Comparing patient-reported outcomes entered at home versus at hospital, and testing touch screens for initial recruitment to scientific trials in arthritis patients.

OBJECTIVES: Touch screens for entering patient-reported outcomes (PROs) are available at all Danish departments of rheumatology reporting to the nationwide DANBIO registry. This project comprises two substudies in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (AxSpA), aiming to (A) investigate the feasibility of first line patient recruitment for research via touch screens, and (B) compare PROs collected at hospital versus at home, including patient preferences. METHOD: Substudy A: using a touch screen, patients answered whether we could contact them about a clinical research project (yes/no). Characteristics of patients who accepted/declined were explored using chi-squared and Mann-Whitney U-tests. Substudy B (randomized crossover agreement study): a random sample of patients from the accepting group in substudy A was contacted by telephone. According to prespecified power and sample size estimation, 56 patients were included. After randomization, 50% of patients entered PROs and information on comorbidities and lifestyle from home and then at hospital, and 50% first from hospital and then at home. Finally, they stated their preference for data entry (hospital/home/equally good). Differences in PROs entered from home and in the hospital were compared (limits of agreement, 95% confidence intervals, and intraclass correlation coefficients). RESULTS: The touch-screen invitation was accepted by 428/952 patients (45%). Patients who accepted and those who declined had similar PROs and demographics. Substudy B was completed by 42 patients (22 RA, 20 AxSpA). They had no significant differences between PROs and lifestyle/comorbidity data entered from home and hospital, except for AxSpA patients on the Bath Ankylosing Spondylitis Functional Index and Bath Ankylosing Spondylitis Disease Activity Index item 5. The preferred method of data entry was hospital (10%), home (50%), and equally good (40%). CONCLUSION: Touch screens seem feasible for first line research recruitment. PROs collected from home were similar to the touch-screen solution. Patients preferred data entry from home.

Monitoring total-body inflammation and damage in joints and entheses: the first follow-up study of whole-body magnetic resonance imaging in rheumatoid arthritis.

OBJECTIVE: To investigate changes in whole-body magnetic resonance imaging (WBMRI) inflammatory and structural lesions in most joints and entheses in patients with rheumatoid arthritis (RA) treated with adalimumab. METHODS: WBMRI was obtained at weeks 0, 6, 16, and 52 in a 52 week follow-up study of 37 RA patients starting treatment with adalimumab. Readability and reliability of WBMRI were investigated for 76 peripheral joints, 23 discovertebral units, the sacroiliac joints, and 33 entheses. Changes in WBMRI joint and entheses counts were investigated. RESULTS: The readability of peripheral and axial joints was 82-100%, being less for elbows and small joints of the feet. For entheses, 72-100% were readable, except for entheses at the anterior chest wall, elbow, knee, and plantar fascia. The intrareader agreement was high for bone marrow oedema (BMO), bone erosion (80-100%), and enthesitis (77-100%), and slightly lower for synovitis and soft tissue inflammation (50-100%). All synovitis, BMO, and soft tissue inflammation counts decreased numerically during treatment. The 26-joint synovitis WBMRI count decreased significantly during the first 16 weeks for patients with a good European League Against Rheumatism (EULAR) response (from median 6 to 4, p < 0.05), but not for patients with a moderate or no EULAR response. There were no overall changes in structural lesions. CONCLUSIONS: WBMRI allows simultaneous monitoring of most axial and peripheral joints and entheses in RA patients and can visualize a decrease in inflammatory counts during treatment. This first WBMRI follow-up study of patients with RA encourages further investigation of the usefulness of WBMRI in RA.

Monitoring patients with rheumatoid arthritis in routine care: experiences from a treat-to-target strategy using the DANBIO registry.

