Low Back Pain in Primary Care
Transcrição
Low Back Pain in Primary Care
SPINE Volume 35, Number 18, pp 1714 –1720 ©2010, Lippincott Williams & Wilkins Low Back Pain in Primary Care Costs of Care and Prediction of Future Health Care Utilization Annette Becker, MD, MPH,* Heiko Held, MD,* Marcus Redaelli, MD,† Konstantin Strauch, PhD,‡ Jean F. Chenot, MD, MPH,§ Corinna Leonhardt, PhD,¶ Stefan Keller, PhD,储 Erika Baum, MD, PhD,* Michael Pfingsten, PhD,** Jan Hildebrandt, MD, PhD,** Heinz-Dieter Basler, PhD,¶ Michael M. Kochen, MD, MPH, PhD, FRCGP,§ and Norbert Donner-Banzhoff, MD, MHSc, PhD* Study Design. Cost of illness study alongside a randomized controlled trial. Objective. To describe the costs of care for patients with low back pain (1) and to identify patient characteristics as predictors for high health care cost during a 1-year follow-up (2). Summary of Background Data. Low back pain (LBP) is one of the leading causes of high health care costs in industrialized countries (Life time prevalence, 70%). A lot of research has been done to improve primary health care and patients⬘ prognosis. However, the cost of health care does not necessarily follow changes in patient outcomes. Methods. General practitioners (n ⫽ 126) recruited 1378 patients consulting for LBP. Sociodemographic data, pain characteristics, and LBP-related cost data were collected by interview at baseline and after 6 and 12 months. Costs were evaluated from the societal perspective. Predictors of high cost during the subsequent year were studied using logistic regression analysis. Results. Mean direct and indirect costs for LBP care are about twice as high for patients with chronic LBP compared to acutely ill patients. Indirect costs account for more than 52% to 54% of total costs. About 25% of direct costs refer to therapeutic procedures and hospital or rehabilitational care. Patients with high disability and limitations in daily living show a 2- to 5-fold change for subsequent high health care costs. Depression seems to be highly relevant for direct health care utilization. From the *Department of General Practice, Preventive, and Rehabilitation Medicine, University of Marburg, Marburg, Germany; †Institute of General Practice and Family Medicine, Private University Witten/Herdecke gGmbH, Witten, Germany; ‡Institute of Medical Biometry and Epidemiology, University of Marburg, Marburg, Germany; §Department of General Practice, University of Göttingen, Göttingen, Germany; ¶Institute of Medical Psychology, University of Marburg, Marburg, Germany; 储Department of Public Health Sciences, University of Hawaii at Manoa, Honolulu, HI; and **Department of Anaesthesiology, Pain Clinic, University of Göttingen, Göttingen, Germany. Acknowledgment date: October 30, 2008. Revision date: September 23, 2009. Acceptance date: September 28, 2009. The manuscript submitted does not contain information about medical device(s)/drug(s). Fedral funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. Supported by the German Ministry for Education and Research (BMBF, FKZ 01 EM 0113). The study was approved by the institutional review boards of the Göttingen university and Marburg university, Germany. Address correspondence and reprint requests to Annette Becker, MD, MPH, Department of General Practice, Preventive, and Rehabilitation Medicine, University of Marburg, Karl-von-Frisch-Str. 4, 35032 Marburg, Germany; E-mail: [email protected] 1714 Conclusion. Interventions designed to reduce high health care costs for LBP should focus on patients with severe LBP and depressive comorbidity. Our results add to the economic understanding of LBP care and may give guidance for future actions on health care improvement and cost reduction. Key words: back pain, primary care, cost-of-illness, severity of low back, depression. Spine 2010;35:1714 –1720 Low back pain (LBP) poses a major health burden on industrialized countries with a point prevalence of 15% to 30% and a life time prevalence between 50% and 85%.1–3 About 10% of patients develop chronic pain, which leads to early retirement and high health care costs. LBP is 1 of the 7 most expensive illnesses in Germany.4 In 1998, about 17.4 billion Euros per year of the total costs went to treat LBP.5 Several European cost of illness studies underline the burden of the illness on society, showing mean total costs of €211 per person in Sweden6 or €260 per person in the United Kingdom.7 Health care for patients with LBP is characterized by the variability of