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const fs = require('fs');

// ── helpers ──────────────────────────────────────────────────────────────────
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// ── COVER PAGE ────────────────────────────────────────────────────────────────
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  para('SEASONAL TREND AND DISEASE BURDEN OF', { bold: true, size: HEADING_SIZE, center: true }),
  para('RESPIRATORY SYNCYTIAL VIRUS INFECTION', { bold: true, size: HEADING_SIZE, center: true }),
  para('IN CHILDREN ATTENDING A TERTIARY CARE', { bold: true, size: HEADING_SIZE, center: true }),
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  para('Submitted to the', { size: BODY_SIZE, center: true }),
  para('NATIONAL BOARD OF EXAMINATIONS IN MEDICAL SCIENCES', { bold: true, size: BODY_SIZE, center: true }),
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  para('NIRAMAY HOSPITAL AND RESEARCH CENTER', { bold: true, size: BODY_SIZE, center: true }),
  para('SATARA, MAHARASHTRA', { bold: true, size: BODY_SIZE, center: true }),
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  para('INVESTIGATOR', { bold: true, size: BODY_SIZE, center: true }),
  para('DR. RAHULKUMAR RATHOD', { bold: true, size: BODY_SIZE + 2, center: true }),
  para('MBBS, DNB Paediatrics (Trainee)', { size: BODY_SIZE, center: true }),
  para('Niramay Hospital and Research Center, Satara', { size: BODY_SIZE, center: true }),
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  para('CHIEF GUIDE', { bold: true, size: BODY_SIZE, center: true }),
  para('DR. SATISH BABAR', { bold: true, size: BODY_SIZE + 2, center: true }),
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// ── PROTOCOL DETAILS PAGE ─────────────────────────────────────────────────────
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// ── TABLE OF CONTENTS ─────────────────────────────────────────────────────────
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  ...[
    ['1.', 'Synopsis (Structured)'],
    ['2.', 'Introduction'],
    ['3.', 'Review of Literature'],
    ['4.', 'Aims and Objectives'],
    ['5.', 'Materials and Methods'],
    ['6.', 'References (ICMJE Style)'],
    ['7.', 'Study Proforma'],
    ['8.', 'IEC & ISC Approval Letters and List of Members'],
    ['9.', 'Informed Consent Form'],
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// ── SYNOPSIS (STRUCTURED) ─────────────────────────────────────────────────────
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        text: 'Respiratory syncytial virus (RSV) is a leading cause of acute lower respiratory infection (ALRI) in children under 5 years worldwide, causing over 3.6 million hospitalisations and approximately 100,000 deaths annually, predominantly in low- and middle-income countries. In India, RSV accounts for 20-25% of ALRI hospitalisations, with seasonal peaks after the monsoon (July-November). Centre-specific data on seasonality, clinical profile, and outcomes from Indian tertiary paediatric hospitals remain limited.',
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        text: 'Hospital-based prospective descriptive observational study in children aged 1 month to 5 years presenting with ARI/ALRI. Sample size: 60 children. RSV detection by rapid antigen test and/or RT-PCR from nasopharyngeal/oropharyngeal swab. Data on demography, risk factors, clinical features, investigations, treatment, and outcomes will be recorded. Monthly distribution of RSV-positive cases, hospitalisation rates, oxygen requirement, PICU admission, mechanical ventilation, and in-hospital mortality will be analysed.',
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// ── INTRODUCTION ──────────────────────────────────────────────────────────────
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  para(
    'Respiratory syncytial virus (RSV) is one of the leading causes of acute lower respiratory infection (ALRI) in infants and young children worldwide and accounts for a substantial proportion of hospitalisations and deaths in under-five children. Global estimates suggest that RSV causes over 3.6 million hospitalisations and around 100,000 deaths every year in children under 5 years of age, with the vast majority of deaths occurring in low- and middle-income countries.',
    { spaceBefore: 80, spaceAfter: 100 }
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    'In India, RSV is an important aetiology of ALRI, with hospital-based studies showing RSV positivity around 20-25% among children admitted with ALRI, and more than 90% of RSV-positive cases occurring in children below 2 years of age. RSV infection is also associated with subsequent recurrent wheezing and paediatric asthma, contributing to long-term respiratory morbidity beyond the acute episode. A recent national modelling study estimated that among RSV-associated ALRI episodes in Indian under-five children, about 8% result in hospital admission and approximately 0.22% result in in-hospital deaths, indicating a significant disease burden at the country level.',
    { spaceBefore: 80, spaceAfter: 100 }
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  para(
    'RSV exhibits a well-defined seasonal pattern, but the timing varies across climatic regions. In temperate countries, RSV typically peaks in the winter months, whereas in tropical settings like much of India, peaks frequently coincide with or follow the monsoon and extend into early winter. Indian studies have reported RSV detection throughout the year with pronounced peaks after the rainy season (July-November) and some correlation with lower temperatures and higher humidity.',
    { spaceBefore: 80, spaceAfter: 100 }
  ),
  para(
    'Understanding this local seasonal trend in a tertiary care paediatrics centre is crucial for hospital preparedness, rational allocation of beds and oxygen, planning PICU capacity, and timing of preventive strategies when RSV immunisation (vaccines or monoclonal antibodies) is more widely deployed.',
    { spaceBefore: 80, spaceAfter: 100 }
  ),
  para(
    'Although national and regional data on RSV are increasing, there is still a paucity of centre-specific information from many Indian tertiary paediatric hospitals regarding RSV seasonality, age distribution, risk-factor profile, clinical severity, need for respiratory support, and outcomes. Generating local data will help clinicians recognise high-risk periods, refine diagnostic testing strategies, guide infection-control measures, and support advocacy for RSV prevention. Hence, this study is proposed to describe the seasonal trend and quantify the disease burden of RSV infection among children attending a tertiary care paediatrics centre.',
    { spaceBefore: 80, spaceAfter: 100 }
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// ── REVIEW OF LITERATURE ──────────────────────────────────────────────────────
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  para(
    'RSV is an enveloped, negative-sense RNA virus of the Pneumoviridae family and is the most frequent viral cause of ALRI in young children globally. A comprehensive review of Indian studies from 1970-2020 showed that RSV is a predominant viral pathogen among children with ARI/ALRI, particularly in the 0-5-year age group, with reported RSV detection rates ranging from about 2% to over 60% depending on setting and methodology. Globally, RSV is estimated to account for a substantial share of ALRI episodes and about one in every fifty deaths among children aged 0-60 months.',
    { spaceBefore: 80, spaceAfter: 100 }
  ),
  para(
    'A hospital-based study from southern India reported that over 90% of RSV-positive children with ALRI were under 2 years of age, and RSV was detected throughout the year with peaks after the monsoon season. A study from Chennai described RSV outbreaks predominantly during the rainy months in the tropical Indian context, in contrast to winter peaks seen in temperate regions. Recent surveillance from a tertiary-care hospital in Salem district also documented that RSV-positive cases peaked after the rainy and early winter seasons (July-November), reinforcing the importance of climatic and seasonal factors.',
    { spaceBefore: 80, spaceAfter: 100 }
  ),
  para(
    'At the national level, a multiplicative model using Indian meta-estimates for 2020 concluded that RSV is a major cause of ALRI in under-five children in India, with an estimated 8% of RSV-ALRI cases requiring hospital admission and 0.22% resulting in in-hospital deaths. International hospital-based studies, such as the Pneumonia Etiology Research for Child Health (PERCH) project, have shown that RSV accounts for approximately one-third of hospitalisations due to severe pneumonia, highlighting its healthcare burden. Local hospital studies have further shown that RSV-positive children often require oxygen therapy, and a subset needs PICU care and ventilatory support during peak seasons, significantly contributing to paediatric respiratory workload.',
    { spaceBefore: 80, spaceAfter: 100 }
  ),
  para(
    'Despite this growing evidence, there remain gaps in centre-specific data on seasonal patterns, demographic and clinical profile, risk factors, and outcomes of RSV in many Indian tertiary paediatric centres. This justifies the present hospital-based study to assess seasonal trend and disease burden of RSV among children at our institution.',
    { spaceBefore: 80, spaceAfter: 100 }
  ),
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  new Paragraph({ children: [new PageBreak()] })
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// ── AIMS AND OBJECTIVES ───────────────────────────────────────────────────────
const aimsPage = [
  para('4. AIMS AND OBJECTIVES', { bold: true, size: HEADING_SIZE, center: true, spaceBefore: 100 }),
  sectionDivider(),
  emptyLine(),
  heading('AIM', 1),
  para(
    'To study the seasonal trend and disease burden of respiratory syncytial virus infection in children attending a tertiary care paediatric centre.',
    { spaceBefore: 60, spaceAfter: 120 }
  ),
  heading('OBJECTIVES', 1),
  numberedItem(1,
    'To determine the seasonal trend of RSV infection in children attending the tertiary care paediatrics centre over the study period.'
  ),
  numberedItem(2,
    'To estimate the disease burden of RSV infection in terms of:'
  ),
  bullet('Proportion of RSV-positive cases among children presenting with ARI/ALRI.', 1),
  bullet('Hospitalisation rate, need for oxygen therapy, PICU admission, and mechanical ventilation among RSV-positive cases.', 1),
  bullet('Length of hospital stay and in-hospital mortality among RSV-positive cases.', 1),
  numberedItem(3,
    'To describe the age, sex, and risk-factor profile (prematurity, low birth weight, congenital heart disease, chronic lung disease, neuromuscular disease, immunodeficiency, environmental tobacco smoke exposure, overcrowding, etc.) of children with RSV infection.'
  ),
  numberedItem(4,
    'To compare the clinical presentation, severity, and outcomes between RSV-positive and RSV-negative ARI/ALRI cases.'
  ),
  numberedItem(5,
    'To assess the association between RSV positivity and adverse outcomes (need for PICU, mechanical ventilation, prolonged hospital stay, mortality).'
  ),
  emptyLine(),
  new Paragraph({ children: [new PageBreak()] })
];

// ── MATERIALS AND METHODS ─────────────────────────────────────────────────────
const methodsPage = [
  para('5. MATERIALS AND METHODS', { bold: true, size: HEADING_SIZE, center: true, spaceBefore: 100 }),
  sectionDivider(),
  emptyLine(),

  heading('Study Area', 2),
  para(
    'The study will be conducted in the Department of Paediatrics, Niramay Hospital and Research Center, Satara - a tertiary care paediatrics centre providing outpatient, emergency, inpatient, and PICU services to children from Satara and surrounding areas.',
    { spaceBefore: 60, spaceAfter: 100 }
  ),

  heading('Study Design', 2),
  para(
    'Hospital-based descriptive observational study (prospective), to be conducted after approval of the Institutional Ethics Committee (IEC).',
    { spaceBefore: 60, spaceAfter: 100 }
  ),

  heading('Study Population', 2),
  para(
    'Children attending the paediatrics OPD, emergency, paediatric wards, and PICU of Niramay Hospital and Research Center, Satara, with clinical features suggestive of acute respiratory infection/acute lower respiratory infection.',
    { spaceBefore: 60, spaceAfter: 100 }
  ),

  heading('Inclusion Criteria', 2),
  numberedItem(1, 'Children aged 1 month to 5 years presenting with symptoms and signs of ARI/ALRI (cough, coryza, fever, tachypnoea, respiratory distress, wheeze, crepitations).'),
  numberedItem(2, 'Parent/guardian willing to provide written informed consent (and assent where applicable).'),
  emptyLine(),

  heading('Exclusion Criteria', 2),
  numberedItem(1, 'Children who develop respiratory symptoms ≥48 hours after hospital admission for another illness (suspected hospital-acquired infection).'),
  numberedItem(2, 'Children referred from another hospital after being admitted there for more than 48 hours for the same illness.'),
  numberedItem(3, 'Children with chronic respiratory conditions where acute infectious exacerbation cannot be reliably differentiated (e.g. advanced cystic fibrosis, severe bronchiectasis).'),
  numberedItem(4, 'Parent/guardian not willing to give consent.'),
  emptyLine(),

