SF-36 health status of workers compensation cases with spinal disorders.

BACKGROUND CONTEXT: Poorer outcomes of treatment are reported in patients with spinal disorders who receive workers compensation. The reason for their suboptimal outcomes is unclear. No study has examined the relationship between workers compensation and the Short Form Health Survey (SF-36) health status of patients with spinal disorders. PURPOSE: To compare the self-perceived health status of spinal disorder patients receiving workers compensation with those not receiving workers compensation. STUDY DESIGN/SETTING: A cross-sectional study on 18,389 patients who were evaluated in the 28 centers comprising the National Spine Network. PATIENT SAMPLE: The study data were derived from patients when first evaluated for back or neck pain between January 1998 and April 2000. OUTCOME MEASURES: The outcome measures used were the eight individual and two component scores of the SF-36. METHODS: All first-visit patients enrolled in the National Spine Network from January 1998 to April 2000 were reviewed. Eight individual scores and two component scores of the SF-36 were compared. RESULTS: Of the 18,389 patients, 1,535 (8%) were receiving workers compensation. Bivariate analyses showed all eight individual scores, and two summary scores of the SF-36 were significantly lower (p<.0001) in patients receiving workers compensation. After controlling for confounding covariates, workers compensation status was a significant predictor of lower SF-36 scores for General Health (p<.0001), Physical Functioning (p<.0001), Role Physical (p<.01), Social Functioning (p<.05), and Mental Health (p<.05). CONCLUSIONS: Workers compensation status is associated with poorer physical and mental health of patients with spinal disorders. Because the workers compensation group is younger, has a shorter duration of symptoms, and fewer comorbid medical problems, the lower SF-36 scores most likely reflect psychological factors and not ill health per se. The lower SF-36 scores may also reflect premorbid personality differences in the workers compensation patients, compared with those not receiving workers compensation. SF-36 is a validated tool that can be used to objectively identify the patient at risk for delayed recovery. Future treatment protocols should pay special attention to improve the health-related quality of life, especially general health and physical functioning of spinal patients receiving workers compensation.     

Gender-related differences in treatment outcomes for patients with musculoskeletal disorders.

BACKGROUND CONTEXT: Clinicians have long hypothesized that gender may be a risk factor in treatment outcomes of patients with chronic disability associated with musculoskeletal disorders. Although the scientific literature shows a higher prevalence of occupational low back injury in men, and a higher rate of repetitive motion and neck injuries in women, few studies have comprehensively investigated the role of gender regarding cost-related outcome variables of significance after work-related injuries. PURPOSE: This study was designed to examine the relationship between gender and biopsychosocial treatment outcomes in a predominately chronically disabled spinal disorder (CDSD) workers' compensation cohort undergoing a tertiary functional restoration program. STUDY DESIGN: A prospective comparison cohort study investigating the effect of gender on biopsychosocial treatment outcomes as risk factors for rehabilitation failure. PATIENT SAMPLE: A cohort of 1,827 consecutively treated patients with CDSD were placed into two gender-based groups: men (n=1,158, average age 40.7+/-10 years) and women (n=669, average age 42.5+/-10 years). OUTCOME MEASURES: Before the start of the program, and again upon completion of the program, all patients received a standard psychosocial assessment and were assessed on a variety of physical factors (leading to a cumulative score, calculated on the basis of the aggregates and averages of these physical measures). A structured clinical interview examining socioeconomic outcomes was conducted at 1 year after program completion, and at least partial information was obtained from this interview on all patients in the present study. METHODS: All patients underwent a medically directed functional restoration program combining quantitatively guided exercise progression with a multimodal disability management approach using psychological and case management techniques. RESULTS: Men had a significantly higher rate of lumbar injury than women, whereas women had a significantly higher rate of cervical injury. Men returned to work and retained work at a 40 hours/week job at a higher rate at 1-year follow-up. Women evidenced a higher rate of health care-seeking behaviors from new providers. On physical testing immediately after treatment, men had a significantly higher cumulative physical score (gender normalized), both before and after treatment. On depression and disability questionnaires, men showed fewer pre- and posttreatment depressive symptoms with lower pretreatment disability scores. CONCLUSIONS: The present study represents the first large-scale examination of the relationship between gender and treatment outcomes for a population with CDSD after work injuries. There was a pattern of moderately better 1-year posttreatment socioeconomic outcome for men. On psychosocial measures, men showed lower disability and depression scores than women, with higher levels of physical functioning both before and after treatment. Overall, male patients with CDSD appeared to show somewhat better biopsychosocial outcomes. This leaves the question of identifying gender-specific risk factors to explain these differences.     

