The Role of decision-analytic modelling in German health technology assessments

BACKGROUND: Decision-analytic modelling (DAM) has become a widespread method in health technology assessments (HTA), but the extent to which modelling is used differs among international HTA institutions. In Germany, the use of DAM is optional within HTAs of the German Institute of Medical Documentation and Information (DIMDI). Our study examines the use of DAM in DIMDI HTA reports and its effect on the quality of information provided for health policies. METHODS: A review of all DIMDI HTA reports (from 1998 to September 2012) incorporating an economic assessment was performed. All included reports were divided into two groups: HTAs with DAM and HTAs without DAM. In both groups, reports were categorized according to the quality of information provided for healthcare decision making. RESULTS: Of the sample of 107 DIMDI HTA reports, 17 (15.9%) used DAM for economic assessment. In the group without DAM, conclusions were limited by the quality of economic information in 51.1% of the reports, whereas we did not find limited conclusions in the group with DAM. Furthermore, 24 reports without DAM (26.7%) stated that using DAM would likely improve the quality of information of the economic assessment. CONCLUSION: The use of DAM techniques can improve the quality of HTAs in Germany. When, after a systematic review of existing literature within a HTA, it is clear that DAM is likely to positively affect the quality of the economic assessment DAM should be used.

Impfung gegen humane Papillomaviren (HPV) zur Prävention HPV 16/18 induzierter Zervixkarzinome und derer Vorstufen

