Standard operating procedures (SOPS) for health and demographic research data quality assurance: the case of VADU HDSS site

A research report submitted to the Faculty of Health Sciences, University of the Witwatersrand in partial fulfilment of the requirements for the degree of Masters of Science In Epidemiology (Research Data Management) Johannesburg, September 2016The idea of data quality assurance and security control is to monitor the quality of research data generated from any research activity. This consists of a thorough collection of documentation regarding all aspects of the research. Data management procedures of health and demographic research constantly changes or emerges through the iterative processes of data collection and analysis and requires that the investigator make frequent decisions that can alter the course of the study. As a result, audit trails that provides justification for these actions will be vital for future analysis. The audit trail provides a mechanism for retroactive assessment of the conduct of the inquiry and a means to address issues related to authenticity of the research datasets. This research seeks to develop an Information Assurance Policy and Standard Operating Procedures for Vadu Health and Demographic Surveillance System Site using ISACA/COBIT 5 family products and ISO/IEC ISMS as benchmark. The work proposes data assurance and security controls and measures for any given research project. To develop such SOP, there is a need to identify existing gaps and inconsistencies within the data management life cycle at VRHP site. This will allow us to establish the areas of focus for the SOP. We used an interview-based approach to identify the existing gaps associated with data management life cycle at VRHP site. The study population included key members of the data management team. The study was conducted utilizing a self-administered questionnaire with structured and open ended questions. Purposive sampling method used to enrol 21 data management team members consisting of 13 Field Research Assistants, 4 Field Research Supervisors, 1 Field Coordinator, 1 Software Application Developer, 1 Head of Data Management and 1 Data Manager. Unstructured interviews were conducted to gather information on respective roles and responsibilities of the members to ensure maximum open interactions. Data gathering and analyses were done concurrently. Two themes arose from the data: Current lapses in data collection at Vadu HDSS and current lapses in data management at Vadu HDSS. The response rate was 95.5%. We adopted the ISACA/COBIT 5 guidelines and ISO/IEC ISMS as benchmark to develop SOPs to guide data management life cycle activities in enforcing data quality assurance. We also included some guidelines that can be used in replicating the SOP at other research institution.MT201

Enhancing LPG Adoption in Ghana (ELAG): A Trial Testing Policy-Relevant Interventions to Increase Sustained Use of Clean Fuels.

Rural Ghanaians rely on solid biomass fuels for their cooking. National efforts to promote the Sustainable Development Goals include the Rural Liquefied Petroleum Gas Promotion Program (RLP), which freely distributes LPG stoves, but evaluations have demonstrated low sustained use among recipients. Our study objective was to assess if cheap and scalable add-on interventions could increase sustained use of LPG stoves under the RLP scheme. We replicated RLP conditions among participants in 27 communities in Kintampo, Ghana, but cluster-randomized them to four add-on interventions: a behavioral intervention, fuel delivery service, combined intervention, or control. We reported on the final 6 months of a 12-month follow-up for participants (n = 778). Results demonstrated increased use for each intervention, but magnitudes were small. The direct delivery intervention induced the largest increase: 280 min over 6 months (p < 0.001), ∼1.5 min per day. Self-reported refills (a secondary outcome), support increased use for the dual intervention arm (IRR = 2.2, p = 0.026). Past literature demonstrates that recipients of clean cookstoves rarely achieve sustained use of the technologies. While these results are statistically significant, we interpret them as null given the implied persistent reliance on solid fuels. Future research should investigate if fuel subsidies would increase sustained use since current LPG promotion activities do not

Non-malaria fevers in a high malaria endemic area of Ghana.

BACKGROUND: The importance of fevers not due to malaria [non-malaria fevers, NMFs] in children in sub-Saharan Africa is increasingly being recognised. We have investigated the influence of exposure-related factors and placental malaria on the risk of non-malaria fevers among children in Kintampo, an area of Ghana with high malaria transmission. METHODS: Between 2008 and 2011, a cohort of 1855 newborns was enrolled and followed for at least 12 months. Episodes of illness were detected by passive case detection. The primary analysis covered the period from birth up to 12 months of age, with an exploratory analysis of a sub-group of children followed for up to 24 months. RESULTS: The incidence of all episodes of NMF in the first year of life (first and subsequent) was 1.60 per child-year (95 % CI 1.54, 1.66). The incidence of NMF was higher among infants with low birth weight [adjusted hazard ratio (aHR) 1.22 (95 % CI 1.04-1.42) p = 0.012], infants from households of poor socio-economic status [aHR 1.22 (95 % CI 1.02-1.46) p = 0.027] and infants living furthest from a health facility [aHR 1.20 (95 % CI 1.01-1.43) p = 0.037]. The incidence of all episodes of NMF was similar among infants born to mothers with or without placental malaria [aHR 0.97 (0.87, 1.08; p = 0.584)]. CONCLUSION: The incidence of NMF in infancy is high in the study area. The incidence of NMF is associated with low birth weight and poor socioeconomic status but not with placental malaria

The Accuracy and Perception of Test-Based Management of Malaria at Private Licensed Chemical Shops in the Middle Belt of Ghana.

