CDE Detailed Report

Disease: Spinal Cord Injury
Sub-Domain: The International SCI Data Sets
CRF: International SCI Pain Basic Data Subset

Displaying 1 - 13 of 13
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C06005 Data collected date and time DataCollDateTime Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date (and time, if applicable and known) the data were collected. This may be the date/time a particular examination or procedure was performed. Date of data collection Date or Date & Time WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-24 21:00:23.88 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Free-Form Entry

C06072 Pain interfere sleep scale PainIntrferSleepScale Scale that evaluates to what extent pain has interfered with the participant's sleep. Scale that evaluates to what extent pain has interfered with the participant's sleep. In general how much has pain interfered with your ability to get a good night's sleep? 1;10;2;3;4;5;6;7;8;9 1;10;2;3;4;5;6;7;8;9 Numeric Values

Choose one alternative for each question. Please note that all interference items apply to overall pain during the last week, rather than to each of the different pain problems. Please note that "last week" specifically refers to the last seven days including today. This question concerns how a person's specific pain problem interfered with his/her ability to get a good night's sleep during the last seven days including today. An interference item that assesses sleep interference was developed for this data set because pain is known to have a significant negative impact on sleep for many patients, and pain's effect on sleep is somewhat distinct from its effect on other functioning domains.

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06056 Pain past seven day indicator PainPstSvnDyInd Indicator of the presence of any type of pain during the last 7 days, including today. Indicator of the presence of any type of pain during the last 7 days, including today. Have you had any pain during the last seven days including today? Yes;No Yes;No Alphanumeric

Choose one. Pain is defined by the International Association for the Study of Pain (IASP) as "An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage" (Merskey & Bogduk, 1994). The seven day interval was chosen in order to be able to capture current pain and both constant and intermittent chronic pain that may be clinically relevant and to have the same time frame in all data sets.

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06073 Pain treatment indicator PainTreatmtInd Indicator for whether the participant is using or receiving any treatment for the pain experienced. Indicator for whether the participant is using or receiving any treatment for the pain experienced. Are you using or receiving any Treatment for your pain problem? Yes;No Yes;No Alphanumeric

By "treatment" is meant any prescribed or non-prescribed medical, surgical, psychological, or physical treatment that the patient is using or receiving for pain that has been present the last seven days to alleviate his/her pain/pains. This variable may include chronic and intermittent drug treatment, physical therapy, relaxation training, nerve blocks etc.

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06057 Pain different problem number PainDiffrntProbNum Number of different pain problems an individual perceives that he or she has experienced during the last seven days including today. A "pain problem" is defined by the person himself as a pain that has a specific character. Number of different pain problems an individual perceives that he or she has experienced during the last seven days including today. A "pain problem" is defined by the person himself as a pain that has a specific character. If yes how many different pain problems did you have? 1;2;3;4;5 or more 1;2;3;4;5 or more Alphanumeric

Only answered if person reports pain during the last seven days. Please note that one pain problem can be located in one or several areas. Data from previous studies suggest that persons with SCI rarely have more than 5 different pain problems. Persons who experience SCI related chronic pain can usually differentiate between different pain problems. Although unusual, it is possible to have two different types of pain in overlapping areas. An example would be musculoskeletal shoulder pain in a person with cervical injury and neuropathic pain at the level of injury.

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06058 Pain problem grade PainProbGrade Grade for the pain problem that indicates whether the person is describing their worst pain problem, their second worst pain problem, or their third worst pain problem. Grade for the pain problem that indicates whether the person is describing their worst pain problem, their second worst pain problem, or their third worst pain problem. Please describe separately up to three of your worst pain problems Alphanumeric

All three classifications should be used if the person reports three or more pain problems in the last 7 days. Each person is only required to describe the three worst pain problems he or she is currently experiencing (within the last 7 days). The reasons for this are twofold. First, most people with SCI experience three or fewer pain problems. Second, describing the details of more than three different simultaneous pain problems may induce errors in the data collection. Please note that the forms should be completed in a columnar fashion for each pain problem and not be read across.

