Global Treatment Outcome Research Articles

A comparative effectiveness study of patient-rated and radiographic outcome after 2 types of decompression with fusion for spondylotic myelopathy: anterior cervical discectomy versus corpectomy

Both anterior cervical discectomy with fusion (ACDF) and anterior cervical corpectomy with fusion (ACCF) are used to treat cervical spondylotic myelopathy; however, there is currently no evidence for the superiority of one over the other in terms of patient-rated outcomes. This comparative effectiveness study compared the patient-rated and radiographic outcomes of 2-level ACDF versus 1-level ACCF. This single-center study was nested within the EuroSpine Spine Tango data acquisition system. Inclusion criteria were the following: consecutive patients presenting with signs of cervical spondylotic myelopathy who underwent 2-level ACDF or 1-level ACCF between 2004 and 2011. Before and 12 months after surgery, patients completed the multidimensional Core Outcome Measures Index (COMI) and also rated global treatment outcome and satisfaction with care on 5-point Likert scales. Cervical lordosis, segmental height, and fusion rate were assessed radiographically before and immediately after surgery and at the last follow-up (20.4 ± 13.7 months, mean ± SD). In total, 118 consecutive patients (80 in the ACDF group and 38 in the ACCF group) were included. Age, sex, comorbidity, baseline symptoms, baseline radiographic data, operation duration, and complication rates did not differ significantly between the 2 groups. Blood loss was significantly (p < 0.04) lower in the ACDF group. Postoperative mean segmental height was significantly (p = 0.0006) greater for ACDF (42.0 ± 4.2 mm, mean ± SD) than for ACCF (39.0 ± 4.0 mm), and global average lordosis improved to a significantly (p = 0.003) greater extent in ACDF (by 1.6° ± 4.1°) than in ACCF (by -1.0° ± 4.0°). Fusion rates for ACDF were 97.5% and for ACCF were 94.7% (p = 0.59). The 12-month patient-rated outcomes did not differ significantly between ACDF and ACCF: 82.4% and 68.6% had a good global outcome (operation helped/helped a lot) (p = 0.10), 86.5% and 82.9% were satisfied/very satisfied with care (p = 0.62), and the reduction in the multidimensional COMI was 2.8 ± 2.7 and 2.2 ± 3 points (p = 0.30), respectively. The postoperative increase in lordosis angle showed low but significant correlations with the improvement in arm pain (r = 0.25, p = 0.014), highest pain (r = 0.25, p = 0.013), and function (r = 0.24, p = 0.016). Both ACDF and ACCF are safe and effective in the treatment of cervical spondylotic myelopathy, indicated by similarly good patient-rated outcomes 1 year after surgery. This precludes any conclusions regarding the superiority of one technique over the other, although it should be noted that ACDF resulted in less blood loss and greater improvements in cervical lordosis and segmental height than ACCF. Patients with improved lordosis angle had a better clinical outcome.

Circumferential Reconstruction of Severe Acetabular Labral Damage Using Hamstring Allograft: Surgical Technique and Case Series

With excessive acetabular coverage, such as coxa profunda or protrusio, contact between the femoral neck and acetabular rim cause direct damage to the labrochondral junction, and indirect edge loading from a levering effect which may result in hip arthrosis. Arthrosis may be delayed or avoided by addressing the overcoverage and restoring mechanical function of the labrum. We describe four cases of adjunctive complete acetabular labral replacement for circumferential, irreparable labral injury using fresh frozen semitendinous allografts through surgical hip dislocation. Over a two-year period four patients (age range: 20 to 47 years) underwent surgical hip dislocation to address femoroacetabular impingement with rim trimming, femoral osteochondroplasty, and labral reconstruction. Pre- and postoperative patient reported outcomes were assessed by Oxford Hip Score (OHS), Hip Outcome Score (HOS), and Global Treatment Outcome (GTO) score. Disease progression was graded using AP pelvic radiographs and arthroMR. The average LCE correction was 18º (range 7-25º), achieving an average LCE of 33º (range 32-35) postoperatively. Using protected weight bearing all trochanteric osteotomies healed within six weeks after surgery. OA did not progress in any hips. Mean OHS and HOS scores improved 6.3 and 19.8 at one-year follow up. All four patients reported good results according to the GTO. There were two adverse events that resolved and did not affect outcome. Despite complex deformities and preexisting cartilage and labrum wear in this young cohort, three of four patients reported significant functional improvement after treatment of this rare condition. Preliminary experience with circumferential labral reconstruction using hamstring allografts is promising, although long-term data needs to be established.