Quality of life assessment before and after lumbar disc surgery

Background Although operative treatment for lumbar disc herniation is a commonly performed neurosurgical procedure, no reports have described whether health-related quality of life before surgery affects the operative treatment outcome. This prospective study assessed health-related quality of life before and after surgery and evaluated the predictor variables affecting outcomes. Methods Subjects were 45 consecutive candidates for lumbar disc herniation surgery who gave informed consent. The Medical Outcomes Study Short Form 36 (SF-36) and 15-point Japanese Orthopaedic Association (JOA) score were evaluated before and after surgery, and the magnitude of the effect was calculated. The possible predictor variables for outcomes were physical functioning, role physical, bodily pain, general health, vitality, social functioning; role emotional and mental health from the SF-36 subscales; subjective symptoms and clinical signs from the JOA scores; and the patient's age, sex, occupation, and history of low back pain and/or leg pain. Results Four patients were excluded from the analyses because they were lost to follow-up within 1 year after operation. All subscales of the SF-36 and JOA scores increased significantly at 6 months and 1 year of follow-up with a maximum effect size in bodily pain and a minimal in general health. Operation results were 29 good, 11 fair, and 1 poor. The selected predictor variables affecting the outcomes were patient age and social functioning on SF-36. Conclusions Surgery for lumbar disc herniation improved health-related quality of life. Patients <50 years old with a <60 score in social functioning on SF-36 were considered good candidates.     

Smoking status and psychosocioeconomic outcomes of functional restoration in patients with chronic spinal disability.

BACKGROUND CONTEXT: Studies have revealed smoking to have a negative impact on spinal surgery. It is assumed that this is the result of the negative impact of nicotine on revascularization of damaged tissue. However, there is a paucity of research on the role of smoking with regard to nonsurgical rehabilitation, but there exists a clear bias for believing that smoking is strongly associated with poor socioeconomic and psychosocial outcome. PURPOSE: This study was designed to examine the relationship between smoking and outcomes in a chronically disabled work-related spinal disorder (CDWRSD) cohort undergoing functional restoration. STUDY DESIGN: A prospective comparison cohort study investigating the effects of smoking status on functional restoration treatment outcomes. PATIENT SAMPLE: A cohort of 1,141 consecutive CDWRSD patients were divided into four groups: Group A, patients who did not smoke (n=710); Group B, patients who smoked less than one cigarette pack/day (n=157); Group C, patients who smoked 1.0 to 1.9 packs/day (n=218); Group D, patients who smoked 2.0 or more packs/day (n=56). OUTCOME MEASURES: Before the start of functional restoration, and upon its completion, patients received a standard psychosocial assessment battery and were assessed on a variety of physical factors. A structured clinical interview examining socioeconomic outcomes was conducted 1 year after the program. METHODS: Patients underwent an intensive functional restoration chronic pain management rehabilitation program consisting of quantitatively directed exercise progression and a multimodal disability management program for CDWRSD. The program consisted of four phases, the most significant of which involved a 3-week full-day intensive phase after preparatory preprogram phases and before a work transition phase. RESULTS: Analysis revealed that the percent of males increased as the smoking level increased (Group A=51.8% vs Group D=73.2%; p<.001). Also, as smoking increased, the level of education significantly decreased. In addition, as smoking level increased, the percent of patients completing the rehabilitation program decreased (from 86.3% to 75%; p=.03). No significant differences in 1-year posttreatment socioeconomic outcomes of work status, health utilization, recurrent injury or case closure were related to smoking except work retention, which decreased with more smoking (85 to 71%, p<.05). Surprisingly, the physical cumulative score at posttreatment increased as smoking frequency increased (p<.01). This finding indicates that those who smoked more performed at a higher level on physical measures. Those who smoked more frequently before treatment also appeared more depressed (p<.001), but after treatment, these differences disappeared. Self-reported pain intensity differed only after treatment, and posttreatment disability ratings showed a significant linear trend. CONCLUSIONS: Contrary to popular belief, CDWRSD patients who smoke do not differ significantly in socioeconomic or psychosocial outcomes relative to those who do not. Although this study does indicate that those who smoke more evidence lower rehabilitation completion rates, those who completed the program had identical 1-year posttreatment outcomes of socioeconomic importance except in retraining work at year end as those who did not smoke. Smokers had slightly higher posttreatment self-reported pain and disability ratings mixed and limited. Overall, there is evidence for the widely held belief that smoking negatively affects tertiary rehabilitation.     

Testing minimal clinically important difference: consensus or conundrum?

