Development of the Knee Quality of Life (KQoL-26) 26-item questionnaire: data quality, reliability, validity and responsiveness

Background This article describes the development and validation of a self-reported questionnaire, the KQoL-26, that is based on the views of patients with a suspected ligamentous or meniscal injury of the knee that assesses the impact of their knee problem on the quality of their lives. Methods Patient interviews and focus groups were used to derive questionnaire content. The instrument was assessed for data quality, reliability, validity, and responsiveness using data from a randomised trial and patient survey about general practitioners' use of Magnetic Resonance Imaging for patients with a suspected ligamentous or meniscal injury. Results Interview and focus group data produced a 40-item questionnaire designed for self-completion. 559 trial patients and 323 survey patients responded to the questionnaire. Following principal components analysis and Rasch analysis, 26 items were found to contribute to three scales of knee-related quality of life: physical functioning, activity limitations, and emotional functioning. Item-total correlations ranged from 0.60–0.82. Cronbach's alpha and test retest reliability estimates were 0.91–0.94 and 0.80–0.93 respectively. Hypothesised correlations with the Lysholm Knee Scale, EQ-5D, SF-36 and knee symptom questions were evidence for construct validity. The instrument produced highly significant change scores for 65 trial patients indicating that their knee was a little or somewhat better at six months. The new instrument had higher effect sizes (range 0.86–1.13) and responsiveness statistics (range 1.50–2.13) than the EQ-5D and SF-36. Conclusion The KQoL-26 has good evidence for internal reliability, test-retest reliability, validity and responsiveness, and is recommended for use in randomised trials and other evaluative studies of patients with a suspected ligamentous or meniscal injury

Development of a behaviour change intervention to encourage timely cancer symptom presentation among people living in deprived communities using the Behaviour Change Wheel

We are grateful to the National Awareness and Early Diagnosis Initiative (NAEDI) for funding this work. The NAEDI funding consortium, under the auspices of the National Cancer Research Institute (NCRI), consists of Cancer Research UK; Department of Health (England); Economic and Social Research Council; Health and Social Care R&D Division, Public Health Agency (Northern Ireland); National Institute for Social Care and Health Research (Wales); and the Scottish Government. We would like to thank ABACus project management team members Tim Banks and Maura Matthews from Tenovus Cancer Care for their ongoing support and involvement in the project. The authors would also like to acknowledge the support of the ABACus steering group (Danny Antebi, Tracey Deacon, Karen Gully, Jane Hanson, Sharon Hillier, Alex Murray, Richard Neal, Gill Richardson, Mark Rogers, and Sara Thomas). Compliance with Ethical StandardsPeer reviewedPublisher PD

Involving lay and professional stakeholders in the development of a research intervention for the DEPICTED Study

Aim: This paper focuses on stakeholders’ active involvement at key stages of the research as members of a Stakeholder Action Group (SAG), particularly in the context of lay stakeholder involvement. Some challenges that can arise and wider issues (e.g. empowerment, the impact of user involvement) are identified and explored within the literature on service user involvement in health care research, reflecting on the implications for researchers. Background: In the DEPICTED study, lay and professional stakeholders were actively involved in developing a complex research intervention. Lay stakeholders comprised teenage and adult patients with diabetes, parents and patient organization representatives. Professional stakeholders were from a range of disciplines. Methods: Three 1-day research meetings were attended by 13–17 lay stakeholders and 10–11 professional stakeholders (plus researchers). The SAG was responsible for reviewing evidence, advising on developing ideas for the research intervention and guiding plans for evaluation of the intervention in a subsequent trial. Formal evaluations were completed by stakeholders following each SAG meeting. Results: Throughout the first (developmental) stage of this two-stage study, lay and professional stakeholders participated or were actively involved in activities that provided data to inform the research intervention. Lay stakeholders identified the need for and contributed to the design of a patient-held tool, strongly influenced the detailed design and content of the research intervention and outcome questionnaire, thus making a major contribution to the trial design. Conclusion: Stakeholders, including teenagers, can be actively involved in designing a research intervention and impact significantly on study outcomes

Talking about human papillomavirus and cancer:development of consultation guides through lay and professional stakeholder coproduction using qualitative, quantitative and secondary data

Background High-risk human papillomaviruses (HPVs) cause all cervical cancer and the majority of vulvar, vaginal, anal, penile and oropharyngeal cancers. Although HPV is the most common sexually transmitted infection, public awareness of this is poor. In addition, many clinicians lack adequate knowledge or confidence to discuss sexual transmission and related sensitive issues. Complex science needs to be communicated in a clear, digestible, honest and salient way. Therefore, the aim of this study was to coproduce with patients who have cancer appropriate resources to guide these highly sensitive and difficult consultations. Methods A matrix of evidence developed from a variety of sources, including a systematic review and telephone interviews with clinicians, supported the production of a draft list of approximately 100 potential educational messages. These were refined in face-to-face patient interviews using card-sorting techniques, and tested in cognitive debrief interviews to produce a ‘fast and frugal’ knowledge tool. Results We developed three versions of a consultation guide, each comprising a clinician guidance sheet and patient information leaflet for gynaecological (cervical, vaginal, vulvar), anal or oropharyngeal cancers. That cancer could be caused by a sexually transmitted virus acquired many years previously was surprising to many and shocking to a few patients. However, they found the information clear, helpful and reassuring. Clinicians acknowledged a lack of confidence in explaining HPV, welcomed the clinician guidance sheets and considered printed information for patients particularly useful. Conclusion Because of the ‘shock factor’, clinicians will need to approach the discussion of HPV with sensitivity and take individual needs and preferences into account, but we provide a novel, rigorously developed and tested resource which should have broad applicability in the UK National Health Service and other health systems

