首页> 外文期刊>Journal of Epidemiology & Community Health >Behavioural dynamics of a clinical trial of sunscreens for reducing solar keratoses in Victoria, Australia
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Behavioural dynamics of a clinical trial of sunscreens for reducing solar keratoses in Victoria, Australia

机译:澳大利亚维多利亚州减少太阳角化症的防晒霜临床试验的行为动力学

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Objective—To determine whether the behaviour of participants based on perception of treatment group in a randomised trial contributed to clinical outcome. Design—A double blind randomised controlled trial of the effect of daily application of SPF 17 broad spectrum sunscreen cream (or placebo) on solar keratoses. Setting—A rural city in Victoria, Australia. Residents aged 40 years or over were invited by letter to attend for a skin cancer screening check. Of these, 588 people with between one and 30 solar keratoses enrolled in the trial and 431 completed the trial, which extended over a six month period that included summer. Participants' perceptions of their treatment allocation, adherence with the treatment regimen, adoption of other sun protection behaviours, side effects, and perceptions of change in condition were measured at two monthly intervals. Results—There were no significant differences between those who completed the study and those that did not for sex, age, treatment group, skin type, number of solar keratoses or correct perception of treatment group. Thirty per cent of those completing the study correctly guessed their treatment allocation, and people were just as likely to be right as to be wrong when they stated their opinion about their treatment allocation (z=1.04; p=0.15). Study group, skin type, amount of time spent outdoors, presence of side effects, perceptions of change in skin condition did not significantly predict correct perception of treatment allocation. Multi-variate analysis of variance indicated that adoption of other sun protection and adherence with cream use were not significantly affected by actual treatment allocation, correct perception of treatment allocation nor by their interaction. Poisson regression analysis showed a significantly lower difference ratio of solar keratoses in the sunscreen group compared with the placebo base cream group (OR 0.55; CI=0.46, 0.64), and for women compared with men (OR=0.76; CI=0.63, 0.93) but no independent effect of any of the indices of other sun protection or adherence. Conclusions—A sufficient level of commitment to study procedures was achieved, so that trial participants did not adopt other behaviours that affected treatment outcomes. It is recommended that the potential threat to validity posed by the behaviour of participants be recognised at an early stage in planning of clinical trials, so that strategies to deal with this can be integrated into study protocols.
机译:目的—基于随机试验中基于治疗组的知觉来确定参与者的行为是否有助于临床结果。设计-每日应用SPF 17广谱防晒霜(或安慰剂)对太阳角化病影响的双盲随机对照试验。设置-澳大利亚维多利亚州的一个乡村城市。邀请40岁以上的居民参加皮肤癌筛查检查。其中,有588人患有1至30个太阳角化病,并有431人完成了试验,试验持续了六个月,其中包括夏天。参与者每隔两个月测量一次他们对治疗分配,对治疗方案的依从性,采用其他防晒措施,副作用以及病情变化的看法。结果-完成这项研究的人与没有完成这项研究的人在性别,年龄,治疗组,皮肤类型,日光性角化病数量或对治疗组的正确认识上无显着差异。完成研究的受访者中有30%正确地猜出了他们的治疗方案分配,当人们对自己的治疗方案发表意见时,人们很可能是对的还是错的(z = 1.04; p = 0.15)。研究组,皮肤类型,在户外度过的时间,副作用的存在,对皮肤状况变化的感知并不能显着预测对治疗分配的正确认识。多变量方差分析表明,采用其他防晒措施和坚持使用乳霜并不受实际治疗方案,对治疗方案的正确理解或相互作用的影响。 Poisson回归分析显示,与安慰剂基础霜剂组相比,防晒霜组中的太阳角化酶差异率显着较低(OR 0.55; CI = 0.46,0.64),女性与男性相比(OR = 0.76; CI = 0.63,0.93) ),但没有其他防晒或坚持指标的独立影响。结论—对研究程序的承诺程度足够高,因此试验参与者没有采取影响治疗结果的其他行为。建议在临床试验计划的早期阶段就认识到参与者行为对有效性造成的潜在威胁,以便将解决这一问题的策略纳入研究方案。

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