Core Outcome Measures Index Research Articles

The assessment of complications after spine surgery: time for a paradigm shift?

Background contextRecent years have witnessed a shift in the assessment of spine surgical outcomes with a greater focus on the patient's perspective. However, this approach has not been widely extended to the assessment of complications. PurposeThe present study sought to quantify the patient-rated impact/severity of complications of spine surgery and directly compare the incidences of surgeon-rated and patient-reported complications. Study designProspective study of patients undergoing surgery for painful degenerative lumbar disorders, being operated in the Spine Center of an orthopedic hospital. Patient sampleA total of 2,303 patients (mean [standard deviation] age, 61.9 [15.1] years; 1,136 [49.3%] women and 1,167 [50.7%] men). Outcome measuresPatients: Core Outcome Measures Index, self-rated complications, bothersomeness of complications, global treatment outcome, and satisfaction. Surgeons: Spine Tango surgery and follow-up documentation forms registering surgical details and complications. MethodsPatients completed questionnaires before and 3 months after surgery. Surgeons documented complications before discharge and at the first postoperative follow-up, 6 to 12 weeks after surgery. ResultsIn total, 615 out of 2,303 (27%) patients reported complications, with “bothersomeness” ratings of 1%, not at all; 22%, slightly; 26%, moderately; 34%, very; and 17%, extremely bothersome. Patients most commonly reported sensory disturbances (35% of those reporting a complication) or ongoing/new pain (27%) followed by wound healing problems (11%) and motor disturbances (8%). The surgeons documented complications in 19% of patients. There was a minimal overlap regarding the presence or absence of complications in any given patient. ConclusionsMost complications reported by the patient are perceived to be at least moderately bothersome and are, hence, not inconsequential. Surgeons reported lower complication rates than the patients did, and there was only moderate agreement between the ratings of the two. As with treatment outcome, complications and their severity should be assessed from both the patient's and the surgeon's perspectives.

A Core Outcome Measures Index (COMI) for Patients Undergoing Hip Arthroplasty

Outcome is best assessed with both generic and disease-specific instruments, but using many, lengthy questionnaires increases the burden, quality, and cost of data collection.We evaluated a short, hip-oriented Core Outcome Measures Index (COMI-hip), comprising six items (pain, function, symptom-specific well-being, quality of life, and disability) extracted from established full-length questionnaires; 214 consecutive total hip arthroplasty (THA) patients participated. Scores for the single items and sum-score of COMI-hip correlated well with those of the full-length instruments (r= -0.56 to -0.88). At 6 and 12 months' follow-up, the COMI-hip showed similar responsiveness (Cohen's d for effect size, 1.36-3.08) to the full-length questionnaires (1.65-2.34). The COMI-hip proved a simple but valid outcome instrument in THA patients. Its brevity renders it a potentially valuable instrument for routine use.

Cross-cultural adaptation and validation of the Polish version of the Core Outcome Measures Index for low back pain

The core outcome measures index (COMI) is a short, multidimensional outcome scale validated for the use by patients with spinal disorders. It is a recommended instrument in the Spine Society of Europe Spine Tango Registry. The purpose of this study was to produce a cross-culturally adapted and validated Polish COMI. The cross-cultural adaptation was carried out using the established guidelines. One-hundred and sixty-nine patients with chronic low back pain were enrolled, 89 took part in the reproducibility part of the study. Data quality, construct validity and reproducibility were assessed. The quality of data was very good with very few missing answers and modest floor effect. Reliability expressed as intraclass correlation coefficient (ICC) was 0.90 (95 % CI 0.85-0.93) for the overall COMI score and for most of the individual core items. The minimum detectable change (MDC95%) was 1.79. The Polish version of COMI showed a favorable reproducibility similar to that of previously tested language versions. The COMI scores correlated sufficiently with existing measures. This version of the COMI is a valuable instrument for the use by Polish-speaking patients with spinal disorders.

