edShare@GCU

edShare@GCU (Glasgow Caledonian University)

Negotiation

This is a standard operating procedure from the Seniors USP (Understanding Sedentary Patterns) study. This SOP is about participant withdrawal from the Seniors USP Study of Lothian Birth Cohort 1936 participant

Coulter, Elaine

Skelton, Dawn

Dall, Philippa

D03b			


Participant Withdrawal- LBC1936


SOP Reference: SeniorsUSP/SOP/D03b
Version Number: 2	Previous Version Number: 1Date: 05.11.14
Author: Dr Elaine Coulter
Cohort Approval: PD [05.11.14] SC [05.11.14]
Approved by: Professor Dawn Skelton, PI, Signature: 
Effective date: November 2014
Review by: May 2015

ASSOCIATED DOCUMENTS:

LBC1936 Wave 4 protocol
SeniorsUSP/SOP/A02- Recruitment of participants-LBC1936
SeniorsUSP/SOP/A03- Obtaining informed consent
SeniorsUSP/SOP/C04- Use of activPAL
SeniorsUSP/SOP/E02- Booking WP2 research appointments


SCOPE: 
The activPAL3 activity monitor will be used to measure physical activity levels and sedentary behaviour of 750 participants from both the Lothian Birth Cohort 1936 (n=300) and West of Scotland Twenty-07 cohorts (n=450). 

This Standard Operating Procedure (SOP) describes how participant withdrawal from the study should be managed from LBC1936 cohort in instances when the participant has agreed to wear an activPAL.

DEFINITIONS: 

	WP2: Work Package 2
	LBC1936: Lothian Birth Cohort 1936


PROCEDURE: 

1.	Potential participant withdrawal prior to 1st visit

1.1	If a participant withdraws from the study before the Wave 4 visit, this should be recorded in the LBC database.  This includes receipt of a death notification for a cohort member.

2.	Participant withdrawal during data collection 

2.1	Note: these instructions only refer to those cohort members who elect to wear the activPAL
2.2	Participants may withdraw from the study for a variety of reasons during the data collection week between visit 1 and visit 2.
2.3	If participants’ phone fieldworkers to inform them that they wish to withdraw from the study, first aim to determine the reason for withdrawal. If appropriate, attempt to persuade the participant to remain in the study until visit 2.
2.4	If it is not suitable or if you are unable to persuade the participant to remain in the study arrange with the participant to return of the activity monitor, and activity diary if able. This will be done by sending them a pre-paid envelope in which they can post the activity monitor and diary back. Thank them for phoning you and for their participation in the study. NOTE: the activity monitor MUST be returned.
2.5	Ask the participant to document on their activity diary what time the activity monitor was removed on the diary if appropriate.
2.6	Record the withdrawal on the ‘Visit 2 data collection sheet’. 
2.7	Ask the participant if they would still like to receive feedback on their activity.
2.8	As participant has withdrawn from the study, do not complete any data collection on the ‘Visit 2 data collection sheet’.
2.9	Download data from activPAL activity monitor.
2.10	Email [University Contact Name & E-mail Address], to inform her of participant withdrawal and if they do or do not want to receive a summary of their physical activity levels in the post. Participants will automatically receive physical activity feedback unless fieldworkers ask if they wish to receive this and a no response is received.
2.11	Inform LBC1936 staff as soon as possible at [Administrative Office E-mail Address].
2.12	The SeniorsUSP research team will be informed of potential participant withdrawals at regular Seniors USP meetings.

