Independently Assessed Research Articles

Association of pretreatment chest CT abnormalities with trastuzumab deruxtecan–associated pneumonitis.

1106 Background: Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate approved for HER2+ metastatic breast cancer (MBC) and HER2-low (IHC 1+ or 2+ with FISH-) MBC . Pneumonitis with T-DXd has been observed in 13.6% of patients (pts) on DESTINY-Breast 01 (including 2.2% fatal events) and 12.1% in pts on DESTINY-BREAST 04 (including 0.8% fatal events). There is an unmet need to determine if pts with baseline lung abnormalities are at increased risk for development of pneumonitis from T-DXd. Methods: This retrospective cohort study included all pts treated with T-DXd for MBC at an academic institution from 1/2020 to 2/2023 for more than 1 cycle (>21 days). Outcomes were evaluated from treatment initiation until 2/1/2023. Two board-certified radiologists blinded to outcomes reviewed staging chest CTs performed before initiating T-DXd and graded each scan on 16 parenchymal abnormalities, including presence of interstitial lung abnormalities (ILA). Pneumonitis was retrospectively adjudicated by an independent oncologist using chart review and graded according to CTCAE v5.0 and compared to the treating physician’s assessment. The difference of proportions was analyzed with the Pearson Chi-Square test. Significance was declared at the 0.05 type I error threshold. Results: A total of 68 pts (median age 57.3 years) were included (30 = HER2+, 24 = HR+/HER2 low, 14 = TNBC/HER2 low). By independent assessment, 16 pts (23.5%) had grade 1 pneumonitis and 3 pts (4.4%) grade 2 pneumonitis. Median time from treatment initiation to pneumonitis was 83 days (range 35-266). By treating physician assessment, 5 pts (7.4%) developed grade 1 pneumonitis and 3 pts (4.4%) developed grade 2 pneumonitis. 16 of 68 pts (23.5%) had baseline ILA and 62 pts (91.2%) had at least one other parenchymal abnormality. As assessed by an independent oncologist, of pts with baseline ILA (N = 16), 12.5% developed T-DXd related pneumonitis, compared to 32.7% of pts without pre-existing ILA (N=52), p=0.16. There was no statistical difference in T-DXd related pneumonitis assessed by treating physician between pts with baseline ILA (2/16 patients, 12.5%) compared to pts without baseline ILA (7/52 pts, 13.5%), p=0.68. Conclusions: In this study, presence of baseline ILA was not associated with subsequent pneumonitis from T-DXd. Notably, the rate of independently assessed pneumonitis was higher than treatment-attributed pneumonitis as defined by the treating physician. Further research is needed to validate these findings and define predictors of treatment-associated pneumonitis. [Table: see text]

Association of Clinical Factors and Degree of Early Background Parenchymal Enhancement on Contrast-Enhanced Mammography.

BACKGROUND. Background parenchymal enhancement (BPE) may impact contrast-enhanced mammography (CEM) interpretation, although factors influencing the degree of BPE on CEM are poorly understood. OBJECTIVE. The purpose of our study was to evaluate relationships between clinical factors and the degree of early BPE on CEM. METHODS. This retrospective study included 207 patients (median age, 46 years) who underwent CEM between April 2020 and September 2021. Two radiologists independently assessed the degree of BPE on CEM as minimal, mild, moderate, or marked on the basis of two criteria (criterion 1, using the first of four obtained views; criterion 2, using the first two of four obtained views). The radiologists reached consensus for breast density on CEM. The EMR was reviewed for clinical factors. Radiologists' agreement for degree of BPE was assessed using weighted kappa coefficients. Univariable and multivariable analyses were performed to assess relationships between clinical factors and degree of BPE, treating readers' independent assessments as repeated measurements. RESULTS. Interreader agreement for degree of BPE, expressed as kappa, was 0.80 for both criteria. For both criteria, univariable analyses found degree of BPE to be negatively associated with age (both OR = 0.94), personal history of breast cancer (OR = 0.22-0.30), history of chemotherapy (OR = 0.18-0.21), history of radiation therapy (OR = 0.20-0.21), perimenopausal status (OR = 0.22-0.34), and postmenopausal status (OR = 0.10-0.11) and to be positively associated with dense breasts (OR = 4.13-4.26) and premenopausal status with irregular menstrual cycles (OR = 7.94-14.02). Among premenopausal patients with regular menstrual cycles, degree of BPE was lowest (using postmenopausal patients as reference) for patients in menstrual cycle days 8-14 (OR = 2.56-3.30). In multivariable analysis for both criteria, the only independent predictors of degree of BPE related to menstrual status and time of menstrual cycle (e.g., using premenopausal patients in days 1-7 as reference: OR = 0.21 for both criteria for premenopausal patients in days 8-14 and OR = 0.03-0.04 for postmenopausal patients). CONCLUSION. Clinical factors, including history of breast cancer or breast cancer treatment, breast density, menstrual status, and time of menstrual cycle, are associated with degree of early BPE on CEM. In premenopausal patients, the degree of BPE is lowest on days 8-14 of the menstrual cycle. CLINICAL IMPACT. Given the potential impact of BPE on diagnostic performance, the findings have implications for CEM scheduling and interpretation.

