Maria-Dolors Estrada

Health-Related Quality of Life Measurement in Children and Adolescents:A Systematic Review of Generic and Disease-Specific Instruments

OBJECTIVE To identify currently available generic and disease-specific health-related quality of life (HRQOL) instruments for children and adolescents up to 19 years old, to describe their content, and to review their psychometric properties. STUDY DESIGN Previous reviews on the subject and a new literature review from 2001 to December 2006 (MEDLINE, the ISI Science Citation Index, HealthSTAR and PsycLit) were used to identify measures of HRQOL for children and adolescents. The characteristics (country of origin, age range, type of respondent, number of dimensions and items, name of the dimensions and condition) and psychometric properties (reliability, validity, and sensitivity to change) of the instruments were assessed following international guidelines published by the Scientific Committee of the Medical Outcomes Trust. RESULTS In total, 30 generic and 64 disease-specific instruments were identified, 51 of which were published between 2001 and 2005. Many generic measures cover a core set of basic concepts related to physical, mental and social health, although the number and name of dimensions varies substantially. The lower age limit for self-reported instruments was 5-6 years old. Generic measures developed recently focused on both child self-report and parent-proxy report, although 26% of the disease-specific questionnaires were exclusively addressed to proxy-respondents. Most questionnaires had tested internal consistency (67%) and to a lesser extent test-retest stability (44.7%). Most questionnaires reported construct validity, but few instruments analyzed criterion validity (n = 5), structural validity (n = 15) or sensitivity to change (n = 14). CONCLUSIONS The development of HRQOL instruments for children and adolescents has continued apace in recent years, particularly with regard to disease-specific questionnaires. Many of the instruments meet accepted standards for psychometric properties, although instrument developers should include children from the beginning of the development process and need to pay particular attention to testing sensitivity to change.

Identifying Bone-Mass-Related Risk Factors for Fracture to Guide Bone Densitometry Measurements: A Systematic Review of the Literature

Abstract: Available evidence suggests that fracture prediction with bone densitometry may improve when used on people at high risk of osteoporotic fractures. The objectives of this literature review were: (1) to identify risk factors for fracture that are associated with the development of a low bone mass for both men and women; (2) to describe and assess the relationship between these factors and the risk of fracture; and (3) to classify them according to the strength of their association with fracture incidence. Studies were identified from MEDLINE (1982–1997), HealthSTAR (1975–1997) and The Cochrane Library (1997) databases. Pre-stated inclusion criteria (original analytic studies assessing risk factors for osteoporotic fractures in men and women) and methodologic quality were assessed by two independent investigators. Information on the study design and analysis, characteristics of participants, exposure (risk factor) and outcome measures (relative risk and odds ratios for fracture incidence), control for potential confounding factors and risk estimates was extracted using a standardized protocol. Qualitative and meta-analytic techniques were used for data synthesis. As a result, risk factors were classified into three groups according to their strength of association with fracture: high risk (RR≥2), moderate risk (1<RR<2) and no risk or protective (RR≤1). Of approximately 80 risk factors identified from 94 cohort and 72 case-control studies, 15% were classified in the high-risk group, including low body weight, loss of weight, physical inactivity, the consumption of corticosteroids or anticonvulsants, primary hyperparathyroidism, diabetes mellitus type I, anorexia nervosa, gastrectomy, pernicious anemia, and aging (>70–80 years). Eighteen percent and 8% of risk factors were classified in the moderate and no risk group respectively, whereas 60% showed either a lack of scientific evidence confirming their association with fracture or contradictory results. An efficient strategy for bone densitometry provision may thus be its selective use in those individuals who present with several strong or moderate risk factors for fracture related to bone mass loss.

The validity of recommendations from clinical guidelines: a survival analysis

Background: Clinical guidelines should be updated to maintain their validity. Our aim was to estimate the length of time before recommendations become outdated. Methods: We used a retrospective cohort design and included recommendations from clinical guidelines developed in the Spanish National Health System clinical guideline program since 2008. We performed a descriptive analysis of references, recommendations and resources used, and a survival analysis of recommendations using the Kaplan–Meier method. Results: We included 113 recommendations from 4 clinical guidelines with a median of 4 years since the most recent search (range 3.9–4.4 yr). We retrieved 39 136 references (range 3343–14 787) using an exhaustive literature search, 668 of which were related to the recommendations in our sample. We identified 69 (10.3%) key references, corresponding to 25 (22.1%) recommendations that required updating. Ninety-two percent (95% confidence interval 86.9–97.0) of the recommendations were valid 1 year after their development. This probability decreased at 2 (85.7%), 3 (81.3%) and 4 years (77.8%). Interpretation: Recommendations quickly become outdated, with 1 out of 5 recommendations being out of date after 3 years. Waiting more than 3 years to review a guideline is potentially too long.