Acceptable Symptom State after Surgery for Femoroacetabular Impingement Compared with Total Hip Arthroplasty

The aim of the study was to examine whether patients undergoing total hip arthroplasty (THA) are better able to accept a given level of pain and disability than patients undergoing surgery for femoro-acetabular impingement (FAI). Before surgery, 417 THA and 162 FAI patients completed the Oxford Hip Score (OHS). At 12-months follow-up (FU), they were requested to complete the OHS again, rate the global treatment outcome, and state whether their symptom state was acceptable. Preoperatively, THA had worse (p<0.001) OHS scores than FAI. At 12 months, 99% THA and 86% FAI patients reported various degrees of improvement. The proportions of patients perceiving notable improvement and considering their current state acceptable were higher (p<0.0001) in THA (95-99%) than FAI (66-70%) and THA had greater (p<0.0001) improvements in OHS scores than FAI. The mean OHS score of the patients perceiving notable improvements at follow-up did not differ (p>0.05) between THA and FAI groups. Higher "success rates" in THA than FAI are not due to a better acceptance of pain and disability, because the OHS of patients considering their current state to be acceptable was similar for both groups. The difference is simply the result of more THA than FAI patients actually achieving an acceptable status after surgery.

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.

Fulfilment of patient-rated expectations predicts the outcome of surgery for femoroacetabular impingement

The aim of this study was to explore the role of expectations in relation to patient-rated global treatment outcome in patients undergoing hip preservation surgery for femoroacetabular impingement (FAI). Pre-operatively, 86 patients completed the Oxford Hip Score (OHS), a question about the motivation for undergoing surgery, and Likert-scales rating the improvement expected in various domains (pain, general function, sport, walking capacity, independence, social function, mental well-being). 12-months post-operatively, they rated the actual perceived improvement in each domain and the global outcome of surgery (GTO, 5-point Likert-scale: operation "helped a lot" through to "made things worse"), and completed the OHS again. The most frequent "top reason" for surgery was "alleviation of pain", being indicated by 33% patients; 20% patients chose "fear of worsening", 16% "improvement in everyday activities", 11% "other therapies failed", 10% "improvement in sporting activities" and 10% other. The 12-month data revealed prior expectations had been overly optimistic in more than 50% patients for hip pain, sport, and general physical capacity, and in 33-45% patients for independence, mental well-being, and walking capacity. Multiple regression revealed significant (P<0.05) unique associations between GTO and "fulfilled expectations" for pain and sport (explaining 47% and 12% variance, respectively). Expectations of surgery were overly optimistic. Having one's expectations fulfilled, especially in relation to pain, was important for a good outcome. The results emphasise the benefit of assessing patient-orientated outcome in routine practice and the factors that might influence it, such that realistic expectations can be established for patients prior to surgery.

The Effect of Urodynamic Testing on Clinical Diagnosis, Treatment Plan and Outcomes in Women Undergoing Stress Urinary Incontinence Surgery

We evaluated the influence of preoperative urodynamic studies on diagnoses, global treatment plans and outcomes in women treated with surgery for uncomplicated stress predominant urinary incontinence. We performed a secondary analysis from a multicenter, randomized trial of the value of preoperative urodynamic studies. Physicians provided diagnoses before and after urodynamic studies and global treatment plans, defined as proceeding with surgery, surgery type, surgical modification and nonoperative therapy. Treatment plan changes and surgical outcomes between office evaluation and office evaluation plus urodynamic studies were compared by the McNemar test. Of 315 subjects randomized to urodynamic studies after office evaluation 294 had evaluable data. Urodynamic studies changed the office evaluation diagnoses in 167 women (56.8%), decreasing the diagnoses of overactive bladder-wet (41.6% to 25.2%, p <0.001), overactive bladder-dry (31.4% to 20.8%, p = 0.002) and intrinsic sphincter deficiency (19.4% to 12.6%, p = 0.003) but increasing the diagnosis of voiding dysfunction (2.2% to 11.9%, p <0.001). After urodynamic studies physicians canceled surgery in 4 of 294 women (1.4%), changed the incontinence procedure in 13 (4.4%) and planned to modify mid urethral sling tension (more or less obstructive) in 20 women (6.8%). Nonoperative treatment plans changed in 40 of 294 women (14%). Urodynamic study driven treatment plan changes were not associated with treatment success (OR 0.96, 95% CI 0.41, 2.25, p = 0.92) but they were associated with increased postoperative treatment for urge urinary incontinence (OR 3.23, 95% CI 1.46, 7.14, p = 0.004). Urodynamic studies significantly changed clinical diagnoses but infrequently changed the global treatment plan or influenced surgeon decision to cancel, change or modify surgical plans. Global treatment plan changes were associated with increased treatment for postoperative urgency urinary incontinence.

