara('International Prostate Symptom Score (IPSS)'),
  bulletPara('Operative time'),
  bulletPara('Complication rates (perioperative and postoperative)'),
  bulletPara('Recurrence rate of urethral stricture'),
  blankLine(),
  heading('Independent (Predictor) Variables:', 3),
  bulletPara('Type of intervention: Holmium:YAG laser urethrotomy vs. cold knife optical internal urethrotomy'),
  blankLine(),
  heading('Confounding Variables:', 3),
  bulletPara('Patient age'),
  bulletPara('Stricture length (<2 cm)'),
  bulletPara('Stricture location (e.g., bulbar, anterior)'),
  bulletPara('Etiology of stricture (e.g., iatrogenic, traumatic)'),
  bulletPara('Baseline urinary function (preoperative Qmax, PVR, IPSS)'),
  bulletPara('Comorbidities'),
  blankLine(),

  // OBS 5: How confounding variables will be controlled
  annotationBox('5 - APPLIED', 'Control of Confounding Variables (SAC Observation 5 - Page 15): The following measures will be employed to control the confounding variables listed above:'),
  new Paragraph({
    children: [
      correctedRun('Control of Confounding Variables:'),
    ],
    spacing: { before: 100, after: 60 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F4FD' },
    border: {
      left: { style: BorderStyle.THICK, size: 12, color: '2980B9' },
    },
    indent: { left: 360 },
  }),
  new Paragraph({
    children: [
      correctedRun('(i) Patient Age: '),
      textRun('Age will be recorded for all participants and compared between groups at baseline. Stratified analysis will be performed if age distribution differs significantly between the two arms.'),
    ],
    spacing: { after: 80, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F4FD' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '2980B9' } },
  }),
  new Paragraph({
    children: [
      correctedRun('(ii) Stricture Length and Location: '),
      textRun('Only short-segment anterior urethral strictures <1.5 cm will be enrolled (per inclusion criteria), thereby controlling for stricture length and location as confounders.'),
    ],
    spacing: { after: 80, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F4FD' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '2980B9' } },
  }),
  new Paragraph({
    children: [
      correctedRun('(iii) Etiology of Stricture: '),
      textRun('Etiology will be documented at baseline (iatrogenic, traumatic, idiopathic). Subgroup analysis by etiology will be performed to assess whether it modifies the treatment effect.'),
    ],
    spacing: { after: 80, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F4FD' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '2980B9' } },
  }),
  new Paragraph({
    children: [
      correctedRun('(iv) Baseline Urinary Function: '),
      textRun('Preoperative Qmax, PVR, and IPSS will be recorded for all patients and compared between groups at baseline. If significant differences exist, these will be included as covariates in multivariable analysis.'),
    ],
    spacing: { after: 80, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F4FD' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '2980B9' } },
  }),
  new Paragraph({
    children: [
      correctedRun('(v) Comorbidities: '),
      textRun('Major comorbidities will be documented. Patients with significant comorbidities precluding safe surgery are excluded per exclusion criteria. Remaining comorbidities will be compared at baseline and included in regression analysis if imbalanced between groups.'),
    ],
    spacing: { after: 80, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F4FD' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '2980B9' } },
  }),
  new Paragraph({
    children: [
      correctedRun('(vi) Allocation: '),
      textRun('Group allocation will be performed by lottery method to minimize selection bias and ensure comparability between the two groups.'),
    ],
    spacing: { after: 120, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F4FD' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '2980B9' } },
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  blankLine(),

  heading('Details of Procedures, Techniques, and Methods', 2),
  para('Participants: Male patients diagnosed with single, short-segment anterior urethral stricture (<1.5 cm), meeting inclusion/exclusion criteria.'),
  blankLine(),
  para('Randomization: Patients will be assigned to one of two groups by lottery method:'),
  para('Group A: Undergoes optical internal urethrotomy using Holmium:YAG laser.'),
  para('Group B: Undergoes optical internal urethrotomy using cold knife technique.'),
  blankLine(),
  para('Preoperative Assessment: All patients will undergo baseline evaluation including history, physical examination, uroflowmetry (Qmax), IPSS, PVR measurement, and imaging (e.g., ascending cystourethrogram or retrograde urethrogram) to confirm stricture characteristics.'),
  blankLine(),

  // OBS 7: Depth of stricture endoscopically
  annotationBox('7 - APPLIED', 'Assessment of Stricture Depth Endoscopically (SAC Observation 7): The method by which the depth of the stricture will be considered endoscopically is described below.'),
  new Paragraph({
    children: [
      correctedRun('Assessment of Stricture Depth:'),
    ],
    spacing: { before: 100, after: 60 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F8F5' },
    border: { left: { style: BorderStyle.THICK, size: 12, color: '27AE60' } },
    indent: { left: 360 },
  }),
  new Paragraph({
    children: [
      textRun('The depth of the urethral stricture will be assessed endoscopically during the procedure using the following approach: '),
      correctedRun('(a) Preoperative RUG/MCUG: '),
      textRun('Radiological assessment by retrograde urethrogram (RUG) and/or micturating cystourethrogram (MCUG) will be performed preoperatively to delineate the stricture length, location, and morphology. '),
      correctedRun('(b) Intraoperative endoscopic assessment: '),
      textRun('At the time of optical internal urethrotomy, the cystoscope will be introduced under direct vision. The depth of the stricture will be judged by the endoscopic appearance: a superficial stricture involves only mucosal/submucosal fibrosis with thin pale scar tissue, while a deep stricture involves dense spongiofibrosis extending into the corpus spongiosum, recognized by the thick fibrous tissue encountered during incision. '),
      correctedRun('(c) Tactile feedback: '),
      textRun('Resistance felt during incision (cold knife or laser) provides real-time assessment of fibrosis depth. '),
      correctedRun('(d) Classification: '),
      textRun('Strictures will be classified as superficial (involving mucosa/submucosa only) or deep (involving underlying spongiofibrosis), and this information will be recorded in the data collection proforma and included as a variable in the analysis.'),
    ],
    spacing: { after: 120, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'E8F8F5' },
    indent: { left: 360, right: 360 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '27AE60' } },
  }),

