Project objectives 

Aims and objectives

This study aims to investigate the feasibility of identifying, recruiting and collecting data from children and adolescents who consult in primary care for musculoskeletal symptoms.

Specific objectives to assess:

• Recruitment process including GP participation, rates of participant identification / invitation, proportion responding to invitation, proportion consenting to participate.
• Acceptability and burden of data collection methods & measures.
• Follow-up preferences (postal or electronic data collection) & response rate.
• Primary outcomes (completion rates, means and standard deviations).

Changes to original proposal

The project was conducted as it was originally outlined. A no cost extension approved by SPCR due to delays experienced at the commencement of the project.

 

Methods, findings against objectives conclusions

Methods

Design:

Feasibility study (prospective cohort). Quantitative data was collected during a face-to-face interview at baseline and by self-report measures (phone, postal mail, email) at the 6-week follow up.

Setting:

The cohort comprised of children and adolescents who sought healthcare (consulting) for musculoskeletal symptoms at one of 13 UK primary care general practices within the NIHR Clinical Research Network: West Midlands.

Study population:

Children and adolescents aged between 8 and 19 years of age who consulted their general practitioner (GP) or nurse practitioner (NP) about musculoskeletal symptoms during the recruitment period were eligible for inclusion. Patients were excluded by their GP or Nurse Practitioner if there was an indication of a serious diagnosis (e.g. cancer, meningitis), the patient was judged to be vulnerable (e.g. child at risk, recent trauma) or the patients and their family was unable to respond to the initial study invitation (e.g. severe learning difficulties, unable to speak / read English).

Recruitment procedures:

Consecutive children and adolescents who consulted their GP or NP about musculoskeletal symptoms between the 13^th of October 2016 and the 28^th February 2017 were identified by the Read code entered at the time of consultation. Read codes are a standardised set of clinical terms that allow the recording of patient findings, procedures and morbidity in UK primary care I.T. systems, and have been shown as suitable for epidemiological studies. Each time a Read code indicating an eligible musculoskeletal symptom was entered into the medical record of a child within the age range, and where the patient has not previously been screened for the study, an electronic prompt was triggered. This prompt reminded the GP or NP that the patient is eligible for the study, to briefly mention the study to the child / adolescent patient and their parent / guardian (if applicable), and give them a study information card. The information card informed the patient that they were eligible for the study and to expect to receive a study pack in the post. Patients could be excluded by the GP / NP either during or after the consultation; when entered by the GP / NP a brief reason for exclusion was captured by the electronic study prompt. Every two weeks, NIHR Clinical Research Network staff downloaded the contact details of eligible patients, and mail prepared study packs to potential participants on behalf of participating GP practices.

Child / adolescent patients (or their parent / guardian, if aged less than 16 years) who received a participant study pack in the post were encouraged to read the enclosed documents carefully (letter of invitation, participant information booklet, reply slip and pre-paid envelope), and respond to the invitation to participate by postal mail, email or telephone. Upon receipt of a positive reply slip by the research team, an experienced research nurse contacted the adolescent (if aged 16 years or older) or their parent / guardian (if aged less than 16 years) to arrange a time to visit the child / adolescent and complete the baseline interview at their home or registered GP Practice.

At the baseline interview, the research nurse obtained written informed assent / consent from both the child / adolescent and parent / guardian (if aged less than 16 years) or from the adolescent themselves (if aged 16 years or older). Once written consent was obtained, the research nurse then proceeded to complete the interview with the participant asking about their musculoskeletal symptoms and related information. Following the completion of the baseline interview and for those who consented, a letter was sent to the participants GP / NP to notify them that their patient is participating in the CAM-Pain study. After 6 weeks, participants (or their parents) were followed up by their preferred mode (phone, postal mail. email) and asked to complete a three question follow up.

Findings:

• Recruitment process including GP participation, rates of participant identification / invitation, proportion responding to invitation, proportion consenting to participate.

From the 13 general practices 90 GPs / NPs triggered the electronic prompt on at least one occasion. An eligible MSK Read code was entered on 343 occasions; 205 patients were excluded either because they declined the invitation to participate or screened as not suitable by the GP / NP, and the remaining 138 patients (40.2%) were mailed a participant information pack and invited to participate. The most common reasons patients were excluded by their GP /NP from taking part in the study were: declined invitation (n=153) or they were considered by the GP /NP to have a serious diagnosis (n= 12), be vulnerable (n= 12), experience learning difficulties (n= 5) or not be proficient in written / spoken English (n= 4).

Of the 138 patients (Under 16 years: n = 92 (66.7%), 16-19 years: n = 46 (33.3%)) who were invited into the study a total of 46 (33.3%) responded to the invitation, 29 (63.0%) indicating a wish to take part and 17 (37.0%) declining the invitation for reasons including no time (n=9), not interested (n=3), and “Other” which allowed respondents to add their own free text response, with responses including “being shy”, having other health conditions or indication that the pain had resolved (n=3). Of the 29 patients who indicated a wish to take part in the study, 2 patients later declined the invitation following multiple attempts by the research nurse to schedule a baseline appointment and consent was obtained from 27 participants (under 16 years: n = 18; 16-19 years: n = 9). The identification (proportion of patients who were sent an invitation to take part in the study of those who had an eligible MSK Read code) was 40.2%, response (proportion of patients who responded to the invitation of those who were sent an invitation) was 33.3%, and recruitment rate (proportion of patients who consented to the study of those who were sent an invite) was 19.6%. 

