Gustavo Zanoli

EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis

The objective was to develop evidence -based recommendations and a research and educational agenda for the non-pharmacological management of hip and knee osteoarthritis (OA). The multidisciplinary task force comprised 21 experts: nurses, occupational therapists, physiotherapists, rheumatologists, orthopaedic surgeons, general practitioner, psychologist, dietician, clinical epidemiologist and patient representatives. After a preliminary literature review, a first task force meeting and five Delphi rounds, provisional recommendations were formulated in order to perform a systematic review. A literature search of Medline and eight other databases was performed up to February 2012. Evidence was graded in categories I–IV and agreement with the recommendations was determined through scores from 0 (total disagreement) to 10 (total agreement). Eleven evidence-based recommendations for the non-pharmacological core management of hip and knee OA were developed, concerning the following nine topics: assessment, general approach, patient information and education, lifestyle changes, exercise, weight loss, assistive technology and adaptations, footwear and work. The average level of agreement ranged between 8.0 and 9.1. The proposed research agenda included an overall need for more research into non-pharmacological interventions for hip OA, moderators to optimise individualised treatment, healthy lifestyle with economic evaluation and long-term follow-up, and the prevention and reduction of work disability. Proposed educational activities included the required skills to teach, initiate and establish lifestyle changes. The 11 recommendations provide guidance on the delivery of non-pharmacological interventions to people with hip or knee OA. More research and educational activities are needed, particularly in the area of lifestyle changes.

Visual analog scales for interpretation of back and leg pain intensity in patients operated for degenerative lumbar spine disorders

Study Design. A prospective observational study of visual analog scale (VAS) scores for pain in patients operated at one institution within the framework of a national registry. Objective. To describe the use of recording VAS for pain intensity in patients operated on for lumbar spine problems. Summary of Background Data. There is no consensus regarding pain outcomes assessment in spine patients. Pain intensity, recorded on a VAS, is one of the most used measures. Still, many aspects of its interpretation are still debated or unclear. Methods. A total of 755 consecutive patients, mean age 50 years (range, 15–86 years), operated from 1993 to 1998 were included in the study; there were 420 males and 335 females. Diagnoses included herniated nucleus pulposus (45%), central stenosis (19%), lateral stenosis (14%), isthmic spondylolisthesis (9%), and degenerative disc disease (9%). Local pain, radiating pain, analgesic intake, and walking ability were recorded before surgery and at 4 and 12 months after surgery. The patients’ opinions regarding the change in pain and satisfaction with the result were assessed separately. Correlation among variables reflecting perceived pain was sought. Results. Preoperative VAS mean values for local and radiating pain were significantly different in the five diagnostic groups. Significant but moderate correlation between different types of pain outcomes and with patient satisfaction was present in all cases. Conclusions. Measuring pain intensity with VAS is a useful tool in describing spine patients. In the search for a standard in the evaluation of pain as an outcome, the differences between the various methods should be taken into account.

Development of the Italian version of the oswestry disability index (ODI-I): A cross-cultural adaptation, reliability, and validity study

Study Design. Evaluation of the psychometric properties of a translated, culturally adapted questionnaire. Objective. Translating, culturally adapting, and validating the Italian version of the Oswestry Disability Index (ODI-I), allowing its use in Italian-speaking patients with low back pain inside and outside Italy. Summary of Background Data. Growing attention is devoted to standardized outcome measures to improve interventions for low back pain. A translated form of the ODI in patients with low back pain has never been validated within the Italian population. Methods. The ODI-I questionnaire was developed involving forward-backward translation, final review by an expert committee and test of the prefinal version to establish as better as possible proper correspondence with the original English latest version (2.1a). Psychometric testing included factor analysis, reliability by internal consistency (Cronbach α) and test-retest repeatability (Intraclass Coefficient Correlation), concurrent validity by comparing the ODI-I to Visual Analogue Scale, (Pearson correlation), and construct validity by comparing the ODI-I to Roland Morris Disability Questionnaire, RMDQ, and to Short Form Health Survey, Short Form Health Survey-36 (Pearson correlation). Results. The authors required a 3-month period before achieving a shared version of the ODI-I. The questionnaire was administered to 126 subjects, showing satisfying acceptability. Factor analysis demonstrated a 1-factor structure (45% of explained variance). The questionnaire showed high internal consistency (α = 0.855) and good test-retest reliability (ICC = 0.961). Concurrent validity was confirmed by a high correlation with Visual Analogue Scale (r = 0.73, P < 0.001), Construct validity revealed high correlations with RMDQ (r = 0.819, P < 0.001), and with Short Form Health Survey-36 domains, highly significant with the exception of Mental Health (r = −0.139, P = 0.126). Conclusion. The ODI outcome measure was successfully translated into Italian, showing good factorial structure and psychometric properties, replicating the results of existing language versions of the questionnaire. Its use is recommended in research practice.

