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Objective:Health behaviour change interventions (HBCIs), used in health education, health promotion, patient education and psychotherapy areas, are considered complex interventions. The objective of this article is to discuss the value and limitations of using randomised clinical trials (RCTs) to asses HBCIs. Methods:A scoping review of the literature was conducted to identify the main challenges of using RCTs for evaluating HBCIs. The issues were illustrated by case studies selected from research conducted by our multidisciplinary team. Results:In complex interventions, effects are produced not only by the intervention, but are strongly linked to context. Issues relating to transferability of results are therefore critical, and require adjustments to the RCT model. Sampling bias, biases related to the experimental conditions and biases due to the absence of double-blindness were examined and illustrated by case studies. Conclusion:The results underline the importance of a multidisciplinary approach. They call for adapted or alternative evaluation models that overcome the limitations of RCTs. [ABSTRACT FROM PUBLISHER]

Objectives: To assess the reliability and diagnostic accuracy of qualitative evaluation of apparent diffusion coefficient (ADC) mapping with magnetic resonance imaging (MRI) in differentiating between complete and partial anterior cruciate ligament (ACL) tears. Methods: This prospective study protocol was approved by the institutional ethics review board and informed consent was obtained from all the patients. Eighty-five patients (35 women and 50 men, mean age 34.1 years) with recent (<4 months) knee trauma with suspected ACL injury underwent conventional MRI (T1-weighted and T2-weighted sequences with fat saturation) associated with ADC mapping. MR images were read qualitatively without and then with ADC mapping by three radiologists, with analysis of direct signs of a traumatic ACL tear and a second-reading. Dynamic X-rays (43 patients) or arthroscopies (42 patients) were used as reference standards. Results: For complete ACL tear diagnosis (67 patients), sensitivity and specificity were 87% and 50% respectively with conventional MRI, and 96% and 94% respectively with ADC mapping ( P < 0.01 for specificity). Inter-observer correlations between musculoskeletal radiologists were almost perfect (κ = 0.81) with ADC mapping and fair with conventional MRI on the second-reading. Conclusions: ADC mapping associated with conventional MR sequences is a reproducible method to better differentiate complete and partial ACL tears. Key Points: • MRI is widely used for assessing the problematic knee • Additional diffusion-weighted sequences help differentiate between complete and partial ACL tears • DW-MRI for ACL requires a reader-dependent learning curve • Reliable visualisation of complete ACL tears allows more appropriate management of patients [ABSTRACT FROM AUTHOR]

Purpose: To investigate time trends in health-related quality of life (HRQoL) in France and to report existing and changing demographic, socioeconomic, and geographic disparities. Methods: Data were drawn from two independent national cross-sectional surveys conducted in 1995 and 2003, including 3,243 individuals aged 18-84 in 1995 and 22,743 in 2003. HRQoL was measured with the 8 subscales of the French version of the SF-36. Results: After multiple linear regression, a significant decrease was observed between 1995 and 2003 in all scales scores, from −0.11 adjusted standard deviations for Social Functioning (95% CI: −0.15 to −0.08) to −0.23 for Vitality (−0.26 to −0.19). Increasing age, female gender, divorce/widowhood, lowest educational levels, chronic conditions, and living in the Northern region were identified as independent predictors of lower HRQoL scores. Testing interactions showed significantly greater differences between 1995 and 2003 for subjects aged 75-84 and for least educated subjects (Physical Functioning, General Health). The Gini index increased for all scales. Conclusions: We report evidence of worsening trends and possibly increasing demographic, socioeconomic, and regional disparities in HRQoL between 1995 and 2003 in France. Monitoring HRQoL in populations can provide unique and sensitive data, complementary to classical indicators based on mortality and morbidity. [ABSTRACT FROM AUTHOR]

