Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy.

INTRODUCTION: Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF. METHODS AND ANALYSIS: The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: 'operative success', the measured decrease in radiculopathy assessed by the visual analogue scale and 'patient success', assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study. TRIAL REGISTRATION NUMBER: NTR5536, pre-results.

Measuring quality of life in heart failure: one versus multiple items.

BACKGROUND: Symptoms of heart failure and consequences of treatment can have a great impact on patients' lives. Improving quality of life is generally recognised as one of the major goals of treatment. The purpose of this study was to determine the relationship between a one-item quality-of-life measure (Ladder of Life) and the Minnesota Living with Heart Failure Questionnaire and possible equality. METHOD: 231 patients who were admitted with symptoms of chronic heart failure to a cardiology ward in a general hospital (53% male, age 75±11, LVEF 40±16) completed the Minnesota Living with Heart Failure Questionnaire (MLwHFQ) and were asked to rate their sense of well-being on the Ladder of Life (10= best possible life, 0= worst possible life). Demographic and clinical data were obtained by chart review. RESULTS: The overall well-being score on the Ladder of Life correlated significantly with the total MLwHFQ (r=-0.36, p<0.001). However, there is a large variation in MLwHFQ scores (12-83) in patients who score a relatively high overall well-being (>6, relatively good Q0L). A large variation in MLwHFQ scores (10-105) also exists in patients with a relatively low score on the Ladder of Life (<1, low QOL). CONCLUSION: Assessment of quality of life with a simple and practical tool using the one-item Ladder of Life can give clinicians and researchers important information on the quality of life of patients. Whether such a single-item question is responsive enough to detect changes in treatment and predict readmission needs to be studied in more detail.