10. Follow up and outcomes
What to write
10a – Clinician and patient-assessed outcomes
10b – Important follow-up test results (positive and negative)
10c – Intervention adherence and tolerability (and how this was assessed)
10d – Adverse and unanticipated events
Explanation
We recommend reporting objective and subjective findings throughout the course of care, to track changes in the outcomes of interest. Clinician-assessed outcomes could include objective outcome measures, such as laboratory biomarkers, physical findings, and imaging. Longitudinal clinical findings may help to create a convincing case and support the discussion of temporal or other relationships between outcomes and treatment, a topic to be explored further in the discussion section1,2.
Reporting results from longitudinal data including patient-assessed and clinician-assessed outcomes may strengthen the case for a causal link. We suggest reporting other clinical management received by the patient, along with its potential impact on outcomes. Consulting with other providers and including their perspective may be helpful.
If the intervention is a focus of the case report, include patient adherence to that intervention and how this information was obtained (e.g., diary/log, telephone call, electronic methods). If available, describe harms attributed to an intervention and make note of the patient’s words, reporting what the adverse outcomes were, how often they occurred, and with what intensity3. All case reports should explicitly mention the presence or absence of adverse events.
Examples
10a—Clinician and patient-assessed outcomes
“The results of 8 weeks of self-directed mindfulness training plus 3 additional weeks of customized mindfulness practice resulted in both personally and clinically meaningful outcomes.
From the patient’s perspective, perceived stress was dramatically reduced. Not only was MR calmer about her previously overwhelming workload but her workload actually decreased because of increases in her efficiency and focus. For example, her e-mail inbox, a source of perpetual stress, came under control… Using MBSR focusing techniques, she turned email into tasks that were immediately accomplished and the email inbox was successfully reduced to very few items and is now emptied several times a day.
Clinically important objective measures of disease risk also improved during her mindfulness meditation experience. MR measured and recorded her blood pressure using an automated blood pressure monitor (Omron model HEM-609, Lake Forest, IL) immediately before and after her meditation sessions. In the first 8 weeks of mindfulness training, baseline blood pressure was typically elevated and classifiable as stage I hypertension. Following 45 minutes of meditation, blood pressure was reduced into the prehypertensive range and into the normal range after 10 weeks of practice. The maximal mean reduction in both systolic and diastolic blood pressure occurred after approximately 4 weeks (−18.5 mm Hg systolic and −25.8 mm Hg diastolic). By week 7, both systolic and diastolic blood pressure had come within the prehypertensive range and continued to decline to optimal levels (Fig. 1). At the end of the 8-week program and an additional 3 weeks of continued self-directed practice and data recording, premeditation mean systolic and diastolic blood pressures were significantly reduced. When all daily blood pressure observations were combined, the mean reductions were highly significant: P < .0001 for systolic and P < .0004 for diastolic blood pressure reductions over the 11-week period (Fig. 2). Notably, as blood pressure came within the normal range, the difference before and after meditation also decreased, suggesting MR was maintaining a lower sympathetic tone.
The additional symptoms and behaviors she tracked, such as migraines and exercise, also were reviewed. Migraine frequency was decreased, and through MRs mindful attention to her inner experience, it was determined that migraines were now occurring only in conjunction with the phase of her menstrual cycle. Knowledge of this enabled her to plan accordingly and use her migraine abortive medications appropriately. Body weight, which has been a long-term struggle, has not changed in the 11 weeks of mindfulness meditation. MR has taken the ‘attitudes and commitment’ portion of her 8-week MBSR training very seriously.”
From Self-directed mindfulness training and improvement in blood pressure, migraine frequency, and quality of life4.
10b—Important follow-up test results (positive and negative)
“Outcome and follow-up [Case 1]
The child was extubated on day 3, but the EVD was retained and kept at 10 cm H2O. It was removed after challenge on day 9. A repeat MRI showed markedly decreased cerebellar edema. The child regained a Glasgow Coma Scale score of 15/15 and was discharged on the 11th day of admission, with no neurological deficits. He remained asymptomatic at 2-year follow-up, at which time an MRI was also found to be normal.”
“Outcome and follow-up [Case 2]
he infant’s condition gradually improved, and he started tolerating breast feed. The EVD was removed after 10 days, and a repeat MRI with and without contrast, and MR venogram, showed no venous involvement and resolution of all pathological findings, including the cerebellar swelling, tonsillar herniation, and hydrocephalus. The patient was discharged on oral dexamethasone tapered over several weeks. At 1-year follow-up, the patient showed no neurological deficits and displayed normal growth and development.”
From Acute cerebellitis successful managed with temporary cerebrospinal fluid diversion using a long tunnel external ventricular drain [EVD]: a long-term radiological follow-up of two cases5.
10c—Intervention adherence and tolerability (and how this was assessed)
“Our patients had a few important predisposing factors for parasomnia including increased work-related stress, depression, and severe sleep apnea with high arousal index. If a patient with parasomnia has any other concomitant primary sleep disorder, the treatment is initially directed toward that aspect which often resolves the parasomnia. Our first patient had severe sleep apnea that was treated adequately, but he continued to have sleepwalking and SRED despite good compliance with treatment probably because his SWS had increased after using BiPAP. Our second patient was not able to be compliant with the CPAP initially until she stopped taking quetiapine.”
From Quetiapine-induced sleep-related eating disorder like behavior: a case series6.
10d—Adverse and unanticipated events
“A 56-year-old man weighing 77 kg was admitted with an acute anterior myocardial infarct having had a previous myocardial infarct 2 years before. He had pulmonary edema due to left ventricular failure which partly responded to treatment with frusemide and diamorphine, and he had occasional ventricular extra systoles which were controlled with small doses of lignocaine. On admission, he was in mild renal failure, and over the next 36 hours, this deteriorated to the point where his plasma urea was 125 mg% and creatinine 2.03 mg%. At that time, he was given a total of 1 mg of digoxin orally (13 μg/kg) in three divided doses and shortly after the third developed the various arrhythmias which are shown in Fig. 2; just before a further dose of 0.25 mg intramuscularly; however, he had reverted to sinus rhythm and following that dose he once more developed various arrhythmias. Treatment at different times with intravenous procainamide and intravenous and oral practolol did not affect his arrhythmias, and he had already reverted to sinus rhythm when only one dose of diphenylhydantoin (50 mg) had been given orally. Other drugs which he received were heparin, warfarin, ampicillin, potassium chloride, and diazepam. His plasma digoxin levels following the fourth dose of digoxin are shown in Fig. 2. Only when the plasma digoxin level fell below 1.7 ng/mL was he free from arrhythmias. His T½β was 37.9 h and his Vd 264 L (32.4 L/kg). At a later date, when his renal function had improved slightly (urea 47 mg%, creatinine 1.37 mg%, creatinine clearance 41 ml/min), his steady-state plasma level on a reintroduced daily maintenance dose of 0.125 mg orally was 0.5 ng/mL indicating a Vd of 349 L (4.5 L/kg).”
From Altered distribution of digoxin in renal failure—a cause of digoxin toxicity?7
Training
The UK EQUATOR Centre runs training on how to write using reporting guidelines.
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