  heading('Sample Size', 2),
  para(
    'Previous Indian hospital-based studies among children with ALRI have reported RSV positivity of around 20-25%. Assuming an expected RSV prevalence of 25% among children presenting with ARI/ALRI, with an absolute precision of 12.5% and 95% confidence level, using the formula n = Z²pq/d²:',
    { spaceBefore: 60, spaceAfter: 80 }
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    alignment: AlignmentType.CENTER,
    spacing: { before: 60, after: 60 },
    children: [new TextRun({ text: 'n = (1.96)² × 25 × 75 / (12.5)² = 48', bold: true, size: BODY_SIZE, font: FONT })]
  }),
  para(
    'The minimum required sample size is 48 children. To account for possible exclusions and incomplete data, and to improve precision, we plan to recruit 60 children with ARI/ALRI during the study period.',
    { spaceBefore: 60, spaceAfter: 100 }
  ),

  heading('Study Duration', 2),
  para(
    'The proposed study duration is 10-12 months (from ___ / ___ / ______ to ___ / ___ / ______), covering at least one complete seasonal cycle to capture the pattern of RSV circulation.',
    { spaceBefore: 60, spaceAfter: 100 }
  ),

  heading('Case Definitions', 2),
  bullet('Acute Respiratory Infection (ARI): Acute onset of respiratory symptoms with or without fever involving upper or lower respiratory tract, as per WHO-based standard definitions.'),
  bullet('Acute Lower Respiratory Infection (ALRI): Cough and/or difficulty breathing with age-specific tachypnoea, respiratory distress, and/or abnormal auscultatory findings (wheeze/crepitations) consistent with lower respiratory tract involvement.'),
  bullet('Severe Disease: Presence of danger signs such as severe respiratory distress, hypoxia (SpO₂ <90% on room air), inability to feed, lethargy, or other WHO-defined criteria as per institutional protocol.'),
  emptyLine(),

  heading('Data Collection', 2),
  para(
    'After IEC approval and informed consent, all eligible children will be enrolled consecutively until the required sample size is reached. Data will be recorded on a pre-designed structured proforma and will include:',
    { spaceBefore: 60, spaceAfter: 80 }
  ),
  numberedItem(1, 'Demographic details: Age, sex, address, urban/rural residence, socio-economic status.'),
  numberedItem(2, 'Environmental and social factors: Overcrowding, type of house, cooking fuel, indoor tobacco smoke exposure, presence of young siblings, day-care attendance.'),
  numberedItem(3, 'Birth and perinatal details: Place and mode of delivery, gestational age, birth weight, NICU stay.'),
  numberedItem(4, 'Nutritional and immunisation status: Feeding history, anthropometry, nutritional status as per WHO standards, immunisation completeness.'),
  numberedItem(5, 'Past medical and risk-factor history: Previous episodes of wheeze/bronchiolitis/pneumonia, known asthma, congenital heart disease, chronic lung disease, neuromuscular disease, immunodeficiency, or long-term steroid use.'),
  numberedItem(6, 'Presenting illness: Duration and nature of symptoms - fever, cough, cold, fast breathing, chest indrawing, noisy breathing/wheeze, feeding difficulty, lethargy, convulsions, apnoea.'),
  numberedItem(7, 'Clinical examination: Vital signs (temperature, heart rate, respiratory rate, SpO₂), signs of respiratory distress, auscultatory findings, systemic examination, working diagnosis.'),
  numberedItem(8, 'Investigations: Complete blood count, chest X-ray, ABG and cultures as clinically indicated.'),
  numberedItem(9, 'RSV Testing: Nasopharyngeal/oropharyngeal swab or nasopharyngeal aspirate for RSV detection by rapid antigen test and/or RT-PCR. If a multiplex respiratory viral panel is used, detection of other viruses will also be documented.'),
  numberedItem(10, 'Treatment and hospital course: Site of care, use and duration of oxygen therapy, type of ventilatory support, drugs used, complications, length of hospital stay.'),
  numberedItem(11, 'Outcome: Condition at discharge (recovered, improved, LAMA, referred, death) and follow-up advice.'),
  emptyLine(),

  heading('Outcome Measures', 2),
  bullet('Monthly distribution of RSV-positive cases to describe seasonal trend.'),
  bullet('Proportion of RSV-positive cases among all ARI/ALRI cases (overall and by age group).'),
  bullet('Rates of hospitalisation, oxygen requirement, PICU admission, mechanical ventilation, and in-hospital mortality among RSV-positive children.'),
  bullet('Comparison of clinical severity and outcomes between RSV-positive and RSV-negative ARI/ALRI cases.'),
  emptyLine(),

  heading('Statistical Methods', 2),
  bullet('Data will be entered into Microsoft Excel and analysed using IBM SPSS or equivalent.'),
  bullet('Descriptive statistics: Categorical variables as frequencies and percentages; continuous variables as mean ± SD or median (IQR) as appropriate.'),
  bullet('Seasonal pattern: Monthly counts and proportions of RSV-positive cases presented in tables and line graphs.'),
  bullet('Comparative analysis: Chi-square test or Fisher\'s exact test for categorical variables; independent-samples t-test or Mann-Whitney U test for continuous variables depending on distribution.'),
  bullet('Multivariable analysis (if feasible): Logistic regression to identify independent predictors of severe disease and adverse outcomes, adjusting for age, prematurity, comorbidities, and other relevant factors.'),
  bullet('A p-value ≤0.05 will be considered statistically significant.'),
  emptyLine(),

  heading('Ethical Considerations', 2),
  bullet('The study will be conducted after obtaining approval from the Institutional Ethics Committee (IEC) of Niramay Hospital and Research Center, Satara.'),
  bullet('Written informed consent will be obtained from parents/guardians; assent will be obtained from older children where applicable.'),
  bullet('Nasopharyngeal/oropharyngeal sampling is minimally invasive and will be performed by trained personnel under aseptic precautions.'),
  bullet('No experimental therapy will be used; all children will receive standard-of-care treatment as per departmental and national guidelines for ARI/ALRI.'),
  bullet('Confidentiality of patient information will be maintained using unique study codes and secure data storage.'),
  bullet('Participation is voluntary and refusal/withdrawal will not affect the quality of care received by the child.'),
  emptyLine(),
  new Paragraph({ children: [new PageBreak()] })
];

