How PrEP delivery was integrated into public ART clinics in central Uganda: A qualitative analysis of implementation processes.

Tailored delivery strategies are important for optimizing the benefit and overall reach of PrEP in sub-Saharan Africa. An integrated approach of delivering time-limited PrEP in combination with ART to serodifferent couples encourages PrEP use in the HIV-negative partner as a bridge to sustained ART use. Although PrEP has been delivered in ART clinics for many years, the processes involved in integrating PrEP into ART services are not well understood. The Partners PrEP Program was a stepped-wedge cluster randomized trial of integrated PrEP and ART delivery for HIV serodifferent couples in 12 public health facilities in central Uganda (Clinicaltrials.gov NCT03586128). Using qualitative data, we identified and characterized key implementation processes that explain how PrEP delivery was integrated into existing ART services in the Partners PrEP Program. In-depth interviews were conducted with a purposefully-selected sub-sample of 83 members of 42 participating serodifferent couples, and with 36 health care providers implementing integrated delivery. High quality training, technical supervision, and teamwork were identified as key processes supporting providers to implement PrEP delivery. Interest in the PrEP program was promoted through the numerous ways health care providers made integrated ART and PrEP meaningful for serodifferent couples, including tailored counseling messages, efforts to build confidence in integrated delivery, and strategies to create demand for PrEP. Couples in the qualitative sample responded positively to providers' efforts to promote the integrated strategy. HIV-negative partners initiated PrEP to preserve their relationships, which inspired their partners living with HIV to recommit to ART adherence. Lack of disclosure among couples and poor retention on PrEP were identified as barriers to implementation of the PrEP program. A greater emphasis on understanding the meaning of PrEP for users and its contribution to implementation promises to strengthen future research on PrEP scale up in sub-Saharan Africa.

Behavioral Modeling and its Association with PrEP and ART Use in Ugandan HIV-Serodifferent Couples.

Integrating Pre-Exposure Prophylaxis (PrEP) delivery into Antiretroviral Therapy (ART) programs bridges the Human Immunodeficiency Virus (HIV) prevention gap for HIV-serodifferent couples prior to the partner living with HIV achieving viral suppression. Behavioral modeling is one mechanism that could explain health-related behavior among couples, including those using antiretroviral medications, but few tools exist to measure the extent to which behavior is modeled. Using a longitudinal observational design nested within a cluster randomized trial, this study examined the factor structure and assessed the internal consistency of a novel 24-item, four-point Likert-type scale to measure behavioral modeling and the association of behavioral modeling with medication-taking behaviors among heterosexual, cis-gender HIV-serodifferent couples. In 149 couples enrolled for research, a five-factor model provided the best statistical and conceptual fit, including attention to partner behavior, collective action, role modeling, motivation, and relationship quality. Behavioral modeling was associated with medication-taking behaviors among members of serodifferent couples. Partner modeling of ART/PrEP taking could be an important target for assessment and intervention in HIV prevention programs for HIV serodifferent couples.

Intimate Partner Violence and Adherence to PrEP and ART Among Ugandan HIV Serodifferent Couples.

BACKGROUND: Intimate partner violence (IPV) is associated with increased risk of HIV acquisition and reduced engagement in HIV care. There is limited understanding of the ways in which IPV exposure and other maladaptive relationship dynamics may influence adherence to antiretroviral treatment (ART) and pre-exposure prophylaxis (PrEP) for individuals in committed, HIV serodifferent partnerships. METHODS: We used binomial generalized linear mixed-effect regression models to evaluate the association between IPV exposure and ART/PrEP adherence among members of serodifferent couples in Uganda. Secondarily, we assessed the association between relationship powerlessness and ART/PrEP adherence. RESULTS: We enrolled and followed both partners in 149 heterosexual serodifferent couples. The partner living with HIV was female in 64% of couples. IPV exposure was associated with low ART adherence (15% vs. 5% in quarters with no IPV, odds ratio: 4.78, 95% confidence interval: 1.48 to 15.42), but not low PrEP adherence (33% vs. 36%, P = 0.69). Among HIV-negative individuals, those reporting moderate relationship powerlessness were less likely to have poor PrEP adherence compared with those with low relationship powerlessness (20% vs. 30%, odds ratio: 0.57, 95% confidence interval: 0.36 to 0.90). We observed no association between relationship powerlessness and ART adherence. CONCLUSIONS: We found that IPV exposure was associated with low adherence to ART and that relationship powerlessness was associated with good adherence to PrEP. These findings contribute to the evidence base outlining the influence of IPV and relationship power on ART/PrEP adherence for individuals in HIV serodifferent unions.

"Gender-based Violence (GBV) and HIV, they are like sister and brother": barriers and facilitators to GBV screening and referral in public HIV treatment settings in Uganda.

