RESUMO
BACKGROUND: Recent data have demonstrated that in locally advanced rectal cancer (LARC), a total neoadjuvant therapy (TNT) approach improves compliance with chemotherapy and increases rates of tumor response compared to neoadjuvant chemoradiation (CRT) alone. They further indicate that the optimal sequencing of TNT involves consolidation (rather than induction) chemotherapy to optimize complete response rates. Data, largely from retrospective studies, have also shown that patients with clinical complete response (cCR) after TNT may be managed safely with the watch and wait approach (WW) instead of preemptive total mesorectal resection (TME). However, the optimal consolidation chemotherapy regimen to achieve cCR has not been established, and a randomized clinical trial has not robustly evaluated cCR as a primary endpoint. Collaborating with a multidisciplinary oncology team and patient groups, we designed this NCI-sponsored study of chemotherapy intensification to address these issues and to drive up cCR rates, to provide opportunity for organ preservation, improve quality of life for patients and improve survival outcomes. METHODS: In this NCI-sponsored multi-group randomized, seamless phase II/III trial (1:1), up to 760 patients with LARC, T4N0, any T with node positive disease (any T, N +) or T3N0 requiring abdominoperineal resection or coloanal anastomosis and distal margin within 12 cm of anal verge will be enrolled. Stratification factors include tumor stage (T4 vs T1-3), nodal stage (N + vs N0) and distance from anal verge (0-4; 4-8; 8-12 cm). Patients will be randomized to receive neoadjuvant long-course chemoradiation (LCRT) followed by consolidation doublet (mFOLFOX6 or CAPOX) or triplet chemotherapy (mFOLFIRINOX) for 3-4 months. LCRT in both arms involves 4500 cGy in 25 fractions over 5 weeks + 900 cGy boost in 5 fractions with a fluoropyrimidine (capecitabine preferred). Patients will undergo assessment 8-12 (± 4) weeks post-TNT completion. The primary endpoint for the phase II portion will compare cCR between treatment arms. A total number of 312 evaluable patients (156 per arm) will provide statistical power of 90.5% to detect a 17% increase in cCR rate, at a one-sided alpha = 0.048. The primary endpoint for the phase III portion will compare disease-free survival (DFS) between treatment arms. A total of 285 DFS events will provide 85% power to detect an effect size of hazard ratio 0.70 at a one-sided alpha of 0.025, requiring enrollment of 760 patients (380 per arm). Secondary objectives include time-to event outcomes (overall survival, organ preservation time and time to distant metastasis) and adverse event rates. Biospecimens including archival tumor tissue, plasma and buffy coat, and serial rectal MRIs will be collected for exploratory correlative research. This study, activated in late 2022, is open across the NCTN and had accrued 330 patients as of May 2024. Study support: U10CA180821, U10CA180882, U24 CA196171; https://acknowledgments.alliancefound.org . DISCUSSION: Building on data from modern day rectal cancer trials and patient input from national advocacy groups, we have designed The Janus Rectal Cancer Trial studying chemotherapy intensification via a consolidation chemotherapy approach with the intent to enhance cCR and DFS rates, increase organ preservation rates, and improve quality of life for patients with rectal cancer. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT05610163; Support includes U10CA180868 (NRG) and U10CA180888 (SWOG).