Implications of disparate uterine and ovarian development observed among heifers evaluated during the peripubertal period

The incidence and implications of disparate ovarian and uterine development during the peripubertal period were evaluated in two experiments. In Experiment 1, two consecutive pre-breeding evaluations were performed on 469 heifers. In Experiment 2, data from 22,174 heifers were retrospectively analyzed. For heifers in both experiments, ovarian and uterine maturity were independently assessed via transrectal evaluation, and a two-digit reproductive tract score (RTS: first digit = ovarian; second digit = uterine) was assigned. Measures of the physical maturity of heifers were recorded at the time of pre-breeding evaluation. Heifers were subjected to 14-day progestin-based protocols for synchronization of estrus, and artificial insemination (AI) was performed. Pregnancy diagnosis was performed via transrectal ultrasonography. Incidence of disparate ovarian and uterine score was 33.7 % (158/469) in Experiment 1 % and 16.3 % (3622/22,174) in Experiment 2. Observations of disparate ovarian and uterine maturity were correlated with physical maturity. Heifers with RTS < 3–3 demonstrated poor reproductive performance, as lesser proportions of these animals conceived to the first AI service in Experiment 2 (P < 0.01) or throughout the breeding season in Experiment 1 (P = 0.03). Conception did not differ between heifers assigned congruent or disparate scores of greater than RTS = 3–3. Disparities in ovarian and uterine development are likely observed as the result of rapid, yet asynchronous growth of reproductive tissues during the peripubertal period and are not indicative of inherently reduced potential for fertility. Independent assessment of ovarian and uterine maturity may increase precision in characterizing physiologic maturity of mixed groups of prepubertal, peripubertal, and pubertal heifers.

Pioglitazone for NAFLD Patients With Prediabetes or Type 2 Diabetes Mellitus: A Meta-Analysis.

ObjectiveTo systematically evaluate the effects of pioglitazone in the treatment of patients with prediabetes or T2DM combined with NAFLD.MethodsThe Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and ClinicalTrials databases were searched until August 2020 for publications written in English. Two reviewers independently assessed study eligibility, continuous data extraction, independent assessment of bias risk, and graded the strength of evidence. Our primary outcomes were the individual number of patients with improvement of at least 1 point in each of the histological parameters. Baseline characteristic data, such as BMI, weight, total body fat, fasting plasma glucose and fasting plasma insulin, and liver biological indicators, such as triglyceride level, HDL cholesterol level, plasma AST, and plasma ALT, were used as secondary outcomes.ResultsA total of 4 studies were included. Compared with placebo, pioglitazone significantly improved steatosis grade, inflammation grade and ballooning grade, while in the fibrosis stage, there was no significant improvement in pioglitazone compared with placebo. In addition, pioglitazone can also improve blood glucose and liver function.ConclusionPioglitazone can significantly improve the histological performance of the liver and insulin sensitivity. Additionally, it can significantly reduce fasting blood glucose, glycosylated hemoglobin, plasma AST, ALT and other liver biological indicators. Due to the lack of relevant randomized controlled trials and short intervention times, long-term studies are still needed to verify its efficacy and safety.Systematic Review Registration[PROSPERO], identifier [CRD42020212025].

Disparities in H1N1 Vaccination Rates: a Systematic Review and Evidence Synthesis to Inform COVID-19 Vaccination Efforts.

