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OBJECTIVE: To identify predictors of flare in a 2-year follow-up study of patients with rheumatoid arthritis (RA) in sustained clinical remission tapering towards withdrawal of biological disease-modifying anti-rheumatic drugs (bDMARDs). METHODS: Sustained clinical remission was defined as Disease Activity Score for 28 joints (DAS28)-C reactive protein (CRP) ≤2.6 without radiographic progression for >1 year. bDMARDs were tapered according to a mandatory clinical guideline to two-thirds of standard dose at baseline, half of dose at week 16 and discontinuation at week 32. Prospective assessments for 2 years included clinical evaluation, conventional radiography, ultrasound and MRI for signs of inflammation and bone changes. Flare was defined as DAS28-CRP ≥2.6 with ∆DAS28-CRP ≥1.2 from baseline. Baseline predictors of flare were assessed by logistic regression analyses. RESULTS: Of 142 included patients, 121 (85%) flared during follow-up of which 86% regained remission within 24 weeks after flare. Patients that flared were more often rheumatoid factor positive, had tried more bDMARDs and had higher baseline ultrasound synovitis sum scores than those not flaring. For patients on standard dose, predictors of flare within 16 weeks after reduction to two-thirds of standard dose were baseline MRI-osteitis (OR 1.16; 95% CI 1.03 to 1.33; p=0.014), gender (female) (OR 6.71; 95% CI 1.68 to 46.12; p=0.005) and disease duration (OR 1.06; 95% CI 1.01 to 1.11; p=0.020). Baseline predictors for flare within 2 years were ultrasound grey scale synovitis sum score (OR 1.19; 95% CI 1.02 to 1.44; p=0.020) and number of previous bDMARDs (OR 4.07; 95% CI 1.35 to 24.72; p=0.007). CONCLUSION: The majority of real-world patients with RA tapering bDMARDs flared during tapering, with the majority regaining remission after stepwise dose increase. Demographic and imaging parameters (MR-osteitis/ultrasound greyscale synovitis) were independent predictors of immediate flare and flare overall and may be of importance for clinical decision-making in patients eligible for tapering.
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Antirreumáticos , Artritis Reumatoide , Osteítis , Sinovitis , Humanos , Femenino , Estudios de Seguimiento , Osteítis/tratamiento farmacológico , Estudios Prospectivos , Antirreumáticos/uso terapéutico , Artritis Reumatoide/diagnóstico por imagen , Artritis Reumatoide/tratamiento farmacológico , Proteína C-Reactiva , Sinovitis/diagnóstico por imagen , Sinovitis/tratamiento farmacológicoRESUMEN
OBJECTIVES: To develop and validate in real-world patients a conversion algorithm from the Multidimensionel Health Assessment Questionnaire physical function scale (MDHAQ) to the Stanford Health Assessment Questionnaire disability index physical function scale (HAQ) score. METHODS: From the DANBIO registry, 13 391 patients with RA (n = 8983), PsA (n = 2649) and axial spondyloarthritis (axSpA, n = 1759) with longitudinal data on HAQ and MDHAQ were included, stratified by diagnosis, and randomized 1:1 into development and validation cohorts. Conversion algorithms were developed by linear regression and applied in validation cohorts. From MDHAQ, the HAQ was calculated (cHAQ) and validated against the observed HAQ for criterion, correlational and construct validity. RESULTS: For RA, we developed the conversion algorithm cHAQ = 0.15+MDHAQ*1.08, and validated it in the RA validation cohort. Criterion validity: HAQ and cHAQ had comparable discriminative power to distinguish between high and low patient global scores (standardized mean difference: HAQ:-1.29, cHAQ:-1.35). Kappa value between HAQ and cHAQ functional states indicated good agreement (0.83). Correlational validity: baseline HAQ and cHAQ, respectively, correlated well with patient global scores (r = 0.65/0.67). Bland-Altman plots showed good agreement across all functional states. Construct validity: HAQ and cHAQ discriminated equally well between patients reporting symptom state as acceptable vs not, and across responses to an external anchor. Aiming for a common algorithm, the RA conversion algorithm was validated for PsA and axSpA with similar results. CONCLUSION: This study suggests that in observational datasets with only the MDHAQ available, a simple algorithm allows valid conversion to HAQ on the group level in RA, PsA and axSpA.