Einleitung: Notwendige Voraussetzung für die Entstehung von Zervixkarzinomen ist eine persistierende Infektion mit humanen Papillomaviren (HPV). Die HPV-Typen 16 und 18 verursachen mit etwa 70% den überwiegenden Teil der Zervixkarzinome. Seit 2006/2007 stehen zwei Impfstoffe gegen HPV 16 und 18 zur Verfügung. Fragestellung: Wie effektiv ist die HPV-Impfung hinsichtlich der Reduktion von Zervixkarzinomen bzw. ihren Vorstufen (CIN)? Stellt die HPV-Impfung eine kosteneffektive Ergänzung zur derzeitigen Screeningpraxis dar? Gibt es Unterschiede bezüglich der Kosten-Effektivität zwischen den beiden verfügbaren Impfstoffen? Sollte aus gesundheitsökonomischer Perspektive eine Empfehlung für den Einsatz der HPV-Impfung gegeben werden? Falls ja, welche Empfehlungen bezüglich der Ausgestaltung einer Impfstrategie lassen sich ableiten? Welche ethischen, sozialen und juristischen Implikationen sind zu berücksichtigen? Methoden: Basierend auf einer systematischen Literaturrecherche werden randomisierte kontrollierte Studien zur Wirksamkeit der HPV-Impfungen für die Prävention von Zervixkarzinomen bzw. deren Vorstufen, den zervikalen intraepithelialen Neoplasien, identifiziert. Gesundheitsökonomische Modellierungen werden zur Beantwortung der ökonomischen Fragestellungen herangezogen. Die Beurteilung der Qualität der medizinischen und ökonomischen Studien erfolgt mittels anerkannter Standards zur systematischen Bewertung wissenschaftlicher Studien Ergebnisse: Bei zu Studienbeginn HPV 16/18 negativen Frauen, die alle Impfdosen erhalten haben, liegt die Wirksamkeit der Impfungen gegen HPV 16/18-induzierten CIN 2 oder höher bei 98% bis 100%. Nebenwirkungen der Impfung sind vor allem mit der Injektion assoziierte Beschwerden (Rötungen, Schwellungen, Schmerzen). Es gibt keine signifikanten Unterschiede für schwerwiegende unerwünschte Ereignisse zwischen Impf- und Placebogruppe. Die Ergebnisse der Basisfallanalysen der gesundheitsökonomischen Modellierungen reichen bei ausschließlicher Berücksichtigung direkter Kostenkomponenten von ca. 3.000 Euro bis ca. 40.000 Euro pro QALY (QALY = Qualitätskorrigiertes Lebensjahr), bzw. von ca. 9.000 Euro bis ca. 65.000 Euro pro LYG (LYG = Gewonnenes Lebensjahr). Diskussion: Nach den Ergebnissen der eingeschlossenen Studien sind die verfügbaren HPV-Impfstoffe wirksam zur Prävention gegen durch HPV 16/18 verursachte prämaligne Läsionen der Zervix. Unklar ist derzeit noch die Dauer des Impfschutzes. Hinsichtlich der Nebenwirkungen ist die Impfung als sicher einzustufen. Allerdings ist die Fallzahl der Studien nicht ausreichend groß, um das Auftreten sehr seltener Nebenwirkungen zuverlässig zu bestimmen. Inwieweit die HPV-Impfung zur Reduktion der Inzidenz und Mortalität des Zervixkarzinoms in Deutschland führen wird, hängt nicht allein von der klinischen Wirksamkeit der Impfstoffe ab, sondern wird von einer Reihe weiterer Faktoren wie der Impfquote oder den Auswirkungen der Impfungen auf die Teilnahmerate an den bestehenden Screeningprogrammen determiniert. Infolge der Heterogenität der methodischen Rahmenbedingungen und Inputparameter variieren die Ergebnisse der gesundheitsökonomischen Modellierungen erheblich. Fast alle Modellanalysen lassen jedoch den Schluss zu, dass die Einführung einer Impfung mit lebenslanger Schutzdauer bei Fortführung der derzeitigen Screeningpraxis als kosteneffektiv zu bewerten ist. Eine Gegenüberstellung der beiden verschiedenen Impfstoffe ergab, dass die Modellierung der tetravalenten Impfung bei der Berücksichtigung von QALY als Ergebnisparameter in der Regel mit einem niedrigeren (besseren) Kosten-Effektivitäts-Verhältnis einhergeht als die Modellierung der bivalenten Impfung, da auch Genitalwarzen berücksichtigt werden. In Sensitivitätsanalysen stellten sich sowohl die Schutzdauer der Impfung als auch die Höhe der Diskontierungsrate als wesentliche Einflussparameter der Kosten-Effektivität heraus. Schlussfolgerung: Die Einführung der HPV-Impfung kann zu einem verringerten Auftreten von Zervixkarzinomen bei geimpften Frauen führen. Jedoch sollten die Impfprogramme von weiteren Evaluationen begleitet werden, um die langfristige Wirksamkeit und Sicherheit beurteilen sowie die Umsetzung der Impfprogramme optimieren zu können. Von zentraler Bedeutung sind hohe Teilnahmeraten sowohl an den Impfprogrammen als auch - auch bei geimpften Frauen - an den Früherkennungsuntersuchungen. Da die Kosten-Effektivität entscheidend von der Schutzdauer, die bislang ungewiss ist, beeinflusst wird, ist eine abschließende Beurteilung der Kosten-Effektivität der HPV-Impfung nicht möglich. Eine langfristige Schutzdauer ist eine bedeutende Vorraussetzung für die Kosten-Effektivität der Impfung. Der Abschluss einer Risk-Sharing-Vereinbarung zwischen Kostenträgern und Herstellerfirmen stellt eine Option dar, um die Auswirkungen der Unsicherheit der Schutzdauer auf die Kosten-Effektivität zu begrenzen.

Propuesta para la creación de un complejo turístico comunitario, sostenible y autosustentanble en la parroquia de San Rafael de Sharug -cantón Pucará

