Improving the Quality of Medical Research Paper

Excerpt from Research Paper :

This is particularly the case in sub-Saharan Africa where clinicians have often come to rely on signs and symptoms alone to make diagnoses." (Nicoll, Walraven, Kigadye, Klokke, 1995)

The laboratory environment is critical to administering testing to determine population rates of HIV / AIDS throughout nations and perhaps continents where the lacking of resources facilitates a substandard environment for care. In the case of the African nation of Mozambique, which perhaps can be understood as a case indicative of the environmental assessment one would find throughout Africa and therefore, can be labelled to be a median statistical nation. A nation representing the median would indicate that half of the population nations that are categorized as resourced deficient, half would be above Mozambique in terms of resource allocation and half would fall below.

Research into the quality of HIV / AIDS case-detection and case-reporting system in Mozambique was conducted by (Chilundo, Sahay, Sundby, 2004). The preliminary argument in the research proposes a fundamental lack of management systems necessary to do the basic work of hematology including medical laboratory procedures and analysis. These facilities, certainly at the mobile level, are lacking throughout Mozambique, from the "peripheral facilities through to those at the national levels." (Chilundo, Sahay, Sundby, 2004)

The inherent flaws in the system are of an interdisciplinary nature, such that the testing performed on ground level, may or may not obtain the correct analytical result of whether or not patient x is positive for HIV / AIDS. Such results, whether positive or negative, then are targeted for misplacement or another form of mismanagement along the transmission of data/information chain as the lack of a strong information system prevents the results from the field to entering into a manageable and reportable database at a central location at the national level.

According to Chilundo, Sahay, Sundby (2004), "HIV / AIDS case-reporting is compromised by poor data quality, including under-reporting and discrepancies across different reporting channels and organizational levels, as well as a lack of standardized data forms, data items collected and report formats. Our analysis of HIV / AIDS surveillance systems in Mozambique leads to the following key recommendations:" (Chilundo, Sahay, Sundby, 2004)

A strengthening and standardization of both the case-detection and case-reporting systems at all levels

The regular training of staff at all peripheral facilities, to allow for better testing and improved local data analysis, validation and interpretation

The redesign of reporting systems for blood banks, including integration of the AIDS case-reporting subsystems into one

The use of baseline data as a foundation for more comprehensive analysis across the country, in response to UNAIDS advice regarding second-generation HIV surveillance

Source: The quality of HIV / AIDS case-detection and case-reporting systems in Mozambique. (Chilundo, Sahay, Sundby, 2004) African Journal of AIDS research 2004. 145-155

The Chilundo et al. research did uncover the details of the current delivery of laboratory services that is currently in place within the geographic borders of Mozambique. Specifically, the measures used to identify patients with positive HIV samples are designed for field work. According to Chilundo et al. (2004), "Similar to most African countries (remember median), the majority of testing facilities in Mozambique use the rapid or simple assays as both a screening and confirmatory test (CDC/WHO-AFRO, 2001; UNAIDS/WHO, 2001)." (Chilundo et al., 2004)

The simple assays offer dual support as a screener and confirmatory test procedure. As with most HIV testing, the simple assay is a serum-based test and therefore detects for the presence of antibodies by the form of t-cell count instead of an exacting presence of the actual human immune-deficiency virus. It is termed a rapid test as the results are obtained in minutes and do not require the use of additional reagents or the use of any additional equipment (Chilundo et al., 2004).

According to Chilundo et al., 2004) "These tests can be easily conducted in a clinic (on-site testing) and in laboratories without electricity or those having limited infrastructure (i.e. lacking highly-skilled staff and special equipment). Thus, these rapid/simple assays are compatible with the existing constraints that exist nationwide in Mozambique's peripheral testing facilities. The commercial rapid tests currently used in all provinces and districts are Determine and Uni-gold. Both are in vitro qualitative immunochromatographic assays able to detect antibodies to HIV1 and HIV2, present in serum, plasma or in the whole blood of infected individuals." (Chilundo et al., 2004)

However, the major problem with the Determine and Uni-gold tests is the sensitivity to operating and environmental temperatures. This is to say, the operating temperature in Celsius/Centigrade will be consistent with temperature within a 'clinical' setting, inside of a 'structure' where patients are tested within a 'closed' environment. This may be within a van, truck, temporary free-standing laboratory facility, or similar, such as a tented field facility. The environmental temperature is that obtained in the raw environment, which is outside in the beating sun with no protection.

The tests have a strict operating temperature environment, operating ostensibly due to the likelihood of the tests being conducted within a structure or pseudo structure capable of reducing the heat and therefore core temperature of the testing equipment. According to Chilundo et al., (2004) "HIV tests are routinely performed in the VCT centres, blood banks and clinical laboratories. Usually the blood banks and laboratories are located in the same building, test kits have a shelf life of 18 months at temperatures of 2-28/30 degrees Celsius. The test kit called Determine has a specificity of 99.4%, and Uni-gold 100%. Determine is utilized to screen for 'positives', while Uni-gold is utilized for confirmation, given its higher specificity, to ensure that all truly negative tests results are identified as negative, thus ruling out false-positive results (UNAIDS/WHO, 2001)." (Chilundo et al., 2004) This is the equivalent to the range of 35.6-82.4/86 on the Farenheit scale. The tests have a sensitivity of approximately 100% (Chilundo et al., 2004)

Africa is a very hot continent and Mozambique's temperature throughout the year is certainly within three standard deviations of what would be the mean temperature of Sub-Saharan Africa. According to data obtained from, the maximum temperatures in Mozambique right at the maximum of 30 degrees Celsius from January through mid March and then decline to about 25 degrees Celsius by June then rising to 30 in mid December. The operating temperature of each type of test is just within the range of the environmental operating temperature.

The issue of Quality Control within these environments where laboratory resources are lacking is of additional concern. According to Chilundo et al., (2004) "External quality assessment (of laboratory results and procedures) is expected to be performed on a regular basis by an external agency or supervisor in order to identify and correct testing facilities that exhibit poor performance. We found such external checking was seldom done. However, we found that on-site evaluation through supervision visits by either provincial or national managers regularly occurred at VCT centres. Laboratories and blood banks appeared to be infrequently and irregularly supervised. For example, the testing facility using outdated test kits had not been visited by a supervisor in the previous two years, despite the fact it was only about 30 kilometres from provincial headquarters." (Chilundo et al., 2004)

According to Consultation on Technical and Operational Recommendations (2008), there is a tiered laboratory network in alignment with a public health delivery network in a country (Consultation on Technical and Operational Recommendations, 2008).

Level One/Primary: Health post and health center laboratories that mainly serve outpatients

Level Two-District: Laboratories in intermediate referral facilities, such as district hospitals

Level Three-Regional/Provincial: Laboratories in a regional or provincial referral hospital that may be a part of a regional or provincial health bureau.

Level Four-National/Multicountry Reference Laboratory: The national/multicountry public health reference laboratory for one or more countries.

Source: Consultation on Technical and Operational Recommendations for Clinical Laboratory Testing Harmonization and Standardization. (2008)

The level One Laboratories as described by the Consultation on Technical and Operational Recommendations for Clinical Laboratory Testing Harmonization and Standardization, these labs would act as the service outpost within the "peripheral branches of Level Two laboratories, which would be the center or hub." Health posts may collect and/or refer specimens to health center laboratories." (Consultation of Technical and Operational Recommendations for Clinical Laboratory Testing Harmonization and Standardization, 2008)

Level One Labs would be extremely efficient in operations, utilizing only the bare necessity needed to perform diagnostic and monitoring services for HIV / AIDS, TB and malaria. To obtain the data necessary to render a diagnosis, the labs must "perform specimen collection and simplified techniques such as the collection of dried blood spot (DBS) and rapid/dipstick tests. When required testing exceeds the scope of services available from Level I facilities, the "parent" Level II laboratories would provide a range of consultant services, including the receipt of referral specimens and patients. In many cases, such as with DBS or a TB culture, the specimen may bypass a Level II laboratory and go directly to…

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Chilundo, B., Sundeep S., Sundby J. The Quality of HIV / AIDS case-detection and case reporting systems in Mozambique. African Journal of AIDS Research 2004, 145-155. Copyright NISC Pty Ltd.

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