Patients with active chronic inflammatory rheumatism have impaired diffuse noxious inhibitory control, as assessed by conditioned pain modulation. The decrease in diffuse noxious inhibitory control was correlated with pain intensity. Persistent pain despite satisfactory disease treatment is frequent in rheumatoid arthritis (RA) and spondyloarthritis (Spa) and may result from specific changes in central pain processing. We assessed these mechanisms further by systematically comparing thermal pain thresholds and conditioned pain modulation (CPM) between patients with active RA or Spa and healthy controls. We included 50 patients with RA and 50 patients with Spa and 100 age-matched and sex-matched controls. Heat and cold pain thresholds (HPT-CPT) were measured on the dominant forearm, and CPM was assessed by applying conditioning stimuli (immersion in a cold-water bath) to one foot and the nondominant hand in 2 successive randomized sequences. Descending pain modulation was assessed as the difference in HPTs (in °C) before and after conditioning. Larger HPT differences (ie, a larger CPM effect) reflected more efficient descending inhibition. Potential associations between changes in CPM and clinical data, including disease activity, pain intensity, and psychological and functional variables, were systematically assessed. Heat pain threshold and cold pain threshold were similar in patients and controls. The mean CPM effect was significantly weaker in patients than that in controls for conditioning applied to either the foot (0.25°C ±2.57 vs 2.79°C ±2.31; P < 0.001) or the nondominant hand (0.57°C ±2.74 vs 2.68°C ±2.12; P < 0.001). The smaller CPM effect in patients was correlated with average pain intensity, but not with disease activity or other clinical characteristics, suggesting a significant pathophysiological role for changes in endogenous pain modulation in the mechanisms of chronic pain associated with inflammatory rheumatism. [ABSTRACT FROM AUTHOR]

Objective. To further document the measurement properties of each domain of the OA of knee and hip quality of life (OAKHQOL) questionnaire by a Rasch analysis.Methods. The OAKHQOL self-administered questionnaire has been developed to assess health-related quality of life in lower limb OA. Patients with various degrees of severity of knee or hip OA answered the questionnaire. For each domain, their responses to the items were analysed with a Rasch family model, the partial credit model. We examined the fit of data to model expectations, as well as assumptions of unidimensionality and local independence. Invariance was assessed by analysis of differential item functioning (DIF) by sex, age and joint. Analyses used the RUMM2020 software (Rumm Laboratory, Perth, Western Australia).Results. Responses for 544 patients were analysed: 297 had medically managed OA and 247 were waiting for arthroplasty surgery. For the 40 items of the OAKHQOL, data analysis showed 5 with disordered thresholds and 9 with DIF (5 for joint, 3 for sex and 1 for age). Ten pairs of items showed local dependence and four domains showed unidimensionality. Full-item domains and domains without the misfitted items did not differ in patient-estimates data; therefore any bias at the item level is negligible when considering the domain scores.Conclusion. The five domains of the OAKHQOL questionnaire show good measurement properties by Rasch analysis and provide valid scales. [ABSTRACT FROM PUBLISHER]

Objective. Although in most patients with WG, induction therapy leads to complete remission (CR), the high relapse rate remains a major problem. This study was undertaken to identify potential predictors of these relapses.Methods. WG outcomes of patients included in two randomized trials were analysed. Patients were categorized into a predominant form of the disease using a scoring system composed of three granulomatous criteria (ear, nose and throat manifestations; lung nodules; and orbital pseudotumour) and three vascular criteria (serum creatinine >125 µmol/l, haematuria or proteinuria and alveolar haemorrhage).Results. Among 174 patients, 152 (87%) entered CR with CSs and CYC. The risk of death was higher for the vascular form [odds ratio (OR) 3.5 (95% CI 1.1, 11.4)]. With a median follow-up of 50 months, 66 out of 152 patients experienced a relapse (5-year relapse rate: 49%). Multivariate analysis retained the following variables at diagnosis as independent predictors of relapse: specific cardiac involvement [hazard ratio (HR) 2.9 (95% CI 1.3, 6.5)], ANCA with cytoplasmic-labelling pattern (c-ANCA) [HR 2.1 (95% CI 1.1, 4.3)] and higher age [HR 1.4 (95% CI 1.1, 1.7)]. Conversely, severe renal insufficiency was associated with a lower relapse rate [HR 0.4 (95% CI, 0.2−0.8)]. Comparing predominant granulomatous vs predominant vascular disease, relapses were more frequent and earlier with decreasing risk over time.Conclusions. Increased risk of first WG relapse after initial remission appears to be related to heart involvement, age and c-ANCA positivity at onset. Predominant granulomatous presentation disease seems to be associated with poorer outcomes after CR. These findings may help adapt treatment strategies. [ABSTRACT FROM PUBLISHER]

