A. Mechteld Lehr

Reliability and validity of the adapted Dutch version of the revised Scoliosis Research Society 22-item questionnaire

BACKGROUND CONTEXT As in other fields of medicine, there is an increasing interest among orthopedic surgeons to measure health-related quality of life in adolescent idiopathic scoliosis patients and to evaluate the burden of disease and the effectiveness of different treatment strategies. The development of the revised Scoliosis Research Society 22-item patient questionnaire (SRS-22r) enabled a comprehensive evaluation of health-related quality of life of these patients. Over the years, the SRS-22r gained wide acceptance and has been used in several different countries, languages, and cultures. The SRS-22r has not been translated into Dutch to date. PURPOSE To translate the SRS-22r into Dutch and adapt it cross-culturally as outlined by international guidelines and to test its psychometric properties to measure health-related quality of life of adolescent idiopathic scoliosis patients in the Netherlands. STUDY DESIGN/SETTING A cross-sectional, multicenter validation study. PATIENT SAMPLE A total of 135 adolescent idiopathic scoliosis patients (mean age 15.1 years old) of three major scoliosis centers in the Netherlands were enrolled in this study. Ninety-two (68%) subjects completed the Dutch SRS-22r, Child Health Questionnaire (CHQ)-CF87 (golden standard for adolescents), and Short Form (SF)-36 (golden standard for adults). Two weeks later, 73 (79%) of 92 respondents returned a second SRS-22r. Demographics, curve type, Risser stage, and treatment status were documented. OUTCOME MEASURES Floor and ceiling effects, internal consistency, reproducibility, concurrent validity, and discriminative ability of the Dutch version of the SRS-22r questionnaire. METHODS For content analysis, SRS-22r domain scores (function, pain, self-image, mental health, and satisfaction with management) were explored and floor and ceiling effects were determined. Cronbachs α was calculated for internal consistency of each domain of the questionnaires and reproducibility was assessed by test-retest reliability analysis. Using Pearsons correlation coefficient, comparison of the domains of the Dutch SRS-22r with the domains of the SF-36 and Child Health Questionnaire-CF87 assessed the concurrent validity. Differences in SRS-22r domain scores between untreated patients with different curve severity determined the discriminative ability of the questionnaire. RESULTS The SRS-22r domains as well as the SF-36 and CHQ-CF87 domains demonstrated no floor effects, but the function, pain, and satisfaction with management domains had ceiling effects, indicating the proportion of subjects with the maximum score between 19.6% and 33.0%. Internal consistency was very satisfactory for all SRS-22r domains: Cronbachs α was between 0.718 and 0.852. By omitting question 15, the internal consistency of the function domain increased from 0.746 to 0.827. Test-retest reliability was ≥0.799 for all SRS-22r domains. The function, pain, mental health, and self-image domains correlated under the 0.001 significance level with the corresponding CHQ-CF87 and SF-36 domains. The satisfaction with management domain did not correlate with the other questionnaires. The SRS-22r had the ability to detect differences between groups with different curve severity; patients with a severe scoliotic curvature had significantly lower pain and self-image domain scores than patients with relatively mild scoliosis. CONCLUSIONS The Dutch SRS-22r had the properties needed for the measurement of patient perceived health-related quality of life of adolescent idiopathic scoliosis patients in the Netherlands. The Dutch SRS-22r could be used for the longitudinal follow-up of adolescent idiopathic scoliosis patients from adolescence to adulthood and for establishing the effects of conservative or invasive surgical treatment.

Toward the development of a universal outcome instrument for spine trauma : A systematic review and content comparison of outcome measures used in spine trauma research using the ICF as reference

Study Design. A systematic literature review. Objective. The aim of this study was (1) to identify patient-reported and clinician-based outcome measures most frequently used to evaluate the function and health of spine trauma patients, (2) to identify and quantify the concepts of these measures using the International Classification of Functioning, Disability, and Health (ICF) as reference, and (3) to describe their clinimetric properties. Summary of Background Data. There is a real need for a disease-specific outcome instrument to measure the effect size of various treatment options in a variety of traumatic spinal column injuries. Methods. A systematic literature search was conducted in several databases. From the included studies, outcome measures were extracted. The items and underlying concepts of the identified outcome measures were specified and linked to the ICF categories. Finally, as far as available in literature, the clinimetric properties of the obtained measures were analyzed. Results. Out of 5117 screened references, 245 were included, and 17 different frequently used outcome measures were identified. Meaningful concepts of the items and response options of the retrieved outcome measures were linked to a total of 105 different ICF categories, aggregated to 57 first- or second-level categories. The categories were linked to the components activities and participation (n = 31), body functions (n = 17), environmental factors (n = 8), and body structures (n = 1). Overall, there is only limited evidence on the measurement properties, except for some disease-specific questionnaires, such as Oswestry Disability Index, Roland–Morris Disability Questionnaire, Neck Disability Index, and Cervical Spine Outcome Questionnaire. Conclusion. The current systematic literature review revealed great diversity in the use and content of outcome measures to evaluate the functioning and health of spine trauma patients, with 17 different outcome measures linked to 57 unique ICF categories. This study creates an evidence base for a consensus meeting during which a core set of ICF categories for outcome measurement in spine trauma will be decided. Level of Evidence: 2

Towards the development of an outcome instrument for spinal trauma: an international survey of spinal surgeons.