La presente monografía es una propuesta de un plan de negocios enfocado a generar el desarrollo de la actividad turística comunitaria en las comunidades de la parroquia de San Rafael de Sharug, este tema surgió debido a las labores realizadas como practicantes en el área de Voluntarios Azuay del Gobierno Provincial del Azuay y del Gobierno Autónomo Descentralizado de la parroquia San Rafael de Sharug; pretendiendo beneficiar a los pobladores fortaleciendo sus actividades cotidianas, costumbres y tradiciones; además de convertirse en un complemento dinamizador de la economía mejorando su calidad de vida. La metodología que se aplicó fue a través de visitas técnicas empleando la observación directa como herramienta clave para el levantamiento de información primaria y recolección de información secundaria, además se realizó entrevistas y encuestas tanto a pobladores como a turistas nacionales y extranjeros. Para el desarrollo de esta propuesta es necesario un estudio previo que indique aspectos precedentes de un diagnóstico situacional de la parroquia que comprenda matrices como el FODA cruzada y la matriz de problemas con la finalidad de determinar aspectos que van a formar parte del complejo, así como también un análisis de las oportunidades y amenazas del entorno competitivo haciendo uso de las fuerzas de mercado de MichellPorter, un plan de marketing para la respectiva difusión del proyecto y la elaboración de la parte financiera para concluir su factibilidad determinando la viabilidad y rentabilidad a través de una investigación de mercado aplicada en un análisis de la demanda y la oferta.

Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations

Background Writing therapy to improve physical or mental health can take many forms. The most researched model of therapeutic writing (TW) is unfacilitated, individual expressive writing (written emotional disclosure). Facilitated writing activities are less widely researched. Data sources Databases including: MEDLINE, EMBASE, PsychINFO, Linguistics and Language Behavior Abstracts, AMED, and CINHAL were searched from inception to March 2013. Review methods Four TW practitioners provided expert advice. Study procedures were conducted by one reviewer and checked by a second. Randomised controlled trials (RCTs) and non-randomised comparative studies were included. Quality was appraised using the Cochrane risk of bias tool. Unfacilitated and facilitated TW studies were analysed separately under ICD-10 chapter headings. Meta-analyses were performed where possible using Revman 5.2. Costs were estimated from an NHS perspective and three cost-consequence case studies were prepared. Realist synthesis followed RAMESES guidelines. Objectives To review the clinical and cost-effectiveness of TW for people with long-term health conditions (LTCs) compared to no writing, or other controls, reporting any relevant clinical outcomes. To conduct a realist synthesis to understand how TW might work, and for whom. Results From 14,658 unique citations, 284 full text papers were reviewed and 64 studies (58 RCTs) were included in the final effectiveness reviews. Five studies examined facilitated TW, these were extremely heterogeneous with unclear or high risk of bias, but suggested that facilitated TW interventions may be beneficial in individual LTCs. Unfacilitated expressive writing was examined in 59 studies of variable, or unreported, quality. Overall there was very little or no evidence of any benefit reported in the following conditions (number of studies): HIV (six); breast cancer (eight); gynaecological and genitourinary cancers (five); mental health (five); asthma (four); psoriasis (three); chronic pain (four). In inflammatory arthropathies (six) there was a reduction in disease severity (n= 191, standardised mean difference (SMD) - 0.61 [95% confidence intervals (95% CI) -0.96, -0.26]) in the short term on meta-analysis of four studies. For all other LTCs there was either no, or sparse, data with no, or inconsistent, evidence of benefit. Meta-analyses conducted across all the LTCs provided no evidence that unfacilitated EW had any effect on depression at short term (n= 1,563, SMD -0.06, 95% CI -0.29 to 0.17, substantial heterogeneity), or long term (n= 778, SMD-0.04 95% CI -0.18 to 0.10, little heterogeneity) follow up, or on anxiety, physiological or biomarker-based outcomes. One study reported costs, none reported cost-effectiveness, twelve reported resource use; meta-analysis suggested reduced medication use but no impact on health centre visits. Estimated costs of intervention were low, but there was insufficient evidence to judge cost-effectiveness. Realist review findings suggested that facilitated TW is a complex intervention and group interaction contributes to the perception of benefit. It was unclear from the available data who might benefit most from facilitated TW. Limitations Difficulties with developing realist review programme theory meant that mechanisms operating during TW remain obscure. Conclusions Overall there is little evidence to support the effectiveness or cost-effectiveness of unfacilitated expressive writing interventions in people with LTCs. Further research focussed on facilitated TW in people with LTCs could be informative.

