CHM Office of Reseach

Writing a Case Report

This page is intended for medical students, residents or others who do not have much experience with case reports, but are planning on writing one.  

What is a case report?  A medical case report, also known as a case study, is a detailed description of a clinical encounter with a patient.  The most important aspect of a case report, i.e. the reason you would go to the trouble of writing one, is that the case is sufficiently unique, rare or interesting such that other medical professionals will learn something from it.   

Case reports are commonly of the following categories :

- Rare diseases

- Unusual presentation of disease

- Unexpected events

- Unusual combination of diseases or conditions

- Difficult or inconclusive diagnosis

- Treatment or management challenges

- Personal impact

- Observations that shed new light on a disease or condition

- Anatomical variations

It is important that you recognize what is unique or interesting about your case, and this must be described clearly in the case report.

Case reports generally take the format of :

1. Background

2. Case presentation

3. Observations and investigation

4. Diagnosis

5. Treatment

7. Discussion

Does a case report require IRB approval?

Case reports typically discuss a single patient. If this is true for your case report, then it most likely does not require IRB approval because it not considered research.    If you have more than one patient, your study could qualify as a Case Series, which would require IRB review.  If you have questions, you chould check your local IRB's guidelines on reviewing case reports.

Are there other rules for writing a case report?

First, you will be collecting protected health information, thus HIPAA applies to case reports.   Spectrum Health has created a very helpful guidance document for case reports, which you can see here:   Case Report Guidance - Spectrum Health

While this guidance document was created by Spectrum Health, the rules and regulations outlined could apply to any case report.  This includes answering questions like: Do I need written HIPAA authorization to publish a case report?  When do I need IRB review of a case report?  What qualifies as a patient identifier?

How do I get started?

1. We STRONGLY encourage you to consult the CARE Guidelines, which provide guidance on writing case reports -  https://www.care-statement.org/

Specifically, the checklist -  https://www.care-statement.org/checklist  - which explains exactly the information you should collect and include in your case report.  

2. Identify a case.  If you are a medical student, you may not yet have the clinical expertise to determine if a specific case is worth writing up.  If so, you must seek the help of a clinician.  It is common for students to ask attendings or residents if they have any interesting cases that can be used for a case report. 

3. Select a journal or two to which you think you will submit the case report.   Journals often have specific requirements for publishing case reports, which could include a requirement for informed consent, a letter or statement from the IRB and other things.  Journals may also charge publication fees (see Is it free to publish? below)   

4. Obtain informed consent from the patient (see " Do I have to obtain informed consent from the patient? " below).  Journals may have their own informed consent form that they would like you to use, so please look for this when selecting a journal.

Once you've identified the case, selected an appropriate journal(s), and considered informed consent, you can collect the required information to write the case report.

How do I write a case report?

Once you identify a case and have learned what information to include in the case report, try to find a previously published case report.  Finding published case reports in a similar field will provide examples to guide you through the process of writing a case report.    

One journal you can consult is BMJ Case Reports .  MSU has an institutional fellowship with BMJ Case Reports which allows MSU faculty, staff and students to publish in this journal for free.  See this page for a link to the journal and more information on publishing-    https://lib.msu.edu/medicalwriting_publishing/

There are numerous other journals where you can find published case reports to help guide you in your writing. 

Do I have to obtain informed consent from the patient?

The CARE guidelines recommend obtaining informed consent from patients for all case reports.  Our recommendation is to obtain informed consent from the patient.  Although not technically required, especially if the case report does not include any identifying information, some journals require informed consent for all case reports before publishing.  The CARE guidelines recommend obtaining informed consent AND the patient's perspective on the treatment/outcome (if possible).  Please consider this as well.  

If required, it is recommended you obtain informed consent before the case report is written.

An example of a case report consent form can be found on the BMJ Case Reports website, which you can access via the MSU library page -  https://lib.msu.edu/medicalwriting_publishing/ .  Go to "Instructions for Authors" and then "Patient Consent" to find the consent form they use.  You can create a similar form to obtain consent from your patient.  If you have identified a journal already, please consult their requirements and determine if they have a specific consent form they would like you to use.

Seek feedback

Once you have written a draft of the case report, you should seek feedback on your writing, from experts in the field if possible, or from those who have written case reports before.   

Selecting a journal

Aside from BMJ Case Reports mentioned above, there are many, many journals out there who publish medical case reports.   Ask your mentor if they have a journal they would like to use.  If you need to select on your own, here are some strategies:

1. Do a PubMed search.  https://pubmed.ncbi.nlm.nih.gov/

   a. Do a search for a topic, disease or other feature of your case report 

   b. When the results appear, on the left side of the page is a limiter for "article type".  Case reports are an article type to which you can limit your search results.  If you don't see that option on the left, click "additional filters". 

   c. Review the case reports that come up and see what journals they are published in.

2. Use JANE -  https://jane.biosemantics.org/

3. Check with specialty societies.  Many specialty societies are affiliated with one or more journal, which can be reviewed for ones that match your needs

4. Search through individual publisher journal lists.  Elsevier publishes many different medical research journals, and they have a journal finder, much like JANE  ( https://journalfinder.elsevier.com/ ).  This is exclusive to Elsevier journals.  There are many other publishers of medical journals for review, including Springer, Dove Press, BMJ, BMC, Wiley, Sage, Nature and many others.

Is it free to publish ?

Be aware that it may not be free to publish your case report.  Many journals charge publication fees. Of note, many open access journals charge author fees of thousands of dollars.  Other journals have smaller page charges (i.e. $60 per page), and still others will publish for free, with an "open access option".  It is best practice to check the journal's Info for Authors section or Author Center to determine what the cost is to publish.  MSU-CHM does NOT have funds to support publication costs, so this is an important step if you do not want to pay out of pocket for publishing

*A more thorough discussion on finding a journal, publication costs, predatory journals and other publication-related issues can be found here:   https://research.chm.msu.edu/students-residents/finding-a-journal

Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D. 2013. The CARE guidelines: Consensus-based clinical case reporting guideline development.  Glob Adv Health Med . 2:38-43. doi:  10.7453/gahmj.2013.008

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. 2017.  CARE guidelines for case reports: explanation and elaboration document . J Clin Epidemiol . 89:218-234. doi: 10.1016/j.jclinepi.2017.04.026 

Guidelines to writing a clinical case report. 2017. Heart Views . 18:104-105. doi:  10.4103/1995-705X.217857

Ortega-Loubon C, Culquichicon C, Correa R. The importance of writing and publishing case reports during medical education. 2017. Cureus. 9:e1964. doi:  10.7759/cureus.1964

Writing and publishing a useful and interesting case report. 2019. BMJ Case Reports.  https://casereports.bmj.com/pages/wp-content/uploads/sites/69/2019/04/How-to-write-a-Case-Report-DIGITAL.pdf

Camm CF. Writing an excellent case report: EHJ Case Reports , Case of the Year 2019. 2020. European Heart Jounrnal. 41:1230-1231.  https://doi.org/10.1093/eurheartj/ehaa176  

*content developed by Mark Trottier, PhD

The George Washington University

Case Reports: Where to Publish Case Reports

What is a Case Report?

"Case reports are solely descriptions of practice, and they can generate ideas, hypotheses, and techniques that can be tested or studied later through controlled experiments. A case report can serve more than one purpose; it might convey experiences to other clinicians while revealing hypotheses for future research, or it might provide material for teaching and learning while assisting in the evolution of theory. It might persuade or motivate other practitioners, or help develop practice guidelines and critical pathways." 

McEwen, I. (2009). Writing case reports: A how-to manual for clinicians. Alexandra, Virginia: The American Physical Therapy Association.

Case Report Author Instructions

The following journals specialize in publishing case reports. Article submission instructions can be viewed by clicking on each title. Many of these titles are open access, meaning the author may have to pay an article processing charge in exchange for having the article immediately readable for all without the need for a subscription. The Article Processing Charge column (accurate as of 1/18/2023, may change over time) shows the cost for authors if their case report is accepted for publication.