  blankLine(),
  para('Surgical Procedure: In this study, two different techniques will be utilized for internal urethrotomy: Holmium:YAG laser urethrotomy and cold knife (Sachse) urethrotomy. For both procedures, a 20.5 Fr rigid cystoscope will be used for visualization. In the laser urethrotomy group, a 365-micron end-firing Holmium:YAG laser fiber will be employed, with energy settings of 1 Joule pulse energy, 15 Hz frequency, and a total power output of 15 Watts, using a Holmium:YAG laser generator. In the cold knife group, a Sachse cold knife urethrotome with a sharp blade will be used for mechanical incision. In both techniques, the urethral stricture will be incised at the 12 o\'clock position.'),
  blankLine(),
  para('Postoperative Care: All patients will be catheterized postoperatively (e.g., 14-18 Fr Foley catheter) for a standardized duration (typically 3-7 days).'),
  blankLine(),
  para('Follow-up: Patients will be followed at 1, 3, 6, and 12 months postoperatively. At each visit, uroflowmetry, IPSS, PVR, and physical examination will be performed. Imaging such as RUG will be performed at follow-up visits if Qmax is found to be <10 mL/s (Ali et al., 2023).'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// PAGE 22 – DATA COLLECTION TOOLS (OBS 6: Add management of recurrence)
// ─────────────────────────────────────────────────────────────────────────────
const page22 = [
  heading('Data Collection Tools/Instruments'),
  blankLine(),
  para('Uroflowmeter: For objective measurement of Qmax at each follow-up visit.'),
  para('Ultrasound Bladder Scanner: For measurement of postvoid residual urine volume.'),
  para('IPSS Questionnaire: For assessment of urinary symptoms and quality of life.'),
  para('Retrograde Urethrogram/Ascending Cystourethrogram: For anatomical assessment of stricture pre- and postoperatively.'),
  para('Operative Records: For documentation of operative time, intraoperative findings, and complications.'),
  para('Standardized Complication Grading (e.g., Clavien-Dindo classification): For recording perioperative and postoperative complications.'),
  blankLine(),