Clinical evaluation of two materials in the restoration of abfraction lesions

Aim: To evaluate the clinical performance of a composite resin (CR) and a resin-modified glassionomer cement (RMGIC) for the treatment of abfraction lesions. Methods: Thirty patients with abfraction lesions in at least two premolar teeth were selected and invited to participate in this study. All restorations were made within the same clinical time frame. One tooth was restored with CR Z100TM (3M, St. Paul, MN, USA), and the other was restored with RMGIC VitremerTM (3M). The restorations were assessed immediately and 1, 6 and 12 months after the restoration, using modified US Public Health Service (USPHS) criteria: marginal integrity, marginal discoloration, wear, retention, secondary caries and hypersensitivity. The statistical analysis was based on Friedman ANOVA test and Mann-Whitney test, considering p<0.05 for statistical significance. Results: Both materials demonstrated satisfactory clinical performance after one year. In the individual analysis of each material, there was a significant difference (p<0.05) in the criteria marginal integrity and wear, for both CR and RMGIC. RMGIC exhibited more damage one year after the restoration. Comparing both materials, it was found a significant difference only for marginal discoloration, while the RMGIC restorations showed the worst prognosis after a year of evaluation. There was no significant difference in the number of retentions, caries or hypersensitivity between CR and RMGIC. Conclusions: It was concluded that CR exhibited the best clinical performance according to the cost-effectiveness and evaluation criteria used in this study.

Sexual Activity Without Condoms and Risk of HIV Transmission in Serodifferent Couples When the HIV-Positive Partner Is Using Suppressive Antiretroviral Therapy

Importance A key factor in assessing the effectiveness and cost-effectiveness of antiretroviral therapy (ART) as a prevention strategy is the absolute risk of HIV transmission through condomless sex with suppressed HIV-1 RNA viral load for both anal and vaginal sex. Objective To evaluate the rate of within-couple HIV transmission (heterosexual and men who have sex with men [MSM]) during periods of sex without condoms and when the HIV-positive partner had HIV-1 RNA load less than 200 copies/mL. Design, Setting, and Participants The prospective, observational PARTNER (Partners of People on ART-A New Evaluation of the Risks) study was conducted at 75 clinical sites in 14 European countries and enrolled 1166 HIV serodifferent couples (HIV-positive partner taking suppressive ART) who reported condomless sex (September 2010 to May 2014). Eligibility criteria for inclusion of couple-years of follow-up were condomless sex and HIV-1 RNA load less than 200 copies/mL. Anonymized phylogenetic analysis compared couples' HIV-1 polymerase and envelope sequences if an HIV-negative partner became infected to determine phylogenetically linked transmissions. Exposures Condomless sexual activity with an HIV-positive partner taking virally suppressive ART. Main Outcomes and Measures Risk of within-couple HIV transmission to the HIV-negative partner. Results Among 1166 enrolled couples, 888 (mean age, 42 years [IQR, 35-48]; 548 heterosexual [61.7%] and 340 MSM [38.3%]) provided 1238 eligible couple-years of follow-up (median follow-up, 1.3 years [IQR, 0.8-2.0]). At baseline, couples reported condomless sex for a median of 2 years (IQR, 0.5-6.3). Condomless sex with other partners was reported by 108 HIV-negative MSM (33%) and 21 heterosexuals (4%). During follow-up, couples reported condomless sex a median of 37 times per year (IQR, 15-71), with MSM couples reporting approximately 22 000 condomless sex acts and heterosexuals approximately 36 000. Although 11 HIV-negative partners became HIV-positive (10 MSM; 1 heterosexual; 8 reported condomless sex with other partners), no phylogenetically linked transmissions occurred over eligible couple-years of follow-up, giving a rate of within-couple HIV transmission of zero, with an upper 95% confidence limit of 0.30/100 couple-years of follow-up. The upper 95% confidence limit for condomless anal sex was 0.71 per 100 couple-years of follow-up. Conclusions and Relevance Among serodifferent heterosexual and MSM couples in which the HIV-positive partner was using suppressive ART and who reported condomless sex, during median follow-up of 1.3 years per couple, there were no documented cases of within-couple HIV transmission (upper 95% confidence limit, 0.30/100 couple-years of follow-up). Additional longer-term follow-up is necessary to provide more precise estimates of risk.

