Body Mass Index Did Not Affect the Risk of Revision 3-9 Years After Total Knee Replacement Surgery.

Background: There are conflicting reports in the literature regarding the risk of revision after primary total knee replacement (TKR) in obese patients. The purpose of this study was to investigate if body mass index (BMI) influences the risk of revision 3-9 years after primary TKR. Methods: All patients undergoing a primary TKR in our institution from 2014 to 2018 were included in a retrospective study. The effect of BMI on all-cause revision was estimated in a logistic regression analysis. A directed acyclic graph was created to identify variables affecting the primary endpoint (revision). According to the directed acyclic graph, adjustment was only needed for age and smoking. However, we also included variables thought to influence the revision risk based on clinical experience and previous research. The final logistic regression analysis was therefore adjusted for age, sex, smoking status, diabetes mellitus and the American Society of Anesthesiologists classification. Results: One thousand fifty-nine primary TKR patients with a mean age of 68.1 (standard deviation 9.4) years were included. There were 609 (57.5%) women, and the median follow-up time was 5.6 (range 3.0-9.0) years. There were 41 (3.9%) revisions. BMI did not affect the risk of revision when adjusted for relevant covariates in a multivariate logistic regression analysis (odds ratio 0.99, 95% confidence interval 0.93-1.05, P = .6). Conclusions: BMI did not influence the risk of revision rate 3-9 years after TKR.

Prevalence of malpractice claims after arthroscopic shoulder surgery: analysis of 69,097 procedures from a national registry in Norway.

BACKGROUND: Systematic analysis of compensation claims following patient injuries is helpful in improving patient safety. The objective of the current study was to assess compensation claims after arthroscopic treatment of rotator cuff ruptures, impingement, and acromioclavicular joint osteoarthritis reported to the Norwegian System of Patient Injury Compensation and evaluate if there was regional variation on the risk of patient injuries leading to an accepted compensation claim. METHODS: Data from the Norwegian System of Patient Injury Compensation and the Norwegian Patient Registry (NPR) from 2008 to 2018 were collected. Demographics (age and sex) and type of claim and reasons for accepted claims were obtained from the Norwegian System of Patient Injury Compensation, while the number of arthroscopic procedures was collected from NPR. The treating institutions were grouped on geography according to Norway's four regional Health Trusts and private institutions and the effect of geography on the probability of an accepted claim was estimated. RESULTS: NPR registered 69,097 shoulder arthroscopies during the study period, of which 216 (0.3%) compensation claims were filed for patient injury. A total of 38% of the claims were accepted, representing 0.1% of the arthroscopic procedures. Infection (37.8%) was the most common reason for accepted claim, followed by no surgical indication (15.9%) and wrong surgical technique (12.2%). We found a statistically significantly increased odds ratio for a claim being accepted in both the smallest and largest regional Health Trusts compared to the other regional Health Trusts and private institutions. CONCLUSIONS: Compensation claims due to patient injury following shoulder arthroscopy are rare (0.3% of patients file a claim, of which a third is accepted (0.1% of all shoulder arthroscopy patients)). The most common reason for accepted claim was infection followed by lack of indication.

Compensation Claims After Hip Fracture Surgery in Norway 2008-2018.

Background: Surgical complications contribute to the significant mortality following hip fractures in the elderly. The purpose of this study was to increase our knowledge of surgical complications by evaluating compensation claims following hip fracture surgery in Norway. Further, we investigated whether the size and location of performing institutions would influence surgical complications. Methods: We collected data from the Norwegian System of Patient Injury Compensation (NPE) and the Norwegian Hip Fracture Register (NHFR) from 2008 to 2018. We classified institutions into 4 categories based on annual procedure volume and geographical location. Results: 90,601 hip fractures were registered in NHFR. NPE received 616 (.7%) claims. Of these, 221 (36%) were accepted, which accounts for .2% of all hip fractures. Men had nearly a doubled risk of ending with a compensation claim compared to women (OR: 1.8, CI, 1.4-2.4, P < .001). Hospital-acquired infection was the most frequent reason for accepted claims (27%). However, claims were rejected if patients had underlying conditions predisposing to infection. Institutions treating fewer than 152 hip fractures (first quartile) annually, had a statistically significant increased risk (OR: 1.9, CI, 1.3-2.8, P = .005) for accepted claims compared to higher volume facilities. Discussion: The fewer registered claims in our study could be due to the relatively high early mortality and frailty in this patient group, which may decrease the likelihood of filing a complaint. Men could have undetected underlying predisposing conditions that lead to increased risk of complications. Hospital-acquired infection may be the most significant complication following hip fracture surgery in Norway. Lastly, the number of procedures performed annually in an institution influences compensation claims. Conclusions: Our findings indicate that hospital acquired infections need greater focus following hip fracture surgery, especially in men. Lower volume hospitals may be a risk factor.

