Methodological quality of 100 recent systematic reviews of health-related outcome measurement instruments: an overview of reviews.

PURPOSE: Systematic reviews evaluating and comparing the measurement properties of outcome measurement instruments (OMIs) play an important role in OMI selection. Earlier overviews of review quality (2007, 2014) evidenced substantial concerns with regards to alignment to scientific standards. This overview aimed to investigate whether the quality of recent systematic reviews of OMIs lives up to the current scientific standards. METHODS: One hundred systematic reviews of OMIs published from June 1, 2021 onwards were randomly selected through a systematic literature search performed on March 17, 2022 in MEDLINE and EMBASE. The quality of systematic reviews was appraised by two independent reviewers. An updated data extraction form was informed by the earlier studies, and results were compared to these earlier studies' findings. RESULTS: A quarter of the reviews had an unclear research question or aim, and in 22% of the reviews the search strategy did not match the aim. Half of the reviews had an incomprehensive search strategy, because relevant search terms were not included. In 63% of the reviews (compared to 41% in 2014 and 30% in 2007) a risk of bias assessment was conducted. In 73% of the reviews (some) measurement properties were evaluated (58% in 2014 and 55% in 2007). In 60% of the reviews the data were (partly) synthesized (42% in 2014 and 7% in 2007); evaluation of measurement properties and data syntheses was not conducted separately for subscales in the majority. Certainty assessments of the quality of the total body of evidence were conducted in only 33% of reviews (not assessed in 2014 and 2007). The majority (58%) did not make any recommendations on which OMI (not) to use. CONCLUSION: Despite clear improvements in risk of bias assessments, measurement property evaluation and data synthesis, specifying the research question, conducting the search strategy and performing a certainty assessment remain poor. To ensure that systematic reviews of OMIs meet current scientific standards, more consistent conduct and reporting of systematic reviews of OMIs is needed.

Does the intensity of pain and disability affect health-related quality of life of older adults with back pain? Multilevel analysis between Brazil and Netherlands: a cross-sectional study of the BACE consortium.

BACKGROUND: The prognosis of back pain (BP) in the older adults is less favorable than in younger adults and progress to adverse outcomes and consequent worsening of health-related quality of life (HRQoL). The present study aimed to verify the association between BP intensity, disability and HRQoL in older adults residents in Brazil and Netherlands, and to evaluate whether the country of residence influences the associations. METHODS: Data were collected from 602 Brazilian and 675 Dutch participants with a new episode of BP from the Back Complaints in Elders (BACE) consortium. For the present study, a cross section was used. Pain intensity and disability were assessed using the Numerical Rating Scale (NRS) and the Roland-Morris Disability Questionnaire (RMDQ), respectively. HRQoL was assessed using the Short Form Health Survey (SF-36) quality of life questionnaire. Age, sex, and education were descriptive variables. Pain intensity (NPS score) and country were the independent variables and quality of life assessed by each SF domain - 36 was the dependent variable. Analysis of models at the individual level was performed to verify the association between pain and disability, also HRQoL in Netherlands and Brazil in the total sample. The multilevel model was used to verify whether the older adults person's country of residence influenced this relationship. RESULTS: The average age of the participants was 67.00 (7.33) years. In the total sample, linear regression analysis adjusted for sex and age showed a significant association between BP intensity scores and HRQoL, for all domains. There was no association between disability and HRQoL. In the multilevel analysis, there was an association between BP intensity and HRQoL in all domains and an association between the country of residence and HRQoL, influencing the effect of pain, in all domains, except for the physical functioning. CONCLUSION: Socioeconomic and cultural aspects of different countries can affect the perception of the elderly about their HRQoL in the presence of BP. Pain and disability in Brazilian and Dutch older adults ones are experienced differently in relation to their HRQoL.

Association between clinical findings and the presence of lumbar spine osteoarthritis imaging features: A systematic review.