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Artritis Psoriásica , Humanos , Algoritmos , Artritis Psoriásica/diagnóstico , Artritis Psoriásica/tratamiento farmacológico , Evaluación de la Discapacidad , Índice de Severidad de la Enfermedad , Encuestas y CuestionariosRESUMEN
OBJECTIVES: To investigate whether tumour necrosis factor alpha inhibitors (TNFis) are associated with an increased risk of neuroinflammatory diseases among patients with arthritic diseases. METHODS: Cohorts of patients with rheumatoid arthritis (RA, n=25 796), psoriatic arthritis (PsA, n=8586) and ankylosing spondylitis (AS, n=9527) who initiated a TNFi treatment year 2000-2017 were identified from nationwide clinical rheumatology registers in Sweden and Denmark. Information on demyelinating disease and inflammatory neuropathy diagnoses was retrieved from prospective linkage to National Patients Register. A Cox proportional hazard model was used to estimate HRs and 95% CI comparing TNFi exposed and non-exposed, by disease and country. RESULTS: Among 111 455 patients with RA, we identified 270 (Sweden) and 51 (Denmark) events (all types of neuroinflammatory diseases combined), corresponding to crude incidence rates (per 1000 person-years) of 0.37 (Sweden) and 0.39 (Denmark) in TNFi-treated patients vs 0.39 (Sweden) and 0.28 (Denmark) in unexposed patients, and an age-sex-calendar-period-adjusted HR (95% CI) of 0.97 (0.72 to 1.33) (Sweden) and 1.45 (0.74 to 2.81) (Denmark) in TNFi exposed compared with non-exposed patients. For a total of 64 065 AS/PsA patients, the corresponding numbers were: 196 and 32 events, crude incidence rates of 0.59 and 0.87 in TNFi-treated patients vs 0.40 and 0.19 in unexposed patients, and HRs of 1.50 (1.07 to 2.11) and 3.41 (1.30 to 8.96), for Sweden and Denmark, respectively. For multiple sclerosis, the patterns of HRs were similar. CONCLUSIONS: Use of TNFi in AS/PsA, but not in RA, was associated with increased risk of incident neuroinflammatory disease, though the absolute risk was below one in 1000 patients/year.
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Artritis Psoriásica/tratamiento farmacológico , Artritis Reumatoide/tratamiento farmacológico , Enfermedades Desmielinizantes/inducido químicamente , Sistema de Registros , Espondilitis Anquilosante/tratamiento farmacológico , Inhibidores del Factor de Necrosis Tumoral/efectos adversos , Anciano , Artritis Psoriásica/diagnóstico , Artritis Reumatoide/diagnóstico , Estudios de Cohortes , Enfermedades Desmielinizantes/epidemiología , Dinamarca , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Enfermedades del Sistema Nervioso/inducido químicamente , Enfermedades del Sistema Nervioso/epidemiología , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Medición de Riesgo , Espondilitis Anquilosante/diagnóstico , Suecia , Inhibidores del Factor de Necrosis Tumoral/administración & dosificación , Factor de Necrosis Tumoral alfa/efectos adversos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresAsunto(s)
Antiinflamatorios no Esteroideos/efectos adversos , Artritis/tratamiento farmacológico , Enfermedades de las Vías Biliares/epidemiología , Biosimilares Farmacéuticos/efectos adversos , Enfermedad Hepática Inducida por Sustancias y Drogas/epidemiología , Etanercept/efectos adversos , Adulto , Anciano , Atención Ambulatoria/estadística & datos numéricos , Enfermedades de las Vías Biliares/etiología , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Estudios de Cohortes , Dinamarca/epidemiología , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Incidencia , Masculino , Registro Médico Coordinado , Persona de Mediana Edad , Sistema de RegistrosRESUMEN
