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Solitary pulmonary nodules (SPNs) measuring 8 to 30 mm in diameter require further workup to determine the likelihood of malignancy.What is the diagnostic performance of a lung cancer prediction convolutional neural network (LCP-CNN) in SPNs using unenhanced and contrast-enhanced CT imaging compared with the current clinical workup?This was a post hoc analysis of the Single Pulmonary Nodule Investigation: Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules trial, a prospective multicenter study comparing the diagnostic accuracy of dynamic contrast-enhanced (DCE) CT imaging with PET imaging in SPNs. The LCP-CNN was designed and validated in an external cohort. LCP-CNN-generated risk scores were created from the noncontrast and contrast-enhanced CT scan images from the DCE CT imaging. The gold standard was histologic analysis or 2 years of follow-up. The area under the receiver operating characteristic curves (AUC) were calculated using LCP-CNN score, maximum standardized uptake value, and DCE CT scan maximum enhancement and were compared using the DeLong test.Two hundred seventy participants (mean ± SD age, 68.3 ± 8.8 years; 49% women) underwent PET with CT scan imaging and DCE CT imaging with CT scan data available centrally for LCP-CNN analysis. The accuracy of the LCP-CNN on the noncontrast images (AUC, 0.83; 95% CI, 0.79-0.88) was superior to that of DCE CT imaging (AUC, 0.76; 95% CI, 0.69-0.82; P = .03) and equal to that of PET with CT scan imaging (AUC, 0.86; 95% CI, 0.81-0.90; P = .35). The presence of contrast resulted in a small reduction in diagnostic accuracy, with the AUC falling from 0.83 (95% CI, 0.79-0.88) on the noncontrast images to 0.80 to 0.83 after contrast (P .05 for 240 s after contrast only).An LCP-CNN algorithm provides an AUC equivalent to PET with CT scan imaging in the diagnosis of solitary pulmonary nodules.ClinicalTrials.gov Identifier; No.: NCT02013063.

Objective: This research examines how partners contribute to clinical consultations for people with prostate cancer. It highlights a social practice where a partner responds to talk that addresses a patient. Methods: A conversation analysis of twenty-eight prostate cancer treatment and diagnostic consultations was carried out using data collected from four clinical sites across England. Results: The analysis demonstrated that this practice was prosocial and patient enabling. Partners oriented to the patient's primary rights to take their turn as the selected next speaker, only initiating after a substantial delay from the clinician's turn-at-talk. Consequently, the partner consistently opened an opportunity space that the patient took to elaborate upon, or collaborate with the partners’ turn as they regularly took up a unified stance resisting the individualised configuration of the encounter. Conclusion: This research highlights the social and clinical utility of partners during these consultations, as they served as important, yet underutilised interactional and informational resources for clinicians and patients. Practice implications: This research indicates a need to reconsider the configuration of these consultations and sanction partners as formal participants. Absent of this, partners will continue to have to work to insert their contributions into consultations while resisting the dyadic structure of these interactions.

Concepts of patient-centredness and shared decision-making inform expectations that clinicians should display sensitivity to patients' expressed preferences. This study examines the organisation of treatment-related preferences expressed by patients and their partners during clinical consultations for people with localised prostate cancer. A conversation analysis of twenty-eight diagnosis and treatment consultations was conducted with data recorded from four clinical sites across England. When clinicians disaligned from expressions of preference such as directing talk away from expressions, or moving to redress perceived misunderstandings, it caused discordance in the unfolding interaction. This led to couples silencing themselves. Two deviant cases were identified that did not feature the misalignment found in all other collected cases. In these two cases, the interaction remained collaborative. These findings highlight the immediate consequences of expressions of preference being resisted, rejected, and dismissed in a context where clinicians are expected to explore expressed preferences in service of SDM. The deviant case analysis offers an alternative practice to the pattern observed across the collection, offering a comparison between misaligned sequences, and cases where social solidarity was maintained. By acknowledging couple's expressions as valid contributions, rather than acting to inform or correct them, clinicians can create opportunity spaces for discussion around treatment preferences.

