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ABSTRACT: To assess the efficacy of neuro-reflexotherapy intervention (NRT) for treating temporomandibular joint dysfunction attributed to myofascial pain. Neuro-reflexotherapy intervention consists of the temporary implantation of epidermal devices in trigger points in the back and ear. It has shown efficacy, effectiveness, and cost-effectiveness in treating subacute and chronic common back pain. No study, however, has explored its efficacy in treating myofascial temporomandibular joint pain (MF/TMJP).
This was a randomized, double-blind, placebo-controlled trial. Patients with MF/TMJP for more than 3 months in spite of conservative treatment, and with no evidence of major structural damage in the joint, were recruited at the Maxillofacial Department of the Hospital Clínico Universitario, a teaching hospital in Madrid, Spain. Patients were randomly assigned to an intervention group and to a control group. Patients in the treated group underwent 2 NRTs, immediately after baseline assessment and 45 days later. Sham interventions in the control group consisted of placement of the same number of epidermal devices within a 5-cm radius of the target zones. In both groups, conservative treatment during follow-up was allowed and recorded. Patients underwent clinical evaluations on 4 occasions: 5 minutes before intervention, 5 minutes after intervention, and 45 and 90 days later. The preintervention assessment was performed by the physician at the hospital service who included the patient in the study. The 3 follow-up assessments were performed independently by 1 of 2 physicians who had no connection with the research team, and who were blinded to patients' assignments. The primary outcome variable was level of pain severity during jaw movements at the last assessment (90 days), and the key comparison of interest was change in pain over time (pain levels at baseline and at 90 days). Level of pain was measured using a visual analog scale (VAS).
Fifty-one patients with MF/TMJP were recruited into the study. Random assignment allocated 27 patients to the intervention group, and 24 to the control group. Differences in pain severity in favor of the intervention group appeared immediately after the intervention, persisted for 45 days, and increased after the second intervention. Differences at last follow-up were highly clinically and statistically significant (4 to 5 points on the VAS, P = .000), allowing for patients in the intervention group to cease drug treatment (P = .005). There were no differences in the evolution of crepitus or clicking in the joint. There were no clinically relevant side effects associated with the intervention.
For patients in whom conservative treatment has failed, NRT improves the chronic pain associated with MF/TMJP syndrome.
Journal of oral and maxillofacial surgery: official journal of the American Association of Oral and Maxillofacial Surgeons 08/2008; 66(8):1664-77. · 1.58 Impact Factor
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Francisco M Kovacs,
Joan Bagó,
Ana Royuela,
Jesús Seco,
Sergio Giménez,
Alfonso Muriel, Víctor Abraira,
José Luis Martín,
José Luis Peña,
Mario Gestoso, [......],
Mariano Ortega,
Miryam Bernal,
Gonzalo Bolado,
Anna Vidal,
Ana Ausín,
Domingo Ramón,
María Antonia Mir,
Miquel Tomás,
Javier Zamora,
Alejandra Cano
[show abstract]
[hide abstract]
ABSTRACT: The NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ).
Translation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed.
Comprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9). Reliability: [ICC, (95%CI)]: NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change: Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92. Validity: Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15.
Although most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance.
Clinical Trials Register NCT00349544.
BMC Musculoskeletal Disorders 02/2008; 9:42. · 1.58 Impact Factor
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Francisco M Kovacs, Víctor Abraira,
Ana Royuela,
Josep Corcoll,
Luis Alegre,
Miquel Tomás,
María Antonia Mir,
Alejandra Cano,
Alfonso Muriel,
Javier Zamora,
María Teresa Gil Del Real,
Mario Gestoso,
Nicole Mufraggi
[show abstract]
[hide abstract]
ABSTRACT: The minimal detectable change (MDC) and the minimal clinically important changes (MCIC) have been explored for nonspecific low back pain patients and are similar across different cultural settings. No data on MDC and MCIC for pain severity are available for neck pain patients. The objectives of this study were to estimate MDC and MCIC for pain severity in subacute and chronic neck pain (NP) patients, to assess if MDC and MCIC values are influenced by baseline values and to explore if they are different in the subset of patients reporting referred pain, and in subacute versus chronic patients.
Subacute and chronic patients treated in routine clinical practice of the Spanish National Health Service for neck pain, with or without pain referred to the arm, and a pain severity > or = 3 points on a pain intensity number rating scale (PI-NRS), were included in this study. Patients' own "global perceived effect" over a 3 month period was used as the external criterion. The minimal detectable change (MDC) was estimated by means of the standard error of measurement in patients who self-assess as unchanged. MCIC were estimated by the mean value of change score in patients who self-assess as improved (mean change score, MCS), and by the optimal cutoff point in receiver operating characteristics curves (ROC). The effect on MDC and MCIC of initial scores, duration of pain, and existence of referred pain were assessed.
658 patients were included, 487 of them with referred pain. MDC was 4.0 PI-NRS points for neck pain in the entire sample, 4.2 for neck pain in patients who also had referred pain, and 6.2 for referred pain. MCS was 4.1 and ROC was 1.5 for referred and for neck pain, both in the entire sample and in patients who also complained of referred pain. ROC was lower (0.5 PI-NRS points) for subacute than for chronic patients (1.5 points). MCS was higher for patients with more intense baseline pain, ranging from 2.4 to 4.9 PI-NRS for neck pain and from 2.4 to 5.3 for referred pain.