Cross-cultural adaptation and validation of the Norwegian version of the Core Outcome Measures Index for low back pain

The Core Outcome Measures Index (COMI) is a short multidimensional scale covering all domains recommended to be included as outcome measures for patients with low back pain (LBP). The purpose of the present study was to translate and cross-culturally adapt the COMI into Norwegian and to test clinimetric properties of the Norwegian COMI version in patients with non-specific LBP recruited from various clinical settings. Ninety patients with non-specific LBP from primary care and hospital settings participated in the validation part and 61 also in the reproducibility part of the study (1 week apart). Acceptability, data quality, reproducibility and construct validity were investigated. The questionnaire was well accepted and with little missing data and end effects. Reliability in terms of intraclass correlations (ICC) was satisfactory for the COMI index [0.89 (95 % CI 0.82-0.94)] and most single-core items. Agreement was acceptable for the COMI index [standard error of measurement (SEM(agreement)) 0.80, minimal detectable change (MDC(individual)) 2.21], but exceeded the minimal standard of acceptability in some of the individual core items. Construct validity was acceptable for the COMI index. The Norwegian version of the COMI index shows acceptable clinimetric properties in our patient population, but some of the sub-items had shortcomings. Our study, however, support the usefulness of the COMI index as an applicable stand-alone global scale when a light respondent burden is advisable.

The bothersomeness of patient self-rated “complications” reported 1 year after spine surgery

The last few decades have witnessed a paradigm shift in the assessment of outcome in spine surgery, with patient-centred questionnaires superseding traditional surgeon-based assessments. The assessment of complications after surgery and their impact on the patient has not enjoyed this same enlightened approach. This study sought to quantify the incidence and bothersomeness of patient-rated complications 1 year after surgery. Patients with lumbar degenerative disorders, operated with the goal of pain relief between October 2006 and September 2010, completed a questionnaire 1 year postoperatively enquiring about complications arising as a consequence of their operation. They rated the bothersomeness of any such complications on a 5-point scale. Global outcome of surgery and satisfaction at the 12-month follow-up were also rated on 5-point Likert scales. The multidimensional Core Outcome Measures Index (COMI) was completed preoperatively and at the 12-month follow-up. Of 2,282 patients completing the questionnaire (92% completion rate), 687 (30.1%) reported complications, most commonly sensory disturbances (36% of those with complications) or ongoing/new pain (26%), followed by motor problems (8%), pain plus neurological disturbances (11%), and problems with wound healing (6%). The corresponding "bothersomeness" ratings for these were: 1% not at all, 23% slightly, 27% moderately, 31% very, and 18% extremely bothersome. The greater the bothersomeness, the worse the global outcome (Rho = 0.51, p < 0.0001), patient satisfaction (Rho = 0.44, p < 0.0001) and change in COMI score (Rho = 0.52, p < 0.0001). Most complications reported by the patient are perceived to be at least moderately bothersome and hence are not inconsequential. Complications and their severity should be assessed from both the patient's and the surgeon's perspectives--not least to better understand the reasons for poor outcome and dissatisfaction with treatment.

Usefulness of the Core Outcome Measures Index in Daily Clinical Practice for Assessing Patients with Degenerative Lumbar Disease

Introduction. Outcome evaluation is an important aspect of the treatment of patients with degenerative lumbar disease. We evaluated the usefulness of the Core Outcome Measures Index (COMI) in assessing people affected by degenerative lumbar disease in daily clinical practice. Methods. We evaluated 221 patients who had completed preoperatively and 2 years after surgery VAS pain, Short Form-36 (SF-36), Oswestry Disability Index (ODI) and COMI. We calculated the change of scores and its sensitivity to change. The internal consistency of the COMI items and the correlation between the COMI scores and the scores of the other measurements were assessed. Results. Statistically significant differences were observed between the mean scores of the preoperative and 2 years questionnaires for nearly all measurements. COMI showed a good internal consistency, except for the preoperative pain subscale. The sensitivity to change was high for the total COMI and its pain and well-being subscales and moderate for the rest. The COMI demonstrated strong correlation with the other measurements. Conclusions. The COMI is a useful tool for assessing the patient-based outcome in the studied population. Given its simplicity, good correlation with the SF-36 and ODI and its good sensitivity to change, it could replace more cumbersome instruments in daily clinical practice.

