Determination of minimum clinically important difference (MCID) in pain,disability, and quality of life after revision fusion for symptomatic pseudoarthrosis

Background contextSpinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis.PurposeTo determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis.Study design/ settingRetrospective cohort study.MethodsIn 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index).ResultsAll patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state.ConclusionsUsing subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.     

单侧椎弓根螺钉固定系统在腰椎退行性疾病治疗中的研究进展

腰椎退行性疾病是临床上导致腰腿痛的常见病因,包括腰椎间盘突出症、腰椎管狭窄症等,保守治疗无效者需要手术治疗。传统的手术方式为经后路双侧椎弓根螺钉棒固定后椎间隙融合,固定不稳定的节段。但其本身也存在缺点,因此仅行单侧固定,通过减少过强的刚度来代替双侧固定的理念孕育而生,近年来在临床应用中取得了良好的满意度。本文从生物力学、临床疗效、单侧固定的优势与局限性等角度,对近年来国内外单侧椎弓根螺钉固定联合椎间融合术治疗腰椎退行性疾病进行综述。     

The meaning of it all: evaluating knowledge of Minimal Clinically Important Difference (MCID) among chiropractic students

Introduction:Patient-reported outcome measures are frequently used to monitor patient progress during chiropractic care, yet student interns utilizing such assessments are unfamiliar with what magnitude of change (MCID) is considered beneficial to the patient.Objective:This work seeks to determine chiropractic intern knowledge of MCID.Methods:A five-item survey was administered to 104 chiropractic student interns.Results:Nearly one-third of the interns correctly defined the MCID acronym, and approximately one-third of the interns knew at least one MCID value for the outcome assessments in the EHR. Surprisingly, 20% of the interns reported knowledge of at least one MCID value, but answered incorrectly pertaining to the MCID acronym.Conclusion:Student interns value patient perception, but have limited knowledge of MCID values. Addressing this gap will improve their understanding of patient progress and inform their treatment decisions both in the outpatient clinic and in their practices following graduation.     

Minimal clinically important difference in patients who underwent decompression alone for lumbar degenerative disease

Background ContextThe minimal clinically important difference (MCID) represents the smallest change in an outcome measure recognized as clinically meaningful to a patient after receiving a clinical intervention. Most studies that discussed the MCIDs for lumbar spinal stenosis (LSS) included mixed pathologies or procedures despite that the MCID value should be different depending on the intervention. Moreover, despite the efficacy of adopting percentage-change improvement for the MCID threshold, there are limited reports and discussions in the field of lumbar surgery.PurposeThe aim of the present study was to elucidate the MCIDs for the Oswestry Disability Index (ODI), EuroQOL 5-dimension 3-level (EQ-5D-3L), physical component summary (PCS) of the Short Form of the Medical Outcomes Study, and Numeric Rating Scale (NRS) in patients with degenerative LSS treated with decompression surgery without fusion.Study Design/SettingA multicenter retrospective cohort study was performed.Patient SampleA total of 422 patients who underwent decompression surgery for LSS and answered a complete set of questionnaires were included in the study. Patients who underwent endoscopic or revision surgery were excluded.Outcome MeasuresPreoperative and 1-year postoperative scores of each health-related quality of life questionnaires (HRQOLs) and patient satisfaction questionnaire responseMethodsThe patient satisfaction question was used as an anchor, and the cutoff values were estimated based on absolute point improvement from baseline using a receiver-operating characteristic (ROC) curve analysis and the “mean change” method for MCIDs. The MCID values for percentage-change in HRQOLs were also calculated using ROC curve analysis. The three cutoff values for each HRQOL were validated using the Youden index for determining the most robust MCIDs.ResultsOf the patients, 356 (84.4%) were at least “somewhat satisfied” with the treatment results. The two cutoff values of absolute point-change in each HRQOL, which were estimated by two different anchor-based methods, were similar. The area under the curve of the ROC curve for percentage-change tended to be higher than that for absolute point-change. Moreover, the Youden index of the percentage-change in each HRQOL was higher than that of the absolute point-change calculated by either the “mean change” method or the ROC curve analysis. Based on these results, it was proposed that MCID was 42.4% for percentage-change in ODI, 22.0% for EQ-5D-3L, 13.7% for PCS, 25.0% for NRS (low back pain), 55.6% for NRS (leg pain), 22.2% for NRS (leg numbness).ConclusionsThe MCIDs of HRQOLs were calculated in patients with LSS treated with decompression surgery without concomitant fusion procedure. The MCID cutoffs based on percentage-change from baseline were more effective than those of absolute point-change.     

