POiSE Delphi Survey 'Round 1'

 

You are invited to participate in this online, Delphi consensus study as you are a clinician and/or researcher with expertise in considering an epidural steroid injection (ESI) as a management option for patients with disc-related sciatica.

 

OVERVIEW
 

The aim of the POiSE project is to conduct a two-round Delphi study to achieve expert consensus on a list of potential factors, to be included in a cohort study, that predict outcome for patients with disc-related sciatica following an epidural steroid injection.

When you have completed the survey, please check that you have answered all of the questions and then click 'submit'.  We would be grateful if you could complete the survey in the next seven days.

When we have analysed the results, we will send you the link to access round 2 of the survey.

If there is anything that is not clear, or you would like further information, please contact the study Lead Investigator, Dr Siobhán Stynes s.stynes@keele.ac.uk

                               

POiSE Study
Keele University
Staffordshire
ST5 5BG
 

Thank you for your help with this study.

 

POiSE Delphi Consensus study v2.0 18 Jan 2021
FMREC MH200160
 

There are 44 questions in this survey.

HELPFUL INFORMATION ON COMPLETING THIS ONLINE SURVEY

  1. This is a multi-page online survey. You will see a 'progress bar' at the top, to indicate how far through completing the survey you are.
     
  2. Once you have answered the questions on the page, please click the 'Next' button at the bottom right-hand side to continue and move on to the next page of the questionnaire.
     
  3. If you would like to go back and revisit previously answered questions, please click the 'Previous' button at the bottom left-hand side of the screen.
     
  4. Once you have completed the survey click the 'Submit' button which is at the end of the form.
     
  5. If you want to leave and come back to this survey, you will be able to 'use your token' to log in again.
     
  6. If you close your Internet Browser window at any point by simply clicking the cross 'X', all responses entered up to the last completed 'page' will automatically be saved. This means that you can pick up from where you left off at a later time.
     
  7. If you select 'Exit and clear survey' (located at the top right hand side of your Internet Browser window), and click 'OK', this will clear any previously entered information from the survey, including all entered data on previous pages. Responses entered will therefore not be saved and on your next login you will start from the beginning of the survey.

 

Thank You

INTRODUCTION: PARTICIPANT INFORMATION

You are invited to participate in this online, Delphi consensus study as you are a clinician and/or researcher with expertise in considering an epidural steroid injection (ESI) as a management option for patients with disc-related sciatica.

We are planning a large multicentre clinical cohort study to determine predictors of outcome in sciatica patients following an ESI. We need to know what data to collect from patients in the future cohort study, and there is a limit to how many potential predictors we can include in the cohort study analysis. We want to ensure that the data we collect reflects current expert opinion.

From the published literature and a workshop with experts, we have compiled a number of items that potentially predict outcome following an ESI. The survey asks you to rate if you think the item is important enough to be included in the data collection as a potential predictor of outcome, specific to an ESI intervention. After each section, the survey asks you to add any additional items that you consider important under that domain.

The purpose of this modified Delphi study is to achieve expert consensus on which items to include for data collection in our clinical cohort study (the POiSE study).

To read the Participant Information Sheet (PIS) for full details about the study, please click on this link below. The PIS was also emailed to you as an attachment.

Participant Information Sheet

Please note: On clicking the link, a new tab will open within your current internet browser.  When you are finished reading and want to return to the survey, simply close the newly opened tab and you will return to this page and click 'Next' to continue.

INTRODUCTION: CONSENT

1.  I have read and understood the Participant Information Sheet dated 18/01/2021 (Version 2.0).

If you do not answer Yes to this question please do not proceed with this consent form until you are fully aware of what your participation in the study will mean. *

Please choose only one of the following:

  • Yes

2.  I have been given the opportunity to ask questions about the project, and have had these answered satisfactorily. *

Please choose only one of the following:

  • Yes

3. I understand that my taking part is voluntary. I also understand that I can discontinue participation at any point. I do not have to give any reasons for why I no longer want to take part and there will be no adverse consequences if I choose to withdraw. I understand that once I submit the completed on-line Delphi study, it will not be possible to withdraw my responses. *

Please choose only one of the following:

  • Yes

4.  I understand that data collected during this research will be processed in accordance with data protection law as explained in the Participant Information Sheet. *

Please choose only one of the following:

  • Yes

5.  I agree to take part in the above study  *

Please choose only one of the following:

  • Yes

Today's date:  {date('d-m-Y')}

If you wish to receive a copy of your completed consent form, please contact the study Principal Investigator,
Dr Siobhan Stynes on s.stynes@keele.ac.uk

INTRODUCTION: ABOUT YOU

This section contains general questions about you. Please follow the instructions and answer ALL of the questions relevant to you.

