Synopsis, Dissertation And Research To PG Students 9352501586, 9789352501588

Table of contents :
Preliminary Pages......Page 1
Chapter-01 Introduction......Page 18
Chapter-02 Routine for a New Postgraduate......Page 21
Chapter-03 Time Table for Three-Year Postgraduate Course......Page 29
Chapter-04 Medical Ethics Involved in Postgraduate Work......Page 33
Chapter-05 Designing Research......Page 55
Chapter-06 Preparation of Synopsis of Dissertation Research......Page 70
Chapter-07 Know-how on Actual Dissertation Research......Page 75
Chapter-08 Biostatistics for the Dissertation Research......Page 81
Chapter-09 Prevention of Hospital Acquired Infection......Page 126
Chapter-10 Computer Technology in PG Dissertation Work......Page 133
Chapter-11 Biostatistical Tests for Dissertation (Learning by Doing)......Page 137
Appendices......Page 158
Index......Page 200

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Synopsis, Dissertation and Research to PG Students

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Key for Your Success in Synopsis, Dissertation and Research Always use your own words throughout write-up Always use your own sentences throughout write-up Always use your own ideas throughout write-up Always use your own outlines throughout write-up Avoid copy and paste Avoid any reproduction Avoid some body’s expression

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Synopsis, Dissertation and Research to PG Students Second Edition

GN Prabhakara MD Professor and Head Department of Community Medicine SDM Medical College Dharwad, Karnataka, India

The Health Sciences Publisher New Delhi | London | Philadelphia | Panama

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Jaypee Brothers Medical Publishers (P) Ltd. Headquarters Jaypee Brothers Medical Publishers (P) Ltd. 4838/24, Ansari Road, Daryaganj New Delhi 110 002, India Phone: +91-11-43574357 Fax: +91-11-43574314 E-mail: [email protected] Overseas Offices J.P. Medical Ltd. 83, Victoria Street, London SW1H 0HW (UK) Phone: +44 20 3170 8910 Fax: +44 (0)20 3008 6180 E-mail: [email protected]

Jaypee-Highlights Medical Publishers Inc. City of Knowledge, Bld. 237, Clayton Panama City, Panama  Phone: +1 507-301-0496 Fax: +1 507-301-0499 E-mail: [email protected]

Jaypee Brothers Medical Publishers (P) Ltd. 17/1-B, Babar Road, Block-B, Shaymali Mohammadpur, Dhaka-1207, Bangladesh Mobile: +08801912003485 E-mail: [email protected]

Jaypee Medical Inc. 325, Chestnut Street Suite 412, Philadelphia, PA 19106, USA Phone: +1 267-519-9789 E-mail: [email protected]

Jaypee Brothers Medical Publishers (P) Ltd. Bhotahity, Kathmandu, Nepal Phone: +977-9741283608 E-mail: [email protected]

Website: www.jaypeebrothers.com Website: www.jaypeedigital.com © 2016, Jaypee Brothers Medical Publishers The views and opinions expressed in this book are solely those of the original contributor(s)/author(s) and do not necessarily represent those of editor(s) of the book. All rights reserved. No part of this publication and may be reproduced, stored or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission in writing of the publishers. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. Medical knowledge and practice change constantly. This book is designed to provide accurate, authoritative information about the subject matter in question. However, readers are advised to check the most current information available on procedures included and check information from the manufacturer of each product to be administered, to verify the recommended dose, formula, method and duration of administration, adverse effects and contraindications. It is the responsibility of the practitioner to take all appropriate safety precautions. Neither the publisher nor the author(s)/editor(s) assume any liability for any injury and/or damage to persons or property arising from or related to use of material in this book. This book is sold on the understanding that the publisher is not engaged in providing professional medical services. If such advice or services are required, the services of a competent medical professional should be sought. Every effort has been made where necessary to contact holders of copyright to obtain permission to reproduce copyright material. If any have been inadvertently overlooked, the publisher will be pleased to make the necessary arrangements at the first opportunity. Inquiries for bulk sales may be solicited at: [email protected]

Synopsis, Dissertation and Research to PG Students First Edition : 2004 Second Edition : 2016 ISBN: 978-93-5250-158-8 Printed at

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Dedicated to The Great Teacher The Great Missile Man Former President of India Bharat Ratna Dr APJ Abdul Kalam

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Preface to the Second Edition It gives me immense pleasure to write the preface to the Second Edition with a new face Synopsis, Dissertation and Research to PG Students brought out by our beloved M/s Jaypee Brothers Medical Publishers (P) Ltd, New Delhi, India. Thousands of postgraduates from different courses and disciplines from various universities, who are seeking guidance regarding their dissertation/thesis work with respect to the preparation of synopsis, methodology, designing research and final presentation, are responsible for the outcome of the book. An attempt has also been made to provide simple and systematic guidance through this on postgraduate course, on university time-table, on medical ethics that are relevant and prevention of hospital-acquired infection. Rajiv Gandhi University of Health Sciences (RGUHS), Bengaluru, Karnataka, India, gave me a platform to prepare library reference record, plan for dissertation work, proforma for synopsis, postgraduate evaluation sheet, guidelines for writing references, and they are added in the appendices for references. Synopsis, Dissertation and Research are updated and elaborated for the use of all postgraduates in University of Health Sciences, viz. Medical, Dental, Pharmacy, Nursing, Ayurveda, Homeopathy, Hospital Administration, and Speech and Hearing. I hope that the book will serve present requirement of any postgraduates and teachers in their endeavors.

GN Prabhakara

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Preface to the First Edition Thousands of postgraduates from different courses and different disciplines from various universities, who have been consulting me for guidance regarding proforma, methodology, dissertation and thesis work are responsible for the outcome of this book. An attempt is made to provide simple and systematic guidance through this text. I hope that the book will serve as a guideline for postgraduates and even teachers in their endeavors.

GN Prabhakara

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Acknowledgments Guidance, corrections and appropriations, and for thorough help of my life-partner Mrs Malathi Prabhakara, Ex-Scientist, Technology Transfer, Industrial Development and Consultancy Services, Central Food Technological Research Institute (CFTRI) and Council of Scientific and Industrial Research (CSIR) is highly acknowledged. Source of inspiration of my son Dr MP Bharat Associate Professor and Head, Department of Radiodiagnosis, Shivamogga Institute of Medical Sciences (SIMS); Consultant Radiologist (Shivamogga); and my Daughter-in-Law, Dr Pooja Bharat, Assistant Professor (Anesthesia), SIMS, Shivamogga, Karnataka, India, is acknowledged. I acknowledge the respect and regard bestowed upon me by postgraduate students of medical, dental, pharmacy, nursing, hospital administration and management, homeopathy, speech and hearing, and Ayurveda during the period 1972–2014, who inspired me to bring out my experience in the present form. I thank the following professional colleagues who gave their valuable opinions: 1. S Kantha Ex-Vice Chancellor Rajiv Gandhi University of Health Sciences (RGUHS) Bengaluru, Karnataka, India 2. SB Kulkarni Ex-Principal Karnataka Institute of Medical Sciences Hubballi, Karnataka, India 3. AT Kulkarni Ex-Principal Maharashtra Institute of Medical Education and Research Pune, Maharashtra, India 4. A Venugopala Sharma Ex-Professor and Head Department of Preventive and Social Medicine (PSM) Tirupati Medical College Tirupati, Andhra Pradesh, India

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xii Synopsis, Dissertation and Research to PG Students 5. Sunanda Kulkarni Ex-Professor Department of Obstetrics and Gynecology Bangalore Medical College Bengaluru, Karnataka, India 6. M Danabalan Ex-Director and Professor Department of Preventive and Social Medicine (PSM) Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry, India 7. MK Sudarshan Principal and Professor Department of Community Medicine Kempegowda Institute of Medical Sciences (KIMS) Bengaluru, Karnataka, India I hereby acknowledge the efforts of M/s Jaypee Brothers Medical Publishers (P) Ltd, New Delhi, India, in giving a good shape to my modest work with my heartfelt thanks.

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Contents 1. Introduction

1

• Felt Need 1 • Why Require Introductory Course?  2 • What is Expected of a Postgraduate? 2

2.

Routine for a New Postgraduate • • • • • • •

3.

Time Table for Three-Year Postgraduate Course • • • • •

4.

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12

Master Plan of the Course 12 Yearwise General Course 12 Yearwise Academic Course 13 Yearwise Dissertation/Research Work 14 Hospital Postings, Field Visits 14

Medical Ethics Involved in Postgraduate Work • • • • • • • • • • • •

4

Departmental Routine 4 Institutional Routine 4 Interdepartmental Routine 5 Journal Club 5 Subject Seminar 6 Pedagogy 8 Lesson Plan 10

16

Medical Ethics  16 Perspective of Medical Ethics 17 Major Principles of Medical Bioethics 20 Major Rules 21 Practice of Medical and Bioethics 23 Ethical Review Committee 24 Laboratory and Clinical Trials 26 Human Experimentation  29 Ethical Problems in AIDS, Children and Mentally Ill  32 Newer Areas of Ethical Interest  33 Computer Ethics  34 e-Research  34

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xiv Synopsis, Dissertation and Research to PG Students • Ethical Issue with Alternative Medicine  34 • Medical Ethics and COPRA  35

5.

Designing Research

38

• Specific Objectives 39 • Need of Design in Research/Project/Thesis/ Dissertation 40 • Drafting of Outline 40 • Nature of Topic to be Selected 41 • Steps in Designing 42 • Descriptive Study  44 • Case Control Study 46 • Cohort Study 47 • Clinical Trial 49 • Blinding 51 • Other Aspects of Designing 51 • College Level Activity in Study Design 52 • Minimizing errors and Bias 52

6.

Preparation of Synopsis of Dissertation/Research 53 • • • • • • • •

7.

Know-how on Actual Dissertation/Research • • • • • •

8.

Basic Information 54 Title of the Topic 54 Need of the Study 54 Objective of the Study 55 Review of Literature 55 Material and Methods 56 List of References 56 Guide and Co-guide 56

58

Content 59 Title 59 Introduction 59 Review of Literature 60 Body 60 Reference  61

Biostatistics for the Dissertation/Research

64

• Data Presentation 74 • Averages 80

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Contents xv

• • • • •

9.

