The characteristics of pain and dysesthesia in patients with diabetic polyneuropathy.

INTRODUCTION/AIMS: Patients with diabetic polyneuropathy (DPN) may experience paresthesia, dysesthesia, and pain. We aimed to characterize the predictors, symptoms, somatosensory profile, neuropathy severity, and impact of painful DPN and dysesthetic DPN. METHODS: This study was a cross-sectional study of type 2 diabetes patients with confirmed DPN, diagnosed using widely accepted methods including a clinical examination, skin biopsy, and nerve conduction studies. FINDINGS: Of 126 patients with confirmed DPN, 52 had DPN without pain or dysesthesia, 21 had dysesthetic DPN, and 53 painful DPN. Patients with painful DPN were less physically active and suffered from more pain elsewhere than in the feet compared to patients with DPN without pain. Patients with painful DPN had the largest loss of small and large sensory fiber function, and there was a gradient of larger spatial distribution of sensory loss from DPN without dysesthesia/pain to dysesthetic DPN and to painful DPN. This could indicate that patients with dysesthesia had more severe neuropathy than patients without dysesthesia but less than patients with painful DPN. Patients with dysesthetic and painful DPN had higher symptom scores for depression and fatigue than those without dysesthesia/pain with no difference between dysesthetic and painful DPN. CONCLUSIONS: There was a gradient of increasing sensory loss from DPN without dysesthesia/pain to dysesthetic DPN and to painful DPN. Pain and dysesthesia are common in DPN and both interfere with daily life. It is therefore important to consider dysesthesia when diagnosing and treating patients with neuropathy.

Differences in work participation between incident colon and rectal cancer patients-a 10-year follow-up study with matched controls.

PURPOSE: Work-related issues have become increasingly relevant for colorectal cancer (CRC) patients, since the cancer is detected at an earlier age due to screening. The aim was to evaluate work participation up to 10 years after colon or rectal cancer diagnosis compared between diagnosis and to a matched cancer-free population. METHODS: In this national register-based cohort study, all first-time CRC patients in the period 2000-2015 with no previous cancer, between 20 and 60 years, were identified in the Danish Cancer Registry. A control group with no previous cancer was matched on gender, age, education, and income. For each year a mean Work Participation Score (WPS) was calculated (a percentage of weeks working) for individuals part of the labour market. RESULTS: A total of 5625 colon cancer patients and 3856 rectal cancer patients and 25,341 and 17,256 matched controls were included in the study, respectively. The WPS increased for colon cancer patients from 45.69% after 1 year to 83.94% after 4 years, while rectal cancer patients had a score of 38.07% after 1 year and 80.07% after 4 years. The WPS was lower for cancer patients compared with controls, but the difference decreased after 4 years. CONCLUSION: CRC patients had a lower work participation up to 10 years after diagnosis compared with controls, while rectal cancer patients had a lower participation the first 7 years after diagnosis compared with colon cancer patients. IMPLICATIONS FOR CANCER SURVIVORS: Work-related issues should be considered in the early stage of rehabilitation to increase work participation and thereby improve quality of life.

Municipal return to work management in cancer survivors: a controlled intervention study.

INTRODUCTION: Resuming work during or after cancer treatment has become an important target in cancer rehabilitation. PURPOSE: The aim was in a controlled trial to study the return to work (RTW) effect of an early, individually tailored vocational rehabilitation intervention targeted to improve readiness for RTW in cancer survivors. MATERIAL AND METHODS: Participants diagnosed with breast, cervix, ovary, testicular, colon-rectal, and head-and-neck cancers as well as being employed were allocated to a vocational rehabilitation intervention provided by municipal social workers (n = 83) or to usual municipal RTW management (n = 264). The intervention contained three elements: motivational communication inspired by Acceptance and Commitment Therapy by which RTW barriers were addressed, municipal cancer rehabilitation and finally employer and workplace contact. RTW effect was assessed as relative cumulative incidence proportions (RCIP) in the control and intervention group within 52 weeks of follow-up, estimated from the week where treatment ended at the hospital. RCIP was interpreted and reported as relative risk (RR) with 95% confidence intervals (CI) adjusted for gender, age cancer diagnosis, education, comorbidity, and sick leave weeks. RESULTS: Across cancer diagnoses 69 (83.1%) and 215 (81.4%) returned to work in the intervention and control group, respectively. No statistical effect was seen (RR 1.08 (95% CI 0.98-1.19)). Repeating the analyses solely for participants with breast cancer (n = 290) showed a significant effect of the intervention (RR 1.12 (95% CI 1.01-1.23)). CONCLUSION: More than 80% returned to work in both groups. However, no statistical difference in RTW effect was seen across cancer diagnoses within one year from being exposed to an early, individually tailored vocational rehabilitation intervention compared with usual municipal RTW management. TRIAL REGISTRATION NUMBER: ISRCTN50753764.

