Incorporating the patient perspective in the study of rare bone disease: insights from the osteogenesis imperfecta community.

There is limited research which examines health concerns of individuals with osteogenesis imperfecta (OI). Discussion groups with leaders of the adult OI community identified a broad range of medical priorities beyond fractures and brittle bones. Our work underscores the need to include patient-reported outcomes in rare bone disease research. INTRODUCTION: Osteogenesis imperfecta (OI) is a rare genetic disorder affecting collagen protein leading to brittle bones and a number of other medical complications. To date, there is limited research which examines the life-long process of aging with this rare disease, much less the perspective of individuals with OI. METHODS: In order to explore and prioritize health concerns that adults with OI feel have been inadequately addressed in health care and research, investigators held discussions with leaders from the global adult OI community. The meetings were held in August 2017 at the 13th International Conference on OI in Oslo, Norway as part of the preconference seminar "Patient Participation in OI Research". Investigators were part of the Brittle Bone Disease Consortium (BBDC), a multicenter research program devoted to the study of OI, and their focus was on patient-reported outcomes (PRO). RESULTS: Participants noted that while fractures and brittle bones are the most common feature of OI, a number of body systems are under-studied in this disorder. They particularly emphasized breathing, hearing, and the effects of aging as primary concerns that researchers and physicians may not fully understand or address. Other areas included pain, gastrointestinal problems, mental health, nutrition, menopause/pregnancy, and basilar invagination. Participants also emphasized that they must be informed of study results. They underscored that outcome measures incorporated into future drug trials must look beyond fractures and consider the whole patient. CONCLUSIONS: This work will help guide the incorporation of PROs into the next phase of the BBDC Natural History Study of OI and underscores the importance of including PROs in the study of rare diseases.

Early Improvement in Pain and Functional Outcome but Not Quality of Life After Surgery for Metastatic Long Bone Disease.

BACKGROUND: Bone metastases represent the most frequent cause of cancer-related pain, affecting health-related quality of life and creating a substantial burden on the healthcare system. Although most bony metastatic lesions can be managed nonoperatively, surgical management can help patients reduce severe pain, avoid impending fracture, and stabilize pathologic fractures. Studies have demonstrated functional improvement postoperatively as early as 6 weeks, but little data exist on the temporal progress of these improvements or on the changes in quality of life over time as a result of surgical intervention. QUESTIONS/PURPOSES: (1) Do patients' functional outcomes, pain, and quality of life improve after surgery for long bone metastases? (2) What is the temporal progress of these changes to 1 year after surgery or death? (3) What is the overall and 30-day rate of complications after surgery for long bone metastases? (4) What are the oncologic outcomes including overall survival and local disease recurrence for this patient population? METHODS: A multicenter, prospective study from three orthopaedic oncology centers in Quebec, Canada, was conducted between 2008 and 2016 to examine the improvement in function and quality of life after surgery for patients with long bone metastases. During this time, 184 patients out of a total of 210 patients evaluated during this period were enrolled; of those, 141 (77%) had complete followup at a minimum of 2 weeks (mean, 23 weeks; range, 2-52 weeks) or until death, whereas another 35 (19%) were lost to followup but were not known to have died before the minimum followup interval was achieved. Pathologic fracture was present in 34% (48 of 141) of patients. The median Mirel's score for those who underwent prophylactic surgery was 10 (interquartile range, 10-11). Surgical procedures included intramedullary nailing (55), endoprosthetic replacement (49), plate osteosynthesis (31), extended intralesional curettage (four), and allograft reconstruction (two). Seventy-seven percent (108 of 141) of patients received radiotherapy. The Musculoskeletal Tumor Society (MSTS), Toronto Extremity Salvage Score (TESS), Brief Pain Inventory (BPI) form, and Quality Of Life During Serious Illness (QOLLTI-P) form were administered pre- and postoperatively at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. Analysis of variance followed by post hoc analysis was conducted to test for significance between pre- and postoperative scores. The Kaplan-Meier estimate was used to calculate overall survivorship and local recurrence-free survival. A p value of < 0.05 was considered statistically significant. RESULTS: MSTS and BPI pain scores improved at 2 weeks when compared with preoperative scores (MSTS: 39% ± 24% pre- versus 62% ± 19% postoperative, mean difference [MD] 23, 95% confidence interval [CI], 16-32, p < 0.001; BPI: 52% ± 21% pre- versus 30% ± 21% postoperative, MD 22, 95% CI, 16-32, p < 0.001). Continuous and incremental improvement in TESS, MSTS, and BPI scores was observed temporally at 6 weeks, 3 months, 6 months, and 1 year; for example, the TESS score improved from 44% ± 24% to 73% ± 21% (MD 29, p < 0.001, 95% CI, 19-38) at 6 months. We did not detect a difference in quality of life as measured by the QOLLTI-P score (6 ± 1 pre- versus 7 ± 4 postoperative, MD 1, 95% CI, -0.4 to 3, p = 0.2). The overall and 30-day rates of systemic complications were 35% (49 of 141) and 14% (20 of 141), respectively. The Kaplan-Meier estimates for overall survival were 70% (95% CI, 62.4-78) at 6 months and 41% (95% CI, 33-49) at 1 year. Local recurrence-free survival was 17 weeks (95% CI, 11-24). CONCLUSIONS: Surgical management of metastatic long bone disease substantially improves patients' functional outcome and pain as early as 2 weeks postoperatively and should be considered for impending or pathologic fracture in patients whose survival is expected to be longer than 2 weeks provided that there are no immediate contraindications. Quality of life in this patient population did not improve, which may be a function of patient selection, concomitant chemoradiotherapy regimens, disease progression, or terminal illness, and this merits further investigation. LEVEL OF EVIDENCE: Level II, therapeutic study.