Measures of Variability 84 Sample Size 87 Significant Test (Tests of Significance) 92 Correlation 100 Workout the Following Problems 103

Prevention of Hospital Acquired Infection • • • • • •

10. Computer Technology in PG Dissertation Work • • • •

109

High-risk Procedures 109 Disinfection Procedure 111 Discard and Disposal Hospital Waste 112 Universal Precaution 113 HIV/AIDS Control and Prevention 113 Protection against Severe Acute Respiratory Syndrome  115

116

Parts of Computer 116 Software for Data Analysis 117 Network/Internet 118 Operating system 119

11. Biostatistical Tests for Dissertation (Learning by Doing) 

120

• S  tandard Error of the Difference between Two Means 120 • Standard Error of the Difference between Two Proportion  122 • Chi-square Test 124 • Student t-Test 126 • Z-Test 134 • Pearson Correlation (r) 136 • Spearman Rank Correlation 139

Appendices • • • •

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141

Appendix I: Lesson Plan 141 Appendix II: Library Reference Record (Annotated Bibliography) 143 Appendix III: Plan for Dissertation Work (From the Date of Admission) 144 Appendix IV: The Hippocratic Oath 145

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xvi Synopsis, Dissertation and Research to PG Students • Appendix V: Declaration of Helsinki 146 • Appendix VI: Proforma for Synopsis of Dissertation Submission within 6 Months after Admission to the Course 151 • Appendix VII Model Synopsis–1: Rajiv Gandhi University of Health Sciences (RGUHS), Bengaluru, Karnataka  155  Model Synopsis–2: Rajiv Gandhi University of Health Sciences (RGUHS), Bengaluru, Karnataka  159 Model Synopsis–3: Rajiv Gandhi University of Health Sciences (RGUHS), Bengaluru, Karnataka  163 • Appendix VIII: PG Dissertation Evaluation Sheet 169 • Appendix IX: Model of ‘Review of Literature’ 171 • Appendix X: Guidelines for Writing References 173 • Appendix XI: Permissible Error and Confidence Interval for Sample Size Determination 176 • Appendix XII: Cumulative Distribution of Chi-Square 177 • Appendix XIII: Short Table of Areas of Normal Curve 178 • Appendix XIV: The Distribution of ‘t’ (Two Tailed Tests) 179 • Appendix XV: First Aid: HIV/AIDS 180 • Appendix XVI: Hospital Guidelines for Severe Acute Respiratory Syndrome Control 181 • Appendix XVII: Format for Ethical Committee Meeting Submission by Postgraduates 182

Index

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1

CHAPTER

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Introduction

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Postgraduate course is a platform for learning, understanding and interacting with surrogates, with peers and with subordinates for an effective gain in knowledge in his / her specialty. The steps in the course give arena for an effective preplanning followed by planning for research through study, survey and surveillance. During the entire postgraduate course of three years, day- to - day activity recording ( Diary) help the postgraduate to accomplish a course of action in the event of anticipated duty, academic achievement, knowledge and skills. Acquaintance of department routine include the steps in prevention of hospital acquired infections, ethical and bioethical issues in relation to patient management, designing a research and conducting a study for dissertation, basic application of statistics in interpretation of collected data.

FELT NEED

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The beginning of the course need refining by gradual exposure to postgraduate training. If a concept of introductory note on postgraduate course is available, acquiring knowledge becomes simple and the balance of time can be diverted to the area of study.

Each postgraduate should: • Acquire routine formal procedure in his department / hospital • Know, how library reference to be made • Know, how samples / specimens are collected

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Know, how collected sample/specimen is transported for laboratory examination Acquaint with universal precautions to be taken for HIV/AIDS Learn research methods required for dissertation Learn basic statistics for data analysis Know existing medical and bioethical code of conduct Help the Institution in carrying out National Health Programme.

WHY REQUIRE INTRODUCTORY COURSE? Introductory course is required to tune up a postgraduate in the following areas: zz Initially he is not well-versed in participating in journal club, subject seminar and other academic activities zz Art of taking undergraduate small group classes need learning zz He will not be in a position to plan out a schedule to complete dissertation work in time zz Professional ethics would not have been known zz Within six months of admission, preparing the synopsis of his dissertation for submitting to university may become difficult zz When the synopsis is approved, how to go about the study with study design seems to be a herculean task zz Without guidance, postgraduate feel difficulty in data analysis and application of significant tests zz Much more so he should protect himself from hospital acquired infections, since he is a risk group as health care worker.

WHAT IS EXPECTED OF A POSTGRADUATE? Postgraduate student when admitted need to attend graded responsibility in: zz Diagnosis and treatment of cases zz Participation in seminar zz Participation in group discussion zz Attend hospital ward rounds zz Skills in case demonstration zz Active participation in case clinics zz Participate in journal club

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Introduction 3 zz zz zz

Attend the scheduled clinical meetings Attend the clinicopathological conferences Involve in undergraduate teaching in small batches.

Postgraduate training include: Imparting knowledge through theory class, research work, and academic activities zz Imparting skills through laboratory work, experiments and case clinics. zz

Following item analysis and understanding is a must for a postgraduate in Health Science course: zz Development of competence in his field zz Keeping abreast of recent development zz Learn to develop research methods zz Learn to interpret data and decision zz Maintenance of professional ethics zz Recognition of our society need.

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CHAPTER

Routine for a New

Postgraduate

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DEPARTMENTAL ROUTINE Outpatient duties Ward duties Undergraduate tutorials When assigned , clinical teaching to undergraduates in small batch Grand round discussion with faculty OT major-duty OT minor-duty Night duties Joining all clinics including undergraduate Attending to routine investigation of patients Collection of sample /specimen Transportation of a sample / specimen for investigation Attending to hospital disinfection procedure.

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Attending and participation in health check- up camps Cancer screening programs Blood donation camps Attending to workshop and symposia and participation in national and state level conferences Participation in extracurricular and co - curricular activities ( representing the college)

• Casualty duties • Health awareness programs in the community

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Routine for a New Postgraduate 5 zz

Attending to National Health Programmes when posted from the college.

INTERDEPARTMENTAL ROUTINE zz zz zz zz

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Clinical meetings Clinicopathological conference Integrated teaching activities Attending to other departmental postings, when posted, as per Medical Council of India (MCI) stipulation Referral activities Study visits.

JOURNAL CLUB Journal club is an academic exposure of a postgraduate student to recent area of research, study, survey and/or critical review. Journal need not mean only periodical publications of an organization. It can include relevant text, special reports, technical reports, health papers, bulletin of an association and organization. This can also include science journal, any associated journals and recognized unpublished data. Postgraduate is expected to study the article, make required additional library references, make required cross references, formulate a mode of presentation and present it in a scheduled journal club of his department. In a journal club presentation, following areas are focused: The article should be research oriented, with feasible application in health sciences zz It should contain objectives, need and research design in the study zz Should have problem identified zz Should meet the standard description of literature review zz It should project ethical issues pertaining to medical ethics and bioethics zz It is better, if the material belong to their area of discipline zz Public health problems or community health problems are always welcome. zz

Common types of article we come across are: Review zz Epidemiological survey zz

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6 Synopsis, Dissertation and Research to PG Students zz zz zz zz zz

Prospective study Retrospective study Experimental study Annuls of academic society Case study.

Requisite at journal club: zz Prepare aids for the presentation zz Try to project the articles as though it is done by you zz Prepare critical review of the following: —— Title —— Sample size —— Selection of case/sampling technique —— Data collection procedure —— Type of the study —— Duration and period of study zz Add a note on presentation pattern zz Critically review: —— How analyzed —— How discussed zz Try to answer whether objective of the study is fulfilled zz Know, how reference are made: —— Vancouver method —— Harvard method zz Try for comparison with similar such study. During your presentation of the article in the journal club, very common question asked by your faculty are: zz Question related to the basics of the topic (Thematic) zz Applied relevance of the article zz Techniques used and their description as to how they are done in laboratory zz How it can be improved.

SUBJECT SEMINAR It is an emphasized topic, selected for an in-depth study by a postgraduate student and is presented in Intradepartmental discussion forum. Subject seminar is always through open-to-open viable discussion and is utilized for practical application in the given specialty.

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Routine for a New Postgraduate 7

Usually major area of interest in the discipline, common health problem faced in day-to-day practice, recently emerged health problem, area where uncertainty prevail, a concept of subject which is subjected to frequent change, etc. are the areas that are selected for the topic to be presented in subject seminar. Objectives of subject seminar: To make a postgraduate to do in-depth study and in-depth analysis of a given situation zz Extensive historical aspect is encased zz Past, present and future of a theme or of a subject give laudable sound concept which is applicable in clinical practice zz An exercise for library reference zz Subject seminar include all aspect of a theme/subject, inclusive of recent advances. zz

Topic of priority: Regional health problem zz National health programme zz Endemic diseases zz Commonly encountered health problem in their discipline, which is encountered as challenging problem in day-to-day practice zz Problem which need multidisciplinary approach zz A syndrome zz Research carried out in the institute/college zz Selected area of research, set by senior faculty of the department or HOD. zz

Learning objective to postgraduate: Get to know, how to do bibliography zz Get to know, how library reference is made zz Get to know the methods of material collection and putting in an order zz Schematic way of learning is available zz Schematic way of presentation is learnt. zz

Other requisite: Always make use of audiovisual aid in the presentation. This helps you for your flow of thought. zz Always get the subject seminar documented and put in order and copies of which are given to all postgraduates and all faculty. zz

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8 Synopsis, Dissertation and Research to PG Students

PEDAGOGY Each postgraduate after graduation with PG degree, whether specialist or a teacher, become obligatory to impart his skill and knowledge to other youngsters during his service period. This makes each postgraduate to learn the basics of art and science of teaching technology. In Greek teaching of nontutorial where boys and girls were allowed in the learning process, there appeared a private element called PEDAGOGUE (servant leading the child to school) which lead to present nomenclature of PEDAGOGY , the Art and Science of Teaching. As PG one has to develop the art and science of teaching. If you prepare and take a lesson for teaching, you would have undergone thorough study, reference and expertise. But it also needs educational technology to be adopted for a better impact. Pedagogy deals with principles and practice of medical education components (Fig. 2.1).

Fig. 2.1  The educational spiral

Suppose you learn the art of taking a clinics to a small batch, the learner (your junior or a UG) in turn learns certain skills and hence,

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Routine for a New Postgraduate 9

could perform better in examination, test and management; which they were unable to do earlier—is a MATTER emerged from the utility of pedagogy. In pedagogy, there are three areas called domain. They are: 1. Area of knowledge (Cognitive domain) e.g. Define hypertension (how to define by verbal expression and demonstration means is by pedagogy. Here your technique is an art under teaching technology 2. Area of skill (Psychomotor domain) e.g. Demonstration of basic cardiopulmonary resuscitation (CPR) 3. Area of attitude (Affective domain) e.g. You demonstrate anxiety of patient and spend little time to overcome it. Teaching technology in medical education are: Lecture zz Practical teaching zz Clinical teaching zz Tutorial zz Group discussion zz Buzz session zz Syndicate session zz Learning by doing zz Micro-teaching zz Adult teaching technology like workshop, continuing medical education (CME), seminar, symposia and conference. zz

Further your exposure in early phase of learning, and participation is a must to add learning experience through: zz Panel discussion zz Symposia zz Seminar zz Institute zz Workshop zz Convention zz Conference. In Pedagogy, your planning and management is needed for: Lesson plan (detailed below and also see appendix). zz Plan for a lesson for: —— Material —— Time zz

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10 Synopsis, Dissertation and Research to PG Students Method of presentation Aid used Curriculum plan: —— Little detail of aspect of your lesson constitute curriculum for a lesson you are taking. Resource management: —— Display —— Media —— Material. —— ——

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LESSON PLAN In a simpler language it refers to the notes, document or content matter of teaching lesson. As PG one has to develop the quality of maintaining lesson plan For carrying out lesson through different teaching methods one has to think, write down the steps, sketch the events, outline the content and stipulate the course, which constitute a PLAN FOR LESSON . It is a skilled professional activity by a learned to a learner in a classroom, ward, OPD, IPD, OT etc., which will give an account of educational objectives in a given duration, through some specific means called LESSON. This can be a unit of educational experience by you. Approaches in lesson plan: zz Regional college of Education Mysore Approach (System Approach) zz Presentation Approach (Approach of Herbart) zz Unit Approach (Approach of Morrison) zz Approach of Evaluation (Approach of Bloom). Criteria to call a lesson good: zz No detailing zz No fragmentation zz Flexible zz Source known zz Relevant zz Clear zz Practiceable. Elements of lesson plan: zz Subject, topic, class and duration of the class zz Objectives, general

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Routine for a New Postgraduate 11 zz zz zz zz

Specific learning objectives Time schedule, contents, methods, media Evaluation Assignment exercise.