Diabetic polyneuropathy and pain, prevalence, and patient characteristics: a cross-sectional questionnaire study of 5,514 patients with recently diagnosed type 2 diabetes.

Most studies of diabetic polyneuropathy (DPN) and painful DPN are conducted in persons with longstanding diabetes. This cross-sectional study aimed to estimate the prevalence of DPN and painful DPN, important risk factors, and the association with mental health in recently diagnosed type 2 diabetes. A total of 5514 (82%) patients (median diabetes duration 4.6 years) enrolled in the Danish Centre for Strategic Research in Type 2 Diabetes cohort responded to a detailed questionnaire on neuropathy and pain. A score ≥4 on the MNSI questionnaire determined possible DPN, whereas pain presence in both feet together with a score ≥3 on the DN4 questionnaire determined possible painful DPN. The prevalence of possible DPN and possible painful DPN was 18% and 10%, respectively. Female sex, age, diabetes duration, body mass index, and smoking were associated with possible DPN, whereas only smoking showed a clear association with possible painful DPN (odds ratio 1.52 [95% confidence interval: 1.20-1.93]). Possible DPN and painful DPN were independently and additively associated with lower quality of life, poorer sleep, and symptoms of depression and anxiety. Possible DPN itself had greater impact on mental health than neuropathic pain. This large study emphasizes the importance of careful screening for DPN and pain early in the course of type 2 diabetes.

The role of afferent input in postamputation pain: a randomized, double-blind, placebo-controlled crossover study.

In this randomized, double-blind, placebo-controlled crossover study, we investigated whether a peripheral nerve block could temporarily eliminate phantom and stump pain after amputation. Amputees with constant postamputation pain were included and randomized to receive a nerve block with lidocaine 2% with adrenaline or saline in a crossover design. Spontaneous phantom and stump pain and evoked responses were assessed at baseline and at fixed time-points until 120 minutes after lidocaine or saline injection. The primary outcome was the difference in absolute change between worst pain intensity, either phantom or stump pain, at baseline and at 30 minutes after lidocaine or saline injection. Twelve amputees were randomized and 9 patients were included in the analysis. The absolute change in median worst pain intensity between lidocaine and saline injection was -2.0 (interquartile range, -4.0 to 0.0) (n = 9, P = 0.12). Nine of 9 patients reported at least some pain relief after lidocaine injection compared with only 2 of 9 patients after saline injection (P = 0.02). Phantom pain intensity was significantly reduced after lidocaine compared with saline injection (P = 0.04), whereas there was no significant change in stump pain intensity between the 2 interventions (P = 0.17). In all 9 amputees, evoked responses were eliminated after lidocaine injection. Thus, our findings suggest that afferent input from the peripheral nervous system plays an important role in postamputation pain.

Intensive client-centred occupational therapy in the home improves older adults' occupational performance. Results from a Danish randomized controlled trial.

BACKGROUND: There is growing interest in enabling older adults' occupational performance. We tested whether 11 weeks of intensive client-centred occupational therapy (ICC-OT) was superior to usual practice in improving the occupational performance of home-dwelling older adults. METHODS: An assessor-masked randomized controlled trial among adults 60 + with chronic health issues, who received or applied for homecare services. Recruitment took place September 2012 to April 2014. All participants received practical and personal assistance and meal delivery as needed. In addition, they were randomized to receive either a maximum 22 sessions of occupation-based ICC-OT (N = 59) or to receive usual practice with a maximum three sessions of occupational therapy (N = 60). The primary outcome was self-rated occupational performance assessed with the Canadian Occupational Performance Measure (COPM). RESULTS: No important adverse events occurred. ICC-OT was accepted by 46 participants (88%), usual practice by 60 (100%). After 3 months, the ICC-OT-group had improved 1.86 points on COPM performance; the Usual-Practice group had improved 0.61 points. The between-group difference was statistically significant (95% confidence interval 0.50 to 2.02), t-test: p = 0.001. CONCLUSIONS: ICC-OT improved older adults' occupational performance more effectively than usual practice. This result may benefit older adults and support programmatic changes.