BACKGROUND: People living with HIV are vulnerable to gender-based violence (GBV), which can negatively impact HIV treatment outcomes. National guidelines in Uganda recommend GBV screening alongside HIV treatment services. We explored barriers and facilitators to providers implementing GBV screening and referral in public antiretroviral therapy (ART) clinics in Uganda. METHODS: We conducted qualitative in-depth interviews. Providers were purposively sampled from 12 ART clinics to represent variation in clinical specialty and gender. We used the Theoretical Domains Framework to structure our deductive analysis. RESULTS: We conducted 30 in-depth interviews with providers implementing GBV screening and/or referral. Respondents had a median age of 36 (IQR: 30, 43) years and had been offering post-GBV care to clients for a median duration of 5 (4, 7) years. 67% of respondents identified as female and 57% were counselors. Facilitators of GBV screening and referral included providers having access to post-GBV standard operating procedures and screening tools, trainings offered by the Ministry of Health, facility-sponsored continuing medical education units and support from colleagues. Respondents indicated that referrals were uncommon, citing the following barriers: negative expectations regarding the quality and quantity of referral services; lack of financial resources to support clients, facilities, and referral partners throughout the referral process; and sociocultural factors that threatened client willingness to pursue post-GBV support services. CONCLUSIONS: Findings from this evaluation support the refinement of GBV screening and referral implementation strategies that leverage facilitators and address barriers to better support individuals living with HIV and who may have heightened vulnerability to GBV.

How Central Ugandan HIV Clinics Adapted During COVID-19 Lockdown Restrictions to Promote Continuous Access to Care: A Qualitative Analysis.

We used qualitative data from the Partners PrEP Program (PPP) to address the question: How did Central Ugandan HIV clinics adapt to COVID-19 lockdown restrictions to promote continuous access to HIV care? PPP was a stepped-wedge cluster randomized trial of integrated PrEP and ART delivery for HIV serodifferent couples at Central Ugandan HIV clinics (NCT03586128). Individual interviews with purposefully selected PPP couples (N = 42) and clinicians, coordinators, and counselors providing HIV care (N = 36) were carried out. Sixty-four interviews were completed after lockdown and included questions about accessing and providing ART/PrEP refills during lockdown restrictions. We used an inductive, content-focused approach to analyze these interview data. Barriers to continuous access identified by interviewees included loss of income with increased cost of transport, reduced staff at clinics, and physical distancing at clinics. Interviewees pointed to multi-month refills, visits to clinics "close to home," transport to clinics for providers, and delivery of refills in neighborhoods as factors promoting continuous access to antiretroviral medications. Access barriers appeared somewhat different for ART and PrEP. Fewer resources for community delivery and pre-refill HIV testing requirements were identified as PrEP-specific access challenges. Participants emphasized their success in continuing ART/PrEP adherence during the lockdown, while providers emphasized missed refill visits. These results highlight the contributions of providers and ART/PrEP users to adaptation of HIV services during COVID-19 lockdown restrictions in Uganda. The roles of direct care providers and service users as drivers of adaptation should be recognized in future efforts to conceptualize and investigate health system resiliency.

The cost of implementing the Systems Analysis and Improvement Approach for a cluster randomized trial integrating HIV testing into family planning services in Mombasa County, Kenya.

BACKGROUND: Although HIV testing in family planning (FP) clinics is a promising approach for engaging women in HIV treatment and prevention services, HIV testing rates are low in FP clinics in Kenya. In 2018, a cluster randomized trial was implemented in Mombasa, Kenya applying the Systems Analysis and Improvement Approach (SAIA) to integrate HIV testing into FP services (1K24HD088229-01). We estimated the incremental costs and explored cost drivers of the FP HIV SAIA implementation in Mombasa, Kenya. METHODS: We conducted a costing evaluation from the payer perspective for the FP HIV SAIA randomized control trial. We identified relevant activities for the intervention including start-up, training, research and FP HIV SAIA. We estimated activity time burden using a time-and motion study. We derived unit costs through staff interviews and programmatic budgets. We present cost estimates for two different scenarios: as-implemented including research and projected costs for a Ministry of Health-supported intervention. All costs are reported in 2018 USD. RESULTS: For an annual program output of 36,086 HIV tests administered to new FP clients, we estimated the total annual program cost to be $91,994 with an average cost per new FP client served of $2.55. Personnel and HIV rapid testing kits comprised 55% and 21% of programmatic costs, respectively. Assuming no changes to program outputs and with efficiency gains under the MOH scenario, the estimated cost per new FP client served decreased to $1.30 with a programmatic cost reduction of 49%. CONCLUSION: FP HIV SAIA is a low-cost and flexible implementation strategy for facilitating integrated delivery of HIV testing alongside FP services. Although cost implications of the FP HIV SAIA intervention must continue to be evaluated over time, these findings provide context-specific cost data useful for budget planning and decision-making regarding intervention delivery and expansion. TRIAL REGISTRATION: The trial was registered on December 15, 2016, with clinicaltrials.gov (NCT02994355).

