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  • Article
    Mann C, Shaw A, Guthrie B, Wye L, Man MS, Hollinghurst S, Brookes S, Bower P, Mercer S, Salisbury C.
    BMJ Open. 2016 05 04;6(5):e011260.
    INTRODUCTION: As an increasing number of people are living with more than 1 long-term condition, identifying effective interventions for the management of multimorbidity in primary care has become a matter of urgency. Interventions are challenging to evaluate due to intervention complexity and the need for adaptability to different contexts. A process evaluation can provide extra information necessary for interpreting trial results and making decisions about whether the intervention is likely to be successful in a wider context. The 3D (dimensions of health, drugs and depression) study will recruit 32 UK general practices to a cluster randomised controlled trial to evaluate effectiveness of a patient-centred intervention. Practices will be randomised to intervention or usual care.
    METHODS AND ANALYSIS: The aim of the process evaluation is to understand how and why the intervention was effective or ineffective and the effect of context. As part of the intervention, quantitative data will be collected to provide implementation feedback to all intervention practices and will contribute to evaluation of implementation fidelity, alongside case study data. Data will be collected at the beginning and end of the trial to characterise each practice and how it provides care to patients with multimorbidity. Mixed methods will be used to collect qualitative data from 4 case study practices, purposively sampled from among intervention practices. Qualitative data will be analysed using techniques of constant comparison to develop codes integrated within a flexible framework of themes. Quantitative and qualitative data will be integrated to describe case study sites and develop possible explanations for implementation variation. Analysis will take place prior to knowing trial outcomes.
    ETHICS AND DISSEMINATION: Study approved by South West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via a final report, peer-reviewed publications and practical guidance to healthcare professionals, commissioners and policymakers.
    TRIAL REGISTRATION NUMBER: ISRCTN06180958.
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  • Article
    Coelho T, Maia LF, da Silva AM, Cruz MW, Planté-Bordeneuve V, Suhr OB, Conceiçao I, Schmidt HH, Trigo P, Kelly JW, Labaudinière R, Chan J, Packman J, Grogan DR.
    J Neurol. 2013 11;260(11):2802-14.
    Tafamidis, a transthyretin (TTR) kinetic stabilizer, delayed neuropathic progression in patients with Val30Met TTR familial amyloid polyneuropathy (TTR-FAP) in an 18-month randomized controlled trial (study Fx-005). This 12-month, open-label extension study evaluated the long-term safety, tolerability, and efficacy of tafamidis 20 mg once daily in 86 patients who earlier received blinded treatment with tafamidis or placebo. Efficacy measures included the Neuropathy Impairment Score in the Lower Limbs (NIS-LL), Norfolk Quality of Life-Diabetic Neuropathy total quality of life (TQOL) score, and changes in neurologic function and nutritional status. We quantified the monthly rates of change in efficacy measures, and TTR stabilization, and monitored adverse events (AEs). Patients who continued on tafamidis had stable rates of change in NIS-LL (from 0.08 to 0.11/month; p = 0.60) and TQOL (from -0.03 to 0.25; p = 0.16). In patients switched from placebo, the monthly rate of change in NIS-LL declined (from 0.34 to 0.16/month; p = 0.01), as did TQOL score (from 0.61 to -0.16; p < 0.001). Patients treated with tafamidis for 30 months had 55.9 % greater preservation of neurologic function as measured by the NIS-LL than patients in whom tafamidis was initiated later. Plasma TTR was stabilized in 94.1 % of patients treated with tafamidis for 30 months. AEs were similar between groups; no patients discontinued because of an AE. Long-term tafamidis was well tolerated, with the reduced rate of neurologic deterioration sustained over 30 months. Tafamidis also slowed neurologic impairment in patients previously given placebo, but treatment benefits were greater when tafamidis was begun earlier.
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  • Article
    Klempner MS, Styrt B.
    JAMA. 1988 Nov 11;260(18):2682-5.
    We conducted a double-blind, controlled trial of low-dose (150 mg/d) oral clindamycin hydrochloride vs placebo to prevent recurrent staphylococcal skin infections. Twenty-two patients (11 in both the placebo and clindamycin treatment groups) completed the trial and were assessable. The two groups did not differ as to age, sex, race, or the number of recurrent abscesses preceding the trial. In pretrial evaluations, no patient had hypogammaglobulinemia or abnormal neutrophil function. Sixty-four percent (7/11) of the placebo-treated patients had a recurrent abscess within three months of enrollment whereas 82% (9/11) of the patients treated with clindamycin were free of any infection during the three-month treatment period. Of the nine patients who responded to clindamycin treatment, six did not have a recurrent infection for at least nine months after discontinuing antibiotic therapy. All patients tolerated the regimen without side effects. We conclude that a three-month course of low-dose oral clindamycin is an effective, convenient, well-tolerated, and often durable approach to prevention of recurrent staphylococcal skin infections.
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