Miranda L. van Hooff

A proposed set of metrics for standardized outcome reporting in the management of low back pain

Background and purpose — Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set. Patients and methods — An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions. Results — Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools. Interpretation — The outcome measures recommended here are structured around specific etiologies of LBP, span a patient’s entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.

A short, intensive cognitive behavioral pain management program reduces health-care use in patients with chronic low back pain: two-year follow-up results of a prospective cohort.

PurposeCognitive behavioral interventions are recommended as non-invasive treatment options for patients with chronic low back pain (CLBP). However, most treatment effects are small and short-lived. Although a 2-week intensive pain management program for patients with CLBP seems to be effective, the long-term results are not known. The purpose of this study is to evaluate the stability of the 2-year follow-up results and whether this is reflected in the use of health-care services.MethodsA prospective cohort study was performed. Pre-treatment characteristics of patients and data of outcomes obtained at 1-year follow-up were used. At 2-year follow-up a structured interview was conducted following the principles of a post-marketing survey. Outcomes included daily functioning, quality of life, current intensity of pain, disturbance of pain during daily activities, and indicators of the use of pain medication and health-care services.ResultsOf the 90 eligible patients 85 (94%) participated in the post-marketing survey. The 1-year clinical relevant effects are maintained at 2-year follow-up. Effect sizes for functioning and quality of life were large. More than 65% reached preset minimal clinically important differences. At pre-treatment all patients consulted their general practitioner (GP) and medical specialist (MS). At 2-year follow-up 73% reported having consulted neither a GP nor an MS during the previous year. Most of the patients indicated not to use any pain medication (57%) and the percentage patients using opioids have decreased (14%). Moreover, 81% reported to be at work.ConclusionsThe gained results from selected and motivated patients with longstanding CLBP at 1-year follow-up are stable at 2-year follow-up. Above all, most of the participants are at work and results indicate that the use of both pain medication and health care have decreased substantially.

The Oswestry Disability Index (version 2.1a): validation of a Dutch language version.

Study Design. A cross-sectional study on baseline data. Objective. To translate the Oswestry Disability Index (ODI) version 2.1a into the Dutch language and to validate its use in a cohort of patients with chronic low back pain in secondary spine care. Summary of Background Data. Patient-reported outcome measures (PROMs) are commonly accepted to evaluate the outcome of spine interventions. Functional status is an important outcome in spine research. The ODI is a recommended condition-specific patient-reported outcome measure used to evaluate functional status in patients with back pain. As yet, no formal translated Dutch version exists. Methods. The ODI was translated according to established guidelines. The final version was built into the electronic web-based system in addition with the Roland Morris Disability Questionnaire, the numeric rating scale for pain severity, 36-Item Short Form Health Survey Questionnaire for quality of life, and the hospital anxiety and depression scale. Baseline data were used of 244 patients with chronic low back pain who participated in a combined physical and psychological program. Floor and ceiling effects, internal consistency, and the construct validity were evaluated using quality criteria. Results. The mean ODI (standard deviation) was 39.6 (12.3); minimum 6, maximum 70. Most of the participants (88%) were moderately to severely disabled. Factor analysis determined a 1-factor structure (36% explained variance) and the homogeneity of ODI items is shown (Cronbach &agr; = 0.79). The construct validity is supported as all (6:6) the a priori hypotheses were confirmed. Moreover, the ODI and Roland Morris Disability Questionnaire, showed a strong significant correlation (r = 0.68, P < 0.001) and an overlap: mean difference of −18 (95% limits of agreement: −44 to 8). Conclusion. The Dutch ODI version 2.1a is a valid and valuable tool for the measurement of functional status and disability among Dutch patients with chronic low back pain. This translated condition-specific patient-reported outcome measure version is recommended for use in future back pain research and to evaluate outcome of back care in the Netherlands. Level of Evidence: 4

The Nijmegen Decision Tool for Chronic Low Back Pain. Development of a Clinical Decision Tool for Secondary or Tertiary Spine Care Specialists

