BIOETHICS OF STEM CELL RESEARCH AND CLONING
ANKUR BARUA, ROMILA SYANGDEN
Sikkim-Manipal University of Health, Medical and Technological Sciences
Gangtok, Sikkim, India 2009
Background: Dr. Ankur Barua had graduated with distinction from the University of Hong Kong (MBuddStud, 2009). He had also completed two other Master Degrees, one from Sikkim Manipal University (MBAIT, 2007) while the other from Manipal University (MBBS-2000, MD in Community Medicine - 2003) and presently working in professional field.
Ms. Romila Syangden is a Hospital Administration professional who has also a keen passion for conducting research on public health, religion and science.
First Publication on 26th October 2009
Sikkim Manipal University of Health, Medical and Technological Sciences, Sikkim, India
Copyright © Ankur Barua and Romila Syangden
Communication Address of Corresponding Author:
Dr. ANKUR BARUA
Block – EE, No.-80, Flat No.-2A,
Salt Lake City, Sector-2,
Kolkata - 700091, West Bengal, INDIA.
Email: ankurbarua26@yahoo.com
Mobile: +91-9434485543 (India), +852-96195078 (Hong Kong)
BIOETHICS OF STEM CELL RESEARCH AND CLONING
SYNOPSIS
Introduction
Stem cells are blank cells that have the potential to develop into any type of cell in the body. Scientists are trying to harvest the cells before they have differentiated, then coax them into becoming certain types. These cell lines are colonies of embryonic stem cells of different types. There is a rapid and astonishing progress in the field of cloning since the making of “Dolly” – the first cloned sheep, a few years ago.
Advantages of Stem Cell Research and Cloning Technology
The Stem Cell Research may lead to cloning a whole human being. In that case, if we can accept surrogate motherhood as an ethically acceptable process, cloning is more or less the same. Cloned individuals need not be necessarily being identified with the donor. Even identical twins are different from each other, influenced by environment and other psycho-social factors. During cloning of various organs and bone marrow transplants, these organs would be an exact genetic match of the recipient and so there will be no rejection.
Disadvantages of Stem Cell Research and Cloning Technology
Every form of reproductive technology raises the question of human values, dignity, worth, jurisdictional rights. A person should not be used as a mere mechanical instrument. Human being is an unrepeatable entity. Cloned embryo may undergo mutation and can lead to the creation of a monster instead of a human being. Natural birth is a product of human love. In cloning, the values of love and human procreation are missing. It violates the principle of equality among human beings and principle of non-discrimination through selective eugenic dimension used for specific cloning.
Conclusions
The clone’s sense of self-worth or individuality or dignity would be difficult to sustain. From the religious perspectives Judaism and Islam support most forms of Stem Cell Research and Cloning. The Vatican has expressed sadness and dismay at the proposal for this human cloning venture by stating that this process of cloning violates the right of a human being to be conceived in human way. Buddhist Bioethics also discourages cloning technology due to the fact that there is no limit to human ambitions and no strict judicious control over Stem Cell Research and Cloning in many countries of the world.
Key words: Stem Cell, Cloning, Bioethics, Research, Theological, Religious
BIOETHICS OF STEM CELL RESEARCH AND CLONING
INTRODUCTION
Stem cells are blank cells that have the potential to develop into any type of cell in the body. Scientists are trying to harvest the cells before they have differentiated, then coax them into becoming certain types. These cell lines are colonies of embryonic stem cells of different types. Stem cells are one of the human body's master cells, with the ability to grow into any one of the body's more than 200 cell types.
All stem cells are unspecialized (undifferentiated) cells that are characteristically of the same family type (lineage). They retain the ability to divide throughout life and give rise to cells that can become highly specialized and take the place of cells that die or are lost.
Stem cells contribute to the body's ability to renew and repair its tissues. Unlike mature cells, which are permanently committed to their fate, stem cells can both renew themselves as well as create new cells of whatever tissue they belong to (and other tissues).
Bone marrow stem cells, for example, are the most primitive cells in the marrow. From them all the various types of blood cells are descended. Bone marrow stem-cell transfusions (or transplants) were originally given to replace various types of blood cells.
The concept of this kind of research was believed to be in the minds of the Indians since long back. The Adi-Parva of Mahabharata gives clear indication that the kauravas were born from the stem cells. Human cloning means the asexual replication of a human individual by taking of cells with genetic materials and cultivation of these cells through egg, embryo and finally into human being.
There is a rapid and astonishing progress in the field of cloning since the making of “Dolly” – the first cloned sheep, a few years ago. “George” and “Charlie”, the two identical, genetically engineered calves that could make medicines in their milk were also successfully created. While “dolly” was cloned from a cell taken from an adult mammal, “Charlie” and “George” were cloned from cells taken from fetuses which are an easier process.
OBJECTIVES
(1) To study the various ethical issues related to Stem Cell Research and Cloning.
(2) To study the theological aspects of Stem Cell Research and Cloning.
REVIEW OF LITERATURE
About Stem Cells
Broadly speaking, a stem cell is one that–in the course of cell division and increase in the numbers of cells–is able to reproduce itself and also mature into various specialized types of cells. The stem cell with the greatest potential (totipotential) is the fertilized egg cell, which is capable of developing into a complete organism.
