Salisbury

This study is a prospective, observational, multi-country, multi-Centre, single-arm registry designed to evaluate the clinical safety and performance of VIVO ISAR, Polymer Free Sirolimus Eluting Coronary Stent System. The study population is made up of subjects who have undergone PCI using VIVO ISAR and are receiving standard of care short DAPT treatment (≤ 3 months) . Subjects will be screened by site teams and offered the opportunity to participate in the registry after their procedure. Rationale for this study is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent in real world CAD patients with follow-up at 1 month, 3 months and 12 months. All medications and procedures to be used/ performed in this registry are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles. The study does not influence the choice of device utilized nor does it alter the routine standard of care. After a patient has been treated with the Vivo ISAR, informed consent will be requested and the eligible patient will be registered in the study. Baseline data will be completed using medical notes. All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days, 3 months and 12 months from the baseline PCI procedure date. The 30 day, 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued, about any lab assessments that might have happened, recording of any adverse events, and any interventional treatment that has occurred since previous contact.

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug in combination with lenalidomide * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * The impact from the study drug on quality-of-life and ability to complete routine daily activities

A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.

The only phase III clinical trial in the UK offering watch and wait, the TRIGGER trial aims to validate mrTRG as an imaging biomarker for the stratified management of patients with locally advanced rectal cancer. The 'good responders' (mrTRG1\&2) often have no evidence of tumour and it may be possible to avoid surgery in this group and so maintaining QoL while not impacting survival rates. The 'poor responders' (mrTRG3-5) are at high risk of poor oncological outcomes and this knowledge is useful in planning ongoing treatment and surveillance. TRIGGER is now a non-cTIMP trial as the protocol does not specify chemotherapy or IMP treatments. Decisions about the use of chemotherapy will be based upon local MDT discussions as is normal practice and national policy and the trial CRFs will capture these decisions and whether more treatment is given to patients or not. TRIGGER does not mandate or recommend the use of any treatments: specifically it does not suggest the use of investigational medicinal products. If any centre wishes to use IMPs this would be in the context of separate trial protocols and would not preclude entry into TRIGGER.

Many patients diagnosed with Early Rectal Cancer (ERC) are currently over-treated. Most patients with confirmed ERC will undergo an MRI, but some are not correctly identified in endoscopy and immediately removed. Of those who undergo MRI, 69% are over-staged and undergo major surgery or unnecessary radiotherapy when local excision surgery to preserve the patients rectum, and quality of life, would have been possible. \<10% of patients with ERC are staged accurately and offered local excision, with the majority who are staged as ERC on MRI still undergoing major surgery, likely due to uncertainty in the staging report. Prof Gina Brown developed a more accurate radiological staging system (PRESERVE) or ERC, whereby T2 tumours are identified and classified according to the degree of preservation of the individual layers of the rectal wall. It has been shown that PRESERVE enabled better identification of ERC suitable for local excision from the expected 30% to 89% accuracy. This improved accuracy was replicated in a further study by training a cohort of 12 radiologists. It is predicted that wider adoption of PRESERVE will result in increased organ-preserving surgery from the current rates of 10% to \>50%.

Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative. OBJECTIVE: To demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.

