Comparison of syndromic diagnosis of reproductive tract infections with laboratory diagnosis among rural married women in Medak district, Andhra Pradesh.

INTRODUCTION: In developing countries, reproductive tract infections (RTI) commonly affect the quality of life. Many reproductive tract infections including sexually transmitted infections (STI) and cervical cancers remain asymptomatic for long periods. Syndromic case management (SCM) is the mainstay in the control of RTI/STI, especially at primary level, where laboratory diagnosis is not possible. However, lab diagnosis should be used when it is available.
OBJECTIVE: To assess the consistency of syndromic diagnosis with laboratory diagnosis.
MATERIALS AND METHODS: A total of 407 women were screened. Women were categorized according to Syndromic Diagnosis of RTI/STI based on history and clinical examination. Microbiological tests and Pap smears were done to confirm the diagnosis and compared with Syndromic Diagnosis.
RESULTS: Microbiologically, 33.14% were positive for at least one organism. Bacterial vaginosis was the most common finding (14%). Pap smear showed 32.9% inflammatory changes and 0.25% low-grade squamous intraepithelial lesion. Sensitivity and specificity of syndromic diagnosis with laboratory findings: Vaginal discharge syndrome with microbiological tests- (Se 58.9; Sp55.1%) Lower abdominal pain syndrome with microbiological tests-(Se 14.4%; Sp76.6%)
CONCLUSION: The findings of this study highlight the wide variation of syndromic and laboratory diagnosis.

INTRODUCTION

Reproductive tract infections including sexually transmitted infections represent an urgent public health priority in developing countries. The 2002 ICMR community based prevalence study of STI/RTI has shown that 5% to 6% of sexually active adult population is suffering from some form of STI/RTI. The 2005 ICMR multicentre rapid assessment survey (RAS) indicates that 12% of female clients and 6% of male clients attend the out-patient departments for complaints related to STI/RTI.[1] According to DLHS-3 18.3% women reported some symptom of reproductive tract infections / sexually transmitted infection.[2]

Most are asymptomatic for long periods. Early diagnosis and treatment of these infections can prevent serious complications and long term sequelae affecting the quality of life. Main barriers to the health seeking behavior among women are illiteracy, ignorance, low socioeconomic status, cultural norms and lack of privacy at the health care facilities. This results in poor availability of data on reproductive tract infections among symptomatic and asymptomatic women. In order to respond to situation of high prevalence and need for effective treatment for RTI/ STI, especially in countries with limited resources, syndromic diagnostic approach was recommended by WHO and was adopted by NACO, India at the primary health center level.[3]

The approach of using simple laboratory tests in conjunction with syndromic approach is called enhanced syndromic management which can enhance the effectiveness i.e increase sensitivity, specificity and predictive values, and contribute to the epidemiological data in programming decision making.[4]

Much of the available data comes from hospital and clinic based studies. There are very few community based prevalence studies with laboratory support on reproductive tract infections/sexually transmitted infections studies among ever married women aged 15-49 years in rural India. To address this issue, this study was carried out among ever married rural women aged 15-49 years with the objective to assess the consistency of syndromic diagnosis with laboratory diagnosis.

MATERIALS AND METHODS

A community-based, cross-sectional study was undertaken in rural field practice area of Osmania medical college, Patancheru, Medak district, Andhra Pradesh between march 2010 and February 2011.

Study setting

Three subcenters under the rural health center with population of 19,081, women population of age group 15-49 years (5002), of this 25% were chosen ie 1250 women.

Sample size

Prevalence was taken as 50%, precision error as 10% 4pq/l2=400

Ethical considerations

Approval for the study was obtained from Osmania Medical College Ethics committee, Hyderabad and informed consent was taken from participants.

Study population recriutment

Inclusion criteria: ever married women of reproductive age group 15-49 years living in the particular village at the time of data collection.

Exclusion criteria: women with missed periods, undergone hysterectomy and unmarried women.

