Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE): a randomized multicentre feasibility trial.

BACKGROUND/PURPOSE: Non-resuscitation fluids constitute the majority of fluid administered for septic shock patients in the intensive care unit (ICU). This multicentre, randomized, feasibility trial was conducted to test the hypothesis that a restrictive protocol targeting non-resuscitation fluids reduces the overall volume administered compared with usual care. METHODS: Adults with septic shock in six Swedish ICUs were randomized within 12 h of ICU admission to receive either protocolized reduction of non-resuscitation fluids or usual care. The primary outcome was the total volume of fluid administered within three days of inclusion. RESULTS: Median (IQR) total volume of fluid in the first three days, was 6008 ml (interquartile range [IQR] 3960-8123) in the restrictive fluid group (n = 44), and 9765 ml (IQR 6804-12,401) in the control group (n = 48); corresponding to a Hodges-Lehmann median difference of 3560 ml [95% confidence interval 1614-5302]; p < 0.001). Outcome data on all-cause mortality, days alive and free of mechanical ventilation and acute kidney injury or ischemic events in the ICU within 90 days of inclusion were recorded in 98/98 (100%), 95/98 (98%) and 95/98 (98%) of participants respectively. Cognition and health-related quality of life at six months were recorded in 39/52 (75%) and 41/52 (79%) of surviving participants, respectively. Ninety out of 134 patients (67%) of eligible patients were randomized, and 15/98 (15%) of the participants experienced at least one protocol violation. CONCLUSION: Protocolized reduction of non-resuscitation fluids in patients with septic shock resulted in a large decrease in fluid administration compared with usual care. A trial using this design to test if reducing non-resuscitation fluids improves outcomes is feasible. TRIAL REGISTRATION: Clinicaltrials.gov, NCT05249088, 18 February 2022. https://clinicaltrials.gov/ct2/show/NCT05249088.

Negligible In Vitro Recovery of Macromolecules from Microdialysis Using 100 kDa Probes and Dextran in Perfusion Fluid.

Microdialysis is applied in neurointensive care to monitor cerebral glucose metabolism. If recoverable, macromolecules may also serve as biomarkers in brain disease and provide clues to their passage across the blood-brain barrier. Our study aimed to investigate the in vitro recovery of human micro- and macromolecules using microdialysis catheters and perfusion fluids approved for clinical use. In vitro microdialysis of a bulk solution containing physiological or supraphysiological concentrations of glucose, lactate, pyruvate, human IgG, serum albumin, and hemoglobin was performed using two different catheters and perfusion fluids. One had a membrane cut-off of 20 kDa and was used with a standard CNS perfusion fluid, and the other had a membrane cut-off of 100 kDa and was perfused with the same solution supplemented with dextran. The flow rate was 0.3 µl/min. We used both push and push-pull methods. Dialysate samples were collected at 2-h intervals for 6 h and analyzed for relative recovery of each substance. The mean relative recovery of glucose, pyruvate, and lactate was > 90% in all but two sets of experiments. In contrast, the relative recovery of human IgG, serum albumin, and hemoglobin from both bulk solutions was below the lower limit of quantification (LLOQ). Using a push-pull method, recovery of human IgG, serum albumin, and hemoglobin from a bulk solution with supraphysiological concentrations were above LLOQ but with low relative recovery (range 0.9%-1.6%). In summary, exchanging the microdialysis setup from a 20 kDa catheter with a standard perfusion fluid for a 100 kDa catheter with a perfusion solution containing dextran did not affect the relative recovery of glucose and its metabolites. However, it did not result in any useful recovery of the investigated macromolecules at physiological levels, either with or without a push-pull pump system.

Biomedical doctoral students' research practices when facing dilemmas: two vignette-based randomized control trials.

Our aim was to describe the research practices of doctoral students facing a dilemma to research integrity and to assess the impact of inappropriate research environments, i.e. exposure to (a) a post-doctoral researcher who committed a Detrimental Research Practice (DRP) in a similar situation and (b) a supervisor who did not oppose the DRP. We conducted two 2-arm, parallel-group randomized controlled trials. We created 10 vignettes describing a realistic dilemma with two alternative courses of action (good practice versus DRP). 630 PhD students were randomized through an online system to a vignette (a) with (n = 151) or without (n = 164) exposure to a post-doctoral researcher; (b) with (n = 155) or without (n = 160) exposure to a supervisor. The primary outcome was a score from - 5 to + 5, where positive scores indicated the choice of DRP and negative scores indicated good practice. Overall, 37% of unexposed participants chose to commit DRP with important variation across vignettes (minimum 10%; maximum 66%). The mean difference [95%CI] was 0.17 [- 0.65 to 0.99;], p = 0.65 when exposed to the post-doctoral researcher, and 0.79 [- 0.38; 1.94], p = 0.16, when exposed to the supervisor. In conclusion, we did not find evidence of an impact of postdoctoral researchers and supervisors on student research practices.Trial registration: NCT04263805, NCT04263506 (registration date 11 February 2020).

