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| Name | Class |
|---|---|
| University of East Anglia | OTHER |
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Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems.
At the time of consent, patients are informed of possible post-operative complications. It is often not known whether these complications actually occur, whether there are others which go unreported and the extent, both quantitatively and qualitatively, of the complications. Patient reported complication data, to our best knowledge has not been previously studied.
This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. In this case, consent is to be sought digitally; the digital consent form includes a procedure specific list of recognised complications but these might not reflect actual patient experience.
If PRC data collection is feasible and reliable, this technique could be scaled to create a consent feedback loop, enabling operative outcome data to be collected from all patients, to be be used to improve the consent process for subsequent patients.
Awareness of post-operative patient complications is important and it is an NHS (National Health Service) requirement that complications are discussed within regular clinical governance (mortality/morbidity) audit departmental meetings. Currently this process relies on clinicians obtaining and reporting these complications. The move towards Patient Initiated Follow Up (PIFU) models may be leading to underreporting of problems. Potentially Patient Reported Complications would allow for a more comprehensive understanding of the benefits and consequences of the various surgical procedures. This in turn might help facilitate 'shared decision making' and allow treatment decisions to be tailored to the individual patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients who respond to the feedback questionnaire | Calculate the proportion of patients who respond to the feedback questionnaire | 6 months |
| Final attrition rate | Calculate the final attrition rate. This is the proportion of patients who fail to respond to the email questionnaire and telephone call. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quoted risks in the consent to the incidence of complications | Compare the quoted risks in the consent to the incidence of complications reported by the patients. | 6 months |
| Frequency of PRC and CRCs (Consent Form Reported Complications) |
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Inclusion Criteria:
Exclusion Criteria:
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Women over 18yrs old with early invasive breast cancer who are undergoing "wide local excision and sentinel lymph node biopsy" operation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ian Gedge | Contact | 02392286000 | 5153 | ian.gedge@porthosp.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Edward St John | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Alexandra Hospital | Recruiting | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Review the monthly department CGM (Clinical Governance Meeting) data for the study period and correlate the frequency of PRC and CRCs.
| 6 months |
| Understanding of consent | Calculate the proportion of patients that feedback that they have understood the consent form. | 6 months |
| Language used in patient reported complications | Examine the language used by patients in the free-text box for reporting complications and whether this matches to that use in their consent form. | 6 months |
| Accuracy of potential complications | To examine the feedback from the patient questionnaire which asks, if they experienced a complication, was it mentioned as a possibility in their consent form. | 6 months |
| Participant preparation for surgery | From the feedback from the patient questionnaire, do patients feel fully informed about the procedure they are undertaking and feel well prepared | 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |