María Pérez

Cultural adaptation and validation of the painDETECT scale into Spanish.

Objective:The aim of this study was to culturally adapt into Spanish and validate the painDETECT questionnaire, a brief self-administered instrument designed to screen the presence of a neuropathic pain component in usual clinical practice. Methods:The original English painDETECT questionnaire was culturally adapted into Spanish (Spain) by 2 independent translators under supervision of an expert panel. The LANNS, and a pain visual analog scale were administered along with the painDETECT questionnaire to a sample of 252 patients with neuropathic, nociceptive, or mixed pain for at least 3 months. Patients were classified by experienced specialists under normal conditions of clinical practice. A retest measure after 24 to 48 hours was also carried out. Reliability, construct validity, convergent validity, criterion, and discriminant validity were assessed. Results:An effective sample of 221 patients with chronic pain was recruited, 32% diagnosed of neuropathic origin, 32% of nociceptive, and remaining 36% presented mixed pain. The average age was 57.8 years (SD=14.2) and 59% were women. Cronbach alpha attained a value of 0.86, and the intraclass correlation coefficient with the retest was 0.93. The factor structure was coherent with the one informed for the original instrument. Pearson correlation with the LANSS scale was 0.88. Area under the receiver operating characteristic curve was 0.88 when comparing neuropathic and nociceptive groups. Using the suggested cutoff value for pain presence of 19 points or higher, the following discriminant values are obtained: sensitivity=75%, specificity=84%, Youden Index=0.595, positive predictive value=92%, and negative predictive value=60%. The absence cutoff value of 12 points or bellow raised the following values: sensitivity=93%, specificity=68%, Youden Index=0.61, positive predictive value=87%, and negative predictive value=80%. When mixed pain patients are included in the group with a neuropathic component, discriminant values are slightly reduced, as expected. Conclusions:The culturally adapted version of the painDETECT presents good psychometric properties and shows to be a valid patient-reported outcome for measuring the presence of a neuropathic component in patients with chronic pain.

Prevalencia del dolor neuropático en España: implicaciones clínicas, laborales y asistenciales

A narrative systematic medical literature review on prevalence of neuropathic pain (NP) in Spain from 1990 to 2004 was conducted. The average number of publications was 3 per year. Prevalence data varied depending on studied population, definition of pain/pathology and time of pain evolution. The most commonly studied pathologies included: mononeuropathies and polyneuropathies: 42%, multiple sclerosis: 35% and entrapment neuropathies: 16%. Some episodes of NP were left untreated. One third of patients with back pain receiving analgesic treatment still had high intensity pain. Future studies on the prevalence of NP should use work definitions and criteria reached by consensus. An awareness of the clinical presentation of NP and an appropriate and early treatment could minimize its clinical, working and health care implications. NP is a diverse and highly prevalent condition in Spain. Efforts should be conducted towards the achievement of diagnostic criteria consensus and higher rates of analgesic success.

Changes in seizure severity and quality of life in patients with refractory partial epilepsy.

This 6-month observational, prospective, multicenter study assessed the influence of changes in seizure severity on quality of life in patients with refractory partial epilepsy. Patients (N = 262) diagnosed with partial epilepsy and receiving two antiepileptic drugs as determined by usual clinical practice were enrolled in this study. The primary endpoint was the mean seizure severity score obtained from the Seizure Severity Questionnaire. Reductions in seizure severity were detected from baseline to months 3 and 6 (P<0.0001). Improvements compared with baseline were found for several secondary measures: Hamilton Anxiety and Depression scales (P<0.0001), most Medical Outcomes Study-Sleep subscales (P<0.05), and seven subscales of the Quality of Life in Epilepsy Inventory-31 (QOLIE-31; P<0.0005). Seizure severity correlated directly with anxiety (P<0.0001) and inversely with QOLIE-31 measures (P<0.0001). In conclusion, reducing seizure severity with appropriate medication may lead to improvement in the overall quality of life of patients with refractory partial epilepsy.

Prevalence of distal diabetic polyneuropathy using quantitative sensory methods in a population with diabetes of more than 10 years’ disease duration

