A Structured Intervention to Support Early Palliative Care Conversations for Oncology Patients - A Qualitative Feasibility Study.

AIMS: For patients with advanced cancer, early access to palliative care can have numerous psychosocial and disease management benefits. However, it can be difficult for clinicians to initiate these initial conversations about palliative care. The aim of the present study was to beta test an intervention to facilitate timely conversations about palliative care between patients and clinicians. MATERIALS AND METHODS: The study reported forms one stage of a complex intervention development study following Medical Research Council guidance for developing complex interventions. Feasibility was explored from patient and clinician perspectives in an oncology outpatient setting. RESULTS: Sixteen patients and 18 clinicians participated. Three phases of the intervention were assessed through patient and clinician interviews. The analysis produced three themes in each phase: (i) Preparation (patient preparedness; healthcare professionals' perspectives on palliative care; administration, data and communication); (ii) STEP consultation (defining perspectives on palliative care; how palliative care fits with the current treatment plan; permission to explore future care); (iii) Outcomes (changes in perspective and approaches to coping; opening the door to future conversations; referrals and involvement of palliative services). CONCLUSIONS: The STEP intervention generated important early conversations about end-of-life care that may otherwise not have occurred. No patients regretted having the STEP consultation, which resulted in palliative care referrals for some. Others felt better informed about the support services available and better able to have further conversations. Participating clinicians found the structured conversation guide useful, as it acted as a prompt for areas to cover, as well as providing an explicit way to open discussion about difficult topics.

Patient perspective on decisions to switch disease-modifying treatments in relapsing-remitting multiple sclerosis.

BACKGROUND: There are now large cohorts of people with relapsing-remitting multiple sclerosis (pwRRMS) who have taken several Disease-Modifying Treatments (DMTs). Studies about switching DMTs mostly focus on clinical outcomes rather than patients' decision-making. Neurologists are now required to support decisions at various times during the relapsing disease course and they do so with concerns about DMTs risks. This qualitative study investigates how pwRRMS weigh up the pros and cons of DMTs, focusing on perceptions of effectiveness and risks when new treatments are considered. OBJECTIVE: To increase understanding of people's experiences of decision-making when switching DMTs. METHODS: 30 semi-structured interviews were conducted with pwRRMS in England. 16 participants had switched DMT and their experiences were compared with those who had only taken one DMT. Interviews were analysed thematically to answer: what main factors influence people's decision-making to switch DMTs and why? RESULTS: Of the 16 participants with experience of switching DMT, eight had taken two or more DMTs; eight had taken three or more. Two was the DMT median. This study demonstrated that despite the term "switching" implying that similar treatments are inter-changeable, for pwRRMS taking new treatments involves different emotions, routines, risks, prognosis and communication experiences. Two meta themes identified were: 1) A distinctive, rapid and emotional decision-making process where old emotions related to MS prognosis are revisited. 2) Switching has a different impact on communication for escalation or de-escalation processes. CONCLUSION: Switching DMT involves different routines, risks, prognosis and communication experiences. These decisions are emotionally difficult because of the fear about transitioning to secondary progressive MS, and DMT effectiveness uncertainty. Patient centred decision aids should include information about first and consecutive treatment decisions.

Are publicly available internet resources enabling women to make informed fertility preservation decisions before starting cancer treatment: an environmental scan?

BACKGROUND: To identify publicly available internet resources and assess their likelihood to support women making informed decisions about, and between, fertility preservation procedures before starting their cancer treatment. METHODS: A survey of publically available internet resources utilising an environmental scan method. Inclusion criteria were applied to hits from searches of three data sources (November 2015; repeated June 2017): Google (Chrome) for patient resources; repositories for clinical guidelines and projects; distribution email lists to contact patient decision aid experts. The Data Extraction Sheet applied to eligible resources elicited: resource characteristics; informed and shared decision making components; engagement health services. RESULTS: Four thousand eight hundred fifty one records were identified; 24 patient resources and 0 clinical guidelines met scan inclusion criteria. Most resources aimed to inform women with cancer about fertility preservation procedures and infertility treatment options, but not decision making between options. There was a lack of consistency about how health conditions, decision problems and treatment options were described, and resources were difficult to understand. CONCLUSIONS: Unless developed as part of a patient decision aid project, resources did not include components to support proactively women's fertility preservation decisions. Current guidelines help people deliver information relevant to treatment options within a single disease pathway; we identified five additional components for patient decision aid checklists to support more effectively people's treatment decision making across health pathways, linking current with future health problems.

