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National Collaborating Centre for Cancer (UK). Bladder Cancer: Diagnosis and Management. London: National Institute for Health and Care Excellence (NICE); 2015 Feb. (NICE Guideline, No. 2.)
The principle of ‘patient-centred care’ has for a long time been embedded and enshrined in the 7 Key Principles of the NHS Constitution as well as in other key NHS policies and practice guidance. This approach has been reflected in the strengthening commitment to providing holistic needs assessments. In March 2011, the national cancer action team published a guide for healthcare professional on holistic needs assessment for people with cancer in which Professor Mike Richards wrote:
“Holistic needs assessment should be part of every cancer patient's care. It can make a huge difference to a patient's overall experience and has the potential to improve outcomes by identifying and resolving issues quickly””.
A growing body of evidence from other cancers supports the patient-centred approach as enhancing outcomes with respect to patients' psychological, emotional and social wellbeing. Further research also suggests that better information and support, alongside greater involvement in decision making and exercising choice in their treatment, can also have a positive, and measurably beneficial, effect on clinical outcomes. In addition, evidence and research points to the highly significant contribution of the clinical nurse specialist, or a key worker, in providing information and support to people with cancer and their resultant level of patient satisfaction.
NICE has established a set of quality standards on Patient experience in adult NHS service (NICE 2012), which aims to raise the quality of the overall patient experience. However there remain significant variations in performance and standards between trusts.
Throughout this guideline, we have emphasised the importance of discussion between the person who has bladder cancer and those involved in their care and the principle of shared decision making and informed patient choice.
Wherever we have done so, there is also an assumption, even where not specifically stated, that if the person with bladder cancer so wishes, they should be able to be accompanied in such discussions by their partner/carer or another supporter. This will be particularly important at points throughout the treatment pathway when potentially distressing information is being shared; for example at first diagnosis of cancer or when difficult decisions are being made. Examples of difficult decisions include choices relating to treatments such as intravesical BCG, radical cystectomy, radical radiotherapy or chemotherapy or choices about palliative care or entry into clinical trials. Some treatments may have implications for survival or life changing impacts on sexual health, relationships and body image and the patient may therefore want to discuss these with those closest to them.
There is an assumption, even where not specifically stated, that all patients should be offered the opportunity to participate in clinical trials and research, wherever possible.
2.1. Patient satisfaction
The National Patient Experience Surveys have shown that compared to people with prostate cancer the experience of people with other urological cancers, of whom the majority have bladder cancer seems to be worse.
Clinical question: What are the causative and contributory factors that result in the comparatively low levels of reported patient satisfaction (compared with the National Patient Satisfaction Surveys) for bladder cancer patients within the group of urological cancers?
Clinical evidence (see also full evidence review)
Study quality and results
The literature search yielded one study reporting an analysis of treatment decision making data from the 2010 National Cancer Patient Experience Survey (NCPES) (El Turabi et al., 2013).
Evidence statements
Data from the National Cancer Patient Experience Survey (NCPES) 2011/12 National Report was used to answer this review question. Compared to other cancer patients, urological cancer patients (including those with bladder and kidney cancer but excluding prostate cancer) were least likely to report being offered a written assessment and care plan or to be provided with information about self-help or support groups. Urological cancer patients were also least likely to be given the contact details of their CNS (Table 6). There were pronounced differences in views between those patients with a CNS and those without one in terms of verbal and written information, involvement, information on financial support and prescriptions, discharge information, post discharge care, and emotional support. This indicates that the presence of a CNS makes a positive difference to the perceived quality of cancer services and may be a reason for the comparatively low levels of patient satisfaction for urological cancer patients. In an analysis of 41,441 responses to one question from the 2010 NCPES, one study (El Turabi et al., 2013) reported that bladder cancer patients were among the least likely to report a positive experience of involvement in treatment decision making (Table 7).
Table 6
Areas in the NCPES where urological cancer patients gave less positive assessments (less than average scores) as compared to other cancer groups.
Table 7
Variation of patient experience of involvement in treatment decision making within urological cancers (El Turabi et al., 2013).
