9. Therapeutic Intervention

What to write

9a – Types of intervention (e.g., pharmacologic, surgical, preventive, self-care)

9b – Administration (e.g., dosage, strength, duration)

9c – Changes in intervention (with rationale)

Explanation

Therapeutic interventions are often the focus of case reports or they may provide key diagnostic information. In either case, we recommend reporting them in enough detail to facilitate replication. Complex or poorly defined interventions may benefit from use of the TIDieR guideline (a CONSORT extension) to enhance the accuracy, transparency, and reproducibility of an intervention1.

A brief explanation of why the patient received a particular intervention (such as the target condition, the preexposure clinical course, etc.) should be provided in this section; however, we suggest reserving a more detailed rationale for the discussion section. The general format for reporting interventions is outlined below (see Table 1). Case reports focusing on harms should include the manufacturer and brand of the products in question. Explain changes made to an intervention and describe care received from other providers.

Therapeutic intervention descriptions

All interventions:

  • Specify type of intervention, indicated condition, and intervention1

Pharmaceuticals (over-the-counter and prescription drugs):

  • International nonproprietary name (INN), dosing regimen, and length of intervention
  • For formulations that are administered as volumes of a fluid (e.g., intravenous infusions or oral liquid formulations) state the concentration of the formulation
  • Provide manufacturer and brand names if relevant

Dietary supplements and botanical medicines:

  • Ingredients and dosing regimen (e.g., EPA [eicosapentaenoic acid] 750 mg plus DHA [docosahexaenoic acid] 250 mg, 1 capsule orally once daily for 6 months)
  • If medicinal plants are used, indicate plant species using the Latin binomial name, the quantity of herbal substance or constituents, and the parts of the plant
  • Provide manufacturer and brand names if relevant

Lifestyle recommendations (e.g., physical activity or exercise):

  • Frequency, intensity, timing, and type

Examples

9a—Types of intervention (e.g., pharmacologic, surgical, preventive, self-care)

“Surgery

Under general anesthesia in the prone position, the C1–C7 laminae were exposed. Twenty millimeters of the width of the C2–C7 laminae were removed using a high-speed drill. Adhesions between the calcification and dura mater were gently stripped off, and the laminae were resected en block with the calcification. Fifteen millimeters of the width of the C1 posterior arch was removed using a high-speed drill. Pulsating dura mater was observed after laminectomy, but the pulse was weak. The dura mater appeared hypertrophic; however, we did not incise the dura mater.”

From Eight years of follow-up after laminectomy of calcium pyrophosphate crystal deposition in the cervical yellow ligament of patient with Coffin–Lowry syndrome: a case report2.

9b—Administration (e.g., dosage, strength, duration)

“The patient was started on induction eculizumab at 900 mg IV weekly for 4 weeks and responded well with improvement in platelet count and renal function. He was transitioned to every-other-week maintenance eculizumab, and hemodialysis was discontinued.”

From Maintenance eculizumab dose adjustment in the treatment of atypical hemolytic uremic syndrome: a case report and review of the literature3.

“Rapid sedation was commenced with ziprasidone, lorazepam, droperidol, and zuclopenthixol acetate (Table 4). Benztropine was administered for prophylaxis against extrapyramidal side effects of the antipsychotic medications. The level of sedation attained was unsatisfactory as he remained severely agitated and combative interspersed with only brief periods of drowsiness. He could not follow direction or adhere to boundaries established by staff. All attempts at de-escalation and distraction were met with aggression.

Table 1: Medications administered to the patient in our emergency department and selected behavioral observations
Time Medication name, dose, and route Behavioral observations
17:20 Approximate time of presentation to our emergency department Extremely aggressive, threatening, and offensive behavior and language
17:26 Ziprasidone 20 mg IM, lorazepam 2 mg IM nbsp;
17:30 Lorazepam 2 mg IM nbsp;
17:40 Zuclopenthixol acetate 150 mg IM, benztropine 2 mg IM nbsp;
18:05 Lorazepam 2 mg IV Vital signs and IV access obtained, blood sampled
18:30 Droperidol 10 mg IM Verbally abusive, threatening, aggressive
22:30 Ziprasidone 20 mg IM nbsp;
23:00 Lorazepam 2 mg IV nbsp;
01:00 Sedated and quiet
04:00 Droperidol 10 mg IM, Lorazepam 2 mg IV Yelling, abusive, shaking bed, threatening staff
06:00 Sedated but intermittent abuse and threats
11:20 Ziprasidone 20 mg IM nbsp;
13:00 Droperidol 25 mg IM Acute arousal, combative during transport to psychiatric ward”

From Polysubstance-induced relapse of schizoaffective disorder refractory to high-dose antipsychotic medications: a case report4.