Percutaneous Vertebroplasty for Pathological Vertebral Compression Fractures Secondary to Multiple Myeloma--Medium-Term and Long-Term Assessment of Pain Relief and Quality of Life.

BACKGROUND: In patients with multiple myeloma (MM) there is a high risk of compression fractures of the spine. In the majority of cases, the method of treatment is percutaneous vertebroplasty (PV) or kyphoplasty (PK). The number of studies verifying their efficacy in MM is still relatively small. OBJECTIVES: The aim of this study has been to assess medium- and long-term pain relief as well as improvement in the quality of life (QL) after PV in MM cases. MATERIAL AND METHODS: There was a prospective group of 34 MM cases in which a total of 131 vertebral bodies were augmented by means of PV. It was possible to follow up 22 patients who agreed to take part in the assessment. Their level of daily activity and the level of pain were assessed using the Oswestry Back Pain scale and a visual analogue scale (VAS) before PV and at a later date (medium-term follow up was a mean of 10 months after the last operation). Five out of eight cases in which 4.5-5 years had elapsed since the first PV were tested again (long-term follow-up). RESULTS: Relief of pain and improvement of QL, assessed a mean of 10 months after PV, proved to be statistically significant. On the average, pain decreased by 4.7 points as measured on the VAS scale and the average improvement in the QL measured on the Oswestry scale was 27.7%. There were no neurological or general complications. After 4.5-5 years, there has not been any significant change in the level of pain relief or the improvement in the QL in the 5 cases in which long-term assessment was possible. CONCLUSIONS: In MM cases, PV is a simple, effective and safe method for the treatment of vertebral infiltration and compression fractures, giving permanent long-term pain relief and concomitant improvement in the QL.

QUALITY OF LIFE FOLLOWING SURGICAL TREATMENT OF LOWER LIMB METASTASES IN LONG BONE.