Outcome measures in chronic low back pain

The purpose of this prospective, single site cohort quasi-experimental study was to determine the responsiveness of the numerical rating scale (NRS), Roland–Morris disability questionnaire (RMDQ), Oswestry disability index (ODI), pain self-efficacy questionnaire (PSEQ) and the patient-specific functional scale (PSFS) in order to determine which would best measure clinically meaningful change in a chronic low back pain (LBP) population. Several patient-based outcome instruments are currently used to measure treatment effect in the chronic LBP population. However, there is a lack of consensus on what constitutes a “successful” outcome, how an important improvement/deterioration has been defined and which outcome measure(s) best captures the effectiveness of therapeutic interventions for the chronic LBP population. Sixty-three consecutive patients with chronic LBP referred to a back exercise and education class participated in this study; 48 of the 63 patients had complete data. Five questionnaires were administered initially and after the 5-week back class intervention. Also at 5 weeks, patients completed a global impression of change as a reflection of meaningful change in patient status. Score changes in the five different questionnaires were subjected to both distribution- and anchor-based methods: standard error of measurement (SEM) and receiver operating characteristic (ROC) curves to define clinical improvement. From these methods, the minimal clinically important difference (MCID) defined as the smallest difference that patients and clinicians perceive to be worthwhile is presented for each instrument. Based on the SEM, a point score change of 2.4 in the NRS, 5 in the RMDQ, 17 in the ODI, 11 on the PSEQ, and 1.4 on the PSFS corresponded to the MCID. Based on ROC curve analysis, a point score change of 4 points for both the NRS and RMDQ, 8 points for the ODI, 9 points for the PSEQ and 2 points for the PSFS corresponded to the MCID. The ROC analysis demonstrated that both the PSEQ and PSFS are responsive to clinically important change over time. The NRS was found to be least responsive. The exact value of the MCID is not a fixed value and is dependent on the assessment method used to calculate the score change. Based on ROC curve analysis the PSFS and PSEQ were more responsive than the other scales in measuring change in patients with chronic LBP following participation in a back class programme. However, due to the small sample size, the lack of observed worsening of symptoms over time, the single centre and intervention studied these results which need to be interpreted with caution.     

Minimum clinically important difference and substantial clinical benefit: Does one size fit all diagnoses and patients?

There is increasing emphasis on the need to routinely utilize validated outcomes measures to assess the treatment effect of both operative and nonoperative management of spinal disorders. The minimum clinically important difference (MCID) describes at what point a marginal treatment effect is clinically relevant (threshold). Substantial clinical benefit (SCB) is a measurement that is intended to identify changes in outcomes that are clinically important. This review will discuss how MCID and SCB are calculated and relative criticisms of each measure; as each is determined based on patient-reported outcomes and does not incorporate cost analysis, the use of these measures has inherent limitations.     

Changes in pain and disability secondary to shoe lift intervention in subjects with limb length inequality and chronic low back pain: a preliminary report

STUDY DESIGN: Preassessment and postassessment of treatment intervention. OBJECTIVE: To determine the changes in pain and disability secondary to shoe lift intervention for subjects with chronic low back pain (LBP) who have a limb length inequality (LLI). BACKGROUND: Previous reports have suggested that LLI may be a cause of LBP Most prior studies of lift therapy for management of LLI in patients with LBP have lacked clear guidelines for clinicians regarding the implementation of shoe lift intervention. METHODS AND MEASURES: Twelve subjects (6 male, 6 female) between the ages of 19 and 62 years with LLI (6.4-22.2 mm) and chronic LBP (1-30 years) participated. Visual analog scale pain ratings and disability questionnaire scores were acquired before and after lift intervention. Subjects determined their lift height based on resolution of LBP symptoms. RESULTS: Subjects experienced relief of general pain symptoms (P = .0006) and pain associated with standing (P= .002) following lift intervention, with minimally clinically important (MCID) reductions in general pain for 9 of 12 subjects and MCID reductions in standing pain for 8 of 10 subjects. Subjects also had less disability on the disability questionnaire (P = .001) following the intervention, with 9 of 12 subjects experiencing MCID reductions in disability. CONCLUSION: Shoe lifts may reduce LBP and improve function for patients who have chronic LBP and an LLI. Randomized controlled trials are needed to assess the efficacy of this intervention.     