Background ContextVarious methodologies have been used in attempting to elucidate a standard method for calculating minimal clinically important difference (MCID). A consensus-based decision (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMMPACT] group) suggested a 30% reduction from baseline as a means to define the MCID of self-report back pain measures. Additionally, important psychometric issues need to be addressed regarding use of an independent measure of the same construct as an external criterion, instead of simply using another self-report measure, when using an anchor-based approach to MCID.PurposeThe purpose was to test the validity of recently published guidelines regarding MCID using self-report back pain measures and objective socioeconomic outcomes.Study Design/SettingThis is a prospective study assessing change scores on commonly used spinal pain assessment measures in patients with chronic disabling occupational spinal disorders (CDOSDs) treated in a regional referral rehabilitation center performing interdisciplinary functional restoration.Patient SampleThe study consisted of consecutive cohort of patients (N=1,180) with CDOSDs completing a functional restoration program.Outcomes MeasuresSelf-report measures including the Oswestry Disability Index (ODI) and the physical component summary (PCS) and mental component summary (MCS) of the Short Form-36 (SF-36) obtained before and after treatment, were compared with objective socioeconomically relevant outcomes obtained 1 year after treatment (ie, work status and additional health-care utilization), that were the external criteria for evaluating MCID.MethodsPre- to posttreatment improvement was calculated separately for each measure, and subjects were divided into two groups based on the change in scores relative to baseline: 30% or greater versus less than 30% improvement. One-year posttreatment objective socioeconomic outcomes were used as independent external criteria relevant to the CDOSD population. This population is often studied as the most costly and problematic cohort in spine care.ResultsThe ODI and SF-36 MCS were not associated with any of the objective 1-year outcomes used as external criteria. Reduced post-rehabilitation health-care utilization (based on the percentage of patients pursuing health care from a new provider) was weakly associated with 30% or greater improvement on the SF-36 PCS, relative to patients whose scores changed by less than 30% relative to baseline (17.0% vs. 21.1%). The same was true for the ODI and return-to-work.ConclusionsWhen objective and independent criteria are used (socioeconomic outcomes) in a CDOSD cohort, the 30% improvement in the ODI and SF-36 may not be a valid MCID index. This replicates similar conclusions made by an independent research group using a distribution-based approach to MCID. The validity of the MCID concept rests on future research using objective external criteria. Moreover, there remains a question whether the term “important” in MCID can be unequivocally and operationally defined as a reliable construct.     

Improved health-related quality of life and left ventricular hypertrophy among dialysis patients treated with parathyroidectomy

BACKGROUND: We prospectively studied changes in the perception of health-related quality of life, pruritus, and degree of left ventricular hypertrophy in end-stage renal disease patients with tertiary hyperparathyroid disorder, before and 6 months after total parathyroidectomy treatment. METHODS: A series of 12 consecutive patients were enrolled. Throughout the follow-up period, all subjects completed the Kidney Disease Quality of Life Short Form-36 (KDQOL SF-36) questionnaire at inclusion and after 6 months. Serial clinical and physiological parameters including uremic pruritus, blood pressure control and left ventricular hypertrophy measured by echocardiography were recorded. RESULTS: Mean scores of the KDQOL SF-36 questionnaires were substantially higher 6 months after parathyroidectomy, with reference to physical functioning, bodily pain, role-physical, role-emotional, symptom list and burden of kidney disease. Parathyroidectomy resulted in a 22% reduction in left ventricular mass index, with significant improvement from the baseline value of 246 +/- 131 to 192 +/- 131 g/m2 (p = 0.03). CONCLUSION: Our findings highlight the potential importance of parathyroidectomy in improving health-related quality of life and left ventricular hypertrophy among dialysis patients with tertiary hyperparathyroidism.     

Prospective analysis of clinical evaluation and self-assessment by patients after decompression surgery for degenerative lumbar canal stenosis.

BACKGROUND CONTEXT: Objective measures including neurological findings, radiographic evaluation, and the Japanese Orthopaedic Association (JOA) score are commonly used for the evaluation of surgical outcomes. Because many surgeries are performed primarily to improve quality of life, a patient's subjective evaluations are also important for accurately assessing surgical outcomes. Currently available instruments for assessing quality of life include the Short-Form 36 (F-36), the Oswestry disability index (ODI), and the visual analog scale (VAS) clinical pain scale. PURPOSE: The aims of this study were to measure surgical outcomes by using both objective measures and subjective measures including patient self-assessments and psychological changes; to assess the adequacy of the JOA alone for measuring outcome; and to determine which measures, the SF-36v2, ODI, VAS, or JOA correlate with the VAS pain scale score in lumbar canal stenosis. STUDY DESIGN: We performed a prospective study to measure surgical outcomes for lumbar canal stenosis using traditional objective measures such as neurological findings and subjective measures such as performance of ADLs, patient self-assessments, and psychological changes. PATIENT SAMPLE: Forty-two surgical patients with a mean age of 66.8+/-10.9 years at the time of surgery were included in the study. All cases were followed for more than 2 years. Surgical indications included no response to conservative treatment and neurological deterioration. Neurological symptoms were classified as nerve root type, cauda equine type, or combined type. We performed surgical decompression at the location of the dural or root indentation by myelography. The concomitant diagnosis causing the spinal stenosis was degenerative spondylolisthesis in 20 cases undergoing posterolateral fusion with pedicle screws. OUTCOME MEASURES: Surgical outcomes were assessed by comparing preoperative and 24-month postoperative JOA scores for low back pain, SF-36v2, ODI-v2, and VAS scores. Statistical analysis was performed by using the analysis of variance. A p value<0.05 was considered statistically significant. METHODS: Objective clinical measures, patient self-assessments, and psychological changes were measured before and at 24 months postoperatively. We also examined which measurements correlated with the VAS scale for pain evaluation, thereby relating patient satisfaction to surgery outcome. RESULTS: All JOA, SF-36v2, ODI-v2, and VAS scores significantly improved postoperatively. The physical component summary (PCS) of the SF-36 v2 showed significant improvement, although all scores remained less than the Japanese norm-based scores (NBSs). The mental component summary (MCS) exhibited such a significant improvement that all postoperative subscales were higher than the Japanese NBS. JOA scores significantly correlated only with postoperative lower-extremity VAS score. All PCS and two MCS scores significantly correlated with the VAS score for low back pain. Parts of the PCS and MCS significantly correlated with the lower-extremity VAS. The ODI significantly correlated with both the preoperative and postoperative VAS scores for low back pain as well as with the postoperative lower-extremity VAS score. CONCLUSIONS: The JOA, SF-36, ODI, and VAS questionnaires are all useful instruments for measuring surgical outcomes. The VAS score is a better assessment of physical rather than mental health. The ODI is more reflective of patients' subjective symptoms. Finally, the SF-36 is particularly informative because it includes questions addressing both psychological and physical status. Therefore, when combined, the SF-36v2, VAS, and ODI scores are a valuable complement to the JOA scores in evaluating outcomes of surgery for lumbar canal stenosis.     