ECONOMIC ANALYSIS of AMAZON RIVER PRAWN FARMING TO THE MARKETS FOR LIVE BAIT and JUVENILES IN PANTANAL, BRAZIL

The implementation of a hypothetical aquaculture facility with hatchery, nursery and grow-out earthen ponds for raising the Amazon River Prawn Macrobrachium amazonicum in the Pantanal was considered. Eight larviculture cycles per year were projected: four to produce post-larvae for stocking in grow-out bait ponds, and four to stock nursery tanks to sell juveniles as seed to grow-out farms, which produce prawns for human consumption. Annual production would be 146,880 dozen bait prawns and 2,938 thousand juveniles. The assumed sale prices were US$ 1.38 per dozen baits and US$ 15.39 per thousand juveniles. The net present value was US$ 555,890.79, internal rate of return was 48% per year, payback period was 2.4 years and benefit-cost ratio was 3.90. The breakeven price to cover total costs per dozen baits was US$ 0.70 and per thousand juveniles was US$ 17.00, indicating that the selling price assumed for juveniles in base scenario is not realistic. Net return was US$ 84,773.80. The results indicate that this activity would be a lucrative and attractive investment in the Pantanal.

A systematic review of economic analyses of active transport interventions that include physical activity benefits

Physical inactivity is one of the leading causes for the growing prevalence of non-communicable diseases worldwide and there is a need for more evidence on the effectiveness and cost-effectiveness of interventions that aim to increase physical activity at the population level. This study aimed to update a systematic review published in 2008 by searching peer-reviewed and unpublished literature of economic evaluations of transport interventions that incorporate the health related effects of physical activity. Our analysis of methods for the inclusion of physical activity related health effects into transport appraisal over time demonstrates that methodological progress has been made. Thirty-six studies were included, reflecting an increasing recognition of the importance of incorporating these health effects into transport appraisal. However, significant methodological challenges in the incorporation of wider health benefits into transport appraisal still exist. The inclusion of physical activity related health effects is currently limited by paucity of evidence on morbidity effects and of more rigorous evidence on the effectiveness of interventions. Significant scope exists for better quality and more transparent reporting. A more consistent approach to the inclusion of benefits and disbenefits would reinforce the synergies between the health, environmental, transport and other sectors. From a transport sector perspective the inclusion of physical activity related health benefits positively impacts cost effectiveness, with the potential to contribute to a more efficient allocation of scarce resources based on a more comprehensive range of merits. From a public health perspective the inclusion of physical activity related health benefits may result in the funding of more interventions that promote active transport, with the potential to improve population levels of physical activity and to reduce prevalence of physical activity related diseases.

Predicting the effectiveness of prevention: a role for epidemiological modeling

It is well known that the current combination of aging populations and advances in health technology is resulting in burgeoning health costs in developed countries. Prevention is a potentially important way of containing health costs. In an environment of intense cost pressures, coupled with developments in disease prevention and health promotion, it is increasingly important for decision-makers to have a systematic, coordinated approach to the targeting and prioritization of preventive strategies. However, such a systematic approach is made difficult by the fact that preventive strategies need to be compared over the long term, in a variety of populations, and in real life settings not found in most trials. Information from epidemiological models can provide the required evidence base. In this review, we outline the role of epidemiological modeling in this context and detail its application using examples. Editors' Strategic Implications: Policymakers and researchers will benefit from this description of the utility of epidemiological modeling as a means of generating translational evidence that helps to prioritize data-based prevention approaches and bridge the gap between clinical research and public health practice.

