AI-support for the detection of intracranial large vessel occlusions: One-year prospective evaluation.

Purpose: Few studies have evaluated real-world performance of radiological AI-tools in clinical practice. Over one-year, we prospectively evaluated the use of AI software to support the detection of intracranial large vessel occlusions (LVO) on CT angiography (CTA). Method: Quantitative measures (user log-in attempts, AI standalone performance) and qualitative data (user surveys) were reviewed by a key-user group at three timepoints. A total of 491 CTA studies of 460 patients were included for analysis. Results: The overall accuracy of the AI-tool for LVO detection and localization was 87.6%, sensitivity 69.1% and specificity 91.2%. Out of 81 LVOs, 31 of 34 (91%) M1 occlusions were detected correctly, 19 of 38 (50%) M2 occlusions, and 6 of 9 (67%) ICA occlusions. The product was considered user-friendly. The diagnostic confidence of the users for LVO detection remained the same over the year. The last measured net promotor score was -56%. The use of the AI-tool fluctuated over the year with a declining trend. Conclusions: Our pragmatic approach of evaluating the AI-tool used in clinical practice, helped us to monitor the usage, to estimate the perceived added value by the users of the AI-tool, and to make an informed decision about the continuation of the use of the AI-tool.

Treatment of cows with parturient paresis using intravenous calcium and oral sodium phosphate.

INTRODUCTION: The goal of this study was to investigate whether intravenous infusion of 1000 ml 40% calcium borogluconate combined with the oral adminstration of 500 g sodium phosphate leads to a better cure rate and longer-lasting normocalcaemia and normophosphataemia than standard intravenous treatment with 500 ml calcium borogluconate in cows with parturient paresis. Forty recumbent cows with hypocalcaemia and hypophosphataemia were alternately allocated to group A or B. Cows of both groups were treated intravenously with 500 ml 40% calcium borogluconate, and cows of group B additionally received another 500 ml calcium borogluconate via slow intravenous infusion and 500 g sodium phosphate administered via an orogastric tube. Thirty-two cows stood within 8 hours after the start of treatment and 8 did not; of the 32 cows that stood, 18 belonged to group A and 14 to group B (90% of group A vs. 70% of group B; P = 0.23). Seven cows relapsed; of these and the 8 that did not respond to initial treatment, 10 stood after two standard intravenous treatments. Downer cow syndrome occurred in 5 cows, 3 of which recovered after aggressive therapy. The overall cure rate did not differ significantly between groups A and B. Twelve (60%) cows of group A and 14 (70%) cows of group B were cured after a single treatment and of the remaining 14, 11 were cured after two or more treatments. Two downer cows were euthanized and one other died of heart failure during treatment. Serum calcium concentrations during the first eight hours after the start of treatment were significantly higher in group B than in group A, and oral sodium phosphate caused a significant and lasting increase in inorganic phosphate. More cows of group B than group A were cured after a single treatment (P > 0.05). These findings, although not statistically significant, are promising and should be verified using a larger number of cows.