Two important points in lesson plan: If the lesson plan is for theory then it is for acquiring knowledge by the learner. zz If the lesson plan is for practical or case clinics, demonstration, then it is for acquiring skills by the learner. zz

Actual preparation of lesson plan: (Appendix 1) Do library reference, read texts, journals and make notes zz Have break up of topic, sub topics for class zz Demarcate clear objectives, general and specific zz Time allocation is done zz Specify media and method of presentation zz In between have interaction, at least once in 10 minutes zz Continue subsequent class from the assignment given in previous class. zz

Additional care in lesson plan: Meet any unexpected reaction in the class zz Not to restrict yourself the lesson plan, but go beyond, if required zz Revise your lesson, each time zz Accept comments. zz

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CHAPTER

Time Table for Threei Year Postgraduate j Course cr

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MASTER PLAN OF THE COURSE Postgraduate course is made useful for the ensuing university scheme of examinations.

It consists of: Dissertation: Every candidate should carry out and submit a dissertation as per respective council stipulation. Acceptance of dissertation is a prerequisite for examination appearance eligibility.

Theory: All three years day-to -day teachings and time scheduled textbook reading should fulfill the knowledge for the written examination.

Practicals and / or Clinicals: Day- to -day practicals and clinicals need repeat study and review. This will help a postgraduate to take practical examination in a competent manner.

Viva : All the three years interaction with peers, surrogates and subordinates make postgraduate fit enough to tackle the viva examination.

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Review of senior PG work : This helps a postgraduate to defend his dissertation, which is a part of Grand Viva.

YEARWISE GENERAL COURSE

First Year • All subjects studied in undergraduate course for example in medical course, Anatomy, Physiology, Biochemistry, Pharmacology,

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Time Table for Three-Year Postgraduate Course 13

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Pathology, Microbiology, Forensic Medicine, Community medicine, Medicine, Surgery, Obstetrics and Gynecology (OBG), and Pediatrics; should be reviewed in the textbooks which a candidate has studied in his UG examination time. Basic science in relation to his subject is to be reviewed. Observe and learn departmental routines. Learn investigative procedures. Observe journal club, subject seminar and UG teaching programs, which you have to undertake in future.

Second Year zz

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Standard textbook reading for the area of his subject should be completed by second year of his course. Practical and clinical orientation books should be given a reading. Participation in journal club, subject seminar, UG teaching, clinicopathological conference and departmental clinical meetings.

Third Year zz

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By now postgraduate must have completed his dissertation and is expected to undertake fully geared library references, which will be for: —— His dissertation defending —— His knowledge for written examination. Active participation in journal club, subject seminar, UG teaching, clinicopathological (CPC) and clinical meetings.

YEARWISE ACADEMIC COURSE First Year Try to learn to make: Library references. zz Annotated bibliography (Appendix-2). zz

Second Year Plan out for a short scientific paper presentation in a conference, from your dissertation work done.

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14 Synopsis, Dissertation and Research to PG Students

Third Year Plan out for sending a paper for journal publication. Participate in journal club, subject seminar, clinical meeting, CPC, and UG training programs.

YEARWISE DISSERTATION/RESEARCH WORK: (APPENDIX 3) First 6 Months zz zz zz zz zz zz

Problem identification Review of literature Preparation of proforma/structured questionnaire Doing a pilot study Taking ethical clearance from your college level ethical committee Submission of synopsis of dissertation to the university.

7th Month to 18 Month zz zz

Dissertation work in hospital/field work in community Collection of data in the prepared proforma.

19th Month to 24 Month zz zz zz

Tabulation of the data collected for dissertation Data analysis Report making to complete dissertation.

25th Month to 36 Month zz zz zz

Concentrate the study in your area/subject Intensification of library study of your PG subject Learn to defend your dissertation.

HOSPITAL POSTINGS, FIELD VISITS You have additional postings as per stipulation of the council for e.g. in medical science: zz Oncology (Cancer hospital)

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Time Table for Three-Year Postgraduate Course 15 zz zz zz zz zz zz zz

Psychiatry (Mental hospital) Other medicine and allied subject institutions Other surgery and allied subject institutions Other OBG and allied subject institutions Regional special hospitals Regional high tech hospitals Study visits to certain organizations/institutions field visits.

You have an obligation to participate and help the institution in all on going National Health Programme e.g., zz IPPI (Intensive Pulse Polio Immunization) zz Acquired immune deficiency syndrome (AIDS) surveillance zz Acute flaccid paralysis (AFP) surveillance. Do attend them without fail and have recording of all your observations. Get the initials from your supervisory staff at the end of each postings.

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CHAPTER

Medical Ethics i Involved in Postgraduate Work j cr

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INTRODUCTION Human values in health profession constitute medical ethics. It is formed with beliefs and values. Under legal aspect of patient care, we have four types of negligence. They are: 1. Civil negligence where patient can demand compensation. 2. Criminal negligence where patient can approach police for action. 3. Corporate negligence such as patient could not get proper care for lack of staff in the hospital, patient succumbs to a fracture by fall in the nursing home. 4. Contributory negligence such as patient does not reveal his sensitivity to penicillin which cause damage, patient is on self medication.

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MEDICAL ETHICS Is a broader terminology which deals with traditions and conventional ethical values related to values and norms. Here social action aimed at achieving good desirable end e.g. • Consent • No malpractice • No negligence • Confidentiality.

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Bioethics Enunciated by Beauchamp and Childress. It deals with problems that has arised from recent developments in science and technology e.g. zz Cloning zz Amniocentesis zz Surrogate mother zz Euthanasia zz Organ transplantation. PG dissertation/research work ultimately reach patients who are human subjects and laboratory animals. This work is of two types: 1. Clinical research (Direct value in patient management). 2. Nonclinical research (No direct value in patient management).

Heteronomous and Autonomous Ethics Heteronomous Ethics Deals with desirability of a thing particularly its usefulness in health practice which is subject to external law e.g. zz Sterilization of an unmarried girl/woman is not accepted zz Defective newborn cannot be allowed to die zz Terminal stage cancer patient cannot be allowed to die.

Autonomous Ethics Deals with desirability of a thing particularly its usefulness in health practice which is independent of others or under one’s own law e.g., zz Patient wants his treatment by traditional system of medicine zz It is sinful to interfere natural reproductive process (e.g. abortion) by religious norm zz Family need a male child for progeny though it is 4th pregnancy.

PERSPECTIVE OF MEDICAL ETHICS Babylonian code is the oldest in existence now preserved in the Louvre, treats of property, of criminal offences, of marriage laws and, what is of great interest to us, of laws relating to medical practice.

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18 Synopsis, Dissertation and Research to PG Students Egyptian code of medical ethics meted out punishments for malpractices even more severe than those of the Babylonian code. Ancient India has the high heritage of bringing us the code of conduct in medical practice with: zz Atreya anushasana zz Charaka samhita zz Sushruta samhita. Hippocratic oath has been adopted as a pattern by medical men throughout the ages. In this noble code of ethics the disciple or graduand is shown the dignity and responsibility of his calling, and there is urged upon him the duty of respect for his school, university, of making freely available any new discovery, of maintaining professional secrecy and refraining from gossip, of seeking above all the benefit of the patient, and of taking no mean advantage of the position of medical adviser (Appendix-4).

Nuremberg Code The code enunciated in 1947. The Nazi physicians were fined for crucial experiment on prisoners and on concentration camps.

The Declaration of Helsinki: (Appendix-5) In 1964 the committee on international organization of medical sciences and world medical organization formulated the declaration of Helsinki. It has given many protocol where certain ethical issues are to be included.

The WHO Declaration of Geneva In 1982, this has given us code of conduct and international guidelines, which are authentic ethical guidelines. International code of medical ethics: In 1983, this has given us many ethical principles. The salient principles of this code are: First: zz No judgment on behalf of patient zz No self advertisement unless permitted by law

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Medical Ethics Involved in Postgraduate Work 19 zz zz zz zz zz zz

Referral done for fee is prohibited Dignity in discharging duty as physician Safeguarding patient’s confidence Using only professional channels for discovery Act only in patient’s interest No certification without verification.

Second: Loyalty zz Confidentiality zz Humanitarian on duty. zz

Third: Respect to professional colleagues.

zz

The Indian Medical Council Act Act of 1956 has given the code of medical ethics to registered medical practitioners. This has enunciated the Professional Medical Ethics to Physician and Medical Practitioners. The code of medical ethics is framed under section 33 of the Indian Medical Council Act 1956. At the time of registration, each applicant shall be given a copy of the following declaration by the Registrar concerned and the applicant shall read and agree to abide by the same.

General Principles zz zz zz zz zz zz

zz zz zz

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Character of the physician The physician’s responsibility Advertising Payment of professional services Patent and copy rights Running an open shop (dispensing of drugs and appliances by physicians) Rebates and commission Secret remedies Evasion of legal restrictions

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20 Synopsis, Dissertation and Research to PG Students

MCI Code of Ethics In 1980, this has given guideline on research and experiment in human subjects. It has dealt with the following aspect: zz Doctor-to-doctor relationship zz Interprofessional relationship zz Consultation zz Case of interference zz Citizen care. This also provide canceling licence and other disciplinary action.

The Patient Self Determination Act This Act of 1990 USA is self explanatory. Patient can direct health profession. He can reject the treatment.

MAJOR PRINCIPLES OF MEDICAL BIOETHICS zz zz

zz

zz

Principle of doing good which is called beneficence in ethics. Social and distributive justice to one and all with a view to serve the ill with fairness, equity and impartiality. This is called Justice in ethics. Full freedom, right of individuals to make choice, right to make decision for themselves. This is called the respect for autonomy in ethics. Other names are ‘self determination’ and ‘liberty’. Principle of not harming patients (First do not harm!). This was true for old crude treatment and is also true for recent advance technology. This is called nonmaleficence in ethics. It is also called ‘fraternity’ which means brotherhood maintained in society.

Other Principles of Medical Ethics For the Profession zz zz zz zz zz zz

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Qualification Responsibility Payment of fees Unethical advertisement Rational use of drug No commercialization.

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Medical Ethics Involved in Postgraduate Work 21

For the Individual zz

Right to health.

Reaching/Achieving Ethical Principles By approach of: Being virtue of prudence zz Being virtue of compassion zz Being virtue of trustworthiness zz Being virtue of integrity. zz

MAJOR RULES The right to be respected: Each person has a right to call for assistance and help by his fellowmen at emergency and illness. A doctor has his role play to treat the sick. There is social obligation for a doctor to treat the sick and for a patient to seek medical help. In this interaction all individuals have the right to be respected. Truth and confidentiality: An individual often has many angles of events in his life time. Illness is such one event. If a person is suffering from tuberculosis or leprosy or psychological disturbances, the situation is true. The truth is that he is a patient of a given disease which may make him social outcast. The information on this will be with doctor or profession which is connected largely with patient’s privacy. An individual has every right to privacy over the issue of truth. This aspect of professional secrecy is called confidentiality. Medical oath and medical declaration makes a doctor obligatory to maintain confidentiality. For example of truth in human life: Homicide zz Fitness for service zz Insurance coverage and claim zz Accident (hit and run). zz

For example of confidentially in human life: Hospital or survey health records zz Confidential information collected by doctor for the purpose of treatment zz

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22 Synopsis, Dissertation and Research to PG Students zz zz

Scientific publication of a case study when pseudoname is used No gossip is done by profession on information about patient’s sexual habit.

