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Abstract 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.

A computational study is carried out on the aqueous p[K.sub.a] of some saturated and unsaturated cyclic and linear esters and ketones, with the integral equation formalism polarizable continuum model for solvation by using a proton exchange mechanism. The low p[K.sub.a] value has shown that deprotonated diketene has not interconverted to a more stable, less acidic [alpha]-[beta] unsaturated isomer.

Background: General dental practitioners (GDPs) regularly prescribe antibiotics to manage dental infections although most infections can be treated successfully by local measures. Published guidance to support GDPs to make appropriate prescribing decisions exists but there continues to be wide variation in dental antibiotic prescribing. An interview study was conducted as part of the Reducing Antibiotic Prescribing in Dentistry (RAPiD) trial to understand the barriers and facilitators of using local measures instead of prescribing antibiotics to manage bacterial infections.Methods: Thirty semi-structured one-to-one telephone interviews were conducted using the Theoretical Domains Framework (TDF). Responses were coded into domains of the TDF and sub-themes. Priority domains (high frequency: ≥50 % interviewees discussed) relevant to behaviour change were identified as targets for future intervention efforts and mapped onto 'intervention functions' of the Behaviour Change Wheel system.Results: Five domains (behavioural regulation, social influences, reinforcement, environmental context and resources, and beliefs about consequences) with seven sub-themes were identified as targets for future intervention. All participants had knowledge about the evidence-based management of bacterial infections, but they reported difficulties in following this due to patient factors and time management. Lack of time was found to significantly influence their decision processes with regard to performing local measures. Beliefs about their capabilities to overcome patient influence, beliefs that performing local measures would impact on subsequent appointment times as well as there being no incentives for performing local measures were also featured. Though no knowledge or basic skills issues were identified, the participants suggested some continuous professional development programmes (e.g. time management, an overview of published guidance) to address some of the barriers. The domain results suggest a number of intervention functions through which future interventions could change GDPs' antibiotic prescribing for bacterial infections: imparting skills through training, providing an example for GDPs to imitate (i.e. modelling) or creating the expectation of a reward (i.e. incentivisation).Conclusions: This is the first theoretically informed study to identify barriers and facilitators of evidence-based management of patients with bacterial infections among GDPs. A pragmatic approach is needed to address the modifiable barriers in future interventions intended to change dentists' inappropriate prescribing behaviour. [ABSTRACT FROM AUTHOR]

Background Audits of blood transfusion demonstrate around 20% transfusions are outside national recommendations and guidelines. Audit and feedback is a widely used quality improvement intervention but effects on clinical practice are variable, suggesting potential for enhancement. Behavioural theory, theoretical frameworks of behaviour change and behaviour change techniques provide systematic processes to enhance intervention. This study is part of a larger programme of work to promote the uptake of evidence-based transfusion practice. Objectives The objectives of this study are to design two theoretically enhanced audit and feedback interventions; one focused on content and one on delivery, and investigate the feasibility and acceptability. Methods Study A (Content): A coding framework based on current evidence regarding audit and feedback, and behaviour change theory and frameworks will be developed and applied as part of a structured content analysis to specify the key components of existing feedback documents. Prototype feedback documents with enhanced content and also a protocol, describing principles for enhancing feedback content, will be developed. Study B (Delivery): Individual semi-structured interviews with healthcare professionals and observations of team meetings in four hospitals will be used to specify, and identify views about, current audit and feedback practice. Interviews will be based on a topic guide developed using the Theoretical Domains Framework and the Consolidated Framework for Implementation Research. Analysis of transcripts based on these frameworks will form the evidence base for developing a protocol describing an enhanced intervention that focuses on feedback delivery. Study C (Feasibility and Acceptability): Enhanced interventions will be piloted in four hospitals. Semi-structured interviews, questionnaires and observations will be used to assess feasibility and acceptability. Discussion This intervention development work reflects the UK Medical Research Council's guidance on development of complex interventions, which emphasises the importance of a robust theoretical basis for intervention design and recommends systematic assessment of feasibility and acceptability prior to taking interventions to evaluation in a full-scale randomised study. The work-up includes specification of current practice so that, in the trials to be conducted later in this programme, there will be a clear distinction between the control (usual practice) conditions and the interventions to be evaluated. [ABSTRACT FROM AUTHOR]