BackgroundData suggest that there were disparities in H1N1 vaccine uptake, and these may inform COVID-19 vaccination efforts. We conducted a systematic review to evaluate disparities in H1N1 vaccine uptake, factors contributing to disparities, and interventions to reduce them.MethodsWe searched English-language articles in MEDLINE ALL, PsycINFO, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials from database inception through May 8, 2020. Observational studies examining H1N1 vaccine uptake by race/ethnicity, socioeconomic status, rurality, and disability status in US settings were included. Two reviewers independently assessed study eligibility. Single-reviewer data abstraction was confirmed by a second reviewer. We conducted independent dual quality assessment, and collective strength of evidence assessment.ResultsWe included 21 studies. African American/Black, Latino, and low-socioeconomic status participants had disproportionately lower H1N1 vaccination rates (low- to moderate-strength evidence). However, Latinos were more likely than Whites to intend to be vaccinated, and African American/Blacks and participants with lower-socioeconomic status were just as likely to intend to be vaccinated as their White and higher-socioeconomic status counterparts (low-strength evidence). Vaccine uptake for other groups has been insufficiently studied. Factors potentially contributing to disparities in vaccine uptake included barriers to vaccine access, inadequate information, and concerns about vaccine safety and efficacy. Studies were largely cross-sectional. Many of the studies are a decade old and were conducted in the context of a different pandemic. The categorization of racial and ethnic groups was not consistent across studies and not all groups were well-studied.DiscussionEfforts to avoid disparities in COVID-19 vaccination uptake should prioritize vaccine accessibility and convenience in African American/Black, Latino, and low-SES communities; engage trusted stakeholders to share vaccine information; and address concerns about vaccine safety and efficacy.Primary Funding SourceDepartment of Veterans Affairs, Veterans Health Administration, Health Services Research & Development.Protocol RegistrationPROSPERO CRD42020187078Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-021-06715-7.

Efficacy of Various Hypoglycemic Agents in the Treatment of Patients With Nonalcoholic Liver Disease With or Without Diabetes： A Network Meta-Analysis.

ObjectiveTo comprehensively evaluate and compare the therapeutic effects of various hypoglycemic agents in NAFLD patients with or without diabetes.MethodsAll literature from the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Clinical Trials was searched, and the language was limited to English. Two reviewers independently assessed study eligibility, continuous data extraction, and independent assessment of bias risk. Our primary outcomes were alanine aminotransferase (ALT), aspartate aminotransferase (AST) and triglyceride levels, while our secondary outcomes were high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels, body weight, BMI, and fasting glucose and glycosylated hemoglobin (HbA1c) levels.ResultsThe review identified 20 eligible trials that met the inclusion criteria. We found that, compared to other drugs, thiazolidinediones, especially pioglitazone, had a greater effect on the levels of ALT (-8.01 (95% CI -14.3 to 2.02)) and AST (-5.0 (95% CI -9.21 to -1,22)) and other biological indicators, but they were also associated with an increased risk of weight gain (3.62 (95% CI 2.25 to 4.99) and increased BMI (0.59 (95% Cl -0.13 to 1.29). GLP1 RAs and metformin also had better therapeutic effects than other drugs as measured by the levels of ALT (liraglutide: -9.36 (95% Cl -18 to -0.34), metformin: -2.84 (95% CI -11.09 to 5.28)) and AST (liraglutide: -5.14 (95% CI -10.69 to 0.37), metformin: -2.39 (95% CI -7.55, 2.49)) and other biological indicators.ConclusionDespite the significant risk of weight gain, thiazolidinediones, especially pioglitazone, are beneficial in normalizing liver and glucose metabolism in NAFLD patients. In clinical practice, we believe that GLP1 RAs such as liraglutide and exenatide or metformin can be used in combination to offset the risk of weight gain associated with thiazolidinediones. However, long-term studies are still needed to verify the efficacy and safety of individual hypoglycemic agents.Systematic Review Registration[PROSPERO], identifier [CRD42020212025].

Current trends and future directions in quantitative geodiversity assessment

Geodiversity assessment is recent and is passing through a stage of methodological development and consolidation. With rapid environmental change, improving the developmental states of geodiversity assessment is of paramount importance. A scientometric analysis is presented to identify knowledge gaps, current trends and avenues for future research in quantitative geodiversity assessment literature. The study is categorised into three areas of analysis: (a) methodological intentions of geodiversity assessment, (b) current trends in geodiversity assessment methods and (c) current geographic trends. A ranking tool was developed to determine whether the current methodological intentions of geodiversity assessments trend towards combined geodiversity and biodiversity assessments or towards the independent assessment of geodiversity. Results showed that about 50% of publications independently assessed geodiversity with no consideration for biodiversity, 32% discussed or reviewed geodiversity by mentioning potential links to biodiversity and 12% more strongly linked geodiversity assessment to biodiversity assessment. Tools used by scholars to determine geodiversity values varied from statistical through to the more frequently adopted geographic information systems (GIS) and spatial analytical software approaches. Study sites selected for geodiversity assessments were predominantly terrestrial at the state-wide scale. Marine assessments, or seabed geodiversity, were mostly absent from the literature, with only two publications found. Brazil in South America had many geodiversity assessments and European scholars have played crucial roles in the development of quantitative geodiversity assessment in recent years. Subsequent research will benefit from developing a unified geodiversity assessment approach, reaching a consensus on an accepted definition and standardising the geodiversity concept, broadening research site environment types and developing strategies to promote further international and intranational collaboration.

