Osteoporosis identification among previously undiagnosed individuals with vertebral fractures.

Because osteoporosis is under-recognized in patients with vertebral fractures, we evaluated characteristics associated with osteoporosis identification. Most patients with vertebral fractures did not receive evaluation or treatment for osteoporosis. Black, younger, and male participants were particularly unlikely to have had recognized osteoporosis, which could increase their risk of negative outcomes. INTRODUCTION: Vertebral fractures may be identified on imaging but fail to prompt evaluation for osteoporosis. Our objective was to evaluate characteristics associated with clinical osteoporosis recognition in patients who had vertebral fractures detected on their thoracolumbar spine imaging reports. METHODS: We prospectively identified individuals who received imaging of the lower spine at primary care clinics in 4 large healthcare systems who were eligible for osteoporosis screening and lacked indications of osteoporosis diagnoses or treatments in the prior year. We evaluated characteristics of participants with identified vertebral fractures that were associated with recognition of osteoporosis (diagnosis code in the health record; receipt of bone mineral density scans; and/or prescriptions for anti-osteoporotic medications). We used mixed models to estimate adjusted odds ratios (ORs) and 95% confidence intervals (95% CIs). RESULTS: A total of 114,005 participants (47% female; mean age 65 (interquartile range: 57-72) years) were evaluated. Of the 8579 (7%) participants with vertebral fractures identified, 3784 (44%) had recognition of osteoporosis within the subsequent year. In adjusted regressions, Black participants (OR (95% CI): 0.74 (0.57, 0.97)), younger participants (age 50-60: 0.48 (0.42, 0.54); age 61-64: 0.70 (0.60, 0.81)), and males (0.39 (0.35, 0.43)) were less likely to have recognized osteoporosis compared to white participants, adults aged 65 + years, or females. CONCLUSION: Individuals with identified vertebral fractures commonly did not have recognition of osteoporosis within a year, particularly those who were younger, Black, or male. Providers and healthcare systems should consider efforts to improve evaluation of osteoporosis in patients with vertebral fractures.

Systematic literature review of imaging features of spinal degeneration in asymptomatic populations.

BACKGROUND AND PURPOSE: Degenerative changes are commonly found in spine imaging but often occur in pain-free individuals as well as those with back pain. We sought to estimate the prevalence, by age, of common degenerative spine conditions by performing a systematic review studying the prevalence of spine degeneration on imaging in asymptomatic individuals. MATERIALS AND METHODS: We performed a systematic review of articles reporting the prevalence of imaging findings (CT or MR imaging) in asymptomatic individuals from published English literature through April 2014. Two reviewers evaluated each manuscript. We selected age groupings by decade (20, 30, 40, 50, 60, 70, 80 years), determining age-specific prevalence estimates. For each imaging finding, we fit a generalized linear mixed-effects model for the age-specific prevalence estimate clustering in the study, adjusting for the midpoint of the reported age interval. RESULTS: Thirty-three articles reporting imaging findings for 3110 asymptomatic individuals met our study inclusion criteria. The prevalence of disk degeneration in asymptomatic individuals increased from 37% of 20-year-old individuals to 96% of 80-year-old individuals. Disk bulge prevalence increased from 30% of those 20 years of age to 84% of those 80 years of age. Disk protrusion prevalence increased from 29% of those 20 years of age to 43% of those 80 years of age. The prevalence of annular fissure increased from 19% of those 20 years of age to 29% of those 80 years of age. CONCLUSIONS: Imaging findings of spine degeneration are present in high proportions of asymptomatic individuals, increasing with age. Many imaging-based degenerative features are likely part of normal aging and unassociated with pain. These imaging findings must be interpreted in the context of the patient's clinical condition.