Italian version of the Roland Disability Questionnaire, specific for low back pain: cross-cultural adaptation and validation

Abstract. Over the last 10 years, patient-oriented evaluations using questionnaires have become an important aspect of clinical spinal outcome studies. Any questionnaire must be translated and culturally adapted in order to be used with different language groups, and the translated version must then be evaluated for reliability and validity, which are fundamental attributes of any measurement tool. The Roland Disability Questionnaire, a low back pain disease-specific tool, was submitted to translation into Italian and to cross-cultural adaptation following the Guillemin criteria. It was then validated on 70 patients (37 male and 33 female; mean age 58, range: 28–67) suffering from low back pain as assessed by clinical examination, imaging and also electromyography in cases of suspected neurological impairment. The test-retest reliability, assessed with intraclass correlation, was 0.92 and the internal consistency reached a Cronbachs alpha of 0.82. The Italian version of the Roland Disability Questionnaire satisfied the validation criteria, showing characteristics of reliability and validity similar to previously published versions translated and adapted for other countries.

Patient outcomes after Harrington instrumentation for idiopathic scoliosis : A 15- to 28-year evaluation

Study Design. A retrospective study was performed, using the Short Form-36 Health Survey and the Roland and Morris Disability Questionnaire, to investigate patient outcomes after fusion for adolescent idiopathic scoliosis using Harrington rod instrumentation. Objective. To evaluate health-related quality of life and low back pain in a long-term follow-up study of surgery for adolescent idiopathic scoliosis. Summary of Background Data. The commonly accepted surgical treatment for idiopathic evolutive scoliosis is vertebral fusion. It has been suggested that this procedure may cause low back pain and a poor quality of life over the long term. Outcome measures after surgery for adolescent idiopathic scoliosis have focused mainly on objective parameters such as radiographic measures. However, this information has proved to be correlated only weakly with outcomes that are more relevant to patients, such as functional status and symptoms. Until recently, only a few long-term outcome studies have used standardized and validated patient-oriented tools to evaluate surgically treated patients with scoliosis. Methods. In this study, 70 patients treated with a standard Harrington technique were recontacted and evaluated by means of self-administered questionnaires (Short Form-36 Health Survey and Roland and Morris Disability, clinical examination, and radiographic analysis. Preoperative and follow-up radiographic findings were registered. Relations between radiographic and patient-oriented data were evaluated. Results. A comparison between the current sample and the Italian age-matched normative data for the Short Form-36 Health Survey showed them to have a similar pattern. Findings showed the patient-oriented outcome to be correlated inversely with the extension of vertebral fusion and the preoperative Cobb angle. Conclusion. Long-term follow-up evaluation of Harrington rod fusion for adolescent idiopathic scoliosis showed no important impairment of health-related quality of life, as measured by patient-oriented evaluation.

Updated Method Guidelines for Cochrane Musculoskeletal Group Systematic Reviews and Metaanalyses

The Cochrane Musculoskeletal Group (CMSG), one of 53 groups of the not-for-profit, international Cochrane Collaboration, prepares, maintains, and disseminates systematic reviews of treatments for musculoskeletal diseases. It is important that authors conducting CMSG reviews and the readers of our reviews be aware of and use updated, state-of-the-art systematic review methodology. One hundred sixty reviews have been published. Previous method guidelines for systematic reviews of interventions in the musculoskeletal field published in 2006 have been substantially updated to incorporate methodological advances that are mandatory or highly desirable in Cochrane reviews and knowledge translation advances. The methodological advances include new guidance on searching, new risk-of-bias assessment, grading the quality of the evidence, the new Summary of Findings table, and comparative effectiveness using network metaanalysis. Method guidelines specific to musculoskeletal disorders are provided by CMSG editors for various aspects of undertaking a systematic review. These method guidelines will help improve the quality of reporting and ensure high standards of conduct as well as consistency across CMSG reviews.