OBJECTIVES: Advances in aggressive use of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) as well as biological DMARDs (bDMARDs) have improved the treatment armamentarium for rheumatologists, and modern treatment principles include a treat-to-target (T2T) strategy. However, little is known about the feasibility of a T2T strategy in patients with rheumatoid arthritis (RA) treated in routine care. The aim of the present study was to (i) present the annual number of patients included in DANBIO between 2006 and 2013 and their disease characteristics and (ii) estimate coverage of DANBIO by 2013. METHODS: Patients who were registered with RA for the first time in the nationwide Danish DANBIO database between year 2006 and 2013 were included. Baseline characteristics were assessed in patients treated with bDMARDs and csDMARDs, respectively. The fraction of patients with low/moderate/high disease activity (i.e. DAS28 (CRP-based, 4 variables) was calculated for each calendar year. RESULTS: From 2006-2013 the number of patients increased from 2,395 to 14,249. By 2013, 29.8% of patients were receiving bDMARD. Patients in the csDMARD group were older, had shorter disease duration, lower disease activity, less disability and radiographic damage. By 2013, 19% of csDMARD (15% of bDMARD) patients were in ACR/Boolean remission. Coverage had increased to between 41% and 79% for patients with RA, for the bDMARD group it was 94%. CONCLUSIONS: Systematic monitoring of RA patients with real-time feedback to the physician is feasible, although the goal of treat-to-target is not achieved in a substantial proportion of patients in routine care.

Inter-examiner reproducibility of tests and criteria for generalized joint hypermobility and benign joint hypermobility syndrome.

OBJECTIVE: To test the reproducibility of tests and criteria for generalized joint hypermobility (GJH) and benign joint hypermobility syndrome (BJHS). METHODS: A standardized protocol for clinical reproducibility studies was followed using a three-phase study (with a training, an overall agreement and a test phase). An overall agreement of at least 0.80 was required to proceed to the test phase. Phases 1, 2 and 3 used 14 patients (with varying degrees of hypermobility), 20 patients (50% cases) and 40 patients (50% cases), respectively. The inclusion criterion for cases was hypermobility (patients with Ehlers-Danlos Syndrome or BJHS) and for controls, non-hypermobility (patients with shoulder and/or back pain); patients were selected from patients' files (phases 1 and 2) or included consecutively from our outpatient clinic (phase 3). RESULTS: The overall agreement in phase 2 was 0.95 for GJH and 0.90 for BJHS. Reproducibility for diagnosing GJH and BJHS in phase 3 showed kappa values of 0.74 and 0.84, respectively. Kappa in the Beighton tests for diagnosing GJH (currently or historically) was generally above 0.80, except for the fifth fingers and elbows (> or = 0.60). In the Brighton tests for diagnosing BJHS, kappa was above 0.73, except for the skin signs (0.63). Lowest kappa was found in the Rotès-Quérol tests, where it was > or = 0.57, except for the right shoulder (0.31). CONCLUSION: We found a good-to-excellent reproducibility of tests and criteria for GJH and BJHS. Future research on the validity of the tests and criteria for joint hypermobility is urgently needed.

The internal and external validity of the Major Depression Inventory in measuring severity of depressive states.

BACKGROUND: We have developed the Major Depression Inventory (MDI), consisting of 10 items, covering the DSM-IV as well as the ICD-10 symptoms of depressive illness. We aimed to evaluate this as a scale measuring severity of depressive states with reference to both internal and external validity. METHOD: Patients representing the score range from no depression to marked depression on the Hamilton Depression Scale (HAM-D) completed the MDI. Both classical and modern psychometric methods were applied for the evaluation of validity, including the Rasch analysis. RESULTS: In total, 91 patients were included. The results showed that the MDI had an adequate internal validity in being a unidimensional scale (the total score an appropriate or sufficient statistic). The external validity of the MDI was also confirmed as the total score of the MDI correlated significantly with the HAM-D (Pearson's coefficient 0.86, P < or = 0.01, Spearman 0.80, P < or = 0.01). CONCLUSION: When used in a sample of patients with different states of depression the MDI has an adequate internal and external validity.

[Pregnancy associated pelvic pain. I: Prevalence and risk factors]. / Graviditetsrelaterede baekkensmerter. I: Praevalens og risikofaktorer.

