Home fortification of foods with multiple micronutrient powders for health and nutrition in children under two years of age (Review).

BACKGROUND: Vitamin and mineral deficiencies, particularly those of iron, vitamin A and zinc, affect more than two billion people worldwide. Young children are highly vulnerable because of rapid growth and inadequate dietary practices. Micronutrient powders (MNP) are single-dose packets containing multiple vitamins and minerals in powder form that can be sprinkled onto any semi-solid food.The use of MNP for home or point-of-use fortification of complementary foods has been proposed as an intervention for improving micronutrient intake in children under two years of age. OBJECTIVES: To assess the effects and safety of home (point-of-use) fortification of foods with multiple micronutrient powders on nutritional, health and developmental outcomes in children under two years of age. SEARCH METHODS: We searched the following databases in February 2011: Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE (1948 to week 2 February 2011), EMBASE (1980 to Week 6 2011), CINAHL (1937 to current), CPCI-S (1990 to 19 February 2011), Science Citation Index (1970 to 19 February 2011), African Index Medicus (searched 23 February 2011), POPLINE (searched 21 February 2011), ClinicalTrials.gov (searched 23 February 2011), mRCT (searched 23 February 2011), and World Health Organization International Clinical Trials Registry Platform (ICTRP) (searched 23 February 2011). We also contacted relevant organisations (25 January 2011) for the identification of ongoing and unpublished studies. SELECTION CRITERIA: We included randomised and quasi-randomised trials with either individual or cluster randomisation. Participants were children under the age of two years at the time of intervention, with no specific health problems. The intervention was consumption of food fortified at the point of use with multiple micronutrient powders formulated with at least iron, zinc and vitamin A compared with placebo, no intervention or the use of iron containing supplements, which is the standard practice. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of studies against the inclusion criteria, extracted data from included studies and assessed the risk of bias of the included studies. MAIN RESULTS: We included eight trials (3748 participants) conducted in low income countries in Asia, Africa and the Caribbean, where anaemia is a public health problem. The interventions lasted between two and 12 months and the powder formulations contained between five and 15 nutrients. Six trials compared the use of MNP versus no intervention or a placebo and the other two compared the use of MNP versus daily iron drops. Most of the included trials were assessed as at low risk of bias. Home fortification with MNP reduced anaemia by 31% (six trials, RR 0.69; 95% CI 0.60 to 0.78) and iron deficiency by 51% (four trials, RR 0.49; 95% CI 0.35 to 0.67) in infants and young children when compared with no intervention or placebo, but we did not find an effect on growth. In comparison with daily iron supplementation, the use of MNP produced similar results on anaemia (one trial, RR 0.89; 95% CI 0.58 to 1.39) and haemoglobin concentrations (two trials, MD -2.36 g/L; 95% CI -10.30 to 5.58); however, given the limited amount of data these results should be interpreted cautiously. No deaths were reported in the trials and information on side effects and morbidity, including malaria, was scarce. It seems that the use of MNP is efficacious among infants and young children six to 23 months of age living in settings with different prevalences of anaemia and malaria endemicity, regardless of whether the intervention lasts two, six or 12 months or whether recipients are male or female. AUTHORS' CONCLUSIONS: Home fortification of foods with multiple micronutrient powders is an effective intervention to reduce anaemia and iron deficiency in children six months to 23 months of age. The provision of MNP is better than no intervention or placebo and possibly comparable to commonly used daily iron supplementation. The benefits of this intervention as a child survival strategy or on developmental outcomes are unclear. Data on effects on malaria outcomes are lacking and further investigation of morbidity outcomes is needed. The micronutrient powders containing multiple nutrients are well accepted but adherence is variable and in some cases comparable to that achieved in infants and young children receiving standard iron supplements as drops or syrups.

Maintenance erlotinib in advanced nonsmall cell lung cancer: cost-effectiveness in EGFR wild-type across Europe.