Background In Western Europe, low back pain has the greatest burden of all diseases. When back pain persists, different medical specialists are involved and a lack of consensus exists among these specialists for medical decision-making in Chronic Low Back Pain (CLBP). Objective To develop a decision tool for secondary or tertiary spine care specialists to decide which patients with CLBP should be seen by a spine surgeon or by other non-surgical medical specialists. Methods A Delphi study was performed to identify indicators predicting the outcome of interventions. In the preparatory stage evidence from international guidelines and literature were summarized. Eligible studies were reviews and longitudinal studies. Inclusion criteria: surgical or non-surgical interventions and persistence of complaints, CLBP-patients aged 18–65 years, reported baseline measures of predictive indicators, and one or more reported outcomes had to assess functional status, quality of life, pain intensity, employment status or a composite score. Subsequently, a three-round Delphi procedure, to reach consensus on candidate indicators, was performed among a multidisciplinary panel of 29 CLBP-professionals (>five years CLBP-experience). The pre-set threshold for general agreement was ≥70%. The final indicator set was used to develop a clinical decision tool. Results A draft list with 53 candidate indicators (38 with conclusive evidence and 15 with inconclusive evidence) was included for the Delphi study. Consensus was reached to include 47 indicators. A first version of the decision tool was developed, consisting of a web-based screening questionnaire and a provisional decision algorithm. Conclusions This is the first clinical decision tool based on current scientific evidence and formal multidisciplinary consensus that helps referring the patient for consultation to a spine surgeon or a non-surgical spine care specialist. We expect that this tool considerably helps in clinical decision-making spine care, thereby improving efficient use of scarce sources and the outcomes of spinal interventions.

Treatment of prosthetic joint infections due to Propionibacterium: Similar results in 60 patients treated with and without rifampicin

Background and purpose — Currently, Propionibacterium is frequently recognized as a causative microorganism of prosthetic joint infection (PJI). We assessed treatment success at 1- and 2-year follow-up after treatment of Propionibacterium-associated PJI of the shoulder, hip, and knee. Furthermore, we attempted to determine whether postoperative treatment with rifampicin is favorable. Patients and methods — We conducted a retrospective cohort study in which we included patients with a primary or revision joint arthroplasty of the shoulder, hip, or knee who were diagnosed with a Propionibacterium-associated PJI between November 2008 and February 2013 and who had been followed up for at least 1 year. Results — We identified 60 patients with a Propionibacterium-associated PJI with a median duration of 21 (0.1–49) months until the occurrence of treatment failure. 39 patients received rifampicin combination therapy, with a success rate of 93% (95% CI: 83–97) after 1 year and 86% (CI: 71–93) after 2 years. The success rate was similar in patients who were treated with rifampicin and those who were not. Interpretation — Propionibacterium-associated PJI treated with surgery in combination with long-term antibiotic administration had a successful outcome at 1- and 2-year follow-up irrespective of whether the patient was treated with rifampicin. Prospective studies are needed to determine whether the use of rifampicin is beneficial in the treatment of Propionibacterium-associated PJI.

Early failures in large head metal-on-metal total hip arthroplasty

Concerns have recently been raised about large head metal-on-metal total hip arthroplasties (LDH THA). Metal ion release due to wear may cause osteolysis, pseudotumours and necrosis. In addition, fixation of certain acetabular components is thought to be suboptimal. We present the short term outcome of the Durom LDH THA. Retrospectively, a consecutive series of 64 implants in 60 patients was analysed with a mean follow-up of 37 months. Clinical and radiological evaluation was performed on a regular basis, followed by additional evaluations when indicated. The 10-year revision percentage was calculated and compared with National Institute for Health and Clinical Excellence (NICE) standards. Six patients (six hips) underwent cup revision (9%). Four of these cups showed no or minimal bone fixation. Three patients had a pseudotumour. In two revision cases, ALVAL (aseptic lymphocyte-dominated vasculitis-associated lesion) was present. Lack of bone ingrowth and the presence of ARMD (adverse reaction to metal debris) seem to contribute to a high failure rate of the Durom LDH THA. The predicted ten-year revision rate of 14.2% (95% CI 5.6–22.8) is, given the broad confidence interval, not significantly outside NICE recommended standards. However, it is not clear which factors, if any, predict implant failure. Therefore, we do not advocate the use of this implant.