In general, improvements < or = 1.5 PI-NRS points could be seen as irrelevant. Above that value, the cutoff point for clinical relevance depends on the methods used to estimate MCIC and on the patient's baseline severity of pain. MDC and MCIC values in neck pain patients are similar to those for low back pain and other painful conditions.
BMC Musculoskeletal Disorders 01/2008; 9:43. · 1.58 Impact Factor
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Francisco Kovacs,
Joan Bagó,
Ana Royuela,
Jesús Seco,
Sergio Giménez,
Alfonso Muriel, Víctor Abraira,
José Martín,
José Peña,
Mario Gestoso, [......],
Mariano Ortega,
Miryam Bernal,
Gonzalo Bolado,
Anna Vidal,
Ana Ausín,
Domingo Ramón,
María Mir,
Miquel Tomás,
Javier Zamora,
Alejandra Cano
[show abstract]
[hide abstract]
ABSTRACT: Abstract
Background
The NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ).
Methods
Translation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed.
Results
Comprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9). Reliability : [ICC, (95%CI)]: NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change : Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92. Validity : Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15.
Conclusion
Although most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance.
Trial Registration
Clinical Trials Register NCT00349544.
BMC Musculoskeletal Disorders. 01/2008;
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Francisco Kovacs, Víctor Abraira,
Ana Royuela,
Josep Corcoll,
Luis Alegre,
Miquel Tomás,
María Mir,
Alejandra Cano,
Alfonso Muriel,
Javier Zamora,
del Real María,
Mario Gestoso,
Nicole Mufraggi
[show abstract]
[hide abstract]
ABSTRACT: Abstract
Background
The minimal detectable change (MDC) and the minimal clinically important changes (MCIC) have been explored for nonspecific low back pain patients and are similar across different cultural settings. No data on MDC and MCIC for pain severity are available for neck pain patients. The objectives of this study were to estimate MDC and MCIC for pain severity in subacute and chronic neck pain (NP) patients, to assess if MDC and MCIC values are influenced by baseline values and to explore if they are different in the subset of patients reporting referred pain, and in subacute versus chronic patients.
Methods
Subacute and chronic patients treated in routine clinical practice of the Spanish National Health Service for neck pain, with or without pain referred to the arm, and a pain severity ≥ 3 points on a pain intensity number rating scale (PI-NRS), were included in this study. Patients' own "global perceived effect" over a 3 month period was used as the external criterion. The minimal detectable change (MDC) was estimated by means of the standard error of measurement in patients who self-assess as unchanged. MCIC were estimated by the mean value of change score in patients who self-assess as improved (mean change score, MCS), and by the optimal cutoff point in receiver operating characteristics curves (ROC). The effect on MDC and MCIC of initial scores, duration of pain, and existence of referred pain were assessed.
Results
658 patients were included, 487 of them with referred pain. MDC was 4.0 PI-NRS points for neck pain in the entire sample, 4.2 for neck pain in patients who also had referred pain, and 6.2 for referred pain. MCS was 4.1 and ROC was 1.5 for referred and for neck pain, both in the entire sample and in patients who also complained of referred pain. ROC was lower (0.5 PI-NRS points) for subacute than for chronic patients (1.5 points). MCS was higher for patients with more intense baseline pain, ranging from 2.4 to 4.9 PI-NRS for neck pain and from 2.4 to 5.3 for referred pain.
Conclusion
In general, improvements ≤ 1.5 PI-NRS points could be seen as irrelevant. Above that value, the cutoff point for clinical relevance depends on the methods used to estimate MCIC and on the patient's baseline severity of pain. MDC and MCIC values in neck pain patients are similar to those for low back pain and other painful conditions.
BMC Musculoskeletal Disorders. 01/2008;
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Francisco M. Kovacs, Víctor Abraira,
Ana Royuela,
Josep Corcoll,
Luis Alegre,
Alejandra Cano,
Alfonso Muriel,
Javier Zamora,
María Teresa Gil del Real,
Mario Gestoso,
Nicole Mufraggi
[show abstract]
[hide abstract]
ABSTRACT: Study Design. Cohort study.
Objective. To estimate the minimal clinically important change (MCIC) on the pain intensity numerical rating scale (PI-NRS) and the Roland Morris Disability Questionnaire (RMQ) in subacute and chronic patients with low back pain (LBP), with and without referred pain to the leg (LP), seen in the routine clinical practice of the Spanish National Health Service.
Summary of Background Data. MCIC have been explored in Anglo-Saxon and Northern European LBP patients. No data on the influence of LP on MCIC are available. In Southern European patients, determinants of disability have shown to be different, and MCIC for pain and disability are unknown.