Objective To review the currently available research into romantic partner involvement during oncology consultations. Methods Studies were identified via database searches plus hand-searching. A narrative review was performed using the principles of Thematic, and Framework syntheses. The search strategy was performed according to the principles of PRISMA. Results From 631 results, 18 studies were included. The findings indicate that romantic partners are most valued by patients when they provide emotional, practical, and informational support. It is also indicated that psychosocial and sexual concerns are rarely discussed. Couples’ self-reported satisfaction with consultations appear related to the extent of romantic partner involvement, the roles that they enacted, and the extent to which psychosocial and sexual concerns were addressed. Conclusion This review indicates that romantic partner involvement during clinical consultations enhances the couple’s experience. However, there are methodological limitations to this body of research, which are discussed in this review. Practice implications Research to date has yet to offer an exploration of the social practices and conversational actions relating to romantic partner involvement during triadic oncology consultations. Future studies that draw upon recordings of these consultations, using methods capable of analysing situated social practices can address this gap.

Background: PROACTIVE is a psycho-educational support intervention for prostate cancer patients managed on Active Surveillance. PROACTIVE is comprised of two interdependent components: group workshops and internet delivered information modules. \ud \ud Aims: We conducted a feasibility study to determine the practicality of delivering PROACTIVE at two prostate cancer centres.\ud \ud Methods: The feasibility study was a mixed methods randomized parallel-group exploratory trial. Participants were randomised using a ratio of 3:1 PROACTIVE group to treatment as usual. Qualitative semi-structured interviews and quantitative measures were completed at baseline, intervention completion (week 6), and at 6-months follow-up. Interview transcripts were analysed thematically using Framework analysis. Descriptive statistics were used to examine recruitment and retention rates, and changing trends in outcome measures. \ud \ud Results: Most aspects of the research design and PROACTIVE intervention were acceptable to those participating in the study. In particular participants valued the opportunity to share and discuss experiences with other prostate cancer patients on Active Surveillance, and receive detailed authoritative information. However, three issues were identified: \ud 1. a low response rate (13 participants recruited, response rate 16%)\ud 2. low utilisation of internet delivered information modules\ud 3. self-perceived low levels of anxiety amongst participants with the majority perceiving their cancer as not impacting on their day-to-day life or causing anxiety. \ud \ud Conclusions: Due to these significant research design issues it is not recommended PROACTIVE be evaluated in a large scale randomised controlled trial. Further research is required to explore the impact of Active Surveillance on anxiety amongst men with localized prostate cancer managed by Active Surveillance.

Objective: Explore how partners are involved in treatment-related decision-making within triadic clinical encounters. Methods: Studies were identified via database searches and reference lists. One author assessed eligibility of studies, which were verified by an additional co-author. Data were extracted by one author and cross-checked for accuracy by a second. Quality of articles was assessed using Qualsyst. Retrieved studies were categorised by one author, and agreed through discussion. Results: From 2442 records, 14 studies were included and categorised as: (1) Descriptions of partner role and behaviour; (2) Role intentions of partners; (3) Relationship between partner and patient behaviour; (4) HCP-Partner interactions. Conclusion: Partners are often involved in triadic clinical consultations that have implications for treatment-related decision making. Most studies offered general descriptions but lacked detailed investigation of communicative processes in triads and how these may operate with partners vs. other companions. Practice implications: Existing studies lack detailed investigation through direct observation of the processes of partner involvement. Research in other areas of clinical communication suggests that future interventions could be informed by attention to the following areas: partner behaviour vs. other companion types in triads; relationships between partner involvement and decision-making processes; partner involvement in triads vs. other groups (e.g. quadratic).