Evidence-based orthopaedic surgery: what is evidence without the outcomes?

With the increased emphasis on evidence-based medicine in orthopaedics, the surgeon is faced with the challenge of evaluating the effectiveness of various treatment interventions. Health care authorities are also interested in measuring competing interventions, but out of concern for controlling costs. The success or failure of an intervention is often determined based on treatment outcomes. There are many outcomes measures available in the orthopaedic literature, and it is not uncommon for different measures to produce conflicting results. The orthopaedic surgeon must have the ability to accurately evaluate an outcomes measure to determine the value of a specific intervention. Similarly, selecting the appropriate outcomes measure for research or clinical purposes is an important decision that may have far-reaching implications on reimbursement and determining treatment success. To best select outcomes measures and to select the appropriate treatment for each patient, the orthopaedic surgeon needs to understand the recommended contents of a quality instrument, the difference between clinician-based and patient-reported outcomes, and how to evaluate outcomes reported in the literature.     

Patients with radiculopathy have worse baseline disability and greater improvements following anterior cervical discectomy and fusion compared to patients with myelopathy

BACKGROUND CONTEXTAnterior cervical discectomy and fusion (ACDF) is commonly performed in patients with radiculopathy and myelopathy. Although the goal of surgery in patients with radiculopathy is to improve function and reduce pain, patients with myelopathy undergo surgery to halt disease progression. Although the expectations between these preoperative diagnoses are generally understood to be disparate by spine surgeons, there is limited literature demonstrating their discordant outcomes.PURPOSETo compare improvements in patient reported outcome measures (PROMs) for patients undergoing ACDF for myelopathy or radiculopathy. Secondarily, we analyzed the proportion of patients who attain the minimum clinically important difference (MCID) postoperatively using thresholds derived from radiculopathy, myelopathy, and mixed cohort studies.STUDY DESIGN/SETTINGSingle institution retrospective cohort studyPATIENT SAMPLEPatients undergoing primary, elective ACDF with a preoperative diagnosis of radiculopathy or myelopathy and a complete set of preoperative and one-year postoperative PROMs.OUTCOME MEASURESOutcome measures included the following PROMs: Short-Form 12 Physical Component (PCS-12) and Mental Component (MCS-12) scores, the Visual Analog Scale (VAS) Arm score, and the Neck Disability Index (NDI). Hospital readmissions and revision surgery were also collected and evaluated.METHODSPatients undergoing an ACDF from 2014 to 2020 were identified and grouped based on preoperative diagnosis (radiculopathy or myelopathy). We utilized “general MCID” thresholds from a cohort of patients with degenerative spine conditions, and “specific MCID” thresholds generated from cohorts of patients with myelopathy or radiculopathy, respectively. Multivariate linear regressions were performed for delta (?) PROMs and multivariate logistic regressions were performed for both general and specific MCID improvements.RESULTSA total of 798 patients met inclusion criteria. Patients with myelopathy had better baseline function and arm pain (MCS-12: 49.6 vs 47.6, p=.018; VAS Arm: 3.94 vs 6.02, p<.001; and NDI: 34.1 vs 41.9, p<.001), were older (p<.001), had more comorbidities (p=.014), more levels fused (p<.001), and had decreased improvement in PROMs following surgery compared to patients with radiculopathy (?PCS-12: 4.76 vs 7.21, p=.006; ?VAS Arm: -1.69 vs -3.70, p<.001; and ?NDI: -11.94 vs -18.61, p<.001). On multivariate analysis, radiculopathy was an independent predictor of increased improvement in PCS-12 (β=2.10, p=.019), ?NDI (β=-5.36, p<.001), and ?VAS Arm (β=-1.93, p<.001). Radiculopathy patients were more likely to achieve general MCID improvements following surgery (NDI: Odds ratio (OR): 1.42, p=.035 and VAS Arm: OR: 2.98, p<.001), but there was no difference between patients with radiculopathy or myelopathy when using radiculopathy and myelopathy specific MCID thresholds (MCS-12: p=.113, PCS-12: p=.675, NDI: p=.108, and VAS Arm: p=.314).CONCLUSIONSPatients undergoing ACDF with myelopathy or radiculopathy represent two distinct patient populations with differing treatment indications and clinical outcomes. Compared to radiculopathy, patients with myelopathy have better baseline function, decreased improvement in PROMs, and are less likely to reach MCID using general threshold values, but there is no difference in the proportion reaching MCID when using specific threshold values.LEVEL OF EVIDENCEIRB     

