Who's minding the shop?:the role of Canadian research ethics boards in the creation and uses of registries and biobanks

Abstract. Background. The amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and biobanks. Methods. Chairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank. Results. There was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied. Conclusion. Participants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation.

Empirical performance of RSSI-based Monte Carlo localisation for active RFID patient tracking systems

The range of potential applications for indoor and campus based personnel localisation has led researchers to create a wide spectrum of different algorithmic approaches and systems. However, the majority of the proposed systems overlook the unique radio environment presented by the human body leading to systematic errors and inaccuracies when deployed in this context. In this paper RSSI-based Monte Carlo Localisation was implemented using commercial 868 MHz off the shelf hardware and empirical data was gathered across a relatively large number of scenarios within a single indoor office environment. This data showed that the body shadowing effect caused by the human body introduced path skew into location estimates. It was also shown that, by using two body-worn nodes in concert, the effect of body shadowing can be mitigated by averaging the estimated position of the two nodes worn on either side of the body. © Springer Science+Business Media, LLC 2012.

Guideline on the design and conduct of cystic fibrosis clinical trials: The European Cystic Fibrosis Society–Clinical Trials Network (ECFS-CTN)

We describe the rationale for disease specific research networks in general as well as the aims and function of the European Cystic Fibrosis Society-Clinical Trials Network (ECFS-CTN) specifically. The ECFS-CTN was founded in 2009 with the aim of improving the quality and quantity of clinical research in the area of cystic fibrosis (CF) in Europe. A network of 18 clinical trial sites in 8 European countries was established according to uniform state-of-the-art quality criteria. To support the ECFS-CTN in the acquisition, planning and conduct of clinical trials, the network is equipped with a coordinating centre, steering and executive committees, and committees for protocol review, standardization, training and networking as well as a data safety monitoring board. A strong partnership with European CF patient parent organizations aims to increase awareness of the need for efficient clinical research and the participation of patients in clinical trials.

The experience of research participation for family caregivers of palliative care cancer patients

There have been concerns raised regarding the ethical merit of involving dying patients and family caregivers as research participants. This study sought feedback from 103 primary family caregivers who had participated in a longitudinal research project. Caregivers were sent a questionnaire regarding the benefits and negative aspects associated with participating in research while also supporting or having supported a relative dying of cancer. The study identified that almost three quarters (71.1%) of the 45 respondents reported benefits of being involved in research and the majority (88.9%) cited no negative aspects associated with research participation. Findings of the study suggest that it is pertinent to invite family caregivers to be involved in palliative care research. Moreover, this study demonstrated that not only is it probably safe for family caregivers to be involved in research but also that many participants actually derive benefits.

Participation of adult mouse bone marrow cells in reconstitution of skin

Results of recent studies have indicated that bone marrow cells can differentiate into various cells of ectodermal, mesodermal, and endodermal origins when transplanted into the body. However, the problems associated with those experiments such as the long latent period, rareness of the event, and difficulty in controlling the processes have hampered detailed mechanistic studies. In the present study, we examined the potency of mouse bone marrow cells to differentiate into cells comprising skin tissues using a skin reconstitution assay. Bone marrow cells from adult green fluorescent protein (GFP)-transgenic mice were transplanted in a mixture of embryonic mouse skin cells (17.5 days post-coitus) onto skin defects made on the backs of nude mice. Within 3 weeks, fully differentiated skin with hair was reconstituted. GFP-positive cells were found in the epidermis, hair follicles, sebaceous glands, and dermis. The localization and morphology of the cells, results of immunohistochemistry, and results of specific staining confirmed that the bone marrow cells had differentiated into epidermal keratinocytes, sebaceous gland cells, follicular epithelial cells, dendritic cells, and endothelial cells under the present conditions. These results indicate that this system is suitable for molecular and cellular mechanistic studies on differentiation of stem cells to various epidermal and dermal cells.