Observational study of the development and evaluation of a fertility preservation patient decision aid for teenage and adult women diagnosed with cancer: the Cancer, Fertility and Me research protocol.

INTRODUCTION: Women diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services while undergoing treatment of their cancer with oncology services. Oncologists identify a need for resources enabling them to support women's fertility preservation decisions more effectively; women report wanting more specialist information to make these decisions. The overall aim of the 'Cancer, Fertility and Me' study is to develop and evaluate a new evidence-based patient decision aid (PtDA) for women with any cancer considering fertility preservation to address this unmet need. METHODS AND ANALYSIS: This is a prospective mixed-method observational study including women of reproductive age (16 years +) with a new diagnosis of any cancer across two regional cancer and fertility centres in Yorkshire, UK. The research involves three stages. In stage 1, the aim is to develop the PtDA using a systematic method of evidence synthesis and multidisciplinary expert review of current clinical practice and patient information. In stage 2, the aim is to assess the face validity of the PtDA. Feedback on its content and format will be ascertained using questionnaires and interviews with patients, user groups and key stakeholders. Finally, in stage 3 the acceptability of using this resource when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning will be evaluated. This will involve a quantitative and qualitative evaluation of the PtDA in clinical practice. Measures chosen include using count data of the PtDAs administered in clinics and accessed online, decisional and patient-reported outcome measures and qualitative feedback. Quantitative data will be analysed using descriptive statistics, paired sample t-tests and CIs; interviews will be analysed using thematic analysis. ETHICS AND DISSEMINATION: Research Ethics Committee approval (Ref: 16/EM/0122) and Health Research Authority approval (Ref: 194751) has been granted. Findings will be published in open access peer-reviewed journals, presented at conferences for academic and health professional audiences, with feedback to health professionals and program managers. The Cancer, Fertility and Me patient decision aid (PtDA) will be disseminated via a diverse range of open-access media, study and charity websites, professional organisations and academic sources. External endorsement will be sought from the International Patient Decision Aid Standards (IPDAS) Collaboration inventory of PtDAs and other relevant professional organisations, for example, the British Fertility Society. TRIAL REGISTRATION NUMBER: NCT02753296; pre-results.

Responding to personalised social norms feedback from a web-based alcohol reduction intervention for students: Analysis of think-aloud verbal protocols.

OBJECTIVES: Web-based interventions enable organisations to deliver personalised individually tailored brief feedback to individuals without the need of a third party. Web-based interventions are effective in reducing alcohol consumption among university students. There is a paucity of evidence to indicate those who access web-based personalised feedback interventions respond in a way consistent with hypothesised active ingredients. This research uses the think-aloud technique to explore how students respond to instant web-based personalised normative feedback. METHODS: Between-subjects experimental design employing qualitative methods. Twenty-one UK university students generated think-aloud transcripts while completing a web-based intervention (Unitcheck). This was followed by a semi-structured interview. One coding frame was developed to classify all utterances. RESULTS: Narrative synthesis revealed five meta-themes: active thinking about alcohol use; comparisons with others; beliefs and knowledge about alcohol consumption; inter-relationship between personal codes and context; and engagement with Unitcheck. CONCLUSIONS: Students willingly engaged with the online assessment and personalised feedback. Students consciously engaged with the intervention and this engagement prompted students to actively consider their own behaviour, knowledge, perceptions, and to reflect on future behaviour. The ability of web-based personalised feedback interventions to effect change in individual's behaviours is likely related to their ability to encourage cognitive engagement and active processing of the information provided.

The development and validation of a psychological questionnaire for patients undergoing orthognathic treatment.

