ANSWER
The purpose of this study is to see if using basic laboratory tests improves diagnosis and treatment outcomes in outpatients at rural primary health care facilities.

Kenya is establishing six rural health centers.

Cross-sectional study to observe changes in diagnosis and treatment made by clinical officers following laboratory testing in outpatients attending six Kenyan rural health centres.

Subject
Before and after basic laboratory testing, the diagnoses and treatments of 1134 patients attending outpatient services in six rural health centers were compared. Each health center has essential clinical diagnostic equipment and laboratory tests. Before the study began, clinical officers and laboratory technicians received on-site refresher training in good diagnostic practices and laboratory procedures.
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Results
704 (62.1%) patients had laboratory tests ordered. Diagnosis and treatment were changed in 45% of tested patients who returned with laboratory results (21% of all clinic patients). Following laboratory testing, 166 (23.5%) patients did not return to the clinician for a final diagnosis and management decision. The most significant changes in diagnosis came from blood slide examination for malaria parasites, wet preparations, urine microscopy, and stool microscopy. Following laboratory testing, there was no discernible change in drug prices. The greatest changes in the number of diseases recorded after laboratory testing were for intestinal worms (53%) and malaria (21%).

Conclusion
The effective use of basic laboratory tests at the primary health care level improves diagnosis and patient treatment significantly. Laboratory testing is easily integrated into routine clinical practice. On-site refresher training is an effective way to improve patient care and communication between clinical and laboratory personnel.

Visit: Introduction
PHC is the first point of contact for medical care, service, and advice. PHC is provided in Kenya by community health workers, as well as at dispensaries, health centers, and hospital outpatient departments. The World Health Organization (WHO) advocates for basic laboratory services to support clinical and public health activities at the primary health care level1, and the Kenyan government has planned for appropriate diagnostic services at all levels of the health care system (Levels 1-6); currently, peripheral laboratories are mostly established at the health center level (Level 3). The majority of health centers are located in rural areas, where the majority of the population lives; however, significant challenges remain in establishing and supporting rural laboratory units.

Six out of ten of the most common diseases and conditions seen in outpatients presenting to health centers and primary level hospitals may benefit from basic laboratory tests to aid in better diagnosis and management.

2,3 More research is needed to determine how clinicians in PHC units use laboratory tests for patient management, as well as which tests are most useful for diagnosing and managing patients in different geographical areas. Garner et al.4 ask in a British Medical Journal editorial: do laboratory tests at this level alter clinical decision-making, and does access to laboratory testing actually improve the quality of patient care?

Between 1992 and 1994, the African Medical and Research Foundation (AMREF) Laboratory Programme conducted an essential laboratory program feasibility study in seven rural health centers in collaboration with the National Public Health Laboratory Services, Ministry of Health, Kenya, to determine an approach to effective and sustainable diagnostic services at the primary health care level. The study’s methodology was previously described (3), and the results are presented in another paper. 5 The study targeted both clinicians and laboratory personnel in order to address the entire diagnostic cycle. During the feasibility study, a sub-study looked at how clinicians used laboratory tests and compared pre- and post-test diagnosis and treatment to see how laboratory testing affected outpatient care.

Go to: Materials and Procedures
This was a cross-sectional study that looked at the work of clinical officers in the outpatient departments of six health centers that were taking part in the feasibility study for the essential laboratory program. Each health center was located in a different rural province of Kenya to account for differences in climate and accessibility. Isibania (Kuria District, Nyanza Province), Katilu (Turkana District, Rift Valley Province), Kimilili (Bungoma District, Western Province), Mariakani (Kilifi District, Coast Province), Matuu (Machakos District, Eastern Province), and Wanjohi (Machakos District, Eastern Province) were among them (Nyandarua District, Central Province). A seventh health center was omitted due to the lack of a full-time clinical officer. The study health centers’ locations and geographical profiles are detailed elsewhere. 5

A baseline survey was conducted prior to the start of the study to determine clinical, laboratory, and public health activities, as well as to review existing facilities and staffing. The following clinical diagnostic equipment and supplies were added to ensure that every clinician had access to them: stethoscope, otoscope, sphygmomanometer, torch, vaginal specula, thermometer, patella hammer, tongue depressors, examination gloves, and weighing scales.