PrEP uptake and HIV viral suppression when PrEP is integrated into Ugandan ART clinics for HIV-negative members of HIV-serodifferent couples: A stepped wedge cluster randomized trial.

Background: Global scale-up of HIV pre-exposure prophylaxis (PrEP) includes services to HIV-negative people in partnerships with people living with HIV (serodifferent couples). Data are needed on HIV outcomes, including uptake and adherence to PrEP and antiretroviral treatment (ART), to describe the impact of integrating PrEP into an existing HIV program. Methods: Using a stepped-wedge cluster randomized trial design, we launched PrEP delivery for HIV-negative members of serodifferent couples in Uganda by integrating PrEP into existing ART programs for people living with HIV. The program provided PrEP training for ART providers, ongoing technical assistance, and a provisional supply chain mechanism for PrEP medication. Primary data on PrEP initiation, PrEP refills, ART initiation, and HIV viremia at 6 months (measured at 42-270 days) were collected through data abstraction of medical records from HIV-serodifferent couples sequentially enrolling at the ART clinics. Modified Poisson regression models, controlling for time and cluster, compared viral suppression (<1000 copies/ml) before and after launch of the PrEP program. This trial was registered at ClinicalTrials.gov, NCT03586128. Findings: From June 1, 2018-December 15, 2020, 1,381 HIV-serodifferent couples were enrolled across 12 ART clinics in Kampala and Wakiso, Uganda, including 730 enrolled before and 651 after the launch of PrEP delivery. During the baseline period, 99.4% of partners living with HIV initiated ART and 85.0% were virally suppressed at 6 months. Among HIV-negative partners enrolled after PrEP launched, 81.0% (527/651) initiated PrEP within 90 days of enrolling; among these 527, 11.2% sought a refill 6 months later. In our powered intent-to-treat analysis, 82.1% and 76.7% of partners living with HIV were virally suppressed, respectively, which was not a statistically significant difference (RR=0.94, 95% CI: 0.82-1.07) and was stable across sensitivity analyses. Interpretation: Integration of PrEP into ART clinics reached a high proportion of people in HIV-serodifferent relationships and did not improve the already high frequency of HIV viral suppression among partners living with HIV. Funding: National Institute of Mental Health (R01MH110296).

A pragmatic approach to identifying implementation barriers and facilitators for a novel pre-exposure prophylaxis (PrEP) delivery model at public facilities in urban Uganda.

BACKGROUND: Scalable HIV pre-exposure prophylaxis (PrEP) delivery models for resource-limited settings are critical for improving PrEP coverage and interrupting HIV transmission. This research uses technical assistance (TA) reports to evaluate implementation barriers and facilitators for a novel delivery model integrating PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples in public health facilities in Kampala, Uganda. METHODS: We used data from the Partners PrEP Program (PPP)-a stepped-wedge cluster randomized trial that is launching PrEP delivery through an integrated model of oral PrEP and antiretroviral therapy (ART) delivery for HIV sero-different couples at public health facilities in Kampala and Wakiso, Uganda (NCT03586128). Technical assistance teams, comprised of PPP program staff, conducted monthly TA visits to implementing facilities where they identified and addressed implementation challenges in collaboration with health facility staff. Findings were recorded in TA reports, a standardized form structured using the Consolidated Framework for Implementation Research (CFIR). We used a conceptual content analysis approach to evaluate TA reports completed from January to December 2019 and identify implementation barriers and facilitators. RESULTS: Among 39 reports from the 8 implementing facilities (~ 5 per facility), we identified 11 CFIR constructs. Key implementation facilitators included sensitizing and educating facility staff about PrEP (knowledge and beliefs about the innovation); establishing formal and informal feedback and accountability mechanisms (reflecting and evaluating); and empowering facility staff to address implementation challenges (self-efficacy). Key implementation barriers were related to ineffective recruitment and referral of sero-different couples to and from nearby facilities (cosmopolitanism) as well as stockouts of laboratory resources and testing supplies (available resources). CONCLUSIONS: This analysis featured a robust implementation science framework to assess the relationship between early implementation determinants and outcomes of this innovative PrEP delivery model. Further, we have provided important descriptions of early implementation barriers and facilitators that will inform scale-up efforts for PrEP delivery within and beyond Uganda. Future work will refine the analysis of pragmatic program data, qualitatively investigate the identified key themes, and explore strategies for addressing implementation barriers.