BACKGROUND: First-line maintenance erlotinib in patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) has demonstrated significant overall survival and progression-free survival benefits compared with best supportive care plus placebo, irrespective of epidermal growth factor receptor (EGFR) status (SATURN trial). The cost-effectiveness of first-line maintenance erlotinib in the overall SATURN population has been assessed and published recently, but analyses according to EGFR mutation status have not been performed yet, which was the rationale for assessing the cost-effectiveness of first-line maintenance erlotinib specifically in EGFR wild-type metastatic NSCLC. METHODS: The incremental cost per life-year gained of first-line maintenance erlotinib compared with best supportive care in patients with EGFR wild-type stable metastatic NSCLC was assessed for five European countries (the United Kingdom, Germany, France, Spain, and Italy) with an area-under-the-curve model consisting of three health states (progression-free survival, progressive disease, death). Log-logistic survival functions were fitted to Phase III patient-level data (SATURN) to model progression-free survival and overall survival. The first-line maintenance erlotinib therapy cost (modeled for time to treatment cessation), medication cost in later lines, and cost for the treatment of adverse events were included. Deterministic and probabilistic sensitivity analyses using Monte Carlo simulation (1000 iterations) were performed. RESULTS: According to the model simulations, first-line maintenance erlotinib compared with best supportive care in EGFR wild-type stable metastatic NSCLC resulted in 4.57 months of life gained (17.82 months for erlotinib versus 13.24 months for best supportive care) and 1.14 months of life without progression gained (erlotinib 4.29 versus best supportive care 3.15), and incremental total costs of erlotinib from €7897 (UK) to €9580 (Germany). The corresponding mean incremental cost per life-year gained of erlotinib ranged between €20,711 (UK) and €25,124 (Germany). Sensitivity analyses confirmed these results. CONCLUSION: First-line erlotinib maintenance treatment is cost-effective compared with best supportive care in EGFR wild-type stable metastatic NSCLC, irrespective of the country setting.

Home fortification of foods with multiple micronutrient powders for health and nutrition in children under two years of age.

BACKGROUND: Vitamin and mineral deficiencies, particularly those of iron, vitamin A and zinc, affect more than two billion people worldwide. Young children are highly vulnerable because of rapid growth and inadequate dietary practices. Micronutrient powders (MNP) are single-dose packets containing multiple vitamins and minerals in powder form that can be sprinkled onto any semi-solid food.The use of MNP for home or point-of-use fortification of complementary foods has been proposed as an intervention for improving micronutrient intake in children under two years of age. OBJECTIVES: To assess the effects and safety of home (point-of-use) fortification of foods with multiple micronutrient powders on nutritional, health and developmental outcomes in children under two years of age. SEARCH STRATEGY: We searched the following databases in February 2011: Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE (1948 to week 2 February 2011), EMBASE (1980 to Week 6 2011), CINAHL (1937 to current), CPCI-S (1990 to 19 February 2011), Science Citation Index (1970 to 19 February 2011), African Index Medicus (searched 23 February 2011), POPLINE (searched 21 February 2011), ClinicalTrials.gov (searched 23 February 2011), mRCT (searched 23 February 2011), and World Health Organization International Clinical Trials Registry Platform (ICTRP) (searched 23 February 2011). We also contacted relevant organisations (25 January 2011) for the identification of ongoing and unpublished studies. SELECTION CRITERIA: We included randomised and quasi-randomised trials with either individual or cluster randomisation. Participants were children under the age of two years at the time of intervention, with no specific health problems. The intervention was consumption of food fortified at the point of use with multiple micronutrient powders formulated with at least iron, zinc and vitamin A compared with placebo, no intervention or the use of iron containing supplements, which is the standard practice. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the eligibility of studies against the inclusion criteria, extracted data from included studies and assessed the risk of bias of the included studies. MAIN RESULTS: We included eight trials (3748 participants) conducted in low income countries in Asia, Africa and the Caribbean, where anaemia is a public health problem. The interventions lasted between two and 12 months and the powder formulations contained between five and 15 nutrients. Six trials compared the use of MNP versus no intervention or a placebo and the other two compared the use of MNP versus daily iron drops. Most of the included trials were assessed as at low risk of bias.Home fortification with MNP reduced anaemia by 31% (six trials, RR 0.69; 95% CI 0.60 to 0.78) and iron deficiency by 51% (four trials, RR 0.49; 95% CI 0.35 to 0.67) in infants and young children when compared with no intervention or placebo, but we did not find an effect on growth.In comparison with daily iron supplementation, the use of MNP produced similar results on anaemia (one trial, RR 0.89; 95% CI 0.58 to 1.39) and haemoglobin concentrations (two trials, MD -2.36 g/L; 95% CI -10.30 to 5.58); however, given the limited amount of data these results should be interpreted cautiously.No deaths were reported in the trials and information on side effects and morbidity, including malaria, was scarce.It seems that the use of MNP is efficacious among infants and young children six to 23 months of age living in settings with different prevalences of anaemia and malaria endemicity, regardless of whether the intervention lasts two, six or 12 months or whether recipients are male or female. AUTHORS' CONCLUSIONS: Home fortification of foods with multiple micronutrient powders is an effective intervention to reduce anaemia and iron deficiency in children six months to 23 months of age. The provision of MNP is better than no intervention or placebo and possibly comparable to commonly used daily iron supplementation. The benefits of this intervention as a child survival strategy or on developmental outcomes are unclear. Data on effects on malaria outcomes are lacking and further investigation of morbidity outcomes is needed. The micronutrient powders containing multiple nutrients are well accepted but adherence is variable and in some cases comparable to that achieved in infants and young children receiving standard iron supplements as drops or syrups.