Basic laboratory tests were chosen based on their potential usefulness in diagnosing and managing the most common diseases and conditions seen in outpatient practice, their operability in resource-constrained settings, their speed and cost, and the technical skills of clinical and laboratory staff at the health center level. Each health centre had the following laboratory tests: haemoglobin estimation to detect anaemia (haemiglobincyanide method); blood slide for malaria and other blood parasites (Field stain); total white blood cell count (manual, improved Neubauer chamber) to support fever investigation; blood film examination for blood cell morphology and differential white blood cell count (reverse Field stain) primarily to support anaemia and fever investigation; urine

At the start of the study, the study physician and laboratory technologist visited each health center for 5 days to introduce and establish project activities, accompanied by the district clinical officer and district laboratory technologist for each district. Through one-on-one training of clinical officers and laboratory technicians during routine outpatient clinics, on-site refresher training addressed improved diagnostic practices. Flow sheets were developed outlining history taking, physical examination, and selection and interpretation of laboratory tests for the major clinical syndromes seen at primary health care level (fever, pallor, diarrhoea, cough, skin diseases, sexually transmitted infections), based on Standard Treatment Guidelines produced by the Ministry of Health. AMREF designed and produced a poster, ‘Use of essential laboratory tests’,6 and clinicians were provided with the following AMREF publications: ‘Communicable Diseases’, ‘Child Health’ and ‘Medicine’.

The study was conducted during 2–4-day support supervisory visits carried out 3–4 times at each site over the two-year period. Subjects were patients attending general outpatient curative clinics with a new condition. Clinical officers were requested to take a brief directed history and perform a targeted physical examination on every patient and to request laboratory tests in every case where results could contribute to diagnosis and/or management. Every patient received a basic laboratory request form that included their name, age, gender, patient number, brief clinical notes, tests needed, clinician signature, and date. Patients took the request form to the lab, waited for the results, and then returned to the clinical officer for a management decision. Except for high vaginal swabs, endocervical swabs, and some pus swabs, which were collected by the clinical officer, all specimens were collected by laboratory staff. Before referring a patient for laboratory testing, clinical officers were asked to make a preliminary clinical diagnosis and treatment decision, which were recorded on the study record sheet. Following the receipt of laboratory results, the diagnosis and treatment were modified as needed. The study physician met with each clinical officer and collected data from all consecutive patients presenting with a new condition, regardless of whether laboratory tests were ordered. Due to a lack of clinical officers in the health centers, most children under the age of five were treated in the maternal and child health clinic, with only the most seriously ill children referred to a clinical officer. The time spent in the laboratory and overall patient time in the health facility were not recorded.

Pre- and post-test diagnosis and treatment were compared in the data. The 95% confidence interval was used to calculate the confidence intervals.

Ethical considerations can be found at:
Kenya’s Ministry of Health provided ethical approval for the study.

Navigate to: Results
The study enrolled 1134 new participants. Over the course of two years, patients were examined by eight clinical officers over the course of 58 days (ranging from 9 to 11 days at each health centre). The average number of patients seen at each health center was 189 (range: 108–339), with 849 (75%) patients being over the age of 12. Except for two health centers (Wanjohi 49%, Isibania 46%), female patients predominated (Table 1).

TABLE 1: Patient characteristics, laboratory testing profile, and changes in patient management.