OBJECTIVE: Spinal osteoarthritis is difficult to study and diagnose, partly due to the lack of agreed diagnostic criteria. This systematic review aims to give an overview of the associations between clinical and imaging findings suggestive of spinal osteoarthritis in patients with low back pain to make a step towards agreed diagnostic criteria. DESIGN: We searched MEDLINE, Embase, Web of Science, and CINAHL from inception to April 29, 2021 to identify observational studies in adults that assessed the association between selected clinical and imaging findings suggestive of spinal osteoarthritis. Risk of bias was assessed using the Newcastle Ottawa Scale and the quality of evidence was graded using an adaptation of the GRADE approach. RESULTS: After screening 7902 studies, 30 met the inclusion criteria. High-quality evidence was found for the longitudinal association between low back pain (LBP) intensity, and both disc space narrowing and osteophytes, as well as for the association between LBP-related physical functioning and lumbar disc degeneration, the presence of spinal morning stiffness and disc space narrowing and for the lack of association between physical functioning and Schmorl's nodes. CONCLUSIONS: There is high- and moderate-quality evidence of associations between clinical and imaging findings suggestive of spinal osteoarthritis. However, the majority of the studied outcomes had low or very low-quality of evidence. Furthermore, clinical and methodological heterogeneity was a serious limitation, adding to the need and importance of agreed criteria for spinal osteoarthritis, which should be the scope of future research.

Pragmatic Delphi study aimed at determining practical components for a tool designed to assist Dutch primary care-givers in opioid deprescribing for non-cancer pain.

BACKGROUND: Over the past decades, opioid prescriptions have increased in the Netherlands. The Dutch general practitioners' guideline on pain was recently updated and now aims to reduce opioid prescriptions and high-risk opioid use for non-cancer pain. The guideline, however, lacks practical measures for implementation. OBJECTIVE: This study aims to determine practical components for a tool that should assist Dutch primary care prescribers and implements the recently updated guideline to reduce opioid prescriptions and high-risk use. METHODS: A modified Delphi approach was used. The practical components for the tool were identified based on systematic reviews, qualitative studies, and Dutch primary care guidelines. Suggested components were divided into Part A, containing components designed to reduce opioid initiation and stimulate short-term use, and Part B, containing components designed to reduce opioid use among patients on long-term opioid treatment. During three rounds, a multidisciplinary panel of 21 experts assessed the content, usability, and feasibility of these components by adding, deleting, and adapting components until consensus was reached on the outlines of an opioid reduction tool. RESULTS: The resulting Part A consisted of six components, namely education, opioid decision tree, risk assessment, agreements on dosage and duration of use, guidance and follow-up, and interdisciplinary collaboration. The resulting Part B consisted of five components, namely education, patient identification, risk assessment, motivation, and tapering. CONCLUSIONS: In this pragmatic Delphi study, components for an opioid reduction tool for Dutch primary care-givers are identified. These components need further development, and the final tool should be tested in an implementation study.

The Effect of a New Payment System on Physiotherapeutic Management of Patients With Low Back Pain in Primary Care.

OBJECTIVE: To evaluate differences regarding the number of treatment sessions, costs, and outcomes (including relapses) between a regular payment-per-session system and the recently introduced product payment system in The Netherlands. DESIGN: Prospective cohort study. SETTING: Dutch physical therapy practices in primary care over a 2-year period. PARTICIPANTS: 16,103 patients with low back pain (LBP). INTERVENTION: The new product payment system is compared with the regular payment-per-session system. MAIN OUTCOME MEASURES: Pain, disability, recovery, number of physical therapy sessions, therapy duration, costs (per episode), and LBP relapse. RESULTS: At baseline, we found greater pain and disability scores associated with an increased risk profile in both payment systems. With regard to the payment systems, we found greater costs (€283.8 vs €210.8) and a greater percentage of relapse (4.5% vs 2.8%) for the product payment system compared with the payment-per-session system. Comparing the 2 payment systems within each risk strata, we found no significant differences, except for a decrease in pain in the medium-risk stratum. Concerning the therapy characteristics, we found that in the payment-per-session group, the therapy took 6 days longer for low-risk patients (median 27 vs 21 days) and 7 days shorter for high-risk patients (median 42 vs 49 days) compared with the product payment group. Moreover, the mean number of sessions in the payment-per-session group was greater for low-risk patients (5.4 vs 4.8 sessions) and lower for high-risk patients (7.7 vs 8.1 sessions) compared with the payment-per-session group. Finally, the costs were significantly greater in all strata of the product payment group compared with the payment-per-session group. CONCLUSIONS: The 2 payment systems are largely comparable regarding patient outcomes, therapy duration, and treatment sessions. Both the average cost per patient per LBP episode and the number of relapses in the product payment system are statistically significantly greater than in the payment-per-session system.