Background : There are more than 1500 UK health helplines in operation, yet we have scant knowledge about the resources in place to support the seeking and delivering of cancer-related telephone help and support. This research aimed to identify and describe cancer and cancer-related helpline service provision: the number of helplines available, the variety of services provided, and the accessibility of those services. Method : This study used online national questionnaire survey sent to 95 cancer and cancer-related helplines in the United Kingdom. Results : A total of 69 (73%) of 95 surveyed cancer and cancer-related helplines completed the survey. Most helplines/organizations were registered charities, supported by donations; 73.5% of helplines had national coverage. Most helplines served all age-groups, ethnic groups, and men and women. Only 13.4% had a number that was free from landlines and most mobile networks, and 56.6% could only be contacted during working hours. More than 50% of helplines reported no provisions for callers with additional needs, and 55% had no clinical staff available to callers. Ongoing support and training for helpline staff was available but variable. Conclusion : Although cancer helplines in the United Kingdom offer reasonably broad coverage across the country, there are still potential barriers to accessibility. There are also opportunities to optimize the training of staff/volunteers across the sector. There are further prospects for helplines to enhance services and sustain appropriate and realistic quality standards.

Aims: The treatment of prostate cancer has evolved markedly over the last 40 years, including radiotherapy, notably with escalated dose and targeting. However, the optimal treatment for localised disease has not been established in comparative randomised trials. The aim of this article is to describe the history ofprostate radiotherapy trials, including their quality assurance processes, and to compare these with the ProtecT trial.Materials and methods: The UK ProtecT randomised trial compares external beam conformal radiotherapy, surgery and active monitoring for clinically localized prostate cancer and will report on the primary outcome (disease-specific mortality) in 2016 following recruitment between 1999 and 2009. The embedded quality assurance programme consists of on-site machine dosimetry at the nine trial centres, a retrospective review of outlining and adherence to dose constraints based on the trial protocol in 54 participants (randomly selected, around 10% of the total randomised to radiotherapy, n ¼ 545). These quality assurance processes and results were compared with prostate radiotherapy trials of a comparable era.Results: There has been an increasingly sophisticated quality assurance programme in UK prostate radiotherapy trials over the last 15 years, reflecting dose escalation and treatment complexity. In ProtecT, machine dosimetry results were comparable between trial centres and with the UK RT01 trial. The outliningreview showed that most deviations were clinically acceptable, although three (1.4%) may have been of clinical significance and were related to outlining of theprostate. Seminal vesicle outlining varied, possibly due to several prostate trials running concurrently with different protocols. Adherence to dose constraints inProtecT was considered acceptable, with 80% of randomised participants having two or less deviations and planning target volume coverage was excellent.Conclusion: The ProtecT trial quality assurance results were satisfactory and comparable with trials of its era. Future trials should aim to standardise treatment protocols and quality assurance programmes where possible to reduce complexities for centres involved in multiple trials. 2016 Published by Elsevier Ltd on behalf of The Royal College of Radiologists.

Objective: to identify call handlers’ key experiences of providing telephone help on a cancer helpline.Methods: semi‐structured qualitative interviews with 30 call handlers from three UK‐based cancer helplines. Transcribed interview data were analysed thematically.Results: thematic analysis identified three themes: (a) call handlers’ perceptions of their role on the helpline, (b) challenges of working on a helpline and (c) the need for training/keeping up with competencies. Call handlers reported satisfaction with their experience. However, there are tensions: whilst advice is formally not part of the remit of the helpline, in practice the boundary between giving advice and giving information can be blurred. No follow‐up with callers could be difficult and experienced as a lost opportunity to help. Managing patient expectations could be challenging, and interviewees described particular difficulties with distressed callers. Training for the role was commonplace, but there was sometimes a desire for more opportunities.Conclusion: there are challenges faced by helpline staff, and it can be difficult to manage callers’ distress and expectations of what they might get from a call experience. Recognising the skill and complexity of the call handler role is important, as it is meeting call handlers’ support and training needs. Support is important to minimise the risk to their own emotional well‐being.