Different protein sources in concentrate feed for dairy cows affect cheese-making properties and yield.

Soybean meal (SBM) is a commonly used protein source in feed. Yeast microbial protein could be used as a substitute for SBM, but its effect on cheese-making properties and yield is not known. Norwegian Red dairy cows (n = 48) in early or mid lactation were divided in 3 groups and fed a ration consisting of grass silage and concentrate, where the concentrates were barley based but with different additional protein sources. These were: completely barley based with no additional protein source (BAR), additional protein from SBM, or additional protein from yeast (Cyberlindnera jadinii; YEA). The SBM and YEA concentrates had a higher protein content than the barley concentrate. Four batches of cheese were made from pooled milk from each of the 3 groups of dairy cows. Milk samples were collected 5 times during the experiment. Milk from cows fed BAR concentrate showed inferior cheese-making properties (lower casein content, longer renneting time, lower content of phosphorus, and lower cheese yield) compared with SBM and YEA concentrates. Overall, SBM or YEA bulk milk had similar cheese-making properties, but when investigating individual milk samples, YEA milk showed better coagulation properties.

Risk factors for hospital-acquired infection during the SARS-CoV-2 pandemic.

OBJECTIVE: To evaluate risk factors for hospital-acquired infection (HAI) in patients during the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic, including historical and concurrent cohorts. DESIGN: Retrospective cohort. SETTING: Three Missouri hospitals, data from 1st January 2017 to 30th September 2020. PARTICIPANTS: Patients aged ≥18 years and admitted for ≥48 h. METHODS: Univariate and multi-variate Cox proportional hazards models incorporating the competing risk of death were used to determine risk factors for HAI. A-priori sensitivity analyses were performed to assess the robustness of the urine-, blood- and respiratory-culture-based HAI definition. RESULTS: The cohort included 254,792 admissions, with 7147 (2.8%) HAIs (1661 blood, 3407 urine, 2626 respiratory). Patients with SARS-CoV-2 had increased risk of HAI (adjusted hazards ratio 1.65, 95% confidence interval 1.38-1.96), and SARS-CoV-2 infection was one of the strongest risk factors for development of HAI. Other risk factors for HAI included certain admitting services, chronic comorbidities, intensive care unit stay during index admission, extremes of body mass index, hospital, and selected medications. Factors associated with lower risk of HAI included year of admission (declined over the course of the study), admitting service and medications. Risk factors for HAI were similar in sensitivity analyses restricted to patients with diagnostic codes for pneumonia/upper respiratory infection and urinary tract infection. CONCLUSIONS: SARS-CoV-2 was associated with significantly increased risk of HAI.

Pain, hand function, activity performance and apprehensiveness, in patients with surgically treated distal radius fractures.

Distal radius fracture (DRF) is a common injury, affecting both function and activity performance. Postoperative rehabilitation is an essential part of the treatment of a surgically treated DRF. The study aims were to assess pain, hand function, activity performance and apprehensiveness and their association, during the first three months after a surgically treated DRF. Eighty-eight patients with a DRF were assessed for pain, hand function, activity performance and apprehensiveness three days and two, six and 12 weeks after surgery. The results indicated that pain, range of motion (ROM), grip strength, apprehensiveness, and activity performance (PRWE) improved significantly between follow-ups (p < .001-.01). Apprehensiveness correlated moderately with activity performance on all visits (0.40-0.47, p < .01), which implies a correlation between the variables, but the regression model showed that the differences in the PRWE at twelve weeks cannot be explained by the differences in apprehensiveness or range of motion at cast removal. At 12 weeks, the study participants had regained almost 70% of their grip strength and 74-96% of the ROM of the uninjured hand.The study shows that, during the study period, the participants improved in both pain, hand function and activity performance, and indicates that a simple question on apprehensiveness in terms of using the injured hand in daily life could be an important factor in distal radius fracture rehabilitation.