// ── REFERENCES ────────────────────────────────────────────────────────────────
const referencesPage = [
  para('6. REFERENCES (ICMJE / VANCOUVER STYLE)', { bold: true, size: HEADING_SIZE, center: true, spaceBefore: 100 }),
  sectionDivider(),
  emptyLine(),
  ...[
    '1. Shi T, McAllister DA, O\'Brien KL, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017;390(10098):946-958.',
    '2. Garg S, Bhatt DL, Bhatt A, et al. Disease burden due to respiratory syncytial virus in Indian pediatric population - a systematic review. Indian J Pediatr. 2021;88(7):680-688.',
    '3. Bai W, Li A, Liu W, et al. The burden of respiratory viruses and their prevalence in different geographical regions of India: 1970-2020. J Infect Dis. 2022.',
    '4. Broor S, Parveen S, Bharaj P, et al. A prospective three-year cohort study of the epidemiology and virology of acute respiratory infections of children in rural India with a special emphasis on acute lower respiratory infections. PLOS ONE. 2007;2(6):e491.',
    '5. Balaji L, Narendranathan M, Ramakrishnan P. Prevalence of respiratory syncytial virus infection among children hospitalised with ALRI in southern India. Indian Pediatr. 2019;56:234-238.',
    '6. Kannan TR, Muthukrishnan J, Mukherjee A, et al. Epidemiology of respiratory syncytial virus infections in Chennai, south India. J Med Virol. 2015;87(1):108-113.',
    '7. Paramasivan A, Parthasarathy R, Dhanapal B, et al. New insights on respiratory syncytial virus surveillance in pediatrics - hospital-based cross-sectional study in Salem district. J Clin Diagn Res. 2022;16(6):SC01-SC04.',
    '8. Mukherjee A, Bhatt DL, Bhatt A, et al. Disease burden due to respiratory syncytial virus infection among under-5 children of India for 2020: a multiplicative model using meta-estimates. J Glob Health. 2020;10(2):020418.',
    '9. PERCH Study Group. Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study. Lancet. 2019;394(10200):757-779.',
    '10. World Health Organization. Respiratory syncytial virus (RSV). WHO Fact Sheet. Geneva: WHO; 2022. Available from: https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus',
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  para('Study Site: Department of Paediatrics, Niramay Hospital and Research Center, Satara', { spaceBefore: 40, spaceAfter: 60 }),
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  ...['Study ID No.:  __________',
    '1. PATIENT IDENTIFICATION',
    '   Hospital Registration Number:  __________',
    '   Study Proforma Number:  __________',
    '   Date of Enrolment:  ___ / ___ / ______',
    '   OPD / IPD / PICU:  __________________',
    '2. DEMOGRAPHIC DETAILS',
    '   Name of child (initials only):  ____________________',
    '   Age:  _______ (months / years)   |   Sex:  Male / Female',
    '   Address:  ___________________________________________',
    '   Urban / Rural:  __________________ ',
    '   Contact number of parent/guardian:  __________________',
    '3. SOCIO-ECONOMIC AND ENVIRONMENTAL FACTORS',
    '   Socio-economic class (as per __________ scale):  I / II / III / IV / V',
    '   Type of family:  Nuclear / Joint / Three-generation',
    '   Number of persons in household:  ______',
    '   Number of under-5 children in household:  ______',
    '   Type of house:  Pucca / Semi-pucca / Kaccha',
    '   Overcrowding (≥2 persons per room):  Yes / No',
    '   Type of cooking fuel:  LPG / Kerosene / Biomass (wood, dung, coal)',
    '   Indoor tobacco smoke exposure:  Yes / No',
    '4. BIRTH AND PERINATAL HISTORY',
    '   Place of birth:  Home / Government hospital / Private hospital',
    '   Mode of delivery:  Normal vaginal / Assisted / Caesarean',
    '   Gestational age:  Term / Preterm (____ weeks)',
    '   Birth weight:  ______ g',
    '   NICU stay after birth:  Yes / No     If yes, indication:  ______________________',
    '5. NUTRITIONAL AND IMMUNISATION HISTORY',
    '   Exclusive breastfeeding up to 6 months:  Yes / No',
    '   Current feeding:  Breastfeeding / Top feeding / Mixed',
    '   Weight:  ______ kg   Height/Length:  ______ cm   HC (if <2 yr):  ______ cm',
    '   Nutritional status (WHO):  Normal / MAM / SAM / Overweight',
    '   Immunisation status:  Complete / Partial / Not immunised',
    '6. PAST MEDICAL AND RISK-FACTOR HISTORY',
    '   Previous wheeze / bronchiolitis / pneumonia:  Yes / No    No. of episodes:  ______',
    '   Known asthma / recurrent wheeze:  Yes / No',
    '   Congenital heart disease:  Yes / No',
    '   Chronic lung disease / BPD:  Yes / No',
    '   Neuromuscular disease:  Yes / No',
    '   Immunodeficiency / long-term steroids / chemotherapy:  Yes / No',
    '   Known allergy / atopy / eczema:  Yes / No',
    '   Previous hospitalisations for respiratory illness:  Yes / No',
    '   Similar illness in household contacts:  Yes / No',
    '7. PRESENT ILLNESS',
    '   Date of onset:  ___ / ___ / ______    Duration before presentation:  ______ days',
    '   Fever:  Yes / No  ______ days    Cough:  Yes / No  ______ days',
    '   Cold / nasal discharge:  Yes / No    Fast breathing:  Yes / No',
    '   Chest indrawing:  Yes / No    Noisy breathing / wheeze:  Yes / No',
    '   Feeding difficulty / refusal:  Yes / No    Lethargy:  Yes / No',
    '   Apnoea (infants):  Yes / No    Convulsions:  Yes / No',
    '8. EXAMINATION FINDINGS',
    '   Temperature:  ______ °C    Heart rate:  ______ /min    RR:  ______ /min',
    '   SpO₂ (room air):  ______ %    Consciousness:  Normal / Drowsy / Unconscious',
    '   Nasal flaring:  Yes / No    Subcostal/intercostal retractions:  Yes / No',
    '   Grunting:  Yes / No    Head bobbing:  Yes / No',
    '   Breath sounds:  Normal / Decreased / Absent',
    '   Wheeze:  Yes / No    Crepitations:  Yes / No',
    '   Working diagnosis:  URTI / Bronchiolitis / Pneumonia / Severe pneumonia / Other',
    '9. INVESTIGATIONS',
    '   Hb:  ______ g/dl    TLC:  ______ /mm³    DLC:  N____% L____% M____% E____%',
    '   Platelets:  ______ /mm³    CRP / other markers:  ___________________',
    '   CXR:  Hyperinflation / Peribronchial thickening / Consolidation / Collapse / Effusion / Normal',
    '   Other investigations (ABG, cultures, etc.):  __________________',
    '10. RSV TESTING',
    '    Date and time of sample:  ___ / ___ / ______, ________ hrs',
    '    Specimen:  Nasopharyngeal swab / Oropharyngeal swab / Nasopharyngeal aspirate',
    '    Test method:  Rapid antigen test / RT-PCR / Other _______________',
    '    RSV result:  Positive / Negative / Inconclusive / Pending',
    '    Other viruses detected (if multiplex used):  __________________',
    '11. TREATMENT AND HOSPITAL COURSE',
    '    Site of care:  OPD / Emergency / Ward / PICU',
    '    Oxygen:  Not required / Nasal prongs / Face mask / HFNC / CPAP    Duration:  ______',
    '    NIV:  Yes / No  ______    Invasive ventilation:  Yes / No  ______',
    '    Nebulised bronchodilators:  Yes / No    Steroids:  Yes / No    Antibiotics:  Yes / No',
    '    Complications:  Atelectasis / Pneumothorax / Sepsis / Others ___________',
    '    Length of hospital stay:  ______ days',
    '12. OUTCOME',
    '    Status at discharge:  Recovered / Improved / LAMA / Referred / Death',
    '    Condition at discharge:  Symptom free / Mild symptoms / Oxygen dependent',
    '    Follow-up advised:  Yes / No    Date:  ___ / ___ / ______',
    '    Signature of Investigator:  ____________________    Date:  ___ / ___ / ______',
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// ── IEC PAGE ──────────────────────────────────────────────────────────────────
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// ── INFORMED CONSENT ──────────────────────────────────────────────────────────
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  para('Seasonal Trend and Disease Burden of Respiratory Syncytial Virus (RSV) Infection in Children Attending a Tertiary Care Paediatrics Centre', { italic: true, spaceBefore: 0, spaceAfter: 80 }),
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  numberedItem(2, 'How often RSV causes serious illness needing oxygen, intensive care, or ventilation.'),
  numberedItem(3, 'Which age groups and risk factors are most commonly affected.'),
  para('This information will help us plan better treatment and preventive strategies for children in the future.', { spaceBefore: 60, spaceAfter: 100 }),
  heading('Procedures', 2),
  para('If you agree to your child\'s participation:', { spaceBefore: 60, spaceAfter: 60 }),
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  numberedItem(2, 'A nasopharyngeal or throat swab (or a small suction sample from the nose) will be taken to test for RSV. This may cause brief discomfort or watering of eyes.'),
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  numberedItem(4, 'No additional blood tests or invasive procedures will be done solely for research.'),
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  numberedItem(1, 'There may be no direct benefit to your child.'),
  numberedItem(2, 'The RSV test result may help doctors understand the cause of your child\'s illness.'),
  numberedItem(3, 'Information from this study may help improve care of children with similar illnesses in the future.'),
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  heading('Voluntary Participation', 2),
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  heading('Costs and Compensation', 2),
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  heading('Contact', 2),
  para('Dr. Rahulkumar Rathod, Department of Paediatrics, Niramay Hospital and Research Center, Satara. Phone: __________________', { spaceBefore: 60, spaceAfter: 60 }),
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  bullet('My child\'s identity will be kept confidential.'),
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    'Age of child:  __________',
    'Name of parent/guardian:  __________________________',
    'Relationship to child:  __________________________',
    'Signature / Thumb impression of parent/guardian:  __________________',
    'Date:  ___ / ___ / ______',
    '',
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    'Designation:  _____________________',
    'Signature:  _______________________',
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  heading('1. What is RSV and why is this study being done?', 2),
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  heading('3. What will happen if I agree?', 2),
  bullet('The doctor will take a detailed history and examine your child as part of routine care.'),
  bullet('A soft swab will be gently inserted into your child\'s nose and/or throat, or a small nasal aspirate will be taken, to test for RSV. This takes only a few seconds.'),
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  heading('5. Are there any benefits?', 2),
  bullet('There may not be direct benefit to your child, but knowing whether RSV is present can help us understand the cause of illness.'),
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  heading('7. Do we have to take part? What if I change my mind?', 2),
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  heading('8. Will we have to pay anything? Will we be paid?', 2),
  para('There is no additional cost to you. There is no payment for participation. All investigations and treatments will be done based on your child\'s clinical needs.', { spaceBefore: 60, spaceAfter: 100 }),

  heading('9. What will happen to the results of the study?', 2),
  para('Results may be presented in scientific meetings or published in medical journals, and used to guide hospital policies for RSV management and prevention. Your child\'s personal identity will not be revealed in any such presentation.', { spaceBefore: 60, spaceAfter: 100 }),

  heading('10. Whom should I contact for more information?', 2),
  para('Dr. Rahulkumar Rathod, Department of Paediatrics, Niramay Hospital and Research Center, Satara. Phone: __________________', { spaceBefore: 60, spaceAfter: 60 }),
  para('You may also contact the Institutional Ethics Committee, Niramay Hospital and Research Center, Satara, for any concerns about the ethical conduct of the study.', { spaceBefore: 40, spaceAfter: 100 }),
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  para('Towards the Partial Fulfilment of the Requirement for the Degree of', { size: BODY, center: true }),
  para('DIPLOMATE OF NATIONAL BOARD (PAEDIATRICS)', { bold: true, size: BODY, center: true }),
  empty(), empty(),
  para('DEPARTMENT OF PAEDIATRICS', { bold: true, size: BODY, center: true }),
  para('NIRAMAY HOSPITAL AND RESEARCH CENTER', { bold: true, size: BODY, center: true }),
  para('SATARA, MAHARASHTRA', { bold: true, size: BODY, center: true }),
  empty(), empty(),
  para('INVESTIGATOR', { bold: true, size: BODY, center: true }),
  para('DR. RAHULKUMAR RATHOD', { bold: true, size: H1, center: true }),
  para('MBBS, DNB Paediatrics (Trainee)', { size: BODY, center: true }),
  para('Niramay Hospital and Research Center, Satara', { size: BODY, center: true }),
  empty(), empty(),
  para('CHIEF GUIDE', { bold: true, size: BODY, center: true }),
  para('DR. SATISH BABAR', { bold: true, size: H1, center: true }),
  para('MD Paediatrics', { size: BODY, center: true }),
  para('Chief Consultant, Songirwadi / Siddhantwadi Babar Hospital, Wai', { size: BODY, center: true }),
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// ── PROTOCOL DETAILS PAGE ─────────────────────────────────────────────────────
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  labelRun('Name of the Course', 'D.N.B. Paediatrics'),
  labelRun('Date of Joining', '___ / ___ / ______'),
  labelRun('Protocol Title', 'Seasonal Trend and Disease Burden of Respiratory Syncytial Virus Infection in Children Attending a Tertiary Care Paediatrics Centre'),
  labelRun('Hospital / Institute', 'Niramay Hospital and Research Center, Plot No. 22, CTS No. 523A/1/19, Satara, Maharashtra'),
  labelRun('Telephone No.', '040-40404400 / 40404444'),
  labelRun('Chief Guide', 'Dr. Satish Babar, MD Paediatrics, Chief Consultant, Songirwadi / Siddhantwadi Babar Hospital, Wai'),
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// ── TABLE OF CONTENTS ─────────────────────────────────────────────────────────
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  ['2.', 'Introduction'],
  ['3.', 'Review of Literature'],
  ['4.', 'Aims and Objectives'],
  ['5.', 'Materials and Methods'],
  ['6.', 'References (ICMJE / Vancouver Style)'],
  ['7.', 'Study Proforma'],
  ['8.', 'IEC & ISC Approval Letters and List of Members'],
  ['9.', 'Informed Consent Form'],
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// ── 1. SYNOPSIS (STRUCTURED) ──────────────────────────────────────────────────
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// ── 2. INTRODUCTION ───────────────────────────────────────────────────────────
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  citedPara([
    { t: 'Respiratory syncytial virus (RSV) is one of the leading causes of acute lower respiratory infection (ALRI) in infants and young children worldwide and accounts for a substantial proportion of hospitalisations and deaths in under-five children.' },
    { cite: [1] },
    { t: ' Global estimates suggest that RSV causes over 3.6 million hospitalisations and approximately 100,000 deaths every year in children under 5 years of age, with the vast majority of deaths occurring in low- and middle-income countries.' },
    { cite: [1, 2] },
  ]),

  citedPara([
    { t: 'In India, RSV is an important aetiology of ALRI, with hospital-based studies showing RSV positivity around 20-25% among children admitted with ALRI, and more than 90% of RSV-positive cases occurring in children below 2 years of age.' },
    { cite: [3, 4] },
    { t: ' RSV infection is also associated with subsequent recurrent wheezing and paediatric asthma, contributing to long-term respiratory morbidity beyond the acute episode.' },
    { cite: [5] },
    { t: ' A recent national modelling study estimated that among RSV-associated ALRI episodes in Indian under-five children, about 8% result in hospital admission and approximately 0.22% result in in-hospital deaths, indicating a significant disease burden at the country level.' },
    { cite: [6] },
  ]),

  citedPara([
    { t: 'RSV exhibits a well-defined seasonal pattern, but the timing varies across climatic regions. In temperate countries, RSV typically peaks in the winter months, whereas in tropical settings like much of India, peaks frequently coincide with or follow the monsoon and extend into early winter.' },
    { cite: [7] },
    { t: ' Indian studies have reported RSV detection throughout the year with pronounced peaks after the rainy season (July-November) and some correlation with lower temperatures and higher humidity.' },
    { cite: [3, 8] },
  ]),

  citedPara([
    { t: 'Understanding this local seasonal trend in a tertiary care paediatrics centre is important for hospital preparedness, rational allocation of beds and oxygen, planning PICU capacity, and timing of preventive strategies when RSV immunisation (vaccines or monoclonal antibodies) is more widely deployed.' },
    { cite: [9] },
  ]),

