Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001505796
Ethics application status
Approved
Date submitted
12/08/2022
Date registered
2/12/2022
Date last updated
4/10/2024
Date data sharing statement initially provided
2/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Observation, Management, and Function Of low back pain Relief Therapies (COMFORT)
Scientific title
Clinical Observation, Management, and Function Of low back pain Relief Therapies (COMFORT): A cluster randomised trial evaluating an intervention to support GPs provide opioid stewardship to their patients with low back pain.
Secondary ID [1] 307680 0
Nil
Universal Trial Number (UTN)
Trial acronym
COMFORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liberal prescribing of opioids by GP 327216 0
Condition category
Condition code
Public Health 325400 325400 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
GPs will receive a baseline educational outreach visit of 0.5-1 hour duration and will also be given resources to implement the opioid stewardship intervention. The support material comprises patient education material “5 questions to ask about using opioids for back pain and osteoarthritis” (designed specifically for the trial) and heat wraps for pain relief (staged supply of up to 12 weeks).

Patient participants will continue to be followed up until 1 year post enrolment.

The topics covered during the education visit are:
Judicious prescribing of opioids and potential harms of opioid use
Pharmacological and non-pharmacological interventions that can be used as alternatives to opioids for back pain.

These topics will be communicated using a 10-minute video designed specifically for the trial and also direct discussion between the GP and trial staff member.

Every six months (until the recruitment target for each practice is met), researchers will schedule site visits involving a refresher training video summarising key messages on opioid stewardship and best practice management of back pain. Live online visits will be permitted in exceptional circumstances where face-to-face visits are not possible.

Patient-participants will be provided with a Consumer Medicines Information (CMI) leaflet for the opioid medicine(s) prescribed at the enrolment visit either electronically or via post and will be advised to discuss any queries or concerns regarding the CMI leaflet with their doctor or pharmacist. This will be determined during the baseline follow-up between the researcher and the patient-participant and provided by the study team. The CMI leaflet is a readily available resource and can be accessed via the following link- "https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg/consumer-medicines-information-cmi". GPs will additionally be given access to the publicly available NPS opioid tapering algorithm.

The heat wraps are single use products intended to provide pain relief for people with low back pain. Patient-participants will be advised on the correct and safe use of heat wraps by the study GPs and study team. Patient-participants will be advised to wear these for 6-8 hours during the day and to have a 1-day break after 3 consecutive days of use. Patients may choose to use, or not use the heat wraps. A heat wrap diary will be used to document use.

Note: The study will also schedule monthly follow-up calls with the study GPs to discuss trial progress, as well as 3 monthly site visits until the study achieves its recruitment target. The site visits will involve the review of trial documents and provide study support. Where required, GPs will be provided an additional supply of study materials (e.g., heat wraps, screening forms, etc). Live online visits will be permitted in exceptional circumstances where face-to-face visits are not possible.
Intervention code [1] 324154 0
Treatment: Other
Comparator / control treatment
Participating general practices assigned to the control arm (no outreach visit) will be asked to treat consenting patient-participants with the usual methods they normally use but will receive no training from study researchers about judicious opioids prescribing and back pain management.

Patient-participants will be provided with a Consumer Medicines Information (CMI) leaflet for the opioid medicine(s) prescribed at the enrolment visit either electronically or via post and will be advised to discuss any queries or concerns regarding the CMI leaflet with their doctor or pharmacist. This will be determined during the baseline follow-up between the researcher and the patient-participant and provided by the study team.

Note: The study will also schedule monthly follow-up calls with the study GP to discuss trial progress, as well as 3 monthly site visits until the study achieves its recruitment target. The site visits will involve review of trial documents and study support. Where required, GPs will be provided an additional supply of trial documents (e.g., screening forms, etc).
Control group
Active