Impact of functional restoration after anterior cervical fusion on chronic disability in work-related neck pain.

BACKGROUND CONTEXT: Spinal surgery in the workers compensation population shows evidence of less favorable outcomes than in general health cases. Although spine surgery has been alleged to be a cause of poor outcomes, such outcomes may be improved by appropriate postsurgical rehabilitation. PURPOSE: To compare objective demographic, physical and psychological measurements and socioeconomic outcomes of treatment in work-related disabling cervical pain for the combination of anterior cervical fusion (ACF) plus functional restoration, compared with rehabilitation alone. STUDY DESIGN/SETTING: A prospective study of patients undergoing ACF for degenerative disc disease before rehabilitation for work-related musculoskeletal disorders versus neck pain unoperated controls, with data collected in an outpatient tertiary interdisciplinary rehabilitation setting. PATIENT SAMPLE: A group of 52 patients completed a functional restoration treatment program after undergoing ACF (Group S) at one or two levels for degenerative cervical disc disease. During the study period, 625 patients with work-related neck pain were identified from the same study population, from which a rehabilitation (Group R) comparison group (n=150) was identified who were stratified according to the number and location of other compensable body parts. OUTCOME MEASURES: Socioeconomic outcomes relevant to chronic disabling work-related cervical spinal disorders are reported based on 1-year posttreatment interviews. Pre- to posttreatment assessment of pain intensity, disability, depression and cumulative physical capability were assessed prospectively. METHODS: All patients were totally or partially disabled before completing an intensive, medically supervised, functional restoration program combining quantitatively directed exercise progression with a multimodal disability management approach. Preprogram preparation included drug detoxification, psychotropic medication management and preparatory aerobic and mobility training. The intensive treatment phase involved strength and endurance training, with counseling geared to goals of work return and fitness maintenance. The 1-year structured clinical interview had a contact rate of 93% to 95%, and partial information acquisition on all patients. RESULTS: Although Group S had lower work return and work retention outcomes, the differences were not significant. Group S patients had significantly more health utilization from a new provider in the year after completion of functional restoration (46% vs 24%; OR=2.7 [1.3, 5.3], p<.004). Group S patients were also more likely to be depressed, both at pre- and postrehabilitation. There were no significant differences in recurrent injury, additional surgery, physical measures or pain/disability self-report between the groups. CONCLUSIONS: Workers compensation patients with chronic disabling work-related cervical spinal disorders who undergo a cervical fusion, combined with functional restoration, have socioeconomic outcomes after their surgery statistically similar to those for unoperated controls. Surgery patients had a higher rate of additional health-care-seeking behaviors from new providers and a greater likelihood of being clinically depressed before and after rehabilitation. This study suggests that cervical fusion for degenerative disc disease in workers compensation patients is not contraindicated, as long as interdisciplinary rehabilitation is available for complex cases after the surgical procedure.     

Health-related quality of life in patients with spinal dural arteriovenous fistulae

Neurological improvement in patients with spinal dural arteriovenous fistulae (SDAVF) is often partial even after adequate treatment. While treatment outcomes have been evaluated primarily on the basis of the postoperative changes in neurological deficits, outcome measures should also reflect the patient-reported outcome (PRO). We conducted a health-related quality of life (HRQOL) survey in 52 SDAVF patients; 33 (63.5%) completed the short-form 36 Health Survey (SF-36) questionnaire. They were 25 males and 8 females ranging in age from 47 to 85 years (mean age 70.0 years). The mean follow-up period was 95.6 months. We analyzed the completed questionnaires and examined the clinical factors associated with their HRQOL. After treatment, gait- and micturition disturbances persisted in 31 (93.9%) and 31 (93.9%) of our patients; 26 (78.8%) reported chronic leg pain. The SF-36 scores of treated SDAVF patients were significantly lower than the national average of 50 for all 8 sub-items in the questionnaire. The scores for physical functioning (PF) and role-physical (RP) were particularly low. With the exception of bodily pain (BP), there was a significant negative correlation between the Aminoff-Logue scale (ALS) scores for gait- and micturition and the sub-item scores. The score for BP showed a significant positive correlation with the scores for the 7 other SF-36 sub-items. The HRQOL of treated SDAVF patients was lower than the national average with respect to both physical and mental aspects. Persistent post-treatment pain and gait- and micturition disturbances were responsible for their lower HRQOL.     

