appendix 1: template “a” - deakin.edu.au · web viewlow back pain is defined as any ache or...

PLAIN LANGUAGE STATEMENT AND CONSENT FORM

TO: Participant

Plain Language Statement

Date: Full Project Title: Risk factors for developing new low back pain: A 3-year prospective cohort study of nurses [URBAN study]Principal Researcher: A/Prof Daniel BelavyAssociate Researchers: Dr Steve Bowe, A/Prof David Connell, Dr Ashish Diwan, Dr Jon Ford, A/Prof Ana Hutchinson, Dr Clint Miller, Dr Patrick Owen, Dr Timo Rantalainen, Dr Nicola Ridgers, Prof Guy Trudel, Dr Andrew Hahne, Ms Sophie AartsStudent Researchers: Mr Matthew Quittner, Mr Scott Tagliaferri, Mr Benjamin Douglas, Ms Rachel Levit

This Plan Language Statement and Consent Form is 11 pages long. Please make sure you have all the pages.

Your Consent

You are invited to take part in this research project.

This Plain Language Statement contains detailed information about the research project. Its purpose is to explain to you as openly and clearly as possible all the procedures involved in this project so that you can make a fully informed decision whether you are going to participate.

Please read this Plain Language Statement carefully. Feel free to ask questions about any information in the document. You may also wish to discuss the project with a relative or friend or your local health worker. Please feel free to do this.

Once you understand what the project is about and if you agree to take part in it, you will be asked to sign the Consent Form. By signing the Consent Form, you indicate that you understand the information and that you give your consent to participate in the research project.

Plain Language Statement & Consent Form to Participants[2018-221]: version 3: [13.12.2018] of 11

Complaints

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about your rights as a research participant, then you may contact:

The Human Research Ethics Office, Deakin University, 221 Burwood Highway, Burwood Victoria 3125, Telephone: 9251 7129, [email protected].

Please quote project number [2018-221].

Purpose

In Australia, one in six people suffer from back pain and an estimated 70-90% will experience this condition during their lives. Approximately 13% of people without a prior history of back pain will develop a new episode in the next one to two years. In nurses, this risk of developing back pain has been shown to be 2-3 times greater. To date, a number of risk factors for back pain have been identified in the wider community, yet there has been less study of the risk factors and how to prevent back pain in nurses. Thus, there is an urgent need to identify these risk factors in this susceptible population group.

You have been invited to participate in this study because you are a currently employed nurse and are free of any health conditions that might affect your spine. Also, you have not previously had back pain. This makes you a prime candidate to help further clinical understanding of why you and your peers are collectively more likely to develop back pain. The main aim of this study is to examine risk factors for new back pain.

Another aim of this study is to examine key questions of what ‘causes’ back pain. For example, there is evidence that muscle wasting may be a ‘cause’ of back pain. Many treatment approaches, such as those focusing on core stability, assume that this muscle wasting is the cause of back pain. Yet, this has never been proven and no study has yet examined whether muscle wasting is simply a ‘side effect’ of back pain or actually a cause. This will have wide reaching implications for how back pain is treated.

With your help, we will examine this and similar critical questions of causality in back pain. Another key aim of this project is to aim to identify which types and amounts of physical activity protect nurses from the development of back pain.

Methods

This study will be a 3-year prospective cohort study in currently employed nurses, who have never had back pain before, and will encompass a nested sub-study. The sub-study will be a 12-week prospective cohort including those who (a) develop back pain over the 3-year


follow-up period or (b) are invited to act as a matched-control for a participant who develops back pain.

What the participation will involve

Cohort initiation (baseline testing)Currently employed nurses without a history of back pain will be recruited into the cohort. Upon your enrolment in the cohort, you will be required to attend two testing sessions in total, which will be conducted on separate days at two locations.

First, an appointment will be made for you at the clinical exercise laboratories located here:

Deakin University, Building J, 221 Burwood Highway, Burwood, VIC 3125https://goo.gl/maps/vyhqb

When you come to Deakin University, walk to building J (arrow marked above) When you enter this building, take the lift or the stairs up to level 5 Find the place in the foyer on level 5 where there are seats


https://goo.gl/maps/vyhqb

When you arrive, you will be met by a member of the investigative team to explain the procedure and clarify any further questions you may have. The following measures will then be administered within our clinical exercise laboratories:

Questionnaires : these will assess your physical and mental health, pain, mood, fear avoidance, physical activity, medical history and demographical information

Trunk endurance and strength : these will assess the ability of your trunk musculature to produce (strength) and sustain (endurance) a contraction

Aerobic fitness : this will assess the ability of your cardiorespiratory system Pain pressure threshold : this will assess your sensitivity to pressure Blood sample : this will assess your genotype and markers of systemic inflammation.

This will be performed by a qualified phlebotomist. Prior to this blood sample, we request you fast for at least one hour prior.