Cross-cultural adaptation and assessment of the reliability and validity of the Core Outcome Measures Index (COMI) for the Brazilian-Portuguese language

The use of patient-orientated questionnaires is of utmost importance in assessing the outcome of spine surgery. Standardisation, using a common set of outcome measures, is essential to aid comparisons across studies/in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders. This study aimed to produce a Brazilian-Portuguese version of the COMI. A cross-cultural adaptation of the COMI into Brazilian-Portuguese was carried out using established guidelines. 104 outpatients with chronic LBP (>3 months) were recruited from a Public Health Spine Medical Care Centre. They completed a questionnaire booklet containing the newly translated COMI, and other validated symptom-specific questionnaires: Oswestry Disability Index (ODI) and Roland Morris disability scale (RM), and a pain visual analogue scale. All patients completed a second questionnaire within 7-10 days to assess reproducibility. The COMI summary score displayed minimal floor and ceiling effects. On re-test, the responses for each individual domain of the COMI were within 1 category in 98% patients for the domain 'function', 96% for 'symptom-specific well-being', 97% for 'general quality of life', 99% for 'social disability' and 100% for 'work disability'. The intraclass correlation coefficients (ICC(2,1)) for COMI pain and COMI summary scores were 0.91-0.96, which compared favourably with the corresponding values for the RM (ICC, 0.99) and ODI (ICC, 0.98). The standard error of measurement for the COMI was 0.6, giving a "minimum detectable change" (MDC95%) of approximately 1.7 points i.e., the minimum change to be considered "real change" beyond measurement error. The COMI scores correlated as hypothesised (Rho, 0.4-0.8) with the other symptom-specific questionnaires. The reproducibility of the Brazilian-Portuguese version of the COMI was comparable to that of other language versions. The COMI scores correlated in the expected manner with existing but longer symptom-specific questionnaires suggesting good convergent validity for the COMI. The Brazilian-Portuguese COMI represents a valuable tool for Brazilian study-centres in future multicentre clinical studies and surgical registries.

Reliability and validity of the cross-culturally adapted French version of the Core Outcome Measures Index (COMI) in patients with low back pain

To conduct a cross-cultural adaptation of the Core Outcome Measures Index (COMI) into French according to established guidelines. Seventy outpatients with chronic low back pain were recruited from six spine centres in Switzerland and France. They completed the newly translated COMI, and the Roland Morris disability (RMQ), Dallas Pain (DPQ), adjectival pain rating scale, WHO Quality of Life, and EuroQoL-5D questionnaires. After ~14days RMQ and COMI were completed again to assess reproducibility; a transition question (7-point Likert scale; "very much worse" through "no change" to "very much better") indicated any change in status since the first questionnaire. COMI whole scores displayed no floor effects and just 1.5% ceiling effects. The scores for the individual COMI items correlated with their corresponding full-length reference questionnaire with varying strengths of correlation (0.33-0.84, P<0.05). COMI whole scores showed a very good correlation with the "multidimensional" DPQ global score (Rho=0.71). 55 patients (79%) returned a second questionnaire with no/minimal change in their back status. The reproducibility of individual COMI 5-point items was good, with test-retest differences within one grade ranging from 89% for 'social/work disability' to 98% for 'symptom-specific well-being'. The intraclass correlation coefficient for the COMI whole score was 0.85 (95% CI 0.76-0.91). In conclusion, the French version of this short, multidimensional questionnaire showed good psychometric properties, comparable to those reported for German and Spanish versions. The French COMI represents a valuable tool for future multicentre clinical studies and surgical registries (e.g. SSE Spine Tango) in French-speaking countries.

