Important documents

• Patient information leaflet (English) 

What is the BAOMS BOS Orthognathic PROMs project?

The Orthognathic PROMs project is a collaboration between the British Association of Oral and Maxillofacial Surgeons (BAOMS, lead organisation) and the British Orthodontic Society (BOS).

• Oral and maxillofacial surgery is the surgical specialty which treats conditions affecting the mouth, jaws, face and neck. The part of oral and maxillofacial surgery that focuses on correcting jaw alignment and facial disproportions is called orthognathic surgery.
• Orthodontics is a dental specialty involved, amongst other things, in correcting mal-positioned teeth and jaws, and misaligned bite patterns.
• Patient-reported outcome measures (PROMs) are a set of tools (usually questionnaires) used to collect opinions about outcomes and/or experiences of care directly from patients.

The Orthognathic PROMs project is collecting opinions about outcomes and experiences directly from patients who underwent orthognathic surgery, with or without orthodontic treatment.

Why are we doing this project? 

BAOMS and BOS are interested in finding out how your quality of life has been affected by your problem with your teeth/jaws/bite and by your treatment. They hope this information will help clinicians and NHS commissioners understand more about this type of treatment and therefore improve care for patients in the future.

What does taking part in this project involve?

• Participation will take up a little bit of your time.
• Because we want to collect information directly from patients, first we need to obtain your consent. During a hospital visit for your treatment, you will be given an information leaflet about the project to read; then if you are happy to take part you will be asked to sign a consent form.
• Afterwards, you will be asked to complete a survey at four points during your treatment (i) prior to the start of your orthodontic treatment, (ii) immediately prior to your surgery, (iii) 4-6 weeks after surgery and (iv) 1 year after your surgery.

What information about me are you collecting?

• Consent forms (with your name and signature) will be stored securely in the hospital where you are being treated and will never be shared with anyone outside.
• The survey asks questions about how your condition affects your quality of life and your opinion about the care you received.
• Your answers to the patient survey will be stored separately online and, apart from your gender and age, will not contain any identifiable or clinical information about you.
• Whether you choose to participate or not, your care will not be affected.

What will happen to my information?

• Your answers will be stored on secure computers managed by the Barts Cancer Research UK Centre at Queen Mary University of London (BCC, QMUL), before being analysed. 
• Data will be kept for at least 10 years.

Can I choose not to take part? What if I change my mind?

• Participation is voluntary and you can change your mind at any stage without it affecting your care.
• If you decide to not take part, when you complete the consent form, simply do not tick “I agree.” This way, we will keep a record of your decision and we will not ask you again at a later stage.
• If you change your mind about taking part, you can withdraw at any point without providing any reasons. Simply let your treating team know. You will be asked whether you want all your information removed or whether you are happy for us to keep your information we have so far, but we will not be contacting you for follow-up.

Important documents

• Patient information leaflet (English)

What are salivary gland cancers?

• The salivary glands are organs and cells in the body that produce saliva. They are classified as major (i.e. big) salivary glands, like the parotid, submandibular, and sublingual salivary glands and as minor, which exist in their hundreds. Any salivary gland can be affected by cancer.
• Salivary gland cancers are a rare group of cancers (around 8 or 9 per 1 million people each year or < 800 new cases each year), which present a range of histological and clinical behaviours.
• They are generally slow growing, and patients can be followed up for 10 years or more before we are confident of the natural history of the histological entity.
• There is little or no strong evidence for their management as randomised clinical trials (i.e. strongest type of clinical evidence) would be too difficult or impossible to conduct for those cancers.

• We must rely instead on “real world” data to develop this evidence. “Real world” data is the clinical information (e.g. surgery, medication, and outcomes) normally / routinely produced when a patient receives treatment in a hospital.
• By putting together this information, we hope to be able to find patterns in the natural history and clinical behaviour of these cancers that could help improve the treatment and quality of care of future patients.