Outcomes
Primary outcome [1] 332156 0
Cumulative opioid dispensed to patient-participants that was prescribed by study GPs: Using Services Australia Pharmaceutical Benefits Scheme (PBS) data, we will determine the cumulative dose of opioid medicines dispensed for patient-participants (in morphine milligram equivalent dose) that were prescribed by study GPs in the intervention vs control groups.
Timepoint [1] 332156 0
1 year post-enrolment
Secondary outcome [1] 412395 0
Type of opioid dispensed to patient-participants that were prescribed by study GPs: Using Services Australia PBS data, we will determine the proportion of patient-participants dispensed long-acting opioids that were prescribed by study GPs in the intervention vs control groups.
Timepoint [1] 412395 0
1 year post-enrolment
Secondary outcome [2] 412396 0
Cumulative opioid dispensed (MME) to patient-participants that was prescribed by any GP: Data will be sourced from Services Australia PBS and/or SafeScript to determine the cumulative opioid dispensed (in morphine milligram equivalent) by any GP for each patient-participant over a 1-year follow-up post enrolment.
Timepoint [2] 412396 0
1 year post-enrolment
Secondary outcome [3] 412397 0
Number of subsidised visits to healthcare providers and services: The study will utilise Medicare Benefits Schedule (MBS) and/or NSW admitted patient data to determine the number of subsidised visits to health care providers and services. This is a composite secondary outcome used to determine healthcare utilisation.
Timepoint [3] 412397 0
1-year post-enrolment
Secondary outcome [4] 412398 0
Number of visits to emergency department: The study will use Medicare Benefits Schedule (MBS) and/or NSW admitted patient-participant data to determine the number of subsidised visits to emergency departments.This is a composite secondary outcome used to determine healthcare utilisation.
Timepoint [4] 412398 0
1-year post-enrolment
Secondary outcome [5] 412401 0
Number of hospitalisations: The study will utilise Medicare Benefits Schedule (MBS) and/or NSW admitted patient-participant data to determine the number of subsidised visits to hospitalisation presentations.
Timepoint [5] 412401 0
1-year post-enrolment
Secondary outcome [6] 412403 0
Total cost of Medicare usage: The study will use Medicare Benefits Schedule (MBS) data to determine the cost of Medicare usage among patient-participants.
Timepoint [6] 412403 0
1-year post-enrolment
Secondary outcome [7] 412404 0
Total cost of PBS usage: Using Services Australia PBS data, we will determine the cost of PBS usage among patient-participants.
Timepoint [7] 412404 0
1-year post-enrolment
Secondary outcome [8] 412405 0
Persistent opioid use at 6 months:
This will be determined using Services Australia PBS data and/or SafeScript (and/or patient-participant report data). Persistent use at 6 months will be defined as having had at least one opioid prescription issued in the prior 30 days AND at least 3 opioid prescriptions issued in the prior 4 months.
Timepoint [8] 412405 0
6 months post-enrolment
Secondary outcome [9] 412408 0
Persistent opioid use at 1 year: This will be determined using Services Australia PBS data and/or SafeScript (and patient-participant reported data). Persistent use at 1 year will be defined as having had 10 or more opioid prescriptions issued in the prior year, with at least one prescription issued in the prior month.
Timepoint [9] 412408 0
1-year post-enrolment
Secondary outcome [10] 412409 0
Number of dispensations for gabapentinoids to patient-participants (e.g. pregabalin, gabapentin) prescribed by study GPs: These data will be collected from Services Australia PBS data and/or self-report data and/or SafeScript, and reported as count data.
Timepoint [10] 412409 0
1-year post-enrolment
Secondary outcome [11] 412410 0
Number of dispensations for gabapentinoids to patient-participants (e.g. pregabalin, gabapentin) prescribed by any GP: These data will be collected from Services Australia PBS data and/or self-report data and/or SafeScript and reported as count data.
Timepoint [11] 412410 0
1-year post-enrolment
Secondary outcome [12] 412411 0
Number of dispensations for benzodiazepines to patient-participants (e.g. diazepam) prescribed by study GP's: These data will be collected from Services Australia PBS data and/or self-report data and/or SafeScript and reported as count data.
Timepoint [12] 412411 0
1-year post-enrolment
Secondary outcome [13] 413488 0
Number of dispensations for benzodiazepines to patient-participants (e.g. diazepam) prescribed by any GP: These data will be collected from Services Australia PBS data and/or self-report data and/or SafeScript and reported as count data.
Timepoint [13] 413488 0
1-year post-enrolment
Secondary outcome [14] 413489 0
Number of dispensations for non-steroidal anti-inflammatory drugs to patient-participants prescribed by study GPs: These data will be collected from Services Australia PBS and/or self-report data and reported as count data.
Timepoint [14] 413489 0
1-year post-enrolment
Secondary outcome [15] 413490 0
Number of dispensations for non-steroidal anti-inflammatory drugs to patient-participants prescribed by any GP: These data will be collected from Services Australia PBS and/or self-report data and reported as count data.
Timepoint [15] 413490 0
1-year post-enrolment
Secondary outcome [16] 413491 0
Opioid-related poisonings over 1 year: The number of patient-participant experiencing an opioid-related poisoning will be determined using data from the Centre for Health Record Linkage or NSW Poisons Registry.
Timepoint [16] 413491 0
1-year post-enrolment
Secondary outcome [17] 413492 0
Deaths over 1 year: The number of patient-participants who died will be determined using data from the Centre for Health Record Linkage. Where possible we will determine if these were opioid related deaths.
Timepoint [17] 413492 0
1-year post-enrolment
Secondary outcome [18] 413493 0
Return of unused opioid medicines (determined as a percentage of patient-participants reporting return of unused opioid medicine): This will be determined using patient-participant self-report data either through the online questionnaire on Red-Cap or via one-on-one phone or videoconference interviews.