BMJ Case Reports

BMJ Case Reports accepts cases in a wide range of clinical and non-clinical specialties, so there are opportunities for students, staff, and faculty in medicine, nursing, and public health. A full list of BMJ Case Reports' specialties can be viewed on their B rowse by Topic  page.

BMJ Case Reports makes it easy to submit cases by providing templates for full cases, "Images in" cases, and global health cases. These templates can be accessed, along with additional guidelines for writing, on the Instructions for Authors page.

GW Institutional Fellowship: 

Himmelfarb Health Sciences Library pays for an institutional fellowship with BMJ Case Reports , which allows GW faculty, staff, and student s to publish case reports without having to pay individual fellowship fees. If you are a GW faculty member, staff member, or student and wish to submit a case to BMJ Case Reports, please contact Ruth Bueter, Serials & Systems Librarian ( [email protected] ) to receive the GW fellowship code.

Information for Non-GW Affiliates:

Non-GW affiliates are encouraged to contact their institutions to learn if their institution pays for an institutional fellowship with BMJ Case Reports. Alternatively, authors may also purchase an individual fellowship with BMJ Case Reports. Individual fellowships allow authors to submit as many cases as they wish during their 12-month fellowship period free of charge.

Other Helpful Research Guides

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Annals of Internal Medicine: Clinical Cases

Clinical Cases on multiple devices

Annals of Internal Medicine: Clinical Cases (AIMCC) is an open access, peer-reviewed journal co-published by the American College of Physicians and the American Heart Association. AIMCC publishes case reports, case series, and image/video cases in subject areas across the spectrum of medicine.

The mission of Annals of Internal Medicine: Clinical Cases is to promote excellence in critical thinking around prevention, diagnosis, and management of challenging clinical situations by disseminating rigorously peer-reviewed reports of real clinical cases encountered by physicians and other medical professionals. 

Access Journal

Additional details and instructions for preparing your manuscript for submission can be found at https://www.acpjournals.org/journal/aimcc/authors .

Case Report: A Beginner’s Guide with Examples

A case report is a descriptive study that documents an unusual clinical phenomenon in a single patient. It describes in details the patient’s history, signs, symptoms, test results, diagnosis, prognosis and treatment. It also contains a short literature review, discusses the importance of the case and how it improves the existing knowledge on the subject.

A similar design involving a group of patients (with the similar problem) is referred to as case series.

Advantages of case reports

Case reports offer, in general a fast, easy and cheap way to report an unusual observation or a rare event in a clinical setting, as these have very small probability of being detected in an experimental study because of limitations on the number of patients that can be included.

These events deserve to be reported since they might provide insights on some exceptions to general rules and theories in the field.

Case reports are great to get first impressions that can generate new hypotheses (e.g. detecting a potential side effect of a drug) or challenge existing ones (e.g. shedding the light on the possibility of a different biological mechanism of a disease).

In many of these cases, additional investigation is needed such as designing large observational studies or randomized experiments or even going back and mining data from previous research looking for evidence for theses hypotheses.

Limitations of case reports

Observing a relationship between an exposure and a disease in a case report does not mean that it is causal in nature.

This is because of:

A case report can have a powerful emotional effect (see examples of case reports below). This can lead to overrate the importance of the evidence provided by such case. In his book Against Empathy: The Case for Rational Compassion , Paul Bloom explains how a powerful story affects our emotions, can distort our judgement and even lead us to make bad moral choices.

When a case report describes a rare event it is important to remember that what we’re reading about is exceptional and most importantly resist generalizations especially because a case report is, by definition, a study where the sample is only 1 patient.

Selection bias is another issue as the cases in case reports are not chosen at random, therefore some members of the population may have a higher probability of being included in the study than others.

So, results from a case report cannot be representative of the entire population.

Because of these limitations, case reports have the lowest level of evidence compared to other study designs as represented in the evidence pyramid below:

Pyramid representing the levels of evidence for each study design

Real-world examples of case reports

Example 1: normal plasma cholesterol in an 88-year-old man who eats 25 eggs a day.

This is the case of an old man with Alzheimer’s disease who has been eating 20-30 eggs every day for almost 15 years. [ Source ]

The man had an LDL-cholesterol level of only 142 mg/dL (3.68 mmol/L) and no significant clinical atherosclerosis (deposition of cholesterol in arterial walls)!

His body adapted by reducing the intestinal absorption of cholesterol, lowering the rate of its synthesis and increasing the rate of its conversion into bile acid.

This is indeed an unusual case of biological adaptation to a major change in dietary intake.

Example 2: Recovery from the passage of an iron bar through the head

This is an interesting case of a construction foreman named Phineas Gage. [ Source ]

In 1848, due to an explosion at work, an iron bar passed through his head destroying a large portion of his brain’s frontal lobe. He survived the event and the injury only affected 1 thing: His personality!

After the accident, Gage became profane, rough and disrespectful to the extent that he was no longer tolerable to people around him. So he lost his job and his family.

His case inspired further research that focused on the relationship between specific parts of the brain and personality.

Further reading

People also looked at

Case report article, case report: clinical and pathological findings in a canine patient with intervertebral disk extrusion resembling progressive myelomalacia.

clinical case report and

A 4-year-old female spayed dog presented to the emergency department for non-ambulatory tetraparesis, which progressed to tetraplegia. Computed tomography (CT) confirmed cervical intervertebral disk extrusion at C5-6 extending to C6-7, and an emergency ventral slot was performed. After the procedure, the patient was placed on mechanical ventilation due to respiratory failure. Repeat assessment upon weaning her ventilatory support suggested the patient's neurological status had declined. Based on her deterioration and suspicion of progressive myelomalacia on magnetic resonance imaging (MRI), she was euthanized. Post-mortem histopathology of the spinal cord supported the presence of progressive myelomalacia. To the author's knowledge, this is the first case report describing a progressive myelomalacia in a canine patient with cervical intervertebral disk extrusion.

Introduction

Cervical intervertebral disk extrusion (IVDE) is generally considered to have a good prognosis, with upwards of 95% improvement following decompressive surgery even when complications occur ( 1 – 3 ). Serious adverse effects related to ventral slot surgery are rare, occurring in only 6.4% of cases in one large study, and are rarely fatal ( 1 ). Progressive myelomalacia is a fatal progressive disease process that is most commonly documented in dogs secondary to an acute intervertebral disk extrusion in the thoracolumbar spine ( 4 , 5 ). It has been previously described as progressive ascending and/or descending hemorrhagic necrosis subsequent to acute IVDE ( 4 , 5 ).

Risk factors for progressive myelomalacia after IVDE have been identified to include the severity of the injury, age, site of disk herniation, and becoming non-ambulatory within 24 h of developing clinical signs ( 6 ). Unfortunately, no treatment is currently available; therefore, patients are humanely euthanized after the onset of progressive myelomalacia or die of respiratory failure ( 7 – 9 ). While some studies have suggested that the odds of developing progressive myelomalacia may be decreased through factors such as faster surgical intervention, performing extensive decompression (in comparison to hemilaminectomy alone), and use of corticosteroids, generally there is no way to predict which dogs will develop the condition before surgery ( 10 , 11 ). The diagnosis of progressive myelomalacia relies on a combination of neurological exam findings, magnetic resonance imaging, cerebral spinal fluid (CSF) analysis, biomarkers, and/or histopathology ( 7 , 12 – 17 ). Several diagnostic biomarkers for IVDE have been previously investigated as outcome predictors ( 14 – 16 ).

Previously reported cases of progressive myelomalacia in veterinary medicine have been only associated with IVDE in the thoracolumbar spinal cord and infrequently reported in patients with fibrocartilaginous embolism ( 13 ). To the author's knowledge, there has been no previous literature on cervical IVDE developing progressive myelomalacia.