A web-based platform to accommodate symptoms of anxiety and depression by featuring social interaction and animated information in patients undergoing lumbar spine fusion: a randomized clinical trial.

BACKGROUND: Approximately one-third of patients undergoing spine surgery have symptoms of anxiety and depression that correlate with pain, disability, and lower health-related quality of life. The use of web-based informative strategies before surgery and principles from cognitive behavioral therapy, have been applied in other patient groups, facilitating mobility and encouraging beneficial coping behavior. PURPOSE: To examine the effect of a web-based Spine Platform featuring Interaction and Information by Animation (w-SPIINA) on symptoms of anxiety and depression, pain, disability, and health-related quality of life. STUDY DESIGN: A single-center, two-arm, randomized controlled trial PATIENT SAMPLE: One hundred fourteen consecutive patients scheduled for instrumented lumbar spine fusion due to degenerative disc disease or spondylolisthesis. OUTCOME MEASURES: Primary outcome was the change in self-reported Hospital Anxiety and Depression Scale (HADS) scores from baseline to 3-month follow-up. Secondary outcomes were change in HADS 1-day before surgery 2days and 6 months after and changes in self-reported disability measured on the Oswestry disability index (ODI), quality of life (EQ-5D-5L questionnaire), and the low back pain rating scale (LBPRS) 2days and 3 and 6 months after surgery. METHOD: Patients were randomized to either a control group receiving a standard information regimen or an intervention group gaining access to w-SPIINA in addition to the standard regimen. The independent charity Helsefonden contributed $45,000, the Health Research Fund of the Regional Hospital Central Jutland contributed $10,000, and the Toyota foundation contributed $10,000 to remunerate a dedicated investigator. The authors have no conflict of interest to declare. RESULTS: There was no statistically significant difference within the w-SPIINA group and the control group regarding changes in HADS at 3-month follow-up (p≥.37). Approximately 40% reached minimum clinically important difference (MCID) in the w-SPIINA group on the HADS at 3 months. In the control group 50% reached MCID on anxiety subscale and 35% on the depression subscale at 3 months. No statistically significant differences were found between groups with regard to the overall outcomes at any of the predefined time points. CONCLUSION: Providing patients with access to w-SPIINA in addition to a standard information regimen had no additional effect on HADS and patient-reported outcomes1day before, 2days, 3 or 6 months after surgery. However, a high compliance and degree of interaction with w-SPIINA indicates that this mode of web-based support could be applicable in this group of patients.

Can visual assessment of blood flow patterns by dynamic contrast-enhanced computed tomography distinguish between malignant and benign lung tumors?

BACKGROUND: Dynamic contrast-enhanced computed tomography (DCE-CT) is a tool, which, in theory, can quantify the blood flow and blood volume of tissues. In structured qualitative analysis, parametric color maps yield a visual impression of the blood flow and blood volume within the tissue being studied, allowing for quick identification of the areas with the highest or lowest blood flow and blood volume. PURPOSE: To examine whether DCE-CT could be used to distinguish between malignant and benign lung tumors in patients with suspected lung cancer. MATERIAL AND METHODS: Fifty-nine patients with suspected lung cancer and a lung tumor on their chest radiograph were included for DCE-CT. The tumors were categorized using structured qualitative analysis of tumor blood flow patterns. Histopathology was used as reference standard. RESULTS: Using structured qualitative analysis of tumor blood flow patterns, it was possible to distinguish between malignant and benign lung tumors (Fisher-Freeman-Halton exact test, P = 0.022). The inter-reader agreement of this method of analysis was slight to moderate (kappa = 0.30; 95% confidence interval [CI] = 0.13-0.46). CONCLUSION: DCE-CT in suspected lung cancer using structured qualitative analysis of tumor blood flow patterns is accurate as well as somewhat reproducible. However, there are significant limitations to DCE-CT.

