case study about urinalysis with discussion

VICTORIA J. SHARP, MD, DANIEL K. LEE, MD, AND ERIC J. ASKELAND, MD

A more recent article on office-based urinalysis is available.

Am Fam Physician. 2014;90(8):542-547

Author disclosure: No relevant financial affiliations.

Urinalysis is useful in diagnosing systemic and genitourinary conditions. In patients with suspected microscopic hematuria, urine dipstick testing may suggest the presence of blood, but results should be confirmed with a microscopic examination. In the absence of obvious causes, the evaluation of microscopic hematuria should include renal function testing, urinary tract imaging, and cystoscopy. In a patient with a ureteral stent, urinalysis alone cannot establish the diagnosis of urinary tract infection. Plain radiography of the kidneys, ureters, and bladder can identify a stent and is preferred over computed tomography. Asymptomatic bacteriuria is the isolation of bacteria in an appropriately collected urine specimen obtained from a person without symptoms of a urinary tract infection. Treatment of asymptomatic bacteriuria is not recommended in nonpregnant adults, including those with prolonged urinary catheter use.

Urinalysis with microscopy has proven to be an invaluable tool for the clinician. Urine dipstick testing and microscopy are useful for the diagnosis of several genitourinary and systemic conditions. 1 , 2 In 2005, a comprehensive review of urinalysis was published in this journal. 3 This article presents a series of case scenarios that illustrate how primary care physicians can utilize the urinalysis in common clinical situations.

Microscopic Hematuria: Case 1

Microscopic hematuria is common and has a broad differential diagnosis, ranging from completely benign causes to potentially invasive malignancy. Causes of hematuria can be classified as glomerular, renal, or urologic 3 – 5 ( Table 1 6 ) . The prevalence of asymptomatic microscopic hematuria varies among populations from 0.18% to 16.1%. 4 The American Urological Association (AUA) defines asymptomatic microscopic hematuria as three or more red blood cells per high-power field in a properly collected specimen in the absence of obvious causes such as infection, menstruation, vigorous exercise, medical renal disease, viral illness, trauma, or a recent urologic procedure. 5 Microscopic confirmation of a positive dipstick test for microscopic hematuria is required. 5 , 7

DIAGNOSTIC APPROACH

Case 1: microscopic hematuria.

A 58-year-old truck driver with a 30-year history of smoking one pack of cigarettes per day presents for a physical examination. He reports increased frequency of urination and nocturia, but does not have gross hematuria. Physical examination reveals an enlarged prostate. Results of his urinalysis with microscopy are shown in Table 2 .

Based on this patient's history, symptoms, and urinalysis findings, which one of the following is the most appropriate next step?

A. Repeat urinalysis in six months.

B. Obtain blood urea nitrogen and creatinine levels, perform computed tomographic urography, and refer for cystoscopy.

C. Treat with an antibiotic and repeat the urinalysis with microscopy.

D. Inform him that his enlarged prostate is causing microscopic hematuria, and that he can follow up as needed.

E. Perform urine cytology to evaluate for bladder cancer.

The correct answer is B .

For the patient in case 1 , because of his age, clinical history, and lack of other clear causes, the most appropriate course of action is to obtain blood urea nitrogen and creatinine levels, perform computed tomographic urography, and refer the patient for cystoscopy. 5 An algorithm for diagnosis, evaluation, and follow-up of patients with asymptomatic microscopic hematuria is presented in Figure 1 . 5 The AUA does not recommend repeating urinalysis with microscopy before the workup, especially in patients who smoke, because tobacco use is a risk factor for urothelial cancer ( Table 3 ) . 5

A previous article in American Family Physician reviewed the American College of Radiology's Appropriateness Criteria for radiologic evaluation of microscopic hematuria. 8 Computed tomographic urography is the preferred imaging modality for the evaluation of patients with asymptomatic microscopic hematuria. 5 , 8 It has three phases that can detect various causes of hematuria. The non–contrast-enhanced phase is optimal for detecting stones in the urinary tract; the nephrographic phase is useful for detecting renal masses, such as renal cell carcinoma; and the delayed phase outlines the collecting system of the urinary tract and can help detect urothelial malignancies of the upper urinary tract. 9 Although the delayed phase can detect some bladder masses, it should not replace cystoscopy in the evaluation for bladder malignancy. 9 After a negative microscopic hematuria workup, the patient should continue to be followed with yearly urinalysis until at least two consecutive normal results are obtained. 5

In patients with microscopic hematuria, repeating urinalysis in six months or treating empirically with antibiotics could delay treatment of potentially curable diseases. It is unwise to assume that benign prostatic hyperplasia is the explanation for hematuria, particularly because patients with this condition typically have risk factors for malignancy. Although urine cytology is typically part of the urologic workup, it should be performed at the time of cystoscopy; the AUA does not recommend urine cytology as the initial test. 5

Dysuria and Flank Pain After Lithotripsy: Case 2

After ureteroscopy with lithotripsy, a ureteral stent is often placed to maintain adequate urinary drainage. 10 The stent has one coil that lies in the bladder and another that lies in the renal pelvis. Patients with ureteral stents may experience urinary frequency, urgency, dysuria, flank pain, and hematuria. 10 They may have dull flank pain that becomes sharp with voiding. This phenomenon occurs because the ureteral stent bypasses the normal nonrefluxing uretero-vesical junction, resulting in transmission of pressure to the renal pelvis with voiding. Approximately 80% of patients with a ureteral stent experience stent-related pain that affects their daily activities. 11

POTENTIALLY MISLEADING URINALYSIS

Case 2: dysuria and flank pain after lithotripsy.

A 33-year-old woman with a history of nephrolithiasis presents with a four-week history of urinary frequency, urgency, urge incontinence, and dysuria. She recently had ureteroscopy with lithotripsy of a 9-mm obstructing left ureteral stone; she does not know if a ureteral stent was placed. She has constant dull left flank pain that becomes sharp with voiding. Results of her urinalysis with microscopy are shown in Table 4 .

A. Treat with three days of ciprofloxacin (Cipro), and tailor further antibiotic therapy according to culture results.

B. Treat with 14 days of ciprofloxacin, and tailor further antibiotic therapy according to culture results.

C. Obtain a urine culture and perform plain radiography of the kidneys, ureters, and bladder.

D. Perform a 24-hour urine collection for a metabolic stone workup.

E. Perform computed tomography.

The correct answer is C .

The presence of a ureteral stent causes mucosal irritation and inflammation; thus, findings of leukocyte esterase with white and red blood cells are not diagnostic for urinary tract infection, and a urine culture is required. In this setting, plain radiography of the kidneys, ureters, and bladder would be useful to determine the presence of a stent. If a primary care physician identifies a neglected ureteral stent, prompt urologic referral is indicated for removal. Retained ureteral stents may become encrusted, and resultant stone formation may lead to obstruction. 10

Flank discomfort and recent history of urinary tract manipulation suggest that this is not an uncomplicated urinary tract infection; therefore, a three-day course of antibiotics is inadequate. Although flank pain and urinalysis suggest possible pyelonephritis, this patient should not be treated for simple pyelonephritis in the absence of radiography to identify a stent. A metabolic stone workup may be useful for prevention of future kidney stones, but it is not indicated in the acute setting. Finally, although computed tomography would detect a ureteral stent, it is not preferred over radiography because it exposes the patient to unnecessary radiation. Typically, microscopic hematuria requires follow-up to ensure that there is not an underlying treatable etiology. In this case , the patient's recent ureteroscopy with lithotripsy is likely the etiology.

Urinalysis in a Patient Performing Clean Intermittent Catheterization: Case 3

Case 3: urinalysis in a patient performing clean intermittent catheterization.

A 49-year-old man who has a history of neurogenic bladder due to a spinal cord injury and who performs clean intermittent catheterization visits your clinic for evaluation. He reports that he often has strong-smelling urine, but has no dysuria, urge incontinence, fever, or suprapubic pain. Results of his urinalysis with microscopy are shown in Table 5 .

A. Inform the patient that he has a urinary tract infection, obtain a urine culture, and treat with antibiotics.

B. Refer him to a urologist for evaluation of a complicated urinary tract infection.

C. Perform computed tomography of the abdomen and pelvis to evaluate for kidney or bladder stones.

D. Inform him that no treatment is needed.

E. Obtain a serum creatinine level to evaluate for chronic kidney disease.

The correct answer is D .

Although the urinalysis results are consistent with a urinary tract infection, the clinical history suggests asymptomatic bacteriuria. Asymptomatic bacteriuria is the isolation of bacteria in an appropriately collected urine specimen obtained from a person without symptoms of a urinary tract infection. 12 The presence of bacteria in the urine after prolonged catheterization has been well described; one study of 605 consecutive weekly urine specimens from 20 chronically catheterized patients found that 98% contained high concentrations of bacteria, and 77% were polymicrobial. 13

Similar results have been reported in patients who perform clean intermittent catheterization; another study of 1,413 urine cultures obtained from 407 patients undergoing clean intermittent catheterization found that 50.6% contained bacteria. 14 Guidelines from the Infectious Diseases Society of America recommend against treatment of asymptomatic bacteriuria in nonpregnant patients with spinal cord injury who are undergoing clean intermittent catheterization or in those using a chronic indwelling catheter. 12

In the absence of symptoms of a urinary tract infection or nephrolithiasis, there is no need to culture the urine, treat with antibiotics, refer to a urologist, or perform imaging of the abdomen and pelvis. There is no reason to suspect acute kidney injury in this setting; thus, measurement of the serum creatinine level is also unnecessary.

Data Sources : Literature searches were performed in PubMed using the terms urinalysis review, urinalysis interpretation, microscopic hematuria, CT urogram, urinary crystals, indwelling ureteral stent, asymptomatic bacteriuria, and bacteriuria with catheterization. Guidelines from the American Urological Association were also reviewed. Search dates: October 2012 and June 2013.

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Nicolle LE, Bradley S, Colgan R, Rice JC, Schaeffer A, Hooton TM Infectious Diseases Society of America; American Society of Nephrology; American Geriatric Society. Infectious Diseases Society of America guidelines for the diagnosis and treatment of asymptomatic bacteriuria in adults [published correction appears in Clin Infect Dis . 2005;40(10):1556]. Clin Infect Dis. 2005;40(5):643-654.

Warren JW, Tenney JH, Hoopes JM, Muncie HL, Anthony WC. A prospective microbiologic study of bacteriuria in patients with chronic indwelling urethral catheters. J Infect Dis. 1982;146(6):719-723.

Bakke A, Digranes A. Bacteriuria in patients treated with clean intermittent catheterization. Scand J Infect Dis. 1991;23(5):577-582.

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Gerald D. Redwine, PhD, MT(ASCP)

The physical and chemical examination of urine samples plays an essential role in the diagnosis of patients’ pathological conditions. However, the sheer number of routine urinalysis can minimize their significance, especially considering that most analyses are automated, which can foster complacency for less than apparent problems. As a result of seemingly more critical concerns, one may defer the interpretation for the clinician to assess. Nevertheless, detecting abnormal results and possible causes is required, regardless of whether the analysis was manual or automated. Knowing the effects of pigmentation, drugs, pH, and ascorbic acid, for example, are samples that always need attention.