Cost-effectiveness evidence
A literature review of published cost-effectiveness analyses did not identify any relevant papers for this topic. Whilst there were potential cost implications of making recommendations in this area, other questions in the guideline were agreed as higher priorities for economic evaluation. Consequently no further economic modelling was undertaken for this question.
| Recommendations | Offer clinical nurse specialist support to people with bladder cancer and give them the clinical nurse specialist's contact details. Ensure that the clinical nurse specialist:
Clinicians caring for people with bladder cancer should ensure that there is close liaison between secondary and primary care with respect to ongoing and community-based support. |
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| Relative value placed on the outcomes considered | Patient satisfaction was the focus of this review question. It is a very important consideration because of the comparatively low levels of bladder cancer patient satisfaction reported in the National Cancer Patient Experience Survey (NCPES). The GDG also considered the role of Clinical Nurse Specialists (CNS) in patient satisfaction and the potential impact of providing information and support on CNS workload. |
| Quality of the evidence | The NCPES was used for this review question, which was considered to be of moderate to high quality as it is a national survey completed by over 70,000 patients. The main limitation of the survey is that responses from bladder cancer patients are included in the broader category of urological cancers, so it was not possible to identify satisfaction scores specifically from bladder cancer patients. Moderate quality evidence from one study which analysed data from the 2010 NCPES reported that within urological cancers patient involvement in decision-making was lowest for bladder cancer patients. The NCPES indicated that for all cancers, CNS input was associated with greater patient satisfaction, and there are low levels of patient satisfaction and access to a CNS within urological cancers. Therefore, it was recommended that access to a CNS is provided for all bladder cancer patients. The recommendation that the CNS should have experience and training in bladder cancer was based on the GDG's clinical experience. It was considered important to specify this due to the broad remit of urology nurse specialists working in several disease sites and sub-specialties. The GDG made a research recommendation because there was a lack of evidence to answer the review question. The research recommendation that bladder cancer patient results be separated out from other urological cancers in nationally collected datasets aims to facilitate understanding of the issues related to patient satisfaction for bladder cancer. The research recommendation should also provide data about the causative and contributory factors that result in the comparatively low levels of patient satisfaction for bladder cancer patients. The lack of evidence about bladder cancer specifically lead to the research recommendation being made. No health economic evidence was identified. |
| Trade-off between clinical benefits and harms | The GDG considered the benefits of the recommendations to be greater patient satisfaction, better shared decision-making, and improved information and support, which could lead to improved clinical patient outcomes. No harms were identified by the GDG. The National Patient Experience Surveys have shown that compared to people with prostate cancer the experience of people with other urological cancers, of whom the majority have bladder cancer, seems to be worse. This led the GDG to try to identify the causative and contributory factors for this. The GDG noted that the main limitation of the National Cancer Patient Experience Survey is that responses from bladder cancer patients are included in the broader category of urological cancers, so it is not possible to identify satisfaction scores specifically from bladder cancer patients. Consequently the GDG were unable to identify the causative/contributory factors for the low satisfaction levels reported by bladder cancer patients. However the GDG felt it was important that this question was answered. They agreed that recommending annual satisfaction surveys of bladder cancer patients would be the first step in obtaining data, specific to people with bladder cancer that could give insight into the causative/contributory factors for the reported low levels of satisfaction. |
| Trade-off between net health benefits and resource use | No health economic model was developed for this topic. However, the GDG acknowledged that there are potential costs associated with the recommendations made. Most notably from the increase in CNS capacity and training costs required to implement the recommendations. The provision of information for patients may also incur some costs, as will the implementation of local patient satisfaction surveys and subsequent quality improvement programmes. The GDG balanced these costs against the potential savings from fewer patient complaints. The recommendations may also have a potential positive impact on patient outcomes and reduced time on avoidable enquiries for both patients and clinical staff. |
