Dr.Suhana is Research Officer (Homoeopathy), Central Council for Research in Homoepathy(CCRH), Janakpuri, New Delhi
Under the Ministry of AYUSH, Government of India
Under the Ministry of AYUSH, Government of India
INTRODUCTION:
A case report is a detailed
narrative that describes, for medical, scientific, or educational purposes, a medical
problem experienced by one or several patients.
Case reports offer a structure for case-based learning in healthcare
education and may facilitate the comparison of healthcare education and
delivery across culture.1 While case reports have long been an
important source of new ideas and information in medicine, it appears that case
reports are likely to begin to play a role in the discovery of what works and
for whom. BioMed Central launched the Journal
of Medical Case Reports in 2007 and its Cases Database in 2012 with more
than 11, 000 published case reports from 50 medical journals. In 6 months, it
has grown to more than 26 000 case reports from 212 medical journals.1
Case reports present
clinical observations customarily collected in healthcare delivery settings.
Well-written and transparent case reports reveal the following1,2 -
·
identification of potential benefits, harms
and information on the use of resources1,2
·
the recognition of new diseases1,2
·
unusual forms of common diseases1,2
·
presentation of rare diseases1,2
·
generate hypotheses for future clinical
studies1
·
prove useful in the evaluation of global
convergences of systems-oriented approaches1
·
guide the individualization and
personalization of treatments in clinical practice1
For example, our
understanding of the relationship between thalidomide and congenital
abnormalities and the use of propranolol for the treatment of infantile
hemangiomas began with case reports1.
DEVELOPMENT OF CARE GUIDELINES:
High-quality case reports
are more likely when authors follow reporting guidelines. During 2011–2012, a
group of clinicians, researchers, and journal editors developed recommendations
for the accurate reporting of information in case reports that resulted in the CARE
(CAseREport) Statement and Checklist. They were presented at the 2013
International Congress on Peer Review and Biomedical Publication, have been
endorsed by multiple medical journals, and translated into nine languages.2
The CARE group followed the
‘Guidance for Developers
of Health Research Reporting Guidelines’ and a three-phase consensus process consisting of (1) pre meeting
literature review and interviews to
generate items for the reporting guidelines, (2) a face-to-face consensus meeting
to draft the reporting guidelines, and (3) post meeting feedback, review, and pilot testing, followed
by finalization of the case report guidelines. This consensus process involved
27 participants and resulted in a
13-item checklist—a reporting guideline
for case reports (Table 1- The CARE guidelines) . The primary items of the
checklist are title, key words, abstract, introduction, patient information,
clinical findings, time- line, diagnostic assessment, therapeutic
interventions, follow-up and out- comes, discussion, patient perspective, and
informed consent.
Table:
The CARE Guidelines
ITEM NAME
|
ITEM NO.
|
BRIEF DESCRIPTION
|
Title
|
1
|
The
words case report (or case study) should appear in the title along with
phenomenon of greatest interest (eg. symptom, diagnosis, test, intervention)
|
Keywords
|
2
|
The
key elements of this case in 2 to 5 words
|
Abstract
|
3
|
Introduction-What
does this case add?
Case
Presentation:
Main
symptoms of the patient
Main
clinical findings
Main
diagnoses and interventions
Main
outcomes
Conclusion-What
was the main takeaway lessons from this case?
|
Introduction
|
4
|
Brief
background summary of this case referencing the relevant medical literature
|
Patient
Information
|
5
|
Demographic
information (eg. age, gender, ethnicity, occupation)
Main
symptoms of the patient (his or her chief complaints)
Medical,
family and psychosocial history-including diet, lifestyle and genetic
information whenever possible and details about relevant comorbidities
including past interventions and their outcomes
|
Clinical
findings
|
6
|
Describe
the relevant physical examination (PE) findings
Clinical history detail (homeopathic symptoms used for
decision, etc.)
|
Timeline
|
7
|
Depict
important dates and times in this case (table or figure)
|
Diagnostic
Assessment
|
8
|
Diagnostic
methods (e.g. PE, laboratory testing, imaging, questionnaires)
Diagnostic
challenges (e.g. financial, language/cultural)
Diagnostic
reasoning including other diagnoses considered
Prognostic
characteristics (e.g. staging) where applicable
|
Therapeutic
intervention
|
9
|
Types
of intervention (e.g. pharmacologic, surgical, preventive, self-care)
Type
of homoeopathy: individualized/formula: single or multiconstituents/isobaths
Medication(s): nomenclature (list individual
prescriptions or constituents + trade names), manufacture, potency, scale and
galenic form
Administration
of intervention (e.g. dosage, strength, duration)
Changes
in intervention (with rationale)
|
Follow-up
and outcomes
|
10
|
Summarize
the clinical course of all follow-up visits, including
Clinician-and
patient-assessed outcomes
Important
follow-up test results (positive or negative)
Intervention
adherence and tolerability (and how this was assessed)
Adverse
and unanticipated events
Objective evidence (if applicable) a
Occurrence homeopathic aggravation b
Possible causal attribution of changes explicitly
assessed/discussed c
|
Discussion
|
11
|
Strengths
and limitations of the management of this case
Relevant
medical literature
Rationale
for conclusions (including assessments of cause and effect)
Main
takeaway lessons of this case report
|
Patient
Perspective
|
12
|
The
patients should share his or her perspective or experience whenever possible
|
Informed
Consent
|
13
|
Did
the patient give informed consent? Please provide if requested
|
a. Objective evidence: findings that reflect
expert external observation of any measurement of the patient. Objective
evidence includes lab tests, X-ray reports, health care provider examination or
observation, or other similar data (proposed by the HPUS Clinical Data Working
Group)3
b.