Litter on the seafloor along the African coast and in the Bay of Bengal based on trawl bycatches from 2011 to 2020.

We present the occurrence of seafloor litter on the coast of Africa and in the Bay of Bengal based on records from the EAF-NANSEN Programme in 2011 to 2020. Litter bycatch records from 534 bottom trawls were standardized to km2 before analysis. Three percent of the records indicated areas of high littering and the highest densities occurred from 100 to 300 m in depth and 50 to 100 km from the coast. Littering was lower in the Indian Ocean compared to Atlantic Africa. Plastic objects and fishing gear dominated the recorded items (47 % and 22 % respectively) but, regional differences were pronounced. Plastic dominated North Atlantic and East African records (58 % and 80 % respectively) and fishing gear dominated (69 %) in South Atlantic Africa while records from the Bay of Bengal were a mix of categories. The relation between littering and population density, marine industry, major cities, and rivers is discussed.

Metastatic melanoma to the ovary in pregnancy: A case report.

Metastatic melanoma to the ovary is an uncommon presentation. We report a case of metastatic melanoma to the ovary that presented as a growing left adnexal mass during pregnancy and was thought to be benign by imaging and frozen section pathology. Here we discuss the challenges in radiologic and pathologic diagnosis, as well as considerations for the mother and newborn.

The Michigan Hand Outcomes Questionnaire (MHQ-Swe) in patients with distal radius fractures-cross-cultural adaptation to Swedish, validation and reliability.

BACKGROUND: The Michigan Hand Outcomes Questionnaire-MHQ-is a well-known self-assessment questionnaire, where patients' own perception in terms of recovery, pain and the ability to return to activities of daily living is assessed. The purpose of the study was to translate and culturally adapt the Michigan Hand Outcomes Questionnaire to Swedish and to test the validity and reliability in patients with surgically treated distal radius fractures. METHODS: The cross-cultural adaptation and the translation process were conducted according to predefined guidelines. Seventy-eight patients with surgically treated distal radius fractures completed the translated version of the questionnaire on their six-week follow-up visit. RESULTS: The translation and cross-cultural adaptation process revealed no major linguistic or cultural issues. The internal consistency of the MHQ-Swe ranged from 0.77 to 0.94 at test 1 and from 0.81 to 0.96 at test 2 for all subscales, which indicates good internal consistency in the subscales. The hand function subscale revealed the lowest results and work performance the highest. The ICCs showed excellent test-retest reliability, ranging from 0.77 to 0.90 on all MHQ subscales and 0.92 on total score. The highest results for the ICC were seen in the satisfaction subscale (ICC = 0.90), while the lowest were seen in the aesthetic subscale (ICC = 0.77). The correlation analysis between the MHQ-Swe, PRWE and VAS showed a generally moderate to high correlation for all the subscales. CONCLUSIONS: The Swedish version of the MHQ, the MHQ-Swe, showed good validity and reliability and it is therefore an appropriate and relevant questionnaire for use in patients with surgically treated distal radius fractures. TRIAL REGISTRATION: FoU i VGR, Projectnumber: 208491 , registered December 9, 2015.

Extreme ecchymoses in a migraine patient using concomitant treatment with calcitonin gene-related peptide receptor antibodies and fish oil supplements: a case report.

BACKGROUND: Erenumab, a monoclonal antibody against the calcitonin gene-related peptide (CGRP) receptor, is registered for migraine prevention. Compared to other conventional migraine prevention medicines (i.e. topiramate, betablockers and amitriptyline) erenumab has better tolerability. Impaired hemostasis has not been reported previously. Here, we report the first case of an increased tendency to bruise in a migraine patient treated with erenumab. CASE PRESENTATION: A 41-year old female migraine patient was treated with erenumab for 12 months, which led to a significant reduction of headache and migraine days. Three months after treatment start, she experienced increased tendency to bruise leading to extreme ecchymosis after 4 months treatment. Platelet counts and aggregation, thromboelastography, activated partial thromboplastin time (APTT) and international normalized ratio (INR) were all normal. Thorough interview revealed intake of fish oil supplements for many years prior to treatment. The increased tendency to bruise subsided after discontinuation of fish oil supplements. CONCLUSION: The combination of fish oil supplements and erenumab may cause increased tendency to bruise. Erenumab has no effect on the platelets per se but may cause impaired wound healing by suppression of CGRP. Thus, small and unnoticeable bruises may be aggravated instead in patients with tendency to bruise caused by for instance fish oil supplements.