Case description

A 4-year-old female spayed, 10 kg non-chondrodystrophic mixed breed dog was presented to the emergency department for acute tetraparesis. The patient was rescued from Mexico in 2018, and other than diet-related allergies and suspected left luxating patella, she was considered to be overall healthy. Clinical signs started 2 days prior to the presentation including soft stool, lethargy, and hyporexia. The patient first presented to her primary care veterinarian for the listed symptoms and development of a stiff pelvic limb gait.

Complete blood cell count, biochemistry, canine pancreas-specific lipase, and urine drug screen were performed when she was evaluated by her primary care veterinarian. Mild thrombocytopenia was reported at 119 × 10 9 /L (range 148–484 × 10 9 /L), and she was noted to be trace positive for tricyclic antidepressants on the urine drug screen. During her visit, hindlimb rigidity developed. She received intravenous (IV) maropitant (1 mg/kg), lactated Ringer's solution (100 ml/h), and was fed 23 ml of activated charcoal. Two hours after presentation, her pelvic limb rigidity was reported to have worsened, and she received a dose of 0.5 mg/kg diazepam IV for a possible seizure prior to arranging for a direct transfer to our specialty hospital.

On presentation to the emergency department, she was tachycardic but otherwise cardiovascularly stable. She was evaluated to be subjectively non-painful (Colorado pain score 0/4). The neurological evaluation demonstrated slightly depressed mentation (suspected secondary to recent administration of diazepam). Cranial nerve examination was unremarkable, but due to aggression, she did not tolerate assessment of physiological nystagmus. She was non-ambulatory tetraplegic with exaggerated spinal reflexes in her pelvic limbs and reduced withdrawals of her thoracic limbs. Pain sensation was present on all four limbs, and spinal pain was not elicited on admission. Her examination was consistent with a C1-T2 myelopathy.

Point of care blood work on admission included packed cell volume/total solids, venous blood gas, electrolytes, metabolites, and co-oximetry, which were all within normal limits. She received isotonic crystalloid IV fluid therapy at 20 ml/h with potassium chloride supplementation at 20 mEq/L and was hospitalized overnight. Blood gas analysis was performed 6 h after admission. Ionized hypercalcemia was identified (1.88 mmol/L, range 1.2–1.5mmol/L) with the remaining parameters within normal limits. Overall, her neurological status was stable overnight, and she was transferred to the neurology service in preparation for further diagnostic workup.

The next morning she became hypothermic (33.3°C) and mildly hypotensive with oscillometric systolic blood pressure at 102 mmHg. Hypoventilation along with poor thoracic movements during inspiration was noted. Hemoglobin oxygen saturation (SPO 2 ) was 99% while breathing room air. Repeat blood gas showed the development of hypercapnia with a partial pressure of carbon dioxide in venous blood of 67.3 mmHg (range 37–45 mmHg), with normal electrolyte parameters. Her neurological examination demonstrated stuporous mentation along with decreased menace bilaterally and poor oculocephalic response. She had absent withdrawal reflexes in her thoracic limbs with withdrawal reflexes intact in her pelvic limbs, and she remained tetraplegic. She had an absent cutaneous trunci reflex, and no spinal pain was elicited. Her nociception was examined and was absent in all four limbs. She received 20 ml of 7.2% hypertonic saline IV, with no significant improvement in mentation. Due to severe hypoventilation and the development of cyanosis, she received alfaxalone for intubation (size 7 endotracheal tube) and manual ventilation. An arterial blood gas was obtained an hour after intubation demonstrating respiratory alkalosis (pH 7.518, range 7.32–7.43; CO 2 28.3 mmHg, range 37–45 mmHg). Given her acute deterioration, the patient underwent CT (Toshiba Aquilion 64; Tokyo; Japan) of her head and cervical spine. No contrast was administered. She received IV fentanyl citrate (2.5 μg/kg) and midazolam (0.2 mg/kg) and was supported with ongoing manual positive pressure ventilation. A measure of 0.5 mm transverse axial CT images of the head and the neck was reconstructed from a volume acquired via a helical scan with an index of 0.5 mm. This CT study demonstrated a severe amount of mineral attenuating extradural material in the left ventral aspect of the vertebral canal extending from the level of mid C5 to C6-7, causing severe rightward dorsal displacement and extradural compression of the spinal cord, suggestive of severe left-sided C5-6 intervertebral disk extrusion ( Figure 1 ). The maximum compression of the spinal cord was noted over the body of C6, and the mineral attenuating extradural material occupied up to 70% of the vertebral canal lumen. The rest of the scan was considered within normal limits. Subsequent to the CT scan, she received one injection of 0.1 mg/kg dexamethasone IV and underwent a ventral slot procedure at C5-6 and C6-7 removing 50–75% of the disk material, as confirmed on postoperative CT. Anesthesia protocol included lidocaine CRI (constant rate infusion, 50 μg/kg/min), ketamine CRI (5 μg/kg/min), fentanyl CRI (15 μg/kg), and isoflurane (minimum alveolar concentration 0.75–1%). Postoperative analgesia was provided with fentanyl (3 μg/kg/h), ketamine (2.5 μg/kg/min), and lidocaine (25 mg/kg/min). On recovery, persistent hypoventilation with minimal chest excursion was noted. Arterial blood gas showed the development of hypercapnia at 70.4 mmHg. The patient could not be safely extubated given respiratory failure and hypercapnia; therefore, mechanical ventilation was initiated (Dräger, Evita 4 edition; Mississauga, ON) on mandatory minute ventilation mode (Fraction of inspired oxygen 0.3; tidal volume 9 ml/kg; respiratory rate 36/min; inspiratory to expiratory ratio 1:1.6; positive end-expiratory pressure 5 cm H 2 O).

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Figure 1 . Severe left-sided C5-6 intervertebral disk extrusion. Sagittal (A) and transverse (B) CT images of the cervical spine illustrate severe mineral-attenuating extradural material in the left ventral aspect of the vertebral canal centered at C5-6 extending cranially to mid-C5 and caudally to C6-7 and subsequent extradural spinal cord compression. The dotted line (A) denotes the axis by which the transverse CT image (B) is reconstructed.

Total intravenous anesthesia (TIVA) was achieved using fentanyl (8–10 μg/kg/h), midazolam (0.2 mg/kg/h), ketamine (2.5–5 μg/kg/min), and propofol (60–90 μg/kg/min) CRI. The patient developed mild systolic hypotension (95 mmHg) 4 h after initiating mechanical ventilation and was supported with a dopamine CRI (5–7 μg/kg/min). Oliguria was noted (urine output 0.87–1.21 ml/kg/h).

The owners elected to attempt to wean her off the mechanical ventilator after 24 h of respiratory support, to re-evaluate whether she had regained her ventilator drive. Upon weaning her TIVA, the patient began masticating her endotracheal tube. She was extubated but was promptly re-intubated, as she became cyanotic. No spontaneous breathing or abdominal excursions were witnessed post-extubation. Upon repeat neurological evaluation, she had persistent absent nociception on all four limbs and tails. She was mentally obtunded despite discontinuing most of her TIVA except for low-dose ketamine CRI at 2 μg/kg/min.

The patient subsequently underwent an MRI (Esaote MR Vet Grande 0.25 tesla; Geneva; Italy) of the neck. Transverse and sagittal MRI images of the neck were acquired in T2-weighted (T2W), T1-weighted (T1W), T2W * , and fluid-attenuated inversion recovery (FLAIR) sequences pre- and post-gadolinium administration. This study demonstrated severe diffusely and heterogeneously increased intramedullary T2W signal intensity within the spinal cord parenchyma centered over the gray matter extending from the level of C1-2 caudally beyond the caudal limit of the cervical spine study at the level of T2 (approximately over 18 cm, nine times the C2 vertebral length). This abnormal cervical intramedullary hyperintensity caused near complete obliteration of the gray matter to white matter distinction and central canal conspicuity. Within the spinal cord, gray matter extending from the level of C2-3 through C4, there was moderate ill-defined and heterogeneous intraparenchymal contrast enhancement. There was complete and circumferential attenuation of the subarachnoid space extending from the level of mid-C2 caudally beyond the caudal limit of the cervical spine study (level of T2), consistent with severe spinal cord swelling. There was no evidence of a T2W * susceptibility artifact identified in the study. These MRI findings were consistent with imaging findings associated with progressive myelomalacia in the thoracolumbar spine, as well as ischemic necrosis ( Figure 2 ). At this point, given the primary suspicion of progressive myelomalacia along with the grave prognosis, the owners opted for euthanasia. A measure of 11 ml of IV pentobarbital was administered, and cardiac arrest was confirmed with auscultation. The brain and cervical spinal cord to the level of T1 were submitted for histopathology interpretation.

