Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Complication of Surgical Procedure. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Feasibility Study to Evaluate if Breast Cancer Patients, Consented Using Digital Consent, Reliably Provide Accurate Patient Reported Complication (PRC) Data Using Feedback Questionnaires
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Proportion of patients who respond to the feedback questionnaire [Срок оценки: 6 months]
- Final attrition rate [Срок оценки: 6 months]
Вторичные конечные точки (6)
- Quoted risks in the consent to the incidence of complications [Срок оценки: 6 months]
- Frequency of PRC and CRCs (Consent Form Reported Complications) [Срок оценки: 6 months]
- Understanding of consent [Срок оценки: 6 months]
- Language used in patient reported complications [Срок оценки: 6 months]
- Accuracy of potential complications [Срок оценки: 6 months]
- Participant preparation for surgery [Срок оценки: 6 months]
Критерии участия
Критерии включения
- Consent form 1- Adult patients who have the capacity to consent for themselves.
- Female adult aged 18years or above
- Diagnosed with early invasive breast cancer suitable for breast conserving surgery
- Undergoing Wide Local Excision of the breast and sentinel lymph node biopsy.
- Participant must be able to fill out an electronic questionnaire or take part in a phone questionnaire.
- Participant is willing and able to give informed consent for participation in the study.
Критерии исключения
- Unable to consent for themselves or do not wish to participate.
- Patients who need an interpreter.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Великобритания · 1 центр
- Queen Alexandra Hospital — Portsmouth
Идентификаторы
NCT: NCT06351865 · PHU/2023/21