Methods. Data from the postmarketing surveillance of 1349 LBP subacute and chronic patients treated in routine clinical practice were used for this study. Three different methods were used to estimate the MCIC over a 12-week period: the mean change score (MCS), the minimal detectable change (MDC), and the optimal cutoff point in receiver operant curves (OCP). Patients' own “global perceived effect” was used as the external criterion. The effect on MCIC of initial scores, duration of pain, and existence of LP were assessed.
Results. Different methods led to different MCIC values, with those deriving from OCP being the smallest. Depending on the methods which were used, the MCIC for LBP ranged from 1.5 to 3.2 PI-NRS points in patients with a baseline score below 7 points, and from 2.5 to 4.3 in patients with a baseline score ≥9 points. The MCIC for disability ranged from 2.5 to 6.8 RMQ points in those with baseline scores below 10 points, and from 5.5 to 13.8 inthose baseline scores ≥15 points. These values were similar for patients with LP, and were not influenced by the duration of pain.
Conclusion. In subacute and chronic patients, improvements in LBP of ≤1.5 PI-NRS points, or in disability of ≤2.5 RMQ points should be seen as irrelevant. In those patients, MCIC range values are similar in patients with LP, are consistent across different cultural settings and remain stable no matter what the duration of pain is.
Spine 11/2007; 32(25):2915-2920. · 2.08 Impact Factor
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ABSTRACT: Correlation between previously validated questionnaires.
To assess the association of fear avoidance beliefs (FAB) with disability and quality of life in elderly Spanish subjects.
As opposed to Anglo-Saxon and Northern European patients, in Spanish low back pain (LBP) patients of working age, the influence of FAB on disability and quality of life is sparse and much less than that of pain. The influence of FAB on LBP-related disability and quality of life in the elderly is unknown.
A visual analogue scale (VAS), the Roland Morris Questionnaire (RMQ), the FAB-Phys questionnaire (FABQ), and the SF-12 questionnaire were used to assess LBP, disability, fear avoidance beliefs, and quality of life in 661 institutionalized elderly in Spain, 439 of whom had LBP.
In all subjects, FAB correlated with LBP (r = 0.477), disability (r = 0.458), the Physical Component Summary of SF-12 (PCS SF-12) (r = -0.389), and the Mental Component Summary of SF-12 (MCS SF-12) (r = -0.165). In subjects with LBP, FABs only correlated weakly with disability (r = -0.110). The stronger correlations were found between LBP and disability, both in all subjects (r = 0.803) and LBP patients (r = 0.445). Regression models including all the participants showed that the influence of FABs on physical quality of life was sparse and that FABs were not associated with either disability or mental quality of life. In elderly subjects with LBP, FABs were not associated with either disability or quality of life.
In Spanish institutionalized elderly subjects, FABs only have a minor influence on physical quality of life, and none on disability or mental quality of life. In elderly subjects with LBP, differences in FABs are not associated with differences in disability or quality of life. Further studies should explore the potential value of FABs in the elderly in other settings.
Spine 10/2007; 32(19):2133-8. · 2.08 Impact Factor
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Francisco Kovacs, Víctor Abraira,
Alfonso Muriel,
Josep Corcoll,
Luis Alegre,
Miquel Tomas,
María Antonia Mir,
Pablo Tobajas,
Mario Gestoso,
Nicole Mufraggi,
María Teresa Gil del Real,
Javier Zamora
[show abstract]
[hide abstract]
ABSTRACT: Prospective cohort follow-up study.
To refine the indication criteria for neuroreflexotherapy (NRT) in the treatment of subacute and chronic neck (NP), thoracic (TP) and low back pain (LBP) in the Spanish National Health Service (SNHS), by identifying prognostic factors for clinical outcome.
NRT consists of the temporary subcutaneous implantation of surgical devices in trigger points. Previous randomized controlled trials have shown its efficacy, effectiveness, and cost-effectiveness for treating subacute and chronic LBP. Clinical audits in routine practice have shown similar results in NP, TP, and LBP patients.
All 1514 patients from the SNHS in the Balearic Islands in which a NRT intervention was performed and who were discharged between January 1, 2004, and December 31, 2005, were included in this study. Treatment failure was defined as a baseline score equivalent to or lower than the corresponding one at discharge for local pain, referred pain, or LBP-related disability. Multivariate logistic regression models were developed for each of those variables. Maximal models included reason for referral (NP, TP, or LBP), age, sex, baseline values for each variable, number of days in which the surgical devices used in NRT were left implanted, duration of the current episode, time elapsed since the first episode, and previous failed surgery for the current episode. Calibration of the models was assessed through the Hosmer-Lemeshow test, while discrimination was assessed through the area under the ROC curve and the Nagelkerke R test.
When referred to NRT, patients' median (IQR) duration of the episode was 210 (90, 730) days. Failure rates ranged between 9.9% for local pain and 14.5% for disability. Variables associated with a worst prognosis for local pain, referred pain, and disability were surgical devices remaining implanted for a shorter duration and, especially, a longer pain duration. Patients referred for NP were more likely to improve than those referred for TP or LBP. Regarding the evolution of local and referred pain, lesser improvement was observed in the least severe complaint at baseline. Models showed a good calibration. The area under the ROC curve ranged between 0.719 and 0.804, and R ranged between 0.101 and 0.255.