Non-steroidal anti-inflammatory drugs for low back pain.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are widely used for patients with low-back pain. Selective COX-2 inhibitors are currently available and used for patients with low-back pain. OBJECTIVES: The objective was to assess the effects of NSAIDs and COX-2 inhibitors in the treatment of non-specific low-back pain and to assess which type of NSAID is most effective. SEARCH STRATEGY: We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials up to and including June 2007 if reported in English, Dutch or German. We also screened references given in relevant reviews and identified trials. SELECTION CRITERIA: Randomised trials and double-blind controlled trials of NSAIDs in non-specific low-back pain with or without sciatica were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed methodological quality. All studies were also assessed on clinical relevance, from which no further interpretations or conclusions were drawn. If data were considered clinically homogeneous, a meta-analysis was performed. If data were lacking for clinically homogeneous trials, a qualitative analysis was performed using a rating system with four levels of evidence (strong, moderate, limited, no evidence). MAIN RESULTS: In total, 65 trials (total number of patients = 11,237) were included in this review. Twenty-eight trials (42%) were considered high quality. Statistically significant effects were found in favour of NSAIDs compared to placebo, but at the cost of statistically significant more side effects. There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low-back pain, but paracetamol had fewer side effects. There is moderate evidence that NSAIDs are not more effective than other drugs for acute low-back pain. There is strong evidence that various types of NSAIDs, including COX-2 NSAIDs, are equally effective for acute low-back pain. COX-2 NSAIDs had statistically significantly fewer side-effects than traditional NSAIDs. AUTHORS' CONCLUSIONS: The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica. However, effect sizes are small. Furthermore, there does not seem to be a specific type of NSAID which is clearly more effective than others. The selective COX-2 inhibitors showed fewer side effects compared to traditional NSAIDs in the RCTs included in this review. However, recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations.

WITHDRAWN: Non-steroidal anti-inflammatory drugs for low-back pain.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are widely used for patients with low back pain. OBJECTIVES: The objective of this systematic review was to assess the effects of NSAIDs in the treatment of non-specific low back pain and to assess which type of NSAID is most effective. SEARCH STRATEGY: We searched the Medline and Embase databases and the Cochrane Controlled Trials Register (CCTR) up to and including September 1998 if reported in English, Dutch or German. We also screened references given in relevant reviews and identified trials. SELECTION CRITERIA: Randomised trials and double-blind controlled trials of NSAIDs in non-specific low back pain with or without radiation were included. DATA COLLECTION AND ANALYSIS: Two authors blinded with respect to authors, institution and journal independently extracted data and assessed methodological quality. A methodological quality score was applied, and studies meeting at least six of 11 specified criteria were considered high quality studies. If data were considered clinically homogeneous, a meta-analysis was performed using a fixed effects model for statistically homogeneous subgroups and a random effects model for statistically heterogeneous subgroups. If data were considered clinically heterogeneous, a qualitative analysis was performed using a rating system with four levels of evidence (strong, moderate, limited, no). MAIN RESULTS: A total of 51 trials (total number of patients = 6057) were included in this review, of which 46 were published in English and five in German. Sixteen trials (31%) were of high quality. The pooled Relative Risk for global improvement after one week was 1.24 (95% CI 1.10 , 1.41) and for additional analgesic use 1.29 (95% CI 1.05 , 1.57), indicating a statistically significant effect in favour of NSAIDs compared to placebo. The results of the qualitative analysis showed that there is conflicting evidence (level 3) that NSAIDs are more effective than paracetamol for acute low back pain, and that there is moderate evidence (level 2) that NSAIDs are not more effective than other drugs for acute low back pain. There is strong evidence (level 1) that various types of NSAIDs are equally effective for acute low back pain. AUTHORS' CONCLUSIONS: In conclusion, the evidence from the 51 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute low back pain. Furthermore, there does not seem to be a specific type of NSAID which is clearly more effective than others. Sufficient evidence on chronic low back pain is still lacking.

Randomized trial of amplification strategies.

