Leveraging routine data in impact evaluation: Understanding data systems in primary healthcare prior to a matched cluster-randomised evaluation of adherence guidelines in South Africa.

BACKGROUND: An essential part of providing high-quality patient care and a means of efficiently conducting research studies relies upon high-quality routinely collected medical information. OBJECTIVES: To describe the registers, paper records and databases used in a sample of primary healthcare clinics in South Africa (SA) with the view to conduct an impact evaluation using routine data. METHODS: Between October 2015 and December 2015, we collected information on the presence, quality and completeness of registers, clinical stationery and databases at 24 public health facilities in SA. We describe each register and type of clinical stationery we encountered, their primary uses, and the quality of completion. We also mapped the ideal flow of data through a site to better understand how its data collection works. RESULTS: We identified 13 registers (9 standard, 4 non-standard), 5 types of stationery and 4 databases as sources of medical information within a site. Not all clinics used all the standardised registers, and in those that did, registers were kept in various degrees of completeness: a common problem was inconsistent recording of folder numbers. The quality of patient stationery was generally high, with only the chronic patient record being considered of varied quality. The TIER.Net database had high-quality information on key variables, but national identification (ID) number was incompletely captured (42% complete). Very few evaluation sites used electronic data collection systems for conditions other than HIV/AIDS. CONCLUSION: Registers, databases and clinical stationery were not implemented or completed consistently across the 24 evaluation sites. For those considering using routinely collected data for research and evaluation purposes, we would recommend a thorough review of clinic data collection systems for both quality and completeness before considering them to be a reliable data source.

Antibiotics for trachoma.

BACKGROUND: Trachoma is the world's leading cause of preventable blindness. In 1997 the World Health Organization launched an initiative on trachoma control based on the 'SAFE' strategy (surgery, antibiotics, facial cleanliness and environmental improvement). OBJECTIVES: To assess the evidence supporting the antibiotic arm of the SAFE strategy by assessing the effects of antibiotics on both active trachoma (primary objective) and on Chlamydia trachomatis infection of the conjunctiva (secondary objective). SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials - CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to February 2005), and EMBASE (1980 to February 2005). We used the Science Citation Index to look for articles that cited the included studies. We searched the reference lists of identified articles and we contacted authors and experts for details of further relevant studies. SELECTION CRITERIA: We included only randomised trials that satisfied either of two criteria: (a) trials in which topical or oral administration of an antibiotic was compared to placebo or no treatment in people with trachoma, (b) trials in which a topical antibiotic was compared with an oral antibiotic in people with trachoma. A subdivision of particular interest was of trials in which topical tetracycline/chlortetracycline was compared with oral azithromycin, as these are the two World Health Organization recommended treatments. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted investigators for missing data. MAIN RESULTS: We found 15 studies that randomised a total of 8678 participants. For both outcomes (active trachoma and laboratory evidence of infection) the results of the chi squared tests suggested that there was significant statistical heterogeneity among the trials. There was also marked clinical heterogeneity. No summary statistics were calculated and we therefore present a narrative summary of the results. For the comparisons of oral or topical antibiotic against placebo/no treatment, the data are consistent with there being no effect of antibiotics but are suggestive of a lowering of the point prevalence of relative risk of both active disease and laboratory evidence of infection at three and 12 months after treatment. For the comparison of oral against topical antibiotics the results suggest that oral treatment is neither more nor less effective than topical treatment. AUTHORS' CONCLUSIONS: There is some evidence that antibiotics reduce active trachoma but results are not consistent and cannot be pooled.

Antibiotics for trachoma.

