Claire Hulme

PET-CT Surveillance versus Neck Dissection in Advanced Head and Neck Cancer

BACKGROUND The role of image-guided surveillance as compared with planned neck dissection in the treatment of patients with squamous-cell carcinoma of the head and neck who have advanced nodal disease (stage N2 or N3) and who have received chemoradiotherapy for primary treatment is a matter of debate. METHODS In this prospective, randomized, controlled trial, we assessed the noninferiority of positron-emission tomography-computed tomography (PET-CT)-guided surveillance (performed 12 weeks after the end of chemoradiotherapy, with neck dissection performed only if PET-CT showed an incomplete or equivocal response) to planned neck dissection in patients with stage N2 or N3 disease. The primary end point was overall survival. RESULTS From 2007 through 2012, we recruited 564 patients (282 patients in the planned-surgery group and 282 patients in the surveillance group) from 37 centers in the United Kingdom. Among these patients, 17% had nodal stage N2a disease and 61% had stage N2b disease. A total of 84% of the patients had oropharyngeal cancer, and 75% had tumor specimens that stained positive for the p16 protein, an indicator that human papillomavirus had a role in the causation of the cancer. The median follow-up was 36 months. PET-CT-guided surveillance resulted in fewer neck dissections than did planned dissection surgery (54 vs. 221); rates of surgical complications were similar in the two groups (42% and 38%, respectively). The 2-year overall survival rate was 84.9% (95% confidence interval [CI], 80.7 to 89.1) in the surveillance group and 81.5% (95% CI, 76.9 to 86.3) in the planned-surgery group. The hazard ratio for death slightly favored PET-CT-guided surveillance and indicated noninferiority (upper boundary of the 95% CI for the hazard ratio, <1.50; P=0.004). There was no significant difference between the groups with respect to p16 expression. Quality of life was similar in the two groups. PET-CT-guided surveillance, as compared with neck dissection, resulted in savings of £1,492 (approximately

Workplace physical activity interventions: a systematic review

2,190 in U.S. dollars) per person over the duration of the trial. CONCLUSIONS Survival was similar among patients who underwent PET-CT-guided surveillance and those who underwent planned neck dissection, but surveillance resulted in considerably fewer operations and it was more cost-effective. (Funded by the National Institute for Health Research Health Technology Assessment Programme and Cancer Research UK; PET-NECK Current Controlled Trials number, ISRCTN13735240.).

Non-pharmacological approaches for dementia that informal carers might try or access: a systematic review

Purpose – This paper aims to report a synopsis of a recent systematic review of the literature regarding the effectiveness of workplace physical activity interventions, commissioned by the National Institute for Health and Clinical Excellence (NICE).Design/methodology/approach – A search for English‐language papers published between 1996 and 2007 was conducted using 12 relevant databases and associated grey literature. Search protocols and analysis regarding study quality as recommended by NICE were utilised. Key inclusion criteria were, workplace intervention aiming to increase physical activity, intervention aimed at working adults, intervention initiated/endorsed by the employer, physical activity outcome. Thirty‐three studies (38 papers) met the inclusion criteria and were independently reviewed (checked by two reviewers) with a narrative synthesis of findings.Findings – Fourteen studies were graded as high quality or good quality. Evidence from previous systematic reviews was inconclusive. Data regar...

The TICOPA protocol (TIght COntrol of Psoriatic Arthritis): a randomised controlled trial to compare intensive management versus standard care in early psoriatic arthritis.

To review non‐drug treatments for dementia; to provide a source of evidence for informal carers who want ideas about non‐drug approaches for dementia, that they might try or that they could try to access. The systematic review addresses: what non‐drug treatments work and what do they work for? What non‐drug treatments might work and what for? What non‐drug treatments do not work?

