Health Transition Item Research Articles

Minimum Clinically Important Difference of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire for Patients with Lumbar Spine Disease Undergoing Posterior Surgery by Generation.

Few studies have assessed the minimum clinically important difference (MCID) of each Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) domain. This study assessed MCIDs of JOABPEQ in patients with lumbar spine disease by generation. We evaluated the JOABPEQ score of 805 consecutive patients with lumbar spine disease undergoing posterior surgery preoperatively and 1 year postoperatively. MCIDs of each JOABPEQ domain were determined using anchor- and distribution-based methods according to age. A question based on the concept of a health transition item was used as the anchor for the MCID decision. Overall, MCIDs of the JOABPEQ were 28.6 and 27.3 points for pain-related disorder and gait disturbance, respectively. The MCID for the lumbar spine dysfunction domain did not reach 0.6 over the area under the curve. Regarding the differences among generations, MCIDs of pain-related disorder and gait disturbance domains differed slightly between the elderly and middle-aged. The psychological disorder domain did not reflect clinically meaningful changes in the elderly. MCIDs of the social life disturbance domain decreased with age. Focusing on achieving the ideal responsiveness of patient-reported outcomes across generations, MCIDs of the pain-related disorder and gait disturbance domains may be valuable for patients, regardless of age, when adopting the JOABPEQ for patients with lumbar spine disease undergoing surgery. This study only evaluated cases that underwent posterior lumbar surgery. Future research will necessitate conducting surveys concerning the outcomes of various treatments for lumbar spine disease.

The minimal important change for the EQ VAS based on the SF-36 health transition item: observations from 25772 spine surgery procedures

PurposeThe EQ VAS is an integral part of EQ-5D, a commonly used instrument for health-related quality of life assessment. This study aimed to calculate the minimal important change (MIC) thresholds for the EQ VAS for improvement and deterioration after surgery for disk herniation or spinal stenosis.MethodsPatients, who were surgically treated for disk herniation or spinal stenosis between 2007 and 2016, were recruited from the Swedish spine register. Preoperative and 1-year postoperative data for a total of 25772 procedures were available for analysis. We used two anchor-based methods to estimate MIC for EQ VAS: (1) a predictive model based on logistic regression and (2) receiver operating characteristics (ROC) curves. The SF-36 health transition item was used as anchor.ResultsThe EQ VAS MIC threshold for improvement after disk herniation surgery ranged from 8.25 to 11.8 while the corresponding value for deterioration ranged from − 6.17 to 0.5. For spinal stenosis surgery the corresponding MIC values ranged from 10.5 to 14.5 and − 7.16 to − 6.5 respectively. There were moderate negative correlations (disk herniation − 0.47, spinal stenosis − 0.46) between the 1 year change in the EQ VAS and the SF-36 health transition item (MIC anchor).ConclusionsFor EQ VAS, we recommend a MIC threshold of 12 points for improvement after surgery for disk herniation or spinal stenosis, whereas the corresponding threshold for deterioration is − 7 points. There are marked differences between the EQ VAS MIC for improvement and deterioration after surgery for disk herniation or spinal stenosis. The MIC value varied depending on the method used for MIC estimation.

Relationship between generic instruments used to measure healthrelated quality of life same or different