Troubling Problem in Truth and Confidentiality zz zz zz zz zz

A patient is diagnosed to suffer from STD A patient is HIV +ve is on OT table for an emergency operation When Insurance company compels for personal information Highly infectious disease of patient A person is selected as railway driver is found to have color blindness (Truth takes off the job. Confidentiality can kill thousands of innocents).

Doctor Patient Relationship Physical distance may deter people from making use of health services provided, but social distance is more important in the present day alienation of health care. It is a question of deculturizing medicine and reculturing it to suit the sociocultural pattern in a given region or country. In this process whole-person-medicine is important. People want to be treated as whole beings and expect more from medicine than a mere scientific study of their individual organ. Health of individual is reflected by his family and his community. Ethical issues involved are: zz Waiting time zz Demanding prompt and personal attention zz Patient from class IV socioeconomic group do not conduct themselves zz Cumbersome hospital procedure zz Doctor’s language not understandable zz Expected information on sickness not available.

Organ Donation Treatment now is involving use of organ to the sick. It is not possible without formal procedures. Values and norms are drawn and ethical issue is a crucial factor.

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Medical Ethics Involved in Postgraduate Work 23

Common organs used in donation are: Kidney zz Cornea zz Blood zz Liver zz Fetal brain tissue zz Bone marrow zz Heart. Demand for organs have created ethical issues. zz

Requirement in organ donation: Compatibility in live donors zz Close relatives for good taking zz Will/consent/declaration is required zz Age of donor must be above 3 years zz Brain death establishment required on many occasion. zz

Ethical Problems Very expensive Compatibility in donor zz Force and compulsion zz Waiting time and loss of lives for want of organs zz Money, agency, commission uproar the issue (unethical practice of commercialization). We have Anatomical Gift Act of USA, Human Organ Transplant Act UK and World Health Assembly Proclamation on these issues. zz zz

PRACTICE OF MEDICAL AND BIOETHICS Informed Consent Real, adequate information and adequate knowledge about research in understandable language when given to human volunteers in research constitute informed consent. This allows human volunteer’s willingness and participation in the research. Literacy and socioeconomic class of volunteers will have a direct bearing on the validity of informed consent. Medical jurisprudence under Indian Penal Code (IPC) worth seven sections deals with consent and the consent to procedures on person. Any consent obtained under fear or misconception does not constitute

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24 Synopsis, Dissertation and Research to PG Students an informed consent. Ethical issues involved are: (a) completeness of information (b) acceptable and understandable (c) no fear of injury (d) no misconception (e) human volunteer in sound mind and sound body (f ) comprehension by human volunteer is provable, and (g) research is of high benefit and low risk. Individual has autonomy and right to take decision. The patient must get required details of information. No consent should be obtained under fear or by force. This is to take care of human dignity, privacy and positive health. There must have been monetary compensation, which should be legally recorded. This should not be made a commercial consent.

Right to Information and Choice Trust play a role here. Though Doctors know better, it is obligatory that patient should be appraised of all available information in diagnosis and treatment.

Protecting the Vulnerable Avoiding as far as possible experiment and research in children, pregnancy, mentally ill and on subordinate workers, will protect the vulnerable.

Equal Access No bias should be there in service/product/drug/screening on patients. It should be free of race, caste, creed, sex and religion.

ETHICAL REVIEW COMMITTEE Each Health Science Institution, where PG teaching and training is going on, should have an Ethical Review Committee, which is an authorized body to give clearance to all PG research activities. Receiving clearance from the ethical committee of your institution is a must and is obligatory on your part to mention the same in the synopsis of dissertation and in the regular dissertation topic ‘material and methods’. Each HOD in their respective departments shall review the topic and research as they form Subethical Review Committee. Later, it is to

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Medical Ethics Involved in Postgraduate Work 25

be brought to the meeting of Ethical Review Committee of the College, which is expected to meet once in three months. Ethical Review Committee should constitute following members which shall be around 6 to 8 members: zz Director of the institute zz Principal as academic chief zz Dean/medical superintendent as administrator zz One member of public zz One Judge/advocate of the cadre of district session judge zz One expert on drug zz One general practitioner zz All heads of the departments. These members assess the issues/dissertations carefully and give clearance to go ahead with dissertation/research work. While submitting, should follow the following protocol: Objective of study zz Justification for suggested investigations zz Proof for harmlessness of investigations zz Experimental design, sample size, type of universe and duration of the study zz Consent required (if other than routine investigation are done) zz Earlier findings of similar studies zz Benefits to patients zz Risk to the patients zz Confidentiality zz Ethical declaration. zz

Matched Pair Design Human Voluntary Research This involves stringent rules which are regulated by National and International codes of conduct. In human voluntary research; to seek the benefit to the human subjects; intend to have potential benefit to a group of patients and a long-term benefit to humanity apart from getting gain in human knowledge in the management of diseases and disabilities. Human volunteer research is guided by the following ethical principles: Ethical consideration of research on the patient zz Medical confidentiality zz

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26 Synopsis, Dissertation and Research to PG Students zz zz zz

Informed consent Doctor and volunteer relationship Profession not doing anything for the sake of money.

Types of human volunteer research are: zz Simple classical human volunteer research zz Within a patient design zz Factorial design.

Drug Trial Drug or substance which is given for therapeutic purpose in a clinically proved case is a traditionally accepted phenomenon. Of late, new chemotherapeutic agents, new vaccines, new antibiotics and other new drugs are being invented. All of them have to undergo drug trial or a clinical trial before getting approval and before releasing to the market for patients’ use. The normal procedure is animal experiments when proved effective is taken for clinical trial or drug trial. Drug trial follows the same bioethical code of conduct which is applicable to human experimentation.

LABORATORY AND CLINICAL TRIALS Research is an essential tool needed for progress anticipated in medical field. Medical research is carried out on animals and human beings apart from laboratory procedures in the laboratory. Thus research ethics provides the strict guidelines for research on laboratory animals as well as on human volunteers. Human experiment is required to provide the expected changes in physiological and pathological changes in health and disease and impact of an intervention. In the present situation all community health measures are time tested as harmless procedures before they are implemented in community health services. Research ethics denotes an area of faithful discrimination of doing right or wrong in professional activities. Clinical case review, change of drug or therapy, allowing for additional investigations, selection of patients or volunteers for future observations, retrospective record review, experiments on animals followed by human experiments are the committed fields in research ethics.

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Medical Ethics Involved in Postgraduate Work 27

Animal and Experimental Research Basically animal experiment differs from qualitative assessment on humans. Exploitation of animals if done unethically leads to an offence. It is mandatory to have (a) a separate animal house; (b) trained animal curators; (c) availability of veterinary surgeons’ advice. The regulation of colleges of health sciences, hospitals and research organizations under affiliation and licence covers the legal requirement for a better animal welfare.

Legal Requirements 1. Animal accommodation:

Mouse zz zz zz zz zz zz

80 sq cm per animal Temperature 24–25°C Relative humidity 45–64% Change for ventilation once in 12–15 hours Bedding by sawdust and wood shavings 12–16 hour exposure to sunlight provision of more space when breeding.

Guinea Pig zz zz zz zz zz zz

0.1 sq m per guinea pig Temperature 15–18°C Relative humidity 60% Change of ventilation once in 4–6 hours Bedding wood shaving If caged, floor made of nearer mesh.

Rabbit zz zz zz zz zz

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0.7 sq m per rabbit Temperature 10–18°C Relative humidity 50% Area with good ventilator Bed by saw dust, wood chip.

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28 Synopsis, Dissertation and Research to PG Students

Dog 1.3 sq m per dog Temperature 5–15°C zz Relative humidity 50% zz Ventilation change once in 10 hours zz Bed raised off the floor. 2. All procedures should be under anesthesia 3. After recovery from anesthesia, care taken with humaneness for its revival. 4. Other procedures: —— If sacrifice is indicated, early permission should be obtained as per the International Committee on Laboratory Animals (ICLA) which is supported by the World Health Organization. —— If sacrifice is permitted, follow humaneness in proper disposal of the dead animal with dignity. —— Learn technical aspects of the study before handling or before undertaking animal experiment, which allows no animal suffering. —— In case of inbred colony development set up of standards for gnotobiotic animal safety, this allows experimental animals free from all pathogens and microorganisms. —— If associated with a specific organism in the animal experiment, care should be taken for lessening animal suffering and provision for reverting to normalcy. 5. Killing and disposal: —— Should be done under anesthesia —— Always to use known painless procedure of destruction. —— Should always have a trained animal technician —— Disposal with respect by incineration and maceration. 6. Biohazards: —— Caution should be taken for animal and animal waste disposal. —— Face mask, glove and other personal protection should be on the guard. 7. Record: —— Meticulous labeling of animal cage —— Accurate record of experiment —— Label should have nature of experiment, number of experiments, name of licence, date of experiment started, species and sex of animal and procedure being followed. zz zz

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Medical Ethics Involved in Postgraduate Work 29

8. Animal supplies: —— Should be from accredited dealers —— Should have been specifically bred —— Should follow import licence procedure (according to the Importing Manual Order 1971 and Disease of Animal Act 1950). —— Choice of animals should be conditioned by cost, availability and facility.

Recent Advances in Animal Experiment (Use of Tissues and Organs) zz zz

It is for Biological Material Research It is more advanced, ethical than traditional animal experiment.

Basic Techniques In Animal Experimentation zz zz zz zz zz zz

zz zz

Handling of animals Restraint of animals Withdrawal of body fluids Sedation Anesthesia Care of surgery —— Preoperative —— Record —— Identification —— At surgery —— Postoperative Biopsy technique Microsurgery.

HUMAN EXPERIMENTATION Human experimentation is regulated through a bioethical code of conduct which had emerged from time-to-time through the following: zz Nuremberg Code,1947 zz Helsinki Declaration,1964 zz Modified Helsinki Declaration,1975 zz ICMR Guidelines,1980 zz CIOMS and WHO Guidelines,1982

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30 Synopsis, Dissertation and Research to PG Students Ethics do not permit human experimentation as an alternative to available successful accepted procedures. Ideal human experimentation is one which is: zz For individual benefit zz For family benefit zz For society benefit zz With informed consent zz Noninvolving children, pregnant women, lactating and mentally ill patients zz No compulsion or rigid force on prisoners. Large scale human experimentation is called Community Health Research. Examples of community health research are AIDS vaccine trial, Framingham study for Cardiovascular Diseases. Check points in human experiments: zz Local ethical committee like hospital ethical committee zz Medical college ethical committee zz Institutional ethical committee zz State ethical committee zz National ethical committee zz International ethical committee.

Ethical Issues Involved in Cancer Patients Who are in Terminal Care zz zz

zz zz zz zz

zz

Right to information on the prognosis of the patient and his family. Torture with pain and suffering of illness which cannot be allowed to end even with voluntary euthanasia. Belief in telling the truth Living will at terminally ill stage Right of dying with dignity Long-term damage caused to the body and mind by chemotherapy and radiotherapy Affordability of family when lost.

General Ethical Principles in Genetic Research zz zz zz zz

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All research in human genetics should have a review committee Investigator must obtain the informed consent A child’s refusal to participate must be respected Investigator must provide all information to human subjects

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Medical Ethics Involved in Postgraduate Work 31 zz

zz

zz

Burden and benefit must be equally distributed among all section of the society Pregnant and nursing mothers should not be subjects in genetic research Secure safeguards for the confidentiality of the research data.

