The international spinal cord injury pain basic data set (version 3.0)

Expert opinion, feedback, revisions, and final consensus. To update the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS version 2.0) and incorporate suggestions from the SCI pain clinical and research community with respect to overall utility. International. The ISCIPBDS working group evaluated these suggestions and made modifications. The revised ISCIPBDS (Version 3.0) was then reviewed by members of the International SCI Data Sets Committee, the American Spinal Injury Association (ASIA) Board, the International Spinal Cord Society (ISCoS) Executive and Scientific Committees, individual reviewers and societies, and posted on the ASIA and ISCoS websites for 1 month to elicit comments before final approval by ASIA and ISCoS. The ISCIPBDS (Version 3.0) was updated to make the dataset more flexible and useful: 1. The assessment can be based on the patient’s perception of several of his/her “worst” pain(s) or based on the International SCI Pain (ISCIP) Classification-defined or other pain types, depending on the specific research questions or clinical needs. 2. Pain interference should usually be rated for overall pain but may also be used for specific pain problems if needed. 3. An optional pain drawing was added to complement the check box documentation of pain location. 4. Data categories consistent with the Extended Pain Dataset list of current treatments were added. 5. Several new training cases were added.


INTRODUCTION
The International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) [1,2] was primarily developed to provide clinically relevant information concerning SCI-related pain that could be collected by health-care professionals with expertise in SCI in various clinical settings.However, it has also served as a basic pain measure in clinical research and clinical registers [3,4] and was included in the National Institute for Neurological Disorders and Stroke project Common Data Elements (CDE) for SCI clinical research [5].This latter paper emphasized that widespread use of CDEs including the ISCIPBDS could facilitate clinical research and trial design, data sharing, and retrospective analyses in the SCI population.The ISCIPBDS, version 1.0 [1] and version 2.0 [2], including the International SCI Pain (ISCIP) Classification [6] have been widely cited (214, 152, and 314 times on Google scholar [as of 7/12/23]).
The ISCIPBDS continues to be used as a core measure of SCIpain and has been used in different types of clinical and experimental research studies.Some of the more recent publications include the psychophysical examination of the impact on central sensitization to tonic noxious stimuli [7], pain impact on health-related quality of life [8], psychophysical and longitudinal studies [9,10], and community surveys [11][12][13][14].Completed clinical trials concerning SCI-pain that have used the ISCIPBDS include a clinical trial examining the effects of virtual reality walking on neuropathic pain (ClinicalTrials.govIdentifier: NCT03735017) and the interaction of physical activity on musculoskeletal and other pain types (NCT04241003, NCT05236933).Of those clinical trials that are still recruiting [as of May 2023] the ISCIPSBDS has been adopted to document SCI-pain following an exercise plan (NCT04160858), a virtual reality walking intervention (NCT05005026), and a cognitive multisensory therapy intervention (NCT04706208).
Another utility for the ISCIPBDS has been to serve as a safety measure or a standardized tool to track potential detrimental effects of "emerging treatment strategies."For this purpose, the ISCIPBDS was used to evaluate potential negative effects including pain development during a Schwann cell (SC) safety study [15].This open-label clinical trial evaluated the safety of autologous human SC transplantation into the spinal cords of six people with subacute paraplegia after SCI.Pain evaluations using the ISCIPBDS were performed at regular intervals to follow individual pains to determine the extent that the development or severity of pain was greater than would be expected for this patient population.
To keep the ISCIPBDS current, this update addresses important suggestions from the clinical and research SCI community to further improve its utility.Specifically, concerns were raised with respect to the division of worst, second worst, and third worst pain in research settings, in research focused on epidemiology, longitudinal investigations, or the prediction of pain.In addition, several clinicians suggested adding a pain drawing as they found it to be more useful than a pain site checklist.The ISCIPBDS working group decided to review and update the current version to address these concerns and suggestions, to improve the utility of the ISCIPBDS.
The ISCIPBDS (3.0) should be used by healthcare professionals who are familiar with SCI.Like previous versions, the ISCIPBDS (3.0) can be used at the initial evaluation and at regular follow-up evaluation in both clinical settings and in research studies.The evaluation should include examination and interview and questions read to the patient or research participant as worded.
The overall goal of the ISCIPBDS (3.0) has not changed from previous versions.The purpose is to standardize the collection and reporting of pain in the SCI population and to be consistent with the purpose and vision of the other International Spinal Cord Injury Data Sets [16].The ISCIPBDS should be used together with the International SCI Core Data Set [17], which includes information on date of birth and injury, sex assigned at birth, the cause of the SCI, and neurological status including positive and negative sensory signs.