For more information, visit the Cancer Research UK website

What is the Salivary Gland Cancers registry? Why create one? 

The SGC registry is a clinical registry dedicated to collecting information about patients diagnosed and treated for salivary gland cancer.

The SGC registry is a multidisciplinary project led by the British Association of Oral and Maxillofacial Surgeons (BAOMS). It was developed surgeons, pathologists and doctors. An independent group of salivary gland cancer patients under the guidance of a representative from Salivary Gland Cancer UK was consulted to address potential patients' concerns and guide the project.

The BAOMS SGC registry is under the umbrella of the Quality and Outcomes in Oral and Maxillofacial Surgery (QOMS) Project, but is independent from the other QOMS registries. QOMS is the Association’s Quality Improvement and Clinical Effectiveness Programme. The overarching aim of the QOMS Project is to measure and improve the care provided by oral and maxillofacial surgeons in NHS hospitals. Read more about QOMS.

Why create a Salivary Gland Cancers registry? 

Normally, guidelines for the treatment of medical conditions are drawn based on strong evidence from randomised clinical trials (RCT). RCTs are expensive and resource-intensive with a relatively short follow up. Because of the diversity and rarity of those cancers and long follow up required, RCTs are not feasible. The next best thing is real-world data, collected in an organised registry.

What does taking part in this project involve?

Participation will take up a little bit of your time. It is not expected to be too onerous.

If you agree, we will contact you on a yearly basis to ask you to complete a questionnaire about your quality of life. The questionnaire is 16 question-long and should take less than 10 minutes to complete. This type of questionnaire is called Patient-Reported Outcomes (PRO).

The rest of the data we need will be collected directly from your medical records by your surgical and medical team and passed onto us securely.

What information about me are you collecting? And why?

• As part of the consent process, we will collect your name, contact details and NHS/CHI number. We need:
  • Your name and contact information to be able to contact you yearly to complete the PRO questionnaire (see above).
  • Your NHS/CHI number to be able to find your information across the different hospital systems.
• The clinical information we need includes for example the location and nature of your tumour, how you were treated (e.g. surgery with or without radio and or chemotherapy) and what happened to you afterwards (e.g. did you have any complications? Did the tumour return?...).
• We will also collect the images and samples of blood/tissue collected from procedures undertaken as part of your treatment (i.e. we will not ask you to undergo any other tests or procedures).

• Finally, for the PRO questionnaire we ask you to complete on a yearly basis, we use a tool called the University of Washington Quality of Life Questionnaire (UW-QOL v4). It contains 16 questions that assess how you are feeling and managing with your condition.

For more details, please have a look at the University of Washington Quality of Life Questionnaire.

• All your information is stored securely. No information that could identify you (e.g. name, postcode, email address…) will ever be shared outside of the registry.

Why are you collecting images and samples of blood/tissue? How will they be used?

The SGC registry is not considered research (and thus does not require ethical approval) but service evaluation. Secondary research is still possible on the data collected in the registry. That’s why an item about future or secondary research is included in the consent form. 

Should this be the case, appropriate ethical approval would be sought and we will put details of the research project on the BAOMS website so patients and members of the public can see what the data is used for. Finally, no identifiable information would be shared out with the researchers leading that work.

How will I be contacted to complete the questionnaire? How many times?

As mentioned above, we will collect your name, contact details – an email address or a mobile number. We will ask you how you would rather be contacted (email and/or text message).

We will contact you once a year for 10 years initially – remember, salivary gland cancers can be slow growing and require long-term follow-up. This might be reviewed at some point in the future and, if appropriate, shortened or extended. Should this be the case, we would contact you to let you know about the change and if an extension of the follow-up has been decided, we would ask you to sign a new consent form.

What will happen to my information?

• Your answers will be stored and kept for at least 10 years on secure computers managed by the Barts Cancer Research UK Centre at Queen Mary University of London (BCC, QMUL), before being analysed. 
• Data will be kept for at least 10 years.
• Besides your treating team, only a few people may have access to your information. They include the registry’s project manager and the staff at the Queen Mary University of London, responsible to maintain the database and the computers it is stored on.

