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Twenty clinical features, oxygen saturation measurements, and results of malaria blood slides could be used for inpatient, syndrome-based management of acute paediatric admissions. The addition of microscopy of the cerebrospinal fluid and haemoglobin measurements would improve syndrome-directed treatment considerably. This approach might rationalize admission policy and standardize inpatient paediatric care in resource-poor countries, although the clinical detection of bacteraemia remains a problem.
Over the last ten years, considerable effort has been put into developing the Integrated Management of Childhood Illness IMCI initiative, a generic, but adaptable, approach to the assessment and management of sick children when they present to first-level health facilities in resource-poor countries. Under the IMCI initiative, algorithms define illness severity and make recommendations about treatment and hospital referral 1.
Target facilities often are run by community nurses or medical assistants. To complement the referral strategy, a manual that addresses inpatient management was produced recently 2. In many government district hospitals in sub-Saharan Africa, however, the health workers who manage inpatients have similar qualifications to those who make referrals.
Often supervision from senior staff is limited and there is little or no access to a reliable, laboratory-based diagnostic service, which makes diagnosis difficult even in the referral facility.
Syndromic management according to IMCI therefore may become the de facto approach to initial medical management for inpatients. In essence, much clinical medicine is syndrome based. Characteristic combinations of symptoms, signs, and investigations often define a disease state.
The emphasis in medical training and texts is still to use clinical skills to maximize the sensitivity and specificity of diagnosis within the paradigm of treating the single most probable cause of illness. However, this reductionist approach may be costly in terms of mortality and morbidity in situations in which the precision of classification is limited by the availability and quality of symptoms, signs, and results of investigations lowering sensitivity, specificity, or both , in which illnesses are particularly severe high case fatality , and in which true mixed pathology is more frequent.
The latter two conditions apply in many resource-poor countries, notably areas where malaria is endemic. As a syndromic approach may offer advantages, such as simplifying training and standardizing inpatient clinical care, and because IMCI may prompt such a move anyway, we examined its potential in children admitted to a Kenyan district hospital.
Malaria is endemic in the area, with two annual peaks of transmission and subsequent disease in June to August, and December to January. Acutely ill children who present to the hospital are assessed in the outpatient department by government clinical officers health professionals with a minimum of three years' training, who are not members of the research team.
These staff provide night and day cover and decide upon admission or discharge. The study ran prospectively from 1 September to 31 August A standardized proforma was produced to record symptoms included in IMCI assessments and signs of proven local value This proforma was completed by a clinical member of the research staff as soon as children were admitted hour cover was provided. Prostration has previously been shown to indicate a high risk of mortality locally 10 , and we have found that it is easier to teach how to assess it than the less objective characteristic of lethargy recommended by IMCI 1.
After the proforma was completed, and before any results from investigations were available, the admitting clinician recorded his or her principal, presumptive diagnosis. Micrococci, Staphylococcus epidermidis , Bacillus spp. Additional investigations available, and performed according to locally agreed clinical management protocols, included the following: Inpatient clinical care comprised at least daily review and was supervised by a consultant paediatrician M.
All changes in the clinical condition or management were recorded in the case notes, as were the results of investigations that were repeated or augmented when clinically indicated. At discharge, the case notes and results of all investigations were reviewed by one of four senior clinical investigators M.
In cases where there was doubt, the final diagnosis was assigned after discussion between the investigators, but no formal assessment was made of the agreement between decisions about the final diagnosis. Where the child had more than one problem, the primary final diagnosis was defined as that which accounted for the admission and the subsequent hospital stay, and the secondary diagnosis as a problem that also required treatment. Final diagnoses were graded as severe or not severe by using the clinical criteria used for the syndromic diagnoses.
Data recorded on the questionnaires were entered in duplicate by different data entry clerks and verified throughout the study period with FoxPro 2. At the end of the data collection period, syndrome diagnoses were computer generated with a series of logical operands derived from the admission questionnaire data and the malaria parasite slide only.
Syndromic diagnosis thus was not used for clinical management. Severe syndromes were classified as those that warranted parenteral treatment 1, 2, The IMCI classification does not distinguish between severe malaria, possible severe sepsis, and possible meningitis, because it aims to ensure appropriate initial treatment before further investigation at a referral centre.
We therefore based the syndrome diagnosis of severe malaria on previous work 10 and that for meningitis on recommendations in the IMCI inpatient care manual 2 and local experience, with the proviso that only signs already part of the IMCI algorithms should be included in a first definition hence assessment of the fontanelle was not included routinely.
Although the definitions for meningitis essentially are "nested" within the definition of severe febrile disease, we felt it was worth examining them both individually as a diagnosis of meningitis might have different implications for the choice and duration of treatment.
Malaria parasitaemia prevalence in all the samples was Positive predictive value was For inter-instrument agreement, all the diagnostic instruments tested, CareStart, Cyscope, and QBC, had good agreement with the light microscopy as shown by Kappa values of 0. The mean turnaround time for LM was This study validated three malaria parasites diagnostic test tools in comparison with light microscopy.