Pathological fractures have a high incidence in musculo-skeletal oncology, and localization in long bone causes severe pain, disability and poor quality of life. The aim of this retrospective case series is to evaluate the clinical results, in particular regarding the quality of life, in patients affected by lower long bone pathological fractures surgically treated. We analyzed 93 patients with pathological fractures of tibia and femur surgically treated in our Orthopaedic Department and followed up for at least 3 years or until their death. Intramedullary nailing or endoprosthetic reconstruction for pathologic fractures located in the metadiaphyseal and diaphyseal or proximal regions in advanced-stage cancer patients are suitable methods for a stable fixation or reconstruction. These approaches guarantee a good mechanical stability, a faster mobilization, a better control of pain with an overall improvement in quality of life in all patients, confirmed also by the trend of the ECOG performance status and QOL-ACD.

Health economic implications of perioperative delirium in older patients after surgery for a fragility hip fracture.

BACKGROUND: Patients who experience a fragility hip fracture are at high risk for perioperative delirium. The purpose of the present study was to evaluate the impact, from a hospital perspective, of perioperative delirium on the length of the hospital stay and episode-of-care costs for elderly patients who underwent surgical treatment of a fragility hip fracture. METHODS: A total of 242 patients sixty-five years of age or older (mean age, eighty-two years; range, sixty-five to 103 years) who underwent surgical treatment of a fragility hip fracture at a single center between January 2011 and December 2012 were evaluated. Demographic, clinical, surgical, and adverse-events data were extracted and analyzed. The confusion assessment method (CAM) was used prospectively to detect perioperative delirium. RESULTS: One hundred and sixteen (48%) of the 242 patients developed perioperative delirium during their stay in the hospital. Compared with patients with no delirium, delirium was associated with a mean incremental total length of hospital stay of 7.4 days (95% confidence interval [CI] = 3.7 to 11.2 days; p < 0.001), a mean incremental length of stay following surgery of 7.4 days (95% CI = 3.8 to 11.1 days; p < 0.001), and a mean incremental episode-of-care cost (in 2012 Canadian dollars) of $8286 (95% CI = $3690 to $12,881; p < 0.001). The total incremental episode-of-care cost attributable to delirium over the study period was $961,131 in 2012 Canadian dollars. CONCLUSIONS: Nearly 50% of elderly patients who underwent surgery for a fragility hip fracture developed perioperative delirium, which was associated with a significant incremental in-hospital length of stay and significant incremental episode-of-care costs. These findings highlight the importance of implementing cost-effective interventions to reduce the prevalence of perioperative delirium in elderly patients with a low-energy hip fracture.

Factors predictive of the perceived osteoporosis-fracture link in fragility fracture patients.

OBJECTIVE: Given the asymptomatic nature of osteoporosis, a fragility fracture provides an opportunity to make the issue of osteoporosis relevant to patients. Patients who link their fragility fracture with osteoporosis are more likely to initiate osteoporosis treatment, yet to date, we know little about who is likely to make this link. This study examined whether demographic, health, and osteoporosis belief factors predicted a perceived link between a fragility fracture and osteoporosis. STUDY DESIGN: This longitudinal cohort study analyzed baseline and follow up data collected as part of a provincial osteoporosis screening initiative targeting fragility fracture patients. Logistic regression analysis was used to examine the relationship between hypothesized predictors and the outcome. MAIN OUTCOME MEASURE: Patient perception of the osteoporosis-fracture link at follow up. RESULTS: At baseline, 93% (1615/1735) of patients did not believe their fracture could have been caused by osteoporosis. Of these, only 8.2% changed this perception at follow up. Adjusted analyses showed that baseline characteristics associated with making the osteoporosis-fracture link at follow up were: a previous fracture (odds ratio (OR) 1.7, confidence interval (CI) 1.2-2.6), perception of osteoporosis pharmacotherapy benefits OR 1.2 (CI 1.0-1.5), diagnosis of rheumatoid arthritis OR 2.6 (CI 1.4-4.9) and the perception of bones as "thin" OR 8.2 (CI 5.1-13.1). CONCLUSION: These results shed more light on patient-level barriers to osteoporosis management following an osteoporosis educational programme. They may be used to identify patients less likely to make the link between their fracture and osteoporosis and to inform interventions for this patient group.

Measurement equivalence of the SF-36 in the Canadian Multicentre Osteoporosis Study.

