|Year : 2002 | Volume
| Issue : 2 | Page : 199-206
Towards excellence in scientific clinical research : The shift from case management record review to planned clinical research
Department of Urology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India
Department of Urology, JIPMER, Pondicherry - 605 006
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Case Management Record Reviews have limited scientific value and there is a need to make a shift from these to Planned Clinical Research. The purpose of this article is to help clinicians in making this shift. This article describes the basic concepts of research, the stages in the shift from Case Management Record Review to Planned Clinical Research, the limitations of Case Management Record Review, Case Management Proforma, Clinical Management Protocol, Clinical Research Plan, the process of Planned Clinical Research including research designs and the benefits of carrying out scientific research.
Keywords: Scientific Research; Clinical Research; Case Management Record Review; Planned Clinical Research
|How to cite this article:|
Kumar S. Towards excellence in scientific clinical research : The shift from case management record review to planned clinical research. Indian J Urol 2002;18:199-206
|How to cite this URL:|
Kumar S. Towards excellence in scientific clinical research : The shift from case management record review to planned clinical research. Indian J Urol [serial online] 2002 [cited 2020 Nov 24];18:199-206. Available from: https://www.indianjurol.com/text.asp?2002/18/2/199/37649
| Introduction|| |
Most of the original articles published in the Indian Journal of Urology and most of the original presentations in the Annual Conferences of the Urological Society of India are Reviews of Case Management Records or Medical Records. The Reviews of Case Management Records have limited scientific value  and there is a need to make a shift to Planned Clinical Research which is scientifically more meaningful and useful and thus is a better investment of effort. Doing Planned Clinical Research will not only boost the self-esteem of the involved clinicians but also enhance the image of Indian Urology.
With the forces of liberalisation, privatisation and globalisation sweeping across all the countries of the world, the private medical sector will be growing and will be acquiring an academic role which will include research function also. Furthermore, global competition will force both public and private medical sectors to perform better academically. Thus all medical organisations will be required to undertake Planned Clinical Research and to strive for excellence in their research endeavours if they will wish to compete academically with the best in the world.
The purpose of this article is to help clinicians in making a shift from Case Management Record Reviews to Planned Clinical Research and also to motivate more clinicians to undertake Planned Clinical Research.
This article describes the basic concepts of research, the stages in the shift from Case Management Record Review to Planned Clinical Research, the limitations of Case Management Record Review, Case Management Proforma, Clinical Management Protocol, Clinical Research Plan, the process of Planned Clinical Research including research designs and the benefits of carrying out scientific research.
| I. Basic Concepts of Research|| |
Efficiency is doing things right.
Effectiveness is doing right things.
Excellence is doing right things right.
The shift from Case Management Record Reviews to Planned Clinical Research is the first step in the long journey towards excellence in scientific clinical research. To excel means "to do something very well or much better than most people".  Excellent implies "extremely good or of very high quality".  Excellence is "the quality of being excellent". 
2. Scientific Research
Research is a search for knowledge. Scientific research is a search for scientific knowledge. Science is not merely the knowledge of facts but it is the process of discovering the interconnections of facts and the general rules that explain them.  Thus scientific knowledge is the knowledge of the relationship of facts and the explanations of these relationships and not only the knowledge of facts.
3. Clinical and Nonclinical Research
Clinical research involves patients or specimens derived from them. Nonclinical research does not involve patients or specimens derived from them. Nonclinical research can involve groups of healthy people (community-based research) or animals (animal experiments) [Table - 1]. As Case Management Records are available only for patients, Case Management Record Review is possible only in clinical research [Table - 1]. The words retrospective (meaning dealing with past events) and prospective (meaning dealing with future events) may have different connotations in clinical and nonclinical research [Table - 1].
4. Basic and Applied Research
Basic research aims to discover more about the laws of nature, including human nature.  It is motivated by mere curiosity. The resultant ideas are used in applied research.
Applied research aims to discover or invent new and useful products or better ways of doing something.  It is motivated by a practical goal. Inventions of instruments are used in basic research.
| II. Stages in the Shift from Case Management Record Review to Planned Clinical Research|| |
There can be following stages in the shift from Case Management Record Review to Planned Clinical Research [Table - 2].
- Case Management Record Review (or Medical Record Review).
- Case Management Proforma.
- Clinical Management Protocol (or Uncontrolled Clinical Trial).
- Clinical Research Plan.
| III. Case Management Record Review|| |
Case Management Records or Case Records or Medical Records include the outpatient and the inpatient case records.
1. The Purpose of Case Management
The goal of case management is to manage the individual patient. This individual case management basically involves the following steps:
A. The elicitation of risk factors utilising history taking, physical examination and investigations.
B. The elicitation of disease manifestations utilising history taking, physical examination and investigations (the process of diagnosis).