providers offering a spectrum of therapies, which are mostly not evidence based. A lot of research has been done to improve treatment effectiveness and efficiency. However, even though intervention studies often show mild effects on clinical outcomes, these effects do not necessarily correlate with economic benefits. The identification and description of subgroups of LBP patients who are likely to induce high cost of care in the future and who would gain most by cost saving actions is mandatory.8,9 But even though the majority of patients are seen in primary care settings,10 the distribution and factors associated with high primary health care costs are hardly known. In fact most cost of illness studies refer to databases of communities or specialized health care settings based on a top down approach with often limited information on patient or illness-related factors.6,7,11,12 The aim of our study was (1) to describe the composition of LBP-related costs of patients having consultations in general practice and (2) to identify patient- and disease-related predictors of high health care costs during a 1-year follow-up. We refer to a secondary analysis of patient interrogation data drawn from a clusterrandomized controlled trial in primary care. LBP: Costs of Illness Study • Becker et al 1715 Table 1. Unit Costs and Valuation of the Most Frequent Categories Used in the Study Description (Available Data) Direct medical costs Medical consultations (general practitioners, specialists) (speciality and no. of contacts) Therapeutic procedures (type and no. sessions) Diagnostic procedures (type and number) Drugs (packages) Hospital care (d) Rehabilitational care (d) Unit Cost Range (€) Estimation and Sources 6.76–100.55 Consultation charges for initiating (the first two contacts per 6 mo) and follow-up contacts14–18 plus 10€ patient co-payment per initiating visit with 13.1% exemption rate* Charges for consultations and therapeutic procedures14–19* Procedure specific charges.14–18* If necessary assuming the most likely provider based on the specified consultation rates Pharmacy prices for 200420 DRG or department specific daily charges (year 2000) inflated for 200421,22 plus patient co-payment Sector specific daily charges (year 2000) for ambulatory and inpatient care. inflated for 200421–23 plus patient co-payment Average prices from 2001 inflated for 200421,22 and prices from medical supply stores 3.50–5000.00 0.75–837.25 1.00–696.27 306–313/d (Daily charges) 7476.65–7480.41 (DRG) 56.24–117.46 Auxiliaries (type and number) 10.00–700.00 Indirect costs Paid work (days on sick leave) 108.38/d Average hourly labour cost multiplied with work hours forgone (Human capital approach). Thirty percent reduction after 42 calender days of sick leave (change to sickness benefits from the statutory health insurance)24 *Assumption of 10% privately insured patients.25 DRG indicates diagnose related groups. Materials and Methods Study Design and Data Sources This study is a secondary analysis of a 3-armed randomized controlled guideline implementation study in primary care.13 Primary aim was to assess the impact of a guideline-based treatment and motivational counseling on functional capacity in patients with LBP compared to the postal dissemination of the guideline. The intervention consisted of intensive seminars for general practitioners on an evidence-based LBP guideline (in both intervention arms) and of training nurses in motivational counseling to promote physical activity of patients (in 1 intervention arm). The cost of illness data is drawn from the cross sectional sample in a bottom up approach referring to all patients who were included in the trial at baseline. Data to analyze the prediction of costs are drawn from follow-up data at 6 and 12 months. At the index visit, patients were asked to fill out 2 sets of questionnaires, one while waiting and another one at home (socio-demographic and disease-related data). One baseline telephone interview (within 4 weeks) and 2 follow-up interviews (after 6 and 12 months) were performed by specially trained study nurses. Data on disease-related health care resource use (Table 1) were collected during all 3 interviews. Patients were explicitly asked only to report health care utilization, which refers to their LBP. To shorten interviews, we had to omit nonmedical costs such as travel and time expenses or out-of-pocket costs. Clinical Measures For classification of the natural history of LBP, we dichotomized the sample