Objectives: to establish: a) feasibility of training GPs in a communication intervention to solicit additional patient concerns early in the consultation, using specific lexical formulations (“do you have ‘any’ vs. ‘some’ other concerns?”) noting the impact on consultation length, and b) whether patients attend with multiple concerns and whether they voiced them in the consultation.Methods: a mixed-methods three arm RCT feasibility study to assess the feasibility of the communication intervention.Results: intervention fidelity was high. GPs can be trained to solicit additional concerns early in the consultation (once patients have presented their first concern). Whilst feasible the particular lexical variation of ‘any’ vs ‘some’ seemed to have no bearing on the number of patient concerns elicited, on consultation length or on patient satisfaction. The level of missing questionnaire data was low, suggesting patients found completion of questionnaires acceptable. Conclusion: GPs can solicit for additional concerns without increasing consultation length, but the particular wording, specifically ‘any’ vs. ‘some’ may not be as important as the placement of the GP solicitation.Practice Implications: GPs can solicit early for additional concerns and GPs can establish patients’ additional concerns in the opening of the consultation, which can plan and prioritise patients multiple concerns.

As possibilities for the early detection of indolent cancers, and precursors to cancer, multiply, GPs will increasingly be involved in discussions with patients about risks and benefits of early diagnosis and treatment. Over time, improvements in evidence may decrease uncertainty about outcomes for patients and clinicians. However, where survival benefits are small, or uncertain, or risks are unacceptable to patients, grounds for preference-sensitive decision-making will remain. How risks and benefits of early detection, and the significance of indolent or low risk cancers, are communicated, will be key, if overtreatment and overdiagnosis are to be avoided.

The aims of this study were to explore relatives' experiences of talking about cancer within the family and to identify their information and support needs. A cross-sectional in-depth interview study with relatives and partners (n = 22) of cancer patients recruited through community settings was conducted. A thematic approach was used for analysis. Information sharing and communication within families operated within a context of cancer-related uncertainty. Discussion about cancer was generally viewed as beneficial, but relatives faced dilemmas, which inhibited information exchange. Participants often devised strategies to manage the challenges faced to fulfil their needs for information and support. This was deemed important as talking about cancer allowed relatives to support patients' preferences for care, deal with practical demands and come to terms with difficult issues. Lack of information was perceived to affect the quality of care participants could provide. Participants did not always want to know everything about the patient's illness, suggesting the importance of tailoring information to individual needs. Offering a range of different kinds of support directly to relatives may improve patient care and emotional well-being. Copyright © 2014 John Wiley & Sons, Ltd.

Background. Lung cancer (LC) is often diagnosed late when curative intervention is no longer viable. However, current referral guidelines (e.g. UK National Institute for Health and Care Excellence guidelines) for suspected LC are based on a weak evidence base. Aim. The purpose of this systematic review is to identify symptoms that are independently associated with LC and to identify the key methodological issues relating to symptomatic diagnosis research in LC. Methods. Medline, Ovid and Cumulative Index to Nursing and Allied Health Literature were searched for the period between 1946 and 2012 using the MeSH terms ‘lung cancer’ and ‘symptom*’. Quality of each paper was assessed using Scottish Intercollegiate Guidelines Network and Consolidated Criteria for Reporting Qualitative Research Checklists and checked by a second and third reviewer. Results. Evidence regarding the diagnostic values of most symptoms was inconclusive; haemoptysis was the only symptom consistently indicated as a predictor of LC. Generally, evidence was weakened by methodological issues such as the lack of standardized data collection (recording bias) and the lack of comparability of findings across the different studies that extend beyond the spectrum of disease. Qualitative studies indicated that patients with LC experienced symptoms months before diagnosis but did not interpret them as serious enough to seek health care. Therefore, early LC symptoms might be under-represented in primary care clinical notes. Conclusion. Current evidence is insufficient to suggest a symptom profile for LC across the disease stages, nor can it be concluded that classical LC symptoms are predictors of LC apart from, perhaps, haemoptysis. Prospective studies are now needed that systematically record symptoms and explore their predictive values for LC diagnosis.