OBJECTIVE: To investigate whether magnetic resonance imaging (MRI) pathologies in the wrist/hand of rheumatoid arthritis (RA) patients are associated with patient-reported outcomes (PROs) at clinical remission and relapse. METHODS: Wrist/hand MRIs and wrists/hands/feet radiographs were obtained in 114 established RA patients in clinical remission, before tapering their biologic disease-modifying antirheumatic drugs. MRIs were assessed according to the Outcome Measures in Rheumatology (OMERACT) RA MRI score (RAMRIS) for inflammation (synovitis/tenosynovitis/bone marrow edema) and damage (bone erosion/joint space narrowing) at baseline (ie remission) and in case of a relapse (n = 70). Radiographs were assessed according to the Sharp/van der Heijde (SvH) method at baseline. These scores were assessed for associations with health assessment questionnaires (HAQ), visual analog scales (VAS global/pain), EuroQol-5 dimensions and Short-Form 36 physical and mental component summary (SF-36 PCS/MCS) using Spearman correlations, univariate/multivariable linear regression analyses and generalized estimating equations. Furthermore, MRI pathologies were assessed for association with specific hand-related HAQ items using Jonckheere trend tests. RESULTS: Magnetic resonance imaging-assessed damage was associated with impaired HAQ and SF-36 PCS at remission and relapse (P < .01), independent of clinical and radiographic measures, and was also associated with most of the hand-related HAQ items (P < .03). In multivariate models including MRI, SvH scores were not associated with PROs. MRI-assessed inflammation was not associated with PROs at remission or relapse. CONCLUSION: Magnetic resonance imaging-assessed wrist/hand damage, but not inflammation, in patients with established RA is associated with patient-reported physical impairment at remission and relapse. The amount of damage in the wrist/hand is associated with reduced hand function.
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Artritis Reumatoide/diagnóstico por imagen , Imagen por Resonancia Magnética , Medición de Resultados Informados por el Paciente , Adulto , Anciano , Antirreumáticos/administración & dosificación , Artritis Reumatoide/tratamiento farmacológico , Dinamarca , Reducción Gradual de Medicamentos , Femenino , Humanos , Articulaciones , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Recurrencia , Inducción de Remisión , Resultado del TratamientoRESUMEN
OBJECTIVE: To explore the patients' views of the collection and use of patient-reported outcomes as part of routine care in patients with inflammatory arthritis. METHODS: We conducted a qualitative focus group study based on interviews in each of the 5 geographical regions of Denmark. The analysis was based on content analysis. Four patient research partners were involved in the study. RESULTS: In total, 32 adult patients (21 female) with rheumatoid arthritis (n = 21), psoriatic arthritis (n = 6), and axial spondyloarthritis (n = 5) participated. The mean age was 60 years (range 32-80 years). Five themes were derived from the analysis: 1) a need for information about why the data are collected, reflecting patients' uncertainty as to whether the collection of patient-reported outcomes primarily served to monitor their own disease, to save money, or to gather data for research purposes; 2) inclusion of patient-reported outcomes in the consultation, encompassing patients' expectations of active use of the patient-reported outcomes data during talks with rheumatologists or nurses; 3) reflections on how to respond to the patient-reported outcome measures (PROMs) to obtain high quality data, referring to patients' concerns about how to respond "correctly" and about issues that could affect their responses; 4) addressing patient-reported outcomes to the individual's challenges, reflecting the need for a more individualized approach; and 5) possibilities for improvement in the use of patient-reported outcomes, referring to patients' ideas for the future use of patient-reported outcomes. CONCLUSION: Information and dialogue regarding the purpose of patient-reported outcomes collection, how to respond to PROMs correctly, and inclusion of the patient-reported outcomes data in the consultation are of importance to patients with inflammatory arthritis who routinely complete patient-reported outcomes.