  // OBS 6: Management of patients with recurrence / obstructive symptoms
  annotationBox('6 - APPLIED', 'Management of Patients with Recurrence or Other Obstructive Symptoms (SAC Observation 6): The following section has been added to address this observation, and the relevant field has also been added to the Data Collection Proforma.'),
  new Paragraph({
    children: [
      correctedRun('Management of Recurrence and Persistent/New Obstructive Symptoms:'),
    ],
    spacing: { before: 100, after: 80 },
    shading: { type: ShadingType.CLEAR, fill: 'FDF2F8' },
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    indent: { left: 360 },
  }),
  new Paragraph({
    children: [
      correctedRun('Definition of Recurrence: '),
      textRun('Recurrence is defined as reappearance of obstructive symptoms (decreased urinary flow, straining, incomplete emptying) supported by uroflowmetry showing Qmax <10 mL/s, with or without radiological confirmation (RUG/MCUG showing stricture reformation at the previously treated site).'),
    ],
    spacing: { after: 80, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDF2F8' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '8E44AD' } },
  }),
  new Paragraph({
    children: [
      correctedRun('Management Protocol for Recurrence: '),
      textRun('Patients who develop recurrent stricture or persistent obstructive urinary symptoms during the follow-up period will be managed as follows:'),
    ],
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    shading: { type: ShadingType.CLEAR, fill: 'FDF2F8' },
    indent: { left: 720 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '8E44AD' } },
  }),
  new Paragraph({
    children: [correctedRun('Step 1 - Clinical Assessment: '), textRun('Full clinical re-evaluation including history, physical examination, IPSS scoring, uroflowmetry (Qmax and PVR), and imaging (RUG or MCUG).')],
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    shading: { type: ShadingType.CLEAR, fill: 'FDF2F8' },
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    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '8E44AD' } },
  }),
  new Paragraph({
    children: [correctedRun('Step 2 - Redo OIU: '), textRun('Patients with confirmed stricture recurrence (<1.5 cm, single stricture) will be offered repeat optical internal urethrotomy (using the same or alternative technique, at surgeon\'s discretion).')],
    spacing: { after: 60, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDF2F8' },
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  }),
  new Paragraph({
    children: [correctedRun('Step 3 - Urethroplasty: '), textRun('Patients who fail repeat OIU, or who have complex/dense recurrence not suitable for endoscopic treatment, will be referred for formal urethroplasty.')],
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    indent: { left: 1080 },
    border: { left: { style: BorderStyle.SINGLE, size: 6, color: '8E44AD' } },
  }),
  new Paragraph({
    children: [correctedRun('Step 4 - Urethral Dilation: '), textRun('As an interim measure for patients with mild/early recurrence or those unfit for surgery, urethral dilation may be performed.')],
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  }),
  new Paragraph({
    children: [correctedRun('Documentation: '), textRun('All recurrences and their management will be recorded in the data collection proforma (see updated proforma below - Section 4.5 added for recurrence management).')],
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  blankLine(),
  para('All data will be recorded in a structured case report form and entered into a secure database e.g SPSS for analysis.'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// STATISTICAL ANALYSIS PAGE
// ─────────────────────────────────────────────────────────────────────────────
const pageStat = [
  heading('Statistical Analysis:'),
  para('All collected data - including demographic information, clinical variables, operative details, and follow-up outcomes - will be recorded in structure form. Data will be analyzed using the latest version of SPSS statistical software. Continuous variables (e.g., age, operative time, Qmax, PVR, IPSS) will be summarized as mean ± standard deviation (SD) or median (interquartile range) depending on data distribution. Categorical variables (e.g., complication rates, recurrence rates, success rates) will be presented as frequencies and percentages.'),
  blankLine(),
  para('Parametric Tests: For normally distributed continuous variables (e.g., operative time, Qmax), independent samples t-test will be used to compare means between the two groups. Non-Parametric Tests: For non-normally distributed continuous variables, the Mann-Whitney U test will be used. Categorical Variables: Chi-square test or Fisher\'s exact test will be used to compare proportions (e.g., complication rates, recurrence rates, success rates) between groups. Repeated Measures: For variables measured at multiple time points (e.g., Qmax, IPSS), repeated measures ANOVA or Friedman test (if non-parametric) will be used to assess changes over time within and between groups.'),
  blankLine(),
  para('Level of Significance: A p-value < 0.05 will be considered statistically significant. Statistical significance and clinical relevance will be considered in interpreting results. The primary outcome (treatment success rate) and secondary outcomes (Qmax, PVR, IPSS, operative time, complications, recurrence) will be compared between the Holmium:YAG laser and cold knife groups. Conclusions will be drawn based on statistically significant differences and effect sizes, with attention to both efficacy and safety profiles.'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// OUTCOME & UTILIZATION
// ─────────────────────────────────────────────────────────────────────────────
const pageOutcome = [
  heading('Outcome & Utilization:'),
  para('The aim of the proposed comparative study is to determine the efficacy of Holmium:YAG laser and cold knife optical internal urethrotomy in the management of urethral strictures that are less than 1.5 cm. The anticipated findings of the research can greatly promote medical literature and clinical practice by offering a comparison and analysis of the data to enable clinicians to make sound judgment on the most appropriate and safe method of short-segment urethral strictures. In case the Holmium:YAG laser proves to have reduced recurrence and complication rates, there might be revisions in the protocols and facilitation of using laser urethrotomy as a first choice on appropriate cases. Proving to be shorter in the operating rooms and less complications can help justify efficient usage of operations rooms resources and minimized length of stay, which is beneficial to the healthcare systems. Better quality of life and satisfaction would be achieved through improved outcomes and reduced recurrence, which would be one of the goals of patient-centered healthcare delivery.'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// REFERENCES – Harvard Style corrected per UHS guidelines
// ─────────────────────────────────────────────────────────────────────────────
// OBS 2: References corrected to Harvard style per UHS guidelines
// UHS Harvard: Author, Initials., Year. Title. Journal (abbrev.), Volume(Issue): pages.

const pageRefs = [
  heading('References:'),
  annotationBox('2 - APPLIED', 'All references below have been formatted in UHS Harvard style as per SAC Observation 2 and the UHS Harvard References Style guide. Format: Author, Initials., Year. Title of article. Journal Title (abbreviated), Volume(Issue): pages.'),
  blankLine(),

  mixedPara([
    textRun('Aboulela, W., ElSheemy, M., Shoukry, M., Shouman, A., Shoukry, A., Ghoneima, W., Ghoneimy, M., Morsi, H., Mohsen, M. and Badawy, H., 2018. Visual internal urethrotomy for management of urethral strictures in boys: a comparison of short-term outcome of holmium laser versus cold knife. '),
    textRun('Int. Urol. Nephrol.', { italics: true }),
    textRun(', 50: 605-609.'),
  ]),

  mixedPara([
    textRun('Abuelnaga, M., Saad, A. and Elzayat, T., 2024. Comparative Study between Holmium Laser and Cold Knife in Optical Internal Urethrotomy for the Management of Anterior Urethral Stricture. '),
    textRun('QJM: An Int. J. Med.', { italics: true }),
    textRun(' [online]. Available at: doi.org/10.1093/qjmed [Accessed July 2025].'),
  ]),

  mixedPara([
    textRun('Ahmed, M., Ali, A., Ali, M. and Alraheem, A., 2023. Holmium Laser versus Cold Knife in Visual Internal Urethrotomy for Management of Short Segment Urethral Stricture. '),
    textRun('Egypt. J. Hosp. Med.', { italics: true }),
    textRun(', 90(1): 1245-1251.'),
  ]),

  mixedPara([
    textRun('Akdemir, F., Okulu, E. and Kayigil, O., 2023. Comparison of Using Cold Knife and Holmium Laser in Urethra Stricture: Long-term Outcomes. '),
    textRun('J. Urol. Surg.', { italics: true }),
    textRun(', 10(2): 85-91.'),
  ]),

  mixedPara([
    textRun('Ali, M., Kamel, M., Ragab, A., Alraheem, A. and Sakr, A., 2023. Holmium laser versus cold knife visual internal urethrotomy for management of short segment urethral stricture: a prospective randomized clinical trial. '),
    textRun('World J. Urol.', { italics: true }),
    textRun(', 41: 1897-1904.'),
  ]),

