The assessment of symptoms and functional limitations in low back pain patients: validity and reliability of a new questionnaire

Many of the existing low back pain (LBP) questionnaires of function and symptoms have a content of different domains of disability presented as a single sum score, making it difficult to derive changes within a specific domain. The present study describes the development of a clinically derived back-specific questionnaire incorporating both a functional limitation and a symptom scale, with a further subdivision of the symptom scale in separate indices for severity and temporal aspects. The aims of the study were to assess the overall reliability and validity of the new questionnaire, named the Profile Fitness Mapping questionnaire (PFM). A total of 193 chronic LBP patients answered the PFM together with five validated criterion questionnaires. For the internal consistency of the questionnaires, the three indices of the PFM had the highest Cronbach’s alpha (0.90–0.95) and all items had item–total correlations above 0.2. The correlation coefficients between the PFM and the back-specific criterion questionnaires ranged between 0.61 and 0.83, indicating good concurrent criterion validity. The best discriminative ability between patients with different pain severities was demonstrated by the functional limitation scale of the PFM. Well centered score distribution with no patient’s score at the floor or the ceiling level indicates that the PFM has the potential to detect the improvement or worsening of symptoms and functional limitations in chronic LBP patients. Classification according to the International Classification of Functioning, Disability and health (ICF) of WHO revealed a high degree of homogeneous item content of the symptom scale to the domain of impairments, and of the functional limitation scale to the domain of activity limitations. The present study suggests that the PFM has a high internal consistency and is a valid indicator of symptoms and functional limitations of LBP patients. It offers the combination of a composite total score and the possibility of evaluations within specific domains of disability. Complementary evaluation of test–retest reliability and responsiveness to change is warranted.     

Validity of health status measures in patients with ulnar wrist disorders.

PURPOSE: To assess measurement properties and construct validity of health status measures. METHOD: Forty-three patients with surgically managed ulnocarpal impingement completed a self-report mail survey, including regional (Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire), disease-specific (Brigham Functional Scale), and generic (Short Form 36 [SF-36] Acute Health Survey) health status measures and questions on condition severity and work status. Statistical analysis: Scores were transformed and frequency distributions constructed to compare the distribution of responses to the measures. Correlation analysis and analysis of variance were applied to assess construct validity. RESULTS: The DASH and Brigham questionnaires had similar distributions of scores, with a slightly greater spread of responses and no ceiling effect on the DASH. Patients appeared slightly less healthy on the basis of the SF-36 scores, which reflected in part the effect of comorbidities. Both the DASH and the Brigham discriminated across levels of severity and work status; the DASH also discriminated on the basis of type of surgery. The SF-36 was able to discriminate some constructs but not as well as the regional and disease-specific measures. CONCLUSION: This study provides evidence of construct validity for the DASH and Brigham questionnaires in patients with ulnar wrist problems in the late post-operative period.     

Psychologic factors in low-back-pain disability

Biomechanical tests, physical examination, spinal radiographs, a modified Minnesota Multiphasic Personality Inventory (MMPI), and a psychologic health inventory derived from the Hopkins Symptom Checklist were applied in 321 randomly selected men, ages 18-55. Each subject was evaluated for prior and current low-back pain (LBP) complaints by use of a modification of the McGill pain questionnaire. Subjects were then categorized as having no LBP (n = 106, 33%), moderate LBP (n = 144, 44.8%), and severe LBP (n = 71, 22.1%). Subjects were further subcategorized as not disabled (defined as equal or less than seven days of work lost in the previous year) and disabled (work loss greater than seven days in the prior year). Results: cumulative scores of the Hopkins Checklist showed that a mean score for no LBP equaled 2.5 +/- 2.9; moderate LBP was 4.3 +/- 3.2; and severe LBP was 4.6 +/- 3 (p = .0000). The disabled group was significantly different on both MMPI and Hopkins Checklist. The 20 disabled subjects had significant elevations of hypochondriasis (p = .0006) and hysteria (p = .005) when compared with nondisabled subjects with LBP. The mean score for disabled subjects on the Hopkins Checklist was 7.35 +/- 4.49, while the score was 4.17 +/- 3.15 (p = .0001) for the nondisabled subjects with LBP. In the general male population, patients with disabling LBP conditions form a distinctive subgroup comparable to those patients seen in selected LBP clinics.     