into acute LBP (ⱕ90 days duration/6 months) and chronic LBP (continuous or episodic LBP ⬎90 consecutive d/6 mo). Pain chronicity was measured by von Korff⬘s severity of chronic pain scale.26 We used the German version of the “Fear-AvoidanceBeliefs-Questionnaire” 27–29 to measure patients’ beliefs about “physical activity as a cause of LBP” (subscale I), and about “work as cause of pain” (subscale II) as well as patients’ assumptions of their “probable return to work” (subscale III). Depression was studied by using the CES-D (German version30). A score of 23 or more (range, 0 – 60) was taken as indicative of depressive disorder.31,32 To gain data on Quality of life, we chose the EuroQol,33 which provides a single index value on a visual analogue scale (0 –100). Descriptive data are shown for pain and sociodemographic characteristics. In addition, GPs evaluated each patient regarding the presence of complicating factors (red flags: being unwell, history of trauma, suspected cancer, major neurologic deficits, signs of rheumatic disease, osteoporosis, fever, immune deficiency, or significant trauma). Measurement of Health Care Utilization Consultation with health care providers (GP, specialists), diagnostic and therapeutic procedures and auxiliaries were given in Study Sample All patients consulting for LBP were recruited consecutively. Inclusion criteria were LBP on the day of inclusion, age above 19, ability to read and to understand German, and written consent. Exclusion criteria were pregnancy and isolated thoracic or cervical pain. Setting The study was conducted in 2 German regions (Marburg, Göttingen) in 2003 to 2004. Overall, 118 practices (126 GPs) participated (883 GPs invited, 52% did not respond, 34% GPs refused participation). GP characteristics are shown in Table 2. For the prediction cohort, we refer to 1211 patients out of 1378 who completed follow-up (12.1% dropouts). Table 2. Characteristics of Participating GP (n ⴝ 126) Sex (males) Age (mean ⫾ SD) Type of practice Single Group practice Practice size (practice attendees per 3-months’-period) Less than 1000 1000–1500 More than 1500 Values are n (%), unless otherwise indicated. 73 (58) 48.73 years ⫾ 6.63 69 (55) 57 (45) 45 (36) 46 (37) 32 (25) 1716 Spine • Volume 35 • Number 18 • 2010 types and numbers. Pharmaceutical information was given in free-text answers on type, doses, and package size of the medication. Data on hospital and rehabilitation were collected as days of care and reason for admission (e.g., surgery, pain management). Valuation of Direct and Indirect Costs All costs were evaluated for the year 2004 from the societal perspective. We postulated a 10% rate of privately insured patients,25 which was drawn from the overall number of physician consultations, diagnostic and therapeutic procedures as well as physiotherapy contacts and priced accordingly. Direct Costs Physician Consultations. To price of medical outpatient consultations (general practitioners and specialists), the number of consultations was multiplied with provider specific charges (“Einheitlicher Bewertungsmaßstab,” medical fee schedule for physicians14 or the “Gebührenordnung für Ärzte,”15 for the privately insured patients). Charges (given in points) were translated into Euros using an average point score for 2004 depending on federal state (Hessen16 and Niedersachsen17). A copayment of €10 for the first physician consultation every 3 months was added allowing a 13.1% rate of patients freed from their own contribution (Verband der Angestellten-Krankenkassen, VdAK e.V., personal information, 2008 – 04 –21). Contacts with nonmedical practitioners (complementary practitioners) were valuated using provider specific charges (Gebührenhandbuch für Heilpraktiker18). Diagnostic and Therapeutic Procedures. Costs for diagnostic und therapeutic procedures (including physiotherapy) were calculated by multiplying the number of procedures, with the procedure-specific charges as drawn from the Einheitlicher Bewertungsmaßstab14 or Gebührenordnung für Ärzte.15 In case of provider specific charges, the reported procedures were valued assuming the most likely provider. For physiotherapy, we accounted for patient copayment.19 Drugs. The costs for drugs were based on package prices according to the official German price list of drugs (“Rote Liste” 200420). For missing values in doses and package sizes, we assumed a small package of medium dosage for patients with acute LBP and a big package for patients with chronic