Background Antibiotic prescribing in dentistry accounts for 9% of total antibiotic prescriptions in Scottish primary care. The Scottish Dental Clinical Effectiveness Programme (SDCEP) published guidance in April 2008 (2nd edition, August 2011) for Drug Prescribing in Dentistry, which aims to assist dentists to make evidence-based antibiotic prescribing decisions. However, wide variation in prescribing persists and the overall use of antibiotics is increasing. Methods RAPiD is a 12-month partial factorial cluster randomised trial conducted in NHS General Dental Practices across Scotland. Its aim is to compare the effectiveness of individualised audit and feedback (A&F) strategies for the translation into practice of SDCEP recommendations on antibiotic prescribing. The trial uses routinely collected electronic healthcare data in five aspects of its design in order to: identify the study population; apply eligibility criteria; carry out stratified randomisation; generate the trial intervention; analyse trial outcomes. Eligibility was determined on contract status and a minimum level of recent NHS treatment provision. All eligible dental practices in Scotland were simultaneously randomised at baseline either to current audit practice or to an intervention group. Randomisation was stratified by single-handed/multi-handed practices. General dental practitioners (GDPs) working at intervention practices will receive individualised graphical representations of their antibiotic prescribing rate from the previous 14 months at baseline and an update at six months. GDPs could not be blinded to their practice allocation. Intervention practices were further randomised using a factorial design to receive feedback with or without: a health board comparator; a supplementary text-based intervention; additional feedback at nine months. The primary outcome is the total antibiotic prescribing rate per 100 courses of treatment over the year following delivery of the baseline intervention. A concurrent qualitative process evaluation will apply theory-based approaches using the Consolidated Framework for Implementation Research to explore the acceptability of the interventions and the Theoretical Domains Framework to identify barriers and enablers to evidence-based antibiotic prescribing behaviour by GDPs. Discussion RAPiD will provide a robust evaluation of A & F in dentistry in Scotland. It also demonstrates that linked administrative datasets have the potential to be used efficiently and effectively across all stages of an randomised controlled trial. Trial registration Current Controlled Trials ISRCTN49204710. [ABSTRACT FROM AUTHOR]

Objectives Behaviour change interventions often target 'important' beliefs. The literature proposes four methods for assessing importance of attitudinal beliefs: elicitation frequency, importance ratings, and strength of prediction (bivariate and multivariate). We tested congruence between these methods in a Delphi study about selective decontamination of the digestive tract ( SDD). SDD improves infection rates among critically ill patients, yet uptake in intensive care units is low internationally. Methods A Delphi study involved three iterations ('rounds'). Participants were 105 intensive care clinicians in the United Kingdom, Canada, and Australia/ New Zealand. In Round 1, semi-structured interviews were conducted to elicit beliefs about delivering SDD. In Rounds 2 and 3, participants completed questionnaires, rating agreement and importance for each belief-statement (9-point Likert scales). Belief importance was assessed using elicitation frequency, mean importance ratings, and prediction of global attitude ( Pearson's correlations; beta-weights). Correlations between indices were computed. Results Participants generated 14 attitudinal beliefs. Indices had adequate variation (frequencies: 4-94, mean importance ratings: 4.93-8.00, Pearson's correlations: ±0.09 to ±0.54, beta-weights: ±0.01 to ±0.30). SDD increases antibiotic resistance was the most important belief according to three methods and was ranked second by beta-weights (behind Overall, SDD benefits patients to whom it is delivered). Spearman's correlations were significant for importance ratings with frequencies and correlations. However, other indices were unrelated. The top four beliefs differed according to the measure used. Conclusions Results provided evidence of congruence across three methods for assessing belief importance. Beta-weights were unrelated to other indices, suggesting that they may not be appropriate as the sole method. Statement of contribution What is already known on this subject? Attitudinal beliefs (specific beliefs about the consequences of performing an action) are key to designing interventions to change intentions and behaviour., The literature reports four methods for assessing the importance of attitudinal beliefs: frequency of elicitation in interviews, importance ratings in questionnaires, and strength of prediction (bivariate and multivariate) of global attitude scores., The congruence between these measures of importance is not known., What does this study add? Four indices of importance were examined in a multi-professional, international study about the use of selective digestive decontamination to prevent infection in intensive care settings., Three indices were correlated with one another., Each method used to assess importance produced a different subset of the most important beliefs. Selection of the most important beliefs should use multiple assessment methods., This evidence suggests that multiple regression approaches may not be appropriate as the sole method for assessing belief importance. [ABSTRACT FROM AUTHOR]