Background: There is a growing population of older patients with End Stage Renal Disease (ESRD) managed without dialysis in Thailand, and services have yet to be developed to specifically respond to the needs of this group. As a consequence this population are likely to have unmet needs with respect to health care and suffer from symptoms that could be better managed. Objective: This qualitative study explored experiences and health care needs during the last year of life among older people with ESRD, managed without dialysis, from the perspective of bereaved carers. Methods: A retrospective post-bereavement approach was adopted to collect qualitative interview data. Purposive sampling was used to select 12 bereaved relatives of older patients with ESRD, managed without dialysis, who had died in the previous 5–10 months. Semi-structured interviews were conducted. Data were digitally recorded, transcribed and analysed through framework analysis. Results: Four main themes were identified: symptom experiences, impacts of being managed without dialysis, symptom management, and health care needs and utilisation of services. Conclusions: Findings confirmed patients' needs were not being met and identified the need to develop approaches to symptom management at home, health education, and psychological and spiritual support at the end of life.

This paper sets out to review the influence of social processes on the timing of the diagnosis of cancer and to explore the potential for promoting earlier diagnosis by addressing social factors that influence symptom recognition and the diagnostic process. Social processes refer to the means by which culture and social organisation may impact on timely cancer diagnosis. The paper calls for concerted action around an important and developing research agenda that may prove highly valuable in the quest to secure prompt diagnosis for cancer and through it improved outcomes for individuals.

Genetic medical technologies have increased the possibilities for detecting future illness in those who appear healthy and asymptomatic. These developments broaden the scope of medicine, complicating distinctions between health, illness and disease. Genetic counselling practice extends health promotion seeking to ‘inform’ individuals of their own risks so that they can minimise possible negative implications for their own lives (Lupton 1995). An extension of disease prevention has been associated with a shift in health such that health is no longer a given but has to be achieved by individuals. While post-structuralist accounts have positioned health promotion as part of an increasing self-surveillance of health, they have rarely based these accounts on empirical studies of individuals’ experiences. This paper explores how ‘early’ diagnosis positions people as ‘at-risk’. Findings inform narratives of social change centred on the individualisation of health, the extension of self-surveillance and the blurring of boundaries between health and disease. Narrative accounts from interviews and observations of clinical consultations with 18 adults who had been told that they had inherited a late onset, degenerative kidney disease (Autosomal Dominant Polycystic Kidney Disease) are used to explore how individuals discursively achieve health and appropriate health protection. This analysis challenges the idea that knowledge of genetic aetiology will reduce individual responsibility for health. Rather than a grand shift to a continuum of health and the disappearance of ‘old’ binaries, these participants appear to use the health/disease dualism to re-position themselves with respect to risk on a moment-by-moment basis.

Background.\ud Lung and colorectal cancer are common and have high UK mortality rates. Early diagnosis is important in reducing cancer mortality, but the literature on lung and colorectal cancers suggests many people wait for a considerable time before presenting symptoms.\ud \ud Objective.\ud To gain in-depth understanding of patients’ interpretations of symptoms of lung and colorectal cancer prior to diagnosis, and to explore processes leading to help-seeking.\ud \ud Methods.\ud Semi-structured interviews were conducted with patients diagnosed with lung (N = 9) or colorectal (N = 20) cancer within the previous 12 months. Patients were asked about symptoms experienced in the period preceding diagnosis, their interpretations of symptoms, and decision making for help-seeking. Thematic analysis was conducted and comparisons drawn within and across the patient groups.\ud \ud Results.\ud Patients were proactive and rational in addressing symptoms; many developed alternative, non-cancer explanations based on their knowledge and experience. Discussions with important others frequently provided the impetus to consult, but paradoxically others often initially reinforced alternative explanations. Fear and denial did not emerge as barriers to help-seeking, but help-seeking was triggered when patients’ alternative explanations could no longer be maintained, for instance due to persistence or progression of symptoms.\ud \ud Conclusion.\ud Patients’ reasoning, decision making and interpersonal interactions prior to diagnosis were complex. Prompting patients for additional detail on symptoms within consultations could elicit critical contextual information to aid referral decisions. Findings also have implications for the design of public health campaigns.

