Validity of the modified Rankin Scale in patients with aneurysmal subarachnoid hemorrhage: a randomized study.

PURPOSE: The modified Rankin Scale (mRS), a clinician-reported outcome measure of global disability, has never been validated in patients with aneurysmal subarachnoid hemorrhage (aSAH). The aims of this study are to assess: (1) convergent validity of the mRS; (2) responsiveness of the mRS; and (3) the distribution of mRS scores across patient-reported outcome measures (PROMs). METHODS: This is a prospective randomized multicenter study. The mRS was scored by a physician for all patients, and subsequently by structured interview for half of the patients and by self-assessment for the other half. All patients completed EuroQoL 5D-5L, RAND-36, Stroke Specific Quality of Life scale (SS-QoL) and Global Perceived Effect (GPE) questionnaires. Convergent validity and responsiveness were assessed by testing hypotheses. RESULTS: In total, 149 patients with aSAH were included for analysis. The correlation of the mRS with EQ-5D-5L was r = - 0.546, while with RAND-36 physical and mental component scores the correlation was r = - 0.439and r = - 0.574 respectively, and with SS-QoL it was r = - 0.671. Three out of four hypotheses for convergent validity were met. The mRS assessed through structured interviews was more highly correlated with the mental component score than with the physical component score of RAND-36. Improvement in terms of GPE was indicated by 83% of patients; the mean change score of these patients on the mRS was - 0.08 (SD 0.915). None of the hypotheses for responsiveness were met. CONCLUSION: The results show that the mRS generally correlates with other instruments, as expected, but it lacks responsiveness. A structured interview of the mRS is best for detecting disabling neuropsychological complaints. REGISTRATION: URL: https://trialsearch.who.int ; Unique identifier: NL7859, Date of first administration: 08-07-2019.

The SOS-SAH questionnaire in clinical practice: a multi-method evaluation study.

BACKGROUND: In patients with mild disabilities after aneurysmal subarachnoid hemorrhage (aSAH), invisible symptoms might be easily overlooked during consultations in the outpatient clinic. We hypothesize that the Questionnaire for the Screening of Symptoms in aneurysmal Subarachnoid Hemorrhage (SOS-SAH), a disease-specific patient-reported outcome measure, might aid in screening for symptoms after aSAH. The objective of this explorative study is to evaluate the perceived impact of using the SOS-SAH in daily clinical practice for patients after aSAH, as well as to explore potential barriers to further implementation. METHODS: This multi-method study consists of a quantitative and a qualitative component. To evaluate differences in quality of care, a patient experience survey was sent to patients receiving usual care and to patients who received the SOS-SAH. A multiple linear regression model was applied, with the intervention group and case mix adjusters as independent variables. We described differences in the number of symptoms discussed between patients receiving usual care and those receiving care post-implementation. Following implementation, 16 patients and 6 healthcare professionals were interviewed about their perceptions concerning the impact of and barriers to using the SOS-SAH. A thematic analysis was performed to identify the main themes. RESULTS: The survey did not reveal any differences between the usual-care group and the post-implementation group on the scales of the patient experience survey. After implementation of the SOS-SAH, the number of symptoms discussed during consultation did not increase. The interviews suggest that the SOS-SAH may improve the preparation of patients by providing them with greater insight into their complaints and by raising issues for the consultation. It could also enhance the structure and efficiency of consultation, in addition to improving communication about issues that matter to patients. All patients and healthcare professionals recommended continuing the use of the SOS-SAH in daily practice. CONCLUSIONS: Although no quantitative improvements were found in patient experience and symptoms discussed during consultation, implementation of the SOS-SAH could aid in screening for symptoms in patients after aSAH, and it might have a positive influence on patient preparation, while helping to structure consultations between patients and healthcare professionals.

The diagnostic value of the pulsatility curve to predict shunt responsiveness in patients with idiopathic normal pressure hydrocephalus.

OBJECTIVE: The aim of this study was to investigate the diagnostic accuracy of the pulsatility curve to predict shunt response in patients with idiopathic normal pressure hydrocephalus (iNPH). METHODS: Lumbar cerebrospinal fluid dynamics were derived from an automatic lumbar infusion test (LIT) protocol. All patients were treated with ventriculoperitoneal shunting and re-examined 6 months after shunting. Patient demographics and outcomes were gathered in a prospective, electronic database that spanned from January 2012 to January 2020. A validated iNPH scale was used to assess patients preoperatively and 6 months postoperatively. The relationship of the relative pulse pressure coefficient (RPPC), delta amplitude, successful lowering of amplitude, and the pressure-value at a hypothetical amplitude of zero (P0), resistance to outflow (Rout), and outcome, were assessed using receiver operating characteristic (ROC) curves. RESULTS: We included 38 patients. The RPPC, delta amplitude, successful lowering of amplitude, and P0 parameters did not predict shunt response. Mean P0 was 0.5 (IQR 0.4-0.9) in improved patients and 0.4 (IQR 0-1.2) in non-improved patients. The delta amplitude was 0.16 kPa (IQR 0.10-0.23) in improved patients and 0.18 kPa (IQR 0.11-0.24) in non-improved patients. Furthermore, we found a technical failure rate of pulsatility curve measurements of 32%. CONCLUSION: Pulsatility curve results were not suitable in predicting shunt response in our cohort. The diagnostic value of LIT in case of normal pressure hydrocephalus should be subject to more rigorous research.