Our Measure of Medical Research Should Be Appreciable Benefit to the Patient

The clinical relevance of research is much more important than statistical significance. Patient-reported outcome measures (PROM) are the strongest determinants of satisfaction as the result of an intervention or treatment. Outcomes can be measured in terms of the minimal clinically important difference (MCID) detectable by a patient, bearing in mind that “detectable” includes worsening as well as improvement. Patient-acceptable symptomatic state (PASS) and substantial clinical benefit (SCB) ultimately correlate with whether patients are happy or willing to undergo an intervention again. These measures should not be reported in terms of group means, where outliers could distort the score. These measures should be reported in terms of the proportion of individual patients whose scores cross the meaningful thresholds of satisfaction.     

The Minimal Clinically Important Difference for PROMIS Physical Function in Patients With Thumb Carpometacarpal Arthritis

Background: This study was performed to determine the minimal clinically important difference (MCID) of Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) computer adaptive test (CAT) for patients with thumb carpometacarpal (CMC) arthritis. Methods: This study retrospectively analyzed data from 152 adults receiving surgical and nonsurgical care for unilateral thumb CMC arthritis at a single institution between January 2016 and January 2018. Patients completed PROMIS PF v1.2/2.0 CAT at each visit. At follow-up, patients also completed two 6-item anchor questions assessing the degree of perceived improvement. Statistical testing analyzed the ability of the clinical anchor to discriminate levels of improvement. An anchor-based MCID estimate was calculated as the mean PROMIS PF change score in the mild improvement group. The anchor-based MCID value was examined for the influence of patient age, initial and final PROMIS scores, and follow-up interval. A distribution-based MCID value was calculated incorporating the standard error of measurement and effect size. Results: The change in PROMIS PF scores was significantly different between encounters where patients reported no change, mild improvement, and much improvement. The anchor-based MCID estimate for PROMIS PF was 3.9 (95% confidence interval, 3.3-4.7). Individual MCID values were weakly correlated with the final absolute PROMIS PF score but did not correlate with patient age, time between visits, or the initial absolute PROMIS PF score. The distribution-based MCID value was 3.5 (95% confidence interval, 3.1-3.9). Conclusions: The estimated range of MCID values for PROMIS PF is 3.5 to 3.9 points in patients treated for thumb CMC arthritis.     

Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit

Background

The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes (PROs): Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain, and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary. However, the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear. In this context, the concept of minimum clinically important difference (MCID) is developing into the standard by which to evaluate treatments, patient satisfaction and cost-effectiveness.

Methods

Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospective blinded database. PROs (NDI, PCS, MCS and VAS) were collected preoperatively, and together with blinded Surgeon Ratings (SR) at 3 months and 6 months post-surgery. Four anchor-based approaches were used to calculate different MCIDs. Three anchors (VAS, HTI (Health Transition Item of the SF-36) and SR) were used to evaluate surgery outcome. The best clinically and statistically relevant MCID was chosen.

Results

On average, all patients presented with a statistically significant improvement (p?<?0.001) postoperatively for NDI (27.42 to 19.42), PCS (33.02 to 42.03), MCS (44 to 50.74) and VAS (2.85 to 1.93). The four MCID anchor-based approaches yielded a range of values for each PRO: 2.23–16.59 for PCS, 0.11–16.27 for MCS and 2.72–12.08 for NDI. When compared to the VAS and HTI anchors, the area under the ROC curve was greater for SR. This finding suggests that SR may be a more reliable anchor for MCID calculation.