Aim The aim of the current research is to explore whether volunteers can be trained to deliver exercise support to older adults across three different sized hospitals in different locations. Researchers will also explore if the intervention is accepted by patients, volunteers and staff and if it has any benefits on patients' health and functional outcomes (e.g., quality of life and muscle strength). Study Design This is a multicentre feasibility study using mixed methods (i.e., quantitative and qualitative measures) to explore the implementation of a volunteer-led physical activity intervention to older adults in hospital. The study will include three intervention sites and one control site. Feasibility studies are used to determine whether an intervention is appropriate for further evaluation, to determine sample sizes for controlled trials and to assess whether the ideas and findings can be shaped to be relevant and sustainable. Sample Size A sample size of 180 patients, 90 intervention (30 from each intervention site) and 90 from the control site, was chosen in line with previous sample size recommendations for feasibility studies of 24-50 participants. This sample size was considered an appropriate number that is pragmatic and achievable within the study timescale and resources available at each site. This research aims to recruit 15 volunteers at each site to provide sufficient cover to deliver the intervention. In a previous study (SoMoVe trial) 17 volunteers were recruited, 16 completed training and 12 were retained. Recruitment and Consent Older adults with an acute medical admission to four hospitals will be screened for eligibility by research nurses. Eligible patients will be introduced to the study by ward staff. Those who are interested in the study will be approached by the research team for further information and information sheets will be provided. Written informed consent will be obtained from all patients who agree to participate in the study. Volunteers will be invited by hospital voluntary services within each hospital site. The voluntary services team will send the interested volunteers details to the research team, who will then get in contact to complete informed consent. Inclusion and Exclusion Criteria Patients: The inclusion criteria are adults aged 65 years and above who are able to provide informed consent. Exclusion criteria are anyone with a severe cognitive impairment (MoCA less than 10), patients isolated for infection control reasons, and patients receiving end of life care. Volunteers: The inclusion criteria for volunteers are age 18 years and above, who have completed the generic clearance and training with the hospital voluntary services, who can provide written informed consent, and are able to communicate fluently enough in English. Fluent English is required to ensure the intervention content can be delivered clearly and thus safely to participants. Volunteers that are unable to safely complete the exercises included in the intervention will be excluded from the study. Intervention The exercises were developed based on clinical expertise from therapists and from our previous research of volunteer-led mobility interventions in hospital (SoMoVe study). Participants will be assessed by the therapy team who will prescribe tailored activity and then liaise with the mobility volunteers, who will deliver the intervention. Participants who can mobilise independently will be encouraged to perform walking exercises, progressing their walking distance over set markers in the hospital (e.g., to the end of the bed and back; to the doorway and back; to the toilet and back). Participants who require assistance in mobility will perform bed (e.g., hip abduction, static quads), or chair exercises (e.g., ankle pumps, knee extension, arm raise), and will be progressed to performing walking exercises when their physical function improves. Volunteers will check with nursing staff that participants are safe to exercise before each activity session. Participants will receive the mobility sessions twice daily, starting upon recruitment and continuing until the day of discharge from hospital. Training The volunteer training package was developed by a clinician and therapist and will cover topics including patient and personal safety, mobility and exercise training, and response to adverse evets, such as falls. Volunteers will participate in practical sessions to practice the exercises with peers. When ready, volunteers will work with patients, initially under close supervision and when deemed competent by the trainer, they will be encouraged to support mobility sessions independently. A volunteer competency checklist will be completed and signed off by the trainer before volunteers work independently. The training will be delivered by a physiotherapist in each intervention site. Fidelity Checks Throughout the study period, fidelity checks will be conducted by the trainers once every 2 weeks to ensure that the volunteers are delivering high quality and safe exercise. The volunteers will be observed and assessed against a competency and implementation checklist, including personal safety, basic patient safety, pre-intervention tasks (e.g., safe set up of exercise space), and exercise delivery (e.g., showing safe and effective exercise technique). Volunteers will be asked to keep an attendance record during the intervention using session completion logs. Regular monthly volunteer meetings will be scheduled online to discuss experiences and gain feedback from peers and trainers. Based upon fidelity checks and volunteer