Current Construct Options for Revision of Large Acetabular Defects: A Systematic Review.

Background:Many treatment options are available for the revision of large acetabular defects. Debate continues as to which technique is most effective. Methods:A systematic review was performed according to the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines to evaluate the effectiveness of interventions for large acetabular defects. Quality assessment was performed next with use of 8 items of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for reports of observational studies. Large acetabular defects were defined as American Academy of Orthopaedic Surgeons (AAOS) type III or IV or Paprosky type 3A or 3B. Outcomes included re-revision, radiographic loosening, complications, and clinical outcomes. Results:We found 7 different treatment options for large acetabular defects in 20 included studies: antiprotrusio cage (8 studies), Trabecular Metal (Zimmer) augment and shell (4 studies), bone impaction grafting with a metal mesh (2 studies), hemispherical implant with hook and flanges (2 studies), Trabecular Metal augment or structural allograft with cup (2 studies), cup-cage reconstruction (1 study), and custom-made triflange component (1 study). Conclusions:Trabecular Metal augments and shells gave the most promising results in terms of the re-revision rate and radiographic loosening. Reconstruction with an antiprotrusio cage was the most frequently reported technique, with good results in a physically low-demand elderly population. Bone impaction grafting seems not appropriate for pelvic discontinuity and prone to failure in patients with Paprosky type-3B defects. In those cases, a custom-made triflange implant or a cup-cage reconstruction might be the best alternative, but few reports of sufficient quality are available yet. Level of Evidence:Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

The impact of trunk impairment on performance of wheelchair activities with a focus on wheelchair court sports: a systematic review

BackgroundTrunk impairment seems to impact significantly on performance in wheelchair court sports, but evidence to support this impression has never been systematically assessed. The objective of this study is to systematically review, describe and synthesise the literature investigating the impact of trunk impairment on wheelchair activities in court sports.MethodsThis systematic review was performed according to the consensus statement for the meta-analysis of observational studies in epidemiology (MOOSE). The search strategy for original articles comprised Medline (1950- November 2014), Cinahl (1981-November 2014), and Embase (1980- November 2014), using the search terms: trunk, trunk muscles, postural balance, posture and wheelchair.Eligibility criteria for further review were 1) participants included experienced wheelchair users, 2) comparisons were made between a) participants with different levels of trunk impairment or b) between able bodied participants and participants with trunk impairment, or c) between participants with trunk impairment with and without compensatory equipment, and 3) outcome measures were quantitative data on wheelchair activities. For methodological quality assessment, the STROBE (Strengthening the reporting of observational studies in epidemiology) checklist was used.ResultsAfter assessment of 358 potentially relevant studies for the eligibility criteria, 25 studies were appropriate for methodological assessment. Twelve articles fulfilled the predetermined minimum of 15 reported items on the 22-item STROBE checklist. These studies were limited to observational studies with small populations. All but one study were restricted to patients with spinal cord injury (SCI).ConclusionsLimited evidence was found about the impact of trunk impairment on wheelchair activities. Reach to the front and multidirectional reach was further in able bodied persons than in persons with SCI. In a perturbation that equals deceleration in wheelchair court sports, able bodied persons maintain balance, whereas persons with SCI lose balance. No evidence was found to support a difference in acceleration between persons with partial trunk muscle strength and persons with full trunk muscle strength. For future research, there is a need for a test that includes all types of trunk impairment and identification of activities that determine performance in wheelchair court sports. Furthermore, populations of athletes with all trunk impairment types should be included.

