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Treatment- and cost-effectiveness of early intervention for acute low-back pain patients: a one-year prospective study |
Gatchel R J, Polatin P B, Noe C, Gardea M, Pulliam C, Thompson J |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology An early intervention programme to prevent acute low-back pain (ALBP) from becoming a chronic disability was studied in high-risk ALBP patients. The programme was compared with no early intervention for high-risk patients, and also with no early intervention for low-risk patients. The early intervention programme comprised four components. More specifically, psychology, physical therapy, occupational therapy and case management, typically spaced over a 3-week period. The perspective adopted in the study appears to have been societal, as both the direct and indirect costs were included.
Type of intervention Secondary prevention and treatment.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients aged 18 to 65 years, presenting with ALBP, who were considered to be "high-risk". The patients were deemed high risk when the results of a receiver operator characteristic (ROC) curve analysis exceeded a certain (unspecified) threshold. The details of the risk factors and logistic regression model can be found elsewhere (Gatchel et al., see Other Publications of Related Interest).
Setting The setting was primary care (local physician) for risk-assessment, and secondary care (the Eugene McDermott Center for Pain Management, University of Texas) for the treatment of ALBP. The economic study was carried out in Dallas, USA.
Dates to which data relate The dates to which the data related were not reported.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing and effectiveness data were derived prospectively from the same patient sample.
Study sample Around 700 participants were screened for inclusion, of which 124 were considered suitable for the study. To be eligible, the patients had to meet several criteria. For example, no more than 2 months since onset of ALBP, constant daily pain when performing activities, and a decreased ability to perform daily tasks. Other inclusion criteria were no history of chronic episodic back pain, no current need for surgery, and fully employed at the time of injury. Of the 124 patients included in the study, 70 (56.5%) were high risk and 54 (43.5%) were low risk. The average age of the cohort was 38.2 (standard deviation, SD=11.0) years, and the average number of weeks since injury was 3.8 (SD=2.4). The sample comprised 65% males and 35% females.
Study design This was a randomised controlled study that was conducted in a single centre. The, high-risk patients were randomly assigned to one of two groups, functional restoration early intervention (HR-EI) or no early intervention (HR-NO). The low-risk patients did not receive any intervention (LR-NO). The patients were followed up for 12 months. They were contacted every 3 months to evaluate disability, return to work and health care use. The telephone raters were blinded to the study hypothesis. No dropouts were reported.
Analysis of effectiveness The primary health outcomes were:
return to work status;
the average number of health care visits whatever the reason;
the average number of health care visits in relation to the original low-back pain;
the average number of disability days due to low-back pain;
injury recurrence; and
medication use.
The issue of whether the analysis was conducted on the basis of intention to treat or treatment completers only is irrelevant since no dropouts were observed. The three groups of HR-EI (n=22), HR-NO (n=48) and LR-NO (n=54) were comparable in all respects of age, gender, race and time since original injury. The patients were assessed by telephone at 3, 6, 9 and 12 months to measure returns to work, health care visits in relation to ALBP, other health care visits, disability days, magnitude of pain and medications used.
Effectiveness results At the 12-month follow-up, the findings were as follows.
In the HR-EI group, 91% had returned to work, compared with 69% in the HR-NO group and 87% in the LR-NO group, (p=0.027 using chi-squared analysis).
There were 17.0 health care visits in relation to ALBP in the HR-EI group, compared with 27.3 in the HR-NO group and 9.3 in the LR-NO group, (p=0.004, using an analysis of variance, ANOVA).
The number of health care visits, regardless of reason, was 25.6 in the HR-EI group, 28.8 in the HR-NO group and 12.4 in the LR-NO group, (p=0.004, ANOVA).
The average number of disability days was 38.2 in the HR-EI group, 102.4 in the HR-NO group and 20.8 in the LR-NO group, (p=0.001, ANOVA).
The most intense pain experienced during the 12 months (on a scale of 1 - 100) averaged 46.4 in the HR-EI group, 67.3 in the HR-NO group and 44.8 in the LR-NO group, (p=0.001, ANOVA).
The average pain during the last 3 months was 26.8 in the HR-EI group, 43.1 in the HR-NO group and 25.7 in the LR-NO group, (p=0.001, ANOVA).
The proportion of patients currently taking narcotic analgesics was 27.3% for the HR-EI group, 43.8% for the HR-NO group and 18.5% for the LR-NO group, (p=0.020, chi-squared).
The proportion of patients currently prescribed psychotropic medication was 4.5% for the HR-EI group, 16.7% for the HR-NO group and 1.9% for the LR-NO group, (p=0.019, chi-squared).
Clinical conclusions The authors concluded that the HR-EI group experienced significantly fewer problems and pain than the HR-NO group. Patients in the HR-EI group were more likely to have returned to work and less likely to use medication.
Measure of benefits used in the economic analysis No summary measure of benefit was used in the analysis.