Municipal return to work management in cancer survivors undergoing cancer treatment: a protocol on a controlled intervention study.

BACKGROUND: Cancer survivors are often left on their own to deal with the challenges of resuming work during or after cancer treatment, mainly due to unclear agreements between stakeholders responsible for occupational rehabilitation. Social inequality exists in cancer risk, survival probability and continues with regard to the chance of being able to return to work. The aim is to apply an early, individually tailored occupational rehabilitation intervention to cancer survivors in two municipalities parallel with cancer treatment focusing on enhancing readiness for return to work. METHODS/DESIGN: In a controlled trial municipal job consultants use acceptance and commitment therapy dialogue and individual-placement-and-support-inspired tools with cancer survivors to engage them in behaviour changes toward readiness for return to work. The workplace is involved in the return to work process. Patients referred to surgery, radiotherapy or chemotherapy at the Oncology Department, Aarhus University Hospital, Denmark for the diagnoses; breast, colon-rectal, head and neck, thyroid gland, testicular, ovarian or cervix cancer are eligible for the study. Patients must be residents in the municipalities of Silkeborg or Randers, 18-60 years of age and have a permanent or temporary employment (with at least 6 months left of their contract) at inclusion. Patients, for whom the treating physician considers occupational rehabilitation to be unethical, or who are not reading or talking Danish are excluded. The control group has identical inclusion and exclusion criteria except for municipality of residence. Return to work is the primary outcome and is indentified in a social transfer payment register. Effect is assessed as relative cumulative incidences within 52 weeks and will be analysed in generalised linear regression models using the pseudo values method. As a secondary outcome; co-morbidity and socio-economic status is analysed as effect modifiers of the intervention effect on return to work. DISCUSSION: The innovative element of this intervention is the timing of the occupational rehabilitation which is much earlier initiated than usual and the active involvement of the workplace. We anticipate that vulnerable cancer survivors will benefit from this approach and reduce the effects of social inequality on workability. TRIAL REGISTRATION: Current Controlled Trials ISRCTN50753764 . Registered August 21(st), 2014.

The change in nasal inflammatory markers after intranasal challenges with particulate chitin and lipopolysaccharide: a randomized, double-blind, placebo-controlled, crossover study with a positive control.

BACKGROUND: We investigated the effect of chitin on the inflammation and immune modulation of the nasal mucosa. This compound was compared to placebo and as a positive control we used lipopolysaccharide (LPS). METHODS: Fourteen healthy nonsmoking volunteers 22 to 28 years of age were included. All persons underwent exposure to chitin microparticles (CP) and placebo in a randomized double-blinded fashion. In a last session we used LPS from Enterobacter agglomerans in a single-blinded fashion. There were 2 weeks between each session. The outcome measures were Total Nasal Symptom Score (TNSS) and nasal lavage for cytokines and cells at 0, 3, 4, 8 hours. RESULTS: We showed that CP was only weakly inflammatory compared to LPS. In contrast to the LPS response, we did however show an immune-regulatory effect of CP on enhanced interleukin (IL)-4 and IL-6 responses known to downregulate T helper 2 (Th2) responses, indicating a potential beneficial effect of CP for the regulation of the allergic Th2 immune response. CONCLUSION: This study also shows that CP is well tolerated in healthy volunteers, and that does not induce significantly more symptoms compared to placebo. In fact there is a tendency for CP instillation to induce less rhinorrhoea compared to placebo.

Comparative Study of Skeletal Stability between Postoperative Skeletal Intermaxillary Fixation and No Skeletal Fixation after Bilateral Sagittal Split Ramus Osteotomy: an 18 Months Retrospective Study.