Homeopathic aggravation: criteria should be specified, e.g. definition in accordance with Stub et al.4,5
c Causal attribution of changes: for assessment, consider using the ‘Modified
Naranjo Criteria’3
The CAse REport (CARE) guidelines
checklist is structured to correspond with key components of a case report and
capture useful clinical information. This 13-item checklist provides a framework
to satisfy the need for completeness and transparency for published case
reports. There is substantial empirical evidence that reporting guidelines
improve the completeness of published scientific reports.
The flow diagram given below
clearly mentions how documentation needs to be done in the initial and final
patient visits in order to make case reports as per CARE guidelines.6
Homeopathic clinical case
reports: Development of a supplement (HOM-CASE) to the CARE clinical case
reporting guideline -
There is a need to promote
transparent and accurate reporting of clinical case reports in Complementary
and Alternative Medicines(CAM), including homeopathy.3The
homeopathic knowledge base is supported by data from healthy subjects obtained
in so-called homeopathic pathogenetic trials (also called ‘provings’) that need
to be further verified and validated in clinical practice. Clinical cases and
case series are important components of the latter process. A solid foundation
in the form of high quality case reports is therefore an essential cornerstone
of the further validation of homeopathic knowledge. Due to the relatively high
level of complexity and individualization of homeopathic case-taking, lessons
learnt are likely to be easily transferable to a wide range of CAM modalities.
The supplementary guidelines
were developed by conducting an online modified Delphi process taking into
consideration the global nature of the experts involved. An agreed check-list
with criteria important for improving the quality of clinical case reports in
homeopathy was deliberated on and 06 supplementary items were added to the CARE
items 6, 9 and 10 as mentioned as bold in the Table of The CARE checklist
above.3
Clinical case report based
data play an important role as a basic ‘building block’ of the evidence
framework proposed for traditionally used CAM modalities. High quality case
reports, are the basis for high quality ‘case series’ as a further aspect of
such a broader framework. The ability to ‘think critically’ is an important
additional prerequisite to fully ‘harvest’ the potential benefits of reporting
guidelines. Clinicians tend to associate the domain of critical thinking more
with science and research than with clinical practice. But it’s equally
important that clinicians apply critical thinking in developing clinical case
reports also . If properly and ‘critically applied’, high quality clinical case
reports can make valuable contributions to the homeopathic knowledge base. Homoeopathic
practitioner’s should be aware of the pitfalls in the form of various biases ranging
from decision making and behavioral biases to biases in probability and belief,
to social biases and memory errors. E.g., an important potential bias could be
due to observed changes being wrongly, or too generously, attributed to the
homeopathic treatment.
If ‘uncritically applied’, even well reported
clinical cases will only add more ‘confusion’ and inaccuracies to the
homeopathic knowledge base. Use of the HOM-CASE guideline extension contributes
to trans-parent and accurate reporting and can greatly improve the quality and
reliability of clinical case reports in homeopathy. 3
This reporting guideline is
principally focused on using clinical cases as ‘observational’ data, with an
emphasis on ‘improving’, rather than ‘proving’, homeopathy. Let the practitioner’s
endorse this reporting guideline to improve the homeopathic database and to
disseminate the clinical findings in high impact journals.
Readers can also refer the following links for
initiatives linked to the topic of clinical case reports in Homoeopathy.
·
‘Empirical homeopathy via the documentation of
cases’ as fostered by ‘WissHom’, the (German) Scientific Society for Homeopathy
(http://www.wisshom.de/index.php?menuid=15)
·
‘Making Cases Count’ initiative by Relton et
al.
·
Various
projects by the (Dutch) Committee for Methods and Validation led by Rutten
REFERENCES:
1.
Gagnier JJ, Kienle G, Altman DG, Moher
D, Sox H, Riley D, CARE Group. The
CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development. Glob Adv Health Med. 2013
Sep;2(5):38-43. doi: 10.7453/gahmj.2013.008. PMID: 2441669
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3833570/ (Last
accessed on 10.11.2017)
2. Riley
DS, Barber MS, Kienle GS, AronsonJK, von Schoen-Angerer T, Tugwell P, Kiene H,
Helfand M, Altman DG, Sox H, Werthmann PG, Moher D, Rison RA, Shamseer L, Koch
CA, Sun GH, Hanaway P, Sudak NL, Kaszkin-Bettag M, Carpenter JE, Gagnier JJ.
CARE guidelines for case reports: explanation and elaboration document. J Clin
Epidemiol. 2017 May 18. pii: S0895-4356(17)30037-9. doi:
10.1016/j.jclinepi.2017.04.026. [Epub ahead of print]
3. R.A
Van Haselen. Homeopathic clinical case reports: Development of a supplement
(HOM-CASE) to the CARE clinical case reporting guideline.Complementary
therapies in Medicine. 2016 April
4. Stub
T, Alraek T, Salamonsen A. The Red flag! risk assessment among medicalhomeopaths
in Norway : a qualitative study. BMC Complement Altern Med.2012;12(1):150.
5. Stub
T, Salamonsen A, Alraek T. Is it possible to distinguish homeopathic
aggravation from adverse effects? A qualitative study.
ForschendeKomplementarmedizin/Res Complement Med. 2011;19(1):13–19.
great starter good information,thanku
ReplyDeleteVery well presented. Concise info in a nutshell.
ReplyDelete