Correlation of SF-12 and SF-36 in a trauma population

BACKGROUND: The SF-36 is a commonly used general measure of health-related quality of life (QoL). The SF-12 is a related tool with less response burden, but its performance in a general trauma population is unknown. Hypothesis: The SF-12 would provide similar QoL information to the SF-36 in blunt trauma patients. METHODS: Adults with nonneurological blunt injury were prospectively enrolled. Demographic, injury, and socioeconomic data were collected. Patients were assessed with functional and psychologic questionnaires 1 and 6 months after injury. Physical (PCS) and mental (MCS) component scores of the SF-36 and SF-12 were compared using Pearson's correlation coefficient. Linear regression identified factors associated with the SF-12 and SF-36 PCS and MCS. Responsiveness to change was assessed using the standardized response mean. RESULTS: Correlation of the PCS was 0.924 and MCS was 0.925 (both P < 0.001). QoL remained below population norms at 6 months. PCS was moderately responsive to change and was equivalent using either the SF-12 or the SF-36. MCS was not responsive to change using either tool. At both time points, at least 25% of patients with normal SF-12 PCS or MCS had SF-36 subscale scores significantly below the normal population. CONCLUSIONS: The SF-12 can be used to assess QoL in trauma patients. The lack of responsiveness to change of the MCS suggests other methods may be necessary to fully evaluate mental QoL. Summary scores may not be sufficient to fully assess QoL in this population. Combining the SF-12 with measures to assess psychosocial variables should be further investigated.     

Health-related quality-of-life outcomes after thoracic (T1–T10) fractures

Background contextThe thoracic spine exhibits a unique response to trauma as the result of recognized anatomical and biomechanical differences. Despite this response, clinical studies often group thoracic fractures (T1–T10) with more caudal thoracolumbar injuries. Subsequently, there is a paucity of literature on the functional outcomes of this distinct group of injuries.PurposeTo describe and identify predictors of health-related quality-of-life outcomes and re-employment status in patients with thoracic fractures who present to a spine injury tertiary referral center.Study designAn ambispective cohort study with cross-sectional outcome assessment.Patient sampleA prospectively collected fully relational spine database was searched to identify all adult (>16 years) patients treated with traumatic thoracic (T1–T10) fractures with and without neurologic deficits, treated between 1995 and 2008.Outcome measuresThe Short-Form-36, Oswestry Disability Index, and Prolo Economic Scale outcome instruments were completed at a minimum follow-up of 12 months. Preoperative and minimum 1-year postinjury X-rays were evaluated.MethodUnivariate and multivariate regression analysis was used to identify predictors of outcomes from a range of demographic, injury, treatment, and radiographic variables.ResultsOne hundred twenty-six patients, age 36±15 years (mean±SD), with 135 fractures were assessed at a mean follow-up of 6 years (range 1–15.5 years). Traffic accidents (45%) and translational injuries (54%) were the most common mechanism and dominant fracture pattern, respectively. Neurologic deficits were frequent—53% had complete (American Spinal Injury Association impairment scale [AIS] A) spinal cord deficits on admission. Operative management was performed in 78%. Patients who sustain thoracic fractures, but escaped significant neurologic injury (AIS D or E on admission) had SF-36 scores that did not differ significantly from population norms at a mean follow-up of 6 years. Eighty-eight percent of this cohort was re-employed. Interestingly, Oswestry Disability Index scores remained inferior to healthy subjects. In contrast, SF-36 scores in those with more profound neurologic deficits at presentation (AIS A, B, or C) remained inferior to normative data. Fifty-seven percent were re-employed, 25% in their previous job type. Using multiple regression analysis, we found that comorbidity status (measured by the Charlson Comorbidity index) was the only independent predictor of SF-36 scores. Neurologic impairment (AIS) and adverse events were independent predictors of the SF-36 physical functioning subscale. Sagittal alignment and number of fused levels were not independent predictors.ConclusionsAt a mean follow-up of 6 years, patients who presented with thoracic fractures and AIS D or E neurologic status recovered a general health status not significantly inferior to population norms. Compared with other neurologic intact spinal injuries, patients with thoracic injuries have a favorable generic health-related quality-of-life prognosis. Inferior outcomes and re-employment prospects were noted in those with more significant neurologic deficits.     

Allergy and health-related quality of life.

OBJECTIVE: We asked patients with allergies to complete the SF-36 Health Survey, a health-related quality-of-life (QOL) measure, to determine the impact of allergy on QOL. Study Design and Setting: In total, 377 adults-140 men (37%) and 237 women (63%)-seen in a tertiary care private neurotologic practice allergy clinic completed the questionnaire before beginning immunotherapy and dietary management. One hundred patients completed both initial and 1-year follow-up questionnaires. The SF-36 measures 8 health concepts ranging from physical to mental health, and scale scores range from 0 to 100. RESULTS: Initial mean scores ranged from a high of 79.1 for the physical functioning scale to a low of 47.2 for the vitality scale, lower (poorer) on all scales than norms for the general US population. Significant improvement occurred from initial to follow-up on all scales. The largest improvements were in role functioning-physical, role functioning-emotional, and social functioning. CONCLUSION: Findings suggest that allergy symptoms can affect QOL and that treatment with specific immunotherapy and/or dietary management may lead to measurable improvements. SIGNIFICANCE: The significant impact of allergy must be recognized, and treatment should be offered. The SF-36 can be used to evaluate treatment outcome.     

