Getting It Wrong Most of The Time: Comparing Trialists’ Choice of Primary Outcome With What Patients And Health Professionals Want

2021 ◽  
Author(s):  
Shaun Treweek ◽  
Viviane Miyakoda ◽  
Dylan Burke ◽  
Frances Shiely
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Health Care Professionals ◽  
Primary Outcome ◽  
Healthcare Professionals ◽  
Breast Cancer Patients ◽  
Additional Information ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
Secondary Outcomes

Abstract Background: Randomised trials support improved decision-making through the data they collect. One important piece of data is the primary outcome – so called because it is what the investigators decide is the most important. Secondary outcomes provide additional information to support decision-making. We were interested in knowing how important patients and healthcare professionals consider the outcomes (especially the primary outcome) measured in a selection of published trials. Methods: The work had three stages: 1. We identified a body of late-stage trials in two clinical areas, breast cancer management and nephrology. 2. We identified the primary and secondary outcomes for these trials. 3. We randomly ordered these outcomes and presented them to patients and healthcare professionals (with experience of the clinical area), and we asked them to rank the importance of the outcomes. They were not told which outcomes trial authors considered primary and secondary. Results: In our sample of 44 trials with 46 primary outcomes, 29 patients, one patient representative and 12 healthcare professionals together ranked the primary outcome as the most important outcome 13/46 times, or 30%. Breast cancer patients and health care professionals considered the primary outcome to be the most important outcome for 8/21 primary outcomes chosen by trialists. For nephrology, the equivalent figure was 5/25. The primary outcome appeared in a respondent’s top 5 ranked outcomes 151/178 (85%) times for breast cancer and 225/259 (87%) times for nephrology even if the primary wasn’t considered the most important outcome. Conclusions: The primary outcome in a trial is the most important piece of data collected. It is used to determine how many participants are required, and it is the main piece of information used to judge whether the intervention is effective or not. Our study found that in the view of patients and healthcare professionals, teams doing trials in breast cancer management and nephrology got their choice of primary outcome wrong 70% of the time.

Suggested modifications in the management of breast cancer patients in the era of COVID-19 pandemic: a web-based survey. (Preprint)

2021 ◽  
Author(s):  
Shereef Elsamany ◽  
Mohamed Elbaiomy ◽  
Ahmed Zeeneldin ◽  
Emad Tashkandi ◽  
Fayza Hassanin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
United Arab Emirates ◽  
Hormonal Therapy ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Web Based ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
Positive Breast Cancer

BACKGROUND Management of cancer patients in the current era of COVID-19 pandemic poses a significant challenge on health care systems. OBJECTIVE We explored the views of oncologists for the management of breast cancer patients during COVID-19 pandemic. METHODS A web-based questionnaire using SurveyMonkey was submitted to licensed oncologists involved in breast cancer management in Saudi Arabia, Egypt and United Arab Emirates. The survey focused on characteristics of participants, infection risk among cancer patients and possible treatment modifications related to different types of breast cancer RESULTS The survey was completed by 82 participants. For early HR positive, HER2-negative breast cancer,74.4% supported using neoadjuvant hormonal therapy in selected patients, and 58.0% preferred giving 6 over 8 cycles of adjuvant chemotherapy when indicated. Only 42.7% preferred CDK4/6 inhibitor with hormonal therapy as first line in all patients with metastatic HR-positive disease. 67.1% of participants supported using adjuvant trastuzumab for 6 instead of 12 months in selected patients with HER2-positive breast cancer. For metastatic HER2-positive, HR-positive breast cancer, 80.5% of participants supported the use of hormonal therapy with dual anti-HER2 blockade in selected patients. The preferred choice of 1st line treatment in metastatic triple negative patients with BRCA mutation and PDL1<1%, was PARP inhibitor according to 42.5% of the participants, and atezolizumab with nabpaclitaxel if the PDL1>1% according to 70.4% of the participants. CONCLUSIONS Several modifications in breast cancer management is supported by the survey participants. These modifications need to be discussed on local basis taking into account the local infrastructure and available resources. CLINICALTRIAL none

scholarly journals Upper limb lymphedema related to breast cancer therapy: incidence, risk factors, diagnostic techniques, risk reduction and optimal management

2018 ◽  
Vol 5 (11) ◽  
pp. 3633
Author(s):  
Hatem A. Saleh ◽  
Tarek M. Rageh ◽  
Suzan A. Alhassanin ◽  
Mohamed A. Megahed
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Cancer Patients ◽  
Upper Limb ◽  
Diagnostic Techniques ◽  
Breast Cancer Patients ◽  
Breast Cancer Therapy ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
Incidence Risk

