Gary Groot

Predicting local recurrence following breast-conserving therapy for early stage breast cancer: The significance of a narrow (≤2 mm) surgical resection margin

Controversy continues over the extent of surgical resection margin required to minimize the risk of local recurrence (LR) in breast‐conserving therapy (BCT) for early stage breast cancer. This study explores whether or not a narrow (≤2 mm) but negative resection margin affects LR.

What is a clinical pathway? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review

Clinical pathways (CPWs) are a common component in the quest to improve the quality of health. CPWs are used to reduce variation, improve quality of care, and maximize the outcomes for specific groups of patients. An ongoing challenge is the operationalization of a definition of CPW in healthcare. This may be attributable to both the differences in definition and a lack of conceptualization in the field of clinical pathways. This correspondence article describes a process of refinement of an operational definition for CPW research and proposes an operational definition for the future syntheses of CPWs literature. Following the approach proposed by Kinsman et al. (BMC Medicine 8(1):31, 2010) and Wieland et al. (Alternative Therapies in Health and Medicine 17(2):50, 2011), we used a four-stage process to generate a five criteria checklist for the definition of CPWs. We refined the operational definition, through consensus, merging two of the checklist’s criteria, leading to a more inclusive criterion for accommodating CPW studies conducted in various healthcare settings. The following four criteria for CPW operational definition, derived from the refinement process described above, are (1) the intervention was a structured multidisciplinary plan of care; (2) the intervention was used to translate guidelines or evidence into local structures; (3) the intervention detailed the steps in a course of treatment or care in a plan, pathway, algorithm, guideline, protocol or other ‘inventory of actions’ (i.e. the intervention had time-frames or criteria-based progression); and (4) the intervention aimed to standardize care for a specific population. An intervention meeting all four criteria was considered to be a CPW. The development of operational definitions for complex interventions is a useful approach to appraise and synthesize evidence for policy development and quality improvement.

Understanding Women’s Choice of Mastectomy Versus Breast Conserving Therapy in Early-Stage Breast Cancer

Objective: To identify factors that influence Saskatchewan women’s choice between breast conserving therapy (BCT) and mastectomy in early-stage breast cancer (ESBC) and to compare and contrast underlying reasons behind choice of BCT versus mastectomy. Methods: Interpretive description methods guided this practice-based qualitative study. Data were analyzed using thematic analysis and presented in thematic maps. Results: Women who chose mastectomy described 1 of the 3 main themes: worry about cancer recurrence, perceived consequences of BCT treatment, or breast-tumor size perception. In contrast, women chose BCT because of 3 different themes: mastectomy being too radical, surgeon influence, and feminine identity. Conclusions: Although individual reasons for choosing mastectomy versus BCT have been discussed in the literature before, different rationale underlying each choice has not been previously described. These results are novel in identifying interdependent subthemes and secondary reasons for each choice. This is important for increased understanding of factors influencing a complicated decision-making process.

Metformin inhibits the development, and promotes the resensitization, of treatment-resistant breast cancer

Multiple drug resistant (MDR) malignancy remains a predictable and often terminal event in cancer therapy, and affects individuals with many cancer types, regardless of the stage at which they were originally diagnosed or the interval from last treatment. Protein biomarkers of MDR are not globally used for clinical decision-making, but include the overexpression of drug-efflux pumps (ABC transporter family) such as MDR-1 and BCRP, as well as HIF1α, a stress responsive transcription factor found elevated within many MDR tumors. Here, we present the important in vitro discovery that the development of MDR (in breast cancer cells) can be prevented, and that established MDR could be resensitized to therapy, by adjunct treatment with metformin. Metformin is prescribed globally to improve insulin sensitivity, including in those individuals with Type 2 Diabetes Mellitus (DM2). We demonstrate the effectiveness of metformin in resensitizing MDR breast cancer cell lines to their original treatment, and provide evidence that metformin may function through a mechanism involving post-translational histone modifications via an indirect histone deacetylase inhibitor (HDACi) activity. We find that metformin, at low physiological concentrations, reduces the expression of multiple classic protein markers of MDR in vitro and in preliminary in vivo models. Our demonstration that metformin can prevent MDR development and resensitize MDR cells to chemotherapy in vitro, provides important medical relevance towards metformin’s potential clinical use against MDR cancers.