Genetic Disorders In case of pedigree studies family members are not entitled to know each other’s diagnosis. Recruitment procedures are free of elements that unduly influence the decision to participate. Potential risks and benefits should be discussed thoroughly with subjects. Indian National Science Academy has given guidelines for care and use of animals in research. The following experience and specifications are to be obtained: Proper handling of animals used in experiment zz Learn adequate skill to give anesthesia zz Learn adequate skill to perform experiment zz Always maintain them in standard environment zz Surgical procedures are permitted under anesthesia zz After experiment, care should be given for its recovery by appropriate measures zz In all possible ways, avoid sacrifice of any animal zz In case of specific requirement of sacrifice, do it with humane sacrifice under anesthesia zz In vitro test are always preferred to animal experiment zz In all, avoid pain and suffering zz Give respectful disposal to the dead and remaining and not indiscriminate throwing. zz

National Science Academy, National Animal Protection Act and Amendments; also Animal Welfare Regulation have suggested “Animal Ethical Committee” in Health Science Institution, who give accordance to animal experiment in research with suggested guidelines. The committee shall consist of: zz Head of institution zz Head of academic activities zz Faculty from physiology zz Faculty from pharmacology zz An advocate or a lawyer practicing law zz Veterinary doctor

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32 Synopsis, Dissertation and Research to PG Students Social worker Heads of departments who conduct animal experiment. These members assess the issues of research work and give clearance for animal experiment in postgraduate research activities. zz zz

ETHICAL PROBLEMS IN AIDS, CHILDREN AND MENTALLY ILL AIDS Human immunodeficiency virus testing can be done only on three allowed specifications. They are for: 1. Blood safety 2. Surveillance and for 3. Diagnosis. HIV testing cannot be done on request, either by government or any other agency request.

Ethical Issues zz

zz zz

zz

zz zz

Pretest counseling, consent and testing are proper procedure in HIV testing It is not affordable by patient/public Information should be given only after western blot confirmation and only after consent Post-counseling and psychological support is needed for test positive cases Outcast and movement restrictions of HIV +ve is not advocated It is unethical to refuse treatment of HIV/AIDS patients.

Children Up to 14-year of age, ethical issue to children holds good, since planning commission has suggested 0–14 years groups as children or pediatric group.

Ethical Issues zz zz

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Involving children is not proper. Consent of parent or guardian (this is very necessary for even treatment of a child by the doctor).

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Medical Ethics Involved in Postgraduate Work 33

Mentally Ill This group does not constitute an indispensable group for any study/ research.

Ethical Issues Better totally avoided Consent of parent/guardian is must even for treatment zz Legally third party consent does not hold well in these cases. All Postgraduates should remember to verify the issues like (a) Violation of ethical values such as fund misuse, safety (b) Informed consent be there in each structured questionnaire (c) No duplication of other’s material (d) No fabrication and (e) No plagiarism. zz zz

NEWER AREAS OF ETHICAL INTEREST Ethical Issue of Symbols Correct use of symbol for red cross, for a doctor, for a hospital, for an ambulance and for pharmacy is advocated (Fig. 4.1). Red cross symbol; this can be used only by Red Cross   Movement members and Army Medical Corps

This symbol can be used by the Doctor

This symbol can be used by a Hospital

This symbol can be used by an Ambulance

This symbol can be used by Pharmacy Fig. 4.1  Correct use of medical symbols

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34 Synopsis, Dissertation and Research to PG Students

COMPUTER ETHICS Computer ethics is an applied ethics which studies ethical problems aggravated, transformed or created by computer technology. Computer enabled invasions of privacy by economically powerful government agencies became a public worry and led to books, articles, government studies and proposed privacy legislation. Computer scientists started adopting codes of conduct for their members. Weizenbaum of 1976 on computer power and human reason is a classic example in computer ethics.

e RESEARCH Online arenas include experimental studies, surveys, interviews, field observations and participant observations. Real time chat rooms are new method of communicating unlike previous forms. This blurs the distinction between what is private and what is public in online communities. Ethical guidelines are to be provided to protect chat room participants’ privacy.

ETHICAL ISSUE WITH ALTERNATIVE MEDICINE Following alternate medicine have found their right place that are totally accepted by the community for their accessibility, affordability and simplicity and naturality which the ancestors had earlier patronized as a panacea for all illness. zz Ayurveda zz Unani zz Siddha zz Homeopathy zz Naturopathy zz Herbal medicine zz Yoga zz Massage zz Acupuncture zz Magnetotherapy. Allopathic or modern medicine which has become more expensive, not being natural and cannot give relief in many illness; has raised doubts about its efficacy with the people. However, both trained and untrained persons practicing the alternate medicine has brought into focus the quacks who are entering the main stream.

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Medical Ethics Involved in Postgraduate Work 35

Value assessment is required in alternative therapies. Can this be done in a healthy attitude? Ethically, standards and qualifications of doctors in alternate medicine are to be insisted. If inappropriate preparations are used to treat, what could be the ethical value of alternate medicine? Allopathic practitioner practicing with alternative medicine and vice versa is unethical. Indiscriminate use of modern medicine and allopathic medicine are producing adverse results. Ethical correction was tried through by the integrated medicine training and practice but has not been successful. On one side Government of India is promoting Indian system of medicine. On the other side knowledge and ethics of its practitioners is ethically questionable. Ethical issues arise due to the poor interprofessional relationship. With high acceptance and increasing confidence on its efficacy of Indian people, Indian system of medicine should be streamlined by enforcing ethical, moral, social standards through Central Council of Indian Medicines and Central Council of Homeopathy which can regulate the practitioners.

MEDICAL ETHICS AND COPRA To keep up values and guidelines for doctors’ service to patients’ illness, COPRA came to existence in 1986 with a view to attend to the Rights to: zz Safety zz Choice zz Information zz Education zz Redressal. The Consumer Protection Act (COPRA), 1986 was enacted to better protect the interest of consumers. With globalization of economy and enhancement of consumerism, the importance of the Act has multiplied manifold. Under the Act, Consumer Forums at District (570) , State (35) and National level established to provide simple, inexpensive and time bound justice to consumer complaints against any defect in goods or deficiency in services including unfair restrictive trade practices adopted by any person. The Act was amended in 1991 and 1993. To make the Consumer Protection Act more functional and purposeful, a comprehensive

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36 Synopsis, Dissertation and Research to PG Students amendment was carried out recently by the Government and brought into force from 15th March 2003. The Amendment Act is expected to greatly strengthen the consumer movement in the country. The word “Consumer” is defined by the Government of India as “Anyone who buys goods and avails services for his or for her use is a consumer. Any user of such goods and services with the permission of the buyer is also a consumer.” It was in 1992 Justice Balakrishna Erade ruled that COPRA is made applicable to Medical profession also without hesitation. Any unethical practice and damages during treatment or operation has to be decided within 90 days. If appeal is to be made to higher Forum that must be within 30 days. As per sec 24 A , the period of limitation for filing the complaint is 2 years. If a patient made false complaint, he can be fined 10,000/- as per sec 26. As per section 27, the Forum can provide provision for imprisonment from 1 month to 3 years with fine of ` 2000 to 10,000/- in case, a doctor or patients does not obey the Forum’s decision. On 17th December 2002 a long awaited comprehensive Amendment Bill to amend the Consumer Protection Act, 1986 has been passed by the Parliament and became an Act an Important Amendment which came into force from 15.3.2003. zz Creation of benches of National Commission and State Commissions and holding of circuit benches zz Prescribing time-frame for admission of complaint, issue of notices and disposal of complaint zz Recovery of compensation amount ordered by the redressal agency through medical certificate case in the same manner as arrears of land revenue zz Provision for issue of interim orders by the redressal agencies zz Establishment of Consumer Protection Council at District level zz Revision of pecuniary jurisdiction in respect of redressal agencies at different levels. —— District Forum Up to ` 20 Lakhs —— State Forum Above ` 20 lakhs up to ` One crore —— National Commission Above ` One crore Doctor acquires scientific knowledge, technical skill and human understanding to treat the suffering of a person who is emotionally disturbed and desperate due to many constrains. The doctor is expected to apply his knowledge and skill with a true spirit of service and devotion.

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Medical Ethics Involved in Postgraduate Work 37

Professional Misconduct and COPRA State Medical Council is authorized to check professional misconducts. But professional misconduct lead to defective service and hence brought also under Consumer Protection Act (COPRA). Criminal operations, treating while under alcohol influence, association with unqualified for treatment, neglect of patient, wrong investigations leading to wrong diagnosis, experimentation of patient, wrong certificates and wrong reports all come under COPRA.

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CHAPTER

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Designing Research

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INTRODUCTION The purpose of research in health sciences is to establish the extent of occurrence of chance of health events. Normally, occurrence of an event will be as though they are occurring in nature and not by chance. Research design should satisfy ( a ) verification of PG 's hypothesis ( b) totally should control bias in the study and (c) should be possible to generalize with accuracy the outcome of research in the society or in the nature. In designed studies of community medicine, it will have coverage of ecological aspect in the causation. This becomes part of study in community based study.

Research studies are undertaken on events occurring on an individual basis or group basis. The main area of concern in research are: • Diagnostic tool • Therapeutic tool • Investigative tool • Screening tool. The therapeutic may be medical, surgical, radiological or chemical in nature. Such research conducted will help and enrich our scientific knowledge eventually helping improving health practice and , which will benefit individual, society and the community. Since inferences are made on the basis of research, it must be designed in a scientific way to avoid bias, mistake and wrong conclusion. This is to safeguard against harmful effects in health practice. When the dissertation is undertaken, student is expected to encounter few problems in spite of guidance, advice and systematic

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Designing Research 39

approach. Such problems are solved by student following a PROTOCOL. The Protocol is a framework constructed on a systematic manner for conducting dissertation work. This is outlined under preparation of synopsis of dissertation/research. After selecting the willing subjects for studies in clinical trial, they should be subjected for general screening examination to check their fitness for the study. This is done soon after the receipt of Ethical Clearance. Screening of experimental animals also follows similar protocol. Normal protocol is as under: zz Initially identification points are written zz Required information of clinical trial or animal experiment is written zz Clinical examination including suggested investigations are done zz Biological habits are recorded zz Depending on exclusion criteria or inclusion criteria, the volunteers or animals are considered for the study in dissertation. Short gap in the protocol in case of animal experiments or human experiments: In case of nonwilling participant, a short gap is given for adjustment. If there is maladjustment, that participant can be dropped from the study. This period is usually 15 to 20 days; by which time preparatory work will be going on. In case of animals, it is made sure that they are healthy. They are allowed to acclimatize to laboratory conditions. Age, gender and weight delineate their selection for the study by the postgraduate.

SPECIFIC OBJECTIVES Main objective of research will be for practical application by enriching or furthering the scientific knowledge. Clinical practice, medical practice and health practice are improved by way of research studies and observations made in research. Cure rate, healing trend, success of operation, preventive measure, technique of investigation, technique of surgical procedure when found of better value, surely benefit the patient and the community. No research work can be good and acceptable without specific rationale objective. Before specific objective is described, the research worker should ask the following questions and put forth the available answers: zz What is your plan for research? zz Is it single man’s work or team work?

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40 Synopsis, Dissertation and Research to PG Students zz zz zz zz zz

Who are the respondents in the study? What are the items in the study? What is the duration of the study? Place of study Expected outcome of the designed study.