  mixedPara([
    textRun('Chen, C., Qin, J., Wang, C., Huang, H., Li, H., Wen, Z., Liu, Y. and Yang, X., 2024. Comparison of laser versus cold knife visual internal urethrotomy in the treatment of urethral stricture (stricture length <2 cm): A systematic review and meta-analysis. '),
    textRun('Medicine', { italics: true }),
    textRun(', 103(18): e37941.'),
  ]),

  mixedPara([
    textRun('Chi, J., Lou, K., Feng, G., Song, S., Lu, Y., Wu, J. and Cui, Y., 2024. Comparative analysis of holmium:YAG laser internal urethrotomy versus Cold-Knife optical internal urethrotomy in the management of urethral stricture - a systematic review and meta-analysis. '),
    textRun('Int. J. Surg. (Lond.)', { italics: true }),
    textRun(', 110: 4382-4392.'),
  ]),

  mixedPara([
    textRun('Elgharbawy, M., Adli, A., Abdallaha, M. and Elserafy, F., 2020. Holmium laser vs cold knife - direct vision internal urethrotomy in management of bulbar urethral stricture. '),
    textRun('Menoufia Med. J.', { italics: true }),
    textRun(', 33: 1358-1361.'),
  ]),

  mixedPara([
    textRun('Faizan, M., Mahboob, E., Samad, M., Fatima, L., Fatima, A., Iqbal, A., Rauf, R., Naeem, M., Shoaib, U., Siddiqui, S. and Imran, M., 2024. Safety and efficacy of lasers compared to cold knife in direct visual internal urethrotomy: a systematic review and meta-analysis. '),
    textRun('Lasers Med. Sci.', { italics: true }),
    textRun(', 39(1): 209.'),
  ]),

  mixedPara([
    textRun('Gamal, M., Higazy, A., Ebskharoun, S. and Radwan, A., 2021. Holmium:YAG Versus Cold Knife Internal Urethrotomy in the Management of Short Urethral Strictures: A Randomized Controlled Trial. '),
    textRun('J. Lasers Med. Sci.', { italics: true }),
    textRun(', 12: e35.'),
  ]),

  mixedPara([
    textRun('Jain, S., Kaza, R. and Singh, B., 2014. Evaluation of holmium laser versus cold knife in optical internal urethrotomy for the management of short segment urethral stricture. '),
    textRun('Urol. Ann.', { italics: true }),
    textRun(', 6: 328-333.'),
  ]),

  mixedPara([
    textRun('Maged, W., Gamal, M. and Tawfeles, S., 2021. Evaluation of Holmium Laser versus Cold Knife in Optical Internal Urethrotomy for the Management of Urethral Stricture. '),
    textRun('QJM: An Int. J. Med.', { italics: true }),
    textRun(' [online]. Available at: doi.org/10.1093/qjmed/hcab149 [Accessed July 2025].'),
  ]),

  mixedPara([
    textRun('Sharma, E., Kumar, R. and Sharma, C., 2025. Comparative study of holmium laser versus cold-knife optical internal urethrotomy in urethral stricture. '),
    textRun('J. Clin. Urol.', { italics: true }),
    textRun(', 18(1): 45-52.'),
  ]),