The Chiropractic Hospital-based Interventions Research Outcomes (CHIRO) Study: a randomized controlled trial on the effectiveness of clinical practice guidelines in the medical and chiropractic management of patients with acute mechanical low back pain

Background contextEvidence-based clinical practice guidelines (CPGs) for the management of patients with acute mechanical low back pain (AM-LBP) have been defined on an international scale. Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments. To date, the value of implementing full and exclusively CPG-based treatment remains unclear.PurposeTo determine if full CPGs-based study care (SC) results in greater improvement in functional outcomes than family physician–directed usual care (UC) in the treatment of AM-LBP.Study design/settingA two-arm, parallel design, prospective, randomized controlled clinical trial using blinded outcome assessment. Treatment was administered in a hospital-based spine program outpatient clinic.Patient sampleInclusion criteria included patients aged 19 to 59 years with Quebec Task Force Categories 1 and 2 AM-LBP of 2 to 4 weeks’ duration. Exclusion criteria included “red flag” conditions and comorbidities contraindicating chiropractic spinal manipulative therapy (CSMT).Outcome measuresPrimary outcome: improvement from baseline in Roland-Morris Disability Questionnaire (RDQ) scores at 16 weeks. Secondary outcomes: improvements in RDQ scores at 8 and 24 weeks; and in Short Form-36 (SF-36) bodily pain (BP) and physical functioning (PF) scale scores at 8, 16, and 24 weeks.MethodsPatients were assessed by a spine physician, then randomized to SC (reassurance and avoidance of passive treatments, acetaminophen, 4 weeks of lumbar CSMT, and return to work within 8 weeks), or family physician–directed UC, the components of which were recorded.ResultsNinety-two patients were recruited, with 36 SC and 35 UC patients completing all follow-up visits. Baseline prognostic variables were evenly distributed between groups. The primary outcome, the unadjusted mean improvement in RDQ scores, was significantly greater in the SC group than in the UC group (p=.003). Regarding unadjusted mean changes in secondary outcomes, improvements in RDQ scores were also greater in the SC group at other time points, particularly at 24 weeks (p=.004). Similarly, improvements in SF-36 PF scores favored the SC group at all time points; however, these differences were not statistically significant. Improvements in SF-36 BP scores were similar between groups. In repeated-measures analyses, global adjusted mean improvement was significantly greater in the SC group in terms of RDQ (p=.0002), nearly significantly greater in terms of SF-36 PF (p=.08), but similar between groups in terms of SF-36 BP (p=.27).ConclusionsThis is the first reported randomized controlled trial comparing full CPG-based treatment, including spinal manipulative therapy administered by chiropractors, to family physician–directed UC in the treatment of patients with AM-LBP. Compared to family physician–directed UC, full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning.     

Health-related quality of life after different types of solid organ transplantation

OBJECTIVE: To describe functional health and health-related quality of life (QOL) before and after transplantation; to compare and contrast outcomes among liver, heart, lung, and kidney transplant patients, and compare these outcomes with selected norms; and to explore whether physiologic performance, demographics, and other clinical variables are predictors of posttransplantation overall subjective QOL. SUMMARY BACKGROUND DATA: There is increasing demand for outcomes analysis, including health-related QOL, after medical and surgical interventions. Because of the high cost, interest in transplantation outcomes is particularly intense. With technical surgical experience and improved immunosuppression, survival after solid organ transplantation has matured to acceptable levels. More sensitive measures of outcomes are necessary to evaluate further developments in clinical transplantation, including data on objective functional outcome and subjective QOL. METHODS: The Karnofsky Performance Status was assessed objectively for patients before transplantation and up to 4 years after transplantation, and scores were compared by repeated measures analysis of variance. Subjective evaluation of QOL over time was obtained using the Short Form-36 (SF-36) and the Psychosocial Adjustment to Illness Scale (PAIS). These data were analyzed using multivariate and univariate analysis of variance. A summary model of health-related QOL was tested by path analysis. RESULTS: Tools were administered to 100 liver, 94 heart, 112 kidney, and 65 lung transplant patients. Mean age at transplantation was 48 years; 36% of recipients were female. The Karnofsky Performance Status before transplantation was 37 +/- 1 for lung, 38 +/- 2 for heart, 53 +/- 3 for liver, and 75 +/- 1 for kidney recipients. After transplantation, the scores improved to 67 +/- 1 at 3 months, 77 +/- 1 at 6 months, 82 +/- 1 at 12 months, 86 +/- 1 at 24 months, 84 +/- 2 at 36 months, and 83 +/- 3 at 48 months. When patients were stratified by initial performance score as disabled or able, both groups merged in terms of performance by 6 months after liver and heart transplantation; kidney transplant patients maintained their stratification 2 years after transplantation. The SF-36 physical and mental component scales improved after transplantation. The PAIS score improved globally. Path analysis demonstrated a direct effect on the posttransplant Karnofsky score by time after transplantation and diabetes, with trends evident for education and preoperative serum creatinine level. Although neither time after transplantation nor diabetes was directly predictive of a composite QOL score that incorporated all 15 subjective domains, recent Karnofsky score and education level were directly predictive of the QOL composite score. CONCLUSIONS: Different types of transplant patients have a different health-related QOL before transplantation. Performance improved after transplantation for all four types of transplants, but the trajectories were not the same. Subjective QOL measured by the SF-36 and the PAIS also improved after transplantation. Path analysis shows the important predictors of health-related QOL. These data provide clearly defined and widely useful QOL outcome benchmarks for different types of solid organ transplants.     

