SF-36 Bodily Pain Research Articles

Danish version of the Oswestry disability index for patients with low back pain. Part 2: Sensitivity, specificity and clinically significant improvement in two low back pain populations

In studies evaluating the efficacy of clinical interventions, it is of paramount importance that the functional outcome measures are responsive to clinically relevant change. Knowledge thereof is in fact essential for the choice of instrument in clinical trials and for clinical decision-making. This article endeavours to investigate the sensitivity, specificity and clinically significant improvement (responsiveness) of the Danish version of the Oswestry disability index (ODI) in two back pain populations. Two hundred and thirty three patients with low back pain (LBP) and/or leg pain completed a questionnaire booklet at baseline and 8 weeks follow-up. Half of the patients were seen in the primary (PrS) and half in the secondary sectors (SeS) of the Danish Health Care System. The booklet contained the Danish version of the ODI, along with the Roland Morris Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. At follow-up, a 7-point transition question (TQ) of patient perceived change and a numeric rating scale relating to the importance of the change were included. Responsiveness was operationalised using three strategies: change scores, standardised response means (SRM) and receiver operating characteristic (ROC) analyses. All methods revealed acceptable responsiveness of the ODI in the two patient populations which was comparable to the external instruments. SRM of the ODI change scores at 2 months follow-up was 1.0 for PrS patients and 0.3 for SeS (raw and percentage). A minimum clinically important change (MCID) from baseline score was established at 9 points (71%) for PrS patients and 8 points (27%) for SeS patients using ROC analyses. This was dependable on the baseline entry score with the MCID increasing with 5 points for every 10 points increase in the baseline score. We conclude that the Danish version of the ODI has comparable responsiveness to other commonly used functional status measures and is appropriate for use in low back pain patients receiving conservative care in both the primary and secondary sector.

Danish version of the Oswestry Disability Index for patients with low back pain. Part 1: Cross-cultural adaptation, reliability and validity in two different populations

Over the past 10 years, a plethora of back-specific patient-orientated outcome measures have appeared in the literature. Standardisation has been advocated by an expert panel of researchers proposing a core set of instruments. Of the condition-specific questionnaires the Oswestry Disability Index (ODI) is recommended for use with low back pain (LBP) patients. To date, no Danish version of the ODI exists which has been cross-culturally adapted, validated and published in the peer-reviewed literature. A cross-cultural adaptation and validation of the ODI for the Danish language was carried out according to established guidelines: 233 patients [half of the patients were seen in the primary sector (PrS) and half in the secondary sector (SeS) of the Danish health care system] with LBP and/or leg pain completed a questionnaire booklet at baseline, 1 day or 1 week and 8 weeks follow-up. The booklet contained the Danish version of the ODI, along with the Roland Morris Disability Questionnaire, the LBP Rating Scale, the SF36 (physical function and bodily pain scales) and a global pain rating. For the ODI test-retest analysis (93 stable patients) resulted in an intraclass correlation coefficient of 0.91, a mean difference of 0.8 and 95% limits of agreements of - 11.5 to + 13. Thus, a worsening greater than 12 points and improvement greater than 13 points can be considered a "real" change above the measurement error. A substantial floor effect was found in PrS patients (14.1%). The ODI showed satisfactory cross-sectional discriminant validity when compared to the external measures. Concurrent validity of the ODI revealed: (a) a 10% and 21% lower ODI score compared to the disability and pain measures, respectively, (b) a poorer differentiation of patient disabilities and (c) an acceptable individual ODI score level compared to the external measures. Longitudinal external construct validity showed moderate correlations (range 0.56-0.78). We conclude that the Danish version of the ODI is both a valid and reliable outcome instrument in two LBP patient populations. The ODI is probably most appropriate for use in SeS patients.