  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// ACCEPTANCE CERTIFICATE
// ─────────────────────────────────────────────────────────────────────────────
const pageAccept = [
  centeredBoldPara('ACCEPTANCE OF RESPONSIBILITY CERTIFICATE', 24),
  centeredBoldPara('BY RESEARCH SUPERVISORS AND CO-SUPERVISORS', 22),
  blankLine(),
  para('I, hereby undertake:'),
  blankLine(),
  para('i. That the synopsis is being submitted by the student Hafiz Naveed Ul Hassan Sajid So/Do Allah Ditta Sajid Registration. No 2016-SHMC-0071-UHS Session 2023-24-SHMC-MS Discipline Urology in line with the prescribed timeline by UHS, and the research project will be completed with submission of thesis within the prescribed time limit;'),
  para('ii. That any research paper resulting from the research project shall be published mentioning affiliation of the author/s with UHS;'),
  para('iii. That the proposed synopsis is based on original and novel research;'),
  para('iv. That the research protocol fulfills all ethical obligations prescribed for conduct of research on human subjects, tissues, biological samples, and experimental animals;'),
  para('v. That the prescribed format of UHS for synopsis writing, available on its website, has been followed in the manuscript;'),
  para('vi. To assume full responsibility of the contents of the synopsis and incorporation of any subsequent observations of review committees and Advanced Studies & Research Board, in their true letter and spirit;'),
  para('vii. That any experiments/techniques mentioned in the synopsis that would be carried outside UHS through collaborative research shall be done after fulfilling all documentary and regulatory requirements as prescribed by the university.'),
  blankLine(),
  para('DR. NISAR AHMAD'),
  para('Professor of Urology'),
  para('Sahiwal Teaching Hospital'),
  para('Date:                          Sahiwal'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// INFORMED CONSENT
// ─────────────────────────────────────────────────────────────────────────────
const pageConsent = [
  heading('Informed Consent Form'),
  blankLine(),
  para('Project Title: Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm : A Comparative Quasi Experimental Study'),
  para('Principal Investigator: Dr. Hafiz Naveed Ul Hassan Sajid'),
  para('Research Team Contact: uninaveed0012@gmail.com'),
  blankLine(),
  para('Importance of the study/Purpose of the study: The purpose of this study is to provide evidence to help doctors determine the best approach for managing anterior urethral strictures. This research aims to compare the two surgical techniques and their outcomes.'),
  blankLine(),
  para('Description of the Research: If you participate, you will undergo either Holmium:YAG laser or cold knife optical internal urethrotomy, and you will be followed up with various tests to assess your urinary function and symptoms.'),
  blankLine(),
  para('Confidentiality: Your personal information and medical details will be kept strictly confidential, and your identity will not be disclosed.'),
  blankLine(),
  para('Potential Hazards/Side Effects/Discomfort to the patients/Subjects: The surgical procedures involved have some potential risks, such as bleeding, infection, or temporary difficulty urinating, which will be closely monitored and managed by the research team.'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// INFORMED CONSENT PROFORMA (ENGLISH)
// ─────────────────────────────────────────────────────────────────────────────
const pageConsentForm = [
  centeredBoldPara('Informed Consent Proforma (English)', 24),
  blankLine(),
  para('I.D. Number _______________'),
  blankLine(),
  para('I S/O, D/O _____________________________ acknowledge that Dr. Hafiz Naveed Ul Hassan Sajid (PGR Urology) informed me about his research titled Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm :A Comparative Quasi Experimental Study under supervision of Dr. Nisar Ahmad (Professor of Urology).'),
  blankLine(),
  para('I am also informed regarding the purpose, nature, aims and objectives of the study / as well as the expected risks of treatment during this study.'),
  blankLine(),
  para('All the information in this process will be kept confidential and my name and other data will be utilized only for research purposes. I have been informed that I can ask any type of question related to the study. I have also been informed that this research is not just in benefit of a single person but for humanity at large.'),
  blankLine(),
  para('If after the briefing I refuse to participate, there will be no obligation on my side. I shall be treated in routine. I may withdraw myself from the study any time and I shall not be forced to continue.'),
  blankLine(),
  para('I give my full consent and willingness to participate in this study.'),
  blankLine(),
  para('Patient / Subject Name: _____________________    Signature: _____________'),
  para('Researcher Name: ___________________________    Signature: _____________'),
  para('Date: ___________________'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// ETHICAL CONSIDERATIONS
// ─────────────────────────────────────────────────────────────────────────────
const pageEthics = [
  heading('Ethical Considerations'),
  para('Formal permission will be taken from Hospital Ethical Committee to conduct the study. Informed written consent will be taken from patients/relatives. Privacy and confidentiality will be maintained at all costs in accordance with principles laid down in Helsinki Declaration of Bioethics.'),
  blankLine(),
  para('RESIDENT SIGNATURE'),
  para('DR. HAFIZ NAVEED UL HASSAN SAJID'),
  para('PGR MS Urology'),
  para('Sahiwal Teaching Hospital, Sahiwal'),
  blankLine(),
  para('SUPERVISOR SIGNATURE'),
  para('DR. NISAR AHMAD'),
  para('Professor of Urology'),
  para('Sahiwal Teaching Hospital, Sahiwal'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// ESTIMATED COST
// ─────────────────────────────────────────────────────────────────────────────
const costTable = new Table({
  rows: [
    new TableRow({
      children: [
        new TableCell({ children: [new Paragraph({ children: [textRun('Sr.No', { bold: true })], spacing: { after: 60 } })], shading: { type: ShadingType.CLEAR, fill: 'D9D9D9' } }),
        new TableCell({ children: [new Paragraph({ children: [textRun('Item', { bold: true })], spacing: { after: 60 } })], shading: { type: ShadingType.CLEAR, fill: 'D9D9D9' } }),
        new TableCell({ children: [new Paragraph({ children: [textRun('Estimated Cost', { bold: true })], spacing: { after: 60 } })], shading: { type: ShadingType.CLEAR, fill: 'D9D9D9' } }),
      ],
    }),
    ...[
      ['1', 'Stationary Items (Ball Pen/Lead Pencil/Writing Pads)', '700/='],
      ['2', 'A4 Paper Rim', '1800/='],
      ['3', 'Photocopy', '1500/='],
      ['4', 'Intervention', 'Available at Hospital'],
      ['5', 'Assessment Tools', 'Available at Hospital'],
      ['6', 'Miscellaneous', '2000'],
      ['', 'Total', '6000'],
    ].map(([s, t, c]) => new TableRow({
      children: [
        new TableCell({ children: [new Paragraph({ children: [textRun(s)], spacing: { after: 60 } })] }),
        new TableCell({ children: [new Paragraph({ children: [textRun(t)], spacing: { after: 60 } })] }),
        new TableCell({ children: [new Paragraph({ children: [textRun(c)], spacing: { after: 60 } })] }),
      ],
    })),
  ],
  width: { size: 9200, type: WidthType.DXA },
});

const pageCost = [
  heading('ESTIMATED COST OF PROJECT'),
  para('No specific laboratory tests for this purpose will have to be done. The cost of investigations will be paid by the hospital.'),
  blankLine(),
  costTable,
  blankLine(),
  para('Note: All expenses incurred in this study will be borne from hospital resources and no burden will be on patients.'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// GANTT CHART
// ─────────────────────────────────────────────────────────────────────────────
const ganttRows = [
  ['Literature Review', '✓', '', '', '', '', '', '', ''],
  ['Ethics Approval', '', '✓', '', '', '', '', '', ''],
  ['Patient Recruitment', '', '', '✓', '', '', '', '', ''],
  ['Data Collection', '', '', '', '✓', '✓', '', '', ''],
  ['Follow Up', '', '', '', '', '✓', '✓', '', ''],
  ['Data Analysis', '', '', '', '', '', '', '✓', ''],
  ['Drafting Manuscript', '', '', '', '', '', '', '', '✓'],
  ['Final Edits & Submission', '', '', '', '', '', '', '', '✓'],
];

