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EDUCATION
Year : 2002  |  Volume : 18  |  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

Correspondence Address:
Santosh Kumar
Department of Urology, JIPMER, Pondicherry - 605 006
India
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Source of Support: None, Conflict of Interest: None


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   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 2019 Nov 22];18:199-206. Available from: http://www.indianjurol.com/text.asp?2002/18/2/199/37649



   Introduction Top


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 [1] 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 Top


1. Excellence

Efficiency is doing things right.

Effectiveness is doing right things.

Excellence is doing right things right.

Derric Johnson

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". [3] Excellent implies "extremely good or of very high quality". [3] Excellence is "the quality of being excellent". [3]

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. [4] 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. [4] 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. [4] 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 Top


There can be following stages in the shift from Case Management Record Review to Planned Clinical Research [Table - 2].

  1. Case Management Record Review (or Medical Record Review).
  2. Case Management Proforma.
  3. Clinical Management Protocol (or Uncontrolled Clinical Trial).
  4. Clinical Research Plan.



   III. Case Management Record Review Top


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 Top


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) Top


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 Top


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 Top


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. [5] 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 ?" [6] 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 ? [6] 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 ?" [6] 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. [7] 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 [8] 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 Top


  1. It provides a chance to make scientific contributions.
  2. It imparts the knowledge of scientific method.
  3. It develops the skill of critical appraisal of medical literature. [9],[10]
  4. It promotes the practice of evidence-based medi­cine. [11],[12]


 
   References Top

1.Margolese RC. Retrospective reviews. Canadian Journal of Sur­gery 1991; 34: 201-202.  Back to cited text no. 1    
2.Burton G, Thakur M. Management Today. New Delhi: Tata McGraw-Hill Publishing Company Limited, 1995.  Back to cited text no. 2    
3.Longman Dictionary of Contemporary English. Third edition, Es­sex: Longman Group Limited, 1995.  Back to cited text no. 3    
4.The New Book of Knowledge. Grolier Incorporated, Danbury, Con­necticut, 1988.  Back to cited text no. 4    
5.Johnson BK. How to ask research questions in clinical practice. American Journal of Nursing 1991; March: 64-65.  Back to cited text no. 5    
6.Dawson-Saunders B, Trapp RG. Basic and Clinical Biostatistics. Connecticut: Appleton & Lange, 1994; 8.  Back to cited text no. 6    
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.  Back to cited text no. 7    
8.CIOM/WHO. International Ethical Guidelines for Biomedical Re­search Involving Human Subjects. Geneva : CIOMS, 1993.  Back to cited text no. 8    
9.Oxman AD, Sackett DL, Guyatt GH. User's guides to the medical literature: 1. How to get started. JAMA 1993; 270: 2093-2095.  Back to cited text no. 9    
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.  Back to cited text no. 10    
11.Davidoff F, Haynes RB, Sackett DL, Smith R. Evidence-based medi­cine. BMJ 1995; 310: 1085-1086.  Back to cited text no. 11    
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.  Back to cited text no. 12    


    Figures

  [Figure - 1], [Figure - 2], [Figure - 3], [Figure - 4]
 
 
    Tables

  [Table - 1], [Table - 2], [Table - 3], [Table - 4]



 

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    Abstract
    Introduction
    I. Basic Concept...
    II. Stages in th...
    III. Case Manage...
    IV. Case Managem...
    V. Clinical Mana...
    VI. Clinical Res...
    VII. The Process...
    VIII. Benefits o...
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