Psychometric properties of the Cervical Spine Outcomes Questionnaire and its relationship to standard assessment tools used in spine research.

BACKGROUND: The Cervical Spine Outcomes Questionnaire (CSOQ), a disease-specific outcomes instrument, has not been systematically compared with the Short Form-36 (SF-36) or the Neck Disability Index (NDI). PURPOSE: To examine the psychometric properties of the CSOQ and to compare them with those of the SF-36 and NDI. STUDY DESIGN: Prospective analysis of outcomes data in patients undergoing surgery. METHODS: We used telephone surveys (CSOQ) and clinical assessments (SF-36 and NDI) to evaluate 534 patients undergoing anterior cervical decompression and fusion at 23 nationwide sites. The psychometric properties of the CSOQ were analyzed for floor/ceiling effect, internal consistency of items within the CSOQ, and concurrent validity with the SF-36 and NDI. RESULTS: The CSOQ domain scores showed good psychometric properties (Cronbach's alpha >0.70). Only physical symptoms (other than pain) showed a ceiling effect. The CSOQ domain scores had good concurrent validity (Spearman rank correlation coefficient >0.70) with the mental health score of the SF-36 and the total disability score of NDI. CONCLUSIONS: The CSOQ domain scores provide a disease-specific assessment of functional limitations resulting from cervical spine disorders. The domain scores for functional disability and psychological distress provide similar information to that provided by the NDI and SF-36. The CSOQ domain scores for pain severity provide information that is more specific to cervical disc disease than does the physical health score of the SF-36.     

Effect of age on outcomes of tertiary rehabilitation for chronic disabling spinal disorders.

STUDY DESIGN: A prospective cohort study evaluating age as a factor in treatment outcomes for chronic disabling work-related spinal disorders undergoing tertiary rehabilitation. OBJECTIVE: To assess the association between age and objective psychosocioeconomic treatment outcomes for work-related spinal disorders undergoing functional restoration. SUMMARY OF BACKGROUND DATA: As early as the 1950s, a link between age and low back symptoms has been identified in the literature. Several studies have demonstrated that the occurrence of low back pain is positively correlated with age up to about 50-60 years, after which prevalence declines. It has been argued that this pattern is stronger for more severe, chronic back pain cases. Little research attention has been given to age as a factor in treatment outcomes for work-related spinal disorders. METHODS: A cohort of 1052 chronically disabled (none working full-time when starting the rehabilitation program) spinal disorder (CDSD) patients were placed into five groups based on age: Group 1, <25 years (22 +/- 2 years, n = 59); Group 2, 25-34 years (30 +/- 3 years, n = 301); Group 3, 35-44 years (39 +/- 3 years, n = 381); Group 4, 45-54 (49 +/- 3 years, n = 237); and Group 5, > or =55 years (59 +/- 4 years, n = 74). All patients completed a functional restoration program combining quantitatively directed exercise progression with a multimodal disability management approach using psychological and case management techniques. Before the start of the program, and again on completion of the program, all patients received a psychosocial evaluation and were also assessed on a variety of physical motion, strength, aerobic, and functional factors, and a cumulative score was calculated, which aggregates and averages these physical measures. A structured clinical interview examining socioeconomic outcomes (work return, health utilization, recurrent injury, and resolution of financial disputes) was conducted at 1 year after program completion, and at least partial information was obtained from this interview on all consecutive patients in the study. RESULTS: The length of pretreatment disability increased with age (P < 0.001), as well as pretreatment surgery rates (P < 0.002). A Mantel-Haenzel chi2 test for linear trend across age groups revealed that the percentage of patients who returned to work declined progressively from 100% in Group 1 to 69% in Group 5 (P < 0.001). The same linear trend was revealed for the percentage of patients retaining work at the end of 1 year (98-62%, P < 0.001). Older workers returned to the same job and/or the same employer (P < 0.005). Younger workers found different jobs with new employers (48-11%, P < 0.0001). Analysis of variance for the disability questionnaire revealed that after treatment subjective disability progressively increased (while improvements decreased) from Group 1 to Group 5 (P < 0.01). The cumulative physical score variable, even normalized for age, was progressively lower from Group 1 to Group 5, both at pretreatment (P < 0.03) and post-treatment (P < 0.02). CONCLUSIONS: The present study represents the first large-scale examination of the association between age and treatment outcomes for a work-related CDSD population. Age is significantly and linearly related to pretreatment duration of disability and frequency of pretreatment surgeries. After rehabilitation treatment there is a linear decrement in both work return and work retention, so that younger patients are far more likely to return and hold work after functional restoration. Older workers who go back to work are much more likely to return to the same employer and do the same job, or to become self-employed. Calculation of odds ratios revealed that patients >55 years are 5.68 times more likely to return to the same job and employer, relative to those <25 years; those >55 years were also approximately three times more likely than those <25 years to return to the same employer, compared with those <25 years. Younger workers are far more likely to take a different job and/or seek a new employer. Older patients are also somewhat more likely to seek a new health provider to deal with perceived residual pain/disability. This trend coincides with their higher post-treatment subjective disability levels, and their lower cumulative physical scores both prerehabilitation and postrehabilitation. However, age does not affect additional surgery rates, subsequent injuries, or delays in settling financial disputes.     