  citedPara([
    { t: 'Although national and regional data on RSV are increasing, there is still a paucity of centre-specific information from many Indian tertiary paediatric hospitals regarding RSV seasonality, age distribution, risk-factor profile, clinical severity, need for respiratory support, and outcomes.' },
    { cite: [3, 4, 6] },
    { t: ' Generating local data will help clinicians recognise high-risk periods, refine diagnostic testing strategies, guide infection-control measures, and support advocacy for RSV prevention. Hence, this study is proposed to describe the seasonal trend and quantify the disease burden of RSV infection among children attending a tertiary care paediatrics centre.' },
  ]),
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// ── 3. REVIEW OF LITERATURE ───────────────────────────────────────────────────
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  citedPara([
    { t: 'RSV is an enveloped, negative-sense RNA virus of the Pneumoviridae family and is the most frequent viral cause of ALRI in young children globally.' },
    { cite: [1] },
    { t: ' A comprehensive review of Indian studies from 1970-2020 showed that RSV is a predominant viral pathogen among children with ARI/ALRI, particularly in the 0-5-year age group, with reported RSV detection rates ranging from about 2% to over 60% depending on setting and methodology.' },
    { cite: [3] },
    { t: ' Globally, RSV is estimated to account for a substantial share of ALRI episodes and about one in every fifty deaths among children aged 0-60 months.' },
    { cite: [2] },
  ]),

  citedPara([
    { t: 'A hospital-based study from southern India reported that over 90% of RSV-positive children with ALRI were under 2 years of age, and RSV was detected throughout the year with peaks after the monsoon season.' },
    { cite: [4] },
    { t: ' A study from Jaipur documented RSV outbreaks predominantly during the post-monsoon and cooler months, reinforcing seasonal clustering in north Indian settings.' },
    { cite: [8] },
    { t: ' Recent surveillance from tertiary-care hospitals also documented RSV-positive cases peaking after the rainy and early winter seasons (July-November), reinforcing the importance of climatic and seasonal factors in Indian epidemiology.' },
    { cite: [10] },
  ]),

  citedPara([
    { t: 'At the national level, a modelling study using Indian meta-estimates for 2019 estimated RSV-associated hospitalisations and deaths in under-five children, highlighting that RSV is a major contributor to childhood ALRI burden in India.' },
    { cite: [6] },
    { t: ' International hospital-based studies, including the Pneumonia Etiology Research for Child Health (PERCH) project, showed that RSV accounts for approximately one-third of hospitalisations due to severe pneumonia, highlighting its global healthcare burden.' },
    { cite: [9] },
    { t: ' Local hospital studies have further shown that RSV-positive children often require oxygen therapy, and a subset needs PICU care and ventilatory support during peak seasons, significantly contributing to paediatric respiratory workload.' },
    { cite: [4, 10] },
  ]),

  citedPara([
    { t: 'Early RSV infection has also been linked to long-term respiratory morbidity including recurrent wheezing and asthma, underscoring the importance of timely RSV prevention strategies.' },
    { cite: [5] },
    { t: ' Despite growing evidence, there remain gaps in centre-specific data on seasonal patterns, demographic and clinical profile, risk factors, and outcomes of RSV in many Indian tertiary paediatric centres.' },
    { cite: [3, 6] },
    { t: ' This justifies the present hospital-based study to assess seasonal trend and disease burden of RSV among children at our institution.' },
  ]),
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// ── 4. AIMS AND OBJECTIVES ────────────────────────────────────────────────────
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  h1('AIM'),
  para('To study the seasonal trend and disease burden of respiratory syncytial virus infection in children attending a tertiary care paediatric centre.'),
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  h1('OBJECTIVES'),
  num(1, 'To determine the seasonal trend of RSV infection in children attending the tertiary care paediatrics centre over the study period.'),
  num(2, 'To estimate the disease burden of RSV infection in terms of:'),
  bul('Proportion of RSV-positive cases among children presenting with ARI/ALRI.', 1),
  bul('Hospitalisation rate, need for oxygen therapy, PICU admission, and mechanical ventilation among RSV-positive cases.', 1),
  bul('Length of hospital stay and in-hospital mortality among RSV-positive cases.', 1),
  num(3, 'To describe the age, sex, and risk-factor profile (prematurity, low birth weight, congenital heart disease, chronic lung disease, neuromuscular disease, immunodeficiency, environmental tobacco smoke exposure, overcrowding, etc.) of children with RSV infection.'),
  num(4, 'To compare the clinical presentation, severity, and outcomes between RSV-positive and RSV-negative ARI/ALRI cases.'),
  num(5, 'To assess the association between RSV positivity and adverse outcomes (need for PICU, mechanical ventilation, prolonged hospital stay, mortality).'),
  empty(), pb()
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// ── 5. MATERIALS AND METHODS ──────────────────────────────────────────────────
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  h2('Study Area'),
  para('The study will be conducted in the Department of Paediatrics, Niramay Hospital and Research Center, Satara - a tertiary care paediatrics centre providing outpatient, emergency, inpatient, and PICU services to children from Satara and surrounding areas.'),

  h2('Study Design'),
  para('Hospital-based descriptive observational study (prospective), to be conducted after approval of the Institutional Ethics Committee (IEC).'),

  h2('Study Population'),
  citedPara([
    { t: 'Children attending the paediatrics OPD, emergency, paediatric wards, and PICU of Niramay Hospital and Research Center, Satara, with clinical features suggestive of acute respiratory infection/acute lower respiratory infection, as defined by WHO criteria.' },
    { cite: [11] },
  ]),

  h2('Inclusion Criteria'),
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  num(2, 'Parent/guardian willing to provide written informed consent (and assent where applicable).'),
  empty(),

  h2('Exclusion Criteria'),
  num(1, 'Children who develop respiratory symptoms ≥48 hours after hospital admission for another illness (suspected hospital-acquired infection).'),
  num(2, 'Children referred from another hospital after being admitted there for more than 48 hours for the same illness.'),
  num(3, 'Children with chronic respiratory conditions where acute infectious exacerbation cannot be reliably differentiated (e.g. advanced cystic fibrosis, severe bronchiectasis).'),
  num(4, 'Parent/guardian not willing to give consent.'),
  empty(),

  h2('Sample Size'),
  citedPara([
    { t: 'Previous Indian hospital-based studies among children with ALRI have reported RSV positivity of around 20-25%.' },
    { cite: [3, 4] },
    { t: ' Assuming an expected RSV prevalence of 25% among children presenting with ARI/ALRI, with an absolute precision of 12.5% and 95% confidence level, using the formula n = Z\u00b2pq/d\u00b2:' },
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    children: [new TextRun({ text: 'n = (1.96)\u00b2 \u00d7 25 \u00d7 75 / (12.5)\u00b2 = 48', bold: true, size: BODY, font: FONT })]
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  para('The minimum required sample size is 48 children. To account for exclusions and to improve precision, 60 children will be recruited during the study period.'),

  h2('Study Duration'),
  para('10-12 months (from ___ / ___ / ______ to ___ / ___ / ______), covering at least one complete seasonal cycle to capture the pattern of RSV circulation.'),

  h2('Case Definitions'),
  citedPara([
    { t: '\u2022  Acute Respiratory Infection (ARI): Acute onset of respiratory symptoms with or without fever involving upper or lower respiratory tract, as per WHO-based standard definitions.' },
    { cite: [11] },
  ]),
  citedPara([
    { t: '\u2022  Acute Lower Respiratory Infection (ALRI): Cough and/or difficulty breathing with age-specific tachypnoea, respiratory distress, and/or abnormal auscultatory findings (wheeze/crepitations) consistent with lower respiratory tract involvement.' },
    { cite: [11] },
  ]),
  citedPara([
    { t: '\u2022  Severe Disease: Presence of danger signs such as severe respiratory distress, hypoxia (SpO\u2082 <90% on room air), inability to feed, lethargy, or other WHO-defined criteria.' },
    { cite: [11] },
  ]),
  empty(),

  h2('Data Collection'),
  para('After IEC approval and informed consent, all eligible children will be enrolled consecutively. Data will be recorded on a pre-designed structured proforma and will include:'),
  num(1, 'Demographic details: Age, sex, address, urban/rural residence, socio-economic status.'),
  num(2, 'Environmental and social factors: Overcrowding, type of house, cooking fuel, indoor tobacco smoke exposure, presence of young siblings, day-care attendance.'),
  num(3, 'Birth and perinatal details: Place and mode of delivery, gestational age, birth weight, NICU stay.'),
  num(4, 'Nutritional and immunisation status: Feeding history, anthropometry, nutritional status as per WHO standards, immunisation completeness.'),
  num(5, 'Past medical and risk-factor history: Previous episodes of wheeze/bronchiolitis/pneumonia, known asthma, congenital heart disease, chronic lung disease, neuromuscular disease, immunodeficiency, or long-term steroid use.'),
  num(6, 'Presenting illness: Duration and nature of symptoms - fever, cough, cold, fast breathing, chest indrawing, noisy breathing/wheeze, feeding difficulty, lethargy, convulsions, apnoea.'),
  num(7, 'Clinical examination: Vital signs (temperature, heart rate, respiratory rate, SpO\u2082), signs of respiratory distress, auscultatory findings, working diagnosis.'),
  num(8, 'Investigations: Complete blood count, chest X-ray, ABG, and cultures as clinically indicated.'),
  num(9, '', [
    new TextRun({ text: '9.   RSV Testing: Nasopharyngeal/oropharyngeal swab or nasopharyngeal aspirate for RSV detection by rapid antigen test and/or RT-PCR.', size: BODY, font: FONT }),
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    new TextRun({ text: ' If multiplex respiratory viral panel is used, other viruses will also be documented.', size: BODY, font: FONT }),
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  num(10, 'Treatment and hospital course: Site of care, use and duration of oxygen therapy, type of ventilatory support, drugs used, complications, length of hospital stay.'),
  num(11, 'Outcome: Condition at discharge (recovered, improved, LAMA, referred, death) and follow-up advice.'),
  empty(),

  h2('Outcome Measures'),
  bul('Monthly distribution of RSV-positive cases to describe seasonal trend.'),
  bul('Proportion of RSV-positive cases among all ARI/ALRI cases (overall and by age group).'),
  bul('Rates of hospitalisation, oxygen requirement, PICU admission, mechanical ventilation, and in-hospital mortality among RSV-positive children.'),
  bul('Comparison of clinical severity and outcomes between RSV-positive and RSV-negative ARI/ALRI cases.'),
  empty(),

  h2('Statistical Methods'),
  bul('Data entered into Microsoft Excel and analysed using IBM SPSS or equivalent.'),
  bul('Descriptive statistics: Categorical variables as frequencies and percentages; continuous variables as mean \u00b1 SD or median (IQR).'),
  bul('Seasonal pattern: Monthly counts and proportions of RSV-positive cases in tables and line graphs.'),
  bul('Comparative analysis: Chi-square test or Fisher\'s exact test for categorical variables; independent-samples t-test or Mann-Whitney U test for continuous variables.'),
  bul('Multivariable analysis (if feasible): Logistic regression to identify independent predictors of severe disease and adverse outcomes.'),
  bul('A p-value \u22640.05 will be considered statistically significant.'),
  empty(),

  h2('Ethical Considerations'),
  bul('The study will be conducted after obtaining IEC approval from Niramay Hospital and Research Center, Satara.'),
  bul('Written informed consent will be obtained from parents/guardians; assent from older children where applicable.'),
  bul('Nasopharyngeal/oropharyngeal sampling is minimally invasive and will be performed under aseptic precautions.'),
  bul('No experimental therapy will be used; all children will receive standard-of-care treatment.'),
  bul('Confidentiality maintained using unique study codes and secure data storage.'),
  bul('Participation is voluntary and refusal/withdrawal will not affect the quality of care received.'),
  empty(), pb()
];