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.     

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.Part 2 of this article is available at:     

Usefulness of QuickDASH in patients with cervical laminoplasty

Purpose

Clumsiness and numbness of the upper extremity is one of the most common complaints of patients with cervical myelopathy. However, most previous evaluations after cervical laminoplasty have only been based on physicians’ points of view. We used Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) self-report questionnaire, which was designed to measure physical function and symptoms in people with upper-limb disorders to evaluate functional outcomes after laminoplasty.

Methods

Ninety-four patients who underwent laminoplasty for cervical myelopathy and replied to the questionnaire were included in this study. The average age was 62 years, and mean follow-up period was 61 months. The Japanese Orthopedic Association (JOA) score, Neck Disability Index (NDI), Short-Form Health Questionnaire of 36 questions (physical component score, PCS), upper-extremity pain (Numerical Rating Scale), and QuickDASH (0–100, 0 being least severe) were used to evaluate surgical outcomes. Satisfaction with treatment was also investigated, and internal consistency and criterion-related validity were evaluated. The QuickDASH cutoff value for patient satisfaction was determined by receiver operating characteristic curve (ROC) analysis.

Results

The mean total JOA scores were 10 before and 13 after surgery, and average postoperative QuickDASH score was 30. Cronbach α of the QuickDASH was 0.94. QuickDASH was significantly correlated with JOA score for upper-extremity motor and sensation, NDI, PCS, and pain. Cutoff value of the QuickDASH was 34.0 by ROC analysis. Significantly better QuickDASH scores were found for patients who were satisfied with treatment than for those who were not, whereas JOA score for upper-extremity motor function did not show a significant difference.

Discussion

QuickDASH had significant correlations with disease-specific JOA scores and other generic outcome measures. Moreover, QuickDASH significantly reflected patients’ satisfaction with treatment, whereas the JOA score for upper-extremity motor function did not.

Conclusion

QuickDASH was useful in evaluating upper-extremity functional outcomes after cervical laminoplasty.     

How little pain and disability do patients with low back pain have to experience to feel that they have recovered?

Epidemiological and clinical studies of people with low back pain (LBP) commonly measure the incidence of recovery. The pain numerical rating scale (NRS), scores from 0 to 10, and Roland Morris disability questionnaire (RMDQ), scores from 0 to 24, are two instruments often used to define recovery. On both scales higher scores indicate greater severity. There is no consensus, however, on the cutoff scores on these scales that classify people as having recovered. The aim of this study was to determine which cutoff scores most accurately classify those who had recovered from LBP. Subjects from four clinical studies were categorized as ‘recovered’ or ‘unrecovered’ according to their self-rating on a global perceived effect scale. Odd ratios were calculated for scores of 0, 1, 2, 3 and 4 on the NRS and RMDQ to predict perceived recovery. Scores of 0 on the NRS and ≤2 on the RMDQ most accurately identify patients who consider themselves completely recovered. The diagnostic odds ratio (OR) for predicting recovery was 43.9 for a score of 0 on the NRS and 17.6 for a score of ≤2 on the RMDQ. There was no apparent effect of LBP duration or length of follow-up period on the optimal cutoff score. OR for the NRS were generally higher than those for RMDQ. Cutoffs of 0 on the NRS and 2 on the RMDQ most accurately classify subjects as recovered from LBP. Subjects consider pain more than disability when determining their recovery status.     