A longer duration of the current episode is the worst detected prognostic factor for response to NRT, but prognostic models are inaccurate for predicting the clinical outcome of a given patient. In order to improve the success rate of this technology, these results only support earlier referral for patients complying with current indication criteria.
Spine 08/2007; 32(15):1621-8. · 2.08 Impact Factor
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ABSTRACT: Cluster randomized clinical trial.
To assess the effectiveness of 2 minimal education programs for improving low back pain (LBP)-related disability in the elderly.
No education program has shown effectiveness on low back pain (LBP)-related disability in the elderly.
A total of 129 nursing homes (6389 residents) in northern Spain were invited to participate in the study. The actual participants were 12 nursing homes randomly assigned to 3 groups and 661 subjects. An independent physician gave a 20-minute talk with slide projections summarizing the content of the Back Book (active management group), the Back Guide (postural hygiene group), and a pamphlet on cardiovascular health (controls). Disability was measured with the Roland-Morris questionnaire (RMQ). Blind assessments were performed before the intervention, and 30 and 180 days later. The effect of the intervention on disability was estimated by generalized mixed linear random effects models.
Mean age of participants ranged between 79.9 and 81.2 years. Disability improved in all groups, but at the 30-day assessment the postural education group showed an additional improvement of 1.1 (95% confidence interval, 0.2-1.9), RMQ points and at the 180-day assessment the active education group an additional improvement of 2.0 (95% confidence interval, 0.6-3.4). In the subset of subjects with LBP when entering the study, postural education had no advantages over controls, while an additional improvement of 3.0 (95% confidence interval, 1.5- 4.5) RMQ points at the 180-day assessment was observed in the active education group.
In institutionalized elderly, the handing out of the Back Book supported by a 20-minute group talk improves disability 6 months later, and is even more effective in those subjects with LBP.
Spine 06/2007; 32(10):1053-9. · 2.08 Impact Factor
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ABSTRACT: We compared the quality of life perceived by patients with non-specific low back pain with that predicted by the social tariff of the Spanish version of EQ-5D questionnaire.
For each health state of the EQ-5D, an adjusted tariff for patients with back pain was obtained using a linear regression model in which the linear effect of the three levels of response for each of the five domains of the EQ-5D was assumed. These coefficients were compared with those obtained for the general Spanish population. In another model, equal in structure to the standard "Dolan N3" model, the linear effect of the five domains was not assumed.
In 633 patients, 93 health states were recorded. Significant differences in the coefficients of self-care (p = 0.003) and the maximum level of severity in any dimension (p < 0.0001) were observed. The social tariff of the healthy population is different from the tariff of low back pain patients, with general population values being lower than those of patients, particularly in the 211 health states in which any dimension is at level 3. Weights of the different EQ-5D dimensions showed a non-linear effect on the patients' quality of life.
Methods used to develop the social tariff for the Spanish version of EQ-5D were inadequate. In addition, this study shows that values given by the general population are different from those of low back pain patients, further confirming that the social tariff of EQ-5D should not be used with actual patients.
Quality of Life Research 04/2007; 16(3):523-31. · 2.30 Impact Factor
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[hide abstract]
ABSTRACT: Background
We compared the quality of life perceived by patients with non-specific low back pain with that predicted by the social tariff of the Spanish version of EQ-5D questionnaire.
Methods
For each health state of the EQ-5D, an adjusted tariff for patients with back pain was obtained using a linear regression model in which the linear effect of the three levels of response for each of the five domains of the EQ-5D was assumed. These coefficients were compared with those obtained for the general Spanish population. In another model, equal in structure to the standard “Dolan N” model, the linear effect of the five domains was not assumed.
Results
In 633 patients, 93 health states were recorded. Significant differences in the coefficients of self-care (p = 0.003) and the maximum level of severity in any dimension (p < 0.0001) were observed. The social tariff of the healthy population is different from the tariff of low back pain patients, with general population values being lower than those of patients, particularly in the 211 health states in which any dimension is at level 3. Weights of the different EQ-5D dimensions showed a non-linear effect on the patients’ quality of life.
Conclusion
Methods used to develop the social tariff for the Spanish version of EQ-5D were inadequate. In addition, this study shows that values given by the general population are different from those of low back pain patients, further confirming that the social tariff of EQ-5D should not be used with actual patients.
Quality of Life Research 01/2007; 16(3-3):523-531. · 2.30 Impact Factor
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ABSTRACT: To perform a systematic review and a meta-analysis of accuracy of monoclonal stool antigen test (SAT) for the diagnosis of Helicobacter pylori infection.
Selection of studies: assessing the accuracy of monoclonal SAT for the diagnosis of H. pylori infection. Search strategy: electronic and manual bibliographical searches. Data extraction: independently done by two reviewers. Data synthesis: meta-analyses combining the sensitivities, specificities, and likelihood ratios (LRs) of the individual studies.
