Computer-assisted interventions in the clinical laboratory process improve the diagnosis and treatment of severe vitamin B12 deficiency.

BACKGROUND: Severe vitamin B12 deficiency can result in serious complications if undiagnosed or untreated. Our aim was to test the efficacy of interventions in the laboratory process to improve the detection and the treatment of severe vitamin B12 deficiency. METHODS: Quasi-experimental investigation with a retrospective 7-year pre-intervention period and 29-month post-intervention follow-up in a university hospital. Two interventions were designed to improve the detection and treatment of subjects with vitamin B12 deficiency: the laboratory information system (LIS) automatically added seru vitamin B12 (s-vitamin B12) based on certain conditions; and created a comment in the report and scheduled an appointment with the general practitioner (GP). We calculated the number of new diagnoses of severe vitamin deficiency (s-vitamin B12 <73.8 pmol/L) and the proportion of identified patients that were correctly treated in the pre- and post-intervention periods. We compared the number of tests needed to detect a new case when ordered by GPs vs. added by the strategy. Finally, we investigated the economic cost of each new case. RESULTS: The strategy added 699 s-vitamin B12 and detected 66 new cases of severe vitamin deficiency. The number of tests needed to identify a new case when s-vitamin B12 was ordered by GPs was 187, as opposed to 10 when added through the intervention (p<0.001). The intervention reagent cost was €26.7 per new case. In the post-intervention cohort, 88% of patients were correctly treated, as opposed to 52% in the pre-intervention (p<0.001). CONCLUSIONS: Interventions in the clinical laboratory process improved the diagnosis and treatment of severe vitamin B12 deficiency.

The changing cost to prevent diabetes: A retrospective analysis of the Diabetes Prevention Program.

OBJECTIVES: Diabetes prevention interventions are poorly implemented. While health care costs generally increase, 2 factors affect the relative cost of diabetes prevention interventions: the declining cost of metformin (even without insurance) and the new recommendation for vitamin B12 monitoring during metformin treatment. The study's objective was to update the relative health system cost estimate of metformin for diabetes prevention by incorporating the current health system cost of metformin and the cost of addressing potential metformin-associated vitamin B12 deficiency. The study was designed to assess whether metformin with vitamin B12 supplementation is a cost-saving measure for diabetes prevention and for the updated cost estimate to be useful in assessing future implementation studies. METHODS: In 2012, the Diabetes Prevention Program Research Group published detailed per capita total direct health system costs for the Diabetes Prevention Program (DPP) and the Diabetes Prevention Program Outcomes Study (DPPOS). The present analysis incorporated the declining cost of metformin and the increasing cost of metformin monitoring into the detailed per capita health system costs found in the DPP and DPPOS. The updated costs were used to assess the total cost of metformin use for diabetes prevention relative to placebo and lifestyle intervention. RESULTS: The current health system cost to acquire metformin ranges from $0 to $72 per year. The estimated health system cost to address potential metformin-associated vitamin B12 deficiency is $28 per metformin-treated patient per year. The 10-year total health system cost for metformin in diabetes prevention can decrease by $329 or increase by $21 depending on the cost to acquire metformin. Compared with placebo, the unadjusted cost savings of metformin is generally maintained, although it may double or quadruple depending on how metformin is acquired by patients. Metformin with vitamin B12 supplementation remained less costly and less effective than lifestyle intervention. CONCLUSION: Metformin is generally more cost-saving for diabetes prevention than previously reported because of decreasing costs for patients to acquire metformin. The cost savings was increased despite increased management cost associated with addressing metformin-associated vitamin B12 deficiency.

Vitamin B12 serostatus in Colombian children and adult women: results from a nationally representative survey.

OBJECTIVE: Vitamin B12 deficiency is associated with many adverse health outcomes and is highly prevalent worldwide. The present study assesses the prevalence of vitamin B12 deficiency and marginal deficiency in Colombian children and women and examines the sociodemographic correlates of serum vitamin B12 concentrations in these groups. DESIGN: Cross-sectional, nationally representative survey. SETTING: Colombia. SUBJECTS: Children <18 years old (n 7243), pregnant women (n 1781), and non-pregnant women 18-49 years old (n 499). RESULTS: The overall prevalence of vitamin B12 deficiency (serum vitamin B12<148 pmol/l) and marginal deficiency (serum vitamin B12=148-221 pmol/l) was, respectively, 6.6 % (95 % CI 5.2%, 8.3%) and 22.5% (95% CI 21.1%, 23.9%). Pregnant women had the highest prevalence of deficiency (18.9 %; 95 % CI 16.6 %, 21.5 %) compared with non-pregnant adult women (18.5%; 95% CI 4.4%, 53.1%) and children (2.8 %; 95 % CI 2.3 % %, 3.3 %). In multivariable analyses among children, mean serum vitamin B12 was positively associated with female sex (12 pmol/l higher compared with males; P=0.004), secondary or higher education of the household head (12 pmol/l higher compared with primary or less; P=0.009) and food security (21 pmol/l higher compared with severe food insecurity; P=0.003). In multivariable analyses among pregnant women, mean serum vitamin B12 was positively associated with education of the household head and inversely associated with living in the National territories, Eastern or Pacific regions. CONCLUSIONS: The prevalence of vitamin B12 deficiency and marginal deficiency in Colombian women and children is substantial. The burden falls largely on adult women, those with lowest education and those living in the poorest, most rural regions of the country.