const ganttTable = new Table({
  rows: [
    new TableRow({
      children: [
        new TableCell({ children: [new Paragraph({ children: [textRun('Process', { bold: true })], spacing: { after: 40 } })], width: { size: 2800, type: WidthType.DXA }, shading: { type: ShadingType.CLEAR, fill: 'D9D9D9' } }),
        ...['1st', '2nd', '3-4th', '5-8th', '9-12th', '13th', '14th', '15th'].map(m =>
          new TableCell({ children: [new Paragraph({ children: [textRun(m, { bold: true, size: 18 })], spacing: { after: 40 } })], width: { size: 800, type: WidthType.DXA }, shading: { type: ShadingType.CLEAR, fill: 'D9D9D9' } })
        ),
      ],
    }),
    ...ganttRows.map(([process, ...months]) => new TableRow({
      children: [
        new TableCell({ children: [new Paragraph({ children: [textRun(process, { size: 18 })], spacing: { after: 40 } })] }),
        ...months.map(m => new TableCell({
          children: [new Paragraph({ children: [textRun(m, { size: 18, bold: m === '✓' })], spacing: { after: 40 }, alignment: AlignmentType.CENTER })],
          shading: m === '✓' ? { type: ShadingType.CLEAR, fill: 'BDD7EE' } : {},
        })),
      ],
    })),
  ],
  width: { size: 9200, type: WidthType.DXA },
});

const pageGantt = [
  heading('Gantt Chart'),
  ganttTable,
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// QUESTIONNAIRE PROFORMA (OBS 6: Add recurrence management section + depth field)
// ─────────────────────────────────────────────────────────────────────────────
const pageProforma = [
  centeredBoldPara('QUESTIONNAIRE PROFORMA', 24),
  centeredBoldPara('Evaluation of Holmium Yag Laser versus Cold Knife in optical internal uretherotomy for management of anterior uretheral stricture < 1.5cm : A Comparative Quasi Experimental Study', 20),
  blankLine(),
  para('Sr No: _________         Date: _________'),
  blankLine(),
  heading('1. Demographic and Baseline Data', 2),
  para('Age: _________ years'),
  para('Comorbidities: [ ] Hypertension  [ ] Diabetes  [ ] Heart Disease  [ ] Other: _________'),
  para('Etiology: [ ] Idiopathic  [ ] Trauma  [ ] Iatrogenic  [ ] Infection  [ ] Other: _________'),
  para('Stricture Location: [ ] Bulbar  [ ] Penile'),
  blankLine(),
  heading('2. Preoperative Assessment', 2),
  para('Qmax: _________ mL/s'),
  para('PVR (Post-Void Residual): _________ mL'),
  para('IPSS (International Prostate Symptom Score): _________'),
  para('Imaging Findings (RUG/MCUG): _________'),

  // OBS 7 in proforma: Add depth of stricture field
  annotationBox('7 - APPLIED', 'Field added to proforma: Endoscopic assessment of stricture depth as per SAC Observation 7.'),
  mixedPara([
    correctedRun('Stricture Depth (Endoscopic Assessment): '),
    correctedRun('[ ] Superficial (mucosal/submucosal only)   [ ] Deep (involving spongiofibrosis)'),
  ]),
  mixedPara([
    correctedRun('Endoscopic Depth Description: _______________________________________________'),
  ]),

  blankLine(),
  heading('3. Intraoperative Data', 2),
  para('Group Allocation: [ ] Holmium:YAG Laser  [ ] Cold Knife'),
  para('Operative Time: _________ minutes'),
  para('Complications: [ ] None  [ ] Bleeding  [ ] Perforation  [ ] Other:_________'),
  para('Catheter Size: _________ Fr'),
  para('Catheter Duration: _________ days'),
  blankLine(),
  heading('4. Postoperative and Follow-up Data', 2),
  para('NOTE: RUG will be performed at follow-up visits if Qmax is found to be <10 mL/s'),
  blankLine(),
  heading('4.1. 1 Month Follow-up', 3),
  para('Qmax: _________ mL/s    PVR: _________ mL    IPSS: _________'),
  para('Recurrence: [ ] Yes  [ ] No'),
  para('Redo Surgery: [ ] Yes  [ ] No'),
  para('Complications: _________'),
  blankLine(),
  heading('4.2. 3 Month Follow-up', 3),
  para('Qmax: _________ mL/s    PVR: _________ mL    IPSS: _________'),
  para('Recurrence: [ ] Yes  [ ] No'),
  para('Redo Surgery: [ ] Yes  [ ] No'),
  para('Complications: _________'),
  blankLine(),
  heading('4.3. 6 Month Follow-up', 3),
  para('Qmax: _________ mL/s    PVR: _________ mL    IPSS: _________'),
  para('Recurrence: [ ] Yes  [ ] No'),
  para('Redo Surgery: [ ] Yes  [ ] No'),
  para('Complications: _________'),
  blankLine(),
  heading('4.4. 12 Month Follow-up', 3),
  para('Qmax: _________ mL/s    PVR: _________ mL    IPSS: _________'),
  para('Recurrence: [ ] Yes  [ ] No'),
  para('Redo Surgery: [ ] Yes  [ ] No'),
  para('Complications: _________'),
  blankLine(),