Longitudinal trends in quality of life after starting home parenteral nutrition: A randomised controlled study of telemedicine

This study defines and quantifies longitudinal changes in quality of life (QoL) at the time of first discharge home on home parenteral nutrition (HPN) and over the first year. Results were compared in patients in standard contact with a nutrition nurse specialist by telephone, with results of those in contact via telemedicine in a randomised controlled trial. Participants were recruited from nine UK HPN centres. Patients were randomised to receive telemedicine upon initial discharge or after 1 year. The SF36 was the principal instrument chosen to determine QoL throughout the year on three predetermined occasions. EQ5D and hospital anxiety and depression scores were also recorded. Thirty participants were recruited to the study from March 2001 to June 2003. In all domains, QoL scores were significantly lower than normative data at discharge. QoL scores significantly improved over the first 6 months in physical functioning, physical role (RP), vitality (VT), social functioning (SF), emotional-role (RE) domains, and mental component summary (MCS). At 6 months RE, mental health (MH) and MCS were no longer significantly lower than normative data. There was no significant change in bodily pain (BP), general health (GH), MH, and physical component summary (PCS). Opiate use significantly reduced SF36 domains RP, BP, VT, SF, MH, and MCS at 6 months and was associated with more subsequent inpatient episodes and central line reinsertions. Patients with an acute onset of intestinal failure had less pain and better GH scores at 6 months, and had less inpatient episodes after discharge than patients with a more chronic onset. Telemedicine had no impact on QoL or subsequent clinical outcome. Aspects of QoL improve over the first 6 months of HPN. Opiate use and chronic diagnosis have a negative impact on some elements of QoL and clinical outcome variables.

Combined Anterior Plus Posterior Stabilization Versus Posterior Short-Segment Instrumentation and Fusion for Mid-Lumbar (L2–L4) Burst Fractures

Prospective randomized study. OBJECTIVES.: To compare the results of the combined anterior-posterior surgery (Group A) with posterior "short-segment" transpedicular fixation (SSTF) (Group B) in mid-lumbar burst fractures. There are no comparative randomized clinical studies on the outcome following operative treatment of mid-lumbar fractures. Forty consecutive patients with L2-L4 fresh single A3-type/AO burst fractures and load sharing score up to 6 were randomly selected to underwent either combined one-stage anterior stabilization with mesh cage and SSTF (Group A) or solely SSTF with intermediate screws in the fractured vertebra (Group B). Kyphotic Gardner angle, anterior and posterior vertebral body height (PVBHr, AVBHr), spinal canal encroachment (SCE), SF-36, VAS, and Frankel classification were used. The follow-up observation averaged 46 and 48 months for Group A and B, respectively. Operative time, blood loss, and hospital stay were significant more in Group A. More surgical complications were observed in the Group A. After surgery, VAS was reduced to 4.3 and 3.6 for Group A and Group B, respectively. The SF-36 domains Role physical and Bodily pain improved significantly only in Group B (P = 0.05) and (P = 0.06), respectively. Correction of AVBHr, PVBHr, and spinal canal clearance was similar in both groups. Spinal canal clearance did not differ between the two groups, but it was continuous until the last evaluation in Group B. The final Gardner angle loss of correction averaged 2 degrees and 5 degrees for Group A and Group B, respectively. The posttraumatic Gardner deformity did not significantly improve by SSTF at the final evaluation in the spines of Group B. Gardner angle correlated significantly with SCE in Group B and Group A in all three periods and in the last evaluation, respectively. Frankel grade did not correlate with loss of correction of AVBHr and PVBHr in Group A, while it significantly correlated with loss of PVBHr correction and SCE in the patients of Group B. There was no neurologic deterioration after surgery in any patient. VAS and SF-36 scores did not significantly correlate with the loss of kyphotic angle correction and AVBHr, PVBHr at the final observation in any patient of both groups. SSTF offered similar significant short-term correction of posttraumatic deformities associated with mid-lumbar A3-burst fractures, but better clinical results as compared to combined surgery. However, SSTF did not significantly maintain the after surgery achieved correction of local posttraumatic kyphosis at the final evaluation. Thus, SSTF is not recommended for operative stabilization of fractures with this severity.