OBJECTIVES: The purpose of the present study was to evaluate skeletal stability after mandibular advancement with bilateral sagittal split osteotomy. MATERIAL AND METHODS: Twenty-six patients underwent single-jaw bilateral sagittal split osteotomy (BSSO) to correct skeletal Class II malocclusion. One group (n = 13) were treated postoperatively with skeletal elastic intermaxillary fixation (IMF) while the other group (n = 13) where threated without skeletal elastic IMF. RESULTS: The mean advancement at B-point and Pog in the skeletal elastic IMF group was 6.44 mm and 7.22 mm, respectively. Relapse at follow-up at B-point was -0.74 mm and -0.29 mm at Pog. The mean advancement at B-point and Pog in the no skeletal elastic IMF group was 6.30 mm and 6.45 mm, respectively. Relapse at follow-up at B-point was -0.97 mm and -0.86 mm at Pog. There was no statistical significant (P > 0.05) difference between the skeletal IMF group and the no skeletal group regarding advancement nor relapse at B-point or Pog. CONCLUSIONS: Bilateral sagittal split osteotomy is characterized as a stable treatment to correct Class II malocclusion. This study demonstrated no difference of relapse between the skeletal intermaxillary fixation group and the no skeletal intermaxillary fixation group. Because of selection-bias and the reduced number of patients it still remains inconclusive whether to recommend skeletal intermaxillary fixation or not in the prevention of relapse after mandibular advancement.

Sick leave patterns as predictors of disability pension or long-term sick leave: a 6.75-year follow-up study in municipal eldercare workers.

OBJECTIVES: The aim was to study whether a workplace-registered frequent short-term sick leave spell pattern was an early indicator of future disability pension or future long-term sick leave among municipal eldercare workers. SETTING: The municipal healthcare sector in the city of Aarhus, which is the second largest city in Denmark. PARTICIPANTS: All elder care employees who worked the entire year of 2004 in the municipality of Aarhus, Denmark (N=2774). The employees' sick leave days during 2004 were categorised into: 0-2 and 3-17 short (1-7 days) spells, 2-13 mixed short and long (8+ days) spells and long spells only. Student workers (n=180), employees who were absent due to maternal/paternal leave (n=536) and employees who did not work the entire year of 2004 (n=1218) were not included. PRIMARY OUTCOME: Disability pension and long-term sick leave (≥8 weeks) were subsequently identified in a National register. The cumulative incidence proportion as a function of follow-up weeks was estimated using the Kaplan-Meier curve. The relative cumulative incidence (RR) of experiencing events within 352 weeks was analysed in a generalised linear regression model using the pseudo values method adjusted for age, occupation, unfavourable work factors and sick leave length. RESULTS: A frequent short-term and a mixed sick leave pattern showed RRs of being granted a disability pension of 2.08 (95% CI 1.00 to 4.35) and 2.61 (95% CI 1.33 to 5.12) compared with 0-2 short spells. The risk of long-term sick leave was significantly increased for all sick leave patterns compared with 0-2 short spells. Adding sick leave length to the models attenuated all RRs and they became non-significant. CONCLUSIONS: Sick leave length was a better indicator of future workability than spell frequency. Preventive actions should target employees engaged in homecare. The more sick leave days the greater the preventive potential seems, irrespective of spell frequency.

Type of hematological malignancy is crucial for the return to work prognosis: a register-based cohort study.

PURPOSE: The aims of this study were to determine the proportion of return to work (RTW) among sick-listed patients diagnosed with one of eight subtypes of hematological malignancies; to evaluate the influence of type of hematological malignancy, comorbidity, use of anxiolytics and antidepressants, socioeconomic and demographic factors on RTW; and to investigate if these associations differ between genders. METHODS: We combined data from national registers on all Danish patients diagnosed with hematological malignancies between 2000 and 2007. A total of 1,741 patients on long-term sick leave were followed until RTW, emigration, permanent withdrawal from the labor market, death, or February 2012, whichever came first. RESULTS: A total of 1,140 (65 %) patients returned to work. A strong association was found between type of diagnosis and RTW (p < 0.001), and the proportion of RTW was lowest for patients with multiple myeloma or acute leukemia compared to patients with Hodgkin lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, chronic myeloid leukemia, and chronic lymphoid leukemia. Use of antidepressants or anxiolytics after diagnosis, gender, age, and educational level were also associated with RTW. Surprisingly, comorbidity was not associated with RTW (p = 0.94); gender only modified the association between age and RTW. CONCLUSION: Two thirds of patients with hematological malignancies on sick leave RTW. A number of factors seem to lead to a poor prognosis, the hematological diagnosis being the most important, and these should be taken into account when performing studies on work outcome for patients with hematological malignancies. IMPLICATIONS FOR CANCER SURVIVORS: Knowledge in this area should assist in identification of hematological cancer patients at risk of not returning to work so that early targeted rehabilitation interventions can be initiated.