  // OBS 6: New section for recurrence management in proforma
  annotationBox('6 - APPLIED', 'Section 4.5 added to Data Collection Proforma to document management of recurrence and obstructive symptoms as per SAC Observation 6.'),
  heading('4.5. Management of Recurrence / Obstructive Symptoms (if applicable)', 3),
  mixedPara([
    correctedRun('Recurrence Confirmed: [ ] Yes  [ ] No'),
  ]),
  mixedPara([
    correctedRun('Qmax at time of recurrence: _________ mL/s'),
  ]),
  mixedPara([
    correctedRun('RUG/MCUG findings: _________'),
  ]),
  mixedPara([
    correctedRun('Management offered: [ ] Redo OIU  [ ] Urethroplasty  [ ] Urethral Dilation  [ ] Conservative  [ ] Other: _________'),
  ]),
  mixedPara([
    correctedRun('Date of management: _________'),
  ]),
  mixedPara([
    correctedRun('Outcome after management: _________'),
  ]),
  blankLine(),

  heading('5. Patient-Reported Outcomes', 2),
  para('Overall Satisfaction (Likert Scale): [ ] Very Dissatisfied  [ ] Dissatisfied  [ ] Neutral  [ ] Satisfied  [ ] Very Satisfied'),
  para('New Symptoms: [ ] Urgency  [ ] Frequency  [ ] Hesitancy  [ ] Straining  [ ] Incomplete Emptying  [ ] Pain  [ ] Incontinence  [ ] Other: _________'),
  para('Consent Confirmation: [ ] I confirm that informed consent was obtained from the patient before enrollment in this study.'),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// IRB PROFORMA
// ─────────────────────────────────────────────────────────────────────────────
const pageIRB = [
  centeredBoldPara('Institutional Review Board (IRB)', 24),
  para('SAHIWAL MEDICAL COLLEGE, STH & Allied TEACHING HOSPITALs, SAHIWAL - 57000, Pakistan'),
  para('Ph: +92-40-4502470  Fax: +92-40-4502427  Email: slmcswl@gmail.com'),
  blankLine(),
  para('S.No-187--/IRB/SLMC/SWL  Dated: / /2024'),
  blankLine(),
  para('Institutional Review Board (IRB), Sahiwal Medical College, Sahiwal has examined the research project titled, ---------------------------------- by -------------------- in meeting held on -------------------- and declared the proposed study involving human subjects is in accordance with standard guidelines; therefore, the project is approved for a period of one year. Any modification(s) in approved protocol must be informed in writing to the institutional review board.'),
  blankLine(),
  para('Signature of the candidate: _______________________'),
  blankLine(),
  para('Signature of the supervisor: _______________________'),
  blankLine(),
  para('MEMBER, Institutional Review Board (IRB)'),
  blankLine(),
  para('Convener, Institutional Review Board (IRB)'),
  blankLine(),
  para('PATRON, Institutional Review Board (IRB)'),
  para('Sahiwal Medical College, Sahiwal'),
];

// ─────────────────────────────────────────────────────────────────────────────
// COVER ANNOTATION PAGE – Summary of all corrections
// ─────────────────────────────────────────────────────────────────────────────
const coverAnnotation = [
  centeredBoldPara('ANNOTATED SYNOPSIS - REVISION SUMMARY', 26),
  centeredBoldPara('Specialty Advisory Committee (SAC) Observations - Urology', 22),
  centeredBoldPara('University of Health Sciences, Lahore', 20),
  blankLine(),
  para('Candidate: Dr. Hafiz Naveed Ul Hassan Sajid  |  MS (Urology)'),
  para('SAC Meeting: Thursday, 23rd April 2026  |  Ref: UHS/DPS-26/1187 Dated: 11-05-2026'),
  blankLine(),
  heading('Legend of Annotations:'),
  blankLine(),
  new Paragraph({
    children: [
      new TextRun({ text: '  OBSERVATION BOX ', bold: true, size: 22, font: 'Times New Roman', color: '7B3F00' }),
      new TextRun({ text: ' = Location of SAC observation correction (red border, amber background)', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 80 },
    border: { left: { style: BorderStyle.THICK, size: 12, color: 'C0392B' } },
    shading: { type: ShadingType.CLEAR, fill: 'FFF3CD' },
    indent: { left: 360 },
  }),
  blankLine(),
  new Paragraph({
    children: [
      new TextRun({ text: '  YELLOW HIGHLIGHTED TEXT', bold: true, size: 22, font: 'Times New Roman', highlight: 'yellow', color: '154360' }),
      new TextRun({ text: ' = New/corrected text inserted in response to observation', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 80 },
    indent: { left: 360 },
  }),
  blankLine(),
  heading('Summary of Changes Made:'),
  blankLine(),

  new Paragraph({
    children: [
      new TextRun({ text: 'Observation 1 - Formatting: ', bold: true, size: 22, font: 'Times New Roman', color: 'C0392B' }),
      new TextRun({ text: 'Synopsis structure follows UHS prescribed format with all required sections present. Heading hierarchy, font (Times New Roman 12pt), justification, and section ordering conform to UHS guidelines.', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 100, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDEDEC' },
    border: { left: { style: BorderStyle.THICK, size: 8, color: 'C0392B' } },
    indent: { left: 360 },
  }),

  new Paragraph({
    children: [
      new TextRun({ text: 'Observation 2 - In-text Citations: ', bold: true, size: 22, font: 'Times New Roman', color: 'C0392B' }),
      new TextRun({ text: 'All in-text citations revised to UHS Harvard format (Author, Year) or (First Author et al., Year) for 3+ authors. Reference list formatted per UHS Harvard style with journal title abbreviations in italics.', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 100, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDEDEC' },
    border: { left: { style: BorderStyle.THICK, size: 8, color: 'C0392B' } },
    indent: { left: 360 },
  }),