Objective\ud To investigate the perspectives of general practitioners (GPs) on the practice of soliciting additional concerns (ACs) and the acceptability and utility of two brief interventions (prompts) designed to aid the solicitation.\ud \ud Methods\ud Eighteen GPs participating in a feasibility randomised controlled trial were interviewed. Interviews were semi-structured and audio-recorded. Data were analysed using a Framework Approach.\ud \ud Results\ud Participants perceived eliciting ACs as important for: reducing the need for multiple visits, identifying serious illness early, and increasing patient and GP satisfaction. GPs found the prompts easy to use and some continued their use after the study had ended to aid time management. Others noted similarities between the intervention and their usual practice. Nevertheless, soliciting ACs in every consultation was not unanimously supported.\ud \ud Conclusion\ud The prompts were acceptable to GPs within a trial context, but there was disagreement as to whether ACs should be solicited routinely. Some GPs considered the intervention to aid their prioritisation efficiency within consultations.\ud \ud Practice implications\ud Some GPs will find prompts which encourage ACs to be solicited early in the consultation enable them to better organise priorities and manage time-limited consultations more effectively.

BackgroundThe World Health Organization (WHO) ICD–10 Primary Health Care (PHC) Guidelines for Diagnosis and Management of Mental Disorders (1996) have not been evaluated in a pragmatic randomised controlled trial (RCT).AimsTo evaluate the effect of local adaptation and dissemination of the guidelines.MethodPragmatic, pair-matched, cluster RCT involving 30 practices.ResultsGuideline practices were less sensitive but more specific in identifying morbidity, but these differences were not significant. Guideline patients did not differ from usual-care patients on 12-item General Health Questionnaire scores at 3-month follow-up or in the proportion who were still cases. There were no significant differences in secondary outcomes.ConclusionsAttempts to influence clinician behaviour through a process of adaptation and extension of guidelines are unlikely to change detection rates or outcomes.

A cross-sectional survey of 794 referrals from 41 general practices working in a defined catchment area is reported. The outcomes studied were the proportion of patients (1) declined on the basis of a referral letter, (2) not attending, (3) considered 'appropriate' by clinicians carrying out assessments and (4) judged to meet 'severity' criteria based upon risk or role impairment. Forty-one (5%) referrals were declined on the basis of their referral letter and 221 (27%) did not attend. Of the remainder, 125 (28%) were considered as inappropriate referrals. There was an inconsistent relationship between clinicians' opinions about 'appropriateness' and judgements in the four domains of severity: 66 (52%) of the 'inappropriate' referrals were judged to meet at least one of four severity criteria, whereas, conversely, of the referrals considered 'appropriate', 64 (20%) did not meet any risk or severity criteria. Nearly half (47%) of all referrals to psychiatric services either fail to attend or are considered 'inappropriate' when seen, findings which highlight serious inefficiencies at the interface between primary care and secondary mental health services. The policy of 'prioritisation' on the basis of severity has proved difficult to implement consistently. In order to reduce these inefficiencies, structured referral criteria are needed involving users, general practitioners and mental health service providers.

Randomized controlled trials are accepted to be the research design of choice to evaluate the effectiveness of health care interventions and are commonly used to evaluate cancer treatments. There are concerns, however, that levels of recruitment to trials are often much lower than anticipated, particularly in cancer trials. Several research methods have been used to collect aspects of users' experiences of participating in cancer trials. Perhaps the most common method has been through measures of outcome and the impact of treatments on quality of life (QoL), using standardized schedules to capture physical, social and psychological health. In some areas of cancer, individual patient testimonies illuminate particular issues or narratives. Another body of research has grown around issues of user involvement in trials, including surveys of recruitment and participation, as well as investigations of patient preferences and experiences of participation. We searched MEDLINE and the Cochrane Trials Library from 1995 to 2001 for relevant publications. In this article, we review the literature in these areas and examine whether users' experiences of participating in cancer trials can be used to assist in the design or conduct of trials.