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Atención Ambulatoria , Actitud , Comunicación , Medición de Resultados Informados por el Paciente , Adulto , Anciano , Anciano de 80 o más Años , Artritis Psoriásica/tratamiento farmacológico , Artritis Reumatoide/tratamiento farmacológico , Femenino , Grupos Focales , Humanos , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Reumatología , Espondiloartritis/tratamiento farmacológicoRESUMEN
Objectives: A cohort of routine care RA patients in sustained remission had biological DMARD (bDMARDs) tapered according to a treatment guideline. We studied: the proportion of patients whose bDMARD could be successfully tapered or discontinued; unwanted consequences of tapering/discontinuation; and potential baseline predictors of successful tapering and discontinuation. Methods: One-hundred-and-forty-three patients (91% receiving TNF inhibitor and 9% a non-TNF inhibitor) with sustained disease activity score (DAS28-CRP)⩽2.6 and no radiographic progression the previous year were included. bDMARD was reduced to two-thirds of standard dose at baseline, half after 16 weeks, and discontinued after 32 weeks. Patients who flared (defined as either DAS28-CRP ⩾ 2.6 and ΔDAS28-CRP ⩾ 1.2 from baseline, or erosive progression on X-ray and/or MRI) stopped tapering and were escalated to the previous dose level. Results: One-hundred-and-forty-one patients completed 2-year follow-up. At 2 years, 87 patients (62%) had successfully tapered bDMARDs, with 26 (18%) receiving two-thirds of standard dose, 39 (28%) half dose and 22 (16%) having discontinued; and 54 patients (38%) were receiving full dose. ΔDAS28-CRP0-2yrs was 0.1((-0.2)-0.4) (median (interquartile range)) and mean ΔTotal-Sharp-Score0-2yrs was 0.01(1.15)(mean(s.d.)). Radiographic progression was observed in nine patients (7%). Successful tapering was independently predicted by: ⩽1 previous bDMARD, male gender, low baseline MRI combined inflammation score or combined damage score. Negative IgM-RF predicted successful discontinuation. Conclusion: By implementing a clinical guideline, 62% of RA patients in sustained remission in routine care were successfully tapered, including 16% successfully discontinued at 2 years. Radiographic progression was rare. Maximum one bDMARDs, male gender, and low baseline MRI combined inflammation and combined damage scores were independent predictors for successful tapering.
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Antirreumáticos/administración & dosificación , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/administración & dosificación , Privación de Tratamiento , Anciano , Artritis Reumatoide/diagnóstico por imagen , Progresión de la Enfermedad , Femenino , Humanos , Quimioterapia de Inducción , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Radiografía , Recurrencia , Índice de Severidad de la Enfermedad , Brote de los Síntomas , Factores de Tiempo , Resultado del TratamientoRESUMEN
OBJECTIVES: In Denmark, patients with rheumatoid arthritis (RA) are registered in the nationwide clinical DANBIO quality register and the Danish National Patient Registry (DNPR). The aim was to study the validity of the RA diagnosis and to estimate the completeness of relevant RA cases in each registry. STUDY DESIGN AND SETTING: Patients registered for the first time in 2011 with a diagnosis of RA were identified in DANBIO and DNPR in January 2013. For DNPR, filters were applied to reduce false-positive cases. The diagnosis was verified by a review of patient records. We calculated the positive predictive values (PPVs) of the RA diagnosis registrations in DANBIO and DNPR, and estimated the registry completeness of relevant RA cases for both DANBIO and DNPR. Updated data from 2011 to 2015 from DANBIO were retrieved to identify patients with delayed registration, and the registry completeness and PPV was recalculated. RESULTS: We identified 1,678 unique patients in DANBIO or in DNPR. The PPV (2013 dataset) was 92% in DANBIO and 79% in DNPR. PPV for DANBIO on the 2015 update was 96%. The registry completeness of relevant RA cases was 43% in DANBIO, increasing to 91% in the 2015 update and 90% in DNPR. CONCLUSION: DANBIO held a high proportion of true RA cases (96%) and was found to be superior to the DNPR (79%) with regard to the validity of the diagnosis. Both registries were estimated to have a high completeness of RA cases treated in hospital care (~90%).