According to the usual–but actually very doubtful–explanation, the fertilized egg cell has totipotential up to the stage of division into eight cells, and in later stages the cells retain only "pluripotential." That is, they can form many different types of tissues, but not the complete organism. Embryonic stem cells–that is, those 50 cells within a blastocyst, which then continue to develop into the embryo proper–have this pluripotential. In the course of further specialization, stem cells of individual tissues are formed, such as that of the bone marrow, from which all the other kinds of blood cells develop.
Behind this description lies the conception that a linear process of differentiation is played out, in the development of the individual, toward increasingly "mature," specialized cells in the individual tissues, from totipotentiality to tissue specificity. This process is supposed to run only forward, but never backward. That is, as soon as a cell has reached a certain degree of "maturity," the way back to earlier stages of development is closed off. So it is evident that a stem cell’s capacity to perform is increasingly limited to specific functions, and it loses, correspondingly, the manifold capabilities still present in earlier developmental stages.
According to latest reports, however, this dogma of developmental biology does not hold. Evidently, tissue-specific stem cells have the ability–as has been impressively demonstrated in experiments with animals–to "transdifferentiate" themselves when in a different environment–that is, to take on the cell functions of the new tissue. Thus, neuronal stem cells of mice have transformed themselves into blood stem cells and produced blood cells. Indeed, there are indications of another capability of adult stem cells: Apparently they have the potential to be "reprogrammed." Not only can they adjust to the specific conditions of a new tissue environment, but they can even assume more generalized, earlier levels of development, so that it even appears possible that they become totipotent again.
Concept of Stem Cell Research and Cloning
Stem cells can divide for an infinite period of time when being grown outside of the body, and which can differentiate into various types of specialized cells. When fertilization of an egg with sperm occurs, the resulting fertilized cell has the capability to form an entire organism. The cell is described as being totipotent (having total potential). After some time, as rounds of cell division occur, specialization of cells occurs. But, early in fetal development, before the developing mass of cells attaches itself to the wall of the uterus, some cells still retain the ability to form virtually every type of cell in the body. These cells are pluripotent (capable of differentiating into many types of cells but not all types required for fetal development). With continued fetal development, further specialization of pluripotent stem cells results in multipotent stem cells--cells that give rise to cells having a particular function, such as blood cells and various types of skin cells. Stem Cell Research is concerned primarily with the pluripotent cells. The field is relatively new. James Thomson reported in Science in late 1998 his success in maintaining undifferentiated embryonic stem cells in their undifferentiated state in lab culture.
Stem cells can be obtained from human embryos at the so-called blastocyst stage (a stage very early in fetal development, only a few division cycles after fertilization). As well, cells can be obtained from fetal tissue from terminated pregnancies. The latter procedure has precipitated much discourse. In August 2001, United States president George W. Bush announced that he would support very limited federal funding of research using stem cells from human embryos. It was a compromise that did not completely satisfy parties on either side of the controversial issue.
Another potential means of obtaining pluripotent stem cells may be a technique called somatic cell nuclear transfer. In the technique involves the physical removal of its nucleus from an egg cell. The nucleus is the specialized area of the cell that contains the organized pieces of genetic material called the chromosomes. The material left behind in the egg cell contains nutrients and other energy-producing materials necessary for development of the embryo. Then, a somatic cell--any cell other than an egg or a sperm cell--is placed next to the denucleated egg cell, and the two cells are chemically fused together. After a requisite number of cell divisions, pluripotent stem cells can be recovered and used.
Pluripotent stem cells are important to science and to advances in health care. At the most fundamental level, study of these cells could advance the understanding of the processes of cellular development, such as the orchestrated mechanisms by which genes are turned on and off during development and growth. Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell specialization and cell division. Pluripotent stem cells could also be used to screen new drugs, eliminating the need to use living subjects for the early phases of drug discovery.
The most far-reaching potential application of the stem cells is the generation of cells and tissue that could be used for so-called cell therapies. Potentially stem cells may function as a kind of universal human donor cell, which could serve as raw material for whatever diseased cell requires replacing. Such donor cells would have to be genetically engineered so as not to form the cell surface molecules that would alert the recipient's immune system. The cells could be used for replacement of defective or diseased cells without the danger of transplantation rejection that occurs presently. Potential applications include the replacement of defective heart tissue and replacement of malfunctioning insulin producing cells in Type I diabetes.
In the last several years, several lines of research have produced concrete results showing the potential of stem cells in cell therapy. Genetic engineering of stem cells may be promising as a cancer eradication strategy. In rats, neural stem cells genetically engineered to convert a compound into a cancer-killing agent have been found to selectively target and destroy cancerous cells in the brain. Elsewhere, neural stem cells have also been shown capable of integration into the diseased retina of rats and of taking on some of the characteristics of retinal cells. This holds the promise that stem cell therapy may aid in repairing retinal damage. Other researchers have demonstrated, again in rats, that stem cells in the brain were able to repair damaged areas and restore function when stimulated by a growth-inducing protein. If replicated in humans, then stem cell treatments for stroke, nervous system and spinal cord injury and diseases such as Parkinson's and Alzheimer's that are marked by degeneration of nerve cells.