Study Design. International web-based survey. Objective. To identify the most relevant aspects of human function and health status from the perspective of health care professionals involved in the treatment of spinal trauma patients. Summary of Background Data. There is no universally accepted outcome instrument available that is specifically designed or validated for spinal trauma patients, contributing to controversies related to the optimal treatment and evaluation of many types of spinal injuries. Therefore, the AOSpine Knowledge Forum Trauma aims to develop such an instrument using the International Classification of Functioning, Disability, and Health (ICF) as its basis. Methods. Experts from the 5 AOSpine International world regions were asked to give their opinion on the relevance of a compilation of 143 ICF categories for spinal trauma patients on a 3-point scale: “not relevant,” “probably relevant,” or “definitely relevant.” The responses were analyzed using frequency analysis. Possible differences in responses between the 5 world regions were analyzed with the Fisher exact test and descriptive statistics. Results. Of the 895 invited AOSpine International members, 150 (16.8%) participated in this study. A total of 13 (9.1%) ICF categories were identified as definitely relevant by more than 80% of the participants. Most of these categories were related to the ICF component “activities and participation” (n = 8), followed by “body functions” (n = 4), and “body structures” (n = 1). Only some minor regional differences were observed in the pattern of answers. Conclusion. More than 80% of an international group of health care professionals experienced in the clinical care of adult spinal trauma patients indicated 13 of 143 ICF categories as definitely relevant to measure outcomes after spinal trauma. This study creates an evidence base to define a core set of ICF categories for outcome measurement in adult spinal trauma patients. Level of Evidence: N/A

Toward Developing a Specific Outcome Instrument for Spine Trauma : An Empirical Cross-sectional Multicenter ICF-Based Study by AOSpine Knowledge Forum Trauma

Study Design. Empirical cross-sectional multicenter study. Objective. To identify the most commonly experienced problems by patients with traumatic spinal column injuries, excluding patients with complete paralysis. Summary of Background Data. There is no disease or condition-specific outcome instrument available that is designed or validated for patients with spine trauma, contributing to the present lack of consensus and ongoing controversies in the optimal treatment and evaluation of many types of spine injuries. Therefore, AOSpine Knowledge Forum Trauma started a project to develop such an instrument using the International Classification of Functioning, Disability and Health (ICF) as its basis. Methods. Patients with traumatic spinal column injuries, within 13 months after discharge from hospital were recruited from 9 trauma centers in 7 countries, representing 4 AOSpine International world regions. Health professionals collected the data using the general ICF Checklist. The responses were analyzed using frequency analysis. Possible differences between the world regions and also between the subgroups of potential modifiers were analyzed using descriptive statistics and Fisher exact test. Results. In total, 187 patients were enrolled. A total of 38 (29.7%) ICF categories were identified as relevant for at least 20% of the patients. Categories experienced as a difficulty/impairment were most frequently related to activities and participation (n = 15), followed by body functions (n = 6), and body structures (n = 5). Furthermore, 12 environmental factors were considered to be a facilitator in at least 20% of the patients. Conclusion. Of 128 ICF categories of the general ICF Checklist, 38 ICF categories were identified as relevant. Loss of functioning and limitations in daily living seem to be more relevant for patients with traumatic spinal column injuries rather than pain during this time frame. This study creates an evidence base to define a core set of ICF categories for outcome measurement in adult spine trauma patients. Level of Evidence: 4

Toward a specific outcome instrument for spinal trauma: how to measure function and health.

Study Design. Validation study. Objective. To investigate the most valid, reliable, and comprehensible response scale for spinal trauma patients to compare their current level of function and health with their preinjury state. Summary of Background Data. In the context of a main project of the AOSpine Knowledge Forum Trauma to develop a disease-specific outcome instrument for adult spinal trauma patients, the need to identify a response scale that uniquely reflects the degree to which a spine trauma patient has returned to his or her preinjury state is crucial. Methods. In the first phase, 3 different question formats and 3 different response formats were investigated in a questionnaire, which was administered twice. Based on the results of the first phase, in the second phase, a modified questionnaire was administered once to a second group of patients to investigate 5 different response formats: 0–10 Numeric Rating Scale-11, 0–100 Numeric Rating Scale-101, Visual Analogue Scale, Verbal Rating Scale, and Adjective Scale. All patients were interviewed in a semistructured fashion to identify their preferences. Multiple statistical analyses were performed: test-retest reliability, internal consistency, and discriminant validity. Results. Twenty eligible patients were enrolled in the first phase and 59 in the second phase. The initial phase revealed the highest preference for 1 specific question format (60.0% and 86.7% after the first and second administration of the questionnaire, respectively). The second phase showed the Verbal Rating Scale as the most preferred response format (35.6%). The semistructured interviews revealed that overall, a subgroup of patients preferred a verbal response format (42.4%), and another group of patients preferred a numerical response format (49.1%). The statistical analysis showed good to excellent psychometric properties for all formats. Conclusion. The most preferred question and response formats were identified for use in a disease-specific outcome instrument for spinal trauma patients. Level of Evidence: 3