NEED OF DESIGN IN RESEARCH/PROJECT/ THESIS/DISSERTATION No research design is acceptable without the need based concept. Is there a need for such a study will answer our point for starting and designing the research procedure. The need for research design is crucial in the following conditions: zz When unexpected outcome is expected in patient management zz When unexpected outcome is expected in group mana­ge­ment zz When there is burning public health problem which need elucidation zz When a hypothesis is to be proved zz When already existing research findings need re-evalua­tion.

DRAFTING OF OUTLINE When a topic is selected for research, it should be with a specific hypothesis, which need verification by research. Regarding conducting the research, following questions are put and answered: zz Who? zz Where? zz On whom? zz When? zz How? The research to be done must have been need based and important in its application to the society. As far as possible, check the resources for your study. Drafting the outline itself is a preplanning process, which is an essential part of the research methodology. It is very essential that the study design adopted should aptly suit the study. While describing the materials and methods, special emphasis should be given on cases design, control design and design of variables. The protocol should be carefully designed leaving no room

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Designing Research 41

for ambiguity. Tests that are used and equipment that are used should be clearly described. It is always advisable to conduct a pilot study in a research design. This pilot study helps in preparation of final proforma, methods to be used in the proposed study. The design should be such that it should be easily replicable by another researcher, any where in the world. The results derived from the study should also pass scientific scrutiny and be acceptable when presented in a scientific congress or to a journal for publication. Drafting the outline constitutes: Structured questionnaire zz Pilot study zz Postulation of hypothesis zz Dummy table preparation zz Anticipated verification points for proving the hypothesis zz Library references zz Methods and material zz Data analysis zz Tests and investigations used zz Anticipated end point zz Possible end point for practical application. zz

NATURE OF TOPIC TO BE SELECTED When a topic is selected, it should reflect the nature of the study. Title must be expressed in a concise way, but should impart much information on the nature of study, type of study, duration of the study and specifications of the objectives of the study. Following facility should be made available in deciding the topic: When a topic is programmed, we should be in a position to postulate a hypothesis which should be acceptable by a research forum zz Decision must be taken on research team, study team, place of research, the universe of study (viz, cases, patients, families, blood samples, etc.) zz The duration of the study must be specific, and normally it will be time bound (to one year study) as per specifications of the affiliated universities zz There must be provision for clinical, medical, health implications in the designed research zz

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42 Synopsis, Dissertation and Research to PG Students zz

Possible resources in terms of men, material, and money should have been worked out.

STEPS IN DESIGNING Following steps are described in research methodology, in all types of studies in health sciences, in all scientific protocol, and in designing a research, which are to be kept in mind.

First Step zz zz

zz

zz

Preplanned and proposed area of study Each department or unit should have topics ready for which any investigator can choose for dissertation, for thesis, for UGC project, for ICMR project. This will help the Institution to have much awaited benefits by the studies It will be still ideal if logistics of such prescheduled topics are made available by earlier studies. This activity minimizes fallacy and bias which normally seen in a new venture With this, by clarifying the requisite, we would have formulated the topic.

Second Step A complete and thorough library reference of related studies, journals and texts are made and got written in a book, which should be in the form of annotated bibliography (Appendix II). All available research outcome of similar studies are collected item wise through annotated bibliography, which will help us in specifying the problem definition. It also justifies the research protocol. The proposed research is readily accepted based on these available information. From step two the questions that arise, hypothesis that are put forth are answered in a better way and are made authentic and answerable in any forum.

Third Step Creation of an appropriate study design is done. zz Descriptive study

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Designing Research 43 zz zz

Analytic study Experimental study.

Specification on zz zz zz zz zz zz

Individual based Group based Interview based Cross-sectional Retrospective Prospective is made.

The Type of Trial is to be Defined zz zz zz zz

Clinical trial Screening test trial Diagnostic test trial Program trial, etc.

This Step Follows the Working of Logistics of zz zz zz zz

Participants Equipment Expertise Time.

Fourth Step This is a major step to be taken on the following areas: Deciding on sample size (refer the chapter on biostatistics). zz Proforma or structured questionnaire preparation. zz

This Contains zz zz zz zz zz zz

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Identification data Socioeconomic data Family data Past history Details of present health examination Specific areas of research questions —— By oral reply

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44 Synopsis, Dissertation and Research to PG Students By investigation By observation. The choice can be structured or open questionnaire This is finalized by doing a small study (Pilot study). —— ——

zz zz

Fifth Step The data collected is tabulated to form a master table. By now, you would have prepared many dummy tables. (As many as dummy tables prepared shall be ready for entry of tabulated data). Simple tables, cross tables and statistical tables are prepared. Application of statistical tests and critical analysis of data is done.

Sixth Step The entire data including tables are presented through type script, got corrected by the guide, and final report is prepared.

DESCRIPTIVE STUDY Main aim of descriptive study is to investigate the characteristics of a specific group of population. Normally components included are deaths, diseases, disabilities, discomfort, dissatisfactions, deviation from social norm and deviation from statistical norm (seven Ds.). Positive aspect of health like medical fitness,life expectation, validity years, person year in good health are justified in descriptive study. Somatic variables like pulse, BP, respiratory rate, serum cholesterol, PPBS, CSF constitute the body of descriptive study. Nonmeasurable qualitative data like behavioral pattern, knowledge, attitude and practice enrich the descriptive study. Investigations may also cover events to study demographic, biological, social, cultural and environmental aspect in descriptive study. In this type of study, ideal correlation of risk factors with: —— Person —— Place —— Time Are undertaken through cross-sectional and longitudinal studies. Differences between cross-sectional and longitudinal studies are tabled below (Table 5.1):

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Designing Research 45 Table 5.1  Differences between cross-sectional study and longitudinal study Cross-sectional study

Longitudinal study

 Single examination at one point  Can be projected to the universe  When repeated, it can be serial survey description  Fast approach  Inexpensive  Study of natural history of disease is not possible  Study of risk factors is not possible  Gives prevalence

 Repeated over long time  It is an universal project  Cannot be repeated easily  Slow approach  Expensive  Possible to study NHD  Possible to study risk factors  Gives incidence

Steps in Descriptive Study zz zz zz zz

zz zz zz zz zz zz

Objective of the study is defined Universe of the study is defined Sample size is determined Operational definition of topic is given and criteria of diagnosis is laid down Sampling procedure is followed Listing of required variables and attributes are done Proforma/questionnaire is prepared Data is collected Analysis is undertaken Formulated hypothesis is tested.

Uses of Descriptive Study zz zz zz zz zz zz zz

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Gives morbidity Gives mortality Gives clue to the cause Gives ideas for hypothesis Help in health planning and evaluation Help in identifying the determinants of diseases Help in identifying the distribution of diseases.

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46 Synopsis, Dissertation and Research to PG Students

CASE CONTROL STUDY It is a type of analytic study. It is started at effect and goes back to cause detection. One of the basic requirement of case control study is a built up good information system in an organization (Table 5.2). Table 5.2  Differences between case and control study Case study

Control study

 Study group  Effect on health is seen  Diagnostic criteria should prove diseased  Exclusive criteria is important

 Control group  Effect on health not seen  Not necessary  Inclusive criteria is important

Design Used in the Study Exposed to effects Case (with cancer breast) e.g.,  Users of oral Control    contraceptives (without cancer breast)         ↑     ↑   In the past    Now

Analysis Used for the Study Exposure: Smoking 5 cigarettes per day (an illustration) Yes No Total Case (Cancer lung) a b a+b 33 2 35 Control (No cancer lung) c d c+d 55 27 82 a + c b + d a + b + c + d 88 29 117 Odds ratio (Cross product ratio) is = ad/bc 33 × 27 = = 8.1 2 × 55  

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Designing Research 47

Inference Cancer lung associated with smoking of 5 cigarettes per day is 8.1 times more. Case control study is useful in: Frequently occurring health problems zz Done in less cost and in small duration zz Identifying risk factors. zz

Steps zz zz zz zz zz zz zz

Design of study Hypothesis is made Record system is reviewed Diagnosis criteria is fixed Case and control study is done Data is collected Odds ratio is determined.

Examples of case control studies: Maternal smoking and birth defects zz Viral infection and bells palsy zz Exercise and myocardial infarction zz Occupation and cancer of urinary bladder zz X-ray and blood cancer. zz

COHORT STUDY Group with similar characteristics constitute a study group called a cohort, e.g. zz Birth cohort zz Marriage cohort. The study in cohort group proceeds forward from cause to effect. Both prospective and retrospective are possible or even the combination of both is accepted. Cohort study is the study of healthy group which has not exposed to effects, but ill-effects are seen during the prospective study follow-up.

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48 Synopsis, Dissertation and Research to PG Students

Design of the Study Healthy population

Exposed to cause

Not exposed to cause

Develop disease Not Develop develop disease disease

Not develop disease

Analysis of the Study   

Disease

Developed Not Total developed Exposed group a b a+b Not exposed group

c a+c

Incidence among exposed =



d b+d



c+d a+b+c+d

a

× 100 (a + b) c Incidence among not exposed = × 100 (c + d) a/(a + b) Relative risk = c/(c + d) Attributable risk =

[a/(a + b)] – [c/(c + d)]

× 100

a/(a + b)

Uses of Cohort Study • Directly, we can calculate —— Relative risk —— Attributable risk • Multifactorial study is possible. • Natural history of a disease can be identified.

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Designing Research 49

Examples of Cohort Study zz zz zz

Risk factors in coronary heart disease. Risk of oral contraceptive in developing cancer. Risk of smoking in developing lung cancer.

CLINICAL TRIAL It is a controlled experimental study that is used to assess safety and efficacy of treatment for human diseases or human health problems.

Steps in Clinical Trial zz zz

zz zz zz zz zz zz

Put forth hypothesis Define —— Study population —— Sample size —— Study period Specify exclusion criteria and inclusion criteria Allocation of treatment is randomized Follow-up done Data is collected Data is analyzed Conclusion drawn.

Specific criteria in case of clinical trial with new treatment: Animal study and experiment are done to substantiate drug action and drug toxicity zz Later human study is undertaken. zz

Stages of Human Study Phase I: For safety and tolerance. Clinical trial is conducted with 20 to 100 cases. Phase II: For potential effectiveness and method of administration. Clinical trial is conducted with 100 to 200 cases. Phase III: For treatment effectiveness and additional safety. Clinical trial is conducted with 500 to 1500 cases. Phase IV: For long-term effect.

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50 Synopsis, Dissertation and Research to PG Students Clinical trial for post marketing studies is done for long-term effect.

Design of the Study to new treatment 1. Exposure Outcome to old treatment Type 1: Parallel design study   Phase I       Phase II to new treatment   A   to new treatment  B 2. Exposure to old treatment  B to old treatment  A Type 2: Cross over design study 3. Exposure

Phase I         Phase II Drug A 

 Drug B

Drug B 

 Drug A

Type 3: Drug change design study

Randomized Clinical Trial Selection by random procedure, for clinical trial helps in: zz Reducing bias zz Equal chances are allowed zz Comparability is accepted. Methods of randomization: zz Alternative assignment zz Coin flipping zz Card shuffling zz Throwing dice zz Using the random table. For example of randomization: —— On duty day every first case is taken to treatment A and

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Designing Research 51 —— —— ——

Every 5th case is taken to treatment B. All odd numbers to treatment A All even numbers to treatment B, etc.

