Case Study Report Documents
Definition of a case study report
A case study report is an article that describes a particular patient's diagnosis and treatment plan. Most of the cases chosen for published medical case studies are of unusual diagnoses, or include complications in treatment. A case study report is written in a specific format and can be submitted to peer-reviewed journals. To write a case study report, the following steps need to be undertaken:
1. Generate a Barwon Health reference number
2. Select a case
- Case reports are written about patients who have rare or unusual illnesses, or where a treatment plan has an unexpected positive or negative outcome - get support from your line manager and advise the Research Ethics, Governance & Integrity (REGI) Unit.
3. Research the case/literature review
4. Provide patient information and seek consent
- The patient who is the focus of the medical case study report must provide written consent (many journals have their own consent forms that must be completed and signed by the patient before the report is submitted) - provide the patient with the Participant Explanatory Statement and seek the patient's consent by providing the patient with the Participant Consent Form
- The consent is to use both patients' data for the purposes of publication, and to access the medical records, including other organisations if required
- Gather the patient's demographic information (age, medical history, medication use, current and past diagnoses, etc.), and provide detailed information about the patient so the audience will be well informed about the case
- Collect relevant copies of the patient's labs, x-rays, or any clinical photographs.
5. Write the medical case study report
- Follow the standard format for the report, as outlined in the Case Study Report Template, sign the Researcher(s) Declaration, and submit to the REGI Unit.
6. Submit your medical case study report to the appropriate professional journal
7. Keep your source records
- Keep a clear record of the progress in writing up the case, in the event of queries or audits - records are usually stored at least one year after publication, or longer in some cases.
Advanced practice pharmacists in the field of diabetes work collaboratively with patients’ medical providers, often in primary care settings or in close proximity to the providers’ practices. They help to integrate the pharmaceutical, medical, education/ counseling, and direct patient care activities necessary to meet patients’ individual self-management and diabetes care needs.
Patient education and self-management behavioral change are underpinnings of pharmaceutical care, and not only as they directly relate to the use of medications. Pharmacists, especially those who are certified diabetes educators (CDEs), frequently provide diabetes patients with education not only on medications, but also on the overall disease state, nutrition, physical activity, decision-making skills, psychosocial adaptation, complication prevention, goal setting, barrier resolution, and cost issues.
In addition to these substantial education responsibilities, advanced practice pharmacists who are Board Certified–Advanced Diabetes Managers (BC-ADMs) play an expanded role that encompasses disease state management. This includes performing clinical assessments and limited physical examinations; recognizing the need for additional care; making referrals as needed; ordering and interpreting specific laboratory tests; integrating their pharmacy patient care plans into patients’ total medical care plans; and entering notes on patient charts or carrying out other forms of written communication with patients’ medical care providers. Depending on state regulations and physician-based protocols, some advanced practice pharmacists can prescribe and adjust medications independently or after consultation with prescribing clinicians.
The clinical activities of BC-ADM pharmacists are not carried out independent of referring, collaborative practitioners. Rather, they are complementary to and serve to enhance the diagnostic, complex physical assessment, and management skills of medical providers.
The following case study illustrates the pharmacotherapeutic challenges of diabetes with other comorbidities, which can lead to potential drug-drug and drug-disease interactions. Although it does not offer detailed solutions to such problems, this case does describe the process of patient care and problem resolution as approached by advanced practice pharmacists.
B.L. is a 58-year-old white woman who has been referred to the pharmacist clinician for pharmacotherapy assessment and diabetes management. Her multiple medical conditions include type 2 diabetes diagnosed in 1995, hypertension, hyperlipidemia, asthma, coronary artery disease, persistent peripheral edema, and longstanding musculoskeletal pain secondary to a motor vehicle accident. Her medical history includes atrial fibrillation with cardioversion, anemia, knee replacement, and multiple emergency room (ER) admissions for asthma.
B.L.’s diabetes is currently being treated with a premixed preparation of 75% insulin lispro protamine suspension with 25% insulin lispro preparation (Humalog 75/25), 33 units before breakfast and 23 units before supper. She says she occasionally “takes a little more” insulin when she notes high blood glucose readings, but she has not been instructed on the use of an insulin adjustment algorithm.
Her other routine medications include the fluticasone metered dose inhaler (Flovent MDI), two puffs twice a day; salmeterol MDI (Serevent MDI), two puffs twice a day; naproxen (Naprosyn), 375 mg twice a day; enteric-coated aspirin, 325 mg daily; rosiglitazone (Avandia), 4 mg daily; furosemide (Lasix), 80 mg every morning; diltiazem (Cardizem CD), 180 mg daily (per cardiologist consult); lanoxin (Digoxin), 0.25 mg daily (per cardiologist consult); potassium chloride, 20 mEq daily; and fluvastatin (Lescol), 20 mg at bedtime. Medications she has been prescribed to take “as needed” include sublingual nitroglycerin for chest pain (has not been needed in the past month); furosemide, additional 40 mg later in the day if needed for swelling (on most days the additional dose is needed); and albuterol MDI (Proventil, Ventolin), two to four puffs every 4–6 hours for shortness of breath. She denies use of nicotine, alcohol, or recreational drugs; has no known drug allergies; and is up to date on her immunizations.