Manual analysis is further complicated, with several idiosyncrasies innate to manufacturers. For example, differences in popular brands, such as, Multistix, that requires reading each chemical pad at the specific time indicated. But the Chemstrip and vChem strips readings are stable between one and two minutes, except leukocytes read at two minutes, all necessitating the need for special attention to the manufacturers’ instructions. Concerning ascorbic acid, knowing that Chemstrip eliminates ascorbic acid interference with blood by overlaying the pad with iodate, and the vChem strips have a detection pad for the substance; in contrast, knowing that the Multistix has neither, is essential. Finally, knowing to ignore the different coloration on the perimeter of the pad on all strips and asking for a recollect on extremely high pH is also vital.

How are the critical thinking skills needed for a urinalysis assessment best developed? In academia, it seemed best, following initial training, to have students complete weeks of daily intensive practice of the entire urinalysis (physical, chemical, and microscopic) in an open lab setting on multiple patient samples. In combination with these analyses, they were given case studies like the ones administered later in a practical examination. The following is a composite of the answer stating what they thought was the most probable cause to three of the 17 cases given on their exam, using Multistix, with further comments in parenthesis. Assessments constrained the students to answer the question under the given condition, knowing they would ask for a recollect in some instances.

What would explain the apparent disagreement between the nitrite and leukocyte reaction?
What accounts for the clarity of the sample in the chemical examination?
What does the Acetest suggest about the chemical reactions, based on literature?
Non-nitrate reducing organism. (i.e., bacteria, yeast, trichomonads, and chlamydia) Or Trauma. (Other less likely possibilities.)
Large blood. (Also slightly enhanced the protein.)
More sensitive because of the added glycine. (Glycine detects acetone. vChem strips have the same.)
What could explain the single most unexpected finding within the chemical reactions?
What could account for the protein and SSA discrepancy?
What should the adjusted strip value read?
What is the definitive source(s) for reporting the final specific gravity (SG) reading (manual/analyzer/and or name another source) on this specimen?
With an SG = 1.040, what value is the final specific gravity?
Negative leukocytes could result from any or all three of the following. 1) Alkalinity 2) >3g/dL glucose 3) High specific gravity.
Alkaline pH can cause a false positive protein; also, the blood that is missing in the supernatant for the SSA could account for the 2+ SSA.
Because pH is ≥ 6.5, then add .005 to the dip strip value. Strip SG = 1.035 . (Multistix only)
Because of the ≥ 100 protein, then run on the refractometer. (Total Solid (TS) meter/Refractometer.)
Subtract 0.003 for every 1 g/dl protein; subtract 0.004 for every 1 g/dl glucose. Report SG: 1.026 .
What could explain the disagreement that exists within the chemical reactions?
Explain the correlation between chemical reactions and the SSA?
What are the two specific adjustments needed for the specific gravity?
What is the final strip specific gravity?
A non-nitrite reducing microbe such as Trichomonas or Chlamydia . Or postrenal trauma. (Other nitrite negative possibilities. Also, if not for the trace protein, ascorbic acid is suspect.) Best observation: Yellow-Green ~ Biliverdin. False-negative bilirubin. Hence, the need for a recollection and run on a fresh sample to ascertain the true values.
Expected the SSA to be greater. Alkaline pH can cause a false positive protein, or in this case, falsely increase the value.
Because pH is ≥ 6.5, then add .005 to the dip strip value. Because of the ≥ 100 protein, then run on the refractometer. TS (Total Solid) meter/Refractometer. (Multistix only)
Strip SG = 1.015.

Responses to the open lab concept, despite significantly more than usual time commitment on behalf of all involved, and reagents, the sacrifices were met with positive feedback from the students on superseding their learning outcomes. The learning outcomes summarized is critical thinking applied to urinalysis case studies.

Reference: Brunzel, N. A., MS, MLS(ASCP) CM . Fundamentals of Urine and Body Fluid Analysis , 4th Edition

Gerald D. Redwine is an associate professor at Texas State University Clinical Laboratory Science Program in San Marcos, Texas.

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Urinary tract infection in an older patient: a case study and review

Advanced Nurse Practitioner, Primary Care

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Gerri Mortimore

Senior lecturer in advanced practice, department of health and social care, University of Derby

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case study about urinalysis with discussion

This article will discuss and reflect on a case study involving the prescribing of nitrofurantoin, by a non-medical prescriber, for a suspected symptomatic uncomplicated urinary tract infection in a patient living in a care home. The focus will be around the consultation and decision-making process of prescribing and the difficulties faced when dealing with frail, uncommunicative patients. This article will explore and critique the evidence-base, local and national guidelines, and primary research around the pharmacokinetics and pharmacodynamics of nitrofurantoin, a commonly prescribed medication. Consideration of the legal, ethical and professional issues when prescribing in a non-medical capacity will also be sought, concluding with a review of the continuing professional development required to influence future prescribing decisions relating to the case study.

Urinary tract infections are common in older people. Haley Read and Gerri Mortimore describe the decision making process in the case of an older patient with a UTI

One of the growing community healthcare delivery agendas is that of the advanced nurse practitioner (ANP) role to improve access to timely, appropriate assessment and treatment of patients, in an attempt to avoid unnecessary health deterioration and/or hospitalisation ( O'Neill et al, 2021 ). The Core Capabilities Framework for Advanced Clinical Practice (Nurses) Working in General Practice/Primary Care in England recognises the application of essential skills, including sound consultation and clinical decision making for prescribing appropriate treatment ( Health Education England [HEE], 2020 ). This article will discuss and reflect on a case study involving the prescribing of nitrofurantoin by a ANP for a suspected symptomatic uncomplicated urinary tract infection (UTI), in a patient living in a care home. Focus will be around the consultation and decision-making process of non-medical prescribing and will explore and critique the evidence-base, examining the local and national guidelines and primary research around the pharmacokinetics and pharmacodynamics of nitrofurantoin. Consideration of the legal, ethical and professional issues when prescribing in a non-medical capacity will also be sought, concluding with review of the continuing professional development required to influence future prescribing decisions relating to the case study.

Mrs M, an 87-year-old lady living in a nursing home, was referred to the community ANP by the senior carer. The presenting complaint was reported as dark, cloudy, foul-smelling urine, with new confusion and night-time hallucinations. The carer reported a history of disturbed night sleep, with hallucinations of spiders crawling in bed, followed by agitation, lethargy and poor oral intake the next morning. The SBAR (situation, background, assessment, recommendation) tool was adopted, ensuring structured and relevant communication was obtained ( NHS England and NHS Improvement, 2021 ). The National Institute for Health and Care Excellence ( NICE, 2021 ) recognises that cloudy, foul-smelling urine may indicate UTI. Other symptoms include increased frequency or pressure to pass urine, dysuria, haematuria or dark coloured urine, mild fever, night-time urination, and increased sweats or chills, with lower abdominal/loin pain suggesting severe infection. NICE (2021) highlight that patients with confusion may not report UTI symptoms. This is supported by Gupta and Gupta (2019) , who recognise new confusion as hyper-delirium, which can be attributed to several causative factors including infection, dehydration, constipation and medication, among others.

UTIs are one of the most common infections worldwide ( O'Grady et al, 2019 ). Lajiness and Lajiness (2019) define UTI as a presence of colonising bacteria that cause a multitude of symptoms affecting either the upper or lower urinary tract. NICE (2021) further classifies UTIs as either uncomplicated or complicated, with complicated involving other systemic conditions or pre-existing diseases. Geerts et al (2013) postulate around 30% of females will develop a UTI at least once in their life. The incidence increases with age, with those over 65 years of age being five times more likely to develop a UTI at any point. Further increased prevalence is found in patients who live in a care home, with up to 60% of all infections caused by UTI ( Bardsley, 2017 ).

Greener (2011) reported that symptoms of UTIs are often underestimated by clinicians. A study cited by Greener (2011) found over half of GPs did not record the UTI symptoms that the patient had reported. It is, therefore, essential during the consultation to use open-ended questions, listening to the terminology of the patient or carers to clarify the symptoms and creating an objective history ( Taylor, 2016 ).

In this case, the carer highlighted that Mrs M had been treated for suspected UTI twice in the last 12 months. Greener (2011) , in their literature review of 8 Cochrane review papers and 1 systematic review, which looked at recurrent UTI incidences in general practice, found 48% of women went on to have a further episode within 12 months.

Mrs M's past medical history reviewed via the GP electronic notes included:

Hypertension
Diverticular disease
Basal cell carcinoma of scalp
Retinal vein occlusion
Severe frailty
Fracture of proximal end of femur
Total left hip replacement
Previous indwelling urinary catheter
Chronic kidney disease (CKD) stage 2
Urinary and faecal incontinence
And, most recently, vesicovaginal fistula.

Bardsley (2017) identified further UTI risk factors including postmenopausal females, frailty, co-morbidity, incontinence and use of urethral catheterisation. Vesicovaginal fistulas also predispose to recurrent UTIs, due to the increase in urinary incontinence ( Stamatokos et al, 2014 ). Moreover, UTIs are common in older females living in a care home ( Bradley and Sheeran, 2017 ). They can cause severe risks to the patient if left untreated, leading to complications such as pyelonephritis or sepsis ( Ahmed et al, 2018 ).

Mrs M's medication included:

Paracetamol 1 g as required
Lactulose 10 ml twice daily
Docusate 200 mg twice daily
Epimax cream
Colecalciferol 400 units daily
Alendronic acid 70 mg weekly.

She did not take any herbal or over the counter preparations. Her records reported no known drug allergies; however, she was allergic to Elastoplast. A vital part of clinical history involves reviewing current prescribed and non-prescribed medications, herbal remedies and drug allergies, to prevent contraindications or reactions with potential prescribed medication ( Royal Pharmaceutical Society, 2019 ). Several authors, including Malcolm et al (2018) , indicate polypharmacy as a common cause of adverse drug reactions (ADRs), worsening health and affecting a person's quality of life. NICE (2015) only recommends review of patients who are on four or more medications on each new clinical intervention, not taking into account individual drug interactions.

Due to Mrs M's lack of capacity, her social history was obtained via the electronic record and the carer. She moved to the care home 3 years ago, following respite care after her fall and hip replacement. She had never smoked or drank alcohol. Documented family history revealed stroke, ischaemic heart disease and breast cancer. Taylor (2016) reports a good thorough clinical history can equate to 90% of the working diagnosis before examination, potentially reducing unnecessary tests and investigations. This can prove challenging when the patient has confusion. It takes a more investigative approach, gaining access to medical/nursing care notes, and using family or carers to provide further collateral history ( Gupta and Gupta, 2019 ).

As per NICE (2021) guidelines, a physical examination of Mrs M was carried out. On examination it was noted that Mrs M had mild pallor with normal capillary refill time, no signs of peripheral or central cyanosis, and no clinical stigmata to note. Her heart rate was elevated at 112 beats per minute and regular, she had a normal respiration rate of 17 breaths per minute, oxygen saturations (SpO 2 ) were 98% on room air and blood pressure was 116/70 mm/Hg. Her temperature was 37.3oC. According to Doyle and Schortgen (2016) , there is no agreed level of fever; however, it becomes significant when above 38.3oC. Bardsley (2017) adds that older patients do not always present with pyrexia in UTI because of an impaired immune response.

