Systematic and continuous collection of patient-reported outcomes and experience in women with cancer undergoing mastectomy and immediate breast reconstruction: a study protocol for the Tuscany Region (Italy)

Abstract

IntroductionMonitoring how patients feel and what they experience during the care process gives health professionals data to improve the quality of care, and gives health systems information to better design and implement care pathways. To gain new insights about specific gaps and/or strengths in breast cancer care, we measure patient-reported outcomes (PROs) and patient-reported experiences (PREs) for women receiving immediate breast reconstruction (iBR).Methods and analysisProspective, multicentre, cohort study with continuous and systematic web-based data collection from women diagnosed with breast cancer, who have an indication for iBR after mastectomy treated at any Breast Unit (BU) in Tuscany Region (Italy). Patients are classified into one of two groups under conditions of routine clinical practice, based on the type of iBR planned (implant and autologous reconstruction). Patient-reported information are obtained prior to and after surgery (at 3-month and 12-month follow-up). We estimate that there are around 700 annual eligible patients.Descriptive analyses are used to assess trends in PROs over time and differences between types of iBR in PROs and PREs. Additionally, econometric models are used to analyse patient and BU characteristics associated with outcomes and experiences. PREs are evaluated to assess aspects of integrated care along the care pathway.Ethics and disseminationThe study has been reviewed and obtained a nihil obstat from the Tuscan Ethics Committees of the three Area Vasta in 2017. Dissemination of results will be via periodic report, journal articles and conference presentations.

Including patient‐reported measures in performance evaluation systems: Patient contribution in assessing and improving the healthcare systems

“…17 The PROMs survey in the Observatory encompasses different surveys targeted to specific groups of patients: those suffering from cancer, specific chronic conditions, as well as patients undergoing hip or knee replacement surgery. [48][49][50] For this reason, PROMs surveys are carried on by involving single clinicians instead of whole hospitals.…”

“…In the surgical pathways, each clinician, or her relative surgical unit, is responsible for informing and enrolling patients before surgery; after the enrolment, the patient receives a personal invitation to the online questionnaire by email or SMS; since PROMs are longitudinal surveys, patients receive different invitations over time; while the patient fills in the questionnaire, data are digitally collected and reported real‐time to healthcare professionals. In this paper, the focus on PROMs will be on orthopaedic and breast cancer surveys because of their well‐established use both in Tuscany and internationally, and according to their advancements in terms of integration inside the Tuscan PES 48,49 . The patient‐reported information collected includes specific scores of health outcomes (i.e., functional status, relational wellbeing, mental health), and are computed and reported also in terms of health gain or loss over time.…”

A longitudinal assessment of chronic care pathways in real-life: self-care and outcomes of chronic heart failure patients in Tuscany

“…Furthermore, the hospital records a remarkable performance in the adherence to pharmacological therapies as visible on the Interregional Performance Evaluation System (IRPES) headed by the Management and Healthcare Laboratory (MeS Lab) of the Sant' Anna School of Advanced Studies in Pisa [23,24]. In FTGM, the chronic heart failure PROMs and PREMs programme was developed, first, as a pilot study and part of a wider ongoing collection of PROMs and PREMs for other specialties (e.g., elective orthopaedic surgery, breast cancer surgery) in several hospitals across Tuscany region and other Italian institutions [18,[25][26][27][28]. Then, PROMs became a part of the routine way of providing care.…”

Promoção Da Saúde Da Mulher

“…As limitações encontradas pelo trabalho foram em virtude de a literatura com resultados relatados pelo paciente e suas experiências estarem, majoritariamente, restritos a uma pequena escala e em período de tempo limitado. Além disso, limita-se a pesquisa com a existência de muitos estudos com avaliações na perspectiva do médico ou da organização de saúde e não propriamente da paciente (FERRÈ et al, 2021). Outra limitação se deve ao fato de a literatura mostrar reconstrução por retalhos realizados apenas em centros especializados, o que pode interferir na generalização dos resultados (GOPIE et al, 2014).…”

“…Por fim, vale salientar a necessidade de mais estudos acerca da eficácia da lipoenxertia autóloga (BENNETT et al, 2017), bem como sobre a forma com que a quimioterapia impacta em complicações em pacientes tratadas com reconstrução por implante (HART et al, 2021). Estudos posteriores realizados por meio da avaliação das experiências relatadas por pacientes através de formulários online também se mostram interessantes, levando em consideração a coleta e análise em maior escala, os relatórios e dados proporcionados em tempo real e a boa relação custo/benefício (FERRÈ et al, 2021). Ademais, analisar a forma com que fatores culturais e sociais influenciam a satisfação das pacientes submetidas a reconstrução também constitui boa linha de pesquisa para futuros estudos (BERLIN et al, 2017).…”