(822): Health-related quality-of-life (HRQoL) outcomes for patients with chronic low back pain (CLBP) treated with once-daily OROS® hydromorphone

Chronic low back pain (CLBP) causes psychological distress and significant impairment in functional status. Although the primary aim of CLBP treatment is to provide pain relief, it is also important to gauge the effectiveness of treatment in helping to restore functional capacity and the psychological well-being of patients. Health-related quality-of-life (HRQoL) measures are well suited for this type of evaluation. A 7-week, open-label, non-comparative, repeated-dose study was designed to characterize the efficacy, safety, and HRQoL impact of once-daily OROS® hydromorphone in CLBP patients who demonstrated at least 2 consecutive days of stabilization on prior oral or transdermal opioid medication. HRQoL was measured with the SF-36 Health Survey, which patients competed at baseline and after 7 weeks of treatment. HRQoL outcomes were defined as changes in SF-36 scale and summary measure scores from baseline to 7 weeks. Patients who terminated early from the study were included in the analysis if the interval of time between baseline and their final assessment was at least 30 days. At baseline, SF-36 scale and summary measure scores of CLBP patients (N= 188) were one to two standard deviations below general US population norms. Overall, SF-36 scales and summary measure scores improved significantly from baseline to final visit (MANOVA: F= 8.9, P< .0001). Statistically significant improvement was observed for SF-36 physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, and mental health scales, and for both physical and mental summary measures. Mean score improvement ranged from 1.8 to 4.5 points (standardized scores), which reflect small to moderate changes. This study confirms the significant functional impairment and psychological distress of CLBP, and demonstrates that patients treated with OROS® hydromorphone have significant improvement in both functional status and psychological well-being.

Effectiveness of Physical Therapy for the Management of Chronic Spine Disorders: A Propensity Score Approach

Evidence on the effectiveness of physical therapy for the management of chronic spine disorders is limited. The purpose of this study was to use a large current database, the National Spine Network database, to assess the effectiveness of physical therapy in the management of chronic spine disorders. The participants were people who had spine problems lasting 3 months or longer and who were seen for an initial visit and a follow-up visit (N=4,479) at 1 of 17 US spine centers. A propensity score approach was used to create a matched sample of participants who received physical therapy (intervention group) and participants who did not receive physical therapy (control group). The 2 groups were similar with regard to more than 50 baseline characteristics. Outcomes were assessed with the Oswestry Disability Index (ODI) and the 36-Item Short-Form Health Survey (SF-36). Both the intervention and control groups improved between the initial and the follow-up visits on ODI scores and on SF-36 physical function, role physical, and bodily pain scores. Although the amount of improvement in the outcome measures was significantly greater for the intervention group than for the control group, the differences were small (3-5 points). When the subgroup of participants who had the greatest propensity for receiving physical therapy was examined, differences in the amount of improvement between the intervention and control groups were larger (5-13 points). Physical therapy was effective in the management of chronic spine disorders in participants with the greatest propensity for receiving physical therapy. When the entire sample was considered, differences in the amount of improvement between the intervention and control groups were not clinically relevant.

A Randomized, Controlled Trial of Distal Radius Fractures With Metaphyseal Displacement but Without Joint Incongruity: Closed Reduction and Casting Versus Closed Reduction, Spanning External Fixation, and Optional Percutaneous K-wires

To compare closed reduction and casting with closed reduction and external fixation with optional K-wire fixation for distal radius fractures with metaphyseal displacement but without joint incongruity. Prospective study. Multicenter study at 3 University teaching hospitals. A total of 113 skeletally mature patients with distal radius fractures with metaphyseal displacement, but without joint incongruity, were randomized to receive 1 of 2 standardized treatment protocols. Patients were evaluated at 6 weeks, 6 months, 1 year, and 2 years. Closed reduction and casting (n = 59) or closed reduction and external fixation (n = 54). Upper extremity function was measured using upper extremity MFA domain scores, overall Jebsen Taylor scores, and pinch and grip strength tests. Global function and pain were measured using the SF-36. Radiographic evaluation and range of motion were documented. Upper extremity MFA scores, Jebsen Taylor scores, SF-36 bodily pain scores, and grip strength improved significantly during the first year for all patients. By 2 years, mean Jebsen Taylor scores and SF 36 bodily pain scores for patients in both groups were similar to scores for normal age- and gender-matched population controls. At all points, there was a trend for better function in the external fixation; however, this did not reach statistical significance. There was a trend for better length and palmar tilt restoration with external fixation. For distal radius fractures with metaphyseal displacement but with a congruous joint, there exists a trend for better functional, clinical, and radiographic outcomes when treated by immediate external fixation and optional K-wire fixation.