How will my data be used?

It is envisaged that initially and most likely for several years, nothing or very little will happen with your data until we have collected enough to be able to analyse it. During this period, we will regularly report to stakeholders the number of cases collected and their completeness…

The plan to analyse the data can be broadly divided into 2:

1. Looking at the cancers’ natural history, e.g. number of patients affected, patient age, if there are disease clusters…
2. Looking at outcomes, e.g. did different treatments have different outcomes, like development of complication, patient survival with or without the cancer returning…? Did different treatments affect the various types of salivary gland cancers differently?

Can I choose not to take part? What if I change my mind?

• Participation is voluntary and you can change your mind at any stage without it affecting your care.
• If you decide to not take part, when you complete the consent form, simply do tick “I DO NOT agree.” This way, we will keep a record of your decision and not ask you again at a later stage.
• If you change your mind later about taking part, you can withdraw at any point without providing any reasons. Simply inform your treating team or contact the registry’s project manager (see instructions below). You will be asked whether you want all your information removed or whether you are happy for us to keep your information we have so far, but we will not be contacting you for follow-up.

Important documents

• Patient information leaflet (English)

What are rare benign lesions and tumours of the jaws?

• The jaws in humans are made up of the lower (mandible) and upper (maxilla) jaws. They may develop the same types of tumours as the other bones of the body (non-odontogenic) but because they also bear teeth, they may also develop tumours from the alveolar processes and the developing teeth (odontogenic). 
• Jaw tumours are relatively rare (3% of all bone tumours) and can be seen in all ages with or without any symptoms. Their cause is not known but some are associated with gene changes (mutations) or genetic syndromes.
• Jaw tumours can vary greatly in size and severity. Although usually benign, they can be locally aggressive and invasive. Local destruction caused by the tumour can mimic a malignancy. They can expand, displace or destroy the surrounding bone, tissue and teeth and affect the functions of mastication, swallowing and cause facial deformity.
• Diagnosis is paramount to decide on proper treatment and combines in a first instance the different clinical and radiological features though the final diagnosis is based on histopathological examination.
• Treatment options vary depending on the type of growth or lesion, the stage of growth, and symptoms. Surgery or (in some cases) medical therapy or a combination of surgery and medical therapy are usually used to treat these tumours. It is important to know that they have a tendency for a local recurrence if a wide excision is not contemplated/achieved at the first attempt. Multiple procedures, including reconstruction, may be required for certain lesions prior to cure.

What is the Rare Benign Lesions of the Jaws registry?

• The Rare Benign Lesions of the Jaws (RBLJ) registry is a clinical registry dedicated to collect information about patients diagnosed and treated for a rare benign lesions of the jaws.

• The RBLJ registry is a multidisciplinary project led by the British Association of Oral and Maxillofacial Surgeons (BAOMS). It was developed by surgeons and pathologists. An independent group of patients was consulted to address potential patients' concerns and guide the project.
• The RBLJ registry is under the umbrella of the Quality and Outcomes in Oral and Maxillofacial Surgery (QOMS) Project, but is independent from the other QOMS registries. QOMS is the Association’s Quality Improvement and Clinical Effectiveness Programme. The overarching aim of the QOMS Project is to measure and improve the care provided by oral and maxillofacial surgeons in NHS hospitals. Read more about QOMS.

Why create a Rare Benign Lesions of the Jaws registry? 

Normally, guidelines for the treatment of medical conditions are drawn based on strong evidence from randomised clinical trials (RCT). RCTs are expensive and resource intensive with a relatively short follow-up. Because of the diversity and rarity of those rare benign lesions and long follow-up required, RCTs are not feasible. The next best thing is real-world data, collected in an organised registry.

What does taking part in this project involve?