Lumbar spinal stenosis: comparison of surgical practice variation and clinical outcome in three national spine registries

BACKGROUND CONTEXT Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation. PURPOSE The present study aimed to evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness. STUDY DESIGN This is an observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark. PATIENT SAMPLE Patients aged 50 and older operated during 2011-2013 for LSS were included. OUTCOME MEASURES Patient-Reported Outcome Measures (PROMs): Oswestry Disability Index (ODI) (primary outcome), Numeric Rating Scale (NRS) for leg pain and back pain, and health-related quality of life (Euro-Qol-5D) were reported. Analysis included case-mix adjustment. In addition, we report differences in hospital stay. METHODS Analyses of baseline data were done by analysis of variance (ANOVA), chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at 1-year follow-up between the countries were done by ANOVA (crude) and analysis of covariance (case-mix adjustment). RESULTS Out of 14,223 included patients, 10,890 (77%) responded at 1-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without or with spondylolisthesis) was 11% (4%, 47%) in Norway, 21% (9%, 56%) in Sweden, and 28% (15%, 88%) in Denmark. At 1-year follow-up, the mean improvement for ODI (95% confidence interval) was 18 (17-18) in Norway, 17 (17-18) in Sweden, and 18 (17-19) in Denmark. Patients operated with arthrodesis had prolonged hospital stay. CONCLUSIONS Real-life data from three national spine registers showed similar indications for decompression surgery but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness.

Can patient-reported profiles avoid unnecessary referral to a spine surgeon? An observational study to further develop the Nijmegen Decision Tool for Chronic Low Back Pain

Introduction Chronic Low Back Pain (CLBP) is a heterogeneous condition with lack of diagnostic clarity. Therapeutic interventions show small effects. To improve outcomes by targeting interventions it is recommended to develop a triage system to surgical and non-surgical treatments based on treatment outcomes. The objective of the current study was to develop and internally validate prognostic models based on pre-treatment patient-reported profiles that identify patients who either respond or do not respond to two frequently performed treatments (lumbar spine surgery and multidisciplinary pain management program). Methods A consecutive cohort study in a secondary referral spine center was performed. The study followed the recommendations of the PROGRESS framework and was registered in the Dutch Trial Register (NTR5946). Data of forty-seven potential pre-consultation (baseline) indicators predicting ‘response’ or ‘non-response’ at one-year follow-up for the two treatments were obtained to develop and validate four multivariable logistic regression models. The source population consisted of 3,410 referred CLBP-patients. Two treatment cohorts were defined: elective ‘spine surgery’ (n = 217 [6.4%]) and multidisciplinary bio-psychosocial ‘pain management program’ (n = 171 [5.0%]). Main inclusion criteria were age ≥18, CLBP (≥6 months), and not responding to primary care treatment. The primary outcome was functional ability: ‘response’ (Oswestry Disability Index [ODI] ≤22) and ‘non-response’ (ODI ≥41). Results Baseline indicators predictive of treatment outcome were: degree of disability (all models), ≥2 previous spine surgeries, psychosocial complaints, age (onset <20 or >50), and patient expectations of treatment outcomes. The explained variances were low for the models predicting response and non-response to pain management program (R2 respectively 23% and 26%) and modest for surgery (R2 30% and 39%). The overall performance was acceptable (c-index; 0.72–0.83), the model predicting non-response to surgery performed best (R2 = 39%; c-index = 0.83). Conclusion This study was the first to identify different patient-reported profiles that predict response to different treatments for CLBP. The model predicting ‘non-response’ to elective lumbar spine surgery performed remarkably well, suggesting that referrals of these patients to a spine surgeon could be avoided. After external validation, the patient-reported profiles could potentially enhance timely patient triage to the right secondary care specialist and improve decision-making between clinican and patient. This could lead to improved treatment outcomes, which results in a more efficient use of healthcare resources.