Background
Methods
Study design
Phase 1: Baseline postal Health Survey questionnaire
Concept | Measurement method | Detail |
---|---|---|
Section A: General health
| ||
Perceived general health | MOS SF12 [33] | Physical and mental component summary scores |
Physical function | MOS SF36 [32] | Physical functioning sub-scale |
Anxiety and depression | Hospital anxiety and depression scale [34] | Anxiety and depression sub-scales |
Participation | 5-items assessing person-perceived, performance-based participation | |
Support | Emotional support: single question | Yes, no, no need |
Physical support: single question | Yes, no, no need | |
Life-style | Smoking status | Current, previous, never |
Anthropometric characteristics | Self-reported height | |
Self-reported weight | ||
Footwear | Toe-box breadth line drawings (Additional File 1: Appendix 1) | Type most frequently worn by decade |
Heel height line drawings (females only) (Additional File 1: Appendix 1) | Type most frequently worn by decade | |
Physical activity | Short-Form International Physical Activity Questionnaire (IPAQ) [36] | Frequency and duration of 4 activities performed during previous 7 days |
Section B: Specific health problems
| ||
Hallux valgus | Self-completed line drawings [37] | 5 line-drawings for each foot depicting increasing severity of hallux valgus |
Co-morbidities | Falls, fractures, chest problems, heart problems, deafness, problem with eyesight, raised blood pressure, diabetes, stroke, cancer, liver disease, kidney disease, poor circulation, rheumatoid arthritis | Yes, for any that apply |
Intermittent claudication | Edinburgh Claudication Questionnaire [38] | Pain or discomfort in legs when walking, pain characteristics, pain location (leg manikin) |
Bodily pain | Self-completed body manikin | In the past 4 weeks, have you had pain that has lasted for one day or longer in any part of your body? If yes, shade pain location on manikin |
Site-specific questions | Have you had any problems with your hands or pain in your hands/hips/knees/feet in the last year? | |
Section C: Foot pain
| ||
Foot pain characteristics | Side of pain | Both, right, left |
Duration in past 12 months | < 7 days, 1-4 weeks, 1-3 months, 3+ months | |
Foot injury: Have you ever injured your foot badly enough to see a doctor about it? | No, right foot only, left foot only, both feet | |
Foot pain, aching, stiffness in last month [39] | No days, few days, some days, most days, all days | |
Location: self-completed foot manikin [14] | In the past month, have you had any ache or pain that has lasted for one day or longer in your feet? If yes, shade pain location on foot manikin | |
Foot pain intensity in last month [40] | 0-10 NRS with verbal anchors (no pain, pain as bad as can be) | |
Complaint-specific functioning | Manchester Foot Pain and Disability Index [41] | 19-items across four constructs: pain, function, appearance, work/leisure |
Coping strategies for foot pain | Foot-related fatigue: single item Single-item coping strategies questionnaire [42] | None of the time, on some days, on most/every day(s) 0-6 NRS with verbal anchors (never do that, always do that) |
Healthcare use | Medication use in last month | For foot pain, for other pain |
Consultation in last 12 months for foot pain | General practitioner, physiotherapist, podiatrist, chiropodist (NHS and private) | |
Section D: Demographic/socioeconomic characteristics
| ||
Demographic characteristics | Date of birth Gender | |
Marital status | Married, separated, divorced, widowed, cohabiting, single | |
Living arrangements | Alone, not alone | |
Socioeconomic characteristics | Current employment status | Employed, not working due to ill-health, retired, unemployed/seeking work, housewife, other |
Current/recent job title | Free text | |
Current/recent job title of spouse | Free text | |
Adequacy of income [43] | Find it a strain to get by from week to week, have to be careful with money, able to manage without much difficulty, quite comfortably off | |
Higher education | Yes/no (If yes, age finished full-time education) | |
Ethnicity | White UK/European, Afro Caribbean, Chinese, Asian, African, Other | |
Section E: Work
| ||
Work status | Working full-time, part time, or off work due to ill-health | |
Work performance | 0-10 NRS with verbal anchors (worst performance, best performance) | |
