RESUMEN
INTRODUCTION: Morbidity from an emergency laparotomy (EmLap) is difficult to define and poorly understood. Morbidity is a holistic concept, reliant upon an interplay of bio-psychosocial outcomes that evolve long after discharge. To date, no previous study has explored the psychosocial outcomes following EmLap as a collective, nor their change over time. This study aims to describe the holistic morbidity following EmLap within the first year following surgery. METHODS AND ANALYSIS: This is a multicentre, mixed-methods prospective 12-month cohort study with two participant populations: patient participants and family caregivers (FCGs). A target of 160 adult patients who undergo EmLap and can give informed consent will be included in the patient participant group. Patient participants will be asked to complete three patient surveys, incorporating validated patient-reported outcome measures (PROMs) to assess bio-psychosocial outcomes (EuroQol five-dimension five-level (EQ5D-5L), Gastrointestinal Quality Life Index-36, Patient Health Questionnaire-9, Generalised Anxiety Disorder 7, International Trauma Questionnaire, Caregiver Interaction Scale and Fatigue Severity Scale) in the 12 months following surgery. A subgroup of 15 patient participants will be asked to take part in two semistructured interviews at 6 and 12 months. A target of 15 associated family caregivers will be included in the FCG group. FCGs will be asked to take part in a semi-structured interview at 6 months to assess the EmLap impact on the wider support network. The primary outcome will be a change in quality of life (EQ5D-5L) at 12 months. Secondary outcomes will be changes in bio-psychosocial status at 3 and 12 months. Qualitative analysis will allow contextualisation of PROMS and further explore themes of EmLap morbidity. It is anticipated that the results of this study will help inform and develop standards of aftercare for future EmLap patients. ETHICS AND DISSEMINATION: This study has received ethical approval (Wales REC7;12/WA/0297) and will be undertaken in accordance with the principles of Good Clinical Practice. We intend to disseminate study results in peer-reviewed journals and medical conferences, as well as a lay report to study participants. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT05281627.
Asunto(s)
Laparotomía , Calidad de Vida , Humanos , Laparotomía/psicología , Estudios Prospectivos , Adulto , Medición de Resultados Informados por el Paciente , Cuidadores/psicología , Urgencias Médicas/psicología , Femenino , Masculino , Proyectos de Investigación , Encuestas y Cuestionarios , Estudios Multicéntricos como Asunto , Complicaciones Posoperatorias/psicologíaRESUMEN
INTRODUCTION: Rectal cancer is common with a 60% 5-year survival rate. Treatment usually involves surgery with or without neoadjuvant chemoradiotherapy or adjuvant chemotherapy. Sphincter saving curative treatment can result in debilitating changes to bowel function known as low anterior resection syndrome (LARS). There are currently no clear guidelines on the management of LARS with only limited evidence for different treatment modalities. METHODS AND ANALYSIS: Patients who have undergone an anterior resection for rectal cancer in the last 10 years will be approached for the study. The feasibility trial will take place in four centres with a 9-month recruitment window and 12 months follow-up period. The primary objective is to assess the feasibility of recruitment to the POLARiS trial which will be achieved through assessment of recruitment, retainment and follow-up rates as well as the prevalence of major LARS.Feasibility outcomes will be analysed descriptively through the estimation of proportions with confidence intervals. Longitudinal patient reported outcome measures will be analysed according to scoring manuals and presented descriptively with reporting graphically over time. ETHICS AND DISSEMINATION: Ethical approval has been granted by Wales REC1; Reference 22/WA/0025. The feasibility study is in the process of set up. The results of the feasibility trial will feed into the design of an expanded, international trial. TRIAL REGISTRATION NUMBER: CT05319054.