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Figure 2 . Ascending/descending cervical myelomalacia. Sagittal (A) and transverse (B) T2W images show severe diffusely and heterogeneously increased intramedullary T2W signal intensity within the cervical spinal cord centered over the gray matter. Notably, the recent C5-6 and C6-7 hemilaminectomy sites characterized by ostectomy and local soft tissue thickening and increased signal intensity (A, B) . Sagittal HASTE image (C) shows complete and circumferential attenuation of the cervical subarachnoid space from the level of mid-C2 beyond the caudal limit of the study (level of T2), suggestive of extensive spinal cord swelling. Pre-contrast sagittal T1W (D) , post-contrast sagittal T1W (E) , and post-contrast transverse T1W (F) images demonstrate ill-defined and heterogeneous intraparenchymal contrast enhancement centered over the gray matter from the level of C2-3 through mid C4. The dotted line (E) denotes the axis by which the post-contrast T1W image is acquired.

The histopathology of her spine showed changes proximal to IVDE sites and was supportive of hemorrhagic progressive myelomalacia. The spinal cord had a loss of distinction between the white and gray matter. This was attributed to acute necrosis, multifocal to coalescing hemorrhage, loss of tissue with occasional cavitation, and mild neutrophilic inflammation ( Figure 3 ). Within and around areas of necrosis, multiple thin-walled vessels were lined with decreased numbers of reactive endothelial cells and had fibrinoid vascular necrosis. In some less severely affected spinal sections, the residual white matter was often comprised of multiple swollen axon sheaths containing swollen hypereosinophilic and glassy axons (spheroids) and rare macrophages (digestion chambers) or was empty from axonal dropout ( Figure 4 ). Histopathology of the brain had mild perivascular cuffs of lymphocytes, plasma cells, and rare macrophages in the meninges and choroid plexus consistent with mild inflammation.

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Figure 3 . Photomicrograph of the cervical spinal cord with multifocal hemorrhage, severe tissue loss, cavitation, and lack of distinction between the gray and white matter. H&E stain.

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Figure 4 . Higher magnification of microscopic changes in the cervical spinal cord. Within the gray matter (A) , there is neuropil rarefaction and vacuolation with low numbers of residual neurons being angular and hypereosinophilic with no nucleus (arrow, necrosis). Within the white matter (B) , there is swelling and hypereosinophilia of axons and marked distension of myelin sheaths, some of which lack axons (axonal loss). In both the gray and white matter, there is multifocal hemorrhage, scattered infiltration by low numbers of neutrophils, and multiple vessel walls are partial to fully obscured by bright eosinophilic fibrillary material (arrow head, fibrinoid vascular necrosis). H&E stain.

Progressive myelomalacia is well documented in dogs secondary to severe thoracolumbar IVDE. However, it has not previously been reported secondary to cervical disk disease. Although the basic physiology of disk extrusions in the cervical and thoracolumbar spine is similar, there are several clinical and histopathological differences. The pathophysiology of progressive myelomalacia is not well understood, although impairment of vascular perfusion secondary to mechanical impact from IVDE is suspected to contribute a significant role following ischemia and accumulation of free radicals ( 6 , 8 , 12 ). One study comparing the epidural pathology of material removed during spinal decompressive surgery found that cervical IVDE was associated with a less intense inflammatory reaction, which may help explain why this complication has not been reported in the cervical disk ( 18 ).

Progressive myelomalacia most commonly affects dogs with absent deep pain perception. Well-known risk factors for its development in the thoracolumbar spine include the severity of neurology signs (i.e., becoming paraplegic with absent nociception) and a rapid progression of clinical signs ( 6 ). This patient had both of these risk factors, with loss of mobility within 24 h, and being tetraplegic without pain sensation; thus, cervical IVDE may share some of the same risk factors.

Since patients who lose pain sensation due to cervical myelopathies are at risk of respiratory musculature and diaphragm paralysis, patients are likely to die (or be euthanized) before imaging and surgery. This means that patients with severe cervical IVDE are likely euthanized before there has been time to develop progressive myelomalacia, unlike in thoracolumbar patients who may be cardiopulmonary stable despite being paralyzed. Patients who are tetraplegic are also likely to require ventilation, thus adding significant financial burden, and are subsequently more likely to be euthanized without treatment. A previous retrospective study reported 4.9% of canine patients with cervical lesions post-ventral slot to require mechanical ventilatory support secondary to hypoventilation ( 19 ). Although the study reported a good prognosis after carrying out ventilatory support, the presence of progressive myelomalacia would significantly change our patients' outcomes, making it important to recognize. Furthermore, the requirement of general anesthesia for mechanical ventilation would likely prevent complete neurological evaluation, thus masking early signs of progressive myelomalacia without weaning the patient off of TIVA.

The diagnosis of progressive myelomalacia can be difficult to confirm antemortem, but clinical suspicion can be supported by MRI, CSF cytology, and/or biomarkers. MRI changes in thoracolumbar IVDE cases that have been associated with the development of progressive myelomalacia include the length of attenuation of the half-Fourier single-shot turbo spin-echo (HASTE) signal and intramedullary T2 hyperintensity, both as a ratio to L2 length ( 7 ). In this case report, the extensive HASTE attenuation and T2 intramedullary hyperintensity both extended at least six intervertebral disk spaces and extended past the caudal end of the imaging study. An extensive T2 intramedullary hyperintensity and/or significant HASTE attenuation should both raise the index of suspicion for progressive myelomalacia in dogs with IVDE in the cervical spine. CSF findings including neutrophilic pleocytosis, high total nucleated cell count, and high protein concentration may be supportive of progressive myelomalacia, although they are non-specific and have been detected in CSF samples, with acute IVDE in patients that make a good recovery ( 12 , 20 ). The utility of biomarkers remains limited to research settings and is not widely available in commercial laboratories, although recent literature investigating glial fibrillary acidic protein (GFAP) and serum phosphorylated neurofilament-heavy chain (pNF-H) has shown promising results in detecting progressive myelomalacia in thoracolumbar IVDE ( 14 – 16 ). Given the limitations surrounding antemortem progressive myelomalacia diagnosis and the inability to monitor a ventilated/anesthetized patient's neurological status, detecting progressive myelomalacia secondary to cervical IVDE poses a significant challenge. While MRI is the most useful diagnostic test at this time, further evaluation of biomarkers may be useful in guiding the clinical outcome of our patients and allow clients to make a well-informed decision in terms of whether to proceed with surgery and mechanical ventilation, respectively. The limitations of this case report include the single sample size given the novelty of our finding and the fact the patient's thoracolumbar spinal cord was not imaged or submitted for histopathology review to determine the extent of progressive myelomalacia. CSF samples should also be considered in the future for cytological interpretation and to look into GFP and pNF-H levels.

In conclusion, this case report highlights the first-ever case of cervical IVDE resembling the progression of myelomalacia and should be discussed as a possible outcome/complication in patients undergoing a ventral slot.

Data availability statement

The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author.

Ethics statement

Ethical review and approval was not required for the study on animals in accordance with the local legislation and institutional requirements. Written informed consent was obtained from the owners for the participation of their animals in this study.