Venlafaxine Extended Release in the Short-Term Treatment of Depressed and Anxious Primary Care Patients With Multisomatoform Disorder

This pilot study explored the efficacy and tolerability of extended-release venlafaxine (venlafaxine ER) in anxious and/or depressed patients with multisomatoform disorder (MSD). This 12-week, multicenter, randomized, double-blind study evaluated adult primary care outpatients with MSD and comorbid major depressive disorder, generalized anxiety disorder, or social anxiety disorder (DSM-IV criteria). The intent-to-treat population included 112 patients (venlafaxine ER, N = 55; placebo, N = 57). The primary efficacy variable was the change in the 15-item Patient Health Questionnaire (PHQ-15) somatic symptom severity score. Secondary outcomes included the Hamilton Rating Scale for Depression (HAM-D-17) and for Anxiety (HAM-A), Clinical Global Impressions-Severity of Illness (CGI-S) and -Improvement (CGI-I) scales, McGill Quality of Life Questionnaire Physical Symptoms Scale (MQOL-PS), and Medical Outcomes Study Short-Form 36-Item questionnaire (MOS SF-36). Data were collected from April 2003 to December 2003. The decline by week 12 in PHQ-15 scores was significant (p < .0001) in both groups; however, the difference between the venlafaxine ER and placebo groups (-8.3 vs. -6.6, respectively) was not (p = .097). Improvement was greater with venlafaxine ER than placebo on the PHQ-15 pain subscale (p = .03), SF-36 bodily pain scale (26.1 vs. 14.5, p = .03), MQOL-PS (-11.7 vs. -6.0, p = .02), HAM-A psychic anxiety subscale (p = .02), SF-36 mental component summary (p = .03), time to response (54 vs. 71 days, p = .01), and CGI-I scale (p = .009). Venlafaxine ER was generally well tolerated. These results suggest that venlafaxine ER may be effective in relieving some types of somatic physical symptoms, particularly pain, in patients with depression and/or anxiety disorders.

Assessment of the Lequesne index of severity for osteoarthritis of the hip in an elderly population

To assess the measurement properties of the Lequesne index of severity for osteoarthritis of the hip (LISOH) together with its overall usefulness with reference to the original stated aims. Postal questionnaire was sent to a random sample of 5500 Oxfordshire residents, aged 65 and above. Respondents with hip symptoms at baseline (but without verification of a diagnosis) were sent an identical follow-up questionnaire 12 months later. The questionnaire included a general health section, including the Short Form-36 survey, and a hip section which began with a screening question about hip pain. Respondents who reported having a prolonged episode of hip pain were asked to complete the LISOH. At baseline, response rate of 66.3% (3341/5039) was obtained from eligible participants; 19.2% (610/3175) of respondents reported having hip pain. Internal reliability (Cronbach's alpha) was 0.84 (95% CI: 0.81-0.86) for all 11 items of the LISOH; however, factor analysis identified two factors (sub-scales): "function and mobility" and "pain and discomfort". Rasch analysis revealed that the two factors were only unidimensional when applied to sub-groups of respondents. Convergent validity of the LISOH was questionable, as the "function and mobility" factor was more highly correlated with SF-36 bodily pain score than was the "pain and discomfort" factor. The assessment of sensitivity over time was problematic due to changing patterns of symptomatic weight-bearing joints over time. The current study identifies major limitations with the LISOH--particularly if used as a single composite measure.