Heart and chest sounds were normal, with no peripheral oedema. The abdomen was non-distended, soft and non-tender on palpation, with no reports of nausea, vomiting, supra-pubic tenderness or loin pain. Loin pain or suprapubic tenderness can indicate pyelonephritis ( Bardsley, 2017 ). Tachycardia, fever, confusion, drowsiness, nausea/vomiting or tachypnoea are strong predictive signs of sepsis ( NICE, 2021 ).

During the consultation, confusion and restlessness were evident. Therefore, it was difficult to ask direct questions to Mrs M regarding pain, nausea and dizziness. Non-verbal cues were considered, as changes in behaviour and restlessness can potentially highlight discomfort or pain ( Swift, 2018 ).

Mrs M's most recent blood tests indicated CKD stage 2, based on an estimated glomerular filtration rate (eGFR) of 82 ml/minute/1.73m 2 . The degree of renal function is vital to establish prior to any prescribing decision, because of the potential increased risk of drug toxicity ( Doogue and Polasek, 2013 ). The agreed level of mild renal impairment is when eGFR is <60 ml/minute/1.73 m 2 , with chronic renal impairment established when eGFR levels are sustained over a 3-month period ( Ahmed et al, 2018 ).

Previous urine samples of Mrs M grew Escherichia coli bacteria, sensitive to nitrofurantoin but resistant to trimethoprim. A consensus of papers, including Lajiness and Lajiness (2019) , highlight the most common pathogen for UTI as E. coli. Fransen et al (2016) indicates that increased use of empirical antibiotics has led to a prevalence of extended spectrum beta lactamase positive (ESBL+) bacteria that are resistant to many current antibiotics. This is not taken into account by the NICE guidelines (2021) ; however, it is discussed in local guidelines ( Barnsley Hospital NHS FT/Rotherham NHS FT, 2022 ).

Mrs M was unable to provide an uncontaminated urine sample due to incontinence. NICE (2021) advocate urine culture as a definitive diagnostic tool for UTIs; however, do not highlight how to objectively obtain this. Bardsley (2017) recognises the benefit of an uncontaminated urinalysis in symptomatic patients, stating that alongside other clinical signs, nitrates and leucocytes strongly predict the possibility of UTI. O'Grady et al (2019) points out that although NICE emphasise urine culture collection, it omits the use of urinalysis as part of the assessment.

Based on Ms M's clinical history and physical examination, a working diagnosis of suspected symptomatic uncomplicated UTI was hypothesised. A decision was made, based on the local antibiotic prescribing guidelines, as well as the NICE (2021) guidelines, to treat empirically with nitrofurantoin modified release (MR), 100 mg twice daily for 3 days, to avoid further health or systemic complications. The use of electronic prescribing was adopted as per local organisational policy and the Royal Pharmaceutical Society (2019) . Electronic prescribing is essential for legibility and sharing of prescribing information. It also acts as an audit on prescribing practices, providing a contemporaneous history for any potential litigation ( Lovatt, 2010 ).

Pharmacokinetics and pharmacodynamics

Lajiness and Lajiness (2019) reflect on the origins of nitrofurantoin back to the 1950s, following high penicillin usage leading to resistance of Gram-negative bacteria. Nitrofurantoin has been the first-line empirical treatment for UTIs internationally since 2010, despite other antibacterial agents being discovered ( Wijma et al, 2020 ). Mckinell et al (2011) highlight that a surge in bacterial resistance brought about interest in nitrofurantoin as a first-line option. Their systematic review of the literature indicated through a cost and efficacy decision analysis that nitrofurantoin was a low resistance and low cost risk; therefore, an effective alternative to trimethoprim or fluoroquinolones. The weakness of this paper is the lack of data on nitrofurantoin cure rates and resistance studies, demonstrating an inability to predict complete superiority of nitrofurantoin over other antibiotics. This could be down to the reduced use of nitrofurantoin treatment at the time.

Fransen et al (2016) reported that minimal pharmacodynamic knowledge of nitrofurantoin exists, despite its strong evidence-based results against most common urinary pathogens, and being around for the last 70 years. Wijma et al (2018) hypothesised this was because of the lack of drug approval requirements in the era when nitrofurantoin was first produced, and the growing incidence of antibiotic resistance. Pharmacokinetics and pharmacodynamics are clinically important to guide effective drug therapy and avoid potential ADRs. Focus on the absorption, distribution, metabolism and excretion (ADME) of nitrofurantoin is needed to evaluate the correct choice for an individual patient, based on a holistic assessment ( Doogue and Polasek, 2013 ).

Nitrofurantoin is structurally made up of 4 carbon and 1 oxygen atoms forming a furan ring, connected to a nitrogroup (–NO 2 ). Its mode of action is predominantly bacteriostatic, with some bactericidal tendencies in high concentration levels ( Wijma et al, 2018 ). It works by inhibiting bacterial cell growth, breaking down its strands of DNA ( Komp Lindgren et al, 2015 ). Hoang and Salbu (2016) add that nitrofurantoin causes bacterial flavoproteins to create reactive medians that halt bacterial ribosomal proteins, rendering DNA/RNA cell wall synthesis inactive.

Nitrofurantoin is administered orally via capsules or liquid. Greener (2011) highlights the different formulations, which originally included microcrystalline tablets and now include macro-crystalline capsules. The increased size of crystals was found to slow absorption rates down ( Hoang and Salbu, 2016 ). Nitrofurantoin is predominantly absorbed via the gastro-intestinal tract, enhanced by an acidic environment. It is advised to take nitrofurantoin with food, to slow down gastric emptying ( Wijma et al, 2018 ). The maximum blood concentration of nitrofurantoin is said to be <0.6 mg/l. Lower plasma concentration equates to lower toxicity risk; therefore, nitrofurantoin is favourable over fluoroquinolones ( Komp Lindgren et al, 2015 ). Wijma et al (2020) found a reduced effect on gut flora compared to fluoroquinolones.

Distribution of nitrofurantoin is mainly via the renal medulla, with a renal bioavailability of 38.8–44%; therefore, it is specific for urinary action ( Hoang and Salbu, 2016 ). Haasum et al (2013) highlight the inability for nitrofurantoin to penetrate the prostate where bacteria concentration levels can be present. Therefore, they do not advocate the use of nitrofurantoin to treat males with UTIs, because of the risk of treatment failure and further complications of systemic infection. This did not appear to be addressed by local guidelines.

The metabolism of nitrofurantoin is not completely understood; however, Wijma et al (2018) indicate several potential metabolic antibacterial actions. Around 0.8–1.8% is metabolised into aminofurantoin, with 80.9% other unknown metabolites ( medicines.org, 2022 ). Wijma et al (2020) calls for further study into the metabolism of nitrofurantoin to aid understanding of the pharmacodynamics.

Excretion of nitrofurantoin is predominantly via urine, with a peak time of 4–5 hours, and 27–50% excreted unchanged in urine ( medicines.org, 2022 ). Komp Lindgren et al (2015) equates the fast rates of renal availability and excretion to lower toxicity risks and targeted treatment for UTI pathogens. Wijma et al (2018) found high plasma concentration levels of nitrofurantoin in renal impairment. Singh et al (2015) indicate that nitrofurantoin is mainly eliminated via glomerular filtration; therefore, its impairment presents the potential risks of treatment failure and increased ADRs. Early guidelines stipulated the need to avoid nitrofurantoin in patients with mild renal impairment, indicating the need for an eGFR of >60 ml/min due to this toxicity risk. This was based on several small studies, cited by Hoang and Salbu (2016) , looking at concentration levels rather than focused on patient treatment outcomes.

Primary research by Geerts et al (2013) involving treatment outcomes in a large cohort study, led to guidelines changing the limit to mild to moderate impairment or eGFR >45 ml/min. However, the risk of ADRs, including pulmonary fibrosis and hepatic changes, were increased in renal insufficiency with prolonged use. The study participants had a mean age of 47.8 years; therefore, the study did not indicate the effects on older patients. Singh et al (2015) presented a Canadian study, looking at treatment success with nitrofurantoin in older females, with a mean age of 79 years. It indicated effective treatment despite mild/moderate renal impairment. It did not address the levels of ADRs or hospitalisation. Ahmed et al (2018) conducted a large, UK-based, retrospective cohort study favouring use of empirical nitrofurantoin in the older population with increased risk of UTI-related hospitalisation and mild/moderate renal impairment. It concluded not treating could increase mortality and morbidity. This led to guidelines to support empirical treatment of symptomatic older patients with nitrofurantoin.

Dosing is highly variable between the local and national guidelines. Greener (2011) highlights that product information for the macro-crystalline capsules recommends 50–100 mg 4 times a day for 7 days when treating acute uncomplicated UTI. Local guidelines from Barnsley Hospital NHS FT/Rotherham NHS FT Adult antimicrobial guide (2022) stipulate 50–100 mg 4 times daily for 3 days for women, whereas NICE (2021) recommends a MR version of 100 mg twice daily for 3 days.

In a systematic literature review on the pharmacokinetics of nitrofurantoin, Wijma et al (2018) found that use of a 5–7 day course had similar strong efficacy rates, whereas 3 days did not, potentially causing treatment failure, equating to poor patient outcomes and resistant behaviour. Deresinski (2018) conducted a small, randomised controlled trial involving 377 patients either on nitrofurantoin MR 100 mg three times a day for 5 days or fosfomycin single dose treatment after urinalysis and culture. It looked at response to treatment after 28 days. Nitrofurantoin was found to have a 78% cure rate compared to 50% with fosfomycin. Therefore, these studies directly contradict current NICE and local guidelines on treatment dosing of UTI in women. More robust studies on dosing regimens are therefore required.

Fransen et al (2016) conducted a non-human pharmacodynamics study looking at time of action to treat on 11 strains of common UTI bacteria including two ESBL+. It demonstrated the kill rate for E. coli was 16–24 hours, slower than Enterobacter cloacae (6–8 hours) and Klebsiella pneumoniae (8 hours). The findings also indicated that nitrofurantoin appeared effective against ESBL+. Dosing and urine concentrations were measured, and found that 100 mg every 6 hours kept the urine concentration levels significant enough to reach peak levels. This study directly contradicted the findings of Lindgren et al (2015) , who conducted similar non-human kinetic style kill rate studies, and found nitrofurantoin's dynamic action to be within 6 hours for E. coli. Both studies have limitations in that they did not take into account human immune response effects.

Wijma et al (2020) highlighted inconsistent dosing regimens in their retrospective audit involving 150 patients treated for UTIs across three Australian secondary care facilities. The predominant dosing of nitrofurantoin was 100 mg twice daily for 5 days for women and 7 days for males. Although a small audit-based paper, it creates debate regarding the lack of clarity around the correct dosing, leaving it open to error. It therefore requires primary research into the follow up of cure rates on guideline prescribing regimens. Dose and timing remains an important issue to reduce treatment failure. It indicates the need for bacteria-dependant dosing, which currently NICE (2021) does not discuss.