1. What is your gender? *

Please choose only one of the following:

  • Male
  • Female
  • Other

2. What country is your current employment located?  *

Please write your answer here:

3. In what discipline is your basic qualification (e.g. medicine, physiotherapy etc.)? *

Please write your answer here:

4. What is your current or most recent job title (and grade if applicable)? *

Please write your answer here:

5. What is the length of time in your profession? *

Please write your answer here:

  • years

6. Please indicate the setting(s) in which you work (e.g. primary care, secondary care, interface clinics, private practice, other) *

Check all that apply
Please choose all that apply:

  • Primary Care
  • Secondary Care
  • Interface clinics
  • Private practice
  • Academic setting
  • Other (please specify)::

7. Please indicate the length of your clinical experience in considering an epidural steroid injection for patients with disc-related sciatica. *

Please write your answer here:

  • years

8a. Do you have any peer-reviewed publications related to epidural steroid injections for disc-related sciatica? *

Please choose only one of the following:

  • Yes
  • No

8b. Please indicate number of relevant publications

Only answer this question if the following conditions are met:
Answer was 'Yes' at question '16 [Intro8a]' (8a. Do you have any peer-reviewed publications related to epidural steroid injections for disc-related sciatica?)

Only numbers may be entered in this field.
Please write your answer here:

INTRODUCTION: CLINICAL SCENARIO

If you think about a patient with clinical and MRI findings of disc-related sciatica leg pain (e.g. right S1 nerve root compression by a central/paracentral disc prolapse at the L5/S1 level). The patient may have severe leg pain and/or tried other conservative management options such as medication prescribed by their GP and/or physiotherapy treatment but has experienced no significant improvement.

You think the patient is suitable for a referral for an Epidural Steroid Injection (ESI) to help improve or relieve their leg pain.

  • Are there any factors such as patient characteristics or clinical examination findings or MRI findings, that would lead you to think they would respond well to an ESI?
  • Are there any factors that would make you think the opposite, that this patient will not respond well to an ESI?

Think about this scenario as you answer the questions.

INTRODUCTION: DEFINITIONS

Before you start the survey, the following working definitions may help you when considering your answers:

Patients with disc-related sciatica: patients with clinical signs and symptoms of radicular leg pain with concordant MRI findings of nerve root compromise due to disc herniation.

ESI: The term epidural steroid injection (ESI) is used throughout to describe any type of therapeutic spinal injection using local anaesthetic and corticosteroid performed using either a caudal, lumbar or transforaminal approach, with or without imaging for guidance.

Predictors of outcome: Also called “prognostic factors”: patient characteristics or items from the clinical examination or imaging findings that could be associated with whether a patient does well or not well after an ESI.

Outcome: Leg pain rated from 0 (no pain) to 10 (worst pain imaginable). This will be the primary outcome in the future cohort study. When you consider each item, think of outcome as either a good outcome (significant reduction in leg pain) or a poor outcome (no significant reduction in leg pain).

Generic predictor versus predictor specific to ESI

When you answer the questions we would like you to think about items you feel predict patients’ pain outcomes specifically with ESI intervention, rather than “generic” predictors of outcome for these patients, irrespective of a specific treatment.

For example, in spinal surgery, we know that the bigger the size of the disc prolapse on MRI, the better the outcome following surgery. Therefore, size of disc prolapse is a predictor of outcome (prognostic factor) specific to surgery. 

However, on a population level, the outcome from surgery, physiotherapy and other treatments is not as good in patients who have high versus low levels of depression. In this case, depression is a generic predictor of outcome as it predicts poor outcome irrespective of the specific treatment.