feedback, extra one-to-one training sessions will be available if necessary. The principle investigator will also visit intervention sites to observe and liaise with volunteers and trainers. Data Collection Data including age, sex, co-morbidities, medications, functional status, and cognition will provide participants' baseline characteristics in both intervention and control sites. Volunteer data including age, occupation, qualifications, volunteering experience, any physiotherapy, sport or therapeutic experience, and employment status will be collected. Data on the study sites including hospital size, size of voluntary service team, the number of hospital volunteers, and information on the therapy services and what usual care looks like will be collected to provide contextual information. The primary outcome measures are feasibility (can it be done?) and acceptability (will volunteers, staff, and patients accept and embrace the programme?) of the intervention. Feasibility will be assessed by: 1. Number of trainers trained and retained in each hospital site (total number and %) 2. Number of volunteers recruited, trained, and retained (total number and %) 3. Recruitment rate (%) of participants in each site 4. Adherence to the intervention (total number and %) Acceptability will be assessed through process evaluation involving: 1. Observation and monitoring of volunteer training 2. Interviews with therapy managers to establish usual care in each site 3. Observation of the interaction between volunteers, patients, and healthcare professionals on the wards, including contextual factors that may potentially influence the delivery and receipt of the intervention. Qualitative interviews will be conducted with service managers, therapy managers, patients, nurses, ward therapists, and volunteers from all study sites, to determine the acceptability of the intervention. Purposive sampling will be conducted to capture a range of experiences and opinions from patients of varying age and mobility levels, staff with varying seniority and gender mix, and volunteers with a range of volunteering experience, age groups, and gender mix. The interviews will explore barriers and facilitators to the implementation of the intervention into routine clinical practice. Fidelity Assessment Fidelity assessment will be conducted across all study sites to ensure that the exercises and prescribed dose are delivered by the volunteers as prescribed. Volunteers will be trained to document each physical activity session in participant exercise diaries, detailing whether all the exercises were carried out as prescribed, or whether some exercises were excluded, and reasons for exclusions. The exercise diaries will be affixed to participants' activity prescription sheet. Further assessments of fidelity of volunteer training and the intervention will be conducted through site visits by the research fellow once every 2 months and to address any issues that arise. Secondary Outcome Measures The secondary outcome measures will include assessment of physical activity levels (StepWatch Activity Monitor; SAM; Modus health, Washington, USA), physical function (Short Physical Performance Battery and grip strength), and quality of life (EuroQol; EQ-5D-5L). Moreover, data on length of hospital stay and hospital readmission will be accessed through electronic patient records. Data collection will be conducted by research nurses, supported by the local principal investigators. Data Analysis Primary Outcome Analyses Participants' baseline characteristics will be described using summary statistics, including mean (standard deviations), medians (interquartile ranges), counts and proportions, as appropriate. Statistical analysis will be conducted using the statistical software SPSS. Summary statistics will be used to describe the feasibility of recruiting, training, and retaining the trainers, the volunteers and study participants. Participants' exercise diaries will be analysed to determine how many physical activity sessions were offered and the number and percentage of completed sessions. Data collected from the interviews will be transcribed verbatim and analysed using thematic analysis (TA). The audio- recordings will be transcribed by an administrative colleague within the research department who is experienced in transcribing qualitative data. TA is a method for identifying, analysing and reporting patterns or themes within data and is widely used in qualitative research. Transcribed text will be read and coded separately and then together by two researchers. The codes will be analysed to generate concepts and ideas to determine the acceptability of the intervention, and to identify facilitators and barriers to the implementation process. The codes act as tags or labels to help catalogue key concepts embedded within the raw data. From the codes, themes will be developed to reflect the views and experiences of the older adults and volunteers regarding the volunteer-led physical activity intervention. Secondary Outcome Analyses Daily step count, Short Physical Performance Battery, grip strength, and quality of life measured on recruitment and discharge, and length of hospital stay will be analysed as continuous variables. The completion rate of each data item will be measured. The distribution of each outcome measure will be assessed for normality and described using parametric or non-parametric statistics accordingly. Hospital readmission in 3 and 6 months will be analysed as a categorical variable. Where there is missing data, the main analyses will be based on available data.