BACKGROUND: Trachoma is the world's leading cause of preventable blindness. In 1997 the World Health Organization launched an initiative on trachoma control based on the 'SAFE' strategy (surgery, antibiotics, facial cleanliness and environmental improvement). OBJECTIVES: The aim of this review is to assess the evidence supporting the antibiotic arm of the SAFE strategy by assessing the effects of antibiotics on both active trachoma (primary objective) and on Chlamydia trachomatis infection of the conjunctiva (secondary objective). SEARCH STRATEGY: We searched The Cochrane Controlled Trials Register - CENTRAL/CCTR, which contains the Cochrane Eyes and Vision Group specialised register (Cochrane Library Issue 3, 2001), MEDLINE (1966 to August 2001), and EMBASE (1980 to September 2001). We used the Science Citation Index to look for articles that cited the included studies. We searched the reference lists of identified articles and we contacted authors and experts for details of further relevant studies. SELECTION CRITERIA: We included only randomised trials that satisfied either of two criteria: (a) trials in which topical or oral administration of an antibiotic was compared to placebo or no treatment in people with trachoma, (b) trials in which a topical antibiotic was compared with an oral antibiotic in people with trachoma. A subdivision of particular interest was of trials in which topical tetracycline/chlortetracycline was compared with oral azithromycin, as these are the two World Health Organization recommended treatments. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. We contacted investigators for missing data. MAIN RESULTS: We found 15 studies that randomised a total of 8678 participants. For both outcomes (active trachoma and laboratory evidence of infection) the results of the chi-square tests suggested that there was significant statistical heterogeneity among the trials. There was also marked clinical heterogeneity. No summary statistics were calculated and we therefore present a narrative summary of the results. For the comparisons of oral or topical antibiotic against placebo/no treatment, the data are consistent with there being no effect of antibiotics but are suggestive of a lowering of the point prevalence of relative risk of both active disease and laboratory evidence of infection at three and 12 months after treatment. For the comparison of oral against topical antibiotics the results suggest that oral treatment is neither more nor less effective than topical treatment. REVIEWER'S CONCLUSIONS: There is some evidence that antibiotics reduce active trachoma but results are not consistent and cannot be pooled.

Efficacy of oral azithromycin versus topical tetracycline in mass treatment of endemic trachoma.

OBJECTIVE: To compare the impact of mass treatment with oral azithromycin and topical tetracycline on the prevalence of active trachoma. METHODS: A total of 1803 inhabitants from 106 households of eight Gambian villages were randomized, in pairs, to receive either three doses of azithromycin at weekly intervals, or daily topical tetracycline over 6 weeks. Ocular examinations were conducted before treatment, and 2, 6 and 12 months after treatment. FINDINGS: Prior to treatment, 16% of the study participants had active trachoma. Two months after treatment, the prevalence of trachoma was 4.6% and 5.1% in the azithromycin and the tetracycline groups, respectively (adjusted odds ratio (OR) = 1.09; 95% confidence interval (CI) = 0.53, 2.02). Subsequently, the prevalence rose to 16% in the tetracycline group, while remaining at 7.7% in the azithromycin group (adjusted OR at 12 months = 0.52; 95% CI = 0.34, 0.80). At 12 months post-treatment, there were fewer new prevalent cases in the azithromycin group, and trachoma resolution was significantly better for this group (adjusted OR = 2.02; 95% CI = 1.42, 3.50). CONCLUSION: Oral azithromycin therefore appears to offer a means for controlling blinding trachoma. It is easy to administer and higher coverages may be possible than have been achieved hitherto.

Age dependence of the multiplicity of Plasmodium falciparum infections and of other malariological indices in an area of high endemicity.

The relationship between age and various malariological indices in the Kilombero valley of Tanzania were examined by compiling data from 6 different community studies carried out between 1989 and 1996. The rate of acquisition of Plasmodium falciparum infection was highest in children 1-5 years of age, while recovery rates were lowest between the first birthday and early adolescence. As a result, peak prevalence was reached in 3-5 years old children. However, the prevalence of clinical malaria (estimated from the excess risk of axillary temperatures > or = 37.5 degrees C attributable to parasitaemia) was highest in children under one year of age. The peak in multiplicity of infection (identified by polymerase chain reaction-restriction fragment length polymorphism of the msp2 locus) occurred in 3-7 years old children. There was a significant correlation between parasite density and multiplicity of infection in infants and young children (1-2 years of age) but not in older individuals.

Effect of insecticide-treated bed nets on haemoglobin values, prevalence and multiplicity of infection with Plasmodium falciparum in a randomized controlled trial in Tanzania.