The sale of artemisinin-based combination therapy (ACT) by private licensed chemical shops (LCS) without testing is contrary to current policy recommendations. This study assessed the accuracy and perception of test-based management of malaria using malaria rapid diagnostic test (mRDT) kits at private LCS in two predominantly rural areas in the middle part of Ghana. Clients presenting at LCS with fever or other signs and symptoms suspected to be malaria in the absence of signs of severe malaria were tested with mRDT by trained attendants and treated based on the national malaria treatment guidelines. Using structured questionnaires, exit interviews were conducted within 48 hours and a follow-up interview on day 7 (±3 days). Focus group discussions and in-depth interviews were also conducted to assess stakeholders' perception on the use of mRDT at LCS. About 79.0% (N = 1,797) of clients reported with a fever. Sixty-six percent (947/1,426) of febrile clients had a positive mRDT result. Eighty-six percent (815/947) of clients with uncomplicated malaria were treated with the recommended ACT. About 97.8% (790/808) of clients with uncomplicated malaria treated with ACT were reported to be well by day 7. However, referral for those with negative mRDT results was very low (4.1%, 27/662). A high proportion of clients with a positive mRDT result received the recommended malaria treatment. Test-based management of malaria by LCS attendants was found to be feasible and acceptable by the community members and other stakeholders. Successful implementation will however require effective referral, supervision and quality control systems

Prevalence of Hypertension in the Middle Belt of Ghana: A Community-Based Screening Study.

OBJECTIVE: Prevalence of hypertension is on the rise and can be attributed to aging populations and changing behavioral or lifestyle risk factors. The objectives of this study were to determine the prevalence, awareness, treatment, control, and risk factors of hypertension in the middle part of Ghana. METHODS: A total of 2,555 participants aged ≥18 years (mean age of 43 years; 60.5% female) were enrolled using a two-stage sampling method. The World Health Organization STEPwise approach to chronic disease risk factor Surveillance-Instrument v2.1 was used for data collection. Blood pressure and anthropometric measurements were assessed. Blood glucose and lipids were also measured using blood samples collected after an overnight fast. RESULTS: Prevalence of hypertension was 28.1% (95% CI: 26.3%-29.8%). Less than half, i.e., 45.9% (95% CI: 42.2%-49.6%), of the respondents were aware of their hypertensive status. Of those aware and had sought medical treatment, 41.3% (95% CI: 36.1-46.8) had their hypertension controlled. Risk factors associated with being hypertensive were current (p=0.053) and past tobacco usage (p < 0.001), prediabetes (p=0.042), high body mass index (p < 0.001), hyperglycaemia (p=0.083), and hypercholesterolaemia (p=0.010). Doing vigorous work and being active in sports were less associated with being hypertensive (p < 0.001). CONCLUSION: Our study showed that close to one-quarter of adults who were involved in the survey in the middle belt of Ghana were hypertensive with less than half being aware of their hypertensive status; nearly half of those on treatment had controlled hypertension. Healthcare systems need adequate resources that enable them to screen, educate, and refer identified hypertensive patients for appropriate management to prevent or minimize the development of hypertension-related complications

Effectiveness of intermittent preventive treatment in pregnancy with sulphadoxine-pyrimethamine (IPTp-SP) in Ghana.

INTRODUCTION: Ghana adopted the revised WHO recommendation on intermittent preventive treatment in pregnancy using sulfadoxine-pyrimethamine (IPTp-SP) in 2012. This study has assessed the effectiveness and safety of this policy in Ghana. METHODS: A total of 1926 pregnant women enrolled at antenatal care (ANC) clinics were assessed for birth outcomes at delivery, and placental histology results for malaria infection were obtained from 1642 participants. Association of reduced placental or peripheral malaria, anaemia and low birth weight (LBW) in women who received ≥4 IPTp-SP doses compared with 3 or ≤2 doses was determined by logistic regression analysis. RESULTS: Among the 1926 participants, 5.3% (103), 19.2% (369), 33.2% (640) and 42.3% (817) of women had received ≤1, 2, 3 or ≥4 doses, respectively. There was no difference in risk of active placental malaria (PM) infection in women who received 3 doses compared with ≥4 doses (adjusted OR (aOR) 1.00, 95% CI 0.47 to 2.14). The risk of overall PM infection was 1.63 (95% CI 1.07 to 2.48) in 2 dose group and 1.06 (95% CI 0.72 to 1.57) in 3 dose group compared with ≥4 dose group. The risk of LBW was 1.55 (95% CI 0.97 to 2.47) and 1.06 (95% CI 0.68 to 1.65) for 2 and 3 dose groups, respectively, compared with the ≥4 dose group. Jaundice in babies was present in 0.16%, and 0% for women who received ≥4 doses of SP. CONCLUSION: There was no difference in the risk of PM, LBW or maternal anaemia among women receiving 3 doses compared with ≥4 doses. Receiving ≥3 IPTp-SP doses during pregnancy was associated with a lower risk of overall PM infection compared with 2 doses. As there are no safety concerns, monthly administration of IPTp-SP offers a more practical opportunity for pregnant women to receive ≥3 doses during pregnancy