INTRODUCTION: On a étudié si on pouvait obtenir plus souvent, chez les vaches souffrant de parésie post-partum auxquelles on administrait par voie intraveineuse 1000 ml d'une solution à 40% de borogluconate de calcium et par voie orale 500 g de phosphate de sodium, une normo-calcémie et normo-phosphatémie durable et un meilleur résultat thérapeutique que chez les animaux recevant uniquement 500 ml de la solution de borogluconate de calcium. Les essais ont été faits sur 40 vaches laitières souffrant de parésie post-partum qui présentaient toutes initialement une hypocalcémie et une hypophosphatémie. Les animaux ont été répartis alternativement en deux groupes de traitement A et B, comprenant chacun 20 vaches. Les animaux des deux groupes ont été traités avec 500 ml d'une solution à 40% de borogluconate de calcium par voie intraveineuse. Ceux du groupe B ont reçu en outre 500 ml de borogluconate de calcium en perfusion continue et 500 g de phosphate de sodium par sonde naso-oesophagienne. En l'espace de 8 heures, 32 vaches se sont levées et 8 pas. Parmi les 32 vaches qui se sont levées, 18 appartenaient au groupe B (90%) et 14 au groupe A (70%) (P = 0.23). Chez 7 des 32 vaches qui se sont levées, on a observé une récidive. Parmi les 7 cas de récidive et les 8 vaches qui ne s'étaient pas levées après 8 heures, 10 animaux se sont levés après une deuxième perfusion de calcium. Cinq vaches ont développé un Downer-Cow-Syndrom, dont trois purent être guéries après un traitement intensif. Le succès thérapeutique global ne diffère pas significativement d'un groupe à l'autre. Dans le groupe A, 12 animaux (60%) ont été guéris après un seul traitement et, dans le groupe B 14 (70%). Sur le solde de 14 vaches, 11 se sont relevées après deux ou plusieurs traitements. Deux vaches ont dû être euthanasiées pour un Downer-Cow-Syndrom et une a péri d'une insuffisance cardiaque. Le traitement à conduit, chez les vaches du groupe B à des concentrations sanguines de calcium significativement plus élevées dans les premières 8 heures que chez celles du groupe A. D'autre part, l'administration, dans le groupe B, de phosphate de sodium a amené une élévation significative et durable de la concentration de phosphate inorganique. Le pourcentage des animaux qui se sont levés dans les 8 heures et étaient guéris après un seul traitement était plus élevé dans le groupe B que dans le groupe A (P > 0.05). D'autres études, avec des nombres d'animaux plus importants, sont nécessaires pour conforter ces résultats.

Calcifediol versus vitamin D3 effects on gait speed and trunk sway in young postmenopausal women: a double-blind randomized controlled trial.

UNLABELLED: In this double-blind RCT, 4-month treatment with calcifediol compared with vitamin D3 improved gait speed by 18% among young postmenopausal women. Consistently, change in 25(OH)D blood levels over time were significantly correlated with improvement in gait speed in these women. No effect could be demonstrated for trunk sway. INTRODUCTION: The aim of this study is to test the effect of calcifediol compared with vitamin D3 on gait speed and trunk sway. METHODS: Twenty healthy postmenopausal women with an average 25(OH)D level of 13.2 ng/ml (SD = ±3.9) and a mean age of 61.5 years (SD = ±7.2) were randomized to either 20 µg of calcifediol or 20 µg (800 IU) of vitamin D3 per day in a double-blind manner. At baseline and at 4 months of follow-up, the same physiotherapist blinded to treatment allocation tested 8-m gait speed and a body sway test battery (Sway star pitch and roll angle plus velocity while walking 8 m, and standing on both legs on a hard and soft surface). All analyses adjusted for baseline measurement, age, and body mass index. RESULTS: Mean 25(OH)D levels increased to 69.3 ng/ml (SD = ±9.5) in the calcifediol group and to 30.5 ng/ml (SD = ±5.0) in the vitamin D3 group (p < 0.0001). Women receiving calcifediol compared with vitamin D3 had an 18% greater improvement in gait speed at 4-month follow-up (p = 0.046) adjusting for baseline gait speed, age, and body mass index. Also, change in gait speed was significantly correlated with change in serum 25(OH)D concentrations (r = 0.5; p = 0.04). Across three tests of trunk sway, there were no consistent differences between groups and no significant correlation between change in 25(OH)D serum concentrations and change in trunk sway. CONCLUSIONS: Calcifediol improved gait speed in early postmenopausal women compared with vitamin D3 and change in 25(OH)D level was moderately correlated with improvement in gait speed. A benefit on trunk sway could not be demonstrated.

[Perioperative risk assessment of geriatric patients undergoing noncardiac surgery]. / Perioperative Risikostratifizierung geriatrischer Patienten bei nichtkardialen Eingriffen.

BACKGROUND: Older patients more often suffer perioperative complications than younger people. Especially geriatric patients who require emergency treatment represent a high-risk group. Therefore, perioperative risk assessment supports the treatment team in identifying patients at risk and in defining the treatment plan accordingly. MATERIALS AND METHODS: A thorough medical history and clinical examination are pivotal elements of any risk stratification. The organ-specific risk assessment is primarily used to plan the surgical and anesthesiological procedures. RESULTS: For a comprehensive risk assessment in geriatric patients, the organ-specific risk stratification is insufficient. Assessment instruments that reflect the idiosyncrasies of multidimensional disease in geriatric patients can complement risk stratification. These should include the assessment of multimorbidity, frailty, nutrition, activities of daily living, and cognition. In addition to risk prediction, geriatric assessment has the major advantage of providing both a diagnostic and a planning perspective. This allows the implementation of supporting measures for optimal perioperative care, which is the goal of any risk stratification. Risk scores provide a global assessment, but they have their limitations in predicting individual patient risk.