Timepoint [18] 413493 0
12 weeks, 1-year post-enrolment
Secondary outcome [19] 413494 0
Pain intensity scale (measured using the numerical pain rating scale (0 to 10) with 0 being no pain and 10 being worst pain) and will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team.
Timepoint [19] 413494 0
Baseline, 1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [20] 413495 0
Low back pain related disability (measured using the Roland Morris Questionnaire), and will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team.
Timepoint [20] 413495 0
Baseline, 1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [21] 413496 0
Global rating of change (using the Global Perceived Effect scale) in the patient-participants low back pain. This will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team.
Timepoint [21] 413496 0
Baseline, 1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [22] 413497 0
Over the counter medicines (OCT) used:
This data will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team and reported as count data. A description of the OTC medicines will also be reported.
Timepoint [22] 413497 0
Baseline, 1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [23] 415389 0
Non-pharmacological interventions:
This data will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team and reported as count data. A description of the non-pharmacological interventions used will also be reported.
Timepoint [23] 415389 0
Baseline, 1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [24] 415390 0
Quality of life measured using the EQ-5D-5L questionnaire and will be collected via self-report either via Red-Cap or one-to-one phone/video conference with the study team.
Timepoint [24] 415390 0
Baseline, 1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [25] 415391 0
Pain Self Efficacy Questionnaire: This will be collected via self-report either via Red-Cap or one-to-one phone/video conference with the study team.
Timepoint [25] 415391 0
Baseline, 1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [26] 415392 0
Duration of use of heat wraps (Intervention arm only). Patient-Participants will be provided with a diary (paper or administered via Red-Cap) and will be asked to document the number of day/s the heat wrap has been used.
Timepoint [26] 415392 0
12 weeks post-enrolment
Secondary outcome [27] 415393 0
Duration of opioid course: Patient-Participants will be asked to complete a self-report medication diary (paper based or via Red-Cap) at each follow up, asking them about use of opioid medicines within the past 7 days.
Timepoint [27] 415393 0
Baseline, week 1, week 4, week 12, week 26, week 52 post-enrolment
Secondary outcome [28] 415394 0
Proportion of patient-participants who ended an opioid course within the first month: This will be determined using the self-report patient-participant medication diary. The opioid course will be considered to have ended after 7 continuous days of no opioid use.
Timepoint [28] 415394 0
Baseline, week 1, week 4, week 12, week 26, week 52 post-enrolment
Secondary outcome [29] 415395 0
Severity of opioid withdrawal symptoms measured using the subjective opioid withdrawal scale, will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team.
Timepoint [29] 415395 0
Week 1, week 4, week 12, week 26 and week 52 post enrolment
Secondary outcome [30] 415396 0
Proportion of patient participants in each study arm who experience any adverse event. This data will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team.
Timepoint [30] 415396 0
1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [31] 415397 0
Frequency and nature of any adverse event. The total number of adverse events experienced by patient-participants in each study arm will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team. A description of the nature of adverse events will also be reported. Examples of adverse events can include nausea, vomiting and dizziness.
Timepoint [31] 415397 0
1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [32] 415985 0
Proportion of patient participants in each study arm who experience any serious adverse event (those resulting in hospitalisation, prolongation of hospitalisation, permanent disability etc). This data will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team.
Timepoint [32] 415985 0
1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [33] 415986 0
Frequency and nature of any serious adverse event The total number of serious adverse events experienced by patient-participants in each study arm will be collected via self-report either via Red-Cap or one to one phone/video conference with the study team. A description of the nature of serious adverse events will also be reported
Timepoint [33] 415986 0
1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [34] 415987 0
Cause of serious adverse event An assessment of the cause of any serious adverse event will be recorded and the reasons reported. This data will be collected via self-report either via Red-Cap or one to one phone/video conference with us, or contact with the treating clinician, and will be adjudicated with the support of the Data Safety Monitoring board (DSMB).
Timepoint [34] 415987 0
1, 4, 12, 26 and 52 weeks post-enrolment
Secondary outcome [35] 422691 0
Opioid therapy survey (Study GP): A 10-item questionnaire to assess practice behaviour and confidence related to opioid therapy for treatment of chronic pain.
Timepoint [35] 422691 0
Collected Pre initial site visit, following site visit, pre 6 monthly site visit, following 6 monthly site visit.
Secondary outcome [36] 422692 0
Concerns about analgesic prescription (Study GP): A 22 item to measure and predict both frequency of prescribing opioids and reluctance to prescribe opioids.
Timepoint [36] 422692 0
Pre initial site visit, following site visit, pre 6 monthly site visit, following 6 monthly site visit.
Secondary outcome [37] 425421 0
Anxiety severity score measured using the Generalised Anxiety Disorder (GAD-7) questionnaire and will be collected via self-report either via Red-Cap or one-to-one phone/video conference with the study team.
Timepoint [37] 425421 0
Baseline, 4, 12, 26 and 52 weeks post-enrolment.