Optimized supply chain model reduces health system costs in DRC.

OBJECTIVE: In 2017, an optimized immunization supply chain (iSC) model was implemented in Equateur Province, Democratic Republic of the Congo. The optimized model aimed to address iSC challenges and featured direct deliveries to service delivery points (SDPs), longer replenishment intervals and increased cold chain capacity. This assessment examines iSC costs before and 5 months after implementing the optimized model. MATERIALS & METHODS: We used a nonexperimental pre-post study design to compare iSC costs before and after implementation. We applied an activity-based costing approach with a comparison arm to assess procurement, management, storage and transportation costs for three iSC tiers: Province (n = 1); Zone (n = 4) and SDP (n = 15). We included data from 3 treatment Zones and 11 treatment SDPs; 1 control Zone and 4 control SDPs. We used sample and population data to estimate iSC costs for the entirety of Equateur Province. RESULTS: In the period immediately before implementing the optimized model, estimated annual iSC costs were $974,237. Following implementation, estimated annual iSC costs were $642,627-a 34% ($331,610) reduction. This change in costs was influenced by a 43% ($180,313) reduction in SDP costs, a 67% ($198,092) reduction in Zonal costs and an 18% ($46,795) increase in Provincial costs. After implementing the optimized model, average iSC costs for treatment Zones was $6,895 (SD: $6,072); for the control Zone was $21,738; for treatment SDPs was $989 (SD: $969); and for control SDPs was $1,356 (SD: $1,062). CONCLUSIONS: We observed an absolute reduction in iSC costs in treatment Zones while control Zone post-implementation iSC costs remained the same or increased. The greatest cost reductions were for storage and transport at Zones and SDPs. Although cost implications of this model must continue to be evaluated over time, these findings are promising and will inform decisions around project expansion.

HIV risk and pre-exposure prophylaxis interest among women seeking post-abortion care in Kenya: a cross-sectional study.

INTRODUCTION: Post-abortion clinics located in regions with high HIV burden may ideal locations to integrate counselling and delivery of HIV pre-exposure prophylaxis (PrEP), aligning with normative goals for integrated delivery of HIV and reproductive health care. The objective of this study was to gauge the degree to which Kenyan women seeking care for a pregnancy loss, including induced abortion, are at risk for HIV and whether women would welcome an introduction to PrEP prior to discharge from post-abortion care. METHODS: We conducted a mixed-methods study from August 2019 to February 2020 with women ages 15 to 30 recruited sequentially as they were accessing post-abortion care at public and private facilities in Thika and Kisumu, Kenya. Data collection was through a cross-sectional survey and laboratory testing for common sexually transmitted infections (N = 200), and in-depth interviews (N = 30). Descriptive statistics summarize PrEP knowledge and referrals and a multivariable log-link binomial model estimated correlates of receiving a referral for PrEP. Qualitative data were analysed using inductive and deductive approaches. RESULTS: Among 200 HIV-negative women (median age 21.0, interquartile range 19.0 to 22.0), the prevalence of Chlamydia trachomatis was 18.2% and Neisseria gonorrhoeae was 2.0%. Half of the women scored ≥5 on a validated tool that would correspond to an expected HIV incidence of 9.5% per year. Approximately half (55.8%) of women were familiar with PrEP prior to the study and 33.3% received a referral from study staff to a clinic offering PrEP. In qualitative interviews, women expressed interest in accessing PrEP from the gynaecology ward that provided post-abortion care but they preferred alternative locations for PrEP refills. CONCLUSIONS: Kenyan women accessing post-abortion care have substantial HIV risk and were favourable about the idea of receiving support to initiate PrEP as part of care offered during post-abortion care. These settings can be integrated into national PrEP programmes as locations providing PrEP referrals and initiation.

A Rapid Cost Modeling Tool for Evaluating and Improving Public Health Supply Chain Designs.

Effective and efficient health supply chains play a vital role in achieving health outcomes by ensuring supplies are available for people to access quality health services. However, supplying health commodities to service delivery points is complex and costly in many low- and middle-income countries. Thus, governments and partner organizations are often interested in understanding how to design their health supply chains more cost efficiently.Several modeling tools exist in the public and private market that can help assess supply chain efficiency and identify supply chain design improvements. These tools are generally capable of providing users with very precise cost estimates, but they often use proprietary software and require detailed data inputs. This can result in a somewhat lengthy and expensive analysis process, which may be prohibitive for many decision makers, especially in the early stages of a supply chain design process. For many use cases, such as advocacy, informing workshop and technical meetings, and narrowing down initial design options, decision makers may often be willing to trade some detail and accuracy in exchange for quicker and lower-cost analysis results. To our knowledge, there are no publicly available tools focused on generating quick, high-level estimates of the cost and efficiency of different supply chain designs.To address this gap, we designed and tested an Excel-based Rapid Supply Chain Modeling (RSCM) Tool. Our assessment indicated that, despite requiring significantly less data, the RSCM Tool can generate cost estimates that are similar to other common analysis and modeling methods. Furthermore, to better understand how the RSCM Tool aligns with real-world processes and decision-making timelines, we used it to inform an ongoing immunization supply chain redesign in Angola. For the use cases described above we believe that the RSCM Tool addresses an important need for quicker and less expensive ways to identify more cost-efficient supply chain designs.