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets 255

Free-Form Entry

C06059 Pain location anatomic site PainLocAntmicSite Anatomic site on the body where the pain is experienced Anatomic site on the body where the pain is experienced Pain locations sites Head;Throat;Neck;Shoulder;Upper arm;Elbow;Forearm;Wrist;Hand/Fingers;Chest;Abdomen;Pelvis/Genitalia;Upper back;Lower back;Buttocks;Hip;Anus;Upper leg/Thigh;Knee;Shin;Calf;Ankle;Foot/Toes Head;Throat;Neck;Shoulder;Upper arm;Elbow;Forearm;Wrist;Hand/Fingers;Chest;Abdomen;Pelvis/Genitalia;Upper back;Lower back;Buttocks;Hip;Anus;Upper leg/Thigh;Knee;Shin;Calf;Ankle;Foot/Toes Alphanumeric

Can be more than one, so check all that apply

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06060 Pain location indicator PainTypLatLoc Indicates if the participant experienced pain in the particular location described jointly by the laterality and anatomic site Indicates if the participant experienced pain in the particular location described jointly by the laterality and anatomic site Pain locations sites Right;Midline;Left Right;Midline;Left Alphanumeric

Can be more than one, so check all that apply. This division into pain areas is based on a pain drawing originally described by Margolis et al.,1988 but which was since recalculated into 8 principal areas (WiderstrÖm-Noga et al., 2001): (1) head; (2) neck/shoulders; (3) arms/hands; (4) frontal torso/genitals; (5) back; (6) buttocks/hips; (7) Upper legs/thighs; and (8) Lower legs/feet. Within each of t hese 8 pain locations, further divisions into more precise locations can be made. For example, in the "arms/hand" category specification of wrist, elbow pain etc. can be made if needed. Each individual is asked to describe the location of all present pain. Please indicate right (R), midline (M) and/or left (L) side. The descriptions of the pain locations in the Basic Pain Data Set are meant to be based on each individual's perception of the location of pain, and can be used to follow pain at subsequent visits. Therefore, the delineations of these areas are not defined with precise anatomical landmarks. Several locations may be given for each pain problem, e.g., neck and either shoulders, or pain in the abdomen extending into the buttocks and thighs areas and further down to the feet.

WiderstrÖm-Noga E, Biering-SØrensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06061 Pain type PainTyp Type of pain present. Eight broad types of pain are specified based on the new SCI pain taxonomy that has been published and validated (Bryce TN, Biering-Sorensen F, Finnerup NB, Cardenas DD, Defrin R, Lundeberg T et al.
International spinal cord injury pain (ISCIP) classification: part I. Background and description. Spinal Cord 2012; 50: 413–417. and Bryce TN, Biering-Sorensen F, Finnerup NB, Cardenas DD, Defrin R, Ivan E et al.
International spinal cord injury pain (ISCIP) classification: part 2. Initial validation using vignettes. Spinal Cord 2012; 50: 404–412.).
Type of pain present. Eight broad types of pain are specified based on the new SCI pain taxonomy that has been published and validated. Type of Pain Neuropathic- At-level SCI;Neuropathic- Below-level SCI;Neuropathic- Other;Nociceptive-musculoskeletal;Nociceptive-other;Nociceptive-visceral;Other pain type;Unknown Neuropathic- At-level SCI;Neuropathic- Below-level SCI;Neuropathic- Other;Nociceptive-musculoskeletal;Nociceptive-other;Nociceptive-visceral;Other pain type (not nociceptive or neuropathic);Unknown Alphanumeric

Check all that apply. Seven broad types of pain are specified based on pain types identified in previous SCI pain taxonomies (Donovan et al., 1982; Siddall et al., 2000; Bryce & Ragnarsson, 2001; Cardenas et al., 2002; Bryce et al., 2012a,b) and based on prevalence in the SCI population. Please note that the ASIA Impairment scale (AIS) and the associated dermatomal map (Kirshblum et al., 2011) are to be used as integral parts of the SCI pain classification. Nociceptive pains that are less prevalent or not directly related to SCI and not categorized as musculoskeletal or visceral can be classified as "Other (Nociceptive)". Pains that are not associated with a lesion or disease affecting the spinal cord or nerve roots yet are nevertheless neuropathic can be classified as "Other (Neuropathic)". "Unknown" should be used when it is not possible to classify the pain into one of the categories listed above. "Unknown" pain refers only to pain of unknown etiology and not to pains with both nociceptive and neuropathic qualities, nor to defined pain syndromes of unknown etiology, like fibromyalgia. For pains that seem to have both nociceptive and neuropathic qualities the two components should be classified separately. Defined pain syndromes of unknown etiology (for example, fibromyalgia) should be coded as "Other".