Characteristics

Sub-characteristics

Patient characteristics
Isibania
Katilu Kimilili Mariakani Matuu Wanjohi
Total (%)
Age > 12 years 93 106 176 116 265 93 849 74.9 5 – 12 years 14 48 31 37 71 20 221 19.5 5 years
1 26 3 29 3 2 64 5.6
Gender
Male 58 87 95 78 142 59 519 45.8 \sFemale 50 93 115 104 197 56 615 54.
2 Total number of laboratory tests ordered per patient
74 123 120 120 214 53 704 -% patients tested 69 68 57 65 63 46 – 62.0 CI 59.2 – 64.9 1 test 50 74 92 82 175 40 513 72.9 19 35 18 23 32 9 136 19.3 CI 16.5 – 22.5 3 tests CI 69.4 – 76.1 2 tests 5 8 7 11 6 2 39 5.5 CI 4.01 – 7.6
4 tests – 4 2 3 1 2 12 1.7 CI 0.9 – 3.0
5 tests – 1 1 1 – – 3 0.4 CI 0.1 – 1.3
6 tests – 1 – – – 1 0.1 CI 0.0 – 0.9 Number of patients with laboratory results 64 109 92 78 137 38 518 73.
6 Incomplete outcomes 3 3 5 4 3 2 20 2.8 No return
7 11 23 38 74 13 166 23.6 Diagnosis, management shift
37 47 41 35 60 22 242 45.0 Total 108 180 210 182 339 115 1134 100.0 Open in a new window
Confidence Interval is abbreviated as CI.

Go to: Case Studies
Laboratory tests were ordered for 704 (62.1%) patients (range 46.1% – 68.5% at each health centre); 971 tests were ordered (range 1-6 tests per patient, average 1.4); and 513 (72.9%: range 60% – 82%) patients had one test ordered for them (Table 1). 166 (23.5%) tested patients did not return to the clinical officer for a final diagnosis and management decision while the study physician was present; 20 (2.8%) patients returned with incomplete laboratory results. In 242 patients (45% of tested patients; 21% of all patients) of the 538 tested patients who returned with all or incomplete laboratory results, diagnosis and/or treatment were changed. Table 1 shows the number of patients with all results, complete results, or who did not return to the clinician at each health center. There were no results in 250 (25.7%) of the 971 tests ordered. 264 (36.6%) of the 721 test results resulted in a change in patient diagnosis, drug treatment, or both. Table 2 displays the types of tests ordered as well as the number of tests that contributed to a change in diagnosis or treatment.

TABLE 2: The impact of laboratory tests on diagnosis and treatment.

Ordered Test Results are now available.
Tests that result in a change in diagnosis/treatment n n % n %
CI
Stool examination 167 105 62.9 46 43.8 34.3 – 53.8 Blood slide 498 400 80.3 157 39.3 34.5 – 44.2
Gram stain 59 46 77.9 14 30.4 18.2 – 45.9 Urine microscopy 91 72 79.1 13 18.1 10.3 – 29.3
53 36 67.9 17 47.2 30.7 – 64.3
Preparation in the rain
32 20 62.5 12 60.0 36.4 – 80.0
Examination of blood films or differential white blood cell count
18 10 55.6 0 0.0 0.0
The chemistry of urine
15 14 93.3 1 7.2 0.4 – 35.8
Syphilis testing
15 7 46.7 3 42.9 11.8 – 79.8
11 8 72.7 0 0.0 0.0 total white blood cell count
Stain Ziehl Neelsen 11 2 18.2 0 0.0 0.0
Examining in a dark field
1 \s1 \s100.0 \s1 \s100.0 \s5.5 \s– \s100.0
Total 971 721 74.3 264 36.5 33.1 – 40.3
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Confidence Interval is abbreviated as CI.

The tests were classified according to whether they were used to make a diagnosis or to define a clinical syndrome. Table 3 shows how each group of tests affected the diagnosis and treatment.

TABLE 3: Diagnosis or treatment modification as a result of laboratory testing.

Groups of laboratory test subjects

Malaria blood slide (n = 400)
Microscopy of feces (n = 105)
STI testing (n = 73)
Estimation of hemoglobin (n = 72)
Microscopy of urine (n = 30)
n % n % n % n % n %
Alteration in diagnosis or treatment 157
39 46 43 32 43 13 18 11 37
Change as a result of negative outcomes
108 69 26 57 17 53 4 31 7 64
Positive outcomes result in change.
49 31 20 43 15 47 9 69 4 36
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†
STI tests included urethral swab examination, HVS, ECS, conjunctival swab in neonates, first part urine examination, darkfield examination of GUD, and syphilis screening.
‡
Microscopy of urine for UTIs and parasites, excluding first-part urine for STI.
Diagnosis modification
The diagnosis data were classified into major diseases and clinical syndromes. The number of diagnoses recorded prior to and following laboratory testing was compared. Figure 1 depicts the ten most common diagnoses in all health care facilities, including patients who were not tested in the laboratory.

