Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study.

BACKGROUND: The ELCID (Early Lung Cancer Investigation and Diagnosis) trial was a feasibility randomised controlled trial examining the effect on lung cancer diagnosis of lowering the threshold for referral for urgent chest x-ray for smokers and recent ex-smokers, aged over 60 years with new chest symptoms. The qualitative component aimed to explore the feasibility of individually randomising patients to an urgent chest x-ray or not and to investigate any barriers to patient recruitment and participation. We integrated this within the feasibility trial to inform the design of any future definitive trial, particularly in view of the lack of research exploring symptomatic patients' experiences of participating in diagnostic trials for possible/suspected lung cancer. Although previous studies contributed valuable information concerning screening for lung cancer and patient participation in trials, this paper is the first to explore issues relating to this specific patient group. METHODS: Qualitative interviews were conducted with 21 patients, comprising 9 who had been randomised to receive an immediate chest x-ray, 10 who were randomised to receive the standard treatment according to the National Institute for Health and Care Excellence guidelines, and 2 who chose not to participate in the trial. Interviews were analysed using a framework approach. RESULTS: The findings of this analysis showed that altruism, personal benefit and the reassurance of not having lung cancer were important factors in patient participation. However, patients largely believed that being in the intervention arm was more beneficial, highlighting a lack of understanding of clinical equipoise. Disincentives to participation in the trial included the stigmatisation of patients who smoked (given the inclusion criteria). Although the majority of patients reported that they were happy with the trial design, there was evidence of poor understanding. Last, for several patients, placing trust in health professionals was preferred to understanding the trial processes. CONCLUSIONS: The integration of a qualitative study focusing on participant experience as a secondary outcome of a feasibility trial enabled exploration of patient response to participation and recruitment. The study demonstrated that although it is feasible to recruit patients to the ELCID trial, more work needs to be done to ensure an understanding of study principles and also of smoking stigmatisation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01344005 . Registered on 27 April 2011.

Postpartum pneumomediastinum and subcutaneous emphysema.

We present the case of a 22-year-old primigravida with symptoms of neck swelling and difficulty breathing 3 hours after uneventful vaginal delivery. On examination, there was surgical emphysema. A CT scan confirmed air in the subcutaneous tissues and also revealed pneumomediastinum. There was no evidence of pneumothorax and gastro-oesophageal endoscopy showed no signs of oesophageal rupture. The patient remained clinically stable throughout her admission and was discharged home after 48 hours of observation. Pneumomediastinum is one of the rare causes of shortness of breath and chest pain during the postpartum period, and it should be considered in the differential diagnosis. Despite the significant abnormalities seen on plain radiography and CT scan, this condition spontaneously resolves. Although postpartum pneumomediastinum has been related to prolonged labour, this was not the case in our patient.

Symptoms at lung cancer diagnosis are associated with major differences in prognosis.

We report a cohort study of survival of patients with lung cancer presenting to a single multidisciplinary team between 1997 and 2011, according to symptoms at presentation. The overall median survival of the 3800 lung cases was 183 days (95% CI 171 to 195). There was a statistically significant difference in survival between the 12 symptom groups identified both without and with adjustment for the prognostic variables of age, gender and histology (P<0.001). Compared with the cough-alone symptom group, the risks of dying or HRs were significantly higher for the groups presenting with breathlessness (HR 1.86, 95% CI 1.54 to 2.24, n=359), systemic symptoms (HR 1.91, 95% CI 1.48 to 2.45, n=95), weight loss (HR 2.46, 95% CI 1.90 to 3.18, n=106), chest pain (HR 1.96, 95% CI 1.56 to 2.45, n=159), cough with breathlessness (HR 1.59 95% CI 1.28 to 1.98, n=177), neurological symptoms (HR 3.07, 95% CI 2.45 to 3.84, n=155) and other symptom combinations (HR 2.05, 95% CI 1.75 to 2.40, n=1963). Cough may deserve particular prominence in public health campaigns.

Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial.

