The role of rodents and shrews in the transmission of Toxoplasma gondii to pigs

Inadequate rodent control is considered to play a role in Toxoplasma gondii infection of pigs. This issue was addressed in the current study by combining a 4-month rodent control campaign and a 7-month longitudinal analysis of T. gondii seroprevalence in slaughter pigs. Three organic pig farms with known rodent infestation were included in the study. On these farms, presence of T. gondii in trapped rodents was evaluated by real-time PCR. All rodent species and shrews investigated had T. gondii DNA in brain or heart tissue. Prevalence was 10.3% in Rattus norvegicus, 6.5% in Mus musculus, 14.3% in Apodemus sylvaticus and 13.6% in Crocidura russula. Initial T. gondii seroprevalence in the slaughter pigs ranged between 8% and 17% and dropped on the three farms during the rodent control campaign to 0–10%, respectively. After 4 months of rodent control, T. gondii infection was absent from pigs from two of the three farms investigated and appeared again in one of those two farms after the rodent control campaign had stopped. This study emphasizes the role of rodents and shrews in the transmission of T. gondii to pigs and the importance of rodent control towards production of T. gondii-free pig meat

Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement–the Mobilise-D study protocol

Background: The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. Methods/design: The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson’s Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. Discussion: The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility. Trial registration: ISRCTN12051706

List of assessments and outcomes collected during screening, baseline assessment and every six months.

T1, Screening/Baseline; T2, 6 month assessment; T3, 12 month assessment; T4, 18 month assessment; T5, 24 month assessment; *, indicates key (primary) cohort specific outcome measure; SPPB, short physical performance battery–PFF key primary cohort specific outcome measure; † falls and fracture data are collected retrospectively, 12 month retrospective at T1 and 6 month retrospective at T2-T5; β, pre-fracture status is measured at T1, current status is measured at T3 and T5; α, only applicable to acute patients; Outcome type, type of outcome measure in accordance with FDA terminology; COA, clinical outcome measure–describes or reflects how a patient feels, functions, or survives; PRO, Patient-reported outcome; ObsRO–Observer-reported outcome; ClinRO, Clinician-reported outcome; PerfO, Performance-based outcome; PerfO-P, Performance-based outcome physical measure; PerfO-C, Performance-based outcome cognitive/mental measure; Construct, validation construct assessed; PC, predictive capacity; CV, construct validity; DC, detect change over 24 months; MID, Minimum Important Difference; MC, medical chart.</p

Proposed data flow.

Proposed data flow.</p

Inclusion and exclusion criteria.

Inclusion and exclusion criteria.</p

Cohort specific sample size calculation.

Cohort specific sample size calculation.</p

Study flow.

Study flow.</p

Flow chart to illustrate full recruitment process.

Flow chart to illustrate full recruitment process.</p

S1 File -

(PDF)</p

SPIRIT checklist.

(DOCX)</p