Validity and responsiveness of the Core Outcome Measures Index (COMI) for the neck

Patient-orientated outcome questionnaires are essential to evaluate treatment success. To compare different treatments, hospitals, and surgeons, standardised questionnaires are required. The present study examined the validity and responsiveness of the Core Outcome Measurement Index for neck pain (COMI-neck), a short, multidimensional outcome instrument. Questionnaires were completed by patients with degenerative problems of the cervical spine undergoing cervical disc arthroplasty before (N = 89) and 3 months after (N = 75) surgery. The questionnaires comprised the EuroQol-Five Dimension (EQ-5D), the North American Spine Society Cervical Spine Outcome Assessment Instrument (NASS-cervical) and the COMI-neck. The COMI and NASS-cervical scores displayed no notable floor or ceiling effects at any time point whereas for the EQ-5D, the highest values [corrected] were reached in around 32.5% of patients at follow-up. With one exception (symptom-specific well-being), the individual COMI items and the COMI summary score correlated to the expected extent (R = 0.4-0.8) with the scores of the chosen reference questionnaires. The area under the curve (AUC) generated by ROC analysis was significantly higher for the COMI (0.96) than for any other instrument/subscale when self reported treatment outcome was used as the external criterion, dichotomised as "good" (operation helped a lot/helped) versus "poor" (operation helped only a little/didn't help/made things worse). The COMI had a high effect size (standardised response mean; SRM) (2.34) for the good global outcome group and a low SRM for the poor outcome group (0.34). The EQ-5D and the NASS-cervical lacked this ability to differentiate between the two groups, showing less distinct SRMs for good and poor outcome groups. This study provides evidence that the COMI-neck is a valid and responsive questionnaire in the population of patients examined. Further investigations should examine its applicability in other patient groups with less severe neck pain or undergoing other treatment modalities.

To fuse or not to fuse in lumbar degenerative spondylolisthesis: do baseline symptoms help provide the answer?

Clinical symptoms in lumbar degenerative spondylolisthesis (LDS) vary from predominantly radiating pain to severe mechanical low back pain. We examined whether the outcome of surgery for LDS varied depending on the predominant baseline symptom and the treatment administered [decompression with fusion (D&F) or decompression alone (D)]. 213 consecutive patients (69 ± 9 years; 155f, 58 m) participated. Inclusion criteria were LDS, maximum three affected levels, no previous surgery at the affected level, and D (N = 56) or D&F (N = 157) as the operative procedure. Pre-op and at 12 months' follow-up (FU), patients completed the multidimensional Core Outcome Measures Index (COMI) including 0-10 leg-pain (LP) and LBP scales. At 12 months' FU, patients rated global outcome which was then dichotomised into "good" and "poor". Pre-operatively, LBP and COMI scores were significantly worse (p < 0.05) in the D&F group than in the D group. The improvement in COMI at 12 months' FU was significantly greater for D&F than for D (p < 0.001) and was not influenced by the patient's declared "main problem" at baseline (back pain, leg pain, or neurological disturbances) (p > 0.05). There was a higher proportion (p = 0.01) of "good" outcomes at 12 months' FU in D&F (86%) than in D (70%). Multiple regression analysis, controlling for possible confounders, revealed treatment group to be the only significant predictor of outcome (adding fusion = better outcome). Our study indicated that LDS patients showed better patient-based outcome with instrumented fusion and decompression than with decompression alone, regardless of baseline symptoms. This may be due to the fact that the underlying slippage as the cause of the stenosis is better addressed with fusion.

Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index

Patient-orientated outcome questionnaires are essential for the assessment of treatment success in spine care. Standardisation of the instruments used is necessary for comparison across studies and in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders and is the recommended outcome instrument in the Spine Society of Europe Spine Tango Registry; currently, no validated Italian version exists. A cross-cultural adaptation of the COMI into Italian was carried out using established guidelines. 96 outpatients with chronic back problems (>3 months) were recruited from five practices in Switzerland and Italy. They completed the newly translated COMI, the Roland Morris disability (RM), adjectival pain rating, WHO Quality of Life (WHOQoL), EuroQoL-5D, and EuroQoL-VAS scales. Reproducibility was assessed in a subgroup of 63 patients who returned a second questionnaire within 1 month and indicated no change in back status on a 5-point Likert-scale transition question. The COMI scores displayed no floor or ceiling effects. On re-test, the responses for each individual domain of the COMI were within one category in 100% patients for "function", 92% for "symptom-specific well-being", 100% for "general quality of life", 90% for "social disability", and 98% for "work disability". The intraclass correlation coefficients (ICC(2,1)) for the COMI back and leg pain items were 0.78 and 0.82, respectively, and for the COMI summary index, 0.92 (95% CI 0.86-0.95); this compared well with 0.84 for RM, 0.87 for WHOQoL, 0.79 for EQ-5D, and 0.77 for EQ-VAS. The standard error of measurement (SEM) for COMI was 0.54 points, giving a ''minimum detectable change'' for the COMI of 1.5 points. The scores for most of the individual COMI domains and the COMI summary index correlated to the expected extent (0.4-0.8) with the corresponding full-length reference questionnaires (r = 0.45-0.72). The reproducibility of the Italian version of the COMI was comparable to that published for the German and Spanish versions. The COMI scores correlated in the expected manner with existing but considerably longer questionnaires suggesting adequate convergent validity for the COMI. The Italian COMI represents a practical, reliable, and valid tool for use with Italian-speaking patients and will be of value for international studies and surgical registries.

The outcome of decompression surgery for lumbar herniated disc is influenced by the level of concomitant preoperative low back pain

Decompression surgery is a common and generally successful treatment for lumbar disc herniation (LDH). However, clinical practice raises some concern that the presence of concomitant low back pain (LBP) may have a negative influence on the overall outcome of treatment. This prospective study sought to examine on how the relative severity of LBP influences the outcome of decompression surgery for LDH. The SSE Spine Tango System was used to acquire the data from 308 patients. Inclusion criteria were LDH, first-time surgery, maximum 1 affected level, and decompression as the only procedure. Before and 12 months after surgery, patients completed the multidimensional Core Outcome Measures Index (COMI; includes 0-10 leg/buttock pain (LP) and LBP scales); at 12 months, global outcome was rated on a Likert scale and dichotomised into "good" and "poor" groups. In the "good" outcome group, mean baseline LP was 2.8 (SD 3.1) points higher than LBP; in the "poor" group, the corresponding value was 1.1 (SD 2.9) (p < 0.001 between groups). Significantly fewer patients with back pain as their "main problem" had a good outcome (69% good) when compared with those who reported leg/buttock pain (84% good) as the main problem (p = 0.04). In multivariate regression analyses (controlling for age, gender, co-morbidity), baseline LBP intensity was a significant predictor of the 12-month COMI score, and of the global outcome (each p < 0.05) (higher LBP, worse outcome). In conclusion, patients with more back pain showed significantly worse outcomes after decompression surgery for LDH. This finding fits with general clinical experience, but has rarely been quantified in the many predictor studies conducted to date. Consideration of the severity of concomitant LBP in LDH may assist in establishing realistic patient expectations before the surgery.

Simple questionnaire for assessing core outcomes in inguinal hernia repair

Patient-oriented questionnaires are indispensable in the assessment of surgical outcome. The psychometric properties of a brief multidimensional instrument were examined in patients with inguinal hernia undergoing surgery. Fifty-one patients (mean(s.d.) age 50·6(17·4) years; 48 men) participated. The following questionnaire properties were assessed for the Core Outcome Measures Index adapted for patients with hernia (COMI-hernia) and the EuroQol: practicability, floor and ceiling effects, test-retest reliability (over 2 weeks), construct validity (by comparison with other relevant scales) and responsiveness 9 months after surgery as standardized response mean (SRM). The questionnaires were easy to implement and well accepted by the patients. Ceiling effects at baseline were 2 per cent for the COMI-hernia, 8 per cent for EuroQol-visual analogue scale (EQ-VAS) and 35 per cent for EuroQol-Five Dimensions (EQ-5D); no instrument showed floor effects. The reproducibility of individual COMI-hernia items was good, with test-retest differences within one grade ranging from 41 of 45 for 'social/work disability' to 44 of 45 for 'general quality of life'. The intraclass correlation coefficients were moderately high for COMI-hernia (0·74) and EQ-VAS (0·77), but low for EQ-5D (0·43). COMI-hernia scores correlated in the expected manner with related scales (r = 0·42-0·72, P < 0·050). COMI-hernia was the most responsive instrument (SRM 1·42). The COMI-hernia and EQ-VAS general health scale represent reliable, valid and sensitive tools for assessing multidimensional outcome in patients with inguinal hernia undergoing surgical treatment.