Haasum et al (2013) found poor adherence to guidelines for choice and dosing in elderly patients in their Swedish register-based large population study. It highlighted high use of trimethoprim in frail older care home residents, despite guidelines recommending nitrofurantoin as first-line. A recent retrospective, observational, quantitative study by Langner et al (2021) involving 44.9 million women treated for a UTI in the USA across primary and secondary care, found an overuse of fluoroquinolones and underuse of nitrofurantoin and trimethoprim, especially by primary care physicians for older Asian and socio-economically deprived patients. Both these studies did not seek a true qualitative rationale for choices of antibiotics; therefore, limiting the findings.

Legal and ethical considerations

NMP regulation of best practice is set by the Royal Pharmaceutical Society framework (2019) , incorporating several acts of law including the medicines act 1968, and medicinal products prescribed by the Nurses Act (1992). As per Nursing Midwifery Council (2021) Code of Conduct and Health Education England (2020), ANPs have a duty of care to patients, ensuring that they work within their area of competence and recognise any limitations, demonstrating accountability for decisions made ( Lovatt, 2010 ).

Empirical treatment of UTIs is debated in the literature. O'Grady et al (2019) summarises that empirical treatment can reduce further UTI complications that can lead to acute health needs and hospitalisation, without increased risk of antibiotic resistance. Greener (2011) states that uncomplicated UTIs can be self-limiting; therefore, not always warranting antibiotic treatment if sound self-care advice is adopted. Chardavoyne and Kasmire (2020) discuss delayed prescribing, involving putting the onus on the patient and carers, which was not advisable in the case of Mrs M. Bradley and Sheeran (2017) found that three quarters of antibiotics in care home residents were prescribed inaccurately, hence recommended a watch and wait approach to treatment in the older care home resident, following implementation of a risk reduction strategy.

Taylor (2016) recommended an individual, holistic approach, incorporating ethical considerations such as choice, level of concordance, understanding and agreement of treatment choice. This can prove difficult in a case such as Mrs M. If a patient is deemed to lack capacity, a decision to act in the patient's best interest should be applied ( Gupta and Gupta, 2019 ). Therefore, understanding a patient's beliefs and values via family or carers should be explored, balancing the needs and possible outcomes. The principle of non-maleficence should be adopted, looking at risks versus benefits on prescribing the antibiotic to the individual patient ( Royal Pharmaceutical Society, 2019 ).

Non-pharmacological advice was provided to the carers to ensure that Mrs M maintained good fluid intake of 2 litres in 24 hours. NICE (2021) advocates the use of written self-care advice leaflets that have been produced to educate patients and/or carers on non-pharmacological actions, supporting recovery and improving outcomes. The use of paracetamol for symptoms of fever and/or pain was also recommended for Mrs M. Prevention strategies proposed by Lajiness and Lajiness (2019) included looking at the benefits of oestrogen cream in post-menopausal women in reducing the incidence of UTIs. Cranberry juice, probiotics and vitamin C ingestion are not supported by any strong evidence base.

There is a duty of care to ensure that follow up of the patient during and after treatment is delivered by the NMP ( Chardavoyne and Kasmire, 2020 ). Clinical safety netting advice was discussed with the carers to monitor Mrs M for any deterioration, and to seek further clinical review urgently. Particular attention to signs of ADRs and sepsis, and the need for 999 response if these occurred, was advocated. A treatment plan was also sent to the GP to ensure sound communication and continuation of safe care ( Taylor, 2016 ).

Professional development issues

The extended role of prescribing brings additional responsibility, with onus on both the NMP and the employer vicariously, to ensure key skills are updated. This is where continued professional development involving research, training and knowledge is sought and applied, using evidence-based, up-to-date practice ( HEE, 2020 ). Adoption of antibiotic stewardship is highlighted by several papers including Lajiness and Lajiness (2019) . They advise nine points to consider, to increase knowledge around the actions and consequences of the drug by the prescriber. Despite no acknowledgment in NICE (2021) guidance, previous results of infections and sensitivities are also proposed as vital in antibiotic stewardship.

The use of decision support tools, proposed by Malcolm et al (2018) , involves an audit approach looking at antibiograms, that highlight local microbiology resistance patterns to aid antibiotic choices, alongside a risk reduction team strategy. Bradley and Sheeran (2017) looked at improving antibiotic use for UTI treatment in a care home in Pennsylvania. They employed a programme of monitoring and educating clinical staff, patients, carers and relatives in evidence-based self-care and clinical assessment skills over a 30-month period. It demonstrated a reduction in inappropriate antibiotic prescribing, and an improvement in monitoring symptoms and self-care practices, creating better patient outcomes. It was evaluated highly by nursing staff, who reported a sense of autonomy and confidence involving team work. Langner et al (2021) calls for further education and feedback to prescribers, involving pharmacists and microbiology data to identify and understand patterns of prescribing.

UTIs can be misdiagnosed and under- or over-treated, despite the presence of local and national guidelines. Continued monitoring of nitrofurantoin use requires priority, due to its first-line treatment status internationally, as this may increase reliance and overuse of the drug, with potential for resistant strains of bacteria becoming prevalent.

Diligent clinical assessment skills and prescribing of appropriate treatment is paramount to ensure risk of serious complications, hospitalisation and mortality are reduced, while quality of life is maintained. The use of competent clinical practice, up-to-date evidence-based knowledge, good communication and understanding of individual patient needs, and concordance are essential to make sound prescribing choices to avoid harm. As well as the prescribing of medications, the education, monitoring and follow-up of the patient and prescribing practices are equally a vital part of the autonomous role of the NMP.

KEY POINTS:

Urinary tract infections (UTIs) can be misdiagnosed and under- or over-treated, despite the presence of local and national guidelines
The incidence of UTI increases with age, with those over 65 years of age being five times more likely to develop a UTI at any point
Nitrofurantoin has been the first-line empirical treatment for UTIs internationally since 2010. Its mode of action is predominantly bacteriostatic, with some bactericidal tendencies in high concentration levels
Diligent clinical assessment skills and prescribing of appropriate treatment is paramount to ensure risk of serious complications, hospitalisation and mortality are reduced, while quality of life is maintained

CPD REFLECTIVE PRACTICE:

How can a good clinical history be gained if the patient lacks capacity?
What factors need to be considered when safety netting in cases like this?
What non-pharmacological advice would you give to a patient with a urinary tract infection (or their carers)?
How will this article change your clinical practice?

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Materials and methods.

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Teaching the microscopic examination of urine sediment to second year medical students using the Urinalysis-Tutor computer program

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Carla Phillips, Paul J Henderson, Lynn Mandel, Sara Kim, Doug Schaad, Mindy Cooper, Claudia Bien, Adam Orkand, Mark H Wener, James S Fine, Michael L Astion, Teaching the microscopic examination of urine sediment to second year medical students using the Urinalysis-Tutor computer program, Clinical Chemistry , Volume 44, Issue 8, 1 August 1998, Pages 1692–1700, https://doi.org/10.1093/clinchem/44.8.1692

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The microscopic examination of urine sediment is a common diagnostic tool taught to medical students, medical technologists, and others. The urine microscopic exam is difficult to teach because supervised instruction and textbook-based teaching suffer from numerous drawbacks. Here, we describe Urinalysis-Tutor, a computer program that uses digitized microscope images and computer-based teaching techniques to systematically teach the urine microscopic exam. In addition, we report the results of a 2-year study that evaluated the effectiveness of the program in 314 second year medical students who were required to use the program. The program contained two, 20-question exams. In the first year of the study (1996), one of the exams was chosen as the pretest and the other as the posttest; the pretest had to be completed before the students viewed the contents of the program, and the posttest was taken after finishing the tutorial. In 1997, the order of the two exams was reversed. In 1996, 159 students completed the study. The mean pretest score was 34% (SD, 14%), the mean posttest score was 71% (SD, 13%), and the improvement was significant ( P <0.001, paired t -test). In 1997, 155 students participated. The mean pretest score was 41% (SD, 11%), the mean posttest score was 71% (SD, 13%), and the improvement was significant ( P <0.001, paired t -test). The study shows that Urinalysis-Tutor helps medical students learn to interpret the microscopic appearance of urine sediment and that it is feasible to implement this tutorial in a medical school class.

Routine analysis of urine is a part of the education of medical students, medical technologists, and other healthcare workers because the analysis of urine chemical constituents, coupled with a careful review of the microscopic elements in urine sediment, can provide physicians with valuable diagnostic information.

The most common approaches to teaching the examination of urine sediment are supervised instruction at a microscope and review of photomicrographs. These approaches have serious drawbacks. Supervised instruction suffers from variability in microscope quality and instructor experience. In addition, many medical schools, medical technology programs, and clinical laboratories do not have the time, the staffing, or the equipment to provide proper supervised instruction. Lastly, specimens that adequately demonstrate the most important urine elements may not be available, and even when available, the samples are often difficult to preserve for demonstration.

Although textbooks of photomicrographs ( 1 )( 2 ) can demonstrate rare specimens usually unavailable to instructors, the quality of photos is variable and often does not faithfully represent what the student views through the microscope. It is also difficult to use photographs to accurately demonstrate the various microscope techniques necessary to characterize specimens. These techniques include polarization, phase contrast, adjusting the plane of focus, simple manipulation of the light, and cell enumeration.

Over the last several years, faculty and staff in the University of Washington Department of Laboratory Medicine have been developing computer programs to teach image-based laboratory tests (for review, see ( 3 )). The goal has been to use computer technology to overcome some of the drawbacks of traditional instruction. Our previous work includes PeripheralBlood-Tutor ( 4 )( 5 ) (Lippincott-Raven Publishers), which teaches the interpretation of peripheral blood smears; GramStain-Tutor ( 6 )( 7 )( 8 ) (Lippincott-Raven), which teaches the interpretation of direct Gram stains of body fluids; Electrophoresis-Tutor ( 9 ) (Beckman Instruments), which teaches the interpretation of protein electrophoresis of serum, urine, and cerebrospinal fluid; Parasite-Tutor ( 10 ) (Lippincott-Raven), which teaches the microscopic identification of clinically important parasites; and ANA-Tutor ( 11 ) (Sanofi Diagnostics Pasteur), which teaches the interpretation of the immunofluorescence assay for anti-nuclear antibodies, and others (12–14) .

The focus of this article is Urinalysis-Tutor TM ( 15 ) (published and distributed by Lippincott-Raven Publishers and also distributed by Bayer Diagnostics), a computer program that uses digital images, text, and microscope simulations to teach the microscopic examination of urine sediment to medical students, medical doctors, medical technologists, and other healthcare workers. We discuss the contents of Urinalysis-Tutor, concentrating on useful features of computer-based teaching, and we detail the results of a 2-year study of >300 second year medical students who were required to use the program in their course on the urinary system. The study suggests that Urinalysis-Tutor is feasible to implement in the medical school curriculum and that it helps teach the interpretation of the microscopic appearance of urine sediment.

program development

Urinalysis-Tutor was written in Microsoft Visual Basic for Windows (Microsoft Corp.). The program runs under Windows on a computer with the following minimal hardware configuration: 80486 computer running at 33 megahertz and equipped with 40 megabytes of hard disk storage or a CD-ROM drive. The minimal display resolution is 640 × 480, 256 colors.

The program was developed by a team of physicians, medical technologists, computer programmers, and artists. An early version of the program was tested by medical technologists from the University of Washington Medical Center (Seattle, WA) and the Harborview Medical Center (Seattle, WA). The feedback from this beta testing was used to prepare the final version of the program.