B.L.’s chief complaint now is increasing exacerbations of asthma and the need for prednisone tapers. She reports that during her last round of prednisone therapy, her blood glucose readings increased to the range of 300–400 mg/dl despite large decreases in her carbohydrate intake. She reports that she increases the frequency of her fluticasone MDI, salmeterol MDI, and albuterol MDI to four to five times/day when she has a flare-up. However, her husband has been out of work for more than a year, and their only source of income is her Social Security check. Therefore, she has been unable to purchase the fluticasone or salmeterol and so has only been taking prednisone and albuterol for recent acute asthma exacerbations.
B.L. reports eating three meals a day with a snack between supper and bedtime. Her largest meal is supper. She states that she counts her carbohydrate servings at each meal and is “watching what she eats.” She has not been able to exercise routinely for several weeks because of bad weather and her asthma.
The memory printout from her blood glucose meter for the past 30 days shows a total of 53 tests with a mean blood glucose of 241 mg/dl (SD 74). With a premeal glucose target set at 70–140 mg/dl, there were no readings below target, 8% within target, and 91% above target. By comparison, her results from the same month 1 year ago averaged 112 mg/dl, with a high of 146 mg/dl and a low of 78 mg/dl.
B.L. is well-appearing but obese and is in no acute distress. A limited physical exam reveals:
Weight: 302 lb; height 5′1″
Blood pressure: 130/78 mmHg using a large adult cuff
Pulse 88 bpm; respirations 22 per minute
Lungs: clear to auscultation bilaterally without wheezing, rales, or rhonchi
Lower extremities +1 pitting edema bilaterally; pulses good
B.L. reports that on the days her feet swell the most, she is active and in an upright position throughout the day. Swelling worsens throughout the day, but by the next morning they are “skinny again.” She states that she makes the decision to take an extra furosemide tablet if her swelling is excessive and painful around lunch time; taking the diuretic later in the day prevents her from sleeping because of nocturnal urination.
For the sake of brevity, only abnormal or relevant labs within the past year are listed below.
Hemoglobin A1c (A1C) measured 6 months ago: 7.0% (normal range: <5.9%; target: <7%)
Creatinine: 0.7 mg/dl (normal range: 0.7–1.4 mg/dl)
Blood urea nitrogen: 16 mg/dl (normal range: 7–21 mg/dl)
Sodium: 140 mEq/l (normal range: 135–145 mEq/l)
Potassium: 3.4 mg/dl (normal range: 3.5–5.3 mg/dl)
Calcium: 8.2 mg/dl (normal range: 8.3–10.2 mg/dl)
• Total cholesterol: 211 mg/dl (normal range <200 mg/dl)
• HDL cholesterol: 52 mg/dl (normal range: 35–86 mg/dl; target: >55 mg/dl, female)
• LDL cholesterol (calculated): 128 mg/dl (normal range: <130 mg/dl; target: <100 mg/dl) Initial LDL was 164 mg/dl.
• Triglycerides: 154 mg/dl (normal range: <150 mg/dl; target: <150 mg/dl)
Liver function panel: within normal limits
Urinary albumin: <30 μg/mg (normal range: <30 μg/mg)
Poorly controlled, severe, persistent asthma
Diabetes; control recently worsened by asthma exacerbations and treatment
Dyslipidemia, elevated LDL cholesterol despite statin therapy
Persistent lower-extremity edema despite diuretic therapy
Hypokalemia, most likely drug-induced
Hypertension JNC-VI Risk Group C, blood pressure within target and stable
Coronary artery disease, stable
Chronic pain secondary to previous injury, stable
Status post–atrial fibrillation with cardioversion
Status post–knee replacement
Financial constraints affecting medication behaviors
Insufficient patient education regarding purposes and role of specific medications
Wellness, preventive, and routine monitoring issues: calcium/vitamin D supplement, magnesium supplement, depression screening, osteoporosis screening, dosage for daily aspirin
Strand et al.1 proposed a systematic method for evaluation of and intervention for a patient’s pharmacotherapy, using a process called the Pharmacist’s Work-Up of Drug Therapy (PWDT). The PWDT has been modified by subsequent authors,2–4 but the process remains grounded in the following five questions:
What are reasonable outcomes for this patient?
Based on current guidelines and literature, pharmacology, and pathophysiology, what therapeutic endpoints would be needed to achieve these outcomes?