Artificial intelligence in lung cancer screening: assessment of the diagnostic accuracy of the algorithm analyzing low-dose computed tomography

The diagnostic accuracy of the artificial intelligence algorithm aimed to detect lesions on low-dose computer tomograms has been independently assessed. The dataset formed as part of the lung cancer screening program in Moscow was used. The following indicators have been defined: sensitivity – 0.817%, specificity – 0.925%, accuracy – 0.860%, area under the characteristic curve – 0.930. High accuracy rates demonstrated through the independent assessment indicate a good reproducibility of the results by artificial intelligence using independent data about the population of Moscow

Concordance between independent and investigator assessment of disease-free survival (DFS) in the APACT trial.

4618 Background: APACT was a phase III trial of adjuvant nab-paclitaxel + gemcitabine ( nab-P + Gem) vs Gem alone in patients with resected pancreatic cancer (PC) and the first adjuvant PC trial to use independently assessed DFS as the primary endpoint (DFS by investigator review was a prespecified sensitivity analysis). We examined concordance between independent and investigator DFS review. Methods: For the independent assessment, reviewers determined recurrence by computed tomography or magnetic resonance imaging but were blinded to treatment and clinical data. Investigator-assessed DFS was based on all available data. Concordance was summarized by κ statistics. Patients who did not have recurrence or were alive were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Patients who received new anticancer therapy or cancer-related surgery prior to recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anticancer therapy or cancer-related surgery or the randomization date if the last tumor assessment date with disease-free status prior to the start of subsequent new anticancer therapy or cancer-related surgery was missing. All censoring rules were the same for analysis of DFS by independent and investigator review. Results: Median DFS by independent review was 19.4 ( nab-P + Gem) vs 18.8 (Gem) months (hazard ratio [HR] 0.88; 95% CI, 0.73 - 1.06; P = 0.18); median investigator-assessed DFS was 16.6 ( nab-P + Gem) vs 13.7 (Gem) months (HR 0.82; 95% CI, 0.69 - 0.97; nominal P = 0.017). Moderate concordance was found between independent- and investigator-assessed DFS (Table); similar results were observed in the nab-P + Gem (concordance, 78%; κ coefficient, 0.56) and Gem alone (concordance, 76%; κ coefficient, 0.53) arms. Conclusions: The results reflect the complexities of defining the recurrence timepoint accurately and suggest that radiological review in the absence of clinical context is suboptimal for recurrence detection in resected PC. These findings may inform future clinical trial design. Registration: EudraCT (2013-003398-91); ClinicalTrials.gov (NCT01964430). Clinical trial information: NCT01964430 . [Table: see text]

Association between quantitative sensory testing and pain or disability in paediatric chronic pain: protocol for a systematic review and meta-analysis

IntroductionThis protocol describes the objective and methods of a systematic review of the association between quantitative sensory testing (QST) measures and pain intensity or disability in paediatric chronic pain (PCP)....

Dilute versus full-strength formula in exclusively formula-fed preterm or low birth weight infants.