With this study, we wanted to determine the incidence of symptom-giving pelvic girdle relaxation during pregnancy and the prevalence post partum, identify predisposing factors, and determine the frequency of sick leave. A total of 1600 pregnant women entered the study. The incidence during pregnancy was 14%, the prevalence two, six, and twelve months post partum was 5%, 4%, and 2%, respectively. Multivariate analysis indicated that the most important predisposing factor was pelvic pain in a previous pregnancy. Other factors were uncomfortable working conditions, lack of exercise, and previous low back and low abdominal pain. At least 37% of the women with symptom-giving pelvic girdle relaxation were on sick leave during pregnancy, on average for twelve weeks. Symptom-giving pelvic girdle relaxation is a considerable problem both in pregnancy and post partum. The occupational risk can possibly be prevented. The syndrome has a great social impact because of the high frequency of sick live.

[Pregnancy associated pelvic pain. II: Symptoms and clinical findings]. / Graviditetsrelaterede baekkensmerter. II: Symptomer og kliniske fund.

Pelvic pain in pregnancy appears to be a problem on the increase. This study was undertaken to describe and analyse the relationship between subjective symptoms, daily disability, and clinical findings in women with symptom-giving pelvic girdle relaxation in pregnancy. Out of 1600 pregnant women, 238 had pelvic pain. After a clinical examination 11 women were excluded due to low back pain. The rest, 227 women, was considered to have symptom-giving pelvic girdle relaxation during pregnancy. Symptom-giving pelvic girdle relaxation in pregnancy seriously interferes with many activities of daily living such as housekeeping, walking, working, and sexual life. The women's statements of pelvic pain are well correlated to the number of positive clinical tests. Symptom-giving pelvic girdle relaxation in pregnancy causes considerable disabilities concerning daily activities.

Symptom-giving pelvic girdle relaxation in pregnancy. I: Prevalence and risk factors.

BACKGROUND: Previous studies concerning symptom-giving pelvic girdle relaxation in pregnancy have to our knowledge been retrospective. We wanted to 1) determine the incidence during pregnancy and the prevalence two, six, and twelve months post partum, 2) identify possible predisposing factors, and 3) determine the frequency and duration of sicklisting, prospectively. MATERIAL AND METHODS: A cohort of 1600 consecutive pregnant women filled in a questionnaire. At the routine prenatal examinations they were asked about pelvic pain. Those who fulfilled the inclusion criteria were examined by a rheumatologist to confirm the diagnosis. The affected women were seen again two, six, and twelve months post partum. All participants were asked about sicklisting in pregnancy. RESULTS: The incidence during pregnancy was 14%, the prevalence two, six, and twelve months post partum were 5%, 4%, and 2% respectively. Multivariate analysis indicates that the most important predisposing factor is pelvic pain in a previous pregnancy. Other factors were uncomfortable working conditions, lack of exercise, and previous low back pain and low abdominal pain. At least 37% of the women with symptom-giving pelvic girdle relaxation had been sicklisted in pregnancy due to pelvic pain, on average for twelve weeks. CONCLUSION: Symptom-giving pelvic girdle relaxation is a considerable problem both in pregnancy and post partum. The occupational risk can possibly be prevented. The syndrome has a great social impact because of the frequent sicklisting.

Symptom-giving pelvic girdle relaxation in pregnancy. II: Symptoms and clinical signs.

BACKGROUND: Pelvic pain in pregnancy appears to be a problem that is increasing. This study was undertaken to describe and analyze the relationship between subjective symptoms, daily disability, and clinical findings in women with symptom-giving pelvic girdle relaxation in pregnancy MATERIALS AND METHODS: Out of 1600 pregnant women 238 had pelvic pain. After a clinical examination 11 women were excluded due to low back pain. The rest, 227 women, was considered having symptom-giving pelvic girdle relaxation during pregnancy. RESULTS: Symptom-giving pelvic girdle relaxation in pregnancy seriously interferes with many activities of daily living such as housekeeping, walking, working, and sexual life. The women's statements of pelvic pain are well correlated to the number of positive clinical tests. CONCLUSION: Symptom-giving pelvic girdle relaxation in pregnancy causes considerable disabilities concerning daily activities.

Relaxin is not related to symptom-giving pelvic girdle relaxation in pregnant women.

