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Abstract Background Neuropathic pain must be correctly diagnosed for optimal treatment. The questionnaire named Neuropathic Pain Symptom Inventory (NPSI) was developed in its original French version to evaluate the different symptoms of neuropathic pain. We hypothesized that the NPSI might also be used to differentiate neuropathic from non-neuropathic pain. Methods We translated the NPSI into German using a standard forward-backward translation and administered it in a case-control design to patients with neuropathic (n = 68) and non-neuropathic pain (headache and osteoarthritis, n = 169) to validate it and to analyze its discriminant properties, its sensitivity to change, and to detect neuropathic pain subgroups with distinct profiles. Results Using a sum score (the NPSI-G score), we found sensitivity to change (r between 0.37 and 0.5 for pain items of the graded chronic pain scale) and could distinguish between neuropathic and other pain on a group basis, but not for individual patients. Post hoc development of a discriminant score with optimized diagnostic properties to distinguish neuropathic pain from non-neuropathic pain resulted in an instrument with high sensitivity (91%) and acceptable specificity (70%). We detected six different pain profiles in the patient group with neuropathic pain; three profiles were found to be distinct. Conclusions The NPSI-G potentially combines the properties of a diagnostic tool and an instrument to identify subtypes of neuropathic pain.

Abstract Background The most commonly used survey methods are self-administered questionnaires, telephone interviews, and a mixture of both. But until now evidence out of randomised controlled trials as to whether patient responses differ depending on the survey mode is lacking. Therefore this study assessed whether patient responses to surveys depend on the mode of survey administration. The comparison was between mailed, self-administered questionnaires and telephone interviews. Methods A four-armed, randomised controlled two-period change-over design. Each patient responded to the same survey twice, once in written form and once by telephone interview, separated by at least a fortnight. The study was conducted in 2003/2004 in Germany. 1087 patients taking part in the German Acupuncture Trials (GERAC cohort study), who agreed to participate in a survey after completing acupuncture treatment from an acupuncture-certified family physician for headache, were randomised. Of these, 823 (664 women) from the ages of 18 to 83 (mean 51.7) completed both parts of the study. The main outcome measure was the comparison of the scores on the 12-Item Short-Form Health Survey (SF-12) and the Graded Chronic Pain Scale (GCPS) questionnaire for the two survey modes. Results Computer-aided telephone interviews (CATI) resulted in significantly fewer missing data (0.5%) than did mailed questionnaires (2.8%; p < 0.001). The analysis of equivalence revealed a difference between the survey modes only for the SF-12 mental scales. On average, reported mental status score was 3.5 score points (2.9 to 4.0) lower on the self-administered questionnaire compared to the telephone interview. The order of administration affected results. Patients who responded to the telephone interview first reported better mental health in the subsequent paper questionnaire (mean difference 2.8 score points) compared to those who responded to the paper questionnaire first (mean difference 4.1 score points). Conclusion Despite the comparatively high cost of telephone interviews, they offer clear advantages over mailed self-administered questionnaires as regards completeness of data. Only items concerning mental status were dependent on the survey mode and sequence of administration. Items on physical status were not affected. Normative data for standardized telephone questionnaires could contribute to a better comparability with the results of the corresponding standardized paper questionnaires.

