Early diagnosis of coeliac disease in the Preventive Youth Health Care Centres in the Netherlands: study protocol of a case finding study (GLUTENSCREEN).

Introduction: Coeliac disease (CD) occurs in 1% of the population, develops early in life and is severely underdiagnosed. Undiagnosed and untreated disease is associated with short-term and long-term complications. The current healthcare approach is unable to solve the underdiagnosis of CD and timely diagnosis and treatment is only achieved by active case finding. Aim: to perform a case finding project to detect CD children who visit the Youth Health Care Centres (YHCCs) in a well-described region in the Netherlands to evaluate whether it is feasible, cost-effective and well accepted by the population. Methods/analysis: Prospective intervention cohort study. Parents of all children aged 12 months and 4 years attending the YHCCs for a regular visit are asked whether their child has one or more CD-related symptoms from a standardised list. If so, they will be invited to participate in the case finding study. After informed consent, a point of care test (POCT) to assess CD-specific antibodies against tissue transglutaminase (TG2A) is performed onsite the YHCCs. If the POCT is positive, CD is highly suspected and the child will be referred to hospital for definitive diagnosis according to the Guideline Coeliac Disease of the European Society for Pediatric Gastroenterology, Hepatology and Nutrition guideline. Main outcomes: Incidence rate of new CD diagnoses in the study region in comparison to the one in the same age diagnosed by standard of care in the rest of the Netherlands.Feasibility and cost-effectiveness of active CD case finding at the YHCCs. All costs of active case finding, diagnostics and treatment of CD and the potential short-term and long-term consequences of the disease will be calculated for the setting with and without case finding.Ethical acceptability: by questionnaires on parental and healthcare professionals' satisfaction.A statistical analysis plan was prepared and is published on the GLUTENSCREEN website (Statistical-Analysis-Plan-11-5-2021_def.pdf (glutenscreen.nl) and added as annex 1). Ethics and dissemination: The Medical Ethics Committee Leiden approved this study. If we prove that case finding at the YHCC is feasible, cost-effective and well accepted by the population, implementation is recommended. Trial registration number: NL63291.058.17.

Costs of different follow-up strategies in early breast cancer: a review of the literature.

We reviewed the literature between January 1985 and June 2011 on the costs of different follow-up strategies for patients treated for early breast cancer. A total of 186 abstracts were retrieved of which eleven publications were considered relevant; 6 randomised clinical trials, 4 retrospective cohort studies and 1 'minisymposium'. The follow-up strategies, outcome measures and methods of analysis used in these studies vary widely, so no general conclusions can be drawn. However, from the results we infer that patient-led follow-up by a nurse practitioner, follow-up by a general practitioner, or telephone follow-up is feasible and cost-effective, without routine additional tests, except annual mammograms. In this era of increasing health care costs, cost-effectiveness, evaluated in a standardised way, should be taken into account in future clinical trials.

A proactive approach to migraine in primary care: a pragmatic randomized controlled trial.

BACKGROUND: Migraine is a common, disabling headache disorder that leads to lost quality of life and productivity. We investigated whether a proactive approach to patients with migraine, including an educational intervention for general practitioners, led to a decrease in headache and associated costs. METHODS: We conducted a pragmatic randomized controlled trial. Participants were randomized to one of two groups: practices receiving the intervention and control practices. Participants were prescribed two or more doses of triptan per month. General practitioners in the intervention group received training on treating migraine and invited participating patients for a consultation and evaluation of the therapy they were receiving. Physicians in the control group continued with usual care. Our primary outcome was patients' scores on the Headache Impact Test (HIT-6) at six months. We considered a reduction in score of 2.3 points to be clinically relevant. We used the Kessler Psychological Distress Scale (K10) questionnaire to determine if such distress was a possible effect modifier. We also examined the interventions' cost-effectiveness. RESULTS: We enrolled 490 patients in the trial (233 to the intervention group and 257 to the control group). Of the 233 patients in the intervention group, 192 (82.4%) attended the consultation to evaluate the treatment of their migraines. Of these patients, 43 (22.3%) started prophylaxis. The difference in change in score on the HIT-6 between the intervention and control groups was 0.81 (p = 0.07, calculated from modelling using generalized estimating equations). For patients with low levels of psychological distress (baseline score on the K10 ≤ 20) this change was -1.51 (p = 0.008), compared with a change of 0.16 (p = 0.494) for patients with greater psychological distress. For patients who were not using prophylaxis at baseline and had two or more migraines per month, the mean HIT-6 score improved by 1.37 points compared with controls (p = 0.04). We did not find the intervention to be cost-effective. INTERPRETATION: An educational intervention for general practitioners and a proactive approach to patients with migraine did not result in a clinically relevant improvement of symptoms. Psychological distress was an important confounder of success. (Current Controlled Trials registration no. ISRCTN72421511.).

Tubular diskectomy vs conventional microdiskectomy for the treatment of lumbar disk herniation: 2-year results of a double-blind randomized controlled trial.

