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Table 1 Details of outcome measures and data collection time points

From: Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial

Construct

Measure

Time (week)

Primary

 Disability

Roland Morris Disability Questionnaire (RMDQ) [3]

0, 6, 12, 26, 52

Secondary

 Pain intensity

11 point (0–10) Numerical Rating Scale [4]

0, 6, 12, 26, 52

 Weight

Objective weight measured to the nearest 0.1 kg [5]

1, 12

Self-reported weight (kg)

0, 6, 12, 26, 52

 Quality of life

12-item Short Form Health Survey version 2 (0–100 scale) [6]

0, 6, 12, 26, 52

 Smoking status

Current smoker (y/n)a and how many cigarettes smoked per day; from the NSW Population Health Survey [7]

0, 6, 12, 26, 52

Exploratory

 Physical activity

International Physical Activity Questionnaire (IPAQ) [8]

0, 6, 12, 26, 52

 Body mass index

Calculated using weight (kg) / height (m2) (height collected at baseline only)

 

 Nutrition quality

21-item Food Frequency Questionnaire of intake over the past month [9]

0, 6, 12, 26, 52

 Sleep quality

Item-6 from the Pittsburgh Sleep Quality Indexa [10]

0, 6, 12, 26, 52

 Pain self-efficacy

2-item Pain Self-Efficacy Questionnaire (PSEQ-2) [11].

0, 6, 12, 26, 52

 Psychological distress

Kessler 6 Psychological Distress Scale [12]

0, 6, 12, 26, 52

 Alcohol consumption

2 items from the Alcohol Use Disorders Identification Test (AUDIT-C) [13]

0, 6, 12, 26, 52

Economic and process

 Health care, medication and carer use

Self-reported inventory of health care, community/carer services and medication use for back pain over the last 6 weeksa

0, 6, 12, 26, 52

 Surgical services

 

52

 Work absenteeism and presenteeism

4 yes/no questionsa assessing patient reported appropriateness of, referral, consultation for, or receipt of surgical procedure

Self-reported number of days off work due to back pain (absenteeism) and days at work despite feeling ill (presenteeism)

0, 6, 12, 26, 52

 Adverse events

Patient reported experience of new medical conditions or an exacerbation of an existing conditiona (yes/no, with open text).

6, 12, 26, 52

 Satisfaction

Patient reported overall satisfaction with the program using a 0–6 Likert scale (0 not at all satisfied, 6 extremely satisfied)

12, 26

  1. Continuous measures unless indicated adichotomous