Exposure to hand-arm vibrations in the workplace and the occurrence of hand-arm vibration syndrome, Dupuytren's contracture, and hypothenar hammer syndrome: a systematic review and meta-analysis.

This study provides an overview of the relationships between exposure to work-related hand-arm vibration and the occurrence of pre-defined disorders of the hands. We searched Medline, Embase, Web of Science, Cochrane Central, and PsycINFO for cross-sectional and longitudinal studies on the association between work-related vibration exposure and the occurrence of hand-arm vibration syndrome (including vibration-induced white finger), Dupuytren's contracture, or hypothenar hammer syndrome. We used a 16-item checklist for assessing the risk of bias. We present results narratively, and we conducted random effects meta-analyses if possible. We included 10 studies with more than 24,381 participants. Our results showed statistically significant associations between the exposure to hand-arm vibrations and the occurrence of the selected disorders, with pooled odds ratios ranging between 1.35 (95% CI: 1.28 to 2.80) and 3.43 (95% CI: 2.10 to 5.59). Considerable between-study heterogeneity was observed. Our analyses show that exposure to vibrating tools at work is associated with an increased risk for the occurrence of selected disorders of the hands. Due to the majority of studies being cross-sectional, no firm conclusion is possible regarding causal relationships between vibration exposure and disorder occurrence. Future research should specifically address whether reducing exposure to hand-held vibrating tools at work reduces the incidence of the disorders of the hands investigated in this systematic review.

Does Pain Medication Use Influence the Outcome of 8 Weeks of Education and Exercise Therapy in Patients with Knee or Hip Osteoarthritis? An Observational Study.

OBJECTIVE: Patients with osteoarthritis are mainly managed in primary care settings and many patients use pain medication as symptomatic treatment. We investigated in OA-patients receiving an education and exercise program, the use and type of pain medication and its impact on outcomes at 3 months follow-up. DESIGN, SETTING AND SUBJECTS: The design was a retrospective cohort study using prospectively collected data from the GLA: D® registry. The study included 15,918 primary care patients. RESULTS: Among the included patients, 62% were pain medication users and 38% were non-users. Among the pain medications users, 35% were classified as paracetamol users, 54% as NSAID users, and 11% as opioid users. Medication users and non-users differed regarding a higher pain intensity, poorer physical and mental health. Pain medication use before and during the education and exercise program was associated with the pain intensity at 3 months follow-up. However, patients either using or not using pain medications improved over time, and the magnitude of the difference between patient groups was small (less than 10 mm on a 0-100 scale). CONCLUSIONS: Pain medication use is weakly associated with outcome at 3 months follow up in OA-patients receiving an education and exercise program. Between-group differences, however, are small and probably not clinically important.

Effectiveness of non-opioid interventions to reduce opioid withdrawal symptoms in patients with chronic pain: a systematic review.

BACKGROUND: Dealing with the opioid crisis, medical doctors are keen to learn how to best treat opioid dependency in patients with chronic non-cancer pain. Opioid replacement therapy is commonly used, but success rates vary widely. Since many patients still experience severe withdrawal symptoms, additional interventions are necessary. OBJECTIVE: To review the effectiveness of interventions in the treatment of withdrawal symptoms during opioid tapering or acute withdrawal in patients with long-term non-cancer pain. METHODS: A systematic review was conducted in Embase.com, MEDLINE, Web of Science, PsycINFO, and Cochrane CENTRAL register of trials. Studies eligible for inclusion were (non-)randomized controlled trials in adults with long-term opioid prescriptions for non-cancer pain. Included trials had to compare a non-opioid intervention to placebo, usual care, no treatment, or non-opioid drug and had to report on withdrawal symptoms as an outcome. Study quality was assessed with the 2.0 Cochrane risk of bias (RoB) tool. Evidence quality was rated following the GRADE approach. RESULTS: One trial (n = 21, some concerns regarding RoB) compared Varenicline to placebo. There was no statistically significant between-group reduction of withdrawal symptoms (moderate-quality evidence). CONCLUSIONS: Evidence from clinical trials on interventions reducing withdrawal symptoms is scarce. Based on one trial with a small sample size, no firm conclusion can be drawn. Meanwhile, doctors are in dire need for therapeutic options to tackle withdrawal symptoms while tapering patients with prescription opioid dependence. We hope this review draws attention to this unfortunate research gap so that future research can provide doctors with answers.