Laminar airflow versus turbulent airflow in simulated total hip arthroplasty: measurements of colony-forming units, particles, and energy consumption.

BACKGROUND: The optimal type of ventilation in operating theatres for joint arthroplasty has been debated for decades. Recently, the World Health Organization changed its recommendations based on articles that have since been criticized. The economic and environmental impact of ventilation is also currently an important research topic but has not been well investigated. AIM: To compare how large, high-volume, laminar airflow (LAF) and turbulent airflow (TAF) ventilation systems perform during standardized simulated total hip arthroplasty (THA), as they pertain to colony-forming units (cfu), particle counts, and energy consumption. METHODS: Two identical operating theatres were used to perform simulated THA. The only difference was that one was equipped with LAF and the other with TAF. Cfu and particles were collected from key points in the operating theatre, and energy was measured for each simulation. Thirty-two simulations were done in total. FINDINGS: LAF had significantly reduced cfu and particle count when compared with TAF, at both 100% and 50% air influx. Furthermore, it was shown that lowering the air influx by 50% in LAF did not significantly affect cfu or particles, although reducing the fresh air influx from 100% to 50% significantly lowered the energy consumption. Most simulations in TAF did not meet the cleanroom requirements. CONCLUSION: Cfu were significantly lower in LAF at both 100% and 50% air influx. It is possible to reduce fresh air influx in LAF operating theatres by 50%, significantly reducing energy consumption, while still maintaining cfu and particle counts below the ISO classification threshold required for THA surgery.

How do multimorbidity and lifestyle factors impact the perceived health of adults with intellectual disabilities?

BACKGROUND: Adults with intellectual disability (ID) have poorer physical and perceived health than the general population. Knowledge of perceived health predictors is both limited and important for guiding the development of preventive actions. The aims of this study were to investigate (1) the associations between perceived health and demographics, degree of ID, physical health conditions, and weight and physical activity level and (2) lifestyle factors and multimorbidity as predictors for perceived health adjusted for age, gender, and level of ID. METHOD: The North Health in Intellectual Disability study is a community based cross-sectional survey. The POMONA-15 health indicators were used. Univariate and multivariate logistic regression analyses with poor versus good health as the dependent variable were applied. RESULTS: The sample included 214 adults with a mean age 36.1 (SD 13.8) years; 56% were men, and 27% reported perceiving their health as poor. In univariate analyses, there were significant associations between poor health ratings and female gender, lower motor function, number of physical health conditions and several indicators of levels of physical activity. In the final adjusted model, female gender [odds ratio (OR) 2.4, P < 0.05], level of ID (OR 0.65, P < 0.05), numbers of physical health conditions (OR 1.6, P < 0.001) and lower motor function (OR 1.5 P < 0.05) were significant explanatory variables for poor perceived health, with a tendency to independently impact failure to achieve 30 min of physical activity daily (OR 2.0, P = 0.07). CONCLUSION: Adults with ID with female gender, reduced motor function and more physical health conditions are at increased risk of lower perceived health and should be given attention in health promoting interventions. A lack of physical activity tends to negatively influence perceived health.

A simulational study of the indirect-geometry neutron spectrometer BIFROST at the European Spallation Source, from neutron source position to detector position.

The European Spallation Source (ESS) is intended to become the most powerful spallation neutron source in the world and the flagship of neutron science in upcoming decades. The exceptionally high neutron flux will provide unique opportunities for scientific experiments but also set high requirements for the detectors. One of the most challenging aspects is the rate capability and in particular the peak instantaneous rate capability, i.e. the number of neutrons hitting the detector per channel or cm2 at the peak of the neutron pulse. The primary purpose of this paper is to estimate the incident rates that are anticipated for the BIFROST instrument planned for ESS, and also to demonstrate the use of powerful simulation tools for the correct interpretation of neutron transport in crystalline materials. A full simulation model of the instrument from source to detector position, implemented with the use of multiple simulation software packages, is presented. For a single detector tube, instantaneous incident rates with a maximum of 1.7 GHz for a Bragg peak from a single crystal and 0.3 MHz for a vanadium sample are found. This paper also includes the first application of a new pyrolytic graphite model and a comparison of different simulation tools to highlight their strengths and weaknesses.