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): The Swedish research Council for Medicine and health - VR Swedish Research Council for health, working life and welfare - FORTE Background Health-related quality of life (HRQoL) is one and possibly the most important follow-up measure that is used to assess outcomes after long term and critical illness, such as heart failure. There is today an abundance of available generic measures relevant for all types of diseases and health states, and therefore suitable in heterogenous patient cohorts. Globally, two of the most common generic measures of HRQoL in use today are the EuroQol-5D (EQ-5D) and the RAND-36/36-item short-form SF-36. Another commonly used instrument is Cantril’s ladder of life. With the purpose to create a valid but not burdensome survey before and after an intervention in a cohort of former critically ill patients after a period of cardiac care, the question was raised what instrument to choose, and if the instruments correlates. If so, not all items have to be used if they measure the same outcome. Purpose To examine the relationship between different generic instruments for HRQoL in patients with heart failure. Methods For EQ-5D the separate five separate dimensions, the index from the combined dimensions, and a visual analog scale (VAS) can be used. For RAND-36 the eight dimensions created from 35 of the 36 questions, and the extern item as a single item called "Health Transition" can be used. Finally, for the Ladder of life the three questions can be used as separate items. The items chosen and measured in a cohort of former critically ill cardiac patients (n=246) were EQ-5D VAS, EQ-index, RAND-36 health transition question, and ladder of life question 1 and 3. Higher scores indicates higher perceived HRQoL on the scales except for RAND-36. The patients had a mean age of 66 years (SD 11.8), 67.3% (n=165) were men. The most common diagnoses in the sample were heart failure 68% (n=148), diabetes 22% (n=31), cancer (17% (n=36), and pulmonary disease 14% (n=31). The Spearman´s rank correlation was used to analyze the strength of association in the nonparametric data. Results Up to moderately strong correlation was seen between the items (see table). The strongest correlation was found between the EQ-5D VAS and RAND-36 Health Transition item (-0,629 (p=0.01)), followed by both RAND-36 and EQ-5D VAS and the ladder of life question "Where on the ladder do you feel you personally stand right now" (0,615 (p=0.01)) and (0.606 (p=0.01)) respectively. The two ladder of life questions correlated moderately (0.689, (p=0.01)). Conclusions Albeit the same focus area, the chosen general instruments, and items for measuring HRQoL was not strongly correlated indicated that they do not measure the exact same concepts and dimension. This is of importance when chosen instruments for HRQoL follow-up. There might be a need to combine more than one generic instrument considering the balance between the burden for the patient and the purpose and depth of the investigation. Further conceptual consideration regarding to these different generic instruments are warranted.

Minimal Clinically Important Difference and Substantial Clinical Benefit Using PROMIS CAT in Cervical Spine Surgery.

This was a prospective cohort study. The objective of this study was to establish minimal clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) in cervical spine pathology. PROMIS enables improved psychometric properties with reduced questionnaire burden through computer adaptive testing. Despite studies showing good correlation with "legacy" outcome measures, literature on the clinical significance of changes in PROMIS scores is scarce. Adult patients undergoing cervical spine surgery at a single institution between 2016 and 2018 were prospectively enrolled. Patients completed questionnaires [Short Form-36 (SF-36), Neck Disability Index (NDI), Visual Analogue Scale Arm/Neck, and PROMIS Pain Interference (PI) and Physical Function (PF)] preoperatively and at 6 months postoperatively. MCID was calculated using distribution-based and SCB using anchor-based methods. The SF-36 Health Transition Item was utilized as an anchor with the cutoff values chosen using receiver operating characteristic curve analysis. There were 139 patients meeting inclusion criteria, with a mean age of 56.4 years and diagnoses of myelopathy (n=36), radiculopathy (n=48) and myeloradiculopathy (n=49). There were significant improvements in PROMIS PF, PROMIS PI, NDI, and SF-36 preoperatively to postoperatively (P<0.001). The test-retest reliability of all tests was excellent (intraclass correlation coefficients=0.87-0.94). PROMIS, SF-36, and NDI were all correlated with the anchor question (|r|=0.34-0.48, P<0.001). MCIDs were 8.5 (NDI), 11.1 (SF-36 Physical Component Score), 9.7 (SF-36 Mental Component Score), 4.9 (PROMIS PI), and 4.5 (PROMIS PF). SCB was 13.0 (NDI), 24.0 (SF-36 Physical Component Score), 11.8 (SF-36 Mental Component Score), 6.9 (PROMIS PI), and 6.8 (PROMIS PF). MCIDs were greater than standard error of measurement for all measures. We report MCID of 4.9 (PI) and 4.5 (PF) and SCB of 6.9 (PI) and 6.8 (PF). These data support the use of PROMIS computer adaptive tests in cervical spine patients and provide important reference as PROMIS reporting becomes more widespread in the literature.