Who will care? Employment participation and willingness to supply informal care

BackgroundPsoriatic Arthritis (PsA) is estimated to occur in 10-15% of people with psoriasis and accounts for 13% of people attending early arthritis clinics. With an increasing awareness of the poor outcomes associated with PsA and the availability of new effective, but costly, treatments, there is an urgent need to research the optimal treatment for patients with PsA. The aim of the TICOPA study is to establish whether, in treatment naive early PsA patients, “tight control” intensive management with protocol driven therapies and pre-defined objective targets for treatment can improve clinical outcome compared to standard care alone.Methods/designTICOPA is a UK multicentre, open-label, randomised controlled, parallel group trial of 206 patients with early PsA. Patients will be randomised on a 1:1 basis to receive either standard care (12 weekly review) or intensive management (4 weekly review) for a period of 48 weeks. Patients assigned to the intensive management group will follow a strict treatment protocol whereby dose continuation/escalation is determined through the objective assessment of the minimal disease activity (MDA) criteria. Patients assigned to the standard care group will have treatment prescribed as felt appropriate by the treating clinician, with no set protocol. The primary objective of the trial is to compare intensive management with standard care in terms of the proportion of patients achieving an ACR 20 response at 48 weeks post-randomisation, in order to determine whether intensive management has superior clinical efficacy. Key secondary outcomes include ACR 50 and 70, PASI 75 and X-ray Van der Heijde score at 48 weeks post-randomisation along with cost-effectiveness at 12, 24 and 28 weeks.DiscussionThe TICOPA trial will provide direct evidence as to whether the use of early and intensive treatment in PsA in routine clinical care leads to an improvement in patients’ disease activity and a reduction in radiological joint damage.Trial registrationISRCTN30147736, NCT01106079

Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial

The impact of informal care responsibilities on the willingness and ability of caregivers to undertake paid employment has been the subject of a number of studies. In contrast, the effect of employment status on willingness to undertake informal care has been less well explored. This paper concentrates on this less-studied direction of causality using the data provided by 15 waves of the British Household Panel Survey. We find that employment participation and earnings both impact negatively on willingness to supply informal care. This evidence has implications for health and social care policy since informal care has been shown to be a significant substitute for formal long-term care.

Giving older workers a voice: constraints on the employment of older people in the North West of England

Importance Robotic rectal cancer surgery is gaining popularity, but limited data are available regarding safety and efficacy. Objective To compare robotic-assisted vs conventional laparoscopic surgery for risk of conversion to open laparotomy among patients undergoing resection for rectal cancer. Design, Setting, and Participants Randomized clinical trial comparing robotic-assisted vs conventional laparoscopic surgery among 471 patients with rectal adenocarcinoma suitable for curative resection conducted at 29 sites across 10 countries, including 40 surgeons. Recruitment of patients was from January 7, 2011, to September 30, 2014, follow-up was conducted at 30 days and 6 months, and final follow-up was on June 16, 2015. Interventions Patients were randomized to robotic-assisted (n = 237) or conventional (n = 234) laparoscopic rectal cancer resection, performed by either high (upper rectum) or low (total rectum) anterior resection or abdominoperineal resection (rectum and perineum). Main Outcomes and Measures The primary outcome was conversion to open laparotomy. Secondary end points included intraoperative and postoperative complications, circumferential resection margin positivity (CRM+) and other pathological outcomes, quality of life (36-Item Short Form Survey and 20-item Multidimensional Fatigue Inventory), bladder and sexual dysfunction (International Prostate Symptom Score, International Index of Erectile Function, and Female Sexual Function Index), and oncological outcomes. Results Among 471 randomized patients (mean [SD] age, 64.9 [11.0] years; 320 [67.9%] men), 466 (98.9%) completed the study. The overall rate of conversion to open laparotomy was 10.1%: 19 of 236 patients (8.1%) in the robotic-assisted laparoscopic group and 28 of 230 patients (12.2%) in the conventional laparoscopic group (unadjusted risk difference = 4.1% [95% CI, −1.4% to 9.6%]; adjusted odds ratio = 0.61 [95% CI, 0.31 to 1.21]; P = .16). The overall CRM+ rate was 5.7%; CRM+ occurred in 14 (6.3%) of 224 patients in the conventional laparoscopic group and 12 (5.1%) of 235 patients in the robotic-assisted laparoscopic group (unadjusted risk difference = 1.1% [95% CI, −3.1% to 5.4%]; adjusted odds ratio = 0.78 [95% CI, 0.35 to 1.76]; P = .56). Of the other 8 reported prespecified secondary end points, including intraoperative complications, postoperative complications, plane of surgery, 30-day mortality, bladder dysfunction, and sexual dysfunction, none showed a statistically significant difference between groups. Conclusions and Relevance Among patients with rectal adenocarcinoma suitable for curative resection, robotic-assisted laparoscopic surgery, as compared with conventional laparoscopic surgery, did not significantly reduce the risk of conversion to open laparotomy. These findings suggest that robotic-assisted laparoscopic surgery, when performed by surgeons with varying experience with robotic surgery, does not confer an advantage in rectal cancer resection. Trial Registration isrctn.org Identifier: ISRCTN80500123

