Time since Vertebral Fracture: An Important Variable Concerning Quality of Life in Patients with Postmenopausal Osteoporosis

The aim of the study was to identify factors affecting patients with postmenopausal osteoporosis who had experienced one or more vertebral fractures. The overall hypothesis was that time after fracture would influence patients’ perception of pain and well-being. The sample (50 patients) was split into two groups (group A, time after fracture ≤24 months; group B, time after fracture >24 months). A fracture was defined as a vertebral height reduction of more than 20% or at least 4 mm. The assessment was carried out using the Spine Deformity Index and was confirmed by an experienced radiologist. To assess quality of life (QoL) the following measures were used: ‘well-being scale’ including social extroversion as a subscale, pain scale, and limitations in everyday life. The Sense of Coherence questionnaire developed by Antonovsky measures the ability of a person to see life meaningful, manageable and explicable. This questionnaire may reflect patients’ coping abilities and was introduced to establish whether these influence the perception of pain and well-being after vertebral fracture. Variance and covariance analysis was carried out using SPSS (version 6.1). Differences between groups A and B were found for perception of average pain (p = 0.017), social extroversion (p = 0.003) and well-being (p = 0.024). No differences were found for limitations in everyday life (p = 0.607), Sense of Coherence (p = 0.638), the Spine Deformity Index (p = 0.171) and loss of height (p = 0.619). All analyses were corrected for age. Concurrent medication was not found to influence the results. Findings suggest that time after fracture is an important variable when considering QoL and well-being after vertebral fracture and should, therefore, be considered in future studies. Received: 25 June 1998 / Accepted: 10 November 1998     

Urine Flow Rates and Residual Urine Volumes in Urogynecology Patients

Two hundred and fifty consecutive women referred because of symptoms of lower urinary tract dysfunction underwent a full clinical and urodynamic assessment. Their urine flow rates and residual urine volumes were analyzed. The urine flow rates of the urogynecology patients were found to be significantly less than those of an asymptomatic population. There were significant declines in urine flow rates in the presence of a previous hysterectomy and with increasing grades of prolapse, particularly uterine prolapse, cystocele and enterocele. Unlike the normal female population, there was also deterioration with increasing parity and age, the latter largely due to the increasing incidence of hysterectomy and prolapse with age. The 10th centile of the Liverpool Nomogram for the maximum urine flow rate was found to be the most useful discriminant for a final urodynamic diagnosis of voiding difficulties. Most urogynecology patients have no or small residual urine volumes, 74% <10 ml and 81% <30 ml (vs 95% <30 ml in asymptomatic women). In urogynecology patients residuals were larger where there had been a prior hysterectomy or with grade 2 or higher uterine prolapse, cystocele and enterocele. Mean residual was 14.8 ml (vs 4.8 ml in asymptomatic women). These data indicate a higher incidence of voiding difficulties (abnormally slow urine flow (under 10th centile) and/or abnormally high residual urine volume (over 30 ml) in urogynecology patients, particularly those with higher grades of prolapse and with prior hysterectomy.     

An Osteoporosis Clinical Pathway for the Medical Management of Patients with Low-Trauma Fracture

Patients with an osteoporotic fracture have at least a 2-fold risk for additional fracture and should benefit from targeted diagnostic and treatment procedures for osteoporosis. To address this issue, we set up an osteoporosis clinical pathway (OCP) for the medical management of patients with low-trauma fracture. Following acute management of the fracture by the orthopedic team, patients are enrolled in the pathway, which is based on an interaction between the OCP multidisciplinary team, orthopedic surgeons and/or primary care physicians. After collection of patient data, suggestions for additional diagnostic examinations with their interpretation, and treatment proposals are made. Patients and their families are also invited to attend a multidisciplinary interactive educational program on physical therapy, lifestyle habits and nutrition. During a 36-month period, 385 patients (311 women, 74 men; mean age ± SD: 73.0 ± 13.5 years; hip fracture 45%, ankle/tibia 24%, proximal humerus 8.6%, spine 5.5%, pelvis 3.9%, distal forearm 3.6%, other sites 17.4%) were enrolled in the OCP. An osteoporosis awareness questionnaire administered within 10 days of fracture showed that 73% of patients believed that their fracture was not related to the disease. Dual-energy X-ray absorptiometry, performed in 63% of patients, showed that 86% had low bone mass or osteoporosis. Specific antiosteoporotic therapy was proposed for 33% of patients in addition to calcium and vitamin D supplements, the latter suggested for 93%. A survey performed in 216 patients 6 months later, indicated that 63% of the suggested treatments had been prescribed and that 67% of this group were continuing treatment. Such a clinical pathway for the medical management of low-trauma fracture can help to identify patients with osteoporosis in a high-risk population, provide support to the orthopedic surgeon and/or the primary care physician for diagnostic and treatment procedures, and should significantly contribute to increase awareness of the disease in patients and their families. Received: 25 June 2001 / Accepted: 23 November 2001     