Anthropometry : your height, weight and hip/waist circumference will be measured using standard techniques

Clinical examination : a comprehensive clinical examination by a trained team of physiotherapists will assess your spine and also muscle function via real-time ultrasound

Following the completion of this testing session, you will be given a waist worn accelerometer and a thigh worn step-tracker to wear for eight days. These devices will objectively measure your habitual physical activity. This accelerometer is to be worn the entire time and only to be taken off when showering or doing any water-based activities. The device can be taken off when you sleep, but does not need to be. The devices can be returned at the magnetic resonance imaging (MRI) appointment.

Second, an appointment will be made for you to attend the MRI scanning facility located here:

Imaging @ Olympic ParkAAMI Park, 60 Olympic BoulevardMelbourne, VIC 3004www.goo.gl/HJndZz

Directions to the scanning facility:

By car: When coming down Swan St (from Richmond end) and after crossing Punt Road, turn left at first set of lights in Swan St (Entrance F). There is parking on the grounds which is free of charge for people attending the scanning center. Bring the parking ticket in for validation when you come

By tram: Route 70, get off at Stop 7D AAMI Park (~150m from scanning center) By train: Richmond Train Station (~600m from scanning center)


http://www.goo.gl/HJndZz

Please ensure you have comfortable clothing and ensure there are no metallic objects on your clothes or underwear, otherwise we may need to give you a gown to wear for the scans. Please refrain from wearing jewelry where possible, especially earrings, most other piercings will not affect the images.

For the testing session, you will be asked to arrive 20 minutes before the scanning appointment time. It is important you sit for 20 minutes so that the discs in your spine return to their resting state. When you arrive, you will complete a form for the scanning centre and then complete the following procedures:

You will be instructed on the scanning procedure You will then enter the MRI scanner and a series of scans will be performed to

measure different parameters of different structures of your spine

MRI is a way of getting images of various parts of your body without the use of radiation. It is estimated that the scanning protocol will be over within 20 minutes. Overall, you should budget on 60 minutes in total at the scanning centre.

Cohort follow-upEvery 1.5 months after baseline testing, you will be sent an email and SMS to ask whether you have had low back pain in the last month (yes/no). Low back pain is defined as any ache or pain that lasted longer than 24 hours, in the area between the 12th rib and gluteal fold, with or without leg pain (see Figure 1). The message will include a reminder that if you experience low back pain for 24 hours or more, to must contact the research team as soon as possible. If you do not respond to two consecutive emails or SMS, the research team will contact you via phone and/or post. Every six months after enrolment in the cohort, the research team will contact you by phone to ask whether you have experienced low back pain in the past six months and remind you to contact the research team should you experience back pain for 24 hours or more. If you experience low back pain for more than 24 hours, the research team will ask to you attend follow-up testing. If you experience no pain, the research team may ask you to act as a matched-pair for a person with pain.


Figure 1. Where is lower back pain?

New-pain case and matched pairIf you develop a new pain case, you will be asked to attend additional testing sessions. These will be completed as close to the onset of back pain as possible (week 0) and then 12 weeks following the onset of back pain (week 12).

If you do not develop back pain, you may be asked to act as a matched based on characteristics such as sex, age, height and weight.

If involved in this aspect of the study, you will once again undergo the clinical examination and MRI scans (see protocol above). During the follow-up at Deakin University, blood samples will also be collected by a qualified phlebotomist to enable the assessment of systemic inflammatory markers. Prior to this blood sample, we request you fast for at least one hour prior.

In addition to these face-to-face testing sessions, you will be given a questionnaire specific to pain at week 0 and week 12, as well as follow-up brief questionnaires pertaining to pain location, intensity and associated disability every two weeks during this 12-week follow-up, as well as in week 14 and week 16.

Risk and potential benefits to participants

Potential risksMRI has no known risks when standard screening procedures are implemented and does NOT expose you to radiation. You will be asked specific questions regarding things that might preclude you from having a MRI scan (e.g. becoming nervous in enclosed spaces, any metal implants or fragments, any electronic implants such as a pacemaker, piercings that cannot be removed, possible pregnancy). If you have a tattoo, there is a slight risk you may get skin irritation (similar to a sun-burn) due to the magnetic fields in the scanner. Some older tattoos and also black-inks may contain iron in the colours used. In the MRI, the magnetic field can cause heating of the iron compounds. As part of screening for this study, the MR operator will clarify what kind of tattoo you may have, if any.

Collection of blood samples may be perceived as unpleasant by some participants, and may cause minor pain and bruising at the site of the needle entry.

Trunk strength and endurance measures may result in minor muscle soreness.

There may be additional unforeseen or unknown risks.

Potential benefits


We cannot guarantee or promise that you will receive any benefits from this project. By participating in this project, you could gain access to information on your own body, via the aforementioned outcome measures, that you would otherwise not have.