Another application of stem cells has been to form a chimera—an animal that grows from an embryo in which stem cells from another animal have been inserted. Some of the chimera's cells have one set of parents, and some cells have another set of parents. "Knockout" mice, research animals lacking specific genes, are chimeras. While theoretically conceivable, human chimeras are not contemplated.
Researchers have claimed success at reprogramming multipotent cells for a function other than that they were programmed for. Specifically, adult skin cells from cattle were reverted to stem cells and then transformed into heart cells. Other studies involved neural stem cells from mice and bone marrow cells from rats have also indicated that functional reprogramming of adult cells may be feasible. These breakthrough studies hold forth the potential of using cells from adults to treat diseases, rather than extracting embryonic cells.
There are several barriers to the use of adult stem cells at present. First of all, more knowledge of the locations of adult stem cells is still required since these cells might not be present in all tissues of the body. Secondly, adult stem cells are present in minute quantities, are difficult to isolate and their number decreases with age. The time necessary to locate, harvest, and grow the cells to usable numbers may be too long for practical purposes. Finally, adult stem cells may contain DNA abnormalities, which have accumulated as a result of a lifetime of exposure to DNA-altering agents such as sunlight and toxic chemicals. Further research may overcome these limitations, allowing stem cells obtained from adults to be used in cell therapy.
Stem cells from bone marrow can also, quite remarkably, give rise to non-marrow cells. In a 1999 report in the journal Nature, scientists from Boston led by Dr. Louis M. Kunkel reported that they gave bone marrow transplants from normal mice to dystrophic mice. Some 12 weeks later about 10% of the muscle fibers in the diseased animals were making the correct form of dystrophin, the protein that is defective in Duchenne muscular dystrophy. This work suggests that bone marrow stem cells may offer new ways of treating muscular dystrophy (and other non-blood diseases).
CONCLUSION FROM THE THEOLOGICAL ASPECT OF STEM CELL RESEARCH AND CLONING
From the religious perspectives, it is interesting to note that, the religions that have strong traditions of legal and religious law, namely Judaism and, Islam support most forms of Stem Cell Research. These two religions also support their beliefs on when life begins and Stem Cell Research by interpreting specific religious texts. While the Catholic Church has put the issue of Stem Cell Research on the forefront of its agenda, Pope John Paul II does not point to any specific biblical text that supports the Catholic Church’s concept of when life begins.
However, since religion can exert influence over the public and politicians, specifically, when it comes to moral arguments; religions such as Judaism and Islam need to be more vocal in their support of Stem Cell Research to balance out Catholicism’s almost blanket prohibition of the medical advance.
While science may never answer the question of when life begins, Catholicism, Judaism and Islam have answered the question in some ways that support and in other ways that prohibit the use of stem cells, even for therapeutic means. Since, there are no limits to human ambitions and no strict judicious control over Stem Cell Research; cloning technology for any purpose is never encouraged according to the Buddhist Bioethics.
Sunday, October 25, 2009
START YOUR RESEARCH PROJECT NOW
START YOUR RESEARCH PROJECT NOW
Dr. ANKUR BARUA
MBBS, MD (Community Medicine), MBAIT, MBuddStud (Hong Kong)
Hong Kong, 2009
Background:
The author had graduated with distinction from the University of Hong Kong (MBuddStud, 2009). He had also completed two other Master Degrees, one from Sikkim Manipal University (MBAIT, 2007) while the other from Manipal University (MBBS-2000, MD in Community Medicine - 2003) and presently working in professional field.
First Publication on 26th October 2009
Sikkim Manipal University of Health Medical and Technological Sciences
Copyright © Ankur Barua
Address for communication:
Dr. ANKUR BARUA
Block – EE, No.-80, Flat No.-2A,
Salt Lake City, Sector-2,
Kolkata - 700091, West Bengal, INDIA.
Email: ankurbarua26@yahoo.com
Mobile: +91-9434485543 (India), +852-96195078 (Hong Kong)
Contents
Items Page No.
Acknowledgements 04
Preface 05
Framework of a Research Project
(a) Introduction, Objectives 06
(b) Review of Literature 07
(c) Materials and Methods 08
(d) Overview of Major Study Designs in Health Research 10
(e) Selection of an Appropriate Study Design 12
(f) Sample Size Estimation 13
(g) Sampling Procedure 15
(h) Study Instruments 17
(i) Organization of Field Work and Plan for Data Collection 17
(j) Study Variables 18
(k) Data Analysis 18
Basic Algorithms of Statistical Tests of Significance
(a) Parametric Tests 20
(b) Non-Parametric Tests 21
Summary Statistics for Continuous Variables 23
Normal Distribution Curve 24
Dummy Tables 24
Summary & Conclusions, Limitations, Recommendations, References 27
Annexure 28
Final Revision, Formatting and Preparation of the Research Project Report 29
Summary of Micro-Planning of Health Research Protocol / Report Presentation 30
Concluding Remarks by the Author 31
Acknowledgements
I would like to express my sincere gratitude to my beloved father Dr. Dipak Kumar Barua, who was the earlier Dean of the Faculty Council for Postgraduate Studies in Education, Journalism & Library Science in the University of Calcutta (1987-1991) and the Director of Nava Nalanda Mahavihara, Nalanda (1996-1999) for his technical guidance and valuable advice throughout the compilation of this handbook.
