LIVE - Research Governance Proforma

Summary of Key Responsibilities of People and Organizations Accountable for the Proper Conduct of a Study.

Title of Project (inc acronym)

 Evaluation of the Clinical Effectiveness and Economic Impact of Symbicort use in Controlled & Uncontrolled Asthmatic Adults (LIVE) 

 Proposed start date

 

 June 2002

 Proposed finish date

 

 December 2003

 Why the research is needed

 

 The introduction of combination therapies such as Symbicort has through defined clinical studies demonstrated the benefits to the patient in terms of quality of life, the physician in terms of clinical improvement in the patients asthma control, and to the health service in terms of cost savings. This study will provide complementary information on evaluating these aspects of asthma care including clinical effectiveness and economic benefits within normal routine primary care clinical practice with Symbicort. 

Principal investigator (PI)

 Dr Peter Edwards 

Principal investigator's contact details

Dr Peter Edwards

Ely Bridge Surgery

Cardiff, Wales

Tel: 02920 561808

Fax: 02920 578871

 Multidisciplinary (details of anyone other than the PI) who is involved in the research i.e. research asst etc)

 Dr H Charles, Co-investigator; Dr G Morgan, Co-investigator; Dr T Thompson, Co-investigator; Nicola Gardner, Study Site Co-ordinator; Melanie Davies, Study Nurse; Una Clark, Study Nurse; Marian Craig, Study Nurse; Jane Kirk, Study Nurse

All the above are employed at Ely Bridge Surgery

Ethical approval (whether required and obtained)

Conditional approval granted 24th May 2002

Medicines Control Agency

Not Required, since Symbicort will be prescribed under licence

Medical Devices Agency

Not Applicable

Approval for the use of human embryos

Not Applicable

Approval for the release of genetically modified organisms and food or food processes

Not Applicable

Animal licenses required

Not Applicable

Sponsor (e.g. CAPRICORN)

Astra Zeneca UK Limited

Employing organizations (of all staff involved in the project)

Staff from Astra Zeneca UK will be supporting the project at site, and in the analysis and reporting of this work

Care organizations (e.g. any other practices involved in the research, all organizations providing health or social care in Wales)

Ely Bridge practice is the only practice involved with this project.

Support required (e.g. if CAPRICORN was the sponsor it may be that you would require some admin support etc)

Astra Zeneca UK Limited are providing support in terms of technical expertise and project management personnel

Support offered ( e.g. any outside grants etc)

Astra Zeneca UK Limited are supporting this study to pay for site personnel time on study related activities at the site

Principal research question

 

The primary objective of this study is to determine whether Symbicort therapy improves clinical effectiveness of asthma treatment in a real life clinical setting, assessed by change in quality of life as assessed by the Standardized Asthma Quality of Life Questionnaire at enrolment and after 12 months treatment, and the level of scoring with the Royal College of Physicians 3 questions at clinic visits to the site during the duration of the study.

Methodology

 

Patient data will be collected on all consenting patients. Data will be entered onto the practice database during normal consultation times, and this will include RCP-3 questions and other health care contacts.

Please refer to the protocol BU-039-0017 for further information on the methodology. (section 3.1)

Sample group description (e.g. how many respondents will be recruited? male or female, age groups etc)

150 patients diagnosed with asthma will be recruited from this site.

Consumer involvement in design, conduct, analysis and reporting of the research (This is an area as you can imagine is not fully exploited and is being looked at closely)

The design of the project has been developed and agreed with the co-ordinating investigator, Dr Edwards. All analysis and reporting will also fully involve Dr Edwards and his group at Ely Bridge Surgery. There has been no consumer involvement with the design, conduct, analysis and reporting of this research.

Methods of dissemination

 

The sites participation in this study will be highlighted on the sites own web page. The results of the study will be disseminated through the distribution of the final clinical study report internally and by members of staff at the site. The data from the study will also be fully published in a reputable Journal accessible to appropriate health Care Professionals

Literature search (attach)

 

No audit work of this nature has been completed on the benefits of Symbicort on Quality of Life Parameters. However, for further background on the scientific rationale of the study the reader is asked to refer to the appropriate references relating to this study included in the Ďreferenceí section of the study protocol.

Identify any health and safety risks (e.g. if researcher is to interview respondents in their own home or indeed any uncontrolled environment you may wish to have some safety element included, I can provide an example)

Some of the consultations may take place at the patientís homes, and in this case there will be a level of risk to the health Care professional comparable with a normal house call.

Arrangements in place for obtaining patient consent if required (what are they)

Patients will be approached for inclusion in this clinical study through contact during clinic visits and phone contacts with site personnel. Patients who are interested in participating in the study will be provided with the option of either only having the data from their routine visits to the site after the start of Symbicort therapy assessed, or in addition would also be willing to perform the AQLQ during 4 visits to the practice over the year.  Consent will be fully reviewed and witnessed before the patientís active participation in the study.

Arrangements in place for patient confidentiality and what are they

Patient confidentiality is of paramount importance, and the level of confidentiality provided to patients is clearly defined in the protocol and consent form. This has been fully explained in the consent form, and verbally explained during the consenting procedure. The patientís data can only be identified through the use of the patient number / initials and the name of the patient will remain fully anonymous and will not be associated with the data that leaves the practice.

Details of any deviation from REC approval prior to project start date

Not applicable

The project protocol must be attached to this document

Protocol version 1 final                     (Dated 16th April 2002)

Ensure that any indemnity arrangements are in place for this research

All indemnity arrangements are agreed and in place for this project

 

Additional comments:

 

The study should in accordance with Research Governance Framework must be audited mid term. (Jan/Feb 2003) 

Patients currently recruited January 2003 = 102

Recruitment has now ceased