The program is based on images collected from fresh urine sediments that were prepared in the clinical laboratories at the University of Washington Medical Center and the Harborview Medical Center. The images were collected using a digital video microscope system, which has been described previously ( 5 ). Briefly, the hardware components of the system were as follows: a color CCD camera (Javelin Chromachip II model JE3462RGB, Javelin Electronics) mounted on a light microscope (Olympus model BH2, Olympus Inc.), an 80486 computer (Gateway 2000 Inc.) containing a video imaging board (MVP-AT, Matrox Electronic Systems Ltd), and a 13-inch closed circuit television monitor (Sony) for image display. The imaging board converted the analog camera signal into a digital image, which could then be saved and edited. The imaging system was operated using Optimas image analysis software (Optimas Corp.). Adobe Photoshop (Adobe Systems Inc.) was used to edit some of the digital images. Image enhancement could include color correction, noise reduction, and contrast and brightness adjustment; the goal of image enhancement was to make the images appear nearly identical to images seen using a high-quality microscope.

medical student evaluation

The subjects in the study were medical students at the University of Washington, who were required to use Urinalysis-Tutor in the second year, 34-h course on the urinary system (Human Biology 562). Directions for use of the program were given at the beginning of the 8-week course. The students could use the program any time during the course by logging onto any of 15 networked computers located in the University of Washington Health Sciences Library.

The first class to use the program was 159 students who entered medical school in August 1994 and who used the program in March and April of 1996. The second class was 155 students who entered in August 1995 and used the program in March and April of 1997.

The version of the program used for the study had two distinct 20-question exams. In the first year of the study (1996), one of the exams was chosen as the pretest and the other as the posttest. The program required the students to take the pretest immediately after logging into the program and before they could view the contents of the program. The posttest was taken after completing Urinalysis-Tutor. In year 2 of the study (1997), the exam order was reversed to assess the equivalency of the pre- and posttests. Thus, the 1996 pretest was used as the 1997 posttest, and the 1996 posttest became the 1997 pretest. Except for the reversal of the tests, the program used in 1996 was the same as that used in 1997.

Student identification numbers and test scores were recorded over the network in a Microsoft Access ® database (Microsoft Corp.). SPSS for Windows, Ver. 7.0 (SPSS Inc.) was used for statistical analysis. Student pretest and posttest data were compared with paired t -tests and analysis of covariance (ANCOVA).

program description

Urinalysis-Tutor requires little or no experience with computers. It is driven completely by pointing with the mouse and clicking the left mouse button. No supplementary reading materials are necessary to use or to understand the contents of the program, and it takes 90–120 min to complete the program.

A schematic of the contents of Urinalysis Tutor is shown in Fig. 1 . The program is divided into the following sections: Introduction, Urine Sediment Structures, Disease Associations, Image Atlas, and Final Exam.

Schematic of the Urinalysis-Tutor computer program.

See Materials and Methods for details.

The introduction uses two-dimensional illustrations, three-dimensional illustrations, photographs, and microscope images to teach renal anatomy, the formation of urine, the basic steps in the laboratory examination of urine, and an introduction to phase contrast microscopy, polarizing microscopy, and the use of stains. Details of urine chemistry are not covered in Urinalysis-Tutor.

The section on urine sediment structures is the largest and most important part of the program. This section is divided into subsections on cells, casts, crystals, and organisms/artifacts. The cells that are detailed are white blood cells, red blood cells, epithelial cells, and oval fat bodies. A number of computer techniques help the student learn to identify and enumerate cells. For example, to learn the enumeration of red and white cells, the student simulates moving the stage of the microscope to look at multiple fields, and the program provides immediate feedback regarding whether the student has correctly identified each cell in an image. Furthermore, in the discussion of oval fat bodies, the student can change the microscope from a bright field to a polarizing configuration to reveal the “Maltese cross” forms that identify cholesterol-containing oval fat bodies.

The tutorial covers the following casts: hyaline, granular, waxy, fatty, renal cell, red cell, and white cell. Two- and three-dimensional illustrations as well as an animation are used to illustrate how casts are formed, and three to four images of each type of cast are shown with descriptive text overlays. A variety of teaching techniques enhance the discussion of casts. For example, the user can change the plane of focus to help identify a hyaline cast. In addition, by pressing a highlight button, some casts that can be difficult to find, e.g., hyaline, granular, waxy, fatty, or renal casts, will be delimited by a red border ( Fig. 2 ). The highlighting feature is also used to point out the location of some of the visible red cells in a red cell cast and some of the white cells in a white cell cast. Another computer technique used to teach the identification of casts is the ability to change from bright field microscopy to either polarization or phase contrast microscopy. This mimics the way a practicing medical technologist might change microscope configuration to help identify a cast. A change in microscope configuration is available several times, including identifying a fatty cast, using polarization microscopy, and identifying a hyaline cast, using phase contrast.

Examples from the casts section of Urinalysis-Tutor.

(A) A typical screen from the casts section of Urinalysis-Tutor showing an image of a waxy cast. Other images of casts (e.g., hyaline, granular, fatty, and others) can be viewed by selecting the buttons on the top of the screen. More examples of waxy casts can be displayed by selecting the “Examples” button located at the lower left of the screen. (B) The image after the user selected the “Highlight” button located directly below the image. This button allows the user to outline the waxy cast with a red border.

The section on crystals presents images of both normal and abnormal crystals. The normal crystals that are covered are uric acid, hippuric acid, calcium oxalate, triple phosphate, calcium carbonate, calcium phosphate, and ammonium biurate. The abnormal crystals are leucine, tyrosine ( Fig. 3 ), cystine, bilirubin, cholesterol, sulfonamide, and radiopaque dye. For each crystal, there are two to four distinct images with optional descriptive text overlays and additional bulleted text describing pH and solubility characteristics of the crystals and the disease states associated with each abnormal crystal. The crystals section incorporates computer techniques such as the ability to simulate polarization microscopy to distinguish uric acid crystals from cystine crystals and the ability to completely delimit the irregular shape of an ammonium biurate crystal.

Examples from the abnormal crystals section of Urinalysis-Tutor.

(A) A typical screen from the abnormal crystals section of Urinalysis-Tutor showing an image of tyrosine crystals. Other images of abnormal crystals are viewed by selecting the buttons on the top of the screen. Two more examples of tyrosine crystals, including the one shown in (B) , can be accessed by selecting the “Examples” button located at the lower left of the screen. These examples demonstrate variation in the appearance of the crystals.

The section on organisms and artifacts covers yeasts, a parasite (Trichomonas vaginalis) , bacteria, sperm, fibers, and starch. An example of each is presented. A number of computer teaching techniques are featured, including the ability to completely highlight all organisms and the ability to invoke polarization microscopy to identify fibers.

The Disease Associations section defines glomerulonephritis, nephrotic syndrome, pyelonephritis, and lower urinary tract infections, and then allows the user to review the characteristic microscopic findings associated with each condition. The image index is a reference tool that allows access to 91 microscope images in the program. The images are listed under the following categories: cells (15 images), casts (23 images), normal crystals (21 images), abnormal crystals (21 images), and organisms/artifacts (11 images). The images can be viewed one or two at a time, and the text overlays can be added or removed by clicking a button. The ability to directly compare any two images in the index is a major advantage of the computer program over a textbook. This is illustrated in Fig. 4 , which shows how a split screen can be used to help the student to differentiate uric acid crystals from cystine crystals.

The split-screen feature of the image index.

The upper panel in the screen shows cystine crystals and uric acid crystals without polarization; the lower panel shows the same crystals under polarizing conditions. Only the uric acid crystals are birefringent.

The two final exams each have 20 image-based questions. The questions are in a variety of formats ranging from straightforward identification of urine sediment structures in a single image ( Fig. 5 ) to the identification of multiple structures, using a microscope simulation to change microscope configurations (e.g., phase contrast or polarization microscopy), or to search the multiple fields in a slide for the structures. For each question, a detailed answer is provided. Users are given their scores at the end of the exam.

An exam question from Urinalysis-Tutor, which tests the ability to recognize white blood cells, transitional epithelial cells, and squamous epithelial cells.

The question is presented in (A) and the answer in (B) . The user chose the answers correctly.

The results for the two medical student classes who used Urinalysis-Tutor are shown in Table 1 .

Performance of second year medical students on the Urinalysis-Tutor pretest and posttest in 1996 (n = 159 students) and 1997 (n = 155 students). 1

1996 pretest = 1997 posttest; 1996 posttest = 1997 pretest.

Significant increase compared with 1996 pretest score, paired t -test; P <0.001.

Significant increase compared with 1997 pretest score, paired t -test; P <0.001.

In 1996, 159 students completed the tutorial; in 1997, 155 students completed the tutorial. In both years of the study, the improvement from pretest to posttest was significant ( P <0.001, paired t -test). Although the average score on the pretest in 1997 (41%; SD, 11%) was greater than the average score on the 1996 pretest (34%; SD, 14%) this difference was not significant.

The purpose of reversing the exams between 1996 and 1997 was to control for the difficulty of the two exams. Ideally, the exams would be of equivalent difficulty, so that a pre- to posttest improvement could not be solely because of a less difficult posttest. Because 1996 and 1997 class performances were similar despite reversal of the tests, the pretest and posttest are approximately equivalent, and the improvement in test scores between pretest and posttest was because of learning the material and not because of a less difficult posttest.

The examination of urine sediment is one of many clinical laboratory procedures that require the proper interpretation of microscope images. Other common microscope-based diagnostic tests include peripheral blood smears, direct Gram stains, wet mounts of vaginal discharge, the direct detection of parasites, the direct detection of fungi, and the anti-nuclear antibody test and related immunofluorescence assays for autoantibodies.

Physicians, such as family practitioners and general internists, commonly perform a subset of the microscope-based tests, most notably urine dipstick and microscopic examination, the direct Gram stain, peripheral blood smears, and wet mounts (16) . Therefore, it is not surprising that directors of internal medicine residencies, physicians who teach internal medicine to medical students, and residents in training agree that it is important to master these laboratory procedures (17–19) . Despite the perceived importance of this training, training of residents and students is inadequate, as measured by surveys as well as by testing of physicians (17 , 19) . For example, Hilborne et al. ( 19 ) reported the poor performance of residents in performing urine microscopic exams and other image-based laboratory procedures. This has led many to conclude that more formal training is necessary in medical school, in residencies, and as part of continuing medical education for practicing physicians ( 17 )( 18 )( 19 ).

The most important reason that microscope-based laboratory tests are not adequately taught to medical doctors is that the two most common teaching approaches, supervised instruction at a microscope and textbook-based teaching, have serious disadvantages. Supervised instruction requires a great deal of resources, including specimens, microscopes, and an instructor’s time. Textbooks have variable image quality and cannot simulate the manipulation of the microscope. The difficulty of teaching microscope-based laboratory procedures in the medical curriculum has caused many medical schools to reduce the teaching of these tests.