Author contributions

AL managed mechanical ventilation and created and finalized the manuscript. RL performed the neurological examination and ventral slot surgery and assisted in multiple draft revisions. CB assisted in multiple draft revisions. MV interpreted the results of histopathology and provided histopathology images. JP interpreted the findings of diagnostic imaging and provided imaging figures. All authors contributed to the manuscript and approved the submitted version of the manuscript.

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Publisher's note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

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Keywords: myelomalacia, IVDE, cervical disc extrusions, ventral slot, mechanical ventilation

Citation: Lin A, Lampe R, Bandt C, Vieson M and Park JY (2023) Case report: Clinical and pathological findings in a canine patient with intervertebral disk extrusion resembling progressive myelomalacia. Front. Vet. Sci. 10:1122566. doi: 10.3389/fvets.2023.1122566

Received: 13 December 2022; Accepted: 22 February 2023; Published: 16 March 2023.

Reviewed by:

Copyright © 2023 Lin, Lampe, Bandt, Vieson and Park. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Rachel Lampe, rvasky@gmail.com

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CARE Case Report Guidelines

  Writing a Case Report

Introduction.

Writing a case report accurately and transparently is not easy. We provide online training in writing case reports at  Scientific Writing in Health and Medicine (SWIHM) which includes access to CARE-writer , an online app that can be used to write case reports or case report preprints.

Tips that may help:

Know that it is easier to write the sections of a case report in a different sequence than the order in which the sections appear in a published case report.

First : Select a case and identify the message you wish to communicate, as well as your audience. Is this case report about an outcome, a diagnostic assessment, an intervention, a new or rare disease, or something else?

Second : Gather the necessary information to accurately write WHAT happened as a timeline and as a narrative. Create the timeline of your case report—a visual summary of WHAT happened in the case report (see examples of timelines that follow the CARE guidelines) before writing the narrative section.

Third : Complete the remainder of the case report using specialty-specific information if necessary with appropriate scientific references and explanations. Support WHY an outcome occurred with reference to the scientific and historic literature whenever possible. Write the abstract last.

De-Identification : Patient information must be de-identified and informed consent obtained prior to submitting your case report to a journal.

Writing Sequence

Part 1 — working title, what happened: timeline and narrative.

Develop a descriptive and succinct working title that describes the phenomenon of greatest interest (symptom, diagnostic test, diagnosis, intervention, outcome).

WHAT happened. Gather the clinical information associated with patient visits in this this case report to create a timeline as a figure or table. The timeline is  a chronological summary of the visits that make up the episodes of care from this case report.

Narrative of the episode of care (including tables and figures as needed).

The presenting concerns (chief complaints) and relevant demographic information .

Clinical findings: describe the relevant past medical history, pertinent co-morbidities, and important physical examination (PE) findings.

Diagnostic assessments: discuss diagnostic testing and results, a differential diagnosis, and the diagnosis.

Therapeutic interventions: describe the types of intervention (pharmacologic, surgical, preventive, lifestyle) and how the interventions were administered (dosage, strength, duration, and frequency). Tables or figures may be useful.

Follow-up and outcomes: describe the clinical course of the episode of care during follow-up visits including (1) intervention modification, interruption, or discontinuation; (2) intervention adherence and how this was assessed; and (3) adverse effects or unanticipated events. Regular patient report outcome measurement surveys such as PROMIS® may be helpful.

Part 2 — WHY it might have happened: Introduction, Discussion, Conclusion

The introduction should briefly summarize why this case report is important and cite the most recent CARE article ( Riley DS, Barber MS, Kienle GS, AronsonJK, et al. CARE guidelines for case reports: explanation and elaboration document. JClinEpi 2017 Sep;89:218-235. doi: 10.1016/jclinepi.2017.04.026 ).

WHY it might have happened. The discussion describes case management, including strengths and limitations with scientific references.

The conclusion, usually one paragraph, offers the most important findings from the case without references.

Part 3 — Abstract, Keywords, References, Acknowledgements, and Informed Consent

Abstract. Briefly summarize in a structured or unstructured format the relevant information without citations. Do this after writing the case report. Information should include: (1) Background, (2) Key points from the case; and (3) Main lessons to be learned from this case report.

Keywords. Provide 2 to 5 keywords that will identify important topics covered by this case report.

References. Include appropriately chosen references from the peer-reviewed scientific literature.

Acknowledgements. A short acknowledgements section should mention funding support or conflicts of interest, if applicable.

Informed Consent and Patient Perspective. The patient should provide informed consent (including a patient perspective) and the author should provide this information if requested. Some journals have consent forms which must be used regardless of informed consents you have obtained. Rarely, additional approval (e.g., IRB or ethics commission) may be needed. The patient should share their perspective on the treatment(s) they received in one to two paragraphs. It is often best to ask for informed consent and the patient’s perspective before you begin writing your case report.

Appendices (If indicated).

Submission to a scientific journal

Follow author guidelines and journal submission requirements when writing and submitting your case report to a scientific journal . You may wish to contact the journal before submitting your manuscript. (Download a partial list of  journals  that accept case reports.) Journals that do not explicitly accept case reports may publish case reports as components of other articles. Online training in writing case reports is available from  Scientific Writing in Health and Medicine (SWIHM) .

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Writing a case report in 10 steps

Victoria Stokes and Caroline Fertleman explain how to turn an interesting case or unusual presentation into an educational report

It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.

It usually falls to the junior to write up the case, so here are a few simple tips to get you started.

First steps

Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.

Getting consent

Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.

Information gathering

Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.

Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.

Coming up with a title

Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.

Background research

Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.

How your case is different

Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.

Finish by explaining why your case report adds to the medical literature and highlight any learning points.

Writing an abstract

The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.

Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!

Competing interests: We have read and understood BMJ’s policy on declaration of interests and declare that we have no competing interests.

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Basics of case report form designing in clinical research

Affiliations.

Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

Keywords: Case report form; case report form design; completion guidelines; electronic case report form; standard templates.

Conflict of interest statement

Conflict of Interest: None declared.

A sample case report form…

A sample case report form (CRF) page. An adverse event page of CRF…

Example of a poorly designed…

Example of a poorly designed case report form

Illustrating the missing indicator question

Coding on the case report…

Coding on the case report form module

Sample page of case report…

Sample page of case report form completion guideline

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Journal of Medical Case Reports welcomes well-described reports of cases that include the following:

Case reports submitted to Journal of Medical Case Reports should make a contribution to medical knowledge and must have educational value or highlight the need for a change in clinical practice or diagnostic/prognostic approaches. The journal will not consider case reports describing preventive or therapeutic interventions, as these generally require stronger evidence.

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For case reports, Journal of Medical Case Reports requires authors to follow the CARE guidelines . The CARE checklist should be provided as an additional files. Submissions received without these elements will be returned to the authors as incomplete.

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Example reference style:

Article within a journal

Smith JJ. The world of science. Am J Sci. 1999;36:234-5.

Article within a journal (no page numbers)

Rohrmann S, Overvad K, Bueno-de-Mesquita HB, Jakobsen MU, Egeberg R, Tjønneland A, et al. Meat consumption and mortality - results from the European Prospective Investigation into Cancer and Nutrition. BMC Medicine. 2013;11:63.

Article within a journal by DOI

Slifka MK, Whitton JL. Clinical implications of dysregulated cytokine production. Dig J Mol Med. 2000; doi:10.1007/s801090000086.

Article within a journal supplement

Frumin AM, Nussbaum J, Esposito M. Functional asplenia: demonstration of splenic activity by bone marrow scan. Blood 1979;59 Suppl 1:26-32.

Book chapter, or an article within a book

Wyllie AH, Kerr JFR, Currie AR. Cell death: the significance of apoptosis. In: Bourne GH, Danielli JF, Jeon KW, editors. International review of cytology. London: Academic; 1980. p. 251-306.

OnlineFirst chapter in a series (without a volume designation but with a DOI)

Saito Y, Hyuga H. Rate equation approaches to amplification of enantiomeric excess and chiral symmetry breaking. Top Curr Chem. 2007. doi:10.1007/128_2006_108.