C. The administration of surgical or medical intervention.
D. The elicitation of disease manifestations utilising history taking, physical examination and investigations (the process of follow-up).
2. The Purpose of Case Management Records
The purpose of these documents is to record the patient management process of the outpatients and the inpatients.
3. The Limitations of the Use of Case Management Records for Clinical Research
The use of Case Management Record for clinical research is an example of the use of existing or secondary data for research. This has the following limitations:
A. Desired records may have been destroyed or lost.
As a policy in some hospitals manual medical records are preserved only for a definite period of 5, 10 or 15 years. In very large hospitals, manual medical records are often misplaced or lost. Similarly X-rays and other pictorial documents are often misplaced or lost.
B. Desired data, although obtained, may not have been recorded or documented.
In very large hospitals, desired data, although obtained, may not have been recorded out of pressure of work or carelessness. This fact is the obvious reason for holding periodic Medical Records Department meetings for completing the medical records. Interesting clinical and operative findings are also often not documented photographically.
C. Recorded data may not be comprehensible.
Data recorded manually in medical records are often incomprehensible due to illegible handwriting and problems of written communication in English language (wrong spellings, wrong choice of words and wrong construction of phrases and sentences) because recording work is usually considered less important and thus left to junior doctors.
D. Desired data may not have been obtained.
The medical investigation methods and the medical intervention methods undergo frequent changes over time. This occurs because of ongoing scientific and technological advances. Thus it is possible that currently desired data may not have been obtained for patients treated in past.
E. The data may be lacking in quantity.
The desired tests or follow-ups might not have been performed as frequently as desired. Sufficient number of patients and diagnostic or operative procedures may also not be available.
F. The data may be lacking in quality.
The data obtained from history taking and physical examination may be inconsistent. Inconsistencies may also occur due to the use of different techniques in performing the same test or investigation.
Interpersonal and also intrapersonal variations in performing and interpreting a test or investigation can create inconsistencies in data. Inconsistencies in surgical and medical interventions occur due to interpersonal and also intrapersonal variations in preferences.
If incomplete Case Management Records are completed during periodic visits to the Medical Records Department by involved persons from memory or by uninvolved persons, errors are very likely to be introduced.
4. The Use of Case Management Records for Descriptive and Analytic Research
The use of Case Management Records for descriptive research (describing risk factors or disease manifestations) is fraught with comparatively less errors than their use for analytic research (diagnosis or treatment). When Case Management Records are used for research, the administration of treatment and the measurement of outcomes have been performed by the same clinician with resultant biases in the measurement of outcomes. While using Case Management Records for research, the researcher has no control over the quality and quantity of data. One cannot choose the type of data to be collected, the quality of data and the method of data recording.
| IV. Case Management Proforma|| |
Case Management Proforma is a proforma which is designed to record the ongoing management process of patients presenting with a particular disease. Case Management Proforma overcomes the problems of destruction or loss of records, incomplete record or documentation and incomprehensibility of data. However, it does not necessarily solve the problems of not obtaining desired data, the deficiencies in quantity and the deficiencies in quality unless special efforts are made in these areas.
| V. Clinical Management Protocol (Uncontrolled Clinical Trial)|| |
This is the simplest Planned Clinical Research which can be carried out by a clinician because its basic requirement of the patient undergoing an intervention (medical or surgical) is part and parcel of clinical practice. In a Clinical Management Protocol or Uncontrolled Clinical Trial planning is necessary to decide selection criteria for patients, to standardise the surgical or medical intervention, to measure all clinically relevant outcomes and to follow up all patients.
The goal of a Clinical Management Protocol is to find out the effectiveness of a particular medical or surgical intervention.
Other Benefits of Clinical Management Protocol
A. It helps in providing uniform quality of care.
B. It records the standard process of care and can be used for medicolegal purposes.
| VI. Clinical Research Plan|| |
This includes all other types of Planned Clinical Research besides Clinical Management Protocol or Uncontrolled Clinical Trial. The goal of Planned Clinical Research can be to answer questions about treatment, diagnosis, prognosis and etiology.
| VII. The Process of Planned Clinical Research|| |
Planned Clinical Research is systematic and planned as the name indicates and what is to be done is decided in advance. Planned Clinical Research process goes through the following stages:
1. Keeping in Touch with Literature
By keeping in touch with literature one can find out what research has already been done and what research needs to be done.
2. Identifying Research Problem
The research problem should be relevant to the local, regional or national needs of the country and it should be interesting to the researcher.
3. Reviewing Literature
After the research problem has been identified, relevant literature should be reviewed to study the research problem in detail.
4. Formulating Research Questions, Objectives and Hypotheses
Research questions and objectives state the purpose of doing research.  Research hypothesis is a statement about the proposed relationship between the variables.