Are environmental characteristics in the municipal eldercare, more closely associated with frequent short sick leave spells among employees than with total sick leave: a cross-sectional study.

BACKGROUND: It has been suggested that frequent-, short-term sick leave is associated with work environment factors, whereas long-term sick leave is associated mainly with health factors. However, studies of the hypothesis of an association between a poor working environment and frequent short spells of sick leave are few and results are inconsistent. Therefore, we aimed to explore associations between self-reported psychosocial work factors and workplace-registered frequency and length of sick leave in the eldercare sector. METHODS: Employees from the municipal eldercare in Aarhus (N = 2,534) were included. In 2005, they responded to a work environment questionnaire. Sick leave records from 2005 were dichotomised into total sick leave days (0-14 and above 14 days) and into spell patterns (0-2 short, 3-9 short, and mixed spells and 1-3 long spells). Logistic regression models were used to analyse associations; adjusted for age, gender, occupation, and number of spells or sick leave length. RESULTS: The response rate was 76%; 96% of the respondents were women. Unfavourable mean scores in work pace, demands for hiding emotions, poor quality of leadership and bullying were best indicated by more than 14 sick leave days compared with 0-14 sick leave days. For work pace, the best indicator was a long-term sick leave pattern compared with a non-frequent short-term pattern. A frequent short-term sick leave pattern was a better indicator of emotional demands (1.62; 95% CI: 1.1-2.5) and role conflict (1.50; 95% CI: 1.2-1.9) than a short-term non-frequent pattern.Age (= < 40 / >40 years) statistically significantly modified the association between the 1-3 long-term sick leave spell pattern and commitment to the workplace compared with the 3-9 frequent short-term pattern. CONCLUSIONS: Total sick leave length and a long-term sick leave spell pattern were just as good or even better indicators of unfavourable work factor scores than a frequent short-term sick leave pattern. Scores in commitment to the workplace and quality of leadership varied with sick leave pattern and age. Thus, different sick leave measures seem to be associated with different work environment factors. Further studies on these associations may inform interventions to improve occupational health care.

Immediate placement and provisionalization of single-tooth implants involving a definitive individual abutment: a clinical and radiographic retrospective study.

AIM: To assess with a mean follow-up period of 33 months (median: 31 month, range: 11-89 month) the treatment outcome after immediate placement and provisionalization of single-tooth oral implants involving a definitive individual abutment and a provisional crown followed by later placement of a definitive crown. MATERIALS AND METHODS: 68 patients with 68 single-tooth implants in the esthetic zone were consecutively treated; 55 of these patients were included in the study. The treatment involved tooth extraction, implant placement, placement of a definitive individual abutment, and a provisional crown in the same visit in private practice. The definitive crown was placed after a mean period of 7 months. The primary outcome measures included implant survival, definitive implant crown survival, and overall treatment survival. The secondary outcome measures included probing depth, bleeding on probing, peri-implant marginal bone level, marginal bone level of the neighboring tooth surfaces, biological complications, and technical complications. RESULTS: Of the inserted implants 98% survived and of the definitive crowns mounted a survival of 100% was observed. Consequently, the overall treatment survival was 98%. The mean probing depth was 2.9 mm at implant level and 63% of the implants were characterized by no bleeding on probing. The mean peri-implant marginal bone level was 2 mm. A significant mean peri-implant marginal bone level gain of 0.5 mm was observed from implant placement to the follow-up (95% CI: 0.07-0.89 mm, P = 0.022). No significant changes of the marginal bone level at the neighboring tooth surfaces were seen. Four episodes of peri-implant inflammation were identified in three patients, while 46 incidents of loosening of the provisional crown occurred in 33 patients. One abutment screw loosened before placement of the definitive crown. Finally, loosening of four definitive crowns occurred in four patients. CONCLUSIONS: Immediate placement and provisionalization of single-tooth oral implants involving a definitive individual abutment and a provisional crown followed by later placement of a definitive crown were characterized by high survival of the implant crowns and implants as well as healthy peri-implant tissues, after a mean follow-up period of 33 months. Loss of retention of the provisional crown occurred frequently.