To overcome the problems associated with teaching microscope-based laboratory tests, our faculty in the Department of Laboratory Medicine has developed Urinalysis-Tutor and related computer programs, including GramStain-Tutor ( 6 )( 7 )( 8 ), PeripheralBlood-Tutor ( 4 )( 5 ), Parasite-Tutor ( 10 ), and ANA-Tutor ( 11 ). In addition, we have developed Microscopy-Tutor ( 20 ) (Lippincott-Raven), a program that complements the above programs by teaching the principles and practice of light microscopy. Our educational software is currently in wide use at the University of Washington in the medical school curriculum, the medical technology program, the pathology and other residency programs, the nurse practitioner curriculum, and other undergraduate and graduate programs. It is also in use in >3000 sites worldwide.

In this work, we studied the required use of the Urinalysis-Tutor in two consecutive classes (n = 159 and n = 155) of second year medical students. The improvement in scores between the exam taken before the tutorial and the exam taken after the tutorial shows that Urinalysis-Tutor helped students interpret the microscopic examination of urine sediment. This result is similar to results obtained in our previous studies of two of our other programs, GramStain-Tutor, which was studied in >140 first year medical students over 2 years( 8 ); and PeripheralBlood-Tutor, which was studied in >250 second year medical students over 2 years ( 5 ). All three studies show that it is relatively easy to implement the tutorials in a medical school class using a library-based computer network. All three of the programs continue to be required in the preclinical medical school curriculum, and they are also being used optionally in the third year clerkship in internal medicine.

Urinalysis-Tutor is used frequently in our clinical laboratory for training, continuing education, and as a reference. Our laboratory also uses a related program that we developed, Urinalysis-Review ( 21 ) (Lippincott-Raven), which provides additional exam questions. Currently, Urinalysis-Review is being distributed four times per year to participating laboratories and schools, the goal being to allow supervisors and teachers to periodically monitor individual and group performance regarding the ability to interpret a urine microscopic exam. Urinalysis-Review can be a stand-alone program, or it can integrate with Urinalysis-Tutor because the images from Urinalysis-Review are accessible from the Urinalysis-Tutor image index if the tutorial is run on the same computer.

Our future work will include a more detailed analysis of the Urinalysis-Tutor exam data ( 22 ). This study is determining the urine sediment structures that are most difficult for medical students to learn. The results will be used to modify Urinalysis-Tutor, and then the effectiveness of the revised tutorial will be studied in the next two classes of second year medical students. Thus, our current software development model, as illustrated by our work with Urinalysis-Tutor, is to create a computer tutorial, to study its effectiveness, to establish that it is feasible to use in a large class, and then to use the results of the study as the basis for improvements in the next version of the software. We hope to apply this model to many of our tutorials.

We thank the staffs of the clinical chemistry laboratories at the University of Washington Medical Center and Harborview Medical Center for participating in the evaluation of Urinalysis Tutor and providing quality specimens. In addition, we thank Chuck Rohrer for help with content of the tutorial, Jennifer Lee and Nathan Kalat for programing, Len Pagliaro for help with our digital video microscope, and Cathy Griffin for help regarding general computing issues. Additional information about educational software from the University of Washington Department of Laboratory Medicine can be found on the department’s world wide web site at: http://www.labmed.washington.edu/Tutors/Tutor.Home.html, or at the web site for Lippincott-Raven Publishers: http://www.lrpub.com/.

Graf L. A handbook of routine urinalysis. Philadelphia: Lippincott-Raven Publishers, 1983:284pp..

Strasinger SK. Urinalysis and body fluids 1994 F.A. Davis Company Philadelphia. .

Astion ML, LeCrone CN, Cookson BT, Orkand AR, Curtis JD, Pagliaro L, et al. Laboratory-Tutors: personal computer programs that teach the interpretation of image-based laboratory tests. Clin Lab Sci 1996 ; 9 : 44 -47.

Wood BL, Curtis JD, Murray C, Behrens JA, Pagliaro L, Astion ML. PeripheralBlood-Tutor: a program that teaches the interpretation of peripheral blood smears [Computer Program] 1995 Lippincott-Raven Publishers Philadelphia. .

Wood B, Mandel L, Schaad D, Curtis JD, Murray C, Broudy V, et al. Teaching the interpretation of peripheral blood smears to a second year medical school class using the PeripheralBlood-Tutor computer program. Am J Clin Pathol 1998 ; 109 : 514 -520.

Cookson BT, Curtis JD, Orkand AR, Fritsche TR, Pagliaro L, McGonagle L, Astion ML. GramStain Tutor: a personal computer program that teaches Gram stain interpretation. Lab Med 1994 ; 25 : 803 -806.

Cookson B, Orkand A, Curtis J, McGonagle L, Pagliaro L, Fritsche T, Astion M. GramStain-Tutor: a program that teaches the interpretation of direct Gram stains [Computer Program] 1995 Lippincott-Raven Publishers Philadelphia. .

Mandel L, Schaad D, Cookson BT, Curtis JD, Orkand AR, DeWitt D, et al. The evaluation of an interactive computer-based program to teach Gram stain interpretation. Acad Med 1996 ; 71 : S100 -S102.

Astion ML, Rank J, Wener MH, Torvik P, Schneider JB, Killingsworth LM. Electrophoresis Tutor: an image-based personal computer program that teaches the clinical interpretation of protein electrophoresis patterns of serum, urine, and cerebrospinal fluid. Clin Chem 1995 ; 41 : 1328 -1332.

Fritsche TR, Curtis JD, Eng S, Davis D, Curran G, Orkand AR, Astion M. Parasite-Tutor: a computer program that teaches the identification of clinically important parasites [Computer Program] 1997 Lippincott-Raven Publishers Philadelphia. .

Astion ML, Orkand AR, Olsen GB, Pagliaro LJ, Wener MH. ANA-Tutor: a computer program that teaches the anti-nuclear antibody test. Lab Med 1993 ; 24 : 341 -344.

Astion ML, Hutchinson KH, Ching AKY, Pagliaro LJ, Wener MH. Cytoplasmic Tutor: a personal computer program that uses high resolution digital images to teach the interpretation of a microscope-based laboratory test. MD Comput 1994 ; 11 : 301 -306.

Wener MH, Pagliaro L, Orkand AR, Olsen GB, Astion ML. ANCA-Tutor: a computer program that teaches interpretation of an immunofluorescence assay. MD Comput 1996 ; 13 : 216 -220.

Fleckman P, Lee J, Astion ML. Nail-Tutor: an image-based personal computer program that teaches the anatomy, patterns of pathology, and disorders of the nails 1997 http://matrix.ucdavis.edu/DOJvol3 num2/index.html. Published October 31 Dermatology Online J [Online] 1997. Available at. .

Phillips CM, Henderson PJ, Bien C, Lee JC, Fine JS, Pagliaro L, et al. Urinalysis-Tutor: a program that teaches microscopic urinalysis [Computer Program] 1995 Lippincott-Raven Publishers Philadelphia. .

Wigton RS, Nicolas JA, Blank LL. Procedural skills of the general internist. Ann Intern Med 1989 ; 111 : 1023 -1034.

Wigton RS, Blank LL, Nicolas JA, Tape TG. Procedural skills training in internal medicine residencies. Ann Intern Med 1989 ; 111 : 932 -938.

Hunskaar S, Seim SH. Assessment of students’ experiences in technical procedures in a medical clerkship. Med Educ (Oxf) 1983 ; 17 : 300 -304.

Hilborne LH, Wenger NS, Oye RK. Physician performance of laboratory tests in self-service facilities. JAMA 1990 ; 264 : 382 -386.

Pagliaro L, Orkand A, Murray C, Curran G, Astion M. Microscopy-Tutor: a program that teaches the principles and practice of light microscopy [Computer Program] 1997 Lippincott-Raven Publishers Philadelphia. .

Phillips C, Henderson P, Bien C, Orkand A, Olsen G, Fine J, et al. Urinalysis-Review: a quality assurance computer program that monitors the ability to identify and quantify urine sediment structures. Clin Chem 1996 ; 42 : S137 .

Kim S, Mandel LP, Astion ML, Schaad DC, Wener MH. Modification of computer-based tutorial programs using participants data: a model and case study of Urinalysis-Tutor. Thirty-sixth annual RIME (Research in Medical Education) Program. Annu Meet Assoc Am Med Coll, November 1997, Washington, DC..

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Patient Presentation

Ms. Smith is a 27-year-old woman who presents to her PCP after just finishing a course of antibiotics for an upper respiratory infection with complaints of dysuria and foul-smelling urine. She also complains of frequency to void, but only able to get out a few drops at a time. She has had 4/10 abdominal discomfort for the past 5 days, endorses lower back pain, and denies any hematuria with urination. She denies nausea/vomiting and denies having a fever.

Past Medical History

Type I diabetic
Recent use of antibiotics for URI
History of chlamydia at age 19

Pertinent Surgical History

No surgical history

Pertinent Family History

Mother healthy and alive at 56 years
Father healthy and alive at 59 years
Sister alive and type I diabetic at age 24 years old
Healthy 3 year old son

Pertinent Social History

Married to husband for 5 years
Sexually active
Spermicide as a contraceptive method
Physically active and attends spinning class 5 times a week

Main Index | Slide Table of Contents | Case Studies Table of Contents

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Case 6–2020: A 34-Year-Old Woman with Hyperglycemia

Presentation of case.

Dr. Max C. Petersen (Medicine): A 34-year-old woman was evaluated in the diabetes clinic of this hospital for hyperglycemia.

Eleven years before this presentation, the blood glucose level was 126 mg per deciliter (7.0 mmol per liter) on routine laboratory evaluation, which was performed as part of an annual well visit. The patient could not recall whether she had been fasting at the time the test had been performed. One year later, the fasting blood glucose level was 112 mg per deciliter (6.2 mmol per liter; reference range, <100 mg per deciliter [<5.6 mmol per liter]).

Nine years before this presentation, a randomly obtained blood glucose level was 217 mg per deciliter (12.0 mmol per liter), and the patient reported polyuria. At that time, the glycated hemoglobin level was 5.8% (reference range, 4.3 to 5.6); the hemoglobin level was normal. One year later, the glycated hemoglobin level was 5.9%. The height was 165.1 cm, the weight 72.6 kg, and the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) 26.6. The patient received a diagnosis of prediabetes and was referred to a nutritionist. She made changes to her diet and lost 4.5 kg of body weight over a 6-month period; the glycated hemoglobin level was 5.5%.

Six years before this presentation, the patient became pregnant with her first child. Her prepregnancy BMI was 24.5. At 26 weeks of gestation, the result of a 1-hour oral glucose challenge test (i.e., the blood glucose level obtained 1 hour after the oral administration of a 50-g glucose load in the nonfasting state) was 186 mg per deciliter (10.3 mmol per liter; reference range, <140 mg per deciliter [<7.8 mmol per liter]). She declined a 3-hour oral glucose tolerance test; a presumptive diagnosis of gestational diabetes was made. She was asked to follow a meal plan for gestational diabetes and was treated with insulin during the pregnancy. Serial ultrasound examinations for fetal growth and monitoring were performed. At 34 weeks of gestation, the fetal abdominal circumference was in the 76th percentile for gestational age. Polyhydramnios developed at 37 weeks of gestation. The child was born at 39 weeks 3 days of gestation, weighed 3.9 kg at birth, and had hypoglycemia after birth, which subsequently resolved. Six weeks post partum, the patient’s fasting blood glucose level was 120 mg per deciliter (6.7 mmol per liter), and the result of a 2-hour oral glucose tolerance test (i.e., the blood glucose level obtained 2 hours after the oral administration of a 75-g glucose load in the fasting state) was 131 mg per deciliter (7.3 mmol per liter; reference range, <140 mg per deciliter). Three months post partum, the glycated hemoglobin level was 6.1%. Lifestyle modification for diabetes prevention was recommended.

