Antibiotic-loaded bone cement in prevention of periprosthetic joint infections in primary total knee arthroplasty: A register-based multicentre randomised controlled non-inferiority trial (ALBA trial)

Introduction The current evidence on the efficacy of antibiotic-loaded bone cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the USA where ALBC use is not approved in low-risk patients. Therefore, we designed a double-blinded pragmatic multicentre register-based randomised controlled non-inferiority trial to investigate the effects of ALBC compared with plain bone cement in primary total knee arthroplasty (TKA). Methods and analysis A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomised into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be: risk of revision due to any reason including aseptic loosening at 1, 6, 10 and 20 years of follow-up; patient-related outcome measures like function, pain, satisfaction and health-related quality of life at 1, 6 and 10 years of follow-up; risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1, 6, 10 and 20 years of follow-up; cost-effectiveness of routine ALBC versus plain bone cement use in primary TKA. We will use 1:1 randomisation with random permuted blocks and stratify by participating hospitals to randomise patients to receive ALBC or plain bone cement. Inclusion, randomisation and follow-up will be through the Norwegian Arthroplasty Register. Ethics and dissemination The trial was approved by the Western Norway Regional Committees on Medical and Health Research Ethics (reference number: 2019/751/REK vest) on 21 June 2019. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations. Trial registration number NCT04135170.publishedVersio

Does a surgical helmet provide protection against aerosol transmitted disease?

Background and purpose - The COVID-19 pandemic caused by infection with SARS-CoV-2 has led to a global shortage of personal protective equipment (PPE). Various alternatives to ordinary PPE have been suggested to reduce transmission, which is primarily through droplets and aerosols. For many years orthopedic surgeons have been using surgical helmets as personal protection against blood-borne pathogens during arthroplasty surgery. We have investigated the possibility of using the Stryker Flyte surgical helmet as a respiratory protective device against airborne- and droplet-transmitted disease, since the helmet shares many features with powered air-purifying respirators. Materials and methods - Using an aerosol particle generator, we determined the filtration capacity of the Stryker Flyte helmet by placing particle counters measuring the concentrations of 0.3, 0.5, and 5 µm particles inside and outside of the helmet. Results - We found that the helmet has insufficient capacity for filtrating aerosol particles, and, for 0.3 µm sized particles, we even recorded an accumulation of particles inside the helmet. Interpretation - We conclude that the Stryker Flyte surgical helmet should not be used as a respiratory protective device when there is a risk for exposure to aerosol containing SARS-CoV-2, the virus causing COVID-19, in accordance with the recommendation from the manufacture

Informacja w bibliotekach i ośrodkach INTE. Użytkownicy, ich preferencje i możliwości zaspokojenia potrzeb

Objectives: Gain an overview of expected response rates (RRs) to patient-reported outcome measures (PROMs) in clinical quality registry-based studies and long-term cohorts in order to better evaluate the validity of registries and registry-based studies. Examine the trends of RRs over time and how they vary with study type, questionnaire format, and the use of reminders. Design: Literature review with systematic search. Data sources: PubMed, MEDLINE, EMBASE, kvalitetsregistre. no, kvalitetsregister. se and sundhed. dk. Eligibility criteria: Articles in all areas of medical research using registry-based data or cohort design with at least two follow-up time points collecting PROMs and reporting RRs. Annual reports of registries including PROMs that report RRs for at least two time points. Primary outcome measure: RRs to PROMs. Results: A total of 10 articles, 12 registry reports and 6 registry articles were included in the review. The overall RR at baseline was 75%±22.1 but decreased over time. Cohort studies had a markedly better RR (baseline 97%±4.7) compared with registry-based data at all time points (baseline 72%±21.8). For questionnaire formats, paper had the highest RR at 86%±19.4, a mix of electronic and paper had the second highest at 71%±15.1 and the electronic-only format had a substantially lower RR at 42%±8.7. Sending one reminder (82%±16.5) or more than one reminder (76%±20.9) to non-responders resulted in a higher RR than sending no reminders (39%±6.7). Conclusions: The large variation and downward trend of RRs to PROMs in cohort and registry-based studies are of concern and should be assessed and addressed when using registry data in both research and clinical practice

Compensation after treatment for anterior cruciate ligament injuries: a review of compensation claims in Norway from 2005 to 2015

