Clinical Data Collection. Patients attending a tertiary referral centre, the King’s MND Care and Research Centre, were studied. (This is a referral centre for local (south east England) and national patients, with about 100-140 new referrals per year. It also provides co- ordinated care for patients from local health authorities). In addition, certain other well defined populations were studied in collaboration with groups internationally. For the UK population, clinical data was collected at the time of the first visit by the examining neurologist using a standard proforma. All patients were also seen by a consultant neurologist if the examining doctor was still in training. All clinical features included in the database were taken from this initial visit except diagnosis and information regarding death. Diagnosis was recorded at this visit and modified in the light of further investigation. If the diagnosis was in doubt or unclear, a suitable non- specific label such as “lower motor neuron syndrome” was used until the diagnosis was clearer. In cases of ALS with atypical features, this was recorded and the El Escorial category taken as “suspected” regardless of the combination of upper and lower motor neuron signs. For date of death, direct telephone enquiry of patient general practitioners and referring consultants was made at 6 monthly intervals if they were no longer under follow up. Pedigree data was collected at the initial visit with a detailed family history where possible. The proforma used for clinical data collection by the neurologist, the patient information sheet and the consent form for blood taking are shown in the appendix.
Clinical Data Collection. Subject to the right of individual Beneficiaries assigned under the MSSP Participation Agreement to opt out of data sharing, Participant shall submit all patient clinical data to ACO as soon as practicable following the date of service, but in all cases by no later than thirty (30) days of the date of service. Participant thereby authorizes ACO to act on behalf of Participant to collect clinical data about Participant’s Beneficiaries from Participant, other Participants, and other sources for the purposes of developing a data warehouse and repository, exchanging clinical data between and among Participant and other Participants, and supporting the other clinical integration, quality management, quality improvement, quality reporting, process improvement, utilization management, and health management activities and programs of ACO. As required by HIPAA and HITECH, the privacy and security of all protected health information will be protected through a Business Associate Agreement between Participant and ACO in the form attached as Exhibit 3.
Clinical Data Collection. This information will be gathered in clinic at your treatment centre and shared with the SMA REACH UK registry. It will include: Basic patient details including age and sex Molecular genetics diagnosis Details of nusinersen treatment and any other therapies a patient is receiving Motor function Mobility Scoliosis, including details of any spinal surgery Fractures Ventilation / respiratory events (e.g. For infections) Survival information This information will be collected when the treatment is started (‘baseline’) and then twice a year afterwards with each visit being at least four months apart. Clinical data collection from your routine clinical appointments will continue if you stop treatment.
Clinical Data Collection. This information will be gathered in clinic at your treatment centre and shared with the SMA REACH UK registry. It will include: • Basic patient details including age and sex • Molecular genetics diagnosis • Details of nusinersen treatment and any other therapies a patient is receiving • Motor function • Mobility • Scoliosis, including details of any spinal surgery • Fractures • Ventilation / respiratory events (e.g. For infections) • Survival information This information will be collected when the treatment is started (‘baseline’) and then twice a year afterwards with each visit being at least four months apart. Clinical data collection from your routine clinical appointments will continue if you stop treatment.