The cost-effectiveness of mandatory folic acid fortification in Australia.

The Australian government recently introduced mandatory folic acid fortification of bread to reduce the incidence of neural tube defects (NTDs). The economic evaluation of this policy contained a number of limitations. This study aimed to address the limitations and to reconsider the findings. Cost-effectiveness analysis was used to assess the cost and benefits of mandatory versus voluntary folic acid fortification. Outcomes measures were quality-adjusted life-years (QALYs), life-years gained (LYG), avoided NTD cases, and additional severe neuropathy cases. Costs considered included industry costs and regulatory costs to the government. It was estimated that mandatory fortification would prevent 31 NTDs, whereas an additional 14 cases of severe neuropathy would be incurred. Overall, 539 LYG and 503 QALYs would be gained per year of mandatory compared with voluntary fortification. Mandatory fortification was cost-effective at A$10,723 per LYG and at A$11,485 per QALY. Probabilistic sensitivity analysis showed that at A$60,000 and A$151,000 per QALY, the probability that mandatory fortification was the most cost-effective strategy was 79% and 85%, respectively. Threshold analysis of loss of consumer choice indicated that with a compensation value above A$1.21 [assuming a willingness to pay (WTP) threshold of A$60,000 per QALY] or A$3.19 (assuming a WTP threshold of A$151,000 per statistical life-year) per capita per year mandatory fortification would not be cost-effective. Mandatory fortification was found to be cost-effective; however, inclusion of the loss of consumer choice can change this result. Even with mandatory fortification, mean folate intake will remain below the recommended NTD preventive level.

Oral or intramuscular vitamin B12?

Vitamin B(12) deficiency is common, becoming more so with age, and estimates of its population prevalence have ranged from 1.5% to 15%. If untreated, it can lead to megaloblastic anaemia and irreversible neurological complications. In the UK, the usual treatment is regular intramuscular injections of hydroxocobalamin. High-dose oral vitamin B(12) replacement is standard practice in some other countries and less costly. Here we review issues around adopting an oral vitamin B(12) replacement regimen more widely in the UK.

A cost-effectiveness analysis of folic acid fortification policy in the United States.

OBJECTIVE: To quantify the health and economic outcomes associated with changes in folic acid consumption following the fortification of enriched grain products in the USA. DESIGN: Cost-effectiveness analysis. SETTING: Annual burden of disease, quality-adjusted life years (QALY) and costs were projected for four steady-state strategies: no fortification, or fortifying with 140, 350 or 700 microg folic acid per 100 g enriched grain. The analysis considered four health outcomes: neural tube defects (NTD), myocardial infarctions (MI), colon cancers and B12 deficiency maskings. SUBJECTS: The US adult population subgroups defined by age, gender and race/ethnicity, with folate intake distributions from the National Health and Nutrition Examination Surveys (1988-1992 and 1999-2000), and reference sources for disease incidence, utility and economic estimates. RESULTS: The greatest benefits from fortification were predicted in MI prevention, with 16 862 and 88 172 cases averted per year in steady state for the 140 and 700 microg fortification levels, respectively. These projections were between 6261 and 38 805 for colon cancer and 182 and 1423 for NTD, while 15-820 additional B12 cases were predicted. Compared with no fortification, all post-fortification strategies provided QALY gains and cost savings for all subgroups, with predicted population benefits of 266 649 QALY gained and $3.6 billion saved in the long run by changing the fortification level from 140 microg/100 g enriched grain to 700 microg/100 g. CONCLUSIONS: The present study indicates that the health and economic gains of folic acid fortification far outweigh the losses for the US population, and that increasing the level of fortification deserves further consideration to maximise net gains.

Prerequisites for establishing general recommendations for diagnosis and treatment of vitamin B12 deficiency and cost-utility evaluation of these guidelines.

There is currently no consensus on how to define, diagnose and treat vitamin B12 deficiency. This is partly due to insufficient and non-uniform study design. It is essential to come to a harmonization of rational study designs. In order to evaluate new tests for the diagnosis of vitamin B12 deficiency, it is important that independent and unequivocal criteria for a clear-cut definition of the disease are used. Furthermore, it is crucial to have a mutual understanding on the progression of the disease, how fast the different symptoms may develop and on the expected time frame of treatment and evaluation of response. The kind and intensity of treatment must also be agreed upon. The present article overviews the potential strategies of how to define and diagnose vitamin B12 deficiency and on follow-up of treatment response. Finally, based on these considerations, the prerequisites of a cost-utility analysis of guidelines for diagnosing vitamin B12 deficiency are discussed.