Twenty-two studies, including 2,499 patients, evaluated the monoclonal SAT before eradication therapy. Pooled sensitivity, specificity, LR+, and LR- were: 0.94 (95% CI 0.93-0.95), 0.97 (0.96-0.98), 24 (15-41), and 0.07 (0.04-0.12). The accuracy of both monoclonal and polyclonal SAT was evaluated together in 13 pretreatment studies, and higher pooled sensitivity was demonstrated with the monoclonal technique (0.95 vs 0.83). Twelve studies, including 957 patients, assessed the monoclonal SAT to confirm eradication after therapy. Pooled sensitivity, specificity, LR+, and LR- were 0.93 (0.89-0.96), 0.96 (0.94-0.97), 17 (12-23), and 0.1 (0.07-0.15). Both tests were evaluated together in eight post-treatment studies and, again, the monoclonal technique showed higher sensitivity (0.91 vs 0.76). Heterogeneity among studies disappeared when a single outlier study was excluded. Subanalysis depending on the reference method, the study population, or the study quality showed similar results.
Monoclonal SAT is an accurate noninvasive method both for the initial diagnosis of H. pylori infection and for the confirmation of its eradication after treatment. The monoclonal technique has higher sensitivity than the polyclonal one, especially in the post-treatment setting.
The American Journal of Gastroenterology 09/2006; 101(8):1921-30. · 7.28 Impact Factor
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ABSTRACT: To evaluate the accuracy of B-type natriuretic peptide levels (BNP) in the diagnosis of heart failure and left ventricular dysfunction.
Electronic search in Medline, Embase, Cochrane Library and Medion database, and hand search of reference lists.
We have included published studies on the accuracy of BNP which had both sufficient information to construct the 2x2 diagnostic cross table and an appropriate spectrum of patients.
Fifty five studies (16,730 patients) were analyzed. The main determinants of diagnostic accuracy were the reference standard analyzed (clinical heart failure versus left ventricular dysfunction), and the methodological quality of the study. BNP levels were highly accurate for the diagnosis of clinical heart failure (diagnostic OR=41; 95% CI 23-74). The negative likelihood ratios were homogeneous, and useful for excluding the existence of heart failure (pooled negative likelihood ratio=0.11; 95% CI 0.08-0.16). The studies focused on the identification of left ventricular dysfunction were heterogeneous, with indications of publication bias, and showed less overall diagnostic accuracy than studies focused on heart failure.
BNP levels are useful for ruling out heart failure. The accuracy of BNP for identifying patients with systolic dysfunction is more limited.
European Journal of Heart Failure 07/2006; 8(4):390-9. · 4.90 Impact Factor
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ABSTRACT: To perform a systematic review and a meta-analysis of diagnostic accuracy of the different tests aimed to detect Helicobacter pylori infection in patients with upper gastrointestinal bleeding (UGIB).
Selection of studies: assessing the accuracy of H. pylori diagnostic methods in patients with UGIB. Search strategy: electronic bibliographical searches. Data extraction: independently done by two reviewers. Data synthesis: meta-analyses of the different tests were performed combining the sensitivities, specificities, and likelihood ratios (LRs) of the individual studies.
Studies showed a high degree of heterogeneity. Pooled sensitivity, specificity, LR+ and LR- (95% confidence interval (CI)) for the different methods were: Rapid urease test (16 studies/1,417 patients): 0.67 (0.64-0.70), 0.93 (0.90-0.96), 9.6 (5.1-18.1), and 0.31 (0.22-0.44). Histology (10 studies/827 patients): 0.70 (0.66-0.74), 0.90 (0.85-0.94), 6.7 (2.5-18.4), and 0.23 (0.12-0.46). Culture (3 studies/314 patients): 0.45 (0.39-0.51), 0.98 (0.92-1.00), 19.6 (4-96), and 0.31 (0.05-1.9). Urea breath test (8 studies/520 patients): 0.93 (0.90-0.95), 0.92 (0.87-0.96), 9.5 (3.9-23.3), and 0.11 (0.07-0.16). Stool antigen test (6 studies/377 patients): 0.87 (0.82-0.91), 0.70 (0.62-0.78), 2.3 (1.4-4), and 0.2 (0.13-0.3). Serology (9 studies/803 patients): 0.88 (0.85-0.90), 0.69 (0.62-0.75), 2.5 (1.6-4.1), and 0.25 (0.19-0.33).
Biopsy-based methods, such as rapid urease test, histology, and culture, have a low sensitivity, but a high specificity, in patients with UGIB. The accuracy of 13C-urea breath test remains very high in these patients. Stool antigen test is less accurate in UGIB. Although serology seems not to be influenced by UGIB, it cannot be recommended as the first diagnostic test for H. pylori infection in this setting.
The American Journal of Gastroenterology 05/2006; 101(4):848-63. · 7.28 Impact Factor
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ABSTRACT: Validation of a translated, culturally adapted questionnaire.
To translate and culturally adapt the Spanish version of the Fear Avoidance Beliefs Questionnaire (FABQ), and to validate its use in Spanish-speaking patients with low back pain (LBP).
The FABQ is a reliable evaluation instrument for fear avoidance beliefs, which includes two subscales (FAB-Work and FAB-Phys). No validated Spanish version was available.