Bioprocess challenges to the isolation and purification of bioactive peptides

Food protein-derived bioactive peptides (BPs) have been reported to trigger certain physiological responses in the body, thereby influencing health positively. These peptides have attracted high research and consumer interests due to their huge potential of use in functional foods and other dietary interventions of disease control and health promotion. However, successful product development is limited by the fact that current manufacturing processes are either difficult to scale up, high in cost, or have the potential to affect the structure-activity properties of these peptides. To overcome these challenges, we have proposed in this review, the use of an integrated ‘-omics’ approach comprising in silico analysis and ‘-omics’ techniques (such as peptidomics) to respectively forecast and validate the biological and physico-chemical properties of the peptides. This information is then used for the rational design of suitable purification steps for peptides of interest. Downstream purification could also be undertaken by liquid chromatography using monolithic adsorbents physico-chemically engineered (using results of in silico analysis) for rapid isolation of peptides. By coupling the high throughput and predictive capability of ‘-omics’ to the enhanced convective hydrodynamics of monolithic columns, it becomes feasible, even at preparative scale, to produce BPs that meet the requirements of high purity, potency, and cost-effectiveness.

Design and conduct of a pragmatic randomized controlled trial to enhance smoking-cessation outcomes with exercise: The Fit2Quit study

Background: Most smokers want to stop smoking and many try to quit. However abstinence rates are low and most smokers do not manage to abstain for even a week. Relapse to smoking can be related to the occurrence of tobacco withdrawal symptoms (e.g., sleep disturbance, irritability, and craving) and weight gain. If regular exercise mitigates these effects it could have potential as an aid to smoking cessation. The aim of the Fit2Quit study is to determine the effects of a home and community-based exercise intervention on smoking abstinence at six months when used as an adjunct to usual care (telephone smoking-cessation counseling and nicotine replacement therapy; NRT). Methods/design: A prospective parallel two-arm randomized controlled trial. Participants (n = 1400, 700 per arm) will be randomized to a structured home and community-based exercise program plus usual care (behavioral counseling and NRT) or to usual-care alone. It is targeted that at least 25% of the sample will be of Mori ethnicity (New Zealand indigenous). Outcomes to be measured using intention-to-treat analysis include: seven-day point prevalence of smoking abstinence verified by salivary cotinine (primary outcome); 6 months continuous abstinence; body mass index (BMI); cardio-respiratory fitness; physical activity levels; and cost effectiveness. Discussion: The Fit2Quit study is an example of a large, pragmatic randomized controlled trial in a community setting. Specific components of the exercise intervention are outlined in detail. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12609000637246.

Minimising impairment: protocol for a multicentre randomised controlled trial of upper limb orthoses for children with cerebral palsy

BACKGROUND: Upper limb orthoses are frequently prescribed for children with cerebral palsy (CP) who have muscle overactivity predominantly due to spasticity, with little evidence of long-term effectiveness. Clinical consensus is that orthoses help to preserve range of movement: nevertheless, they can be complex to construct, expensive, uncomfortable and require commitment from parents and children to wear. This protocol paper describes a randomised controlled trial to evaluate whether long-term use of rigid wrist/hand orthoses (WHO) in children with CP, combined with usual multidisciplinary care, can prevent or reduce musculoskeletal impairments, including muscle stiffness/tone and loss of movement range, compared to usual multidisciplinary care alone.

METHODS/DESIGN: This pragmatic, multicentre, assessor-blinded randomised controlled trial with economic analysis will recruit 194 children with CP, aged 5-15 years, who present with flexor muscle stiffness of the wrist and/or fingers/thumb (Modified Ashworth Scale score ≥1). Children, recruited from treatment centres in Victoria, New South Wales and Western Australia, will be randomised to groups (1:1 allocation) using concealed procedures. All children will receive care typically provided by their treating organisation. The treatment group will receive a custom-made serially adjustable rigid WHO, prescribed for 6 h nightly (or daily) to wear for 3 years. An application developed for mobile devices will monitor WHO wearing time and adverse events. The control group will not receive a WHO, and will cease wearing one if previously prescribed. Outcomes will be measured 6 monthly over a period of 3 years. The primary outcome is passive range of wrist extension, measured with fingers extended using a goniometer at 3 years. Secondary outcomes include muscle stiffness, spasticity, pain, grip strength and hand deformity. Activity, participation, quality of life, cost and cost-effectiveness will also be assessed.

