Table 3

Secondary outcome measures

DomainName of outcome measureNo. of ItemsResponse scaleScoringMeasurement properties of Nepali versions of the scale
Pain interferencePROMIS Pain Interference short-form 6b54 65-point, ordinalRespondents are asked to rate how much pain interfered with their daily life (eg, enjoyment of life, ability to concentrate and day-to-day activities) in past 7 days on 5-point Likert scales (=‘Not at all’, 2=‘A little bit’, 3=‘Somewhat’, 4=‘Quite a bit’, 5=‘Very much’). Responses are scored as a T-score that can range from 0 to 100, with a mean of 50 and SD of 10 in the normative sample.
  • Good internal consistency (Cronbach’s alpha=0.85).

  • Excellent reliability (ICC=0.80) in a sample of individuals with chronic pain from Nepal.54

Pain catastrophisingPain Catastrophizing Scale (PCS)55 135-point, ordinalRespondents are asked to indicate the degree or frequency with which they have each catastrophising response listed when they ‘… are experiencing pain’ on a 5-point Likert scale (0=‘Not at all’, 1=‘To a slight degree’, 2=‘To a moderate degree’, 3=‘To a great degree’ and 4=‘All the time’). The total PCS score can range from 0 to 52, with higher scores representing higher pain catastrophising.
  • Good to excellent internal consistencies: Cronbach’s alpha=0.85–0.93.

  • Excellent test–retest stability (ICC=0.89–0.90).

  • Positive moderate correlations with measures of pain intensity, depression and anxiety in a sample of individuals with chronic pain from Nepal.55

Patient’s global rating of changeGlobal Rating of Change57 66 67 11–7, ordinalRespondents are asked to rate their ‘overall improvement’ their health condition since the study enrolment. Responses can range from 1 to 7 with 4=‘No change’. Scores greater than 4 indicate greater improvement and scores lower than 4 indicate a perceived worsening in the respondent’s health condition.MIC: 1 point change.57 58
Quality of life (QOL)QOL rating scale25-point, ordinalRespondents are asked to rate their general QOL and general health by responding to the questions:
•‘In general, how would you rate your overall quality of life during the past week?
•‘How would you rate your general health during the past week?
The response options are: 1=‘Very bad’, 2=‘Bad’, 3=‘Fair’, 4=‘Good’ and 5=‘Very good’.68 Greater score indicate better QOL.
Not available during the time of protocol writing the study protocol.
Pain intensityPROMIS Pain Intensity short-form 3b54 35-point, ordinalRespondents are asked to rate their current pain and their worst and average pain intensity in past 7 days on 5-point Likert scales (1=‘Had no Pain’, 2=‘Mild’, 3=‘Moderate’, 4=‘Severe’, and 5=‘Very severe’). Responses are scored as a T-score that can range from 0 to 100, with a mean of 50 and SD of 10 in the normative sample.Good test–retest reliability (ICC=0.71) in a sample of individuals with chronic pain from Nepal.54
Sleep disturbancePROMIS Sleep disturbance short-form 8b54 7*5-point, ordinalRespondents are asked to rate sleep quality items on a 5-point Likert scale. Responses are scored as a T-score that can range from 0 to 100, with a mean of 50 and SD of 10 in the normative sample.Although the Nepali translation of the 8-item Sleep Disturbance short-form showed poor reliability, removal of one item, improved the test–retest stability to excellent. (ICC=0.78).
Good internal consistency of 7-items (Cronbach’s alpha=0.89).54
DepressionPROMIS Emotional Distress- Depression short-form 8b54 85-point, ordinalRespondents are asked to indicate the frequency of depressive symptoms in the past 7 days on a 5-point verbal rating scale (1=‘Never’, 2=‘Rarely’, 3=‘Sometimes’, 4=‘Often’ and 5=‘Always’). Responses are scored as a T-score that can range from 0 to 100, with a mean of 50 and SD of 10 in the normative sample.
  • Excellent internal consistency (Cronbach’s alpha=0.93).

  • Excellent test–retest reliability (ICC=0.81) in a sample of individuals with chronic pain from Nepal.54

Resilience10-item Connor Davidson Resilience Scale56 104-point, ordinalRespondents are asked to rate each resilience item on a 5-point Likert scale: 0=‘Not true at all’, 1=‘Rarely true’, 2=‘Sometimes true’, 3=‘Often true’, and 4=‘True nearly all the time’. Responses are summed such that total scores range from 0 to 40, with higher scores indicating more resilience.
  • Good to excellent internal consistency (Cronbach’s alpha=0.87–0.90).56

  • Excellent test–retest stability (ICC=0.89).56

  • SE of measurement=2.42 points.

  • Minimum detectable change=6.72 points.

  • Significant negative and moderate association with the PCS in a sample of individuals with chronic pain from Nepal.56

Use of pain medications and other pain treatmentsNames and dosage of pain medication intake will be recorded by the assessor by asking the research participant via interview. Medications will then be categorised into analgesic type (opioids, non-steroidal anti-inflammatory drugs, sedatives and antiseizure medications), as will the number of days each type of medication is taken.
Other pain treatments provided to or used by the study participants will also be recorded and classified (eg, physical therapy and naturopathy). The number of days each treatment was provided to or used by the participants will be recorded.
  • No validity data for self-reported analgesic or pain treatment use in Nepali patients available at the time of protocol writing.

  • *Only seven items out of eight items will be included, as the measurement properties of the total eight-item was poor, and only after removal of one item, the reliability improved.

  • ICC, Intraclass Correlation Coefficient; MIC, minimum important change; SE, standard error.