Randomised controlled trial and economic evaluation of a targeted cancer awareness intervention for adults living in deprived areas of the UK

Background: Cancer outcomes are poor in socioeconomically deprived communities, with low symptom awareness contributing to prolonged help-seeking and advanced disease. Targeted cancer awareness interventions require evaluation. Methods: Randomised controlled trial involving adults aged 40+ recruited in community and healthcare settings in deprived areas of South Yorkshire and South-East Wales. Intervention: personalised behavioural advice facilitated by a trained lay advisor. Control: usual care. Follow-up at 2-weeks and 6-months post-randomisation. Primary outcome: total cancer symptom recognition score 2-weeks post-randomisation. Results: 234 participants were randomised. The difference in total symptom recognition at 2-weeks [adjusted mean difference (AMD) 0.6, 95% CI:-0.03, 1.17, p=0.06] was not statistically significant. Intervention participants reported increased symptom recognition (AMD 0.8, 95% CI:0.18, 1.37, p=0.01) and earlier intended presentation (AMD -2.0, 95% CI:-3.02, -0.91, p<0.001) at 6-months. “Lesser known” symptom recognition was higher in the intervention arm (2-weeks AMD 0.5, 95% CI:0.03, 0.97 and 6-months AMD 0.7, 95% CI:0.16, 1.17). Implementation cost per participant was £91.34, with no significant between-groups differences in healthcare resource use post-intervention. Conclusions: Improved symptom recognition and earlier anticipated presentation occurred at longer-term follow-up. The ABACus Health Check is a viable low-cost intervention to increase cancer awareness in socioeconomically deprived communities. Clinical Trial Registration: ISRCTN1687254

Improving cancer symptom awareness and help-seeking among adults living in socioeconomically deprived communities in the UK using a facilitated health check: A protocol for the Awareness and Beliefs About Cancer (ABACus) Randomised Control Trial

Background Cancer survival is lower in socioeconomically deprived communities, partly due to low awareness of symptoms, negative beliefs and delayed help-seeking. We developed an interactive health check questionnaire facilitated by trained lay advisors. It entails 29 questions about background, lifestyle and health with tailored behaviour change advice. Personalised results are printed using a traffic light (red/amber/green) system, highlighting areas where action should be taken. This is an individually randomised control trial to test effectiveness of the health check on symptom recognition. Methods A total 246 participants aged 40+ years will be recruited from community and healthcare settings in socioeconomically deprived areas of Yorkshire and South Wales. Participants will be randomised to receive the health check or standard care (1:1 ratio). Outcome measures include: adapted Awareness and Beliefs about Cancer (primary outcome), brief State Trait Anxiety Inventory, intentions and motivation to adopt recommended health behaviours (early symptom presentation, cancer screening and lifestyle behaviours), adapted Client Service Receipt Inventory, brief medical history/screening and demographic questionnaire at: baseline; 2-weeks; and 6-months post-randomisation. A purposive sample of intervention sessions will be audio-recorded (n = 24) and half will additionally be observed (n = 12). Semi-structured interviews will take place at 2-weeks (n = 30) and 6-months (n = 15–20) post-randomisation. The primary analysis will compare cancer symptom recognition scores between arms at 2-weeks. Secondary analysis will assess cancer beliefs, barriers/time to presentation, screening and lifestyle behaviours, anxiety and costs. A process evaluation will assess intervention fidelity, dose and contamination

What is agenda setting in the clinical encounter? Consensus from literature review and expert consultation

Objective To establish consensus on the core domains of agenda setting in consultations. Methods We reviewed the healthcare literature and, using a modified Delphi technique to embrace both patient and clinician perspectives, conducted an iterative online survey, with 30 experts in health communication. Participants described agenda setting and rated the importance of proposed domains. Consensus was determined where the group median was ≥5 on a 7-point Likert-like response scale, and the interquartile range fell to within one point on this scale. Results Relevant publications were identified in three overlapping bodies of healthcare literature. Survey respondents considered that agenda setting involved a process whereby patients and clinicians establish a joint focus for both their conversation and their working relationship. Consensus was obtained on six core domains: identifying patient talk topics, identifying clinician talk topics, agreement of shared priorities, establishing conversational focus, collaboration and engagement. New terminology – agenda mapping and agenda navigation - is proposed. Conclusion We identified core agenda setting domains that embraced patient and clinician perspectives. Practice implications An integrated conceptualization of agenda setting may now be used by researchers and educators in both clinician and patient focused interventions