A protocol for a randomised controlled trial of prefabricated versus customised foot orthoses for people with rheumatoid arthritis: the FOCOS RA trial [Foot Orthoses – Customised v Off-the-Shelf in Rheumatoid Arthritis]

Abstract Background Foot pain is common in rheumatoid arthritis and appears to persist despite modern day medical management. Several clinical practice guidelines currently recommend the use of foot orthoses for the treatment of foot pain in people with rheumatoid arthritis. However, an evidence gap currently exists concerning the comparative clinical- and cost-effectiveness of prefabricated and customised foot orthoses in people with early rheumatoid arthritis. Early intervention with orthotics may offer the best opportunity for positive therapeutic outcomes. The primary aim of this study is to evaluate the comparative clinical- and cost-effectiveness of prefabricated versus customised orthoses for reducing foot pain over 12 months. Methods/design This is a multi-centre two-arm parallel randomised controlled trial comparing prefabricated versus customised orthoses in participants with early rheumatoid arthritis (< 2 years disease duration). A total of 160 (a minimum of 80 randomised to each arm) eligible participants will be recruited from United Kingdom National Health Service Rheumatology Outpatient Clinics. The primary outcome will be foot pain measured via the Foot Function Index pain subscale at 12 months. Secondary outcomes will include foot related impairments and disability via the Foot Impact Scale for rheumatoid arthritis, global functional status via the Stanford Health Assessment Questionnaire, foot disease activity via the Rheumatoid Arthritis Foot Disease Activity Index, and health-related quality of life at baseline, 6 and 12 months. Process outcomes will include recruitment/retention rates, data completion rates, intervention adherence rates, and participant intervention and trial participation satisfaction. Cost-utility and cost-effectiveness analyses will be undertaken. Discussion Outcome measures collected at baseline, 6 and 12 months will be used to evaluate the comparative clinical- and cost- effectiveness of customised versus prefabricated orthoses for this treatment of early rheumatoid arthritis foot conditions. This trial will help to guide orthotic prescription recommendations for the management of foot pain for people with early rheumatoid arthritis in future. Trial registration ISRCTN13654421. Registered 09 February 2016

The impact of mass media interventions on tuberculosis awareness, health-seeking behaviour and health service utilisation : a systematic review protocol

Introduction: Tuberculosis (TB) is a serious public health problem in many parts of the world. Strategies to curb the spread of TB must match the multifaceted nature of the epidemic. The use of mass media is one of the important strategies in communicating behavioural change in relation to TB prevention and the treatment. However, the benefits of this intervention are unclear. We, therefore, plan to conduct a systematic review on the effects of mass media interventions on TB awareness, health-seeking behaviour and health service utilisation. Methods and analysis: We will preferably include randomised controlled trials (RCTs) in this systematic review. However, non-randomised studies will be included if there is an inadequate number of RCTs. We will perform electronic searches in PubMed, Scopus and other databases, along with manual searches. Articles written (or translated) in English and French and published between 1 January 1980 and 31 October 2013 will be eligible for inclusion in this review. The primary outcomes will be TB knowledge, attitudes and awareness, healthcare-seeking behaviour and service utilisation. The secondary outcomes will include stigma and discrimination against people with TB and the costs of the interventions. We will investigate clinical and statistical heterogeneity and pool studies judged to be clinically and statistically homogeneous. Relative risks will be calculated for dichotomous outcomes and mean differences for continuous outcomes, both with their corresponding 95% CIs. Ethics and dissemination: The systematic review will use data that is not linked to individuals. The review findings may have implications for clinical practice and future research, and will be disseminated electronically and in print through peer-reviewed publications

Dynamic plantar loading index detects altered foot function in individuals with rheumatoid arthritis but not changes due to orthotic use

Background Altered foot function is common in individuals with rheumatoid arthritis. Plantar pressure distributions during gait are regularly assessed in this patient group; however, the association between frequently reported magnitude-based pressure variables and clinical outcomes has not been clearly established. Recently, a novel approach to the analysis of plantar pressure distributions throughout stance phase, the dynamic plantar loading index, has been proposed. This study aimed to assess the utility of this index for measuring foot function in individuals with rheumatoid arthritis.Methods Barefoot plantar pressures during gait were measured in 63 patients with rheumatoid arthritis and 51 matched controls. Additionally, 15 individuals with rheumatoid arthritis had in-shoe plantar pressures measured whilst walking in standardized footwear for two conditions: shoes-only; and shoes with prescribed custom foot orthoses. The dynamic plantar loading index was determined for all participants and conditions. Patient and control groups were compared for significant differences as were the shod and orthosis conditions.Findings The patient group was found to have a mean index of 0.19, significantly lower than the control group's index of 0.32 (p > 0.001, 95% CI [0.054, 0.197]). No significant differences were found between the shoe-only and shoe plus orthosis conditions. The loading index was found to correlate with clinical measures of structural deformity.Interpretation The dynamic plantar loading index may be a useful tool for researchers and clinicians looking to objectively assess dynamic foot function in patients with rheumatoid arthritis; however, it may be unresponsive to changes caused by orthotic interventions in this patient group.</p

Evaluation of a morpholinothiolporphyrin for use in photodynamic therapy.