An external file containing a picture, illustration, or other data.
AJLM-1-8-g001.jpg is the name of the object. FIGURE 1 shows the ten most common diagnoses in all health centers.

Drug usage and cost changes
To assess the impact of laboratory testing on drug prescription practices, drug use indicators were used.
7 These were the total number of medicines prescribed, the percentage of patients who received an antibiotic, and the percentage of patients who received an injection. The drug use indicators in Table 4 are compared before and after laboratory testing. The drugs were classified into major treatment categories. Before and after laboratory testing, the number of drug courses prescribed and costs were compared (Figure 2).

TABLE 4: Changes in drug use indicators following laboratory testing.

Drug use detection

Every patient
Patients who have been tested
Before and after testing Before and after testing
The average number of prescriptions
1.44 1.43 (p = 0.377)
1.47 1.45 (p = 0.297)
Percentage of patients who received an antibiotic prescription
29.1 28.0 (p = 0.242)
28.7 27.0 (p = 0.294)
Percentage of patients who received an injection
6.5 6.1 (p = 0.242)
3.8 3.0 (p = 0.045)
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An external file containing a picture, illustration, or other data.
The filename for this object is AJLM-1-8-g002.jpg.
Figure 2 shows the number of drug courses prescribed as well as the costs before and after laboratory testing.

Visit: Discussion
Many clinics do not have the necessary diagnostic equipment to examine patients. In each consultation room, sterile packs of vaginal specula and swabs were provided to allow for immediate vaginal examination. Laboratory tests typically took 1 to 3 hours per patient and were completed by the end of the morning or afternoon clinic sessions. Clinical officers worked efficiently with all equipment on hand and easily incorporated laboratory testing into their procedures. At this level, a basic laboratory request form for all tests was appropriate. Before referring the patient to the laboratory, the clinical impression or provisional diagnosis recorded in the patient’s notes aided the final management decision after the laboratory results were received.

Almost a quarter of the patients tested (23.6%) did not return with laboratory results, and 2.8% returned with incomplete results. Although the study supervisors were present at each health center for one to three full days at a time, some patients may have returned with results after the supervisors had left. Because the tests are performed quickly and are intended to provide results before patients leave the facility, looking into the causes of the delays would be beneficial. Many health centers were overcrowded, and patients may have become discouraged due to the length of their wait. Improved patient flow organization and adequate clinical and laboratory staffing should increase the number of patients who complete investigations. Patients may not have produced specimens for some tests, such as stool, urine, and sputum examination; syphilis screening was frequently done in batches, and patients were often asked to return for results on another day. Given that nearly half of all patients referred to the laboratory had a change in diagnosis or treatment as a result of laboratory testing, it is critical that more patients return to the clinician with completed results.

Clinical officers were advised to interpret laboratory results in light of the symptoms and signs of patients. In general, the presence of pathology in symptomatic patients’ specimens was reported as a positive diagnosis, and patients were appropriately treated; however, symptomatic patients with negative test results were sometimes treated for the following conditions based on clinicians’ judgment: malaria, intestinal helminthic and protozoal infection, fungal skin infection, pelvic inflammatory disease, or fungal vaginal infection. A change in diagnosis usually resulted in a change in treatment; however, a few test results changed the diagnosis but not the treatment, such as switching from E. histolytica to G. lamblia infection; these data may have public health implications. Laboratory testing reduced malaria diagnoses while increasing all other diagnoses due to better assessment of other causes of fever and the laboratory’s ability to confirm alternative diagnoses. In our study, 222 patients were diagnosed with malaria based on 192 positive blood slides. Over-diagnosis of malaria has been demonstrated in other studies8,9, and is a major limitation to improved case management and cost savings on treatment. 10 Using a laboratory confirmed diagnosis of malaria as the gold standard, the sensitivity of clinical malaria diagnosis was 78% and the specificity was 39% in this study. Malaria infection lacks specific symptoms and signs, and better history taking does not improve clinical diagnosis. 11 Based on physical examination or basic laboratory testing, there was no difference in blood-slide positivity rate in the presence (48.6%) or absence (47.8%) of another condition causing fever (p = 0.872). This finding has been reported elsewhere12, but it warrants further investigation.