Updated Cost-Effectiveness Analysis of Trastuzumab for Early Breast Cancer A UK Perspective Considering Duration of Benefit, Long-Term Toxicity and Pattern of Recurrence

This article contributes to the literature on older workers and employment, providing a regional perspective on the relationship between age and work. The study is based on interviews in conjunction with occupational-event calendars with 56 individuals in North West England. The primary aim was to gain in-depth understanding of perceived constraints that older people feel hinder their employment prospects within the context of their daily lives. Significant constraints on employment and re-employment were identified and attributed to health, negative perceptions of self, lack of formal human capital and undervaluation of experience, financial disincentives for employers to employ older workers and prevailing ageist attitudes.

What is the cost of a healthy diet? Using diet data from the UK Women's Cohort Study

AbstractBackground: Trastuzumab has significantly improved survival outcomes for women with Human Epidermal growth factor Receptor 2 (HER2)-positive early breast cancer. Trastuzumab was established as a cost-effective adjuvant treatment in 2006. We present an updated cost-effectiveness analysis from the UK perspective, which explores assumptions about the duration of benefit from treatment, pattern of metastatic recurrence and long-term cardiac toxicity. Objective: The objective of this study was to calculate, from the UK NHS perspective, expected costs (year 2008 values) and benefits over the lifetime of an average cohort of women with HER2-positive early breast cancer treated with or without 1 year of adjuvant trastuzumab sequentially after chemotherapy. Methods: A cost-utility analysis was performed using a discrete-state timedependent semi-Markov model. Probabilistic sensitivity analysis was used to characterize uncertainty around expected outcomes. Value-of-information (VOI) analysis was used to identify areas of priority for further research. Results: The cost-effectiveness estimates were highly sensitive to the estimated duration of treatment benefit. Trastuzumab remained a cost-effective treatment strategy at a willingness-to-pay threshold of £30000 per QALY provided the duration of benefit was more than 3.6 years from treatment initiation, assuming the hazard ratio for disease-free survival was 0.63. An increasing proportion of brain metastases with trastuzumab produced a small change towards worse cost effectiveness. Long-term cardiac toxicity needed to rise to high levels to affect overall life expectancy and cost effectiveness. VOI analysis placed highest value on research into the duration of treatment benefit. The relationships between progression-free survival and overall survival and the costs of cancer recurrence were also important. Conclusion: The cost effectiveness of adjuvant trastuzumab remains uncertain and dependent on assumptions regarding its clinical effect. Uncertainty around cost effectiveness could be reduced by further research into the duration of treatment effect, particularly in subgroups where this may be shorter. Longterm follow-up is warranted and methods to accurately measure duration of treatment effect and late toxicities should be developed for future adjuvant drug studies.

The TRACTISS Protocol: a randomised double blind placebo controlled clinical TRial of Anti-B-Cell Therapy In patients with primary Sjögren's Syndrome

Background A healthy diet is important to promote health and well-being while preventing chronic disease. However, the monetary cost of consuming such a diet can be a perceived barrier. This study will investigate the cost of consuming a range of dietary patterns. Methods A cross-sectional analysis, where cost of diet was assigned to dietary intakes recorded using a Food Frequency Questionnaire. A mean daily diet cost was calculated for seven data-driven dietary patterns. These dietary patterns were given a healthiness score according to how well they comply with the UK Department of Healths Eatwell Plate guidelines. This study involved ∼35 000 women recruited in the 1990s into the UK Womens Cohort Study. Results A significant positive association was observed between diet cost and healthiness of the diet (p for trend >0.001). The healthiest dietary pattern was double the price of the least healthy, £6.63/day and £3.29/day, respectively. Dietary diversity, described by the patterns, was also shown to be associated with increased cost. Those with higher education and a professional or managerial occupation were more likely to consume a healthier diet. Conclusions A healthy diet is more expensive to the consumer than a less healthy one. In order to promote health through diet and reduce potential inequalities in health, it seems sensible that healthier food choices should be made more accessible to all.