5. Assessing Resources
An assessment of available monetary, material and time resources is made to find out whether the proposed research is feasible.
6. Choosing Research Design
This is the most important decision to be made. The research design should be appropriate to the research question. In choosing a research design following three major decisions have to be made:
A. Will it be an observational study or an interventional study ?
In an observational study, the events taking place in subjects are only observed. In an interventional study an intervention (surgical or medical) is made and the effects of this intervention are assessed.
B. Will it be a one-time study or a longitudinal study ?
In a one-time study each subject is examined only once. In a longitudinal study each subject is examined over a period of time.
C. Will it be a descriptive study or an analytic study ?
In a descriptive study the aim is only to describe the variables. In an analytic study the aim is to define the relationship between the variables.
The following four typical research designs can be used in Planned Clinical Research [Table - 3]. They are described in an increasing order of their complexity.
A. Cross-sectional study
This is the simplest research design. It is observational, one-time and descriptive study. It is designed to find out "What is happening ?"  It is used for studying prevalence and diagnosis and for surveys [Table - 4]. It is depicted in [Figure - 1].
B. Case control study
It is observational, one-time and analytic study. It is designed to find out "What happened ?  It is used for studying causation [Table - 4]. It is depicted in [Figure - 2].
C. Cohort study
It is observational, longitudinal and analytic study. It is designed to find out "What will happen ?"  It is used for studying causation. incidence and prognosis [Table - 4]. It is depicted in [Figure - 3].
D. Clinical trial
It is interventional, longitudinal and analytic study. Randomised controlled trial provides the best evidence of causation.  It is used for studying prevention and treatment [Table - 4]. It is depicted in [Figure - 4].
7. Choosing Subjects or Materials (Choosing Sampling Method and Sample Size Determination)
Population is a group of subjects or materials whose variables are to be studied. A sample is a part of the population to be studied. Choosing subjects or materials involves choosing a sampling method and sample size determination.
8. Choosing Variables and Methods of their Measurement
Variables are the characteristics of the study subjects which will be measured. The measurement tools and methods to be used for measuring variables have to be decided.
9. Choosing Data Analysis Methods
Statistical methods for data analysis have to be decided in advance.
10. Writing Research Plan
The research plan is written down for the purpose of Research and Ethics Committee approval  and also for ready reference.
11. Pilot Study and Data Collection
Pilot study is a short study used to test whether the research plan is feasible before implementing the research plan. Periodic reviews are needed during data collection for quality control and for solving any problem which might have emerged.
12. Data Analysis and Interpretation
Data analysis includes organisation, summarisation, presentation and actual analysis of data using statistical methods. Statistical results are interpreted for their clinical significance.
| VIII. Benefits of Carrying Out Scientific Research|| |
- It provides a chance to make scientific contributions.
- It imparts the knowledge of scientific method.
- It develops the skill of critical appraisal of medical literature. ,
- It promotes the practice of evidence-based medicine. ,
| References|| |
|1.||Margolese RC. Retrospective reviews. Canadian Journal of Surgery 1991; 34: 201-202. |
|2.||Burton G, Thakur M. Management Today. New Delhi: Tata McGraw-Hill Publishing Company Limited, 1995. |
|3.||Longman Dictionary of Contemporary English. Third edition, Essex: Longman Group Limited, 1995. |
|4.||The New Book of Knowledge. Grolier Incorporated, Danbury, Connecticut, 1988. |
|5.||Johnson BK. How to ask research questions in clinical practice. American Journal of Nursing 1991; March: 64-65. |
|6.||Dawson-Saunders B, Trapp RG. Basic and Clinical Biostatistics. Connecticut: Appleton & Lange, 1994; 8. |
|7.||DerSimonian R, Charette L, McPeek B, Mosteller F. Reporting on methods in clinical trials. The New England Journal of Medicine 1982; June 3: 1332-1337. |
|8.||CIOM/WHO. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva : CIOMS, 1993. |
|9.||Oxman AD, Sackett DL, Guyatt GH. User's guides to the medical literature: 1. How to get started. JAMA 1993; 270: 2093-2095. |
|10.||Guyatt GH, Sackett DL, Cook DJ. User's guides to the medical literature: II. How to use an article about therapy or prevention. A. Are the results of the study valid ? JAMA 1993; 270: 2598-2601. |
|11.||Davidoff F, Haynes RB, Sackett DL, Smith R. Evidence-based medicine. BMJ 1995; 310: 1085-1086. |
|12.||Sackett DL, Rosenberg WM, Gray JA, Hayner RB, Richardson WS. Evidence-based medicine : What is it and what is it not ? BMJ 1996; 312: 71-72. |
[Figure - 1], [Figure - 2], [Figure - 3], [Figure - 4]
[Table - 1], [Table - 2], [Table - 3], [Table - 4]