I would also like to convey my sincere thanks to my mother Mrs. Dipa Barua and Ms. Mary Anne Basilio for their constant encouragement, keen interest and support throughout this project.
Preface
This book provides first-hand guidance and adequate information on publication in indexed journals. Due to paucity of space in most of the indexed journals, researchers are advised to be stringent with the use of language and make an attempt to express the maximum information by using optimum words in their research reports. This book is a simplified version and a ready guide on how to frame and conduct a health research, analyze the data and present the final report in an effective manner.
Ankur Barua
FRAMEWORK OF A RESEARCH PROJECT
1) INTRODUCTION
a) Problem Statement of Incidence / Prevalence:
In World – with recent studies
In India – with recent examples
In Locality – with recent examples
b) Psycho–Socio–Demographic correlates identified by the WHO or any other renowned indexed journal.
c) Defending the need for study and how researchers as well as community can benefit from this study.
2) OBJECTIVES
a) Clear cut and well defined easily measurable quantitatively:
Max 5 objectives but prefer to restrict the study within 3 objectives.
b) If ≥5 objectives are to be mentioned, then set an AIM by combining the statements and meanings of one or two main objectives. The objectives should address & clarify the following points –
Define study design
Define study population
Define study area
Study Period (not mandatory)
Define main outcome variable (department variable)
Define Risk factors / Psycho–Socio–Demographic correlates
Define comparison groups
[* Please do remember that each objective mentioned here, has to be addressed independently in the results section]
3) REVIEW OF LITERATURE
a) Global Burden of Disease and DALYs lost due to the diseased condition under scrutiny
b) ICD–10 Disease Clarification for the disease to be studied
c) Case Definition according to ICD-10 and Operational Case Definition
d) Problem Statement in detail –
Incidence or Prevalence of the disease in World
Incidence or Prevalence of the disease in India
Incidence or Prevalence of the disease in Locality
Give a table showing major studies conducted in the world and in India. Mention in chronological order of studies preferably from a Meta-analysis if available:
Sl. No. Name of Chief Investigator Study Period Study Area Sample
Size Incidence or Prevalence Rates Instrument / Diagnostic Criteria
EXAMPLE
Sl. No. CHIEF INVESTIGATOR/
FIRST AUTHOR YEAR STUDY AREA SAMPLE
SIZE PREVALENCE OF DEPRESSIVE DISORDERS
(%) INSTRUMENT/
DIAGNOSTIC CRITERIA
1. Fuhrer 1992 France 2792 13.6 CES-D
2. Kua 1992 Singapore 612 5.7 GMS-AGECAT
3. Madianos 1992 Greece 251 27.1 CES-D
4. Henderson 1993 Australia 945 1.0 CIE
5. Ihara 1993 Japan 695 5.3 CES-D
6. Saunders 1993 UK 5222 10.0 GMS-AGECAT
e) Socio – demographic correlates – examples from previous studies conducted
f) Associated co-morbid conditions – examples from previous studies conducted
g) Defining other parameters needs to be measured from the study instruments other than outcome variable e.g., QOL, Wellbeing, Cognitive impairment.
h) Defining the age cut off for selection of study population
i) Any National Health Programme associated with the study outcome
History of the National Health Programme associated with the disease
Any National Health Policy associated with the disease
Review & critical evaluation of the National Health Programme associated with the disease
Goals set for control or eradication of the diseased condition in future / recent years
Any suggestions / recommendations to improve the services under the national programme associated with the disease by renowned authors / researchers
j) Discussion on problems with field surveys in India –
Sampling errors
Case definition
Classification of Disease (standard)
Statistical Analysis
Training of investigators
4) MATERIALS & METHODS
Materials & Methods should provide the following information:
a) BACKGROUND INFORMATION –
Geographical location with map of India and local map of study area
Numbers of Province / Districts / Taluks
Total population of Province / Districts / Taluks
Socio–cultural– demographical profile of the study population
Health care providers in study area
b) STUDY PERIOD Data collection time
c) SETTING Study area
d) STUDY DESIGN Choose the appropriate study design based on need of the study
e) STUDY POPULATION Sample size estimation
f) SAMPLING PROCEDURE done to avoid sampling error in selecting participants of the study
g) STUDY INSTRUMENTS
Acceptability, Validity & Reliability after Pre-testing or conducting a Pilot Study
Translation, Back Translation & Re-Translation of study instruments
h) ORGANIZATION OF FIELD WORK AND PLAN FOR DATA COLLECTION
Training of investigators & participating volunteers for data collection on how to collect un-biased information by interview technique or questionnaire method
Mention the actual data collection procedure with sequence of administration of each questionnaire including time management
Vocational / Medical / Financial benefits offered to the study subjects after providing valuable information on research topic
i) STUDY VARIABLES provide a list of study variables in annexure
j) PLAN FOR DATA ANALYSIS Mention the Statistical Software Package used & level of significance
SUMMARY OF MICRO-PLANNING OF HEALTH RESEARCH PROTOCOL / REPORT PRESENTATION
A. Title page: Title of research, Institution symbol, Name of principal author(s) & Date
B. Certificate from University duly signed by Guide & Co- Guide
C. Certificate from the respective department duly signed by Guide & Co- Guide
D. Certificate from HOD of the respective department
E. Acknowledgements:
HOD of department undertaking the project
Guide
Co- Guide
Others for significant contribution and moral support.