Eligibility
Key inclusion criteria
Patient Inclusions
• Patient-participants greater than or equal to 18 years
• Low back pain of any duration at the time of presentation
• Has been prescribed an opioid analgesic for their low back pain by the participating GP within the past month
• Sufficient understanding of English to complete questionnaires, or translation available.
• Holds an Australian Medicare card number (for data linkage purposes).
• Willingness to give written informed consent.

GP Inclusions:

* Consults with patients who have LBP
• Has no prescribing restrictions, that is, eligible to prescribe an opioid analgesic (including schedule 8 opioid analgesics).
* Consent to researchers gaining access to their prescribing data

General Practice Inclusions
* Has at least one practicing GP registered with the Australian Health Practitioner Regulation Agency.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient Exclusions:
• Be engaged in an opioid tapering regimen at the time of enrolment into the study i.e. have already begun to reduce their opioid medicine within the past month
• Be actively treated for cancer, or receiving palliative treatment

General Practice Exclusions:
• Participating GP at that practice have received an education visit by any organisation on judicious opioid prescribing in the previous 12 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation (using Red-Cap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be determined using randomisation software.
The study will randomise a minimum of 40 general practice sites using stratified randomisation, by SEIFA (area-level socioeconomic status) and remoteness. SEIFA will be split into tertiles (highest, middle, lowest) based on the 2021 index for relative advantage and disadvantage (IRSAD). Remoteness will be also classified into two categories based on the ARIA+ classification and based on the Australian Statistical Geography Standard (ASGS): 1) Urban and 2) Regional/Remote/very remote.

There will thus be two strata variables, one with two levels and one with three levels, giving a total of six strata. Separate randomisation schedules will be generated for each of the six strata, using permuted blocks.
Randomisation will also account for a planned study within a trial (SWAT) that is being embedded within the COMFORT trial. The study protocol for the SWAT is separate and will test whether additional monetary reimbursement (versus no additional reimbursement) will encourage greater participation of culturally and linguistically diverse patient-participants with limited English proficiency into the COMFORT trial.

Because around 70% of the population of Australia is in the urban areas, we will recruit sites proportionally, with 70% from urban strata and 30% from regional/remote/very remote strata. This gives a target sample size of n=9-10 sites in each of the urban strata, and n=4 sites in each of the three regional/remote/very remote strata.

To maximise balance while maintaining blindness, we will use blocks of size 2 and 4. In order to allow greater recruitment from some strata than others without exhausting the randomisation schedule, schedules of n=40 will be generated for each strata (that is, a maximum of n=40 clusters can be randomised to any particular combination of SES and remoteness).

GP sites will be randomised to either the intervention or control arm. Each practice will recruit at least 12-15 participants (n=410 total). We have assumed an ICC of 0.045 based on 145 ICCs from cluster randomised trials in primary care.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The trial statistician(s), staff member determining eligibility and outcome assessor will be blinded to treatment group. The analyses will be conducted and interpreted blind to treatment group with dummy codes used for the two groups
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study will explore the effect of including a random intercept of cluster, and the analyses will be by intention to treat. Our primary outcome will be analysed using a linear regression model to explore the effect of the intervention on cumulative opioid medicine dispensed (in morphine milligram equivalent).