Helplines are core feature of the contemporary U.K. health care system, however little is known about callers' experiences of seeking cancer-related telephone help. Qualitative interviews were conducted with 32 cancer helpline callers. The findings suggest cancer helplines offer callers (1) time to discuss their issues, (2) anonymity, (3) convenience, and (4) an open outlet for anyone affected by cancer including family/friends. Further, the findings highlighted that callers' help-seeking behavior was multifaceted, with their psychosocial needs being intrinsically intertwined with their information or advice-seeking needs. The implications are discussed in relation to the role of cancer helplines in the healthcare system.

The aims of this study were to explore relatives' experiences of talking about cancer within the family and to identify their information and support needs.A cross-sectional in-depth interview study with relatives and partners (n = 22) of cancer patients recruited through community settings was conducted. A thematic approach was used for analysis.Information sharing and communication within families operated within a context of cancer-related uncertainty. Discussion about cancer was generally viewed as beneficial, but relatives faced dilemmas, which inhibited information exchange. Participants often devised strategies to manage the challenges faced to fulfil their needs for information and support. This was deemed important as talking about cancer allowed relatives to support patients' preferences for care, deal with practical demands and come to terms with difficult issues. Lack of information was perceived to affect the quality of care participants could provide.Participants did not always want to know everything about the patient's illness, suggesting the importance of tailoring information to individual needs. Offering a range of different kinds of support directly to relatives may improve patient care and emotional well-being.

INTRODUCTION: Solitary pulmonary nodules (SPNs) are common on CT. The most cost-effective investigation algorithm is still to be determined. Dynamic contrast-enhanced CT (DCE-CT) is an established diagnostic test not widely available in the UK currently.METHODS AND ANALYSIS: The SPUtNIk study will assess the diagnostic accuracy, clinical utility and cost-effectiveness of DCE-CT, alongside the current CT and 18-flurodeoxyglucose-positron emission tomography) ((18)FDG-PET)-CT nodule characterisation strategies in the National Health Service (NHS). Image acquisition and data analysis for (18)FDG-PET-CT and DCE-CT will follow a standardised protocol with central review of 10% to ensure quality assurance. Decision analytic modelling will assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs.ETHICS AND DISSEMINATION: Approval has been granted by the South West Research Ethics Committee. Ethics reference number 12/SW/0206. The results of the trial will be presented at national and international meetings and published in an Health Technology Assessment (HTA) Monograph and in peer-reviewed journals.TRIAL REGISTRATION NUMBER: ISRCTN30784948; Pre-results.

Objective Multicenter randomized trials are required for pragmatic evaluations of health care interventions, but recruitment is difficult. Systematic reviews failed to identify robust strategies to improve recruitment. We developed and evaluated a complex intervention to increase levels of randomization and informed consent. Study Design and Setting The ProtecT ( Pro state te sting for c ancer and T reatment) trial compares radical surgery, radical conformal radiotherapy, and active monitoring for men aged 50–69 years with localized prostate cancer. The intervention was developed using qualitative research methods (content, thematic and conversation analysis). Rates of randomization and immediate acceptance of allocation were measured every 6 months to evaluate the impact of the intervention. Results The complex intervention comprised reviews of centers falling below study targets, training programmes, documents and individually tailored feedback. Over 65% of eligible participants consented to randomization. Trial participants became increasingly well informed as immediate acceptance of allocation rose from 65% to 81% between 2001 and 2005. Conclusion This complex intervention resulted in high levels of randomization and informed consent in a difficult trial. The generic aspects of the intervention could be applied to other trials to maximize randomization and informed consent, and allow the mounting of trials previously considered too difficult.