There is a global increase of patients depended on opioids prescribed by a doctor for chronic non-cancer pain. Tapering these drugs is challenging, especially since treatment options for withdrawal symptoms are lacking. We conducted a systematic review of controlled studies on interventions aimed at reducing withdrawal symptoms during opioid tapering in patients with long term opioid treatment for chronic non-cancer pain. One trial could be included. No firm conclusions can be drawn from this one trial. Hence, this review demonstrates that to improve care for patients depended on opioids for chronic non-cancer pain, more high-quality research in this field is necessary.

Completeness of Reporting Is Suboptimal in Randomized Controlled Trials Published in Rehabilitation Journals, With Trials With Low Risk of Bias Displaying Better Reporting: A Meta-research Study.

OBJECTIVE: Primary: To evaluate the completeness of reporting of randomized controlled trials (RCTs) published in rehabilitation journals through the evaluation of the adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist and investigate the relationship between reporting and risk of bias (ROB). Secondary: To study the association between completeness of reporting and the characteristics of studies and journals. DATA SOURCES: A random sample of 200 RCTs published between 2011 and 2020 in 68 rehabilitation journals indexed under the "rehabilitation" category in the InCites Journal Citation Report. STUDY SELECTION: One reviewer evaluated the completeness of reporting operationalized as the adherence to the CONSORT checklist. Two independent reviewers evaluated the ROB using the Cochrane risk-of-bias 2.0 tool. DATA EXTRACTION: Overall adherence and adherence to each CONSORT section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (quartile range, publication modalities, study protocol registration). DATA SYNTHESIS: The mean overall CONSORT adherence across studies was 65%. Studies with high ROB have less adherence than those with low ROB (-5.5%; CI, -10.9 to 0.0). There was a 10.2% (% CI, 6.2-14.3) increase in adherence if the RCT protocol was registered. Studies published in first quartile journals displayed an overall adherence of 11.7% (% CI 17.1-6.4) higher than those published in the fourth quartile. CONCLUSIONS: Reporting completeness is still suboptimal and is associated with ROB, journal impact ranking, and registration of the study protocol. Trial authors should improve adherence to the CONSORT guideline, and journal editors should adopt new strategies to improve the reporting.

Modifiable prognostic factors of high costs related to healthcare utilization among older people seeking primary care due to back pain: an identification and replication study.

BACKGROUND: Back pain is an extensive burden to our healthcare system, yet few studies have explored modifiable prognostic factors associated with high costs related to healthcare utilization, especially among older back pain patients. The aims of this study were to identify modifiable prognostic factors for high costs related to healthcare utilization among older people seeking primary care with a new episode of back pain; and to replicate the identified associations in a similar cohort, in a different country. METHODS: Data from two cohort studies within the BACE consortium were used, including 452 and 675 people aged ≥55 years seeking primary care with a new episode of back pain. High costs were defined as costs in the top 25th percentile. Healthcare utilization was self-reported, aggregated for one-year of follow-up and included: primary care consultations, medications, examinations, hospitalization, rehabilitation stay and operations. Costs were estimated based on unit costs collected from national pricelists. Nine potential modifiable prognostic factors were selected based on previous literature. Univariable and multivariable binary logistic regression models were used to identify and replicate associations (crude and adjusted for selected covariates) between each modifiable prognostic factor and high costs related to healthcare utilization. RESULTS: Four modifiable prognostic factors associated with high costs related to healthcare utilization were identified and replicated: a higher degree of pain severity, disability, depression, and a lower degree of physical health-related quality of life. Kinesiophobia and recovery expectations showed no prognostic value. There were inconsistent results across the two cohorts with regards to comorbidity, radiating pain below the knee and mental health-related quality of life. CONCLUSION: The factors identified in this study may be future targets for intervention with the potential to reduce high costs related to healthcare utilization among older back pain patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04261309, 07 February 2020. Retrospectively registered.

Psychometric properties of the patient-reported outcomes measurement information system scale v1.2: global health (PROMIS-GH) in a Dutch general population.