Are there potential medication-related problems that prevent these endpoints from being achieved?
What patient self-care behaviors and medication changes are needed to address the medication-related problems? What patient education interventions are needed to enhance achievement of these changes?
What monitoring parameters are needed to verify achievement of goals and detect side effects and toxicity, and how often should these parameters be monitored?
Outcomes and Endpoints
Clinical outcomes are distinctly different from therapeutic or interventional endpoints. The former refers to the impact of treatment on patients’ overall medical status and quality of life and should emphasize patient-oriented evidence that matters (POEMs) rather than disease-oriented evidence (DOEs).
Therapeutic endpoints include the anticipated and desired clinical effects from drug therapy that are expected, ultimately, to achieve the desired outcome(s). As such, therapeutic endpoints are used as surrogate markers for achievement of outcomes. Commonly, more than one endpoint will be needed to achieve an outcome. For example, near-normal glycemic control and normalization of blood pressure (endpoints) would be necessary to significantly reduce the risk of end-stage renal disease (outcome).
Therapeutic endpoints should be specific, measurable, and achievable within a short period of time. Achievement of clinical outcomes usually cannot be determined except by long-term observation or retrospective analysis.
Outcomes and endpoints for any given patient should be determined collaboratively between patient and provider before selecting or initiating pharmacotherapy or nonpharmacological interventions. Taking the time to identify these components up front (and periodically revise them later on) helps ensure that subsequent medications or strategies are appropriately directed. It further ensures a common vision and commitment for ongoing patient care and self-management among the care team (including the patient), thus maximizing the potential for optimal disease control and patient satisfaction.
The outcomes and endpoints for a patient such as B.L. are numerous and obviously would not be addressed or attained in a single session. Therefore, after desired outcomes and endpoints are determined, they should be prioritized according to medical urgency and patient preference. Implementation and goal setting related to these priorities can then be undertaken, thus establishing a treatment plan for the eventual attainment of the full list.
During ongoing and follow-up visits, this care plan should be reviewed and modified as indicated by changes in patient status, preferences, and medical findings. Examples of desired outcomes and endpoints for B.L. are given in Tables 1 and 2. For the sake of brevity, these tables are not intended to be inclusive.
Medication-Related Problems and Proposed Interventions
With agreement between patient and clinician concerning desired outcomes and endpoints, the next logical step is to evaluate whether the current treatment plan is likely to achieve those goals, or, if treatment is to be initiated, which therapies or interventions should be selected.
According to Strand et al.,1 a medication-related problem is any aspect of a patient’s drug therapy that is interfering with a desired, positive patient (therapeutic) outcome or endpoint. The PWDT proposes a systematic and comprehensive method to identify, resolve, or prevent medication-related problems based on the following major categories:
No indication for a current drug
Indication for a drug (or device or intervention) but none prescribed
Wrong drug regimen (or device or intervention) prescribed/more efficacious choice possible
Too much of the correct drug
Too little of the correct drug
Adverse drug reaction/drug allergy
Drug-drug, drug-disease, drug-food interactions
Patient not receiving a prescribed drug
Routine monitoring (labs, screenings, exams) missing
Other problems, such as potential for overlap of adverse effects
Once problems are identified, resolutions must be developed, prioritized, and implemented. Patient or caregiver input is especially helpful at this stage because the individual can describe subjective as well as objective data, expectations or concerns that may be affecting drug therapy, and deficits in drug knowledge, understanding, or administration.
Resolutions may result from numerous strategies, including dose alteration, addition or discontinuation of medication, adjunct medications, regimen adjustment, complementary therapies, instruction on medication administration or devices, disease or medication education, development of “cues” as compliance reminders (e.g., pill boxes), and identification of ways to avoid, detect, or manage side effects or toxicities. Needless to say, the involvement of patients and family or caregivers is critical for successful implementation of most resolution strategies and for optimal disease management.
Because of the extent of B.L.’s medication-related problems and potential interventions (Tables 3 and 4), it was agreed to tackle first her asthma exacerbations and high blood glucose levels. To this end, B.L. was counseled about the role of maintenance asthma medications versus rescue drugs. The root of her confusion between these agents was easy to understand—because the prednisone and fluticasone were both called steroids, it seemed likely that the tablets were a cheaper and easier way to take the medicine. Likewise, since albuterol and salmeterol were both called bronchodilators, it seemed that the albuterol was the cheaper way to take the medicine.
Having grasped the concept of asthma prevention, she was willing to convert to a product combining fluticasone and salmeterol (Advair Diskus) for maintenance/prevention and to reserve the albuterol for quick relief of acute symptoms. Free samples of the new product were dispensed, and B.L. was enrolled in the manufacturer’s indigent drug program for subsequent supplies.