BACKGROUND: Studies that compare health-related quality of life (HRQOL) and other patient-reported outcomes in different populations rest on the assumption that the measure has equivalent psychometric properties across groups. This study examined the measurement equivalence (ME) of the 36-item Medical Outcomes Study Short Form Survey (SF-36), a widely-used measure of HRQOL, by sex and race in a population-based Canadian sample. FINDINGS: SF-36 data were from the Canadian Multicentre Osteoporosis Study, a prospective cohort study that randomly sampled adult men and women from nine sites across Canada. Confirmatory factor analysis (CFA) techniques were used to test hypotheses about four forms of ME, which are based on equality of the factor loadings, variances, covariances, and intercepts. Analyses were conducted for Caucasian and non-Caucasian females (n = 6,539) and males (n = 2,884). CFA results revealed that a measurement model with physical and mental health factors provided a good fit to the data. All forms of ME were satisfied for the study groups. CONCLUSIONS: The results suggest that sex and race do not influence the conceptualization of a general measure of HRQOL in the Canadian population.

Patients reject the concept of fragility fracture--a new understanding based on fracture patients' communication.

UNLABELLED: We examined patients' communication about fragility fractures to gain insight into why patients do not connect fractures to bone health. The term "fragility" fracture was a misnomer to patients who perceived the event as physically and emotionally traumatic. Improved communication about such fractures could facilitate awareness of bone health. INTRODUCTION: We examined patients' communication about fragility fractures to gain insight into why patients do not perceive the connection between their fracture and low bone mass. METHODS: A descriptive phenomenological (qualitative) study was conducted. During face-to-face interviews, the participants described the experience of their fracture in detail and the circumstances surrounding the fracture. Data analysis was guided by Giorgi's methodology. English-speaking male and female patients aged 65+ years and "high" risk for future fracture were eligible and screened for osteoporosis through an established screening program at an urban teaching hospital. RESULTS: We recruited 30 participants (9 males, 21 females), aged 65-88, who presented with a hip (n = 11), wrist (n = 11), shoulder (n = 6), or other (n = 2) fracture. Ten of the 30 fractures occurred inside the home and the remaining fractures occurred outside the home. Sustaining a fragility fracture was perceived as a traumatic event, both physically and emotionally. In general, participants used forceful, action-oriented words and referred to hard surfaces to describe the experience. Explanations for the fracture, other than bone quality, were often reported, especially that falls were "freak" or "fluke" events. Patients who sustained a fracture under more mundane circumstances seemed more likely to perceive a connection between the fracture and their bone health. CONCLUSIONS: The term fragility fracture was a misnomer for many older adults. By reexamining how this term is communicated to fracture patients, health care providers may better facilitate patients' awareness of bone health.

Health-related quality of life in patients with osteopenia or osteoporosis with and without fractures in a geriatric rehabilitation department.

BACKGROUND: Health-related quality of life (HRQOL) is an important aspect in the management of patients with osteoporosis. The objective of this study was to estimate differences in HRQOL in women and men with osteopenia and osteoporosis with and without a fracture history and to assess HRQOL with a generic and disease-specific instrument. METHODS: Women and men were recruited from a geriatric rehabilitation department. Osteopenia or osteoporosis was diagnosed by Dual X-Ray Energy Absorptiometry (DXA). HRQOL was evaluated with the generic SF-36 questionnaire and the quality of life questionnaire of the International Osteoporosis Foundation (QUALEFFO-41). All subjects were instructed to complete these questionnaires. The level of pain was documented with a VAS (Visual Analogue Scale). RESULTS: 173 women and 49 men at a mean age of 79.3 +/- 8.5 years were enrolled. 85 participants reported a history of vertebral or hip fractures. The QUALEFFO score was 49.8 +/- 19.2 in patients with osteopenia, but significantly higher in osteoporotic patients without fractures (mean 58.1 +/- 13.3; p < 0.05). In osteoporotic patients with a fracture history the mean QUALEFFO score was significantly higher still, i.e. 63.8 +/- 13.6 (p < 0.05). The mean SF-36 summation scores of osteopenic patients and osteoporotic patients without fractures were similar (314 +/- 117 and 312 +/- 99, respectively). Osteoporotic patients with a fracture history showed lower mean scores (276 +/- 88; p < 0.05). VAS scores did not differ significantly. CONCLUSIONS: Osteoporosis has a considerably greater impact on HRQOL than osteopenia. Patients with a history of vertebral or hip fractures have a significantly poorer quality of life. These differences should be taken into account when prioritizing health care management.