Complete book, authored

Blenkinsopp A, Paxton P. Symptoms in the pharmacy: a guide to the management of common illness. 3rd ed. Oxford: Blackwell Science; 1998.

Online document

Doe J. Title of subordinate document. In: The dictionary of substances and their effects. Royal Society of Chemistry. 1999. http://www.rsc.org/dose/title of subordinate document. Accessed 15 Jan 1999.

Online database

Healthwise Knowledgebase. US Pharmacopeia, Rockville. 1998. http://www.healthwise.org. Accessed 21 Sept 1998.

Supplementary material/private homepage

Doe J. Title of supplementary material. 2000. http://www.privatehomepage.com. Accessed 22 Feb 2000.

University site

Doe, J: Title of preprint. http://www.uni-heidelberg.de/mydata.html (1999). Accessed 25 Dec 1999.

Doe, J: Trivial HTTP, RFC2169. ftp://ftp.isi.edu/in-notes/rfc2169.txt (1999). Accessed 12 Nov 1999.

Organization site

ISSN International Centre: The ISSN register. http://www.issn.org (2006). Accessed 20 Feb 2007.

Dataset with persistent identifier

Zheng L-Y, Guo X-S, He B, Sun L-J, Peng Y, Dong S-S, et al. Genome data from sweet and grain sorghum (Sorghum bicolor). GigaScience Database. 2011. http://dx.doi.org/10.5524/100012 .

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Annual Journal Metrics

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Usage  4,322,849 Downloads (2021) 3,006 Altmetric mentions (2021)

New Content Item

Journal of Medical Case Reports

ISSN: 1752-1947

Formplus Blog

Case report forms are one of the most important data instruments used for clinical researches and medical examinations. When conducting clinical trials, the researcher needs to record even the smallest of observations as they happen. A case report form is designed for this purpose.

In a case report form, you can track the unique changes of each research subject as the clinical trial progresses. This article will discuss different case report forms and show you how to create this form from scratch using Formplus. 

What is a Case Report Form? 

A case report form is an essential tool for clinical research, although it has been extended for use in other areas of medicine. Primarily, it is a record of all symptoms, signs, diagnosis, treatment, follow-up, observations, changes, and other important information from each research subject during clinical trials. The data gathered via case report forms (CRFs) are analyzed to arrive at the research results and draw valid conclusions. 

It is one of the most effective ways to systematically collect and store all the information from research for use. For example, during clinical trials to test the efficacy of a drug, you need to collect data at every stage of the process to answer all your research questions. 

In a broader sense, a case study is a questionnaire used for collecting data from patients in the course of any medical procedure, including diagnoses and treatments. It provides valid information that makes up the patient’s medical history which can be used for medical research.

Importance of a Case Report Form  

Types of Case Report Form  

Paper case report form.

A paper case report form is the traditional method of collecting data during clinical trials. It is the use of paper questionnaires and paper-based systems to gather detailed information from research subjects as per the study protocol. This data is extracted, organized and analyzed to arrive at valid research outcomes. 

Advantages of Paper Case Report Forms

Disadvantages of Paper Case Report Forms

Electronic Case Report Form

An electronic case report form is an online questionnaire used for data collection in medical studies and clinical trials. This method of data collection in medical research was introduced in the late 1990s following the shortcomings of paper forms. Electronic case report forms support more accurate data collection and faster data processing. 

Advantages of Electronic Case Report Forms

Disadvantage of Electronic Case Report Forms

Case Report Form Template Examples  

Use this case report form from Formplus to collect specific data from patients as part of the standard medical research procedure. With this survey, you can gather all the important information you need from the patients at once, and then go ahead with a proper diagnosis.

The Formplus health care proxy form serves as a legal document for individuals who want to empower others to make decisions for them when they are sick or unavailable. With this form, individuals can formally select their health care providers to act on their behalf when the need arises. You can also edit this proxy form to suit unique needs in the form builder.

With the Formplus medical information form, patients can easily keep track of their health status by having all the information they need in one place. This form collects relevant information about the individual’s medical history, bio-data and doctor’s contact information in case of emergency. 

Are you conducting any type of clinical research? This form will help you to seamlessly gather and analyze all the data you need for your systematic investigation. While this is a template, you can always edit it to suit your needs using the different features in our drag-and-drop form builder.

As you conduct physical examination of your patient, you can put all the information you gather in a Formplus physical examination form. This form allows you to collect data like the gender, weight, blood pressure and height of the patient. Our physical examination form makes it easy to document the patient’s health history. 

To make it easier for patients to check for symptoms and monitor their health, you can edit this self-report form and embed it on your hospital’s website for easy access. With this form, health officials and medical practitioners can keep track of and monitor the health status of their patients and employees if the need arises.

Why Use Formplus to Create a Case Report Form? 

A case report form can be administered as a paper form or an online form; that is, ECRF. Data collection platforms like Formplus allow you to create secure online CRFs with data validation and data export features. You can also generate reports from the data in the form analytics dashboard.

How to Create Electronic Case Report Forms With Formplus

1. Create a free Formplus account on www.formpl.us . Then log into your new account to view your dashboard. 

clinical case report and

2. Click on the “create new form” button to access the Formplus dashboard. 

clinical case report and

3. In the Formplus dashboard, you can add multiple fields to the online case report form. Drag and drop the fields you want from the builder’s fields section into your form. 

clinical case report and

4. Edit the form fields to include your question, options and other information. Here, you can also set the fields as required or read-only. 

5. Save all the changes you’ve made to access the form customization section. Use the different features and options to tweak the look and feel of your case report form. 

6. Copy the form link and share with respondents. 

clinical case report and

Conclusion  

In this article, we have looked at different types and use-cases for case report forms. As a researcher, it is best to use electronic CRFs that reduce your risk of data losses and help you record information faster. 

When you sign up for a Formplus account, you can access different case report form templates to help your research. From medical information surveys to health care proxy forms, you are sure to find a template that suits your research purpose. In the form builder, you can edit these templates to align them with your research goals. 

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Create case report forms and monitor your examinations with Formplus for free.

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Mirror Therapy Case Report

Mirror therapy case report presentation, free google slides theme and powerpoint template.

Mirror therapy is a form of treatment involving the use of a mirror to manage, for example, phantom limb pain. Essentially, it works by providing a reflective image that tricks the brain into thinking that the patient still has both limbs intact. In effect, it can help rewire the neural pathways in the brain and reduce physical sensations of pain. Sounds interesting, so we're more than ready to hear the report of a clinical case from you. In fact, you can use this template, whose backgrounds mimic reflections, to present that report in a visual manner. We have a variety of editable layouts so that you can show things like treatment, patient medical history, and evolution of the case.

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Novotech Publishes Multi-Specific Monoclonal Antibodies Global Clinical Trial Landscape Report

Novotech team at bio europe to share benefits of expanded global operations, experts share insights on evolving global vaccine landscape including mrna trends, 급성 골수성 백혈병(aml) - 글로벌 임상시험 개요 - 아시아 태평양 지역을 중심으로., 류마티스 관절염 - 글로벌 임상시험 개요 - 아시아 태평양 지역을 중심으로, 알츠하이머- 임상시험 개요, keeping pace with the evolving global landscape in vaccine development, 암 치료의 차세대 혁신, 생명공학 분야 개요: 시장 동향, 우선 순위, 예측 및 미국 식품의약국(fda)의 승인 과정, 제1상 임상시험으로 기업은 호주에서 건강한 자원자 연구를 통해 주력 제품에 대한 2차 적응증을 확보할 수 있었습니다..

What are the benefits of a well-designed, robust preclinical development plan?

다중 특이적 단일클론 항체 - 글로벌 임상시험 전망 - 아시아 태평양 지역을 중심으로

CNS 솔루션 > 초기 단계 CRO 서비스

생물분석 실험실 서비스, 종양학 cro 서비스, cns의 고유 gmo 솔루션, 간질환 cro 서비스, 감염성 질환 및 백신 cro 서비스, 희귀질환 cro 서비스.