Should smoking habit dictate the fusion technique?

The aim of this study was to evaluate the influence of smoking on the outcome of patients undergoing surgery for degenerative spinal diseases, and to examine whether smoking had a differential impact on outcome, depending on the fusion technique used. The cohort included 120 patients treated with two different fusion techniques (translaminar screw fixation and TLIF). They were categorised with regard to their smoking habits at the time of surgery and completed the Core Outcome Measures Index at baseline and follow-up (FU) (3, 12 and 24 months FU); at FU they also rated the global outcome of surgery. The distribution of smokers was comparable in the two groups. For the TS group, the greater the number of cigarettes smoked, the less the reduction in pain intensity from pre-op to 24 months FU; the relationship was not significant for the TLIF group. The percentage of good global outcomes declined with time in the TS smokers such that by 24 months FU, there was a significant difference between TS smokers and TS-non-smokers. No such difference between smokers and non-smokers was evident in the TLIF group at any FU time. In conclusion, the TS technique was more vulnerable to the effects of smoking than was TLIF: possibly the more extensive stabilisation of the 360° fusion renders the environment less susceptible to the detrimental effects on bony fusion of cigarette smoking.

An Observational Study of Patient-rated Outcome After Atlantoaxial Fusion in Patients With Rheumatoid Arthritis and Osteoarthritis

Fusion is used to address several types of abnormality of the atlantoaxial segment. Traditionally, outcome has been assessed by achieving solid bony union. Recently, however, patient-rated outcome instruments have been increasingly used, although these may be influenced by concomitant comorbidity. We therefore asked whether patients with rheumatoid arthritis (RA), with its associated comorbidity, had worse self-rated outcomes after C1-2 fusion than patients with osteoarthritis (OA). We retrospectively reviewed all 30 (23 OA and seven RA) prospectively followed patients in our local Spine Registry (part of the Spine Society of Europe Spine Tango Registry) who had undergone C1-2 fusion. Before surgery and 3 and 12months later, patients completed the multidimensional Core Outcome Measures Index (COMI) questionnaire. Global outcome and satisfaction with treatment were also assessed. We found no group differences for duration of operation, blood loss, or perioperative surgical or general complications. Compared with the OA group, the RA group showed a better baseline COMI score and less improvement in the COMI from preoperatively to 12months followup. However, the proportion of "good" global scores at 12months followup was similarly high in both groups (87% OA and 86% RA) as was satisfaction (96% for OA versus 86% for RA). Symptoms and impairment were less severe in the RA group at baseline and showed less improvement after surgery, but the proportion of "good global outcomes" was similar in both groups, and the great majority of patients in both groups were satisfied with their treatment. Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Development of a documentation instrument for the conservative treatment of spinal disorders in the International Spine Registry, Spine Tango

Spine Tango is the first and only International Spine Registry in operation to date. So far, only surgical spinal interventions have been recorded and no comparable structured and comprehensive documentation instrument for conservative treatments of spinal disorders is available. This study reports on the development of a documentation instrument for the conservative treatment of spinal disorders by using the Delphi consensus method. It was conducted with a group of international experts in the field. We also assessed the usability of this new assessment tool with a prospective feasibility study on 97 outpatients and inpatients with low back or neck pain undergoing conservative treatment. The new 'Spine Tango conservative' questionnaire proved useful and suitable for the documentation of pathologies, conservative treatments and outcomes of patients with low back or neck problems. A follow-up questionnaire seemed less important in the predominantly outpatient setting. In the feasibility study, between 43 and 63% of patients reached the minimal clinically important difference in pain relief and Core Outcome Measures Index at 3 months after therapy; 87% of patients with back pain and 85% with neck pain were satisfied with the received treatment. With 'Spine Tango conservative' a first step has been taken to develop and implement a complementary system for documentation and evaluation of non-surgical spinal interventions and outcomes within the framework of the International Spine Registry. It proved useful and feasible in a first pilot study, but it will take the experience of many more cases and therapists to develop a version similarly mature as the surgical instruments of Spine Tango.