Determining the Minimally Important Difference for the VascuQol Sumscore and Its Domains in Patients with Intermittent Claudication

The VascuQol is a questionnaire for health related quality of life (HRQL) in patients with intermittent claudication (IC), and is frequently used to evaluate treatment effects. Yet, the interpretation of change in score on a questionnaire is not always obvious. The minimally important difference (MID) represents the smallest change in score on a questionnaire that is considered relevant by patients. This study aims to determine the MID for the VascuQol sumscore and its different domains for patients with IC. A total of 118 participants were recruited from the SUPER study, a multicenter randomized controlled trial comparing angioplasty with supervised exercise therapy for alleviation of IC due to an iliac artery stenosis or occlusion. All patients completed the VascuQol and the Short Form 36 (SF-36) questionnaires at baseline and after 12 months of follow up. Two anchor based methods for MID calculation were applied. Two anchors were used: six global rating of change questions aimed at the VascuQol sumscore and subscales and the health transition item of the SF-36, both recorded at 12 months of follow up. The MID for the VascuQol sumscore ranged between 1.19 and 1.66 for improvement and 0.08 and 0.41 for deterioration. For the pain domain, MID values ranged from 1.48 to 1.91 for improvement and 0.19 to 0.34 for deterioration. Finally, for the activities domain MID values ranging from 1.55 to 2.2 and from 0.12 to 0.26 for improvement and deterioration were found, respectively. Since the correlations between the anchors and the symptom, social and emotional subscales were below the threshold of 0.3, the MID was not calculated for these subscales. The range of MID values found in this study is an indication of the smallest change score on the VascuQol questionnaire score that is considered relevant by patients with IC. They may help to better interpret trial results and set treatment goals.

Is the Oswestry Disability Index a valid measure of response to sacroiliac joint treatment?

PurposeDisease-specific measures of the impact of sacroiliac (SI) joint pain on back/pelvis function are not available. The Oswestry Disability Index (ODI) is a validated functional measure for lower back pain, but its responsiveness to SI joint treatment has yet to be established. We sought to assess the validity of ODI to capture disability caused by SI joint pain and the minimum clinically important difference (MCID) after SI joint treatment.MethodsPatients (n = 155) participating in a prospective clinical trial of minimally invasive SI joint fusion underwent baseline and follow-up assessments using ODI, visual analog scale (VAS) pain assessment, Short Form 36 (SF-36), EuroQoL-5D, and questions (at follow-up only) regarding satisfaction with the SI joint fusion and whether the patient would have the fusion surgery again. All outcomes were compared from baseline to 12 months postsurgery. The health transition item of the SF-36 and the satisfaction scale were used as external anchors to calculate MCID. MCID was estimated for ODI using four calculation methods: (1) minimum detectable change, (2) average ODI change of patients’ subsets, (3) change difference between patients’ subsets, and (4) receiver operating characteristic (ROC) curve.ResultsAfter SI fusion, patients improved significantly (p < .0001) on all measures: SI joint pain (48.8 points), ODI (23.8 points), EQ-5D (0.29 points), EQ-5D VAS (11.7 points), PCS (8.9 points), and MCS (9.2 points). The improvement in ODI was significantly correlated (p < .0001) with SI joint pain improvement (r = .48) and with the two external anchors: SF-36 health transition item (r = .49) and satisfaction level (r = .34). The MCID values calculated for ODI using the various methods ranged from 3.5 to 19.5 points. The ODI minimum detectable change was 15.5 with the health transition item as the anchor and 13.5 with the satisfaction scale as the anchor.ConclusionsODI is a valid measure of change in SI joint health. Hence, researchers and clinicians may rely on ODI scores to measure disability caused by SI pain. We estimated the MCID for ODI to be 13–15 points, which falls within the range of that previously reported for lumbar back pain and indicates that an improvement in disability should be at least 15 % to be beyond random variation.

Determination of the minimum improvement in pain, disability, and health state associated with cost-effectiveness: introduction of the concept of minimum cost-effective difference.

Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients. To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED). Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of < $50,000/QALY and < $75,000/QALY. MCID was determined with the health transition item as the anchor. Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42,854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43,560 vs $112,087), visual analog scale for back pain ($41,280 vs $129440), Oswestry Disability Index ($30,954 vs $121,750), and EuroQol 5D ($35800 vs $189412). MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of < $50,000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry Disability Index, and 0.31 QALYs for EuroQol 5D.