Osteoporosis risk perceptions among patients who have sustained a fragility fracture.

OBJECTIVE: To explore the perceptions of patients who have sustained a fragility fracture regarding their future fracture risk and the beliefs underlying their perceptions. METHODS: Patients with fragility fracture participated in a telephone interview. Quantitative and qualitative methods were used to characterize patient characteristics and perspectives of future fracture risk. Content analysis of qualitative statements was independently performed by three investigators to identify common themes and contrasting statements, and the findings were discussed to ensure consensus. RESULTS: Consistent themes were identified among participant responses irrespective of whether they responded "yes", "no" or "unsure" when asked whether they were at increased fracture risk: (1) patients' perception of risk was influenced by whether or not they believed they had osteoporosis, which may be altered by interaction with health care providers; (2) patients' had their own perceptions of their bone health; (3) patients' attributed their risk to their own actions or "carefulness"; and (4) patients' had specific beliefs about their fracture and determinants of fracture risk. CONCLUSION: Patients who experience fragility fractures develop perceptions about future fracture risk that are influenced by interactions with health care providers, as well as beliefs about their fracture and beliefs that they can modify their risk. PRACTICE IMPLICATIONS: Health care providers should discuss strategies for fracture prevention with all patients after fragility fracture to ensure that patients understand that participation in preventative behaviours can modify their risk.

Long-term cost and effect on quality of life of osteoporosis-related fractures in Sweden.

BACKGROUND AND PURPOSE: Few economic or quality-of-life studies have investigated the long-term consequences of fragility fractures. This prospective observational data collection study assessed the cost and quality of life related to hip, vertebral, and wrist fracture 13-18 months after the fracture, based on 684 patients surviving 18 months after fracture. PATIENTS AND METHODS: Data regarding resource use and quality of life related to fractures was collected using questionnaires at 7 research centers in Sweden. Information was collected using patient records, register sources, and by asking the patient. Quality of life was estimated using the EQ-5D questionnaire. Direct and indirect costs were estimated from a societal standpoint. RESULTS: The mean fracture-related cost 13-18 months after a hip, vertebral, or wrist fracture were estimated to be euro2,422, euro3,628, and euro316, respectively. Between 12 and 18 months after hip, vertebral, and wrist fracture, utility increased by 0.03, 0.05, and 0.02, respectively. Compared to prefracture levels, the mean loss in quality of life between 13 and 18 months after fracture was estimated to be 0.05, 0.11, and 0.005 for hip, vertebral, and wrist fracture. INTERPRETATION: The sample of vertebral fracture patients was fairly small and included a high proportion of fractures leading to hospitalization, but the results indicate higher long-term costs and greater loss in quality of life related to vertebral fracture than previously believed.

Do patients perceive a link between a fragility fracture and osteoporosis?