Abstract Background Distal radius and proximal femoral fractures are typical injuries in later life, predominantly due to simple falls, but modulated by other relevant factors such as osteoporosis. Fracture incidence rates rise with age. Because of the growing proportion of elderly people in Western industrialized societies, the number of these fractures can be expected to increase further in the coming years, and with it the burden on healthcare resources. Our study therefore assessed the effects of these injuries on the health status of older people over time. The purpose of this paper is to describe the study method, clinical parameters of fracture patients during hospitalization, mortality up to one and a half years after discharge in relation to various factors such as type of fracture, and to describe changes in mobility and living situation. Methods Data were collected from all consecutive patients (no age limit) admitted to 423 hospitals throughout Germany with distal radius or femoral fractures (57% acute-care, femoral and forearm fractures; 43% rehabilitation, femoral fractures only) between January 2002 and September 2003. Polytrauma and coma patients were excluded. Demographic characteristics, exact fracture location, mobility and living situation, clinical and laboratory parameters were examined. Current health status was assessed in telephone interviews conducted on average 6–7 months after discharge. Where telephone contact could not be established, at least survival status (living/deceased/date of death) was determined. Results The study population consisted of 12,520 femoral fracture patients (86.8% hip fractures), average age 77.5 years, 76.5% female, and 2,031 forearm fracture patients, average age 67.6 years, 81.6% female. Women's average age was 6.6 (femoral fracture) to 10 years (forearm fracture) older than men's (p < 0.0001). Only 4.6% of femoral fracture patients experienced changes in their living situation post-discharge (53% because of the fracture event), although less than half of subjects who were able to walk without assistive devices prior to the fracture event (76.7%) could still do so at time of interview (34.9%). At time of interview, 1.5% of subjects were bed-ridden (0.2% before fracture). Forearm fracture patients reported no change in living situation at all. Of the femoral fracture patients 119 (0.95%), and of the forearm fracture patients 3 (0.15%) died during hospital stay. Post-discharge (follow-up one and a half years) 1,463 femoral fracture patients died (19.2% acute-care patients, 8.5% rehabilitation patients), but only 60 forearm fracture patients (3.0%). Ninety percent of femoral fracture deaths happened within the first year, approximately 66% within the first 6 months. More acute-care patients with a pertrochanteric fracture died within one year post-discharge (20.6%) than patients with a cervical fracture (16.1%). Conclusion Mortality after proximal femoral fracture is still alarmingly high and highest after pertrochanteric fracture. Although at time of interview more than half of femoral fracture patients reported reduced mobility, most patients (96%) attempt to live at home. Since forearm fracture patients were on average 10 years younger than femoral fracture patients, forearm fractures may be a means of diagnosing an increased risk of later hip fractures.

Background: Proximal femoral fracture is a common condition in the elderly but very little is known about fracture-related hip pain in these patients after discharge from stationary treatment., Aims: To identify risk factors associated with persistent hip pain in elderly hip-fracture patients., Methods: We analysed data from a large observational study, evaluating the health care situation of hip-fracture patients between January 2002 and September 2003 in Germany. For this analysis, we focused on a sub-sample of patients who were 65 years or older, had sustained an isolated proximal femoral fracture and had undergone surgical intervention. A telephone interview was conducted 6-12 months after discharge. Pain intensity, pain-related disability and severity of chronic pain were measured using the Graded Chronic Pain Scale (GCPS). Multivariate linear regression methods were applied to test hospital patient data for their value in predicting post-hospitalisation presence of fracture-related pain., Results: In total, 1541 patients (mean age 78.4, 76.1% female) were enrolled in this analysis. The prevalence of fracture-related hip pain was 13.4% (206/1541). Among these 206 patients, 57.3% had pain intensity scores 50, 65.0% had pain disability scores 50, and the severity of chronic pain (Grades 1-4) was assessed as follows: (1) 34.0%, (2) 19.4%, (3) 31.5%, (4) 15.1%. The clinical variables age, weight and operative procedure were found to be predictive of post-hospitalisation fracture-related pain., Conclusions: This analysis shows that a substantial percentage of elderly patients with proximal femoral fracture suffer intense fracture-related hip pain after stationary treatment.

Objective: The aim of this study was to evaluate osteoporosis diagnosis and treatment on the basis of medical history, at hospital discharge, and 6-12 months after discharge, as well as to assess the frequency of subsequent fractures in postmenopausal women with distal radius fracture., Research Design and Methods: A prospective, observational study of hospitalized women aged 55 years and older with an isolated distal radius fracture from minimal trauma. Subjects were recruited in 242 acute care hospitals in Germany., Outcome Measures: Potential risk factors for osteoporosis, frequency of osteoporosis assessment, frequency of medication treatment and subsequent fractures 6-12 months after discharge., Results: Among 2031 patients we identified 652 appropriate postmenopausal women. Less than one-third of patient histories contained any bone density parameters, and only a minority of subjects (33%, 217) underwent bone density assessment while in hospital. Of these, 55% (119) were diagnosed with low bone density, yet only 30% of those were prescribed supplements (calcium/vitamin D) and/or specific osteoporosis medication (mostly bisphosphonates) at discharge. Six to twelve months after hospital discharge, the low rate of treatment had not changed substantially. In the interval, 4.3% had sustained a subsequent fracture from minimal trauma: 1.4% a distal radius fracture (0.3% a refracture) and 2.9% a hip joint or other fracture (not specified). A significant age difference between those with and without subsequent distal radius fractures was found (p = 0.01) but not a significant difference between patients with or without osteoporosis medication (p = 0.79), primarily because the case numbers were too small., Conclusions: A substantial proportion of postmenopausal women hospitalized with distal radius fracture were not sufficiently evaluated or treated for their potential risk of osteoporosis.