LBP. Imprecise information on type of drugs (like “pain killer”) at follow-up was replaced by the previously prescribed medication. Hospital and Rehabilitational Care. Expenditures for hospital care are based on diagnose related groups21 or on department specific daily charges,22 inflated for 2004 by the sector and land specific inflation rate (adopted from classification of individual consumption on purpose,23 Hessen: 21.4%, Niedersachsen: 24.3%). A daily €10 patient copayment for hospital stay was added up to a maximum of 28 d/yr. For costs of inpatient rehabilitation we used sector specific charges (year 2000, information from regional rehabilitation clinics) inflated for 2004.23 Again, a €10 daily patient copayment was added up to a maximum of 28 d/yr. Auxiliaries. Cost estimations for auxiliaries, like walking sticks or insoles, are based on average prices recommended by Krauth et al22 (inflated for 2004) or by personal information from medical supply stores. Indirect Costs Lost Productivity/Paid Work. For an estimation of indirect costs, the number of missed working hours were multiplied by the average daily labor cost in Germany (human capital approach, €108.38 per day, assuming 21 working d/mo).24 In case of prolonged sick leave (⬎42 calendar days), patients receive sickness benefits from the statutory health insurance (70% of the gross income). We then reduced the daily labor costs by 30%. Statistical Analysis Statistical analysis was performed with SPSS 17.0 (SPSS, Inc., Chicago, IL). Nonparametric bootstrapping (99.999 replications) was applied to present means and confidence intervals of cost data for subgroups of acute and chronic LPB. Health care costs during 12-months follow-up were dichotomized into high and low health care costs by defining the upper 25% of costs as “high health care costs” (ⱖ€1723 for total costs, ⱖ€325 for indirect costs and ⱖ€983 for direct costs). We used logistic regression analysis in 2 blocks to model the influence of independent prediction variables on high health care costs. Independent variables (block 1) were chosen according to the results from univariate analysis (P ⬍ 0.05, Table 5). A backward variable elimination process was performed (log likelihood ratio test, P ⬍ 0.10). To account for potential confounders, we included variables on interventional effects and work status (block 2). The Spearman correlation coefficient between predictors remained below 0.5 for all variables. Logistic regression analysis for prediction of high indirect costs is based on a subgroup of wage and salary earners. We used Nagelkerkes r2 as indicator of model fit. For sensitivity analysis, we calculated costs for sick leave based on a friction period of 72 days and 80% of the average daily labor cost or the sickness benefits (as used for the human capital approach). We performed a second sensitivity analysis by replacing missing data for total health care costs (at 6- and 12-months follow-up), according to the “last observation carried forward” procedure. Results Study Sample Our cross sectional analysis refers to 1094 patients of 1378 trial participants who reported relevant baseline data to classify their pain in acute and chronic LBP. The prediction cohort includes 1211 patients who completed the 12 months follow-up (12.1% drop out). Dropouts showed no relevant differences to trial participants.13 Logistic regression analysis only refers to the subgroup of patients with complete data on all relevant predictors. Baseline and socio-demographic characteristics of all patients are shown in Table 3. Costs of Care Distribution of costs, stratified for subgroups of acute and chronic patients with LBP is shown in Table 4. Indirect cost account for approximately 54% of all health care cost irrespective of disease duration. LBP: Costs of Illness Study • Becker et al 1717 Table 3. Baseline Characteristics of the Study Sample (n ⴝ 1378) Demographic Characteristics Age Gender (males) Employment status Working full or part-time Keeping house Retired Unemployed Other Net income ⱕ1000€ 1001–2000€ 2001–3000€ ⬎3000€ Characteristics of LBP Functional capacity Pain intensity (Numeric pain scale: 0–10) Days of pain in the previous year Duration of the current episode Quality of life (Visual analogue scale: 0–100) Chronic Pain grade* (n (%)) Low disability/low intensity Low disability/high intensity High disability/moderately limiting High disability/severely limiting Red flags Generally unwell Neurological deficits History of cancer Chronic inflammatory disease Osteoporosis with danger of fracture Fever Immune deficiency Severe trauma Activity (Metabolic equivalent hours/wk)† Job satisfaction (Numeric pain scale: 0–10) Depression score Fear avoidance beliefs score Score I (physical activity ⫽ cause of pain) Score II (work ⫽ cause of pain) Score III (prognostic job) Mean (Range. SD) n (%) n (%) N (%) 48.85 (20–91. 