Dutch-Flemish translation and cross-cultural adaption of the Spinal Cord Injury-Quality of Life (SCI-QOL) short forms.

PURPOSE: A spinal cord injury (SCI) has a large impact on a person's physical, psychological, and social health. Previous studies focused on physical recovery in patients with SCI and assessed their health-related quality of life (HRQOL) with general questionnaires, which often contain irrelevant questions. The SCI-QOL questionnaire was developed to specifically assess the HRQOL of the SCI population. A comprehensive translation and cross-cultural adaptation are required to use this questionnaire in the Netherlands and Flanders, Belgium. METHODS: All 23 short forms of the SCI-QOL for adults were translated from English into Dutch-Flemish using the Functional Assessment of Chronic Illness Therapy translation methodology, with a cognitive debriefing being performed with 10 patients with SCI and 10 persons from the general population. RESULTS: The Dutch-Flemish PROMIS group previously translated 46 of the 207 items in the 23 short forms. Here, we achieved an acceptable translation of the other 161 items. A single Dutch-Flemish translation was obtained for 20 short forms, while separate Dutch and Flemish translations were necessary for the short forms Ambulation, Manual Wheelchair, and Stigma. CONCLUSION: The Dutch-Flemish translation of the SCI-QOL is now available for clinical and research purposes. Future studies should focus on the psychometric properties of this cross-culturally adapted version.

Inter-method reliability of the modified Rankin Scale in patients with subarachnoid hemorrhage.

BACKGROUND AND OBJECTIVES: The modified Rankin Scale (mRS) is one of the most frequently used outcome measures in trials in patients with an aneurysmal subarachnoid hemorrhage (aSAH). The assessment method of the mRS is often not clearly described in trials, while the method used might influence the mRS score. The aim of this study is to evaluate the inter-method reliability of different assessment methods of the mRS. METHODS: This is a prospective, randomized, multicenter study with follow-up at 6 weeks and 6 months. Patients aged ≥ 18 years with aSAH were randomized to either a structured interview or a self-assessment of the mRS. Patients were seen by a physician who assigned an mRS score, followed by either the structured interview or the self-assessment. Inter-method reliability was assessed with the quadratic weighted kappa score and percentage of agreement. Assessment of feasibility of the self-assessment was done by a feasibility questionnaire. RESULTS: The quadratic weighted kappa was 0.60 between the assessment of the physician and structured interview and 0.56 between assessment of the physician and self-assessment. Percentage agreement was, respectively, 50.8 and 19.6%. The assessment of the mRS through a structured interview and by self-assessment resulted in systematically higher mRS scores than the mRS scored by the physician. Self-assessment of the mRS was proven feasible. DISCUSSION: The mRS scores obtained with different assessment methods differ significantly. The agreement between the scores is low, although the reliability between the assessment methods is good. This should be considered when using the mRS in clinical trials. TRIAL REGISTRATION: www.trialregister.nl ; Unique identifier: NL7859.

Subtraction CTA: An Alternative Imaging Option for the Follow-Up of Flow-Diverter-Treated Aneurysms?

BACKGROUND AND PURPOSE: This was a pilot study to explore the diagnostic accuracy and safety of subtraction CTA combined with a single-energy metal artifact reduction algorithm (SEMAR) compared to DSA for the evaluation of intracranial aneurysm occlusion after flow diverter treatment. MATERIALS AND METHODS: We included patients treated with a flow diverter for an unruptured intracranial aneurysm between November 2015 and November 2016. The patient cohort comprised 2 groups: those who underwent follow-up imaging 1 month after flow-diverter treatment and those with a known residual intracranial aneurysm after flow diverter treatment who underwent imaging at regular follow-ups. Full-brain subtraction CTA was performed on a 320-detector row CT system. A low-dose non-enhanced volume acquisition was followed by a contrast-enhanced volume CTA. Iterative and noise-reduction filters, SEMAR, and SURESubtraction algorithms were applied. DSA was performed on a flat panel C-arm angiography system. Standard posteroanterior, lateral, 3D, and detailed 2D acquisitions were performed. Imaging was independently scored by 2 clinicians. Aneurysm occlusion (Raymond scale) was our primary outcome parameter. RESULTS: Thirteen intracranial aneurysms were evaluated with subtraction CTA and DSA. Nine aneurysm remnants were demonstrated by both subtraction CTA and DSA. The sensitivity and specificity of subtraction CTA for the detection of aneurysm occlusion were 100% (95% CI, 82.41%-100%) and 100% (95% CI, 67.55%-100%), respectively. Agreement between readers was perfect (κ = 1.0). The smallest neck remnant detected on subtraction CTA was 1.2 mm. No complications occurred. CONCLUSIONS: Subtraction CTA with single-electron metal artifact reduction is effective in the reduction of metal artifacts of flow diverters and might therefore be a viable alternative in the assessment of intracranial aneurysm occlusion after flow diverter treatment.

