The development of a regional referral pathway for locally recurrent rectal cancer: A Delphi consensus study.

BACKGROUND: The management of patients with locally recurrent rectal cancer (LRRC) is often complex and requires multidisciplinary input whereas only few patients are referred to a specialist centre. The aim of this study was to design a regional referral pathway for LRRC, in Nouvelle Aquitaine (South-West, France). METHODS: In 2016, we conducted with a Study Steering Committee (SC) a three phase mixed-methods study including identification of key factors, identification of key stakeholders and Delphi voting consensus. During three rounds of Delphi voting, a consensus was defined as favorable, if at least 80% of participating experts rate the factor, below or equal to 3/10 using a Likert scale, or consider it as "useful" using a binary scale (third round only). Finally, the SC drafted guidelines. RESULTS: Among the 423 physicians involved in 29 regional digestive Multi-Disciplinary Team (MDT) meeting, 59 participants (from 26 MDT meeting) completed all three rounds of Delphi voting. Thirteen out of twenty initially selected factors reached a favorable consensus. All patients with a LRRC need to be included into a referral pathway. Patients with a central pelvic recurrence offered curative treatment in their local hospital and patients with unresectable metastatic disease were excluded of the referral. Key performance indicators were also agreed including the time to referral and completion of pelvic MRI-, CT-, PET-scan prior to MDT referral. CONCLUSION: The development of this referral pathway represents an innovative health service, which will improve the management of patients with LRRC in France.

A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm.

BACKGROUND: Patients with gastrointestinal (GI) cancer are exposed to cachexia, which is highly correlated with chemotherapy-induced side effects. Research suggests that specific immunonutrients could prevent such toxicities. AIMS: The primary objective of this phase III study was to evaluate the efficacy of glutamine and transforming growth factor-ß2 (TGF-ß2) in the prevention of grade 3-4 non-hematological toxicities induced by chemotherapy in patients with GI cancer. PATIENTS AND METHODS: We designed a double-blind, randomized, controlled and multicenter trial stratified according to center, type of chemotherapy, presence of cachexia, and age. Patients were randomized to receive either Clinutren Protect(®) (CP) or a control isocaloric diet (without TGF-ß2 or glutamine). RESULTS: Between November 2007 and October 2011, 210 patients were enrolled in the study, of which 201 were included in the intention-to-treat analysis. Grade 3-4 non-hematological toxicities were not significantly different between the CP and control groups when evaluated by univariate and multivariate analyses. Likewise, no difference was observed regarding grade 3-4 hematological toxicities or reasons for treatment interruption. CONCLUSION: This randomized study does not support the hypothesis that oral glutamine and TGF-ß2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.

Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island.

BACKGROUND: Self-management education programs can reduce the complications and mortality in type 2 diabetes. The need to structure these programs for outpatient and community care with a vision for long-term maintenance has been recognised. In Reunion Island, an area affected by epidemiological and nutritional transition, diabetes affects 18% of the adult population over 30 years, with major social disparities, poor glycaemic control and frequent cardiovascular complications. METHODS/DESIGN: ERMIES is a randomised controlled trial designed to test the efficacy of a long-term (2 years) structured group self management educational intervention in improving blood glucose in non-recent, insufficiently controlled diabetes. After an initial structured educational cycle carried out blind for the intervention arm, patients will be randomised in two parallel group arms of 120 subjects: structured on-going group with educational intervention maintained over two years, versus only initial education. Education sessions are organised through a regional diabetes management network, and performed by trained registered nurses at close quarters. The educational approach is theoretically based (socio-constructivism, social contextualisation, empowerment, action planning) and reproducible, thanks to curricula and handouts for educators and learners. The subjects will be recruited from five hospital outpatient settings all over Reunion Island. The main eligibility criteria include: age ≥18 years, type 2 diabetes treated for more than one year, HbA1c ≥ 7.5% for ≥3 months, without any severe evolving complication (ischaemic or proliferative retinopathy, severe renal insufficiency, coronaropathy or evolving foot lesion), and absence of any major physical or cognitive handicap. The primary outcome measure is HbA1c evolution between inclusion and 2 years. The secondary outcome measures include anthropometric indicators, blood pressure, lipids, antidiabetic medications, level of physical activity, food ingestion, quality of life, social support, anxiety, depression levels and self-efficacy. An associated nested qualitative study will be conducted with 30 to 40 subjects in order to analyse the learning and adaptation processes during the education cycles, and throughout the study. CONCLUSIONS: This research will help to address the necessary but difficult issue of structuring therapeutic education in type 2 diabetes based on: efficacy and potential interest of organising on-going empowerment group-sessions, at close quarters, over the long term, in a heterogeneous socioeconomic environment. TRIAL REGISTRATION: ID_RCB number: 2011-A00046-35Clinicaltrials.gov number: NCT01425866.