The Effect of Ulnar Styloid Fractures on Patient-Reported Outcomes After Surgically Treated Distal Radial Fractures.

Ulnar styloid fractures (USFs) are often associated with distal radial fractures (DRFs). When unstable DRFs are treated surgically, any associated USF is most commonly left untreated. The purpose of this study was to evaluate the effect of a concomitant USF on outcome after surgical stabilization of a DRF. Methods: Data from 2 randomized controlled trials on the treatment of unstable DRFs were pooled. The effect of a USF on the QuickDASH, EQ-5D, pain, and range of motion at 2 years was evaluated. Results: Two hundred and eighty-one patients were included; 177 (63%) had an associated, untreated USF. An unadjusted analysis demonstrated no significant difference in functional or patient-reported outcome measures (PROMs) at 2 years between patients with or without a concomitant USF. When controlling for confounding factors, the presence of a USF did not predict change in any of the PROMs from baseline to 2 years. A concomitant USF also did not predict change in grip strength or range of motion, except for a small effect on extension (-4.1°; 95% confidence interval, -7.5° to -0.8°; p = 0.02), which probably does not have clinical relevance. Conclusions: A USF in combination with a DRF does not affect PROMs, range of motion, or grip strength. We recommend that concomitant USFs be left untreated when treating a DRF with surgical fixation. Level of Evidence: Prognostic Level I. See Instructions for Authors for a complete description of levels of evidence.

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.

What it takes to become an orthopaedic surgeon: A comparison of orthopaedic surgical training programmes in 10 countries focusing on structure and fellowship requirements.

BACKGROUND: The quality of surgical training has been highlighted as one of the most important patient safety issues in the future. Training surgeons and supporting them to do their best should be considered integral in providing optimum and safe care for the individual patient and the best possible return on investment in training medical professionals. In 2011, an international consensus statement defined fundamental principles for surgical training. PURPOSE: This study examines orthopaedic surgical training to explore the similarities and differences in the requirements for trainees to obtain board certification in ten countries. METHODS: Countries of the Commonwealth Health Care Comparison: Canada, the United Kingdom, the United States of America, Australia, New Zealand, Germany, France, the Netherlands, Norway and Switzerland were chosen to be compared. The relevant information was extracted from official information from authorities and administrative bodies. RESULTS: The study revealed significant differences in duration, organisation and assessment of training. So-called "competency-based" training is not featured in every country, and the manner of its implementation is variable. In particular, the numbers in surgical cases required to be accredited varies by country ranging from 1260 (UK) to 340 (Norway). CONCLUSION: Despite the recommendation in 2011 for some degree of uniformity across surgical training in industrialised countries, evidence suggests wide variation in the training programmes which is likely to be a concern in both quality of training as well as present and future patient safety.

Compensation claims after knee arthroplasty surgery in Norway 2008-2018.

Background and purpose - Orthopedic surgery is one of the specialties with most compensation claims. We assessed the claims following knee arthroplasty surgery reported to the Norwegian System of Patient Injury Compensation (NPE) in light of institutional procedure volume.Patients and methods - We collected data from NPE and the Norwegian Arthroplasty Register (NAR) for the study period (2008-2018). Age, sex, type of claim, and reason for compensation were collected from NPE, while the number of arthroplasty surgeries was collected from NAR. The treating hospitals were grouped by quartiles according to annual procedure volume. The effect of hospital volume on the likelihood of an accepted claim was estimated.Results - NAR received 64,241 reports of arthroplasty procedures, of which 572 (0.9%) patients filed a claim for treatment injury. 55% of the claims were accepted, representing 0.5% of all knee arthroplasties. The most common reason for accepted claim was a hospital-acquired infection, in 28% of the patients, followed by misplaced implant (26%) and aseptic loosening (13%). The hospitals with the lowest annual volume (57 or fewer arthroplasties per year, first quarter) had a statistically significantly larger fraction of granted claims per procedures compared with other institutions.Interpretation - The overall risk of ending up with compensation due to treatment error following knee arthroplasty was 0.5%. The risk of accepted claim was greater for patients operated in the lowest volume hospitals.