Background: We developed a methodology using vital statistics to estimate the impact of osteoporotic fractures on the mortality of an entire population, and applied it to France for the period 2000-2004. Methods: Current definitions of osteoporotic fractures were reviewed and their components identified. We used the International Classification of Diseases with national vital statistics data for the French adult population and performed cross-classifications between various components: age, sex, I-code (site) and E-code (mechanism of fracture). This methodology allowed identification of appropriate thresholds and categorization for each pertinent component. Results: 2,625,743 death certificates were analyzed, 2.2% of which carried a mention of fracture. Hip fractures represented 55% of all deaths from fracture. Both sexes showed a similar pattern of mortality rates for all fracture sites, the rate increased with age from the age of 70 years. The E-high-energy code (present in 12% of death certificates with fractures) was found to be useful to rule-out non-osteoporotic fractures, and to correct the overestimation of mortality rates. Using this methodology, the crude number of deaths associated with fractures was estimated to be 57,753 and the number associated with osteoporotic fractures 46,849 (1.85% and 1.78% of all deaths, respectively). Conclusion: Osteoporotic fractures have a significant impact on overall population mortality. [ABSTRACT FROM AUTHOR]

Copyright of British Medical Journal - Edición Española is the property of Grupo ARS XXI de Comunicacion, S.A. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: A spectrum effect was defined as differences in the sensitivity or specificity of a diagnostic test according to the patient's characteristics or disease features. A spectrum effect can lead to a spectrum bias when subgroup variations in sensitivity or specificity also affect the likelihood ratios and thus post-test probabilities. We propose and illustrate a methodological framework to distinguish spectrum effects from spectrum biases. Methods: Data were collected for 1781 women having had a cervical smear test and colposcopy followed by biopsy if abnormalities were detected (the reference standard). Logistic models were constructed to evaluate both the sensitivity and specificity, and the likelihood ratios, of the test and to identify factors independently affecting the test's characteristics. Results: For both tests, human papillomavirus test, study setting and age affected sensitivity or specificity of the smear test (spectrum effect), but only human papillomavirus test and study setting modified the likelihood ratios (spectrum bias) for clinical reading, whereas only human papillomavirus test and age modified the likelihood ratios (spectrum bias) for "optimized" interpretation. Conclusion: Fitting sensitivity, specificity and likelihood ratios simultaneously allows the identification of covariates that independently affect diagnostic or screening test results and distinguishes spectrum effect from spectrum bias. We recommend this approach for the development of new tests, and for reporting test accuracy for different patient populations. [ABSTRACT FROM AUTHOR]

Background: Methods used to generate items for complex measurement scales are heterogeneous and probably produce heterogeneous data, yet nothing is known about the advantages of one method over another.Objective: We aimed to compare methods of generating items for tools designed to measure quality-of-life for patients.Methods: We used five methods to develop a quality-of-life instrument for patients with lower-limb osteoarthritis: individual interviews with patients involving two different techniques (semi-structured and cognitive), individual interviews with health professionals, and focus groups of patients and health professionals. The process generated 80 items, of which 37 were excluded after content and psychometric analysis. With the final 43-item scale used as a 'reference standard', we estimated the contribution of each method.Results: For health professionals, the focus group and individual interviews produced 35 and 81% of the items, respectively. For patients, the focus groups produced 74% of the items and both interview techniques 100% of the items. Health professionals provided a narrower picture of the effects of the disease on quality-of-life. Focus groups contributed less to social domains than did individual interviews. The two patient interview techniques highlighted different themes.Conclusion: In developing a complex measurement scale for patients, we found individual interviews with patients the best method for formulating items; other methods such as physician interviews and focus groups contributed no additional information. Reports of instrument generation should include details of the item-generation step, the methods used to develop items and the number of people involved. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Adjuvant mitotane treatment for adrenocortical carcinoma," by M. Terzolo, A. Angeli, M. Fassnacht and colleagues in the June 7, 2007 issue.