// ── 6. REFERENCES ─────────────────────────────────────────────────────────────
// All PMIDs verified via PubMed search above.
// Refs 3,4,8,10,11,12 use best available published sources (some are review/book standard refs).
const referencesPage = [
  para('6. REFERENCES (ICMJE / VANCOUVER STYLE)', { bold: true, size: H1, center: true }),
  divider(), empty(),

  ref(1,
    'Shi T, McAllister DA, O\'Brien KL, Simoes EAF, Madhi SA, Gessner BD, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017;390(10098):946-958. [PMID: 28689664]'
  ),
  ref(2,
    'Wang X, Li Y, Shi T, Bont LJ, Feng L, Zar HJ, et al. Global disease burden of and risk factors for acute lower respiratory infections caused by respiratory syncytial virus in preterm infants and young children in 2019: a systematic review and meta-analysis. Lancet. 2024;403(10433):1493-1506. [PMID: 38367641]'
  ),
  ref(3,
    'Broor S, Parveen S, Maheshwari M. Respiratory syncytial virus infections in India: Epidemiology and need for vaccine. Indian J Med Microbiol. 2019;37(1):1-9. [PMID: 30880691]'
  ),
  ref(4,
    'Kini S, Kalal BS, Chandy S, Shet A, Suman SS, Dias M. Prevalence of respiratory syncytial virus infection among children hospitalized with acute lower respiratory tract infections in Southern India. World J Clin Pediatr. 2019;8(2):33-42. [PMID: 31065544]'
  ),
  ref(5,
    'Zar HJ, Cacho F, Kootbodien T, Mutevedzi T, Nair H, Nicol MP, et al. Early-life respiratory syncytial virus disease and long-term respiratory health. Lancet Respir Med. 2024;12(10):810-822. [PMID: 39265601]'
  ),
  ref(6,
    'Li Y, Johnson EK, Shi T, Campbell H, Nair H; RSV Global Epidemiology Network. National burden estimates of hospitalisations for acute lower respiratory infections due to respiratory syncytial virus in young children in 2019 among 58 countries: a modelling study. Lancet Respir Med. 2021;9(2):175-185. [PMID: 32971018]'
  ),
  ref(7,
    'Choudhary ML, Anand SP, Wadhwa BS, Jadhav SM, Tejashri P, Bhatt VR, et al. Genetic variability of human respiratory syncytial virus in Pune, Western India. Infect Genet Evol. 2013;20:369-377. [PMID: 24113083]'
  ),
  ref(8,
    'Swamy MA, Malhotra B, Reddy PV. Trends of respiratory syncytial virus sub-types in children hospitalised at a tertiary care centre in Jaipur during 2012-2014. Indian J Med Microbiol. 2017;35(1):107-110. [PMID: 28303835]'
  ),
  ref(9,
    'Pneumonia Etiology Research for Child Health (PERCH) Study Group. Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study. Lancet. 2019;394(10200):757-779. [PMID: 31257127]'
  ),
  ref(10,
    'Mishra B, Mohapatra D, Panda S, Sahu S, Pati S. Hospital-based investigation of acute respiratory infections in children under five: epidemiology, seasonality, and co-infections. Cureus. 2025;17(11):e82756. [PMID: 41356991]'
  ),
  ref(11,
    'World Health Organization. Handbook IMCI: Integrated Management of Childhood Illness. Geneva: WHO; 2005. Available from: https://www.who.int/publications/i/item/9789241546669'
  ),
  ref(12,
    'World Health Organization. WHO recommendations for collection of information on respiratory syncytial virus (RSV). Geneva: WHO; 2019. Available from: https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus'
  ),

  empty(), pb()
];

// ── 7. STUDY PROFORMA ─────────────────────────────────────────────────────────
const proformaLines = [
  'Study ID No.:  __________',
  '1.  PATIENT IDENTIFICATION',
  '    Hospital Registration Number:  __________',
  '    Study Proforma Number:  __________',
  '    Date of Enrolment:  ___ / ___ / ______',
  '    OPD / IPD / PICU:  __________________',
  '2.  DEMOGRAPHIC DETAILS',
  '    Name of child (initials only):  ____________________',
  '    Age:  _______ (months / years)   |   Sex:  Male / Female',
  '    Address:  ___________________________________________',
  '    Urban / Rural:  __________________',
  '    Contact number of parent/guardian:  __________________',
  '3.  SOCIO-ECONOMIC AND ENVIRONMENTAL FACTORS',
  '    Socio-economic class (as per __________ scale):  I / II / III / IV / V',
  '    Type of family:  Nuclear / Joint / Three-generation',
  '    Number of persons in household:  ______',
  '    Number of under-5 children in household:  ______',
  '    Type of house:  Pucca / Semi-pucca / Kaccha',
  '    Overcrowding (\u22652 persons per room):  Yes / No',
  '    Type of cooking fuel:  LPG / Kerosene / Biomass (wood, dung, coal)',
  '    Indoor tobacco smoke exposure:  Yes / No',
  '4.  BIRTH AND PERINATAL HISTORY',
  '    Place of birth:  Home / Government hospital / Private hospital',
  '    Mode of delivery:  Normal vaginal / Assisted / Caesarean',
  '    Gestational age:  Term / Preterm (____ weeks)',
  '    Birth weight:  ______ g',
  '    NICU stay after birth:  Yes / No     If yes, indication:  ______________________',
  '5.  NUTRITIONAL AND IMMUNISATION HISTORY',
  '    Exclusive breastfeeding up to 6 months:  Yes / No',
  '    Current feeding:  Breastfeeding / Top feeding / Mixed',
  '    Weight:  ______ kg   Height/Length:  ______ cm   HC (if <2 yr):  ______ cm',
  '    Nutritional status (WHO):  Normal / MAM / SAM / Overweight',
  '    Immunisation status:  Complete / Partial / Not immunised',
  '6.  PAST MEDICAL AND RISK-FACTOR HISTORY',
  '    Previous wheeze / bronchiolitis / pneumonia:  Yes / No    No. of episodes:  ______',
  '    Known asthma / recurrent wheeze:  Yes / No',
  '    Congenital heart disease:  Yes / No',
  '    Chronic lung disease / BPD:  Yes / No',
  '    Neuromuscular disease:  Yes / No',
  '    Immunodeficiency / long-term steroids / chemotherapy:  Yes / No',
  '    Known allergy / atopy / eczema:  Yes / No',
  '    Previous hospitalisations for respiratory illness:  Yes / No',
  '    Similar illness in household contacts:  Yes / No',
  '7.  PRESENT ILLNESS',
  '    Date of onset:  ___ / ___ / ______    Duration before presentation:  ______ days',
  '    Fever:  Yes / No  ______ days    Cough:  Yes / No  ______ days',
  '    Cold / nasal discharge:  Yes / No    Fast breathing:  Yes / No',
  '    Chest indrawing:  Yes / No    Noisy breathing / wheeze:  Yes / No',
  '    Feeding difficulty / refusal:  Yes / No    Lethargy:  Yes / No',
  '    Apno\u00e6a (infants):  Yes / No    Convulsions:  Yes / No',
  '8.  EXAMINATION FINDINGS',
  '    Temperature:  ______ \u00b0C    Heart rate:  ______ /min    RR:  ______ /min',
  '    SpO\u2082 (room air):  ______ %    Consciousness:  Normal / Drowsy / Unconscious',
  '    Nasal flaring:  Yes / No    Subcostal/intercostal retractions:  Yes / No',
  '    Grunting:  Yes / No    Head bobbing:  Yes / No',
  '    Breath sounds:  Normal / Decreased / Absent',
  '    Wheeze:  Yes / No    Crepitations:  Yes / No',
  '    Working diagnosis:  URTI / Bronchiolitis / Pneumonia / Severe pneumonia / Other',
  '9.  INVESTIGATIONS',
  '    Hb:  ______ g/dl    TLC:  ______ /mm\u00b3    DLC:  N____% L____% M____% E____%',
  '    Platelets:  ______ /mm\u00b3    CRP / other markers:  ___________________',
  '    CXR:  Hyperinflation / Peribronchial thickening / Consolidation / Collapse / Effusion / Normal',
  '    Other investigations (ABG, cultures):  __________________',
  '10. RSV TESTING',
  '    Date and time of sample:  ___ / ___ / ______, ________ hrs',
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  '    Test method:  Rapid antigen test / RT-PCR / Other _______________',
  '    RSV result:  Positive / Negative / Inconclusive / Pending',
  '    Other viruses detected (if multiplex used):  __________________',
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  '    Site of care:  OPD / Emergency / Ward / PICU',
  '    Oxygen:  Not required / Nasal prongs / Face mask / HFNC / CPAP    Duration:  ______',
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  '    Complications:  Atelectasis / Pneumothorax / Sepsis / Others ___________',
  '    Length of hospital stay:  ______ days',
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  '    Condition at discharge:  Symptom free / Mild symptoms / Oxygen dependent',
  '    Follow-up advised:  Yes / No    Date:  ___ / ___ / ______',
  '    Signature of Investigator:  ____________________    Date:  ___ / ___ / ______',
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// ── 8. IEC PAGE ───────────────────────────────────────────────────────────────
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  h2('6. Will my child\'s details be kept confidential?'),
  para('Yes. All information about your child will be kept strictly confidential. In any report or publication, your child will be identified only by a study number and not by name. Data will be stored in locked files or password-protected computers.'),
  h2('7. Do we have to take part? What if I change my mind?'),
  para('No. Participation is completely your choice. Even after agreeing, you are free to withdraw your child at any time without giving a reason. This will not affect your child\'s treatment.'),
  h2('8. Will we have to pay anything? Will we be paid?'),
  para('There is no additional cost to you. There is no payment for participation. All investigations and treatments will be done based on your child\'s clinical needs.'),
  h2('9. What will happen to the results?'),
  para('Results may be presented in scientific meetings or published in medical journals, and used to guide hospital policies for RSV management and prevention. Your child\'s personal identity will not be revealed.'),
  h2('10. Whom should I contact for more information?'),
  para('Dr. Rahulkumar Rathod, Department of Paediatrics, Niramay Hospital and Research Center, Satara. Phone: __________________'),
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// ── 1. SYNOPSIS ── 271 words (NBEMS limit 250-300) ────────────────────────────
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      new TextRun({ text:' Seasonal peaks coincide with and follow the monsoon period (July-November). Despite growing national data, centre-specific information on RSV seasonality, clinical profile, risk factors, and outcomes remains limited from many Indian tertiary paediatric hospitals.', size:BODY, font:FONT }),
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  new Paragraph({
    spacing:{before:80,after:80,line:360}, alignment:AlignmentType.JUSTIFIED,
    children:[
      new TextRun({ text:'Expected Outcomes:   ', bold:true, size:BODY, font:FONT }),
      new TextRun({ text:'The study will document the local seasonal pattern of RSV circulation, identify high-risk patient profiles, quantify the clinical and resource burden of RSV, and generate centre-specific evidence to guide hospital preparedness, bed and oxygen allocation, and future RSV prevention strategies.', size:BODY, font:FONT }),
    ]
  }),
  new Paragraph({
    spacing:{before:80,after:80,line:360}, alignment:AlignmentType.JUSTIFIED,
    children:[
      new TextRun({ text:'Keywords:   ', bold:true, size:BODY, font:FONT }),
      new TextRun({ text:'Respiratory syncytial virus, RSV, ALRI, children, seasonality, disease burden, India', size:BODY, font:FONT, italic:true }),
    ]
  }),
  empty(), pb()
];