The early outcome of surgical treatment for femoroacetabular impingement: success depends on how you measure it

To evaluate the proportion of "successes" after surgery for femoroacetabular impingement (FAI) using different external criteria, "feeling better" and "feeling good", and to determine the corresponding cut-off scores indicating "success" for the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (0-10-point response scale), Oxford Hip Score (OHS) and EuroQoL-5D (EQ-5D and EQ-VAS). Prospective, observational study based in an orthopaedic hospital. Ninety-nine consecutive patients with FAI completed the questionnaires before and 6 months after surgery (arthroscopy or mini-open surgical dislocation). Patient-ratings of change in state ("feeling better") were assessed using a global treatment outcome (GTO) item. Acceptability of the current health state was assessed using the symptom-specific well-being (SSWB) item. Cut-off (threshold) scores for the different instruments indicating the minimal clinically important change (MCIC) and acceptable symptom state were calculated using Receiver Operating Characteristics (ROC) analyses. Significant improvements in all scores (P < 0.001) were recorded 6 months after surgery. The proportion of good outcomes measured with GTO was 60%; 55% of patients reported having achieved an acceptable symptom state. The MCIC scores for improvement were ≥6 for the OHS (0-48 total score range), ≥15 for EQ-VAS, ≥0.16 for EQ-5D index, and ≥22 for the WOMAC-total score (0-100 total score range); absolute scores of ≥40, ≥80, ≥0.682 and ≤8, respectively, were associated with an acceptable symptom state. The results show that feeling better does not always equate to feeling good, and that improvements in outcome scores, even large, do not necessarily indicate acceptability of the current state. The cut-off values may help in the interpretation of trial results and individual change-scores recorded in clinical practice.

Early improvement on antipsychotic treatment as a predictor of subsequent response in schizophrenia: analyses from ziprasidone clinical studies

We examine data from short-term placebo-controlled and comparator-controlled clinical trials of ziprasidone in schizophrenia to confirm the predictive capacity of early symptom changes for response. We pose the question of how early is too early to consider "stay or switch" and evaluate the predictive capability of a clinical measure in this regard. We presented two separate pooled analyses of (i) two placebo-controlled and (ii) two active comparator (risperidone and olanzapine) randomized trials of ziprasidone in schizophrenia. Relationship between early changes in Positive and Negative Syndrome Scale (PANSS) total, Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression-Improvement (CGI-I) scores and treatment outcome was evaluated. Week 2 improvement was more reliably predictive of subsequent outcome than week 1 improvement using PANSS and BPRS scores with high sensitivity and specificity, whereas CGI-I had much lower specificity. Overall, non-improvement at week 1 or week 2 was highly predictive of non-response using BPRS scores and PANSS but not CGI-I. These data, independent of antipsychotic used, confirm prior research showing that early improvement in symptoms is predictive of response. There appears to be an important window of time, beyond week 1, during which important clinical decisions to stay or switch medication may be made.

Depressive Disorders in Restless Legs Syndrome

Epidemiological studies report a 2- to 4-fold risk of a depressive disorder in patients with restless legs syndrome (RLS) compared with healthy controls. The high prevalence rates of depression in RLS indicate an association between the two disorders. Severe sleep disturbance due to the nightly occurrence of RLS symptoms is a common complaint of patients with moderate or severe RLS and may substantially contribute to the emergence of depressive symptoms. Difficulty in the diagnosis of a depressive disorder in patients with RLS may arise from the overlap of symptoms in the two disorders, as sleep-related complaints are frequent both in RLS and depression. The treatment of depression in RLS has some unique aspects, as several antidepressants have been reported to trigger or worsen RLS. To date, no studies have been published regarding the course of depression in untreated and treated patients with RLS. On the other hand, the presence of co-morbid depression can have a substantial impact on the global treatment outcome. In patients with co-morbid moderate/severe depression, antidepressant therapy in parallel with or shortly after commencing RLS treatment is usually necessary. Data from recent trials with dopamine receptor agonists indicate that mild to moderate depressive symptoms are often relieved with improvement of RLS symptoms.