| Other considerations | The recommendations were developed to address any inequalities and ensure universal CNS access to all bladder cancer patients. Data from the NCPES demonstrates that around 25% of urological cancer patients were not given name of a CNS and a high proportion of patients were not given advice about financial benefits etc. Therefore, the GDG considered that significant change in practice in terms of CNS support to bladder cancer patients will be required. Also, CNS training specifically for bladder cancer will need to be expanded. The GDG were made aware of CNS census data that suggests that urological nurse specialists see an average of 176 newly diagnosed urological cancer patients a year, compared to around 94 patients per year in gynaecological cancer. The recommendations attempt to address this imbalance across cancer sites. The GDG were also aware that communication between primary and secondary care is often unsatisfactory, in particular, updates on significant events in secondary care (for example change of disease stage or treatment) may not reach primary care in a timely fashion. This can result in primary care teams not being able to provide proper support to distressed people. In view of this, the GDG felt strongly that the need for close liason between the two sectors had to be stressed. |
| Research recommendation | What are the causative and contributory factors underlying the persistently very low levels of reported patient satisfaction for bladder cancer? |
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| Why is this important | The urological cancers grouping (which includes bladder cancer but excludes prostate cancer) has consistently appeared near the bottom of the table of patient satisfaction comparisons of all cancer types in national patient experience surveys. Prostate cancer (which is also managed in urological services) is recorded separately and has continued to appear near the top of the tables. It is uncertain why this is the case, except that there is now an accepted link between the level of clinical nurse specialist allocation, information and support provision and patient satisfaction. The urological cancers grouping has the lowest level of clinical nurse specialist allocation in comparison with all other cancer types or groupings (including prostate cancer). The prolonged pattern of intrusive procedures that dominate investigation, treatment and follow-up regimens for bladder cancer may also contribute to this position. Additionally, there is concern that people with bladder cancer at or near the end of life, who are by that stage often quite frail and elderly, may not always have access to the full range of palliative and urological support and may, at times, be treated in general wards in hospital and experience significant symptoms of pain and bleeding (haematuria). To explore this research question bladder cancer patients need to be identified separately from the generic group of urological cancer patients in nationally collected data sets. |
2.2. Role of the clinical nurse specialist in giving information and advice
People with bladder cancer have a wide spectrum of information and support needs, dependant on the stage of their cancer and their treatments and follow-up options. These treatment and follow-up options may have marked physical, psychological, sexual and social implications for the patient, which emphasises the need for specialist information and support.
Clinical question: Which elements of the information and support provided by clinical nurse specialists (CNS)/key workers are most important for bladder cancer patients and/or their carers, at the various stages of the patient pathway?
Clinical evidence (see also full evidence review)
Study quality and results
Low quality evidence from six studies were included: three studies were qualitative interview studies, two studies used questionnaires to collect data, and one study reported data from a randomised trial. Details of the included studies are summarised in Table 8.
Table 8
Summary of included studies.
Evidence statement
In four studies (Fitch et al., 2010; Mansson et al., 1991; Kressin et al., 2010; Ronaldson, 2004), data were collected from 76 bladder cancer patients who had undergone radical cystectomy. Common physical and psychological post-operative issues reported by patients included the ability to self-manage urinary diversion, adjustment to body image, and changes in sexual function. In one UK study (Dearing, 2005) of 78 patients with superficial bladder cancer (pTa or pT1), 47% were aware of their underlying diagnosis. 33% of the 55 smoking patients had been told to stop smoking by their general practitioner and 7% had been told to stop by their urologist. Faithful et al. (2001) reported patient satisfaction and quality of life from a randomised trial of nurse-led or conventional follow-up in 115 men treated with radical radiotherapy for prostate or bladder cancer. The nurse-led protocol focused on coping with symptoms and provided continuity of care and telephone support. There were few differences between groups in terms of overall quality of life. However, men in the nurse-led group were significantly more satisfied with their follow-up care than men in the control group. The nurse-led clinic was perceived as providing a greater amount of information. Patients liked the continuity of care provided and the fact that their families could be included in the consultation.
Cost-effectiveness evidence
A literature review of published cost-effectiveness analyses did not identify any relevant papers for this topic. Whilst there were potential cost implications of making recommendations in this area, other questions in the guideline were agreed as higher priorities for economic evaluation. Consequently no further economic modelling was undertaken for this question.