BACKGROUND: To evaluate factors associated with whether patients associate their fracture with future fracture risk. METHODS: Fragility fracture patients participated in a telephone interview. Unadjusted odds ratios (OR, [95% CI]) were calculated to identify factors associated with whether patients associate their fracture with increased fracture risk or osteoporosis. Predictors identified in univariate analysis were entered into multivariable logistic regression models. RESULTS: 127 fragility fracture patients (82% female) participated in the study, mean (SD) age 67.5 (12.7) years. An osteoporosis diagnosis was reported in 56 (44%) participants, but only 17% thought their fracture was related to osteoporosis. Less than 50% perceived themselves at increased risk of fracture. The odds of an individual perceiving themselves at increased risk for fracture were higher for those that reported a diagnosis of osteoporosis (OR 22.91 [95%CI 7.45;70.44], p < 0.001), but the odds decreased with increasing age (0.95 [0.91;0.99], p<0.009). The only variable significantly associated with the perception that the fracture was related to osteoporosis was self-reported osteoporosis diagnosis (39.83 [8.15;194.71], p<0.001). CONCLUSION: Many fragility fracture patients do not associate their fracture with osteoporosis. It is crucial for physicians to communicate to patients that an osteoporosis diagnosis, increasing age or a fragility fracture increases the risk for future fracture.

[Bisphosphonates in oncology]. / Einsatz der Bisphosphonate in der Onkologie.

Since bone metastases occur as a result of hematogenous spreading of tumor cells, therapy with curative intent is no longer feasible and palliative options for treating and preventing skeletal events are essential. Today, bisphosphonates are established in the systemic treatment of bone metastases. This report provides an overview of molecular mechanisms of action and clinical data of bisphosphonates in patients with skeletal metastases of breast and prostate cancer as the most common solid tumors which spread to the bone.

A clinical tool to determine the necessity of spine radiography in postmenopausal women with osteoporosis presenting with back pain.

BACKGROUND: Vertebral fractures are underdiagnosed, although the resulting mortality and morbidity in postmenopausal women with osteoporosis is now recognised. In a population of postmenopausal women with osteoporosis and back pain, symptoms may be related to vertebral fractures or degenerative changes of the spine. AIM: To evaluate a population of postmenopausal women presenting with back pain and factors associated with vertebral fractures which were assessable in a clinical setting in order to determine the necessity for spine radiography. METHODS: Patient questioning and physical examination were carried out and spinal radiographic data collected from 410 postmenopausal women with osteoporosis, with an average age of 74 years, who consulted a rheumatologist for back pain. Of these, 215 (52.4%) patients were diagnosed with at least one vertebral fracture. Logistic regression was used to identify the most relevant clinical features associated with existing vertebral fractures, and to derive a quantitative index of risk. RESULTS: The model included six parameters: age, back pain intensity, height loss, history of low trauma non-vertebral fractures, thoracic localisation of back pain and sudden occurrence of back pain. The scoring system, or the quantitative index, had a maximal score of 16. For a score >or=7, the probability of existing vertebral fracture was >or=43%. The correlation between this quantitative index and the logistic model probability was 0.98, suggesting an excellent and highly significant approximation of the original prediction equation. CONCLUSIONS: From six clinical items, an index was built to identify women with osteoporosis and back pain who should have spine radiography. This simple tool may help clinicians to optimise vertebral fracture diagnosis and to make a proper therapeutic decision.

Why does depression develop in complicated osteoporosis?

PATIENTS AND METHODS: In a prospective study we observed which female patients developed depression following an acute and painful vertebral fracture. For the statistical evaluation of questionnaires we chose randomly 32 patients with depression (out of 33 patients) aged 51-73, and 32 patients without depression (out of 44 patients) aged 52-70. THE AIM OF THE STUDY: To verify the hypothesis that the patients with more traumatic experience in the anamnesis (Questionnaire No. 1) are more depression prone following the osteoporotic vertebrae fractures and their character features are typical for subjects with higher emotional vulnerability (Questionnaire No. 2). STATISTICAL ANALYSIS: 1. Questionnaires 1 and 2 were evaluated by two statistical methods: a) automatization of mathematical and statistical estimates and tests based on binomial distribution; b) ADALINE Programme. 2. Assessment of relative risk for developing depression. RESULTS AND CONCLUSION: We recommend to use questionnaires No. 1 and 2 in female patients with acute painful vertebrae fractures to select patients with the risk of depression development. These patients should be followed more frequently as outpatients and in case of first clinical symptoms of depression should be recommended for special psychiatric care. Early therapy of depression enables to accelerate the mobilisation, rehabilitation and resocialisation of patients, to improve the quality of their lives and to reduce the costs of analgetic treatment of pain, sedatives and rehabilitation (Tab. 10, Fig. 2, Ref. 17).