Bryce TN, Biering-Sorensen F, Finnerup NB, Cardenas DD, Defrin R, Lundeberg T et al. International spinal cord injury pain (ISCIP) classification: part I. Background and description. Spinal Cord 2012; 50: 413&#8211;417.<br />Bryce TN, Biering-Sorensen F, Finnerup NB, Cardenas DD, Defrin R, Ivan E et al. International spinal cord injury pain (ISCIP) classification: part 2. Initial validation using vignettes. Spinal Cord 2012; 50: 404&#8211;412. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Multiple Pre-Defined Values Selected

C06062 Pain intensity average past week scale PainIntnstAvgPstWkScale Scale of the participant's/subject's pain intensity in the past week. A 0 – 10 Numerical Rating Scale (ranging from 0 = "No pain" to a maximum of 10 = "Pain as bad as you can imagine") of average pain intensity for the past week Numerical Rating Scale (ranging from 0 = "No pain" to a maximum of 10 = "Pain as bad as you can imagine") of average pain intensity for the past week No pain to pain as bad as you can imagine 0;1;2;3;4;5;6;7;8;9;10 No Pain;;;;;;;;;;pain as bad as you can imagine Numeric Values

Choose one. Please note that "last week" specifically refers to the last seven days including today. Pain intensity is the most common pain domain assessed in research and clinical settings. Although different rating scales have proven to be valid for assessing pain intensity, including the Numerical Rating Scale (NRS), the Verbal Rating Scale (VRS), and the Visual Analogue Scale (VAS), the 0 – 10 NRS has the most strengths and fewest weaknesses of available measures (Jensen & Karoly, 2001). Moreover the 0 – 10 NRS, and specifically the 0 – 10 with the endpoints listed, has been recommended by the IMMPACT consensus group for use in pain clinical trials (Dworkin et al., 2005) and by the 2006 NIDRR SCI Pain outcome measures consensus group (Bryce et al., 2007), so using this measure will help ensure consistency in the assessment of average pain intensity across studies. The seven day time frame was selected to balance the need to assess pain over a long enough epoch to capture usual pain, against the need to keep the time frame short enough to maximize recall accuracy.

Bryce TN, Budh CN, Cardenas DD, Dijkers M, Felix ER, Finnerup NB, Kennedy P, Lundeberg T, Richards JS, Rintala DH, Siddall P, Widerstrom-Noga E. Pain after spinal cord injury: an evidence-based review for clinical practice and research. Report of the National Institute on Disability and Rehabilitation Research Spinal Cord Injury Measures meeting. J Spinal Cord Med. 2007;30:421-40. Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allan RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott, MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113:9-19. Jensen MP, Karoly P. (2001). Self-report scales and procedures for assessing pain in adults. In DC Turk & R Melzack (Eds.), Handbook of pain assessment, 2nd edition. New York: Guilford Publications, pp. 15-34. <br />Widerstr&Ouml;m-Noga E, Biering-S&Oslash;rensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06063 Pain onset date PainOnstDate Date (and time, if applicable and known) the particular pain problem started Date (and time, if applicable and known) the particular pain problem started Date of onset for pain Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Widerstr&Ouml;m-Noga E, Biering-S&Oslash;rensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Free-Form Entry

C06070 Pain interfere daily activity scale PainIntrferDlyActScale Scale that evaluates to what extent pain has interfered with the participant's daily activities. Scale that evaluates to what extent pain has interfered with the participant's daily activities. In general how much has pain interfered with your day to day activities in the last week? 1;10;2;3;4;5;6;7;8;9 1;10;2;3;4;5;6;7;8;9 Numeric Values

This question concerns how a person's specific pain problem interfered with general activity during the last seven days including today. Pain interference (the extent to which pain interferes with functioning and mood) is a key pain domain. An interference item that assesses general activity interference was designed specifically for this data-set in order to provide a global summary interference rating.

Widerstr&Ouml;m-Noga E, Biering-S&Oslash;rensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

C06071 Pain interfere mood scale PainIntrferMoodScl Scale that evaluates to what extent pain has interfered with the participants mood. Scale that evaluates to what extent pain has interfered with the participants mood. In general how much has pain interfered with your overall mood in the past week? 1;10;2;3;4;5;6;7;8;9 1;10;2;3;4;5;6;7;8;9 Numeric Values

Choose one alternative for each question. Please note that all interference items apply to overall pain during the last week, rather than to each of the different pain problems. Please note that "last week" specifically refers to the last seven days including today. This question concerns how a person's specific pain problem interfered with mood during the last seven days including today. An interference item that assesses mood interference was developed for this data set because pain is known to have a significant negative impact on mood for many patients, and pain's effect on mood is somewhat distinct from its effect on other functioning domains.

Widerstr&Ouml;m-Noga E, Biering-S&Oslash;rensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Adult Supplemental 3.00 2013-07-17 09:26:36.973 International SCI Pain Basic Data Subset The International SCI Data Sets The International SCI Data Sets

Single Pre-Defined Value Selected

CSV