13.7) 574 (41.65) 925 (67.1) 120 (8.7) 228 (16.6) 55 (4.0) 50 (3.6) 199 (14.4) 478 (34.7) 288 (20.9) 120 (8.7) Mean (SD) Mean (SD) 67.45 (21.43) 53.87 (17.03) Mean (SD) Mean (SD) Mean (SD) 104.87 (128.83) 25.79 (62.93) 57.05 (19.27) N (%) N (%) 303 (22.0) 258 (18.7) 260 (18.9) 164 (11.9) 28 (2.0) 20 (1.5) 22 (1.6) 32 (2.3) 29 (2.1) 2 (0.1) 0 8 (0.6) Mean (SD) 17.26 (20.25) Mean (SD) 6.10 (2.46) Mean (SD) 15.36 (9.38) Mean (SD) 17.59 (6.80) 13.46 (8.60) 8.91 (8.38) *More than 20% missing. †Outlier corrected by “winsorizing”: values ⱖ98th percentile were equated to this value. SD indicates standard deviation; LBP, low back pain. Health Care Utilization Apart from the index visit, most patients had seen their GP at least once during the 6 months before the day of recruitment (n ⫽ 1266, 95.7%). The mean consultation rate was 4.8 (s ⫽ 7.75). Patients who went to see their GP at least 5 times (26% of all patients), account for 70% of all GP consultations. Specialists were seen by 41% (n ⫽ 548) of patients. Patients who went to see them at least twice (26%) account for 92% of all specialist visits. More use of radiologic procedures (ⱖ1 test) occurred in 32% of all patients. A third of all patients (n ⫽ 430, 32.5%) were on sick leave for 8 days on average (s ⫽ 25.49); high utilizer (ⱖ5 days) accounted for 98% of all days of sick leave (n ⫽ 9372 in total). About 20% of the patients had been submitted to hospital care with a total number of 457 days in hospital (range, 1– 41 days), 4% of all patients (n ⫽ 54) participated in rehabilitative care (in total 1320 days; range, 1– 42 days). NSAIDs were the most frequently used drugs in patients with LBP (50.3% of patients) followed by opioids (13%), muscle relaxants (6.3%), and analgesics (6.8%). Prediction of High Health Care Cost During the Following Year The distribution of cost during follow-up was similar to their composition at baseline, with indirect cost accounting for 55% of total costs. Again therapeutic procedures and hospital care had the highest share of direct cost. Table 5 presents univariate associations of potential predictors and high cost of care during the following year. Results from multivariate logistic regression analysis are shown in Table 6. The models predicted 80% of high total cost, 78% of high direct cost, and 68% of high indirect cost. Sensitivity Analysis At baseline indirect cost valued by the friction cost approach amount to €410.98 per patient with acute LBP (95% CI: 345.6 – 492.4) and to €577.44 (95% CI: 453.6 –731.8) per patient with chronic LBP. Logistic regression analysis on the prediction of high indirect cost (ⱖ€606) revealed the same predictors as in the initial model except for LBP severity grade III (high disability, moderately limiting). We found no effective changes in the logistic regression analysis for total costs after replacement of missing values (LVCF, cut of for high total costs: ⱖ€1829). Discussion We performed a cost-of-illness study based on data from a cluster randomized trial in primary care. Mean costs for chronic LBP patients are about twice as high as for acutely ill patients. Sick-leave accounts for about 52% to 54% of total costs. Almost 25% of direct costs refer to therapeutic procedures and hospital or rehabilitational care. Back pain severity and depression are the most important predictors for future costs, whereas fear avoidance beliefs and radiation of pain to the leg do add to subsequent costs, but they are of minor importance. To our knowledge, this is the first cost of illness study in the field of LBP, which includes cohort data on pain, patient characteristics, and a reasonable observation period in the context of German general practice. We found one comparable German survey on the costs of LBP evaluated by a bottom up approach by Wenig et al.34 Valuation of costs in this study is based on the same recommendations as in our analysis.22 Similar to our study, they found a proportion of indirect costs of 54% in a sample of 5650 LBP patients. Total costs were estimated to be €1322 per year, which is about twice the total costs 1718 Spine • Volume 