Community-acquired pneumonia (CAP) that is of sufficient severity to require admission to an intensive care unit (ICU) is associated with substantial mortality. Patients with pneumonia who are being treated in an ICU will receive therapy that consists of many different treatments, as many as 20 or 30. These treatments act together to treat both the infection and its effects on the body. When treating a patient, doctors choose from many different treatments, most of which are known or believed to be safe and effective. However, doctors don't always know which treatment option is the better one, as individuals or groups of individuals may respond differently. This study aims to help doctors understand which treatments work best. This clinical study has been designed in a way that allows the information from patients already in the study to help new patients joining the study. Most studies aren't able to do that. REMAP-CAP has been designed to: * Evaluate multiple treatment strategies, at the same time, in the same patient. * Reach platform conclusions when sufficient data is accrued, rather than when a pre-specified sample size is reached * Utilise data that is already accrued to increase the likelihood that patients within the trial are randomised to treatments that are more likely to be beneficial * New questions can be substituted into the trial as initial questions are answered, meaning that the trial can be perpetual or open-ended * Interactions between interventions in different domains can be evaluated It is reasonable to presume that any pandemic respiratory infection of major significance to public health will manifest as life-threatening respiratory infection including Severe Acute Respiratory illness and severe Community Acquired Pneumonia (CAP) with concomitant admission to hospital, and for some patients, admission to an Intensive Care Unit (ICU). Previous pandemics and more localized outbreaks of respiratory emerging infections have resulted in severe CAP and ICU admission. Previous pandemics and outbreaks of emerging infectious diseases have outlined the urgent need for evidence, preferably from Randomized Controlled Trials (RCTs), to guide best treatment. However, there are substantial challenges associated with being able to organize such trials when the time of onset of a pandemic and its exact nature are unpredictable. As an adaptive platform trial that enrolls patients during the interpandemic period, REMAP-CAP is ideally positioned to adapt, in the event of a respiratory pandemic, to evaluate existing treatments as well as novel approaches.

This is an observational multicentre retrospective and prospective cohort study, and a qualitative study. The project will have three working packages: * Work package 1 - maintenance of a colorectal surgery database * Work package 2 - prospective collaborative national UK study * Work package 3 - qualitative analysis with semi-structured interviews WORK PACKAGE 1 - COLORECTAL SURGERY DATABASE: Data collected includes: * Basic demographic information * Co-morbidities at time of surgery * Other cancer treatments * Final cancer staging and diagnosis * Type of procedure * Methods of reconstruction * Use of healthcare resource: (theatre time, surgical teams, use of consumables, index operation intensive care stay, total length of stay, planned or emergency readmissions, use of imaging for complications, re-interventions, and outpatient clinic use). * Morbidity - empty pelvis syndrome complications with collation of all complications that occurred summarised into: (the highest Clavien-Dindo (CD) score, and the comprehensive complication index by accumulating CD graded complications that a patient has as a result of their surgery. * Survival: overall and disease-free survival * Patient reported outcome measures Any other routinely collected clinical data will be included. Of particular mention we will include and analyse Cardiopulmonary exercise testing data, data derived from the perioperative medicine screening and assessment, data derived from prehabilitation, radiomic data e.g. muscle/fat structure and function derived from CT, MRI or PET-CT. WORK PACKAGE 2 - PROSPECTIVE COLLABORATIVE STUDY: Abdominoperineal excision and pelvic exenteration can be used in a wide range of cancer types, and in the case of pelvic exenteration can be used to manage both recurrent and primary cancers. The principal PROM used will be the EORTC QLQ-C30 with its modular questionnaires giving additional insight into disease-specific quality of life. All amendments have been made in line with NIHR RfPB funding received in November 2024. Patients will be recruited once a decision to undertake abdominoperineal excision or pelvic exenteration surgery has taken place. Participants will be sent a participant information sheet which will include the dates of when participants can expect follow up telephone calls, with information on how to contact the study team to change these should participants wish to. Once consented participants will undergo the following PROMs as part of their baseline questionnaire: * EORTC QLQ-C30 with specific cancer-type modules * EQ-5D-5L * LRRC QoL * Decision Regret * Comprehensive Score for Financial Toxicity (COST), financial status questionnaire (non-validated) and Patient employment status