The Use of Short-Form Quality of Life Questionnaires to Measure the Impact of Imipramine on Women with Urge Incontinence

Short-form questionnaires were used to measure the change in quality of life (QOL) of women with urge-predominant urinary incontinence treated with imipramine hydrochloride. Short forms of the Incontinence Impact Questionnaire (IIQ-7) and the Urogenital Distress Index (UDI-6) were integrated into a patient questionnaire, which was given to 25 patients with urge-predominant urinary incontinence before and after treatment with imipramine. Demographic data and self-reports of the number of incontinent episodes were also recorded. Total and subscale QOL scores and number of incontinent episodes were recorded and compared with Wilcoxson’s signed ranks test, as well as correlated to the change in number of incontinent episodes with Pearson’s correlation coefficient. Treatment with imipramine resulted in a clinical improvement or cure in 16/22 patients (72.7%), with an average reduction in incontinent episodes of 78.7% (P<0.001). The average per cent improvement in QOL scores for total IIQ-7 was 42.1% (P<0.01) and total UDI-6 score was 44.1% (P<0.001). All subscale QOL differences were also significant (P<0.01). The incidence of side effects to imipramine was 41%, which resulted in dose changes. Fourteen per cent eventually discontinued therapy. Neither total nor subscale QOL improvement scores were correlated with improvement in number of incontinent episodes. The short form IIQ-7 and UDI-6 are effective tools to determine change in QOL, as evidenced by the effectiveness of imipramine for the treatment of urge-predominant urinary incontinence. Significant reductions in incontinent episodes and improvements in IIQ-7 and UDI-6 QOL scores were both seen, but were not correlated. Short-form QOL measures can easily be integrated into a patient questionnaire to objectively measure a very subjective topic.     

Effect and Offset of Effect of Treatments for Hip Fracture on Health Outcomes

We investigated the cost-effectiveness of treatments that reduce the risk of hip fracture using a computer simulation model. Cost-effectiveness was measured as cost per quality-adjusted life-year (QALY) gained using a threshold value for cost-effectiveness of $30.000/QALY gained. The baseline simulations assumed a 5-year intervention that reduced the risk of hip fracture by 50% during the intervention period, and an effect which reversed to the pretreatment risk during the next 5 years. Sensitivity analyses inlcuded the effects of age, different fracture risks, and different treatment costs and duration of therapeutic effect once treatment was stopped. Cost-effectiveness was critically dependent upon absolute risk determined by the age and the relative risk of hip fracture at any given age. Reasonable cost-effectiveness was shown even with relatively high intervention costs for women with a risk about twice the average at the age of 70 or more years. Cost-effectiveness was critically dependent upon the assumptions made concerning offset of effect of intervention after the end of treatment. Where no residual effect was assumed, it was difficult to show cost-effectiveness from any intervention except for the most effective and least expensive. Conversely, cost-effectiveness improved considerably where effectiveness persisted for a longer time. These studies support the view that intervention in the elderly with agents affecting skeletal metabolism alone may be preferred to such interventions at the time of the menopause, and that offset time, hitherto poorly characterized, is a critical component of cost-effectiveness, particularly in younger women. Received: 26 May 1998 / Accepted: 8 February 1999     