BACKGROUND: Little is known about quality of life after the use of specific types of hearing aids, so it is difficult to determine whether technologies such as programmable circuits and directional microphones are worth the added expense. OBJECTIVE: To compare the effectiveness of an assistive listening device, a nonprogrammable nondirectional microphone hearing aid, with that of a programmable directional microphone hearing aid against the absence of amplification. DESIGN: Randomized controlled trial. SETTING: Audiology clinic at the VA Puget Sound Health Care System, Seattle, Wash. PATIENTS: Sixty veterans with bilateral moderate to severe sensorineural hearing loss completed the trial. Half the veterans (n = 30) had hearing loss that the Veterans Affairs clinic determined was rated as "service connected," which meant that they were eligible for Veterans Affairs-issued hearing aids. INTERVENTION: Veterans with non-service-connected hearing loss, who were ineligible for Veterans Affairs-issued hearing aids, were randomly assigned to no amplification (control arm) or to receive an assistive listening device. Veterans with service-connected loss were randomly assigned to receive either the nonprogrammable hearing aid that is routinely issued ("conventional") or a programmable aid with a directional microphone ("programmable"). MAIN OUTCOME MEASURES: Hearing-related quality of life, self-rated communication ability, adherence to use, and willingness to pay for the amplification devices (measured 3 months after fitting). RESULTS: Clear distinctions were observed between all 4 arms. The mean improvement in hearing-related quality of life (Hearing Handicap Inventory for the Elderly) scores was small for control patients (2.2 points) and patients who received an assistive listening device (4.4 points), excellent for patients who received a conventional device (17.4 points), and substantial for patients who received a programmable device (31.1 points) (P<.001 by the analysis of variance test). Qualitative analyses of free-text diary entries, self-reported communication ability (Abbreviated Profile of Hearing Aid Benefit) scores, adherence to hearing aid use, and willingness to pay for replacement devices showed similar trends. CONCLUSIONS: A programmable hearing aid with a directional microphone had the highest level of effectiveness in the veteran population. A nonprogrammable hearing aid with an omnidirectional microphone was also effective compared with an assistive listening device or no amplification.

Can evidence change the rate of back surgery? A randomized trial of community-based education.

CONTEXT: Timely adoption of clinical practice guidelines is more likely to happen when the guidelines are used in combination with adjuvant educational strategies that address social as well as rational influences. OBJECTIVE: To implement the conservative, evidence-based approach to low-back pain recommended in national guidelines, with the anticipated effect of reducing population-based rates of surgery. DESIGN: A randomized, controlled trial. SETTING: Ten communities in western Washington State with annual rates of back surgery above the 1990 national average (158 operations per 100,000 adults). PARTICIPANTS: Spine surgeons, primary care physicians, patients who were surgical candidates, and hospital administrators. INTERVENTION: The five communities randomized to the intervention group received a package of six educational activities tailored to local needs by community planning groups. Surgeon study groups, primary care continuing medical education conferences, administrative consensus processes, videodisc-aided patient decision making, surgical outcomes management, and generalist academic detailing were serially implemented over a 30-month intervention period. OUTCOME MEASURE: Quarterly observations of surgical rates. RESULTS: After implementation of the intervention, surgery rates declined in the intervention communities but increased slightly in the control communities. The net effect of the intervention is estimated to be a decline of 20.9 operations per 100,000, a relative reduction of 8.9% (P = 0.01). CONCLUSION: We were able to use scientific evidence to engender voluntary change in back pain practice patterns across entire communities.

Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects.

STUDY DESIGN: A subanalysis of data derived from a randomized clinical trial was performed. OBJECTIVE: To evaluate the association of a patient's expectation for benefit from a specific treatment with improved functional outcome. SUMMARY OF BACKGROUND DATA: Psychosocial factors, ambiguous diagnoses, and lack of a clearly superior treatment have complicated the management of patients with chronic low back pain. The authors hypothesized that patient expectation for benefit from a specific treatment is associated with improved functional outcomes when that treatment is administered. METHODS: In a randomized trial, 135 patients with chronic low back pain who received acupuncture or massage were studied. Before randomization, study participants were asked to describe their expectations regarding the helpfulness of each treatment on a scale of 0 to 10. The primary outcome was level of function at 10 weeks as measured by the modified Roland Disability scale. RESULTS: After adjustment for baseline characteristics, improved function was observed for 86% of the participants with higher expectations for the treatment they received, as compared with 68% of those with lower expectations (P = 0.01). Furthermore, patients who expected greater benefit from massage than from acupuncture were more likely to experience better outcomes with massage than with acupuncture, and vice versa (P = 0.03). CONCLUSIONS: The results of this study suggest that patient expectations may influence clinical outcome independently of the treatment itself. In contrast, general optimism about treatment, divorced from a specific treatment, is not strongly associated with outcome. These results may have important implications for clinical trial design and recruitment, and may help to explain the apparent success of some conventional and alternative therapies in trials that do not control for patient expectations. The findings also may be important for therapy choices made in the clinical setting.