Participation will not take up any of your time, once you have signed your consent form. The data for the registry will be collected directly from your medical records by your surgical and medical team and passed onto us securely.

What information about me are you collecting? And why?

• As part of the consent process, we will collect your name, contact details and NHS/CHI number. We need:
  • Your name and contact information to be able to send you a copy of your consent form and inform you of any progress and changes in the registry.
  • Your NHS/CHI number to be able to find your information across the different hospital systems.
• The clinical information we need includes for example the location and nature of your tumour, how you were treated (e.g. surgery to remove the lesion, if you needed reconstruction…) and what happened to you afterwards (e.g. did you have any complications? Did the lesion return?...).
• We will also collect the images and samples of blood/tissue collected from procedures undertaken as part of your treatment (i.e. we will not ask you to undergo any other tests or procedures).

• All your information is stored securely. No information that could identify you (e.g. name, postcode, email address…) will ever be shared outside of the registry.

Why are you collecting images and samples of blood/tissue? How will they be used?

Images and blood/tissue samples will be used for the following purposes:

• The RBLJ registry is not considered research (and thus does not require ethical approval) but service evaluation. Secondary research is still possible on the data collected in the registry. That’s why an item about future or secondary research is included in the consent form. 

Should this be the case, appropriate ethical approval would be sought and we will put details of the research project on the BAOMS website so patients and members of the public can see what the data is used for. Finally, no identifiable information would be shared out with the researchers leading that work.

• There is little or no opportunities for clinicians (surgeons, pathologists…) treating rare benign lesions of the jaws to discuss cases with other colleagues also involved in the treatments of these conditions. This type of discussions regularly takes place in hospitals for other conditions like cancers and involve a multidisciplinary team of clinicians. The discussions are about finalising / confirming the diagnosis and recommend treatment.

Part of the registry’s work will be to establish a virtual network of clinicians that will meet quarterly to discuss the cases of rare benign lesions of the jaws they encounter in their practice.

Why am I not directly contacted to answer some questions? 

Patient-reported outcomes (PRO) are usually a common feature of clinical registry. They are used to collect information directly from patients about their experience (treatment, satisfaction with process and outcomes), how they feel and if they have any side-effects or new symptoms. PRO are collected using standardised and validated questionnaires, which means that they tend to be specific to a condition or patients.

Because of the range of possible conditions and treatments, and their rarity, there are no PRO tools available specifically for rare benign lesions of the jaws. The decision was taken earlier on by the registry’s working group that the registry would not collect PRO.

What will happen to my information?

• Your answers will be stored and kept for at least 10 years on secure computers managed by the Barts Cancer Research UK Centre at Queen Mary University of London (BCC, QMUL), before being analysed. 
• Data will be kept for at least 10 years.
• Besides your treating team, only a few people may have access to your information. They include the registry’s project manager and the staff at the Queen Mary University of London, responsible for maintaining the database and the computers it is stored on.

How will my data be used?

It is envisaged that initially and most likely for several years, nothing or very little will happen with your data until we have collected enough to be able to analyse it. During this period, we will regularly report to stakeholders the number of cases collected and their completeness…

The plan to analyse the data can be broadly divided into 2:

1. Looking at the lesions’ natural history, e.g. number of patients affected, patient age, if there are disease clusters…
2. Looking at how different lesions are treated, patient’s outcomes, e.g. d development of complication, recurrence…

Can I choose not to take part? What if I change my mind?

• Participation is voluntary and you can change your mind at any stage without it affecting your care.
• If you decide to not take part, when you complete the consent form, simply do tick “I DO NOT agree.” This way, we will keep a record of your decision and not ask you again at a later stage.
• If you change your mind later about taking part, you can withdraw at any point without providing any reasons. Simply inform your treating team or contact the registry’s project manager (see instructions below). You will be asked whether you want all your information removed or whether you are happy for us to keep your information we have so far, but we will not be contacting you for follow-up.