MATERIALS AND METHODS
The development of the original ISCIPBDS (1.0) and the revised version (2.0) and information regarding the members of the working group have been described in detail previously [1,2].
The ISCIPBDS is designed to collect a minimal amount of standardized information concerning pain's interference with physical and emotional function and sleep, probable pain diagnosis, pain location, pain intensity, and duration.To ensure consistency in data collection and to facilitate interpretation, detailed information including updated training cases is provided in the updated syllabus for each variable and response category.
The development of the revised version of the ISCIPBDS (3.0) followed these procedures steps: 1.The working group made the revisions as described below via e-mail discussions.
2. The ISCIPBDS (3.0) draft was reviewed by members of the International SCI Data Sets Committee.Suggestions were minor and concerned adding clarifications regarding how to complete the form and how to label the specific pain problem of interest.These suggestions were addressed and the ISCIPBDS draft revised.
3. The ISCIPBDS (3.0) draft was reviewed by members of the International Spinal Cord Society (ISCoS) Executive and Scientific Committees and the American Spinal Injury Association (ASIA) Board, and their suggestions were addressed.Suggestions concerned minor typos, minor inconsistencies, and format.The ISCIPBDS (3.0) draft was further revised based on these suggestions.
4. Organizations, societies, and individuals with an interest in SCI-related pain were invited to review and comment on the ISCIPBDS (3.0) draft.The Data Set was also posted on the ISCoS and ASIA websites to elicit additional comments and suggestions.This elicited requests for further clarifications (e.g., regarding treatment data, specific pain-relevant items, and reference updates).
5. The ISCIPBDS (3.0) draft, was then reviewed by members of the ISCoS Executive and Scientific Committees and the ASIA Board who had no further comments or suggestions.
Detailed information regarding the modifications made to the ISCIPBDS over time and instructions how to use the ISCIPBDS including training cases can be found here: https://www.iscos.org.uk/uploads/2022.09.23_International_SCI_Bas.0%20syllabus_including%20training% 20cases.pdf.

RESULTS
Several changes and recommendations were made from Version 2.0 to Version 3.0.These included: 1. recommendations and clarifications regarding the selection of pain types and pain problems to assess; 2. recommendations regarding the use of the pain interference items; 3. adding an optional pain drawing; 4. adding treatment categories consistent with the Pain Extended Data Set (ISCIPEDS) [18]; and 5. adding more detailed instructions and examples regarding the use of the ISCIPBDS via new and updated training cases.

Recommendations and clarifications regarding the selection of pain types and pain problems to assess
We updated the recommendations regarding how to use the ISCIPBDS items.Specifically, our intent was to make the dataset more flexible and useful.We clarified that although the initial intent of the ISCIPBDS was to evaluate the three worst pain problems, a greater number of distinct pain problems may also be evaluated if needed.The assessment can be based on the patient's perception of several of his/her "worst" pain(s), which may be particularly useful in clinical settings, or on one or several pain types of specific interest.The selection of pain problem(s) may also be determined by a clinical or research question.For example, for longitudinal follow-up of a specific pain, pain type or a combination of labels may be used e.g., pain location (e.g., shoulder, legs), temporal pattern (e.g., continuous, intermittent), pain quality (e.g., burning, electric) or evoked pain (e.g., mechanical allodynia).Similarly, if a research project aims to evaluate the prevalence or mechanisms of a particular type of pain, including those defined by the ISCIP Classification [6], e.g., neuropathic pain, the use of the three worst pain problems could be misleading.In these situations, neuropathic pain (which may or may not always be the worst pain at a specific timepoint) should always be evaluated.There might also be situations where a research aim is best addressed by first examining if each pain type (e.g., neuropathic pain, musculoskeletal pain, visceral pain, other pain) is present or not, and if present, described for each type separately.

Recommendations regarding the use of the pain interference items
Pain interference is recommended to be assessed for overall pain because it can be difficult for an individual to distinguish the unique and distinct impact of one pain problem on quality of life when more than one pain problem is present.However, there may be situations where a clinician or investigator may determine that one or more pain interference questions are relevant for one or for all types of pain present.For example, this could be the case if a research project focuses on one specific pain type or aims to assess which type of pain has the most impact on a specific outcome (e.g., mood or sleep).However, validity data are currently lacking regarding the validity of assessing pain interference separately for specific pain problems in individuals who experience multiple pain problems.

Adding an optional pain drawing with dermatomes
We added an optional pain drawing with a frontal and dorsal view to complement the pain location checklist [19], given feedback from some clinicians that they find a pain drawing more useful than the checklist.The pain drawing can also be used when discussing the pain problem(s) with the patient or research participant.Furthermore, the dermatome map from the ISNCSCI exam can be used to determine at-and below-level neuropathic pain based on the drawing as previously shown [20].
Adding treatment categories consistent with the International SCI Pain Extended Data Set Check boxes for treatment categories consistent with the ISCIPEDS [18], were added to the form, and multiple examples for each category were added to the syllabus to facilitate the consistent collection of treatment data.The following categories are listed on the form with more examples in the syllabus comments under "Treatments used to reduce this pain": (1) Physiotherapy, (2) Passive and stimulation therapy, (3) Relaxation and psychotherapy, (4) Oral and topical medication, (5) Procedural intervention, (6) Surgical intervention, and ( 7) Other.More details with examples are included in the Syllabus in accordance with Appendix C in ISCIPEDS [18].