Formal education and back pain: a review.

OBJECTIVES: To summarise the scientific evidence on the relation between educational status and measures of the frequency and the consequences of back pain and of the outcomes of interventions among back pain patients, and to outline possible mechanisms that could explain such an association if found. DESIGN: Sixty four articles published between 1966 and 2000 that documented the association of formal education with back pain were reviewed. MAIN RESULTS: Overall, the current available evidence points indirectly to a stronger association of low education with longer duration and/or higher recurrence of back pain than to an association with onset. The many reports of an association of low education with adverse consequences of back pain also suggest that the course of a back pain episode is less favourable among persons with low educational attainment. Mechanisms that could explain these associations include variations in behavioural and environmental risk factors by educational status, differences in occupational factors, compromised "health stock" among people with low education, differences in access to and utilisation of health services, and adaptation to stress. Although lower education was not associated with the outcomes of interventions in major studies, it is difficult, in light of the current limited available evidence, to draw firm conclusions on this association. CONCLUSION: Scientific evidence supports the hypothesis that less well educated people are more likely to be affected by disabling back pain. Further study of this association may help advance our understanding of back pain as well as understanding of the relation between socioeconomic status and disease as a general phenomenon.

The Longitudinal Assessment of Imaging and Disability of the Back (LAIDBack) Study: baseline data.

STUDY DESIGN: Prospective cohort study of randomly selected Veterans Affairs (VA) outpatients. OBJECTIVE: To determine the prevalence of magnetic resonance imaging (MRI) findings in the lumbar spine among persons without current low back pain or sciatica and to examine which findings are related to age or previous back symptoms. SUMMARY OF BACKGROUND INFORMATION: Previous studies of patients without low back pain have not explored the possible association of various MRI findings to past symptoms. METHODS: We randomly selected an age-stratified sample of subjects without low back pain in the past 4 months from clinics at a VA hospital. We collected information on demographics, comorbidity, functional status, and quality of life. MR images were obtained using a standardized protocol through each of the five lumbar disc levels. RESULTS: Of 148 subjects, 69 (46%) had never experienced low back pain. There were 123 subjects (83%) with moderate to severe desiccation of one or more discs, 95 (64%) with one or more bulging discs, and 83 (56%) with loss of disc height. Forty-eight subjects (32%) had at least one disc protrusion and 9 (6%) had one or more disc extrusions. CONCLUSION: Many MR imaging findings have a high prevalence in subjects without low back pain. These findings are therefore of limited diagnostic use. The less common findings of moderate or severe central stenosis, root compression, and extrusions are likely to be diagnostically and clinically relevant.

Surgical and nonsurgical management of sciatica secondary to a lumbar disc herniation: five-year outcomes from the Maine Lumbar Spine Study.