Personality and Symptom Change in Treatment-Refractory Inpatients: Evaluation of the Phase Model of Change Using Rorschach,TAT, and DSM-IV Axis V

In this study, we examined global treatment outcomes during 16 months of intensive, psychodynamic treatment for 77 inpatients suffering from treatment-refractory disorders. Hypotheses based on the phase model of treatment change (Howard, Lueger, Maling, & Martinovich, 1993; Howard, Moras, Brill, Martinovich, & Lutz, 1996) were supported in the study results. Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994) Axis V scales assessing behavioral functioning demonstrated large and medium effect size change, whereas stable, enduring personality functioning assessed by psychoanalytic Rorschach scales and the Social Cognition and Object Relations Scale (Westen, 1995) for the Thematic Apperception Test (Murray, 1943) demonstrated small and medium effect size change. We also report assessment of reliable change index and clinical significance. The ecological validity of Rorschach measures is supported by significant validity coefficients (in the hypothesized directions) between implicit measures of personality functioning and behavioral ratings.

Evidence-Based Review of Patient-Reported Outcomes With Botulinum Toxin Type A

This review systematically examines the effects of botulinum toxin type A (BTX-A) on patient-reported outcomes across disorders using evidence-based criteria. The evidence provided by these studies ranged from randomized, controlled trials to case series. The effects of BTX-A on quality of life or global treatment outcomes were assessed in 48 studies across 16 different conditions. All but 7 of these reported benefits of BTX-A over baseline or the comparator condition (placebo or other treatment). The effects of BTX-A on impairment, activities, or participation were assessed in 46 studies across 17 different conditions. All but 4 reported benefits of BTX-A over baseline or the comparison group. The effects of BTX-A on satisfaction or preference were assessed in 14 studies across 11 different conditions, all of which reported high rates of satisfaction with BTX-A or preference over the comparator. These studies provide evidence that BTX-A exerts meaningful benefits on the quality of life of patients treated with this biologic agent.

Effectiveness of home treatment in children and adolescents with externalizing psychiatric disorders

The study examines effectiveness of home treatment in children and adolescents with severe externalizing behavior disorders. Fifty patients with ICD-10 diagnosis F90, F91, or F92 aged 5-16 years were treated in a home treatment setting for 3.5 months. Assessments were made using multiple informants (patients, parents, therapists, supervisors, and clinicians not involved in the treatment) to evaluate psychiatric symptoms, various aspects of psychosocial functioning, and global treatment outcome. Findings showed a significant decrease in psychiatric symptoms and improvement in psychosocial adjustment. Positive treatment effects were seen in almost every area of social functioning. The child's compliance and the therapist's professionalism were found to be the most important predictors of treatment outcome. Findings suggest that extent of achieved home treatment effects in externalizing disorders is similar to that in internalizing disorders.

Cognitive vulnerabilities predict medical outcome in a sample of pain patients

This study was designed to evaluate whether measures of specific cognitive vulnerabilities to psychopathology assessed prior to medical treatment are related to treatment outcome for outpatient pain patients. A sample of 71 consecutive admissions to an out-patient pain clinic was assessed at initial intake; 43 patients were reassessed at the termination of treatment or at one-year post-intake. Results from 19 of these patients for whom complete data were available indicate that three cognitive vulnerability variables derived from Weissman and Beck's (1978) Dysfunctional Attitude Scale, measures of ‘Dichotomous Thinking’, ‘Imperatives’ and ‘Vulnerability’, but not self-reported depression scores or pain severity ratings, predict clinician-rated global treatment outcome; a fourth vulnerability, ‘Need to Succeed’, was marginally related to outcome. One of the cognitive vulnerability measures, ‘Imperatives’, also predicted patient-rated post-treatment pain severity. Multiple regression analyses indicate that a combination of two cognitive vulnerability measures, ‘Vulnerability’ and ‘Imperatives’, predicted more than half of outcome variance after the effects of initial depression and initial pain severity were statistically controlled.

Gender differences in depression and anxiety among alcoholics.

Recent research suggests that psychopathology, in particular depression and anxiety, differentially affects the substance abuse treatment response of men and women. This study explores the relationship between global psychopathology, depression, anxiety, and alcoholism treatment outcome. These variables were assessed in a sample of 507 (373 men; 134 women) substance abuse clients at intake and at a 6-month follow-up. With the exception of alcohol dependence, there were significant differences in the levels of alcohol problems, depression, anxiety, and global psychopathology for men and women at both intake and follow-up. For the whole sample and for men, initial levels of alcohol problems and alcohol dependence were the best predictors of alcohol problems at follow-up. For women, the initial levels of alcohol dependence and a global measure of psychological functioning were predictive of outcome at follow-up. These findings are compared with past research, and suggestions for further investigation are proposed.