Background: Lymphedema remains to be a great source of morbidity for breast cancer survivors. The aim of this work is to study upper limb lymphedema following breast cancer therapy for breast cancer patients regarding its incidence, risk factors, diagnostic techniques, risk reduction and optimal management.Methods: This prospective study was done on two hundred breast cancer patients who underwent breast cancer management. The study was done in the period between May 2016 and July 2018. Exclusion criteria were Male patients, Female patients with metastatic breast cancer and who already had upper limb lymphedema before breast cancer management. All patients underwent follow up for incidence, risk factors, diagnostic techniques and management of lymphedema. Statistical analysis used: The collected data were organized, tabulated and statistically analyzed using SPSS softwareResults: The incidence of lymphedema was (18 %) distributed as follow: grade I = 55.6%, grade II = 33.3%, grade III = 11.1 % and grade IV = 0 %. The most relevant risk factors for development of lymphedema were: age between 41 and 50 years and diabetes mellitus. Higher incidence of pain (66.7%) and restricted motion (61.1%) were observed in lymphedema cases.Conclusions: Old (41:50 years) and diabetic patients are at the highest risk for developing lymphedema. Breast cancer patients of stage IIIB who had undergone modified radical mastectomy or who developed postoperative seroma are at higher risk for developing lymphedema. Physical exercises and compression garment are important part of treatment plan.

scholarly journals Breast Medical Oncology in the Era of COVID-19 Pandemic

2020 ◽  
Vol 5 (S1) ◽  
pp. 187-190
Author(s):  
Rania Chacha ◽  
Said Afqir
Keyword(s):  
Breast Cancer ◽  
World Health ◽  
Breast Cancer Patients ◽  
Negative Effects ◽  
Infected People ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
Life Threatening ◽  
Working Groups ◽  
Health Organization

The coronavirus disease 2019 (COVID-19) has spread over the majority of countries and it was declared as a pandemic on March 11th, 2020 by The World Health Organization. The number of infected people worldwide is still in progress. Patients diagnosed with cancer are a fragile population because of their chronic disease and related treatments, and therefore, requiring a particular management. Several international initiatives from scientific societies and working groups have provided updated guidance to improve the medical treatments of breast cancer. These recommendations aimed to mitigate the negative effects of this outbreak on prevention, diagnosis, and treatments. Notably, this should be used for prioritizing the various aspects of cancer care particularly breast cancer patients’ safety. In this editorial, we shortly review the current guidelines for breast cancer management during this pandemic and illustrate the available treatments that should be prioritized. We believe this paper will be useful for young oncologists and physicians dealing with this emerging life-threatening disease.

scholarly journals Correlating imaging parameters with molecular data: An integrated approach to improve the management of breast cancer patients

2020 ◽  
Vol 35 (1_suppl) ◽  
pp. 47-50 ◽  
Author(s):  
Mariarosaria Incoronato ◽  
Peppino Mirabelli ◽  
Anna Maria Grimaldi ◽  
Andrea Soricelli ◽  
Marco Salvatore
Keyword(s):  
Breast Cancer ◽  
Integrated Approach ◽  
Molecular Data ◽  
Cancer Tissue ◽  
Breast Cancer Patients ◽  
Cancer Management ◽  
Imaging Parameters ◽  
Diagnosis And Prognosis ◽  
Breast Cancer Management ◽  
Genetic Level

The goal of this review is to provide an overview of the studies aimed at integrating imaging parameters with molecular biomarkers for improving breast cancer patient’s diagnosis and prognosis. The use of diagnostic imaging to extract quantitative parameters related to the morphology, metabolism, and functionality of tumors, as well as their correlation with cancer tissue biomarkers is an emerging research topic. Thanks to the development of imaging biobanks and the technological tools required for extraction of imaging parameters including radiomic features, it is possible to integrate imaging markers with genetic data. This new field of study represents the evolution of radiology–pathology correlation from an anatomic–histologic level to a genetic level, which paves new interesting perspectives for breast cancer management.

scholarly journals Updates in COVID-19 Related Lymphadenopathy - Frequent Deep Axillary Location and Possible Contralateral Involvement

2021 ◽  
Vol 6 (10) ◽  
pp. 725-730
Author(s):  
Pintican Roxana ◽  
Duma Magdalena ◽  
Szep Madalina ◽  
Schiau Calin ◽  
Feier Diana ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Emotional Stress ◽  
Side Effect ◽  
Breast Cancer Patients ◽  
Oncology Patients ◽  
Axillary Lymphadenopathy ◽  
Cancer Management ◽  
Breast Cancer Management

Ipsilateral axillary lymphadenopathy related to COVID-19 vaccine was reported as a side effect and started to raise diagnostic dilemmas especially in oncology patients. Breast cancer patients are particularly prone to this benign pitfall that may result in unfortunate management changing or unnecessary biopsy, both causing additional emotional stress for the patients. We present three cases with axillary lymphadenopathy and one with axillary and bilateral supraclavicular lymphadenopathy, and focus on what haven’t been reported yet: the deep and more superior location for the axillary lymphadenopathy and the possibility of contralateral lymphadenopathy secondary to COVID-19 vaccine. Their implication in breast cancer management will also be briefly discussed.

