Author, date and country | Patient group | Study type (level of evidence) | Outcomes | Key results | Study Weaknesses |
---|---|---|---|---|---|
Kerry S 2001 England | 94 GP practices in SE England. 659 patients included. 506 observed under routine care. 153 randomised to either immediate X-ray or observation. Followed up at 6 months and 1 year. Participants had Roland disability scale, SF-36 and Hospital Anxiety and Depression Scale assessments. | PRCT with separate non-randomised observational arm | Follow up in 506 in observation arm | 427 completed initial assessment, 352 completed at 6 months, 317 competed at one year. GP records reviewed on 480 at one year. | This is the final paper from an original Health Technology Assessment published in 2000. There is poor follow up of patients, particularly in the observational group. In the RCT group there was a difference at baseline due to chronicity of symptoms which may have influenced the result. No assessment of pathology found, or missed! |
Follow up in 153 trial patients | 153 completed initial assessment, 126 completed at 6 months, 108 competed at one year. GP records reviewed on 140 at one year. | ||||
Baseline characteristics | No difference in RCT group. In the observational group X-ray more likely in older population and for those with back pain more than 8 weeks | ||||
Outcome at 6 weeks in RCT group | No difference in physical function, pain or disability. Better mental health (7 points in mental health score, 8 points on SF36 vitality score) in patients who had X-ray | ||||
Outcome at 6 weeks in observational group | Patients referred for X-ray had more pain and more disability though not if adjusted for chronicity. X-ray's patients had lower adjusted depression scores. | ||||
Outcome at one year in RCT group. | Only difference was small benefit in mental health score (7 points) in X-ray group. | ||||
Outcome at one year in observational group | Patients referred for X-ray had more pain and more disability though not if adjusted for chronicity. X-ray's patients had lower adjusted depression scores. | ||||
Patient expectation, satisfaction, repeat consultation and referrals. | No difference in RCT group. In observational group, those X-ray'd were more satisfied, more likely to reconsult and more likely to be referred for physio or top another health professional. | ||||
Kendrick D 2001 England | 421 patients with back pain presenting to the GP at 73 practices in Midlands, UK. Patients had to have had pain for more than 6 weeks and on the day of randomisation. No "red-flag" symptoms and aged 20-55. Randomised to either immediate radiography or later imaging at the discretion of the GP. Participants were assessed using the Roland score (the primary outcome measure), VAS, EuroQol, patient satisfaction, duration of pain, duration of sick leave, use of other services and sck leave. Assessments made at 3 and 9 months. | PRCT | Patient follow up | 394/421 completed the trial. | These patients had medium term back pain. As most back pain episodes resolve spontaneously they are a select group. |
3 month assessment - pain | 74% for X-ray vs. 65% for control p=0.04 | ||||
3 month assessment - Roland disability score | 4 for X-ray vs 3 for control p=0.05 (control better) | ||||
3 month assessment - repeat visit | 53% for X-ray vs. 30% for control p<0.01 | ||||
3 month assessment. selected factors showing no statistical difference | time off work, Median Euroqual score, Satisfaction, use of meds, physiotherapy, osteopathy, chiropractic, acupuncture. | ||||
9 month assessment - pain | 65% for X-ray vs. 57% for control p=NS | ||||
9 month assessment - Roland disability score | 3 for X-ray vs. 2 for control p=0.06 | ||||
9 month assessment - selected factors showing no statistical difference | visited doctor, time off work, Median Euroqual score, Satisfaction, use of meds, physiotherapy, osteopathy, chiropractic, acupuncture. | ||||
9 month assessment - satisfaction | better for X-ray group 21 vs. 19 points. (RR-2.69). p<0.01 | ||||
Serious pathology found | No life threatening lesions found in any patients. | ||||
Miller P 2001 England | Same group as Kendrick paper. This is the economic analysis of the same study. | PRCT with | Data collection | Prospective collection of 8 direct (radiography, inpatient admission, outpatient attendance, gp visits, physical therapies, medications, special equipment purchase) and 5 indirect cost variables (practical help, extra expenses incurred, social security paymenyts, loss of earnings, loss of productivity for the employer). Valuation of radiography was defined by how much the patient would pay for it if they had to. | Like many economic analyses this is difficult to do and to interpret. The original figures suggest little benefit to radiography but the hypothetical analyses (like a sensitivity analysis) show that the results could be significantly skewed based on some of the assumptions made in the paper. |
Economic calculation | Net economic impact = change in direct costs + change in indirect costs + value of reassurance from radiography - perceived value of risk of radiation | ||||
Clinical outcomes | As detailed in the Kendrick paper. Satisfaction did differ at 9 months with the X-ray group having greater satisfaction. | ||||
Cost-benefit analysis | Assuming reassurance from radiography=£30 and risk=£43 then overall cost is £115 per patient | ||||
Cost-effectiveness analysis | Heavily in favour of control group. | ||||
Boot strap analysis of cost effectiveness data | A hypothetical analysis of the data based on a higher value of radiography to the patient suggests that if satisfaction is considered at a higher level then X-ray may be of benefit to patient satisfaction. |