Report to the NHS Central Research & Development Committee
Annex 9 - Justifications of Priorities










JUSTIFICATION A
Ways of effecting, maintaining and evaluating behavioural changes leading to a reduction in smoking at all ages, particularly children

Background

Smoking is the major causative factor for a wide range of cancers, particularly those of the lung and upper aero digestive tract. A reduction in smoking is a major target of the Health of the Nation programme. For instance, 80-90% of lung cancer is attributable to smoking.

The earlier in life regular smoking is begun, the greater is the risk of lung cancer and heart disease later in life.

In the 1992 survey carried out by the OPCS on behalf of the DH, 21% of boys and 25% of girls aged 15 years and still at school were smoking regularly. Allowing for the latent period for lung cancer, the incidence of even this one disease will be undiminished and will be extremely costly both in terms of life and money.

If elements of smoking control which are acceptable and meaningful to young people can be identified and used as the basis for interventions, their effectiveness in delaying the onset of smoking would be intensified. The consequent effect would be, in the long term, a reduction in the incidence of lung cancer and heart disease, both of which are very costly to the NHS in terms of treatment. In the short term, delaying or reducing smoking among young people would have a direct and immediate health effect. Children who smoke are more likely than non-smokers to suffer from minor ailments such as coughs, colds, sore throats and earache and consequently to require treatment and to have time off school. This set of circumstances can be perpetuated when these young smokers are later themselves parents and affect the health of their own offspring.

Objectives

To investigate ways to bring about behavioral changes leading to a reduction of smoking at all ages, particularly children, and evaluate the cost effectiveness of different approaches. Success of programmes should be assessed not only in terms of children exposed to the intervention but in actual outcome. Costs need to be weighed against those incurred through the NHS of treatment of established diseases.

Justification

Effective interventions will reduce the incidence of many cancers most of which are not curable by current means. Morbidity and death rates can be reduced by this approach.


JUSTIFICATION B
The organisation and evaluation of services, including medical, psychosocial, counselling and other services, to meet the needs of those found to be at high risk of cancer due to a genetic susceptibility

Background

During the past few years a number of genes, which in mutant form confer an increased risk of cancer, have been identified and characterised. These include genes for retinoblastoma, Wilm's tumour, neurofibromatosis, multiple endocrine neoplasia II, adenomatous polyposis coli, von Hippel-Lindau syndrome and the p53 gene, which when mutated in the germline predisposes to a variety of cancers. It is technically feasible to test for the presence of constitutional mutations in these genes in persons suspected to be carriers. However, such mutations are rare in the general population. Genes which have been located but not yet identified include the BRCA1 gene, which predisposes to breast and ovarian cancers, two genes for hereditary non-polyposis colon cancer, and the ataxia telangiectasia (AT) gene. Persons heterozygous for the AT gene appear to be at increased risk for a number of cancers including breast. At present it is possible to assess carrier status for these genes by linkage analysis in large informative families or by inference (i.e. obligate carriers) in certain other families. Once these genes are identified and characterised it will be possible to test individuals for carrier status regardless of family size and structure.

For those more common genes such as BRCA1, the gene for AT, and genes for hereditary colon cancer, the issue of general population screening arises. The identification of carriers of cancer susceptibility genes could be of great public health benefit, subject to the availability of efficient techniques for early detection of cancers which offer increased chance of cure, and advice on lifestyle habits to reduce cancer risk. As an alternative to general population screening, selected groups could be targeted e.g. all women with a first degree relative with breast cancer diagnosed under age 50 could be screened for BRCA1. In addition, individuals with a family history of cancer, or members of families with cancer predisposition syndromes, may present themselves to be referred for counselling, testing and screening.

As more genes are identified and with advances in molecular biological techniques for detecting mutations, there is likely to be an increasing demand for genetic testing. The management of those found to be carriers of high risk genes is uncertain. Screening for early detection of specific cancers is frequently advocated, but for some cancers e.g. premenopausal breast, this is of unknown effectiveness. The social and psychological effects of being found to be a carrier are also unknown.

Objectives

In order to avoid uncoordinated piecemeal services being set up for this group of people, various questions need to be answered by research.