Reduced Pulmonary Function in Patients with Spinal Osteoporotic Fractures

Vertebral deformation in spinal osteoporosis results in spinal and thoracic deformation, causing pain, disability and an overall decrease in quality of life. We sought to determine whether thoracic spinal deformation may lead to impaired pulmonary function. We studied expiratory relaxed vital capacity (VC) and forced expiratory volume in 1 s (FEV1) in 34 patients with spinal osteoporotic fractures and 51 patients with chronic low back pain (CLBP) due to reasons other than osteoporosis. Measurements of pulmonary function tests were calculated as a percentage of the normal range adjusting for age, sex, and height using the equations for normal values of the EKGS (Europ?ische Gesellschaft für Kohle und Stahl). Severity of osteoporosis was determined by calculation of the spine deformity index (SDI-total and SDI-anterior) on lateral radiographs of the spine and clinical measures of body stature (height reduction, distance from lowest ribs to iliac crest and distance from the occiput to the wall). Patients with osteoporosis had a lower vital capacity (%VC of the reference value) than patients with CLBP. The differences were more prominent (p<0.05) when the previous body height, at age 25 years, was used as reference for calculation of VC (mean ± SD: 93.6%± 15.3% in patients with osteoporosis v 105.6%± 15.1% in patients with CLBP). FEV1 was significantly (p<0.05) lower in patients with osteoporosis when previous body height was considered, in comparison with patients with CLBP (mean ± SD: 85.0%± 14.2% in patients with osteoporosis v 92.4%± 13.6% in patients with CLBP). In patients with osteoporosis VC (standardized on previous body height) was significantly negatively correlated with SDI-anterior (r=–0.4, p<0.03). Furthermore, VC standardized on previous body height showed a weak but significant negative correlation with some clinical measures of osteoporosis (height reduction vs %VC: r=–0.34, p<0.05; distance from the lowest ribs to iliac crest vs %VC: r= 0.35, p<0.04). In conclusion, we found that pulmonary function is significantly diminished in patients with spinal osteoporotic fractures as compared with CLBP patients without evidence of manifest osteoporosis. Reduction of pulmonary function is correlated significantly with clinical and radiological measures of severity of spinal deformation due to osteoporotic fractures. Received: 17 March 1997 / Accepted: 21 October 1997     

A Prospective Clinical and Urodynamic Study of Bladder Function During and After Pregnancy

The aim of the study was to determine whether clinical and/or urodynamic changes in bladder function occur during pregnancy. Assessment consisted of a urinary symptom questionnaire, urogynecological examination and urodynamic investigations, which were repeated 6 weeks after pregnancy. Sixty-six patients had the initial and 40 the follow-up assessments. Statistical analysis was done by 95% confidence intervals (95% CI). Nocturia, frequency, dysuria, urgency and stress incontinence occurred significantly more frequently during pregnancy. Urinary tract infection was diagnosed in 18% of patients during pregnancy and asymptomatic bacteriuria in 9%. Genuine stress incontinence was diagnosed in 12% during pregnancy and in none after pregnancy (95% CI 1% to 24%). An unstable detrusor was diagnosed in 23% of patients during pregnancy and in 15% after pregnancy (95% CI –8% to 23%). Strong desire to void, urgency, maximum cystometric capacity, maximum flow rate and average flow rate were all statistically significantly decreased during pregnancy. It is concluded that significant changes occur in bladder function during pregnancy.     

Quality of Life in Patients with Vertebral Fractures: Validation of the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)

