BACKGROUND: Despite its importance, there is no consensus definition of access to care, and several fundamental philosophical questions about access remain unanswered. Lack of clarity impedes interventional research designed to develop and test methods of correcting barriers to access. To help remedy this problem, we propose a conceptual framework to help guide empirical research about access to gynecologic cancer care.
METHODS: Relevant philosophical and empirical literature was reviewed and analyzed to highlight key elements needed to refine research on access to care.
RESULTS: The DIMeS framework involves 1) choice and justification of a Definition of access to cancer care that will guide research; 2) Identification of essential gynecologic cancer care services for which access disparities are ethically unacceptable; 3) quantitative MEasurement of specific parameters that affect access to care; and 4) Selection of a target threshold on measured parameters above which access is acceptable.
CONCLUSIONS: The DIMeS framework provides clarity and reproducibility for investigators seeking to develop and test interventions to improve cancer health equity. This framework should be considered for use in research on access to gynecologic cancer care.

UNASSIGNED: Approximately fifteen million women in the United States live > 50 miles from a gynecologic oncologist. Telemedical technology allows patients\' local physicians to consult with subspecialist gynecologic oncologists without burdening patients with unnecessary in-person visits. Although critical to adoption of this technology, physicians\' input into implementation of clinician-to-clinician consultation has not been sought. We therefore gathered feedback about experiences with referrals, communication, and openness to telemedical consultation from gynecologic oncologists, gynecologists, and medical oncologists.
UNASSIGNED: We recruited gynecologic oncologists, gynecologists, and medical oncologists from practices serving rural patients to participate in semi-structured interviews. The Consolidated Framework for Implementation Research and the Theoretical Domains Framework guided the interviews. Questions focused on factors influencing adoption and implementation of clinician-to-clinician telemedicine. Interviews were conducted via WebEx, recorded, and transcribed. Two investigators coded interviews using the combined frameworks and identified salient themes.
UNASSIGNED: We conducted 11 interviews (6 gynecologic oncologists, 3 gynecologists, 2 medical oncologists) and identified themes encompassing communication burnout, barriers to sharing patient information, need for further logistical information, and potential benefits to patients.
UNASSIGNED: Clinician-to-clinician telemedicine may improve access to gynecologic cancer care by decreasing barriers to subspecialty expertise while simultaneously benefiting referring and consultant clinicians through improved identification and workup of patients who may need in-person consultation. To optimize desired outcomes, telemedical consultation must allow for communication of relevant patient information and records and easy integration into clinical workflow. Importantly, clinicians must perceive the consultation as improving patients\' access to specialty care.

UNASSIGNED: Knowing the predictive factors of the variation in a center-level continuous outcome of interest is valuable in the design and analysis of parallel-arm cluster randomized trials. The symbolic two-step method for sample size planning that we present incorporates this knowledge while simultaneously accounting for patient-level characteristics. Our approach is illustrated through application to cluster randomized trials in cancer care delivery research. The required number of centers (clusters) depends on the between- and within-center variance; the within-center variance is a function of estimates obtained by regressing the log within-center variance on predictive factors. Obtaining accurate estimates of the components needed to characterize the within-center variation is challenging.
UNASSIGNED: Using our previously derived sample size formula, our objective in the current research is to directly account for the imprecision in these estimates, using a Bayesian approach, to safeguard against designing an underpowered study when using the symbolic two-step method. Using estimates of the required components, including the number of centers that contribute to those estimates, we make formal allowance for the imprecision in these estimates on which a sample size will be based.
UNASSIGNED: The mean of the distribution for power is consistently smaller than the single point estimate that the sample size formula yields. The reduction in power is more pronounced in the presence of increased uncertainty about the estimates with the reduction becoming more attenuated with increased numbers of centers that contribute to the estimates.
UNASSIGNED: Accounting for imprecision in the estimates of the components required for sample size estimation using the symbolic two-step method in the design of a cluster randomized trial yields conservative estimates of power.

