Disease activity-guided tapering of biologics in patients with inflammatory arthritis: a pragmatic, randomized, open-label, equivalence trial.

OBJECTIVE: To evaluate whether disease activity-guided tapering of biologics compared to continuation as usual care enables a substantial dose reduction while disease activity remains equivalent. METHOD: In this pragmatic, randomized, open-label, equivalence trial, adults with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis in low disease activity on stable-dose biologics for ≥ 12 months were randomized 2:1 into either the tapering group, i.e. disease activity-guided prolongation of the biologic dosing interval until flare or withdrawal, or the control group, i.e. maintaince of baseline biologics with a possible small interval increase at the patients request. The co-primary outcome in the intention-to-treat population was met if superiority in ≥ 50% biologic reduction at 18 months was demonstrated and disease activity was equivalent (equivalence margins ± 0.5). RESULTS: Ninety-five patients were randomized to tapering and 47 to control, of whom 37% (35/95) versus 2% (1/47) achieved ≥ 50% biologic reduction at 18 months. The risk difference was statistically significant [35%, 95% confidence interval (CI) 24%-45%], while disease activity remained equivalent [mean difference 0.05, 95% CI -0.12-0.29]. A statistically significant flare risk was observed [tapering 41% (39/95) vs control 21% (10/47), risk difference 20%, 95% CI 4%-35%]; but, only 1% (1/95) and 6% (3/47) had persistent flare and needed to switch to another biological drug. CONCLUSIONS: Disease activity-guided tapering of biologics in patients with inflammatory arthritis enabled one-third to achieve ≥ 50% biologic reduction, while disease activity between groups remained equivalent. Flares were more frequent in the tapering group but were managed with rescue therapy.

Using a novel smartphone application for capturing of patient-reported outcome measures among patients with inflammatory arthritis:A randomized, crossover, agreement study.

Objectives: In Denmark, patients with inflammatory arthritis (IA) have completed patient-reported outcome measures (PROMs) via touchscreens in the outpatient clinic since 2006. However, current technology makes it possible for patients to use their own smartphone via an application (app) developed for the Danish Rheumatology Database (DANBIO). This study aims to evaluate the agreement of PROMs between the DANBIO app and outpatient touchscreen in patients with IA.Method: Patients with IA (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis) were enrolled in a randomized, crossover, agreement study. Participants answered PROMs through the two device types in a randomized order. Differences in PROM scores with 95% confidence intervals (CIs) were evaluated for similarity according to prespecified equivalence margins.Results: The touchscreen invitation was accepted by 138 patients. Sixty patients (20 with each diagnosis) were included. The difference in Health Assessment Questionnaire Disability Index between the two device types was -0.007 (95% CI -0.043 to 0.030); thus, equivalence was demonstrated. In addition, all other PROMs obtained with the two device types were equivalent, except for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which was within the limits of minimally clinically important difference (MCID). In total, 78.3% preferred the DANBIO app.Conclusion: In patients with IA, equivalence was demonstrated between two device types for all PROMs except BASDAI; however, BASDAI was within the limits of the MCID. Implementation of the DANBIO app is expected to optimize outpatient visits, thereby improving healthcare for the individual patient and society.

The PERFORM-P (Principles of Evidence-based Reporting in FORensic Medicine-Pathology version).

INTRODUCTION: Most findings of forensic pathology examinations are presented as written reports. There are currently no internationally accepted recommendations for writing forensic pathology reports. Existing recommendations are also varied and reflect the differences in the scope and role of forensic medical services and local settings in which they are to be implemented. The legal fact-finder thus faces wide variation in the quality of forensic pathology reports, which poses a threat to the reliability of legal decision-making. To address this issue, the development of the "PERFORM-P (Principles of Evidence-based Reporting in FORensic Medicine-Pathology version)" was undertaken. The goal of the PERFORM-P is to provide common practice recommendations adaptable to local requirements to promote evidence-based practice (EBP) in forensic pathology. METHODS: An international consensus study was conducted in three phases by (1) developing a long-list of items to be considered in the reporting recommendations, (2) conducting a Delphi process (an iterative survey method to transform individual opinions into group consensus) with international forensic pathologists, and (3) designing the PERFORM-P prototype and its accompanying manual. RESULTS: With assistance from 106 forensic pathologists/forensic medical practitioners from 41 countries, the PERFORM-P was developed. The PERFORM-P consists of a list of 61 items to be included in a forensic pathology report, which is accompanied by its Explanation and Elaboration (E&E) document. DISCUSSION: To prepare forensic pathology (postmortem) reports that incorporate principles of evidence-based practice, internationally accepted recommendations might be helpful. The PERFORM-P identifies recommendations for necessary elements to include in a forensic pathology report. PERFORM-P can be applied to a wide range of matters requiring forensic pathological analysis, acceptable to forensic pathologists from a representative selection of jurisdictions and medico-legal systems.