STUDY DESIGN: A prospective cohort study. OBJECTIVE: To assess 5-year outcomes for patients with sciatica caused by a lumbar disc herniation treated surgically or nonsurgically. SUMMARY OF BACKGROUND DATA: There is limited knowledge about long-term treatment outcomes of sciatica caused by a lumbar disc herniation, particularly the relative benefits of surgical and conservative therapy in contemporary clinical practice. METHODS: Eligible, consenting patients recruited from the practices of orthopedic surgeons, neurosurgeons, and occupational medicine physicians throughout Maine had baseline interviews with mailed follow-up questionnaires at 3, 6, and 12 months and annually thereafter. Clinical data were obtained at baseline from a physician questionnaire. Outcomes included patient-reported symptoms of leg and back pain, functional status, satisfaction, and employment and compensation status. RESULTS: Of 507 patients initially enrolled, 5-year outcomes were available for 402 (79.3%) patients: 220 (80%) treated surgically and 182 (78.4%) treated nonsurgically. Surgically treated patients had worse baseline symptoms and functional status than those initially treated nonsurgically. By 5 years 19% of surgical patients had undergone at least one additional lumbar spine operation, and 16% of nonsurgical patients had opted for at least one lumbar spine operation. Overall, patients treated initially with surgery reported better outcomes. At the 5-year follow-up, 70% of patients initially treated surgically reported improvement in their predominant symptom (back or leg pain) versus 56% of those initially treated nonsurgically (P < 0.001). Similarly, a larger proportion of surgical patients reported satisfaction with their current status (63% vs. 46%, P < 0.001). These differences persisted after adjustment for other determinants of outcome. The relative advantage of surgery was greatest early in follow-up and narrowed over 5 years. There was no difference in the proportion of patients receiving disability compensation at the 5-year follow-up. The least symptomatic patients at baseline did well regardless of initial treatment, although function improved more in the surgical group. CONCLUSIONS: For patients with moderate or severe sciatica, surgical treatment was associated with greater improvement than nonsurgical treatment at 5 years. However, patients treated surgically were as likely to be receiving disability compensation, and the relative benefit of surgery decreased over time.

Racial differences in the use of lumbar spine radiographs: results from the Veterans Health Study.

STUDY DESIGN: We analyzed data from the Veterans Health Study, a longitudinal study of male patients receiving VA ambulatory care. OBJECTIVE: To determine whether clinical differences and/or race account for disparities between white and nonwhite patients in the use of lumbar spine radiographs. SUMMARY AND BACKGROUND DATA: Four hundred one patients with low back pain (LBP) receiving ambulatory care services in four VA outpatient clinics in the greater Boston area were followed for 12 months. METHODS: Participants were mailed the Medical Outcome Study Short Form Health Survey (SF-36) and had scheduled interviews that included the completion of a low back questionnaire, a comorbidity index, and a straight leg raising (SLR) test. Using self-reported racial data, patients were grouped as whites (315 patients) and nonwhites (among whom 22 were black, 4 nonwhite Hispanics, and 1 other race). RESULTS: Nonwhite patients had lumbar spine films more often (13 of 27, 48%) than white patients (87 of 315, 27%)(P = 0.02). Nonwhite patients had higher pain intensity scores than white patients (63 +/- 21 vs. 48 +/- 21, P < 0.01) and were more likely to have radiating leg pain (20 of 27, 76%; compared with 171 of 315, 55%; P = 0.01) than white patients. Nonwhite patients had worse physical functioning (P = 0.01), general health perception (P = 0.05), social functioning (P = 0.02), and role limitations because of emotional problems (P < 0.01). At higher LBP intensity level, nonwhite patients received more lumbar spine films (20 of 27, 74%) than did white patients (155 of 315, 50%)(P < 0.01). Among patients with positive SLR test, nonwhite patients also had lumbar spine films more often (5 of 22, 23%) than white patients (29 of 315, 11%) (P < 0.01). However, after adjusting for multiple clinical characteristics, race was no longer found to be an independent predictor of lumbar spine radiograph use. A positive SLR test remained to be associated with higher radiograph use, whereas better mental health status was associated with lower radiograph use. CONCLUSIONS: There was greater use of lumbar spine radiographs by nonwhite patients compared with white patients. This remained true when patients were subcategorized by severity of LBP or SLR test. However, race had no influence when multiple clinical characteristics of the patients were controlled for simultaneously. This study demonstrates the importance of careful and comprehensive case-mix adjustment when assessing apparent differences in the use of medical services.

Randomized trial comparing traditional Chinese medical acupuncture, therapeutic massage, and self-care education for chronic low back pain.