Domain-specific transition questions demonstrated higher validity than global transition questions as anchors for clinically important improvement

ObjectivesEstimates of minimal clinically important differences in health measures may be affected by the anchor used. We examined if domain-specific transition questions had higher construct validity than global health transition questions as anchors for measures in a given domain. Study Design and SettingIn a prospective study of 249 patients with rheumatoid arthritis, we examined changes in pain, physical function, joint swelling, stiffness, fatigue, and depression with treatment. We related these changes to a domain-specific transition question, global arthritis transition question, and the Short Form-36 (SF-36) health transition item. ResultsChanges in all six clinical measures were more highly correlated with the domain-specific transition questions than with the global arthritis question and SF-36 transition question. Discrimination between patients who improved or not was also better using domain-specific questions. Estimates of minimal clinically important improvement (MCII) differed with the anchor when these were based on mean changes. MCII estimates from receiver operating characteristic curve analysis were not influenced by the choice of anchor when anchors had high agreement. ConclusionDomain-specific transition questions had higher construct validity as anchors for determining clinically important differences in health measures focused on a single domain than either global disease or general health transition questions.

The Italian MacNew heart disease health-related quality of life questionnaire: a validation study.

Patient-centered treatment outcomes such as health-related quality of life are recommended in clinical care and research studies. Health-related quality of life questionnaires need to be validated in the language of the target population. The reliability and validity of the Italian version of the MacNew Questionnaire was determined in patients with angina, myocardial infarction, or ischemic heart failure. Sociodemographic and clinical data were collected on 298 patients [angina, n = 88; MI, n = 106; heart failure, n = 104; mean age, 64.8 (±10.6) years] at three centers in Italy. MacNew mean scores were higher (p < 0.001) in patients with myocardial infarction than in patients with either angina or heart failure with no floor and minimal ceiling effects. The three-factor structure of the original MacNew form was largely confirmed explaining 54.6% of the total variance. The Italian MacNew version demonstrates high internal consistency reliability (Cronbach's α ≥ 0.86), confirms the convergent validity hypotheses with strong correlations on six of eight comparisons (r ≥ 0.86), partially confirms discriminative validity with the SF-36 health transition item, and fully confirms discriminative validity with the Hospital Anxiety and Depression Scale. The Italian version of the MacNew Questionnaire demonstrates satisfactory psychometric properties, and is reliable and valid in Italian-speaking patients with angina, MI, or heart failure. Responsiveness could not be tested due to the cross-sectional design of the parent study, and needs to be investigated in an intervention study.

Validation of the French version of the MacNew heart disease health-related quality of life questionnaire

Assessment of health-related quality of life is widely recommended by European health agencies in relevant research studies as well as in clinical care. To validate the French version of the MacNew heart disease health-related quality of life questionnaire. As part of the International HeartQoL Project, 323 French-speaking patients with ischaemic heart disease (angina, n=76; myocardial infarction [MI], n=155; heart failure, n=91; mean age 58.6±11.3 years) were recruited at seven cardiac rehabilitation centres. All patients completed the French versions of the MacNew questionnaire, the Short Form-36 Health Survey (SF-36) and the Hospital Anxiety and Depression Scale, to evaluate the psychometric properties of the French version of the MacNew instrument. The mean MacNew global scale scores were 4.6±0.8, 5.0±1.0 and 4.8±0.9 in patients with angina, MI and heart failure, respectively (P<0.05, MI versus angina). We observed minimal missing items and ceiling effects and no floor effects. Factor analysis confirmed a three factorial structure explaining 55.9% of the observed variance. Internal consistency reliability (Cronbach's α) ranged from 0.86 to 0.94 and test-retest reliability ranged from 0.68 to 0.73 Convergent validity was confirmed in the total group and each diagnosis, although the correlations between the MacNew physical subscale and the SF-36 mental component summary were higher than expected. Discriminative validity was partially confirmed with the SF-36 health transition item and fully confirmed with anxiety and depression as predictor variables. The French version of MacNew questionnaire is recommended for assessing health-related quality of life in French-speaking patients with ischaemic heart disease.