Direct costs The direct costs used in the analysis were for health care visits and medication, and costs associated with the early intervention (e.g. therapy, management and psychology). The unit costs were obtained from appropriate published guidelines. The quantities and the costs were not reported separately. The costs were not discounted because the time horizon was one year. No price year was stated.
Statistical analysis of costs An independent t-test, to compare the total costs of each group, was carried out.
Indirect Costs Lost wages arising from disability were included in the study. These were based on figures obtained from the American Bureau of Labor Statistics. The costs were not discounted because the time horizon was one year. No price year was given.
Sensitivity analysis No sensitivity analysis was performed.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The average costs per patient were:
for total health care visits related to ALBP, $1,670 for the HR-EI group and $2,677 for the HR-NO group;
for narcotic medication, $70 for the HR-EI group and $160 for the HR-NO group;
for psychotropic medication, $24 for the HR-EI group and $55 for the HR-NO group;
for wages lost because of disability, $7,072 for the HR-EI group and $18,951 for the HR-NO group; and
for the early intervention programme, $3,885 for the HR-EI group and $0 for the HR-NO group.
The total one-year cost of ALBP for the HR-EI group was $12,721, compared with $21,843 for the HR-NO group, (p<0.05). The majority of this cost resulted from lost wages.
Synthesis of costs and benefits The costs and benefits were not combined.
Authors' conclusions Early intervention in the case of high-risk acute low-back pain (ALBP) patients led to a lower incidence of complications, fewer medications, and less wages lost due to work absence.
CRD COMMENTARY - Selection of comparators Early intervention for high-risk patients was compared with no early intervention. This was an appropriate comparison because these are two of the major options in the management of ALBP. In addition, a second control group made up of low-risk patients was included. This allowed comparisons to be made between high- and low-risk patients undergoing no early intervention.
Validity of estimate of measure of effectiveness The effectiveness measures were derived appropriately from the patients. Relevant factors such as intensity of pain, duration of pain, health care visits and reliance on medication, were included. Telephone interviews were used to derive the effectiveness measures and the interviewers were blinded to the study hypothesis. The patients included in the no early intervention group were able to, and indeed did, receive other therapy "on their own". No details as to the stage of injury at which this took place (i.e. whether or not it could be classed as early intervention) were given.
Validity of estimate of measure of benefit No summary measure of benefit was used in the study. This limits the analysis in that no synthesis of the costs and benefits can be performed. If the outcomes had been measured using quality-adjusted life-years (QALYs), this would have incorporated all factors and would have allowed a full comparison of the two cohorts.
Validity of estimate of costs Appropriate health care and medication costs were included in the study, although "other", non-ALBP-related medication costs were omitted. However, the estimate of wages lost because of disability was overstated, as only full-time workers were included in the study. If the study's findings were to be applied to the general population, non-working patients should also be included because health care providers would be unable to discriminate between the groups. The costs and the quantities were not reported separately.
Other issues No summary measure of benefit (e.g. QALYs) was used in the analysis. Thus, the costs and benefits were not combined. Consequently, the authors did not state the incremental cost-effectiveness ratios associated with early intervention. This makes it difficult to draw conclusions from the study. In addition, problems arise when trying to compare this intervention with alternatives reviewed in other studies. The authors compared early intervention with no intervention for high-risk patients. However, early intervention may also be effective in reducing pain, disability days and medication use for low-risk patients. The authors do not appear to have presented their results selectively. The study enrolled patients aged 18 to 65 years with ALBP and this was reflected in the authors' conclusions.
Implications of the study The authors concluded that early intervention for high-risk patients led to substantial cost-savings in terms of lost wages, medications and health care provision. Because ALBP is a major cause of disability days (particularly in the under-40 age group), this should be addressed. As already discussed, future research should aim to include both low-risk patients and those patients who are not in full-time work.
Source of funding Supported in part by grants 2R01-MH46452 and 2K02-MH01107 from the National Institute of Mental Health.
Bibliographic details Gatchel R J, Polatin P B, Noe C, Gardea M, Pulliam C, Thompson J. Treatment- and cost-effectiveness of early intervention for acute low-back pain patients: a one-year prospective study. Journal of Occupational Rehabilitation 2003; 13(1): 1-9 Other publications of related interest Gatchel RJ, Polatin PB, Mayer TG. The dominant role of psychosocial risk factors in the development of chronic low back pain disability. Spine 1995;20:2702-9.
Indexing Status Subject indexing assigned by NLM MeSH Acute Disease; Adolescent; Adult; Aged; Analysis of Variance; Chi-Square Distribution; Cost-Benefit Analysis; Humans; Interviews as Topic; Low Back Pain /economics /rehabilitation; Middle Aged; Odds Ratio; Outcome and Process Assessment (Health Care); Patient Acceptance of Health Care /statistics & Prospective Studies; Risk Assessment; Surveys and Questionnaires; Time Factors; United States; Work Capacity Evaluation; numerical data AccessionNumber 22003009412 Date bibliographic record published 31/12/2004 Date abstract record published 31/12/2004 |
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