- What is the potential workload if all individuals at high genetic risk of cancer request advice and/or screening and what is the present unmet need?
- What is the likely uptake of such a service among those at risk?
- How many dedicated laboratories with coordinated genetic counselling services are needed in the UK?
- How should they be linked to primary care for referral?
- How should they be linked to screening programmes for different cancers and how should the performance be monitored?
- What are the social and psychological effects of being identified as being at risk?
- How can age-specific cancer incidence and cancer mortality be monitored in high risk individuals?
- What are the resource costs of providing a service for genetic testing, counselling and management of high risk individuals?

Justification

Identification of individuals with high risk of cancer due to genetic susceptibility and their management is a major challenge to the NHS requiring appropriate choices of management and service provision.



JUSTIFICATION C
Factors influencing delayed presentation by patients (e.g. psychosocial) and variations in onward referrals by physicians to oncology specialists

Background

Delay in responding to symptoms may be associated with later stage at presentation (1) and shorter overall survival (2). The psychological factors underlying the variability in time to presentation are poorly understood, although suggestions have been made (3). If risk factors within the population who delay seeking medical attention could be identified, proactive interventions in primary care could be developed.

Studies in the international literature on cancer survival in relation to patterns of care indicate improved outcomes are associated with specialised care for uncommon cancers (4). Some studies also suggest this association exists for the more common cancers. The care of cancer involves the primary, secondary and tertiary services. Variations in onward referrals between clinicians will result in variation of care.

Objectives and justification

Understanding why such variation in referral occurs may allow interventions which should lead to consistency of better care.

References

1. Richardson JL et al. Stage and delay in breast cancer diagnosis by race; socioeconomic class, age and year. Br J Cancer 1992;65:922-26
2. Ellwood M, Moorehead WP. Delay in diagnosis and long term survival in breast cancer. BMJ 1980;280:291-94
3. Greer S. Psychological aspects; delay in the treatment of breast cancer. J R Soc Med 1974;67:470-3
4. Harding MJ et al. Management of malignant teratoma; does referral to a specialist unit matter? Lancet 1993;341:999-1002


JUSTIFICATION D
Factors influencing the accrual of patients into cancer trials

Background

Without doubt randomised clinical trials are needed to evaluate new and much needed treatments for the benefit of future cancer patients. Such trials have been highly influential in changing the clinical management of common cancers. Also, there is evidence to suggest that the outlook is better for those patients who are included in clinical trials. However, except for the childhood cancers, the leukaemias and some of the rare tumours, a small proportion of eligible patients are entered into trials. Adequate support for clinicians entering patients, failure to obtain consent and inadequate infrastructure for trials are all suggested to contribute to this shortcoming.

Objectives

Understanding more about what inhibits the accrual of patients into randomised trials may help point to ways which will influence a desirable increase.

Justification

Clinical trials are a major tool in evaluating cancer care. Methods to increase accrual into studies, when appropriate questions have been identified, are urgently needed.

References

1. Gelber RD, Goldhirsch A. Can a clinical trial be the treatment of choice for patient with cancer? J Natl Cancer Inst 1988;80:886-7
2. Early Breast Cancer Trialists Collaborative Group. Systematic treatment of early breast cancer by hormonal, cytotoxic or immune therapy. Lancet 1992;339:1-15, 71-85
3. Williams CJ ed. Introducing new treatments for cancer: practical, ethical and legal problems. Chichester, Wiley (1992)


JUSTIFICATION E
Studies designed to explain variations in disease outcomes, particularly in relation to variations in patterns of practice

Background

There is considerable geographical variation in standardised mortality rates from certain cancers both within the UK and internationally. It is thought to be unlikely that these differences in cancer survival are entirely due to known problems with the quality of data in cancer registries.

Studies usually do not include sufficient information to consider the patient and tumour prognostic variables which may relate to the observed outcome variations. A small number of studies point towards patterns of practice being relevant to outcome. This has been shown in ovarian and colorectal cancers, testicular cancer and paediatric oncology.

Objectives and Justification

Further studies are needed to extend this work into other tumour types and more importantly, to include studies designed to understand the genesis of the variations are needed and assess the quality of outcomes as well as survival.