Chronic pain in individuals with spinal cord injury: a survey and longitudinal study

Cross-sectional and longitudinal postal survey. To (1) compare the severity of pain in persons with spinal cord injury (SCI) to national norms, (2) examine the association between pain and measures of (a) psychological functioning, (b) community integration and (c) pain interference with daily activities, and (3) examine the change in the prevalence and intensity of pain over time. Community. A total of 147 adults with SCI were surveyed twice, 2-6 years apart. Main outcome measures included presence/absence of pain in general and at specific body sites, 0-10 numerical rating scale of average pain intensity, modified Brief Pain Inventory Pain Interference scale, SF-36 Bodily Pain scale, SF-36 Mental Health scale, Community Integration Questionnaire. Pain was more severe, on average, in this sample of patients with SCI than it is in normative samples. The presence of pain was associated with trends towards poorer psychological functioning and social integration, and the intensity of pain was associated with interference with a number of important basic activities of daily living. Little systematic change was found in pain over a 2-6-year-period, although there was evidence that the prevalence of shoulder pain increases over time. The current findings underscore the serious nature of pain in persons with SCI and provide additional support for the need to identify effective treatments for SCI-related pain.

Indirect reduction and percutaneous fixation versus open reduction and internal fixation for displaced intra-articular fractures of the distal radius

A total of 179 adult patients with displaced intra-articular fractures of the distal radius was randomised to receive indirect percutaneous reduction and external fixation (n = 88) or open reduction and internal fixation (n = 91). Patients were followed up for two years. During the first year the upper limb musculoskeletal function assessment score, the SF-36 bodily pain sub-scale score, the overall Jebsen score, pinch strength and grip strength improved significantly in all patients. There was no statistically significant difference in the radiological restoration of anatomical features or the range of movement between the groups. During the period of two years, patients who underwent indirect reduction and percutaneous fixation had a more rapid return of function and a better functional outcome than those who underwent open reduction and internal fixation, provided that the intra-articular step and gap deformity were minimised.

Chronic pain in individuals with spinal cord injury: A survey and longitudinal study

Cross-sectional and longitudinal postal survey. To (1) compare the severity of pain in persons with spinal cord injury (SCI) to national norms, (2) examine the association between pain and measures of (a) psychological functioning, (b) community integration and (c) pain interference with daily activities, and (3) examine the change in the prevalence and intensity of pain over time. Community. A total of 147 adults with SCI were surveyed twice, 2–6 years apart. Main outcome measures included presence/absence of pain in general and at specific body sites, 0–10 numerical rating scale of average pain intensity, modified Brief Pain Inventory Pain Interference scale, SF-36 Bodily Pain scale, SF-36 Mental Health scale, Community Integration Questionnaire. Pain was more severe, on average, in this sample of patients with SCI than it is in normative samples. The presence of pain was associated with trends towards poorer psychological functioning and social integration, and the intensity of pain was associated with interference with a number of important basic activities of daily living. Little systematic change was found in pain over a 2–6-year-period, although there was evidence that the prevalence of shoulder pain increases over time. The current findings underscore the serious nature of pain in persons with SCI and provide additional support for the need to identify effective treatments for SCI-related pain.

Impact of low back pain on health-related quality of life before and after treatment with an analgesic medication

This post hoc analysis of two multicenter, randomized, double-blind, placebo-controlled trials assessed the burden of chronic low back pain (LBP) on health-related quality of life (HRQoL) before and after treatment with an analgesic. The pooled sample included 660 patients with chronic (>3 months), moderate-to-severe LBP (Pain Visual Analogue [PVA] scale score 40-100). Patients in both trials received an oral analgesic or placebo for 13 weeks. Baseline scores on the Short Form 36 Health Survey (SF-36) for trial participants were compared with: (1) U.S. normative scores for the general population; and (2) disease-specific benchmarks from the Medical Outcomes Study (MOS). Overall, patients with chronic LBP had significantly lower mean SF-36 scores than the U.S. norm for all scales (MANOVA F=289.2, p<0.001), including scores >1.5 standard deviations (SD) lower than the U.S. norm for most physical health scales. Patients with moderate-to-severe LBP in the clinical trials had greater HRQoL burden on most SF-36 scales compared with disease-specific benchmarks from patients in the MOS who had LBP (any severity), hypertension, congestive heart failure, type 2 diabetes, recent myocardial infarction, or depression. The burden of LBP was greater among trial patients who experienced more severe pain. SF-36 bodily pain scores were >2 SD lower than U.S. norms among patients with PVA scale scores between 80–100 mm; and they were >1 SD lower among those with PVA scale scores between 40-80 mm. Physical health domains had better discriminant validity than mental health domains. Statistically significant HRQoL benefits emerged in physical health domains when pain improved by 21–30 points on the PVA scale and clear improvement in all aspects of HRQoL occurred when pain improved by at least 31 points on the PVA scale. This analysis confirms the tremendous burden of chronic LBP on HRQoL and demonstrates that pain relief may reduce this major HRQoL burden.