Singapore - Novotech, the leading Asia Pacific centred biotech CRO has published

Singapore - Novotech, the leading Asia Pacific centred biotech CRO will be at BI

Novotech, the leading Asia Pacific centred biotech CRO with extensive experience in vaccine trial

2020년 아시아 태평양 지역에서 발생한 AML 사례는 약 4만 6천 건이며, 중국, 인도, 일본이 전 세계 사례의 40%를 차지하고 있습니다.

인도와 중국은 각각 1,000만 건과 500만 건으로 류마티스 관절염의 유병률이 가장 높은 것으로 나타났으며, 동아시아는 연령 표준화 발생률과 유병률이 가장 빠르게 증가하고 있습니다.

알츠하이머병은 치매를 유발하는 가장 흔한 원인이고 아시아 태평양 지역이 2030년까지 전 세계 치매 사례의 절반 이상에 기여할 것으로 예상됩니다.

Kari Abitbol: Hi, everyone.

Dr. Peter Paul Yu:

Hi, everyone. Arsalan Arif here with Endpoints News.

배경  미국의 초기 임상 단계 생명공학 기업인 DiaMedica는 CRO 서비스를 제공받고 호주의 유리한 초기 단계 연구 환경과 신속한 규제 프로세스를 활용하기 위해 노보텍의 도움을 받았습니다.

Felicity Grzemski PhD DABT

아시아 태평양 지역은 2018년 이후 다중 특이적 단일클론 항체 임상시험과 관련하여 가장 빠르게 성장하는 지역으로, 전 세계 임상시험의 40% 이상을 차지하며 이는 미국과 유럽보다 상대적으로 높은 수치입니다.

Covid-19 공지 중요 업데이트

다음과 관련된 콘텐츠 찾기:.

노보텍의 의료 및 규제 컨설팅 팀은 모든 범위의 전임상, 규제 업무 지원, 의료 및 부작용모니터링 컨설팅 서비스를 제공합니다.

노보텍은 오랜 경험, 국가 내 지식 및 실제 빅 데이터를 활용하여 연구와 관련하여 성과가 가장 좋은 임상시험기관 및 시험자를 발굴 및 추천합니다. 

호주는 단순하고 신속한 규제 체계 및 수익성이 좋은 R&D 현금 환급 시스템으로 인해 초기 단계 임상시험에서 선호되는 지역입니다.

노보텍의 간소화된 통합 임상시험 서비스는 임상 개발의 모든 단계 전반에서 심층적인 산업 및 치료 분야 전문성을 갖춘 전문가 팀이 제공합니다.

통계적 계획 수립, 분석 및 보고 등 임상시험 서비스에서 적시에 정확한 고품질 생물 통계 를 제공합니다.

가상 임상시험은 어떻게 기존 시험에 비해 시험대상자 유지와 비용상 이점을 제공하는가?

실사용데이터를 이용한 환자 모집 및 의약품개발과정 가속화

당사의 생체시료 분석 서비스는 분자 개발의 모든 단계에서 고객을 지원합니다.

우리의 사명:모든 사람에게 성장의 기회를 창조한다.

아시아 태평양 지역에서의 종양학 현황 생명공학 기업들은 참가자 모집 및 유지, 매우 긴 기간 및 상대적으로 높은 비용과 관련한 문제 증가에 직면하고 있습니다. 

당사의 재능 있고 풍부한 경험을 갖춘 팀은 모든 임상시험 단계(제0상, 제I상, 제II상, 제III상)와

목표를 염두에 둔 임상 여정의 시작 – 의약품 개발 계획의 중요성 의약품 등록에 필요한 복잡한 프로세스를 명확히 하려면 처음부터 지능형 임상 개발 프로그램 경로를 수립하는 것이 매우 중요합니다.

CNS는 호주의 OGTR(Gene Technology Regulator) 사무소로부터 승인을 획득한 호주 최초의 민간 소유 상업 기관인 생물안전위원회(IBC)를 시작했습니다. IBC에 접근할 수 있어 조직은 호주에서 유전자 변형 생물체(GMO) 시험 제품을 사용하여 연구를 수행하기 위한 인증을 획득하고 유지할 수 있습니다.

아시아 태평양 지역의 간질환 현황 생명공학 회사는 한국, 중국과 같은 아시아 태평양 지역의 위치를 고려하여 치료 경험이 없는 방대한 환자 모집단에 접근하여 보다 낮은 비용으로 임상시험을 가속화합니다.

감염성 질환 및 백신 CRO 서비스 제공 많은 생명공학 기업들은 간염(B형 간염, C형 간염), HIV 및 인플루엔자의 높은 발생률로 인해 아시아 태평양 지역에서 감염성 질환 및 백신의 임상시험 진행을 모색하고 있습니다.

아시아 태평양 지역에서의 희귀질환 현황 희귀질환은 약 8,000가지가 있을 수 있으며 전 세계 총 인구의 6% ~ 8%가 질병을 앓고 있습니다. EU 및 북미에서는 약 3,000만명 그리고 아시아 지역에서는 4,500만명 이상(중국의 경우 1,000만명)이 희귀질환을 앓고 있는 것으로 추산됩니다.

여러 생명공학 기업들은 간소화된 규제 체계 및 43.5%의 R&D 현금 환급 체계의 이점을 활용하기 위해 호주에서 초기 단계 임상시험을 진행합니다. 그리고 생명공학 기업들은 한국, 태국 및 중국 등 아시아 지역에서 대규모 치료 무경험 환자를 활용하여 후기 임상시험 단계를 진행합니다.

Our workplace culture reflects the passion of our people, and we will support you to develop and achieve at all stages of your career and life.

Novotech is the leading asia-pacific contract research organisation (cro) providing clinical development services across all clinical trial phases and therapeutic areas and global product development and regulatory affairs consulting through our in-house biodesk team., there are many reasons people love working at novotech, but when you join it will be our open, inclusive, and flexible work culture that you notice first., we are committed to providing ongoing professional development training, a competitive bonus structure, a supportive work environment, variety in their role, and the opportunity for career development and advancement across all areas of the organisation to our employees., we are committed to hiring ambitious and ethical professionals genuinely excited to be a part of the dynamic life sciences industry and who relish a challenge., search novotech, what is a case report form.

A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting. It is the main tool that Investigators use to collect information from clinical trial participants which is why there needs to be one completed CRF for each participant. 

The Sponsor-Investigator puts together the CRF Completion Guidelines and ensures that the site staff have received training before collecting, entering and reviewing data. 

All users are given a unique username and password to gain access to the CRF and the trial database. The Principal Investigator assigns permissions to each user which includes ‘data entry’ or ‘data view only’. Permission to access the data must be in accordance with the consent given by participants. 

The CRF should be completed soon after each participant's initial visit which ensures that information can be followed up on while the participant is easily accessible. 

All the data should be collected with users in mind and the requirements set out by regulatory agencies. The questions should be as clear and concise as possible to prevent any duplication. 

Relationship to Protocol 

The clinical trial protocol determines what kind of data should be collected - all the information found in the CRF should be specified by the protocol. Any data that will not be analyzed shouldn’t be included in the CRF. 

Elements of a CRF 

A Case Report Form consists of three main parts: a header, a safety-related module and an efficacy-related module. 

The header must contain key identification information including a study number, a site number and a participant ID number. 

Safety Modules 

Consists of the key safety analysis requirements found in the protocol which includes demographic information, adverse events, medical history, physical exam, deaths, drop-outs and eligibility confirmation. 

Efficacy Modules 

The protocol outlines the elements which are required in the efficacy modules. The elements of this module include the key efficacy endpoints of trial, additional tests to measure efficacy, how lesions will be measured and requited diagnostics. 

CRF Development Process 

The development of the CRF begins as soon as the development process begins. The responsibility of the design varies between Clinical Research Organizations, Clinical Research Associates, Data Managers, Research Nurses and Database Development. 