scholarly journals Possible Association of Typhoon Hagibis and the COVID-19 Pandemic on Patient Delay in Breast Cancer Patients: a case report

2021 ◽  
Author(s):  
Yudai Kaneda ◽  
Akihiko Ozaki ◽  
Masahiro Wada ◽  
Tomohiro Kurokawa ◽  
Toyoaki Sawano ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Case Report ◽  
Cancer Patient ◽  
Breast Cancer Patient ◽  
Patient Care ◽  
Cancer Patients ◽  
Initial Presentation ◽  
Breast Cancer Patients ◽  
Cancer Management ◽  
Breast Cancer Management

Little is known on how disasters interact in their impacts on patient care. We experienced a breast cancer patient whose initial presentation was delayed for two years due to the COVID-19 pandemic and Typhoon Hagibis. Increasing awareness is needed on the combined impacts of disasters on breast cancer management.

Intraoperative Considerations in Sentinel Lymph Node Biopsy for Breast Cancer

2011 ◽  
Vol 07 (02) ◽  
pp. 111
Author(s):  
Anees B Chagpar ◽  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Lymph Node Biopsy ◽  
Axillary Node ◽  
Breast Cancer Patients ◽  
Cancer Management ◽  
Current State ◽  
Breast Cancer Management ◽  
State Of The Science

Sentinel lymph node (SLN) biopsy has revolutionized breast cancer management and has been generally accepted as a mainstay in lymph node evaluation for breast cancer patients. Still, there are many controversies that surround both the surgical technique involved and how the SLNs should be evaluated intraoperatively. The ramifications of isolated tumor cells and micrometastases and the need for axillary node dissection in all SLN-positive patients remain subjects of debate. This article reviews the literature with regard to these issues and presents the current state of the science of SLN biopsy.

Review of Clinical Studies of CA 27.29 in Breast Cancer Management

1999 ◽  
Vol 14 (1) ◽  
pp. 36-39 ◽  
Author(s):  
R.A. Beveridge
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Critical Review ◽  
Early Stage ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Review Of The Literature ◽  
Cancer Management ◽  
Breast Cancer Management

A critical review of CA 27.29 and CA 15-3 is performed in this paper. A review of the literature is undertaken. A review of the FDA submissions for 27.29 for both early stage and monitoring metastatic breast cancer patients is reviewed.

A Qualitative Study: Early Detection of Breast Cancer in Indonesia (After Universal Health Coverage Implementation)

2021 ◽  
Author(s):  
Ajeng Viska Icanervilia ◽  
Lina Choridah ◽  
Antoinette D.I. Asselt ◽  
Johanna P.M Vervoort ◽  
Maarten J. Postma ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Health Care ◽  
Early Detection ◽  
Health Care Services ◽  
Breast Cancer Patients ◽  
Levels Of Care ◽  
Cancer Management ◽  
Care Services ◽  
Breast Cancer Management ◽  
Depth Interviews

Abstract ObjectivesEarly detection is of vital importance in breast cancer management. BPJS Kesehatan, as Indonesia’s national health insurance, is expected to provide an adequate health service for breast cancer patients. This study aimed to obtain insight into the current conditions of health care services in Indonesia, related to early detection of breast cancer, particularly after BPJS Kesehatan implementation. MethodsThe study was conducted in 2017 in Yogyakarta, Indonesia with a wide range of socio-demographic backgrounds. Subjects comprised breast cancer patients and their relatives, health care professionals (HCPs), and healthy women from the general population who had no history of breast cancer and no family members with breast cancer. The subjects’ experiences and knowledge of health care services regarding early detection of breast cancer, were investigated through in-depth interviews. The thematic analysis guided the result synthesis from semi-structured in-depth interviews with 25 participants.ResultsDespite more patients with earlier stages presenting in high level of care after the implementation of universal coverage, this study identified the lack of both screening as well as diagnostic procedures as a prominent obstacle in breast cancer management. Study results indicated a lack of knowledge and misperception among the community about breast cancer screening. Also, problems in implementing early diagnosis were revealed such as the lack of urgency and access for patients to get a proper diagnostic procedure. Furthermore, varying adherence to the guidelines in all levels of care were found. ConclusionsThis study identified several issues that cause delay in the detection of breast cancer in Indonesia. All these factors lead to suboptimal breast cancer management. BPJS Kesehatan (the national health insurance) must focus its attention on the improvement of enabling factors in all levels of care for early detection (i.e. increasing awareness, access, referral system and facilities).

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