Translation/retranslation of the English version of the FABQ was done blindly and independently by a multidisciplinary team. The study was done in 12 primary care centers and 9 hospital outpatient clinics from seven regions in Spain, with 209 acute, subacute, and chronic patients who visited their physician for LBP: 53 in the pilot phase and 156 in the validation phase. Subjects were given the FABQ, two VAS for LBP and referred pain, and the Roland-Morris and SF-12 Questionnaires on their first visit and 14 days later. In the pilot phase, on day 1 test-retest reliability was estimated by giving a second FABQ in which the name and order of the items had been changed.
Time necessary to complete the FABQ was [median, P25, P75] 10 minutes (5,15). FABQ values were not normally distributed. Comprehensibility: No request for aid in interpretation was made during the validation phase and no item was left unanswered by >or= 10% of patients. Reliability: Scores [median, P25, P75] of the two FABQ were: 72.00 (47.25, 82.00) and 72.00 (49.50, 83.75), with an intraclass correlation coefficient of 0.9668 (95% confidence interval, 0.9421,0.9823). Mean of kappa values for all items was 0.743. Internal Consistency: Cronbach's alpha was 0.9337. Validity: Values of FAB and FAB-Work were >37% higher for patients on sick leave. For FAB-Phys differences were below 8%. FABQ, FAB-Work and FAB-Phys strongly correlated with disability on days 1 and 15.
The Spanish version of the FABQ has good comprehensibility, internal consistency, and reliability. It cannot be analyzed parametrically, but only nonparametrically. The total FABQ is at least as valid as its subscales and simpler to score, making it more suitable for routine clinical use.
Spine 01/2006; 31(1):104-10. · 2.08 Impact Factor
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ABSTRACT: Follow-up study.
To document differences between acute and subacute low back pain (LBP) based on the risk of developing chronic disability and on the correlation between pain, disability, and quality of life.
The subacute stage should identify the time in which the risk of developing chronic disability increases and specific measures should be considered, but its definition is currently inconsistent.
366 patients were given Visual Analog Scales (VAS) for LBP and referred pain (RP), Roland-Morris questionnaires (RMQs), and EuroQol (EQ) questionnaires on their first visit and 14 and 59 days later.
Median duration of pain when entering the study was 4 days (P25, P75: 2,10). Simple correlations among LBP, VAS, and RMQ were r = 0.407 (day 1), 0.688 (day 15), and 0.739 (day 60). Among LBP, VAS, and EQ, r = -0.523, r = -0.701, and r = -0.760. Among RP, VAS, and RMQ, r = 0.280, r = 0.561, and r = 0.583. Between RP, VAS, and EQ, r = -0.306, r = -0.534 and r = -0.600. Between RMQ and EQ, r = -0.650, r = -0.765 and r = -0.815. In 42 patients, disability did not improve throughout the study period, and a prestudy duration of > or = 14 days was the only independent predictor. All these models were significant at the P < 0.007 level. Improvement in quality of life was more likely to occur in patients in which disability improved [odds ratio (OR), 18.29; 95% CI; 8.64, 38.73; P < 0.001]. As opposed to acute patients, in those with a prestudy duration of pain of > or = 14 days, on day 60 RP had no influence on disability, and LBP had no influence on quality of life.
LBP influences disability and quality of life more than RP. Disability is predicted by pain duration and quality of life is predicted by disability, but pain severity predicts neither one of them. Changes related to determinants of disability and quality of life, and to the prediction of chronic disability, appear 14 days after the onset of pain, supporting that cutoff point for considering a patient as being subacute.
Spine 08/2005; 30(15):1786-92. · 2.08 Impact Factor
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Margarita Sánchez-Beato,
Esther Sánchez,
Juan F García,
Alberto Pérez-Rosado,
María C Montoya,
Mario Fraga,
M Jesús Artiga,
Mercedes Navarrete, Víctor Abraira,
Manuel Morente,
Manel Esteller,
Haruhiko Koseki,
Miguel Vidal,
Miguel A Piris
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ABSTRACT: The Polycomb group (PcG) of proteins comprises a family of repressors of homeobox genes that play key roles in body formation, haematopoiesis and cell cycle control. In this study, a large-scale analysis of PcG protein expression (BMI1, MEL18, PH1, RNF2, RING1, and RYBP) was performed in 321 Hodgkin's lymphoma (HL) biopsies and in reactive lymphoid tissues using tissue microarrays. The relevance of PcG proteins in HL was also investigated by the simultaneous analysis of PcG and other proteins involved in the control of cell cycle, transcription machinery and lymphoid differentiation. The analysis revealed increased expression of a set of PcG proteins (particularly RYBP and BMI1) in tumour cells in comparison with reactive lymphoid tissue. One of the most striking findings was anomalous RYBP expression in 55% of classical HL cases associated with an unfavourable response to treatment and shorter survival. The data obtained in this study also show an association of PcG proteins with E2F6 and NFkappaB transcription factors. The statistical relationship between PcG and NFkappaB activation was further explored in HL-derived cell lines treated with curcumin, an NFkappaB inhibitor, and TNFalpha. Up- or downregulation of MEL18 was paralleled by loss or gain of activated NFkappaB, which suggests that NFkappaB may regulate expression of this protein. Investigation of the relationship between E2F6 and RING1 by immunofluorescence and confocal analysis, in HL cell lines and paraffin sections, revealed co-expression of both proteins in the same tumour cells. These results allow us to propose that the formation of transcription complexes with E2F6 may modify the functional status of PcG proteins in HSR cells.