The only data collected for the CRF should be what is required by the protocol- nothing more, nothing less. An interdisciplinary review is needed for every CRF: 

Properly and Poorly Designed CRFs 

An effective CRF allows for components to be reused across the clinical trial, saving time and money. 

A poorly designed CRF is one that is missing requested data or has unnecessary information meaning that it requires edits and modifications throughout the clinical trial. 

CRF Completion 

For a CRF to be completed, it needs to have: 

The data needs to be collected from the relevant source documentation (medical records) and entered into the CRFs by study personnel. Only designated members of the clinical trial staff are allowed to record or edit data in the CRFs. 

Important Tips for Completion 

Electronic CRF (eCRF) 

Confidentiality and Security 

To protect confidential participant and clinical trial data, eCRFs must be stored on secure servers with restricted access, while paper CRFs must be stored in a secure location. Regular backups and archiving for future copies must be utilized. 

Freezing the Database 

Once the data has been finalized, it is necessary to lock the database which protects the integrity of the collected data and prevents any unauthorized edits from being made. 

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  6. MESIODENS ¬ Dientes Supernumerarios / Cirugía // Dr. Omar Noriega Gtz. / www.midentista.tv

COMMENTS

  1. Clinical Case Reports

    Clinical Case Reports welcomes case reports, clinical images, and procedural videos from all areas of Medicine, Nursing, Dentistry, Psychology, Medical Ethics, Social Work and Veterinary Science. Clinical Case Reports aims to publish cases which illustrate the use of important systematic reviews.

  2. How to write a medical case report

    A case report is the first line of medical evidence, and over time has become an important medium for sharing new findings (box 1). High quality case reports successfully bring together the various domains of medicine such as physiology, pathology, and anatomy.

  3. Writing A Case Report

    It is important that you recognize what is unique or interesting about your case, and this must be described clearly in the case report. Case reports generally take the format of: 1. Background 2. Case presentation 3. Observations and investigation 4. Diagnosis 5. Treatment 6. Outcome 7. Discussion Does a case report require IRB approval?

  4. Case Reports: Where to Publish Case Reports

    BMJ Case Reports accepts cases in a wide range of clinical and non-clinical specialties, so there are opportunities for students, staff, and faculty in medicine, nursing, and public health. A full list of BMJ Case Reports' specialties can be viewed on their B rowse by Topic page.

  5. SAGE Open Medical Case Reports: SAGE Journals

    Open Access Case report First published Mar 11, 2023 A rare case report of uterine didelphys, in which one uterus carried a pregnancy while the other prolapsed, with a successful pregnancy outcome resulting in an alive-term delivery Amanuel Admasu Yayna Adane Ayza Wokil Wolde Dana Abinet Desalegn [...] View all Open Access Case report

  6. Guideline on writing a case report

    Case report, as a research design, describes important scientific observations that are encountered in a clinical setting to expand our knowledge base. Preparing a case report is far easier than conducting any other elaborative research design. Case report, with its main components, should be focused and delivers a clear message.

  7. PDF Guidance on Case Reports and Patient Privacy

    A case report is an unsystematic clinical observation that states the outcome or response of a single patient to a diagnostic strategy or treatment. Case reports serve to document and share novel cases amongst the medical community for educational purposes. Q. Is IRB approval required to prepare a clinical case study? A. Generally, case studies ...

  8. A young researcher's guide to writing a clinical case report

    Clinical case reports are the first-line evidence in medical literature as they present original observations and can be an excellent way for medical students and practitioners to get started with academic writing. Additionally, a published case report is definitely a contribution to medical science and a great addition to a CV.

  9. Annals of Internal Medicine: Clinical Cases

    Annals of Internal Medicine: Clinical Cases (AIMCC) is an open access, peer-reviewed journal co-published by the American College of Physicians and the American Heart Association. AIMCC publishes case reports, case series, and image/video cases in subject areas across the spectrum of medicine.

  10. Case Report: A Beginner's Guide with Examples

    Case reports offer, in general a fast, easy and cheap way to report an unusual observation or a rare event in a clinical setting, as these have very small probability of being detected in an experimental study because of limitations on the number of patients that can be included.

  11. Frontiers

    A 4-year-old female spayed dog presented to the emergency department for non-ambulatory tetraparesis, which progressed to tetraplegia. Computed tomography (CT) confirmed cervical intervertebral disk extrusion at C5-6 extending to C6-7, and an emergency ventral slot was performed. After the procedure, the patient was placed on mechanical ventilation due to respiratory failure. Repeat assessment ...

  12. BMJ Case Reports

    BMJ Case Reports is a repository of evidence regarding health and its social determinants. Our case reports may be used for education and the improvement of clinical practice. The modules below offer opportunities to test your developing clinical skills. Education Section Most read Microsurgical replantation of a traumatic total scalp avulsion

  13. How to Write a Case Report

    Gather the clinical information associated with patient visits in this this case report to create a timeline as a figure or table. The timeline is a chronological summary of the visits that make up the episodes of care from this case report. ... Follow author guidelines and journal submission requirements when writing and submitting your case ...

  14. Clinical Case Reports

    Clinical Case Reports is an open access journal with a comprehensive peer review policy, and a very rapid publication process. We guarantee that Clinical Case Reports will publish all high quality original case reports meeting our submission guidelines which have an important, practical, and generalisable teaching message.

  15. Writing a case report in 10 steps

    First steps Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved.

  16. PDF How to write a clinical case report

    format adopted for most case reports. Introduction . Summarise your case report in a sentence. Mention how rare this condition is, and why your case report is important eg as a differential to consider in a patient presenting with X, Y and Z. Case report . Narrate your case in a way that is easy and enjoyable to follow.

  17. Basics of case report form designing in clinical research

    Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online ...

  18. How to choose the best journal for your case report

    Clinical issues covered by case report journals include previously unreported adverse effects of drugs or other treatments, unexpected events that occur in the course of observing or treating a patient, observations on disease pathogenesis, presentations and/or management of new and emerging diseases, new therapeutic approaches, ethical ...

  19. AIM: Clinical Cases

    Annals of Internal Medicine: Clinical Cases is a new peer-reviewed open access journal published in partnership between the American College of Physicians and the American Heart Association. The primary missions of the journal are to contribute to the scientific body of knowledge and provide an accessible educational resource for the research and clinical communities by publishing case reports ...

  20. Journal of Medical Case Reports

    Case reports submitted to Journal of Medical Case Reports should make a contribution to medical knowledge and must have educational value or highlight the need for a change in clinical practice or diagnostic/prognostic approaches. The journal will not consider case reports describing preventive or therapeutic interventions, as these generally ...

  21. Case Report Form: Types Uses & Template Examples

    Case report forms are one of the most important data instruments used for clinical researches and medical examinations. When conducting clinical trials, the researcher needs to record even the smallest of observations as they happen. A case report form is designed for this purpose.

  22. Annals of Clinical and Medical Case Reports

    Case reports are characterized as the logical documentation of a solitary clinical perception and have a long-established and rich custom in medication ... Annals of Clinical and Medical Case Reports is an esteemed and zealous in publishing various scientific and medical journals which acts as a shell that provides latest research information ...

  23. Mirror Therapy Case Report

    Mirror therapy is a form of treatment involving the use of a mirror to manage, for example, phantom limb pain. Essentially, it works by providing a reflective image that tricks the brain into thinking that the patient still has both limbs intact. In effect, it can help rewire the neural pathways in the brain and reduce physical sensations of ...

  24. Case Report

    An article that describes and interprets an individual case, often written in the form of a detailed story. Case reports often describe: Unique cases that cannot be explained by known diseases or syndromes. Cases that show an important variation of a disease or condition. Cases that show unexpected events that may yield new or useful information.

  25. What is a Case Report Form?

    A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. ... It is the main tool that Investigators use to collect information from clinical trial participants which is why there needs to be one completed CRF for each participant. ...