An Academic presentation by

Dr. Nancy Agnes, Head, Technical Operations, Pubrica Group:www.pubrica.com

Email: sales@pubrica.com

HOW MANY PATIENTS DOES CASE SERIES SHOULD HAVE

IN COMPARISON TO CASE REPORTS

Today's Discussion

In-Brief

Introduction

When to Consider a Case Series

When High Acceptance Rate is Possible Subjects in Case Series and Case Report Merits and Demerits

Criteria

Conclusion

Outline

In-Brief

The medical research field is continuously expanding, with more amount of data, being generated every day. In clinical research, several studies have been classified into descriptive and analytic studies. Descriptive studies include cross- sectional studies, ecological correlational studies, case reports writing, case series report writing and surveillance studies. On the other hand, analytical studies examine a hypothesis about a causal relationship between exposure and outcome. Since the objective of this article is on case report and case series, the analyses would be restricted only to those type of studies alone.

Introduction

A case series and case reports consist of either of aggregate of individual cases in one publication on the diagnosis and treatment or a report of a single patient.

A high number of case reports been received for publication, but it seems the rejection rate of CRs is quite high across many journals.

This is because, according to the principle of evidence-based medicine, they provide a lower strength of evidence among clinical studies, as shown in Figure 1.

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Out of two different forms of clinical research studies

– (i) descriptive and (ii) analytic, case series (CS) and case reports (CR) fall under descriptive one.

In specific, case reports/series are usually retrospective and occasionally be prospective, such as the Herrick’s first case report of sickle cell disease.

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When to Consider a Case Series

Ifyouintendtopublishyourcasereportsandcase

series, remember your reports should be the first document medical breakthroughs i.e., reporting of rare diseases in identifying adverse or beneficial outcomes of intervention or novel diagnostic or therapeutic strategies.

Further, the primary purpose was to generate hypotheses that can be subsequently tested in studies of greater methodological rigour.

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Therefore, case series can be applied to assess the treatment safety and diagnostic accuracy, and in fact, no control group is necessary with good long-term follow-up.

In order to get your research to be funded, there is a need for preliminary evidence on which to base the belief that a treatment may be efficacious.

In this case, these reports often provide the first level of evidence.

A study published in the Journal of Clinical Epidemiology examined the case reports and case series published in The Lancet Journal.

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The study demonstrated that case series that are carefully designed and, of course, similar to clinical trials are likely to minimize bias and maximize the information that can be deduced from a limited number of patients.

Besides, in order to publish your reports, need to ensure that both case series and reports have to follow a standard structure and methodological rigour with reference to selection, ascertainment, casualty and reporting.

The following section highlights the difference between these two reports and possible ways to get it published in High impact journals.

When High Acceptance Rate is Possible

Difference between a case series and a case report

A case series in general carries information acquired from various sources containing one or more information about the disease, treatment, diagnostic methods, etc., whereas a case report contains a very less amount of data and may contain in-depth demographical details.

Ittakesmoretimetoacceptthecaseseriesthanthe time taken to accept the case report by any publisher.

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Case reports are professional narratives that offer feedback on clinical practice guidelines and provides a framework for adverse events, initial signals of effectiveness, and cost.

They can be shared for medical, scientific, or educational purposes.

Subjects in Case Series and Case Report

Manypublishersstronglysticktothecountofthe patients reported in the study.

After the study reports, [1] suggested that a case report contain patients of less than five individuals, whereas a case series can contain four and more patients.

Few journals have no upper limit set for the case series; other journals accept nearly 20 patients report as a single case series.

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Merits and Demerits

Bothcaseseriesandcasereportwritinghavetheir merits and demerits.

Case series is very useful in rare case scenarios where a new kind of disease or disorder harms the subject.

Also, the publishers may make few negotiations in considering a case series due to the biased contents based upon the editors' personal opinions.

Besides, case series has high external validity, no interference in treatment decision process, wide range of patients and finally inexpensive.

Contd...

In terms of limitations, the study lack of comparison groups, data collection often be incomplete, susceptible to bias, selection and measurement bias.

On the other hand, case reports help healthcare professionals easily understand the cases and take less time to be prepared.

But case reports may not possess all the relevant and minute details to treat the subjects.

No randomisation is followed in a case series; therefore, it becomes more efficient and affordable.

Criteria

Wheneveracaseseriesisgettingdeveloped,few criteria need to be followed.

Title – Remember to include the words “case series” and the area of focus in the title

Abstract’ – Introduction - Unifying theme of the case series should be emphasized

Methods – what was done, how and when.

Results – what was found.

Conclusion – what we have learned.

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Introduction – emphasize the scientific background and rationale.

Design –the research registry number (ResearchRegistry.com or ClinicalTrials.gov or ISRCTN), list the intended population, process manner, and end outcome.

There must be a proper method to acquire the data like regular telephone calls, clinical observation, and more.

Study design should be sated including prospective, retrospective in design.

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Also, enough time should be given between continuous follow-ups.

Not a case series would be attractive when taking the subject cases that last more than a year because increasing the period may lead to disruption of study in the middle due to any unexpected situations like the patient would die or relocate his/her place or change the hospital.

(ii) Analysis – Descriptive statistics and methodologies must be used while analysing and no comparative tests yielding p values should be carried out.

Contd...

(iii) Reporting – A case series must report the subject details and progress, complete details, and analyse every follow-up.

There must be no declared conclusions at the end because once a valid conclusion is declared, it makes the investigators keep on updating the results by comparing with other results, which develops a need for hypothesis testing.

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The researcher must understand the limitations before getting engaged and possess awareness about the conclusions.

Pubrica has extensive experience in developing a detailed clinical case report Writing Services that assist in highlighting the scientific documentation.

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Conclusion

Both case series and case reports in the clinical research field are meant to be utilized by healthcare professionals.

Except for the distinguishing features between a case series and a case report, they both tend to give valid information with timely intervention.

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If both are well prepared from the initial stages, they can even be alternatives to another level of studies employed more confidently than the former.

Reporting case series in a standardized and statistically appropriate manner would allow for proper interpretation at the same time enable to conduct of future meta-analyses to produce estimates for the long-term outcomes.

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