Validation of sick leave measures: self-reported sick leave and sickness benefit data from a Danish national register compared to multiple workplace-registered sick leave spells in a Danish municipality.

BACKGROUND: Previous validation studies of sick leave measures have focused on self-reports. Register-based sick leave data are considered to be valid; however methodological problems may be associated with such data. A Danish national register on sickness benefit (DREAM) has been widely used in sick leave research. On the basis of sick leave records from 3,554 and 2,311 eldercare workers in 14 different workplaces, the aim of this study was to: 1) validate registered sickness benefit data from DREAM against workplace-registered sick leave spells of at least 15 days; 2) validate self-reported sick leave days during one year against workplace-registered sick leave. METHODS: Agreement between workplace-registered sick leave and DREAM-registered sickness benefit was reported as sensitivities, specificities and positive predictive values. A receiver-operating characteristic curve and a Bland-Altman plot were used to study the concordance with sick leave duration of the first spell. By means of an analysis of agreement between self-reported and workplace-registered sick leave sensitivity and specificity was calculated. Ninety-five percent confidence intervals (95% CI) were used. RESULTS: The probability that registered DREAM data on sickness benefit agrees with workplace-registered sick leave of at least 15 days was 96.7% (95% CI: 95.6-97.6). Specificity was close to 100% (95% CI: 98.3-100). The registered DREAM data on sickness benefit overestimated the duration of sick leave spells by an average of 1.4 (SD: 3.9) weeks. Separate analysis on pregnancy-related sick leave revealed a maximum sensitivity of 20% (95% CI: 4.3-48.1).The sensitivity of self-reporting at least one or at least 56 sick leave day/s was 94.5 (95% CI: 93.4 - 95.5) % and 58.5 (95% CI: 51.1 - 65.6) % respectively. The corresponding specificities were 85.3 (95% CI: 81.4 - 88.6) % and 98.9 (95% CI: 98.3 - 99.3) %. CONCLUSIONS: The DREAM register offered valid measures of sick leave spells of at least 15 days among eldercare employees. Pregnancy-related sick leave should be excluded in studies planning to use DREAM data on sickness benefit. Self-reported sick leave became more imprecise when number of absence days increased, but the sensitivity and specificity were acceptable for lengths not exceeding one week.

Postural balance in low back pain patients: criterion-related validity of centre of pressure assessed on a portable force platform.

INTRODUCTION: Altered postural control has been observed in low back pain (LBP) patients. They seem to be more dependent on vision when standing. The objective of the study was to determine concurrent and predictive validity of measures of postural stability in LBP patients. MATERIALS AND METHODS: Centre of Pressure (CoP) measurements were tested against pain, fear of pain, and physical function. Velocity, anterior-posterior displacement, and the Romberg Ratio obtained on a portable force platform were used as measures of postural stability. RESULTS: Baseline and 12-week follow-up results of 97 LBP patients were evaluated. The correlations between CoP measurements and pain, fear of pain, and physical function were poor. There were no significant differences in CoP measurements between patients with no change or deterioration and patients with improvement in pain and back-specific function. CONCLUSION: This first study of concurrent and predictive validity of postural balance in LBP patients revealed no association between CoP measures and pain, fear of pain, and physical function.

Protein replacement therapy partially corrects the cholesterol-storage phenotype in a mouse model of Niemann-Pick type C2 disease.