Impact of chemotherapy-induced neutropenia on quality of life: a prospective pilot investigation

In this exploratory, prospective study evaluated quality of life (QoL) changes in patients with diverse cancers during the first cycle of myelosuppressive chemotherapy. Of 80 patients enrolled, 71 were observed during one of five chemotherapy regimens: docetaxel; CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone); carboplatin-paclitaxel; carboplatin-docetaxel; and carboplatin-gemcitabine. Complete blood counts were taken weekly. QoL and symptom burden measures were administered at baseline and throughout the cycle, and included SF-36, Cancer Care Monitor (CCM), Hospital Anxiety and Depression Scale (HADS), and Psychosocial Adjustment to Illness Scale (PAIS). Using generalized estimating equations, we modeled the change in each measure from baseline to the end of each week using the following covariates: baseline QoL measure, baseline SF-36 Physical and Mental Health Summary scores, sex, age, cycle week, grade 4 neutropenia any time in the past 7 days (yes/no), and the interaction of the latter two covariates. Of the 71 patients observed, 33 developed grade 4 neutropenia during the first 2 weeks. Changes from baseline in SF-36 Bodily Pain, HADS Anxiety, and PAIS Social Environment scores were significantly less favorable (P<0.05) when patients experienced grade 4 neutropenia any time in the past 7 days compared to when they did not (grade 0-3). A similar, but non-significant, trend was also observed for 12 other QoL measures. QoL may be adversely affected up to 7 days after patients experience grade 4 (versus grade 0-3) neutropenia. Such findings need to be examined further in studies with adequate statistical power to test a priori hypotheses regarding specific QoL measures.

Impact of fibromyalgia pain on health-related quality of life before and after treatment with tramadol/acetaminophen

To assess health-related quality of life (HRQOL) in patients with moderate-to-severe fibromyalgia pain compared with the general population, and to assess the relationship between pain severity and HRQOL before and after treatment with an analgesic. Data were obtained from a randomized, double-blind study of patients with moderate-to-severe fibromyalgia pain. Patients received either tramadol/acetaminophen or placebo 4 times/day as needed for 91 days. HRQOL was measured with the Short Form 36 Health Survey (SF-36) and the Fibromyalgia Impact Questionnaire (FIQ). Baseline HRQOL scores were compared with a national sample of noninstitutionalized adults and a sample of patients with impaired HRQOL due to congestive heart failure. Patients with fibromyalgia were divided into tertiles by change in pain severity, and SF-36 scores were compared across the tertiles. Mean changes in SF-36 and FIQ scores were compared between treatment groups. Patients with fibromyalgia scored lower than the US norm on all SF-36 scales (P < 0.0001) and lower than patients with congestive heart failure on most scales. More severe pain was associated with greater impairment of HRQOL compared with less severe pain (P < 0.0001). Patients in the highest tertile for improved pain severity had greater improvement in HRQOL scores than patients in the lower tertiles. Compared with patients who received placebo (n = 157), patients treated with tramadol/acetaminophen (n = 156) showed greater improvement on SF-36 physical functioning, role physical, bodily pain, and physical summary scales, as well as FIQ scales for ability to do job, pain, and stiffness (P < 0.01). Moderate-to-severe fibromyalgia pain significantly impairs HRQOL, and effective pain relief in these patients significantly increases HRQOL.

Effort-limited treadmill walk test: reliability and validity in subjects with postpolio syndrome.