OBJECTIVES: To develop a questionnaire to assess the psychosocial aspects which orthognathic patients considered important regarding their dento-facial deformity. SETTING AND SAMPLE POPULATION: A multicentre, prospective, questionnaire development and validation study based in the UK. MATERIAL AND METHODS: Questionnaire development involved item (question) selection through literature review, consultation and feedback from a questionnaire development group and semi-structured interviews. A 'final' questionnaire was tested on a cross-sectional sample of 110 pre-operative and 74 post-operative orthognathic patients and a longitudinal sample of 23 orthognathic patients. Validity was tested using Rasch analysis. RESULTS: Reliability for the Hospital Anxiety and Depression Scale (HADS) section was unsatisfactory (ICC = 0.232-0.829, Cronbach alpha = 0.625-0.670), but for the well- being (ICC = 0.857, Cronbach alpha = 0.827-0.895) and expectations (ICC = 0.861, Cronbach alpha = 0.804-0.882) sections were satisfactory. The well-being section was the only section found to be valid for the pre-and post-operative samples. Responsiveness was satisfactory for the well-being scale (p = 0.001). CONCLUSIONS: A new condition-specific orthognathic questionnaire has been developed which has been shown to be reliable, valid and responsive for the well-being scale. The HADS, as tested by Rasch analysis, was found not to be valid for this orthognathic population.

A cluster randomised controlled trial of a web based decision aid to support parents' decisions about their child's Measles Mumps and Rubella (MMR) vaccination.

OBJECTIVE: To evaluate the effectiveness of a web based decision aid versus a leaflet versus, usual practice in reducing parents' decisional conflict for the first dose MMR vaccination decision. The, impact on MMR vaccine uptake was also explored. DESIGN: Three-arm cluster randomised controlled trial. SETTING: Fifty GP practices in the north of, England. PARTICIPANTS: 220 first time parents making a first dose MMR decision. INTERVENTIONS: Web, based MMR decision aid plus usual practice, MMR leaflet plus usual practice versus usual practice only, (control). MAIN OUTCOME MEASURES: Decisional conflict was the primary outcome and used as the, measure of parents' levels of informed decision-making. MMR uptake was a secondary outcome. RESULTS: Decisional conflict decreased post-intervention for both intervention arms to a level where, parents could make an informed MMR decision (decision aid: effect estimate=1.09, 95% CI -1.36 to -0.82; information leaflet: effect estimate=-0.67, 95% CI -0.88 to -0.46). Trial arm was significantly, associated (p<0.001) with decisional conflict at post-intervention. Vaccination uptake was 100%, 91%, and 99% in the decision aid, leaflet and control arms, respectively (χ(2) (1, N=203)=8.69; p=0.017). Post-hoc tests revealed a statistically significant difference in uptake between the information leaflet, and the usual practice arms (p=0.04), and a near statistically significant difference between the, decision aid and leaflet arms (p=0.05). CONCLUSIONS: Parents' decisional conflict was reduced in both, the decision aid and leaflet arms. The decision aid also prompted parents to act upon that decision and, vaccinate their child. Achieving both outcomes is fundamental to the integration of immunisation, decision aids within routine practice. TRIAL REGISTRATION: ISRCTN72521372.

The risk of foot ulceration in people with diabetes screened in community settings: findings from a cohort study.

BACKGROUND: Annual foot checks are recommended in patients with diabetes mellitus (DM) to identify those at risk of foot ulceration. Systematic reviews have found few studies evaluating the predictive value of tests in community-based diabetic populations. AIM: To quantify the predictive value of clinical risk factors in relation to foot ulceration in a community population. METHODS: A cohort of 1192 people with diabetes receiving care in community settings was recruited and a screening procedure, covering symptoms, signs and diagnostic tests was conducted at baseline. At an average 1-year follow-up patients who developed a foot ulcer were identified by an independent blind assessor. Multivariable analysis was performed to identify clinical predictors of foot ulceration. FINDINGS: The incidence of foot ulceration was 1.93% [95% confidence interval (CI) 1.27-2.89). Three time-independent clinical predictors with five factors were selected: previous amputation [odds ratio (OR) 14.7, 95% CI 3.1-69.5), use of insulin before 3 months with inability to distinguish between cool and cold temperatures (OR 2.97, 95% CI 1.9-4.5) and failure to obtain at least one blood pressure reading for the calculation of ankle-brachial index with the failure to feel touch with a 10-g monofilament (OR 1.7, 95% CI 1.3-2.2). INTERPRETATION: Recommendations for annual diabetic foot check in low-risk, community-based patients should be reviewed as absolute events of ulceration are low. The accuracy of foot risk assessment tools to predict ulceration requires evaluation in randomized controlled trials with concurrent economic evaluations.