PURPOSE: To assess the psychometric properties of the Dutch-Flemish Patient-Reported Outcome Measurement Information System Scale v1.2 - Global Health (PROMIS-GH). METHODS: The PROMIS-GH (also referred to as PROMIS-10) was administered to 4370 persons from the Dutch general population. Unidimensionality (CFI ≥ 0.95; TLI ≥ 0.95; RMSEA ≤ 0.06; SRMR ≤ 0.08), local independence (residual correlations < 0.20), monotonicity (H > 0.30), model fit with the Graded Response Model (GRM, p < 0.001), internal consistency (alpha > 0.75), precision (total score information across the latent trait), measurement invariance (no Differential Item Functioning [DIF]), and cross-cultural validity (no DIF for language, Dutch vs. United States English) of its subscales, composed of four items each, Global Mental Health (GMH) and Global Physical Health (GPH), were assessed. RESULTS: Confirmatory factor analyses, on both subscales, revealed slight departures from unidimensionality for GMH (CFI = 0.98; TLI = 0.95, RMSEA = 0.22; SRMR = 0.04) and GPH (CFI = 0.99; TLI = 0.97; RMSEA = 0.12; SRMR = 0.03). Local independence, monotonicity, GRM model fit, internal consistency, precision and cross-cultural validity were supported. However, Global10 (emotional problems) showed misfit on the GMH subscale, while Global08 (fatigue) presented DIF for age. CONCLUSION: The psychometric properties of the PROMIS-GH in the Dutch population were considered acceptable. Sufficient local independence, monotonicity, GRM fit, internal consistency, measurement invariance and cross-cultural validity were found. If future studies find similar results, structural validity of the GMH could be enhanced by improving or replacing Global10 (emotional problems).

Understanding regional activation of thoraco-lumbar muscles in chronic low back pain and its relationship to clinically relevant domains.

BACKGROUND: Altered regional activation of the lumbar extensors has been previously observed in individuals with low back pain (LBP) performing high-effort and fatiguing tasks. It is currently unknown whether similar alterations can be observed during low-effort functional tasks. Similarly, previous studies did not investigate whether side differences in regional activation are present in individuals with LBP. Finally, there is limited evidence of whether the extent of the alteration of regional activation is associated with clinical factors. Therefore, the aim of this study was to investigate whether individuals with LBP exhibit asymmetric regional activation of the thoraco-lumbar extensor muscles during functional tasks, and if the extent of neuromuscular control alteration is associated with clinical and psychosocial outcome domains. METHODS: 21 participants with and 21 without LBP performed five functional tasks (gait, sit-to-stand, forward trunk flexion, shoulder flexion and anterior pelvic tilt). The spatial distribution of activation of the thoraco-lumbar extensor muscles was assessed bilaterally using high-density electromyography. For each side, the distribution of electromyographic (EMG) amplitude was characterized in terms of intensity, location and size. Indices of asymmetry were calculated from these features and comparisons between groups and tasks were performed using ANOVA. The features that significantly differed between groups were correlated with self-reported measures of pain intensity and other outcome domains. RESULTS: Indices of asymmetry did not differ between participants with and without LBP (p > 0.11). The cranio-caudal location of the activation differed between tasks (p < 0.05), but not between groups (p = 0.64). Participants with LBP showed reduced EMG amplitude during anterior pelvic tilt and loading response phase during gait (both p < 0.05). Pearson correlation revealed that greater pain intensity was associated with lower EMG amplitude for both tasks (R<-0.5, p < 0.05). CONCLUSIONS: Despite clear differences between tasks, individuals with and without LBP exhibited similar distributions of EMG amplitude during low-effort functional activities, both within and between sides. However, individuals with LBP demonstrated lower activation of the thoraco-lumbar muscles during gait and anterior pelvic tilt, especially those reporting higher pain intensity. These results have implications in the development or refinement of assessment and intervention strategies focusing on motor control in patients with chronic LBP.

Establishing Central Sensitization-Related Symptom Severity Subgroups: A Multicountry Study Using the Central Sensitization Inventory.