References

1. Silman AJ, Evans JW. Regional differences in survival from cancer. Commun Med 1981;3:291-97
2. Gillis CR et al. Medical audit, cancer registration and survival in ovarian cancer. Lancet 1991;337:611-12
3. McArdle CS, Hole D. Impact of variability among surgeons on post-operative morbidity and mortality and ultimate survival. BMJ 1991;302:150-1
4. Wilson S, Prior P, Woodman CBJ. Use of cancer surveillance data for comparative analyses. J Public Health Med 1992;14:151-56


JUSTIFICATION F
Comparison of care for common cancers in specialist and non-specialist treatment settings with respect to psychosocial and clinical outcomes; and the relative costs of managing each step of disease progression

Background

Patients with cancer may receive care in specialist or non-specialist care settings, or in a combination of both settings for specific active phases of treatment and for palliative care. For example, in advanced cancer, 19% of patients are admitted to a hospice at some point and 29% receive care from specialist community teams (1). However, these proportions vary greatly throughout the country (2). The benefits and disadvantages of these different treatment settings are poorly researched, especially
with respect to psychosocial outcomes. Research is needed to compare clinical and psychological outcomes resulting from care in the different settings and to identify which types of patients and families will benefit most from care in the different settings.

Objectives

To compare clinical and psychological outcomes for patients cared for in different settings with different degrees of specialist involvement and evaluate cost effectiveness in the different settings. Studies may be appropriate in primary care, early management, specific surgical or active non-surgical treatment and palliative care.

Justification

To establish appropriate options for care and for service developments ensuring best clinical and psychological outcomes for cancer patients.

References

1. Addington-Hall J. Regional study of care of the dying. Feedback for Health Districts. London: University College London (1993)
2. Higginson I. Palliative care: a review of past changes and future trends. J Public Health Med 1993;15:1:3-8


JUSTIFICATION G
The clinical utility of second-line chemotherapy in advanced common cancers, particularly its comparison to best supportive care

Background

The role of second-line chemotherapy in advanced cancer is understood to be palliative. Often treatments are given which have not been formally proven to be of benefit in the particular type of cancer being managed and these drugs have not been approved for such use by the licensing authorities. It is probable that these treatments are administered not infrequently more in hope than expectation of benefit, and because of a strong desire to be perceived as not having given up therapeutic hope.

Chemotherapy may be toxic and is potentially dangerous. It may lead to both a deterioration in the quality of life as well as a reduction of life. The option not to have a specific anti-cancer treatment is very difficult to define, present or measure. Surveys of attitudes suggest that the frequency of ineffective interventions is unlikely to be reduced unless the professional and lay view of best supportive care is more clearly defined.

Objectives

Research into the clinical utility of chemotherapy in these circumstances and how it compares with alternative management strategies such as best supportive care is required.

Justification

Better definition of clinical utility (or lack thereof) for chemotherapies in these settings and a clearer understanding of patients' reasons for wishing to receive it or not and of professionals' wish (or not) to deliver it, should lead to more informed choices which may improve outcomes and may reduce toxicity and cost.

References

1. Maher EJ, Jefferis AF. Decision making in advanced cancer of the head and neck; differences in perspective between doctors and patients: future avenues for research . Palliat Med 1990;4:185-189
2. Maher EJ. The influence of national attitudes on the use of radiotherapy in advanced and metastatic cancer with particular reference to differences between the United Kingdom and the United States of America: implications for future studies. Inst J Radiat Oncol Biol Phys 1991;20:1369-1373


JUSTIFICATION H
Effective ways of helping health professionals break bad news, elicit concerns and respond to patients and relatives for their best psychological adjustment

Background

The extent to which cancer patients perceive that information given about their illness and treatment was adequate to their needs appears crucial in determining their subsequent psychological adjustment (1). Those who feel they were given too much or too little information are much more likely to develop clinical anxiety and/or depression (2). Moreover, these affective disorders are more likely if patients' concerns about their predicament remain undisclosed and unresolved (3). Unfortunately, few health professionals have been taught effective ways of breaking bad news, eliciting and responding to patients' concerns (4). Yet this is a source of considerable stress for them and leads to emotional exhaustion (5).

Objectives

Ways of helping health professionals break bad news, elicit and respond to patients' concerns need critically to be evaluated. This would also have great utility in relation to treating other forms of bad news.