Preterm infants have fewer nutrient reserves at birth than full-term infants and often receive artificial formula feeds in the absence of expressed breast milk. Although it is generally agreed that feeding must be initiated slowly and advanced with much greater deliberation than in a healthy, full-term infant, the way in which feeds are introduced and advanced in preterm infants varies widely. This review focuses on whether dilute or full-strength formula is the preferable mode of introducing feeds in preterm infants for whom expressed breast milk is unavailable. To assess the effects of dilute versus full-strength formula on the incidence of necrotising enterocolitis, feeding intolerance, weight gain, length of stay in hosptial and time to achieve full calorie intake in exclusively formula-fed preterm or low birth weight infants. A secondary objective was to assess the effects of different dilution strategies. We used the standard search strategy of Cochrane Neonatal to update the search in the Cochrane Central Register of Controlled Trials (CENTRAL 2018, Issue 9), MEDLINE via PubMed (1966 to 1 October 2018), Embase (1980 to 1 October 2018), and CINAHL (1982 to 1 October 2018).We searched clinical trials' registries for ongoing or recently completed trials (clinicaltrials.gov; the World Health Organization's International Trials Registry and Platform; and the ISRCTN Registry). Randomised or quasi-randomised trials comparing strengths of formula milk in exclusively formula-fed preterm or low birth weight infants. We excluded studies if infants received formula as a supplement to breast milk. We independently assessed studies for inclusion. We collected data using the standard methods of Cochrane Neonatal, with independent assessment of risk of bias and data extraction. We synthesised mean differences using a fixed-effect meta-analysis model. We used the GRADE approach to assess the certainty of evidence. We included three studies involving 102 preterm or low birth weight infants in the review. The studies compared dilute (double-volume, half-strength) formula with full-strength (20 kcal/oz (˜ 68 to 70 kcal/100 mL)) formula. We assessed all three studies as having unclear risk of bias due to the likely absence of blinding of study personnel and the potential for selection bias in the largest trial. Data for the primary outcome of necrotising enterocolitis were not reported in any of the studies. We could combine two of the studies (88 infants) in the meta-analysis. The evidence suggests that dilute formula with double-volume (half-strength) may lead to fewer episodes of gastric residuals per day (one study; mean difference (MD) -1.20, 95% confidence interval (CI) -2.20 to -0.20; low-certainty evidence), fewer episodes of gastric residuals per baby until attaining 100 kcal/kg (one study; MD -0.80, 95% CI -1.32 to -0.28; low-certainty evidence), fewer episodes of vomiting per day (one study; MD -0.04, 95% CI -0.07 to -0.01; low-certainty evidence) and fewer occurrences of abdominal distension greater than 2 cm (two studies; MD -0.16, 95% CI -0.19 to -0.13; low-certainty evidence). For the secondary outcomes, data suggest that infants in the dilute formula with double-volume (half-strength) group may have attained an adequate energy intake earlier than infants in the full-strength group (two studies; MD -2.26, 95% CI -2.85 to -1.67; low-certainty evidence). There was no evidence of a difference between groups for weight gain one week after commencement of intragastric feeds (one study; MD 0.05 kg, 95% CI -0.06 to 0.15; low-certainty evidence). Data were not reported for length of hospital stay. There is low-certainty evidence from three small, old trials that use of dilute formula in preterm or low birth weight formula-fed infants may lead to an important reduction in the time taken for preterm infants to attain an adequate energy intake.However, our confidence in this result is limited due to uncertainty over risk of bias and sparsity of available data. Dilute formula may reduce incidence of feeding intolerance, but the clinical significance of the reduction is uncertain. The impact on serious gastrointestinal problems, including necrotising enterocolitis, was not reported in any of the trials. Further randomised trials are needed to confirm these results.

C-reactive protein for diagnosing late-onset infection in newborn infants.

Late-onset infection is the most common serious complication associated with hospital care for newborn infants. Because confirming the diagnosis by microbiological culture typically takes 24 to 48 hours, the serum level of the inflammatory marker C-reactive protein (CRP) measured as part of the initial investigation is used as an adjunctive rapid test to guide management in infants with suspected late-onset infection. To determine the diagnostic accuracy of serum CRP measurement in detecting late-onset infection in newborn infants. We searched electronic databases (MEDLINE, Embase, and Science Citation Index to September 2017), conference proceedings, previous reviews, and the reference lists of retrieved articles. We included cohort and cross-sectional studies evaluating the diagnostic accuracy of serum CRP levels for the detection of late-onset infection (occurring more than 72 hours after birth) in newborn infants. Two review authors independently assessed eligibility for inclusion, evaluated the methodological quality of included studies, and extracted data to estimate diagnostic accuracy using hierarchical summary receiver operating characteristic (SROC) models. We assessed heterogeneity by examining variability of study estimates and overlap of the 95% confidence interval (CI) in forest plots of sensitivity and specificity. The search identified 20 studies (1615 infants). Most were small, single-centre, prospective cohort studies conducted in neonatal units in high- or middle-income countries since the late 1990s. Risk of bias in the included studies was generally low with independent assessment of index and reference tests. Most studies used a prespecified serum CRP threshold level as the definition of a 'positive' index test (typical cut-off level between 5 mg/L and 10 mg/L) and the culture of a pathogenic micro-organism from blood as the reference standard.At median specificity (0.74), sensitivity was 0.62 (95% CI 0.50 to 0.73). Heterogeneity was evident in the forest plots but it was not possible to conduct subgroup or meta-regression analyses by gestational ages, types of infection, or types of infecting micro-organism. Covariates for whether studies used a predefined threshold or not, and whether studies used a standard threshold of between 5 mg/L and 10 mg/L, were not statistically significant. The serum CRP level at initial evaluation of an infant with suspected late-onset infection is unlikely to be considered sufficiently accurate to aid early diagnosis or select infants to undergo further investigation or treatment with antimicrobial therapy or other interventions.