Improving Patient Safety Through Formal and Informal Learning Networks

This paper explores a novel perspective on patient safety improvements, which draws on
contemporary social network and learning theories. A case study was conducted at a Portuguese
acute university hospital. Data collection followed a staged approach, whereby 46 interviews
were conducted involving 49 respondents from a broad array of departments and professional
backgrounds. This case study highlights the importance of two major interlinked factors in
contributing to patient safety improvements. The first of these is the crucial role of formal and
informal, internal and external social networks. The second is the importance and the possible
advantage of combining formal and informal learning. The analysis suggests that initiatives
rooted in formal learning approaches alone do not necessarily lead to the creation of long-term
grounded internal safety networks, and that patient safety improvements can crucially depend on
bottom-up initiatives of communities of practice and informal learning. Traditional research on
patient safety places a strong emphasis on top-down and managerialist approaches and is often
based on the assumption that „safety? learning is primarily formal and context-independent. This
paper suggests that bottom-up initiatives and a combination of formal and informal learning can
make a major contribute to patient safety improvements.

Recurrent vitreous occlusion of glaucoma drainage device tube in a patient with glaucoma in aphakia:A case report

Patients with spontaneous lens dislocation and glaucoma can be challenging to manage. We present a forty-six year old Caucasian lady who was referred with bilateral high intraocular pressure, and was subsequently diagnosed with glaucoma in association with lens dislocation and Marfan syndrome. Baerveldt glaucoma drainage device tubes were inserted in both eyes due to poor response to medical therapy. However, this was complicated by recurrent vitreous occlusion of both glaucoma drainage tubes requiring further multiple surgical interventions. There have not been any further recurrences of vitreous incarceration or posterior segment complications since, but the patient remains under close follow-up. © 2010 Ang et al; licensee BioMed Central Ltd.

Pre-validation methods for developing a patient reported outcome instrument

BACKGROUND: Measures that reflect patients' assessment of their health are of increasing importance as outcome measures in randomised controlled trials. The methodological approach used in the pre-validation development of new instruments (item generation, item reduction and question formatting) should be robust and transparent. The totality of the content of existing PRO instruments for a specific condition provides a valuable resource (pool of items) that can be utilised to develop new instruments. Such 'top down' approaches are common, but the explicit pre-validation methods are often poorly reported. This paper presents a systematic and generalisable 5-step pre-validation PRO instrument methodology.

METHODS: The method is illustrated using the example of the Aberdeen Glaucoma Questionnaire (AGQ). The five steps are: 1) Generation of a pool of items; 2) Item de-duplication (three phases); 3) Item reduction (two phases); 4) Assessment of the remaining items' content coverage against a pre-existing theoretical framework appropriate to the objectives of the instrument and the target population (e.g. ICF); and 5) qualitative exploration of the target populations' views of the new instrument and the items it contains.

RESULTS: The AGQ 'item pool' contained 725 items. Three de-duplication phases resulted in reduction of 91, 225 and 48 items respectively. The item reduction phases discarded 70 items and 208 items respectively. The draft AGQ contained 83 items with good content coverage. The qualitative exploration ('think aloud' study) resulted in removal of a further 15 items and refinement to the wording of others. The resultant draft AGQ contained 68 items.

CONCLUSIONS: This study presents a novel methodology for developing a PRO instrument, based on three sources: literature reporting what is important to patient; theoretically coherent framework; and patients' experience of completing the instrument. By systematically accounting for all items dropped after the item generation phase, our method ensures that the AGQ is developed in a transparent, replicable manner and is fit for validation. We recommend this method to enhance the likelihood that new PRO instruments will be appropriate to the research context in which they are used, acceptable to research participants and likely to generate valid data.

Choosing appropriate patient-reported outcomes instrument for glaucoma research: a systematic review of vision instruments

PURPOSE: To identify vision Patient-Reported Outcomes instruments relevant to glaucoma and assess their content validity.

METHODS: MEDLINE, MEDLINE in Process, EMBASE and SCOPUS (to January 2009) were systematically searched. Observational studies or randomised controlled trials, published in English, reporting use of vision instruments in glaucoma studies involving adults were included. In addition, reference lists were scanned to identify additional studies describing development and/or validation to ascertain the final version of the instruments. Instruments' content was then mapped onto a theoretical framework, the World Health Organization International Classification of Functioning, Disability and Health. Two reviewers independently evaluated studies for inclusion and quality assessed instrument content.