Management of Patients With Glomerulonephritis During the COVID-19 Pandemic: Recommendations From the Canadian Society of Nephrology COVID-19 Rapid Response Team.

PURPOSE OF PROGRAM: This article will provide guidance on how to best manage patients with glomerulonephritis (GN) during the COVID-19 pandemic. SOURCES OF INFORMATION: We reviewed relevant published literature, program-specific documents, and guidance documents from international societies. An informal survey of Canadian nephrologists was conducted to identify practice patterns and expert opinions. We hosted a national webinar with invited input and feedback after webinar. METHODS: The Canadian Society of Nephrology (CSN) Board of Directors invited physicians with expertise in GN to contribute. Specific COVID-19-related themes in GN were identified, and consensus-based recommendations were made by this group of nephrologists. The recommendations received further peer input and review by Canadian nephrologists via a CSN-sponsored webinar. This was attended by 150 kidney health care professionals. The final consensus recommendations also incorporated review by Editors of the Canadian Journal of Kidney Health and Disease. KEY FINDINGS: We identified 9 areas of GN management that may be affected by the COVID-19 pandemic: (1) clinic visit scheduling, (2) clinic visit type, (3) provision of multidisciplinary care, (4) blood and urine testing, (5) home-based monitoring essentials, (6) immunosuppression, (7) other medications, (8) patient education and support, and (9) employment. LIMITATIONS: These recommendations are expert opinion, and are subject to the biases associated with this level of evidence. To expedite the publication of this work, a parallel review process was created that may not be as robust as standard arm's length peer review processes. IMPLICATIONS: These recommendations are intended to provide optimal care during the COVID-19 pandemic. Our recommendations may change based on the evolving evidence.

A Retrospective Study of Chronic Kidney Disease Burden in Saskatchewan's First Nations People.

BACKGROUND: Chronic kidney disease is more prevalent among First Nations people than in non-First Nations people. Emerging research suggests that First Nations people are subject to greater disease burden than non-First Nations people. OBJECTIVE: We aimed to identify the severity of chronic kidney disease and quantify the geographical challenges of obtaining kidney care by Saskatchewan's First Nations people. DESIGN: This study is a retrospective analysis of the provincial electronic medical record clinical database from January 2012 to December 2013. SETTING: The setting involved patients followed by the Saskatchewan provincial chronic kidney care program, run out of two clinics, one in Regina, SK, and one in Saskatoon, SK. PATIENTS: The patients included 2478 individuals (379 First Nations and 2099 non-First Nations) who were older than 18 years old, resident in Saskatchewan, and followed by the provincial chronic kidney care program. First Nations individuals were identified by their Indigenous and Northern Affairs Canada (INAC) Number. MEASUREMENTS: The demographics, prevalence, cause of end-stage renal disease, severity of chronic kidney disease, use of home-based therapies, and distance traveled for care among patients are reported. METHODS: Data were extracted from the clinical database used for direct patient care (the provincial electronic medical record database for the chronic kidney care program), which is prospectively managed by the health care staff. Actual distance traveled by road for each patient was estimated by a Geographic Information System Analyst in the First Nations and Inuit Health Branch of Health Canada. RESULTS: Compared with non-First Nations, First Nations demonstrate a higher proportion of end-stage renal disease (First Nations = 33.0% vs non-First Nations = 21.4%, P < .001), earlier onset of chronic kidney disease (MFN = 56.4 years, SD = 15.1; MNFN = 70.6 years, SD = 14.7, P < .001), and higher rates of end-stage renal disease secondary to type 2 diabetes (First Nations = 66.1% vs non-First Nations = 39.0%, P < .001). First Nations people are also more likely to be on dialysis (First Nations = 69.7% vs non-First Nations = 40.2%, P < .001), use home-based therapies less frequently (First Nations = 16.2% vs non-First Nations = 25.7%; P = 003), and must travel farther for treatment (P < .001), with First Nations being more likely than non-First Nations to have to travel greater than 200 km. LIMITATIONS: Patients who are followed by their primary care provider or solely through their nephrologist's office for their chronic kidney disease would not be included in this study. Patients who self-identify as Aboriginal or Indigenous without an INAC number would not be captured in the First Nations cohort. CONCLUSIONS: In Saskatchewan, First Nations' burden of chronic kidney disease reveals higher severity, utilization of fewer home-based therapies, and longer travel distances than their non-First Nations counterparts. More research is required to identify innovative solutions within First Nations partnering communities.