A randomized controlled trial of insecticide-treated bed nets (ITNs) was conducted in an area of high malaria transmission in Tanzania in order to assess the effects of ITNs on infection and anaemia. One hundred and twenty-two children, aged 5 to 24 months, were randomly allocated to 2 groups, one of which received ITNs. Outcome measures were assessed in 6 consecutive months with monthly cross-sectional surveys. These measures were haemoglobin values, Plasmodium falciparum prevalence and density, and multiplicity of infection determined by polymerase chain reaction-restriction fragment length polymorphism analysis (PCR-RFLP) of the msp2 locus. There was a significant increase in mean heamoglobin values and a significant decrease of 16.4% in microscopically determined P. falciparum prevalence in children in the ITN group six months after the start of the trial. Both effects were more pronounced in younger children. However, no significant difference was observed in parasite density or multiplicity of infection among infected children. Comparison with PCR results indicated that microscopically subpatent parasitaemia was more frequently found in children in the ITN group. This, together with the observed similar multiplicity in the 2 groups, suggests that infections are maintained despite ITN use, owing to the chronicity of infections. This study shows that ITNs reduce the risk of anaemia in highly exposed young children. The virtually unchanged multiplicity of infection indicates that the potentially protective concomitant immunity is not compromised.

Effect of insecticide-treated bed nets on the dynamics of multiple Plasmodium falciparum infections.

The rates of acquisition and loss of individual genotypes belonging to the FC27 family of the Plasmodium falciparum merozoite surface protein 2 (msp2) gene were studied in 120 children aged 5 months to 2.5 years, in a randomized controlled trial of insecticide-treated bed nets (ITNs) in Kiberege village, Tanzania. Analysis of longitudinal changes in positivity for individual alleles in samples collected at intervals of one month indicated that the average duration of infections, allowing for undetected parasite genotypes, was 73 d in those aged < 18 months and 160 d in children aged > or = 18 months, consistent with a shift from acute to chronic infection with age. Overall, 51% of genotypes infecting the host were estimated to be detected by polymerase chain reaction-restriction fragment length polymorphism analysis in any one sample of 0.5 microL of packed peripheral blood cells. In children less than 18 months old this sensitivity was 61% (SE = 6%) compared with 41% (SE = 6%) in older children. Conversely, the rate of appearance of new parasite genotypes was higher in children < 18 months of age than in older children, but this partly reflected the difference in sensitivity. The overall incidence of new infections was estimated to be reduced by 17% in ITN users. There was no statistically significant difference between users and non-users in observed infection multiplicity, sensitivity, recovery rate, or estimated infection rates for individual alleles. This suggests that, in areas of high P. falciparum endemicity, ITNs have little effect on the establishment of chronic malaria infection.

Safety in infants of SPf66, a synthetic malaria vaccine, delivered alongside the EPI.

The most likely mechanism to deliver a malaria vaccine in African countries is through the Expanded Program of Immunization (EPI). So far only SPf66, a multistage synthetic peptide, has shown any evidence of protection in Phase III field trials. In Tanzania, SPf66 reduced the risk of clinical malaria by 31% in children aged 1-5 years. In order to progress in the critical path of vaccine development and testing towards the implementation of a new vaccine in malaria control programs, we carried out a randomized double-blind placebo controlled efficacy trial of SPf66 when given alongside the EPI scheme. Monitoring of safety and reactogenicity during this trial included detailed clinical and laboratory assessments on 98 infants and assessment of adverse effects within 1 h of vaccination for all 1207 children vaccinated. Surveillance systems monitored attendances as outpatients, admissions to hospital and fatal events in the community. No serious adverse effects were detected more frequently amongst SPf66 recipients compared to placebo. This first assessment in very young infants of a synthetic vaccine provides evidence of a good safety profile.

Insecticide-treated nets and treatment service: a trial using public and private sector channels in rural United Republic of Tanzania.

The Rotary Net Initiative, implemented in Kilombero District, southern United Republic of Tanzania, allowed us to explore different sales channels for the distribution of insecticide-treated nets (ITNs) and the insecticide treatment service in a rural area of very high malaria transmission. Several types of ITNs were promoted and sold through different channels in the public and private sector, i.e. hospital pharmacy, mother and child health (MCH) clinic, net committee, village health workers and retail shops. The ITNs were sold for US$ 5.0-9.2, with profit margins of 9-16%. Net treatment cost US$ 0.33, with commission fees of 75%. Net transport and treatment were partially subsidized. Some outlets established their own fund by ITN sales. Sales of nets and treatments were seasonal, and certain net types were preferred. Demand for insecticide treatment was generally low. Changes in net coverage were assessed in two villages. A range of outlet features were compared qualitatively. Our experience supports suggestions that ITN technology should be delivered through MCH care services and demonstrates that specific promotion and innovation are necessary to achieve substantial net treatment levels. A large-scale ITN project in the same area and other ITN studies should lead to better understanding of ITN implementation at the population level.