Four and a half years before this presentation, the patient became pregnant with her second child. Her prepregnancy BMI was 25.1. At 5 weeks of gestation, she had an elevated blood glucose level. Insulin therapy was started at 6 weeks of gestation, and episodes of hypoglycemia occurred during the pregnancy. Serial ultrasound examinations for fetal growth and monitoring were performed. At 28 weeks of gestation, the fetal abdominal circumference was in the 35th percentile for gestational age, and the amniotic fluid level was normal. Labor was induced at 38 weeks of gestation; the child weighed 2.6 kg at birth. Neonatal blood glucose levels were reported as stable after birth. Six weeks post partum, the patient’s fasting blood glucose level was 133 mg per deciliter (7.4 mmol per liter), and the result of a 2-hour oral glucose tolerance test was 236 mg per deciliter (13.1 mmol per liter). The patient received a diagnosis of type 2 diabetes mellitus; lifestyle modification was recommended. Three months post partum, the glycated hemoglobin level was 5.9% and the BMI was 30.0. Over the next 2 years, she followed a low-carbohydrate diet and regular exercise plan and self-monitored the blood glucose level.

Two years before this presentation, the patient became pregnant with her third child. Blood glucose levels were again elevated, and insulin therapy was started early in gestation. She had episodes of hypoglycemia that led to adjustment of her insulin regimen. The child was born at 38 weeks 5 days of gestation, weighed 3.0 kg at birth, and had hypoglycemia that resolved 48 hours after birth. After the birth of her third child, the patient started to receive metformin, which had no effect on the glycated hemoglobin level, despite adjustment of the therapy to the maximal dose.

One year before this presentation, the patient became pregnant with her fourth child. Insulin therapy was again started early in gestation. The patient reported that episodes of hypoglycemia occurred. Polyhydramnios developed. The child was born at 38 weeks 6 days of gestation and weighed 3.5 kg. The patient sought care at the diabetes clinic of this hospital for clarification of her diagnosis.

The patient reported following a low-carbohydrate diet and exercising 5 days per week. There was no fatigue, change in appetite, change in vision, chest pain, shortness of breath, polydipsia, or polyuria. There was no history of anemia, pancreatitis, hirsutism, proximal muscle weakness, easy bruising, headache, sweating, tachycardia, gallstones, or diarrhea. Her menstrual periods were normal. She had not noticed any changes in her facial features or the size of her hands or feet.

The patient had a history of acne and low-back pain. Her only medication was metformin. She had no known medication allergies. She lived with her husband and four children in a suburban community in New England and worked as an administrator. She did not smoke tobacco or use illicit drugs, and she rarely drank alcohol. She identified as non-Hispanic white. Both of her grandmothers had type 2 diabetes mellitus. Her father had hypertension, was overweight, and had received a diagnosis of type 2 diabetes at 50 years of age. Her mother was not overweight and had received a diagnosis of type 2 diabetes at 48 years of age. The patient had two sisters, neither of whom had a history of diabetes or gestational diabetes. There was no family history of hemochromatosis.

On examination, the patient appeared well. The blood pressure was 126/76 mm Hg, and the heart rate 76 beats per minute. The BMI was 25.4. The physical examination was normal. The glycated hemoglobin level was 6.2%.

A diagnostic test was performed.

DIFFERENTIAL DIAGNOSIS

Dr. Miriam S. Udler: I am aware of the diagnosis in this case and participated in the care of this patient. This healthy 34-year-old woman, who had a BMI just above the upper limit of the normal range, presented with a history of hyperglycemia of varying degrees since 24 years of age. When she was not pregnant, she was treated with lifestyle measures as well as metformin therapy for a short period, and she maintained a well-controlled blood glucose level. In thinking about this case, it is helpful to characterize the extent of the hyperglycemia and then to consider its possible causes.

CHARACTERIZING HYPERGLYCEMIA

This patient’s hyperglycemia reached a threshold that was diagnostic of diabetes 1 on two occasions: when she was 25 years of age, she had a randomly obtained blood glucose level of 217 mg per deciliter with polyuria (with diabetes defined as a level of ≥200 mg per deciliter [≥11.1 mmol per liter] with symptoms), and when she was 30 years of age, she had on the same encounter a fasting blood glucose level of 133 mg per deciliter (with diabetes defined as a level of ≥126 mg per deciliter) and a result on a 2-hour oral glucose tolerance test of 236 mg per deciliter (with diabetes defined as a level of ≥200 mg per deciliter). On both of these occasions, her glycated hemoglobin level was in the prediabetes range (defined as 5.7 to 6.4%). In establishing the diagnosis of diabetes, the various blood glucose studies and glycated hemoglobin testing may provide discordant information because the tests have different sensitivities for this diagnosis, with glycated hemoglobin testing being the least sensitive. 2 Also, there are situations in which the glycated hemoglobin level can be inaccurate; for example, the patient may have recently received a blood transfusion or may have a condition that alters the life span of red cells, such as anemia, hemoglobinopathy, or pregnancy. 3 These conditions were not present in this patient at the time that the glycated hemoglobin measurements were obtained. In addition, since the glycated hemoglobin level reflects the average glucose level typically over a 3-month period, discordance with timed blood glucose measurements can occur if there has been a recent change in glycemic control. This patient had long-standing mild hyperglycemia but met criteria for diabetes on the basis of the blood glucose levels noted.

Type 1 and Type 2 Diabetes

Now that we have characterized the patient’s hyperglycemia as meeting criteria for diabetes, it is important to consider the possible types. More than 90% of adults with diabetes have type 2 diabetes, which is due to progressive loss of insulin secretion by beta cells that frequently occurs in the context of insulin resistance. This patient had received a diagnosis of type 2 diabetes; however, some patients with diabetes may be given a diagnosis of type 2 diabetes on the basis of not having features of type 1 diabetes, which is characterized by autoimmune destruction of the pancreatic beta cells that leads to rapid development of insulin dependence, with ketoacidosis often present at diagnosis.

Type 1 diabetes accounts for approximately 6% of all cases of diabetes in adults (≥18 years of age) in the United States, 4 and 80% of these cases are diagnosed before the patient is 20 years of age. 5 Since this patient’s diabetes was essentially nonprogressive over a period of at least 9 years, she most likely does not have type 1 diabetes. It is therefore not surprising that she had received a diagnosis of type 2 diabetes, but there are several other types of diabetes to consider, particularly since some features of her case do not fit with a typical case of type 2 diabetes, such as her age at diagnosis, the presence of hyperglycemia despite a nearly normal BMI, and the mild and nonprogressive nature of her disease over the course of many years.

Less Common Types of Diabetes

Latent autoimmune diabetes in adults (LADA) is a mild form of autoimmune diabetes that should be considered in this patient. However, there is controversy as to whether LADA truly represents an entity that is distinct from type 1 diabetes. 6 Both patients with type 1 diabetes and patients with LADA commonly have elevated levels of diabetes-associated autoantibodies; however, LADA has been defined by an older age at onset (typically >25 years) and slower progression to insulin dependence (over a period of >6 months). 7 This patient had not been tested for diabetes-associated autoantibodies. I ordered these tests to help evaluate for LADA, but this was not my leading diagnosis because of her young age at diagnosis and nonprogressive clinical course over a period of at least 9 years.

If the patient’s diabetes had been confined to pregnancy, we might consider gestational diabetes, but she had hyperglycemia outside of pregnancy. Several medications can cause hyperglycemia, including glucocorticoids, atypical antipsychotic agents, cancer immunotherapies, and some antiretroviral therapies and immunosuppressive agents used in transplantation. 8 However, this patient was not receiving any of these medications. Another cause of diabetes to consider is destruction of the pancreas due to, for example, cystic fibrosis, a tumor, or pancreatitis, but none of these were present. Secondary endocrine disorders — including excess cortisol production, excess growth hormone production, and pheochromocytoma — were considered to be unlikely in this patient on the basis of the history, review of symptoms, and physical examination.

Monogenic Diabetes

A final category to consider is monogenic diabetes, which is caused by alteration of a single gene. Types of monogenic diabetes include maturity-onset diabetes of the young (MODY), neonatal diabetes, and syndromic forms of diabetes. Monogenic diabetes accounts for 1 to 6% of cases of diabetes in children 9 and approximately 0.4% of cases in adults. 10 Neonatal diabetes is diagnosed typically within the first 6 months of life; syndromic forms of monogenic diabetes have other abnormal features, including particular organ dysfunction. Neither condition is applicable to this patient.

MODY is an autosomal dominant condition characterized by primary pancreatic beta-cell dysfunction that causes mild diabetes that is diagnosed during adolescence or early adulthood. As early as 1964, the nomenclature “maturity-onset diabetes of the young” was used to describe cases that resembled adult-onset type 2 diabetes in terms of the slow progression to insulin use (as compared with the rapid progression in type 1 diabetes) but occurred in relatively young patients. 11 Several genes cause distinct forms of MODY that have specific disease features that inform treatment, and thus MODY is a clinically important diagnosis. Most forms of MODY cause isolated abnormal glucose levels (in contrast to syndromic monogenic diabetes), a manifestation that has contributed to its frequent misdiagnosis as type 1 or type 2 diabetes. 12

Genetic Basis of MODY

Although at least 13 genes have been associated with MODY, 3 genes — GCK , which encodes glucokinase, and HNF1A and HNF4A , which encode hepatocyte nuclear factors 1A and 4A, respectively — account for most cases. MODY associated with GCK (known as GCK-MODY) is characterized by mild, nonprogressive hyperglycemia that is present since birth, whereas the forms of MODY associated with HNF1A and HNF4A (known as HNF1A-MODY and HNF4A-MODY, respectively) are characterized by the development of diabetes, typically in the early teen years or young adulthood, that is initially mild and then progresses such that affected patients may receive insulin before diagnosis.

In patients with GCK-MODY, genetic variants reduce the function of glucokinase, the enzyme in pancreatic beta cells that functions as a glucose sensor and controls the rate of entry of glucose into the glycolytic pathway. As a result, reduced sensitivity to glucose-induced insulin secretion causes asymptomatic mild fasting hyperglycemia, with an upward shift in the normal range of the fasting blood glucose level to 100 to 145 mg per deciliter (5.6 to 8.0 mmol per liter), and also causes an upward shift in postprandial blood glucose levels, but with tight regulation maintained ( Fig. 1 ). 13 This mild hyperglycemia is not thought to confer a predisposition to complications of diabetes, 14 is largely unaltered by treatment, 15 and does not necessitate treatment outside of pregnancy.