| Recommendations | Follow the recommendations on communication and patient-centred care in NICE's guideline on patient experience in adult NHS services and the advice in NICE's guidelines on improving outcomes in urological cancers and improving supportive and palliative care for adults with cancer throughout the person's care. Use a holistic needs assessment to identify an individualised package of information and support for people with bladder cancer and, if they wish, their partners, families or carers, at key points in their care such as:
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| Relative value placed on the outcomes considered | The GDG considered the most important issue to be patient and/or carer satisfaction (with communication, information support and treatment received). The following issues were also considered to be important:
Referral to support groups and social support were specified as issues in the PICO but were not reported in the evidence. Social support, financial advice (compensation scheme), talking to other patients, and holistic needs assessment were issues that were not reported in the evidence but the GDG used their clinical knowledge, patient experience and knowledge of other sources of information on patient experience (such as patient experience surveys) to make recommendations on these issues. |
| Quality of the evidence | All evidence was assessed as being of low quality using the NICE methodology checklist for qualitative studies. The main limitation of the evidence was that there was no direct evidence to answer review question. Most studies included patients having cystectomy so there was a lack of evidence from patients with non-muscle invasive disease. The included qualitative studies were also limited by small sample sizes. The GDG is aware of other studies in which patient information and support needs were met by health professionals other than the CNS, but this was not the focus of this review question. The GDG drew upon their clinical knowledge and patient experience to form recommendations in the absence of any direct high quality evidence. The GDG made the recommendations about providing opportunities to talk to other patients, referral to support groups and holistic needs assessment based on their clinical experience. Also the recommendation to provide financial advice including industrial compensation was based on GDG experience because one of the best described risk factors for bladder cancer is occupational exposure to chemicals used in industry. Patients exposed in this way may be eligible for compensation through the Industrial Injuries Disablement Benefits Scheme. The GDG specifically highlighted this as many patients and their clinicians may not be familiar with this entitlement. Moreover, recognition of occupational risk is important epidemiologically to assess the effectiveness of health and safety legislation. No health economic evidence was identified. |
| Trade-off between clinical benefits and harms | The GDG considered the main clinical benefits of the recommendations to be: improved patient satisfaction, psychological and social well-being; empowerment of patients to participate in the management of their disease; improved equality of care; reduced sense of loss of independence; and enhanced patient-felt locus of control. The GDG also considered that there is a potential for increased patient anxiety from receiving too much information. The GDG considered it important to achieve a balance between the types of advice given and the strength of the evidence base which underpins them. The GDG felt that currently many patients do not get holistic needs assessment and opportunities for reviewing patients' needs during the patient pathway are missed. Emphasising the patient perspective was thought to outweighs the potential harms. The GDG agreed that it is important to improve patient satisfaction and considered that few people are likely to have information overload |
| Trade-off between net health benefits and resource use | No health economic evidence was identified for this topic and no economic model was developed. The GDG considered that the potential costs of the recommendations include: increased resource to provide patient information and support; increased time to do holistic needs assessment; increased costs from providing resources such as booklets; and an increase in free prescriptions The potential savings include: fewer patient complaints; reduced time on avoidable enquiries; less inappropriate treatment and investigation The GDG considered that the benefits in terms of patient well-being justify the potential additional costs. It is unknown whether there will be a net cost or saving. |
| Other considerations | The GDG recommended individualised holistic needs assessment with the expectation that health professionals will take into account patient specific needs such as for translation, health literacy, and help with a full range of disabilities. The GDG noted that there needs to be gender relevant sexual advice because there is a concern that advice about sexual function has been focused on men. The GDG felt that holistic needs assessment would address many potential areas of inequality. The GDG expect that a considerable increase in the use of holistic needs assessment and associated resources will result from these recommendations. There will be an increased need for uro-oncology CNS time and other specialists. The GDG also considered the existing NICE guidance, notably the Improving Outcomes Guidance for Urological Cancers and the Cancer Service Guideline for Supportive and Palliative Care. |
2.3. Specialist palliative care needs at end of life
People with bladder cancer approaching the end of life may experience particular physical symptoms, such as intractable bleeding, obstruction and pain, and associated psychological distress. This can create specific end of life care needs for bladder cancer patients, in addition to their more general physical, psychological and spiritual palliative care needs.
The management of specific symptoms related to locally advanced bladder cancer are discussed in Chapter 6.
Clinical question: Which elements of specialist palliative care services are most important for bladder cancer patients and/or their carers during end-of-life care?
Clinical evidence (see also full evidence review)
Study quality and results
Six studies were identified, including one systematic review and five cross-sectional questionnaire studies. Details of the included studies are summarised in table 9.
Table 9
Summary of included studies.