questionnaires. The investigators anticipate that participants will be able to self-assess the above PROMs on a paper printed form, however a member of the research team will be available to support the participant if required. Clinical information will also be collected pre-operatively, including: demographic information, co-morbidities, cancer staging, and previous cancer treatments. Patients will be given copies of the follow up questionnaires at this time so participants have them as a reference when completing follow up questionnaires. Patients can opt for either email or telephone follow up for quality of life, if opting for email REDCap study will automatically send out emails based on the date of surgery. The patient will then undergo their surgery with method of reconstruction at the discretion of the operating surgeon(s). Following the index admission researchers will enter details on the hospital stay: * Type of procedure * Methods of reconstruction * Theatre time * Theatre teams * Use of consumables * Length of intensive care and hospital stay * Use of imaging for complications * Re-interventions for complications * Discharge destination following index admission * Final cancer staging and other pathological outcomes. * Perineal and empty pelvis morbidity, and overall Clavien-Dindo and Comprehensive Complication Index * NHS healthcare utilisation costs * If applicable survival and cause of death At 3 months post-operatively questionnaires will be repeated over the telephone including: * EORTC QLQ-C30 with cancer-specific module * EQ-5D-5L * LRRC QoL * Decision Regret * Comprehensive Score for Financial Toxicity (COST), Patient reported heath resource utilisation and NHS healthcare utilisation costs. At this same time point researchers will review routinely collected clinical data and use of in-hospital health resources to include: * In-hospital health resource use: planned or emergency re-admissions, use of imaging to investigate complications, re-interventions (surgical and radiological), planned or unplanned outpatient visits. * Longitudinal CCI scores updated, and if applicable an increase in CD if a more severe complication develops. * If applicable cancer recurrence, survival and cause of death will be recorded. Patients will be emailed or telephoned on the date specified on their participant information sheet, however if this time is not convenient then a better time will be arranged with the patient. If participants do not respond to the email or first telephone call then the investigators will make a further three separate attempts to contact the patient. If there is still no response participants will be deemed lost to the study. This follow up process will be repeated again at 6 months and 12 months. At the 12 month time point the investigators will ask patients additional questions on their use of health care resources and their current financial status, to include: * Use of community health resource use due to complications including: GP appointments and nursing home care days required for recovery from surgery. * Use of healthcare resources at hospitals other than the treating hospital - clinic appointments and admissions At the end of this time the patient will have completed the study. WORK PACKAGE 3 - QUALITATIVE STUDY: The qualitative study will recruit patients from work packages 1 and 2. The investigators will invite 30 purposefully sampled patients that are 3 months following their surgery. Suitable patients will be contacted with a posted participant information sheet and a telephone follow up call to allow participants to ask questions about the study. Following informed consent semi-structured interviews will take place with semi-structured open questions to guide the discussions. Interviews will be recorded on an encrypted audiorecorder and then transcribed. The investigators will initially undertake three pilot interviews to review that the semi-structured interview schedule is adequate to fully explore our objectives and to obtain good quality interview transcripts for analysis. These pilot interviews once completed will be reviewed by the research team. The semi-structured interview schedule questions may be changed if the interviews are of poor quality, pilot interviews demonstrate new insights from participants that suggest fruitful lines of enquiry, or inconsistencies that require further exploration. If subsequent interviews are very different than the pilot interviews following these changes, then these early interviews will not be included in the qualitative analysis and additional patients will be recruited. Patients recruited at 3-months following surgery will be offered a repeat interview at 12-months following their surgery DATA ANALYSIS PLAN: Statistical analysis: The investigators will be collecting data on the timepoints as described above. Continuous data will be will be summarised using descriptive statistics (mean, median, standard deviation, lower and upper quartiles). Categorical data will be summarised using counts and percentages. As studies are non-randomised, the investigators will utilise regression models and principal component analysis to adjust for confounding in this observational study. In order to obtain our outcomes a brief summary of analyses is below. Work package 1 (Colorectal