• Acceptability and burden of data collection methods & measures.

All participants found the interview questions to be acceptable in terms of difficulty and would consider participating in a similar study in the future. On average baseline interviews (obtaining consent and completing the interview) took 49 minutes (SD 15mins, range 22-74). The majority (n=26) of participants found the duration of the interview to be acceptable with only one participant (16 years old) indicating that it was “too long”.

• Follow-up preferences (postal or electronic data collection) & response rate.

Data analysis 

All 27 (100%) participants who consented to participate in the CAM-Pain study completed the 6-week follow up questions. Follow up preferences were as follows:

Table: Preferences for mode of followup, n(%)

	Number (%)
Phone	19 (70.4)
Postal mail	6 (22.2)
Email	2 (7.4)

• Primary outcomes(completion rates, means and standard deviations)

Completion rates

	Number
Number of patients meeting the eligibility criteria	343
Number of patients invited	138
Number of patients who responded	46
Negative response to invitation Reason: (>1 reason could be reported) No time Not interested Unable to arrange baseline appointment I do not wish to say I did not see my doctor for bodily pain No reason provided Other:	19   9 3 2 2 1 1 3
Number of people who consented	27 (response rate 19.6%)
Number of people who completed 6-week follow up	27 (follow-up response rate 100%)
Duration from index consultation to consent, mean number of days (standard deviation)	61.9 (10.3)

 

Baseline characteristics, n=27:

DEMOGRAPHIC CHARACTERISTICS
Sex, n (%) Boys Girls	13 (48.1) 14 (51.9)
Age, mean (SD) Range	13.7 (2.7) 9 to 18 years
Ethnic: White British, n (%)	26 (96.3)
Pain location (>1 pain site could be reported)
Spinal pain (e.g. low back, thoracic spine ), n	8
Lower limb pain (e.g. knee, ankle, foot, hip), n	33
Upper limb pain (e.g. wrist, hand pain), n	5
Comorbidities
Yes, n (%)	22 (81)
Number comorbidities, mean (SD) Range	2.1 (1.9) 0-7
Most common comorbidities reported:
Musculoskeletal pain, n (%)	11 (40.7)
Headache, n (%)	9 (33.3)
Eczema, n (%)	8 (29.6)
School / employment
School, n (%)	27 (100)
Part time/full time work, n (%)	5 (18.5)
Satisfaction with school: Very Satisfied or Satisfied, n (%) Slightly dissatisfied or Severely dissatisfied, n (%)	24 (88.9) 3 (11.1)
Screen time < 3 hours/day, n (%) 3-4 hours/day, n (%) > 5 hours/ day, n (%) Don’t know, n (%)	4 (14.8) 10 (37.0) 12 (44.4) 1 (3.7)
Exercise <1 time/day, n (%) 1-2 times/day, n (%) 3-4 times/day, n (%) >5 times/day, n (%) Don’t know, n (%)	6 (22.2) 10 10 (37.0) 9 (33.3) 1 1 (3.7) 1 1 (3.7)

Selected outcome measures, n=27

PAIN INTENSITY
Current pain intensity (0-10 NRS), mean (SD) Range	2.8 (2.7) 0-8
Pain over last 7 days (0-10 NRS), mean (SD) Range	4.3 (2.1) 0-7
Bothersomeness Not at all, n (%) Slightly, n (%) Moderately, n (%) Very much, n (%) Extremely, n (%)	7 (25.9) 2 (7.4) 14 (51.9) 4 (14.8) 0 (0)
Time off school Yes, n (%) Duration:	7 (25.9) < 1 week 100%
Pediatric Pain screening tool
Low risk (total <=2) , n (%) Medium risk (total >=3, psychosocial <=2) , n (%) High risk (total >=3, psychosocial >=3) , n (%)	12 (44) 9 (33) 6 (22)
PSYCHOLOGICAL
Child self-efficacy scale, mean (SD) Range	16.1 (6.9) 7-35
FUNCTION
Pain interference past month (0-10 scale, no interference – unable to carry out any activities), mean (SD)	3.7 (2.1)
Functional Disability Index, mean (SD)	25.7 (8.2)
QUALITY OF LIFE (KIDSCREEN-27)
Physical well-being, mean T-value (SD)	43.3 (7.9)
Psychological well-being, mean T-value (SD)	45.8 (6.8)
Autonomy and parent relations, mean T-value (SD)	50.8 (8.3)
Social support and peers, mean T-value (SD)	50.4 (12.0)
School environment, mean T-value (SD)	48.5 (8.2)
SLEEP
Sleep duration (n=26), mean hr:min (SD minutes) Range	9.30 (56) 7.30 – 11.30

6 week follow up, n=27

Compared to when patients consulted their GP / NP about a MSK pain condition, 3 patients (11.1%) considered themselves completely recovered, 13 (48.1%) reported to be better, 7 patients (25.9%) felt that their pain had not changed and 4 (14.8%) reported that their pain had become worse. Mean 7 day pain score for participants at follow up was 3.5 (SD 2.3) out of 10 and for majority of patients (n=20, 74%) this pain was either not, or only slightly bothersome.