Barriers to access to cancer care are profoundly threatening to patients with gynecologic malignancies. Implementation science focuses on empirical investigation of factors influencing delivery of clinical best practices, as well as interventions designed to improve delivery of evidence-based care. We outline one prominent framework for conducting implementation research and discuss its application to improving access to gynecologic cancer care.
Literature on the use of the Consolidated Framework for Implementation Research (CFIR) was reviewed. Delivery of cytoreductive surgery for advanced ovarian carcinoma was selected as an illustrative case of an evidence-based intervention (EBI) in gynecologic oncology. CFIR domains were applied to the context of cytoreductive surgical care, highlighting examples of empirically-assessable determinants of care delivery.
CFIR domains include Innovation, Inner Setting, Outer Setting, Individuals, and Implementation Process. \"Innovation\" relates to characteristics of the surgical intervention itself; \"Inner Setting\" relates to the environment in which surgery is delivered. \"Outer Setting\" refers to the broader care environment influencing the Inner Setting. \"Individuals\" highlights attributes of persons directly involved in care delivery, and \"Implementation Process\" focuses on integration of the Innovation within the Inner Setting.
Prioritization of implementation science methods in the study of access to gynecologic cancer care will help ensure that patients are able to utilize interventions with the greatest prospect of benefiting them.

Generating actionable research findings quickly and efficiently is critical for improving the delivery of cancer-related care and outcomes. To address this issue, the National Cancer Institute convened subject matter experts, researchers, clinicians, and patients for a 2-day virtual meeting in February 2022. The purpose of this meeting was to identify how rapid cycle interventional research methods can be used to generate findings useful in improving routine clinical practice. The meeting yielded an initial conceptualization of rapid cycle interventional research as being comprised of 6 key elements: use of iterative study designs; reliance on proximal primary outcomes; early and continued engagement with community and clinical partners; use of existing data sources to measure primary outcomes; facilitative features of the study setting and context; and consideration of appropriate rigor relative to intended use of findings. The meeting also identified the types of study designs that can be leveraged to conduct rapid cycle interventional research and provided examples of these; considered this approach from the perspective of key partners; described the clinical and data infrastructure, research resources, and key collaborations needed to support this work; identified research topics best addressed using this approach; and considered needed methodological advances. The National Cancer Institute is committed to exploring opportunities to encourage further development and application of this research approach as a means for better promoting improvements in the delivery of cancer-related care.

BACKGROUND: Alliance for Clinical Trials in Oncology (Alliance) coordinated trials utilize Medidata Rave® (Rave) as the primary clinical data capture system. A growing number of innovative and complex cancer care delivery research (CCDR) trials are being conducted within the Alliance with the aims of studying and improving cancer-related care. Because these trials encompass patients, providers, practices, and their interactions, a defining characteristic of CCDR trials is multilevel data collection in pragmatic settings. Consequently, CCDR trials necessitated innovative strategies for database development, centralized data management, and data monitoring in the presence of these real-world multilevel relationships. Having real trial experience in working with community and academic centers, and having recently implemented five CCDR trials in Rave, we are committed to sharing our strategies and lessons learned in implementing such pragmatic trials in oncology.
METHODS: Five Alliance CCDR trials are used to describe our approach to analyzing the database development needs and the novel strategies applied to overcome the unanticipated challenges we encountered. The strategies applied are organized into 3 categories: multilevel (clinic, clinic stakeholder, patient) enrollment, multilevel quantitative and qualitative data capture, including nontraditional data capture mechanisms being applied, and multilevel data monitoring.
RESULTS: A notable lesson learned in each category was (1) to seek long-term solutions when developing the functionality to push patient and non-patient enrollments to their respective Rave study database that affords flexibility if new participant types are later added; (2) to be open to different data collection modalities, particularly if such modalities remove barriers to participation, recognizing that additional resources are needed to develop the infrastructure to exchange data between that modality and Rave; and (3) to facilitate multilevel data monitoring, orient site coordinators to the their trial\'s multiple study databases, each corresponding to a level in the hierarchy, and remind them to establish the link between patient and non-patient participants in the site-facing NCI web-based enrollment system.
CONCLUSIONS: Although the challenges due to multilevel data collection in pragmatic settings were surmountable, our shared experience can inform and foster collaborations to collectively build on our past successes and improve on our past failures to address the gaps.

