№ files_lp_3_process_7_063620
File format: docx
Character count: 7229
File size: 59 KB
Participant information sheet for an AUT-approved narrative inquiry study outlining purpose, eligibility criteria, procedures, risks, confidentiality, and ethical oversight for interviews with physically active adults living with Multiple Sclerosis in New Zealand.
Date Information Sheet Produced:
2 March 2022
Project Title:
Facilitators and barriers to adherence to a physical activity for people with Multiple Sclerosis (MS) in New Zealand: A narrative inquiry
Researcher:
Debbie Skilton
Qualification:
MPhil in Sport & Exercise (post graduate student)
Project Supervisor:
Gemma Alder
Institution:
Auckland University of Technology
Ethics Committee:
Auckland University of Technology Ethics Committee (AUTEC)
AUTEC Reference Number:
22/101
Date of Ethics Approval:
9 June 2022
Research Institute:
Health & Rehabilitation Research Institute (HRRI)
Country:
New Zealand
Study Design:
Narrative inquiry
Data Collection Method:
One-on-one interview (in person or online)
Interview Duration:
Approximately 1 hour
Recording Method:
Audio recording and written notes
Target Population:
Adults diagnosed with Multiple Sclerosis living in New Zealand
Eligibility Criteria:
Diagnosed with MS more than 3 months ago; stable symptoms; physically active; not an elite athlete; not undertaking structured rehabilitation; no cognitive or communication difficulties; able to communicate in English
Participation:
Voluntary with right of withdrawal
Data Storage Period:
6 years at AUT premises
Confidentiality:
De-identified and confidential data accessible only to the research team
Support Services:
AUT Health Counselling and Wellbeing (Auckland area)
Feedback to Participants:
Summary of findings and transcript review available upon request
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Document type:
Shared Care Guideline
Organization / Institution:
North Central London Joint Formulary Committee
Target Audience:
Primary Care Prescribers
Year:
2023
Region / Country:
Australia
Drug:
Edaravone (Radicava®)
Type of Document:
Pharmaceutical Benefits Submission
Regulatory Body:
Therapeutic Goods Administration (TGA)
Submission Purpose:
PBS Section 100 Highly Specialised Drugs Listing
Indication:
Amyotrophic lateral sclerosis (ALS)
Treatment Phase:
Initial and Continuing treatment
Prescriber Type:
Medical Practitioners, Nurse Practitioners (continuing therapy only)
Clinical Criteria:
Diagnosis by neurologist, disease duration ≤ 2 years, FVC or SVC ≥ 80% predicted, ambulatory or upper limb/swallowing ability, ALSFRS-R ≥ 2 on each item, no tracheostomy or respiratory failure
Population:
Adult patients (≥18 years)
Pricing:
Special Pricing Arrangements apply
Regulatory Dates:
Orphan designation 17 August 2021, TGA registration 15 February 2023
Comparator:
Standard of care with or without riluzole
Outcomes Measured:
ALS Functional Rating Scale – Revised (ALSFRS-R) after 6 months
Year:
2019
Region / City:
South East London
Subject:
Shared care prescribing guidelines for spasticity treatment
Document type:
Clinical guideline
Author:
Not specified
Target audience:
General Practitioners (GPs), specialists, healthcare providers
Period of validity:
Ongoing
Approval date:
Not specified
Date of modifications:
Not specified
Year:
2023
Region / city:
UK
Theme:
Respiratory issues, multiple sclerosis (MS), physiotherapy
Document type:
Guidance
Organization / institution:
MS Trust
Author:
Jody Barber, Michelle Davies, Michelle Koch, Wendy Hendrie, Rhian O’Halloran, Ruth O’Regan
Target audience:
Physiotherapists, healthcare professionals
Action period:
Ongoing
Approval date:
March 2023
Revision date:
None mentioned
Year of Discovery:
1870s
Location of Discovery:
Paris, France
Medical Field:
Neurology
Document Type:
Informational article
Author:
Samantha Budge
Target Audience:
General public, students of human biology
Affected Population:
Mostly active adults
Symptoms:
Muscle weakness, poor balance, speech and swallowing difficulties, fatigue
Progression:
Loss of mobility, respiratory support needed, dietary adjustments
Life Expectancy:
Typically 2–8 years, occasionally over 10 years
Treatment Approaches:
Medications for spasms and cramps, physical therapy, rest, dietary management
Title:
Sample Letter of Medical Necessity for a Treatment-Naïve Patient
Product Name:
TYSABRI® (natalizumab)
Indication:
Relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Target Population:
Adult patients with RMS
Document Type:
Sample letter template and prescribing safety information
Program:
TOUCH® Prescribing Program (REMS)
Risk Information:
Boxed Warning for Progressive Multifocal Leukoencephalopathy (PML)
Contraindications:
History of PML; hypersensitivity to TYSABRI
Safety Topics:
PML, JCV infection, IRIS, herpes encephalitis and meningitis, acute retinal necrosis, hepatotoxicity
Monitoring Requirements:
MRI monitoring, anti-JCV antibody testing, clinical surveillance for neurological symptoms
Intended Users:
Healthcare providers
Purpose:
Support for medical necessity appeals and safety guidance for prescribing
Organisation:
Business Disability Forum
Related condition:
Multiple Sclerosis (MS)
Document type:
Workplace adjustment agreement template
Purpose:
Record of reasonable adjustments between employee and line manager
Scope:
Workplace accommodations and sickness absence procedures
Parties involved:
Employee; Line Manager; HR Team
Review occasions:
One-to-one meetings; return to work meetings; six monthly or annual appraisals; changes in role or circumstances
Includes:
Adjustment record; emergency contacts; keeping in touch arrangements; return to work planning; unauthorised absence procedure
Intended users:
Employees with MS and their line managers
Associated resources:
Work and MS tool kit; Understanding your work situation sheet
Year:
2023
Region / City:
Oxford, England
Topic:
Multiple Sclerosis, Patient Advocacy, Health Awards
Document Type:
Award Announcement
Organization:
Oxford Health Policy Forum
Author:
Not specified
Target Audience:
MS patients, healthcare professionals, advocacy groups
Date of Approval:
25 May 2023
Period of Validity:
Not specified
Date of Changes:
Not specified
Year:
2021
Region / City:
Galway, Ireland
Theme:
Cognitive Rehabilitation, Multiple Sclerosis, Health Research
Document Type:
Job Advertisement
Institution:
National University of Ireland, Galway
Author:
Dr. Sinéad Hynes
Target Audience:
Researchers, Academic Professionals, Health Practitioners
Duration:
4 months
Approval Date:
N/A
Modification Date:
N/A
Year:
2017
Region / Country:
Australia
Document type:
Regulatory submission
Organization:
Pharmaceutical Benefits Advisory Committee (PBAC)
Manufacturer:
Roche Products Pty Ltd
Drug name:
Ocrelizumab (Ocrevus®)
Condition:
Primary progressive multiple sclerosis (PPMS)
Treatment phase:
Initial and continuation
Dosage form:
Solution concentrate for I.V. infusion 300 mg in 10 mL
Administration criteria:
Must be treated by a neurologist; clinical diagnosis of PPMS confirmed; specific MRI or CSF evidence required for initial treatment; previous treatment and tolerance required for continuation
Regulatory status:
TGA registered 13 July 2017
Program category:
Section 100 Highly Specialised Drugs program
Pricing arrangement:
Special Pricing Arrangement proposed
Clinical trial reference:
ORATORIO
Published Date:
Monday 23 April 2018
Last Reviewed:
Monday 23 April 2018
Authors:
Helen Cliffe; Marium Ahmed; Helen Ford; Mark Igra
Topic:
MRI surveillance and PML screening in multiple sclerosis
Type of Document:
Clinical audit protocol
Target Population:
Adult patients with highly active multiple sclerosis receiving Natalizumab (Tysabri)
Regulatory Framework:
European Medicines Agency recommendations; Summary of Product Characteristics for Tysabri
Clinical Focus:
Progressive multifocal leukoencephalopathy risk monitoring
Imaging Requirements:
Baseline MRI within 3 months prior to treatment; annual MRI surveillance including T1, T2/proton density, FLAIR, DWI and T1 post contrast
Risk Stratification:
JC virus antibody status; treatment duration over 2 years; prior immunosuppressant use
Audit Targets:
100% baseline MRI; 100% annual MRI; 100% protocol adherence
Suggested Cohort Size:
30–100 patients depending on hospital size
Referenced Guidance:
NICE Technology Appraisal TA127 (22 August 2007)
Producing organisation:
Bristol Technology Assessment Group
Document type:
Addendum to systematic review and economic model
Subject:
Clinical and cost effectiveness of natalizumab and its biosimilar in highly active relapsing-remitting multiple sclerosis
Interventions assessed:
Natalizumab (intravenous and subcutaneous) and natalizumab biosimilar (Tyruko)
Population:
Adults with highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy
Study inclusion criteria:
Randomised controlled trials comparing eligible interventions or placebo
Comparators considered:
Alemtuzumab, cladribine tablets, fingolimod, ocrelizumab, ofatumumab, ponesimod, interferon beta formulations, peginterferon beta 1a, glatiramer acetate
Manufacturers involved:
Biogen and Sandoz
Assessment components:
Clinical effectiveness review, network meta-analysis, cost-effectiveness modelling
Data sources:
Company submissions, published literature, previous technology appraisals
Economic perspective:
Cost-comparison submissions and EAG base case model
Geographical context:
United Kingdom
Regulatory context:
NICE technology appraisal process
Year:
2023
Type of document:
Supplemental Material
Authors:
Nola Chambers, Tosca-Marie Heunis, Sugnet Gardner-Lubbe, Jamie K Capal, Stacey Bissell, Anna W Byars, Sebastián Cukier, Peter E Davis, Jennifer Flinn, Tanjala T Gipson, J Chris Kingswood, Aubrey J Kumm, Eva Schoeters, Catherine Smith, Shoba Srivastava, Megumi Takei, Stephanie Vanclooster, Agnies M van Eeghen, Robert Waltereit, Darcy A Krueger, Mustafa Sahin, Liesbeth De Waele, Anna C Jansen, Petrus J de Vries