35 • Number 18 • 2010 Table 4. Costs of Low Back Pain During 6 Month Classified by Duration of Pain (Baseline Data) Direct costs Physician consultations Drugs Diagnostic procedures Therapeutic procedures Auxiliaries Hospital care Rehabilitational care Indirect costs Total costs Acute LBP Chronic LBP n ⫽ 643 (58%) n ⫽ 451 (41%) (Mean (95% Confidence Interval)) % of Total Costs (Mean 关95% Confidence Interval兴) % of Total Costs 456.49 (365.7–587.5) 58.85 (52.15–71.69) 16.74 (14.41–22.51) 59.41 (45.49–77.41) 123.74 (107.1–146.9) 10.14 (6.47–16.81) 120.38 (65.4–206.0) 67.23 (38.58–110.72) 545.49 (451.5–680.2) 1001.97 (847.0–1208.0) 45.6 5.9 1.7 5.9 12.4 1.0 12.0 6.7 54.4 100 853.81 (713.6–1044.7) 98.66 (81.75–130.40) 61.05 (46.66–85.82) 106.14 (81.6–141.1) 255.69 (223.2–297.0) 27.05 (19.65–37.13) 137.38 (72.1–245.5) 167.84 (111.6–246.3) 936.00 (708.1–1236.0) 1789.81 (1470.0–2202.0) 47.7 5.5 3.4 5.9 14.3 1.5 7.7 9.4 52.3 100 Means and 95%-confidence intervals are drawn from Bootstrap analysis. LBP indicates low back pain. estimated in our study and which is possibly due to the different study settings. A recent study by Martin et al35 found increased spine-related per-user expenditures going back to increased expenditures for inpatient hospitalization, prescription medication, and emergency department visits. The authors discuss the contribution of an increasing use of imaging, surgical technology, etc., which is in line with our findings. However, we were able to test for the influence of clinical data, which showed LBP severity and depression to be the most important predictors for future costs, which is different from Martin⬘s study. Similar analyses based on cross sectional data underline this observed association (measured with von Korff chronic pain grade or the Roland and Morris scale).6,34,36 In a sample of consecutive LBP patients of an HMO primarycare clinic, Engel et al36 confirmed increasing chronic pain grade to be the strongest predictor of high LBP costs, followed by disc disorder/sciatica and increasing pain persistence. Depression was the strongest predictor of total health care costs which is why the authors hypothesize that physicians initiate expensive health services if they are confronted with dysfunction and chronicity or mood disorders. None of the above-mentioned studies have so far examined the impact of high fear avoidance beliefs on subsequent health care costs. The patients’ own prognosis about returning to work adds significantly to the prediction of future costs. Obviously long-term consequences of catastrophic misinterpretations of pain initiate a vicious circle Table 5. Univariate Association of Potential Predictors of High Health Care Costs Within the Following Year (Follow-up Cost Data) Crude OR (95% CI) Predictor Sex (0 ⫽ men, 1 ⫽ women) Age Paid work Applying for pension Quality of life (VAS: 1–100) Depression (score ⬎23 ⫽ 1) FABQ Activity as cause of pain Work as cause of pain Prognosis for work Severity of disease Low disability-low intensity Low disability-high intensity High disability-moderately limiting High disability-severely limiting Days of pain in 12 mo Radiation of pain Duration of current episode Red flags High Total Costs (ⱖ1723€) High Indirect Costs (ⱖ325€) High Direct Costs (ⱖ983€) 1.060 (0.812–1.382) 1.00 (0.989–1.010) 1.201 (0.892–1.616) 2.070 (1.316–3.256)* 0.981 (0.974–0.988)* 1.041 (1.025–1.056)* 1.769 (1.374–2.278)* 0.960 (0.949–0.971)* — 1.055 (0.652–1.706)* 0.990 (0.983–0.996)* 1.015 (1.001–1.030)* 0.613 (0.465–0.806)* 1.012 (1.001–1.022)* 0.65 (0.49–0.86) 1.847 (1.172–2.910)* 0.984 (0.977–0.991)* 1.038 (1.022–1.053)* 1.047 (1.024–1.071)* 1.069 (1.049–1.088)* 1.081 (1.062–1.101)* 1.040 (1.018–1.062)* 1.053 (1.035–1.071)* 1.057 (1.040–1.075)* 1.038 (1.016–1.061)* 1.045 (1.027–1.063)* 1.063 (1.045–1.081)* —* 1.17 (0.71–1.92)* 3.18 (2.05–4.93)* 8.47 (5.21–13.76)* 1.002 (1.001–1.003)* 2.155 (1.584–2.932)* 1.003 (1.001–1.005) 1.448 (0.935–2.242)* —* 1.66 (1.01–2.73)* 3.24 (2.01–5.24)* 8.30 (4.38–15.74)* 0.999 (0.998–1.000)* 1.21 (1.03–1.41)* 1.00 (1.00–1.00) 0.83 (0.43–1.61)* —* 1.45 (0.90–2.34)* 3.18 (2.05–4.93)* 7.50 (4.62–12.16)* 1.003 (1.001–1.004)* 1.55 (1.35–1.78)* 1.00 (1.00–1.01) 1.88 (1.23–2.88)* *Variables included in the logistic regression model block 1 with backward selection. CI indicates confidence intervals; OR, odd ratio; FABQ, Fear-Avoidance-Beliefs-Questionnaire. LBP: Costs of Illness Study • Becker et al 1719 Table 6. Results From Logistic Regression Analysis (Stepwise