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.

Compensation claims after hip arthroplasty surgery in Norway 2008-2018.

Background and purpose - Orthopedic surgery is one of the specialties with most compensation claims, therefore we assessed the most common reasons for complaints following total hip arthroplasty (THA) reported to the Norwegian System of Patient Injury Compensation (NPE) and viewed these complaints in light of the data from the Norwegian Arthroplasty Register (NAR).Patients and methods - We collected data from NPE and NAR for the study period (2008-2018), including age, sex, and type of complaint, and reason for accepted claims from NPE, and the number of arthroplasty surgeries from NAR. The institutions were grouped by quartiles into quarters according to annual procedure volume, and the effect of hospital procedure volume on the risk for accepted claim was estimated.Results - 70,327 THAs were reported to NAR. NPE handled 1,350 claims, corresponding to 1.9% of all reported THAs. 595 (44%) claims were accepted, representing 0.8% of all THAs. Hospital-acquired infection was the most common reason for accepted claims (34%), followed by wrong implant position in 11% of patients. Low annual volume institutions (less than 93 THAs per year) had a statistically significant 1.6 times higher proportion of accepted claims compared with higher volume institutions.Interpretation - The 0.8% risk of accepted claims following THAs is 1.6 times higher for patients treated in low-volume institutions, which should consider increasing the volume of THAs or referring these patients to higher volume institutions.

Cost-Effectiveness of Volar Locking Plate Compared with Augmented External Fixation for Displaced Intra-Articular Wrist Fractures.

BACKGROUND: The purpose of the present study was to estimate the cost-effectiveness of treating displaced, intra-articular distal radial fractures with volar locking plate fixation compared with augmented external fixation. METHODS: A cost-utility analysis was conducted alongside a randomized, clinical trial comparing 2 surgical interventions for intra-articular distal radial fractures. One hundred and sixty-six patients were allocated to either volar locking plate fixation (84 patients) or external fixation (82 patients) and were followed for 2 years. Health-related quality of life was assessed with the EuroQol-5 Dimensions and was used to calculate patients' quality-adjusted life-years (QALYs). Resource use was identified prospectively at the patient level at all follow-up intervals. Costs were estimated with use of both a health-care perspective and a societal perspective. Results were expressed in incremental cost-effectiveness ratios, and uncertainty was assessed with use of bootstrapping methods. RESULTS: The average QALY value was equivalent between the groups (1.70463 for the volar locking plate group and 1.70726 for the external fixation group, yielding a nonsignificant difference of -0.00263 QALY). Health-care costs were equal between the groups, with a nonsignificant difference of &OV0556;52 (p = 0.8) in favor of external fixation. However, the external fixation group had a higher loss of productivity due to absence from work (5.5 weeks in the volar locking plate group compared with 9.2 weeks for the external fixation group; p = 0.02). Consequently, the societal costs were higher for the external fixation group compared with the volar locking plate group (&OV0556;18,037 compared with &OV0556;12,567, representing a difference of &OV0556;5,470; p = 0.04) in favor of the volar locking plate group. Uncertainty analyses showed that there is indifference regarding which method to recommend from a health-care perspective, with volar locking plate treatment and external fixation having a 47% and 53% likelihood of being cost-effective, respectively. From the societal perspective, volar locking plate treatment had a 90% likelihood of being cost-effective. CONCLUSIONS: External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work. LEVEL OF EVIDENCE: Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.

Review of response rates over time in registry-based studies using patient-reported outcome measures.

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.

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 manufacturer.

Early Mobilization and Physiotherapy Vs. Late Mobilization and Home Exercises After ORIF of Distal Radial Fractures: A Randomized Controlled Trial.

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. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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.

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. LEVEL OF EVIDENCE: Level III.

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 (χ(2) 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.