SECTION A: PATIENT CHARACTERISTICS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Age
b. Gender

Please use this box to list any other patient characteristics that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION B: HEALTH AND LIFESTYLE

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Body Mass Index (BMI)
b. Smoking
c. Alcohol consumption
d. Previous history of lumbar surgery
e. Comorbidities (reported diagnosis of at least one of: heart disease, high blood pressure, poor circulation, lung disease, kidney
disease, neurological disorder, liver disease, cancer,
inflammatory arthritis)
f. Impact of comorbidities
g. Diabetes

Please use this box to list any other health or lifestyle related items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION C: WORK ITEMS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Type of job/occupation
b. Work status (working/ not working/ retired etc)
c. Litigation (ongoing claim/secondary gain)
d. Off work due to sciatica symptoms
e. Disability related benefit (e.g. Disability living allowance)
f. Heavy physical demands at work

Please use this box to list any other work items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION D: MEDICATION ITEMS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Long term Opioid use (i.e. for >3 months as usage thought to increase sensitivity to pain)
b. Good response to NSAIDs
c. Good response to neuropathic medication

Please use this box to list any other medication items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION E: ONSET OF SCIATICA ITEMS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Identified cause/event e.g. lifting injury
b. Nature of onset (sudden v gradual)
c. History of previous episodes (first episode v recurrent symptoms)

Please use this box to list any other onset of sciatica items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION F: PAIN ITEMS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Current leg pain intensity
b. Current back pain intensity
c. Coexistent back pain
d. Leg pain greater than back pain
e. Duration of current sciatica symptoms
f. Bilateral leg symptoms
g. Leg pain with specific activities: e.g. walk, stairs, doing housework
h. Leg pain distribution on body chart
i. Number of additional pain sites in the body
j. Leg pain worse at rest
k. Leg pain worse with activity
l. Sleep disturbed due to sciatica symptoms
m. Presence of neuropathic pain features (e.g. unpleasant sensations in the skin such as pricking, tingling, pins and needles or pain descriptors used such as electric shock, shooting or burning)

Please use this box to list any other pain items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION G: PHYSICAL FUNCTION ITEMS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Physical function

Please use this box to list any other physical function items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica

Please write your answer here:

SECTION H: PSYCHOSOCIAL ITEMS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Anxiety
b. Depression
c. Self-efficacy
d. Fear avoidance beliefs
e. Patient’s treatment expectations

Please use this box to list any other psychosocial items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION I: CLINICAL ASSESSMENT FINDINGS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Positive Straight Leg Raise (SLR) test
b. Sensory deficit
c. Motor deficit
d. Reflex deficit
e. Lumbar flexion range of movement
f. Presence of Crossed SLR response

Please use this box to list any other clinical assessment findings that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION J: MRI FINDINGS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Type of disc herniation (e.g. protrusion, extrusion, sequestration/migration)
b. Location of herniated disc (e.g. central, left/right central/subarticular, foraminal/extraforaminal)
c. Associated spinal stenosis/degenerative changes (at the segment affected by the herniation)
d. Grade of nerve root compression (e.g. I contacts (abutment) II: displaces (preserving CSF/epidural fat) III: obliterated CSF/fat (entrapment) IV: morphologically distorted
e. Tandem lesion (high grade nerve root compression proximal to level injected)
f. Level of disc herniation e.g. L4-L5

Please use this box to list any other imaging items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION K: INJECTION ITEMS

Do you think this item is important enough to be included in the cohort study as a potential predictor of outcome following an ESI?

Refer back to the guidance page if needed for information/clarity on terms used.

*

Please choose the appropriate response for each item:

Extremely
Important

Very
Important

Moderately
Important

Slightly
Important

Low
Importance

Not at all
Important
a. Type of injection (e.g. Transforaminal ESI, caudal ESI)

Please use this box to list any other injection items that you feel are relevant at predicting outcome following an ESI for disc-related sciatica.

Please write your answer here:

SECTION L: FINAL COMMENTS

Please list any other items, not previously mentioned, that you feel are relevant at predicting outcome following ESI for a patient with disc-related sciatica.

Please write your answer here:

You have now finished round 1 of the Delphi study. The results will be emailed to you within a few weeks with your token and link to access Round 2. 
Thank you very much for your time in completing round 1 of the POiSE Delphi consensus study.

POiSE Delphi Consensus Study

Thank you for taking the time to fill in this survey

 

Your response has been successfully submitted

POiSE Study
Keele University
Staffordshire
ST5 5BG

Email: s.stynes@keele.ac.uk

 

 

 

 

 

POiSE Delphi Consensus study v2.0 18 Jan 2021
FMREC MH200160


29.03.2021 – 14:10

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