Conclusion

The MDC (minimum detectable change) approach together with the SR anchor appears to be the most appropriate MCID method. It offers the greatest area under the ROC curve (threshold above the 95 % CI), and the choice of the anchor did not significantly affect this result. MCID values for this dataset were 5.6 for PCS, 5.12 for MCS and 2.41 for NDI.     

Alcohol interventions for trauma patients treated in emergency departments and hospitals: a cost benefit analysis

OBJECTIVE: To determine if brief alcohol interventions in trauma centers reduce health care costs. SUMMARY BACKGROUND DATA: Alcohol-use disorders are the leading cause of injury. Brief interventions in trauma patients reduce subsequent alcohol intake and injury recidivism but have not yet been widely implemented. METHODS: This was a cost-benefit analysis. The study population consisted of injured patients treated in an emergency department or admitted to a hospital. The analysis was restricted to direct injury-related medical costs only so that it would be most meaningful to hospitals, insurers, and government agencies responsible for health care costs. Underlying assumptions used to arrive at future benefits, including costs, injury rates, and intervention effectiveness, were derived from published nationwide databases, epidemiologic, and clinical trial data. Model parameters were examined with 1-way sensitivity analyses, and the cost-benefit ratio was calculated. Monte Carlo analysis was used to determine the strategy-selection confidence intervals. RESULTS: An estimated 27% of all injured adult patients are candidates for a brief alcohol intervention. The net cost savings of the intervention was 89 US dollars per patient screened, or 330 US dollars for each patient offered an intervention. The benefit in reduced health expenditures resulted in savings of 3.81 US dollars for every 1.00 US dollar spent on screening and intervention. This finding was robust to various assumptions regarding probability of accepting an intervention, cost of screening and intervention, and risk of injury recidivism. Monte Carlo simulations found that offering a brief intervention would save health care costs in 91.5% of simulated runs. If interventions were routinely offered to eligible injured adult patients nationwide, the potential net savings could approach 1.82 billion US dollars annually. CONCLUSIONS: Screening and brief intervention for alcohol problems in trauma patients is cost-effective and should be routinely implemented.     

Editorial Commentary: Patients Who Achieve a Minimal Clinically Important Difference (Feel Better) Early After Hip Arthroscopy Have the Highest Rates of Long-Term Satisfaction

Analyzing patient-reported outcomes using the lens of the minimal clinical important difference (MCID) and patient acceptable symptomatic state allows surgeons to assess patient recovery at the individual level and make necessary changes to management if necessary. When patients with femoroacetabular impingement achieve MCID 6 months after arthroscopic treatment, they achieve patient acceptable symptomatic state 2 years postoperatively 88% of the time. The findings highlight the importance of the postoperative recovery trajectory and illustrate a quantitative way to study the progress of individual patients along their care journey.     

Mobilization with movement as an adjunct intervention in a patient with complicated de Quervain's tenosynovitis: a case report

STUDY DESIGN: Case study. OBJECTIVES: To describe the use of conventional physical therapy interventions together with Mobilization With Movement (MWM) techniques in the treatment of an individual with a complicated scenario of de Quervain's tenosynovitis. BACKGROUND: The patient was a 61-year-old woman who presented with signs and symptoms consistent with de Quervain's tenosynovitis of the right hand. Range limitations in all motions of the right wrist and first carpometacarpal joint complicated her presentation. METHODS AND MEASURES: Physical therapy included conventional intervention with superficial heat, ice, iontophoresis, and transverse friction massage directed to the first dorsal tunnel. Conventional joint mobilization techniques addressed the motion limitations of the first carpometacarpal, radiocarpal, and midcarpal joints. In addition, MWM techniques were utilized to promote pain-free wrist and thumb mobility. The specific MWM techniques used with this patient involved active movements of the thumb and wrist superimposed on a passive radial glide of the proximal row of carpal bones. RESULTS: The described treatment regime, which involved conventional physical therapy interventions, along with MWM, aided in the complete resolution of this patient's impairments and functional limitations. CONCLUSION: The combination of conventional physical agents, exercise, and manual therapy, and the less conventional MWM techniques, proved successful with this patient. MWM involving the correction of minutejoint malalignments, coupled with active motion of the wrist and first carpometacarpal joints, was an effective and efficient adjunct physical therapy intervention. Because subtle changes injoint alignment may contribute to painful syndromes in the tendon complexes that cross a malaligned joint, use of MWM as a treatment technique warrants continued research.     