BACKGROUND: Because the value of popular forms of alternative care for chronic back pain remains uncertain, we compared the effectiveness of acupuncture, therapeutic massage, and self-care education for persistent back pain. METHODS: We randomized 262 patients aged 20 to 70 years who had persistent back pain to receive Traditional Chinese Medical acupuncture (n = 94), therapeutic massage (n = 78), or self-care educational materials (n = 90). Up to 10 massage or acupuncture visits were permitted over 10 weeks. Symptoms (0-10 scale) and dysfunction (0-23 scale) were assessed by telephone interviewers masked to treatment group. Follow-up was available for 95% of patients after 4, 10, and 52 weeks, and none withdrew for adverse effects. RESULTS: Treatment groups were compared after adjustment for prerandomization covariates using an intent-to-treat analysis. At 10 weeks, massage was superior to self-care on the symptom scale (3.41 vs 4.71, respectively; P =.01) and the disability scale (5.88 vs 8.92, respectively; P<.001). Massage was also superior to acupuncture on the disability scale (5.89 vs 8.25, respectively; P =.01). After 1 year, massage was not better than self-care but was better than acupuncture (symptom scale: 3.08 vs 4.74, respectively; P =.002; dysfunction scale: 6.29 vs 8.21, respectively; P =.05). The massage group used the least medications (P<.05) and had the lowest costs of subsequent care. CONCLUSIONS: Therapeutic massage was effective for persistent low back pain, apparently providing long-lasting benefits. Traditional Chinese Medical acupuncture was relatively ineffective. Massage might be an effective alternative to conventional medical care for persistent back pain.

Evaluating and managing acute low back pain in the primary care setting.

Acute low back pain is a common reason for patient calls or visits to a primary care clinician. Despite a large differential diagnosis, the precise etiology is rarely identified, although musculoligamentous processes are usually suspected. For most patients, back symptoms are nonspecific, meaning that there is no evidence for radicular symptoms or underlying systemic disease. Because episodes of acute, nonspecific low back pain are usually self-limited, many patients treat themselves without contacting their primary care clinician. When patients do call or schedule a visit, evaluation and management by primary care clinicians is appropriate. The history and physical examination usually provide clues to the rare but potentially serious causes of low back pain, as well as to identify patients at risk for prolonged recovery. Diagnostic testing, including plain x-rays, is often unnecessary during the initial evaluation. For patients with acute, nonspecific low back pain, the primary emphasis of treatment should be conservative care, time, reassurance, and education. Current recommendations focus on activity as tolerated (though not active exercise while pain is severe) and minimal if any bed rest. Referral for physical treatments is most appropriate for patients whose symptoms are not improving over 2 to 4 weeks. Specialty referral should be considered for patients with a progressive neurologic deficit, failure of conservative therapy, or an uncertain or serious diagnosis. The prognosis for most patients is good, although recurrence is common. Thus, educating patients about the natural history of acute low back pain and how to prevent future episodes can help ensure reasonable expectations.

Finding cancer in primary care outpatients with low back pain: a comparison of diagnostic strategies.

OBJECTIVE: To compare strategies for diagnosing cancer in primary care patients with low back pain. Strategies differed in their use of clinical findings, erythrocyte sedimentation rate (ESR), and plain x-rays prior to imaging and biopsy. DESIGN: Decision analysis and cost effectiveness analysis with sensitivity analyses. Strategies were compared in terms of sensitivity, specificity, and diagnostic cost effectiveness ratios. SETTING: Hypothetical MEASUREMENTS: Estimates of disease prevalence and test characteristics were taken from the literature. Costs were represented by the Medicare reimbursement for the tests and procedures employed. MAIN RESULTS: In the baseline analysis, using magnetic resonance imaging (MRI) as the imaging procedure prior to a single biopsy, strategies ranged in sensitivity from 0.40 to 0.73, with corresponding diagnostic costs of $14 to $241 per patient and average cost effectiveness ratios of $5,283 to $49,814 per case of cancer found. Incremental cost effectiveness ratios varied from $8,397 to $624,781; 5 strategies were dominant in the baseline analysis. Use of a higher ESR cutoff point (50 mm/hr) improved specificity and cost effectiveness for certain strategies. Imaging with MRI, or bone scan followed in series by MRI, resulted in a fewer unnecessary biopsies than imaging with bone scan alone. Cancer prevalence was an important determinant of cost effectiveness. CONCLUSIONS: We recommend a strategy of imaging patients who have a clinical finding (history of cancer, age > or = 50 years, weight loss, or failure to improve with conservative therapy) in combination with either an elevated ESR (> 50 mm/hr) or a positive x-ray, or using the same approach but imaging directly those patients with a history of cancer.