Measuring Surgical Outcomes in Subaxial Degenerative Cervical Spine Disease Patients

Although the concept of minimum clinically important difference (MCID) as a measurement of surgical outcome has been extensively studied, there is lack of consensus on the most valid or clinically relevant MCID calculation approach. To compare the range of MCID threshold values obtained by different anchor-based and distribution-based approaches to determine the best clinically meaningful and statistically significant MCID for our studied group. Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were analyzed from a prospective blinded database. Preoperative, 3-, and 6-month postoperative patient reported outcome (PRO) scores and blinded surgeon ratings were collected. Four calculation methods were used to calculate MCID threshold values: average change, change difference, minimum detectable change, and receiver operating characteristic (ROC) curve. Three anchors were used to evaluate meaningful improvement postsurgery: health transition item, patient overall status, and surgeon ratings. On average, all patients had a statistically significant improvement (P < .001) postoperatively for neck disability index (score 27.42 preoperatively to 19.42 postoperatively), physical component of the Short Form of the Medical Outcomes Study (SF-36) (33.02-42.23), mental component of the SF-36 (44-50.74), and visual analog scale (2.85-1.93). The 4 MCID approaches yielded a range of values for each PRO: 2.23 to 16.59 for physical component of the SF-36, 0.11 to 16.27 for mental component of the SF-36, and 2.72 to 12.08 for neck disability index. In comparison with health transition item and patient overall status anchors, the area under the ROC curve was consistently greater for surgeon ratings for all 4 PROs. Minimum detectable change together with surgeon ratings anchor appears to be the most appropriate MCID method. Based on our findings, this combination offers the greatest area under the ROC curve (threshold above the 95% confidence interval). The choice of the anchor did not significantly affect this result.

Validation of the urogenital distress inventory (UDI-6) and incontinence impact questionnaire (IIQ-7) in a Dutch population

The Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7) assess symptom distress and the impact on daily life of urinary incontinence. The UDI-6 has not been validated before in males. Our aim was to validate the UDI-6 and IIQ-7 in Dutch men and women. The translation to Dutch followed standardized procedures. We validated the IIQ-7 with and without an additional gender-neutral item (IIQ-SF). Adults with urinary incontinence for at least 3 months, completed the measures at inclusion; 1-week after inclusion to evaluate the test-retest reproducibility; and 6 months after inclusion with the addition of the RAND-36 health transition item to assess responsiveness and interpretability. To assess the discriminate ability, a reference population was enrolled. To assess construct validity, the urodynamic diagnosis was used. Questionnaire data of 160 patients were analyzed. Patients reported more symptoms and bother than the reference population (P < 0.001). The internal consistency was good in the IIQ-SF baseline scores (Cronbach's alphas 0.86-0.92), though moderate in the UDI-6 (Cronbach's alphas 0.44-0.66). Both measures showed good reproducibility at the test-retest (Intraclass Correlations Coefficients 0.75-0.85). Construct was adequate with 75% confirmed hypotheses of urodynamic data with measure scores. The measures were responsive after treatment with smaller measurement errors than the minimal important change. No floor or ceiling effects were observed in baseline data. The Dutch UDI-6 and IIQ-7 are reliable, valid, and responsive instruments for assessing symptom distress of urinary incontinence and its impact on daily life in both men and women.

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

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. 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. 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. 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.

Clinically important deterioration in patients undergoing lumbar spine surgery: a choice of evaluation methods using the Oswestry Disability Index, 36-Item Short Form Health Survey, and pain scales

Health-related quality of life (HRQOL) measures have become the mainstay for outcome appraisal in spine surgery. Clinically meaningful interpretation of HRQOL improvement has centered on the minimum clinically important difference (MCID). The purpose of this study was to calculate clinically important deterioration (CIDET) thresholds and determine a CIDET value for each HRQOL measure for patients undergoing lumbar fusion. Seven hundred twenty-two patients (248 males, 127 smokers, mean age 60.8 years) were identified with complete preoperative and 1-year postoperative HRQOLs including the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), and numeric rating scales (0-10) for back and leg pain following primary, instrumented, posterior lumbar fusion. Anchor-based and distribution-based methods were used to calculate CIDET for each HRQOL. Anchor-based methods included change score, change difference, and receiver operating characteristic curve analysis. The Health Transition Item, an independent item of the SF-36, was used as the external anchor. Patients who responded "somewhat worse" and "much worse" were combined and compared with patients responding "about the same." Distribution-based methods were minimum detectable change and effect size. Diagnoses included spondylolisthesis (n = 332), scoliosis (n = 54), instability (n = 37), disc pathology (n = 146), and stenosis (n = 153). There was a statistically significant change (p < 0.0001) for each HRQOL measure from preoperatively to 1-year postoperatively. Only 107 patients (15%) reported being "somewhat worse" (n = 81) or "much worse" (n = 26). Calculation methods yielded a range of CIDET values for ODI (0.17-9.06), SF-36 physical component summary (-0.32 to 4.43), back pain (0.02-1.50), and leg pain (0.02-1.50). A threshold for clinical deterioration was difficult to identify. This may be due to the small number of patients reporting being worse after surgery and the variability across methods to determine CIDET thresholds. Overall, it appears that patients may interpret the absence of change as deterioration.