OBJECTIVES Results of studies on the prevalence of distal diabetic polyneuropathy (DPN) are contradictory. Conventional methods used for the diagnosis of DPN in clinical practice have limited effectiveness. The present study aimed to assess the prevalence of DPN in a population with long-standing diabetes (more than 10 years disease duration) by measuring vibratory, thermal and tactile sensitivities with quantitative sensory devices, as well as their relationship with associated clinical risk factors. PATIENTS AND METHODS A total of 1011 diabetic patients were evaluated in a multicenter, cross-sectional, observational study. The three sensitivities were assessed by ultrabiothesiometer, aesthesiometer and thermoskin devices, respectively. The prevalence of neuropathic pain was validated by the DN4 questionnaire. RESULTS Of the 1011 cases included, 400 (39.6%) met the diagnostic criteria of DPN, while no DPN was found in the remaining 611 (60.4%). Of the 400 patients with DPN, 253 (63.2%) showed clinical manifestations, while 147 (36.8%) were diagnosed as subclinical DPN. The prevalence of DPN increased with disease duration. There was a progressive loss of the three sensitivities with increased disease duration, particularly thermal and vibratory sensitivities. This loss was statistically significant for the latter two sensitivities. Among patients with clinical DPN, 84.2% had painful neuropathic symptoms. The prevalence of DPN was positively related to micro- and macroangiopathic complications and with dyslipidemia. CONCLUSION This study reveals a high degree of underdiagnosis of DPN, most likely due to the asymptomatic nature of the disease in a considerable proportion of patients. Our observations provide evidence of the usefulness of specific equipment for quantitative and objective assessment of polyneuropathy.

Prevalence of Neuropathic Pain in Radiotherapy Oncology Units

PURPOSE Neuropathic pain (NP) in cancer patients severely impacts quality of life. Radiotherapy (RT) may cause NP, and at the same time, cancer patients visit RT units for pain relief. NP prevalence at these sites and current analgesic treatment should be assessed to improve management. METHODS AND MATERIALS This epidemiological, prospective, multicenter study was undertaken to assess NP prevalence, according to Douleur Neuropathique 4 questions questtionaire (DN4) test results, and analgesic management in cancer pain patients visiting RT oncologic units. Secondary analyses assessed NP etiology and pain intensity (using the Brief Pain Inventory-Short Form) and impact (using the Hospital Anxiety and Depression Scale (HADS), Medical Outcomes Study [MOS] for Sleep, and the Health Survey Short Form-12). RESULTS A total of 1,098 patients with any kind of pain were registered. NP prevalence was 31.1% (95% confidence interval, 28.4%--33.9%); 291 NP patients (mean age, 62.2 ±12.5 years and 57.7% men) were eligible for study; 49% of patients were overweight. The most frequent tumors were those of breast and lung, and stage IIIB was the most common cancer stage. The tumors caused 75% of NP cases. Anxiety, sleepiness, and depression were common. At 8 weeks, pain intensity and interference with daily activities decreased significantly for 50.8% of responders. Depression and anxiety (p < 0.0001) scores on the Physical Component Summary and Mental Component Summary measures (p < 0.0001) and all MOS-Sleep subscales, except for snoring, improved significantly. The percentage of satisfied patients increased from 13.8% to 87.4% (p < 0.0001) with the current analgesic treatment, which meant a 1.2- and 6-fold increase (p < 0.0001) in narcotic analgesics and anticonvulsants, respectively, compared to previous treatment. CONCLUSIONS NP is highly prevalent at RT oncology units, with sleepiness, anxiety, and depression as frequent comorbidities. There is a need to improve management of NP with increased use of more specific NP-targeting drugs.

Effects of Pregabalin on Subjective Sleep Disturbance Symptoms during Withdrawal from Long-Term Benzodiazepine Use

Aim: To evaluate the effectiveness of pregabalin as a tapering therapy on the subjective sleep quality of patients who underwent a benzodiazepine withdrawal program in routine medical practice. Methods: Secondary analysis of a 12-week prospective, open noncontrolled study carried out in patients who met DSM-IV-TR criteria for benzodiazepine dependence. Sleep was evaluated with the Medical Outcomes Study Sleep Scale (MOS Sleep Scale). Results: 282 patients were included in the analysis. Mean (±SD) pregabalin dose was 315 ± 166 mg/day at the end of the trial. We observed a significant and clinically relevant improvement in sleep outcomes at the endpoint, with a total score reduction from 55.8 ± 18.9 to 25.1 ± 18.0 at week 12 (i.e. a 55% reduction). Similar findings were apparent using the six dimensions of the MOS Sleep Scale. Moderate correlations were observed between the MOS Sleep summary index and sleep domains, and there were improvements in anxiety symptoms and disease severity. Conclusions: These findings suggest that pregabalin may improve subjective sleep quality in patients who underwent a benzodiazepine withdrawal program. This effect appears to be partly independent of improvements in symptoms of anxiety or withdrawal. However, controlled studies are needed to establish the magnitude of the effect of pregabalin.

Broadening of Generalized Anxiety Disorders Definition Does not Affect the Response to Psychiatric Care: Findings from the Observational ADAN Study.