9c—Changes in intervention (with rationale)

“Partial resolution of the hemolytic process was observed while the patient was treated with daily plasmapheresis with 5% albumin, at a volume of 3L–4L. A total of seven daily plasmapheresis treatments were performed, which resulted in a gradual decrease of the patient’s LDH and bilirubin and a rise in his level of haptoglobin. However, the patient still required almost daily blood transfusions. On the basis of earlier reports indicating an anecdotal benefit of rituximab treatment for immune cytopenias, plasmapheresis was discontinued and our patient was placed on rituximab therapy at a dose of 375 mg/m2 every week. A total of four doses were administered over a period of 4 weeks. Although an initial increase in LDH level after the initiation of rituximab treatment was noted, there was no evidence of worsening hemolysis. After the first two courses of rituximab therapy, the patient showed a marked clinical improvement. His hemoglobin level stabilized… and he no longer required blood transfusions.”

From Severe refractory autoimmune hemolytic anemia with both warm and cold autoantibodies that responded completely to a single cycle of rituximab: a case report5.

Training

The UK EQUATOR Centre runs training on how to write using reporting guidelines.

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References

1.
Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348(mar07 3):g1687-g1687. doi:10.1136/bmj.g1687
2.
Morino T, Ogata T, Horiuchi H, Yamaoka S, Fukuda M, Miura H. Eight years of follow-up after laminectomy of calcium pyrophosphate crystal deposition in the cervical yellow ligament of patient with coffin–lowry syndrome: A case report. Medicine. 2016;95(31):e4468. doi:10.1097/md.0000000000004468
3.
Thomson N, Ulrickson M. Maintenance eculizumab dose adjustment in the treatment of atypical hemolytic uremic syndrome: A case report and review of the literature. Clinical Case Reports. 2016;4(8):773-776. doi:10.1002/ccr3.628
4.
Tucker MG, Kekulawala S, Kent M, Mostafa S, Harvey R. Polysubstance-induced relapse of schizoaffective disorder refractory to high-dose antipsychotic medications: A case report. Journal of Medical Case Reports. 2016;10(1). doi:10.1186/s13256-016-1031-3
5.
Gupta S, Szerszen A, Nakhl F, et al. Severe refractory autoimmune hemolytic anemia with both warm and cold autoantibodies that responded completely to a single cycle of rituximab: A case report. Journal of Medical Case Reports. 2011;5(1). doi:10.1186/1752-1947-5-156

Citation

For attribution, please cite this work as:
Gagnier JJ, Kienle G, Altman DG, et al. The CARE reporting guideline for writing clinical case report articles. The EQUATOR Network guideline dissemination platform. doi:10.1234/equator/1010101

Reporting Guidelines are recommendations to help describe your work clearly

Your research will be used by people from different disciplines and backgrounds for decades to come. Reporting guidelines list the information you should describe so that everyone can understand, replicate, and synthesise your work.

Reporting guidelines do not prescribe how research should be designed or conducted. Rather, they help authors transparently describe what they did, why they did it, and what they found.

Reporting guidelines make writing research easier, and transparent research leads to better patient outcomes.

Easier writing

Following guidance makes writing easier and quicker.

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Maximum impact

From nobel prizes to null results, articles have more impact when everyone can use them.

Who reads research?

You work will be read by different people, for different reasons, around the world, and for decades to come. Reporting guidelines help you consider all of your potential audiences. For example, your research may be read by researchers from different fields, by clinicians, patients, evidence synthesisers, peer reviewers, or editors. Your readers will need information to understand, to replicate, apply, appraise, synthesise, and use your work.

Cohort studies

A cohort study is an observational study in which a group of people with a particular exposure (e.g. a putative risk factor or protective factor) and a group of people without this exposure are followed over time. The outcomes of the people in the exposed group are compared to the outcomes of the people in the unexposed group to see if the exposure is associated with particular outcomes (e.g. getting cancer or length of life).

Source.

Case-control studies

A case-control study is a research method used in healthcare to investigate potential risk factors for a specific disease. It involves comparing individuals who have been diagnosed with the disease (cases) to those who have not (controls). By analysing the differences between the two groups, researchers can identify factors that may contribute to the development of the disease.

An example would be when researchers conducted a case-control study examining whether exposure to diesel exhaust particles increases the risk of respiratory disease in underground miners. Cases included miners diagnosed with respiratory disease, while controls were miners without respiratory disease. Participants' past occupational exposures to diesel exhaust particles were evaluated to compare exposure rates between cases and controls.

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Cross-sectional studies

A cross-sectional study (also sometimes called a "cross-sectional survey") serves as an observational tool, where researchers capture data from a cohort of participants at a singular point. This approach provides a 'snapshot'— a brief glimpse into the characteristics or outcomes prevalent within a designated population at that precise point in time. The primary aim here is not to track changes or developments over an extended period but to assess and quantify the current situation regarding specific variables or conditions. Such a methodology is instrumental in identifying patterns or correlations among various factors within the population, providing a basis for further, more detailed investigation.

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Systematic reviews

A systematic review is a comprehensive approach designed to identify, evaluate, and synthesise all available evidence relevant to a specific research question. In essence, it collects all possible studies related to a given topic and design, and reviews and analyses their results.

