Objectives: To develop a conceptual framework of preferences for interventions in the context of randomised controlled trials (RCTs), as well as to examine the extent to which preferences affect recruitment to RCTs and modify the measured outcome in RCTs through a systematic review of RCTs that incorporated participants' and professionals' preferences. Also to make recommendations on the role of participants' and professionals' preferences in the evaluation of health technologies.Data sources: Electronic databases.Review methods: The conceptual review was carried out on published papers in the psychology and economics literature concerning concepts of relevance to patient decision-making and preferences, and their measurement. For the systematic review, studies across all medical specialities meeting strict criteria were selected. Data were then extracted, synthesised and analysed.Results: Key elements for a conceptual framework were found to be that preferences are evaluations of an intervention in terms of its desirability and these preferences relate to expectancies and perceived value of the process and outcome of interventions. RCTs differed in the information provided to patients, the complexity of techniques used to provide that information and the degree to which preference elicitation may simply produce pre-existing preferences or actively construct them. Most current RCTs used written information alone. Preference can be measured in many different ways and most RCTs did not provide quantitative measures of preferences, and those that did tended to use very simple measures. The second part of the study, the systematic review included 34 RCTs. The findings gave support to the hypothesis that preferences affect trial recruitment. However, there was less evidence that external validity was seriously compromised. There was some evidence that preferences influenced outcome in a proportion of trials. However, evidence for preference effects was weaker in large trials and after accounting for baseline differences. Preference effects were also inconsistent in direction. There was no evidence that preferences influenced attrition. Therefore, the available evidence does not support the operation of a consistent and important 'preference effect'. Interventions cannot be categorised consistently on degree of participation. Examining differential preference effects based on unreliable categories ran the risk of drawing incorrect conclusions, so this was not carried out.Conclusions: Although patients and physicians often have intervention preferences, our review gives less support to the hypothesis that preferences significantly compromise the internal and external validity of trials. This review adds to the growing evidence that when preferences based on informed expectations or strong ethical objections to an RCT exist, observational methods are a valuable alternative. All RCTs in which participants and/or professionals cannot be masked to treatment arms should attempt to estimate participants' preferences. In this way, the amount of evidence available to answer questions about the effect of treatment preferences within and outwith RCTs could be increased. Furthermore, RCTs should routinely attempt to report the proportion of eligible patients who refused to take part because of their preferences for treatment. The findings also indicate a number of approaches to the design, conduct and analysis of RCTs that take account of participants' and/or professionals' preferences. This is referred to as a methodological tool kit for undertaking RCTs that incorporate some consideration of patients' or professionals' preferences. Future research into the amount and source of information available to patients about interventions in RCTs could be considered, with special emphasis on the relationship between sources inside and outside the RCT context. Qualitative research undertaken as part of ongoing RCTs might be especially useful. The processes by which this information leads to preferences in order to develop or extend the proposed expectancy-value framework could also be examined. Other areas for consideration include: how information about interventions changes participants' preferences; a comparison of the feasibility and effectiveness of different informed consent procedures; how strength of preference varies for different interventions within the same RCT and how these differences can be taken account of in the analysis; the differential effects of patients' and professionals' preferences on evidence arising from RCTs; and whether the standardised measurement of preferences within all RCTs ( and analysis of the effect on outcome) would allow the rapid development of a significant evidence base concerning patient preferences, albeit in relation to a single preference design.

/pdf/conceptual-framework-and-systematic-review-of-the-effects-of-445kc3dncj.pdf

Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials.

A single topical agent is clinically equivalent to the combination of topical and oral antibiotic treatment for otitis externa

Bleaching gel containing hydrogen peroxide (H2O2) cause damages in pulp tissue. This study investigated the action of a topical anti-inflammatory, the Otosporin®, in rats' bleached teeth with the null hypothesis of which the Otosporin® is no able to minimize the pulp inflammation that bleaching gel generates. The rat's molars were divided into groups: BLE: bleached (35% H2O2 concentration /single application of 30 min); BLE-O: bleached followed by Otosporin® (10 min); and control: placebo gel. In the second day after dental bleaching, the rats were killed, and the jaws were processed for hematoxylin-eosin and immunohistochemistry analysis for tumor necrosis factor alpha (TNF-α), interleukin (IL)-6 and IL-17. The data collected were subjected to Kruskal-Wallis and Dunn statistical tests with at a 5% level of significance (p 0.05). The BLE group had a high immunoexpression of TNF-α than BLE-O and control groups (p 0.05). The topical anti-inflammatory Otosporin® can reduce pulp inflammation after dental bleaching in the rat teeth.

/pdf/in-vivo-study-of-the-action-of-a-topical-anti-inflammatory-3cnoakmjhm.pdf

In Vivo Study of the Action of a Topical Anti-Inflammatory Drug In Rat Teeth Submitted To Dental Bleaching.

The relation of patient satisfaction with treatment of otitis externa to clinical outcomes: development of an instrument.

Topical eardrops are commonly prescribed by otolaryngologists and general practitioners and many believe that patient compliance is poor, although this has not been studied in a properly controlled manner. Thirty-nine patients with otitis externa were reviewed four times during a two-week course of topical eardrops and their treatment compliance studied. The patients tended to undermedicate themselves, and this tendency increased over the two-week period. Patients were administering significantly fewer drops by the end of day 11 than by the end of day 3 (p = 0.2). Compliance patterns were extremely poor, in that only 40 per cent of patients were managing to self-medicate within a 25 per cent error margin by the end of day 3. These findings may have future implications in the ongoing debate on eardrop use.

Accuracy of patient self-medication with topical eardrops.

SummaryAn open, multi-centre study was carried out in general practice to compare the efficacy, tolerability and acceptability of a neomycin/ dexamethasone preparation administered by spray (‘Otomize’) and neomycin/polymyxin B/hydrocortisone administered as drops (‘Otosporin’) in the treatment of 187 patients with otitis externa. Patients were allocated at random to receive one or other preparation 3-times daily for 10 days irrespective of response and were followed up again 14 days after cessation of therapy. Assessments were made on entry and at Days 10 and 24 of the severity of erythema, swelling and debris. A global assessment of clinical outcome was made by the doctor on Day 10. There were no significant differences between the two groups at the start of treatment. Significant improvement occurred in both groups from Day 0 to Day 10 and from Day 10 to Day 24 in all symptoms, but no statistically significant differences were recorded between the two drugs. However, significantly more patients in the ‘...

Comparative efficacy and tolerability of two antibacterial/ anti-inflammatory formulations (‘Otomize’ spray and ‘Otosporin’ drops) in the treatment of otitis externa in general practice

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Comparative efficacy and tolerability of two antibacterial/ anti-inflammatory formulations (‘Otomize’ spray and ‘Otosporin’ drops) in the treatment of otitis externa in general practice