Other department heads involved / staffs involved
Participants of this study / research.
F. Structured Abstract (Brief report after completion of the project):
1) Title of the project
2) Name of all authors (surname first)
3) Name of Institute where the study is conducted
4) Introduction
5) Objectives
6) Materials & Methods
7) Results & Discussion
8) Summary & Conclusions (including implications for nursing care if applicable)
9) Limitations / Recommendations
10) Key words (3 to 5 in number)
G. Body of Contents of research project in details:
1) Introduction
2) Objectives
3) Review of Literature
4) Materials & Methods
5) Results & Discussion
6) Summary & Conclusions (including implications for nursing care if applicable)
7) Limitations & Recommendations
8) References
9) Annexure
Concluding Remarks by the Author
The objective of this handbook is to present the basic concepts of epidemiology and Biostatistics in an attempt to provide the reader with a practical application of the concepts. This book will help the reader to select appropriate methods and study designs to conduct a research and also to correctly analyze any database for information.
Dr. ANKUR BARUA
MBBS, MD (Community Medicine), MBAIT, MBuddStud (Hong Kong)
Hong Kong, 2009
Background:
The author had graduated with distinction from the University of Hong Kong (MBuddStud, 2009). He had also completed two other Master Degrees, one from Sikkim Manipal University (MBAIT, 2007) while the other from Manipal University (MBBS-2000, MD in Community Medicine - 2003) and presently working in professional field.
First Publication on 26th October 2009
Sikkim Manipal University of Health Medical and Technological Sciences
Copyright © Ankur Barua
Address for communication:
Dr. ANKUR BARUA
Block – EE, No.-80, Flat No.-2A,
Salt Lake City, Sector-2,
Kolkata - 700091, West Bengal, INDIA.
Email: ankurbarua26@yahoo.com
Mobile: +91-9434485543 (India), +852-96195078 (Hong Kong)
Contents
Items Page No.
Acknowledgements 04
Preface 05
Framework of a Research Project
(a) Introduction, Objectives 06
(b) Review of Literature 07
(c) Materials and Methods 08
(d) Overview of Major Study Designs in Health Research 10
(e) Selection of an Appropriate Study Design 12
(f) Sample Size Estimation 13
(g) Sampling Procedure 15
(h) Study Instruments 17
(i) Organization of Field Work and Plan for Data Collection 17
(j) Study Variables 18
(k) Data Analysis 18
Basic Algorithms of Statistical Tests of Significance
(a) Parametric Tests 20
(b) Non-Parametric Tests 21
Summary Statistics for Continuous Variables 23
Normal Distribution Curve 24
Dummy Tables 24
Summary & Conclusions, Limitations, Recommendations, References 27
Annexure 28
Final Revision, Formatting and Preparation of the Research Project Report 29
Summary of Micro-Planning of Health Research Protocol / Report Presentation 30
Concluding Remarks by the Author 31
Acknowledgements
I would like to express my sincere gratitude to my beloved father Dr. Dipak Kumar Barua, who was the earlier Dean of the Faculty Council for Postgraduate Studies in Education, Journalism & Library Science in the University of Calcutta (1987-1991) and the Director of Nava Nalanda Mahavihara, Nalanda (1996-1999) for his technical guidance and valuable advice throughout the compilation of this handbook.
I would also like to convey my sincere thanks to my mother Mrs. Dipa Barua and Ms. Mary Anne Basilio for their constant encouragement, keen interest and support throughout this project.
Preface
This book provides first-hand guidance and adequate information on publication in indexed journals. Due to paucity of space in most of the indexed journals, researchers are advised to be stringent with the use of language and make an attempt to express the maximum information by using optimum words in their research reports. This book is a simplified version and a ready guide on how to frame and conduct a health research, analyze the data and present the final report in an effective manner.
Ankur Barua
FRAMEWORK OF A RESEARCH PROJECT
1) INTRODUCTION
a) Problem Statement of Incidence / Prevalence:
In World – with recent studies
In India – with recent examples
In Locality – with recent examples
b) Psycho–Socio–Demographic correlates identified by the WHO or any other renowned indexed journal.
c) Defending the need for study and how researchers as well as community can benefit from this study.