Work limitation due to a health problem or physical limitation | Not affected, changed the way I do the job, reduced the number of hours, currently off work | |
Job lock | Would like to leave work but can't due to financial needs |
Phase 2: Baseline Clinical Assessment Study of the Foot (CASF)
Concept | Measurement method | Detail |
---|---|---|
Clinical Interview
| ||
Pre-assessment screening: | ||
Screen for clinical "red flags" | Recent significant foot or hand injury Recent sudden change in foot symptoms | |
Screen for joint surgery | History of joint operations | |
Foot pain characteristics | Side of pain | |
Comparative severity of bilateral symptoms | ||
Duration | Within 12 months, 1-5 years, 5-10 years, 10+ years (for each foot) | |
Preceding accident/injury | Yes/no | |
Foot pain/aching/discomfort in last month | Yes/no | |
Foot pain quality | Short-form McGill Pain Questionnaire [47] | 15 sensory and affective descriptors |
Sleep disturbance | Self-report | Yes/no |
Sensory disturbance | Self-reported tingling/numbness/pins and needles | Yes/no (for each foot) |
Causal attribution | What do you think has caused the problem with your foot/feet? | Recorded verbatim |
Diagnostic attribution | What do you think is the matter with your foot/feet now? | Recorded verbatim |
Foot surgery | Details of any foot surgery | Nature of surgery Right/left < 1 year, 1- < 5 years, 5- < 10 years, 10+ years ago |
Foot/ankle injury | Details of foot/ankle injury | Sprain, fracture, other Right/left; forefoot, mid-foot, heel, ankle < 1 year, 1- < 5 years, 5- < 10 years, 10+ years ago |
Planned treatment | Are you waiting for any appointments or treatments for this foot or ankle problem? | Yes/no (free text comments for yes) |
Importance of health problems | What would you consider to be your two most important health problems at the moment? [Includes foot problem]
| Recorded verbatim |
Physical examination
| ||
Screen for clinical "red flags" | Acutely, swollen, hot, painful feet or hands | Yes/no (free text for comments) |
Observation | Skin lesions | Bunionette, hyperkeratotic lesions, ulcers (plantar and dorsal aspect) |
Toe deformity | MTPJ and interphalangeal joint hyperextension Mallet toe, hammer toe, claw toe, retracted toe | Present/absent (great toe) Present/absent (lesser toes) |
Palpation | Mid-foot bony exostosis Plantar fascia tenderness | Present/absent Present/absent (insertion and mid-arch) |
Foot posture | Foot Posture Index [50] | Six-criterion scoring system |
Navicular Height [49] | Millimetres | |
Foot Length [51] | Millimetres | |
Weightbearing footprint. Length of footprint excluding toes is divided into equal thirds. Arch index = area of middle third divided by area of entire footprint | ||
Range of movement (foot/ankle) | Ankle dorsiflexion (with knee flexed and extended) [53] | Degrees |
Subtalar inversion [52] | Degrees | |
Subtalar eversion [52] | Degrees | |
1st MTP joint dorsiflexion [54] | Degrees | |
Knee valgus/varus deformity | Intercondylar distance | Centimetres |
Intermalleolar distance | Centimetres | |
Anthropometric measurements | Height | Metres |
Weight | Kilograms | |
Lower limb physical function | Short physical performance battery (SPPB) [57] | Standing balance test, timed repeated chair stand test, 4-metre gait speed test |
Hand osteoarthritis | Deformity, enlargement, swelling, nodes [55] | Observation and palpation: swelling (MCPJ), nodes (PIPJ and DIPJ), deformity and enlargement (1st CMCJ, PIPJ and DIPJ) |
Hand function | Power grip strength (Jamar dynanometer) [56] | Pounds |
Pinch grip strength (B&L pinch gauge) [56] | Pounds | |
Self-complete questionnaire
| ||
Section A: Foot Pain
| ||
Foot pain chronicity | Chronic Pain Grade [59] | 6 questions (0-10 NRS) and 1 question (4 response options) giving grade I-IV |
Complaint-specific functioning | Symptom satisfaction [64] | 5-point Likert scale (Very dissatisfied to Very satisfied) |
Section B: Hand pain and problems
| ||
Hand pain characteristics | Hand pain in last 12 months Side of pain Duration in past 12 months Hand pain, aching, stiffness in last month [55] | Present/absent < 7 days, 1-4 weeks, 1-3 months, 3+ months No days, few days, some days, most days, all days |
Hand pain intensity in last month [40] | 0-10 NRS with verbal anchors (no pain, pain as bad as could be) | |