3.	Participant withdrawal at Visit 2 

3.1	Fieldworkers will manage contact with participants during data collection.
3.2	If at visit 2 a participant states that they wish to withdraw from the project and does not want to complete any further data collection, fieldworkers should aim to determine the reason for withdrawal. If appropriate, attempt to persuade the participant to remain in the study in order to complete this research appointment. 
3.3	If the participant is willing to complete the final research appointment, complete as normal. Ask the participant if they would like to receive the feedback letter on their activity levels for the time in which they wore the activity monitor. Record the outcome and complete the feedback if required.
3.4	If the participant is not willing to complete the final research appointment, record this on the ‘Visit 2 data collection sheet’. 
3.5	Collect the activPAL activity monitor, if they have removed the device from their thigh ask them when it was removed and document this on their activity diary. If they have not removed the device from their thigh, follow Section 5 in SeniorsUSP/SOP/C04 as normal. 
3.6	Ask the participant if they would still like to receive feedback on their activity.
3.7	Thank the participant for their participation in the study.
3.8	Download data from activPAL activity monitor.
3.9	Email [University Contact Name & E-mail Address], to inform her of participant withdrawal and if they do or do not want to receive a summary of their physical activity levels in the post. Participants will automatically receive physical activity feedback unless fieldworkers ask if they wish to receive this and a no response is received.
3.10	Inform LBC1936 staff as soon as possible [Administrative Office E-mail Address].
3.11	The SeniorsUSP research team will be informed of potential participant withdrawals at regular Seniors USP meetings.



Review Acknowledgements
I acknowledge that I have read and reviewed this SOP and that no changes are required.
Name	Job Title	Signature	Date	Next Review due
				
				
				
				





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Version 2
Page 1 of 3




Seniors USP SOP: D03b Participant Withdrawal LBC1936

This is a standard operating procedure from the Seniors USP (Understanding Sedentary Patterns) study. This SOP is about booking research appointments for West of Scotland Twenty07 Study cohort participant

E01		


Booking WP2 research appointments- Twenty-07


SOP Reference: SeniorsUSP/SOP/E01
Version Number: 2 	Previous Version Number: 1Date: 13.11.14
Author: Dr Philippa Dall
Cohort Approval: PD [13.11.14] SS [13.11.14]
Approved by: Professor Dawn Skelton, PI, Signature: 
Effective date: November 2014
Review by: May 2015

ASSOCIATED DOCUMENTS:

SeniorsUSP/SOP/A01 – Recruiting Participants- Twenty-07
response rate form
Seniors USP confirmation Letter

SCOPE: 

Fieldworkers involved in this work package are required to conduct two research appointments with 750 participants from both the LBC1936 (n=300) and the Twenty-07 Cohort (n=450). 

The purpose of this Standard Operating Procedure (SOP) is to provide clear guidance to staff on preparation required for booking WP2 research appointments for the Twenty-07 cohort only. Research appointments will take place in participants’ homes. The SOP for contacting participants to ascertain if they are willing to participate in the study is described in SeniorsUSP/SOP/A01.


DEFINITIONS: 

	SOP: Standard Operating Procedure
	LBC1936: Lothian Birth Cohort 1936
	T07: West of Scotland Twenty 07 cohort
	WP2: Work Package 2

PROCEDURE: 

1.	Arrange Date and Time for Visit 1 and Visit2

1.1	If the respondent is willing to take part in the Seniors USP study, fieldworkers should arrange a date and time for two research appointments.  Research appointments for both visit 1 and visit 2 should be booked at the same time.
1.2	The first research appointment (visit) should be at least a week after the phone call to arrange it.  This is to allow time both for participant to receive the self-report questionnaire through the post, and to have adequate time to complete the questionnaire.  If you are struggling to arrange a suitable time for both research appointments, then the time between arrangement and visit1 can be slightly shorter (5 days) by mutual agreement of fieldworker and participant.  Please make sure the participant is aware that they may not have much time to complete the questionnaire if this is the case.  Adequate time for postage of documents to the participant is required.
1.3	The second research appointment (visit 2) should ideally occur exactly 9 days after visit 1.  This is the minimum time required to collect seven complete calendar days of physical activity data from the participant.  Visit 2 can take place more than 9 days after visit 1, by mutual agreement of the fieldworker and participant.  Fieldworkers should explain to participants they this means they will be wearing the monitor for longer than necessary, and that more data will be collected than is required for the study.  Visit 2 should not be arranged for more than 14 days after Visit1.
1.4	The fieldworkers should enquire whether the participant plans to fly in the period between research appointments.  The activPAL activity monitor can pass through airport security, however it may be noticed by security personnel who may question the participant.  In order to avoid any stress or discomfort to the participant, and to minimize the risk that activity monitors are removed and abandoned at airport security, research appointments should not be booked if the participant intends to fly between visits 1 and 2.
1.5	When arranging research appointments, fieldworkers should check whether the participant is planning to be on holiday between visits.  Levels of physical activity and sedentary behavior during a holiday period may be significantly different to habitual levels.  Where possible research appointments should not be booked if a holiday is planned between visits 1 and 2.
1.6	Research appointments will take place in the participant’s home.