2) OBJECTIVES
a) Clear cut and well defined easily measurable quantitatively:
Max 5 objectives but prefer to restrict the study within 3 objectives.
b) If ≥5 objectives are to be mentioned, then set an AIM by combining the statements and meanings of one or two main objectives. The objectives should address & clarify the following points –
Define study design
Define study population
Define study area
Study Period (not mandatory)
Define main outcome variable (department variable)
Define Risk factors / Psycho–Socio–Demographic correlates
Define comparison groups
[* Please do remember that each objective mentioned here, has to be addressed independently in the results section]
3) REVIEW OF LITERATURE
a) Global Burden of Disease and DALYs lost due to the diseased condition under scrutiny
b) ICD–10 Disease Clarification for the disease to be studied
c) Case Definition according to ICD-10 and Operational Case Definition
d) Problem Statement in detail –
Incidence or Prevalence of the disease in World
Incidence or Prevalence of the disease in India
Incidence or Prevalence of the disease in Locality
Give a table showing major studies conducted in the world and in India. Mention in chronological order of studies preferably from a Meta-analysis if available:
Sl. No. Name of Chief Investigator Study Period Study Area Sample
Size Incidence or Prevalence Rates Instrument / Diagnostic Criteria
EXAMPLE
Sl. No. CHIEF INVESTIGATOR/
FIRST AUTHOR YEAR STUDY AREA SAMPLE
SIZE PREVALENCE OF DEPRESSIVE DISORDERS
(%) INSTRUMENT/
DIAGNOSTIC CRITERIA
1. Fuhrer 1992 France 2792 13.6 CES-D
2. Kua 1992 Singapore 612 5.7 GMS-AGECAT
3. Madianos 1992 Greece 251 27.1 CES-D
4. Henderson 1993 Australia 945 1.0 CIE
5. Ihara 1993 Japan 695 5.3 CES-D
6. Saunders 1993 UK 5222 10.0 GMS-AGECAT
e) Socio – demographic correlates – examples from previous studies conducted
f) Associated co-morbid conditions – examples from previous studies conducted
g) Defining other parameters needs to be measured from the study instruments other than outcome variable e.g., QOL, Wellbeing, Cognitive impairment.
h) Defining the age cut off for selection of study population
i) Any National Health Programme associated with the study outcome
History of the National Health Programme associated with the disease
Any National Health Policy associated with the disease
Review & critical evaluation of the National Health Programme associated with the disease
Goals set for control or eradication of the diseased condition in future / recent years
Any suggestions / recommendations to improve the services under the national programme associated with the disease by renowned authors / researchers
j) Discussion on problems with field surveys in India –
Sampling errors
Case definition
Classification of Disease (standard)
Statistical Analysis
Training of investigators
4) MATERIALS & METHODS
Materials & Methods should provide the following information:
a) BACKGROUND INFORMATION –
Geographical location with map of India and local map of study area
Numbers of Province / Districts / Taluks
Total population of Province / Districts / Taluks
Socio–cultural– demographical profile of the study population
Health care providers in study area
b) STUDY PERIOD Data collection time
c) SETTING Study area
d) STUDY DESIGN Choose the appropriate study design based on need of the study
e) STUDY POPULATION Sample size estimation
f) SAMPLING PROCEDURE done to avoid sampling error in selecting participants of the study
g) STUDY INSTRUMENTS
Acceptability, Validity & Reliability after Pre-testing or conducting a Pilot Study
Translation, Back Translation & Re-Translation of study instruments
h) ORGANIZATION OF FIELD WORK AND PLAN FOR DATA COLLECTION
Training of investigators & participating volunteers for data collection on how to collect un-biased information by interview technique or questionnaire method
Mention the actual data collection procedure with sequence of administration of each questionnaire including time management
Vocational / Medical / Financial benefits offered to the study subjects after providing valuable information on research topic
i) STUDY VARIABLES provide a list of study variables in annexure
j) PLAN FOR DATA ANALYSIS Mention the Statistical Software Package used & level of significance
SUMMARY OF MICRO-PLANNING OF HEALTH RESEARCH PROTOCOL / REPORT PRESENTATION
A. Title page: Title of research, Institution symbol, Name of principal author(s) & Date
B. Certificate from University duly signed by Guide & Co- Guide
C. Certificate from the respective department duly signed by Guide & Co- Guide
D. Certificate from HOD of the respective department
E. Acknowledgements:
HOD of department undertaking the project
Guide
Co- Guide
Others for significant contribution and moral support.
Other department heads involved / staffs involved
Participants of this study / research.
F. Structured Abstract (Brief report after completion of the project):
1) Title of the project
2) Name of all authors (surname first)
3) Name of Institute where the study is conducted
4) Introduction
5) Objectives
6) Materials & Methods
7) Results & Discussion
8) Summary & Conclusions (including implications for nursing care if applicable)
9) Limitations / Recommendations
10) Key words (3 to 5 in number)
G. Body of Contents of research project in details:
1) Introduction
2) Objectives
3) Review of Literature
4) Materials & Methods
5) Results & Discussion
6) Summary & Conclusions (including implications for nursing care if applicable)
7) Limitations & Recommendations
8) References
9) Annexure
Concluding Remarks by the Author
The objective of this handbook is to present the basic concepts of epidemiology and Biostatistics in an attempt to provide the reader with a practical application of the concepts. This book will help the reader to select appropriate methods and study designs to conduct a research and also to correctly analyze any database for information.
