Young people's opinions of cancer care in England: the BRIGHTLIGHT cohort

OBJECTIVES: The BRIGHTLIGHT cohort study was the national evaluation of cancer services for teenager and young adults (TYA). This was analysis of free-text survey data to better understand their experiences of cancer care. DESIGN: Cohort study SETTING: National Health Service hospitals delivering cancer care in England PARTICIPANTS: 830 young people newly diagnosed with cancer. INTERVENTIONS: Exposure to specialist care in the first 6 months after diagnosis defined as care in a TYA Principal Treatment Centre (PTC). This was categorised as follows: all care in a TYA-PTC (ALL-TYA-PTC), no care in a TYA-PTC (NO-TYA-PTC) so care delivered in a children/adult unit only and some care in a TYA-PTC with additional care in a children's/adult unit (SOME-TYA-PTC). PRIMARY OUTCOME: Data were collected through the BRIGHTLIGHT survey included free-text questions which asked patients 'what was the best aspects of their experiences of care' and 'what aspects could be improved'. These comments were analysed using content analysis. Themes were compared between categories of care, then ranked in order of frequency, ranging from the most endorsed to the least. RESULTS: Overall, young people were most positive about their healthcare team, while the area highlighted for improvement was diagnostic experience. Differences between the three groups suggested those who had some or all treatment in a TYA-PTC valued the place of care. Regardless of where TYA were treated their healthcare teams were favourably viewed. Age appropriate place of care was highlighted to be of value for those in PTCs. CONCLUSIONS: These data show the value young people placed on the care they received in TYA specific wards. Young people who accessed some or all of their care in a TYA-PTC highly endorsed their place of care as one of the best elements of their care, and it is further emphasised by those who had shared care who experienced difficulty with lack of age-appropriate care when treated outside the TYA-PTC

Increasing voluntary medical male circumcision uptake among adult men in Tanzania.

OBJECTIVE: We evaluated a demand-creation intervention to increase voluntary medical male circumcision (VMMC) uptake among men aged 20-34 years in Tanzania, to maximise short-term impact on HIV incidence. METHODS: A cluster randomized controlled trial stratified by region was conducted in 20 outreach sites in Njombe and Tabora regions. The sites were randomized 1 : 1 to receive either a demand-creation intervention package in addition to standard VMMC outreach, or standard VMMC outreach alone. The intervention package included enhanced public address messages, peer promotion by recently circumcised men, facility setup to increase privacy, and engagement of female partners in demand creation. The primary outcome was the proportion of VMMC clients aged 20-34 years. FINDINGS: Overall, 6251 and 3968 VMMC clients were enrolled in intervention and control clusters, respectively. The proportion of clients aged 20-34 years was slightly greater in the intervention than control arm [17.7 vs. 13.0%; prevalence ratio = 1.36; 95% confidence intervals (CI):0.9-2.0]. In Njombe region, the proportion of clients aged 20-34 years was similar between arms but a significant two-fold difference was seen in Tabora region (P value for effect modification = 0.006). The mean number of men aged 20-34 years (mean difference per cluster = 97; 95% CI:40-154), and of all ages (mean difference per cluster = 227, 95% CI:33-420) were greater in the intervention than control arm. CONCLUSION: The intervention was associated with a significant increase in the proportion of clients aged 20-34 years in Tabora but not in Njombe. The intervention may be sensitive to regional factors in VMMC programme scale-up, including saturation

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

Background: Multiple laboratory tests are used to diagnose and manage patients with diabetes mellitus. The quality of the scientific evidence supporting the use of these tests varies substantially. Approach: An expert committee compiled evidence-based recommendations for the use of laboratory testing for patients with diabetes. A new system was developed to grade the overall quality of the evidence and the strength of the recommendations. Draft guidelines were posted on the Internet and presented at the 2007 Arnold O. Beckman Conference. The document was modified in response to oral and written comments, and a revised draft was posted in 2010 and again modified in response to written comments. The National Academy of Clinical Biochemistry and the Evidence-Based Laboratory Medicine Committee of the American Association for Clinical Chemistry jointly reviewed the guidelines, which were accepted after revisions by the Professional Practice Committee and subsequently approved by the Executive Committee of the American Diabetes Association. Content: In addition to long-standing criteria based on measurement of plasma glucose, diabetes can be diagnosed by demonstrating increased blood hemoglobin A$_{1c}$ (HbA$_{1c}$) concentrations. Monitoring of glycemic control is performed by self-monitoring of plasma or blood glucose with meters and by laboratory analysis of HbA$_{1c}$. The potential roles of noninvasive glucose monitoring, genetic testing, and measurement of autoantibodies, urine albumin, insulin, proinsulin, C-peptide, and other analytes are addressed. Summary: The guidelines provide specific recommendations that are based on published data or derived from expert consensus. Several analytes have minimal clinical value at present, and their measurement is not recommended

Anti-tumour necrosis factor discontinuation in inflammatory bowel disease patients in remission: study protocol of a prospective, multicentre, randomized clinical trial