Vertebral fractures may be minor or lead to pain, decreased physical function, immobility, social isolation and depression, which together contribute to quality of life. A Working Party of the European Foundation for Osteoporosis has developed a specfic questionnaire for patients with vertebral fractures. This questionnaire, QUALEFFO, includes questions in the domains pain, physical function, social function, general health perception and mental function. QUALEFFO was validated in a multicenter study in seven countries. The study was done in 159 patients aged 55–80 years with clinical osteoporosis, i.e., back pain and other complaints with at least one vertebral fracture and lumbar bone mineral density T-score <−1. Patients with a recent vertebral fracture were excluded because of unstable disease. Controls were age- and sex-matched, and did not have chronic back pain or vertebral fractures. Subjects with conditions exerting a major influence on quality of life were excluded. The QUALEFFO was administered twice within 4 weeks and compared with a generic questionnaire, the Short Form 36 of the Medical Outcomes Study (SF-36). Standard spinal radiographs were made for assessment of vertebral height. Seven questions were removed from the analysis because of low response rate, linguistic ambiguities or redundancy. The 41 remaining questions were analyzed for repeatability, internal consistency and the capacity to discriminate between patients with vertebral fractures and controls. Comparison with the SF-36 was performed within similar domains by conditional logistic regression and by receiver operating characteristic (ROC) curves. The repeatability of QUALEFFO was good (kappa statistics 0.54–0.90) and 26 of 41 questions had a kappa score ≥0.70. The internal consistency of the five domains was adequate, with Crohnbach α around 0.80. All except five questions discriminated significantly between patients and controls. The median scores of QUALEFFO were significantly higher in patients with vertebral fractures than in controls in all five domain (p<0.001), which is consistent with decreased quality of life in patients with osteoporosis. Spinal radiographs were assessed using the McCloskey–Kanis algorithm. According to this, 124 patients (78%) had vertebral fractures of ≥3 SD severity, in contrast with 7 controls (4%). Significant correlations existed between scores of similar domains of QUALEFFO and the SF-36, especially for pain, physical function and mental function. All five domains within each questionnaire discriminated significantly between fracture cases and controls. The odds ratios for pain and social function were greater for QUALEFFO, while general health perception was more discriminating using the SF-36. The ROC curve analysis of QUALEFFO indicated that all five domains were significantly predictive of vertebral fractures. When comparing similar domains of the two questionnaires, QUALEFFO domains demonstrated significantly better performance for pain, physical function and social function. The QUALEFFO total score and SF-36 physical composite score showed similar performance. In conclusion, QUALEFFO is repeatable, coherent and discriminates well between patients with vertebral fractures and control subjects. The results of this study confirm the decreased quality of life in patients with vertebral fractures. Received: 4 August 1998 / Accepted: 28 December 1998     

Deterioration in Quality of Life Following Hip Fracture: A Prospective Study

To examine longitudinal change in health- related quality of life (HRQoL) following hip fracture in elderly subjects, 32 patients with hip fractures and 29 sex-matched non-fracture control subjects (mean ± SD age 82 ± 8 and 86 ± 6 years respectively) were enrolled in a prospective, case–control study. Fracture subjects completed a generic questionnaire, Short Form 36 (SF-36), and a disease-targeted measure, the revised Osteoporosis Assessment Questionnaire (OPAQ2), on two separate occasions, within 1 week of fracture and 12–15 weeks after fracture. Controls completed both questionnaires on two occasions 12 weeks apart. SF-36 scores were significantly correlated with OPAQ2 in comparable domains of Physical Function (r= 0.76), General Health (r= 0.70) and Mental Health/Tension (r = 0.86). Control subjects had stable scores with the OPAQ2 and SF-36. At 3 months after fracture there was a significant reduction in HRQoL in the SF-36 domains Physical Function (–51%), Vitality (–24%) and Social Function (–26%) and in the OPAQ2 domains Physical Function (–20%), Social Activity (–49%) and General Health (–24%). Hip fracture patients thus had a lower baseline HRQoL and experienced a significant deterioration in HRQoL after hip fracture on both the SF-36 and OPAQ2. HRQoL should be part of a comprehensive assessment of the costs of osteoporosis including fracture-associated morbidity. Received: 21 October 1999 / Accepted: 15 November 1999     

Positive Effects of Physiotherapy on Chronic Pain and Performance in Osteoporosis