Development of a program theory for shared decision-making: a realist review protocol

BackgroundThe practicality of applying evidence to healthcare systems with the aim of implementing change is an ongoing challenge for practitioners, policy makers, and academics. Shared decision- making (SDM), a method of medical decision-making that allows a balanced relationship between patients, physicians, and other key players in the medical decision process, is purported to improve patient and system outcomes. Despite the oft-mentioned benefits, there are gaps in the current literature between theory and implementation that would benefit from a realist approach given the value of this methodology to analyze complex interventions. In this protocol, we outline a study that will explore: “In which situations, how, why, and for whom does SDM between patients and health care providers contribute to improved decision making?”MethodsA seven step iterative process will be described including preliminary theory development, establishment of a search strategy, selection and appraisal of literature, data extraction, analysis and synthesis of extracted results from literature, and formation of a revised program theory with the input of patients, physicians, nurse navigators, and policy makers from a stakeholder session.DiscussionThe goal of the realist review will be to identify and refine a program theory for SDM through the identification of mechanisms which shape the characteristics of when, how, and why SDM will, and will not, work.Systematic review registrationPROSPERO CRD42017062609

Patient and provider experiences with active surveillance: A scoping review

Objective Active surveillance (AS) represents a fundamental shift in managing select cancer patients that initiates treatment only upon disease progression to avoid overtreatment. Given uncertain outcomes, patient engagement could support decision-making about AS. Little is known about how to optimize patient engagement for AS decision-making. This scoping review aimed to characterize research on patient and provider communication about AS, and associated determinants and outcomes. Methods MEDLINE, EMBASE, CINAHL, and The Cochrane Library were searched from 2006 to October 2016. English language studies that evaluated cancer patient or provider AS views, experiences or behavioural interventions were eligible. Screening and data extraction were done in duplicate. Summary statistics were used to describe study characteristics and findings. Results A total of 2,078 studies were identified, 1,587 were unique, and 1,243 were excluded based on titles/abstracts. Among 344 full-text articles, 73 studies were eligible: 2 ductal carcinoma in situ (DCIS), 4 chronic lymphocytic leukemia (CLL), 6 renal cell carcinoma (RCC) and 61 prostate cancer. The most influential determinant of initiating AS was physician recommendation. Others included higher socioeconomic status, smaller tumor size, comorbid disease, older age, and preference to avoid adverse treatment effects. AS patients desired more information about AS and reassurance about future treatment options, involvement in decision-making and assessment of illness uncertainty and supportive care needs during follow-up. Only three studies of prostate cancer evaluated interventions to improve AS communication or experience. Conclusions This study revealed a paucity of research on AS communication for DCIS, RCC and CLL, but generated insight on how to optimize AS discussions in the context of routine care or clinical trials from research on AS for prostate cancer. Further research is needed on AS for patients with DCIS, RCC and CLL, and to evaluate interventions aimed at patients and/or providers to improve AS communication, experience and associated outcomes.

Review of Factors Influencing Women’s Choice of Mastectomy Versus Breast Conserving Therapy in Early Stage Breast Cancer: A Systematic Review

&NA; We have performed a narrative synthesis. A literature search was conducted between January 2000 and June 2014 in 7 databases. The initial search identified 2717 articles; 319 underwent abstract screening, 67 underwent full‐text screening, and 25 final articles were included. This review looked at early stage breast cancer in women only, excluding ductal carcinoma in situ and advanced breast cancer. A conceptual framework was created to organize the central constructs underlying womens choices: clinicopathologic factors, physician factors, and individual factors with subgroups of sociodemographic, geographic, and personal beliefs and preferences. This framework guided our reviews synthesis and analysis. We found that larger tumor size and increasing stage was associated with increased rates of mastectomy. The results for age varied, but suggested that old and young extremes of diagnostic age were associated with an increased likelihood of mastectomy. Higher socioeconomic status was associated with higher breast conservation therapy (BCT) rates. Resident rural location and increasing distance from radiation treatment facilities were associated with lower rates of BCT. Individual belief factors influencing womens choice of mastectomy (mastectomy being reassuring, avoiding radiation, an expedient treatment) differed from factors influencing choice of BCT (body image and femininity, physician recommendation, survival equivalence, less surgery). Surgeon factors, including female gender, higher case numbers, and individual surgeon practice, were associated with increased BCT rates. The decision‐making process for women with early stage breast cancer is complicated and affected by multiple factors. Organizing these factors into central constructs of clinicopathologic, individual, and physician factors may aid health‐care professionals to better understand this process.