Background: Patients with inflammatory bowel disease who achieve remission with anti-tumour necrosis factor (anti-TNF) drugs may have treatment withdrawn due to safety concerns and cost considerations, but there is a lack of prospective, controlled data investigating this strategy. The primary study aim is to compare the rates of clinical remission at 1?year in patients who discontinue anti-TNF treatment versus those who continue treatment. Methods: This is an ongoing, prospective, double-blind, multicentre, randomized, placebo-controlled study in patients with Crohn?s disease or ulcerative colitis who have achieved clinical remission for ?6?months with an anti-TNF treatment and an immunosuppressant. Patients are being randomized 1:1 to discontinue anti-TNF therapy or continue therapy. Randomization stratifies patients by the type of inflammatory bowel disease and drug (infliximab versus adalimumab) at study inclusion. The primary endpoint of the study is sustained clinical remission at 1?year. Other endpoints include endoscopic and radiological activity, patient-reported outcomes (quality of life, work productivity), safety and predictive factors for relapse. The required sample size is 194 patients. In addition to the main analysis (discontinuation versus continuation), subanalyses will include stratification by type of inflammatory bowel disease, phenotype and previous treatment. Biological samples will be obtained to identify factors predictive of relapse after treatment withdrawal. Results: Enrolment began in 2016, and the study is expected to end in 2020. Conclusions: This study will contribute prospective, controlled data on outcomes and predictors of relapse in patients with inflammatory bowel disease after withdrawal of anti-TNF agents following achievement of clinical remission. Clinical trial reference number: EudraCT 2015-001410-1

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Abstract BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)

When Research Evidence and Healthcare Policy Collide: Synergising Results and Policy into BRIGHTLIGHT Guidance to Improve Coordinated Care for Adolescents and Young Adults with Cancer

Background/Objectives: BRIGHTLIGHT was the national evaluation of adolescent and young adult (AYA) cancer services in England. BRIGHTLIGHT results were not available when the most recent healthcare policy (NHSE service specifications for AYA Cancer) for AYA was drafted and therefore did not consider BRIGHTLIGHT findings and recommendations. We describe the co-development and delivery of a Policy Lab to expedite the implementation of the new service specification in the context of BRIGHTLIGHT results, examining the roles of multi-stakeholders to ensure service delivery is optimised to benefit AYA patients. We address the key question, &ldquo;What is the roadmap for empowering different stakeholders to shape how the AYA service specifications are implemented?&rdquo;. Methods: A 1-day face-to-face policy lab was facilitated, utilising a unique, user-centric engagement approach by bringing diverse AYA stakeholders together to co-design strategies to translate BRIGHTLIGHT evidence into policy and impact. This was accompanied by an online workshop and prioritisation survey, individual interviews, and an AYA patient workshop. Workshop outputs were analysed thematically and survey data quantitatively. Results: Eighteen professionals and five AYAs attended the face-to-face Policy Lab, 16 surveys were completed, 13 attended the online workshop, three professionals were interviewed, and three AYAs attended the patient workshop. The Policy Lab generated eight national and six local recommendations, which were prioritised into three national priorities: 1. Launching the service specification supported by compelling communication; 2. Harnessing the ideas of young people; and 3. Evaluation of AYA patient outcomes/experiences and establishing a national dashboard of AYA cancer network performance. An animation was created by AYAs to inform local hospitals what matters to them most in the service specification. Conclusions: Policy and research evidence are not always aligned, so when emerging evidence does not support current guidance, further exploration is required. We have shown through multi-stakeholder involvement including young people that it was possible to gain a different interpretation based on current knowledge and context. This additional insight enabled practical recommendations to be identified to support the implementation of the service specification

Evaluation of specialist cancer services for teenagers and young adults in England: interpreting BRIGHTLIGHT study results through the lens of young people with cancer

Abstract Background BRIGHTLIGHT was the first national evaluation of teenage and young adult (TYA) cancer services in England. BRIGHTLIGHT evaluated care for TYA aged 13 to 24 years at diagnosis and comprised six interlinked studies. Young people have been involved in BRIGHTLIGHT design, operational troubleshooting and dissemination. Divergent conclusions emerged from the programme, which healthcare professionals could not explain. We sought to gather young people’s interpretation of the results based on their lived experience of cancer. Methods Seven members of the BRIGHTLIGHT Young Advisory Panel (YAP) participated in a one-day workshop and two members acted as co-researchers. An overview of the BRIGHTLIGHT studies and key results were presented. To facilitate interpretation an artist illustrated the results in real-time. A focus group style discussion followed the presentation and was also illustrated. Results The YAP made some key interpretations of the results not identified by researchers including the length of follow-up (3-years was not long enough) and how specialist care had been defined (using number of admissions rather than duration of hospitalisation). They explained the higher healthcare costs in those receiving care in more than one hospital, could be due to duplication of tests/scans. The YAP also identified that the results did not relay the importance of the diagnostic experience, which also incurred costs to TYA/families. Conclusions Patient experience adds further interpretation to complex study results beyond what is visible to healthcare professionals. The YAP added further insight to results and contributed to the formulation of the conclusion for the BRIGHTLIGHT programme grant