She was further instructed on the use of a peak flow meter and advised to monitor her readings and symptoms. At the next visit, these data will be used to determine her maximal expiratory effort (“personal best”) and to construct an asthma action plan.
B.L.’s insulin was changed to a basal-based regimen utilizing bedtime glargine (Lantus) insulin and premeal lispro (Humalog) insulin. Education was provided on this dosing concept. She and the pharmacist discussed how this regimen can give greater flexibility in dosing, especially for responding to changes in diet, exercise, and disease exacerbations or medications. She was also given an initial supplementary adjustment algorithm (sliding scale) to correct for any temporary elevation of blood glucose. She agreed to test four times daily and to record her blood glucose results, carbohydrate intake, and insulin doses. At the next visit, these data will be used to modify the adjustment algorithm and to construct a prospective algorithm for matching premeal bolus insulin to the anticipated carbohydrate intake (insulin-to-carbohydrate ratio).
The final interventions for this visit were to increase the dose of potassium chloride and change the fluvastatin to atorvastatin (Lipitor) to further reduce B.L.’s LDL cholesterol. Medication education for atorvastatin was provided, and patient questions were answered.
Other medication-related problems and interventions identified for B.L. are listed and briefly discussed in Tables 3 and 4. For the sake of brevity, these lists are not inclusive nor are all pharmacotherapy issues discussed.
Monitoring for Effectiveness, Side Effects, and Toxicity
The last step in the PWDT process is to develop a plan to evaluate the patient’s progress in attaining desired outcomes, therapeutic endpoints, and behavior changes; to assess effectiveness of pharmacotherapy; and to identify side effects, drug interactions, or toxicity issues that need to be addressed.
The monitoring/follow-up component is the most tedious aspect of the PWDT. For each medication or intervention, key parameters must be identified as markers for effectiveness, for side effects, for drug interactions, and for toxicity. In addition, the time frame and process for assessing those parameters must be determined. Finally, the desired range for the parameter must be listed or a “decision point” must be identified to signal that additional action will be required.
It should be noted that only a limited number of parameters are selected for a given patient. For example, it is not necessary to list and monitor for every possible side effect with equal intensity and frequency. Selection of the monitoring parameters is based on the positive effects (efficacy) that are most important to the care of that patient, as well as the adverse effects (side effects, toxicity, or drug interactions) that are most important to avoid for the safety of that patient or to which that patient is most prone.
Because the monitoring component is usually extensive, examples listed for B.L. in Table 5 have been limited to three of the medication or regimen changes that were made at the first pharmacist visit: switching from fluvastatin to atorvastatin; switching from two shots of premixed 75/25 lispro to bedtime glargine with premeal lispro; and substituting the combination inhaler product for her fluticasone and salmeterol MDI prescriptions. Because atorvastatin and fluvastatin differ chemically, the monitoring parameters for this change are similar to those for initiation of a new medication. Monitoring for the new insulin regimen (basal insulin with premeal bolus) focuses primarily on glycemic control patterns and hypoglycemic episodes. Because B.L. has previously used the two ingredients of her new inhaler product (fluticasone and salmeterol) without adverse effect, monitoring of her new asthma therapy is focused on effectiveness, tolerance of inhalation of its dry powder formula, and use of the administration device.
Diabetes patients with multiple co-morbidities have concerns about all of their problems, not just the diabetes; therefore, BC-ADM pharmacists must comprehensively explore all the ramifications of comorbidities as well as patients’ feelings, expectations, and concerns for total health. B.L. is a good example of this; even though her referral was for “diabetes management,” her greatest concern at this visit was her asthma exacerbations.
As can be seen in this case, each coexisting disease or coprescribed drug has a domino effect, affecting other diseases or drugs and ultimately affecting quality of life. With input from B.L., the pharmacist clinician was able to develop a PWDT that addresses her diabetes as well as her other health care needs.
B.L. was able to leave the health center with a few achievable self-care goals and medication changes that address her acute concerns and with the knowledge and confidence that, at each subsequent visit, additional progress will be made toward her personalized health status goals.
Examples of B.L.’s Desired Outcomes
Examples of B.L.’s Therapeutic Endpoints
Examples of B.L.’s Medication-Related Problems
Examples of B.L.’s Interventions (Prioritized and to be Implemented Accordingly)
Examples of B.L.’s Monitoring Plans
Peggy Yarborough, PharmD, MS, BC-ADM, CDE, FAPP, FASHP, NAP, is a professor at Campbell University School of Pharmacy in Buies Creek, N.C., and a pharmacist clinician at Wilson Community Health Center in Wilson, N.C.
For information concerning POEMs and DOEs: a multitude of literature on this topic is available through Internet sources. Search for “patient oriented evidence that matters” using a medical topic browser.
- American Diabetes Association