2.	Preparing Paperwork to post ahead of Visit 1 

2.1	Once research appointments have been arranged, fieldworkers should prepare a pack of paperwork to post to the participant ahead of visit 1.
2.2	Take an unassigned document pack from the supply.
2.3	Take the remaining bar-code sticker form the pack, and stick it on the front of the response rate form.
2.4	Select a blank copy of the “Seniors USP confirmation letter”.  Fill in today’s date in the top right corner.  Fill in the date and time of visit 1 that has been arranged with the participant. You will be provided with a letter with your photo. You will need to complete the participant details on the form and include the date and time of visit.
2.5	Place the completed “Seniors USP confirmation letter”, and the self-completion questionnaire booklet form the document pack into the pre-paid seniors USP envelope.
2.6	Use the second name and address sticker for the participant on the front of the envelope and seal.
2.7	Post the envelope to the participant as soon as possible.  Delay in posting may mean that the participant does not have adequate time to complete the self-complete questionnaire prior to Visit 1.


3.	Fieldworker administration

3.1	Make a note of the agreed dates and times of the two research appointments in your diary.
3.2	Add the date and time of each visit, along with the participant number, to the online diary. This diary can be accessed by the survey team in order to check the location of the fieldworkers at any time [link to online calendar].
3.3	Fieldworkers will be provided with usernames and passwords for the diary – they only have access to their own details while survey office will be able to see all the fieldworker movements. 
3.4	Please update progress on the seniors USP spreadsheet on a weekly basis. A sheet is saved on the [Online Cloud Storage] within fieldworker folders. The team in [Survey Administrative Office] will access this inform. This log should be saved on a Friday each week, to allow the number of completed visits to be tracked and to facilitate sending feedback from the activity monitor to the participant after visit 2.




Review Acknowledgements
I acknowledge that I have read and reviewed this SOP and that no changes are required.
Name	Job Title	Signature	Date	Next Review due
				
				
				
				






PAGE  



Version 2
Page 3 of 3




Seniors USP SOP: E01 Booking WP2 research appointments T07

This is a standard operating procedure from the Seniors USP (Understanding Sedentary Patterns) study. This SOP is about preparing assessment document for research visit

E03			


Preparing WP2 Assessment Documentation


SOP Reference: SeniorsUSP/SOP/E03
Version Number: 2	Previous Version Number: 1Date: 08.11.14
Author: Dr Elaine Coulter
Cohort Approval: PS [08.11.14] SC [05.11.14] SS [08.11.14]
Approved by: Professor Dawn Skelton, PI, Signature: 
Effective date: November 2014
Review by: May 2015

ASSOCIATED DOCUMENTS:

LBC1936 Wave 4 Protocol
LBC1936 Wave 4 SOP
SeniorsUSP/SOP/C01a- Overview of WP2 Data Collection Methods (Twenty-07)
SeniorsUSP/SOP/C01b- Overview of WP2 Data Collection Methods (LBC1936)
SeniorsUSP/SOP/C02a- WP2 Visit 1 Procedure (Twenty-07)
SeniorsUSP/SOP/C02b- WP2 Visit 1 Procedure (LBC1936)
SeniorsUSP/SOP/C03a- WP2 Visit 2 Procedure (Twenty-07)
SeniorsUSP/SOP/C03b- WP2 Visit 2 Procedure (LBC1936)