Correction: Profiles of Plasmodium falciparum infections detected by microscopy through the first year of life in Kintampo a high transmission area of Ghana.

[This corrects the article DOI: 10.1371/journal.pone.0240814.]

Profiles of Plasmodium falciparum infections detected by microscopy through the first year of life in Kintampo a high transmission area of Ghana.

Although malaria mortality among children under five years of age is high, the characteristics of their infection patterns are not well described. The aim of this study was to examine the longitudinal sequence pattern of Plasmodium falciparum infections in the first year of life within a birth cohort in Kintampo, Ghana (N = 1855). Infants were monitored at home with monthly sampling and also at the clinic for any febrile illness between 2008 and 2011. Light microscopy was performed on monthly scheduled visits and febrile ill visits over twelve months of follow-ups (n = 19231). Microscopy-positive visits accompanied with or without symptoms were rare during the first five months of life but were common from six to twelve months of age. Among 1264 infants with microscopy data over a minimum of eight monthly visits and also throughout in sick visits, some were microscopy negative (36%), and others positive: only-symptomatic (35%), alternating (22%) and only-asymptomatic (7%). The median age of microscopic infection was seven months for the alternating group and eight months for both the only-symptomatic and only-asymptomatic groups. The alternating group had the highest cumulative incidence of microscopic infections, the lowest age at first infection and 87 different infection patterns. Parasite densities detected by microscopy were significantly higher for symptomatic versus asymptomatic infection. We conclude that infants in malaria endemic areas experience diverse infection profiles throughout their first year of life. Further investigations should include submicroscopic reservoir and may shed more light on the factors that determine susceptibility to malaria during infancy

Epidemiology of malaria among pregnant women during their first antenatal clinic visit in the middle belt of Ghana: a cross sectional study.

BACKGROUND: Malaria during pregnancy may result in unfavourable outcomes in both mothers and their foetuses. This study sought to document the current burden and factors associated with malaria and anaemia among pregnant women attending their first antenatal clinic visit in an area of Ghana with perennial malaria transmission. METHODS: A total of 1655 pregnant women aged 18 years and above with a gestational age of 13-22 weeks, who attended an antenatal care (ANC) clinic for the first time, were consented and enrolled into the study. A structured questionnaire was used to collect socio-demographic and obstetric data and information on use of malaria preventive measures. Venous blood (2 mL) was collected before sulfadoxine-pyrimethamine administration. Malaria parasitaemia and haemoglobin concentration were determined using microscopy and an automated haematology analyser, respectively. Data analysis was carried out using Stata 14. RESULTS: Mean age (SD) and gestational age (SD) of women at enrolment were 27.4 (6.2) years and 16.7 (4.3) weeks, respectively. Overall malaria parasite prevalence was 20.4% (95% CI 18.5-22.4%). Geometric mean parasite density was 442 parasites/µL (95% CI 380-515). Among women with parasitaemia, the proportion of very low (1-199 parasites/µL), low (200-999 parasites/µL), medium (1000-9999 parasites/µL) and high (≥ 10,000 parasites/µL) parasite density were 31.1, 47.0, 18.9, and 3.0%, respectively. Age ≥ 25 years (OR 0.57, 95% CI 0.41-0.79), multigravid (OR 0.50, 95% CI 0.33-0.74), educated to high school level or above (OR 0.53, 95% CI 0.33-0.83) and in household with higher socio-economic status (OR 0.34, 95% CI 0.21-0.54) were associated with a lower risk of malaria parasitaemia. The prevalence of anaemia (< 11.0 g/dL) was 56.0%, and the mean haemoglobin concentration in women with or without parasitaemia was 9.9 g/dL or 10.9 g/dL, respectively. CONCLUSION: One out of five pregnant women attending their first ANC clinic visit in an area of perennial malaria transmission in the middle belt of Ghana had Plasmodium falciparum infection. Majority of the infections were below 1000 parasites/µL and with associated anaemia. There is a need to strengthen existing malaria prevention strategies to prevent unfavourable maternal and fetal birth outcomes in this population