Serious head and neck injury as a predictor of occupant position in fatal rollover crashes.

Serious head and neck injuries are a common finding in fatalities associated with rollover crashes. In some fatal rollover crashes, particularly when ejection occurs, the determination of which occupant was driving at the time of the crash may be uncertain. In the present investigation, we describe the analysis of rollover crash data from the National Automotive Sampling System-Crashworthiness Data System for the years 1997 through 2007 in which we examined the relationship between a serious head and neck injury in an occupant and a specified degree of roof deformation at the occupant's seating position. We found 960 occupants who qualified for the analysis, with 142 deaths among the subjects. Using a ranked composite head and neck injury score (the HNISS) we found a strong relationship between HNISS and the degree of roof crush. As a result of the analysis, we arrived at a predictive model, in which each additional unit increase in HNISS equated to an increased odds of roof crush as follows: for ≥8 cm of roof crush compared with <8 cm by 4%, for ≥15 cm of roof crush compared to <8 cm by 6% and for ≥30 cm of roof crush compared to <8 cm by 11%. We describe two hypothetical scenarios in which the model could be applied to the real world investigation of occupant position in a rollover crash-related fatality.

Degenerative and traumatic changes in the lower cervical spine facet joints.

OBJECTIVE: The aim of this study was to examine anatomical variables of the lower cervical spine facet joints with regard to age, gender, and exposure to trauma. METHODS: The lower four cervical spine segments (C4-C7 included) were obtained from 40 subjects during autopsy: 12 females and 28 males (median age 35 years, range 20-49). Through an available 636 unique facets (318 joints), 1830 randomly obtained observation lines were defined. Each of these lines resembled a 3-mm-thick parasaggital slice through a facet from which 10-microm-thick histological sections were produced and evaluated microscopically. Inter- and intraobserver agreement was tested on four randomly selected facets from each subject. RESULTS: Significant age-, gender-, and trauma-related changes in the bone, cartilage, and soft tissues were observed, including subchondral sclerosis, fibrillation and splitting of cartilage, and cartilage length differences. Females were less affected by changes in the cartilage than males. Two synovial folds were present in all but one joint. Moderate interobserver and good intraobserver agreement were achieved. CONCLUSIONS: This study provides knowledge of the anatomy of the cervical spine facet joints. The findings support existing knowledge that males are more commonly affected by degenerative changes than females and that these changes are common from a young age. Histomorphometry confirms the presence of synovial folds in all of the facet joints. Following spinal trauma, pathological lesions may be produced in the facet joints and/or accentuate already existing pathology. The information provided in this study may have relevance for patients with neck pain.

Granular cell tumor of the uvula.

We describe the first case of granular cell tumor (GCT) of the uvula, which occurred in an 18-year-old woman. GCT is a relatively rare tumor, and is almost always benign. The most frequent locations are the skin and the oral cavity. These tumors usually present clinically as small, slowly growing tumors of characteristic histological appearance. Although its histogenesis is uncertain, our study as well as recent reports support a currently held theory of a neurogenic derivation. The recommended treatment for the granular cell tumor is local excision whenever possible.

Histochemistry of sacrococcygeal chordoma.

A characteristic feature of chordomas is the content of a great amount of mucinous material. A sacrococcygeal chordoma surgically removed from a 76-year-old man was histochemically investigated in order to obtain some information about the composition of the mucopolysaccharides. From the results of the staining reactions, we concluded that they are of the acid category and probably a mixture of weakly sulphated and carboxylated glycoproteins.