Purpose To assess the most common reasons for complaints following anterior cruciate ligament (ACL) injuries reported to the Norwegian System of Patient Injury Compensation (NPE), and to view these complaints in light of the ACL reconstructions (ACL-Rs) reported to the Norwegian Knee Ligament Registry (NKLR). Method Data from the NPE and the NKLR were collected for the study period (2005–2015). The age and gender and type of complaint and reason for granted compensation were collected from the NPE, while the graft choice and total number of ACL-R were collected from the NKLR. Risk for successful grant was estimated for graft type. Results 18,810 primary ACL-Rs were reported to the NKLR during the study period. A hamstring graft was used in 12,437 (66.1%) but the bone-patellar tendon-bone (BPTB) became the graft of choice at the end of the study period. 240 patients filed a complaint to the NPE, of which 101 were granted compensation. The odds ratio for a claim being granted following a hamstring graft was 2.9 compared to that of a BPTB graft (p = 0.002) The most common reason for compensation was a hospital-acquired infection in 39 patients (38.6%) followed by inadequate surgical technique (27, 26.7%) and delayed diagnosis (13, 12.9%). Of the 39 patients with infection, 27 had received a hamstring graft and six a BPTB graft (two patients were not reconstructed, data missing for three patients). Of the 27 patients who were granted compensation due to inadequate surgical technique, 24 had received a hamstring graft and three a BPTB graft. Conclusion Infection and inadequate surgical technique are the most common causes for granted compensation from the NPE following ACL injury. Hamstring grafts have a threefold risk of complication that yields compensation from the NPE compared to BPTB grafts. This information is relevant for patients and surgeons when choosing graft type. The trend of increased use of BPTB grafts is warranted based on the results from this study

Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice

Objectives Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998–2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Design Cohort study of trials with systematic searches for published results. Setting Clinical drug trials in Norwegian general practice. Methods We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. Main outcome measures We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Results Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ2 test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. Conclusions We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published

Can Generic Outcome Questionnaires Replace QuickDASH in Monitoring Clinical Outcome Following Surgical Treatment of Distal Radius Fractures?

Purpose In contrast to region-specific patient-reported outcome measures (PROMs), generic PROMs can be argued to have an added benefit of enabling cost-utility analyses and allowing for comparisons to be made across different conditions. The aim of this study was to assess the responsiveness and strength of the association between region-specific and generic PROMs in patients treated operatively for a displaced intra-articular distal radius fracture. Methods Over a 4-year period, 166 patients aged 18–70 years with a displaced intra-articular fracture of the distal radius were treated with either a volar locking plate or external fixation augmented by K-wires and followed-up prospectively for 2 years. The main outcome measure was the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score, but EuroQol-5D (EQ-5D) and 36-Item Short Form Survey (SF-36) were also employed. The associations between the QuickDASH score and EQ-5D and between the QuickDASH score and SF-36 were assessed using a linear mixed model. Results There was a significant positive association between the QuickDASH score and EQ-5D and between the QuickDASH score and SF-36 throughout the follow-up period, although wide dispersion existed for the outcome measures at an individual level. However, the association between the QuickDASH score and SF-36 was significantly weaker at 6 weeks and 3 months than that at baseline, indicating that EQ-5D more closely mirrors changes in the QuickDASH score in the early postoperative period. Conclusions The study demonstrates that the QuickDASH score and EQ-5D correlate well on a group level, but large individual variations exist. The SF-36 had decreased sensitivity for the changes in the QuickDASH score at 6 weeks and 3 months. Clinical relevance Our findings indicate that generic PROMs cannot fully replace the region-specific QuickDASH score when evaluating the outcomes of distal radius fractures

