Blinded interpretation of study results can feasibly and effectively diminish interpretation bias

Peer reviewe

Assessment of animal diseases caused by bacteria resistant to antimicrobials: Horses

In this opinion, the antimicrobial-resistant bacteria responsible for transmissible diseases that constitute a threat to the health of horses have been assessed. The assessment has been performed following a methodology composed of information collected via an extensive literature review and expert judgement. Details on the methodology used for this assessment are explained in a separate opinion. A global state of play of antimicrobial-resistant Actinobacillus equuli, Dermatophilus congolensis, Enterococcus spp., Escherichia coli, Klebsiella pneumoniae, Pasteurella spp., Pseudomonas aeruginosa, Rhodococcus equi, Staphylococcus aureus and Streptococcus dysgalactiae subsp. dysgalactiae/equisimilis and Streptococcus equi subsp. equi and subsp. zooepidemicus has been provided. Among those bacteria, EFSA identified E. coli, Staphylococcus aureus and R. equi with more than 66% certainty as the most relevant antimicrobial-resistant bacteria in the EU, given their importance as causative agents of clinical disease in horses and the significant levels of resistance to clinically relevant antimicrobials. The animal health impact of these ‘most relevant’ bacteria as well as their eligibility of being listed and categorised within the animal health law framework will be assessed in separate scientific opinions

Assessment of the control measures of the category A diseases of Animal Health Law: peste des petits ruminants

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases (‘Animal Health Law’). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for peste des petits ruminants (PPR). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radii of the protection and surveillance zones, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, the transmission kernels used for the assessment of the minimum radii of the protection and surveillance zones are shown. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. The monitoring period of 21 days was assessed as effective, except for the first affected establishments detected, where 33 days is recommended. It was concluded that beyond the protection (3 km) and the surveillance zones (10 km) only 9.6% (95% CI: 3.1–25.8%) and 2.3% (95% CI: 1–5.5%) of the infections from an affected establishment may occur, respectively. This may be considered sufficient to contain the disease spread (95% probability of containing transmission corresponds to 5.3 km). Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad-hoc requests in relation to PPR

Assessment of the control measures of the category A diseases of Animal Health Law: Classical Swine Fever

EFSA received a mandate from the European Commission to assess the effectiveness of some of the control measures against diseases included in the Category A list according to Regulation (EU) 2016/429 on transmissible animal diseases (‘Animal Health Law’). This opinion belongs to a series of opinions where these control measures will be assessed, with this opinion covering the assessment of control measures for Classical swine fever (CSF). In this opinion, EFSA and the AHAW Panel of experts review the effectiveness of: (i) clinical and laboratory sampling procedures, (ii) monitoring period and (iii) the minimum radii of the protection and surveillance zones, and the minimum length of time the measures should be applied in these zones. The general methodology used for this series of opinions has been published elsewhere; nonetheless, details of the model used for answering these questions are presented in this opinion as well as the transmission kernels used for the assessment of the minimum radius of the protection and surveillance zones. Several scenarios for which these control measures had to be assessed were designed and agreed prior to the start of the assessment. Here, several recommendations are given on how to increase the effectiveness of some of the sampling procedures. Based on the average length of the period between virus introduction and the reporting of a CSF suspicion, the monitoring period was assessed as non-effective. In a similar way, it was recommended that the length of the measures in the protection and surveillance zones were increased from 15 to 25 days in the protection zone and from 30 to 40 days in the surveillance zone. Finally, the analysis of existing Kernels for CSF suggested that the radius of the protection and the surveillance zones comprise 99% of the infections from an affected establishment if transmission occurred. Recommendations provided for each of the scenarios assessed aim to support the European Commission in the drafting of further pieces of legislation, as well as for plausible ad hoc requests in relation to CSF

Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear : a 2-year follow-up of the randomised controlled trial

Objective To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus. Methods In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35-65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out. Results In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, -4.3; 95% CI, -11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (-3.2; -8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (-0.4; -1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups. Conclusions In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.Peer reviewe

Gait in Pregnancy-related Pelvic girdle Pain: amplitudes, timing, and coordination of horizontal trunk rotations