This finding is in concordance with earlier studies in Nigeria and Uganda on sensitivity of diagnostic tools for malaria parasite detection which showed that QBC and Cyscope demonstrated higher sensitivity and CareStart lower sensitivity when compared with light microscopy [ 11 , 12 ].
However, CareStart showed better specificity and PPV than other instruments, which could tend to forestall inappropriate antimalarial treatment. Previous studies conducted using different HRP-2 rapid diagnostic kits for P. CareStart was validated in this study as a new introduction to the country's diagnosis tools.
The absolute necessity for rational therapy in the face of ever increasing occurrence of drug resistance places increasing importance on the accuracy of malaria diagnosis [ 15 ].
Currently, Giemsa microscopy and rapid diagnostic tests RDTs are the two diagnostics which seem to have the largest impact on malaria control [ 16 , 17 ]. This finding compares with studies by Hassan et al. However, Sousa-Figueiredo et al. The latter study was done in field setting and subjected to likelihood of higher false positives.
With respect to the operational characteristics of the tools, while light microscopy will produce about one result per hour, CareStart will produce three, and QBC and Cyscope will produce seven and twelve results per hour, respectively.
Light microscopy is dependent on availability of electrical power for functionality. Only the Cyscope microscope has a standby battery as an alternative source of electric current. Considering the cost per hour of use of other tools, the cost of a test result from light microscopy is equivalent to cost of five test samples examined by Cyscope.
In the same vein, costs of each of QBC and CareStart are equivalent to the cost of three test samples examined by Cyscope. Light microscopy, aside relatively cheap reagents, is the least cost-effective of all the instruments.
We found that Cyscope fluorescent microscope is a reliable diagnostic tool that is very sensitive and specific in diagnosing falciparum malaria, the predominant Plasmodium species Cyscope microscope for malaria detection is currently designed to detect only falciparum species. However, studies by Sousa-Figueiredo et al. Further studies are recommended to assess its effectiveness in differentiating other Plasmodium species.
Although QBC has the best sensitivity and can detect all Plasmodium spp. Cyscope microscope is a new technology that involves the use of lyophilized DNA probe in a fluorescein dye mounted on glass slide using wet preparation to detect malaria parasite in blood sample within 5 minutes, although it has likely chances of false positives especially in uncontrolled field setting [ 11 ].
Its performance feature of high sensitivity, being cost-effective, and its requirement of electrical supply lend credence to its suitability for programmatic deployment at health care settings. The Engineering and Physical Sciences Research Council, United Kingdom, holds that all new points of care diagnostics, including diagnostics for infectious diseases, should meet the ASSURED criteria, that is, Affordable by those at risk of infection, Sensitive with very few false negatives, Specific with very few false positives, User-friendly tests that are simple to perform and require minimal training, Rapid, to enable treatment at first visit, and Robust, for example, not requiring refrigerated storage, Equipment-free, and Delivered to those who need it.
Based on these criteria and the need to expand malaria diagnostic services as part of a greater framework of health system strengthening within resource-limited settings [ 21 ], Cyscope fits in as a point-of-care diagnostic device for health care settings in resource-limited malaria endemic areas.
The findings of this study showed that CareStart, QBC fluorescent microscopy, and Cyscope fluorescent microscopy are valuable complements to light microscopy because they help expand the coverage of parasite-based diagnosis and minimize presumptive diagnosis.
The cost of improved malaria diagnosis will inevitably increase, by investment in whether light microscopy or CareStart or both. However, such investment offers a more promising cost-effective strategy with the deployment of Cyscope fluorescent microscopy in appropriate settings. Cyscope fluorescent microscope had the least turnaround diagnostic time and the highest throughput and it is the most cost-effective of all the laboratory diagnostic instruments evaluated.
We therefore strongly recommend Cyscope fluorescent microscope for malaria parasite detection especially in secondary and tertiary health care facilities where the request for malaria diagnosis is increasingly high. The authors acknowledge the contributions of Dr.
Florence Bamgbola Cyscope Microscopist , and Mrs. Bimbo Awokson and Mr. Ishmail worked as Field Research Assistants.
This publication was supported by Cooperative Agreement no. This study was carried out during the malaria low transmission season and studies have shown that low parasitaemia could affect the parasite detection rate by light microscopy [ 22 ].
Hence the low parasite detection rate of light microscopy as a gold standard in this study could have reduced the validity indices of the tool tested. However, with the engagement of WHO certified and experienced microscopists and quality control in place during slide reading as mentioned earlier, we observed that, having compared with findings from other studies, this effect was insignificant.
Also, we conducted this study amongst patients suspected to have uncomplicated malaria. We excluded patients who had severe malaria as they were expected to have been confirmed as having malaria and admitted to the hospital ward. A study to compare the cost-effectiveness of the diagnostic tools in clinical setting of severe malaria could be a subject of future research. This paper's contents are solely the responsibilities of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention or the Department of Health and Human Services.
The authors declare that there is no competing interests in the conduct of this study and no form of support was received from the Cyscope fluorescent microscope manufacturers. Fawole, and Ikeoluwapo O.