Synkende obduksjonsrate : KLoK-oppgave

Obduksjoner utføres ved sykehus av flere årsaker. Obduksjon er gullstandard for postmortal diagnostisering og således en kvalitetsindikator for sykehusets arbeid. I tillegg er det en obligat del av patologispesialiseringen, samt viktig for forskning og statistikk. Obduksjonsraten har likevel gått ned i den vestlige verden de siste tiårene. I Norge har den nye loven om obduksjon fra 2004, med krav om innhenting av samtykke fra pårørende, antagelig forsterket denne effekten. Vi har i arbeidet vårt valgt å se på forholdene ved Ullevål universitetssykehus og hva som kan gjøres for å øke obduksjonsraten. Etter systematisk gjennomgang av litteraturen, har vi kommet frem til et pakketiltak bestående av et informasjonsmøte for klinikerne, et skjema som skal fylles ut samtidig med dødsattesten (der en bekrefter at en har spurt om samtykke til å utføre obduksjon), samt å innføre som rutine at alle dødsfall blir tatt opp på morgenmøtet, hvor det vurderes om obduksjon bør rekvireres hvis dette ikke er gjort. Dette tiltaket krever små ressurser (internundervisningsmøte, trykking av skjema med gjennomslag samt endring av rutine ved morgenmøte). Prospektive studier har vist nytte av tiltakene, men at de krever oppfølging og vedlikehold. Vi foreslår at patologisk anatomisk avdeling blir ansvarlig for å holde internundervisning, for utarbeidelse og bekostning av skjema og ukentlig tilbakemelding til de kliniske avdelinger. I tillegg må det settes ned en prosjektgruppe sammensatt av representanter for patologisk anatomisk avdeling og de kliniske avdelingene, som vurderer effekten av tiltakene samt har ansvar for kontinuerlig prosessforbedring. Tiltakene bør være permanente

Early Mobilization and Physiotherapy Vs. Late Mobilization and Home Exercises After ORIF of Distal Radial Fractures

Background: Volar locking plates have permitted early mobilization, omitting the need for prolonged cast immobilization, after distal radial fractures (DRFs). However, the type of rehabilitation following plate fixation of DRFs remains an unresolved issue. The purpose of this study was to evaluate the effect of physiotherapy after volar plate fixation of DRFs. At a 2-year follow-up, we compared the results of immediate physiotherapy (early mobilization) with those of home exercises following 2 weeks in a dorsal plaster splint (late mobilization). Methods: Patients with an extra-articular DRF scheduled for open reduction and internal fixation (ORIF) with a volar locking plate were evaluated for eligibility for enrollment in the study. The patients were randomized into 2 groups: (1) early mobilization and physiotherapy and (1) late mobilization and home exercise. In the early mobilization group, the plaster splint was removed after 2 to 3 days. During the first 3 months, the patients met with the institution’s physiotherapist every other week. The late mobilization group wore the dorsal splint for 2 weeks and only met with our physiotherapist once, when the splint was removed. This group was provided with a home physiotherapy program and instructed to perform home exercises on their own. Results: One hundred and nineteen patients were included in the study. The 2 groups had similar demographics with respect to age, sex, and baseline values. Seven patients were lost to follow-up. No clinically relevant difference in scores on the shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire was found between the 2 groups at any of the follow-up evaluations. The largest difference in the QuickDASH score was found at 6 weeks, when the early mobilization group had a mean score of 30 compared with a mean of 37 in the late mobilization group (p = 0.05). Conclusions: Early mobilization and multiple physiotherapy visits did not improve wrist function compared with standard treatment of 2 weeks in a dorsal plaster splint, a single physiotherapy visit, and home exercises. Early mobilization following ORIF of an extra-articular DRF is safe

Examining participant perceptions of an interprofessional simulation-based trauma team training for medical and nursing students

High quality care relies on interprofessional teamwork. We developed a short simulation-based course for final year medical, nursing and nursing anaesthesia students, using scenarios from emergency medicine. The aim of this paper is to describe the adaptation of an interprofessional simulation course in an undergraduate setting and to report participants’ experiences with the course and students’ learning outcomes. We evaluated the course collecting responses from students through questionnaires with both closed-ended and open-ended questions, supplemented by the facilitators’ assessment of students’ performance. Our data is based on responses from 310 students and 16 facilitators who contributed through three evaluation phases. In the analysis, we found that students reported emotional activation and learning outcomes within the domains self-insight and stress management, understanding of the leadership role, insight into teamwork, and skills in team communication. In subsequent questionnaire studies students reported having gained insights about communication, teamwork and leadership, and they believed they would be better leaders of teams and/or team members after having completed the course. Facilitators’ observations suggested a progress in students’ non-technical skills during the course. The facilitators observed that nursing anaesthesia students seemed to be more comfortable in finding their role in the team than the two other groups. In conclusion, we found that an interprofessional simulation-based emergency team training course with a focus on leadership, communication and teamwork, was feasible to run on a regular basis for large groups of students. The course improved the students’ team skills and received a favourable evaluation from both students and faculty