Study design and pilot work to inform the study
This cross-sectional analysis was based on baseline data within the child and adolescent musculoskeletal (ChiBPS) pain cohort study. The aim of the ChiBPS study was to describe prognostic factors associated to long term MSK pain among children and adolescents consulting their GP with MSK pain.
The STROBE checklist for cross-sectional studies was used in the reporting of the study (9).
Setting and recruitment
GP clinics
From October 2018, general practice clinics across Denmark were approached by the lead author (NP), a physician, who offered to visit the clinics in order for a proper introduction to the ChiBPS study (10). Seventeen rural and urban area clinics were included (Supplementary file 1) with GPs of both genders.
Participants
Children and adolescents were recruited either by an employee prior to consultation or by the consulting GP either prior to or during the consultation. Prior to the first consultation of the day, an employee was suggested to screen all scheduled patients for eligibility according to: 1. MSK pain complaint and 2. Age 8 to 19 years. The word MSK could be added next to the name of the eligible patient, thus reminding the consulting GP to recruit this patient for this study. If the GP opted to screen or recruit participants without involvement of other employees, they could do so. Several suggested ways of recruitment were presented, of which the GP could choose the most suitable in relation to the infrastructure of their clinic.
We didn’t have a pre-defined minimum or maximum MSK pain duration as an eligibility criterion, and patients were eligible regardless of whether this was their first consultation or not for their MSK complaint. Pain regions were labelled according to the region affected, e.g. back, neck, shoulder, knee pain etc.
Once the study was explained to the children and adolescents by the GP and the decision was made to participate, they were requested to complete a REDCap questionnaire hosted by a secure server at University of Aalborg (AAU), not given any specific information of the content of the questionnaire beforehand.
Study population
To be eligible, MSK pain had to be mentioned during the consultation with the GP, but not required as the main reason for consultation. MSK pain included pain arising from muscle, tendon, bone, and joint as per the International Association for the Study of Pain (IASP) definition (11).
Inclusion Criteria:
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Age 8–19 years.
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Self-reported MSK pain (non-traumatic and traumatic caused by soft tissue damage, contusion or otherwise (excluding diagnosed fracture).
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Ability to read and understand either Danish or English.
Exclusion Criteria:
Data collection and management
Data was collected and managed using REDCap electronic data capture tools hosted at Aalborg University (12, 13). REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources (REDCap link). The REDCap questionnaire was installed as a shortcut on the desktop on tablets placed at the majority of clinics except a few who chose to give NP the name and phone number of eligible patients (with their consent) instead. NP subsequently sent these children and adolescents a link to the questionnaire.
All extracted data was handled in concurrence with The Danish Data Protection Agency (14) and all data extracted from REDCap and transferred to an Excel table, with anonymized participant ID.
Questionnaire and measures
The questionnaire was developed based on our systematic review, discussions with a GP reference group, and questions used in previous work (8, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26) (Appendix 1). Our measures are divided in four sections: demographics, pain characteristics, psychosocial measures, and physical measures.
To ensure comprehensibility, we piloted the questionnaire with seven 8–19 year old children and adolescents with recent MSK pain; two girls (11 and 17 years old) and five boys (8, 9, 11, 13, 14, and 19 years old) and received feedback concerning difficulties comprehending the words: mark (mark the region), previous, and: in what extent. Most of the pilots preceded without any problems in reading and understanding the questions and the language was appropriate to abilities according to the youngest eligible participant entering the study. The mentioned obstacles in interpretation were handled with revision of wording to enhance readability.
Musculoskeletal pain
We differentiated between activity limiting and non-activity limiting pain and single or multi-site pain. Single site pain was defined as pain experienced in one of 33 predefined regions on a mannequin (Appendix 1) and rated on a 11-point numerical rating scale from 0 to 10. Activity limiting pain was defined as pain during the past two weeks leading to not being able to participate in play in the school yard (15) or spare time activities while pain not impacting on activities was defined as non-activity limiting pain (Fig. 1). Multi-site pain (Table 1) was defined as activity limiting MSK pain experienced in at least two of the predefined 33 regions on the mannequin during the past two weeks leading to not being able to participate in play in the school yard or spare time activities. Headache was not defined as MSK pain region and thus not countable as a MSK pain region. Our questionnaire was initiated with three questions, each ensuring eligibility, and which will be referred to as: Pain questions 1, 2, and 3 (Appendix 1). Pain question 1 was the only one requesting activity limiting pain, whereas pain questions 2 and 3 requested non-activity limiting pain. Ex.: In the case a child or adolescent responded no to pain question 1 and yes to pain question 2, the individual was considered without activity limiting pain and with non-activity limiting pain. Confirmed pain solely to pain question 3 was considered as non-activity limiting pain. To limit the effect of recall bias, we used a short recall period of two weeks on questions related to pain.
Data handling and statistical methods
All data from the questionnaires exported from REDCap to the Excel table were checked for any potential errors by NP. Descriptive statistics were used to summarize data (Table 1 and Table 2). Normally distributed continuous data were described using mean and standard deviations while non-normally data were described using median and interquartile range. Categorical data were described using percentages.