Characteristics and quality of reporting of cluster randomized trials in children: reporting needs improvement.

OBJECTIVE: To describe the characteristics and quality of reporting of cluster randomized trials (CRTs) in children published from 2004 to 2010. STUDY DESIGN AND SETTING: Four databases were searched for reports of CRTs in children (0-18 years). Characteristics of the studies were summarized and the quality of reporting assessed using consolidated standards of reporting trial-CRT (CONSORT-CRT). RESULTS: Of 1,949 identified references, 106 were included. The number of published CRTs in children increased since 2004. The greatest proportion of CRTs was undertaken in Europe (29%), whereas 40% was conducted in low- and middle-income countries. Most studies were of complex rather than simple interventions (83%); were preventive rather than treatment interventions (76%); and most frequently addressed infectious disease (21%), diet/physical activity interventions (19%), health-risk behaviors (15%), and undernutrition (13%). The majority used schools as units of randomization (72%) and enrolled 1,000-10,000 children per study (51%). Reporting was generally poor, with 34% of CRTs inadequately reporting on more than half of the CONSORT-CRT criteria. Although 85% of CRTs reported that they had ethics approval for the study, consent or assent was not obtained from children in most studies. CONCLUSION: Children-specific elements of reporting are needed to improve the quality of reporting of CRTs and consequently their planning and implementation.

What is the value of computered tomography colonography in patients screening positive for fecal occult blood? A systematic review and economic evaluation.

BACKGROUND & AIMS: Computerized tomography colonography (CTC) is a highly accurate test for the detection of colorectal polyps and cancers and has been proposed as a potential alternative to colonoscopy. Bowel cancer screening using fecal occult blood testing (FOBT) and follow-up diagnostic colonoscopy is an effective intervention that currently is being implemented in screening programs internationally. Because of high false-positive rates for FOBT, concerns have been raised about patient uptake and access to colonoscopy services. This study assessed the value of CTC as an alternative to colonoscopy in FOBT-positive individuals. METHODS: A systematic review of studies comparing the accuracy of CTC and colonoscopy for the detection of lesions 10 mm or greater and cancers in nonscreening populations was conducted. A modeled economic analysis was undertaken to assess cost per life-year saved. RESULTS: Five eligible studies were identified. Pooled sensitivity and specificity for the detection of lesions 10 mm or greater were 63% (95% confidence interval [CI], 55%-71%) and 95% (95% CI, 94%-97%) for CTC, and 95% (95% CI, 90%-98%) and 99.8% (95% CI, 99.5%-100%) for colonoscopy, respectively (3 studies). Pooled sensitivity and specificity for the detection of cancer were 89% (95% CI, 70%-98%) and 97% (95% CI, 95%-98%) for CTC, and 96% (95% CI, 80%-100%) and 99.7% (95% CI, 99%-100%) for colonoscopy, respectively (3 studies). The base case economic analysis showed that CTC is less effective and more costly than colonoscopy. At a low prevalence of polyps, sensitivity analysis found CTC was less effective and less costly than colonoscopy; if CTC was more sensitive than colonoscopy, CTC was more effective, at higher cost. CONCLUSIONS: Overall, CTC appears less accurate, less effective, and potentially more costly than colonoscopy in individuals with a positive FOBT.

The cost effectiveness of screening for genital Chlamydia trachomatis infection in Australia.

BACKGROUND: In Australia, there is no published study on the cost effectiveness of screening for chlamydia. The aim of this study was to examine the cost effectiveness of a hypothetical screening programme for chlamydia based on annual opportunistic testing of all women 25 years of age or younger consulting a general practitioner, compared with no screening. METHODS: A decision-analytic modelling approach was used to determine the incremental cost effectiveness ratio (ICER) of screening compared with no screening over 25 years. The analysis measured Australian health-care costs and benefits were assessed in terms of quality-adjusted life years (QALYs). RESULTS: The analysis resulted in a cost per QALY of 2968 dollars for screening. One-way sensitivity analyses on all variables, and multi-way sensitivity analyses on some variables, showed a wide range for the cost effectiveness, from dominance (where screening is effective and saves money overall) to an ICER of 67,715 dollars per QALY. CONCLUSIONS: The results indicate that annual opportunistic screening for chlamydia in women under 25 is a potentially worthwhile undertaking. However, the analysis also highlights uncertainties around the natural history of chlamydia and the effectiveness of chlamydia screening. Given these uncertainties, the need for further primary data collection in these areas becomes apparent.