Justification

Improvements in professional skills in this area should reduce the psychological morbidity of cancer.

References

1. Fallowfield LJ, Hall A, Maguire GP, Baum MJ. Psychological outcomes of different treatment policies in women with early breast cancer outside a clinical trial. BMJ 1990;301:575-580
2. Hopwood P et al. Factors relating to the communication of a cancer diagnosis and the impact on early adjustment. Qual Life Res 1993;2:49
3. Parle M, Jones B, Maguire P. Coping with multiple demands of cancer: patients' appraisal patterns, coping responses and mental health. Psycho-Oncology (Abs) In press
4. Simpson M, Buckman R, Stewart M, Maguire P, Lipkin M, Novack D, Till J. Doctor-Patient communication: The Toronto Consensus Statement. BMJ 1991;303:1385-87
5. Ramirez AJ, Graham J, Richards MA, Cull A, Snashall DC, Leaning M, Gregory WM, Hanks GW, Timothy AR. Work-related distress among cancer clinicians. British Psychological Oncology Group Annual Conference (1993)


JUSTIFICATION I
Optimal management strategies for unrelieved symptoms, including pain and non-pain, in cancer patients

Background

Symptom control has improved greatly in recent years. Standard approaches escalating from simple analgesics to opiates will be successful in controlling pain in most patients but in some patients control may be unsatisfactory. Unrelieved pain may be a consequence of inadequate treatment or, with incident and neuropathic pain, it may result from apparent resistance to seemingly optimal treatment.

Anorexia and asthenia, dyspnoea and sometimes nausea and vomiting may be intractable to all available treatments. A knowledge of the incidence of these problems and a cost benefit analysis of simple versus more complex treatment strategies would allow the development of an algorithm to facilitate the management of these different symptoms.

Objectives

To assess accurately the scale of the problem of unrelieved symptoms in cancer patients and evaluate existing and new treatment approaches. These may include the introduction of new drugs and methods, better usage of existing treatments and the impact of new service configurations.

Justification

Symptom control is a useful determinant of quality of life in cancer patients.

References

1. Higginson I, McCarthy M. Measuring symptoms in terminal cancer: are pain and dyspnoea controlled? J R Soc Med 1989;82:264-67
2. Dunlop GM. A study of relative frequency and importance of gastrointestinal symptoms and weakness in patients with far advanced cancer: student paper. Palliat Med 1989;4:37-43
3. Hanks GW, Justins DM. Cancer pain: management. Lancet 1992;339:1031-1036


JUSTIFICATION J
The most appropriate and cost effective model of service delivery and level of provision of palliative care services, including the role of nurse practitioners in hospitals and the community, and for the care of patients dying in acute hospitals

Background

Specialist palliative care is provided by hospices and NHS palliative care units, by hospital palliative care teams, home care and day care services. Some patients also require long stay care. The components and balance of a model system for a health care district have not been determined. Service provisions have been more influenced by local fundraising efforts than by needs assessment.

Interest is increasing in alternative mixes of skills in palliative care teams and in extending the scope of the role of the nurse. Routine, regular monitoring of patients with advanced cancer is critical, but costly. It is not yet known which health care professionals might be best used to support this group of patients.

Most patients who die from cancer, die in an acute hospital bed. The advantages and disadvantages of designated palliative care beds in an acute hospital setting are not known. There is a lack of evaluative information about the composition and effectiveness of hospital palliative care teams.

Objectives

Research to clarify the most appropriate and cost effective models for delivering palliative care services is needed. This should include testing alternative approaches including different mixes of health care professionals in teams and the value of designated beds for palliative care in an acute hospital.

Justification

Further appropriate developments in these services should reduce morbidity and increase patient and carer satisfaction. Equity of quality and access for these services is essential.

References

1. Smith AM et al. Palliative care services in Britain and Ireland 1990 - an overview. Palliat Med 1992;6:277-91
2. Castledine G. The Advanced Nurse Practitioner Parts 1 and 2. Nursing Standard 1991;5 Nos. 43,44:33-36
3. O'Neill WM et al. Hospital palliative care services: three models in three countries. J Pain Sympt Manag 7; 406-413 (1992)


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