Objective  To examine the psychometric properties of a revised scale, named ‘observing patient involvement in decision making’ (OPTION), by analysing its reapplication to a sample of routine primary care consultations. The OPTION instrument assesses to what degree clinicians involve patients in decision making.Design  Cross‐sectional assessment of medical interaction by two calibrated raters.Setting  Primary care.Participants  Twenty‐one general practitioners provided 186 consultations for assessment.Measurements  Observational score using the OPTION instrument.Results  Compared with the first version of the OPTION scale, the revised scale that uses a magnitude instead of an attitude scale, when applied to the same data set, resulted in improvement in the scale's reliability and to lower scores for the levels of involvement achieved by the practitioners. Factor analysis confirms that it is acceptable to regard the scale as a single construct. Although there is moderate variability when raters are assessed on an item by item basis, the agreements between raters at the level of the overall OPTION score is high (the intraclass correlation coefficient scores for total OPTION score was 0.77), a level that is acceptable for the evaluation of a set of consultations per practitioner (e.g. between 5 and 10 consultations), where aggregate scores would be used for determining overall performance.Conclusions  We conclude that OPTION is sufficiently reliable to be used for formal assessment at the level of the whole instrument (all 12 items).

Rationale, aims, and objectives: “Implementation science,” the scientific study of methods translating research findings into practical, useful outcomes, is contested and complex, with unpredictable use of results from routine clinical practice and different levels of continuing assessment of implementable interventions. The authors aim to reveal how implementation science is presented and understood in health services research contexts and clarify the foundational concepts: diffusion, dissemination, implementation, adoption, and sustainability, to progress knowledge in the field.Method: Implementation science models, theories, and frameworks are critiqued, and their value for laying the groundwork from which to implement a study's findings is emphasised. The paper highlights the challenges of turning research findings into practical outcomes that can be successfully implemented and the need for support from change agents, to ensure improvements to health care provision, health systems, and policy. The paper examines how researchers create implementation plans and what needs to be considered for study outputs to lead to sustainable interventions. This aspect needs clear planning, underpinned by appropriate theoretical paradigms that rigorously respond to a study's aims and objectives.Conclusion: Researchers might benefit from a return to first principles in implementation science, whereby applications that result from research endeavours are both effective and readily disseminated and where interventions can be supported by appropriate health care personnel. These should be people specifically identified to promote change in service organisation, delivery, and policy that can be systematically evaluated over time, to ensure high‐quality, long‐term improvements to patients' health.

Infliximab and ciclosporin are of similar efficacy in treating acute severe ulcerative colitis, but there has been no comparative evaluation of their relative clinical effectiveness and cost-effectiveness. In this mixed methods, open-label, pragmatic randomised trial, we recruited consenting patients aged 18 years or older at 52 district general and teaching hospitals in England, Scotland, and Wales who had been admitted, unscheduled, with severe ulcerative colitis and failed to respond to intravenous hydrocortisone within about 5 days. Patients were randomly allocated (1:1) to receive either infliximab (5 mg/kg intravenous infusion given over 2 h at baseline, and again at 2 weeks and 6 weeks after the first infusion) or ciclosporin (2 mg/kg per day by continuous infusion for up to 7 days, followed by twice-daily tablets delivering 5·5 mg/kg per day for 12 weeks). Randomisation used a web-based password-protected site, with a dynamic algorithm to generate allocations on request, thus protecting against investigator preference or other subversion, while ensuring that each trial group was balanced by centre, which was the only stratification used. Local investigators and participants were aware of the treatment allocated, but the chief investigator and analysts were masked. Analysis was by treatment allocated. The primary outcome was quality-adjusted survival—ie, the area under the curve (AUC) of scores from the Crohn's and Ulcerative Colitis Questionnaire (CUCQ) completed by participants at baseline, 3 months, and 6 months, then every 6 months from 1 year to 3 years. This trial is registered with the ISRCTN Registry, number ISRCTN22663589. Between June 17, 2010, and Feb 26, 2013, 270 patients were recruited. 135 patients were allocated to the infliximab group and 135 to the ciclosporin group. 121 (90%) patients in each group were included in the analysis of the primary outcome. There was no significant difference between groups in quality-adjusted survival (mean AUC 564·0 [SD 241·9] in the infliximab group vs 587·0 [226·2] in the ciclosporin group; mean adjusted difference 7·9 [95% CI −22·0 to 37·8]; p=0·603). Likewise, there were no significant differences between groups in the secondary outcomes of CUCQ scores, EQ-5D, or SF-6D scores; frequency of colectomy (55 [41%] of 135 patients in the infliximab group vs 65 [48%] of 135 patients in the ciclosporin group; p=0·223); or mean time to colectomy (811 [95% CI 707–912] days in the infliximab group vs 744 [638–850] days in the ciclosporin group; p=0·251). There were no differences in serious adverse reactions (16 reactions in 14 participants receiving infliximab vs ten in nine patients receiving ciclosporin); serious adverse events (21 in 16 patients vs 25 in 17 patients); or deaths (three in the infliximab group vs none in the ciclosporin group). There was no significant difference between ciclosporin and infliximab in clinical effectiveness. NIHR Health Technology Assessment programme.