Walking is impaired in Pregnancy-related Pelvic girdle Pain (PPP). Walking velocity is reduced, and in postpartum PPP relative phase between horizontal pelvis and thorax rotations was found to be lower at higher velocities, and rotational amplitudes tended to be larger. While attempting to confirm these findings for PPP during pregnancy, we wanted to identify underlying mechanisms. We compared gait kinematics of 12 healthy pregnant women and 12 pregnant women with PPP, focusing on the amplitudes of transverse segmental rotations, the timing and relative phase of these rotations, and the amplitude of spinal rotations. In PPP during pregnancy walking velocity was lower than in controls, and negatively correlated with fear of movement. While patients’ rotational amplitudes were larger, with large inter-individual differences, spinal rotations did not differ between groups. In the patients, peak thorax rotation occurred earlier in the stride cycle at higher velocities, and relative phase was lower. The earlier results on postpartum PPP were confirmed for PPP during pregnancy. Spinal rotations remained unaffected, while at higher velocities the peak of thorax rotations occurred earlier in the stride cycle. The latter change may serve to avoid excessive spine rotations caused by the larger segmental rotations

Obesity and smoking are factors associated with poor prognosis in patients with bacteraemia

BACKGROUND: Bacteraemia is still a major cause of case fatality in all age groups. Our aim was to identify the major underlying conditions constituting risk factors for case fatality in bacteraemia patients. METHODS: The study involved 149 patients (79 male and 70 female) with bacteraemia caused by Staphylococcus aureus (S. aureus) (41 patients), Streptococcus pneumoniae (Str. pneumoniae) (42 patients), β-hemolytic streptococcae (β-hml str.) (23 patients) and Eschericia coli (E. coli) (43 patients). Underlying diseases, alcohol and tobacco consumption and body mass index (BMI) were registered. Laboratory findings and clinical data were registered on admission and 6 consecutive days and on day 10–14. Case fatality was studied within 30 days after positive blood culture. Associations between underlying conditions and case fatality were studied in univariate analysis and in a multivariate model. RESULTS: Nineteen patients (12.8%) died of bacteraemia. We found obesity (p = 0.002, RR 9.8; 95% CI 2.3 to 41.3), smoking (p < 0.001, RR 16.9; 95% CI 2.1 to 133.5), alcohol abuse (p = 0.008, RR 3.9; 95% CI 1.3 to 11.28), COPD (p = 0.01, RR 8.4; 95% CI 1.9 to 37.1) and rheumatoid arthritis (p = 0.045, RR 5.9; 95% CI 1.2 to 28.8) to be significantly associated with case fatality in bacteraemia in univariate model. The median BMI was significantly higher among those who died compared to survivors (33 vs. 26, p = 0.003). Obesity and smoking also remained independent risk factors for case fatality when their effect was studied together in a multivariate model adjusted with the effect of alcohol abuse, age (continuos variable), sex and causative organism. CONCLUSION: Our results indicate that obesity and smoking are prominent risk factors for case fatality in bacteraemic patients. Identification of risk factors underlying fatal outcome in bacteraemia may allow targeting of preventive efforts to individuals likely to derive greatest potential benefit

Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546]

BACKGROUND: Open discectomy is the standard surgical procedure in the treatment of patients with long-lasting sciatica caused by lumbar disc herniation. Minimally invasive approaches such as microendoscopic discectomy have gained attention in recent years. Reduced tissue trauma allows early ambulation, short hospital stay and quick resumption of daily activities. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in patients with lumbar disc herniation. METHODS/DESIGN: Patients (age 18–70 years) presenting with sciatica due to lumbar disc herniation lasting more than 6–8 weeks are included. Patients with disc herniation larger than 1/3 of the spinal canal diameter, or disc herniation less than 1/3 of the spinal canal diameter with concomitant lateral recess stenosis or sequestration, are eliglible for participation. Randomisation into microendoscopic discectomy or conventional unilateral transflaval discectomy will take place in the operating room after induction of anesthesia. The length of skin incision is equal in both groups. The primary outcome measure is the functional assessment of the patient, measured by the Roland Disability Questionnaire for Sciatica, at 8 weeks and 1 year after surgery. We will also evaluate several other outcome parameters, including perceived recovery, leg and back pain, incidence of re-operations, complications, serum creatine kinase, quality of life, medical consumption, absenteeism and costs. The study is a randomised prospective multi-institutional trial, in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 2 years. DISCUSSION: Currently, open discectomy is the golden standard in the surgical treatment of lumbar disc herniation. Whether microendoscopic discectomy is more cost-effective than unilateral transflaval discectomy has to be determined by this trial