Updated training cases
More detailed instructions and examples regarding the use of the ISCIPBDS are provided in the new and updated training cases found in the syllabus.

DISCUSSION
The basic dataset was developed to be used in the clinic but not necessarily as a research tool.However, it has and can be used in clinical research studies as a standardized tool to document pain.The advantages over other tools include: 1. it is a SCI-specific and free tool that captures information relevant to all the major types of SCI-related pain as characterized by the ISCIP group, and not just one specific broad subtype such a neuropathic pain; 2. it reduces assessment burden with respect to the domains that the ISCIPBDS requires clinicians and investigators to administer, given the alternative of using many different measures, some of which have not been validated for people with SCI and some of which are not open source/freely available; 3. the SCI Pain Basic Data Set is incorporated within the NINDS Common Data Elements.
The ISCIPBDS (Version 3.0) was revised in direct response to the suggestions from the clinical and research SCI communities to improve clarity and update the recommendations regarding how to use the ISCIPBDS items.Thus, the focus of the ISCIPBDS (3.0) was to make changes to make the dataset more flexible and optimally useful for a variety of clinical and research settings.
Concerns were raised by the SCI research and clinical communities with regards to longitudinal pain studies that aim to follow one or several specific pain types whether or not these were viewed as the worst pain problem at the initial assessment.To address this issue, each person should be asked to describe one or several of his/her pains experienced within the last 7 days.The pain problems could include one or several of the worst pains as defined by the patient, or one or more pain type of particular interest, depending on a clinical or research question.Each person can also be asked to describe all pain types present, e.g., neuropathic, musculoskeletal, visceral and other pain.The selection of pain problem(s) may also be determined based on the clinical needs or research question.
Additionally, there were also questions regarding how to best use the data set when there is a focus on a particular type of pain and how this specific pain problem-rather than overall pain-impacts activities, mood or sleep.We updated the recommendations and suggest that the 3 interference items can be assessed for individual pains or for overall pain.To ensure comparability across studies, even when a user allows respondents to rate pain interference for more than one pain problem, we recommend that respondents always also be invited to rate overall pain interference.Although validity data regarding the use of the pain interference items for specific individual pain problems in a person who experiences several concomitant pains are currently lacking, there may be situations where there is a clinical or research interest in assessing pain interference separately for individual pain problems.
The ISCIPBDS committee addressed these concerns and provided additional improvement and clarity.
The structure or intent of the ISCIPBDS (3.0) was not significantly changed from previous versions.The revised version presented in this paper focuses on the same domains as the original version [1] (i.e., pain classification, pain severity, and pain interference).Like previous versions, the ISCIPBDS (3.0) was designed to collect essential and clinically relevant pain information in the daily practice of healthcare professionals with expertise in SCI.Another goal was to ensure that the evaluation was logistically feasible across various clinical and research settings and countries, including in developing countries.The ISCIPBDS (3.0) should ideally be used in conjunction with the International Standards for Neurological Classification of SCI (ISNCSCI), including the ASIA Impairment Scale, the neurological level of injury, and the associated dermatomal map [8] to determine the extent of neurological injury and to determine the location of pain relative to injury (i.e., above, at, and below).An optional pain drawing that is compatible with the ISNCSCI was added to the data set to facilitate the integration of neurological data and pain classification.
To further improve clarity and provide guidance with respect to the utility of the ISCIPBDS, we added the treatment categories with check boxes consistent with the ISCIPEDS [18] and much more detail and clarification regarding the treatment categories in the syllabus.In addition, we added several new training cases to the syllabus where the data set was used in different ways to provide examples of how the data set could be used for different purposes.
In summary, the ISCIPBDS (Version 3.0) is modified to improve its clarity and utility for evaluating pain globally across different settings.With respect to research and specialized pain clinics that manage chronic pain associated with SCI, bedside and/or quantitative sensory assessments would add diagnostic precision.Bedside sensory assessment is included in the ISCIPEDS [18].
The utility of the revised ISCIPBDS is increased by further clarification regarding its use and should be more clinically useful with the addition of a pain drawing.The addition of the list of treatment categories that are found in the ISCIPEDS should facilitate the collection of more detailed treatment information.This revision is consistent with our intention to continue to update and improve the ISCIPBDS.Our working group (through the corresponding author) welcomes additional suggestions and comments for further improvement.
To maximize the utility of this new version, we encourage users to download the Syllabus that is freely available on the ISCoS website (https://www.iscos.org.uk/international-sci-data-sets), which includes detailed information and explanations for each variable.