Field:
Neurodevelopmental Disorders
Focus:
Internal consistency and discriminant validity of TAND-SQ clusters
Population:
Individuals with Tuberous Sclerosis Complex (TSC)
Sample size:
92 (individuals), 66 (caregivers)
Data type:
Self-report checklist
Reference studies:
Alperin et al., 2021; de Vries et al., 2021; Leclezio et al., 2018; de Vries et al., 2020; Heunis et al., 2023
Year:
Not specified
Field of study:
Neuroscience; Neuroimmunology; Molecular Biology
Topic:
Meningeal inflammation and immune cell interactions in multiple sclerosis
Document type:
PhD research project description
Institution:
Imperial College London
Faculty:
Faculty of Medicine
Author / Supervisor:
Roberta Magliozzi
Research focus:
Multi-omic analysis of meningeal immune landscape and tertiary lymphoid-like structures in progressive multiple sclerosis
Methods:
Spatial transcriptomics; Mass spectrometry; Genome-wide association data integration; In-vitro cell culture models using hiPSC-derived neuronal and glial cells
Biological material:
Post-mortem meninges from multiple sclerosis donors and neurologically healthy controls
Sample size:
20 multiple sclerosis cases and 10 control individuals
Research objectives:
Identification of immune signatures, cellular interactions and molecular pathways associated with neuro-axonal damage and disease progression
Experimental models:
Human-induced pluripotent stem cell-derived neuronal and glial cell lines
Funding:
UKRI stipend and Faculty of Medicine course fees for three years with additional research consumables funding
Target applicants:
Graduates with honours degree in Biomedical Sciences and background in neuroscience, computer science, molecular biology or cell culture
Application materials:
Curriculum vitae and cover letter with contact details of two referees
Contact person:
Roberta Magliozzi
Year:
2022
Region / city:
Italy, United Kingdom
Topic:
Sero-epidemiology, Multiple Sclerosis, Herpesviruses
Document type:
Research Protocol
Organization / institution:
N/A
Author:
Bruno Gran, Peter Maple, Chris Tench
Target audience:
Researchers, Medical professionals
Duration:
N/A
Approval date:
05 September 2022
Modification date:
N/A
Documentation Recommendations to Assist with Adherence to the Peripheral Vestibular Hypofunction CPG
Year:
2023
Region / city:
N/A
Theme:
Vestibular rehabilitation
Document type:
Clinical guidelines
Author:
N/A
Target audience:
Healthcare professionals working with vestibular dysfunction
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A
Year:
2026
Programme:
EUP OHAMR Joint Transnational Call
Document type:
Pre-proposal application form and guidelines
Thematic focus:
Antimicrobial resistance, treatments, adherence to treatment protocols
One-Health scope:
Human Health, Animal Health, Plant Health, Environment
Call topics:
Combination antimicrobial treatments; adherence to treatment protocols; impact of veterinary and agricultural antimicrobials on AMR transmission
Targeted pathogens:
Bacteria; Fungi; Bacteria and Fungi
Eligible applicants:
Transnational research consortia
Consortium requirements:
3–6 project partners from participating countries (up to 7 under specified conditions)
Maximum project duration:
36 months
Funding framework:
National and regional funding organisations participating in the Call
Submission deadline:
2 February 2026, 13:00 CET
Submission format:
Single PDF via electronic submission tool (PT-Outline)
Issuing body:
Joint Call Secretariat and participating funding organisations
Source type:
Official call documentation defining eligibility, structure, and content of research pre-proposals within a European transnational funding programme
Documentation Recommendations to Assist with Adherence to the Peripheral Vestibular Hypofunction CPG
Year:
Not specified
Region / City:
Not specified
Topic:
Vestibular rehabilitation, exercise compliance
Document Type:
Clinical guidelines, recommendations
Organization / Institution:
Not specified
Author:
Not specified
Target Audience:
Healthcare professionals, clinicians
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Note:
Contextual description
Year:
2026
Region / City:
Global
Theme:
Mental health therapy, cognitive behavioral therapy
Document Type:
Evaluation rubric
Institution:
Unspecified
Author:
Unspecified
Target Audience:
Mental health professionals, therapists
Effective Period:
Ongoing
Approval Date:
Unspecified
Revision Date:
Unspecified
Year:
2026
Region / City:
Worcester, MA
Theme:
Commercial Support for Medical Education
Document Type:
Agreement
Organization:
New England Society of Allergy (NESA)
Author:
NESA CME Committee
Target Audience:
Exhibitors, Corporate Sponsors
Period of Validity:
Spring 2026
Approval Date:
03/10/2026
Date of Changes:
N/A