OBJECTIVE: To evaluate the psychosocial impact of participation in a population-based prostate-specific antigen (PSA) testing programme, akin to screening, and to explore the relationship between urinary symptoms reported before PSA testing and the response to the subsequent PSA result. PATIENTS AND METHODS: This prospective questionnaire study was nested within the case-finding component of the ProtecT (prostate testing for cancer and treatment) feasibility study (ISRCTN20141297). Men aged 50-69 years from 18 general practices in three cities in the UK completed the Hospital Anxiety and Depression Scale (HADS), the Short Form-12 (SF-12) Health Survey, and the International Continence Society 'male' (ICSmale) questionnaires before giving consent for a PSA test in a community clinic (baseline). Men with an 'abnormal' PSA result returned for further investigation (including biopsy) and repeated these questionnaires before biopsy. RESULTS: At baseline, study participants had similar levels of anxiety and depression to the general male population. There was no increase in the HADS scores, or reduction in the SF-12 mental health component summary score, on attendance at the biopsy clinic after receiving an 'abnormal' PSA result. Urinary symptoms were associated with levels of anxiety and depression before receiving a PSA result (baseline), but were not associated with anxiety and depression at biopsy independently of baseline scores. Therefore changes in anxiety or depression at biopsy did not appear to differ between those with and without urinary symptoms. CONCLUSIONS: This study confirms the findings of other studies that the deleterious effects of receiving an abnormal PSA result during population screening are not identified by generic health-status questionnaires. Comparisons with outcomes of studies measuring cancer-specific distress and using qualitative research methods raise the question of whether a prostate cancer screening-specific instrument is required. However, a standardized measure of anxiety identified differences at baseline between those who did and did not report urinary symptoms. These findings suggest that it might be advisable to better inform men undergoing PSA testing about the uncertain relationship between urinary symptoms and prostate cancer, to minimize baseline levels of psychological distress.

Problem: Recruitment to randomised trials is often difficult, and many important trials are not mounted because recruitment is thought to be “impossible.” Design: Controversial ProtecT (prostate testing for cancer and treatment) trial embedded within qualitative research. Background and setting: Screening for prostate cancer is hotly debated, and evidence from trials about the effectiveness of treatments (surgery, radiotherapy, and monitoring) is lacking. Mounting a treatment trial is controversial because of past failures and concerns that differences in complications of treatment but not survival make randomisation unacceptable to patients and clinicians, particularly for a trial including monitoring. Strategy for change: In-depth interviews explored interpretation of study information. Audiotape recordings of recruitment appointments enabled scrutiny of content and presentation of study information by recruiters. Initial qualitative findings showed that recruiters had difficulty discussing equipoise and presenting treatments equally; they unknowingly used terminology that was misinterpreted by participants. Findings were used to determine changes to content and presentation of information. Effects of change: Changes to the order of presenting treatments encouraged emphasis on equivalence, misinterpreted terms were avoided, the non-radical arm was redefined, and randomisation and clinical equipoise were presented more convincingly. The randomisation rate increased from 40% to 70%, all treatments became acceptable, and the three arm trial became the preferred design. Lessons learnt: Changes to information and presentation resulted in efficient recruitment acceptable to patients and clinicians. Embedding this controversial trial within qualitative research improved recruitment. Such methods probably have wider applicability and may enable even the most difficult evaluative questions to be tackled.

Objectives To investigate why symptoms indicative of early-stage lung cancer (LC) were not presented to general practitioners (GPs) and how early symptoms might be better elicited within primary care. Design, setting and participants A qualitative cross-sectional interview study about symptoms and help-seeking in 20 patients from three south England counties, awaiting resection of LC (suspected or histologically confirmed). Analysis drew on principles of discourse analysis and constant comparison to identify processes involved in interpretation and communication about symptoms, and explain non-presentation. Results Most participants experienced health changes possibly indicative of LC which had not been presented during GP consultations. Symptoms that were episodic, or potentially caused by ageing or lifestyle, were frequently not presented to GPs. In interviews, open questions about health changes/symptoms in general did not elicit these symptoms; they only emerged in response to closed questions detailing specific changes in health. Questions using disease-related labels, for example, pain or breathlessness, were less likely to elicit symptoms than questions that used non-disease terminology, such as aches, discomfort or ‘getting out of breath’. Most participants described themselves as feeling well and were reluctant to associate potentially explained, non-specific or episodic symptoms with LC, even after diagnosis. Conclusions Patients with early LC are unlikely to present symptoms possibly indicative of LC that they associate with normal processes, when attending primary care before diagnosis. Faced with patients at high LC risk, GPs will need to actively elicit potential LC symptoms not presented by the patient. Closed questions using non-disease terminology might better elicit normalised symptoms.