The photonecrotic effectiveness of a morpholinothiolporphyrin derived from haematoporphyrin was measured in an animal model of cerebral glioma. The dose administered was 20 mg kg-1 and the laser dose varied from 0 to 200 J cm-2. The tumour necrosis was at least as good as that of HpD, and this therapeutic response may be attributed to the targeting of specific 'photopotent' subcellular sites

Design and Additive Fabrication of Foot and Ankle-Foot Orthoses

Foot and ankle-foot orthoses are prescribed in order to promote mobility through supporting and/or realigning the lower leg and alleviating pain in the foot in different parts of the gait cycle. This paper will outline new approaches to the design and manufacture of personalised foot and ankle-foot orthoses (FO and AFO) using additive fabrication technology. The research is addressing the need for specific software design tools for orthosis design which enable their properties to be locally tailored within a mass customisation framework. Structure/material testing to support that activity is also being undertaken and will be described.Mechanical Engineerin

Costbook of the digitisation infrastructure of DiSSCo

There has been little work to compare and understand the operating costs of digitisation using a standardised approach. This paper discusses a first attempt at gathering digitisation cost information from multiple institutions and analysing the data. This paper has been written: for other digitisation managers who want to breakdown and compare project costs; as a potential baseline for future digitisation projects; as a starting point for prioritising research and development to reduce digitisation costs

Risk Factors for Helminth, Malaria, and HIV Infection in Pregnancy in Entebbe, Uganda

Background: Infections during pregnancy may have serious consequences for both mother and baby. Assessment of risk factors for infections informs planning of interventions and analysis of the impact of infections on health outcomes. Objectives: To describe risk factors for helminths, malaria and HIV in pregnant Ugandan women before intervention in a trial of de-worming in pregnancy. Methods: The trial recruited 2,507 pregnant women between April 2003 and November 2005. Participants were interviewed and blood and stool samples obtained; location of residence at enrolment was mapped. Demographic, socioeconomic, behavioral and other risk factors were modelled using logistic regression. Results: There was a high prevalence of helminth, malaria and HIV infection, as previously reported. All helminths and malaria parasitemia were more common in younger women, and education was protective against every infection. Place of birth and/or tribe affected all helminths in a pattern consistent with the geographical distribution of helminth infections in Uganda. Four different geohelminths ( hookworm, Trichuris, Ascaris and Trichostrongylus) showed a downwards trend in prevalence during the enrolment period. There was a negative association between hookworm and HIV, and between hookworm and low CD4 count among HIV-positive women. Locally, high prevalence of schistosomiasis and HIV occurred in lakeshore communities. Conclusions: Interventions for helminths, malaria and HIV need to target young women both in and out of school. Antenatal interventions for malaria and HIV infection must continue to be promoted. Women originating from a high risk area for a helminth infection remain at high risk after migration to a lower-risk area, and vice versa, but overall, geohelminths seem to be becoming less common in this population. High risk populations, such as fishing communities, require directed effort against schistosomiasis and HIV infection

Free-surface profiles, velocity and pressure distributions on a broad-crested weir: a physical study

Basic experiments were conducted on a large-size broad-crested weir with a rounded corner. Detailed free-surface, velocity, and pressure measurements were performed for a range of flow conditions. The results showed the rapid flow distribution at the upstream end of the weir and next to the weir brink at large flow rates. The flow properties above the crest were analyzed taking into account the nonuniform velocity and nonhydrostatic pressure distributions. Introducing some velocity and pressure correction coefficients, it is shown that critical flow conditions were achieved above the weir crest for 0.1 < x/L-crest < 1. The velocity measurements highlighted a developing boundary layer. The data differed from the smooth turbulent boundary layer theory, although the present results were consistent with earlier studies. On average, the boundary stress was approximately tau(o)/(rho x g x H-1) 0.0015-0.0025. DOI: 10.1061/(ASCE)IR.1943-4774.0000515. (C) 2012 American Society of Civil Engineers