CONTEXTE: La prévalence de l'insuffisance rénale chronique (IRC) est plus élevée chez les autochtones (AUT) que chez les allochtones (ALL); de nouvelles études indiquent que les Premières Nations seraient davantage affligés que les allochtones par le fardeau de la maladie. OBJECTIFS: Notre objectif était bipartite : i) mesurer la gravité de l'IRC chez les autochtones et; ii) quantifier le défi géographique posé par la distance que les Saskatchewanais autochtones ont à parcourir pour obtenir des soins de santé rénale. TYPE D'ÉTUDE: L'étude est une analyse rétrospective de la base de données provinciale des dossiers médicaux informatisés pour la période s'échelonnant de janvier 2012 à décembre 2013. CADRE: L'étude concerne les patients suivis dans deux cliniques saskatchewanaises (une à Régina et une autre à Saskatoon) participant au programme provincial de soins des maladies rénales chroniques. SUJETS: L'étude porte sur 2 478 patients adultes (379 autochtones et 2 099 allochtones) résidents de la Saskatchewan et suivis par le programme provincial de soins des maladies rénales chroniques. Les membres des Premières Nations ont été identifiés par leur numéro de Certificat de statut Indien (CSI) émis par le ministère des Affaires Autochtones et du Nord Canada (AADNC*). MESURES: Ont été colligées les données démographiques des patients, la prévalence de la maladie, les causes de l'insuffisance rénale terminale (IRT), la gravité de l'atteinte, le recours ou non à des traitements à domicile, et la distance à parcourir pour obtenir des soins. MÉTHODOLOGIE: Les données ont été extraites de la base de données cliniques utilisée pour les soins directs aux patients (dossiers médicaux informatisés du programme de soin des maladies rénales chroniques), gérée prospectivement par le personnel soignant. La distance parcourue par le patient pour obtenir des soins a été estimée par un analyste du système d'informations géographiques de la Direction générale de la santé des Premières Nations et des Inuits, de Santé Canada. RÉSULTATS: Comparativement aux patients allochtones, les patients autochtones : présentaient une plus grande prévalence d'IRT (33,0 % vs 21,4 %; p < 0,001); présentaient un déclenchement plus précoce de la maladie (âge moyenAUT : 56,4 ans [SD=15,1]; âge moyenALL : 70,6 ans [SD=14,7]; p < 0,001) et un taux plus élevé d'IRT consécutive à un diabète de type 2 (66,1 % vs 39,0 %; p < 0,001); étaient plus susceptibles d'être dialysés (69,7 % vs 40,2 %; p < 0,001); recouraient moins à des traitements à domicile (AUT : 16,2 %; ALL : 25,7 %; p = 0,003); et étaient contraints de se déplacer davantage pour suivre leurs traitements (p < 0,001) ­ notamment, les autochtones étaient plus susceptibles de devoir parcourir au-delà de 200 km pour obtenir des soins. LIMITES: Les patients qui recevaient leurs traitements chez leur fournisseur de soins primaires ou uniquement via le cabinet de leur néphrologue n'étaient pas inclus dans l'étude. Les patients s'identifiant comme autochtones, mais ne possédant pas de numéros de CSI, n'ont pu être répertoriés aux fins de l'étude. CONCLUSION: En Saskatchewan, le fardeau différentiel que représente l'IRC chez les gens issus des Premières Nations se traduit par une atteinte plus sévère, par un moindre recours aux traitements à domicile et par de plus grandes distances à parcourir pour obtenir des soins. Des recherches supplémentaires sont requises pour proposer des solutions innovantes aux communautés partenaires des Premières Nations.

Patient Reflections on Decision Making for Laryngeal Cancer Treatment.