Steps in Randomization zz zz zz zz zz zz

Required number of treatment A (say 1 to X) is labeled Required number of treatment B (say 1 to Y) is labeled (1) and (2) are put to cover and sealed All envelop are shuffled They are numbered from 1 to X (or A to Z) By using random table, a particular cover is taken and treatment is given.

BLINDING In clinical trial bias is a major concern. This can be overcome by blinding. Blinding is a method of reducing the bias in a clinical trial.

Types of Blinding Single blind: Treatment is concealed from participants Double blind: Treatment is concealed from investigator and the study group zz Triple blind: Treatment is concealed from investigator, participants and evaluator. Double blind method is very common type of blinding used in clinical trials. zz zz

OTHER ASPECTS OF DESIGNING Important aspect of designing in day-to-day practice is to adopt technoeconomic feasibility. There are many feasibility studies available for reference. CSIR, ICMR, and UGC have many feasibility studies with special reference to techno-economic feasibility. The issues noted in this area are: Availability of subjects/cases/participants

zz

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52 Synopsis, Dissertation and Research to PG Students zz zz zz

Availability of equipment/investigations Availability of expertise Availability of time.

COLLEGE LEVEL ACTIVITY IN STUDY DESIGN zz

zz

zz

zz

zz

zz

zz

zz

Project and assignment at undergraduate level helps both students and staff to acquire skills of conducting research All such studies conducted in a college/hospital will be the property of said college/hospital Each department or unit should undertake preliminary survey to map out required area of research for the department. This helps to assign a topic to a new postgraduate dissertation work Research committee at college level should help the departments in maintaining standards in research activities Periodic review of postgraduate dissertation work is required for any required modifications or for guidance Research committee should be coordinated with college level ethical committee for the required specifications All postgraduate dissertation work should be (i.e. the study/research/ experiment/field work/clinical trial, etc.) time bound and is expected to be completed in twelve months. This is in appropriation with the syllabus of affiliated university of health sciences (or universities) College can welcome funding agencies for the research activities.

MINIMIZING ERRORS AND BIAS In research studies, different types of errors and different types of biases are seen. We should overcome them. One of the time test method is using control group in research study. Subsequently randomization by using random tables followed. Third method is known as allocation method wherein one will allocate the case or the family or a patient from a given number say from even number or odd number as the case may be. In clinical trials, role of placebo is very critical in taking care of errors and biases.

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6

CHAPTER

Preparation of Synopsis of Dissertation/ Research

INTRODUCTION As part of learning curricula, Postgraduates are assigned a dissertation which is part of the fulfillment of PG degree in his/her examination. He/ She learns to carry out a research project called dissertation under the guidance of a University qualified guide. In majority of University of Health Sciences, the preparation for dissertation lasts for 6 months wherein a synopsis is submitted (summary content of the dissertation) by the Postgraduate to the University. When accepted, he/she will have one year for actual study period which follow another 16 months for report preparation for university submission. Synopsis is the preliminary justified particulars of future dissertation and brief description of work outline on scientific basis. Normally, it is based on a proforma prescribed by the affiliated university. This is a requisite for submission to the affiliated university for the topic acceptance. The synopsis is a prerequisite in a script for approval and registration of dissertation topic by the said university. Review of synopsis is done by the experts at university who proclaim it fit for: Registration zz Provisionally fit for registration subject to suggested corrections effecting and resubmission zz Not accepted for registration. The criteria they follow are based on a set of research criteria fixed from time-to-time and also medical council at the national level. Basic understanding of the components in synopsis make the postgraduate to attend to its completion and submission for registration. zz

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54 Synopsis, Dissertation and Research to PG Students

BASIC INFORMATION Basic information refers to identification of information of the postgraduate in the column provided like name, address, college studying, course studying and subject of the study, date of admission to the course. Date of admission to the course is to stipulate the submission of synopsis within six months of admission to the course.

TITLE OF THE TOPIC Selection of topic must be relevant to the course of study selected. zz The title should be concise but informative zz The title must be short, active and brisk in flavor to attract the attention zz The title should not be abbreviated (except on certain usage of internationally accepted abbreviation) zz Dissertation topic given should be as brief as possible but should carry as much information as required. Since there will be duplication of the study title, following assertion is required: zz To check college list of dissertation to avoid duplication zz To check university list of dissertation to avoid dupli­ca­tion zz In case if department/guide have thought of a greater need of a topic, then the study can be suffixed to the place of conducting the study which solves the problem of duplication. Examples: 1. “A study of ultrasonography in clinically suspected cases with gallbladder pathology presenting in Jawaharlal Nehru Medical College, Belgaum.” 2. “A study on the impact of leprosy control in an urban field practice area attached to Karnataka Institute of Medical Sciences, Hubballi.” 3. “A study on the health profile of under five children in Rural Health Training Center (RHTC). Attached to Karnataka Institute of Medical Sciences, Hubballi.”

NEED OF THE STUDY Give a brief introduction to the work you intend doing by focussing on present literature on the subject. Specify the need of your study undertaken. The reason for undertaking the study could be:

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For local benefit For benefit over other line of management zz For improvising the existing diagnostic tool zz For uncovering the burning health problem zz Connected with National Health Programme zz Need for studying the pattern of a particular regional endemic disease, which is peculiar to the region. About 200 words can be in a separate enclosure along with the university proforma. zz zz

OBJECTIVE OF THE STUDY Careful outline of objective form basis of dissertation work. Normally 3–4 objectives of the study can be outlined, looking to the feasibility, applicability and utility of the study. Objectives should focus on the key questions raised in the need of the study. About 100 words of objectives to be delineated and enumerated, singly, which serve as the basis of future study observation and study discussion.

REVIEW OF LITERATURE Review of literature is always larger unit of any dissertation. Reading this unit reflects the proficiency of the postgraduate student. Each review requires separate write up. This can be annotated bibliography. Review in different heading is appreciated. It is suggested to write 3–5 references pertaining to the subject and work already done and published. It should be related to the objectives of the study. Postgraduates should be acquainted with publications in health sciences. Scientific work done already or research work done already and got published should be reviewed which gives an idea on research and on how to go about PGs own dissertation. Literature review gives room to peep into problems on research methodology. Review overcomes duplication of work which is not permitted by the university. If it is not duplicated, it shall allow PG to sail smoothly on the research project. Publications are primary source of literature and abstracts like PubMed, IndMed, etc. are secondary sources. Both are part and parcel of research.

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56 Synopsis, Dissertation and Research to PG Students Review of literature is different from reference. It brings us the information about author, place and year of the study. It points out in brief, the outcome of study including sample size, and sampling. In other words list of the study is depicted in the review of literature which is a modified version of annotated bibliography. Sample of review of literature is given in appendix.

MATERIAL AND METHODS As name implies, material used and methods adopted in the study is briefly described. An effort should be made to bring about the following (which are specific requisite of Material and Methods of any Research Study): zz Source of data zz Method of collection of data including sampling procedure zz Does the study require any animal experiment zz Does the study require any animal experiment (other than routine) and intervention (other that routine) on patients selected zz Mention must be made of the clearance obtained from the College Level Ethical Committee.

LIST OF REFERENCES It is expected to provide recent study reference, done in the past 5 years, in/on the same topic/subject. Four to six references are expected of a postgraduate in the synopsis. One, should note that references are entirely different from review of literature. The referred material is put in an acceptable manner, like author, title, volume number, serial number of the said volume, page numbers, year of publication, place of publication in case of journal. It differs with text, editorial, mimeography, etc. a sample reference is made available in Appendix 9. Reference gives us the source to where the material is available, but do not specify any outcome or summary.

GUIDE AND CO-GUIDE As per the norms by medical council, one guide per one postgraduate per term of admission is allowed. In case of paucity of guides, concession

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Preparation of Synopsis of Dissertation/Research 57

is given to heads of the departments to guide TWO postgraduates per term of admission. If this guideline is overlooked, there are chances of rejecting the registration of topic of dissertation. College or Institution should takes care in this regard. However, postgraduate student should also help the college/institution in the norms of guide selection. Whenever supplementary and interdepartmental coordination for the study is required, such department faculty can be referred to as co-guides. For example surgery postgraduate doing a study where Histo­ pathology aspect is mainly emphasised, he should obtain a co-guide, who shall be a faculty from the department of Pathology. Similarly, Medicine and Biochemistry, Microbiology and Community Medicine, Radiology and Medicine, Skin and sexually transmitted diseases (STD) and Microbiology, etc. Sociologists, biostatisticians, super specialty faculty in the same department can also serve as co-guides, helping and co-guiding the candidate. If the study is in rural or urban field practice area faculty at RHTC or Urban Health Training Center (UHTC) can be co-guides. In all, guide or co-guide should fulfill the medical council guidelines of having 7 years of teaching experience after their PG qualification, in a recognized Institution.

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7

CHAPTER

Know-how on Actual Dissertation/ Research

The term Dissertation often used as a synonym with project, thesis, study, case study, research, clinical trial. Dissertation work should help PGs to have good publications in National and International journals. They are going to be useful and found beneficial in shaping their future career like zz Interview zz Promotions zz Obtaining scores zz Getting research grants But, Universities of Health Sciences and Medical Council have stipulated certain criteria and defined Dissertation as a formal, often lengthy treatise or disclosure, especially the one written by a PG candidate, as a part of fulfillment of PG degree award. It should contain: (Appendix 8) zz Title zz Preface (Introduction) containing aims and objectives zz Survey of previous work called the review of literature zz Material and methods zz Results or observations zz Discussion zz Summary zz References. To improve the quality of actual dissertation work, it is suggested to have a small initial study with a small number of cases called pilot study. When data, on rough basis, collected on small sample, which give good foothold on the study. This helps to improve structured questionnaire

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Know-how on Actual Dissertation/Research 59

and standardize the proforma. It is advisable to have a pilot study that should precede any dissertation work. Pilot study overcome future logistic problems, short comings in methodology and allows additional required data to include in the main study.

CONTENT Initially dissertation should depict the content in an order. Pagination is not required for certificates, acknowledgement and content. Preferably content should have all titles mentioned earlier and details of tables, figures and diagrams. Sub grouped items should be considered under appendix. The idea of giving content is for quick search of a required item when we refer back the dissertation.

TITLE Title should be short, informative and concise, without any unaccepted abbreviations. The title should describe the content in limited words. Title invariably present the covered objective, type of study, duration of the study and place of study.

INTRODUCTION The introduction should not have long preambles, should specify why you did start the study, should state the purpose, the hypothesis being tested, the method employed and your specific objectives. Introduction should not exceed more than 500 words. Precisely, introduction should state: The nature and scope of the problem zz The rationale for the present study. Introducing the title/topic is of two types. One is by quick approach or the other by slow approach (Figs 7.1 and 7.2). zz

Fig. 7.1  Quick approach  

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Fig. 7.2  Slow approach

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60 Synopsis, Dissertation and Research to PG Students If the description is given from the beginning on topic/problem of the dissertation to the reader, it is slow pace introductory note in dissertation. If the built up narration is given which follow the description of topic/problem it is slow approach of topic introduction in dissertation write up. All in all, introduction emphasizes the aspect of (a) problem/topic of dissertation (b) left out aspect of dissertation topic and (c) what is intended to be undertaken in the present study.

REVIEW OF LITERATURE (APPENDIX 9) Under the above, one should give strictly pertinent references. When review of literature is done, critical approach to the reliability of previous work is expected. One should use description regarding retrospective studies, since same old repetition or retrospective rambling may be boring. In the narration, appropriateness should be considered for enumerated objectives of the study. Narration should have a consistent theme. When reporting the previous/earlier similar studies, one should not give conclusion from the work being reported.