A physiotherapy-directed occupational health programme for Austrian school teachers: a cluster randomised pilot study

BackgroundAlthough physiotherapists have long advocated workplace health, school teachers have not traditionally been a focus of study by these professionals. However, classroom teaching contributes to a range of occupational health issues related to general health as well as ergonomics that can be prevented or addressed by physiotherapists. ObjectivesTo undertake a pilot study to explore the potential effects of a physiotherapy-directed occupational health programme individualised for school teachers, develop study methodology and gather preliminary data to establish a ‘proof of concept’ to inform future studies. DesignCluster randomised pilot study using a convenience sample. SettingEight Austrian regional secondary schools. ParticipantsSchools and their teachers were recruited and allocated to an intervention group (IG, n=26 teachers) or a control group (CG, n=43 teachers). Teachers were eligible to participate if they reported no health issues that compromised their classroom responsibilities. InterventionsThe IG participated in an individualised physiotherapy-directed occupational health programme (six 30-minute sessions) related to ergonomics and stress management conducted over a 5-month semester. The CG had a pseudo-intervention of one oral education session. Main outcome measuresPrimary outcomes included scores from the physical and mental components and health transition item of the Short-Form-36 Health Survey questionnaire (SF-36), and emotional well-being and resistance to stress items from the work-related behaviour and experience patterns questionnaire. Data were collected before and after one semester. ResultsThe primary outcome measure, the SF-36 physical component score, showed a reduction in the CG and no change in the IG, meaning that the CG deteriorated over the study semester while the IG did not show any change. ConclusionsA physiotherapy-directed occupational health programme may prevent deterioration of physical health of school teachers in one semester (proof of concept). This pilot study provided valuable information to inform the design of replication and extension studies related to this work.

Measuring Surgical Outcomes in Cervical Spondylotic Myelopathy Patients Undergoing Anterior Cervical Discectomy and Fusion: Assessment of Minimum Clinically Important Difference

ObjectThe concept of minimum clinically important difference (MCID) has been used to measure the threshold by which the effect of a specific treatment can be considered clinically meaningful. MCID has previously been studied in surgical patients, however few studies have assessed its role in spinal surgery. The goal of this study was to assess the role of MCID in patients undergoing anterior cervical discectomy and fusion (ACDF) for cervical spondylotic myelopathy (CSM).MethodsData was collected on 30 patients who underwent ACDF for CSM between 2007 and 2012. Preoperative and 1-year postoperative Neck Disability Index (NDI), Visual-Analog Scale (VAS), and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary PRO scores were collected. Five distribution- and anchor-based approaches were used to calculate MCID threshold values average change, change difference, receiver operating characteristic curve (ROC), minimum detectable change (MDC) and standard error of measurement (SEM). The Health Transition Item of the SF-36 (HTI) was used as an external anchor.ResultsPatients had a significant improvement in all mean physical PRO scores postoperatively (p<0.01) NDI (29.24 to 14.82), VAS (5.06 to 1.72), and PCS (36.98 to 44.22). The five MCID approaches yielded a range of values for each PRO: 2.00–8.78 for PCS, 2.06–5.73 for MCS, 4.83–13.39 for NDI, and 0.36–3.11 for VAS. PCS was the most representative PRO measure, presenting the greatest area under the ROC curve (0.94). MDC values were not affected by the choice of anchor and their threshold of improvement was statistically greater than the chance of error from unimproved patients.ConclusionSF-36 PCS was the most representative PRO measure. MDC appears to be the most appropriate MCID method. When MDC was applied together with HTI anchor, the MCID thresholds were: 13.39 for NDI, 3.11 for VAS, 5.56 for PCS and 5.73 for MCS.

