Dataset Information

Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

ABSTRACT: Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis.Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study.Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment.Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system.The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications.NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .

SUBMITTER: Garcia-Gutierrez S

PROVIDER: S-EPMC5759866 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

García-Gutierrez Susana S Orive Miren M Sarasqueta Cristina C Legarreta Maria Jose MJ Gonzalez Nerea N Redondo Maximino M Rivero Amado A Serrano-Aguilar Pedro P Castells Xavier X Quintana Jose Maria JM Sala Maria M

BMC cancer 20180108 1

<h4>Background</h4>Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis.<h4>Methods</h4>Prospective cohort study involving 13 hospitals in Spain with a follow-up per ...[more]

PMID: 29310641

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Project description:BackgroundColorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients.MethodsDesigna prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention.Statistical analysisIn relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models.DiscussionThe identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this large cohort of patients may provide useful information to answer different health services research questions.Trial registrationClinicalTrials.gov Identifier: NCT02488161 . Registration date: June 16, 2015.

Project description:PurposeDetection of multifocal, multicentric, and contralateral breast cancers in patients affects surgical management. Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) can identify additional foci that were initially undetected by conventional imaging. However, its use is limited owing to low specificity and high false-positive rate. Multiparametric MRI (DCE-MRI + diffusion-weighted [DW] MRI) can increase the specificity. We aimed to describe the protocols of our prospective, multicenter, observational cohort studies designed to compare the diagnostic performance of DCE-MRI and multiparametric MRI for the diagnosis of multifocal, multicentric cancer and contralateral breast cancer in patients with newly diagnosed breast cancer.MethodsTwo studies comparing the performance of DCE-MRI and multiparametric MRI for the diagnosis of multifocal, multicentric cancer (NCT04656639) and contralateral breast cancer (NCT05307757) will be conducted. For trial NCT04656639, 580 females with invasive breast cancer candidates for breast conservation surgery whose DCE-MRI showed additional suspicious lesions (breast imaging reporting and data system [BI-RADS] category ≥ 4) on DCE-MRI in the ipsilateral breast will be enrolled. For trial NCT05307757, 1098 females with invasive breast cancer whose DCE-MRI showed contralateral lesions (BI-RADS category ≥ 3 or higher on DCE-MRI) will be enrolled. Participants will undergo 3.0-T DCE-MRI and DW-MRI. The diagnostic performance of DCE-MRI and multiparametric MRI will be compared. The receiver operating characteristic curve, sensitivity, specificity, positive predictive value, and characteristics of the detected cancers will be analyzed. The primary outcome is the difference in the receiver operating characteristic curve between DCE-MRI and multiparametric MRI interpretation. Enrollment completion is expected in 2024, and study results are expected to be presented in 2026.DiscussionThis prospective, multicenter study will compare the performance of DCE-MRI versus multiparametric MRI for the preoperative evaluation of multifocal, multicentric, and contralateral breast cancer and is currently in the patient enrollment phase.Trial registrationClinicalTrials.gov Identifier: NCT04656639, NCT05307757. Registered on April 1 2022.

Project description:IntroductionPolypharmacy in patients with advanced cancer represents a major public health problem, leading to risk of iatrogenesis, decrease of quality of life and increase of healthcare costs. In the field of geriatrics, health policies have been developed to address polypharmacy through the use of deprescribing tools. Recently, palliative care initiatives have been introduced, yet these have not fully considered the specificities of this population, particularly their perceptions. It is therefore important to better understand patients' perceptions of deprescribing in order to adapt tools and actions to make these approaches more effective.ObjectivesThe aim is to investigate patients' perceptions of deprescribing in palliative oncology care, and to explore factors that may influence patients' attitudes and beliefs about deprescribing and to validate a specific questionnaire (rPATD) in this population. An ancillary study will investigate the relationship between patients' health literacy and their perception of deprescribing.MethodA prospective, observational, multicenter study will be conducted using a sequential mixed exploratory design in a population of patients living with advanced cancer and with a physician-estimated life expectancy of less than 1 year. The study will include an initial qualitative phase. Individual semi-structured interviews using a descriptive approach (thematic analysis) will be conducted (upon saturation). Following analysis of the qualitative data, a quantitative study including 300 patients will be realized to meet secondary objectives. Several data will be collected and 2 self-questionnaires will be administered: the BMQ (beliefs about medicine) and rPATD (perception of deprescribing) possibly supplemented by additional items if required by the qualitative analysis. The auxiliary study will be conducted during this second phase, using a validated self-questionnaire to assess patients' level of literacy.ConclusionThe disparate outcomes will facilitate the understanding of the perception of deprescribing in palliative oncology care, enabling the development of tailored approaches adapted to this population.Trial registrationClinicalTrials Identifier: NCT06193083.