Independent assessment and outcomes of 196 short-tapered stems short-term follow-up and review of the literature.

Longer term outcome data are now becoming available for short-tapered femoral stems for cementless total hip arthroplasty. The shorter stem has a metaphyseal fit, loading the bone in this area, leading to physiological bone remodelling. It is also bone preserving, as it is 35 mm shorter. It may be easier to insert through a smaller incision and potentially reduce complication rates. We present a retrospective single surgeon case series of 196 patients (>53% follow-up over 5 years). All patients had the cementless 'Microplasty Taperloc' (Biomet). Primary outcome measures were femoral component revision rates. Secondary outcome measures included complications, patient-reported functional outcome scores (Oxford hip) and radiographic evidence of loosening. Patients were identified using electronic software. All were routinely followed up and assessed in clinic since implant introduction in 2009. Oxford hip scores were routinely obtained. A surgeon who had not carried out the procedure independently assessed radiographs. One hundred ninety-six patients were identified. The revision rate was 0.5% due to an intraoperative peri-prosthetic fracture of the femur identified on post-operative radiograph. The complication rate was 2%, attributable to: subsidence of the prosthesis (one hip), post-operative dislocation (two hips), one of which required acetabular revision. Oxford hip scores increased on average from 21 to 45 (pre- to post-operatively). There were no signs of radiographic loosening. The results show that using the short-tapered stem is proving so far to be a reliable and safe alternative to its longer counterpart, with low complication rates in the short term.

Education of healthcare professionals for preventing pressure ulcers.

Pressure ulcers, also known as bed sores or pressure sores, are localised areas of tissue damage arising due to excess pressure and shearing forces. Education of healthcare staff has been recognised as an integral component of pressure ulcer prevention. These educational programmes are directed towards influencing behaviour change on the part of the healthcare professional, to encourage preventative practices with the aim of reducing the incidence of pressure ulcer development. To assess the effects of educational interventions for healthcare professionals on pressure ulcer prevention. In June 2017 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. We included randomised controlled trials (RCTs) and cluster-RCTs, that evaluated the effect of any educational intervention delivered to healthcare staff in any setting to prevent pressure ulceration. Two review authors independently assessed titles and abstracts of the studies identified by the search strategy for eligibility. We obtained full versions of potentially relevant studies and two authors independently screened these against the inclusion criteria. We identified five studies that met the inclusion criteria for this review: four RCTs and one cluster-RCT. The study characteristics differed in terms of healthcare settings, the nature of the interventions studied and outcome measures reported. The cluster-RCT, and two of the RCTs, explored the effectiveness of education delivered to healthcare staff within residential or nursing home settings, or nursing home and hospital wards, compared to no intervention, or usual practices. Educational intervention in one of these studies was embedded within a broader, quality improvement bundle. The other two individually randomised controlled trials explored the effectiveness of educational intervention, delivered in two formats, to nursing staff cohorts.Due to the heterogeneity of the studies identified, pooling was not appropriate and we have presented a narrative overview. We explored a number of comparisons (1) education versus no education (2) components of educational intervention in a number of combinations and (3) education delivered in different formats. There were three primary outcomes: change in healthcare professionals' knowledge, change in healthcare professionals' clinical behaviour and incidence of new pressure ulcers.We are uncertain whether there is a difference in health professionals' knowledge depending on whether they receive education or no education on pressure ulcer prevention (hospital group: mean difference (MD) 0.30, 95% confidence interval (CI) -1.00 to 1.60; 10 participants; nursing home group: MD 0.30, 95% CI -0.77 to 1.37; 10 participants). This was based on very low-certainty evidence from one study, which we downgraded for serious study limitations, indirectness and imprecision.We are uncertain whether there is a difference in pressure ulcer incidence with the following comparisons: training, monitoring and observation, versus monitoring and observation (risk ratio (RR) 0.63, 95% CI 0.37 to 1.05; 345 participants); training, monitoring and observation, versus observation alone (RR 1.21, 95% CI 0.60 to 2.43; 325 participants) or, monitoring and observation versus observation alone (RR 1.93, 95% CI 0.96 to 3.88; 232 participants). This was based on very low-certainty evidence from one study, which we downgraded for very serious study limitations and imprecision. We are uncertain whether multilevel intervention versus attention control makes any difference to pressure ulcer incidence. The report presented insufficient data to enable further interrogation of this outcome.We are uncertain whether education delivered in different formats such as didactic education versus video-based education (MD 4.60, 95% CI 3.08 to 6.12; 102 participants) or e-learning versus classroom education (RR 0.92, 95% CI 0.80 to 1.07; 18 participants), makes any difference to health professionals' knowledge of pressure ulcer prevention. This was based on very low-certainty evidence from two studies, which we downgraded for serious study limitations and study imprecision.None of the included studies explored our other primary outcome: change in health professionals' clinical behaviour. Only one study explored the secondary outcomes of interest, namely, pressure ulcer severity and patient and carer reported outcomes (self-assessed quality of life and functional dependency level respectively). However, this study provided insufficient information to enable our independent assessment of these outcomes within the review. We are uncertain whether educating healthcare professionals about pressure ulcer prevention makes any difference to pressure ulcer incidence, or to nurses' knowledge of pressure ulcer prevention. This is because the included studies provided very low-certainty evidence. Therefore, further information is required to clarify the impact of education of healthcare professionals on the prevention of pressure ulcers.