To determine the reliability and construct validity of an effort-limited treadmill walk test to measure functional ability in subjects with postpolio syndrome in an outpatient postpolio clinic. Functioning and distance walked on a treadmill to a Borg "hard" effort level were measured three times, a week apart, by two blinded raters in 15 subjects with postpolio syndrome, aged 37-67 yrs, with new weakness, fatigue, and pain but with no other cause of symptomatology or condition-limiting walking. One rater tested them twice. Fatigue activity level, mobility, and health-related quality of life (Medical Outcome Study Short Form Health Survey [SF-36]) defined functioning. Generalizability correlation coefficients determined intrarater, test-retest and interrater reliability. The correlations relating the distance walked and functioning determined construct validity. Reliability for generalizability correlation coefficients were: intrarater, 0.91; test-retest, 0.85; and interrater, 0.58. Interrater reliability improved to 0.91 with adherence to a standardized protocol. Validity was established with correlations between the distance walked and SF-36 physical component score (0.66), physical role (0.60), bodily pain (0.60), and vitality (0.55). The treadmill walk test provides a reproducible and valid measure of ability in persons with postpolio syndrome with a single rater, but a standardized protocol is essential for reliability.

Assessment of quality of life (QOL) in MA.17, a randomized placebo-controlled trial of letrozole in postmenopausal women following five years of tamoxifen

517 Background: The NCIC CTG MA.17 demonstrated substantial improvement in DFS by administering letrozole after 5 years of adjuvant tamoxifen to postmenopausal women with early stage breast cancer. An increase in low-grade hot flashes, arthritis, arthralgias and myalgias were identified in patients treated with letrozole. The objective of this sub-study was to evaluate QOL. Methods: Patients completed the Medical Outcomes Study 36 Item Short Form General Health Survey (SF36) and the Menopause Specific QOL (MENQOL) questionnaire at baseline, six months and annually. Mean change scores from baseline were compared between letrozole and placebo for summary measures and domains. The proportion of patients who demonstrated a minimally important worsening in QOL (defined as a difference from baseline of 5 points for SF36 and 0.5 for MENQOL) was also compared. An alpha of 0.01 was used in view of multiple comparisons. The analysis was limited to the first 3 years. Results: Of 5,187 women enrolled, 3,582 participated in the QOL sub-study. Baseline scores on the SF36 physical and mental health summary measures were similar to healthy populations and decreased over time in both groups. There were no significant differences between groups in mean change scores at 6, 12, 24 and 36 months. Small [<0.1 standard deviation (SD)] but statistically significant differences were seen for SF36 physical functioning (6, 12 months), bodily pain (6 months), vitality (6, 12 months) and MENQOL physical domains (12 months). Moderate (0.2–0.3 SD) differences were observed for the MENQOL vasomotor (6, 12, 24 months), and sexual domains (12, 24 months). Absolute increases in % of patients reporting worsening in their QOL at any time on letrozole compared to placebo for the different domains were: SF36 physical functioning (6%, p < .001); bodily pain (5%, p=.001); vitality (5%, p=.005); MENQOL vasomotor (8%, p< .001); physical (5%, p=.004); and sexual (4%, p=.02). Conclusions: Letrozole did not have a substantial adverse impact on QOL. Small effects were seen in some domains consistent with a minority of patients experiencing adverse effects. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis

Assessment of quality of life (QOL) in MA.17, a randomized placebo-controlled trial of letrozole in postmenopausal women following five years of tamoxifen

