The RECORD reporting guidelines: meeting the methodological and ethical demands of transparency in research using routinely-collected health data

Routinely-collected health data (RCD) are now used for a wide range of studies, including observational studies, comparative effectiveness research, diagnostics, studies of adverse effects, and predictive analytics. At the same time, limitations inherent in using data collected without specific a priori research questions are increasingly recognized. There is also a growing awareness of the suboptimal quality of reports presenting research based on RCD. This has created a perfect storm of increased interest and use of RCD for research, together with inadequate reporting of the strengths and weaknesses of these data resources. The REporting of studies Conducted using Observational Routinely-collected Data (RECORD) statement was developed to address these limitations and to help researchers using RCD to meet their ethical obligations of complete and accurate reporting, as well as improve the utility of research conducted using RCD. The RECORD statement has been endorsed by more than 15 journals, including Clinical Epidemiology. This journal now recommends that authors submit the RECORD checklist together with any manuscript reporting on research using RCD

Early-Onset Progressive Degeneration of the Area Centralis in RPE65-Deficient Dogs.

PURPOSE: Retinal epithelium-specific protein 65 kDa (RPE65)-deficient dogs are a valuable large animal model species that have been used to refine gene augmentation therapy for Leber congenital amaurosis type-2 (LCA2). Previous studies have suggested that retinal degeneration in the dog model is slower than that observed in humans. However, the area centralis of the dog retina is a cone and rod photoreceptor rich region comparable to the human macula, and the effect of RPE65 deficiency specifically on this retinal region, important for high acuity vision, has not previously been reported. METHODS: Spectral-domain optical coherence tomography, fundus photography, and immunohistochemistry of retinal wholemounts and sagittal frozen sections were used to define the time-course and cell-types affected in degeneration of the area centralis in affected dogs. RESULTS: Area centralis photoreceptor degeneration was evident from 6 weeks of age, and progressed to involve the inner retina. Immunohistochemistry showed that RPE65-deficient dogs developed early loss of S-cone outer segments, with slower loss of L/M-cone outer segments and rods. CONCLUSIONS: Early-onset severe photoreceptor degeneration in the area centralis of dogs with RPE65-deficiency offers a model of the early foveal/perifoveal degeneration in some patients with LCA2. This model could be used to refine interventions aiming to improve function and halt the progression of foveal/perifoveal photoreceptor degeneration

Morphologic adjustments of actively evolving highly curved neck cutoffs

Neck cutoffs and their resultant oxbow lakes are important and prominent features of riverine landscapes. Detailed field-based research focusing on the morphologic evolution of neck cutoffs is currently insufficient to fully characterize cutoff evolution. High-resolution bathymetric data were collected over 3 years for the purpose of determining channel morphology and morphologic change on three actively evolving neck cutoffs. Results indicate the following general trends in morphologic adjustment: (1) a longitudinal bar in the upstream meander limb that develops near the entrance to the abandoned bend; (2) a deep scour hole in the downstream meander limb immediately downstream of the cutoff channel; (3) erosion of the bank opposite the cutoff in the downstream meander limb; (4) a cutoff bar in the downstream meander limb at the junction corner of the cutoff channel and the downstream meander limb; and (5) perching of the exit of the abandoned bend above the cutoff channel due to channel bed incision. The results presented herein were used to develop a conceptual model that depicts the morphologic evolution of highly curving neck cutoffs. The findings of this research are combined with recent analyses of the three-dimensional flow structure through neck cutoffs to provide a mechanistic explanation for the morphodynamics of neck cutoffs. (c) 2019 John Wiley & Sons, Ltd

Effects of steady state free precession parameters on cardiac mass, function, and volumes

G0400444/Medical Research Council/United Kingdom Wellcome Trust/United Kingdo

Changes in the use of coronary artery revascularization procedures in the Department of Veterans Affairs, the National Hospital Discharge Survey, and the Nationwide Inpatient Sample, 1991–1999

BACKGROUND: There have been dramatic increases in the number of coronary artery bypass surgeries (CABS) and percutaneous coronary interventions (PCI) performed during the last decade. Whether this finding is true for revascularization procedures performed in Department of Veterans Affairs (VA) medical centers is the subject of this paper. METHODS: This study compared the number of revascularization procedures and rates of use in the VA, the National Hospital Discharge Survey, and the Nationwide Inpatient Sample. Included were men who underwent isolated CABS and/or PCI, including stenting, between 1991 and 1999, although data for the Nationwide Inpatient Sample were available only between 1993 and 1997. Age adjusted use rates were calculated with the direct method of standardization. RESULTS: The percent of users of VA healthcare 75 years and older increased from 10% in 1991 to 20% in 1999. In the VA, the number of isolated CABS declined from 6227 in 1991 to 6147 in 1999, whereas age adjusted rates declined from 167.6 per 100,000 in 1991 to 107.9 per 100,000 in 1999. In the 2 national surveys, both the estimated numbers of procedures and use rates increased over time. In all 3 settings, there were increases in both numbers and rate of PCI from 1993, although in the VA, use rates decreased from 191.2 per 100,000 in 1996 to 139.7 per 100,000 in 1999. VA use rates for both CABS and PCI were lower than those in the 2 national surveys. CONCLUSION: Age adjusted rates of CABS and PCI were lower in the VA than in 2 national surveys. Since 1996, there has been a decrease in the rate of use of revascularization procedures in the VA