Helping patients decide about back surgery: a randomized trial of an interactive video program.

STUDY DESIGN: A randomized trial of 100 patients with low back pain who were potential surgical candidates. OBJECTIVES: To determine whether an interactive videodisc with a booklet is superior to a booklet alone for informing patients about back surgery. SUMMARY OF BACKGROUND DATA: Substantial geographic variation has been observed in lumbar spine surgery. Informed patient preferences should play an important role in decisions about surgery. However, little is known about optimal strategies for informing patients. METHODS: Subjects were randomized to receive an interactive videodisc (with a booklet) or a booklet alone. A knowledge test administered at baseline and follow-up was used to measure improvement in knowledge about treatment options for lumbar spine problems. Patients' reactions to the videodisc and booklet and preferences for treatment were also assessed. RESULTS: The patients' knowledge improved after exposure to either intervention. Multivariate analyses adjusted for baseline score, age, education, gender, and diagnosis showed a significant advantage for the videodisc with booklet over the booklet alone. The videodisc-booklet group showed significantly greater gains in knowledge among subjects with the worst baseline knowledge scores. A larger proportion of subjects in the videodisc-booklet group rated the materials easy to understand (93% vs.- 72%,P = 0.04), containing the right amount of information (93% vs.- 80%,P = 0.3), and adequate to assist in choice of treatment (75% vs.- 51%,P = 0.2). Those who viewed the videodisc expressed a somewhat lower preference for surgery than those who received the booklet alone (23% vs.- 42%,P = 0.4). CONCLUSIONS: Both the booklet alone and the combination of videodisc and booklet improved knowledge. The combination produced greater knowledge gains than the booklet alone for the subgroup with the least knowledge at baseline. Patients preferred the combination and had a slightly lower preference for surgery if they had viewed the video presentation. For some patients, the video may enhance involvement in clinical decisions.

Measuring quality of life in children with obstructive sleep disorders.

OBJECTIVE: To validate a disease-specific health-related quality of life (HRQOL) instrument for children with obstructive sleep disorders (OSDs). DESIGN: Prospective cohort study using a 6-item health-related instrument (OSD-6). SUBJECTS: One hundred caregivers of patients with OSDs secondary to adenotonsillar hypertrophy (age range, 2-12 years) from 2 tertiary care, pediatric otolaryngology practices. INTERVENTION: The OSD-6 was administered on initial presentation and 4 to 5 weeks after adenotonsillectomy. A subset of patients repeated the OSD-6 within 3 weeks after presentation to assess test-retest reliability. MAIN OUTCOME MEASURES: Test-retest reliability, internal consistency, construct validity, and responsiveness to clinical change of the OSD-6 score. RESULTS: Test-retest reliability was good (intraclass correlation coefficient = 0.74). Median OSD-6 score was 4.5 (0- to 6-point scale) with higher scores indicating poorer quality of life (QOL). Construct validity was demonstrated by the moderate correlation between OSD-6 score and global adenoid and tonsil-related QOL (R = -0.62), strong correlation between the OSD-6 change score and change in global adenoid and tonsil-related QOL (R = -0.63), and the moderate correlation between the change score and parent estimate of clinical change (R = 0.40). The mean change in OSD-6 score after adenotonsillectomy was 3.0 (95% confidence interval, 2.7-3.4). The mean standardized response was 2.3 (95% confidence interval, 1.9-2.7) indicating the instrument's large responsiveness to clinical change. The change score was very reliable (R = 0.85). CONCLUSIONS: The OSD-6 is a reliable, responsive, easily administered instrument. It is valid for detecting change after adenotonsillectomy in children with OSDs. Arch Otolaryngol Head Neck Surg. 2000;126:1423-1429