Women with gynecologic cancers may face geographic barriers to standard-of-care consultation with a gynecologic oncologist. While telemedicine may help overcome these geographic barriers, there are no qualitative data exploring gynecologic cancer patients\' attitudes towards telemedicine for cancer care. Patients with gynecologic malignancies may have preferences distinct from general oncology populations due to the sensitive nature of the diseases and anatomy involved.
Semi-structured interviews were conducted with 15 patients with gynecologic cancers to identify perceived advantages and disadvantages of telemedicine use for gynecologic cancer care. Past experience with telemedicine was elicited as were suggestions for cancer care encounters most compatible with telemedicine. Interviews were transcribed, coded, and analyzed for emergent themes.
All patients interviewed were open to the use of telemedicine. Emergent themes regarding advantages of telemedicine included convenience, cost savings, reduced travel, avoidance of infectious disease, and availability of care for those too unwell for in-person visits. Themes regarding disadvantages of telemedical care included technical difficulties, perceived need for examination or testing, and potential compromise of therapeutic relationship. Patients were particularly concerned that difficulty in establishing a therapeutic relationship would compromise initial consultations with gynecologic oncologists via telemedicine.
Patients with gynecologic cancer are open to use of telemedicine for their care. Particular attention should be paid to overcoming patients\' hesitancy to have initial visits with gynecologic oncologists, as these consultations have the greatest potential to improve access to high-quality gynecologic cancer care.

暂无摘要。

In 1971, Congress passed the National Cancer Act, landmark legislation that reorganized the National Institutes of Health\'s National Cancer Institute (NCI). The Act included a new focus on cancer control, including the requirement that the NCI award research grants and contracts, in collaboration with other public agencies and private industry, to conduct cancer control activities related to the diagnosis, prevention, and treatment of cancer. The requirement placed the NCI at the nexus of a rapidly changing science and a complex and dynamic healthcare delivery system and involved an evolutionary transformation to advance cancer control and cancer care delivery research along the cancer care continuum. Analysis is based on a qualitative ethnographic approach using historical records, oral histories, and targeted interviews. The multimethod approach provided the opportunity to describe the vision, leadership, and struggle to build an infrastructure, expand expertise, and forge collaboration with the NCI and a complex and changing healthcare system. As the 50th anniversary of the National Cancer Act approaches in 2021, the process and these achievements are at risk of being taken for granted or lost in the flow of history. Documenting the process, milestones, and key players provides insight and guidance for continuing to improve cancer care, advance research, and reduce cancer incidence and mortality. Cancer care is a microcosm of the larger healthcare system providing insight and lessons on the importance of developing and maintaining a research infrastructure and the role of multi-level collaboration and partnerships involving both the private and public sectors.

Patients with gynecologic cancers experience better outcomes when treated by specialists and institutions with experience in their diseases. Unfortunately, high-volume centers tend to be located in densely populated regions, leaving many women with geographic barriers to care. Remote management through telemedicine offers the possibility of decreasing these disparities by extending the reach of specialty expertise and minimizing travel burdens. Telemedicine can assist in diagnosis, treatment planning, preoperative and postoperative follow-up, administration of chemotherapy, provision of palliative care, and surveillance. Telemedical infrastructure requires careful consideration of the needs of relevant stakeholders including patients, caregivers, referring clinicians, specialists, and health system administrators.