BACKGROUND: Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom. Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation. METHODS: We undertook a mixed methods feasibility individually randomised controlled trial (the ELCID trial) to assess the feasibility and inform the design of a definitive, fully powered, UK-wide, Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer. Patients over 60, with a smoking history, presenting with new chest symptoms to primary care, were eligible to be randomised to intervention (urgent chest X-ray) or usual care. RESULTS: The trial design and materials were acceptable to GPs and patients. We randomised 255 patients from 22 practices, although the proportion of eligible patients who participated was lower than expected. Survey responses (89%), and the fidelity of the intervention (82% patients X-rayed within 3 weeks) were good. There was slightly higher anxiety and depression in the control arm in participants aged >75. Three patients (1.2%) were diagnosed with lung cancer. CONCLUSIONS: We have demonstrated the feasibility of individually randomising patients at higher risk of lung cancer, to a trial offering urgent investigation or usual care.

A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial.

BACKGROUND: In order to improve lung cancer survival in the UK, a greater proportion of resectable cancers must be diagnosed. It is likely that resectability rates would be increased by more timely diagnosis. Aside from screening, the only way of achieving this is to reduce the time to diagnosis in symptomatic cancers. Currently, lung cancers are mainly diagnosed by general practitioners (GPs) using the National Institute for Health and Clinical Excellence (NICE) guidelines for urgent referral for chest X-ray, which recommend urgent imaging or referral for patients who have one of a number of chest symptoms for more than 3 weeks. We are proposing to expand this recommendation to include one of a number of chest symptoms of any duration in higher-risk patients. METHODS/DESIGN: We intend to conduct a trial of imaging in these higher-risk patients and compare it with NICE guidelines to see if imaging improves stage at diagnosis and resection rates. This trial would have to be large (and consequently resource-intensive) because most of these patients will not have lung cancer, making optimal design crucial. We are therefore conducting a pilot trial that will ascertain the feasibility of running a full trial and provide key information that will be required in order to design the full trial. DISCUSSION: This trial will assess the feasibility and inform the design of a large, UK-wide, clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer. It utilizes a combination of workshop, health economic, quality of life, qualitative, and quantitative methods in order to fully assess feasibility. TRIAL REGISTRATION: Clinicaltrials.gov NCT01344005.

Early diagnosis of lung cancer: evaluation of a community-based social marketing intervention.

BACKGROUND: Poor U.K. lung cancer survival rates may, in part, be due to late diagnosis. OBJECTIVES: To evaluate the effectiveness of a mixed-method community-based social marketing intervention on lung cancer diagnoses. METHODS: A public awareness campaign in conjunction with brief intervention training in general practices was piloted in six localities with a high lung cancer incidence. End points were self-reported awareness of lung cancer symptoms; intention to seek healthcare; chest x-ray referral rates in primary care; secular trends in the incidence of lung cancer and stage at diagnosis, compared before and after the intervention. RESULTS: 21% (128/600) (95% CI 18% to 25%) of the targeted population recalled something about the campaign. Compared with a responder in the control area, the odds of a responder in the intervention area saying that they would visit their general practitioner and request a chest x-ray for a cough was 1.97 times (95% CI 1.18 to 3.31, p=0.01). Primary care chest x-ray referral rates increased by 20% in the targeted practices in the year following the intervention compared with a 2% fall in the control practices. The difference was highly significant, with an incidence rate ratio of 1.22 (95% CI 1.12 to 1.33, p=0.001). There was a 27% increase in lung cancer diagnoses in the intervention area compared with a fall in the control area. The incidence rate ratio was 1.42 (95% CI 0.83 to 2.44 p=0.199). CONCLUSION: This is encouraging early evidence that an awareness and early recognition initiative may facilitate lung cancer diagnosis.

Primary care radiography in the early diagnosis of lung cancer.

Finding an abnormality on a plain chest radiograph is usually the first definite evidence of a lung cancer, so this investigation is currently pivotal in the diagnosis of the disease. Although the National Institute for Clinical Excellence (NICE) has produced guidance on when a chest radiograph should be done for putative lung cancer presentations, cancer will usually be only one of a number of possible diagnoses, so this is somewhat artificial. Neither is there any evidence that obtaining a chest radiograph for these features leads to an improved outcome. Another major concern is the poor public awareness of the symptoms for which a chest radiograph is recommended. This article discusses the role of the chest radiograph in the early diagnosis of lung cancer with particular emphasis on the limited value of a single negative result and on the potential implications of interventions to increase the number of chest radiographs done in primary care.