The process involves a highly sensitive search strategy to ensure that as much pertinent information as possible is gathered. Once collected, this evidence is often critically appraised to assess its quality and relevance, ensuring that conclusions drawn are based on robust data. Systematic reviews often involve defining inclusion and exclusion criteria, which help to focus the analysis on the most relevant studies, ultimately synthesising the findings into a coherent narrative or statistical synthesis. Some systematic reviews will include a meta-analysis.

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Systematic review protocols

TODO

Meta analyses of Observational Studies

TODO

Randomised Trials

A randomised controlled trial (RCT) is a trial in which participants are randomly assigned to one of two or more groups: the experimental group or groups receive the intervention or interventions being tested; the comparison group (control group) receive usual care or no treatment or a placebo. The groups are then followed up to see if there are any differences between the results. This helps in assessing the effectiveness of the intervention.

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Randomised Trial Protocols

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Qualitative research

Research that aims to gather and analyse non-numerical (descriptive) data in order to gain an understanding of individuals' social reality, including understanding their attitudes, beliefs, and motivation. This type of research typically involves in-depth interviews, focus groups, or field observations in order to collect data that is rich in detail and context. Qualitative research is often used to explore complex phenomena or to gain insight into people's experiences and perspectives on a particular topic. It is particularly useful when researchers want to understand the meaning that people attach to their experiences or when they want to uncover the underlying reasons for people's behavior. Qualitative methods include ethnography, grounded theory, discourse analysis, and interpretative phenomenological analysis.

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Case Reports

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Diagnostic Test Accuracy Studies

Diagnostic accuracy studies focus on estimating the ability of the test(s) to correctly identify subjects with a predefined target condition, or the condition of interest (sensitivity) as well as to clearly identify those without the condition (specificity).

Prediction Models

Prediction model research is used to test the accurarcy of a model or test in estimating an outcome value or risk. Most models estimate the probability of the presence of a particular health condition (diagnostic) or whether a particular outcome will occur in the future (prognostic). Prediction models are used to support clinical decision making, such as whether to refer patients for further testing, monitor disease deterioration or treatment effects, or initiate treatment or lifestyle changes. Examples of well known prediction models include EuroSCORE II for cardiac surgery, the Gail model for breast cancer, the Framingham risk score for cardiovascular disease, IMPACT for traumatic brain injury, and FRAX for osteoporotic and hip fractures.

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Animal Research

TODO

Quality Improvement in Healthcare

Quality improvement research is about finding out how to improve and make changes in the most effective way. It is about systematically and rigourously exploring "what works" to improve quality in healthcare and the best ways to measure and disseminate this to ensure positive change. Most quality improvement effectiveness research is conducted in hospital settings, is focused on multiple quality improvement interventions, and uses process measures as outcomes. There is a great deal of variation in the research designs used to examine quality improvement effectiveness.

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Economic Evaluations in Healthcare

TODO

Meta Analyses

A meta-analysis is a statistical technique that amalgamates data from multiple studies to yield a single estimate of the effect size. This approach enhances precision and offers a more comprehensive understanding by integrating quantitative findings. Central to a meta-analysis is the evaluation of heterogeneity, which examines variations in study outcomes to ensure that differences in populations, interventions, or methodologies do not skew results. Techniques such as meta-regression or subgroup analysis are frequently employed to explore how various factors might influence the outcomes. This method is particularly effective when aiming to quantify the effect size, odds ratio, or risk ratio, providing a clearer numerical estimate that can significantly inform clinical or policy decisions.

How Meta-analyses and Systematic Reviews Work Together

Systematic reviews and meta-analyses function together, each complementing the other to provide a more robust understanding of research evidence. A systematic review meticulously gathers and evaluates all pertinent studies, establishing a solid foundation of qualitative and quantitative data. Within this framework, if the collected data exhibit sufficient homogeneity, a meta-analysis can be performed. This statistical synthesis allows for the integration of quantitative results from individual studies, producing a unified estimate of effect size. Techniques such as meta-regression or subgroup analysis may further refine these findings, elucidating how different variables impact the overall outcome. By combining these methodologies, researchers can achieve both a comprehensive narrative synthesis and a precise quantitative measure, enhancing the reliability and applicability of their conclusions. This integrated approach ensures that the findings are not only well-rounded but also statistically robust, providing greater confidence in the evidence base.

Why Don't All Systematic Reviews Use a Meta-Analysis?

Systematic reviews do not always have meta-analyses, due to variations in the data. For a meta-analysis to be viable, the data from different studies must be sufficiently similar, or homogeneous, in terms of design, population, and interventions. When the data shows significant heterogeneity, meaning there are considerable differences among the studies, combining them could lead to skewed or misleading conclusions. Furthermore, the quality of the included studies is critical; if the studies are of low methodological quality, merging their results could obscure true effects rather than explain them.

Protocol

A plan or set of steps that defines how something will be done. Before carrying out a research study, for example, the research protocol sets out what question is to be answered and how information will be collected and analysed.

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