Brittle bones: ageing or threat of disease exploring women's cultural models of osteoporosis.

AIMS: To explore elderly Danish women's ideas about osteoporosis and the possible threat to health. The authors discuss the issue of risk interpretations in itself, using osteoporosis as a case. METHODS: A qualitative study based on material from focus-group discussions. Twenty-two 60- to 61-year-old healthy women were selected on the basis of questionnaire answers. Analysis was based on a meaning-centred approach. RESULTS: Comprehension of osteoporosis was mainly based on images representing various dimensions of osteoporosis. The women drew on experiences with relatives, friends, and health information. Physical appearance seemed to be the most common way of assessing those who had osteoporosis or who might have it in the future. Women's ideas about osteoporosis were influenced by two main, parallel stereotypes of knowledge based on models of ageing with bodily decay and the threat of a preventable disease. They seemed to vacillate, often integrating elements from both models in their comprehension. The scenarios for women with or liable to develop osteoporosis as a disease appeared to be founded on worst-case scenarios. CONCLUSION: It is suggested that health professionals pay greater attention to people's models and images of risk conditions and carefully decide which images they wish to promote. Health education regarding osteoporosis comprises an ethical obligation to avert the construction of the more extreme and anxiety-producing prototypes. This is especially important when informing individuals about risk and prevention and when decisions on screenings and other medical examinations are made.

[The impact of vertebral fractures on quality of life in postmenopausal women with osteoporosis. Validity of the Italian version of mini-Osteoporosis Quality of Life Questionnaire.]. / Impatto sulla qualità della vita delle fratture vertebrali in donne in età postmenopausale affette da osteoporosi. Validità della versione italiana del mini-Osteoporosis Quality of Life Questionnaire.

BACKGROUND: Vertebral fracture is one of the most commonly occurring osteoporotic fractures. Vertebral fractures associated with osteoporosis are a major cause of pain in elderly people and may hardly affect patient's health-related quality of life (HRQOL), making this an important parameter for assessment in these patients. Studies comparing the performance of HRQOL instruments in osteoporosis are lacking. OBJECTIVES: The purposes of this study were to assess the effect of vertebral fractures on health HRQOL in post-menopausal women with osteoporosis and to investigate the validity of the Italian version of the mini-Osteoporosis Quality of Life Questionnaire (mini-OQOL) in a clinical setting. METHODS: Patients were divided into two study groups, according to fracture status: vertebral fractures (41 patients) and no vertebral fractures (27 patients). Baseline assessments of anthropometric data, medical history, and prevalent fracture status were obtained from all participants. All of the participants were evaluated using both disease-targeted mini-OQOL and QUALEFFO, generic instrument (EUROQoL), disability scale (Roland Morris Disability questionnaire- RMDQ) and chronic pain grade questionnaire. RESULTS: Vertebral fractures due to osteoporosis significantly decreases scores on physical function, socio-emotional status, clinical symptoms, and overall HRQOL. Both disease-targeted questionnaires showing an association between the number of prevalent vertebral fractures and decreased HRQOL. Significant correlations existed between scores of similar domains of mini-OQOL and the QUALEFFO, especially for symptoms, physical function, activities of daily living and social function. The receiver operating characteristic (ROC) curve analysis of mini-OQOL and the QUALEFFO indicated that both questionnaires were significantly predictive of vertebral fractures. Number of concomitant diseases presented a weak significant correlation with EUROQoL (p=0.041). CONCLUSIONS: Our study suggests that the patients with vertebral fractures due to osteoporosis have a relevant impairment in quality of life. Both disease-targeted questionnaires discriminated between patients with and without vertebral fractures though the mini-OQOL, originally developed to measure the effect of vertebral fractures on quality of life, showed slightly better discriminant power. The benefit of the mini-OQOL is that it is efficient, self administered, and requires 3-4 minutes to complete.