Asunto(s)
Terapia por Estimulación Eléctrica , Neoplasias del Recto , Humanos , Neoplasias del Recto/cirugía , Estudios de Factibilidad , Síndrome de Resección Anterior Baja , Estudios de Cohortes , Tratamiento Conservador , Complicaciones Posoperatorias/terapia , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
INTRODUCTION: Incisional hernia (IH) is a common complication of abdominal surgery affecting between 10% and 20% of patients and is associated with significant morbidity along with cost to the National Health Service. With high recurrence rates following repair, focus must be on prevention of IH rather than cure. There is an increasing evidence that patients at high risk of developing IH may benefit from prophylactic mesh placement during their index operation. With recent controversy surrounding the use of mesh in the UK, however, there is little understanding of whether this intervention would be acceptable to patients. METHODS AND ANALYSIS: INVITE is a mixed-methods, cross-sectional study to explore patient perceptions of the use of mesh as prophylaxis to prevent IH. Patients with and without IH who have undergone colorectal surgery between 2017 and 2020 in a single UK health-board will be approached to participate. 120 participants will be asked to complete a questionnaire and a subgroup of 24 participants will be invited to semistructured interviews. The primary outcome is to assess the acceptability of prophylactic mesh to patients. Secondary outcomes include understanding patients' knowledge of IH, and factors that may influence or alter the acceptability of mesh. Questionnaires have been developed using a 5-point Likert scale to allow quantitative analysis. Qualitative analysis of interviews will be conducted using NVivo software and thematic analysis. Data will be presented using the Journal Article Reporting Standards for mixed-methods research. ETHICS AND DISSEMINATION: Ethical approval has been granted by REC Wales (22/PR/0678), and the study is currently in setup. All participants will be required to provide informed consent prior to their participation in the study. We plan to report the results of the study in peer-reviewed scientific and medical journals and via presentations at scientific meetings. Results from this study will aid the design of interventional trials using prophylactic mesh. TRIAL REGISTRATION NUMBER: NCT05384600.
Asunto(s)
Hernia Incisional , Humanos , Hernia Incisional/prevención & control , Estudios Transversales , Mallas Quirúrgicas/efectos adversos , Medicina Estatal , Medición de RiesgoRESUMEN
BACKGROUND: The rate of cognitive decline in Alzheimer's disease (AD) has been found to vary widely between individuals, with numerous factors driving this heterogeneity. OBJECTIVE: This study aimed to compute a measure of cognitive decline in patients with AD based on clinical information and to utilize this measure to explore the genetic architecture of cognitive decline in AD. METHODS: An in-house cohort of 616 individuals, hereby termed the Cardiff Genetic Resource for AD, as well as a subset of 577 individuals from the publicly available ADNI dataset, that have been assessed at multiple timepoints, were used in this study. Measures of cognitive decline were computed using various mixed effect linear models of Mini-Mental State Examination (MMSE). After an optimal model was selected, a metric of cognitive decline for each individual was estimated as the random slope derived from this model. This metric was subsequently used for testing the association of cognitive decline with apolipoprotein E (APOE) genotype. RESULTS: No association was found between the number of APOEÉ2 or É4 alleles and the rate of cognitive decline in either of the datasets examined. CONCLUSION: Further exploration is required to uncover possible genetic variants that affect the rate of decline in patients with AD.
Asunto(s)
Enfermedad de Alzheimer/genética , Apolipoproteínas E/genética , Disfunción Cognitiva/psicología , Pruebas de Estado Mental y Demencia/estadística & datos numéricos , Anciano de 80 o más Años , Alelos , Estudios de Cohortes , Femenino , Genotipo , Humanos , Estudios Longitudinales , MasculinoRESUMEN
Genetic discoveries of Alzheimer's disease are the drivers of our understanding, and together with polygenetic risk stratification can contribute towards planning of feasible and efficient preventive and curative clinical trials. We first perform a large genetic association study by merging all available case-control datasets and by-proxy study results (discovery n = 409,435 and validation size n = 58,190). Here, we add six variants associated with Alzheimer's disease risk (near APP, CHRNE, PRKD3/NDUFAF7, PLCG2 and two exonic variants in the SHARPIN gene). Assessment of the polygenic risk score and stratifying by APOE reveal a 4 to 5.5 years difference in median age at onset of Alzheimer's disease patients in APOE É4 carriers. Because of this study, the underlying mechanisms of APP can be studied to refine the amyloid cascade and the polygenic risk score provides a tool to select individuals at high risk of Alzheimer's disease.