Evidence statements
In three studies, the respondents were carers of cancer patients who had received palliative care. The study by Fakhoury et al. (1997) reports carer's (n=1858) satisfaction with community nurses, hospital doctors and GPs, but does not specify that patients were treated within a specialist palliative care team. Most carers were highly satisfied with the different providers, but the least satisfaction was reported by those who cared for patients with genito-urinary tumours. Duration of pain was not related to any of the satisfaction measures. In a study of 181 patients, Teunissen et al. (2006) reported that the main support needs in palliative care for all ages was the need for functional support and support in coping. Older patients (aged 70 or over) reported less need for relational support or support in communication than younger respondents. A Swedish study of 379 women who had lost their husband/partner to prostate or bladder cancer reported that 93% of patients had adequate access to pain control during the last 3 months of life, whereas only 33% had access to psychological support. The cancer patient's mental health status at the end-of-life was also predictive of the widows' anxiety and depression at follow-up (Valdimarsdottir et al., 2002).
A Japanese study including 469 bereaved family members of cancer patients rated that 25% of patients experienced a mild self-perceived burden, and 25% experienced moderate to severe self-perceived burden. Family members rated care strategies to alleviate patient-perceived burden, the most useful being 1) eliminating pain and other symptoms that restrict patient activity; 2) quickly disposing of urine and stools so that they are out of sight; 3) supporting patients' efforts to care for themselves (Akazawa et al., 2010). One systematic review aimed to explore self-care strategies in end-of-life care in advanced cancer (Johnston et al., 2009). Although self- care strategies such as using information and using distraction techniques were identified these were largely initiated by researchers. No research used a patient-centred approach and the author concluded that self-care in advanced cancer is an under-explored area. Factors that prevented patients to self-care were low education, poor socio-economic status, psychological distress and physical limitations.
One study of a UK urology ward's inpatients and outpatients (n=881) with advanced or metastatic urological cancer reported that 75% of out-patients had specific problems or were generally unwell as a result of their disease and would have benefitted from specialist palliative care. 25% were well at the time of their visit but potential psychosocial problems arising from coping with terminal disease were not addressed (Brierly & O'Brien, 2008).
Cost-effectiveness evidence
A literature review of published cost-effectiveness analyses did not identify any relevant papers for this topic. Whilst there were potential cost implications of making recommendations in this area, other questions in the guideline were agreed as higher priorities for economic evaluation. Consequently no further economic modelling was undertaken for this question.
| Recommendations | A member of the treating team should offer people with incurable bladder cancer a sensitive explanation that their disease cannot be cured and refer them to the urology multidisciplinary team. Tell the primary care team that the person has been given a diagnosis of incurable bladder cancer within 24 hours of telling the person. A member of the urology multidisciplinary team should discuss the prognosis and management options with people with incurable bladder cancer. Discuss palliative care services with people with incurable bladder cancer and if needed and they agree, refer them to a specialist palliative care team (for more information see recommendations in section 2.2 on holistic needs assessment and NICE's guidelines on improving supportive and palliative care for adults with cancer and improving outcomes in urological cancers). Offer people with symptomatic incurable bladder cancer access to a urological team with the full range of options for managing symptoms. |
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| Relative value placed on the outcomes considered | The GDG considered all aspects of the modified PICO table as important. The GDG considered it crucial that patient and carer information and support needs are met during end-of-life care. It was also felt important that the person's primary care team were informed of the diagnosis to enable them to support the person and their family. The GDG emphasised the importance of psychological well-being and quality of life as well as relief from symptoms such as bleeding and pain. The evidence presented for this review question was very limited and there was no evidence specific to bladder cancer. There was no evidence about informed choice/decision-making or about referral to support groups/networks. |
| Quality of the evidence | The quality of the evidence was assessed as being of low quality using the NICE methodology checklist for qualitative studies. The limitations of the evidence were mainly related to the lack of good data to answer the review question. None of the studies were specific to bladder cancer. Only one study was about urological cancer. The included studies were qualitative interview studies or cross-sectional questionnaire studies, a majority of which were conducted in a non-UK setting and did not specify if care was provided by a specialist palliative care team. The published systematic review that was presented concluded that there is a lack of evidence about self-care in advanced cancer. The lack of direct evidence meant that the GDG had to base their recommendations upon clinical consensus. The GDG noted that access to the specialist palliative care team was central to the recommendations, with a view to ensuring that there is rapid access and effective liaison between teams. This is also in line with existing NICE guidance (Improving Outcomes in Urological Cancer and Supportive and Palliative care). The GDG considered the specific issues for bladder cancer patients such as bleeding, haematuria and bladder irrigation which require urological input while under the care of the palliative team One study presented in the evidence review also suggested that there may be lack of psychosocial support for urological cancer patients with advanced disease. No research recommendation was made. |