Development,validity, and reliability of The Assessment of Pain and Occupational Performance (POP): a new instrument using two dimensions in the investigation of disability in back pain

Background contentQuestionnaires for measuring the functional status of patients with low back pain (LBP) focus on disability and present responses for each question in a predetermined, fixed relationship between “can do/difficulties and pain.” Their design does not permit a separation of the two.PurposeTo present the development of The Assessment of Pain and Occupational Performance (POP) and to evaluate validity and reliability.Study designA prospective, consecutive study of patients investigated by use of the POP.Patient sampleA total of 220 patients participated in the study.MethodsIn a cross-sectional study including 53 patients with chronic musculoskeletal pain, empirical tests of content and construct validity established the definitive version of the POP. The POP focuses on performance of activities. It is a disease-specific, discriminative assessment instrument designed for patients with back pain (BP) and LBP. Based on a semi-structured interview the POP investigates each of 36 activities in two dimensions, with separate, defined scales from “normally healthy” to “extremes” for level of activity (x-scale) and pain intensity (y-scale). The final scores are expressed in percent, 0% to 100%. Patients with chronic LBP (CLBP) (n=142) were allocated to the specific (S) group, that is, patients with specific LBP problems (n=97) or to the nonspecific (NS) group, that is, those with NS BP (n=45). The ability of the POP to differentiate between the two known groups was evaluated. Construct–convergent validity between the POP and the Oswestry Disability Index (ODI) was carried out for the S group. Inter-rater reliability was established between six pairs of raters who examined 25 patients recruited from primary health care, the P-LBP group.ResultsIn construct known group validity, the median, the interquartile range, and the Mann-Whitney U test showed that the S group had a significantly higher level of activity (p<.001) combined with worse pain (p=.001) compared with the NS group. There were significant differences between the two groups in performing activities in the forward bending position (10 items) and in the upright standing position (9 items). The result of Spearman rank order correlation showed a strong relationship between the ODI and the POP for level of activity (r=0.70, p≤.001). The multiple correlation coefficient between the total score of the ODI (10 items) and the total score of the POP (36 items) was r=0.72 and p≤.001. Inter-rater reliability—the standard deviation of the differences was less than 1 point (scale 0–5). A Bland–Altman plot showed the mean differences for the level of activity of the dressing/undressing item. The average percentage agreement was 80% on the x- and y-scales. In POP 36, the average Kappa for level of activity was 0.79, which is good agreement, and for pain 0.84, which is very good agreement.ConclusionThe construction of the POP allows the patient to count, and the occupational therapist to investigate, from full level of activity to avoidance and from no pain to worst imaginable pain for each physically loaded task in personal activities of daily living (ADL), transfer/transport, instrumental ADL, and social activities. The POP can differentiate between groups concerning level of activity and pain, and appears to be a valid and reliable instrument for evaluating LBP. The POP should be considered for use in both clinical and research applications.     

Outcome evaluation measures for wrist and hand – which one to choose?

The aim of this study was to critically analyse the various outcome measures available for assessing wrist and hand function. To this end, an extensive literature search was performed on Medline, PubMed and the Science Citation Index, focusing on terms associated with the method of development of the outcome measures item generation, item reduction, validity, reliability, internal consistency and their strengths and weaknesses. The most commonly used outcome measures described in literature were the DASH score (disability of shoulder, arm and hand questionnaire), the PRWE score (patient-rated wrist evaluation questionnaire), the Brigham and Women's carpal tunnel questionnaire and the Gartland and Werley score. Our study provides very useful evidence to suggest that the PRWE score is the most responsive instrument for evaluating the outcome in patients with distal radius fractures, while the DASH score is the best instrument for evaluating patients with disorders involving multiple joints of the upper limb. The Brigham and Women's score is a disease-specific outcome instrument for carpal tunnel syndrome; it has been validated and demonstrated to show good responsiveness and reliability in evaluating outcome in patients with carpal tunnel release. The Gartland and Werley score, although the most commonly described instrument in the literature for evaluating outcome after wrist surgery, has not been validated so to date.     