Small-cell lung cancer: 8 years experience of a single multidisciplinary team.

Aims. We have audited the changes in treatment practice for small-cell lung cancer (SCLC) presented to a single multidisciplinary team (MDT) at Doncaster and Bassetlaw Hospitals between January 1998 and December 2005. Materials and Methods. The MDT database was used to identify all patients with SCLC. Anonymised demographic, treatment, and outcome details were extracted from the database supplemented by patient records. Results. 235 patients were identified. 112 (48%) had limited disease at presentation. Chemotherapy was the initial treatment for 195 patients, 77% of whom had a documented radiological response with a complete response in 24%. Chemotherapy regimes evolved during the study period with the increasing use of platinum-based chemotherapy. Anthracycline-based chemotherapy was most used before 2004 and was given to 57% of all patients. 42% received consolidation thoracic radiotherapy and 24% prophylactic cranial irradiation. The median and 2-year survival were 8 months and 18%, respectively, for patients with limited disease and 5 months and 5%, respectively, for extensive disease. Conclusion. We have documented changes in treatment practice and service delivery of SCLC over the 8 years during which the MDT has been operating. However, there has not achieve any significant improvement in outcome for the population of patients with SCLC.

Are we failing workers with symptoms suggestive of occupational asthma?

AIMS: To assess the route to secondary care for patients with possible occupational asthma, and to document the duration of workrelated symptoms and referral times. METHODS: Consecutive patients with suspected occupational asthma were recruited to a case series from six secondary care clinics with an interest in occupational asthma. Semi-structured interviews were performed and hospital case notes were reviewed to summarise relevant investigations and diagnosis. RESULTS: 97 patients were recruited, with a mean age of 44.2 years (range 24-64), 51 of whom (53%) had occupational asthma confirmed as a diagnosis. Most (96%) had consulted their general practitioner (GP) at least once with work-related respiratory symptoms, although these had been present for a mean of 44.6 months (range 0-320 months) on presentation to secondary care. Patients experienced a mean delay for assessment in secondary care of 4 years (range 1-27 years) following presentation in primary care. CONCLUSIONS: Significant diagnostic delay currently occurs for patients with occupational asthma in the UK.

Occupational asthma: an assessment of diagnostic agreement between physicians.

OBJECTIVES: To investigate the levels of agreement between expert respiratory physicians when making a diagnosis of occupational asthma. METHODS: 19 cases of possible occupational asthma were identified as part of a larger national observational cohort. A case summary for each case was then circulated to 12 physicians, asking for a percentage likelihood, from the supplied information, that this case represented occupational asthma. The resulting probabilities were then compared between physicians using Spearman's rank correlation and Cohen's kappa coefficients. RESULTS: Agreement between the 12 physicians for all 19 cases was generally good as assessed by Spearman's rank correlation. For all 66 physician-physician interactions, 45 were found to correlate significantly at the 5% level. The agreement assessed by kappa analysis was more variable, with a median kappa value of 0.26, (range -0.2 to +0.76), although 7 of the physicians agreed significantly (p<0.05) with >or=5 of their colleagues. Only in one case did the responses for probability of occupational asthma all exceed the "on balance" 50% threshold, although 12 of the 19 cases had an interquartile range of probabilities not including 50%, implying "on balance" agreement. The median probability values for each physician (all assessing the identical 19 cases) varied from 20% to 70%. Factors associated with a high probability rating were the presence of a positive serial peak expiratory flow Occupation Asthma SYStem (OASYS)-2 chart, and both the presence of bronchial hyper-reactivity and significant change in reactivity between periods of work and rest. CONCLUSIONS: Despite the importance of the diagnosis of occupational asthma and reasonable physician agreement, certain variations in diagnostic assessment were seen between UK expert centres when assessing paper cases of possible occupational asthma. Although this may in part reflect the absence of a normal clinical consultation, a more unified national approach to these patients is required.