Lucy Brindle

Development of a complex intervention improved randomization and informed consent in a randomized controlled trial

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 (Prostate testing for cancer and Treatment) 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.

Measuring the psychosocial impact of population-based prostate-specific antigen testing for prostate cancer in the UK.

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.

Eliciting symptoms interpreted as normal by patients with early-stage lung cancer: could GP elicitation of normalised symptoms reduce delay in diagnosis? Cross-sectional interview study

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.

The influence of social processes on the timing of cancer diagnosis: a research agenda

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.

Symptom perceptions and help-seeking behaviour prior to lung and colorectal cancer diagnoses: a qualitative study

Background. 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. Objective. 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. Methods. 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. Results. 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. Conclusion. 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.

The role of helplines in cancer care: intertwining emotional support with information or advice-seeking needs.

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.

Facilitating early diagnosis of lung cancer amongst primary care patients: the views of GPs

Early diagnosis of lung cancer (LC) is a policy priority. However, symptoms are vague, associated with other morbidities, and frequently unrecognised by both patients and general practitioners (GPs). This qualitative study, part of a larger mixed methods study, explored GP views regarding the potential for early diagnosis of LC within primary care. Five focus group discussions (FGDs) were conducted with GPs (n = 16) at primary care practices (n = 5) across four counties in south England. FGDs were audio‐recorded, transcribed verbatim and analysed using a framework approach. Four broad themes emerged: patients’ reporting of symptoms; GP response to symptoms; investigating LC, and; potential initiatives for early diagnosis. GPs reported they often required high levels of suspicion to refer patients on to specialist respiratory consultations, and concerns of ‘system overload’ were prevalent. Greater access to more sensitive diagnostic investigations such as computed tomography, was argued for by some, particularly for symptomatic patients with negative chest X‐rays. GPs challenged current approaches to promoting earlier diagnosis through national symptom awareness campaigns, arguing instead that interventions targeted at high‐risk individuals might be more effective without burdening services already under pressure. Further work is needed to identify primary care patients who might most benefit from such targeted interventions.

Soliciting additional concerns in the primary care consultation and the utility of a brief communication intervention to aid solicitation: a qualitative study

OBJECTIVE 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. METHODS 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. RESULTS 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. CONCLUSION 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. PRACTICE IMPLICATIONS 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.

Promoting Help-Seeking in Response to Symptoms amongst Primary Care Patients at High Risk of Lung Cancer: A Mixed Method Study

Background Lung cancer symptoms are vague and difficult to detect. Interventions are needed to promote early diagnosis, however health services are already pressurised. This study explored symptomology and help-seeking behaviours of primary care patients at ‘high-risk’ of lung cancer (≥50 years old, recent smoking history), to inform targeted interventions. Methods Mixed method study with patients at eight general practitioner (GP) practices across south England. Study incorporated: postal symptom questionnaire; clinical records review of participant consultation behaviour 12 months pre- and post-questionnaire; qualitative participant interviews (n = 38) with a purposive sample. Results A small, clinically relevant group (n = 61/908, 6.7%) of primary care patients was identified who, despite reporting potential symptoms of lung cancer in questionnaires, had not consulted a GP ≥12 months. Of nine symptoms associated with lung cancer, 53.4% (629/1172) of total respondents reported ≥1, and 35% (411/1172) reported ≥2. Most participants (77.3%, n = 686/908) had comorbid conditions; 47.8%, (n = 414/908) associated with chest and respiratory symptoms. Participant consulting behaviour significantly increased in the 3-month period following questionnaire completion compared with the previous 3-month period (p = .002), indicating questionnaires impacted upon consulting behaviour. Symptomatic non-consulters were predominantly younger, employed, with higher multiple deprivation scores than their GP practice mean. Of symptomatic non-consulters, 30% (18/61) consulted ≤1 month post-questionnaire, with comorbidities subsequently diagnosed for five participants. Interviews (n = 39) indicated three overarching differences between the views of consulting and non-consulting participants: concern over wasting their own as well as GP time; high tolerance threshold for symptoms; a greater tendency to self-manage symptoms. Conclusions This first study to examine symptoms and consulting behaviour amongst a primary care population at ‘high- risk’ of lung cancer, found symptomatic patients who rarely consult GPs, might respond to a targeted symptom elicitation intervention. Such GP-based interventions may promote early diagnosis of lung cancer or other comorbidities, without burdening already pressurised services.

A descriptive survey of cancer helplines in the United Kingdom: Who they are, the services offered, and the accessibility of those services

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.