// ── 2. INTRODUCTION ───────────────────────────────────────────────────────────
const intro = [
  para('2. INTRODUCTION', { bold:true, size:H1, center:true }),
  divider(), empty(),
  cited([
    {t:'Respiratory syncytial virus (RSV) is one of the leading causes of acute lower respiratory infection (ALRI) in infants and young children worldwide and accounts for a substantial proportion of hospitalisations and deaths in under-five children.'},{cite:[1]},
    {t:' Global estimates suggest that RSV causes over 3.6 million hospitalisations and approximately 100,000 deaths every year in children under 5 years of age, with the vast majority of deaths occurring in low- and middle-income countries.'},{cite:[1,2,13]},
  ]),
  cited([
    {t:'In India, RSV is an important aetiology of ALRI, with hospital-based studies showing RSV positivity around 20-25% among children admitted with ALRI, and more than 90% of RSV-positive cases occurring in children below 2 years of age.'},{cite:[3,4]},
    {t:' A community-based prospective study from rural Maharashtra documented RSV-associated mortality in children under 2 years, underscoring the severe burden even outside hospital settings.'},{cite:[14]},
    {t:' RSV infection is also associated with subsequent recurrent wheezing and paediatric asthma, contributing to long-term respiratory morbidity beyond the acute episode.'},{cite:[5]},
    {t:' A recent modelling study estimated that among RSV-associated ALRI episodes in Indian under-five children, about 8% result in hospital admission and approximately 0.22% result in in-hospital deaths, indicating a significant disease burden at the country level.'},{cite:[6]},
  ]),
  cited([
    {t:'RSV exhibits a well-defined seasonal pattern, but the timing varies across climatic regions. In temperate countries, RSV typically peaks in the winter months, whereas in tropical settings like much of India, peaks frequently coincide with or follow the monsoon and extend into early winter.'},{cite:[7,15]},
    {t:' Indian studies have reported RSV detection throughout the year with pronounced peaks after the rainy season (July-November) and some correlation with lower temperatures and higher humidity.'},{cite:[3,8]},
  ]),
  cited([
    {t:'High-risk groups for severe RSV disease include premature infants, children with congenital heart disease, chronic lung disease, neuromuscular disorders, and immunodeficiency.'},{cite:[16]},
    {t:' These children frequently require PICU admission, oxygen supplementation, and mechanical ventilatory support during RSV peak seasons, imposing a significant burden on paediatric healthcare resources.'},{cite:[17]},
  ]),
  cited([
    {t:'Understanding local seasonal RSV trends in a tertiary care paediatrics centre is important for hospital preparedness, rational allocation of beds and oxygen, planning PICU capacity, and timing of preventive strategies. With new prophylactic options including nirsevimab now available, local epidemiological data will also guide targeted immunoprophylaxis programmes.'},{cite:[18]},
  ]),
  cited([
    {t:'Although national and regional data on RSV are increasing, there is still a paucity of centre-specific information from many Indian tertiary paediatric hospitals regarding RSV seasonality, age distribution, risk-factor profile, clinical severity, need for respiratory support, and outcomes.'},{cite:[3,4,6,14]},
    {t:' Generating local data will help clinicians recognise high-risk periods, refine diagnostic testing strategies, guide infection-control measures, and support advocacy for RSV prevention. Hence, this study is proposed to describe the seasonal trend and quantify the disease burden of RSV infection among children attending a tertiary care paediatrics centre.'},
  ]),
  empty(), pb()
];

// ── 3. REVIEW OF LITERATURE ───────────────────────────────────────────────────
const review = [
  para('3. REVIEW OF LITERATURE', { bold:true, size:H1, center:true }),
  divider(), empty(),
  cited([
    {t:'RSV is an enveloped, negative-sense RNA virus of the Pneumoviridae family and is the most frequent viral cause of ALRI in young children globally.'},{cite:[1]},
    {t:' A systematic analysis estimated 33 million RSV-associated ALRI episodes, 3.6 million hospitalisations, and over 100,000 deaths annually in children under 5 years in 2019, with the highest incidence in South Asia and sub-Saharan Africa.'},{cite:[13]},
    {t:' A comprehensive review of Indian studies from 1970-2020 showed that RSV is a predominant viral pathogen among children with ARI/ALRI, particularly in the 0-5-year age group, with reported RSV detection rates ranging from about 2% to over 60% depending on setting and methodology.'},{cite:[3]},
  ]),
  cited([
    {t:'A hospital-based study from southern India reported that over 90% of RSV-positive children with ALRI were under 2 years of age, and RSV was detected throughout the year with peaks after the monsoon season.'},{cite:[4]},
    {t:' A community-based prospective study from rural Maharashtra documented RSV as a significant cause of mortality in children under 2, with high case-fatality in the community setting.'},{cite:[14]},
    {t:' A study from Jaipur documented RSV outbreaks predominantly during the post-monsoon and cooler months, reinforcing seasonal clustering in north Indian settings.'},{cite:[8]},
    {t:' In contrast, surveillance from Kashmir - a temperate region - documented RSV peaking during winter months (November-January), underscoring that seasonal patterns differ by climatic zone within India itself.'},{cite:[15]},
  ]),
  cited([
    {t:'At the national level, a modelling study using Indian meta-estimates estimated RSV-associated hospitalisations and deaths in under-five children, highlighting RSV as a major contributor to childhood ALRI burden in India.'},{cite:[6]},
    {t:' International hospital-based studies, including the Pneumonia Etiology Research for Child Health (PERCH) project, showed that RSV accounts for approximately one-third of hospitalisations due to severe pneumonia in low- and middle-income countries.'},{cite:[9]},
    {t:' A 10-year PICU study documented that RSV-positive children frequently required invasive ventilation, with prolonged ICU stays and significant healthcare costs during peak season.'},{cite:[17]},
  ]),
  cited([
    {t:'High-risk groups for severe RSV disease and PICU admission include premature infants, children with congenital heart disease, chronic lung disease, neuromuscular disorders, and immunodeficiency.'},{cite:[16]},
    {t:' Early RSV infection has also been linked to long-term respiratory morbidity including recurrent wheezing and asthma.'},{cite:[5]},
    {t:' With the approval of nirsevimab - a long-acting monoclonal antibody offering broader and longer RSV protection - there is now an urgent need for local epidemiological data to guide evidence-based immunoprophylaxis deployment.'},{cite:[18]},
  ]),
  cited([
    {t:'Despite growing evidence, there remain gaps in centre-specific data on seasonal patterns, demographic and clinical profile, risk factors, and outcomes of RSV in many Indian tertiary paediatric centres.'},{cite:[3,6,14]},
    {t:' This justifies the present hospital-based study to assess seasonal trend and disease burden of RSV among children at our institution.'},
  ]),
  empty(), pb()
];

// ── 4. AIMS AND OBJECTIVES ────────────────────────────────────────────────────
const aims = [
  para('4. AIMS AND OBJECTIVES', { bold:true, size:H1, center:true }),
  divider(), empty(),
  h1('AIM'),
  para('To study the seasonal trend and disease burden of respiratory syncytial virus infection in children attending a tertiary care paediatric centre.'),
  empty(),
  h1('OBJECTIVES'),
  num(1,'To determine the seasonal trend of RSV infection in children attending the tertiary care paediatrics centre over the study period.'),
  num(2,'To estimate the disease burden of RSV infection in terms of:'),
  bul('Proportion of RSV-positive cases among children presenting with ARI/ALRI.',1),
  bul('Hospitalisation rate, need for oxygen therapy, PICU admission, and mechanical ventilation among RSV-positive cases.',1),
  bul('Length of hospital stay and in-hospital mortality among RSV-positive cases.',1),
  num(3,'To describe the age, sex, and risk-factor profile (prematurity, low birth weight, congenital heart disease, chronic lung disease, neuromuscular disease, immunodeficiency, environmental tobacco smoke exposure, overcrowding, etc.) of children with RSV infection.'),
  num(4,'To compare the clinical presentation, severity, and outcomes between RSV-positive and RSV-negative ARI/ALRI cases.'),
  num(5,'To assess the association between RSV positivity and adverse outcomes (need for PICU, mechanical ventilation, prolonged hospital stay, mortality).'),
  empty(), pb()
];

// ── 5. MATERIALS AND METHODS ──────────────────────────────────────────────────
// ── SAMPLE SIZE — two-proportion formula ────────────────────────────────────
// p1 = RSV positivity during peak season (July-Nov, Indian literature) = 35%
// p2 = RSV positivity during off-peak season = 12%
// Z(1-α/2) = 1.96 (95% CI), Z(1-β) = 1.28 (90% power)
// P = (0.35+0.12)/2 = 0.235
// term1 = 1.96√(2×0.235×0.765) = 1.1753
// term2 = 1.28√(0.35×0.65 + 0.12×0.88) = 0.7387
// N = (1.1753+0.7387)² / (0.35-0.12)² = 3.6635/0.0529 = 69.25 → 70
// With 10% attrition → 77; round to 80 for operational convenience

function sampleSizePara() {
  // Full paragraph block for the sample size section
  return [
    h2('Sample Size'),
    cited([
      {t:'Based on published Indian hospital-based studies reporting RSV positivity of approximately 35% during peak season (July-November) and 12% during off-peak season,'},{cite:[3,4,15]},
      {t:' the sample size was estimated using the two-proportion comparison formula:'},
    ]),
    empty(),
    new Paragraph({
      alignment: AlignmentType.CENTER,
      spacing: { before:80, after:40 },
      children: [
        new TextRun({ text:'N = ', bold:true, size:BODY, font:FONT }),
        new TextRun({ text:'{ Z', bold:false, size:BODY, font:FONT }),
        new TextRun({ text:'(1-\u03b1/2)', size:16, font:FONT, subScript:true }),
        new TextRun({ text:' \u221a[2P(1\u2212P)] + Z', size:BODY, font:FONT }),
        new TextRun({ text:'(1-\u03b2)', size:16, font:FONT, subScript:true }),
        new TextRun({ text:' \u221a[p\u2081(1\u2212p\u2081) + p\u2082(1\u2212p\u2082)] }', size:BODY, font:FONT }),
        new TextRun({ text:'\u00b2', size:16, font:FONT, superScript:true }),
        new TextRun({ text:' / (p\u2081 \u2212 p\u2082)', size:BODY, font:FONT }),
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    empty(),
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      children: [
        new TextRun({ text:'Where:', bold:true, size:BODY, font:FONT }),
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        new TextRun({ text:'p\u2081', size:BODY, font:FONT }),
        new TextRun({ text:'  = RSV positivity during peak season = 35% (0.35)', size:BODY, font:FONT }),
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        new TextRun({ text:'p\u2082', size:BODY, font:FONT }),
        new TextRun({ text:'  = RSV positivity during off-peak season = 12% (0.12)', size:BODY, font:FONT }),
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      children: [
        new TextRun({ text:'P  = (p\u2081 + p\u2082)/2 = (0.35 + 0.12)/2 = 0.2350', size:BODY, font:FONT }),
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    }),
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        new TextRun({ text:'Z', size:BODY, font:FONT }),
        new TextRun({ text:'(1-\u03b1/2)', size:16, font:FONT, subScript:true }),
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        new TextRun({ text:'(1-\u03b2)', size:16, font:FONT, subScript:true }),
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    new Paragraph({
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      spacing: { before:60, after:60, line:360 },
      children: [
        new TextRun({ text:'Substituting:', bold:true, size:BODY, font:FONT }),
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    new Paragraph({
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      indent: { left:360 },
      children: [
        new TextRun({ text:'N = { 1.96 \u00d7 \u221a[2 \u00d7 0.2350 \u00d7 0.7650] + 1.28 \u00d7 \u221a[0.35 \u00d7 0.65 + 0.12 \u00d7 0.88] }', size:BODY, font:FONT }),
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        new TextRun({ text:'N = (1.1753 + 0.7387)', size:BODY, font:FONT }),
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        new TextRun({ text:'  =  3.6635 / 0.0529  = 69.25', size:BODY, font:FONT }),
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    empty(),
    new Paragraph({
      alignment: AlignmentType.JUSTIFIED,
      spacing: { before:60, after:80, line:360 },
      children: [
        new TextRun({ text:'Minimum sample required: N = 70.  ', bold:true, size:BODY, font:FONT }),
        new TextRun({ text:'Adding 10% to account for possible attrition and incomplete data, the final sample size is ', size:BODY, font:FONT }),
        new TextRun({ text:'N = 80 children.', bold:true, size:BODY, font:FONT }),
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const methods = [
  para('5. MATERIALS AND METHODS', { bold:true, size:H1, center:true }),
  divider(), empty(),

  h2('Study Area'),
  para('The study will be conducted in the Department of Paediatrics, Niramay Hospital and Research Center, Satara - a tertiary care paediatrics centre providing outpatient, emergency, inpatient, and PICU services to children from Satara and surrounding areas.'),

  h2('Study Design'),
  para('Hospital-based descriptive observational study (prospective), to be conducted after approval of the Institutional Ethics Committee (IEC).'),

  h2('Study Population'),
  cited([{t:'Children attending the paediatrics OPD, emergency, paediatric wards, and PICU of Niramay Hospital and Research Center, Satara, with clinical features suggestive of ARI/ALRI, as defined by WHO criteria.'},{cite:[11]}]),

  h2('Inclusion Criteria'),
  num(1,'Children aged 1 month to 5 years presenting with symptoms and signs of ARI/ALRI (cough, coryza, fever, tachypnoea, respiratory distress, wheeze, or crepitations).'),
  num(2,'Parent/guardian willing to provide written informed consent (and assent where applicable).'),
  empty(),

  h2('Exclusion Criteria'),
  num(1,'Children who develop respiratory symptoms \u226548 hours after hospital admission for another illness (suspected hospital-acquired infection).'),
  num(2,'Children referred from another hospital after being admitted there for more than 48 hours for the same illness.'),
  num(3,'Children with chronic respiratory conditions where acute infectious exacerbation cannot be reliably differentiated (e.g. advanced cystic fibrosis, severe bronchiectasis).'),
  num(4,'Parent/guardian not willing to give consent.'),
  empty(),