Location: self-completed hand manikin [60] | In the past month, have you had any ache or pain that has lasted for one day or longer in your hand? If yes, shade location on hand manikin | |
Pain and stiffness sub-scales | ||
Complaint-specific functioning | Physical function sub-scale | |
Hand dominance | Self-report | Right, left, both |
Healthcare use | GP consultation within last 12 months for hand problem | |
Section C: Hip pain
| ||
Hip pain characteristics | Side of pain | Both, right, left |
Duration in past 12 months | < 7 days, 1-4 weeks, 1-3 months, 3+ months | |
Hip pain, aching, stiffness in last month [61] | No days, few days, some days, most days, all days. | |
WOMAC (hip) [62] | Pain and stiffness sub-scales | |
Complaint-specific functioning | WOMAC (hip) [62] | Physical function sub-scale |
Healthcare use | GP consultation within last 12 months for hip pain | |
Section D: Knee pain
| ||
Knee pain characteristics | Side of pain | Both, right, left |
Duration in past 12 months | < 7 days, 1-4 weeks, 1-3 months, 3+ months | |
Knee pain, aching, stiffness in last month [63] | No days, few days, some days, most days, all days. | |
WOMAC (knee) [62] | Pain and stiffness sub-scales | |
Complaint-specific functioning | WOMAC (knee) [62] | Physical function sub-scale |
Healthcare use | GP consultation within last 12 months for knee pain |
Digital photography
Plain radiography of the feet and hands
Ultrasound of the plantar fascia
Clinical interview and physical examination
Simple anthropometric measurements
Self-complete clinic questionnaire
Post-clinic procedure
Communication with participants' general practice
Mandatory notification of clinical 'red flags'
Mandatory notification of radiographic 'red flags'
Discretionary notification of other significant radiographic abnormality
Availability of x-ray report on request
Quality assurance and control
Phase 3: Review of general practice medical records
Phase 4: Follow-up mailed survey at 18 months (Phase 2 respondents only)
Concept | Measurement method | Detail |
---|---|---|
Foot pain characteristics | Change in foot pain over past 18 months | Completely recovered, much better, better, no change, worse, much worse |
Since your assessment 18 months ago, have you ever injured your foot badly enough to see a doctor about it? | No/right only/left only/both | |
Foot pain, aching, stiffness in last month [39] | No days, few days, some days, most days, all days | |
Foot pain intensity in past month [40] | 0-10 NRS with verbal anchors (no pain, pain as bad as could be) | |
Foot pain chronicity | Chronic Pain Grade [59] | 6 questions (0-10 NRS) and 1 question (4 response options) giving grade I-IV |
Complaint-specific functioning | Manchester Foot Pain and Disability Index [41] | 19-items across four constructs: pain, function, appearance, work/leisure |
Symptom satisfaction [64] | 5-point Likert scale (Very dissatisfied to Very satisfied) | |
Healthcare use | Use of services/treatments for foot pain in past 18 months | GP, physiotherapist, hospital specialist, acupuncture, podiatrist, chiropodist, drugs on prescription, foot injection, foot surgery, osteopath/chiropractor, other (specify) |
Medication use in last month | For foot pain, for other pain | |
Coping strategies for foot pain | Single-item coping strategies questionnaire [42] | 0-6 NRS with verbal anchors (never do that, always do that) |
Perceived general health | MOS SF 12 [33] | Physical and mental component summary scores |
Physical function | MOS SF 36 [32] | Physical functioning sub-scale |
Anxiety and depression | Hospital anxiety and depression scale [34] | Anxiety and depression sub-scales |
Hallux valgus | Self-completed line drawings [37] | 5 line-drawings for each foot depicting increasing severity of hallux valgus |
Bodily pain | Self-completed body manikin | In the past 4 weeks, have you had pain that has lasted for one day or longer in any part of your body? If yes, shade location of pain on manikin |
Regional pain | Site-specific questions | Have you had any problems with your hands or pain in your hands/hips/knees in the last year? |
Demographic characteristics | Date of birth Gender | |
Socioeconomic characteristics | Current employment status | Employed, not working due to ill-health, retired, unemployed/seeking work, housewife, other |
