There are five downloadable content (DLC) packs, including three challenge packs and two character packs. Each challenge pack has four short levels, some packed with fiendish traps, others swarming with enemies. Each can be played solo or co-op and requires players to beat either a time challenge or score challenge to win. Character packs let you play through the entire game as characters other than Lara Croft and Totec.
Grappling With A Guardian: Part 1 Download
When parents are asked to consider enrolling their child in a paediatric clinical trial their primary responsibility is the best interests of their child. This role is very different to an adult deciding about their own participation in a trial, whose role involves exercising individual autonomy [1]. Grappling with complex, medical information is always part of trial decision making but when this is on behalf of a vulnerable and dependent child, rather than to serve one's own rights and interests, the decision will likely feel more serious and possibly overwhelming. Despite this fundamental difference between trials in adult and paediatric medicine, relatively little is known about how the particular role of parents influences the communication about a trial. Insight into this is important if we are to improve families' experiences of trial recruitment, as well as optimise enrolment procedures and suggest appropriate directions for future research.
This discussion does not aim to make specific recommendations for how to discuss randomised clinical trials with parents, rather its intention is to increase awareness of how parents make sense of trials and suggest directions for future research to improve the experience of recruitment to trials from the perspective of all parties involved.
The seriousness of the child's condition and the urgency surrounding trial entry will be important influences on how parents experience recruitment to trials, their sense of vulnerability, and the success of communication [23]. In turn, these will have consequences for whether parents retain a sense that they have operated in their child's best interests [30]. Parents considering oncology and neonatal trials report particularly high levels of distress during trial discussions and a sense that this impairs their ability to ask questions or seek additional information [31] occasionally leading them to later doubt their decisions [32]. In these situations the thoughts and emotions of parents are dominated by the fact that they have a very sick child [33] or worse, the fear that their child might die [34]. By contrast, parents of children with less serious chronic illnesses report more comfort in making decisions about trial entry [32] and in judging what is in the best interests of the child because they have experience of the disease. It follows that parents' priorities will vary with the seriousness of their child's illness. For example, parents of children participating in research on mild to moderate asthma rated "learn more about disease" as the primary motivation (from 14 choices) [35]. In chronic childhood illness, the day to day management of the condition, the child's quality of life and the simple practicalities of trial participation may gain importance. This is in marked contrast to parents of children whose lives were in the balance, some of whom struggled even to understand or recall that research participation was voluntary [10].
The generally high rates of recruitment to trials in neonatology [37] and childhood cancer [38] suggests the level of threat and parents' consequent needs for hope could be important influences on how they view trials. Parents of chronically and terminally ill children stated that they were prepared to take greater risks in treatment in the hope of a cure [7]. Similarly, parents' decisions about Phase 1 cancer trials, which can bring side-effects and offer little chance of long term medical benefit, may turn upon a fear of 'giving-up' on their child and the need to 'leave no stone unturned'[39, 40]. High recruitment rates may also be testament to the importance that is deservedly placed on research in neonatology and childhood cancer by both parents and trial staff [41, 42]. But they could also be a sign of parents' reluctance to decline a trial where it involves saying "no" to the clinical team on whom their child's care depends. By contrast parents of healthy children considering participation in vaccine research believed that children should only take part in research where the medical benefits outweigh any potential risk [43]. Work comparing what researchers say and intend when they discuss trials with parents, and what parents interpret from these discussions will yield further insights into the challenges for both parties [44] and how they co-construct their views of trials and their respective roles.
In deciding about hypothetical research scenarios, parents and children were more likely to respond intuitively and emotionally to research information than to systematically attempt to consider and weight all the available information. The result was that the 'information' participants used to underpin their decisions was often very different to the information that the researchers intended them to use [45]. Participants' emotional responses to information were shaped by their particular life experiences. Similarly, Chantler and colleagues report that parents who received the same information about a vaccine study varied widely in their perceptions of the risks of the trial, with some seeing it as potentially dangerous while others viewed it as safe with no negative effects. Parents from a professional background in science or ongoing experience of medical care were less likely to cite anxiety and unfamiliarity as a reason for declining the trial, and in the view of the authors, were more open to research and better able to judge the trial's importance and value [43].
If the same information can mean different things to different people, clinicians' assessment of risk will also be influenced by their professional experience, and trial risks as seen by parents may be very different to those perceived by trial staff. Moreover, relative risk, a concept familiar to clinicians accustomed to the uncertainty that is intrinsic to medical practice, could seem very different to parents for whom even improbable risks may be intolerable [46]. Parents and investigators agreed that the risks associated with participation in clinical anaesthesia or surgery research was the most important information to disclose, but parents were more convinced than the investigators of the importance of disclosing the benefits of the research [47]. One interpretation is that risks resonate more deeply with parents and they therefore need to balance these with positive information. Similarly, clinicians viewed the CANDA trial as a low risk, routine trial of broadly equivalent interventions [48] but many parents consenting to the trial viewed it as offering an otherwise unavailable option which might save their baby's life. To the clinician research can be considered low risk when it involves no greater risk than conventional treatment. To the parent everything is high risk because they have a sick child.
Discussions about trial participation may have lasting effects for those who decline trials as well as those who accept. Non participants report inaccurate [65] or even harmful misconceptions [48] after being approached about research. Those conducting trials need to understand the processes that underpin these difficulties if they are to be ameliorated. Concern that those who decline or drop out may come to regret their decision [65] might be extended to consider how individuals approached about trials may differ in their tendency to trust others. Evidence suggests that a substantial minority of people find it difficult to trust other people [66] and are less likely to perceive relationships with health professionals as supportive [67]. Such people may be especially at risk of harmful misconceptions if trialists cannot vary their approach according to individual needs. Indeed, the assumption that 'good' communication is synonymous with providing information that is ever more specific or systematic runs counter to the requirement, in complex discussions about trials, to select and tailor according to individual need [59]. There is, of course, a baseline level of information necessary for informed consent [25]. Beyond this, trialists and ethicists could consider how far communication about trials can be configured around the needs and preferences of individual parents [68] as well as the social norms of the setting [25].
Of the few studies that have considered group differences in trial recruitment, most have focussed on families of children with leukaemia. How parents from different socio-demographic backgrounds experience trials has not been explored, though researchers have investigated group differences in rates of trial participation and researcher-defined understanding of trials. Miller and colleagues [59] report that low socio-economic status (SES) and membership of a minority ethnic group (in this case largely Hispanic) was associated with lower understanding of key components of informed consent. A related study reported no differences in likelihood to enrol a child in a trial between English speaking majority parents, English speaking minority parents and non-English speaking minority parents [69]. Parents in the non-English speaking group asked fewer questions than parents in the other groups. The authors link this to Latino cultural norms such as 'respeto' and 'fatalismo' which discourage questions and interactivity and encourage the idea that God will decide the fate of the child [70]. Emphasising the diversity that also exists within different ethnic groups [70] the authors point out that such traditional values are far from uniform within Hispanic groups and tend to be less common in immigrant groups with high SES. 2ff7e9595c
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