OBJECTIVES: The goal of this study was to identify central sensitization-related symptom severity subgroups in a large multicountry sample composed of patients with chronic pain and pain-free individuals using the Central Sensitization Inventory (CSI). METHODS: A large, pooled international (N = 8 countries) sample of chronic pain patients plus healthy subjects (total N = 2,620) was randomly divided into two subsamples for cross-validation purposes. First, a hierarchical cluster analysis (HCA) was performed using CSI item-level data as clustering variables (test sample; N = 1,312). Second, a latent profile analysis (LPA) was conducted to confirm the optimal number of CSI clusters (validation sample; N = 1,308). Finally, to promote implementation in real-world clinical practice, we built a free online Central Sensitization Inventory Symptom Severity Calculator. RESULTS: In both HCA (N = 1,219 valid cases) and LPA (N = 1,245 valid cases) analyses, a three-cluster and three-profile solution, respectively, emerged as the most statistically optimal and clinically meaningful. Clusters were labeled as follows: (i) Low Level of CS-Related Symptom Severity, (ii) Medium Level of CS-Related Symptom Severity, and (iii) High Level of CS-Related Symptom Severity. CONCLUSIONS: Our results indicated that a three-cluster solution clearly captured the heterogeneity of the CSI data. The calculator might provide an efficient way of classifying subjects into the cluster groups. Future studies should analyze the extent to which the CSI cluster classification correlates with other patient-reported and objective signs and symptoms of CS in patients with chronic pain, their associations with clinical outcomes, health-related costs, biomarkers, (etc.), and responsiveness to treatment.

PROMIS Physical Function Short Forms Display Item- and Scale-Level Characteristics at Least as Good as the Roland Morris Disability Questionnaire in Patients With Chronic Low Back Pain.

OBJECTIVE: To compare dimensionality, item-level characteristics, scale-level reliability, and construct validity of PROMIS Physical Function short forms (PROMIS-PF) and 24-item Roland Morris Disability Questionnaire (RMDQ-24) in patients with chronic low back pain (LBP). DESIGN: Cross-sectional study. SETTING: Secondary care center for rehabilitation and rheumatology. PARTICIPANTS: Patients with nonspecific LBP ≥3 months (N=768). Mean age was 49±13 years, 77% were female, and 54% displayed pain for more than 5 years. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Dutch versions of the 4-, 6-, 8-, 10-, and 20-item PROMIS-PF and of the RMDQ-24. RESULTS: PROMIS-PF-6, PROMIS-PF-8, and RMDQ-24 exhibited sufficient unidimensionality (confirmatory factor analysis: comparative fit index>0.950, Tucker-Lewis index>0.950, root means square error of approximation<0.060), whereas the other instruments did not. All instruments were free of local dependence except PROMIS-PF-20 with 4 item pairs with clear residual correlations. Mokken scale analysis found 1 nonmonotone item for PROMIS-PF-20 and 8 for RMDQ-24 (ie, the probability of endorsing these items was not increasing with increasing level on the underlying construct). PROMIS-PF-20 displayed 2 misfitting items (S-χ2P value>.001). Two-parameter item response theory models found 2 items with low discrimination for RMDQ-24. All other instruments had adequate fit statistics and item parameters. PROMIS-PF-20 displayed the best scale-level reliability. Construct validity was sufficient for all instruments as all hypotheses on expected correlations with other instruments and differences between relevant subgroups were met. CONCLUSIONS: PROMIS-PF-6, PROMIS-PF-8, and RMDQ-24 exhibited better unidimensionality, whereas PROMIS-PF-4, PROMIS-PF-6, PROMIS-PF-8, and PROMIS-PF-10 showed superior item-level characteristics. PROMIS-PF-20 was the instrument with the best scale-level reliability. This study warrants assessment of other measurement properties of PROMIS-PF short forms in comparison with disease-specific physical functioning instruments in LBP.

The Italian version of the Quebec Back Pain Disability Scale: cross-cultural adaptation, reliability and validity in patients with chronic low back pain.

BACKGROUND AND AIM: Growing attention is being given to physical functioning measures to assess interventions for low back pain (LBP). The Quebec Back Pain Disability Questionnaire (QBPDS) has never been validated in Italian patients, and the aim of the study was culturally adapting and validating the Italian version of the QBPDS (QBPDS-I), to allow its use with Italian-speaking patients with chronic LBP. METHODS: The QBPDS-I was developed by means of forward-backward translation, a final review by an expert committee and a test of the prefinal version to evaluate its comprehensibility. The psychometric testing included structural validity by exploratory factor analysis (EFA), reliability by internal consistency (Cronbach's alpha) and test-retest reliability (intraclass correlation coefficient, ICC 2.1), measurement error by calculating the minimum detectable change (MDC), construct validity by assessing hypotheses of QBPDS correlations with the Roland Morris Disability Scale (RMDQ), the Oswestry Disability Questionnaire (ODI) and a pain numerical rating scale (NRS) (Spearman's correlations). RESULTS: It took one month to develop a consensus-based version of the QBPDS-I. The questionnaire was administered to 201 subjects with chronic LBP and was well accepted. EFA suggested a one-factor 20-item solution (first factor variance explained = 54.7%). Internal consistency (α = 0.95) and test-retest reliability (ICC = 0.90) were excellent. The MDC was 12 scale points. Construct validity was good as all of the hypotheses were met; correlations: RMDQ (r = 0.40), ODI (r = 0.48) and NRS (r = 0.44). CONCLUSIONS: The QBPDS-I is unidimensional, reliable and valid in patients with chronic LBP. Its use is recommended for clinical and research purposes.