Das RECORD-Statement zum Berichten von Beobachtungsstudien, die routinemäßig gesammelte Gesundheitsdaten verwenden [The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement]

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist as well as explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included. This document, as well as the accompanying website and message board (http://www.record-statement.org), will improve the implementation and understanding of RECORD. By implementing RECORD, authors, journals editors, and peer reviewers can enhance transparency of research reporting

Social robots as psychometric tools for cognitive assessment: a pilot test

Recent research demonstrated the benefits of employing robots as therapeutic assistants and caregivers, but very little is known on the use of robots as a tool for psychological assessment. Socially capable robots can provide many advantages to diagnostic practice: engage people, guarantee standardized administration and assessor neutrality, perform automatic recording of subject behaviors for further analysis by practitioners. In this paper, we present a pilot study on testing people’s cognitive functioning via social interaction with a humanoid robot. To this end, we programmed a social robot to administer a psychometric tool for detecting Mild Cognitive Impairment, a risk factor for dementia, implementing the first prototype of robotic assistant for mass screening of elderly population. Finally, we present a pilot test of the robotic procedure with healthy adults that show promising results of the robotic test, also compared to its traditional paper version

Pregnant women's responses to a tailored smoking cessation intervention: turning hopelessness into competence

Background: Cognitive behavioral interventions consisting of brief counseling and the provision of self-help material designed for pregnancy have been documented as effective smoking cessation interventions for pregnant women. However, there is a need to understand how such interventions are perceived by the targeted group. Aim: To understand the cognitive, emotional, and behavioral responses of pregnant women to a clinic-based smoking cessation intervention. Methods: In-depth interviews with women attending four antenatal clinics in Cape Town, South Africa, who were exposed to a smoking intervention delivered by midwives and peer counselors. Women were purposively selected to represent a variation in smoking behavior. Thirteen women were interviewed at their first antenatal visit and 10 were followed up and reinterviewed later in their pregnancies. A content analysis approach was used, which resulted in categories and themes describing women's experiences, thoughts, and feelings about the intervention. Results: Five women quit, five had cut down, and three could not be traced for follow-up. All informants perceived the intervention positively. Four main themes captured the intervention's role in influencing women's smoking behavior. The process started with ‘understanding their reality,’ which led to ‘embracing change’ and ‘deciding to hold nothing back,’ which created a basis for ‘turning hopelessness into a feeling of competence.’Conclusion: The intervention succeeded in shifting women from feeling pessimistic about ever quitting to feeling encouraged to try and quit. Informants rated the social support they received very highly and expressed the need for the intervention to become a routine component of clinic services

Effect of multivitamin and multimineral supplementation on cognitive function in men and women aged 65 years and over : a randomised controlled trial

Background: Observational studies have frequently reported an association between cognitive function and nutrition in later life but randomised trials of B vitamins and antioxidant supplements have mostly found no beneficial effect. We examined the effect of daily supplementation with 11 vitamins and 5 minerals on cognitive function in older adults to assess the possibility that this could help to prevent cognitive decline. Methods: The study was carried out as part of a randomised double blind placebo controlled trial of micronutrient supplementation based in six primary care health centres in North East Scotland. 910 men and women aged 65 years and over living in the community were recruited and randomised: 456 to active treatment and 454 to placebo. The active treatment consisted of a single tablet containing eleven vitamins and five minerals in amounts ranging from 50–210 % of the UK Reference Nutrient Intake or matching placebo tablet taken daily for 12 months. Digit span forward and verbal fluency tests, which assess immediate memory and executive functioning respectively, were conducted at the start and end of the intervention period. Risk of micronutrient deficiency at baseline was assessed by a simple risk questionnaire. Results: For digit span forward there was no evidence of an effect of supplements in all participants or in sub-groups defined by age or risk of deficiency. For verbal fluency there was no evidence of a beneficial effect in the whole study population but there was weak evidence for a beneficial effect of supplementation in the two pre-specified subgroups: in those aged 75 years and over (n 290; mean difference between supplemented and placebo groups 2.8 (95% CI -0.6, 6.2) units) and in those at increased risk of micronutrient deficiency assessed by the risk questionnaire (n 260; mean difference between supplemented and placebo groups 2.5 (95% CI -1.0, 6.1) units). Conclusion: The results provide no evidence for a beneficial effect of daily multivitamin and multimineral supplements on these domains of cognitive function in community-living people over 65 years. However, the possibility of beneficial effects in older people and those at greater risk of nutritional deficiency deserves further attention.Peer reviewedPublisher PD