Because endocervical smear microscopy is not a sensitive predictor of disease, symptomatic patients with negative endocervical swabs were treated for pelvic inflammatory disease.

13 The sensitivity of clinical diagnosis of sexually transmitted infections was 65% based on the sum of results from a group of tests. The examination of wet preparations of high vaginal swabs made the most difference in diagnosis (53% change in diagnosis); examination of sediment of first part of morning urine to rule out urethritis changed the diagnosis in a single symptomatic male patient. These findings have significant implications for the continued use of syndromic approaches in disease control programs. Testing for specific diagnoses is recommended to reduce treatment costs and improve compliance. 13 Syndromic management would be more effective if it was tailored to clinical staff skills and available laboratory investigations at various health facility levels.

The ability of a laboratory test to change a diagnosis is an important indicator of usefulness, but it is not the only one. Tests were generally used to confirm a suspected diagnosis, but tests performed to rule out conditions are also useful. A list of core tests for an outpatient health service can be developed based on the number of patients for whom laboratory tests changed diagnosis and the clinical and public health importance of the diseases confirmed. Total and differential white cell count, as well as thin blood film examination, made little difference in diagnosis or patient management in this study, but they were useful in providing a more complete clinical picture. Although useful, potassium hydroxide preparation and dark field examination address fewer cases and may be more technically demanding. The Ziehl Neelsen stain and syphilis screening addressed a small number of cases, but they are important in diagnosing serious and treatable diseases and should be kept. Patients with suspected tuberculosis or syphilis would have been referred to another facility for laboratory confirmation in this study setting, so the diagnosis was recorded as ‘changed’ in the health facility records.

If applied nationally, the change in diagnostic data resulting from improved laboratory use in outpatient services could have a significant impact on national health estimates and planning. Malaria diagnosis, for example, was reduced by 21% in this study. The difference in drug costs before and after laboratory testing was less than 1%, because a change in diagnosis generally resulted in a change in treatment from the first proposed treatment to another. Selected drug use indicators for primary health care facilities7 revealed an increase in the rational use of medicines in conjunction with laboratory use. All four injections canceled following laboratory testing were for antibiotic treatment of STI in adults. If repeat visits for second or third treatments are avoided, laboratory diagnosis may reduce drug costs.

The presence of the study physician in this study may have had an impact on clinician practice (Hawthorne effect).

14 In the absence of the study physician, data collected during the overall 2-year study period revealed that clinical officers maintained the level of patient referral to the laboratory in two health centers5. As a result, the proportion of patients referred for laboratory testing can be used as an indicator of efficient laboratory use. 5 Despite the fact that these data were collected several years ago, the findings are particularly pertinent given the growing recognition of the importance of more accurate patient diagnosis, rational drug use, quality health services, and cost-effectiveness; and government efforts to develop effective diagnostic services at peripheral health care levels. More research is needed to determine how clinicians use laboratory services in various health care settings and how diagnostic services can be designed to be as useful and effective as possible.

QUESTION
Subacute polyarticular arthralgias • swelling of the ankles and right knee • recent travel to the Dominican Republic • Dx?
A 78-year-old woman with a history of anxiety and hypertension presented to our family medicine residency practice in Massachusetts with subacute polyarticular arthralgias that had been present for 2 months. She complained of pain and swelling of both ankles and the right knee. She noted that her symptoms had started on a recent trip to the Dominican Republic, where she developed generalized joint pain and a fever that lasted 1 to 2 weeks and subsequently resolved with the lingering polyarthralgia. She denied any rash,

constitutional symptoms, photosensitivity, headaches, photophobia, or history of tick bite. Physical examination revealed normal vital signs, notable warmth and swelling of the bilateral ankles that was worse on the right side, and swelling of the right knee with effusion—but no tenderness—to palpation.

1- definition

2- Possible Diagnosis with rationale explanation.
3-At least 3 differentials must be mentioned with rationales explanation.

at least 3 references with no less then 5 years