Association between obesity and depressive symptoms in Mexican population.

PURPOSE: Obesity and depression are among the leading causes of disability in Mexico, but their association has not been explored yet. The aim of the current study was to investigate the association between obesity and depression in Mexican population. METHODS: We used data from the health and nutrition survey (ENSANUT 2012), which is representative of the Mexican population. Obesity was determined using the body mass index (BMI) and abdominal obesity by measuring waist circumference. Depressive symptoms were reported using the Center for Epidemiological Studies Depression Scale Short-Form (CES-D-SF, scale 0-21). Regression analyses were performed between obesity and depression, adjusting for gender, age, living with a partner, education, and diabetes history. RESULTS: Obese women had 1.28 (95% CI 1.07-1.53) times the odds of having depression in comparison with normal-weight women, whereas no association was found for men (OR 0.94; 95% CI 0.74-1.19). A significant association between BMI and depressive symptoms score (ß = 0.05, 95% CI 0.02-0.07) was present in women, but no association was found for men (ß = - 0.02, 95% CI - 0.05 to 0.00). There was a statistically significant association between waist circumference and depression scores again for women (ß = 0.03, 95% CI 0.01-0.04) but not for men (ß = 0.00, 95% CI - 0.01 to 0.01). No associations were found between abdominal obesity and depression for both genders. No association was found between different obesity severity levels and depression for both genders. CONCLUSION: Obesity was associated with depression in Mexican women, whereas no association was found between obesity and depression in men.

Development, validity and reliability of the Italian version of the Copenhagen neck functional disability scale.

BACKGROUND: Valid and reliable patient-reported outcome measures support health professionals in evaluating the results of clinical research and practice. The Copenhagen Neck Functional Disability Scale (CNFDS) has shown promising measurement properties to measure disability in patients with neck pain, but an Italian version of this questionnaire is not available. The objective of this study was to cross-culturally adapt the CNFDS into Italian (CNFDS-I), and to assess its validity and reliability in patients with neck pain. METHODS: The CNFDS-I was developed according to well-established guidelines for cross-cultural adaptation of patient-reported outcome measures. A cross-sectional clinimetric study was conducted to evaluate its validity and reliability. Patients with chronic neck pain (pain > 3 months) participated in this study. The following measurement properties (defined by the COSMIN initiative) were assessed: structural validity (exploratory factor analysis), internal consistency (Cronbach's α), construct validity [by testing hypotheses on expected correlations with the Neck Disability Index (NDI), the Neck Bournemouth Questionnaire (NBQ), and pain Visual Analogue Scale (VAS)]. Test-retest reliability [Intraclass Correlation Coefficient for agreement (ICCagreement)], and measurement error [Smallest Detectable Change (SDC)] were also assessed in 50 clinically stable patients. Floor/ceiling effects and acceptability were calculated. RESULTS: One-hundred and sixty-two patients (mean age = 47.9 ± 14.5 years, 70% female) were included. The CNFDS-I exhibited sufficient unidimensionality (one factor explained 83% of the variability) and internal consistency (α = 0.83). Construct validity was sufficient as all correlations with the other questionnaires were as expected (r = 0.846 with NDI, r = 0.708 with NBQ, r = 0.570 with VAS). Test-retest reliability was excellent (ICCagreement = 0.99, 95% CI from 0.995 to 0.999), while measurement error was equal to 8.31 scale points (27% scale range). No floor/ceiling effects were detected. The average time for filling the questionnaire was two minutes. CONCLUSIONS: The CNFDS-I proved to be a valid and reliable outcome measure to assess disability in patients with chronic neck pain. Head-to-head comparison studies on the CNFDS-I measurement properties against other disability measures for neck pain (e.g. NDI and NBQ) are required to determine the relative merits of these different measures.