Friday, October 23, 2009
Hospital Based Study on Psychoses in Mangalore
Indian Journal of Community Medicine Vol. 31, No. 1 (2006-01 - 2006-03)
Hospital Based Study on Psychoses in Mangalore
A. Barua, H. Shankar, A. Jain, V.K. Bhat, N. U. Kiran, S. Jayarama
Department of Community Medicine, Kasturba Medical College, Mangalore
Introduction
Schizophrenia and related psychoses are severe mental disorders, which usually start in adolescence or early adult life, and often become chronic and disabling. They are considered a major public health problem in many parts of the world, representing a heavy burden both for the families of affected individuals as well as national health systems. These are group of chronic debilitating psychiatric illness, characterized by loss of touch with reality and disorders of thought, behavior, appearance and speech1.
While psychiatric disorders in total have a worldwide prevalence of 32.5%, schizophrenia has a prevalence of 1.5% (worldwide). The prevalence of schizophrenia in India is about 1%, this may be due to diagnostic drawbacks rather than decreased number of cases2. The etiological factors involved in the pathogenesis of the disease include genetic predisposition (60% concordance rates in monozygotic twins), family environment (presence of stressors and disease among other family members), viral infection (inconclusive proof), cerebral infections and neurotransmitter disturbances2-4. This study was conducted with on objective to study the socio-demographic characteristics of the patients suffering from schizophrenia and related psychoses in a Mangalore hospital.
Material and Methods
Kasturba Medical College Hospital, Attavar is a tertiary care level private institute, situated at the centre of port town of Mangalore in Dakshina Kannada District of Karnataka state in India. The migratory population from Tamil Nadu and Kerala also often utilize the health care facilities of this hospital. This is a Retrospective study design based on Case Series Analysis. All in-patients admitted to Department of Psychiatry during March 1999 and December 2000, constituted a sample size of 98.
Data was collected by using a structured proforma after scrutinizing from case files from Medical Records Department. The data collected was tabulated and analyzed using the statistical package of SPSS (Statistical Package for Social Sciences) Version 7.5.
Results and Discussion
None of the patients were found to be below 16 yrs. of age. Majority (85.7%) were in the age of 16-55 years. This observation is in concordance with the figures quoted by others, who observed in their studies that 90% of schizophrenics belonged to the age group of 15 and 54 years3,4. Incidence of schizophrenia was highest for men between 15 and 24 years and for women the peak appeared between 25 and 34 years3,4. We also observed that females were more affected than males (65.4%) in the age group of 16-25 years and more than 65 years (83.3%). The distribution of cases remained almost equal for both sexes in other age groups.
Majority of the patients were Hindus (68.4%). Most of them (85.7%) hailed from Karnataka. 14.3% came from Kerala for treatments of their mental disorders. 58.2% individuals were married and majority were females (57.4%). Among female patients, 24.1% were unmarried and only 12.2% were either widow, separated or divorced.
More than half (53.0%) of the unemployed and housewives were affected with schizophrenia and related psychoses. Among the unemployed group, 10.2% were students. Occupational status remained unknown in 14.3% cases. We observed that mental illnesses were common in working class of society (32.7%).
In this study, only 16.3% patients belonged to below poverty level. But since this hospital was a tertiary care level private Institute, majority of the in-patients were above poverty level and could afford the treatment cost. While majority (88.8%) of the patients were literates, but the illiterates and those with lower level of education, together constituted 50.0% of these cases. It is a well-documented fact that schizophrenia is more prevalent among the lower socio-economic classes and in people with low level of education3.
Majority, 58.2% of the patients were living with their spouse, 31.6% living only with their children and relatives and only 10.2% were living alone. In 85.7% of cases, one of the 1st degree relatives in the family had suffered from some confirmed psychiatric illness in the past among a total of 21.4% patients who gave a positive family history of psychiatric illness. Only 5.1% patients had a positive family history of suicide or suicidal attempts. 11.2% of schizophrenics in our study had made an attempt at suicide. The risk of suicide in individuals with schizophrenia has been reported to range from (2-13)%3. Among the stressors, marital disturbances were a precipitating factor for 23.5% cases of schizophrenia and related psychoses. This was found to be the most important stressor in this study. History of death in the family within the last 12 months was positive in 17.3% cases. Family disputes accounted for 15.3% and Personal problems, including intra and interpersonal conflicts acted as a precipitating factor for in 9.2% of the cases. Here, on patient was subjected to more than one stressor. No specific references are given to numbers but importance is given to family environment marital disturbances and problems in professional life as possible stressors for schizophrenia3,4.
References
1.Braff L. Schizophrenic Disorders. In: Anthony et. al. (editors) Harrison’s Principles of Internal Medicine. New Delhi: McGraw Hill; 1998; P. 2415.
2.Carpenter WT, Buchana RW. Schizophrenia Introduction and Overview. In: Kaplan Hl, Sadock BJ (editors). Comprehensive Text Book of Psychiatry. Philadelphia: Williams & Wilkins; 1995; 889-90.
3.Africa B, Schwartz RS. Schizophrenic Disorders. In: Howard H Goldman (editor). Review of General Psychiatry. New York Appleton & Lange; 1995, 22.
4.Kasyc M, Norquist GS. Schizophrenia-Epidemiology, In: Kaplan Hl,Sadock BJ, editors. Comprehensive Text Book of Psychiatry. Philadelphia: Williams & Wilkins: 1995; P. 908.