Preoperative patient activation predicts minimum clinically important difference for PROMIS pain and physical function in patients undergoing elective spine surgery

BACKGROUND CONTEXTPatient activation is a patient's willingness to take independent actions to manage their own health care.PURPOSEThe goal of this study is to determine whether preoperative patient activation measure (PAM) predicts minimum clinically important difference (MCID) for Patient-Reported Outcomes Measurement Information System (PROMIS) pain, physical function, depression, and anxiety for patients undergoing elective spine surgery.STUDY DESIGN/SETTINGRetrospective review.PATIENT SAMPLEA single-institution, academic database of patients undergoing elective spine surgery.OUTCOME MEASUREMCID at 1-year follow-up for PROMIS pain, physical function, depression and anxiety.METHODSWe retrospectively reviewed a single-institution, academic database of patients undergoing elective spine surgery. Preoperative patient activation was evaluated using the PAM-13 survey, which was used to stratify patients into four activation stages. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on PROMIS pain and the physical function.RESULTSOf the 430 patients, 220 (51%) were female with a mean age of 58.2±16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year follow up, 248 (58%) achieved MCID for PROMIS physical function, 256 (60%) achieved MCID for PROMIS pain, 151 (35.28%) achieved MCID for PROMIS depression, and 197 (46%) achieved MCID for PROMIS anxiety. For PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.49, 95% CI:1.27, 9.59), stage 3 (aOR:3.54, 95% CI:1.40, 8.98) and stage 4 (aOR:7.88, 95% CI:3.29, 18.9) were more likely to achieve MCID. For PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.82, 95% CI:1.18, 6.76) and stage 4 (aOR:5.44, 95% CI:2.41, 12.3) were more likely to achieve MCID. For PROMIS depression, when compared against patients at stage 1, patients at stage 4 were more likely to achieve MCID (Adjusted Odds Ratio (aOR):2.59, 95% CI:1.08–6.19). For PROMIS anxiety, when compared against patients at stage 1, stage 3 (Adjusted Odds Ratio (aOR):3.21, 95% CI:1.20–8.57), and stage 4 (aOR:5.56, 95% CI:2.20–14.01) were more likely to achieve MCID.CONCLUSIONPatients at higher stages of activation were more likely to achieve MCID for PROMIS pain, physical function, depression, and anxiety at 1-year follow-up. Routine preoperative assessment of patient activation may help identify patients at risk of poor outcomes.     

Testing minimal clinically important difference: consensus or conundrum?

Background ContextVarious methodologies have been used in attempting to elucidate a standard method for calculating minimal clinically important difference (MCID). A consensus-based decision (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMMPACT] group) suggested a 30% reduction from baseline as a means to define the MCID of self-report back pain measures. Additionally, important psychometric issues need to be addressed regarding use of an independent measure of the same construct as an external criterion, instead of simply using another self-report measure, when using an anchor-based approach to MCID.PurposeThe purpose was to test the validity of recently published guidelines regarding MCID using self-report back pain measures and objective socioeconomic outcomes.Study Design/SettingThis is a prospective study assessing change scores on commonly used spinal pain assessment measures in patients with chronic disabling occupational spinal disorders (CDOSDs) treated in a regional referral rehabilitation center performing interdisciplinary functional restoration.Patient SampleThe study consisted of consecutive cohort of patients (N=1,180) with CDOSDs completing a functional restoration program.Outcomes MeasuresSelf-report measures including the Oswestry Disability Index (ODI) and the physical component summary (PCS) and mental component summary (MCS) of the Short Form-36 (SF-36) obtained before and after treatment, were compared with objective socioeconomically relevant outcomes obtained 1 year after treatment (ie, work status and additional health-care utilization), that were the external criteria for evaluating MCID.MethodsPre- to posttreatment improvement was calculated separately for each measure, and subjects were divided into two groups based on the change in scores relative to baseline: 30% or greater versus less than 30% improvement. One-year posttreatment objective socioeconomic outcomes were used as independent external criteria relevant to the CDOSD population. This population is often studied as the most costly and problematic cohort in spine care.ResultsThe ODI and SF-36 MCS were not associated with any of the objective 1-year outcomes used as external criteria. Reduced post-rehabilitation health-care utilization (based on the percentage of patients pursuing health care from a new provider) was weakly associated with 30% or greater improvement on the SF-36 PCS, relative to patients whose scores changed by less than 30% relative to baseline (17.0% vs. 21.1%). The same was true for the ODI and return-to-work.ConclusionsWhen objective and independent criteria are used (socioeconomic outcomes) in a CDOSD cohort, the 30% improvement in the ODI and SF-36 may not be a valid MCID index. This replicates similar conclusions made by an independent research group using a distribution-based approach to MCID. The validity of the MCID concept rests on future research using objective external criteria. Moreover, there remains a question whether the term “important” in MCID can be unequivocally and operationally defined as a reliable construct.     