Comparison of patient and surgeon ratings of outcome 12 months after spine surgery

ObjectThe contemporary assessment of spine surgical outcome primarily relies on patient-centered reports of symptoms and function. Such measures are considered to reduce bias compared with traditional surgeon-based outcome ratings. This study examined the agreement between patients' and surgeons' ratings of outcome 1 year after spine surgery.MethodsThe study involved 404 patients (mean age 56.6 ± 16.4 years; 259 women, 145 men) and their treating surgeons. At baseline and 12 months postoperatively patients completed the Core Outcome Measures Index (COMI) rating pain, function, quality of life, and disability. At 12 months postoperatively, they also rated the global outcome of surgery and their satisfaction with treatment. The surgeon, blinded to the patient's evaluation, rated the global outcome of surgery as excellent, good, fair, or poor.ResultsSeventy-six percent of the patients who were considered by the surgeon to have an excellent or good outcome achieved the minimum clinically important difference (MCID) of a 2.2-point reduction on the COMI; 24% achieved less than the MCID. There was a significant correlation between the surgeons' and patients' global outcome ratings (Spearman ρ = 0.56; p &lt; 0.0001). The degree of absolute agreement between them was significantly influenced by surgeon seniority: senior surgeons “overrated” the outcome in 24.5% of cases (compared with patients' ratings) and “underrated” it in 17.5% of cases. Junior surgeons overrated in 7.8% of cases and underrated in 43.8% of cases (p &lt; 0.0001). Surgeon overrating occurred significantly more frequently for patients with a poor self-rated outcome (measured as global outcome, COMI score, or satisfaction with treatment). In a multivariate model, the independent variables “senior surgeon” and “patient dissatisfaction with care” were the most significant unique predictors of surgeon overrating of the global outcome (p &lt; 0.0001; adjusted R2for the model = 0.16).ConclusionsOverall, agreement between surgeon and patient was reasonably good. The majority of patients who were rated as excellent/good by the surgeons had achieved the MCID in the prospectively measured COMI score. Discrepancies in outcome ratings were influenced by surgeon seniority and patient satisfaction. For a balanced view of the surgical result, outcomes should be assessed from the perspectives of both the patient and the surgeon.

A comparison of outcomes of cervical disc arthroplasty and fusion in everyday clinical practice: surgical and methodological aspects

Randomised controlled trials (RCTs) of cervical disc arthroplasty vs fusion generally show slightly more favourable results for arthroplasty. However, RCTs in surgery often have limited external validity, since they involve a select group of patients who fit very rigid admission criteria and who are prepared to subject themselves to randomisation. The aim of this study was to examine whether the findings of RCTs are verified by observational data recorded in our Spine Center in association with the Spine Society of Europe Spine Tango surgical registry. Patients undergoing fusion/stabilisation or disc arthroplasty for degenerative cervical spinal disease were selected for inclusion. They completed a questionnaire pre-operatively and at 12 and 24 months follow-up (FU). The questionnaire comprised the multidimensional Core Outcome Measures Index (COMI; 0-10 scale) and, at FU, questions on global outcome and satisfaction with treatment (5-point scales, dichotomised to "good" and "poor"), re-operation and patient-rated complications. The surgeon completed a Spine Tango Surgery form. The outcome data from 266 (208 fusion, 58 arthroplasty) out of 284 eligible patients who had reached 12 months FU, and 169 (139 fusion, 30 arthroplasty) out of 178 who had reached 24 months FU, were included. Patients with cervical disc arthroplasty were younger [46 (SD 8) years vs 56 (SD 11) years for fusion; P < 0.05], had less comorbidity (P < 0.05), more often had only mono-segmental pathology (69% arthroplasty, 47% fusion) and only one type of degenerative pathology (69% arthroplasty, 46% fusion). Surgical complication rates were similar in each group (arthroplasty, 1.5%; fusion, 2.6%). The reduction in the COMI score was significantly greater in the arthroplasty group (at 12 months, 4.8 (SD 3.0) vs 3.7 (SD 2.9) points for fusion, and at 24 months 5.1 (SD 2.8) vs 3.8 (SD 2.9) points; each P < 0.05). In the arthroplasty group, a "good" global outcome was recorded in 90% patients (at 12 months) and 93% (at 24 months); in the fusion group the figures were 80 and 82%, respectively (group differences at each timepoint, P > 0.09). Satisfaction with treatment was similar in both groups (89-93%), at each timepoint. In multiple regression analysis, treatment group was of borderline significance as a unique predictor of the change in COMI at FU (P = 0.059 at 12 months, P = 0.055 at 24 months) in a model in which known confounders (age, comorbidity, number of affected levels) were controlled for. Being in the arthroplasty group was associated with an approximately 1-point greater reduction in the COMI score at FU. The results of this observational study appear to support those of the RCTs and suggest that, in patients with degenerative pathology of the cervical spine, disc arthroplasty is associated with a slightly better outcome than fusion. However, given the small size of the difference, its clinical relevance is questionable, especially in view of the a priori more favourable outcome expected in the arthroplasty group due to the more rigorous selection of patients.