Hospital Based Study on Psychoses in Mangalore
A. Barua, H. Shankar, A. Jain, V.K. Bhat, N. U. Kiran, S. Jayarama
Department of Community Medicine, Kasturba Medical College, Mangalore
Introduction
Schizophrenia and related psychoses are severe mental disorders, which usually start in adolescence or early adult life, and often become chronic and disabling. They are considered a major public health problem in many parts of the world, representing a heavy burden both for the families of affected individuals as well as national health systems. These are group of chronic debilitating psychiatric illness, characterized by loss of touch with reality and disorders of thought, behavior, appearance and speech1.
While psychiatric disorders in total have a worldwide prevalence of 32.5%, schizophrenia has a prevalence of 1.5% (worldwide). The prevalence of schizophrenia in India is about 1%, this may be due to diagnostic drawbacks rather than decreased number of cases2. The etiological factors involved in the pathogenesis of the disease include genetic predisposition (60% concordance rates in monozygotic twins), family environment (presence of stressors and disease among other family members), viral infection (inconclusive proof), cerebral infections and neurotransmitter disturbances2-4. This study was conducted with on objective to study the socio-demographic characteristics of the patients suffering from schizophrenia and related psychoses in a Mangalore hospital.
Material and Methods
Kasturba Medical College Hospital, Attavar is a tertiary care level private institute, situated at the centre of port town of Mangalore in Dakshina Kannada District of Karnataka state in India. The migratory population from Tamil Nadu and Kerala also often utilize the health care facilities of this hospital. This is a Retrospective study design based on Case Series Analysis. All in-patients admitted to Department of Psychiatry during March 1999 and December 2000, constituted a sample size of 98.
Data was collected by using a structured proforma after scrutinizing from case files from Medical Records Department. The data collected was tabulated and analyzed using the statistical package of SPSS (Statistical Package for Social Sciences) Version 7.5.
Results and Discussion
None of the patients were found to be below 16 yrs. of age. Majority (85.7%) were in the age of 16-55 years. This observation is in concordance with the figures quoted by others, who observed in their studies that 90% of schizophrenics belonged to the age group of 15 and 54 years3,4. Incidence of schizophrenia was highest for men between 15 and 24 years and for women the peak appeared between 25 and 34 years3,4. We also observed that females were more affected than males (65.4%) in the age group of 16-25 years and more than 65 years (83.3%). The distribution of cases remained almost equal for both sexes in other age groups.
Majority of the patients were Hindus (68.4%). Most of them (85.7%) hailed from Karnataka. 14.3% came from Kerala for treatments of their mental disorders. 58.2% individuals were married and majority were females (57.4%). Among female patients, 24.1% were unmarried and only 12.2% were either widow, separated or divorced.
More than half (53.0%) of the unemployed and housewives were affected with schizophrenia and related psychoses. Among the unemployed group, 10.2% were students. Occupational status remained unknown in 14.3% cases. We observed that mental illnesses were common in working class of society (32.7%).
In this study, only 16.3% patients belonged to below poverty level. But since this hospital was a tertiary care level private Institute, majority of the in-patients were above poverty level and could afford the treatment cost. While majority (88.8%) of the patients were literates, but the illiterates and those with lower level of education, together constituted 50.0% of these cases. It is a well-documented fact that schizophrenia is more prevalent among the lower socio-economic classes and in people with low level of education3.
Majority, 58.2% of the patients were living with their spouse, 31.6% living only with their children and relatives and only 10.2% were living alone. In 85.7% of cases, one of the 1st degree relatives in the family had suffered from some confirmed psychiatric illness in the past among a total of 21.4% patients who gave a positive family history of psychiatric illness. Only 5.1% patients had a positive family history of suicide or suicidal attempts. 11.2% of schizophrenics in our study had made an attempt at suicide. The risk of suicide in individuals with schizophrenia has been reported to range from (2-13)%3. Among the stressors, marital disturbances were a precipitating factor for 23.5% cases of schizophrenia and related psychoses. This was found to be the most important stressor in this study. History of death in the family within the last 12 months was positive in 17.3% cases. Family disputes accounted for 15.3% and Personal problems, including intra and interpersonal conflicts acted as a precipitating factor for in 9.2% of the cases. Here, on patient was subjected to more than one stressor. No specific references are given to numbers but importance is given to family environment marital disturbances and problems in professional life as possible stressors for schizophrenia3,4.
References
1.Braff L. Schizophrenic Disorders. In: Anthony et. al. (editors) Harrison’s Principles of Internal Medicine. New Delhi: McGraw Hill; 1998; P. 2415.
2.Carpenter WT, Buchana RW. Schizophrenia Introduction and Overview. In: Kaplan Hl, Sadock BJ (editors). Comprehensive Text Book of Psychiatry. Philadelphia: Williams & Wilkins; 1995; 889-90.
3.Africa B, Schwartz RS. Schizophrenic Disorders. In: Howard H Goldman (editor). Review of General Psychiatry. New York Appleton & Lange; 1995, 22.
4.Kasyc M, Norquist GS. Schizophrenia-Epidemiology, In: Kaplan Hl,Sadock BJ, editors. Comprehensive Text Book of Psychiatry. Philadelphia: Williams & Wilkins: 1995; P. 908.
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