Objectives: To identify predictors of total fertilization failure (TFF) and thereby optimize the primary allocation of patients with no well-defined male factor to either IVF or intracytoplasmatic sperm injection (ICSI). Further, to evaluate the long-term fertility prognosis of couples experiencing TFF., Study Design: A retrospective case-control study including 304 couples with TFF and 304 controls with fertilization after IVF during a 10-year period from year 2000-2010. The controls were the patients with minimum one fertilized oocyte just prior to the cases. Multiple logistic regression analysis was used to evaluate the predictors of TFF., Results: The multiple regression analysis identified the following independent predictors of TFF: female smoking, adjusted odds ratio (AOR) 1.7 (95% CI 1.1-2.3), non-tubal factor AOR 2.2 (95% CI 1.5-3.4), progressive motile spermatozoa after preparation × 10(6)/ml (Log2 scale) AOR 1.4 (95% CI 1.2-1.6). For every oocyte, decreasing from four to one oocytes, the risk of TFF increased with AOR 2.0 (95% CI: 1.5-2.9) and from seven to four oocytes with AOR 1.2 (95%CI: 1.0-1.3), respectively. In case of more than seven oocytes the risk of TFF did not vary significantly by the number of oocytes. Female age, BMI, duration of infertility, earlier natural or IUI conceptions were not predictors of TFF. After a minimum of 30 months of follow-up from the index cycle, 50% of the TFF patients succeeded in a live childbirth compared with 70% of the controls. Only thirty five percent of the total number of births in the TFF patients was after ICSI., Conclusion: The risk of TFF is associated with the number of available oocytes for fertilization, female smoking, non-tubal factor infertility and an apparently minor sperm factor. However, anticipated predictors like advanced female age, duration of infertility and earlier conceptions proved not to have any predictive value. Couples experiencing TFF have a significantly reduced overall long-term chance of live birth compared with controls., (Copyright © 2014. Published by Elsevier Ireland Ltd.)

Background: Hospital-acquired infections (HAIs) are a major cause of morbidity and mortality. Critically ill patients in intensive care units (ICUs) are particularly susceptible to these infections. One intervention that has gained much attention in reducing HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of intravenous (i.v.) antibiotics. SDD may reduce infections and improve mortality, but has not been widely adopted in the UK or internationally. Hence, there is a need to identify the reasons for low uptake and whether or not further clinical research is needed before wider implementation would be considered appropriate., Objectives: The project objectives were to (1) identify and describe the SDD intervention, (2) identify views about the evidence base, (3) identify acceptability of further research and (4) identify feasibility of further randomised controlled trials (RCTs)., Design: A four-stage approach involving (1) case studies of two ICUs in which SDD is delivered including observations, interviews and documentary analysis, (2) a three-round Delphi study for in-depth investigation of clinicians' views, including semi-structured interviews and two iterations of questionnaires with structured feedback, (3) a nationwide online survey of consultants in intensive care medicine and clinical microbiology and (4) semistructured interviews with international clinical triallists to identify the feasibility of further research., Setting: Case studies were set in two UK ICUs. Other stages of this research were conducted by telephone and online with NHS staff working in ICUs., Participants: (1) Staff involved in SDD adoption or delivery in two UK ICUs, (2) ICU experts (intensive care consultants, clinical microbiologists, hospital pharmacists and ICU clinical leads), (3) all intensive care consultants and clinical microbiologists in the UK with responsibility for patients in ICUs were invited and (4) international triallists, selected from their research profiles in intensive care, clinical trials and/or implementation trials., Interventions: SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of i.v. antibiotics., Main Outcome Measures: Levels of support for, or opposition to, SDD in UK ICUs; views about the SDD evidence base and about barriers to implementation; and feasibility of further SDD research (e.g. likely participation rates)., Results: (1) The two case studies identified complexity in the interplay of clinical and behavioural components of SDD, involving multiple staff. However, from the perspective of individual staff, delivery of SDD was regarded as simple and straightforward. (2) The Delphi study (n = 42) identified (a) specific barriers to SDD implementation, (b) uncertainty about the evidence base and (c) bimodal distributions for key variables, e.g. support for, or opposition to, SDD. (3) The national survey (n = 468) identified uncertainty about the effect of SDD on antimicrobial resistance, infection rates, mortality and cost-effectiveness. Most participants would participate in further SDD research. (4) The triallist interviews (n = 10) focused largely on the substantial challenges of conducting a large, multinational clinical effectiveness trial., Conclusions: There was considerable uncertainty about possible benefits and harms of SDD. Further large-scale clinical effectiveness trials of SDD in ICUs may be required to address these uncertainties, especially relating to antimicrobial resistance. There was a general willingness to participate in a future effectiveness RCT of SDD. However, support was not unanimous. Future research should address the barriers to acceptance and participation in any trial. There was some, but a low level of, interest in adoption of SDD, or studies to encourage implementation of SDD into practice., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 25. See the NIHR Journals Library website for further project information.