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Fluoruracila , Terapia Neoadjuvante , Neoplasias Retais , Humanos , Neoplasias Retais/terapia , Neoplasias Retais/patologia , Neoplasias Retais/mortalidade , Neoplasias Retais/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Terapia Neoadjuvante/métodos , Fluoruracila/administração & dosagem , Fluoruracila/uso terapêutico , Masculino , Feminino , Intervalo Livre de Doença , Leucovorina/administração & dosagem , Leucovorina/uso terapêutico , Oxaliplatina/administração & dosagem , Oxaliplatina/uso terapêutico , Capecitabina/administração & dosagem , Capecitabina/uso terapêutico , Irinotecano/administração & dosagem , Irinotecano/uso terapêutico , Pessoa de Meia-Idade , Resultado do Tratamento , Qualidade de Vida , Estadiamento de Neoplasias , Compostos OrganoplatínicosRESUMO
BACKGROUND: Vulnerable persons are individuals whose life situations create or exacerbate vulnerabilities, such as low income, housing insecurity and social isolation. Vulnerable people often receive a patchwork of health and social care services that does not appropriately address their needs. The cost of health and social care services escalate when these individuals live without appropriate supports. Compassionate Communities apply a population health theory of practice wherein citizens are mobilized along with health and social care supports to holistically address the needs of persons experiencing vulnerabilities. AIM: The purpose of this study was to evaluate the implementation of a compassionate community intervention for vulnerable persons in Windsor Ontario, Canada. METHODS: This applied qualitative study was informed by the Consolidated Framework for Implementation Research. We collected and analyzed focus group and interview data from 16 program stakeholders: eight program clients, three program coordinators, two case managers from the regional health authority, one administrator from a partnering community program, and two nursing student volunteers in March through June 2018. An iterative analytic process was applied to understand what aspects of the program work where and why. RESULTS: The findings suggest that the program acts as a safety net that supports people who are falling through the cracks of the formal care system. The 'little things' often had the biggest impact on client well-being and care delivery. The big and little things were achieved through three key processes: taking time, advocating for services and resources, and empowering clients to set personal health goals and make authentic community connections. CONCLUSION: Compassionate Communities can address the holistic, personalized, and client-centred needs of people experiencing homelessness and/or low income and social isolation. Volunteers are often untapped health and social care capital that can be mobilized to promote the health of vulnerable persons. Student volunteers may benefit from experiencing and responding to the needs of a community's most vulnerable members.
Assuntos
Pessoas Mal Alojadas , Humanos , Ontário , Pesquisa Qualitativa , Apoio Social , Serviço SocialRESUMO
AIMS: The objectives of this study were to bring the experience of the transitioning process for the transgender population to the nursing profession and address the lack of knowledge to promote improved patient outcomes. DESIGN: This study used a narrative review using the literature matrix method. Because of the dearth of trans specific literature, editorials and monologues were included. DATA SOURCE: A broad search was undertaken across all databases including CINAHL, PubMed, PsycINFO, Ovid MEDLINE, ProQuest Nursing & Allied Health and Google Scholar. Literature from June 1994 to May 2020 was appraised. Non-peer reviewed literature and published texts were procured via Google Alerts. REVIEW METHODS: Selection for inclusion was based on credibility and relevance from a variety of social science disciplines. A narrative analysis was used to identify common themes, incongruencies in schools of thought and perspectives that require consideration. RESULTS: Analysis of the literature revealed the following themes: (a) literature and terminology evolution, (b) transitioning as a process, (c) medicalization of transitioning, (d) generational views on transitioning and (e) needs during transition. CONCLUSION: This review highlights key issues about the transitioning process imperative to nursing when meeting the needs of the transgender population. IMPACT: This review addresses the lack of trans specific literature and lack of consistency in the literature about the understanding of the transitioning process for the transgender population. Main findings? Terminology to explain the transitioning process is ever evolving. Future studies about transitioning need to go beyond the medical lens. Generational views differ in the approach to transitioning, and there are needs unique to this population required during the process. Where and whom will the research impact? The review has significant implications for change in health delivery, nursing policy and formulating nursing practice and education to improve trans competent care.
Assuntos
Pessoas Transgênero , HumanosRESUMO
INTRODUCTION: Despite the plethora of research on the use of emergency department services for nonurgent primary health care, the vast majority of this research is quantitative in nature. To date, there is little research that reports on the problem from the patients' perspective and/or lived experience, which compromises health care providers' understanding of the essence of the problem as described by the patients. Thus, this study will provide a qualitative description of nonurgent ED visits from the patients' perspective. Specifically, this study answers the following research questions: 1) What are the reasons for patients and/or caregivers visiting the emergency department for nonurgent health conditions? and 2) What are the barriers experienced by patients and/or caregivers when seeking access to health care? METHODS: A qualitative descriptive design with face-to-face interviews of 33 consenting participants was conducted at 4 emergency departments. All interviewed participants were triaged as nonurgent patients by the ED personnel. RESULTS: Three themes surfaced from the data regarding reasons for using the emergency department: 1) Practitioner referral; 2) Efficacy of care; and 3) Time saver. When describing barriers that participants experienced when seeking care outside of the emergency department for their nonurgent conditions, 3 themes that emerged are lack of primary care provider, financial difficulties, and lack of comprehensive care outside the emergency department. DISCUSSION: The results of the study can help inform patient-centered care and future policy initiatives that will address the practices and barriers contributing to nonurgent ED visits.
Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Mau Uso de Serviços de Saúde/estatística & dados numéricos , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Adulto , Idoso , Feminino , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Encaminhamento e Consulta/estatística & dados numéricos , Tempo , Adulto JovemRESUMO
INTRODUCTION: Nonurgent visits to the emergency department compromise efficiency in treating patients with urgent conditions and inversely influence the satisfaction of patients and staff. There is inconclusive evidence of the factors associated with nonurgent ED visits. Therefore, the purpose of this study was to explore the independent factors associated with nonurgent ED visits in a midsize community-based Canadian hospital system. METHODS: This was a retrospective, secondary analysis of data from 2 community hospitals in southwestern Ontario, Canada. We included ED patients in the analysis if they were local residents from the city or the surrounding county. RESULTS: Nonurgent visits constituted approximately 27% of all ED visits and were more likely to be associated with patients with a primary care provider referral (odds ratio = 2.87; 95% confidence interval, 2.75-2.99) and with patients who had no primary care provider (odds ratio = 1.10; 95% confidence interval, 1.04-1.16). Other predictors included younger age, season, time of day, ED arrival mode, geographical proximity of residence to the emergency department, and case presentation. DISCUSSION: The findings of this study may assist health care providers and stakeholders in developing strategies to minimize nonurgent ED visits.
Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Mau Uso de Serviços de Saúde/estatística & dados numéricos , Eficiência Organizacional , Feminino , Hospitais Comunitários , Humanos , Masculino , Pessoa de Meia-Idade , Ontário , Estudos RetrospectivosRESUMO
Proteasome inhibitors have become an integral part of myeloma therapy. Considerable efforts have gone into optimizing this therapeutic approach to obtain maximal proteasome inhibition with least toxicity. Ixazomib is the first oral proteasome inhibitor to enter the clinic and has been studied as a single agent as well as in various combinations. The current trial was designed to examine the efficacy and toxicity of combining 2 different doses of ixazomib (4 mg and 5.5 mg given weekly for 3 of 4 weeks) with 40 mg weekly of dexamethasone, in relapsed myeloma. Seventy patients were enrolled, 35 patients randomly assigned to each ixazomib dose. Overall, 30 (43%; 95% confidence interval, 31-55) of the patients achieved a confirmed partial response or better, with 31% achieving a response with 4 mg and 54% with 5.5 mg of ixazomib. The median event-free survival (EFS) for the entire study population was 8.4 months; 1-year overall survival was 96%. The EFS was 5.7 months for patients with prior bortezomib exposure and 11.0 months for bortezomib-naïve patients. A grade 3 or 4 adverse event considered at least possibly related to treatment was seen in 11 (32%) patients at 4 mg and in 21 (60%) at 5.5 mg. Dose reductions were more frequent with 5.5 mg dose. Overall, the ixazomib with dexamethasone has good efficacy in relapsed myeloma, is well-tolerated and with higher response rate at 5.5 mg, albeit with more toxicity. This study was registered at www.clinicaltrials.gov as #NCT01415882.
Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Compostos de Boro/administração & dosagem , Bortezomib/uso terapêutico , Dexametasona/administração & dosagem , Resistencia a Medicamentos Antineoplásicos/efeitos dos fármacos , Glicina/análogos & derivados , Mieloma Múltiplo/tratamento farmacológico , Recidiva Local de Neoplasia/tratamento farmacológico , Idoso , Idoso de 80 Anos ou mais , Compostos de Boro/efeitos adversos , Dexametasona/efeitos adversos , Feminino , Glicina/administração & dosagem , Glicina/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/mortalidade , Mieloma Múltiplo/patologia , Análise de Sobrevida , Resultado do TratamentoRESUMO
INTRODUCTION: Belief in one's ability to control pain is a significant predictor of health outcomes and is related to improved functional status. The purpose of this study was to introduce a novel formulation of the construct, Perceived Control Over Pain and to test its effects on functional status. METHODS: Participants (N = 301) were primarily African American (92%); and were adults with low income attending a primary care clinic and reporting pain within the past 2 weeks. A cross-sectional design was used with confirmatory factor analysis and structural equation modeling. The Perceived Control Over Pain construct consisted of four measures-two specific measures of control over pain and two general measures of control over life events. Perceived Control Over Pain has not been defined in this way previously. RESULTS: Mean worst pain scores for the past week were 8.4, where "0" (no pain) to "10" (pain as bad as you can imagine). The model demonstrated good construct validity for the components of pain, Perceived Control Over Pain and functional status. Mediation by Perceived Control Over Pain was partial but strong, accounting for a reduction of 29% in the effect of pain on functional status. DISCUSSION: In minority populations with low income, factors such as perceived control over pain and its effect on the outcome of patient function need to be considered. Improving Perceived Control Over Pain has the potential for improving patients' feelings of life control and purpose or meaning in life, and psychological and physical functioning for adults living with pain.
Assuntos
Dor/psicologia , Percepção , Adulto , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
An RN credential has been called "a ticket to the world." Canadian RNs have been active participants in migration, especially to the United States. In an increasingly globally oriented world, Canadian nurse graduates have many employment options. The purpose of this study was to explore the job values and expectations of baccalaureate nursing students who indicated they were considering migrating for work abroad for their first job and to explore their confidence in having these values met in Canada compared to another country. This was a quantitative study guided by the Value-Expectancy Framework. Data were collected through a Web-based self-report survey and analyzed using descriptive statistics for sample characteristics and t tests for comparison. Nonprobability convenience sampling of graduating baccalaureate nursing students from a Canadian border region was used. Of 130 respondents, 92 (70.8%) indicated that they were considering migrating from Canada for work. Respondents believed that working abroad would provide more adventure, full-time work, professional development, appropriate staffing, flexible scheduling, and freedom to choose their preferred job sector/specialty. The authors conclude that there is a need to study nursing graduates' labour mobility both within and outside of Canada and the factors that influence their decision-making and to address the factors that encourage them to leave Canada. Human resource planning will become increasingly important given the predicted nursing shortage and changes to nurse licensure in Canada with the potential to influence migration.
On dit du titre d'infirmière ou infirmier autorisé qu'il est un "billet pour le monde". Les infirmières et infirmiers du Canada participent activement à l'émigration, en particulier vers les États-Unis. Dans un monde de plus en plus tourné vers l'international, les infirmières et infirmiers diplômés du Canada ont accès à de nombreuses possibilités d'emploi. L'objectif de la présente étude est d'explorer les valeurs et les attentes en matière d'emploi d'étudiantes et étudiants au baccalauréat en sciences infirmières qui ont indiqué envisager de partir à l'étranger pour leur premier emploi, ainsi que d'évaluer leur confiance dans l'éventualité de retrouver les valeurs qu'ils recherchent au Canada comparativement à un autre pays. Il s'agit d'une étude quantitative s'appuyant sur le modèle attentes-valeurs. Les données ont été recueillies au moyen d'un sondage par autodéclaration en ligne et analysées à l'aide de la statistique descriptive pour la caractérisation de l'échantillon et de tests t pour les comparaisons. Un échantillonnage de commodité non probabiliste a été utilisé pour constituer un échantillon composé d'étudiantes et étudiants de dernière année d'un programme de baccalauréat en sciences infirmières vivant dans une région frontalière du Canada. Parmi les 130 répondantes et répondants, 92 (70,8 %) ont dit envisager de partir du Canada pour le travail. Les répondantes et répondants estiment que de travailler à l'étranger leur offrira plus d'aventure, du travail à plein temps, du perfectionnement professionnel, des milieux de travail adéquatement dotés en personnel, des horaires souples et la liberté d'investir le secteur ou la spécialité de leur choix. En conclusion de leur étude, les auteures signalent la nécessité d'étudier la mobilité de l'effectif des infirmières et infirmiers diplômés à l'intérieur et à l'extérieur du Canada et les facteurs influençant leur prise de décision, afin de trouver des moyens d'atténuer l'effet de ceux qui favorisent le départ à l'étranger. La planification des ressources humaines est appelée à devenir de plus en plus importante, étant donné la pénurie annoncée de personnel infirmier et les modifications apportées à l'autorisation d'exercer au Canada, lesquelles sont susceptibles d'avoir une influence sur la migration des effectifs.