A prospective, cohort study comparing translaminar screw fixation with transforaminal lumbar interbody fusion and pedicle screw fixation for fusion of the degenerative lumbar spine

In a prospective observational study we compared the two-year outcome of lumbar fusion by a simple technique using translaminar screws (n = 57) with a more extensive method using transforaminal lumbar interbody fusion and pedicular screw fixation (n = 63) in consecutive patients with degenerative disease of the lumbar spine. Outcome was assessed using the validated multidimensional Core Outcome Measures Index. Blood loss and operating time were significantly lower in the translaminar screw group (p < 0.01). The complication rates were similar in each group (2% to 4%). In all, 91% of the patients returned their questionnaire at two-years. The groups did not differ in Core Outcome Measures Index score reduction, 3.6 (sd 2.5) (translaminar screws) vs 4.0 (sd 2.8) (transforaminal lumbar interbody fusion) (p = 0.39); 'good' global outcomes, 78% (translaminar screws) vs 78% (transforaminal lumbar interbody fusion) (p = 0.99) or satisfaction with treatment, 82% (translaminar screws) vs 86% (transforaminal lumbar interbody fusion) (p = 0.52). The two fusion techniques differed markedly in their extent and the cost of the implants, but were associated with almost identical patient-orientated outcomes. Extensive three-point stabilisation is not always required to achieve satisfactory patient-orientated results at two years.

How to Tango: a manual for implementing Spine Tango

The generic approach of the Spine Tango documentation system, which uses web-based technologies, is a necessity for reaching a maximum number of participants. This, in turn, reduces the potential for customising the Tango according to the individual needs of each user. However, a number of possibilities still exist for tailoring the data collection processes to the user's own hospital workflow. One can choose between a purely paper-based set-up (with in-house scanning, data punching or mailing of forms to the data centre at the University of Bern) and completely paper-free online data entry. Many users work in a hybrid mode with online entry of surgical data and paper-based recording of the patients' perspectives using the Core Outcome Measures Index (COMI) questionnaires. Preoperatively, patients can complete their questionnaires in the outpatient clinic at the time of taking the decision about surgery or simply at the time of hospitalisation. Postoperative administration of patient data can involve questionnaire completion in the outpatient clinic, the handing over the forms at the time of discharge for their mailing back to the hospital later, sending out of questionnaires by post with a stamped addressed envelope for their return or, in exceptional circumstances, conducting telephone interviews. Eurospine encourages documentation of patient-based information before the hospitalisation period and surgeon-based information both before and during hospitalisation; both patient and surgeon data should be acquired for at least one follow-up, at a minimum of three to six months after surgery. In addition, all complications that occur after discharge, and their consequences should be recorded.