RESULTS: Thirty-three instruments were identified. Instruments were categorised into thirteen vision status, two vision disability, one vision satisfaction, five glaucoma status, one glaucoma medication related to health status, five glaucoma medication side effects and six glaucoma medication satisfaction measures according to each instruments' content. The National Eye Institute Visual Function Questionnaire-25, Impact of Vision Impairment and Treatment Satisfaction Survey-Intraocular Pressure had the highest number of positive ratings in the content validity assessment.

CONCLUSION: This study provides a descriptive catalogue of vision-specific PRO instruments, to inform the choice of an appropriate measure of patient-reported outcomes in a glaucoma context.

Pseudocapsulorrhexis in a patient with iridocorneal endothelial syndrome

We describe a patient with Chandler's syndrome variant of the iridocorneal endothelial syndrome in whom ectopic Descemet's membrane was found intraoperatively on the anterior surface of the lens. Initially, the membrane was confused with the anterior lens capsule during extracapsular cataract extraction, leading to the performance of a pseudocapsulorrhexis. Electron microscopy disclosed that the epilenticular membrane was composed of multiple layers of abnormal basement membrane consistent with the iridocorneal endothelial syndrome.

Non-medical prescribers and pharmacovigilance:participation, competence and future needs

To determine UK non-medical prescribers' (NMPs) (supplementary or independent) current participation and self-reported competence in pharmacovigilance, and their perceptions of training and future needs.

Collective Participation Impacts Social Identity::A Longitudinal Study with Control Data

How does participation in collective activity affect our social identifications and behavior? We investigate this question in a longitudinal questionnaire study conducted at one of the world’s largest collective events – the Magh Mela (a month-long Hindu religious festival in north India). Data gathered from pilgrims and comparable others who did not attend the event show that one month after this mass gathering was over, those who had participated (but not controls) exhibited a heightened social identification as Hindu and increased levels of religious activity (e.g., performing prayer rituals). Additional data gathered from the pilgrim respondents during the festival show that the pilgrims’ perceptions of sharing a common identity with other pilgrims, and of being able to enact their social identity in this event, predicted these outcomes.

Surgical checklist for cataract surgery:progress with the initiative by the Royal College of Ophthalmologists to improve patient safety

PurposeThe World Health Organisation (WHO) identified patient safety in surgery as an important public health matter and advised the adoption of a universal peri-operative surgical checklist. An adapted version of the WHO checklist has been mandatory in the National Health Service since 2010. Wrong intraocular lens (IOL) implantation is a particular safety concern in ophthalmology. The Royal College of Ophthalmologists launched a bespoke checklist for cataract surgery in 2010 to reduce the likelihood of preventable errors. We sought to ascertain the use of checklists in cataract surgery in 2012.Patients and methodsA survey of members of the Royal College of Ophthalmologists seeking views on the use of checklists in cataract surgery. Four hundred and sixty-nine completed responses were received (18% response rate).ResultsRespondents worked in England (75%), Scotland (11%), Wales (5%), Northern Ireland (2%), the Republic of Ireland (1%), and overseas (6%). Ninety-four per cent of respondents support the use of a checklist for cataract surgery and 85% say that they always use a checklist before cataract surgery. Sixty-seven per cent of cataract surgeons stated they undertake a pre-operative team brief. Thirty-six per cent use a cataract surgery checklist developed locally, 18% use the college's bespoke cataract surgery checklist, 39% use a generic surgical checklist, and 4% reported that they do not use a checklist.ConclusionNinety-three per cent of cataract surgeons responding to the questionnaire report using a surgical checklist and 67% use a team brief. However, only 54% use a checklist, which addresses the selection of the correct intraocular implant. We recommend wider adoption of checklists, which address risks relevant to cataract surgery, in particular the possibility of selection of an incorrect IOL.Eye advance online publication, 24 May 2013; doi:10.1038/eye.2013.101.