RESUMO
OBJECTIVES: The World Health Organization emphasises the need for cost-effective alternative methods to lower blood pressure (BP). Endorsed nationally in HTN guidelines, isometric handgrip (IHG) training is an alternative method of BP control. The purpose of this study was to compare the BP, heart rate (HR) and rates of perceived exertion (RPE) responses between a bout of IHG training performed using the traditional computerized device and a more affordable, inflatable stress ball. METHODS: Twenty healthy adults performed one bout (4, 2-min isometric contractions, with 1-min rests between each contraction at 30% maximal voluntary contraction) of IHG training using the traditional computerized device, and one bout with the inflatable stress ball. BP, HR, and RPE were recorded. RESULTS: No statistically significant differences between devices were observed with HR, BP, and RPE (p < 0.05). However, average RPE for both devices ranged between 5 and 6 indicating that participants were rating 30% of their MVC, consistent with previous work. DISCUSSION: The similar cardiovascular and psychophysical responses provide support for the potential use of this low individual- and provider-burden, cost-efficient IHG device, and lay the foundation for a future training study to test the hypothesis of benefit.
Assuntos
Força da Mão , Hipertensão , Adulto , Humanos , Pressão Sanguínea/fisiologia , Força da Mão/fisiologia , Análise Custo-Benefício , Contração Isométrica/fisiologiaRESUMO
PURPOSE: There has been an increase in research on the effect that virtual reality (VR) can have on physical rehabilitation following stroke. However, research exploring participant perceptions of VR for post-stroke rehabilitation has been limited. METHOD: Semi-structured interviews were conducted with 10 chronic stroke participants (10 males, mean age = 72.1, mean time since injury = 38.6 mos.) who had recently completed an upper extremity VR stroke rehabilitation programme. RESULTS: Four main themes emerged: 'the VR experience,' 'functional outcomes,' 'instruction,' and the 'future of VR in stroke rehabilitation,' along with nine sub-themes. Participants illustrated the positive impact that VR training had on their functional abilities as well as their confidence towards completing activities of daily living (ADL). Participants also expressed the need for increased rehabilitation opportunities within the community. CONCLUSION: Overall, participants were optimistic about their experience with VR training and all reported that they had perceived functional gain. VR is an enjoyable rehabilitation tool that can increase a stroke survivor's confidence towards completing ADL. Implications for Rehabilitation Although there is an increase in rehabilitation programmes geared towards those with chronic stroke, we must also consider the participants' perception of those programmes. Incorporating participant feedback may increase enjoyment and adherence to the rehabilitation programmes. The VR experience, as well as provision of feedback and instruction, are important aspects to consider when developing a VR programme for stroke survivors. VR for rehabilitation may be a feasible tool for increasing the survivors' confidence in completing ADL post-stroke.
