Consent processes in cluster-randomised trials in residential facilities for older adults : a systematic review of reporting practices and proposed guidelines

Objective: To assess the quality of reported consent processes of cluster-randomised trials conducted in residential facilities for older people and to explore whether the focus on improving the general conduct and reporting of cluster-randomised trials influenced the quality of conduct and reporting of ethical processes in these trials. Design: Systematic review of cluster-randomised trials reports, published up to the end of 2010. Data sources: National Library of Medicine (Medline) via PubMed, hand-searches of BMJ, Journal of the American Medical Association, BMC Health Services Research, Age and Ageing and Journal of the American Geriatrics Society, reference search in Web of Knowledge and consultation with experts. Eligibility for selecting studies: Published cluster-randomised trials where the unit of randomisation is a part or the whole of a residential facility for older people, without language or year of publication restrictions. Results: We included 73 trials. Authors reported ethical approval in 59, obtaining individual consent in 51, and using proxies for this consent in 37, but the process to assess residents’ capacity to consent was clearly reported in only eight. We rated only six trials high for the quality of consent processes. We considered that individual informed consent could have been waived legitimately in 14 of 22 trials not reporting obtaining consent. The proportions reporting ethical approval and quality of consent processes were higher in recent trials. Conclusions: Recently published international recommendations regarding ethical conduct in cluster-randomised trials are much needed. In relation to consent processes when cognitively impaired individuals are included in these trials, we provide a six-point checklist and recommend the minimum information to be reported. Those who lack capacity in trials with complex designs should be afforded the same care in relation to consent as competent adults in trials with simpler designs

Regulatory Body Shops

Agencies do not always write their own rules. Contractors assist agencies in nearly all tasks relating to rulemaking, including reviewing public comments, conducting specialized research, and writing regulatory text. Despite perceptions that contractors’ roles are entirely ministerial, the reality is that contractors fulfill many more functions in the rulemaking process than is commonly understood, including everything right “up to pushing the big red policymaking button,” as one agency employee put it. The use of contractors in rulemaking fits within a broader pattern of increased government reliance on service contractors. Scholars have documented a bevy of governance concerns relating to ethics, capacity, and more, stemming from the fact that contractors are in privity with the government, not the public. This scholarship does not take up the implications of service contracting for rulemaking, the primary mode of executive branch lawmaking, nor does it delineate between types of contracting arrangements, which vary dramatically. This Article takes variation in rulemaking contracting arrangements seriously. We define three types: ministerial contractors, who perform administrative work; expertise contractors, who provide discrete scientific and technical inputs; and regulatory body shops, which are embedded into agencies and function like staff. We argue that while the former two arrangements pose minimal risks to an agency, regulatory body shops are a different story. Not only do they open the door to conflicts of interest that are not adequately addressed under current law, they also threaten the quality of agency reasoning and have the potential to hollow out an agency’s rulemaking apparatus over the long run. Reliance on regulatory body shops has the potential to put an agency’s rules in legal jeopardy by violating the Administrative Procedure Act and diminishing an agency’s claim to Chevron deference. These various risks, which pose challenges for the quality of public decision-making, sit in tension with the reality that some agencies lack adequate resources to staff their rulemakings and turn to regulatory body shops as a pragmatic matter. The Article concludes with reforms to help agencies responsibly manage the risks posed by regulatory body shops

CQ and the Invention of Modernism

This essay discusses the relationship between the invention of modernism as a category and the journal 'Critical Quarterly'

PEN and the Universal Declaration of Human Rights

This is a pamphlet about the history of the relationship between International PEN and the Universal Declaration of Human Right

Diffusion of Oxygen and Lithium Isotopes at a Contact between the Bushveld Complex and Metasedimentary Rock: Implications for the Timescale of Phepane Dome Diapirism

Within the Eastern Lobe of the Bushveld Complex, the Phepane Dome is a circular structure of metasedimentary rock hypothesized to have formed as a wallrock diapir. To constrain the duration of Phepane Dome formation using one-dimensional diffusion models of oxygen and lithium exchange between the Bushveld Complex and the Phepane Dome, samples taken across the contact between these two lithologies were measured for their O and Li isotopic compositions and Li concentrations. Models of O and Li diffusion through melt and through aqueous fluid were fit to the data, resulting in a diffusive distance of 1.0 m for oxygen and 14.1 m for lithium. Using experimentally constrained parameters for O and Li diffusion, a range of 2 kyrs to 2 Myrs was calculated from the diffusive distances. This is consistent with previous studies of the time for crystallization of the Bushveld Complex and a model of Phepane diapir development

The general practitioner workforce crisis in England : a qualitative study of how appraisal and revalidation are contributing to intentions to leave practice

Background The general practice (GP) workforce in England is in crisis, with declining morale and job satisfaction, increasing early retirement and declining interest in training to become a GP. We recently reported on factors that are influencing this, with appraisal and revalidation emerging as an unexpected finding; 28.6 % of GPs stating an intention to leave general practice within the next 5 years included this as ‘very important’ or ‘important’ to their decision. In this study we undertook a secondary analysis to identify how the experience of appraisal and revalidation might be influencing intentions to leave general practice. Methods Qualitative analysis of free text comments made by GPs in a survey of career intentions. All comments that included mention of appraisal or revalidation were extracted. Emergent themes were identified and a coding framework devised. Results Forty-two participants made comments that related to appraisal and revalidation. Compared to all 1192 participants who completed the main survey, they were older (76.2 % compared to 46.2 % aged 50 years and older), with more years’ general practice experience (80.0 % compared to 48.0 % with >20 years’ experience) and more likely to state an intention to retire within 5 years (72.2 % compared to 41.9 %). Key themes were appraisal and revalidation as: a bureaucratic, inflexible exercise that added to an already pressured workload; an activity that has little educational value, relevance to professional development or quality of care; and an issue that contributes to low morale, work-related distress and intentions to leave general practice. Revalidation was depicted as a cumbersome tick-box exercise that had little to do with quality of care or protecting patients. There were no comments that countered these negative views. Conclusions While the representativeness of these comments to the experience of GPs as a whole cannot be judged, it is likely that that they reflect the concerns of GPs whose experience of appraisal and revalidation is influencing their intention to leave general practice. Through its impact on GP morale and burnout, the current appraisal and revalidation system in England appears to be contributing to the workforce crisis. The findings indicate that the appraisal system may be in urgent need of re-design to increase its relevance to individual GPs’ experience and seniority, clinical activities being undertaken and professional development needs

The Limits of Foreign Aid Diplomacy: How Bureaucratic Design Shapes Aid Distribution

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/113691/1/isqu12191-sup-0001-appendixS1.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/113691/2/isqu12191.pd

Bureaucratic politics: blind spots and opportunities in political science

Bureaucracy is everywhere. Unelected bureaucrats are a key link between government and citizens, between policy and implementation. Bureaucratic politics constitutes a growing share of research in political science. But the way bureaucracy is studied varies widely, permitting theoretical and empirical blind spots as well as opportunities for innovation. Scholars of American politics tend to focus on bureaucratic policy making at the national level, while comparativists often home in on local implementation by street-level bureaucrats. Data availability and professional incentives have reinforced these subfield-specific blind spots over time.We highlight these divides in three prominent research areas: the selection and retention of bureaucratic personnel, oversight of bureaucratic activities, and opportunities for influence by actors external to the bureaucracy. Our survey reveals how scholars from the American and comparative politics traditions can learn from one another