Feeding concentrates with different protein sources to high-yielding, mid-lactation Norwegian Red cows: Effect on cheese ripening.

Soybean meal is one of the most important protein sources in concentrate feeds for dairy cows. The objective of the present study was to provide knowledge on the effects of using a novel yeast microbial protein source (Candida utilis) in concentrate feed for dairy cows on the production and quality of a Gouda-type cheese. Forty-eight Norwegian Red dairy cows in early to mid lactation were fed a basal diet of grass silage, which was supplemented with 3 different concentrate feeds. The protein source of the concentrates was based on conventional soybean meal (SBM), novel yeast (C. utilis; YEA), or barley (BAR; used as negative control because barley has a lower protein content). The experiment was carried out for a period of 10 wk, with the first 2 wk as an adaptation period where all dairy cows were fed grass silage and the SBM concentrate. The cows were then randomly allocated to 1 of the 3 different compound feeds: SBM, yeast, or barley. Cheeses were made during wk 8 and 9 of the experiment, with 4 batches of cheese made from milk from each of the 3 groups. The cheeses made from milk from cows fed SBM concentrate (SBM cheese) had a higher content of dl-pyroglutamic acid and free amino acids than the other cheeses, indicating a faster ripening in the SBM cheeses. Despite these differences, the sensory properties, the microbiota, and the Lactococcus population at 15 wk of ripening were not significantly different between the cheeses. This experiment showed that although the raw materials used in the concentrate feed clearly influenced the ripening of the cheeses, this did not affect cheese quality. Yeast (C. utilis) as a protein source in concentrate feed for dairy cows can be used as a replacement for soybean meal without compromising the quality of Norwegian Gouda-type cheeses.

Microbial community changes in a female rat model of Rett syndrome.

Rett syndrome (RTT) is an X-linked neurodevelopmental disorder that is predominantly caused by alterations of the methyl-CpG-binding protein 2 (MECP2) gene. Disease severity and the presence of comorbidities such as gastrointestinal distress vary widely across affected individuals. The gut microbiome has been implicated in neurodevelopmental disorders such as Autism Spectrum Disorder (ASD) as a regulator of disease severity and gastrointestinal comorbidities. Although the gut microbiome has been previously characterized in humans with RTT compared to healthy controls, the impact of MECP2 mutation on the composition of the gut microbiome in animal models where the host and diet can be experimentally controlled remains to be elucidated. By evaluating the microbial community across postnatal development as behavioral symptoms appear and progress, we have identified microbial taxa that are differentially abundant across developmental timepoints in a zinc-finger nuclease rat model of RTT compared to WT. We have additionally identified p105 as a key translational timepoint. Lastly, we have demonstrated that fecal SCFA levels are not altered in RTT rats compared to WT rats across development. Overall, these results represent an important step in translational RTT research.

The Baltic Sea: An ecosystem with multiple stressors.

This introductory chapter to our Environment International VSI does not need an abstract and therefore we just include our recommendations below in order to proceed with the resubmission. Future work should examine waterbirds as food web sentinels of multiple stressors as well as Baltic Sea food web dynamics of hazardous substances and how climate change may modify it. Also, future work should aim at further extending the new frameworks developed within BALTHEALTH for energy and contaminant transfer at the population level (Desforges et al., 2018, Cervin et al., 2020/this issue Silva et al., 2020/this issue) and their long term effects on Baltic Sea top predators, such as harbour porpoises, grey seals ringed seals, and white-tailed eagles. Likewise, the risk evaluation conducted for PCB in connection with mercury on Arctic wildlife (Dietz et al., 2019, not a BONUS BALTHEALTH product) could be planned for Baltic Sea molluscs, fish, bird and marine mammals in the future. Finally, future efforts could include stressors not covered by the BONUS BALTHEALTH project, such as food web fluxes, overexploitation, bycatches, eutrophication and underwater noise.

Prevalence of visual snow syndrome in the UK.