BODY Material and Methods Material and Methods form main item of the body, which outlines the scientific approach. At most importance should be given to sample size, how selection is done (criteria of selection), sampling technique, data collection procedure and investigations done (both routine and special). If detailing is there of a unique method, it can be in appendix.

Results/Observation and Discussion In Results/Observation one should follow the order of satisfying the objectives. It is better to formulate relevant tests to be applied. With the help of tables, stratification is expected in observation. Wherever relevant, use of diagram, figure, chart, map and illustrations are to be used.

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Analysis of the data should have statistical measures, confidence interval and level of significance.

Discussion In discussion, the outcome can be similar to other such studies or may differ from earlier studies. Establishing inter and intra relationship among variables, discussing as to why it has disagreed with other studies and arriving at generalization from findings is the critical step in research studies. Required and relevant correlation is a must and spurious correlation is avoided. Always make a note on limitations wherever wanted. The scope of future work is established from the present study. A comparative statement of outcome from earlier studies with the present study make a good presentation at discussion.

SUMMARY AND CONCLUSION In giving summary one should avoid all experimental details. In summarizing the issue, the schematic shall be the problem studied, the outcome observed and result got. Drawing the major conclusions from the study is always imperative. Observation and discussion can be together, but separate is preferred. Similarly summary and conclusion can be together, but separate highlighting is preferred. Limitation can be separated but is preferred in discussion.

REFERENCE (APPENDIX 10) Reference highlights that the given study material available at the mentioned source. It gives an idea of where the material is available and not about its detail. Reference material like journals, books or special publications is documented in such a way as to be made easily available to refer by the reader. The source of reference should be made available and should be easily accessible. Proper reference overcomes duplication and plagiarism. Very common reference may be avoided, to make the material more qualitative. But all special or rare studies should be cited.

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62 Synopsis, Dissertation and Research to PG Students

Vancouver In the year 1978, International Committee of Medical Journal editors met in Vancouver BC, Canada. This has given a common style of reference for major Medical journals. This also is found useful for cataloguing. Leurs R, Church MK, Taglialatela M. H1-antihistamines: inverse agonism, anti-inflammatory actions and cardiac effects. Clin Exp Allergy. 2002;32(4):489-98. Guilbert TW, Morgan WJ, Zeiger RS, Mauger DT, Boehmer SJ, Szefler SJ, et al. Long-term inhaled corticosteroids in preschool children at high risk for asthma. N Engl J Med. 2006;354(19):1985-97. PubMed Style is accepted for journals titles in their abbreviations. More authors are there, usage of et al. is advocated rather than writing all authors. Be it remembered that full stop, comma, semicolon, colon all are important in reference. von Itzstein M, et al. Rational design of potent sialidase-based inhibitors of influenza virus replication. Nature. 1993;363(6428):418-23.  Here the reference is at the order of appearance in the text. This is very helpful for the reader (in research) to locate the source of data and further to log on to its detail. There will be no waste of time in this set up. Vancouver style of writing reference is preferred to other method in publication of a scientific article.

Harvard It existed earlier for many decades. But in the year 2001 American Psychology Association formulated this style. Author- year style which is popularly called was quite common till the introduction of Vancouver style. For example, Maynard Smith, John (1998). “The origin of altruism,” Nature 393: 639–40.  Chernin, Ei (1988). “The ‘Harvard system’: a mystery dispelled”, British Medical Journal. October 22, 1988. pp. 1062–1063. In a smaller context, in abstract work, in other than research work; it is always expected to have the reference in Harvard style, i.e. arranged alphabetically by Author. In projects, dissertations and in small scale research work which are part of fulfillment of PG degree, Harvard style is preferred to Vancouver style.

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Digital reference often mentioned as software bibliography is nowadays common with Endnote and Library Master in the present day practice. Whichever style it may be, one should not miss any reference and all should be traceable. One should avoid duplication of reference.

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8

CHAPTER

Biostatistics for the Dissertation/ Research

Without statistical analysis and interpretation, the scientific data is just a data and cannot serve as health information. Hence, basic understanding of Biostatistics to every PG student is mandatory and should be undertaken in PG dissertation/research, lest the weight age shall not be given as per the guidelines of the respective councils (Medical, Dental, etc.).

INTRODUCTION Primary objective of statistics is to provide reliable, relevant and up-todate data to medical profession to carry out day-to-day technical and scientific routine studies. Statistics are of following types: zz Health statistics which mainly deals with normal health aspect. zz Medical statistics which deals with data of case management zz Vital statistics which deals with data pertaining to vital events like births, deaths etc. zz Biostatistics which deals with data of biological and biosciences. These data are presently called “Health Information” and the system or organization which works for it is called “Health Information System.”

Definition WHO has defined statistics as: A mechanism for the collection, processing, analysis and transmission of information required for organizing and operating health science and also for research and training.

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Mainly, statistics has a major role and is of great importance in National Health System. It has become a basic tool of management in public health. Following terminologies are commonly used in elementary statistics: Data: They are discrete observations and do not carry any meaning. Information: They are tabulated data which give meaning. Intelligence: They are transformed information based on social and political value.

Characteristics Each individual is characterized by certain physical characters like age, sex, weight, Hb%, BP, WBC count, etc. Similarly, there are some socioeconomic characters like occupation, literacy, income. These qualities are called characteristics. These characteristics are grouped under two categories: 1. Attributes: Characters that are not measurable are called attributes. e.g. sex, death, survival, etc. The person having attribute is countable and attribute as such is not countable. 2. Variable: Characteristics that are measurable are called variables. For example, height, Hb%, etc.

Importance Importance of statistics are enumerated as under: It is a guide for medical care services zz It is a tool for research zz It is a measure of health status of a community zz It identifies health problems zz It identifies health needs. zz It helps in providing a scientific basis for recording, collection, compilation, presentation and analysis. zz For comparing health status between: —— Individual to Individual. —— Society-to-Society —— Hospital-to-Hospital —— Community-to-Community —— District-to-District zz

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66 Synopsis, Dissertation and Research to PG Students State-to-State Country-to-Country For planning and health administration It helps in finding out: —— Impact of a health program and health management —— Success or failure of an operation It helps in health program evaluation It is a key to all health administration. —— ——

zz zz

zz zz

Biostatistics and Health Science Application of statistical principles and methods are necessary, not only for understanding of biological and medical sciences but also for effective practice in health professions. Biological, clinical and laboratory data are variable and hence need statistics for understanding and interpretation. In health science, a course on statistics is necessary because: zz Decisions on diagnosis, prognosis and therapy are based on concepts of probability. zz Interpretation of tests, observations and measurements require knowledge of variations of physiological, observer and information. zz Epidemiological facts are necessary for controlling or preventing disease. zz Health workers who are primary data generators should know about statistics. zz Describing health level, health trend and health resources are possible through interpretations and inferences. zz Statistics in health sciences foster critical and analytical mind which are required during the course and later in professional practice.

Parameters Parameter is a characteristic which describe population. When we say average size of family in India is 5.3, infant mortality rate (IMR) in India is 71 per thousand LB, they indicate parameters. When a sample is described by a unit it is called statistic. In a sample study of a village in Agra showed average family size as 6.0 and IMR of the same village as 74 per thousand livebirths, then characteristic describing this sample is statistic. Parameter is always single for a universe when compared to statistic which are many folds (for many samples).

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Estimates Estimates are observed values of a sample or a population. We select, for example, 50 nurses for their Hb%. We have average Hb% of Nurse Population. Mean Hb% of 50 Nurses is 10.8 G% and population mean of nurse population is 11.6 G%. 10.8 and 11.6 are single numbers. They are called point estimates.

Point Estimates Suppose we want range of Hb% in 50 nurse sample and in nurse population. This is called range estimates commonly called, confidence interval (CI). Point estimate in 50 nurse sample: It is 10.8 G% because sample mean is best estimate of population mean. Range estimate in 50 nurse samples: Let us say SE is 0.7 and interval with 2 times SE (it is 1.96) below and above the mean will be: 10.8 ± 2 SE (correctly 10.8 ± 1.96 SE) 10.8 ± 2(0.7) = 10.8 ± 1.4 Lowest is 10.8 – 1.4 = 9.4 Highest is 10.8 + 1.4 = 12.2 So range estimate is (CI) = 9.4–12.2 Hb% In statistical estimate, we always use mean (point estimate) and Range (confidence interval) (Fig. 8.1). It can be represented as:

Fig. 8.1  Statistical estimates

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Descriptive Statistics Descriptive statistics are used to describe or characterize data by summarizing them into more understandable terms without losing or disturbing much of the information. Examples zz Pie diagram zz Bar chart zz Frequency polygon zz Mean, median, mode.

Inferential Statistics Inferential statistics consists of a set of statistical techniques that provide predictions about population characteristics based on information in a sample taken from the population. Example By Hb% data of 50 nurses given above, we can infer as under: zz 50 nurses selected is a sample of study zz Mean Hb% is 10.8 zz Confidence interval (Range estimate) is 9.4–12.2. We infer from the sample study that mean Hb% of nurse population is 10.8 and CI is 9.4–12.2 (± 1.96 SE). So we have predicted values for nurse population by sample nurse population. It is called inferential statistics.

Scale of Measurement Measurement is the assignment of numerical to objects or events according to a set of rules. For example, chest measurements of nurses are done with measuring tape which is calibrated by centimeters or inches. According to Stevens (1946), there are four types of measurement scales for variables.

1. Nominal Scale When people, object or event are categorized say A, B, C, D, etc. or 0, 1, 2, 3, 4, etc. we are assigning a number or a letter as labels. It is categorical scale.

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Examples Sex

0 = Female 1 = Male

Hygiene 0 = Worst 1 = Bad 2 = Good

2. Ordinal Scale When characteristics are put into categories which give meaning, but distance between the categories are not properly known, it is ordinal scale. For example in final BSc (Nursing), Asha, Rita and Zinat secured I, II and III Ranks respectively. This does not tell us by how many marks they differ? Examples Socioeconomic class: 1 = Low 2 = Middle 3 = High IQ 0 = Idiot 1 = Moron 2 = Normal 3 = Genius

3. Interval Scale When characteristics have fixed and equal distance between them, we refer it as interval scale. (Divisible unit) Fahrenheit temperature 98° F 99° F 100° F Inch scale 1′′ 2′′ Examples of discrete “interval scale” (Gap is there) (Indivisible unit) Para 1 2 3 Family members 4 5 6

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(No gap) 98.2 F 98.3 F 98.4 F 2.5 cm 5.0 cm

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4. Ratio Scale It is a precise level of measurement. Here characteristics have equal intervals. Zero in the scale is determined by nature (not arbitrary). Ratio scale has characteristics of interval scale but has a true zero point as its origin. Example IQ Mental age/Chronological age DF Indoor illumination/outdoor illumination NPU N2 retained/N2 intake Quetelet index Weight/Height Calorie Coefficient, etc.

Raw Data, the Array, Frequency Distribution Mass of raw data is available when they are collected. They do not mean anything for a profession to infer. No useful information is immediately evident from a mass of raw data. They are the array of number, words and response. These collected data need to be organized in such a way that the information they contain clearly reveals the pattern of variation. Table 8.1  Frequency table showing protein-energy malnutrition (PEM) cases according to age in a sample survey Age group Tally mark