The aim of this placebo-controlled, randomized, single-masked study was to establish the effects of a 10-week ambulatory exercise programme for osteoporotic patients on pain, use of analgesics, functional status, quality of life, balance and muscle strength. Fifty-three ambulatory postmenopausal women with at least one spinal crush fracture and pains within the last 3 years were randomized for physiotherapeutic training twice a week for 10 weeks or no training. The training included general training of balance and muscle strength, with stabilization of the lumbar spine. The participants were tested at baseline, week 5 and week 10 with a balance test, muscle strength test and questionnaires on pain, use of analgesics, functional status and quality of life. Twelve weeks after the supervised training had finished (week 22) they answered the same questionnaires. The study groups were comparable at baseline. The training group had a significant reduction in use of analgesics (p= 0.02) and pain level (p= 0.01) during the training period. Distribution of functional score improved; the improvement was reduced at week 22. Quality of life score improved significantly throughout the study (p= 0.0008), even after week 22. Balance improved non-significantly (p= 0.08). Quadriceps muscle strength improved significantly after 5 weeks (p= 0.04). Back extensor muscle strength improved almost significantly (p= 0.09). In conclusion, this training programme for osteoporotic patients improved balance and level of daily function and decreased experience of pain and use of analgesics. Quality of life was improved even beyond the active training period. Received: 3 March 1997 / Accepted: 30 September 1997     

Dietary Caffeine, Fluid Intake and Urinary Incontinence in Older Rural Women

Forty-one women completed the first phase (self-monitoring) of the Behavioral Management for Continence (BMC) intervention, while working with a nurse during home visits to reduce involuntary urine loss as part of the parent study involving older, rural women living at home. A decrease in dietary caffeine intake and an increase in fluid intake were most frequently recommended. The relationship between a decrease in the amount of dietary caffeine consumed and fewer daytime episodes of involuntary urine loss approached significance –P = 0.0744 – whereas an increase in the average amount of fluid intake was significantly related to an increase in the average volume of urine voided –P = 0.0479 – and not to involuntary urine loss.     

The Ethnic Cultural and Social Aspects of Incontinence – A Pilot Study

This cross-sectional study aimed to study the religious and cultural practices of ethnic minorities that might affect the experience and ideas that sufferers of incontinence have. Subjects were multiparous women from the local community who suffered from incontinence. Structured and unstructured interviews were conducted to assess the effect of incontinence and menstruation on home life, sexual life, personal and communal prayer, rules and customs associated with menstruation, and the ability to discuss problems with their doctor and partners. Individual women differed in how they rated their daily activities, and this was not related to religious or ethnicity. Higher restrictions on activity were perceived for fecal than for urinary incontinence. Sexual relationships were restricted for Jewish and Muslim women during menses. Incontinence led to religious restriction, which was most marked for Jewish and Muslim women, and this was related to the need for cleanliness for prayer. Less then 50% of patients sought help, and this was not related to duration and severity of symptoms. Only Muslim women had a strong preference for female doctors, and this was for cultural reasons.     

Patient Satisfaction and Complications Following Sacral Nerve Stimulation for Urinary Retention, Urge Incontinence and Perineal Pain: a Multicenter Evaluation

The aim of the study was to determine the success rate, the complications, the failures and the solutions found in troublesome cases. A retrospective study was performed in three university centers in Belgium. Between March 1994 and April 1998, a quadripolar electrode and a pulse generator were implanted in 53 patients (8 men, 45 women, 43 ± 12 years, mean follow-up 24 ± 8 months, range 13–39 months). During the first few months, 45 (85%) of the 53 patients had an objective response. Eight late failures occurred, with a mean failure delay of 9 ± 5 months. We performed 15 revisions in 12 patients. Major complications were pain and current-related troubles. The outcome was significantly better (P= 0.001) in post-stress incontinence surgery patients. Device-related pain was found more frequently in patients with dysuria and/or retention or perineal pain, and the test stimulation was less reliable (P= 0.025) in patients with a psychiatric history. Sacral nerve stimulation is efficient in treating patients with refractory lower urinary tract symptoms and/or perineal pain.     