Gender-specific hip fracture risk in community-dwelling and institutionalized seniors age 65 years and older.

UNLABELLED: In this study of acute hip fracture patients, we show that hip fracture rates differ by gender between community-dwelling seniors and seniors residing in nursing homes. While women have a significantly higher rate of hip fracture among the community-dwelling seniors, men have a significantly higher rate among nursing home residents. INTRODUCTION: Differences in gender-specific hip fracture risk between community-dwelling and institutionalized seniors have not been well established, and seasonality of hip fracture risk has been controversial. METHODS: We analyzed detailed data from 1,084 hip fracture patients age 65 years and older admitted to one large hospital center in Zurich, Switzerland. In a sensitivity analysis, we extend to de-personalized data from 1,265 hip fracture patients from the other two large hospital centers in Zurich within the same time frame (total n = 2,349). The denominators were person-times accumulated by the Zurich population in the corresponding age/gender/type of dwelling stratum in each calendar season for the period of the study. RESULTS: In the primary analysis of 1,084 hip fracture patients (mean age 85.1 years; 78% women): Among community-dwelling seniors, the risk of hip fracture was twofold higher among women compared with men (RR = 2.16; 95% CI, 1.74-2.69) independent of age, season, number of comorbidities, and cognitive function; among institutionalized seniors, the risk of hip fracture was 26% lower among women compared with men (RR = 0.77; 95% CI: 0.63-0.95) adjusting for the same confounders. In the sensitivity analysis of 2,349 hip fracture patients (mean age 85.0 years, 76% women), this pattern remained largely unchanged. There is no seasonal swing in hip fracture incidence. CONCLUSION: We confirm for seniors living in the community that women have a higher risk of hip fracture than men. However, among institutionalized seniors, men are at higher risk for hip fracture.

Before and after hip fracture, vitamin D deficiency may not be treated sufficiently.

UNLABELLED: Our findings show that only about 20% of seniors receive vitamin D supplementation prior to their index hip fracture or after the event. We further confirm the high prevalence of severe vitamin D deficiency in this population and show that those who receive supplementation have significantly higher 25-hydroxyvitamin D (25(OH)D) status. INTRODUCTION: The aim of this study is to assess current practice in pre- and post-hip fracture care practice with respect to vitamin D supplementation. METHODS: We surveyed 1,090 acute hip fracture patients age 65 and older admitted to acute care for hip fracture repair; 844 had serum 25-hydroxyvitamin D levels measured upon admission to acute care, and 362 agreed to be followed at 12 month after their hip fracture. Prevalence of vitamin D supplementation was assessed upon admission to acute care (at the time of hip fracture), upon discharge from acute care, and at 6 and 12 months follow-up. RESULTS: Of 1,090 acute hip fracture patients (mean age 85 years, 78% women, 59 % community-dwelling), 19% had received any dose of vitamin D prior to the index hip fracture, 27% (of 854 assessed) at discharge from acute care, 22 % (of 321 assessed) at 6 month, and 21% (of 285 assessed) at 12 month after their hip fracture. At the time of fracture, 45% had 25(OH)D levels below 10 ng/ml, 81% had levels below 20 ng/ml, and 96% had levels below 30 ng/ml. Notably, 25(OH)D levels did not differ by season or gender but were significantly higher among 164 hip fracture patients, with any vitamin D supplementation compared with 680 without supplementation (19.9 versus 10.8 ng/ml; p < 0.0001). CONCLUSION: Only about 20% of seniors receive vitamin D at the time of their fracture and after the event. This is despite the documented 81% prevalence of vitamin D deficiency. Interdisciplinary efforts may be warranted to improve vitamin D supplementation in seniors both before a hip fracture occurs and after.

[Multidimensional geriatric assessment as clinical approach to the multimorbid patient in acute care]. / Multidimensionales geriatrisches Assessment als klinischer Zugang zum multimorbiden Patienten im Spital.