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OBJECTIVES: To estimate the prevalence of Danish RA patients currently on biologic monotherapy and compare the effectiveness and drug adherence of biologic therapies applied as monotherapy. METHODS: All RA patients registered in the Danish biologics database (DANBIO) as receiving biologic DMARD (bDMARD) treatment as monotherapy without concomitant conventional synthetic DMARDs (csDMARDs) during the study period 1 May, 2011 through 30 April 2013 were eligible for inclusion. All patient files were checked to ensure that they were in accordance with the treatment registration in DANBIO. Descriptive statistics for prevalence, effectiveness and drug adherence of bDMARD monotherapy were calculated. RESULTS: Of the 775 patients on bDMARD monotherapy, adalimumab (21.3%), etanercept (36.6%) and tocilizumab (15.3%) were the most prevalent biologic agents administered. At the 6-month follow-up, the overall crude clinical disease activity index remission rate in patients still on a biologic drug was 22%, the 28-joint DAS remission rate was 41% and the response rate of those with a 50% improvement in ACR criteria was 28%. At the 6-month follow-up, the drug adherence rates were similar for the different bDMARDs, with the exception of infliximab, which had significantly poorer drug adherence (P < 0.001). The overall drug adherence (except for infliximab) was approximately 70% after 2 years. CONCLUSION: Nearly one in five (19%) biologic treatments for RA was prescribed in Denmark as monotherapy, of which 70% were on monotherapy from bio-initiation and 30% were on monotherapy after cessation of a concomitant csDMARD. Acceptable drug adherence and remission rates were achieved with bDMARDs. With the exception of infliximab, no statistically significant differences were observed between anti-TNFs and biologics with other modes of action.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Cumplimiento de la Medicación/estadística & datos numéricos , Adalimumab/uso terapéutico , Adulto , Anciano , Anticuerpos Monoclonales Humanizados/uso terapéutico , Artritis Reumatoide/epidemiología , Dinamarca/epidemiología , Etanercept/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Pronóstico , Sistema de Registros , Inducción de Remisión , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
BACKGROUND AND AIMS: Restricted physical activity as a consequence of chronic disease or injury is a predictor of functional decline. The aim of this study was to test the hypothesis that a 6- month multidimensional training program would have sustained beneficial effects upon the physiological, functional and psychological condition of old women with a recent history of falls. METHODS: Participants were 65 home-dwelling women (70-90 years) identified from hospital records as having had an accidental fall. After assessment of muscle strength, balance performance, walking speed, balance confidence, and physical activity level, the participants were randomly assigned to a control group (n=33) or a training group (n=32), who performed a multidimensional training program including moderate resistance exercise and balance exercise twice weekly for 6 months. Measurements were repeated after 6 and 12 months. RESULTS: Six months of multidimensional training resulted in significant improvements and between-group differences in isometric knee extension strength (p<0.05), trunk extension/ flexion strength (p<0.001), habitual/maximal walking speed (p<0.001) and balance performance (p<0.001). At follow-up, 6 months after intervention, these improvements were preserved in the training group and there was also a significant between- group difference with regard to balance confidence. No between-group differences were found concerning number of falls or physical activity level during the one-year study period. CONCLUSIONS: A multi-dimensional training program produced significant improvements in physiological and functional risk factors for falls and disability in women aged 70-90 years with a recent history of falls.
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Accidentes por Caídas , Ejercicio Físico/fisiología , Fuerza Muscular/fisiología , Rehabilitación/métodos , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Equilibrio Postural/fisiología , Factores de Tiempo , Resultado del Tratamiento , Caminata/fisiologíaRESUMEN
OBJECTIVE: This literature review of generalized joint hypermobility (GJH) syndromes discusses information regarding sex-, age-, and race-related factors from publications that specifically document validated GJH criteria. METHODS: We present an analysis of criterion-referenced connections that identify similarities among major and minor clinical criteria that identify both GJH and benign joint hypermobility syndrome (BJHS). In our search, we found considerable empirical evidence that supports an increased prevalence of hypermobility among children, women, and certain racial groups. Two commonly used clinical assessment tools, the Carter and Wilkinson criteria (>or= 3 positive tests out of 5) and the Beighton method (>or= 4 positive tests out of 9), are the sources of these data. BJHS is diagnosed through a set of major and minor criteria - a combination of symptoms and objective findings -- that include arthralgia, back pain, spondylosis, spondylolysis/spondylolisthesis, joint dislocation/subluxation, soft tissue rheumatism, marfanoid habitus, abnormal skin, eye signs, varicose veins or hernia or uterine/rectal prolapse. RESULTS: Clinically, there is some evidence that arthralgia, the proposed BJHS major criterion, is a major component of alleged hypermobility-related problems. In contrasting, there is no clear evidence that proposed BJHS minor diagnostic criteria are associated with hypermobility-related problems. An empirical correlation between hypermobility and osteoarthritis is possible, but so far unproven. There are no randomized controlled studies regarding effects of existing treatments. CONCLUSION: Generalized hypermobility is both sex- and age-related. Racial differences are also identifiable. The existence of BJHS can be accepted using present criteria.