Project description:IntroductionBreast cancer is still the most common malignancy among women worldwide. The Prospective Breast Cancer Biobank (PBCB) collects blood and urine from patients with breast cancer every 6 or 12 months for 11 years from 2011 to 2030 at two university hospitals in Western Norway. The project aims to identify new biomarkers that enable detection of systemic recurrences at the molecular level. As blood represents the biological interface between the primary tumour, the microenvironment and distant metastases, liquid biopsies represent the ideal medium to monitor the patient's cancer biology for identification of patients at high risk of relapse and for early detection systemic relapse.Including patient-reported outcome measures (PROMs) allows for a vast number of possibilities to compare PROM data with biological information, enabling the study of fatigue and Quality of Life in patients with breast cancer.Methods and analysisA total of 1455 patients with early-stage breast cancer are enrolled in the PBCB study, which has a one-armed prospective observational design. Participants consent to contribute liquid biopsies (i.e., peripheral blood and urine samples) every 6 or 12 months for 11 years. The liquid biopsies are the basis for detection of circulating tumour cells, circulating tumour DNA (ctDNA), exosomal micro-RNA (miRNA), miRNA in Tumour Educated Platelet and metabolomic profiles. In addition, participants respond to 10 PROM questionnaires collected annually. Moreover, a control group comprising 200 women without cancer aged 25-70 years will provide the same data.Ethics and disseminationThe general research biobank PBCB was approved by the Ministry of Health and Care Services in 2007, by the Regional Ethics Committee (REK) in 2010 (#2010/1957). The PROM (#2011/2161) and the biomarker study PerMoBreCan (#2015/2010) were approved by REK in 2011 and 2015 respectively. Results will be published in international peer reviewed journals. Deidentified data will be accessible on request.Trial registration numberNCT04488614.

Project description:ObjectiveTo describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics.DesignExplanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data.Principal findingsApproximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site.ConclusionsSeveral features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.

Project description:OBJECTIVES:To assess the trends concerning utilisation of maternal and child health (MCH) services before, during and after the Ebola outbreak, quantifying the contribution of a reorganised referral system (RS). DESIGN:A prospective observational study of MCH services. SETTING:Pujehun district in Sierra Leone, 77 community health facilities and 1 hospital from 2012 to 2017. MAIN OUTCOME MEASURES:MCH utililization was evaluated by assessing: (1) institutional deliveries, Cesarean-sections, paediatric and maternity admissions and deaths, and major direct obstetric complications (MDOCs), at hospital level; (2) antenatal care (ANC) 1 and 4, institutional delivery and family planning, at community level. Contribution of a strengthened RS was also measured. RESULTS:At hospital level, there is a significant difference between trends Ebola versus pre-Ebola for maternal admissions (7, 95% CI 4 to 11, p<0.001), MDOCs (4, 95% CI 1 to 7, p=0.006) and institutional deliveries (4, 95% CI 2 to 6, p=0.001). There is also a negative trend in the transition from Ebola to post-Ebola for maternal admissions (-7, 95% CI -10 to -4, p<0.001), MDOCs (-4, 95% CI -7 to -1, p=0.009) and institutional deliveries (-3, 95% CI -5 to -1, p=0.001). The differences between trends pre-Ebola versus post-Ebola are only significant for paediatric admissions (3, 95% CI 0 to 5, p=0.035). At community level, the difference between trends Ebola versus pre-Ebola and Ebola versus post-Ebola are not significant for any indicators. The differences between trends pre-Ebola versus post-Ebola show a negative difference for institutional deliveries (-7, 95% CI -10 to -4, p<0.001), ANC 1 (-6, 95% CI -10 to -3, p<0.001), ANC 4 (-8, 95% CI -11 to -5, p<0.001) and family planning (-85, 95% CI -119 to -51, p<0.001). CONCLUSIONS:A stronger health system compared with other districts in Sierra Leone and a strengthened RS enabled health facilities in Pujehun to maintain service provision and uptake during and after the Ebola epidemic.

Dataset Information

Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

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Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

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