Instrumento para la lectura crítica y la evaluación de estudios epidemiológicos transversales

The aim was to develop a tool for the critical appraisal of epidemiological cross-sectional studies. Several recommendations or guidelines for assessing the strength of scientific evidence provided by observational studies were reviewed, like those from the Agency for Healthcare Research and Quality, the Scottish Intercollegiate Guidelines Group, the Osteba (Basque Office for Health Technology Assessment), and the STROBE Initiative. The tool has 27 items to assess: study question or objective, participants, comparability between groups, definition and measure of main variables; analysis and confusion, results, conclusions, external validity and applicability, and conflict of interest. This tool can be used to critically appraise research papers or to rate evidence during the elaboration of systematic reviews.

Validation of the FRAX Predictive Model for Major Osteoporotic Fracture in a Historical Cohort of Spanish Women

FRAX is a fracture risk assessment tool to estimate the 10-yr probability of a major osteoporotic fracture or a hip fracture. The aim of the study was to assess the predictive ability of FRAX for major osteoporotic fracture in a cohort of Spanish women. The study was based on a retrospective cohort of women aged 40-90 yr. Patients were followed from their first bone densitometry to the first major osteoporotic fracture event (forearm, proximal humerus, clinical spine, or hip fracture) or for 10 yr whichever comes first. A total of 1231 women were included. Bone mineral density data and self-reported data on risk factors for fracture were obtained. The predictive ability of FRAX was assessed by analyzing calibration and discrimination, with the calculation of observed-to-expected (O/E) fracture ratios and the receiver operating characteristic (ROC) curve, respectively. A total of 222 women (18.1%) reported at least 1 fracture after the first assessment. The incidence of fracture was 14 (95% confidence interval [CI]: 10-17), 19 (95% CI: 15-23), 28 (95% CI: 21-36), and 67 (95% CI: 8-125) cases per 1000 woman-years in women aged <55, 55-64, 65-74, and ≥75 yr, respectively. The O/E ratio was 3.9 (95% CI: 3.4-4.5; p<0.0001). The area under the ROC curve was 61% (95% CI: 57-65%). FRAX underestimated the risk of major osteoporotic fracture in this cohort of Spanish women, particularly in those with a low risk of fracture according to the clinical factors used in the FRAX tool. Our findings highlight the need for validation studies of FRAX in Spain.

Factores de riesgo de fracturas por fragilidad en una cohorte de mujeres españolas

INTRODUCTION Fragility fractures are an important public health issue. The aim of this study was to analyze the association of the main osteoporotic risk factors related to fragility fracture in a cohort of women with an indication of bone densitometry (BD). METHODS A retrospective cohort was followed-up until a fragile fracture occurred, in a population of women aged 40 to 90 years with a first visit for BD between January 1992 and February 2008. We calculated the incidence rate of fracture per 1000 women-years of follow-up, and the hazard ratio (HR) of fragile fracture using a Cox regression model. RESULTS A total of 49,735 women were studied. The average age of participants was 57.8 years (SD: 8.5). Of these, 3631 women (7.1%) reported a new fragility fracture in post-baseline visits. Risk factors with higher adjusted HR were age ≥ 75 years compared with age < 55 years (HR: 3.8; 95% CI: 3.3-4.4) and having a BC result evaluated as osteoporosis compared to normal (HR: 2.0; 95% CI: 1.8-2.2). A personal history of humerus, hip or vertebral fractures had an adjusted HR of 1.2 (95% CI: 1.1-1.3). CONCLUSIONS The main risk factors for fragility fracture were advanced age, BD result and a personal history of fracture, although 74% of fractures were detected with a bone mineral density classified as normal or osteopenia. Other relevant factors were rheumatoid arthritis or having received prolonged corticosteroid therapy.

Risk factors for fragility fractures in a cohort of Spanish women

INTRODUCTION Fragility fractures are an important public health issue. The aim of this study was to analyze the association of the main osteoporotic risk factors related to fragility fracture in a cohort of women with an indication of bone densitometry (BD). METHODS A retrospective cohort was followed-up until a fragile fracture occurred, in a population of women aged 40 to 90 years with a first visit for BD between January 1992 and February 2008. We calculated the incidence rate of fracture per 1000 women-years of follow-up, and the hazard ratio (HR) of fragile fracture using a Cox regression model. RESULTS A total of 49,735 women were studied. The average age of participants was 57.8 years (SD: 8.5). Of these, 3631 women (7.1%) reported a new fragility fracture in post-baseline visits. Risk factors with higher adjusted HR were age ≥ 75 years compared with age < 55 years (HR: 3.8; 95% CI: 3.3-4.4) and having a BC result evaluated as osteoporosis compared to normal (HR: 2.0; 95% CI: 1.8-2.2). A personal history of humerus, hip or vertebral fractures had an adjusted HR of 1.2 (95% CI: 1.1-1.3). CONCLUSIONS The main risk factors for fragility fracture were advanced age, BD result and a personal history of fracture, although 74% of fractures were detected with a bone mineral density classified as normal or osteopenia. Other relevant factors were rheumatoid arthritis or having received prolonged corticosteroid therapy.