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.

MRA versus DSA for follow-up of coiled intracranial aneurysms: a meta-analysis.

MR angiography is proposed as a safer and less expensive alternative to the reference standard, DSA, in the follow-up of intracranial aneurysms treated with endovascular coil occlusion. We performed a systematic review and meta-analysis to evaluate the accuracy of TOF-MRA and contrast-enhanced MRA in detecting residual flow in the follow-up of coiled intracranial aneurysms. Literature was reviewed through the PubMed, Cochrane, and EMBASE data bases. In comparison with DSA, the sensitivity of TOF-MRA was 86% (95% CI: 82-89%), with a specificity of 84% (95% CI: 81-88%), for the detection of any recurrent flow. For contrast-enhanced MRA, the sensitivity and specificity were 86% (95% CI: 82-89%) and 89% (95% CI: 85-92%), respectively. Both TOF-MRA and contrast-enhanced MRA are shown to be highly accurate for detection of any recanalization in intracranial aneurysms treated with endovascular coil occlusion.

The perioperative use of oral anticoagulants during surgical procedures for carpal tunnel syndrome. A preliminary study.

BACKGROUND: To evaluate the feasibility of designing a randomized controlled study whether open carpal tunnel release (OCTR) surgery can be performed safely under systemic anticoagulant therapy using acetylsalicylacid (ASA) or acenocoumarol (ACM), this preliminary, observational study was performed. METHODS: Prospectively, during 1 year, data were collected from all patients who underwent conventional OCTR at the neurosurgical department of the Canisius Wilhelmina Hospital, Nijmegen, The Netherlands. Patients continued anticoagulant treatment perioperatively. RESULTS: A total of 364 patients were operated on, of whom 45 continued ASA and seven ACM treatment. Only one patient using ASA complained of a postoperative subcutaneous hemorrhage. In the control group without anticoagulants, none of the patients had a bleeding postoperatively. CONCLUSION: Continuation of anticoagulant treatment is safe for OCTR. The adverse effects of stopping treatment for surgery can be severe. As a result of this study, we have changed our surgery protocol for OCTR and continue anticoagulant treatment perioperatively.

Risk factors for ulnar nerve compression at the elbow: a case control study.

BACKGROUND: Ulnar nerve compression at the elbow is frequently encountered as the second most common compression neuropathy in the arm. As dexterity may be severely affected, the disease entity can seriously interfere with daily life and work. However, epidemiological research considering the risk factors is rarely performed. This study intended to investigate whether potential risk factors based on historical belief contribute to the development of ulnar nerve compression at the elbow. METHOD: A hospital based case control study was performed of patients that underwent surgical treatment for ulnar nerve compression at the elbow at the neurosurgical department from June 2004 until June 2005. Controls were those patients treated for a cervical or lumbar herniated disc. The main outcome measure was the presence of ulnar nerve compression at the elbow proven clinically, and electrodiagnostically. RESULTS: 110 patients with ulnar nerve lesions and 192 controls were identified. Smoking, education level and related working experience were identified as risk factors. Conversely, gender, BMI, alcohol consumption, trauma to the elbow, diabetes mellitus, and hypertension are not risk factors for the development of ulnar nerve compression at the elbow. CONCLUSION: Risk factors are clearly defined. In the past many factors have been described, but mostly in surgical series. This study concludes that gender, previous fracture of the elbow and BMI are not predictive factors for ulnar entrapment neuropathy. However, education and working experience are closely correlated with this entity.

Anterior submuscular transposition of the ulnar nerve. For post-operative focal neuropathy at the elbow.

Outcome studies of revision surgical treatment for recurrent or persistent neuropathy of the ulnar nerve at the elbow are relatively rare and none involves patient self-assessment. In this study of 40 patients (41 elbows), a clear discrepancy is shown between clinical assessment and the patient's own view. From clinical assessment, 20% of patients had an excellent result, whereas only one (2.5%) patient self-reported a complete cure. More reports using patient self-assessment and validated scores are required.

The arcade of Struthers: an anatomical study.

BACKGROUND: The arcade of Struthers has been described as possible cause of compression of the ulnar nerve but several authors and our own experience have doubt cast on its existence. We, therefore, performed an anatomical study to determine whether or not the arcade of Struthers exists. METHODS: Ten arms from fresh frozen cadavers were dissected. Special attention was given to the fascial layers of the medial aspect of the upper arm and the medial intermuscular septum and their relation ships to the ulnar nerve. FINDINGS: An arcade of Struthers was not found in any specimen. INTERPRETATION: The arcade of Struthers does not exist and is not an anatomical structure, but a man-made construct.