| Trade-off between clinical benefits and harms | The potential benefits of the recommendations include greater informed patient choice, better symptom control, improved access to information and psychosocial and spiritual support during palliative care. Efficient referral to the appropriate team (e.g. urological input) may also reduce inappropriate treatment. The GDG also considered that if the patient has improved end-of-life care there is a potential benefit to bereaved relatives in terms of reduced distress. The GDG considered a potential harm from engaging the patient and their family in conversations about their prognosis and palliative care is that this could be very distressing. The GDG noted that recent information suggests not all patients wish to be informed of their diagnosis of incurable disease. The GDG balanced the benefits against the harms by considering that it is vital that patients are offered a full and sensitive explanation about their prognosis and options for palliative treatment. The GDG considered that, for the majority, the benefits of improved support during palliative care and referral to the appropriate clinicians outweigh any potential harms, but that patient consent should be acquired before making a palliative care referral. |
| Trade-off between net health benefits and resource use | No health economic model was developed for this topic and no economic evidence was identified. The GDG considered the potential costs of the recommendations to be from increased palliative care activity (e.g. more referrals) and clinical nurse specialist involvement. There may also be increased NHS community care costs. The potential savings are likely to arise from reduced hospital-based costs, reduced bed days and admissions. The GDG considered there may be fewer investigations and a potential reduction in futile treatments The GDG considered that there is likely to be net saving to the NHS. |
| Other considerations | The GDG considered equalities issues about access to palliative care services from minority ethnic groups and according to age. The recommendations made should help address any inequalities by enabling access to palliative care for all patients with incurable bladder cancer. The GDG also considered the existing NICE guidance, notably the Improving Outcomes Guidance for Urological Cancers, the Cancer Service Guideline for Supportive and Palliative Care. The GDG considered that it is likely to require considerable change in practice to implement the recommendations. The GDG highlighted the shortage of CNSs for urological cancers as a potential issue in the implementation of the guideline. There is likely to be an increase in input from palliative care teams and uro-oncology CNSs for patients with incurable disease. |
2.4. Smoking cessation and long term outcomes for people with bladder cancer
Compared to non-smokers, smokers have approximately three times the risk of developing bladder cancer. People who stop smoking reduce their risk of developing bladder cancer by 30-60% within four years. Given the relationship between smoking and bladder cancer, there is an opportunity to discuss a person's smoking history during consultations about bladder cancer.
For people with bladder cancer who smoke, other potential benefits of smoking cessation include reduction in the risk of developing other smoking-related cancers and cardiorespiratory disease, improved efficacy of radical radiotherapy and reduction in peri-operative risk for radical cystectomy.
The timing of discussions about smoking and smoking cessation may be difficult to judge in view of the distress and anxiety caused by a new diagnosis of bladder cancer and associated treatment decisions.
Given the association between smoking and bladder cancer, and the known benefits of smoking cessation, experts have questioned whether smoking cessation would reduce the risk of progression and recurrence in people with bladder cancer.
Clinical question: Does smoking cessation affect outcomes for patients with bladder cancer?
Clinical evidence (see also full evidence review)
Study quality and results
One systematic review (Crivelli et al., 2014) and a further three prognostic studies (Kim et al., 2014; Wyszynski et al., 2014; Wang et al., 2014) were identified for the outcomes of recurrence, progression, cancer-specific survival, overall survival and treatment-related morbidity. One study presenting baseline data from a randomised trial (Ditre et al., 2011) was identified for the outcome of health-related quality of life. The systematic review was clearly focused and relevant to the review question for this topic. However, many of the included studies focused on the impact of patients' smoking status on clinical outcomes rather than the effect of smoking cessation. The literature search was judged to be sufficiently rigorous and the methodology was well reported. No formal study quality assessment was reported in the systematic review. However, the studies were limited by heterogeneity in patient characteristics (i.e. stage and grade), follow-up time, and the categorization of smoking status, which precluded a meta-analysis. The use of intravesical therapy and repeat TURBT also varied across studies and was often not reported. The study by Ditre et al. (2011) was considered to be of low quality because the population was not relevant to the review question (the majority of participants had lung or breast cancer). Study quality for the three further prognostic studies was assessed using the NICE methodology checklist for prognostic studies. The quality assessment item regarding loss to follow-up was not considered relevant to this review question. In all studies the study sample was clearly defined and represented the population of interest. All studies used an appropriate method of analysis and hazard ratios (HRs) were provided. A narrative summary of the evidence is presented.