The multidimensional geriatric assessment is an interdisciplinary diagnostic process, taking into account several health dimensions. The resulting know-ledge is used to establish a treatment plan. The multidimensional geriatric assessment has shown its efficacy in the acute care treatment of multidimensionally ill and polymorbid patients in acute geriatric structures. The multidimensional geriatric assessment plays a central role in questions regarding the allocation of resources and is becoming more important because of the demographic development and the rapidly changing framework in our health system. It ensures that older patients don't slip through the net in a more fragmented clinical medicine. Growing evidence allows using this assessment approach in polymorbid patients being treated in specialised fields as traumatology, cardiology, oncology and nephrology.

Mild to moderate cognitive impairment is a major risk factor for mortality and nursing home admission in the first year after hip fracture.

BACKGROUND: It is not well established if and to what extent mild to moderate cognitive impairment predicts mortality and risk of nursing home admission after hip fracture. OBJECTIVE: To investigate prospectively whether and to what extent mild to moderate cognitive impairment, contributes to mortality and admission to nursing home in the first year after acute hip fracture. METHODS: We enrolled 173 patients with acute hip fracture age 65 and older who reached a Mini-Mental State Examination (MMSE) score of at least 15 during acute care after hip fracture repair. An MMSE score of 15 to 24 (median) was classified as mild to moderate cognitive impairment. Primary outcomes were mortality in all and admission to nursing home among seniors who lived at home prior to their hip fracture. Follow-up was 12 months with clinical visits at baseline, 6, and 12 months, plus monthly phone calls. We used Cox proportional hazards models controlling for age, sex, body mass index, baseline number of comorbidities and 25-hydroxyvitamin D status, and severe incident infections to assess the risk of mortality and nursing home admission. Because the study population was enrolled in a factorial design clinical trial testing high dose vitamin D and/or an exercise home program, all analyses also controlled for these treatment strategies. RESULTS: Of 173 acute hip fracture patients enrolled, 79% were women, 77% were admitted from home, and 80% were vitamin D deficient (<20ng/ml). Mean age was 84 years. 54% had mild to moderate cognitive impairment. Over the 12-month follow-up, 20 patients died (27% of 173) and 47 (35% of 134) were newly admitted to a nursing home. Mild to moderate cognitive impairment was associated with a more than 5-fold increased risk of mortality (HR=5.77; 95% CI: 1.55-21.55) and a more than 7-fold increased risk of nursing home admission (HR=7.37; 95% CI: 1.75-30.95). Additional independent risk factors of mortality were male gender (HR=3.55; 95% CI: 1.26-9.97), low BMI (HR=7.25; 95% CI: 1.61-33.74), and baseline 25-hydroxyvitamin D level (per 1ng/ml: HR=0.93; 95% CI: 0.87-0.998; p=0.04). CONCLUSIONS: Mild to moderate cognitive impairment in patients with acute hip fracture is associated with a high risk of mortality and nursing home admission during the first year after hip fracture. Female gender, a greater BMI and a higher 25-hydroxyvitamin D status may protect against mortality after hip fracture independent of cognitive function.

The bothersomeness of patient self-rated "complications" reported 1 year after spine surgery.

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

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

INTRODUCTION: 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)]. METHODS: 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". RESULTS: 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). DISCUSSION: 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.

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.

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.

Five-year outcome of surgical decompression of the lumbar spine without fusion.

As the average life expectancy of the population increases, surgical decompression of the lumbar spine is being performed with increasing frequency. It now constitutes the most common type of lumbar spinal surgery in older patients. The present prospective study examined the 5-year outcome of lumbar decompression surgery without fusion. The group comprised 159 patients undergoing decompression for degenerative spinal disorders who had been participants in a randomised controlled trial of post-operative rehabilitation that had shown no between-group differences at 2 years. Leg pain and back pain intensity (0-10 graphic rating scale), self-rated disability (Roland Morris), global outcome of surgery (5-point Likert scale) and re-operation rates were assessed 5 years post-operatively. Ten patients had died before the 5-year follow-up. Of the remaining 149 patients, 143 returned a 5-year follow-up (FU) questionnaire (effective return rate excluding deaths, 96%). Their mean age was 64 (SD 11) years and 92/143 (64%) were men. In the 5-year follow-up period, 34/143 patients (24%) underwent re-operation (17 further decompressions, 17 fusions and 1 intradural drainage/debridement). In patients who were not re-operated, leg pain decreased significantly (p < 0.05) from before surgery to 2 months FU, after which there was no significant change up to 5 years. Low back pain also decreased significantly by 2 months FU, but then showed a slight, but significant (p < 0.05), gradual increase of <1 point by 5-year FU. Disability decreased significantly from pre-operative to 2 months FU and showed a further significant decrease at 5 months FU. Thereafter, it remained stable up to the 5-year FU. Pain and disability scores recorded after 5 years showed a significant correlation with those at earlier follow-ups (r = 0.53-0.82; p < 0.05). Patients who were re-operated at some stage over the 5-year period showed significantly worse final outcomes for leg pain and disability (p < 0.05). In conclusion, pain and disability showed minimal change in the 5-year period after surgery, but the re-operation rate was relatively high. Re-operation resulted in worse final outcomes in terms of leg pain and disability. At the 5-year follow-up, the "average" patient experienced frequent, but relatively low levels of, pain and moderate disability. This knowledge on the long-term outcome should be incorporated into the pre-operative patient information process.