Selection, Follow-up Cost Data) Adjusted OR (95% CI) Predictor Sex (female ⫽ 1, male ⫽ 2) Radiation to the leg Days of pain in 12 mo Depression (score ⬎23) FABQ–Prognosis for work FABQ–Activity as cause of pain Severity of disease Low disability low intensity Low disability-high intensity High disability-moderately limiting High disability-severely limiting Paid work Study arm Nagelkerkes r2 High Total Costs (ⱖ1723€) n ⫽ 577 High Indirect Costs (ⱖ325€) n ⫽ 380 High Direct Costs (ⱖ983€) n ⫽ 576 0.65 (0.42–1.01) 1.27 (1.03–1.58) 1.96 (1.18–3.24) 1.06 (1.03–1.09) 1.07 (1.03–1.10) 1.05 (1.01–1.09) — 1.23 (0.65–2.34) 2.86 (1.57 ⫺ 5.23) 7.47 (3.66–15.25) 2.46 (1.48–4.08) 0.90 (0.69–1.17) 0.28 — 1.36 (0.78–2.38) 2.25 (1.27–4.01) 3.83 (1.71–8.57) — 1.01 (0.79–1.38) 0.22 1.81 (1.11–2.98) 1.04 (1.01–1.07) — 1.42 (0.76–2.66) 2.83 (1.54–5.19) 4.78 (2.36–9.69) 0.90 (0.58–1.40) 1.01 (0.78–1.31) 0.23 OR indicates odd ration; CI, confidence intervals FABQ, Fear-Avoidance-Beliefs-Questionnaire. of pain-related fear, avoidance of physical activity and, finally, the emergence of a “disuse syndrome” as a consequence of long-lasting avoidance behavior.37,38 However, their influence on subsequent cost development is rather small and has to be validated in future studies. Limitations The results of our study are based on a secondary analysis of a randomized controlled trial. Even though trial results are negative,13 we controlled for confounding by study arm. However, a selection bias may be present, because physicians participating in research studies may be more interested in evidence-based care than nonparticipants. It remains unclear in which direction this bias would change the observed associations. The overall inclusion rate of the RCT was 44%, which makes selection bias on patient level likely as well. One of the key issues of the implemented guideline is the early activation of LBP patients. Trial participants may have felt less disabled by the pain, and may have had a higher level of physical activity than LBP patients in general. This bias would dilute the observed associations. Another limitation of the study is its reliance on selfreport instruments. Recall bias, information bias (e.g., by patients who are unable to distinguish between LBP-related procedures and others) or social desirability bias cannot be excluded. Under- or overestimation of costs are possible. We included the Euroqol as a measurement of quality of life. However, we did not adjust for potential confounding by comorbidity which may lead to misclassification of LBP related expenditures and—most likely— overestimation of LBP-related health care utilization or which may influence our logistic regression model. We studied the costs of LBP in primary care from a societal perspective. Total costs are most likely underestimated, because we had to restrict interviews to key issues for practical reasons. For a valuation of physician contacts, we followed the recommendations from Krauth et al.22 These authors based their calculation on assumptions about standard operating procedures instead of on detailed patient questioning which only allows an approximation of costs and may result in their over- or underestimation. Conclusion Current studies underline the need for identification of LBP subgroups in view of an efficient tailoring of cost reduction strategies. As shown in our study severity of LBP and depression are crucial variables for prediction of future health care costs. Future studies will have to corroborate these findings or to add further information about determinants of increased cost. Increased knowledge will serve to assign resources to cost limiting procedures and to facilitate decisions on health care priorities. Key Points ● ● ● ● ● LBP is one of the most expensive illnesses in industrialized countries. Defining subgroups of patients who are likely to account for future high health care costs is crucial. We present a cost-of-illness estimate based on data drawn from a randomized controlled trial in primary care. The aim is to study the pattern of health care utilization and potential predictors of high health care costs during a 12-months follow-up. Mean direct and indirect costs for LBP care are about twice as high for patients with chronic LBP than for patients with acute LBP. Severity (high disability and moderate to severe limitations in daily living) and depression are the most important predictors of future costs. 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