Interventions are needed to support patient–provider decision-making for DCIS: a scoping review

PurposePrognostic and treatment uncertainty make ductal carcinoma in situ (DCIS) complex to manage. The purpose of this study was to describe research that evaluated DCIS communication experiences, needs and interventions among DCIS patients or physicians.MethodsMEDLINE, EMBASE, CINAHL and The Cochrane Library were searched from inception to February 2017. English language studies that evaluated patient or physician DCIS needs, experiences or behavioural interventions were eligible. Screening and data extraction were done in duplicate. Summary statistics were used to describe study characteristics and findings.ResultsA total of 51 studies published from 1997 to 2016 were eligible for review, with a peak of 8 articles in year 2010. Women with DCIS lacked knowledge about the condition and its prognosis, although care partners were more informed, desired more information and experienced decisional conflict. Many chose mastectomy or prophylactic mastectomy, often based on physician’s recommendation. Following treatment, women had anxiety and depression, often at levels similar to those with invasive breast cancer. Disparities were identified by education level, socioeconomic status, ethnicity and literacy. Physicians said that they had difficulty explaining DCIS and many referred to DCIS as cancer. Despite the challenges reported by patients and physicians, only two studies developed interventions designed to improve patient–physician discussion and decision-making.ConclusionsAs most women with DCIS undergo extensive treatment, and many experience treatment-related complications, the paucity of research on PE to improve and support informed decision-making for DCIS is profound. Research is needed to improve patient and provider discussions and decision-making for DCIS management.

Creation of a new clinical framework – why women choose mastectomy versus breast conserving therapy

BackgroundClinical medicine has lagged behind other fields in understanding and utilizing frameworks to guide research. In this article, we introduce a new framework to examine why women choose mastectomy versus breast conserving therapy in early stage breast cancer, and highlight the importance of utilizing a conceptual framework to guide clinical research.MethodsThe framework we present was developed through integrating previous literature, frameworks, theories, models, and the author’s past research.ResultsWe present a conceptual framework that illustrates the central domains that influence women’s choice between mastectomy versus breast conserving therapy. These have been organized into three broad constructs: clinicopathological factors, physician factors, and individual factors with subgroups of sociodemographic, geographic, and individual belief factors. The aim of this framework is to provide a comprehensive basis to describe, examine, and explain the factors that influence women’s choice of mastectomy versus breast conserving therapy at the individual level.ConclusionWe have developed a framework with the purpose of helping health care workers and policy makers better understand the multitude of factors that influence a patient’s choice of therapy at an individual level. We hope this framework is useful for future scholars to utilize, challenge, and build upon in their own work on decision-making in the setting of breast cancer. For clinician-researchers who have limited experience with frameworks, this paper will highlight the importance of utilizing a conceptual framework to guide future research and provide an example.

Assessing the implementation processes of a large-scale, multi-year quality improvement initiative: survey of health care providers

BackgroundBeginning in 2012, Lean was introduced to improve health care quality and promote patient-centredness throughout the province of Saskatchewan, Canada with the aim of producing coordinated, system-wide change. Significant investments have been made in training and implementation, although limited evaluation of the outcomes have been reported. In order to better understand the complex influences that make innovations such as Lean “workable” in practice, Normalization Process Theory guided this study. The objectives of the study were to: a) evaluate the implementation processes associated with Lean implementation in the Saskatchewan health care system from the perspectives of health care professionals; and b) identify demographic, training and role variables associated with normalization of Lean.MethodsLicensed health care professionals were invited through their professional associations to complete a cross-sectional, modified, online version of the NoMAD questionnaire in March, 2016. Analysis was based on 1032 completed surveys. Descriptive and univariate analyses were conducted. Multivariate multinomial regressions were used to quantify the associations between five NoMAD items representing the four Normalization Process Theory constructs (coherence, cognitive participation, collective action and reflexive monitoring).ResultsMore than 75% of respondents indicated that neither sufficient training nor resources (collective action) had been made available to them for the implementation of Lean. Compared to other providers, nurses were more likely to report that Lean increased their workload. Significant differences in responses were evident between: leaders vs. direct care providers; nurses vs. other health professionals; and providers who reported increased workload as a result of Lean vs. those who did not. There were no associations between responses to normalization construct proxy items and: completion of introductory Lean training; participation in Lean activities; age group; years of professional experience; or employment status (full-time or part-time). Lean leader training was positively associated with proxy items reflecting coherence, cognitive participation and reflexive monitoring.ConclusionsFrom the perspectives of the cross-section of health care professionals responding to this survey, major gaps remain in embedding Lean into healthcare. Strategies that address the challenges faced by nurses and direct care providers, in particular, are needed if intended goals are to be achieved.