517 Background: The NCIC CTG MA.17 demonstrated substantial improvement in DFS by administering letrozole after 5 years of adjuvant tamoxifen to postmenopausal women with early stage breast cancer. An increase in low-grade hot flashes, arthritis, arthralgias and myalgias were identified in patients treated with letrozole. The objective of this sub-study was to evaluate QOL. Methods: Patients completed the Medical Outcomes Study 36 Item Short Form General Health Survey (SF36) and the Menopause Specific QOL (MENQOL) questionnaire at baseline, six months and annually. Mean change scores from baseline were compared between letrozole and placebo for summary measures and domains. The proportion of patients who demonstrated a minimally important worsening in QOL (defined as a difference from baseline of 5 points for SF36 and 0.5 for MENQOL) was also compared. An alpha of 0.01 was used in view of multiple comparisons. The analysis was limited to the first 3 years. Results: Of 5,187 women enrolled, 3,582 participated in the QOL sub-study. Baseline scores on the SF36 physical and mental health summary measures were similar to healthy populations and decreased over time in both groups. There were no significant differences between groups in mean change scores at 6, 12, 24 and 36 months. Small [<0.1 standard deviation (SD)] but statistically significant differences were seen for SF36 physical functioning (6, 12 months), bodily pain (6 months), vitality (6, 12 months) and MENQOL physical domains (12 months). Moderate (0.2–0.3 SD) differences were observed for the MENQOL vasomotor (6, 12, 24 months), and sexual domains (12, 24 months). Absolute increases in % of patients reporting worsening in their QOL at any time on letrozole compared to placebo for the different domains were: SF36 physical functioning (6%, p < .001); bodily pain (5%, p=.001); vitality (5%, p=.005); MENQOL vasomotor (8%, p< .001); physical (5%, p=.004); and sexual (4%, p=.02). Conclusions: Letrozole did not have a substantial adverse impact on QOL. Small effects were seen in some domains consistent with a minority of patients experiencing adverse effects. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis

Opioids in non-cancer pain: Health-related quality of life of chronic low back pain patients: impact of disease and treatment effect of fentanyl transdermal system

Measures of pain frequency and intensity do not capture the extent to which chronic low back pain (CLBP) affects a person’s life and may underestimate the broad benefits of treatment. Understanding the full impact of CLBP and its treatment requires a multidimensional approach that includes health-related quality of life (HRQoL) measures. To assess the impact of CLBP on HRQoL and the effect of transdermal fentanyl treatment on HRQoL. An observational study conducted at 17 clinical centers in the U.S. Eligible patients had CLBP diagnosis for at least 3 months and were transitioned from short-acting opioids to transdermal fentanyl. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF-36 Health Survey, at baseline and ≥ 9 weeks of treatment. The HRQoL burden of CLBP was determined by comparing patient's SF-36 scores to general U.S. population norms. The HRQoL impact of transdermal fentanyl was determined by comparing baseline and follow-up TOPS and SF-36 scores. At baseline CLBP patients (N=122) scored one to two standard deviations (SD) below age and gender adjusted SF-36 general population norms (MANOVA F(8,2102)=119.3, p<0.0001). Significant improvement (p<0.05) was observed on the SF-36 physical functioning, role physical, bodily pain, vitality, social functioning, and physical summary scales and the TOPS total pain summary scale. The magnitude of change in scores in standard deviation units among these scales ranged from 0.21 to 0.73, which are considered small to moderate effect size changes. These changes suggest significant improvements not only in pain relief, but also physical and social functioning. In this preliminary analysis in a usual care setting, CLBP patients who chronically used short-acting opioids showed tremendous HRQoL burden that was significantly reduced after transitioning to transdermal fentanyl.

Validity of the Brief Pain Inventory for Use in Documenting the Outcomes of Patients With Noncancer Pain

The Brief Pain Inventory (BPI) is a short, self-administered questionnaire that was developed for use in cancer patients. While most empirical research with the BPI has been in pain of that etiology, the questionnaire is increasingly evident in published studies of patients with non-cancer pain. The current research addresses the need for formal evaluation of the reliability and validity of the BPI for use in non-cancer pain patients. Approximately 250 patients with arthritis or low back pain (LBP) self-administered a number of generic and condition-specific health status measures (including the BPI) in the clinic of their primary care provider at 2 time points: the initial clinic visit and the first visit following treatment. The reliability of BPI data collected from non-cancer pain patients was comparable to that reported in the literature for cancer patients and sufficient for group-level analyses (coefficient alphas were greater than 0.70). The factor structure of the BPI was replicated in this sample and the relationship of the BPI to generic measures of pain was strong. The BPI exhibited similar relationships to general and condition-specific measures of health as did a generic pain scale (SF-36 Bodily Pain). Finally, the BPI discriminated among levels of condition severity and was sensitive to change in condition over time in arthritis and LBP patients. Results support the validity of the BPI as a measure of pain in patients without cancer and, in particular, as a measure of pain for arthritis and LBP patients.