Any expected benefits to the wider community

This study will identify key risk factors that will enable prophylaxis to reduce future incidence of pain and the subsequent costs to society in both nurses and the wider community. Additionally, these findings will enable the development of more effective countermeasures for primary prevention of back pain in theses susceptible population groups. The findings will enable the clinical and scientific community to understand key questions of causality in back pain. Finally, outcomes will help guide the design of interventions designed to specifically target outcome/s causing back pain.

Provision of services to participants adversely affected by the research

If you suffer any injuries or complications as a result of this research project, you should contact the study team as soon as possible and you will be assisted with arranging appropriate medical treatment. If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital.

How privacy and confidentiality will be protected

Any information obtained in connection with this project and that can identify you will be remain confidential. It will only be disclosed with your permission, subject to legal requirements. Forms with identifying information will be stored in a locked filing cabinet in the researcher’s office or in a password protected electronic file.

A unique code will be used on all forms and data collected from you, and not with your name or any other identifying information. These data will be stored on a password protected Deakin University server.

Only the investigators will have access to the data. Sharing of data between investigators will occur only in a coded, anonymised way and no identifying or personal information will be shared.

None of the information provided will be made public in any form that would reveal a participant’s identity to an outside party, thus all participants will remain anonymous. In all cases your identity and personal information will not be disclosed. Information will be provided in such a way that you cannot be identified.


Data will stored for a period of seven years after publication, after which paper copies will be destroyed as per Deakin University guidelines. Electronic copies of all data will be retained indefinitely. In accordance with the Freedom of Information Act 1982 (VIC), you have the right to access and to request correction of information held about you by Deakin University.

Dissemination of the research results

On request, a summary of the project will be emailed to you at the completion of the study. If you wish, you will also be able to obtain a copy of the magnetic resonance images after the completion of the study.

As part of normal MRI routine, if the radiologist, in reviewing your images, see any abnormal findings requiring medical follow-up, you will be advised on this and an appropriate course of action including referral to your GP.

The results of this study will be presented at research conferences and communicated in scientific journals.

Blood samples

Blood samples will be stored securely at Deakin University and only the investigators will have access. Some of the samples will be tested immediately at the end of the study and some will be frozen and stored for seven years following the publication of study findings. We wish to store these samples to conduct further testing to look for other risk factors of back pain when and if funding for this becomes available in the future. These samples will be disposed according to standard laboratory practice immediately after testing. Any ‘at risk’ information will be sent to you in a letter by the chief investigator, advising you to discuss the results with your medical practitioner.

Remuneration

Participants who complete the follow-up period will be enrolled in a raffle for 4 x AUD$500 prepaid VISA cards. Participants will also be provided with an additional single raffle entry for each participant they refer to the study (assuming the referred participant also completes the follow-up period). Since recruitment will stretch out over time, one raffle will be held for each for enrollment numbers 1-50, 51-100, 101-150 and 151-200. Matched pairs will be given an additional AUD$20. Participants reporting a new back pain in the 3-year follow-up period will not be given any additional sum, so as not to give an ‘incentive’ for developing new back pain.



TO: Participant

Consent Form

Date: Full Project Title: Risk factors for developing new low back pain: A 3-year prospective cohort study of nurses [URBAN study]Reference Number: 2018-221

I have read and I understand the attached Plain Language Statement. I freely agree to participate in this project according to the conditions in the Plain

Language Statement. I have been given a copy of the Plain Language Statement and Consent Form to keep. The researcher has agreed not to reveal my identity and personal details, including

where information about this project is published, or presented in any public form. I understand that the researchers intend to store the data for future research for which

ethical approval will be sought and participant consent obtained.

Please indicate below whether you agree to have your contact details stored to be invited to participate in future research.

[ ] Yes, I would like to be invited to participate in future research.

Please indicate below if you would like to receive a copy of the study results, via email, at the end of the study.

[ ] Yes, I would like to receive a copy of the study results via email.

Participant’s Name (printed) ………………………………………………………………………………………………….

Signature ……………………………………………………………………………………………… Date ……………………

Please email or fax this form to:

A/Prof Daniel [email protected] Fax: +61 3 9244 6017


mailto:[email protected]


TO: Participant

Withdrawal of Consent Form(To be used for participants who wish to withdraw from the project)

Date:Full Project Title: Risk factors for developing new low back pain: A 3-year prospective cohort study of nurses [URBAN study]Reference Number: 2018-221

I hereby wish to WITHDRAW my consent to participate in the above research project and understand that such withdrawal WILL NOT jeopardise my relationship with Deakin University.

Participant’s Name (printed) ………………………………………………………………………………………………….

Signature ……………………………………………………………………………………………… Date ……………………

Please email or fax this form to:

A/Prof Daniel [email protected] Fax: +61 3 9244 6017


mailto:[email protected]

appendix 1: template “a” - deakin.edu.au · web viewlow back pain is defined as any ache or...

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