The SMile Card: a computerised data card for multiple sclerosis patients

The SMile Card was developed as a means for computerising clinical information for the purpose of transferability, accessibility, standardisation and compilation of a national database of demographic and clinical information about multiple sclerosis (MS) patients. In many European countries, centres for MS are organised independently from one another making collaboration, consultation and patient referral complicated. Only the more highly advanced clinical centres, generally located in large urban areas, have had the possibility to utilise technical possibilities for improving the organisation of patient clinical and research information, although independently from other centres. The information system, developed utilising the Visual Basic language for Microsoft Windows 95, stores information via a 'smart card' in a database which is initiated and updated utilising a microprocessor, located at each neurological clinic. The SMile Card, currently being tested in Italy, permits patients to carry with them all relevant medical information without limitations. Neurologists are able to access and update, via the microprocessor, the patient's entire medical history and MS-related information, including the complete neurological examination and laboratory test results. The SMile Card provides MS patients and neurologists with a complete computerised archive of clinical information which is accessible throughout the country. In addition, data from the SMile Card system can be exported to other database programs

The Italian Fibromyalgia Registry: a new way of using routine real-world data concerning patient-reported disease status in healthcare research and clinical practice

Objective. Fibromyalgia (FM), the most frequently encountered cause of widespread musculoskeletal pain, affects an estimated 2% of the general Italian population. However, it is not a homogeneous clinical entity, and a number of interacting factors can influence patient prognosis and the outcomes of standardised treatment programmes. Registries are a source of high-quality data for clinical research, but relating this information to individual patients is technically challenging. The aim of this article is to describe the structure and objectives of the first Italian Fibromyalgia Registry (IFR), a new web-based registry of patients with FM. Methods. The IFR was developed to collect, store, and share information electronically entered by physicians throughout Italy who are members of the Italian Society of Rheumatology and have a particular interest in FM. It has a web-based architecture that uses two separate servers and an encryption algorithm to ensure the confidentiality and integrity of the exchanged data. The questionnaires included on the platform are the Revised Fibromyalgia Impact Questionnaire (FIQR), the modified Fibromyalgia Assessment Status (ModFAS), and the Polysymptomatic Distress Scale (PDS). Results. The registry includes data relating to 2,339 patients (93.2% female) who satisfied the 1990 or 2010/2011 American College of Rheumatology Classification Criteria for Fibromyalgia at the time of diagnosis. At the time of this analysis, the patients had a mean age of 51.9 years (SD 115) and a mean disease duration of 73 years (SD 6.9). The majority were married (713%), and generally well educated. The overall median FIQR, ModFAS and PDS scores and 25th-75th percentiles were respetively 61.16 (41.16-77.00), 8.91 (41.16-77.00), and 19.0 (13.00-24.00). The six highest scoring items indicating the greatest impact of the disease on the patients related to fatigue/energy (7.18), sleep quality (6.87), tenderness (6.69), pain (6.68), stiffness (6.66), and environmental sensitivity (6.35). A high proportion of the responding patients reported experiencing pain in the neck (80.46%), upper back (6836%), and lower back (75.05%). Conclusion. The IFR is the most comprehensive FM registry in Italy, and provides healthcare professionals with a secure, reliable, and easy-to-use means of monitoring the patients' clinical progression, treatment history and treatment responses. This can help clinicians to plan patient management, facilitates research study patient recruitment, and provides the participating pain clinics with statistics based on real-world data. It also helps address the Italian Ministry of Health long-term goal of using precision medicine for chronic pain prevention and treatment. It is hoped that the IFR will enhance both scientific research and clinical practice

A randomized, double-blind phase 2b trial to evaluate efficacy of ChAd63-KH for treatment of post kala-azar dermal leishmaniasis

In a recent phase 2a clinical trial, the candidate leishmaniasis vaccine ChAd63-KH was shown to be safe and immunogenic in Sudanese patients with post kala-azar dermal leishmaniasis (PKDL). However, its value as a stand-alone therapeutic was unknown. To assess the therapeutic efficacy of ChAd63-KH, we conducted a randomized, double-blind, placebo-controlled phase 2b trial (ClinicalTrials.gov: NCT03969134). Primary outcomes were safety and efficacy (≥90% improvement in clinical disease). Secondary outcomes were change in severity grade and vaccine-induced immune response. 86 participants with uncomplicated PKDL of ≥6 month duration were randomized to receive ChAd63-KH (7.5 × 1010 viral particles, once by the intramuscular route) or placebo. 75 participants (87%) completed the trial as per protocol. No severe or serious adverse events were observed. At day 90 post-vaccination, 6/40 (15%) and 4/35 (11%) participants in the vaccine and placebo groups, respectively, showed ≥90% clinical improvement (risk ratio [RR] 1.31 [95% confidence interval (CI), 0.40–4.28], p = 0.742). There were also no significant differences in PKDL severity grade between study arms. Whole-blood transcriptomic analysis identified transcriptional modules associated with interferon responses and monocyte and dendritic cell activation. Thus, a single vaccination with ChAd63-KH showed no therapeutic efficacy in this subset of Sudanese patients with PKDL