BACKGROUND AND PURPOSE: Visual snow syndrome is a recently described condition of unknown prevalence. We investigated the prevalence in a representative population sample from the UK and tested the hypothesis that visual snow syndrome is associated with young age, headache, tinnitus and mood impairment. METHODS: Using a crowdsourcing platform, we recruited a representative sample of 1015 adult laypeople from the UK, matched for age, gender and ethnicity according to national census data. Participants were unprimed, i.e. were inquired about the 'frequency of certain medical conditions' but not 'visual snow syndrome'. RESULTS: A total of 38 of 1015 participants reported symptoms compatible with visual snow [3.7%; 95% confidence interval (CI), 2.7-5.2] and 22/1015 met criteria for visual snow syndrome (2.2%; 95% CI, 1.4-3.3). The female-to-male ratio for visual snow syndrome was 1.6:1. Subjects with visual snow syndrome were older (50.6 ± 14 years) than the population mean (44.8 ± 15 years), although this was not statistically different (P = 0.06). Of 22 participants with visual snow syndrome, 16 had mood symptoms (72.7%; P = 0.01), 12 had headache (54.5%; P = 0.06), including five with visual migraine aura (22.7%; P = 0.15) and 13 had tinnitus (59.1%; P < 0.001). No participant had diabetes or a cleft lip (control questions). Following a multivariable regression analysis to adjust for age and gender, only the association between visual snow syndrome and tinnitus remained significant (odds ratio, 3.93; 95% CI, 1.63-9.9; P = 0.003). CONCLUSIONS: The UK prevalence of visual snow syndrome is around 2%. We confirmed an association with tinnitus, but unprimed laypeople with visual snow syndrome are on average older than those seeking medical attention.

Risk factors for Clostridioides difficile infection in hospitalized patients and associated mortality in Japan: a multi-centre prospective cohort study.

BACKGROUND: Although population characteristics and antimicrobial prescribing practices suggest that the hospitalized population in Japan is at high risk of Clostridioides difficile infection (CDI), the epidemiology of CDI in Japan is poorly understood. AIM: This prospective cohort study aimed to investigate the epidemiology of CDI at 12 hospitals in Japan. METHODS: Patients with clinically significant diarrhoea (CSD) were enrolled. Stool specimens were tested for C. difficile by toxin A and/or B enzyme immunoassay (EIA) in the hospital laboratories, and a toxigenic culture and nucleic acid amplification tests were performed at a central laboratory. The risk factors of CDI and the impact of CDI on mortality were investigated. FINDINGS: In total, 566 patients with CSD were included in the analyses. A total of 152 patients received the diagnosis of CDI by Toxin A/B EIA, toxigenic culture, or nucleic acid amplification test. Factors associated with CDI included low albumin (adjusted odds ratio (aOR): 1.56; 95% confidence interval (CI): 1.03-2.34) and length of hospital stay before stool collection >18 days (aOR: 1.73; 95% CI: 1.09-2.75). CDI was associated with an increased mortality on univariate analysis (OR: 1.6, 95% CI: 1.0-2.6) but was not associated with an increased risk of mortality on multivariable analysis. CONCLUSION: Risk factors for CDI in Japan were similar to those identified in the USA and Europe. However, CDI was not associated with an increased risk of mortality in this population of patients with CSD.

Use of test accuracy study design labels in NICE's diagnostic guidance.

BACKGROUND: A variety of study designs are available to evaluate the accuracy of tests, but the terms used to describe these designs seem to lack clarity and standardization. We investigated if this was the case in the diagnostic guidance of the National Institute of Care and Health Excellence (NICE), an influential source of advice on the value of tests. OBJECTIVES: To describe the range of study design terms and labels used to distinguish study designs in NICE Diagnostic Guidance and the underlying evidence reports. METHODS: We carefully examined all NICE Diagnostic Guidance that has been developed from inception in 2011 until 2018 and the corresponding diagnostic assessment reports that summarized the evidence, focusing on guidance where tests were considered for diagnosis. We abstracted labels used to describe study designs and investigated what labels were used when studies were weighted differently because of their design (in terms of validity of evidence), in relevant sections. We made a descriptive analysis to assess the range of labels and also categorized labels by design features. RESULTS: From a total of 36 pieces of guidance, 20 (56%) were eligible and 17 (47%) were included in our analysis. We identified 53 unique design labels, of which 19 (36%) were specific to diagnostic test accuracy designs. These referred to a total of 12 study design features. Labels were used in assigning different weights to studies in seven of the reports (41%) but never in the guidance documents. CONCLUSION: Our study confirms a lack of clarity and standardization of test accuracy study design terms. There seems to be scope to reduce and harmonize the number of terms and still capture the design features that were deemed influential by those compiling the evidence reports. This should help decision makers in quickly identifying subgroups of included studies that should be weighted differently because their designs are more susceptible to bias.