The Journal of Pathology 01/2005; 204(5):528-37. · 6.32 Impact Factor
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Carlos Montalbán,
Juan F García, Víctor Abraira,
Leocricia González-Camacho,
Manuel M Morente,
Jose L Bello,
Eulogio Conde,
Miguel A Cruz,
Ramón García-Sanz,
José García-Laraña,
Carlos Grande,
Marta Llanos,
Rafael Martínez,
Eduardo Flores,
Miguel Méndez,
Concepción Ponderós,
Concepción Rayón,
Pedro Sánchez-Godoy,
Javier Zamora,
Miguel A Piris
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ABSTRACT: Current therapies fail to cure a significant proportion of patients with Hodgkin's lymphoma (HL). Predictive systems for stratification of the disease and selection of treatment based on sets of clinical variables, such as the international prognostic score (IPS), are of relatively small practical value. The predictive use of biologic parameters has so far provided limited and inconsistent results. Here we explore the influence of a set of molecular markers on the outcome of HL.
Forty molecular markers involved in B-cell differentiation and activation, signal transduction, cell cycle, and apoptosis control were analyzed in 259 classic HL patient cases by using tissue microarrays. Univariate analysis was performed to evaluate the influence of markers on favorable outcome (complete remission of > 12 months). Significant variables were included in a multivariate logistic regression analysis, and the probability of favorable outcome was estimated.
Univariate analysis revealed four molecular markers that predicted outcome, and the multivariate analysis showed p53, Bcl-X(L), and terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick-end labeling (TUNEL) to have independent significance. The combination of these factors determined two groups of patients (group I, zero to one factor; group II, two to three factors) with a probability of a favorable outcome of.948 and.687, respectively. A multivariate Cox's model shows that these biologic risk groups have special predictive power in low-IPS patients.
The data from this exploratory study suggest that the accumulation of molecular events seems to influence the outcome of HL, particularly in the low-IPS group.
Journal of Clinical Oncology 05/2004; 22(9):1664-73. · 18.37 Impact Factor
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ABSTRACT: Study Design. Correlation among previously validated questionnaires.
Objectives. To determine the correlation between pain, disability, and quality of life in patients with low back pain.
Summary of Background Data. The Visual Analogue Scale (VAS), and the Roland-Morris (RMQ), Oswestry (OQ), and EuroQol (EQ) Questionnaires are validated instruments to assess pain, low back pain-related disability, and quality of life.
Methods. The study was done in the primary care setting, in Mallorca, with 195 patients who visited their physician for LBP. Individuals were given the VAS, RMQ, OQ, and EQ on their first visit and 14 days later.
Results. Median duration of pain when entering the study was 10 days (P25,P75: 3, 40). On day 1, simple correlation was r = 0.347 between VAS and RMQ, r = −0.422 between VAS and EQ, and r = −0.442 between RMQ and EQ. On day 15, simple correlation was r = 0.570 between VAS and RMQ, r = −0.672 between VAS and EQ, and r = −0.637 between RMQ and EQ. Multiple linear regression models showed that, on day 1, the VAS score explains 12% of the RMQ score and the VAS and RMQ scores explain 27% of the EQ score. On day 15, the VAS score explains 33% of the RMQ score, and the VAS and RMQ scores explain 58% of the EQ score. On day 1, a 10% increase in VAS worsens disability by 3.3% and quality of life by 2.65%. On day 15, a 10% increase in VAS worsens disability by 4.99% and quality of life by 3.80%. Prestudy duration of pain had no influence on any model. All these correlation coefficients and models are significant at the P < 0.001 level. The OQ had lower correlation values with the other three scales, and only two of them were significant.
Conclusion. Clinically relevant improvements in pain may lead to almost unnoticeable changes in disability and quality of life. Therefore, these variables should be assessed separately when evaluating the effect of any form of treatment for low back pain. The influence of pain and disability on quality of life progresses while they last, and doubles in 14 days. In acute and subacute patients, this increase is not dependent on the previous duration of pain.
Common, or nonspecific, low back pain (LBP) is one of the most frequent ailments in the industrialized world, and it may have an impact on the functional status of the individual with LBP. More than 70% of the general population has back pain at any moment, 1,2 and LBP is the most expensive cause of disability related to work in terms of Workers’ Compensation and medical expenses. 1,3,4 It is also the most frequent reason for work-related disability in those younger than 45 years. 5
LBP can interfere with activity that ranges from basic activities of daily living such as walking and dressing to many work-related functions. It might seem obvious that pain determines disability in patients with LBP. However, it is not so. The intensity of pain and the degree of disability do not correlate well and are associated with different risk factors. Biomechanical factors influence pain, but psychosocial factors have more of an influence on the development and duration of disability. 2,4,6–11
Self-assessment pain and disability scales correlate with pain and disability better than objective measures of physical performance, which have been reported to have even weaker correlations with self-assessment scales than those between the self-assessments. Indeed, disability scales have been shown to correlate with disability better than scales that measure the intensity of pain, radiographs, MRI, and CT scans. 2,6,7,9,10,12 It might seem obvious that both pain and disability determine quality of life in patients with LBP. However, other factors unrelated to LBP may influence quality of life, there is sparse evidence on the correlation between LBP and decrease in quality of life, and there are few data on the correlation between pain and disability with quality of life.