Reconsideration of the clinical and histopathological significance of angiogenesis in prostate cancer: Usefulness and limitations of microvessel density measurement

Angiogenesis plays important roles in tumor growth and cancer cell dissemination in almost all cancers. In prostate cancer, there is general agreement that increased angiogenesis is an important factor in determining tumor development and prognosis in these patients. Microvessel density is recognized as a useful marker for evaluating the angiogenic status of cancer tissues. Many investigators have reported that microvessel density is significantly associated with pathological features and outcomes in prostate cancer patients; however, some researchers have expressed opposing opinions. As the reason for such discrepancy, previous reports have suggested differences in the methodologies of measuring microvessel density in cancer tissues. In the present review, we focus on the variation in such methods, including the selected area and the method used for (semi)quantification. In particular, we discuss the relationship between malignancy potential, tumor progression, and survival and differences in the antibodies used for detection of endothelial cells in detail. We briefly compare the pathological significance and prognostic roles of microvessel density measured using von Willebrand factor, CD31, CD34, and CD105. Based on these analyses, the advantages and limitations of microvessel density measurements in prostate cancer tissues are clarified. Improved “real” and “specific” markers of cancer‐related angiogenesis are necessary for better predictions of prognoses and for discussion of treatment strategies for patients with prostate cancer. However, establishment of a satisfactory cancer‐related endothelial marker could take a long time. Therefore, knowledge regarding the pathological significance of microvessel density – based on understanding of the advantages and limitations of microvessel density determination methods – is important.     

What is an acceptable outcome of treatment before it begins? Methodological considerations and implications for patients with chronic low back pain

Understanding changes in patient-reported outcomes is indispensable for interpretation of results from clinical studies. As a consequence the term “minimal clinically important difference” (MCID) was coined in the late 1980s to ease classification of patients into improved, not changed or deteriorated. Several methodological categories have been developed determining the MCID, however, all are subject to weaknesses or biases reducing the validity of the reported MCID. The objective of this study was to determine the reproducibility and validity of a novel method for estimating low back pain (LBP) patients’ view of an acceptable change (MCID_pre) before treatment begins. One-hundred and forty-seven patients with chronic LBP were recruited from an out-patient hospital back pain unit and followed over an 8-week period. Original and modified versions of the Oswestry disability index (ODI), Bournemouth questionnaire (BQ) and numeric pain rating scale (NRS_pain) were filled in at baseline. The modified questionnaires determined what the patient considered an acceptable post-treatment outcome which allowed us to calculate the MCID_pre. Concurrent comparisons between the MCID_pre, instrument measurement error and a retrospective approach of establishing the minimal clinically important difference (MCID_post) were made. The results showed the prospective acceptable outcome method scores to have acceptable reproducibility outside measurement error. MCID_pre was 4.5 larger for the ODI and 1.5 times larger for BQ and NRS_pain compared to the MCID_post. Furthermore, MCID_pre and patients post-treatment acceptable change was almost equal for the NRS_pain but not for the ODI and BQ. In conclusion, chronic LBP patients have a reasonably realistic idea of an acceptable change in pain, but probably an overly optimistic view of changes in functional and psychological/affective domains before treatment begins.