BACKGROUND: Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking. OBJECTIVE: To evaluate the 2-year results of tubular diskectomy compared with conventional microdiskectomy. METHODS: Three hundred twenty-eight patients with persistent leg pain caused by lumbar disk herniation were randomly assigned to undergo tubular diskectomy (167 patients) or conventional microdiskectomy (161 patients). Main outcome measures were scores from Roland-Morris Disability Questionnaire for Sciatica, Visual Analog Scale for leg pain and low-back pain, and Likert self-rating scale of global perceived recovery. RESULTS: On the basis of intention-to-treat analysis, there was no significant difference between tubular diskectomy and conventional microdiskectomy in Roland-Morris Disability Questionnaire for Sciatica scores during 2 years after surgery (between-group mean difference [Δ] = 0.6; 95% confidence interval [CI], -0.3-1.6). Patients treated with tubular diskectomy reported more leg pain (Δ = 3.3 mm; 95% CI, 0.2-6.2) and more low-back pain (Δ = 3.0 mm; 95% CI, -0.2-6.3) than those patients treated with conventional microdiskectomy. At 2 years, 71% of patients assigned to tubular diskectomy documented a good recovery vs 77% of patients assigned to conventional microdiskectomy (odds ratio, 0.76; 95% CI, 0.45-1.28; P = .35). Repeated surgery rates within 2 years after tubular diskectomy and conventional microdiskectomy were 15% and 10%, respectively (P = .22). CONCLUSION: Tubular diskectomy and conventional microdiskectomy resulted in similar functional and clinical outcomes. Patients treated with tubular diskectomy reported more leg pain and low-back pain, although the differences were small and not clinically relevant.

Tubular diskectomy vs conventional microdiskectomy for the treatment of lumbar disk-related sciatica: cost utility analysis alongside a double-blind randomized controlled trial.

BACKGROUND: Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica caused by lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence of its efficacy is lacking. OBJECTIVE: To determine whether a favorable cost-effectiveness for tubular diskectomy compared with conventional microdiskectomy is attained. METHODS: Cost utility analysis was performed alongside a double-blind randomized controlled trial conducted among 325 patients with lumbar disk related sciatica lasting >6 to 8 weeks at 7 Dutch hospitals comparing tubular diskectomy with conventional microdiskectomy. Main outcome measures were quality-adjusted life-years at 1 year and societal costs, estimated from patient reported utilities (US and Netherlands EuroQol, Short Form Health Survey-6D, and Visual Analog Scale) and diaries on costs (health care, patient costs, and productivity). RESULTS: Quality-adjusted life-years during all 4 quarters and according to all utility measures were not statistically different between tubular diskectomy and conventional microdiskectomy (difference for US EuroQol, -0.012; 95% confidence interval, -0.046 to 0.021). From the healthcare perspective, tubular diskectomy resulted in nonsignificantly higher costs (difference US $460; 95% confidence interval, -243 to 1163). From the societal perspective, a nonsignificant difference of US $1491 (95% confidence interval, -1335 to 4318) in favor of conventional microdiskectomy was found. The nonsignificant differences in costs and quality-adjusted life-years in favor of conventional microdiskectomy result in a low probability that tubular diskectomy is more cost-effective than conventional microdiskectomy. CONCLUSION: Tubular diskectomy is unlikely to be cost-effective compared with conventional microdiskectomy.

Tubular diskectomy vs conventional microdiskectomy for sciatica: a randomized controlled trial.

CONTEXT: Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica due to lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking of its efficacy. OBJECTIVE: To determine outcomes and time to recovery in patients treated with tubular diskectomy compared with conventional microdiskectomy. DESIGN, SETTING, AND PATIENTS: The Sciatica Micro-Endoscopic Diskectomy randomized controlled trial was conducted among 328 patients aged 18 to 70 years who had persistent leg pain (>8 weeks) due to lumbar disk herniations at 7 general hospitals in The Netherlands from January 2005 to October 2006. Patients and observers were blinded during the follow-up, which ended 1 year after final enrollment. INTERVENTIONS: Tubular diskectomy (n = 167) vs conventional microdiskectomy (n = 161). MAIN OUTCOME MEASURES: The primary outcome was functional assessment on the Roland-Morris Disability Questionnaire (RDQ) for sciatica (score range: 0-23, with higher scores indicating worse functional status) at 8 weeks and 1 year after randomization. Secondary outcomes were scores on the visual analog scale for leg pain and back pain (score range: 0-100 mm) and patient's self-report of recovery (measured on a Likert 7-point scale). RESULTS: Based on intention-to-treat analysis, the mean RDQ score during the first year after surgery was 6.2 (95% confidence interval [CI], 5.6 to 6.8) for tubular diskectomy and 5.4 (95% CI, 4.6 to 6.2) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, -0.2 to 1.7). At 8 weeks after surgery, the RDQ mean (SE) score was 5.8 (0.4) for tubular diskectomy and 4.9 (0.5) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, -0.4 to 2.1). At 1 year, the RDQ mean (SE) score was 4.7 (0.5) for tubular diskectomy and 3.4 (0.5) for conventional microdiskectomy (between-group mean difference, 1.3; 95% CI, 0.03 to 2.6) in favor of conventional microdiskectomy. On the visual analog scale, the 1-year between-group mean difference in improvement was 4.2 mm (95% CI, 0.9 to 7.5 mm) for leg pain and 3.5 mm (95% CI, 0.1 to 6.9 mm) for back pain in favor of conventional microdiskectomy. At 1 year, 107 of 156 patients (69%) assigned to tubular diskectomy reported a good recovery vs 120 of 151 patients (79%) assigned to conventional microdiskectomy (odds ratio, 0.59 [95% CI, 0.35 to 0.99]; P = .05). CONCLUSIONS: Use of tubular diskectomy compared with conventional microdiskectomy did not result in a statistically significant improvement in the Roland-Morris Disability Questionnaire score. Tubular diskectomy resulted in less favorable results for patient self-reported leg pain, back pain, and recovery. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN51857546.

Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: a prospective randomised controlled trial [NTR1300].

BACKGROUND: Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion, i.e. Gill's procedure, is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis. METHODS/DESIGN: All patients (age between 18 and 70 years) with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II, are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill, either unilateral or bilateral, or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include, incidence of re-operations, complications, serum creatine phosphokinase, quality of life, medical consumption, costs, absenteeism, work perception, depression and anxiety, and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years. DISCUSSION: Currently, nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis, although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best surgical treatment of symptomatic patients with low-grade spondylolytic spondylolisthesis.