Health-related quality of life in dialysis patients. A report from an Italian study using the SF-36 Health Survey. DIA-QOL Group.

BACKGROUND: Interest in measuring health-related quality of life (HRQoL) has increased together with an awareness that such humanistic outcomes require valid and reliable measures. In the last decade short, simple and multidimensional generic and disease-specific questionnaires have been developed. Among the several generic questionnaires available, the Short Form 36 Items Health Survey (SF-36) was translated and validated in several languages, and applied to different settings and diseases. METHODS: Within the framework of a larger, prospective, multicentre study (DIA-QOL project) the SF-36 was administered to 304 patients to test its characteristics in terms of patient acceptability, and psychometric and clinical validity. Standard psychometric techniques were used to evaluate its validity in terms of convergence, divergence and internal consistency reliability (Cronbach's alpha). Correlations between clinical variables and HRQoL scores were performed to test the questionnaire's capability to capture differences across patients groups. RESULTS: Overall, the findings show that, in this sample, the SF-36's performance was very good. Acceptability was satisfactory, with a response rate higher than 80%. All the questionnaire scales met the psychometric standards suggested in terms of grouping and scaling assumptions. The internal reliability coefficients actually replicate the satisfactory findings reported previously for the original SF-36. In terms of the ability of the questionnaire scales to discriminate between groups expected to differ in a given health concept in relation to clinical variables, the results were also good. On average, females reported lower scores, the impact of ageing was more evident for physical scales. Diabetic patients score significantly worse on the physical function scale and patients with mental health problems score significantly lower on the mental health scale. No significant association was found with the index KtV, haemoglobin levels, body mass index, parathyroid hormone and type of dialysis. A strong association was indeed found between SF-36 scales measuring physical health concepts and the serum albumin level. This association held after adjusting for the confounding effect of age. Comparison of the health profile of the present sample with others from the US and UK and from a representative sample of the Italian general population highlights the potential of such questionnaire in dialysis setting. CONCLUSIONS: The SF-36 questionnaire is easy to use in Italian dialysis patients and SF-36 scores are related to important clinical aspects. This approach can help in caring for dialysis patients and can be useful in outcome assessment programmes.     

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.     

Late outcome of isolated tibial fractures treated by intramedullary nailing: the correlation between disease-specific and generic outcome measures

OBJECTIVES: To measure the late morbidity of nailed isolated tibial fractures, using both a generic health score and disease-specific scores. To determine the correlation between the two types of outcome measure. DESIGN: Retrospective study, using a combination of case notes and radiographic review plus current clinical assessment. SETTING: Fracture Outcomes Research Unit in a U.K. teaching hospital. PATIENTS: Eighty-three patients with isolated fractures of the tibial diaphysis. Follow-up time was a minimum of three years from injury (mean fifty-seven months). INTERVENTION: All patients were treated primarily by closed, reamed intramedullary nailing. OUTCOME MEASUREMENTS: Iowa Knee and Ankle Scores, visual analogue pain scores for fracture site and knee and ankle joints, and the Short Form 36 health status questionnaire. RESULTS: Sixty-four (77.1%) fractures united after the first procedure. Twenty-nine (34.9%) patients had pain around the knee at rest, fifty-nine (71.1%) had difficulty in kneeling, and thirteen (15.7%) were still experiencing some pain at their fracture site; 69% of patients had excellent results based on the Iowa scores as well as the SF-36 scores. Pain at the knee correlated with low Physical Component Summary and Mental Component Summary scores, and fracture site pain correlated with only low Physical Component Summary score. There was a significant correlation between the disease-specific scores and the SF-36 scores, and only patients with an excellent Iowa grade had "normal" SF-36 scores. CONCLUSION: After tibial nailing, mild deficits registered by Iowa scores are associated with a significant disability and unhappiness as registered by the SF-36. According to the patient-oriented outcomes tool, 31% of late results are "unsatisfactory."     