Niemann-Pick type C2 (NPC2) disease is a fatal autosomal recessive neurovisceral degenerative disorder characterized by late endosomal-lysosomal sequestration of low-density lipoprotein derived cholesterol. The breach in intracellular cholesterol homeostasis is caused by deficiency of functional NPC2, a soluble sterol binding protein targeted to the lysosomes by binding the mannose-6-phosphate receptor. As currently there is no effective treatment for the disorder, we have investigated the efficacy of NPC2 replacement therapy in a murine gene-trap model of NPC2-disease generated on the 129P2/OlaHsd genetic background. NPC2 was purified from bovine milk and its functional competence assured in NPC2-deficient fibroblasts using the specific cholesterol fluorescent probe filipin. For evaluation of phenotype correction in vivo, three-week-old NPC2(-/-) mice received two weekly intravenous injections of 5 mg/kg NPC2 until trial termination 66 days later. Whereas the saline treated NPC2(-/-) mice exhibited massive visceral cholesterol storage as compared to their wild-type littermates, administration of NPC2 caused a marked reduction in cholesterol build up. The histological findings, indicating an amelioration of the disease pathology in liver, spleen, and lungs, corroborated the biochemical results. Little or no difference in the overall cholesterol levels was observed in the kidneys, blood, cerebral cortex and hippocampus when comparing NPC2(-/-) and wild type mice. However, cerebellum cholesterol was increased about two fold in NPC2(-/-) mice compared with wild-type littermates. Weight gain performance was slightly improved as a result of the NPC2 treatment but significant motor coordination deficits were still observed. Accordingly, ultrastructural cerebellar abnormalities were detected in both saline treated and NPC2 treated NPC2(-/-) animals 87 days post partum. Our data indicate that protein replacement may be a beneficial therapeutic approach in the treatment of the visceral manifestations in NPC2 disease and further suggest that neurodegeneration is not secondary to visceral dysfunction.

Postural balance in low back pain patients: Intra-session reliability of center of pressure on a portable force platform and of the one leg stand test.

Low back pain (LBP) patients have poorer postural control compared to healthy controls, and the importance of assessing and addressing balance is a matter of debate. In the clinic, balance is often tested by means of the one leg stand test (OLST) while research often employs center of pressure (CoP) on a force platform. Portable force platforms might be of clinical relevance, but their reliability for LBP patients in a clinical setting has not been demonstrated. As LBP patients are more dependent on vision compared to healthy controls, the ratio of tests performed with eyes open and eyes closed (Romberg Ratio) might be of clinical interest. This study aimed to assess postural balance in LBP patients by analyzing intra-session reliability of CoP parameters on a portable force platform, the Romberg Ratio, and the OLST. Furthermore, we aimed to determine whether CoP parameters and OLST measure identical aspects of postural stability. We examined 49 LBP patients and found acceptable reliability of the CoP parameters' trace length and velocity, whereas reliability regarding C90 area, the Romberg Ratio, and the OLST was poor. Correlations between the CoP parameters and OLST were insignificant. Reliability of trace length and velocity is acceptable and can be used as parameters when assessing CoP in LBP patients.

Superior fixation of pegged trabecular metal over screw-fixed pegged porous titanium fiber mesh: a randomized clinical RSA study on cementless tibial components.

BACKGROUND AND PURPOSE: Lasting stability of cementless implants depends on osseointegration into the implant surface, and long-term implant fixation can be predicted using radiostereometric analysis (RSA) with short-term follow-up. We hypothesized that there would be improved fixation of high-porosity trabecular metal (TM) tibial components compared to low-porosity titanium pegged porous fiber-metal (Ti) polyethylene metal backings. METHODS: In a prospective, parallel-group, randomized unblinded clinical trial, we compared cementless tibial components in patients aged 70 years and younger with osteoarthritis. The pre-study sample size calculation was 22 patients per group. 25 TM tibial components were fixed press-fit by 2 hexagonal pegs (TM group) and 25 Ti tibial components were fixed press-fit and by 4 supplemental screws (Ti group). Stereo radiographs for evaluation of absolute component migration (primary effect size) and single-direction absolute component migration (secondary effect size) were obtained within the first postoperative week and at 6 weeks, 6 months, 1 year, and 2 years. American Knee Society score was used for clinical assessment preoperatively, and at 1 and 2 years. RESULTS: There were no intraoperative complications, and no postoperative infections or revisions. All patients had improved function and regained full extension. All tibial components migrated initially. Most migration of the TM components (n = 24) occurred within the first 3 months after surgery whereas migration of the Ti components (n = 22) appeared to stabilize first after 1 year. The TM components migrated less than the Ti components at 1 year (p = 0.01) and 2 years (p = 0.004). INTERPRETATION: We conclude that the mechanical fixation of TM tibial components is superior to that of screw-fixed Ti tibial components. We expect long-term implant survival to be better with the TM tibial component.