Evidence statements
Moderate quality evidence from one systematic review of 19 studies (Crivelli et al., 2014) and three further observational studies (Kim et al., 2014; Wyszynski et al., 2014; Wang et al., 2014) was identified (14,863 patients in total).
For patients treated with TURBT, nine out of 13 studies found a statistically significant association of smoking with disease recurrence. Two out of eight studies and two out of two studies, when stratified by smoking status and smoking exposure respectively, found statistically significant associations between smoking and disease progression. The only study that evaluated the influence of smoking on disease-specific survival revealed no association. Overall survival was reported by four studies, three of which showed no significant associations with smoking, whilst one study reported that continued smoking after diagnosis, but not former smoking, was associated with shorter overall survival compared to never smoking (Wyszynski et al., 2014).
For patients treated with radical cystectomy, three out of seven studies found statistically significant associations of smoking status with recurrence. The same studies also found that smoking was associated with disease-specific survival and overall survival, with smoking history being an independent prognostic factor for overall survival in one study (HR 1.31, 95% CI 1.05-1.63). However, no distinction was made between former or current smokers. The systematic review reported that in one study a reduced risk of recurrence (HR 0.44, 95% CI 0.31-0.62), disease-specific mortality (HR 0.42, 95% CI 0.29-0.63) and overall mortality (HR 0.69, 95% CI 0.52-0.91) was found for patients who quit smoking ≥10 years prior to diagnosis compared with current smokers.
One study of 623 patients treated with BCG therapy for recurrent high-grade NMIBC reported the effects of smoking status on BCG response. A response to BCG was defined as a negative cystoscopy and negative urine cytology six months after treatment. There were no differences in the probability of a complete response between never smokers vs. past smokers vs. current smokers (77% vs. 76% vs. 77%, p=0.95). Adjustment for time since smoking cessation was not associated with BCG response.
Low quality evidence was identified from one study which reported on the associations between pain and current smoking status among cancer patients due to begin chemotherapy treatment (Ditre et al., 2011). Only 6% of the study population were diagnosed with bladder cancer. Current smokers reported more severe pain and greater interference from pain than never smokers. There were no differences in pain severity between former smokers and either current or never smokers. Current smokers also reported experiencing greater interference from pain than former smokers. Pain-related distress scores did not significantly differ between groups.
Cost-effectiveness evidence
A literature review of published cost-effectiveness analyses did not identify any relevant papers for this topic. Whilst there were potential cost implications of making recommendations in this area, other questions in the guideline were agreed as higher priorities for economic evaluation. Consequently no further economic modelling was undertaken for this question.
| Recommendations | Offer smoking cessation support to all people with bladder cancer who smoke, in line with NICE's guidelines on smoking cessation services and brief interventions and referral for smoking cessation. |
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| Relative value placed on the outcomes considered | The GDG considered recurrence, progression, and survival to be the most important outcomes. Recurrence was considered to be important because it necessitates more cystoscopies, follow-up, and treatment. Therefore, reductions in recurrence can be very beneficial to patients and the NHS. Likewise, progression is important because it is associated with worse outcomes for patients and further treatment. Overall survival was considered to be important as it is a crucial aspect for most medical interventions. There were no outcomes from the PICO that were not reported in the evidence and no additional outcomes (i.e. not specified in the PICO) were used to make recommendations. Quality of life and treatment-related morbidity were not considered to be useful once the evidence was appraised. This was because there was limited evidence in this area. |
| Quality of the evidence | The systematic review was assessed as being of high quality using the NICE methodology checklist for systematic reviews, although no formal study quality assessment of individual studies was reported in the review. The quality of the additional prognostic studies was assessed as being of high quality using the NICE methodology checklist for prognostic studies. The study reporting quality of life data was considered to be low quality because the population was not relevant to the review question (the majority of participants had lung or breast cancer). Although the evidence was generally assessed as being of good quality using the NICE checklists, the reviewer highlighted some potential issues with the evidence. Most notably, many of the studies included in the systematic review focused on the impact of patients' smoking status on clinical outcomes rather than the effect of smoking cessation. Also, different definitions of smoking cessation were used in the studies and patient populations were heterogeneous, which prevented the pooling of data. In addition, there were a very small number of events for progression, which may reduce