Balance of baseline characteristics will be assessed and any characteristics not well balanced will be included in the model, as a secondary analysis. Subgroup analyses will be used to evaluate differences in our primary outcome between patient-participants who were using opioids persistently in the 1 year prior to study entry, versus those who were not using opioid medicines persistently (according to our definition of persistent use at 1 year described earlier).

Subgroup analyses will be performed to examine if the following factors modify the effect of treatment on the primary outcome: (i) chronicity- patient participants with acute vs chronic pain (LBP), (ii) type of low back pain- non-specific back pain versus back pain due to specific causes (e.g. pregnancy), (iii) age and (iv) gender.

In addition, subgroup analyses will also be performed to compare outcomes from patient-participants enrolled via telehealth versus face to face, years of experience of study GPs, and geographical location of participating general practices. Continuous secondary outcomes will be analysed with the use of repeated-measures linear mixed models. Adjusted mean differences will be tested for the end of treatment (12 weeks) and the time point for the primary analysis (1 year). A binary logistic regression will be conducted for binary outcomes. Serious adverse events and adverse events will be reported descriptively for both number of events and number of patient-participants experiencing an event. Appropriate model checking will be conducted for all analyses.

Health economic analyses
A within-trial economic evaluation will be conducted using the health care perspective. Costs associated with the intervention (heat wrap therapy, patient information booklets, training) will be collected using trial financial records and staff wage rates. Health care costs will be incorporated in the analysis, using administratively linked data for Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS) and hospital admission costs, as well as self-reported diaries for over-the-counter medications. The health outcome measure will use the Short Form 12 (SF-12), which will be converted to a preference-based measure of health (SF-6D) to estimate quality-adjusted life years (QALYs). To calculate incremental cost-effectiveness ratios, linear mixed models will be used to analyse both costs and outcomes.
An additional analysis will be conducted to compare the total Pharmaceutical Benefits Scheme (PBS) cost of analgesic medicines dispensed among patient-participants randomised to the intervention versus usual care over a 1-year period using the dispensed price for maximum quantity (DPMQ).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/08/2023
Actual
5/09/2023
Date of last participant enrolment
Anticipated
27/01/2026
Actual
Date of last data collection
Anticipated
27/01/2027
Actual
Sample size
Target
410
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311949 0
Government body
Name [1] 311949 0
National Health and Medical Research Council's (NHMRC)
Country [1] 311949 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 314413 0
None
Name [1] 314413 0
Address [1] 314413 0
Country [1] 314413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311379 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 311379 0
Ethics committee country [1] 311379 0
Australia
Date submitted for ethics approval [1] 311379 0
29/06/2022
Approval date [1] 311379 0
14/12/2022
Ethics approval number [1] 311379 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120894 0
A/Prof Christina Abdel Shaheed
Address 120894 0
Institute for Musculoskeletal Health
Level 10, North King George V Building, Royal Prince Alfred Hospital (C39)
Missenden Road
Camperdown NSW 2050
Country 120894 0
Australia
Phone 120894 0
+61 2 8627 6236
Fax 120894 0
Email 120894 0
christina.abdelshaheed@sydney.edu.au
Contact person for public queries
Name 120895 0
Lisa Vizza
Address 120895 0
Institute for Musculoskeletal Health
Level 10 North King George V Building, Royal Prince Alfred Hospital (C39)
Missenden Road
Camperdown NSW 2050
Country 120895 0
Australia
Phone 120895 0
+61296647623
Fax 120895 0
Email 120895 0
lisa.vizza@sydney.edu.au
Contact person for scientific queries
Name 120896 0
Christina Abdel Shaheed
Address 120896 0
Institute for Musculoskeletal Health
Level 10 North King George V Building, Royal Prince Alfred Hospital (C39)
Missenden Road
Camperdown NSW 2050
Country 120896 0
Australia
Phone 120896 0
+61 2 8627 6236
Fax 120896 0
Email 120896 0
christina.abdelshaheed@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Data will be available after the publication of the study findings upon request and with agreement from the study researchers. There will be no end date for when the data will or will not be available
Available to whom?
By the researchers
Available for what types of analyses?
To be determined by the Chief Investigator of the Study
How or where can data be obtained?
By contacting the chief investigator of the study at christina.abdelshaheed@sydney.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.