Reporting of Clinical Adverse Events Scale: a measure of doctor and nurse attitudes to adverse event reporting.

OBJECTIVE: To develop a validated measure of professionals' attitudes towards clinical adverse event reporting (CAER). DESIGN: Cross-sectional survey with follow-up. PARTICIPANTS: 201 doctors and nurse/nurse-midwives undergoing postqualification training in Leeds, York and Hull Universities in 2003. MATERIALS: A questionnaire which comprised 73 items extracted from interviews with professionals; a second, statistically reduced version of this questionnaire. RESULTS: The analysis supported a 25-item questionnaire comprising five factors: blame as a consequence of reporting (six items); criteria for reporting (six items); colleagues' expectations (six items); perceived benefits of reporting events (five items); and clarity of reporting procedures (two items). The resulting questionnaire, the Reporting of Clinical Adverse Effects Scale (RoCAES), had satisfactory internal consistency (Cronbach's alpha = 0.83) and external reliability (Spearman's correlation = 0.65). The construct validity hypothesis-doctors have less positive attitudes towards CAER than nurses-was supported (t = 5.495; p<0.0001). CONCLUSION: Initial development of an evidence-based, psychometrically rigorous measure of attitudes towards CAER has been reported. Following additional testing, RoCAES may be used to systematically elicit professionals' views about, and inform interventions to improve, reporting behaviour.

Elective orthognathic treatment decision making: a survey of patient reasons and experiences.

OBJECTIVE: Few studies have explored decisions about orthognathic treatment (OGT) from the patient's perspective. This study describes the factors associated with the patient's decision to have or not have orthognathic treatment, and assesses whether the process can be considered to be informed decision making. DESIGN: A cross-sectional survey employing both interview and questionnaire methods, conducted in four OGT services in Yorkshire. SAMPLE: Participants were patients aged over 16 years, either making an OGT decision over a 6-month period or had made their treatment choice 18-42 months prior to the study start date in 2003. MEASURES: Questionnaires assessed patient demographics, dental history and psychopathology (anxiety, satisfaction with self, body satisfaction, facial appearance); interviews explored patients' reasons for, and experiences of, orthognathic treatment. RESULTS: Of 138 patients approached, 61 participated (mean age 25 years, 66% female). Psychopathology scores were within the normal range. The thematic content analysis of interview transcripts found: reasons given for having OGT were to improve the 'bite', as well as gaining a more normal facial appearance; most patients reported the service information was satisfactory, but about half made negative comments, with some reporting staff communications made them feel worse; knowledge of OGT risks and benefits was poor; patients had strong emotions about their facial appearance and the orthognathic treatment they received, which did not seem to be addressed by current practice. CONCLUSIONS: Some OGT patients do not appear to be making informed decisions about their treatment. They seem to have unmet needs in relation to support for their decision making, and managing the emotional effects of undergoing and adjusting to treatment. The implications for information provision, assessment and support during treatment are discussed.

Perceptions of professionalism in medicine: a qualitative study.

PURPOSE: Current guidelines for medical undergraduate education require students to develop appropriate attitudes towards professionalism. As much of the literature defines professionalism in vague terms--altruism, humanism, excellence--few studies have operationalised medical professionalism. This study aims to describe the views and experiences individuals have about medical professionalism to provide a more comprehensive understanding of medical professionalism. METHODS: An interview study of medical educators, medical students, doctors, allied health professionals and lay professionals was employed to assess views and experiences of professionalism in medicine. Thematic content analysis was applied to the resulting transcripts; the data were managed by NUD*IST software. RESULTS: Twenty-three people participated. Two types of examples about professionalism were provided: conceptual (honest, trustworthy, competent); behavioural (communicating effectively, treating patients equally, working in teams). Seven themes were elicited from the data: compliance to values, patient access, doctor-patient relationship, demeanour, professional management, personal awareness and motivation. CONCLUSION: The study provided a description of views about medical professionalism. These data allowed for a more thorough conceptualisation which should be used to inform measures of medical professionalism in order to improve the validity of assessments of medical students' attitudes.