Validity of a single-item measure to assess leg or back pain as the predominant symptom in patients with degenerative disorders of the lumbar spine

Purpose

Recent studies suggest that the location of predominant pain (back or leg) can be a significant predictor of the outcome of surgery for degenerative spinal disorders. However, others challenge the notion that the predominant symptom can be reliably identified. This study examined the validity of a single item used to determine the most troublesome symptom.

Methods

A total of 2,778 patients with degenerative disorders of the lumbar spine scheduled for surgery with the goal of pain relief completed a questionnaire enquiring as to their most troublesome symptom [“main symptom”; back pain (BACK) or leg/buttock pain (LEG)]. They also completed separate 0–10 graphic rating scales for back pain (LBP) and leg/buttock pain (LP) intensity. Receiver operating characteristics (ROC) analysis was used to determine the accuracy with which the “LP minus LBP” score was able to classify patients into their declared “main symptom” group. Sub-studies evaluated the test–retest reliability of the patients’ self-rated pain scores (N = 45) and the agreement between the main symptom declared by the patient in the questionnaire and that documented by the surgeon after the clinical consultation (N = 118).

Results

Test–retest reliability of the back and leg pain scores was good (ICC_2,1 of 0.8 for each), as was patient–surgeon agreement regarding the main symptom (BACK or LEG) (κ value 0.79). In the BACK group, the mean values for pain intensity were 7.3 ± 2.0 (LBP) and 5.2 ± 2.9 (LP); in the LEG group, they were 4.3 ± 2.9 (LBP) and 7.5 ± 1.9 (LP). The area under the curve for the ROC was 0.95 (95 % CI 0.94–0.95), indicating excellent discrimination between the BACK and LEG groups based on the “LP minus LBP” scores. A cutoff score >0.0 for “LP minus LBP” score gave optimal sensitivity and specificity for indicating membership of the LEG group (sensitivity 79.1 %, specificity 95.7 %).

Conclusions

The responses on the single item for the “main symptom” were in good agreement with the differential ratings on the 0–10 pain scales for LBP and LP intensity. The cutoff >0 for “LP minus LBP” for classifying patients as LEG pain predominant seemed appropriate and suggests good concurrent validity for the single-item measure. The single item may be of use in sub-grouping patients with the same disorder (e.g. spondylolisthesis) or as an indication in surgical decision-making.     

II. Validity and sensitivity to change of the Musculoskeletal Functional Assessment Questionnaire in primary gonarthrosis and total endoprosthetic joint replacement

INTRODUCTION: Scoring systems used so far in total knee arthroplasty are limited by their non-fulfillment of basic test criteria. The aim of the study was to demonstrate the validity and responsiveness of a German version of the new short musculoskeletal function assessment questionnaire (SMFA-D) in patients with primary osteoarthritis and total knee arthroplasty. METHODS: 66 patients with a tricompartmental cemented PFC-Sigma total knee arthroplasty completed the SMFA-D and the WOMAC questionnaire preoperatively and at 12 to 16 weeks follow-up. Preoperatively, physicians' rating of function of the leg, patients' self-selected walking speed, pain and arthritis severity score were registered for demonstration of criterion validity. Construct validity was evaluated with the WOMAC. Discriminant validity was assessed by comparing patients with or without previous surgery at the knee, use of pain medication and use of walking aids. The function and bother indexes of the SMFA-D were correlated with these parameters. Standardized response means were calculated. RESULTS: The function index correlated with physicians' rating (r = 0.51), walking speed (r = 0.61), pain (r = 0.36) and the arthritis severity index (r = 0.36). The bother index correlated with pain (r = 0.37) and the arthritis severity index (r = 0.25). The function and bother index correlated with the WOMAC (r = 0.77) and (r = 0.81), respectively. Patient groups with or without walking aids (p = 0.02) and with or without pain medication (p = 0.001) differed in the function index. The bother index of patients with or without pain medication (p < 0.001) and with or without walking aids (p < 0.006) differed. Function and bother index improved from 46 (SD 17) to 34 (SD 19, p < 0.001) and 43 (SD 18) to 33 (SD 22 p < 0.001), respectively. The standardized response mean was 0.86 for the function index and 0.53 for the bother index. CONCLUSIONS: The SMFA-D questionnaire is valid and responsive in patients with primary osteoarthritis of the knee and total knee arthroplasty. It measures function and bother from the perspective of these patients.     