[The spinal intervertebral disc]. / Zervikale Bandscheibe.

The spinal intervertebral disc can cause neurocompression or pain as a result of degeneration. Surgical interventions, therefore, include decompression, fusion, disc replacement or a combination thereof. Identifying the painful segment in the case of axial pain requires accurate segment diagnosis and may require invasive diagnostic measures (joint infiltration, discography), since imaging is often not fluid enough. In the case of fusion following disc removal, the placeholder is substitued in the form of a cage or autologous iliac crest graft. Alternatively, when dorsal elements are intact, a disc prosthesis can be inserted. In the case of compression, removal of the compromised structures (disc, osteophytes) becomes necessary. If the indication is correctly made and the appropriate surgical technique used, good results can be expected from cervical spine surgery.

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.

The quality of spine surgery from the patient's perspective: part 2. Minimal clinically important difference for improvement and deterioration as measured with the Core Outcome Measures Index.

The Core Outcome Measures Index (COMI) is a reliable and valid instrument for assessing multidimensional outcome in spine surgery. The minimal clinically important score-difference (MCID) for improvement (MCID(imp)) was determined in one of the original research studies validating the instrument, but has never been confirmed in routine clinical practice. Further, the MCID for deterioration (MCID(det)) has never been investigated; indeed, this needs very large sample sizes to obtain sufficient cases with worsening. This study examined the MCIDs of the COMI in routine clinical practice. All patients undergoing surgery in our Spine Center since February 2004 were asked to complete the COMI before and 12 months after surgery. The COMI has one question each on back (neck) pain intensity, leg/buttock (arm/shoulder) pain intensity, function, symptom-specific well-being, general quality of life, work disability, and social disability, scored as a 0-10 index. At follow-up, patients also rated the global effectiveness of surgery, on a 5-point Likert scale. This was used as the external criterion ("anchor") in receiver operating characteristics (ROC) analyses to derive cut-off scores for individual improvement and deterioration. Twelve-month follow-up questionnaires were returned by 3,056 (92%) patients. The group mean COMI score change for patients declaring that the "operation helped" was a reduction of 3.1 points; the corresponding value for those whom it "did not help" was a reduction of 0.5 points. The group MCID(imp) was hence 2.6 points reduction; the corresponding group MCID(det) was 1.2 points increase (0.5 minus -0.7). The area under the ROC curve was 0.88 for MCID(imp) and 0.89 for MCID(det) (both P < 0.0001), indicating that the COMI had good discriminative ability. The cut-offs for individual improvement and deterioration, respectively, were > or =2.2 points decrease (sensitivity 81%, specificity 83%) and > or =0.3 points increase (sensitivity 83%, specificity 88%). The MCID(imp) score of 2.2 points was similar to that reported in the original study (2-3 points, depending on external criterion used). The MCID(det) suggested that the COMI is less responsive to deterioration than to improvement, a phenomenon also reported for other spine outcome instruments. This needs further investigation in even larger patient groups. The MCIDs provide essential information for both the planning (sample size) and interpretation of the results (clinical relevance) of future clinical studies using the COMI.

The quality of spine surgery from the patient's perspective. Part 1: the Core Outcome Measures Index in clinical practice.