Background: Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment., Methods: This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23-26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557., Findings: Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 .3 days (95% CI 1.9-2.7) in the verum acupuncture group, 1.5 days (1.1-2.0) in the sham acupuncture group, and 2.1 days (1.5-2.7) in the standard therapy group. These differences were statistically significant compared with baseline (p<0.0001), but not across the treatment groups (p=0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133)., Interpretation: Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

Background: Little is known about potential long-term effects of body acupuncture. The aim of the study was to determine such long-term effects 3 and 6 months after the end of a course of acupuncture treatment for chronic low-back pain (cLBP) or chronic pain caused by gonarthrosis., Methods: Prospective cohort study with patients who had received 10 sessions of needle body acupuncture within a maximum of 10 weeks. Data source was our survey of all patients receiving acupuncture treatment in Germany. A total of 1096 eligible patients with cLBP or gonarthrosis pain were identified (68.1% female) and invited by letter to participate in the study. Ultimately 249 patients remained, with no loss of representativeness. Two telephone interviews were conducted 3 and 6 months after the last acupuncture session using standardized questionnaires, available as electronic case report forms. The primary target criteria were self-assessment of pain tolerability prior to the start of acupuncture and after the end of treatment, and pain intensity (GCPS) over time. Secondary target criteria were changes to functional impairment (HFAQ for cLBP, WOMAC for gonarthrosis), quality of life (SF12), depression (CES-D) and patient global assessment of treatment effectiveness (PGA). For the indication cLBP, pain-related fear avoidance beliefs (FABQ) were also queried., Results: Pain tolerability before acupuncture was reported as being significantly worse than pain tolerability at the time of the two post-acupuncture interviews. The scores for all post-acupuncture questionnaires showed no significant changes over time, with the exception of treatment effectiveness for gonarthrosis. Mean scores for each of the questionnaires at the 3 and 6 month follow-up interviews were as follows: cLBP: Pain tolerability (pre: 6.8, post: 3.4 / 3.4), pain intensity (41.8 / 42.6), PGA (2.4 / 2.6), SF12 physical (35.8 / 35.8), SF12 mental (45.3 / 46.9), CES-D (14.9 / 14.9), HFAQ (67.2 / 67.1), FABQ total (2.9 / 2.9). GONARTHROSIS: Pain tolerability (pre: 6.9, post: 3.6 / 3.9), pain intensity (42.9 / 42.8), PGA (2.6 / 2.9), SF12 physical (32.2 / 31.3), SF12 mental (45.0 / 46.2), CES-D (15.6 / 14.7), WOMAC total (34.6 / 34.0)., Conclusions: Pain tolerability was significantly improved after acupuncture and remained so up to 6 months after treatment. The mean scores of almost all questionnaires did not change significantly between 3 and 6 months. We therefore conclude that acupuncture had a long-term effect on important aspects of cognitive and emotional pain coping.

Background: Reporting of all serious adverse events (SAEs) is a requirement for regulatory approval of a drug. Can equally rigorous reporting standards be expected in studies of non-drug treatments and how can underreporting, if any, be detected and proven? Using data from our large-scale prospective cohort study of acupuncture on outpatients, we examine the use of an internal standard, a principle taken from laboratory medicine, to quantify real event rates., Methods: A total of 190,924 patients (68.6% women) seeking treatment for chronic pain (headache, low back pain, coxarthrosis or gonarthrosis) from 12,000 physicians in private practice in Germany were observed during a six-month period ending in May 2002. Most received ten sessions of body acupuncture. Mean treatment time was six weeks. All practitioners were certified in acupuncture and received written instructions on completing forms for basic patient data and SAE monitoring. They were also informed that payment by insurers would be made only upon return of the completed form. All SAEs occurring between start of the first acupuncture session and end of the last one were to be reported, whether causally related to the treatment or not. Multiple minor adverse events (AEs) per single patient were to be reported only once. As the internal standard we chose the expected number of deaths, based on the death rate for the German population, adjusted for age, sex distribution and mean observation time of our study patients., Results: 45 SAEs and 14,404 AEs were reported (i.e. 2.4 SAEs and 754 AEs per 10,000 patients). The number of reported deaths (9) was only 5% of the statistically expected number (180). Applying the resulting correction factor of 20 to all reported SAEs, resulted in 900 expected SAEs (versus 45 reported) or 47 per 10,000 patients., Conclusions: Without verifying the accuracy of a measurement, results remain speculative. Our internal standard for the first time provides a means of verifying the accuracy of the reported SAE rate and correcting it to the statistically expected SAE rate.