BACKGROUND: The pregnancy associated hormone relaxin induces loosening of the pelvic ligaments in several species. This study was undertaken to evaluate whether pregnant women with symptom-giving girdle relaxation had increased serum relaxin concentrations during pregnancy. METHOD: Serum relaxin concentrations were measured in 38 pregnant women with symptom-giving pelvic girdle relaxation at the time of diagnosis, in the 30th and 38th week of pregnancy as well as 2 and 6 months after delivery. Fourteen pregnant women without symptoms served as a control group. Relaxin concentrations were measured by a homologous enzyme linked immuno-sorbent assay. All participants were clinically examined including tests for symptom-giving pelvic girdle relaxation. RESULTS: No differences in serum relaxin concentrations were found throughout pregnancy and after delivery. CONCLUSION: The present results do not suggest an important role for relaxin in symptom-giving pelvic girdle relaxation during human pregnancy.

Improved survival in patients with diabetic nephropathy.

The effect of early antihypertensive treatment on survival of patients with diabetic nephropathy was evaluated by studying two cohorts of Type 1 (insulin-dependent) diabetic patients developing persistent proteinuria in I: 1957-1973 (late treatment group n = 49) and II: 1979-1983 (early treatment group n = 71). At onset of nephropathy, the two cohorts were comparable with regard to age (29(8) vs 30(8) years, mean (SD], duration of diabetes (16(6) vs 18(7) years), blood pressure (132(16)/85(11) vs 134(16)/86(8) mm Hg), proteinuria (0.8(0.5-1.2) vs 0.8(0.6-1.2) g x 24 h-1, median (quartiles] and serum creatinine (87(14) vs (85(16) mumol x 1(-1]. The patients were followed frequently at the outpatients' clinic until death or for a median duration of 8 years. In the first cohort antihypertensive treatment was seldom used, whereas, in the second cohort antihypertensive treatment was started when blood pressure reached 144(18)/93(7) mm Hg. The probability of survival with a functioning kidney for more than 8 years was 48% in the first cohort and 87% in the second cohort, p less than 0.001. The improvement of survival was due mainly to a decreased mortality from uraemia. Early antihypertensive treatment is the most likely explanation for this improvement.

Hearing sensitivity in farmers.

Hearing sensitivity was measured for tones from 1,000 through 8,000 hertz (Hz) in 534 males and 278 females who resided in rural Wisconsin and ranged in age from 16 to 85 years. The hearing sensitivity for all subjects decreased with advancing age and at higher frequencies, but hearing loss over the range most susceptible to excessive noise exposure (3,000-6,000 Hz) was much greater for males than for females at all ages. The hearing loss was greater than could be accounted for by age and was similar whether the subject was a farmer or not. The results suggested that approximately 25 percent of the males had a communication handicap due to hearing loss by age 30, and the proportion rose to 50 percent by age 50. Less than 20 percent of farmers reported consistent use of personal hearing protection in their farm-related duties. Overall, the findings suggest that men who live in rural areas, including farmers, demonstrate a high prevalence of hearing loss and associated communication problems due to excessive noise exposure. This, in turn, clearly indicates a need for intensification of educational hearing conservation programs for the rural population.

Prostaglandins in the menstrual cycle of women. A review.

The changes of concentrations of prostaglandins (PG) are cyclic in the uterine tissues and related to steroid ovarian hormones. The role in normal menstruation is presumably related to a local haemodynamic effect. PGF2 alpha vasoconstricts the endometrial vessels during menstruation and contracts the smooth muscle of the myometrium. PGE2 vasodilates the vessels of the endometrium, and PGI2 relaxes smooth muscle, vasodilates the vessels of the myometrium and inhibits thrombocyte aggregation. The pathological conditions dysmenorrhea and menorrhagia relates to symptoms which seem to be exaggerations of normal activities, probably due to increased PG levels. Prostaglandin synthesis inhibitors (PGSI) in women have not been able to prevent ovulation, but animal experiments have shown that the bursting of the follicle demands prostaglandins. In vitro experiments with human tissue have shown that PG is necessary for the occurrence of dissociation of connective tissue around the apex. Luteolysis is due to PG in several species, but it has not been possible to find this direct effect of PG upon luteolysis in women. However, there are indications that the PG functions as a mediator for or is mediated by catecholamines and/or oxytocin.