To assess the correlation between pain, disability, and quality of life in patients with LBP, those variables must be measured with self-assessment instruments that are valid, reliable, and sensitive to change. The Visual Analogue Scale (VAS) is a widely used instrument for measuring pain. 13 It is a simple scale, consisting of a 100-mm horizontal line. The left end represents no pain and the right end represents the worst pain imaginable. The patient marks the spot that best corresponds to his or her level of pain. The score corresponds to the distance (measured in centimeters) from the left end to the marked spot. The possible values range from 0 (no pain) to 10 (worst pain imaginable).
The Roland-Morris Questionnaire (RMQ) is a validated scale for measuring disability related to LBP. 14 It consists of a list of 24 items that reflect limitation in different activities of daily living. The questionnaire is filled out by the patient who has to indicate those items reflecting his/her current state. Results range from 0 (no disability) to 24 (maximum disability).
The Oswestry Questionnaire (OQ) is also a validated instrument for measuring disability related to LBP. 15 It is composed of 10 six-point scales, with the first one rating intensity of pain and the other nine measuring disability in different contexts of daily living. The patient marks the statement(s) in each section that best describes his/her state. Each section is scored on a scale from 0 to 5, and the higher the value, the greater the disability. Although it is usually given as a percentage of the maximum possible score, the score ranges from 0 (no disability) to 50 (maximum disability).
The EuroQol Questionnaire (EQ), is a validated scale for measuring quality of life. It is also filled out by the patient and covers five dimensions of health: mobility, self-care, main activity, family or leisure activities, pain, and mood. In each dimension, the patient chooses one of three items that best describes his or her situation. The scoring system is complicated and the values (within the Spanish population) range from −0.1304 (worst possible quality of life) to 1 (total well-being), with 0 corresponding to death (and the range between −0.1304 and 0 to those situations that, according to the standards of the Spanish population, are thought to be worse than death). 16
The objective of this study was to determine the correlation of pain, disability, and quality of life in patients with LBP.
Spine 01/2004; 29(2):206-210. · 2.08 Impact Factor
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Francisco M Kovacs, Víctor Abraira,
Javier Zamora,
María Teresa Gil del Real,
Joan Llobera,
Carmen Fernández,
José Ramón Bauza,
Kunibert Bauza,
Josep Coll,
María Cuadri, [......],
María Arrate Olivera,
Patricia Pascual,
Lourdes Perelló,
Francisco Pozo,
Teresa Revuelta,
Vicente Reyes,
Sebestián Ribot,
Jaime Ripoll,
Juana Ripoll,
Elena Rodríguez
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ABSTRACT: Correlation among previously validated questionnaires.
To determine the correlation between pain, disability, and quality of life in patients with low back pain.
The Visual Analogue Scale (VAS), and the Roland-Morris (RMQ), Oswestry (OQ), and EuroQol (EQ) Questionnaires are validated instruments to assess pain, low back pain-related disability, and quality of life.
The study was done in the primary care setting, in Mallorca, with 195 patients who visited their physician for LBP. Individuals were given the VAS, RMQ, OQ, and EQ on their first visit and 14 days later.
Median duration of pain when entering the study was 10 days (P25,P75: 3, 40). On day 1, simple correlation was r = 0.347 between VAS and RMQ, r = -0.422 between VAS and EQ, and r = -0.442 between RMQ and EQ. On day 15, simple correlation was r = 0.570 between VAS and RMQ, r = -0.672 between VAS and EQ, and r = -0.637 between RMQ and EQ. Multiple linear regression models showed that, on day 1, the VAS score explains 12% of the RMQ score and the VAS and RMQ scores explain 27% of the EQ score. On day 15, the VAS score explains 33% of the RMQ score, and the VAS and RMQ scores explain 58% of the EQ score. On day 1, a 10% increase in VAS worsens disability by 3.3% and quality of life by 2.65%. On day 15, a 10% increase in VAS worsens disability by 4.99% and quality of life by 3.80%. Prestudy duration of pain had no influence on any model. All these correlation coefficients and models are significant at the P < 0.001 level. The OQ had lower correlation values with the other three scales, and only two of them were significant.
Clinically relevant improvements in pain may lead to almost unnoticeable changes in disability and quality of life. Therefore, these variables should be assessed separately when evaluating the effect of any form of treatment for low back pain. The influence of pain and disability on quality of life progresses while they last, and doubles in 14 days. In acute and subacute patients, this increase is not dependent on the previous duration of pain.
Spine 01/2004; 29(2):206-10. · 2.08 Impact Factor