Phase 5: Follow-up mailed survey at 3 years (Phase 1 and Phase 2 respondents)
Concept | Measurement method | Detail |
---|---|---|
Section A: General health
| ||
Perceived general health | MOS SF 12 [33] | Physical and mental component summary scores |
Physical function | MOS SF 36 [32] | Physical functioning sub-scale |
Anxiety and depression | Hospital anxiety and depression scale [34] | Anxiety and depression sub-scales |
Participation | 5-items assessing person-perceived, performance-based participation | |
Physical activity | Short-Form International Physical Activity Questionnaire (IPAQ) [36] | Frequency and duration of 4 activities performed during previous 7 days |
Section B: Specific health problems
| ||
Hallux valgus | Self-completed line drawings [37] | 5 line-drawings for each foot depicting increasing severity of hallux valgus |
Co-morbidities | Falls, fractures, chest problems, heart problems, deafness, problems with eyesight, raised blood pressure, diabetes, stroke, cancer, liver disease, kidney disease, poor circulation, rheumatoid arthritis | Yes for any that apply |
Intermittent claudication | Edinburgh Claudication Questionnaire [38] | Pain or discomfort in legs when walking, pain characteristics, pain location (leg manikin) |
Bodily pain | Self-completed body manikin | In the past 4 weeks, have you had pain that has lasted for one day or longer in any part of your body? If yes, shade location of pain on manikin |
Site-specific questions | Have you had any problems with your hands or pain in your hands/hips/knees/feet in the last year? | |
Section C: Foot pain
| ||
Foot pain characteristics | Side of pain | Both, right, left |
Duration in past 12 months | < 7 days, 1-4 weeks, 1-3 months, 3+ months | |
Have you ever injured your foot badly enough to see a doctor about it? | No/right foot only/left foot only/both feet | |
Location: self-completed foot manikin [14] | In the past month, have you had any ache or pain that has lasted for one day or longer in your feet? If yes, shade location of pain on foot manikin | |
Foot pain, aching, stiffness in last month [39] | No days, few days, some days, most days, all days | |
Foot pain intensity in last month [40] | 0-10 NRS with verbal anchors (no pain, pain as bad as could be) | |
Complaint-specific functioning | Manchester Foot Pain and Disability Index [41] | 19-items across four constructs: pain, function, appearance, work/leisure |
Coping strategies for foot pain | Single-item coping strategies questionnaire [42] | 0-6 NRS with verbal anchors (never do that, always do that) |
Healthcare use | Medication use in last month | For foot pain, for other pain |
Consultation with general practitioner in last 12 months for foot pain | ||
Section D: Demographic/socioeconomic characteristics
| ||
Demographic characteristics | Date of birth Gender | |
Marital status | Married, separated, divorced, widowed, cohabiting, single | |
Living arrangements | Alone, not alone | |
Anthropometric characteristics | Self-reported height | |
Self-reported weight | ||
Socioeconomic characteristics | Current employment status | Employed, not working due to ill-health, retired, unemployed/seeking work, housewife, other |
Current/recent job title | Free text | |
Current/recent job title of spouse | Free text | |
Adequacy of income [43] | Find it a strain to get by from week to week, have to be careful with money, able to manage without much difficulty, quite comfortably off | |
Additional questions for phase 2 participants only
| ||
Foot pain characteristics | Change in foot pain over past 3 years | Completely recovered, much better, better, no change, worse, much worse |
Since your assessment 3 years ago, have you injured your foot badly enough to see a doctor about it? | No/right foot only/left foot only/both feet | |
Foot pain severity | Chronic Pain Grade [59] | 6 questions (0-10 NRS) and 1 question (4 response options) giving grade I-IV |
Symptom satisfaction [64] | 5-point Likert scale (Very dissatisfied to Very satisfied) | |
Healthcare use | Use of services/treatments for foot pain in past 3 years | GP, physiotherapist, hospital specialist, acupuncture, podiatrist, chiropodist, drugs on prescription, foot injection, foot surgery, osteopath/chiropractor, other (specify) |