Objective To describe the reflections of patients treated for laryngeal cancer with regard to treatment-related decision making. Study Design Cross-sectional survey-based pilot study. Setting Single-institution tertiary care cancer center. Subjects/Methods Adults with laryngeal carcinoma were eligible to participate (N = 57; 46% treated surgically, 54% nonsurgically). Validated surveys measuring decisional conflict and regret explored patients' reflections on their preferences and priorities regarding treatment-related decision making for laryngeal cancer and how patient-reported functional outcomes, professional referral patterns, and desired provider input influenced these reflections. Results When considering the level of involvement of surgeons, radiation oncologists, and medical oncologists in their care, patients were more likely to believe that the specialist whom they saw first was the most important factor in deciding how to treat their cancer (Fisher's exact, ~χ2 = 16.2, df = 6, P = .02). Patients who were treated for laryngeal cancer who reported worse voice-related quality of life recalled more decisional conflict ( P = .01) and experienced more decisional regret ( P < .001). Of the patients for whom speech was a top priority prior to treatment, better voice-related quality of life overall scores were correlated with less decision regret about treatment decisions ( P < .02). Of the patients for whom eating and drinking were top priorities prior to treatment, better MD Anderson Dysphagia Inventory global scores were correlated with less decision regret about treatment decisions ( P < .002). Conclusion Patient priorities and attitudes, coupled with functional outcomes and professional referral patterns, influence how patients reflect on their choices regarding management of laryngeal cancer. Better understanding of these variables may assist in ensuring that patients' voices are integrated into individualized laryngeal cancer treatment planning.

Level 7 disease does not confer worse outcome than level 6 disease in differentiated thyroid cancer.

BACKGROUND: Level 7 nodal disease increases patients from N1a to N1b in the American Joint Committee on Cancer (AJCC) TNM classification of differentiated thyroid cancers (DTCs). This results in upstaging of patients older than 45 years of age from stage III to IV. Our objective was to determine if patients with level 7 disease had poorer outcome in comparison to patients with isolated level 6 disease. METHODS: A total of 599 patients with DTC limited to the central neck (level 6 and 7) were identified from an institutional database. Patients with N1b disease due to lateral compartment (level 1-5) involvement or M1 disease were excluded. Fifty-seven patients had positive level 7 disease, and 542 patients had nodal disease limited to level 6. Disease-specific survival (DSS) and recurrence-free survival (RFS) were calculated for each group. RESULTS: Median age was 41 years (range 12-91) and follow-up was 61 months (range 1-330). There were no disease-specific deaths at 5 years. Among patients with level 6 disease at presentation, there were 42 nodal recurrences, and among patients with level 7 disease, there were two recurrences. There were no differences in overall RFS between patients with level 6 or 7 disease (5-year RFS 90.7 vs. 98.2 %, respectively; p = 0.096). CONCLUSIONS: Our results suggest that N1b disease due to level 7 disease does not confer worse DSS or RFS compared with patients with level 6 disease only. Classifying all central neck disease (levels 6 and 7) into the N1a category, and reserving the N1b classification only for patients with lateral neck disease may be more reflective of prognosis.

Comparable outcomes for patients with pT1a and pT1b differentiated thyroid cancer: Is there a need for change in the AJCC classification system?

INTRODUCTION: The current American Joint Committee on Cancer TNM classification for differentiated thyroid cancer (DTC) separates T1 status into T1a and T1b based on a 1-cm cutoff for maximal tumor dimension. In 2009, the American Thyroid Association recommended total thyroidectomy for tumors >1 cm in contrast to the possibility of lobectomy for tumors ≤ 1 cm. Our aim was to investigate the prognostic significance of a 1-cm tumor cutoff. METHODS: From an institutional database of 3,664 patients with DTC, 1,522 patients with T1 tumors without neck disease or distant metastases were identified. Patient, tumor, and treatment characteristics were compared. Disease-specific survival (DSS) and recurrence-free survival (RFS) outcomes were analyzed. RESULTS: Total thyroidectomy rates were similar between patients with T1a and T1b tumors (P = .307). With a median follow-up of 46 months (range, 1-320), there were no disease-specific deaths in the T1a or T1b groups. In total, 18 patients (1.2%) experienced a recurrence. Five-year RFS was comparable for patients with T1a and T1b tumors (98.6 vs 98.6%; P = .224). CONCLUSION: T1a and T1b tumors have similar prognosis both in terms of DSS and RFS. It seems that a distinction between tumors of <1 and >1 cm is of no prognostic benefit.

Central lymph node characteristics predictive of outcome in patients with differentiated thyroid cancer.

BACKGROUND: The aim of our study was to determine central compartment lymph node (LN) characteristics predictive of outcomes in patients with differentiated thyroid cancer (DTC) and pathologically confirmed positive central LNs, in the absence of lateral neck disease or distant metastases at presentation. METHODS: An institutional database of 3664 previously untreated patients with DTC operated between 1986 and 2010 was reviewed. Six hundred patients with central compartment nodal disease on histopathology were identified. Patient demographics, number of positive LNs, size of largest LN, and presence of extranodal spread (ENS) were recorded for each patient. Variables predictive of recurrence-free survival (RFS) were identified using the Kaplan-Meier method. Univariate analysis was carried out by the log-rank test and multivariable analysis was carried out using cox proportional hazard model. RESULTS: The median age of the cohort was 41 years (range 12-91 years). The median follow-up was 61 months (range 1-330 months). Neck recurrence occurred in 43 patients. Recurrence occurred in the central neck in 11 patients, lateral neck in 27 patients, and both compartments in five patients. Factors predictive of neck RFS on univariate analysis were higher T stage (p=0.007), increased number of positive LNs, increased LN diameter, and presence of ENS (p=0.001). Multivariable analysis of LN characteristics showed that the only statistically significant predictor of neck recurrence was the presence of ENS. Neck RFS at five years for patients with and without ENS was 84.7% and 94.5% respectively (p=0.001). CONCLUSION: The LN feature most predictive of neck recurrence appears to be the presence of ENS in the positive central neck.