Missed low-grade infection in suspected aseptic loosening has no consequences for the survival of total hip arthroplasty

Background and purpose — Aseptic loosening and infection are 2 of the most common causes of revision of hip implants. Antibiotic prophylaxis reduces not only the rate of revision due to infection but also the rate of revision due to aseptic loosening. This suggests under-diagnosis of infections in patients with presumed aseptic loosening and indicates that current diagnostic tools are suboptimal. In a previous multicenter study on 176 patients undergoing revision of a total hip arthroplasty due to presumed aseptic loosening, optimized diagnostics revealed that 4–13% of the patients had a low-grade infection. These infections were not treated as such, and in the current follow-up study the effect on mid- to long-term implant survival was investigated. Patients and methods — Patients were sent a 2-part questionnaire. Part A requested information about possible re-revisions of their total hip arthroplasty. Part B consisted of 3 patient-related outcome measure questionnaires (EQ5D, Oxford hip score, and visual analog scale for pain). Additional information was retrieved from the medical records. The group of patients found to have a low-grade infection was compared to those with aseptic loosening. Results — 173 of 176 patients from the original study were included. In the follow-up time between the revision surgery and the current study (mean 7.5 years), 31 patients had died. No statistically significant difference in the number of re-revisions was found between the infection group (2 out of 21) and the aseptic loosening group (13 out of 152); nor was there any significant difference in the time to re-revision. Quality of life, function, and pain were similar between the groups, but only 99 (57%) of the patients returned part B. Interpretation — Under-diagnosis of low-grade infection in conjunction with presumed aseptic revision of total hip arthroplasty may not affect implant survival.

The selection of core International Classification of Functioning, Disability, and Health (ICF) categories for patient-reported outcome measurement in spine trauma patients-results of an international consensus process

BACKGROUND CONTEXT There is no outcome instrument specifically designed and validated for spine trauma patients without complete paralysis, which makes it difficult to compare outcomes of different treatments of the spinal column injury within and between studies. PURPOSE The paper aimed to report on the evidence-based consensus process that resulted in the selection of core International Classification of Functioning, Disability, and Health (ICF) categories, as well as the response scale for use in a universal patient-reported outcome measure for patients with traumatic spinal column injury. STUDY DESIGN/SETTING The study used a formal decision-making and consensus process. PATIENT SAMPLE The sample includes patients with a primary diagnosis of traumatic spinal column injury, excluding completely paralyzed and polytrauma patients. OUTCOME MEASURES The wide array of function and health status of patients with traumatic spinal column injury was explored through the identification of all potentially meaningful ICF categories. METHODS A formal decision-making and consensus process integrated evidence from four preparatory studies. Three studies aimed to identify relevant ICF categories from three different perspectives. The research perspective was covered by a systematic literature review identifying outcome measures focusing on the functioning and health of spine trauma patients. The expert perspective was explored through an international web-based survey among spine surgeons from the five AOSpine International world regions. The patient perspective was investigated in an international empirical study. A fourth study investigated various response scales for their potential use in the future universal outcome instrument. This work was supported by AOSpine. AOSpine is a clinical division of the AO Foundation, an independent medically guided non-profit organization. The AOSpine Knowledge Forums are pathology-focused working groups acting on behalf of AOSpine in their domain of scientific expertise. RESULTS Combining the results of the preparatory studies, the list of ICF categories presented at the consensus conference included 159 different ICF categories. Based on voting and discussion, 11 experts from 6 countries selected a total of 25 ICF categories as core categories for patient-reported outcome measurement in adult traumatic spinal column injury patients (9 body functions, 14 activities and participation, and 2 environmental factors). The experts also agreed to use the Numeric Rating Scale 0-100 as response scale in the future universal outcome instrument. CONCLUSIONS A formal consensus process integrating evidence and expert opinion led to a set of 25 core ICF categories for patient-reported outcome measurement in adult traumatic spinal column injury patients, as well as the response scale for use in the future universal disease-specific outcome instrument. The adopted core ICF categories could also serve as a benchmark for assessing the content validity of existing and future outcome instruments used in this specific patient population.