How do HIV-infected smokers react to cigarette price increases? Evidence from the APROCO-COPILOTE-ANRS CO8 Cohort.

BACKGROUND: Smoking prevalence is very high among people living with HIV/AIDS, and smoking is riskier for them than for HIV-seronegative people. Promoting smoking cessation among HIV-infected people is therefore an emerging public health priority. Raising cigarette prices is usually considered as one of the most effective ways to reduce smoking, but its effectiveness has never been studied among HIV-infected smokers. METHODS: We studied the impact of cigarette price increases among HIV-infected smokers, with data extracted from the French cohort study APROCO-COPILOTE conducted between 1997 and 2007 among 1,146 patients. Data regarding respondents' smoking status was collected every 8 months over the first 5 years, and every 12 months thereafter. RESULTS: We found striking differences across transmission groups regarding socio-demographic background and smoking prevalence. The Intravenous Drug Use (IDU) group was characterised by a lower socioeconomic status, a higher smoking prevalence and a smaller decrease in this prevalence over the period 1997-2007. The homosexual group had a higher socioeconomic status, an intermediate smoking prevalence in 1997, and the highest rate of smoking decrease. In the dynamic multivariate analysis, smoking remained correlated with indicators of socioeconomic disadvantage and with infection through IDU. Aging and cigarette price increase had a negative impact on smoking among the homosexual group, but not for the IDU group. CONCLUSION: Among seropositive people, just as for the general population, poor smokers are poor quitters. Public health authorities should consider interventions which are not smoking-specific, but which contribute to improve the living conditions of the most deprived HIV-infected smokers.

Prevalence and predictors of deterioration of a trustful patient-provider relationship among HIV-infected persons treated with antiretroviral therapy.

OBJECTIVES: We studied the evolution of the patient-provider relationship (PPR) in HIV-infected patients who reported trustful relationships at highly active antiretroviral therapy (HAART) treatment initiation. METHODS: Psychosocial and clinical data were obtained from the French ANRS CO-8 cohort. Break of trust was defined using the question "How much do you trust the provider who usually treats you at this clinic?" Predictors of a possible break of trust during the 5 years after initiating treatment for those patients reporting a trustful PPR at month 0 were identified using a Cox model. RESULTS: During a total follow-up of 3,044 person-years, 68 (7%) patients reported having at least 1 break of trust in their PPR. Break of trust is independently associated with younger age, dissatisfaction with medical staff's explanations, cigarette smoking, and self-reported side effects and is independently inversely associated with severe HIV-related events and changes of treatment. CONCLUSIONS: A patient's break of trust in his provider is relatively infrequent. Accounting for the influence of immunologic status and psychosocial factors, self-reported side effects are shown to be detrimental to the PPR. Interestingly, clinical events and changes of treatment prevent a possible break of trust by reinforcing the provider's role. These results underline the importance of recognizing a patient's perceived secondary effects and developing appropriate care.