Database): Primary analysis: \- Frequency of morbidity relating to the empty pelvis syndrome and perineal wound will be compared for different types of perineal reconstruction will be analysed using multiple linear regression. Secondary analysis: * Overall morbidity will be obtained using highest CD scores for different methods of perineal reconstruction analysed using multiple linear regression. * Disease free and overall survival will be analysed using Kaplan-Meier curves and log rank tests with a multivariate Cox regression hazard model to identify factors independently associated with survival, including method of reconstruction. Exploratory analysis: * Other factors including age, gender, BMI, final staging, co-morbidities, type of operation, neoadjuvant chemoradiotherapy and use of intra-operative electron radiotherapy will be included in the analysis * Other outcomes including primary operation time, lengths of stay, and readmissions will be explored Work package 2 (prospective study): Primary and secondary analysis: * Patient reported outcome measures will be analysed using regression models, including linear mixed-effects models for repeat measures and adjusted analyses. * The same clinical data fields will be collected as per work package 1, the analysis above repeated with exploratory analysis to find factors that are independently significantly associated with changes in the PROMs. Health economic analysis: Work package 1 (retrospective study): The investigators will collect data on use of hospital healthcare resources in each patient group. The investigators will collect resource use for each parameter required for each patient. The investigators will then undertake costing using a micro-costing approach and health resource group costing for each parameter. Applying costs to each parameter will use a combination of manufacturer prices for consumables, National Cost Collection for the NHS, National Schedule of NHS Costs, NHS National Tariff and the Unit Costs of Health and Social Care from the Personal Social Services Research Unit. The investigators will then report overall costs associated with different methods of perineal reconstruction and the cost of complications that were encountered. Work package 2 (prospective study): The investigators will collect hospital healthcare resource use data prospectively and apply micro-costing to these parameters in the same way as per work package 1 for each patient and their method of reconstruction. The investigators will also ask patients to provide us with use of community healthcare resources as a result of their surgery, data for which the investigators will not be able to obtain from their clinical notes. Participants will receive EQ-5D-5L and EORTC QLQ-C30 questionnaires at baseline, 3 months, 6 months and 12 months. From these responses the investigators will map onto EQ-5D-3L in order to reduce the overall number of questionnaires patients are undertaking in our study. This will allow us to plot EQ-5D-3L responses for different methods of reconstruction and plot the area under the curve. Within the trial time a health economic model would be built which would follow the NICE reference case and ISPOR Task Force guidelines on health economic analysis. This will enable us to present Quality Adjusted Life Years and incremental cost-effective ratios for the different methods of perineal reconstruction. Qualitative analysis: Audio transcription will be transcribed verbatim, checked against the recording and anonymised. Data will be uploaded to NVivo for data management. Preliminary summaries will be written after each interview to identify emerging themes to follow-up discussions. The follow-up interview will ask patients to reflect on the content of their previous interview and discuss any changes. Longitudinal interview analyses will use constant comparative methods from grounded theory and data coded using NVivo's framework matrix facility to examine themes longitudinally, enabling comparisons within each case and across cases, focusing on changes over time. The stages of data analysis, drawing on longitudinal comparisons, will include: 1. Initial reading: Review interview data. 2. Preliminary coding: Two researchers code the data. 3. Team meeting: Discuss and refine codes with wider research/PPI team. 4. Individual Case Coding: Code all interview data for each participant. 5. Categorising Codes: Group codes into categories for each case. 6. Longitudinal comparisons: Within case and category comparisons focussing on changes over time. 7. Focused coding: Examine categories in relation to emerging concepts and phases. 8. Discussion on Themes: PPI co-led focus group discussions of final themes. 9. Development and Dissemination: Report write up are dissemination. Based on an iterative process, emerging themes will be used to develop explanatory accounts. Analysis will draw on sociological perspectives of illness adaptation, recovery and self-management in addition to psychological theories of individual behaviour change. All qualitative and quantitative data will inform 3 patient focus groups, where PPI and charity collaborators along with 5 newly trained PPI members will discuss data analyses from a patient perspective, contributing to initial discussions around developing a patient decision aid.