At Rural Health Center, convergence meeting was conducted which included medical officers, Auxillary Nurse Midwives, Health supervisors, ASHA workers, Anganwadi workers and other staff. And they were assessed on awareness on Reproductive tract infections. And the study aims and objectives with inclusion and exclusion criteria were explained. Household survey was conducted with the help of Asha workers, postgraduate students and assistant professors using interview schedule to collect demographic data. The participants were informed that they would be tested for RTIs and STIs and that they would be offered free treatment if found to be infected. Informed consent was obtained in all cases. Before being recruited the purpose of the study was explained to eligible women in their homes and to close family members, e.g. husbands, mothers-in-law. Each woman who agreed to participate attended clinic (Sub center building or Gram Panchayat office or Primary school or Rural health centre) and was interviewed in private about her socio demographic and reproductive history, current and past clinical symptoms affecting the reproductive tract, treatment-seeking behavior, and sexual behavior. Two gynecologists conducted a comprehensive physical examination that included a speculum-based examination of the cervix and vagina and bimanual examination.

Of the 751 women agreed to come for the study, only 536 women turned up to the camps, of whom 96 refused for examination and 33 were excluded due to menstruation and missed periods; so a total of 407 were taken up for the study. Criteria for clinical diagnosis were standardized [Table 1] and findings recorded. During per speculum examination, papnicolaou smear, 3 vaginal, 3 cervical swabs, and a 5 ml blood sample were taken for mirobiological investigations as per Standard Operating Procedures (SOP) Manual of Regional STD Reference Laboratory, Safdarjung Hospital, New Delhi and NACO guidelines [Table 2] and the samples were transported to Regional STI center at Osmania general hospital on the same day by the technician.

Table 1

Criteria for diagnosis as per NACO guidelines

Table 2

Criteria for laboratory diagnosis[11]

Data analysis

Done using MS EXCEL 2007 and EPIINFO version 3.5.6.

RESULTS

Study population characteristics

Most of them were in the age group of 26-30 years comprising 29.2%, education was less than 5 years in 57.2%, most of them belonged to middle class(38%) followed by lower class(34%) as per BG Prasad's socioeconomic status classification.

Prevalence of reproductive tract infections/sexually transmitted infections by syndromic diagnosis was 61.9% and by laboratory diagnosis was 33.1% [Figure 1]. Of the syndromes diagnosed, the most common is vaginal discharge syndrome (34%) followed by lower abdominal pain syndrome (28%). No cases of genital ulcers and genital warts were reported.

Figure 1

Syndromic vs laboratory diagnosis

Results by microbiological investigations using gold standard procedures are shown in Figure 2 and via Papnicalaou smears shown in Table 3.

Figure 2

Prevalence of RTI/STI by confirmed microbiological investigations

Table 3

Prevalence of RTI/STI by pap smear

For vaginal discharge syndrome, sensitivity was 58.95% and specificity was 55.13%; and for lower abdominal pain syndrome sensitivity is very low (14.49%) and high specificity 76.63% [Tables 4 and 5].

Table 4

Vaginal Discharge syndrome

Table 5

Lower abdominal pain syndrome

DISCUSSION

The present study found the prevalence of STI/RTI by laboratory diagnosis as 33.1% which is similar to that reported by the study done by Prasad et al in rural Tamil Nadu.[5] Also,vaginal discharge syndrome is the most common syndromic diagnosis, which is consistent with previous studies.[6-8] The most common infection identified by laboratory diagnosis was bacterial vaginosis (14.3%) which was similar to that (17.4%) reported by the study done by Patnaik et al in urban slums of Berhampur.[9]

None of them complained of genital ulcers and growths similar to the study by Krishna Ray et al.[10] Syndromic diagnosis of vaginal discharge syndrome had high sensitivity but low specificity similar to the study conducted in urban slums of Delhi by Suneela Garg et al.[6] Pap smear findings reported inflammatory changes as 33% and low-grade squamous epithelial lesion as 0.25% which was similar to the above study.

CONCLUSIONS

The results of this study provide wide variation between syndromic and laboratory diagnosis of reproductive tract infections in rural women, showing that enhanced syndromic management would be more effective. This study also demonstrated the feasibility of prevalence and early detection of precancerous and cancerous lesions.