Effect of a Urinary Control Insert on Quality of Life in Incontinent Women

The aim of the study was to evaluate the efficacy, safety and effect on quality of life of the Reliance urinary control insert (Uromed Corp., Needham, MA) in women with genuine stress incontinence. Efficacy was evaluated at baseline and at the end of the 12-month study period by standardized pad-weight studies and by rating scales measuring acceptability, incontinence symptom improvement, ease of learning, comfort and time to habituation, recorded in diaries at monthly intervals in 63 women. The SF-36 Health Survey questionnaire was used to assess quality of life status at baseline without the device and after 12 months of device use. A significant decrease in urine loss at 12 months compared with baseline was shown by standardized pad-weight studies, with and without the device in situ. Urine loss was reduced by more than 80% in 91% of the 63 patients, and 79% were completely dry. Patient diaries showed significant improvement in control of leakage, comfort, and ease of device use during the study period. Short-term-36 Health Status data also indicated significant improvement in the physical functioning score at 12 months. Urinary tract infection and hematuria were the most common adverse effects. The Reliance urinary control insert is an efficacious and safe means of controlling genuine stress incontinence in women. The device was perceived as easy to use and comfortable for these 63 women, and resulted in improved quality of life.     

Controversies in Female Urethral Anatomy and their Significance for Understanding Urinary Continence: Observations and Literature Review

To re-examine the anatomy of the female urethra and related structures, three female pelves serially sectioned in sagittal, coronal or transverse planes, and four sets of transverse histological slides of female urethras, were studied. The observations were assembled, rendered as illustrations, and correlated with published works to present an overall explanation of the gross and histological anatomy of the female pelvis and perineum as related to continence. The figures accompanying the text present the anatomy in a series of views in the three anatomical planes. The anatomical relationships of the paraurethral and paravaginal tissues are examined in relation to the conflicting nomenclature applied to these structures. The figures show the spatial relationships within the pelves and perineum that explain their effective function in urinary continence.     

Use of the Artificial Urinary Sphincter in Women

Persistent urinary incontinence after failed surgical repair can be successfully treated with the artificial urinary sphincter. The English literature was reviewed from 1985 to 1996. Eleven articles and abstracts addressing placement of the artificial urinary sphincter in women were identified. Discussion includes two operative techniques. Success rates were in the range of 91%–99%. Erosion rates were 7%–29%. The artificial urinary sphincter is an effective treatment for women failing other procedures. Appropriate work-up and diagnosis for type III stress urinary incontinence is crucial.     

Validity of Self-Report of Fractures: Results from a Prospective Study in Men and Women Across Europe

In population-based studies of osteoporosis, ascertainment of fractures is typically based on self-report, with subsequent verification by medical records. The aim of this analysis was to assess the validity of self-report of incident nonspine fractures using a postal questionnaire. The degree of overreporting of fracture (false positives) was assessed by comparing self-reports of new fracture from respondents in the multicenter European Prospective Osteoporosis Study with data from other sources including radiographs and medical records. In the analysis, 563 subjects reported nonspine fractures. Verification of the presence of fracture was possible in 510 subjects. Of these, fractures were not confirmed in 11% (false positives). The percentage of false positives was greater in men than in women (15% vs 9%, p=0.04), and less for fractures of the distal forearm and hip than for fractures at other sites. In a separate study, the degree of underreporting (false negatives) was assessed by follow-up of 251 individuals with confirmed fracture ascertained from the records of fracture clinics in three European centers (Lubeck, Oviedo, Warsaw). Questionnaire responses were received from 174 (69%) subjects. Of these, 12 (7%) did not recall sustaining a fracture (false negatives). The percentage of false negatives was lower for hip and distal forearm fractures with only 3 of 90 (3%) such fractures not recalled. Using the combined data from both studies, of those who reported a ‘date’ of fracture on the questionnaire, 91% of subjects were correct to within 1 month of the actual date of the fracture. A postal questionnaire is a relatively simple and accurate method for obtaining information about the occurrence of hip and distal forearm fractures, including their timing. Accuracy of ascertainment of fractures at other sites is less good and where possible self-reported fractures at such sites should be verified from other sources. Received: 22 March 1999 / Accepted: 20 August 1999     

A Case–Control Study of Quality of Life and Functional Impairment in Women with Long–Standing Vertebral Osteoporotic Fracture