SCOPE: 

Fieldworkers involved in this work package are required to conduct two research appointments with 750 participants from both the LBC1936 (n=300) and the Twenty-07 Cohort (n=450). 
The purpose of this Standard Operating Procedure (SOP) is to provide clear guidance for the preparation of WP2 study documentation of research appointments.
Field work for the Seniors USP study is being conducted as part of Wave 4  of the LBC1936.  Full details of all elements of Wave 4 are included in the Wave 4 protocol and SOP.  Only those items specific to Seniors USP, are reported in detail in this SOP.


DEFINITIONS: 

	WP2: Work Package 2
	LBC1936: Lothian Birth Cohort 1936
	Twenty-07: West of Scotland Twenty 07 cohort

PROCEDURE: 

1.	PRIOR TO THE RESEARCH APPOINTMENT 

1.1	The Fieldworker should prepare documentation and equipment in good time prior to the research appointment, generally at least a day in advance.
1.2	The activPAL3 should not be programmed earlier than 1 day in advance of the research appointment.
1.3	Ensure there are enough copies of the study documentation printed/photocopied prior to the appointment.
1.4	Ensure an extra copy of the self-completed questionnaire is available if required.


1.5	

	Twenty-07	LBC1936
Visit 1DocumentationEquipment	Consent form (carbon copy)Visit 1 data collection leaflet (T-07)SeniorsUSP Daily DiarySkin reaction advice sheetspare copy of the ‘self-completed questionnaire’ Green & Red pen x2Programmed waterproofed activPAL/PALstickie/waterproof dressing Communicare Mobile phoneDisposable hospital gown	Researchers:Consent form Visit 1 data collection leaflet (LBC1936)SeniorsUSP Daily DiarySkin reaction advice sheetCRF nurses:physical forms wave 4researchers:pen x2activPAL, docking station, heat sealer, PALstickie, waterproof dressingCRF nurses:Pen x2Weighing scalesStopwatchthermometer
Visit 2DocumentationEquipment	Visit 2 data collection leaflet (T-07)Green & Red pen x2Weighing scalesWood blocktimer[Lone Worker Service Provider] Mobile phoneThermometerDisposable hospital gown	Visit 2 data collection leaflet (LBC1936)Visit 2 top pagepen x2

Review Acknowledgements
I acknowledge that I have read and reviewed this SOP and that no changes are required.
Name	Job Title	Signature	Date	Next Review due
				
				
				
				




PAGE  



Version 2
Page 3 of 4




Seniors USP SOP: E03 Preparing WP2 assessment documentation

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Library Blog Style Guide 
 
Categories 
Categories should be assigned to every post. This will allow the post to be retrieved by the category 
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Last updated: 17 December 2014 Page 1 
 
Library Blog Style Guide 
 
News posts 
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Examples: 
 
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The library will be open as normal on Friday 26th, Saturday 27th and Sunday 28th 
September 2014. It will open from 9am to 5pm on Monday 29th September 2014. 
 
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Technical issues 
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Proquest Central will be unavailable on 31st January 2015 from 10am to 11am due to a 
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• Technical issue [Library Catalogue / Database A-Z] 
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Last updated: 17 December 2014 Page 2 
 
Library Blog Style Guide 
 
When the issue is resolved, we must blog with the good news. If the original blogger is not around to 
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Examples: 
 
• Resolved: Technical issue [CINAHL] 
 
***Access to CINAHL has now been restored*** 
 
CINAHL is unavailable due to a technical issue on the supplier’s web server. They have been 
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Managing comments 
You will find that some blog posts will attract comments. These fall into several categories: 
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Last updated: 17 December 2014 Page 3 
 
Library Blog Style Guide 
 
Managing older posts 
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Last updated: 17 December 2014 Page 4 
 


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