A systematic review of nonpharmacological prenatal interventions for pregnancy-specific anxiety and fear of childbirth.

Despite a sharp increase in the number of publications that report on treatment options for pregnancy-specific anxiety and fear of childbirth (PSA/FoB), no systematic review of nonpharmacological prenatal interventions for PSA/FoB has been published. Our team addressed this gap, as an important first step in developing guidelines and recommendations for the treatment of women with PSA/FoB. Two databases (PubMed and Mendeley) were searched, using a combination of 42 search terms. After removing duplicates, two authors independently assessed 208 abstracts. Sixteen studies met eligibility criteria, ie, the article reported on an intervention, educational component, or treatment regime for PSA/FoB during pregnancy, and included a control group. Independent quality assessments resulted in the retention of seven studies. Six of seven included studies were randomized controlled trials (RCTs) and one a quasi-experimental study. Five studies received moderate quality ratings and two strong ratings. Five of seven studies reported significant changes in PSA/FoB, as a result of the intervention. Short individual psychotherapeutic interventions (1.5-5hours) delivered by midwives or obstetricians were effective for women with elevated childbirth fear. Interventions that were effective for pregnant women with a range of different fear/anxiety levels were childbirth education at the hospital (2hours), prenatal Hatha yoga (8weeks), and an 8-week prenatal education course (16hours). Findings from this review can inform the development of treatment approaches to support pregnant women with PSA/FoB.

Design and Testing of a Postanesthesia Care Unit Readiness for Discharge Assessment Tool

This article describes the development and psychometric testing of a new Postanesthesia Care Unit (PACU) Readiness for Discharge Assessment Tool (RDAT) that can be used in assessing patients' readiness for discharge from a phase 1 PACU. This study used an instrument development methodology described by Waltz and Strickland that included item development and testing for content and convergent validity and interrater reliability. Items were developed from a review the literature, best practice exemplars, and input from an expert panel. Ten items were identified for patient assessment using a dichotomous response set (yes/no). Two nurses independently assessed the patients using the RDAT and Respiration, Energy, Alertness, Circulation, and Temperature, and comparing independent assessments using the RDAT. The content validity index was determined to be a=.80, and interrater reliability index was a=1.0. The RDAT is a useful, safe tool to assess patients' readiness for discharge from the PACU.

Short- and Long-Term Effects of Parent Training for Preschool Children With or at Risk of ADHD: A Systematic Review and Meta-Analysis

Objective: The aim of the study was to synthesize the evidence of parent training (PT) as an early intervention for preschool children aged 2.5 to 6 years with ADHD or ADHD symptoms. Method: A systematic review and meta-analysis was conducted. Results: Sixteen studies including 1,003 children were analyzed. Parent-rated outcomes revealed moderate effect sizes (ESs; Hedges’ g) of 0.51 for ADHD symptoms, 0.4 for conduct problems, and 0.63 for negative parenting. Based on independent assessment, results were only significant for negative parenting. Parent-rated outcomes were sustained at follow-ups of 3 to 12 months. Program type, intervention modality, and child diagnostic status did not moderate the effect. Conclusion: PT was partially supported as an efficacious intervention for preschool children with ADHD or ADHD symptoms with moderate ESs on parent-rated outcomes, but no significant results on independently assessed ADHD symptoms.