The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument, with excellent psychometric properties, that has been recommended for use in monitoring the outcome of spinal surgery from the patient's perspective. This study examined the feasibility of implementation of COMI and its performance in clinical practice within a large Spine Centre. Beginning in March 2004, all patients undergoing spine surgery in our Spine Centre (1,000-1,200 patients/year) were asked to complete the COMI before and 3, 12 and 24 months after surgery. The COMI has one question each on back (neck) pain intensity, leg/buttock (arm/shoulder) pain intensity, function, symptom-specific well being, general quality of life, work disability and social disability, scored as a 0-10 index. At follow-up, patients also rated the global effectiveness of surgery, and their satisfaction with their treatment in the hospital, on a five-point Likert scale. After some fine-tuning of the method of administration, completion rates for the pre-op COMI improved from 78% in the first year of operation to 92% in subsequent years (non-response was mainly due to emergencies or language or age issues). Effective completion rates at 3, 12 and 24-month follow-up were 94, 92 and 88%, respectively. The 12-month global outcomes (from N = 3,056 patients) were operation helped a lot, 1,417 (46.4%); helped, 860 (28.1%); helped only little, 454 (14.9%); did not help, 272 (8.9%); made things worse, 53 (1.7%). The mean reductions in COMI score for each of these categories were 5.4 (SD2.5); 3.1 (SD2.2); 1.3 (SD1.7); 0.5 (SD2.2) and -0.7 (SD2.2), respectively, yielding respective standardised response mean values ("effect sizes") for each outcome category of 2.2, 1.4, 0.8, 0.2 and 0.3, respectively. The questionnaire was feasible to implement on a prospective basis in routine practice, and was as responsive as many longer spine outcome questionnaires. The shortness of the COMI and its multidimensional nature make it an attractive option to comprehensively assess all patients within a given Spine Centre and hence avoid selection bias in reporting outcomes.

Microdiscectomy compared with standard discectomy: an old problem revisited with new outcome measures within the framework of a spine surgical registry.

Studies comparing the relative merits of microdiscectomy and standard discectomy report conflicting results, depending on the outcome measure of interest. Most trials are small, and few have employed validated, multidimensional patient-orientated outcome measures, considered essential in outcomes research. In the present study, data were collected prospectively from six surgeons participating in a surgical registry. Inclusion criteria were: lumbar/lumbosacral degenerative disease; discectomy/sequestrectomy without additional fusion/stabilisation; German or English-speaking. Before and 3 and 12 months after surgery, patients completed the Core Outcome Measures Index comprising questions on leg/buttock pain, back pain, back-related function, symptom-specific well-being, general quality-of-life, and social and work disability. At follow-up, they rated overall satisfaction, global outcome, and perceived complications. Compliance with the registry documentation was excellent: 87% for surgeons (surgery forms), 91% for patients (for 12 months follow-up). 261 patients satisfied the inclusion criteria (225 microdiscectomy, 36 standard discectomy). The standard discectomy group had significantly greater blood-loss than the microdiscectomy (P < 0.05). There were no group differences in the proportion of surgical complications or duration of hospital stay (P > 0.05). The groups did not differ in relation to any of the patient-orientated outcomes or individual outcome domains (P > 0.05). Though not equivalent to an RCT, the study included every single eligible patient in our Spine Center and allowed surgeons to use their regular procedure; it hence had extremely high external validity (relevance/generalisability). There was no clinically relevant difference in outcome after lumbar disc excision dependent on the use of the microscope. The decision to use the microscope should rest with the surgeon.

[Lumbar total disc replacement]. / Bandscheibenprothese der Lendenwirbelsäule.

Total disc replacement has been introduced to avoid the biomechanical changes often caused in adjacent segments by the traditional fusion of two or more vertebrae in the lumbar spine. It also aims to maintain mobility and eliminate pain. Total disc replacement using a flexible prosthesis is currently a popular solution. The main indication for this procedure is low back pain caused by disc degeneration. Diagnostic procedures are important to correctly identify and localize the affected disc. To this end, discography represents the most reliable test; however, imaging and clinical investigations are also important adjuncts. To date, there are insufficient long-term data available on the relatively new total disc replacement technique to be able to confirm its superiority compared to traditional fusion procedures in terms of low back pain and patient satisfaction, but short- and mid-term results indicate that, when correctly indicated, both procedures have similar outcomes.