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Systemic Anti Cancer
Therapy Study: Frequently Asked Questions
(Publication date: Late 2008)
- When did the main study start?
- The main study has now commenced. Hospitals/Centres/Units will be asked to supply details of patients that received SACT in June and July 2006 and they will also be asked for all death data regardless of disease or disorder for the months of June, July and August 2006.
- I would like to read the protocol - could you send me a copy?
- Yes. All hospital/units/centres will be asked to take part regardless of whether or not they treat patients with SACT as NCEPOD need all death data from all hospitals for this study.
- Is participation in this study mandatory?
- Yes. All hospital/units/centres will be asked to take part regardless of whether or not they treat patients with SACT as NCEPOD need all death data from all hospitals for this study.
- How has this study come about? Have there been areas of concern?
- Through NCEPOD's usual process of choosing studies. To our knowledge, it is an area that has not been explored before. The Joint Specialty Committee (JSC) of Medical Oncology of the Royal College of Physicians submitted this cancer study proposal to NCEPOD in February 2005. It was subsequently supported by both the JSC and Joint Collegiate Council for Oncology (JCCO). No area of concern noted.
- Definition - should this be "systemic anti-cancer chemotherapy treatment" rather than "systemic anti-cancer therapy treatment"?
- No, therapy is stated to include monoclonal antibodies (e.g. Herceptin), for example.
- Do you we need to complete the questionnaire from a Trust or hospital point of view?
- Questions are posed at the hospital /centre/unit level, not Trust level. Therefore, all the hospitals/centres/units in a Trust need to complete a separate questionnaire.
- Do all hospitals need to complete an organisational questionnaire?
- No, only those who treat patients with SACT.
- Is the completion of clinical questionnaires mandatory?
- Yes. Participation in the Confidential Enquires is mandated by both the Department of Health and the GMC. In their guidance on Clinical Governance, the DOH state that trusts must take part (Clinical Governance Reporting Processes - 14th November (2002) DoH and 'A First Class Service: Quality in the New NHS' (1998)).
The GMC also state that clinicians must take part: Good Medical Practice states: 'You must... take part in confidential enquiries and adverse event recognition and reporting to help reduce risk to patients' (Para 12 Good Medical Practice 2001).
- How many questionnaires are there and who completes them?
- There are two questionnaires per case:
Questionnaire A - The Lead Consultant who had overall responsibility for the administration of SACT for this case.
Questionnaire B - The Admitting Consultant who was involved in the hospital admission of this patient due to progression of the disease or complications experienced following the SACT date identified by your hospital/centre/unit.
- In our case these are the same person, so should a single clinician complete both?
- Yes, that is correct.
- The clinician responsible is not able to complete the questionnaire (e.g. has retired/left the Trust/is on long-term leave of absence of sick leave etc). What should I do?
- We would ask that another clinician be approached to complete the questionnaire. Failing that, we would still ask for the case notes so that our clinical advisors can assess the case.
- Do I need to obtain permission to release the case notes to NCEPOD?
- Section 60 approval has been obtained to perform this study. Approval for the study methods of all NCEPOD studies is granted by the Patient Information Advisory Group (PIAG) during an annual review. This means that it is an ongoing process and you do not need to approach your legal departments regarding the release of the case notes to us.
- By what method should I send the cases? Should I anonymise them? Can I send the originals for you to copy them?
- We often receive case notes via recorded post. We anonymise them on our side but many hospitals anonymise them to some degree prior to sending them. Please do not send the originals - only photocopies.
- Do I need to provide the data for all patients who were treated with SACT during the specified time period, or just those who died within 30 days?
- All patients who were treated with SACT please (not just patients that died).
- What is the clinician specialty code?
- National codes are outlined on page 5 of the following: http://www.connectingforhealth.nhs.uk/dscn/dscn2005/172005.pdf
The most likely codes for the Lead Consultant for this study are:
303 Clinical haematology
370 Medical oncology
800 Clinical oncology
823 Haematology
- Why do you require all these identifiers?
- Hospital number required by hospital to help identify patients
- NHS number, Surname and First Name required by the Office of National Statistics who help us identify deaths in the community
- Date of birth required to exclude patients who are under 16 and to differentiate between patients with same name if no NHS number given
- Primary Diagnosis - ICD-10 Code required in order to confirm that the patient meets our study critieria.
- Date of SACT and Date of Death are required to identify patients who died within 30 days of treatment and also to identify the cycle of SACT we would like to examine.
- Please clarify whether oral or subcutaneous outpatient chemotherapy should be included.
- Yes, but exclude hormonal therapies such as Tamoxifen and novel gene therapies.
- Should we include patient data for those that participated in trials?
- Yes. If possible, the data set should be grouped by Trials/Non Trials.
- I am assuming you want data from the responsible service, rather than GPs who might continue prescribing?
- Yes, only data from specialist units/clinics and hospitals.
- Can I confirm that by ' within 30 days of their last...therapy' you mean 'within 30 days of their most recent...therapy' (i.e. not just the last session in a planned course of chemotherapy)?
- Yes that is the case.
- Confirming that you will need the details if someone dies part way through a planned course of chemotherapy (e.g. within 30 days of cycle 2 of a planned course of 6 cycles).
- The 30 day period will be defined as 30 days from Day 1 of the SACT cycle immediately prior to death. If SACT is given continuously, then 30 days from the date of the last prescription. So, yes - we want to identify all patients who died within 30 days of receiving SACT- the date of SACT being the first day of their most recent i.e. final chemotherapy cycle. It is not related to the number of cycles planned.
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