Assuntos
Atividades Cotidianas , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/fisiopatologia , Jogos de Vídeo , Realidade Virtual , Idoso , Idoso de 80 Anos ou mais , Canadá , Doença Crônica , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Sobreviventes , Resultado do Tratamento , Extremidade Superior/fisiopatologiaRESUMO
PURPOSE: The purpose of this study was to investigate the effectiveness of commercial gaming as an intervention for fine motor recovery in chronic stroke. METHODS: Ten chronic phase post-stroke participants (mean time since CVA = 39 mos; mean age = 72 yrs) completed a 16-session program using the Nintendo Wii for 15 min two times per week with their more affected hand (10 right handed). Functional recovery (Jebsen Hand Function Test (JHFT), Box and Block Test (BBT), Nine Hole Peg Test (NHPT)), and quality of life (QOL; Stroke Impact Scale (SIS)) were measured at baseline (pre-testing), after 8 sessions (mid-testing) and after 16 sessions (post-testing). RESULTS: Significant improvements were found with the JHFT, BBT and NHPT from pre-testing to post-testing (p = 0.03, p = 0.03, p = 0.01, respectively). As well, there was an increase in perceived QOL from pre-testing to post-testing, as determined by the SIS (p = 0.009). CONCLUSION: Commercial gaming may be a viable resource for those with chronic stroke. Future research should examine the feasibility of this as a rehabilitation tool for this population. IMPLICATIONS FOR REHABILITATION: Stroke survivors often live with lasting effects from their injury, however, those with chronic stroke generally receive little to no rehabilitation due to a perceived motor recovery plateau. Virtual reality in the form of commercial gaming is a novel and motivating way for clients to complete rehabilitation. The Nintendo Wii may be a feasible device to improve both functional ability and perceived quality of life in chronic stroke survivors.
Assuntos
Desempenho Psicomotor , Qualidade de Vida , Reabilitação do Acidente Vascular Cerebral , Extremidade Superior/fisiopatologia , Jogos de Vídeo , Atividades Cotidianas , Adulto , Idoso , Doença Crônica , Feminino , Humanos , Masculino , Destreza Motora , Desempenho Psicomotor/fisiologia , Recuperação de Função Fisiológica , Características de Residência , Acidente Vascular Cerebral/psicologia , Resultado do Tratamento , Interface Usuário-ComputadorRESUMO
OBJECTIVES: Pain is a symptom reported in 50% to 70% of primary care visits and negatively impacts both physical and psychological functioning. People at risk of receiving inadequate management of pain include the indigent and people of color. The purpose of this exploratory, descriptive, cross-sectional study was to describe the prevalence of pain and its relation to functional status, depressive symptoms, perception of control over pain and coping in an urban, primary care clinic for indigent adults. METHODS: Individuals (N=301) attending a primary care clinic for indigent adults were surveyed. Patients were 22 to 64 years of age, experienced pain during the past 2 weeks, and were able to understand and respond in English. RESULTS: Ninety-two percent of the sample was African American and the average worst pain score was 8.4/10. The majority of patients had depression symptoms (77%), with pain most affecting patients' function with sleep, ability to work, and walking. Patients reporting higher pain scores had significantly lower perception of control over pain and reduced control over life in general. Higher reported pain levels were also significantly correlated with higher catastrophizing, depressive symptoms, and interference with function scores. DISCUSSION: Pain levels were reported as high and affected psychological and physical functioning. This study was unique in the high percentage of African American participants and being conducted in a primary care clinic for indigent adults. Greater understanding of this population's pain will assist clinicians to assess pain comprehensively, provide education, and make treatment decisions for these patients.
Assuntos
Catastrofização/etnologia , Catastrofização/psicologia , Depressão/etnologia , Depressão/psicologia , Dor/etnologia , Dor/psicologia , Pobreza/etnologia , Adulto , Negro ou Afro-Americano/estatística & dados numéricos , Distribuição por Idade , Comorbidade , Estudos Transversais , Feminino , Humanos , Masculino , Michigan , Pessoa de Meia-Idade , Prevalência , Atenção Primária à Saúde/estatística & dados numéricos , Psicologia , Fatores de Risco , Distribuição por SexoRESUMO
An evidence-based study examined the effectiveness of 2 solutions, heparin and normal saline, when used to flush capped pediatric peripheral intravenous (CPP IV) catheters. This experimental study assessed patency, redness, swelling, clotting, bruising, leakage, and patient pain after each intervention/flush. Study participants included 62 children (32 heparin and 30 normal saline) who had CPP IV catheters using 20-, 22-, or 24-gauge catheters. No statistically significant differences were found in IV catheter patency between children in the normal saline group and children in the heparin group. A postimplementation follow-up study with 30 patients who received normal saline only as a flush experienced no patency issues.