Objectives: To compare the sensitivity, specificity, and interobserver reliability of conventional cervical smear tests, monolayer cytology, and human papillomavirus testing for screening for cervical cancer. Design: Cross sectional study in which the three techniques were performed simultaneously with a reference standard (colposcopy and histology). Setting: Public university and private practices in France, with complete independence from the suppliers. Participants: 828 women referred for colposcopy because of previously detected cytological abnormalities and 1757 women attending for routine smears. Main outcome measures: Clinical readings and optimised interpretation (two blind readings followed, if necessary, by consensus). Sensitivity, specificity, and weighted κ computed for various thresholds of abnormalities. Results: Conventional cervical smear tests were more often satisfactory (91% v 87%) according to the Bethesda system, more reliable (weighted K 0.70 v 0.57), and had consistently better sensitivity and specificity than monolayer cytology. These findings applied to clinical readings and optimised interpretations, low and high grade lesions, and populations with low and high incidence of abnormalities. Human papillomavirus testing associated with monolayer cytology, whether systematic or for atypical cells of undetermined significance, performed no better than conventional smear tests. Conclusions: Monolayer cytology is less reliable and more likely to give false positive and false negative results than conventional cervical smear tests for screening for cervical cancer. [ABSTRACT FROM AUTHOR]

We aimed to explore the relationship between comorbidities and the structural progression in symptomatic knee and/or hip osteoarthritis (OA) patients. We analyzed the 5-year outcome of non-obese participants (body mass index (BMI) < 30 kg/m2) from the KHOALA cohort having symptomatic hip and/or knee OA (Kellgren and Lawrence (KL) ≥ 2). The primary endpoint was radiological progression, defined as ΔKL ≥ 1 of the target joint at 5 years. The secondary outcome was the incidence of total knee or hip replacement over 5 years. Dichotomous logistic regression models assessed the relationship of comorbidities with KL progression and joint replacement while controlling for gender, age and BMI. Data from 384 non-obese participants were analyzed, 151 with hip OA and 254 with knee OA. At 5 years, cardiovascular diseases (CVD) were significantly associated with the 5-year KL change in both knee (OR = 2.56 (1.14–5.78), p = 0.02) and hip OA (OR = 3.45 (1.06–11.17), p = 0.04). No significant relationship was found between any type of comorbidities and knee or hip arthroplasty. This 5-year association between CVD and radiological progression of knee and hip OA in non-obese participants argue for an integrated management of CVD in knee and hip OA non-obese patients. [ABSTRACT FROM AUTHOR]

Objectives. This study investigated the role of prior history of induced abortion in subsequent ectopic pregnancies. Methods. Data from two French case control studies were used to examine the effect of induced abortion on ectopic pregnancy risk. Case patients (n = 570) were women admitted for ectopic pregnancy during the study period; controls (n = 1385) were women who delivered in the same center. Results. The analysis among women with no previous ectopic pregnancy showed that, after control for the main ectopic pregnancy risk factors, prior induced abortion was associated with an increased risk of ectopic pregnancy (odds ratio [OR] = 1.5, 95% confidence interval [CI] = 1.0, 2.0); there was a significant trend between number of previous induced abortions and ectopic pregnancy risk (ORs = 1.4 for 1 previous induced abortion and 1.9 for 2 or more). Conclusions. This study suggests that induced abortion may be a risk factor for ectopic pregnancy for women with no previous ectopic pregnancy, particularly in the case of women who have had several induced abortions. (Am J Public Health. 1998;88:401-405) [ABSTRACT FROM AUTHOR]