Stakeholder involvement in systematic reviews: a protocol for a systematic review of methods, outcomes and effects

Background There is an expectation for stakeholders (including patients, the public, health professionals, and others) to be involved in research. Researchers are increasingly recognising that it is good practice to involve stakeholders in systematic reviews. There is currently a lack of evidence about (A) how to do this and (B) the effects, or impact, of such involvement. We aim to create a map of the evidence relating to stakeholder involvement in systematic reviews, and use this evidence to address the two points above. Methods We will complete a mixed-method synthesis of the evidence, first completing a scoping review to create a broad map of evidence relating to stakeholder involvement in systematic reviews, and secondly completing two contingent syntheses. We will use a stepwise approach to searching; the initial step will include comprehensive searches of electronic databases, including CENTRAL, AMED, Embase, Medline, Cinahl and other databases, supplemented with pre-defined hand-searching and contacting authors. Two reviewers will undertake each review task (i.e., screening, data extraction) using standard systematic review processes. For the scoping review, we will include any paper, regardless of publication status or study design, which investigates, reports or discusses involvement in a systematic review. Included papers will be summarised within structured tables. Criteria for judging the focus and comprehensiveness of the description of methods of involvement will be applied, informing which papers are included within the two contingent syntheses. Synthesis A will detail the methods that have been used to involve stakeholders in systematic reviews. Papers from the scoping review that are judged to provide an adequate description of methods or approaches will be included. Details of the methods of involvement will be extracted from included papers using pre-defined headings, presented in tables and described narratively. Synthesis B will include studies that explore the effect of stakeholder involvement on the quality, relevance or impact of a systematic review, as identified from the scoping review. Study quality will be appraised, data extracted and synthesised within tables. Discussion This review should help researchers select, improve and evaluate methods of involving stakeholders in systematic reviews. Review findings will contribute to Cochrane training resources

Changes in posterior scleral collagen microstructure in canine eyes with an ADAMTS10 mutation

Purpose: We aimed to characterize alterations in the posterior scleral collagen microstructure before detectable disease onset in a canine model of open-angle glaucoma caused by an ADAMTS10 mutation. Methods: Collagen orientation, anisotropy degree (proportion of preferentially aligned collagen), and relative density were measured at 0.4 mm spatial resolution using synchrotron wide-angle X-ray scattering. For statistical evaluation of structure parameters, regional averages of the peripapillary and mid-posterior sclera were compared between ADAMTS10 mutant (affected) dogs (n = 3) and age-matched (carrier) controls (n = 3). Results: No marked differences in the general pattern of preferential collagen fibril orientation were noted between the control and affected dogs. The peripapillary sclera of all specimens featured strongly aligned circumferential collagen ringing the optic nerve head. Collagen anisotropy was significantly reduced in the mid-posterior sclera of the affected dogs (carrier: 0.27±0.11; affected: 0.24±0.10; p = 0.032) but was not statistically significantly different in the peripapillary sclera (carrier: 0.46±0.15; affected: 0.45±0.17; p = 0.68). Collagen density was statistically significantly reduced in the affected dogs for the mid-posterior sclera (carrier: 28.1±9.14; affected: 18.3±5.12; p<0.0001) and the peripapillary sclera (carrier: 34.6±9.34; affected: 21.1±6.97; p = 0.0002). Conclusions: Significant alterations in the posterior scleral collagen microstructure are present before the onset of clinical glaucoma in ADAMTS10 mutant dogs. A reduction in fibrous collagen density is likely an important contributory factor in the previously reported mechanical weakening of the sclera in this model. Baseline scleral abnormalities have the potential to interact with intraocular pressure (IOP) elevations in determining the course of glaucoma progression in animal models of the disease, and potentially in human glaucoma

The Influence of Cyber-Sexual Assault on the Mental Health Outcomes of Survivors

Researchers examined data collected from the only national sample of cyber-sexual assault (CBSA) survivors (N = 97; 3.75\% response rate to the online survey) using three valid instruments that measure symptomology of sexual assault. We found that participants scored high across each of the inventories, indicating CBSA survivors respond in ways that are similar to sexual assault survivors concerning emotional dysregulation, depression, and post-traumatic stress symptomology, particularly if they had a history of sexual assault. Implications for counselors are reviewed, and clinical recommendations are offered

Climate Impacts on Agriculture: Implications for Crop Production

Changes in temperature, CO2, and precipitation under the scenarios of climate change for the next 30 yr present a challenge to crop production. This review focuses on the impact of temperature, CO2, and ozone on agronomic crops and the implications for crop production. Understanding these implications for agricultural crops is critical for developing cropping systems resilient to stresses induced by climate change. There is variation among crops in their response to CO2, temperature, and precipitation changes and, with the regional differences in predicted climate, a situation is created in which the responses will be further complicated. For example, the temperature effects on soybean [Glycine max (L.) Merr.] could potentially cause yield reductions of 2.4% in the South but an increase of 1.7% in the Midwest. The frequency of years when temperatures exceed thresholds for damage during critical growth stages is likely to increase for some crops and regions. The increase in CO2 contributes significantly to enhanced plant growth and improved water use efficiency (WUE); however, there may be a downscaling of these positive impacts due to higher temperatures plants will experience during their growth cycle. A challenge is to understand the interactions of the changing climatic parameters because of the interactions among temperature, CO2, and precipitation on plant growth and development and also on the biotic stresses of weeds, insects, and diseases. Agronomists will have to consider the variations in temperature and precipitation as part of the production system if they are to ensure the food security required by an ever increasing population