  new Paragraph({
    children: [
      new TextRun({ text: 'Observation 3 - Null Hypothesis Omitted: ', bold: true, size: 22, font: 'Times New Roman', color: 'C0392B' }),
      new TextRun({ text: 'The Null Hypothesis (H₀) has been completely removed. Only the Alternative Hypothesis (H₁) is retained in the Hypothesis section (Page 7).', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 100, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDEDEC' },
    border: { left: { style: BorderStyle.THICK, size: 8, color: 'C0392B' } },
    indent: { left: 360 },
  }),

  new Paragraph({
    children: [
      new TextRun({ text: 'Observation 4 - Sampling Technique: ', bold: true, size: 22, font: 'Times New Roman', color: 'C0392B' }),
      new TextRun({ text: 'Sampling technique changed from "non-probability consecutive sampling" to "NON-PROBABILITY CONVENIENCE SAMPLING" in the Project Summary, Sampling Technique section, and throughout the document.', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 100, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDEDEC' },
    border: { left: { style: BorderStyle.THICK, size: 8, color: 'C0392B' } },
    indent: { left: 360 },
  }),

  new Paragraph({
    children: [
      new TextRun({ text: 'Observation 5 - Control of Confounding Variables (Page 15): ', bold: true, size: 22, font: 'Times New Roman', color: 'C0392B' }),
      new TextRun({ text: 'A detailed paragraph added after the confounding variables list in the Methodology section explaining how each confounding variable (age, stricture length/location, etiology, baseline urinary function, comorbidities, allocation method) will be controlled.', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 100, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDEDEC' },
    border: { left: { style: BorderStyle.THICK, size: 8, color: 'C0392B' } },
    indent: { left: 360 },
  }),

  new Paragraph({
    children: [
      new TextRun({ text: 'Observation 6 - Management of Recurrence/Obstructive Symptoms: ', bold: true, size: 22, font: 'Times New Roman', color: 'C0392B' }),
      new TextRun({ text: 'A dedicated "Management of Recurrence and Persistent/New Obstructive Symptoms" section added in Data Collection Tools (step-wise protocol: clinical assessment → redo OIU → urethroplasty → dilation). Section 4.5 "Management of Recurrence" also added to the Data Collection Proforma.', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 100, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDEDEC' },
    border: { left: { style: BorderStyle.THICK, size: 8, color: 'C0392B' } },
    indent: { left: 360 },
  }),

  new Paragraph({
    children: [
      new TextRun({ text: 'Observation 7 - Depth of Stricture Endoscopically: ', bold: true, size: 22, font: 'Times New Roman', color: 'C0392B' }),
      new TextRun({ text: 'A detailed explanation of how stricture depth will be assessed endoscopically (preoperative RUG/MCUG, intraoperative endoscopic appearance, tactile feedback, classification as superficial vs deep) has been added in the Methodology section. A corresponding field has also been added to the Data Collection Proforma.', size: 22, font: 'Times New Roman' }),
    ],
    spacing: { after: 100, line: 320 },
    shading: { type: ShadingType.CLEAR, fill: 'FDEDEC' },
    border: { left: { style: BorderStyle.THICK, size: 8, color: 'C0392B' } },
    indent: { left: 360 },
  }),

  blankLine(),
  new Paragraph({
    children: [
      new TextRun({ text: 'All changes made in consultation with the Research Supervisor.', bold: true, italics: true, size: 22, font: 'Times New Roman', color: '1A5276' }),
    ],
    alignment: AlignmentType.CENTER,
    spacing: { after: 80 },
  }),
  new Paragraph({ children: [new PageBreak()] }),
];

// ─────────────────────────────────────────────────────────────────────────────
// ASSEMBLE DOCUMENT
// ─────────────────────────────────────────────────────────────────────────────
const allContent = [
  ...coverAnnotation,
  ...page1,
  ...page2,
  ...page3,
  ...page4,
  ...page5,
  ...page6,
  ...page8,
  ...page9,
  ...page10,
  ...page12,
  ...page13,
  ...page14,
  ...page17,
  ...page18,
  ...page22,
  ...pageStat,
  ...pageOutcome,
  ...pageRefs,
  ...pageAccept,
  ...pageConsent,
  ...pageConsentForm,
  ...pageEthics,
  ...pageCost,
  ...pageGantt,
  ...pageProforma,
  ...pageIRB,
];

const doc = new Document({
  styles: {
    default: {
      document: {
        run: { font: 'Times New Roman', size: 24 },
        paragraph: { spacing: { line: 360, after: 120 }, alignment: AlignmentType.JUSTIFIED },
      },
    },
  },
  sections: [{
    properties: {
      page: {
        margin: { top: 1440, bottom: 1440, left: 1440, right: 1080 },
      },
    },
    children: allContent,
  }],
});

Packer.toBuffer(doc).then(buffer => {
  fs.writeFileSync('/home/daytona/workspace/naveed-synopsis-revised/NAVEED_SYNOPSIS_FINAL_ANNOTATED.docx', buffer);
  console.log('SUCCESS: NAVEED_SYNOPSIS_FINAL_ANNOTATED.docx created');
}).catch(err => {
  console.error('ERROR:', err.message);
  process.exit(1);
});

cd /home/daytona/workspace/naveed-synopsis-revised && node build_final.js 2>&1

ls -lh /home/daytona/workspace/naveed-synopsis-revised/NAVEED_SYNOPSIS_FINAL_ANN…

python3 -c " import zipfile with zipfile.ZipFile('/home/daytona/workspace/naveed…

cd /home/daytona/workspace/naveed-synopsis-revised && pandoc NAVEED_SYNOPSIS_FIN…

grep -n "Null Hypothesis\|null hypothesis" /tmp/verify.txt