Additional file 1: of Treatment with L-citrulline in patients with post-polio syndrome: study protocol for a single-center, randomised, placebo-controlled, double-blind trial

Recommended items to address in a clinical trial protocol and related documents. (PDF 57 kb

Sample characteristics.

<p>a/b/c represent the lower quartile a, the median b, and the upper quartile c for continuous variables.</p><p>n is the number of non-missing values.</p><p>Numbers after percentages are frequencies.</p

Estimated proportions of patients with undertriage in the pre- and post- treatment groups.

<p>The proportions are given as ratios of the kernel probability density estimate of age of patients with undertriage and the kernel probability density estimate of age of all patients.</p

Reasons for undertriage (according to the decision points A-D of the ESI triage algorithm).

<p>Reasons for undertriage (according to the decision points A-D of the ESI triage algorithm).</p

Results of simple logistic regression models for undertriage on risk factors. Intercepts (odds) are not shown.

<p>^* The variables “admission mode” and “presenting complaint” were collected in the post test group only.</p><p>nsc, non-specific complaint.</p

Logistic regression for correct triage on the predictors “vital signs” and “respiratory rate” which serve as surrogate for adherence, and full adherence, respectively.

<p>(post treatment group, N = 174).</p

Patient reported outcomes.

<p>Individual trials’ outcomes expressed on a 0 to 100 scale. RTW coord. = return to work coordination. MID = minimal important difference.</p

Characteristics of interventions and comparisons.

<p>RTW = return to work, n.r. = not reported, OP = occupational physician, PT = physical therapist, GP = general practitioner, rehab. = rehabilitation.</p>1<p>The trial compared three intervention arms with usual practice. We considered only the arm “combined intervention” because the other arms were restricted to either workplace or health care interventions.</p>2<p>In the Dutch system, each company is obliged to have company insurance for sick leave and to offer their employees access to occupational health care. Occupational physicians provide social-medical guidance for sick listed employees with the aim to return to work (RTW) as quickly as possible. Usually, occupational physicians are organised as third party service providers.</p>3<p>From personal correspondence.</p

Study selection.

<p>Last update of electronic search to April 2, 2012.</p

Return to Work Coordination Programmes for Work Disability: A Meta-Analysis of Randomised Controlled Trials

<div><h3>Background</h3><p>The dramatic rise in chronically ill patients on permanent disability benefits threatens the sustainability of social security in high-income countries. Social insurance organizations have started to invest in promising, but costly return to work (RTW) coordination programmes. The benefit, however, remains uncertain. We conducted a systematic review to determine the long-term effectiveness of RTW coordination compared to usual practice in patients at risk for long-term disability.</p> <h3>Methods and Findings</h3><p>Eligible trials enrolled employees on work absence for at least 4 weeks and randomly assigned them to RTW coordination or to usual practice. We searched 5 databases (to April 2, 2012). Two investigators performed standardised eligibility assessment, study appraisal and data extraction independently and in duplicate. The GRADE framework guided our assessment of confidence in the meta-analytic estimates. We identified 9 trials from 7 countries, 8 focusing on musculoskeletal, and 1 on mental complaints. Most trials followed participants for 12 months or less. No trial assessed permanent disability. Moderate quality evidence suggests a benefit of RTW coordination on proportion at work at end of follow-up (risk ratio = 1.08, 95% CI = 1.03 to 1.13; absolute effect = 5 in 100 additional individuals returning to work, 95% CI = 2 to 8), overall function (mean difference [MD] on a 0 to 100 scale = 5.2, 95% CI = 2.4 to 8.0; minimal important difference [MID] = 10), physical function (MD = 5.3, 95% CI = 1.4 to 9.1; MID = 8.4), mental function (MD = 3.1, 95% CI = 0.7 to 5.6; MID = 7.3) and pain (MD = 6.1, 95% CI = 3.1 to 9.2; MID = 10).</p> <h3>Conclusions</h3><p>Moderate quality evidence suggests that RTW coordination results in small relative, but likely important absolute benefits in the likelihood of disabled or sick-listed patients returning to work, and associated small improvements in function and pain. Future research should explore whether the limited effects persist, and whether the programmes are cost effective in the long term.</p> </div