SF-36 scores in degenerative lumbar spine disorders: Analysis of prospective data from 451 patients

Background When using Health-Related Quality of Life (HRQoL) in assessing outcomes of treatment, normative data for different diagnoses are needed to allow cross-comparisons of existing and future studies. We determined the SF-36 scores in patients with surgical lumbar spine problems. Methods This is a prospective observational study of consecutive surgical patients in one institution. In addition to SF-36 questionnaire responses, local pain, radiating pain, analgesic intake and walking ability were recorded, together with several other demographic variables. 451 patients (50% women) with median age 52 (13–88) years, operated from 1998 through 2002, were included in the study. Results Preoperative SF-36 scores were significantly lower than those derived from previously published material (the general population, nonspecific low back pain (LBP) patients, other samples of non-LBP patients), also with the use of normbased scoring. Sick-leave and workers compensation seemed to affect perceived Health-Related Quality of Life (HRQoL), but smoking habits did not. Some SF-36 domains showed a possible discriminating pattern between diagnoses. Interpretation HRQoL reported by patients scheduled for lumbar spine surgery was much worse than for the normal population and for LBP patients. The normative SF-36 values provided may be used as a benchmark in future studies.

Cross-cultural Adaptation of the Lumbar North American Spine Society Questionnaire for Italian-speaking Patients With Lumbar Spinal Disease

Study Design. A cross-cultural adaptation and cross-sectional study of a sample of lumbar spine patients, with a subsample followed prospectively for retest reliability. Objectives. To assess the Italian version instrument reliability and validity. Summary of Background Data. The orthopaedic outcome measurements have been usually focused on objective parameters as radiograph measures or other technical aspects. However, these parameters are weakly related with outcomes that are more relevant to patients as functional status and symptoms. In the last ten years, the patient-oriented measures have become an important aspect of spinal clinical outcome evaluation. The most common instruments to assess patient perspective are self-administered questionnaires that must be validated by a widely accepted process to evaluate reliability and validity, which are fundamental for every instrumental measure. Methods. The North American Spine Society (NASS) questionnaire was culturally adapted for Italian-speaking people following the Guillemin criteria. The Italian version was tested on 74 consecutive patients who were referred to the authors’ department and suffered from low back pain with leg irradiation. The results were compared with other validated patient-oriented measures. Forty-eight-hour retests were performed on a subsample of 45 patients. Results. The questionnaire was favorably accepted by patients. The lumbar spine pain and disability and neurogenic symptoms subscales showed a high correlation with other patient-oriented measures, as hypothesized, and it also showed good values on test-retest. Conclusions. The questionnaire should be considered for patient health status monitoring and for clinical trials.

Reliability of the prospective data collection protocol of the Swedish Spine Register: Test-retest analysis of 119 patients

Background The Swedish Lumbar Spine Register has been collecting patient-based data since 2000, and more than 80% of all spinal units in Sweden are now including their patients. In a few years, it will produce useful clinical information just as arthroplasty registers have, but to permit proper interpretation of data in the future, the reliability of the protocol must be tested. Methods Between January 2000 and March 2003, a sample of 122 patients was asked to fill in the questionnaire twice: 63 preoperatively and 59 postoperatively. Test-retest reliability was calculated with intra-class correlation coefficient (ICC) or weighted kappa when appropriate. Results Test-retest interval varied (range 0–235 days); in the “worst case scenario”, the lowest ICC for SF-36 was 0.62 for the postoperative RE. Other values were above 0.70; for non-SF variables, ICC was in the range 0.79–0.89. Kappa values for the ordinal outcomes were high (0.74–0.91). Interpretation When separate reliability analysis was performed according to the time interval, a 0–2 days interval produced a significant memory effect; after 3 weeks, the reliability seemed to drop in the preoperative group, whereas results were reproducible up to 9 weeks postoperatively. The protocol studied can reliably detect postoperative improvements between large groups of patients such as in a register.

Zanoli's procedure for overlapping fifth toe: Retrospective study of 18 cases followed for 4–17 years

Digitus quintus superductus pedis (overlapping fifth toe) is a congenital deformity, often bilateral, in which the fifth toe is medially directed, rotated and hyperextended. There is no consensus regarding the best treatment. We describe our experience using Zanolis procedure, which is a tenodesis procedure using the extensor tendon of the fifth toe. Between 1979 and 1993, we operated on 16 patients (7 bilateral, total 23 feet). 13 (10 women) patients (18 feet), with a mean age of 26 (19-40) years, were seen on follow-up. The mean follow-up time was 8 (4-17) years. Pain relief was achieved in all patients. From the surgeons point of view, 3 toes overcorrected due to technical errors were considered unsatisfactory. All patients, however, were satisfied with the result and would advise other patients to undergo the same operation.