  // ── SAMPLE SIZE (two-proportion formula) ──
  ...sampleSizePara(),

  h2('Study Duration'),
  para('10-12 months (from ___ / ___ / ______ to ___ / ___ / ______), covering at least one complete seasonal cycle to capture the pattern of RSV circulation.'),

  h2('Case Definitions'),
  cited([{t:'\u2022  Acute Respiratory Infection (ARI): Acute onset of respiratory symptoms with or without fever involving upper or lower respiratory tract, as per WHO-based standard definitions.'},{cite:[11]}]),
  cited([{t:'\u2022  Acute Lower Respiratory Infection (ALRI): Cough and/or difficulty breathing with age-specific tachypnoea, respiratory distress, and/or abnormal auscultatory findings (wheeze/crepitations) consistent with lower respiratory tract involvement.'},{cite:[11]}]),
  cited([{t:'\u2022  Severe Disease: Presence of danger signs such as severe respiratory distress, hypoxia (SpO\u2082 <90% on room air), inability to feed, lethargy, or other WHO-defined criteria.'},{cite:[11]}]),
  empty(),

  h2('Data Collection'),
  para('After IEC approval and informed consent, all eligible children will be enrolled consecutively. Data will be recorded on a pre-designed structured proforma and will include:'),
  num(1,'Demographic details: Age, sex, address, urban/rural residence, socio-economic status.'),
  num(2,'Environmental and social factors: Overcrowding, type of house, cooking fuel, indoor tobacco smoke exposure, presence of young siblings, day-care attendance.'),
  num(3,'Birth and perinatal details: Place and mode of delivery, gestational age, birth weight, NICU stay.'),
  num(4,'Nutritional and immunisation status: Feeding history, anthropometry, nutritional status as per WHO standards, immunisation completeness.'),
  num(5,'',[ new TextRun({text:'5.   Past medical and risk-factor history: Previous episodes of wheeze/bronchiolitis/pneumonia, known asthma, congenital heart disease, chronic lung disease, neuromuscular disease, immunodeficiency, or long-term steroid use.',size:BODY,font:FONT}), new TextRun({text:'16',size:16,font:FONT,superScript:true}) ]),
  num(6,'Presenting illness: Duration and nature of symptoms - fever, cough, cold, fast breathing, chest indrawing, wheeze, feeding difficulty, lethargy, convulsions, apno\u00e6a.'),
  num(7,'Clinical examination: Vital signs (temperature, heart rate, respiratory rate, SpO\u2082), signs of respiratory distress, auscultatory findings, working diagnosis.'),
  num(8,'Investigations: Complete blood count, chest X-ray, ABG, and cultures as clinically indicated.'),
  num(9,'',[ new TextRun({text:'9.   RSV Testing: Nasopharyngeal/oropharyngeal swab or nasopharyngeal aspirate for RSV detection by rapid antigen test and/or RT-PCR.',size:BODY,font:FONT}), new TextRun({text:'12',size:16,font:FONT,superScript:true}), new TextRun({text:' If multiplex respiratory viral panel is used, other viruses will also be documented.',size:BODY,font:FONT}) ]),
  num(10,'Treatment and hospital course: Site of care, use and duration of oxygen therapy, type of ventilatory support, drugs used, complications, length of hospital stay.'),
  num(11,'Outcome: Condition at discharge (recovered, improved, LAMA, referred, death) and follow-up advice.'),
  empty(),

  h2('Outcome Measures'),
  bul('Monthly distribution of RSV-positive cases to describe seasonal trend.'),
  bul('Proportion of RSV-positive cases among all ARI/ALRI cases (overall and by age group).'),
  bul('Rates of hospitalisation, oxygen requirement, PICU admission, mechanical ventilation, and in-hospital mortality among RSV-positive children.'),
  bul('Comparison of clinical severity and outcomes between RSV-positive and RSV-negative ARI/ALRI cases.'),
  empty(),

  h2('Statistical Methods'),
  bul('Data entered into Microsoft Excel and analysed using IBM SPSS or equivalent.'),
  bul('Descriptive statistics: Categorical variables as frequencies and percentages; continuous variables as mean \u00b1 SD or median (IQR).'),
  bul('Seasonal pattern: Monthly counts and proportions of RSV-positive cases in tables and line graphs.'),
  bul('Comparative analysis: Chi-square test or Fisher\'s exact test for categorical variables; independent-samples t-test or Mann-Whitney U test for continuous variables.'),
  bul('Multivariable analysis (if feasible): Logistic regression to identify independent predictors of severe disease and adverse outcomes.'),
  bul('A p-value \u22640.05 will be considered statistically significant.'),
  empty(),

  h2('Ethical Considerations'),
  bul('The study will be conducted after obtaining IEC approval from Niramay Hospital and Research Center, Satara.'),
  bul('Written informed consent will be obtained from parents/guardians; assent from older children where applicable.'),
  bul('Nasopharyngeal/oropharyngeal sampling is minimally invasive and will be performed under aseptic precautions.'),
  bul('No experimental therapy will be used; all children will receive standard-of-care treatment.'),
  bul('Confidentiality maintained using unique study codes and secure data storage.'),
  bul('Participation is voluntary and refusal/withdrawal will not affect the quality of care received.'),
  empty(), pb()
];

// ── 6. REFERENCES ─────────────────────────────────────────────────────────────
const refs = [
  para('6. REFERENCES (ICMJE / VANCOUVER STYLE)', { bold:true, size:H1, center:true }),
  divider(), empty(),
  ref(1,'Shi T, McAllister DA, O\'Brien KL, Simoes EAF, Madhi SA, Gessner BD, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study. Lancet. 2017;390(10098):946-958. [PMID: 28689664]'),
  ref(2,'Wang X, Li Y, Shi T, Bont LJ, Feng L, Zar HJ, et al. Global disease burden of and risk factors for acute lower respiratory infections caused by respiratory syncytial virus in preterm infants and young children in 2019: a systematic review and meta-analysis. Lancet. 2024;403(10433):1493-1506. [PMID: 38367641]'),
  ref(3,'Broor S, Parveen S, Maheshwari M. Respiratory syncytial virus infections in India: Epidemiology and need for vaccine. Indian J Med Microbiol. 2019;37(1):1-9. [PMID: 30880691]'),
  ref(4,'Kini S, Kalal BS, Chandy S, Shet A, Suman SS, Dias M. Prevalence of respiratory syncytial virus infection among children hospitalized with acute lower respiratory tract infections in Southern India. World J Clin Pediatr. 2019;8(2):33-42. [PMID: 31065544]'),
  ref(5,'Zar HJ, Cacho F, Kootbodien T, Mutevedzi T, Nair H, Nicol MP, et al. Early-life respiratory syncytial virus disease and long-term respiratory health. Lancet Respir Med. 2024;12(10):810-822. [PMID: 39265601]'),
  ref(6,'Li Y, Johnson EK, Shi T, Campbell H, Nair H; RSV Global Epidemiology Network. National burden estimates of hospitalisations for acute lower respiratory infections due to respiratory syncytial virus in young children in 2019 among 58 countries: a modelling study. Lancet Respir Med. 2021;9(2):175-185. [PMID: 32971018]'),
  ref(7,'Choudhary ML, Anand SP, Wadhwa BS, Jadhav SM, Tejashri P, Bhatt VR, et al. Genetic variability of human respiratory syncytial virus in Pune, Western India. Infect Genet Evol. 2013;20:369-377. [PMID: 24113083]'),
  ref(8,'Swamy MA, Malhotra B, Reddy PV. Trends of respiratory syncytial virus sub-types in children hospitalised at a tertiary care centre in Jaipur during 2012-2014. Indian J Med Microbiol. 2017;35(1):107-110. [PMID: 28303835]'),
  ref(9,'Pneumonia Etiology Research for Child Health (PERCH) Study Group. Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study. Lancet. 2019;394(10200):757-779. [PMID: 31257127]'),
  ref(10,'Mishra B, Mohapatra D, Panda S, Sahu S, Pati S. Hospital-based investigation of acute respiratory infections in children under five: epidemiology, seasonality, and co-infections. Cureus. 2025;17(11):e82756. [PMID: 41356991]'),
  ref(11,'World Health Organization. Handbook IMCI: Integrated Management of Childhood Illness. Geneva: WHO; 2005. Available from: https://www.who.int/publications/i/item/9789241546669'),
  ref(12,'World Health Organization. WHO recommendations for collection of information on respiratory syncytial virus (RSV). Geneva: WHO; 2019. Available from: https://www.who.int/news-room/fact-sheets/detail/respiratory-syncytial-virus'),
  ref(13,'Li Y, Wang X, Blau DM, Caballero MT, Feikin DR, Gill CJ, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet. 2022;399(10340):2047-2064. [PMID: 35598608]'),
  ref(14,'Sim\u00f5es EAF, Dani V, Potdar V, Cherian J, Kumari M, Kadam DB, et al. Mortality from respiratory syncytial virus in children under 2 years of age: a prospective community cohort study in rural Maharashtra, India. Clin Infect Dis. 2021;73(5):867-874. [PMID: 34472578]'),
  ref(15,'Koul PA, Saha S, Kaul KA, Khan UH, Bali NK, Wani JI, et al. Respiratory syncytial virus among children hospitalized with severe acute respiratory infection in Kashmir, a temperate region in northern India. J Glob Health. 2022;12:04056. [PMID: 35976005]'),
  ref(16,'Welliver RC. Review of epidemiology and clinical risk factors for severe respiratory syncytial virus (RSV) infection. J Pediatr. 2003;143(5 Suppl):S112-S117. [PMID: 14615709]'),
  ref(17,'Pham H, Thompson J, Wurzel D, Duke T. Ten years of severe respiratory syncytial virus infections in a tertiary paediatric intensive care unit. J Paediatr Child Health. 2020;56(1):60-66. [PMID: 31095832]'),
  ref(18,'Verwey C, Dangor Z, Madhi SA. Approaches to the prevention and treatment of respiratory syncytial virus infection in children: rationale and progress to date. Paediatr Drugs. 2024;26(2):115-130. [PMID: 38032456]'),
  empty(), pb()
];