Effects of hemodialysis dose and membrane flux on health-related quality of life in the HEMO Study

BACKGROUND: It has been widely supposed that high dose and high flux hemodialysis would affect the quality as well as the length of life of patients treated by maintenance hemodialysis. The HEMO Study examined changes in health-related quality of life as a secondary study outcome. Specific hypotheses were that study interventions would affect physical functioning, vitality, Short Form-36 Health Survey (SF-36) physical and mental component summary scores, symptoms and problems associated with kidney disease, and sleep quality. METHODS: At baseline and annually, subjects responded to both the Index of Well-Being and the Kidney Disease Quality of Life-Long Form questionnaires. The interventions were assessed on the basis of their average effects over 3 years. RESULTS: At baseline, the SF-36 physical component summary score was lower than in healthy populations, but the mental component score was nearly normal. Over 3-year follow-up, physical health continued to decline; mental health and kidney disease-targeted scores remained relatively stable. The high dose hemodialysis intervention was associated with significantly less pain (4.49 points, P < 0.001) and higher physical component scores (1.23 points P= 0.007), but these effects were small compared to the natural variability in scores. High flux membranes were not associated with statistically significant differences in health-related quality of life. CONCLUSION: The HEMO Study results demonstrate the marked burden of chronic kidney failure and hemodialysis treatment on daily life. In this trial among patients undergoing maintenance three times a week hemodialysis, the SF-36 physical component summary score and pain scale showed significant but very small clinical effects favoring the higher dialysis dose. No clinically meaningful benefits or either the dose or flux interventions were observed for other indices of health-related quality of life.     

Predictors of health-related quality of life after coronary artery bypass surgery

BACKGROUND: Little is known about the determinants of health-related quality of life after coronary artery bypass surgery. We determined the predictors of overall physical and mental health status 6 months after the operation. METHODS: We evaluated 1,973 patients enrolled in a multicenter Veterans Affairs prospective cohort study who completed preoperative and 6-month postoperative Short Form-36 (SF-36) health status surveys. Multiple linear regression was used to identify the significant independent predictors of 6-month physical and mental component summary scores from the SF-36. RESULTS: In multivariable analyses adjusting for baseline health status, significant predictors of postoperative physical health status were a history of neurologic disease, peripheral vascular disease, chronic obstructive pulmonary disease, hypertension, current smoking, forced expiratory volume, left ventricular ejection fraction, and serum creatinine. Significant predictors of postoperative mental health status were a history of psychiatric disease, chronic obstructive pulmonary disease, current smoking, age, and New York Heart Association functional class. CONCLUSIONS: These predictors of health-related quality of life after coronary artery bypass surgery may be useful for preoperative risk assessment and counseling of patients with regard to anticipated health status outcomes. Factors such as current smoking and psychiatric disease may be targets for interventions to improve health-related quality of life outcomes.     

Do worker's compensation patients with neck pain have lower SF-36 scores?

Poorer outcomes of treatment are reported in patients with spinal disorders who receive worker's compensation. The reason for their suboptimal outcomes is unclear. No study has examined the relationship between worker's compensation and SF-36 health status of patients with neck pain. The aim of our study was to compare the self-perceived health status of patients with neck pain receiving worker's compensation, with that of patients not receiving worker's compensation. A cross-sectional study was conducted on 2356 patients with neck pain who were evaluated at the 27 centers comprising the National Spine Network, between January 1998 and April 2000. The outcome measures used were the eight individual and two component scores of the SF-36 health survey. Of the 2356 patients, 171 (7%) were receiving worker's compensation. Bivariate analyses revealed seven individual scores (except General Health) and two summary scores of the SF-36 were significantly lower in patients receiving worker's compensation. After controlling for confounding covariates, worker's compensation status was a significant predictor of lower SF-36 scores for Physical Functioning ( P<0.05). The results of this study indicate that worker's compensation status is associated with poorer Physical Functioning in patients presenting with neck pain. Another significant finding of the study is that confounding factors can exert major effects on the SF-36 scores obtained on normal validated instruments.