Development of a cancer-specific anterior skull base quality-of-life questionnaire

OBJECT: The goal of this study was to develop a disease-specific, multidimensional quality of life (QOL) assessment instrument for patients undergoing surgical extirpation of anterior skull base tumors. METHODS: This investigation included 35 patients who had been surgically treated for more than 3 months before the study was begun. Relevant QOL questions were generated from a review of the literature and interviews with health professionals, patients, and their caregivers. The initial multidimensional, 80-item questionnaire was reduced to a 35-item questionnaire by using standard psychometric criteria. Six relevant domains were identified using factor analysis: performance, physical function, vitality, pain, specific symptoms, and influence on emotions. The internal consistency of the instrument had a correlation coefficient of 0.8 and a reliability coefficient (test-retest reliability) of 0.9. The validity of the construct was assessed by testing whether the clinical variable of the patient influenced his QOL domain score as hypothesized. Patients older than 60 years of age had significantly poorer scores in the domains of performance and physical function than younger patients. Patients with malignant tumors had significantly poorer scores in the domains of specific symptoms, influence on emotions, physical function, and performance compared with patients with benign tumors. Radiotherapy was associated with poorer scores in the domains of specific symptoms and influence on emotions. Comorbidity was associated with poor physical function scores. Using the final questionnaire, we prospectively evaluated the QOL of 12 additional patients before they underwent surgery and again between 5 and 6 months postoperatively to test the utility and validity of the instrument further. Again, significantly poorer QOL scores were recorded for patients with malignancy. CONCLUSIONS: The proposed questionnaire appears to be sufficiently reliable and valid in estimating a patient's QOL after extirpation of anterior skull base tumors. The instrument can be used in face-to-face interviews and via electronic or regular mail.     

Changes in pain and disability secondary to shoe lift intervention in subjects with limb length inequality and chronic low back pain: a preliminary report

STUDY DESIGN: Preassessment and postassessment of treatment intervention. OBJECTIVE: To determine the changes in pain and disability secondary to shoe lift intervention for subjects with chronic low back pain (LBP) who have a limb length inequality (LLI). BACKGROUND: Previous reports have suggested that LLI may be a cause of LBP Most prior studies of lift therapy for management of LLI in patients with LBP have lacked clear guidelines for clinicians regarding the implementation of shoe lift intervention. METHODS AND MEASURES: Twelve subjects (6 male, 6 female) between the ages of 19 and 62 years with LLI (6.4-22.2 mm) and chronic LBP (1-30 years) participated. Visual analog scale pain ratings and disability questionnaire scores were acquired before and after lift intervention. Subjects determined their lift height based on resolution of LBP symptoms. RESULTS: Subjects experienced relief of general pain symptoms (P = .0006) and pain associated with standing (P= .002) following lift intervention, with minimally clinically important (MCID) reductions in general pain for 9 of 12 subjects and MCID reductions in standing pain for 8 of 10 subjects. Subjects also had less disability on the disability questionnaire (P = .001) following the intervention, with 9 of 12 subjects experiencing MCID reductions in disability. CONCLUSION: Shoe lifts may reduce LBP and improve function for patients who have chronic LBP and an LLI. Randomized controlled trials are needed to assess the efficacy of this intervention.     