Determination of the Minimum Improvement in Pain, Disability, and Health State Associated With Cost-Effectiveness

ABSTRACT BACKGROUND: Minimum clinical important difference (MCID) has been adopted as the smallest improvement in patient-reported outcome needed to achieve a level of improvement thought to be meaningful to patients. OBJECTIVE: To use a common MCID calculation method with a cost-utility threshold anchor to introduce the concept of minimum cost-effective difference (MCED). METHODS: Forty-five patients undergoing transforaminal lumbar interbody fusion for degenerative spondylolisthesis were included. Outcome questionnaires were administered before and 2 years after surgery. Total cost per quality-adjusted life-year (QALY) gained was calculated for each patient. MCED was determined from receiver-operating characteristic curve analysis with a cost-effective anchor of &amp;lt; $50 000/QALY and &amp;lt; $75 000/QALY. MCID was determined with the health transition item as the anchor. RESULTS: Significant improvement was observed 2 years after transforaminal lumbar interbody fusion for all outcome measures. Mean total cost per QALY gained at 2 years was $42 854. MCED was greater than MCID for each outcome measure, meaning that a greater improvement was required to represent cost-effectiveness than a clinically meaningful improvement to patients. The area under the receiver-operating characteristic curve was consistently ≥ 0.70 with both cost-effective anchors, suggesting that outcome change scores were accurate predictors of cost-effectiveness. Mean cost per QALY gained was significantly lower for patients achieving compared with those not achieving an MCED in visual analog scale for leg pain ($43 560 vs $112 087), visual analog scale for back pain ($41 280 vs $129 440), Oswestry Disability Index ($30 954 vs $121 750), and EuroQol 5D ($35 800 vs $189 412). CONCLUSION: MCED serves as the smallest improvement in an outcome instrument that is associated with a cost-effective response to surgery. With the use of cost-effective anchor of &amp;lt; $50 000/QALY, MCED after transforaminal lumbar interbody fusion was 4 points for visual analog scale for low back pain, 3 points for visual analog scale for leg pain, 22 points for Oswestry Disability Index, and 0.31 QALYs for EuroQol 5D.

Comparative responsiveness of the EuroQol‐5D and Short Form 6D to improvement in patients with rheumatoid arthritis treated with tumor necrosis factor blockers: Results of the Dutch Rheumatoid Arthritis Monitoring registry

For cost-utility analyses of health technologies, utilities are commonly measured with the EuroQol-5D (EQ-5D) or the Short Form 6D (SF-6D). Although most studies in rheumatoid arthritis (RA) found the SF-6D to be more responsive than the EQ-5D, evidence is not convincing. The aim of this study was to compare the responsiveness of the EQ-5D and SF-6D to improvement in RA patients treated with tumor necrosis factor (TNF) blockers. Data from 278 RA patients included in the Dutch Rheumatoid Arthritis Monitoring registry were used. Internal responsiveness over 1 year was evaluated by using standardized response means (SRMs). External responsiveness was evaluated by using receiver operating characteristic curves based on perceived health change (self-reported health transition item Short Form 36) and change in disease activity (European League Against Rheumatism response criteria based on the Disease Activity Score in 28 joints). The scores of the EQ-5D and SF-6D changed moderately over 1 year (SRMs 0.50 and 0.67, respectively). The SF-6D was significantly more responsive to treatment than the EQ-5D. The EQ-5D and SF-6D were moderately able to correctly classify patients according to health transition (areas under the curve [AUCs] 0.67 and 0.72, respectively) and change in disease activity (AUCs 0.71 and 0.65, respectively). The EQ-5D and SF-6D were only moderately responsive to improvement in RA patients treated with TNF blockers. Overall, the SF-6D was more responsive than the EQ-5D.