There have been several studies of the impact of vertebral osteoporotic fracture on the quality of life and functionality of individual subjects. To date, however, no direct comparisons with age-matched normal subjects without vertebral fracture have been made. The radiographs of 145 female clinic patients with vertebral fractures were reviewed by the study physicians. The controls were recruited from the electoral role and by media appeal. One hundred and sixty-seven women had radiographs taken to determine those without vertebral fracture. Fracture subjects and controls had to be ambulant and were excluded if they had significant radiologic evidence of degenerative disk or joint disease of the spine. One hundred cases and one hundred controls were matched by 5-year age groups. The number, position and severity of the vertebral fracture on the lateral radiographs of the cases was recorded. Quality of life was measured using the Short Form-36 (SF-36) (maximum score 100) and a utility score calculated from thesese results (maximum score 1). Two measurements of functionality were employed: the Modified Barthel Index (MBI) to assess the activities of daily living (maximum score 100) and the Timed ‘Up & Go’ (TUG) that measured the time taken for the subject to rise from sitting in a chair, walk 3 m along a line, return to the chair and sit down. The fracture subjects had 2.9 + 1.6 (mean + SD) vertebral fractures and the time since last fracture was 5.1 + 4.8 years. The SF-36 physical function component summary index results were: fracture subjects 36 + 11, controls 48 + 9 (p < 0.001). The SF-36 mental health component summary index results were: fracture subjects 50 + 11, controls 54 + 8 (p <0.05). The utility scores were: fracture subjects 0.64 + 0.08, controls 0.72 + 0.07 (p <0.001). The MBI results were: fracture subjects 97 + 5, controls 99 + 1 (p< 0.01). The TUG results were: fracture subjects 13.8 + 7.3 s, controls 10.1 + 4.1 s (p <0.01). TUG and MBI scores correlated well with SF-36 scores; however, no domain of the SF-36 or functional measure correlated with either the number of vertebral fractures or the time since last vertebral fracture. Thus, clinically reported vertebral fractures impair both the quality of life and functionality of these subjects. The adverse impact of vertebral fracture on quality of life and functionality needs to be recognized by medical practitioners, subjects and the community, so that adequate health resources can be devoted to the prevention and treatment of this debilitating condition condition. Received: 17 June 1998 / Accepted: 28 October 1998     

Development and Validation of the Mini-Osteoporosis Quality of Life Questionnaire (OQLQ) in Osteoporotic Women with Back Pain due to Vertebral Fractures. Osteoporosis Quality of Life Study Group

The objective of the study was to evaluate a shortened osteoporosis quality of life questionnaire (OQLQ) in osteoporotic women with back pain due to vertebral fractures. From the longer 30-item OQLQ (four to nine items per domain) we created the mini-OQLQ by choosing the two items with the highest impact in each of five domains (symptoms, physical function, activities of daily living, emotional function, leisure). We administered the OQLQ, the Sickness Impact Profile, the SF-36 and the Brief Pain Index to patients at baseline, after 2 weeks and after 6 months. The intraclass correlations between baseline and the 2-week follow-up for the five mini-OQLQ domains ranged from 0.72 to 0.86. Cross-sectional correlations between the domains of the mini-OQLQ and other health instruments were moderate to large (0.35–0.80) and greater than predicted. The mini-OQLQ items showed moderate to large correlations with items omitted from the shortened questionnaire (0.44–0.88). Correlations between the OQLQ domains and the other three instruments were greater than those of the mini-OQLQ, and partial correlations between OQLQ items omitted from the mini-OQLQ and the other three instruments after considering mini-OQLQ items were substantial (0.19–0.71) and statistically significant. Sample sizes of less than 200 per group should be required to detect minimally important differences in parallel-group clinical trials. Longitudinal correlations between the mini-OQLQ and the other measures were often significant but generally lower than predicted (0.10–0.49). The partial correlations revealed that the omitted items explained a significant portion of the longitudinal variance in each domain. We conclude that in a selected group of patients with back pain caused by vertebral fractures, the mini-OQLQ demonstrated good discriminative and adequate evaluative properties. The mini-questionnaire should be useful in clinical settings. Received: 14 September 1998 / Accepted: 8 February 1999