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Key features suggesting maturity-onset diabetes of the young (MODY) in this patient were an age of less than 35 years at the diagnosis of diabetes, a strong family history of diabetes with an autosomal dominant pattern of inheritance, and hyperglycemia despite a close-to-normal body-mass index. None of these features is an absolute criterion. MODY is caused by single gene–mediated disruption of pancreatic beta-cell function. In MODY associated with the GCK gene (known as GCK-MODY), disrupted glucokinase function causes a mild upward shift in glucose levels through-out the day and does not necessitate treatment. 13 In the pedigree, circles represent female family members, squares male family members, blue family members affected by diabetes, and green unaffected family members. The arrow indicates the patient.

In contrast to GCK-MODY, the disorders HNF1A-MODY and HNF4A-MODY result in progressive hyperglycemia that eventually leads to treatment. 16 Initially, there may be a normal fasting glucose level and large spikes in postprandial glucose levels (to >80 mg per deciliter [>4.4 mmol per liter]). 17 Patients can often be treated with oral agents and discontinue insulin therapy started before the diagnosis of MODY. 18 Of note, patients with HNF1A-MODY or HNF4A-MODY are typically sensitive to treatment with sulfonylureas 19 but may also respond to glucagon-like peptide-1 receptor agonists. 20

This patient had received a diagnosis of diabetes before 35 years of age, had a family history of diabetes involving multiple generations, and was not obese. These features are suggestive of MODY but do not represent absolute criteria for the condition ( Fig. 1 ). 1 Negative testing for diabetes-associated autoantibodies would further increase the likelihood of MODY. There are methods to calculate a patient’s risk of having MODY associated with GCK , HNF1A , or HNF4A . 21 , 22 Using an online calculator ( www.diabetesgenes.org/mody-probability-calculator ), we estimate that the probability of this patient having MODY is at least 75.5%. Genetic testing would be needed to confirm this diagnosis, and in patients at an increased risk for MODY, multigene panel testing has been shown to be cost-effective. 23 , 24

DR. MIRIAM S. UDLER’S DIAGNOSIS

Maturity-onset diabetes of the young, most likely due to a GCK variant.

DIAGNOSTIC TESTING

Dr. Christina A. Austin-Tse: A diagnostic sequencing test of five genes associated with MODY was performed. One clinically significant variant was identified in the GCK gene (NM_000162.3): a c.787T→C transition resulting in the p.Ser263Pro missense change. Review of the literature and variant databases revealed that this variant had been previously identified in at least three patients with early-onset diabetes and had segregated with disease in at least three affected members of two families (GeneDx: personal communication). 25 , 26 Furthermore, the variant was rare in large population databases (occurring in 1 out of 128,844 European chromosomes in gnomAD 27 ), a feature consistent with a disease-causing role. Although the serine residue at position 263 was not highly conserved, multiple in vitro functional studies have shown that the p.Ser263Pro variant negatively affects the stability of the glucokinase enzyme. 26 , 28 – 30 As a result, this variant met criteria to be classified as “likely pathogenic.” 31 As mentioned previously, a diagnosis of GCK-MODY is consistent with this patient’s clinical features. On subsequent testing of additional family members, the same “likely pathogenic” variant was identified in the patient’s father and second child, both of whom had documented hyperglycemia.

DISCUSSION OF MANAGEMENT

Dr. Udler: In this patient, the diagnosis of GCK-MODY means that it is normal for her blood glucose level to be mildly elevated. She can stop taking metformin because discontinuation is not expected to substantially alter her glycated hemoglobin level 15 , 32 and because she is not at risk for complications of diabetes. 14 However, she should continue to maintain a healthy lifestyle. Although patients with GCK-MODY are not typically treated for hyperglycemia outside of pregnancy, they may need to be treated during pregnancy.

It is possible for a patient to have type 1 or type 2 diabetes in addition to MODY, so this patient should be screened for diabetes according to recommendations for the general population (e.g., in the event that she has a risk factor for diabetes, such as obesity). 1 Since the mild hyperglycemia associated with GCK-MODY is asymptomatic (and probably unrelated to the polyuria that this patient had described in the past), the development of symptoms of hyperglycemia, such as polyuria, polydipsia, or blurry vision, should prompt additional evaluation. In patients with GCK-MODY, the glycated hemoglobin level is typically below 7.5%, 33 so a value rising above that threshold or a sudden large increase in the glycated hemoglobin level could indicate concomitant diabetes from another cause, which would need to be evaluated and treated.

This patient’s family members are at risk for having the same GCK variant, with a 50% chance of offspring inheriting a variant from an affected parent. Since the hyperglycemia associated with GCK-MODY is present from birth, it is necessary to perform genetic testing only in family members with demonstrated hyperglycemia. I offered site-specific genetic testing to the patient’s parents and second child.

Dr. Meridale V. Baggett (Medicine): Dr. Powe, would you tell us how you would treat this patient during pregnancy?

Dr. Camille E. Powe: During the patient’s first pregnancy, routine screening led to a presumptive diagnosis of gestational diabetes, the most common cause of hyperglycemia in pregnancy. Hyperglycemia in pregnancy is associated with adverse pregnancy outcomes, 34 and treatment lowers the risk of such outcomes. 35 , 36 Two of the most common complications — fetal overgrowth (which can lead to birth injuries, shoulder dystocia, and an increased risk of cesarean delivery) and neonatal hypoglycemia — are thought to be the result of fetal hyperinsulinemia. 37 Maternal glucose is freely transported across the placenta, and excess glucose augments insulin secretion from the fetal pancreas. In fetal life, insulin is a potent growth factor, and neonates who have hyperinsulinemia in utero often continue to secrete excess insulin in the first few days of life. In the treatment of pregnant women with diabetes, we strive for strict blood sugar control (fasting blood glucose level, <95 mg per deciliter [<5.3 mmol per liter]; 2-hour postprandial blood glucose level, <120 mg per deciliter) to decrease the risk of these and other hyperglycemia-associated adverse pregnancy outcomes. 38 – 40

In the third trimester of the patient’s first pregnancy, obstetrical ultrasound examination revealed a fetal abdominal circumference in the 76th percentile for gestational age and polyhydramnios, signs of fetal exposure to maternal hyperglycemia. 40 – 42 Case series involving families with GCK-MODY have shown that the effect of maternal hyperglycemia on the fetus depends on whether the fetus inherits the pathogenic GCK variant. 43 – 48 Fetuses that do not inherit the maternal variant have overgrowth, presumably due to fetal hyperinsulinemia ( Fig. 2A ). In contrast, fetuses that inherit the variant do not have overgrowth and are born at a weight that is near the average for gestational age, despite maternal hyperglycemia, presumably because the variant results in decreased insulin secretion ( Fig. 2B ). Fetuses that inherit GCK-MODY from their fathers and have euglycemic mothers appear to be undergrown, most likely because their insulin secretion is lower than normal when they and their mothers are euglycemic ( Fig. 2D ). Because fetal overgrowth and polyhydramnios occurred during this patient’s first pregnancy and neonatal hypoglycemia developed after the birth, the patient’s first child is probably not affected by GCK-MODY.

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Pathogenic variants that lead to GCK-MODY, when carried by a fetus, change the usual relationship of maternal hyperglycemia to fetal hyperinsulinemia and fetal overgrowth. GCK-MODY–affected fetuses have lower insulin secretion than unaffected fetuses in response to the same maternal blood glucose level. In a hyperglycemic mother carrying a fetus who is unaffected by GCK-MODY, excessive fetal growth is usually apparent (Panel A). Studies involving GCK-MODY–affected hyperglycemic mothers have shown that fetal growth is normal despite maternal hyperglycemia when a fetus has the maternal GCK variant (Panel B). The goal of treatment of maternal hyperglycemia when a fetus is unaffected by GCK-MODY is to establish euglycemia to normalize fetal insulin levels and growth (Panel C); whether this can be accomplished in the case of maternal GCK-MODY is controversial, given the genetically determined elevated maternal glycemic set point. In the context of maternal euglycemia, GCK-MODY–affected fetuses may be at risk for fetal growth restriction (Panel D).

In accordance with standard care for pregnant women with diabetes who do not meet glycemic targets after dietary modification, 38 , 39 the patient was treated with insulin during her pregnancies. In her second pregnancy, treatment was begun early, after hyperglycemia was detected in the first trimester. Because she had not yet received the diagnosis of GCK-MODY during any of her pregnancies, no consideration of this condition was given during her obstetrical treatment. Whether treatment affects the risk of hyperglycemia-associated adverse pregnancy outcomes in pregnant women with known GCK-MODY is controversial, with several case series showing that the birth weight percentile in unaffected neonates remains consistent regardless of whether the mother is treated with insulin. 44 , 45 Evidence suggests that it may be difficult to overcome a genetically determined glycemic set point in patients with GCK-MODY with the use of pharmacotherapy, 15 , 32 and affected patients may have symptoms of hypoglycemia when the blood glucose level is normal because of an enhanced counterregulatory response. 49 , 50 Still, to the extent that it is possible, it would be desirable to safely lower the blood glucose level in a woman with GCK-MODY who is pregnant with an unaffected fetus in order to decrease the risk of fetal overgrowth and other consequences of mildly elevated glucose levels ( Fig. 2C ). 46 , 47 , 51 In contrast, there is evidence that lowering the blood glucose level in a pregnant woman with GCK-MODY could lead to fetal growth restriction if the fetus is affected ( Fig. 2D ). 45 , 52 During this patient’s second pregnancy, she was treated with insulin beginning in the first trimester, and her daughter’s birth weight was near the 16th percentile for gestational age; this outcome is consistent with the daughter’s ultimate diagnosis of GCK-MODY.

Expert opinion suggests that, in pregnant women with GCK-MODY, insulin therapy should be deferred until fetal growth is assessed by means of ultrasound examination beginning in the late second trimester. If there is evidence of fetal overgrowth, the fetus is presumed to be unaffected by GCK-MODY and insulin therapy is initiated. 53 After I have counseled women with GCK-MODY on the potential risks and benefits of insulin treatment during pregnancy, I have sometimes used a strategy of treating hyperglycemia from early in pregnancy using modified glycemic targets that are less stringent than the targets typically used during pregnancy. This strategy attempts to balance the risk of growth restriction in an affected fetus (as well as maternal hypoglycemia) with the potential benefit of glucose-lowering therapy for an unaffected fetus.

Dr. Udler: The patient stopped taking metformin, and subsequent glycated hemoglobin levels remained unchanged, at 6.2%. Her father and 5-year-old daughter (second child) both tested positive for the same GCK variant. Her father had a BMI of 36 and a glycated hemoglobin level of 7.8%, so I counseled him that he most likely had type 2 diabetes in addition to GCK-MODY. He is currently being treated with metformin and lifestyle measures. The patient’s daughter now has a clear diagnosis to explain her hyperglycemia, which will help in preventing misdiagnosis of type 1 diabetes, given her young age, and will be important for the management of any future pregnancies. She will not need any medical follow-up for GCK-MODY until she is considering pregnancy.

FINAL DIAGNOSIS

Maturity-onset diabetes of the young due to a GCK variant.

Acknowledgments

We thank Dr. Andrew Hattersley and Dr. Sarah Bernstein for helpful comments on an earlier draft of the manuscript.

This case was presented at the Medical Case Conference.

No potential conflict of interest relevant to this article was reported.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org .

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COMMENTS

Urinalysis: Case Presentations for the Primary Care Physician
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