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Artralgia/epidemiología , Artrometría Articular/métodos , Inestabilidad de la Articulación/diagnóstico , Inestabilidad de la Articulación/epidemiología , Índice de Severidad de la Enfermedad , Adolescente , Adulto , Anciano , Artralgia/etnología , Artralgia/etiología , Población Negra , Niño , Femenino , Humanos , Inestabilidad de la Articulación/etnología , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Osteoartritis/epidemiología , Osteoartritis/etnología , Osteoartritis/etiología , Prevalencia , Reproducibilidad de los Resultados , Factores Sexuales , Síndrome , Población BlancaRESUMEN
OBJECTIVE: In this review we focus on current knowledge of the reliability of tests and diagnostic criteria for generalized joint hypermobility (GJH) and benign joint hypermobility syndrome (BJHS). METHODS: Currently, The British Society of Rheumatology recommends the Beighton scoring system. With this approach, GJH is judged present when 4 or more of 9 tests are positive. Curiously, only one inter/intrarater reproducibility study is available and it uses a cutoff level of 6, rather than the Beighton-recommended 4 positive tests. RESULTS: Using a 6 cut level, intra- and interobserver kappa scores were 0.75 and 0.78, respectively. Beighton scoring recommendations have been correlated with a global joint mobility index as well as with 2 other scoring systems, the Carter and Wilkinson, and the Rotès-Quérol. All illustrate high concurrent validity with one another. For the recently proposed Brighton criteria diagnosing BJHS no reproducibility studies exist. In the latter, the recommendations reflect high nosographic sensitivity and specificity while predictive values for positive test scores are poor. CONCLUSION: In general, the reproducibility of the various tests seems to be good, especially when performed by experienced rheumatologists.
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Artrometría Articular/métodos , Inestabilidad de la Articulación/diagnóstico , Índice de Severidad de la Enfermedad , Humanos , Inestabilidad de la Articulación/inmunología , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , SíndromeRESUMEN
BACKGROUND: The etiology of pelvic joint syndrome (PJS) is not fully clarified. As a consequence, there is a lack of diagnostic methods to confirm the diagnosis, which today is mainly based on medical history. OBJECTIVE: The aim of this study was to examine women with PJS using various diagnostic methods. The hypothesis is that there are characteristics in this group of women that separate them from women who only suffer from pelvic pain during pregnancy and shortly after delivery, or healthy women. METHODS: Fifty-eight women participated in this follow-up study--twenty-one with PJS, 17 women who suffered from pelvic pain during pregnancy and shortly after delivery, and 20 controls with no history of pregnancy-induced pelvic pain. Clinical examination, gynecologic examination, psychological tests, spine X-ray, magnetic resonance imaging (MRI), blood samples, and urine dipsticks were performed. RESULTS: Clinical examination showed significant differences with regard to provocative tests and tenderness in the muscles and ligaments in the low back and the pelvis. Furthermore, psychological testing showed bad coping strategies when women with PJS were compared with those of the two control groups. However, no diagnostic method could explicitly differentiate between women with PJS and those of the two control groups. Thus, there was no significant difference in MRI, X-ray, blood or urine sample analysis. CONCLUSIONS: Women with PJS have positive provocative tests and ligament and muscular tenderness. Bad coping strategies might be an explanation why these women develop PJS.