Objective: To elucidate the consequences of broadening DSM-IV criteria for generalized anxiety disorder (GAD), we examined prospectively the evolution of GAD symptoms in two groups of patients; one group diagnosed according to DSM-IV criteria and the other, according to broader criteria. Method: Multicentre, prospective and observational study conducted on outpatient psychiatric clinics. Patients were selected from October 2007 to January 2009 and diagnosed with GAD according to DSM-IV criteria (DSM-IV group) or broader criteria. Broader criteria were considered 1-month of excessive or non-excessive worry and only 2 of the associated symptoms listed on DSM-IV for GAD diagnosis. Socio-demographic data, medical history and functional outcome measures were collected three times during a 6-month period. Results: 3,549 patients were systematically recruited; 1,815 patients in DSM-IV group (DG) and 1,264 in broad group (BG); 453 patients did not fulfil inclusion criteria and were excluded. Most patients (87.9% in DG, 82.0% in BG) were currently following pharmacological therapies (mainly benzodiazepines) to manage their anxiety symptoms. The changes observed during the study were: 49.0% and 58.0%, respectively of patients without anxiety symptoms as per HAM-A scale at the 6 month visit (p=0.261) and 59.7% and 67.7%, respectively (p=0.103) of responder rates (> 50% reduction of baseline scoring). Conclusion: Broadening of GAD criteria does not seem to affect psychiatric care results in subjects with GAD, is able to identify the core symptoms of the disease according to the DSM-IV criteria and could lead to an earlier diagnosis.

Clinical Characteristics, Patient-Reported Outcomes, and Previous Therapeutic Management of Patients with Uncontrolled Neuropathic Pain Referred to Pain Clinics

Background. The aim of this report was to evaluate the clinical profile and previous management of patients with uncontrolled neuropathic pain who were referred to pain clinics. Methods. We included adult patients with uncontrolled pain who had a score of ≥4 in the DN4 questionnaire. In addition to sociodemographic and clinical data, we evaluated pain levels using a visual analog scale as well as anxiety, depression, sleep, disability, and treatment satisfaction employing validated tools. Results. A total of 755 patients were included in the study. The patients were predominantly referred to pain clinics by traumatologists (34.3%) and primary care physicians (16.7%). The most common diagnoses were radiculopathy (43%) and pain of oncological origin (14.3%). The major cause for uncontrolled pain was suboptimal treatment (88%). Fifty-three percent of the patients were depressed, 43% had clinical anxiety, 50% rated their overall health as bad or very bad, and 45% noted that their disease was severely or extremely interfering with their daily activities. Conclusions. Our results showed that uncontrolled neuropathic pain is a common phenomenon among the specialties that address these clinical entities and, regardless of its etiology, uncontrolled pain is associated with a dramatic impact on patient well-being.

Effect of Pregabalin in the Treatment of Refractory Neck Pain: Cost and Clinical Evidence from Medical Practice in Orthopedic Surgery and Rehabilitation Clinics

Background:  The study aims to prospectively analyze the effect of adding pregabalin upon costs and consequences in the treatment of refractory neck pain under routine medical practice.

Clinical and Resource Utilization Patterns in Patients with Refractory Neuropathic Pain Prescribed Pregabalin for the First Time in Routine Medical Practice in Primary Care Settings in Spain

CONTEXT AND OBJECTIVE To describe clinical and resource utilization patterns in patients with refractory neuropathic pain (NeP) who were prescribed pregabalin for the first time in routine medical practice in primary care settings. METHODS Post-hoc analysis of a 12-week prospective observational study including pregabalin naïve adult patients with refractory chronic NeP of at least 6-months duration. Self-reported pain intensity, disability, sleep disturbances, symptoms of anxiety and depression, disability, health-related quality of life (HRQoL), health care resource utilization, and corresponding costs were assessed in this post-hoc analysis. RESULTS One thousand three hundred fifty-four patients were enrolled in the study, and three treatment groups were identified: (1) 598 patients replaced prior pain treatments with pregabalin as monotherapy; (2) 589 added pregabalin to their existing pain treatments; and (3) 167 other pain treatments were prescribed according with physician routine medical practice. Statistically significant differences were reported at baseline for intensity of pain, patient disability, severity of depressive symptoms, and HRQoL (P < 0.01 in all cases). No statistically significant differences were reported among the three treatment groups for anxiety severity or sleep disturbances. Subjects who received add-on pregabalin had greater use of direct and indirect resources vs the other groups, resulting in significantly higher quarterly overall costs per patient: €2,397 (2,308), €2,470 (1,857), and €3,110 (2,496), respectively (P < 0.001). CONCLUSION These findings suggest that primary care physicians chose pregabalin as an option for treating refractory patients who tended to have much more severe NeP profiles, costing society more than when they chose other therapeutic strategies not including pregabalin.