Objectives: Individuals with hearing loss often report a need for increased effort when listening, particularly in challenging acoustic environments. Despite audiologists’ recognition of the impact of listening effort on individuals’ quality of life, there are currently no standardized clinical measures of listening effort, including patient-reported outcome measures (PROMs). To generate items and content for a new PROM, this qualitative study explored the perceptions, understanding, and experiences of listening effort in adults with severe-profound sensorineural hearing loss before and after cochlear implantation. Design: Three focus groups (1 to 3) were conducted. Purposive sampling was used to recruit 17 participants from a cochlear implant (CI) center in the United Kingdom. The participants included adults (n = 15, mean age = 64.1 years, range 42 to 84 years) with acquired severe-profound sensorineural hearing loss who satisfied the UK’s national candidacy criteria for cochlear implantation and their normal-hearing significant others (n = 2). Participants were CI candidates who used hearing aids (HAs) and were awaiting CI surgery or CI recipients who used a unilateral CI or a CI and contralateral HA (CI + HA). Data from a pilot focus group conducted with 2 CI recipients were included in the analysis. The data, verbatim transcripts of the focus group proceedings, were analyzed qualitatively using constructivist grounded theory (GT) methodology. Results: A GT of listening effort in cochlear implantation was developed from participants’ accounts. The participants provided rich, nuanced descriptions of the complex and multidimensional nature of their listening effort. Interpreting and integrating these descriptions through GT methodology, listening effort was described as the mental energy required to attend to and process the auditory signal, as well as the effort required to adapt to, and compensate for, a hearing loss. Analyses also suggested that listening effort for most participants was motivated by a need to maintain a sense of social connectedness (i.e., the subjective awareness of being in touch with one’s social world). Before implantation, low social connectedness in the presence of high listening effort encouraged self-alienating behaviors and resulted in social isolation with adverse effects for participant’s well-being and quality of life. A CI moderated but did not remove the requirement for listening effort. Listening effort, in combination with the improved auditory signal supplied by the CI, enabled most participants to listen and communicate more effectively. These participants reported a restored sense of social connectedness and an acceptance of the continued need for listening effort. Conclusions: Social connectedness, effort-reward balance, and listening effort as a multidimensional phenomenon were the core constructs identified as important to participants’ experiences and understanding of listening effort. The study’s findings suggest: (1) perceived listening effort is related to social and psychological factors and (2) these factors may influence how individuals with hearing loss report on the actual cognitive processing demands of listening. These findings provide evidence in support of the Framework for Understanding Effortful Listening a heuristic that describes listening effort as a function of both motivation and demands on cognitive capacity. This GT will inform item development and establish the content validity for a new PROM for measuring listening effort.

There are few systematic studies of the incidence of cross-border fertility care and even fewer reports of qualitative research with those undertaking treatment outside their country of origin. This paper reports findings from a qualitative study of UK residents with experience of cross-border care: the socio-demographic characteristics of UK travellers; their reasons for seeking treatment abroad; the treatments they sought; the destinations they chose and the outcomes of their treatment. Data regarding cross-border fertility treatment were collected from a purposive sample of 51 people by means of in-depth, semi-structured interviews between May 2009 and June 2010. Data were analysed using a systematic thematic coding method and also subjected to quantitative translation. Patient motivations for travelling abroad are complex. A desire for timely and affordable treatment with donor gametes was evident in a high number of cases (71%). However, most people gave several reasons, including: the cost of UK treatment; higher success rates abroad; treatment in a less stressful environment and dissatisfaction with UK treatment. People travelled to 13 different countries, the most popular being Spain and the Czech Republic. Most organized their own treatment and travel. The mean age of women seeking treatment was 38.8 years (range 29–46 years) and the multiple pregnancy rate was 19%. UK residents have diverse reasons for, and approaches to, seeking overseas treatment and do not conform to media stereotypes. Further research is needed to explore implications of cross-border treatment for donors, offspring and healthcare systems.