DISCUSSION: This study will provide evidence to inform clinicians, services, funding agencies and parents/carers of children with CP whether the provision of a rigid WHO to reduce upper limb impairment, in combination with usual multidisciplinary care, is worth the effort and costs.

Dynamic on-the-fly minimum cost benchmarking for storing generated scientific datasets in the cloud

Massive computation power and storage capacity of cloud computing systems enable users to either store large generated scientific datasets in the cloud or delete and then regenerate them whenever reused. Due to the pay-as-you-go model, the more datasets we store, the more storage cost we need to pay, alternatively, we can delete some generated datasets to save the storage cost but more computation cost is incurred for regeneration whenever the datasets are reused. Hence, there should exist a trade-off between computation and storage in the cloud, where different storage strategies lead to different total costs. The minimum cost, which reflects the best trade-off, is an important benchmark for evaluating the cost-effectiveness of different storage strategies. However, the current benchmarking approach is neither efficient nor practical to be applied on the fly at runtime. In this paper, we propose a novel Partitioned Solution Space based approach with efficient algorithms for dynamic yet practical on-the-fly minimum cost benchmarking of storing generated datasets in the cloud. In this approach, we pre-calculate all the possible minimum cost storage strategies and save them in different partitioned solution spaces. The minimum cost storage strategy represents the minimum cost benchmark, and whenever the datasets storage cost changes at runtime in the cloud (e.g. new datasets are generated and/or existing datasets' usage frequencies are changed), our algorithms can efficiently retrieve the current minimum cost storage strategy from the partitioned solution space and update the benchmark. By dynamically keeping the benchmark updated, our approach can be practically utilised on the fly at runtime in the cloud, based on which the minimum cost benchmark can be either proactively reported or instantly responded upon request. Case studies and experimental results based on Amazon cloud show the efficiency, scalability and practicality of our approach.

VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health

Introduction Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6–8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. Methods nd analysis Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited.

Shopsmart 4 health: results of a randomized controlled trial of a behavioral intervention promoting fruit and vegetable consumption among socioeconomically disadvantaged women

BACKGROUND: Behavioral interventions show potential for promoting increased fruit and vegetable consumption in the general population. However, little is known about their effectiveness or cost-effectiveness among socioeconomically disadvantaged groups, who are less likely to consume adequate fruit and vegetables. OBJECTIVE: This study investigated the effects and costs of a behavior change intervention for increasing fruit and vegetable purchasing and consumption among socioeconomically disadvantaged women. DESIGN: ShopSmart 4 Health was a randomized controlled trial involving a 3-mo retrospective baseline data collection phase [time (T) 0], a 6-mo intervention (T1-T2), and a 6-mo no-intervention follow-up (T3). Socioeconomically disadvantaged women who were primary household shoppers in Melbourne, Australia, were randomly assigned to either a behavior change intervention arm (n = 124) or a control arm (n = 124). Supermarket transaction (sales) data and surveys measured the main outcomes: fruit and vegetable purchases and self-reported fruit and vegetable consumption. RESULTS: An analysis of supermarket transaction data showed no significant intervention effects on vegetable or fruit purchasing at T2 or T3. Participants in the behavior change intervention arm reported consumption of significantly more vegetables during the intervention (T2) than did controls, with smaller intervention effects sustained at 6 mo postintervention (T3). Relative to controls, vegetable consumption increased by ∼0.5 serving · participant(-1) · d(-1) from baseline to T2 and remained 0.28 servings/d higher than baseline at T3 among those who received the intervention. There was no intervention effect on reported fruit consumption. The behavior change intervention cost A$3.10 (in Australian dollars) · increased serving of vegetables(-1) · d(-1)CONCLUSIONS: This behavioral intervention increased vegetable consumption among socioeconomically disadvantaged women. However, the lack of observed effects on fruit consumption and on both fruit and vegetable purchasing at intervention stores suggests that further investigation of effective nutrition promotion approaches for this key target group is required. The ShopSmart 4 Health trial was registered at www.isrctn.com as ISRCTN48771770.