Referee Report For: Journal ratings as predictors of articles quality in Arts, Humanities and Social Sciences: an analysis based on the Italian Research Evaluation Exercise

The aim of this paper is to understand whether the probability of receiving positive peer reviews is influenced by having published in an independently assessed, high-ranking journal: we eventually interpret a positive relationship among peer evaluation and journal ranking as evidence that journal ratings are good predictors of article quality. The analysis is based on a large dataset of over 11,500 research articles published in Italy in the period 2004-2010 in the areas of architecture, arts and humanities, history and philosophy, law, sociology and political sciences. These articles received a score by a large number of externally appointed referees in the context of the Italian research assessment exercise (VQR); similarly, journal scores were assigned in a panel-based independent assessment, which involved all academic journals in which Italian scholars have published, carried out under a different procedure. The score of an article is compared with that of the journal it is published in: more specifically, we first estimate an ordered probit model, assessing the probability for a paper of receiving a higher score, the higher the score of the journal; in a second step, we concentrate on the top papers, evaluating the probability of a paper receiving an excellent score having been published in a top-rated journal. In doing so, we control for a number of characteristics of the paper and its author, including the language of publication, the scientific field and its size, the age of the author and the academic status. We add to the literature on journal classification by providing for the first time a large scale test of the robustness of expert-based classification.

Journal ratings as predictors of articles quality in Arts, Humanities and Social Sciences: an analysis based on the Italian Research Evaluation Exercise.

The aim of this paper is to understand whether the probability of receiving positive peer reviews is influenced by having published in an independently assessed, high-ranking journal: we eventually interpret a positive relationship among peer evaluation and journal ranking as evidence that journal ratings are good predictors of article quality. The analysis is based on a large dataset of over 11,500 research articles published in Italy in the period 2004-2010 in the areas of architecture, arts and humanities, history and philosophy, law, sociology and political sciences. These articles received a score by a large number of externally appointed referees in the context of the Italian research assessment exercise (VQR); similarly, journal scores were assigned in a panel-based independent assessment, which involved all academic journals in which Italian scholars have published, carried out under a different procedure. The score of an article is compared with that of the journal it is published in: more specifically, we first estimate an ordered probit model, assessing the probability for a paper of receiving a higher score, the higher the score of the journal; in a second step, we concentrate on the top papers, evaluating the probability of a paper receiving an excellent score having been published in a top-rated journal. In doing so, we control for a number of characteristics of the paper and its author, including the language of publication, the scientific field and its size, the age of the author and the academic status. We add to the literature on journal classification by providing for the first time a large scale test of the robustness of expert-based classification.

Pelvic floor muscle training for bowel dysfunction following colorectal cancer surgery: A systematic review.

To identify, evaluate and synthesize the evidence examining the effectiveness of pelvic floor muscle training (PFMT) on bowel dysfunction in patients who have undergone colorectal cancer surgery. Eight electronic databases (MEDLINE 1950-2014; CINAHL 1982-2014; EMBASE 1980-2014; Scopus 1823-2014; PsycINFO 1806-2014; Web of Science 1970-2014; Cochrane Library 2014; PEDro 1999-2014) were systematically searched in March 2014. Reference lists of identified articles were cross referenced and hand searched. Randomized controlled trials, cohort studies and case series were included if they investigated the effects of conservative treatments, including PFMT on bowel function in patients with colorectal cancer following surgery. Two reviewers independently assessed the risk of bias of studies using the Newcastle-Ottawa Scale (NOS). Six prospective non-randomized studies and two retrospective studies were included. The mean (SD) NOS risk of bias score was 4.9 (1.2) out of 9; studies were limited by a lack of non-exposed cohort, lack of independent blinded assessment, heterogeneous treatment protocols, and lack of long-term follow-up. The majority of studies reported significant improvements in stool frequency, incontinence episodes, severity of fecal incontinence, and health-related quality of life (HRQoL) after PFMT. Meta-analysis was not possible due to lack of randomized controlled trials. Pelvic floor muscle training for patients following surgery for colorectal cancer appears to be associated with improvements in bowel function and HRQoL. Results from non-randomized studies are promising but randomized controlled trials with sufficient power are needed to confirm the effectiveness of PFMT in this population.