the power to observe an effect. The data on overall survival was limited because only eight studies reported this outcome, and only two of these studies showed an impact of smoking on overall survival. A further limitation was that the follow-up periods in the studies were highly variable. A general lack of long-term follow-up also reduces the power of events observed. The GDG noted these limitations and they affected the recommendations that were made. The GDG felt they could only make general recommendations (PH1). The different definitions of smoking cessation proved particularly troublesome. The GDG felt this prevented them from drawing stronger conclusions because the data on patients who quit smoking could not be pooled. The GDG made a research recommendation because they wanted to address the limited availability of data on the impact of smoking cessation, particularly on progression and overall survival. Furthermore, the GDG considered that getting a definitive answer on whether offering smoking cessation interventions improves bladder cancer specific outcomes was very important. Despite the limitations of the evidence base (significant enough to warrant a research recommendation), the GDG wanted to make a recommendation in this area. The GDG felt this was appropriate as the recommendation is in line with existing NICE guidance and there is a low likelihood of harmful effects associated with recommending smoking cessation. |
| Trade-off between clinical benefits and harms | The GDG considered the potential benefits of the recommendation to be accrued by current smokers that decide to give up smoking. The primary potential benefits were identified as a reduction in recurrence and progression and an improvement in overall survival. The GDG also felt that there may be further benefits associated with reduced complication rates after surgery. The GDG considered the potential harms of the recommendation to be an increase in patient anxiety and weight gain after smoking cessation. In balancing the potential harms and benefits, the GDG felt that the potential benefits strongly outweighed the potential harms. This is because improved survival and potentially a reduced need for further treatment is likely to be far more important to patients and the NHS than a potential for weight gain and anxiety. |
| Trade-off between net health benefits and resource use | A health economic evaluation was not conducted for this topic and no suitable health economic data was identified in the literature review. However when making their decision, the GDG did consider the potential costs and savings of the recommendations. The GDG recognised that there would be some costs associated with the smoking cessation interventions but felt that they were relatively cheap. In addition, the recommendation is line with existing guidance and so smoking cessation support should already be offered. The GDG considered one of the economic benefits to be a reduced need for medical interventions, including general anaesthetic, cystoscopy, intravesical therapy, imaging, cystectomy and radiotherapy. The GDG felt that a further benefit could be a reduction in post-operative complications. Overall, the GDG felt that there was unlikely to be any substantial increase in costs as a result of the recommendation. This is because smoking cessation interventions are relatively cheap and are likely to be offset by a reduced need for medical interventions and a reduction in post-operative complications. |
| Other considerations | In terms of equalities concerns, the GDG noted that the prevalence of smoking is higher in more deprived groups who are also less likely to give up smoking following the offer of interventions. The GDG further noted that bladder cancer incidence increases and relative survival decreases with increasing deprivation The GDG also thought that there could be a potential language barrier to people whose first language is not English. The GDG also considered the possibility of any changes in practice necessitated to implement recommendations. The GDG believes that smoking cessation is not routinely offered in urology clinics to all bladder cancer patients who smoke. Therefore, there may be a need for further resources in these clinics to support smoking cessation. However, all patients should be advised to quit smoking according to current NICE guidance. Communication between primary and secondary/tertiary care needs to be strengthened to support smoking cessation in bladder cancer patients. When making their recommendations, the GDG also considered the well-evidenced general health and economic benefits from smoking cessation. |
| Research recommendation | In people with newly diagnosed bladder cancer who smoke, is an enhanced smoking cessation programme more effective than a standard programme in terms of bladder cancer recurrence, progression and overall survival |
|---|---|
| Why is this important | The benefits of smoking cessation are well described, in terms of general health. The causative link between smoking and bladder cancer is also well known. There is also evidence that stopping smoking after the diagnosis of bladder cancer reduces risk of recurrence. this may be the case for those with bladder cancer. A diagnosis of bladder cancer for people who smoke therefore allows them the opportunity to help themselves by taking the opportunity to stop smoking, and reduce their risk of recurrence. This research will examine whether an enhanced cessation programme is more effective than the current standard cessation support. |
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