A Single, Global Patient‐Centered Measure from the SF‐36 Instrument to Assess Surgical Outcomes and Quality of Life: A Pilot Study

Many quality of life (QoL) and patient-reported outcomes (PRO) measures have been developed to assess the effects of disease processes and treatments. Although these instruments are valuable, the process is hampered because of their number and lack of interchangeability. We identified a cohort of patients across a variety of operations within 3-12 months postoperatively. Patients completed the SF-36, measuring eight domains of QoL (physical functioning, role-physical, role-emotional, bodily pain, vitality, mental health, social functioning, and general health), plus a health transition item: Compared to one year ago, how would you rate your health in general now?. (1) Much better now than one year ago. (2) Somewhat better now than one year ago. (3) About the same as one year ago. (4) Somewhat worse than one year ago. (5) Much worse than one year ago. Additional data included improvement of preoperative symptoms, the occurrence of any postoperative symptoms, and the occurrence of any postoperative complications. Of 217 patients, 28 % were much better, 28 % somewhat better, 27 % unchanged, 13 % somewhat worse, and 3 % much worse. The health transition results were associated with all SF-36 domains, preoperative symptom change (p = 0.03) and persistent or new postoperative symptoms (p = 0.001), but not postoperative complications. Patients with persistent or new symptoms postoperatively had worse scores in the role-emotional (p = 0.01), bodily pain (p = 0.05), social functioning (p = 0.02), and mental health (p = 0.009) domains of the SF-36. This single, global assessment of health transition may be a promising practical alternative to assess postoperative patient-centered outcomes. Improved patients had better QoL scores, preoperative symptoms elimination, and no operation-related symptoms, but the occurrence of complications did not affect improvement.

Determination of minimum clinically important difference in pain, disability, and quality of life after extension of fusion for adjacent-segment disease

Spinal surgical outcome studies rely on patient-reported outcome (PRO) measurements to assess treatment effect. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lack a direct clinical meaning. As a result, the concept of minimum clinical important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. As utilization of spinal fusion has increased over the past decade, so has the incidence of adjacent-segment degeneration following index lumbar fusion, which commonly requires revision laminectomy and extension of fusion. The MCID remains uninvestigated for any PROs in the setting of revision lumbar surgery for adjacent-segment disease (ASD). In 50 consecutive patients undergoing revision surgery for ASD-associated back and leg pain, PRO measures of back and leg pain on a visual analog scale (BP-VAS and LP-VAS, respectively), Oswestry Disability Index (ODI), 12-Item Short Form Health Survey Physical and Mental Component Summaries (SF-12 PCS and MCS, respectively), and EuroQol-5D health survey (EQ-5D) were assessed preoperatively and 2 years postoperatively. The following 4 well-established anchor-based MCID calculation methods were used to calculate MCID: average change; minimum detectable change (MDC); change difference; and receiver operating characteristic curve (ROC) analysis for the following 2 separate anchors: health transition item (HTI) of the SF-36 and satisfaction index. All patients were available for 2-year PRO assessment. Two years after surgery, a statistically significant improvement was observed for all PROs (mean changes: BP-VAS score [4.80 ± 3.25], LP-VAS score [3.28 ± 3.25], ODI [10.24 ± 13.49], SF-12 PCS [8.69 ± 12.55] and MCS [8.49 ± 11.45] scores, and EQ-5D [0.38 ± 0.45]; all p < 0.001). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS score, 2.3-6.5; LP-VAS score, 1.7-4.3; ODI, 6.8-16.9; SF-12 PCS, 6.1-12.6; SF-12 MCS, 2.4-10.8; and EQ-5D, 0.27-0.54). The area under the ROC curve was consistently greater for the HTI anchor than the satisfaction anchor, suggesting this as a more accurate anchor for MCID. Adjacent-segment disease revision surgery-specific MCID is highly variable based on calculation technique. The MDC approach with HTI anchor appears to be most appropriate for calculation of MCID after revision lumbar fusion for ASD because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was not significantly affected by choice of anchor. Based on this method, MCID following ASD revision lumbar surgery is 3.8 points for BP-VAS score, 2.4 points for LP-VAS score, 6.8 points for ODI, 8.8 points for SF-12 PCS, 9.3 points for SF-12 MCS, and 0.35 quality-adjusted life-years for EQ-5D.