A randomised controlled trial of a decision-aid leaflet to facilitate women's choice between pregnancy termination methods.

OBJECTIVE: To evaluate the effectiveness of a decision aid to help women choose between surgical and medical methods of pregnancy termination. DESIGN: A randomised controlled trial comparing a decision-aid leaflet about termination methods with a control leaflet about contraception. SETTING: An NHS regional centre for pregnancy termination. SAMPLE: All women less than 9 weeks of gestation referred for termination of pregnancy over 7 months in 2002. METHODS: Participants were given an envelope containing either the decision-aid or the control leaflet prior to choosing between medical and surgical termination methods and completed two questionnaires, one immediately after this consultation and another after the termination procedure. MAIN OUTCOME MEASURES: Choice of termination method; measures of effective decision making including risk perception, attitudes and knowledge of both the medical and surgical methods; decisional conflict; anxiety and usefulness of the leaflet. RESULTS: Three hundred and twenty-eight women participated. There was no difference in the method chosen between the groups (60/162 women in the decision-aided group chose a medical method versus 54/164 women in the control group (OR 1.2; 95% CI 0.76-1.9). Women in the decision-aided group had higher knowledge and lower risk-perception scores about both methods, more positive attitudes about the medical method, lower decisional conflict, more stable evaluations of the decision information over time and higher perceived usefulness of information ratings. Anxiety was high but unrelated to leaflet type. CONCLUSIONS: Women made more informed decisions when provided with an evidence-based decision-aid leaflet preceding a routine consultation about choices of termination method.

Psychosocial aspects of genetic screening of pregnant women and newborns: a systematic review.

OBJECTIVES: To address five broad questions concerned with knowledge, anxiety, factors associated with participation/non-participation in screening programmes and the long-term sequelae of false-positive, true-positive in newborns and true-negative results. DATA SOURCES: Five electronic databases, two journals and attempts were made to locate unpublished work. REVIEW METHODS: This review started from a substantial literature base that provided the basis for (a) scoping the literature, (b) informing search strategy terms and (c) identifying preliminary article inclusion and exclusion criteria. The main eligibility criteria were: any screening programme aimed at pregnant women or newborn babies that included a 'genetic' target condition, this included chromosomal anomalies; any study that reported psychosocial data collected directly from parents. The data extraction form developed for this study elicited data from the selected studies. The data were entered into a database, which provided a summary of the included papers. RESULTS: A total of 288 candidate publications were identified, 106 of which were eligible: 78 were concerned with antenatal screening and 28 with newborn screening. It was found that levels of knowledge adequate for decision-making were not being achieved despite information leaflets and videos having some effect. Studies that have succeeded in increasing knowledge have not observed a corresponding increase in anxiety, although some anxiety might be an appropriate response and may aid coping and decision-making. Anxiety is clearly raised in women receiving positive screening results, especially young women. However, evidence is lacking of a beneficial (i.e. reassuring) effect of receiving a screen-negative result. Anxiety in screen-positive women falls on receipt of subsequent reassuring results, but some residual anxiety may remain. A minority (perhaps up to 30%) of women receiving a screen-positive result in pregnancy expressed regret about their screening decision. Uptake of neonatal screening has been treated as a 'given' and not as a research topic. CONCLUSIONS: The results of this review have many implications for the work of the National Screening Committee. The most pressing of these, in order of priority, relate to: the inadequacy of current procedures for achieving informed consent; the cost of providing a satisfactory service; the unmet needs of 'false-positives', and the unmet needs of women's partners, particularly in carrier screening. It is suggested that research is conducted on the above four topics in order to fill gaps in the evidence base that relate to screening technologies which have been available for many years. In addition, future screening programmes will create a new list of research questions, based on the same main agenda but applied to new areas, for example, new conditions such as haemoglobinopathies and fragile X syndrome; new client groups such as young women and minority ethnic groups; and new testing modalities such as ultrasound.