Age-adjusted baseline data for women with hallux valgus undergoing corrective surgery

BACKGROUND: Functional and health-related quality-of-life data on a population of patients with hallux valgus are lacking. Similarly, the correlation of the severity of the deformity with these measures is unknown. METHODS: Two hundred and eighty-five women with an average age of forty-nine years who were scheduled for bunion surgery were enrolled in the study. The patients completed a baseline American Academy of Orthopaedic Surgeons (AAOS) foot and ankle outcomes questionnaire, which includes the Short Form-36 (SF-36) and a specific lower-extremity section on the foot and ankle. Preoperative radiographic data with regard to the hallux valgus angle and the intermetatarsal angle were stratified into groups according to the severity of the deformity (mild, moderate, or severe). The data were then stratified into age-groups consistent with those reported for the SF-36, and the results were compared with the SF-36 scores for the general population. The global foot and ankle score and the shoe comfort score were compared with general population scores that were published previously. The severity of the preoperative deformity was correlated with the baseline scores. RESULTS: General health scores were noted to be relatively stable throughout the age-groups for patients with bunions, with the older groups demonstrating better scores than the general population. Bodily pain scores were consistently worse for patients with a bunion through all age-groups compared with the general population. The average global foot and ankle score and the shoe comfort score were significantly lower (p < 0.001 for both) for the patients with a bunion than for the general population. The severity of the preoperative deformity did not correlate with any of the outcome scores. CONCLUSIONS: The bodily pain score from the SF-36 appears to be a sensitive measure of problems experienced by patients undergoing bunion surgery. Surprisingly, the severity of the deformity as measured radiographically did not correlate with any of the fifteen scores measured. These data may serve as a baseline for clinical hallux valgus studies with use of the SF-36 or the AAOS outcomes questionnaire.     

Clinical impact of JOABPEQ mental health scores in patients with low back pain: Analysis using the neuropathic pain screening tool painDETECT

Background

In patients with low back pain (LBP) who combine psychosocial factors with clinical findings of pain, there is a possibility that the psychosocial factors modify the pain. In the current study, we investigated the relationship between the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) mental health score and the characteristics of LBP.

Developing the Vascular Quality of Life Questionnaire: a new disease-specific quality of life measure for use in lower limb ischemia

AIMS: The purpose of this study was to develop and validate an easily used disease-specific quality of life (QOL) measure for patients with chronic lower limb ischemia and to design an evaluative instrument, responsive to within-subject change, that adds to clinical measures of outcome when comparing treatment options in the management of lower limb ischemia. METHODS: The first phase consisted of item generation, item reduction, formulating, and pretesting in patients with ischemia. The proportion of patients who selected an item as troublesome and the mean importance they attached to it were combined to give a clinical impact factor. Items with the highest clinical impact factor were used to formulate a new 25-item questionnaire that was then pretested in 20 patients with lower limb ischemia. In the second phase, reliability, validity, and responsiveness of the new questionnaire were assessed in 39 patients with lower limb ischemia who were tested at 0 and 4 weeks. The King's College Hospital's Vascular Quality of Life Questionnaire and the Short-Form 36 were administered at each visit, and treadmill walking distance and ankle/brachial pressure indices were recorded. The new questionnaire's reliability, internal consistency, responsiveness, and validity were determined. RESULTS: Areas of QOL impairment were consistent through the ranges of disease severity and age, with no apparent differences between the men and women. Therefore, a single questionnaire is applicable to all patients with chronic lower limb ischemia. In stable patients test-retest scores demonstrated a reliability of r more than 0.90. Each item had internal consistency (item-domain Cronbach alpha =.7-.9). The questionnaire was responsive to change, with correlation between change in the questionnaire's total score and both global and clinical indicators of change (P <.001). The questionnaire showed face and construct validity. CONCLUSIONS: This disease-specific questionnaire is reliable, responsive, valid, and ready for use as an outcome measure in clinical trials. It is sensitive to the concerns of patients with lower limb ischemia, offering a simple method to measure the effect of interventions on their QOL.