Multi-organ distant metastases confer worse disease-specific survival in differentiated thyroid cancer.

BACKGROUND: Differentiated thyroid cancer (DTC) is usually associated with an excellent prognosis. With appropriate management of disease in the neck, death from thyroid cancer is more commonly related to the impact of distant metastases rather than locoregional recurrence. However, many patients with distant metastases can have very long periods of progression-free survival. The aims of this study were to determine the impact of single and multi-organ distant metastases (SODM and MODM) on survival, and identify factors that predict SODM progressing to MODM. METHODS: An institutional database of 3664 previously untreated patients with DTC who had surgery between 1986 and 2010 was reviewed. One hundred and twenty-five (3.4%) patients developed distant metastases, of whom 93 developed SODM and 32 MODM. Overall survival was determined for each group by the Kaplan-Meier method. Factors predictive of MODM were identified by univariate and multivariate analysis. Multi-organ recurrence-free survival (MORFS) is a measure of SODM progressing to MODM disease. MORFS was calculated from the time of first distant metastasis to the time of second organ involvement by distant metastases. RESULTS: The median age was 56 years (range 5-86 years). The median follow-up was 77 and 79 months (range 2-318 months) for the SODM and MODM groups respectively. SODM patients had five-year survival of 77.6% from the time of first distant metastasis, whereas MODM patients had a significantly poorer survival of just 15.3% from the time of second organ distant metastasis to death (p<0.001). The median time from first to second distant metastasis was 14.7 months (range 1-121 months). Seventy-one (57%) patients had M1 disease at presentation. Being aged ≥ 45 years (p = 0.05) and having an unstimulated serum thyroglobulin (Tg) level of ≥ 30 ng/mL at the time of diagnosis of initial distant metastasis (p<0.001) were univariate predictors of developing MODM. Controlling for age, an unstimulated serum Tg level of ≥ 30 ng/mL conferred a hazard ratio of 5.77 ([CI 2.13-15.64]; p = 0.001) for diagnosis of MODM. CONCLUSIONS: MODM are associated with a poorer survival compared to patients with SODM. A serum Tg level >30 ng/mL at the time of first distant metastases confers more than a fivefold risk of having MODM identified during follow-up.

Preoperative neck ultrasound in clinical node-negative differentiated thyroid cancer.

BACKGROUND: The impact of preoperative neck ultrasound (US) on management of the lateral neck in patients with differentiated thyroid cancer is unclear. The objective of this study was to assess the impact of preoperative neck US on the rate of lateral neck dissection in clinical N0 neck and initial response to therapy. METHODS: An institutional review board-approved retrospective review of 890 patients that had thyroid surgery for differentiated thyroid cancer between 2009 and 2010 was performed at our institution. Patients with palpable neck disease, distant metastases, less than total thyroidectomy, no postoperative thyroglobulin (Tg) determinations, and positive Tg antibodies were excluded, leaving 465 patients available for analysis. Patients were divided into those who had a preoperative neck US to evaluate lateral neck nodes (n = 234) and those who did not (n = 231). Patient and tumor characteristics were compared using the χ(2) test. The primary end point was response to therapy, defined by postoperative US and Tg levels. RESULTS: There were no significant differences in age, histology, T stage, postoperative radioactive iodine dose, American Joint Committee on Cancer stage, American Thyroid Association risk category, or duration of follow up between the 2 groups. Patients with preoperative neck US were more likely to have lateral neck dissection compared with patients without preoperative neck US [n = 31 (13.2%) vs n = 2 (0.9%); P < .001]. Preoperative neck US resulted in a better response to therapy (P = 0.005), a greater likelihood of no evidence of disease, and a smaller likelihood of having a biochemical or structural incomplete response or a return for delayed neck dissection. The preoperative US group also resulted in fewer recurrences; 10 patients from the no preoperative US group returned to the operating room compared with two patients (4.3% vs 0.9%, P = .018) who had a preoperative neck US. CONCLUSION: Preoperative neck US detects more lateral neck disease, leading to an increase in lateral neck dissection with subsequent improvement in response to therapy and fewer return to the operating room for regional recurrence management.