Combining PPI with qualitative research to engage ‘harder-to-reach’ populations: service user groups as co-applicants on a platform study for a trial

Abstract Background: Patient and public involvement (PPI) in all research studies is recommended from the earliest point and in as many stages as possible. Qualitative research is also recommended in the early stages of designing. complex intervention trials. Combining both together might enable inclusion of ‘harder-to-reach’ perspectives from the target population(s), particularly when the research is intended for their benefit. However, the interface between PPI and qualitative research has received little attention. Methods: In a multi-disciplinary, mixed methods study to inform the design of incentive trials for smoking cessation in pregnancy and breastfeeding, we combined PPI and qualitative research, with some overlap. Mother and baby groups from two geographically separate disadvantaged areas, with diverse experiences of the smoking and breastfeeding, but no training or previous involvement in research, were recruited as PPI research grant co-applicants. An iterative partnership approach facilitated involvement in research conduct and design across all project phases. Group PPI members were also invited to contribute to more formal qualitative data collection, as and when indicated by the research questions, and emerging analysis. Results: We engaged with ‘harder-to-reach’ women in mother and baby group settings, rather than in academic or home environments. These settings were relaxed and informal, which facilitated rapport-building, disclosures of unexpected information and maintained trust. 21 women participated in standard PPI activities: feedback on study protocols and documents; piloting questionnaires and interview schedules. PPI members voiced some different perspectives from those captured within the qualitative dataset. 19 participated in focused qualitative research. Novel aspects were audio recorded PPI discussions, which contributed qualitative data; first, to interpret systematic review findings and construct intervention vignettes for use in the qualitative research; second, to assist with recruitment to improve sample diversity in the formal qualitative dataset; and third, to translate theory and findings presented in a researcher generated logic model into a lay tool. This had face validity for potential trial participants and used the metaphor of a ladder. Conclusions: Combining and overlapping PPI and qualitative research added ‘harder-to-reach’ contributions, sample diversity, trust and engagement in creative approaches beyond what could be achieved through PPI or qualitative research alone. (350/350

In vivo measurements of prelamina and lamina cribrosa biomechanical properties in humans

Purpose: To develop and use a custom virtual fields method (VFM) to assess the biomechanical properties of human prelamina and lamina cribrosa (LC) in vivo. Methods: Clinical data of 20 healthy, 20 ocular hypertensive (OHT), 20 primary open-angle glaucoma, and 16 primary angle-closure glaucoma eyes were analyzed. For each eye, the intraocular pressure (IOP) and optical coherence tomography (OCT) images of the optic nerve head (ONH) were acquired at the normal state and after acute IOP elevation. The IOP-induced deformation of the ONH was obtained from the OCT volumes using a three-dimensional tracking algorithm and fed into the VFM to extract the biomechanical properties of the prelamina and the LC in vivo. Statistical measurements and P values from the Mann-Whitney-Wilcoxon tests were reported. Results: The average shear moduli of the prelamina and the LC were 64.2 ± 36.1 kPa and 73.1 ± 46.9 kPa, respectively. The shear moduli of the prelamina of healthy subjects were significantly lower than those of the OHT subjects. Comparisons between healthy and glaucoma subjects could not be made robustly due to a small sample size. Conclusions: We have developed a methodology to assess the biomechanical properties of human ONH tissues in vivo and provide preliminary comparisons in healthy and OHT subjects. Our proposed methodology may be of interest for glaucoma management

An Effective Strategy for the Synthesis of Biocompatible Gold Nanoparticles Using Cinnamon Phytochemicals for Phantom CT Imaging and Photoacoustic Detection of Cancerous Cells

This is a post-print version of the Pharmaceutical Research Article. The original publication is available at www.springerlink.com. DOI 10.1007/s11095-010-0276-6Purpose: The purpose of the present study was to explore the utilization of cinnamon coated gold nanoparticles (Cin-AuNPs) as CT/optical contrast enhancement agent for detection of cancer cells. Methods: Cin-AuNPs were synthesized by a “Green” procedure and the detailed characterization has been performed by physic-chemical analysis. Cytotoxicity and cellualar uptake studies were carried out in normal human fibroblast and cancerous (PC-3 and MCF-7) cells respectively. The efficacy of detecting cancerous cells was monitored using photoacoustic technique. In vivo biodistribution was studied after IV injection of Cin-AuNPs in mice and a CT phantom model was generated. Results: Biocompatible Cin-AuNPs were synthesized with high purity. Significant uptake of these gold nanoparticles was observed in PC-3 and MCF-7 cells. Cin-AuNPs internalized in cancerous cells facilitate detectable photoacoustic signals. In vivo biodistribution in normal mouse shows steady accumulation of gold nanoparticles in lungs and rapid clearance from blood. Quantitative analysis of CT values in phantom model reveals that the cinnamon phytochemicals coated AuNPs has reasonable attenuation efficiency. Conclusions: The results indicate that these non-toxic Cin-AuNPs can serve as excellent CT/ photoacoustic contrast enhancement agents and may provide a novel approach toward the tumor detection through nanopharmaceuticals.This work has been supported by grants from the National Institutes of Health/National Cancer Institute under the Cancer Nanotechnology Platform program (grant number: 5R01CA119412-01), NIH - 1R21CA128460-01; NIH-SBIR-Contract no. 241, and University of Missouri-Research Board - Program C8761 RB 06-030