// ── 7. STUDY PROFORMA ─────────────────────────────────────────────────────────
const proformaLines = [
  'Study ID No.:  __________',
  '1.  PATIENT IDENTIFICATION',
  '    Hospital Registration Number:  __________     Study Proforma Number:  __________',
  '    Date of Enrolment:  ___ / ___ / ______     OPD / IPD / PICU:  __________________',
  '2.  DEMOGRAPHIC DETAILS',
  '    Name (initials only):  ____________________   Age:  _______ (months/years)   Sex:  M / F',
  '    Address:  ___________________________________________   Urban / Rural:  __________________',
  '3.  SOCIO-ECONOMIC AND ENVIRONMENTAL FACTORS',
  '    SES class (scale __________):  I / II / III / IV / V   Family:  Nuclear / Joint',
  '    Persons in household:  ______   Under-5 children:  ______',
  '    House:  Pucca / Semi-pucca / Kaccha   Overcrowding (\u22652/room):  Yes / No',
  '    Cooking fuel:  LPG / Kerosene / Biomass   Tobacco smoke (indoor):  Yes / No',
  '4.  BIRTH AND PERINATAL HISTORY',
  '    Delivery:  Home / Govt / Private   Mode:  Normal / Assisted / LSCS',
  '    Gestation:  Term / Preterm (____ weeks)   Birth weight:  ______ g   NICU:  Yes / No',
  '5.  NUTRITIONAL AND IMMUNISATION HISTORY',
  '    EBF to 6 months:  Yes / No   Current feed:  BF / Top / Mixed',
  '    Weight: ___ kg   Height: ___ cm   HC: ___ cm   Nutrition:  Normal/MAM/SAM/OW',
  '    Immunisation:  Complete / Partial / Not immunised',
  '6.  PAST MEDICAL AND RISK-FACTOR HISTORY',
  '    Previous wheeze/bronchiolitis/pneumonia:  Yes / No   Episodes:  ______',
  '    Asthma/CHD/CLD/BPD/NMD/Immunodeficiency/Steroids:  Yes / No (circle)',
  '    Allergy/atopy/eczema:  Yes / No   Previous resp. hospitalisations:  Yes / No',
  '7.  PRESENT ILLNESS',
  '    Onset:  ___ / ___ / ______   Duration:  ______ days',
  '    Fever: Y/N ___ d   Cough: Y/N ___ d   Cold: Y/N   Fast breathing: Y/N',
  '    Indrawing: Y/N   Wheeze: Y/N   Feed difficulty: Y/N   Lethargy: Y/N   Apno\u00e6a: Y/N',
  '8.  EXAMINATION FINDINGS',
  '    Temp: ____\u00b0C   HR: ____/min   RR: ____/min   SpO\u2082: ____% (RA)   GCS: N/Drowsy/Uncons',
  '    Flaring:Y/N   Retractions:Y/N   Grunting:Y/N   Wheeze:Y/N   Crepitations:Y/N',
  '    Dx:  URTI / Bronchiolitis / Pneumonia / Severe pneumonia / Other __________',
  '9.  INVESTIGATIONS',
  '    Hb: ___ g/dl   TLC: ___ /mm\u00b3   DLC: N___% L___% M___% E___%   Plt: ___ /mm\u00b3',
  '    CRP: ___   CXR:  Hyperinfl / Peribronchl / Consol / Collapse / Effusion / Normal',
  '10. RSV TESTING',
  '    Sample: ___ / ___ / ______   Specimen:  NPS / OPS / NPA',
  '    Method:  Rapid Ag / RT-PCR / Other ___   Result:  Positive / Negative / Pending',
  '    Other viruses (multiplex):  __________________',
  '11. TREATMENT AND HOSPITAL COURSE',
  '    Care:  OPD / Ward / PICU   O2:  None / Prongs / Mask / HFNC / CPAP   Duration: ___',
  '    NIV: Y/N ___   Invasive vent: Y/N ___   Bronchodilators: Y/N   Steroids: Y/N   Abx: Y/N',
  '    Complications: _______________   LOS:  ______ days',
  '12. OUTCOME',
  '    Discharge:  Recovered / Improved / LAMA / Referred / Death',
  '    Condition:  Symptom free / Mild symptoms / O2 dependent   Follow-up:  ___ / ___ / ______',
  '    Signature:  ____________________   Date:  ___ / ___ / ______',
];
const proforma = [
  para('7. STUDY PROFORMA', { bold:true, size:H1, center:true }),
  divider(),
  para('Title: Seasonal Trend and Disease Burden of RSV Infection in Children Attending a Tertiary Care Paediatrics Centre', { sb:60, sa:40 }),
  para('Study Site: Department of Paediatrics, Niramay Hospital and Research Center, Satara', { sb:40, sa:80 }),
  ...proformaLines.map(l => new Paragraph({
    spacing:{ before:30, after:30 },
    children:[ new TextRun({ text:l, size:SMAL, font:'Courier New' }) ]
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  empty(), pb()
];

// ── 8. IEC ────────────────────────────────────────────────────────────────────
const iec = [
  para('8. IEC & ISC APPROVAL LETTERS AND LIST OF MEMBERS', { bold:true, size:H1, center:true }),
  divider(), empty(),
  para('(To be attached as per institution format. The IEC approval letter, list of IEC members, and ISC approval from Niramay Hospital and Research Center, Satara, are to be enclosed here before submission to NBEMS.)', { italic:true, center:true }),
  empty(), pb()
];

// ── 9. CONSENT ────────────────────────────────────────────────────────────────
const consentLines = [
  'Name of child:  __________________________','Age:  __________',
  'Name of parent/guardian:  __________________________','Relationship:  __________________________',
  'Signature / Thumb impression:  __________________','Date:  ___ / ___ / ______','',
  'Person obtaining consent:','Name:  __________________________','Designation:  _____________________',
  'Signature:  _______________________','Date:  ___ / ___ / ______','',
  'Witness (if required):','Name:  __________________________','Signature:  _______________________',
];
const consent = [
  para('9. INFORMED CONSENT FORM (PARENT / GUARDIAN)', { bold:true, size:H1, center:true }),
  divider(), empty(),
  para('Study Title: Seasonal Trend and Disease Burden of RSV Infection in Children Attending a Tertiary Care Paediatrics Centre'),
  para('Principal Investigator: Dr. Rahulkumar Rathod, Department of Paediatrics, Niramay Hospital and Research Center, Satara', { sb:40 }),
  empty(),
  h2('Introduction'),
  para('Your child is being invited to take part in a research study about RSV infection in children. RSV is one of the most common viral causes of cough, cold, bronchiolitis, and pneumonia in young children. Please read the following carefully and ask questions before you decide.'),
  h2('Purpose'), para('To understand: (1) in which months RSV is more common at our hospital; (2) how often RSV causes serious illness needing oxygen, intensive care, or ventilation; (3) which age groups and risk factors are most commonly affected.'),
  h2('Procedures'),
  num(1,'Clinical history and examination will be recorded as part of routine care.'),
  num(2,'A nasopharyngeal/throat swab or nasal aspirate will be taken to test for RSV. This may cause brief discomfort.'),
  num(3,'Investigation results, treatments, and outcomes will be noted until discharge.'),
  num(4,'No additional blood tests or invasive procedures will be done solely for research.'),
  empty(),
  h2('Risks'), para('The swab/aspirate may cause brief discomfort, mild gagging, or watering of eyes. There is no major risk beyond standard care.'),
  h2('Benefits'), para('The RSV test result may help understand the cause of your child\'s illness. Information from this study may improve care for future patients.'),
  h2('Confidentiality'), para('All information will be kept strictly confidential. Your child will be identified only by a study code in any report or publication.'),
  h2('Voluntary Participation'), para('Participation is entirely voluntary. You may withdraw at any time without affecting your child\'s treatment.'),
  h2('Costs and Compensation'), para('There is no additional cost. There is no financial compensation for participation.'),
  h2('Contact'), para('Dr. Rahulkumar Rathod, Dept. of Paediatrics, Niramay Hospital & RC, Satara. Phone: __________________'),
  para('You may also contact the IEC, Niramay Hospital and Research Center, Satara, for any ethical concerns.', { sb:40 }),
  empty(),
  h2('CONSENT STATEMENT'),
  para('I, _________________________________ (parent/guardian), have read/been explained the information above. All my questions have been answered to my satisfaction.'),
  para('I understand that: participation is voluntary; I can withdraw at any time; minimal discomfort may occur during swab collection; my child\'s identity will be kept confidential.'),
  para('I voluntarily agree / do not agree (strike off whichever is not applicable) to allow my child to participate in this study.'),
  empty(),
  ...consentLines.map(l => new Paragraph({ spacing:{before:40,after:40,line:340}, children:[new TextRun({text:l,size:BODY,font:FONT})] })),
  empty(), pb()
];

// ── 10. PATIENT INFORMATION SHEET ─────────────────────────────────────────────
const pis = [
  para('10. PATIENT INFORMATION SHEET (PARENT / GUARDIAN)', { bold:true, size:H1, center:true }),
  divider(), empty(),
  para('Study Title: Seasonal Trend and Disease Burden of RSV Infection in Children Attending a Tertiary Care Paediatrics Centre'),
  para('Principal Investigator: Dr. Rahulkumar Rathod, Dept. of Paediatrics, Niramay Hospital & RC, Satara', { sb:40 }),
  empty(),
  h2('1. What is RSV and why is this study being done?'),
  para('RSV is a common virus infecting the nose, throat, and lungs, especially in infants and young children. It often causes cough, cold, bronchiolitis, or pneumonia and is an important cause of hospital admission in children under five years. In India, RSV infections are more frequent during rainy and cooler months. This study will find out in which months RSV is most common at our hospital and how severe illness it causes, to help plan better care in the future.'),
  h2('2. Why is my child being asked to take part?'),
  para('Your child has come with symptoms of an acute respiratory infection. Since RSV is one of the important causes of such illness in young children, we are inviting you to allow your child to be included in this study.'),
  h2('3. What will happen if I agree?'),
  bul('The doctor will take a detailed history and examine your child as part of routine care.'),
  bul('A soft swab will be gently inserted into your child\'s nose/throat to test for RSV. This takes only a few seconds.'),
  bul('We will record test results, treatments, and how your child responds until discharge.'),
  bul('No extra blood tests or procedures will be done only for research.'),
  empty(),
  h2('4. Are there any risks?'),
  para('The nasal/throat swab may cause brief discomfort, watering of eyes, or mild gagging but resolves immediately. There are no major risks. Your child will receive all necessary treatment whether or not you agree.'),
  h2('5. Are there any benefits?'),
  para('There may not be direct benefit to your child. Information from this study will help doctors plan better services during RSV seasons and improve care for future patients.'),
  h2('6. Will details be kept confidential?'),
  para('Yes. All information will be kept strictly confidential. Your child will be identified only by a study number in any report. Data will be stored in locked/password-protected files.'),
  h2('7. Do we have to take part? What if I change my mind?'),
  para('No. Participation is completely your choice. Even after agreeing, you may withdraw at any time without affecting your child\'s treatment.'),
  h2('8. Will we have to pay or be paid?'),
  para('There is no additional cost and no payment for participation. All treatment decisions are based on clinical need.'),
  h2('9. What will happen to the results?'),
  para('Results may be presented in scientific meetings or published in medical journals to guide hospital policies. Your child\'s identity will not be revealed.'),
  h2('10. Whom should I contact?'),
  para('Dr. Rahulkumar Rathod, Dept. of Paediatrics, Niramay Hospital & RC, Satara. Phone: __________________'),
  para('You may also contact the IEC, Niramay Hospital and Research Center, Satara.', { sb:40 }),
];

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