Conclusions

This study aimed to test a method of identifying, recruiting and collecting data from children and adolescence who consulted about MSK pain condition in primary care. The expected numbers of consulting patients were invited, but response rates were low (19.6%). Used in isolation, this method of identifying and recruiting children and young people is not feasible for use in a large prospective study. Once participants were recruited into the study however data collection procedures were acceptable and all participants completed the 6-week follow up.

This study provides realistic estimates for the recruitment of children and adolescents with musculoskeletal pain from general practice setting in the UK. This information was previously not known and is important in the design of future studies in this setting. Further research is needed however in order to identify the most effective and feasible ways of identifying and recruiting children and adolescents with MSK pain from primary care into longitudinal research.

Plain English summary

Background

Bodily pain is common in adults, and leads to time off work and GP visits. Pain conditions often last for many years and it is difficult to find out what causes people to have these problems in the first place. Surveys show that up to 40% of children report bodily pain during any one month, so this may be the start of long-term problems. However, there are few studies of children visiting their doctor about bodily pain, and none in the UK, so we know little about who gets persistent pain and who recovers quickly. We also know little about how to do such studies, e.g. about inviting children (and their care-givers) to take part, and collecting information about pain and its impact on their life. Finding out more about bodily pain in children and how to do this work may help to find out what causes long-term problems, and hopefully how to prevent them.

We tested a way of identifying, recruiting and collecting information from children and adolescents aged 8 to 19 years who see their doctor for bodily pain. Once identified, a research nurse visited participants and asked questions about their pain and related issues. Participants were followed up after 6 weeks.

Findings

In the 4 month recruitment period, 343 patients from 13 general practices were identified as eligible to take part in the study (right age, and right pain condition), many decided not to take part when asked by the GP at consultation, and the GP screened out some others. This left 138 patients who were sent an invitation to take part. The response rate to the invitation was 33.3% (n=46) with 27 (19.6%) patients consenting to participate. On average baseline interviews took 49 minutes (SD 15mins, range 22-74) and the majority of participants found the duration and questions to be acceptable. All participants completed the 6-week follow up and this was by phone (70.4%), postal mail (22.2%) or email (7.4%).

Conclusions:

The expected numbers of consulting patients were invited, but response rates to take part were low. Based on our results, this method of identifying and recruiting children and young people is not feasible, though response rate at follow up were good for those who did decide to take part. Further work is needed to identify ways to conduct studies in this population in order to address the current knowledge gap in this field

Dissemination

Public involvement

The CAM-Pain study protocol and processes have had extensive patient and parent input from the National Institute for Health Research (NIHR) Rheumatology Clinical Studies Group (CSG) whose role is to assist researchers with refining the research question, assess feasibility, facilitate patient and parent input, comment on recruitment, and comment on study design. In light of feedback for example, inclusion / exclusion criteria and terminology were refined. The study was also reviewed by the GenerationR Young Person’s Advisory Group (YPAG) in Liverpool, (a group of child / adolescent users) specifically for review and feedback on study processes and materials including the participant information booklet and questions that we plan to use. The feedback we received from the YPAG resulted in a number of changes e.g. revision of the wording to make it more child friendly and age specific participant information booklets were developed. These processes therefore ensured that the study procedures and materials were appropriate and acceptable for use by the target population of children and adolescents.

Lessons learnt:

• We did not engage the parents of children in the discussion of their child participating in research
• Future studies in this area need to be designed to assess other means of participation e.g. online, or social media platforms that young people use

Impact

This study has identified true rates of recruitment (from identification to consent) of children and adolescents with musculoskeletal pain from general practice settings in the UK. This information was previously unknown and is important in the design of future studies in this setting.

We believe our findings will be informative to researchers who wish to recruit children and adolescents from primary care settings who seek healthcare for musculoskeletal pain. Previously little research had been carried out on this topic (only a few studies worldwide, none within the UK) and our results confirm other recent feasibility studies of the difficulties engaging children and adolescents who seek healthcare for musculoskeletal pan in research. These results can form a basis for further investigation of ways in which children and adolescents might engage. For example the main reason given for not taking part in out cohort study was a lack of time. This may indicate that a range of options might be offered to children and adolescents (i.e. different levels of engagement), perhaps utilising up to date ways of communication (e.g. social media), in order to test optimum recruitment methods for this population.

This project was funded by the National Institute for Health Research School for Primary Care Research (project number 252)

Department of Health Disclaimer

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR School for Primary Care Research, NIHR, NHS or the Department of Health.