The SF-36 is widely used to evaluate the health-related quality of life of patients with musculoskeletal tumors. The minimum clinically important difference (MCID) is useful for interpreting changes ...in functional scores because it defines the smallest change each patient may perceive. Since the MCID is influenced by the population characteristics, MCIDs of the SF-36 should be defined to reflect the specific conditions of orthopaedic oncology patients.
(1) What is the MCID of SF-36 physical component summary (PCS) and mental component summary (MCS) scores in patients with orthopaedic oncologic conditions when calculated with distribution-based methods? (2) What is the MCID of SF-36 PCS and MCS scores in patients with orthopaedic oncologic conditions when calculated by anchor-based methods?
Of all 960 patients who underwent surgery from 1999 to 2005, 32% (310) of patients who underwent musculoskeletal oncologic surgery and completed two surveys during postoperative follow-up were reviewed. We evaluated a dataset that ended in 2005, completing follow-up of data accrued as part of the cooperative effort between the American Academy of Orthopaedic Surgeons and the Council of Musculoskeletal Specialty Societies to create patient reported quality of life instruments for lower extremity conditions. This effort, started in 1994 was validated and widely accepted by its publication in 2004. We believe the findings from this period are still relevant today because (1) this critical information has never been available for clinicians and researchers to distinguish real differences in outcome among orthopaedic oncology patients, (2) the SF-36 continues to be the best validated and widely used instrument to assess health-related quality of life, and unfortunately (3) there has been no significant change in outcome for oncology patients over the intervening years. SF-36 PCS and MCS are aggregates of the eight scale scores specific to physical and mental dimension (scores range from 0 to 100, with higher scores representing better health). Their responsiveness has been shown postoperatively for several surgical procedures (such as, colorectal surgery). Two different methods were used to calculate the MCID: the distribution-based method, which was based on half the SD of the change in score and standard error of the measurement at baseline, and anchor-based, in which a receiver operating characteristic (ROC) curve analysis was performed. The anchor-based method uses a plain-language question to ask patients how their individual conditions changed when compared with the previous survey. Answer choices were "much better," "somewhat better," "about the same," "somewhat worse," or "much worse." The ROC curve-derived MCIDs were defined as the change in scores from baseline, with sensitivity and specificity to detect differences in patients who stated their outcome was, about the same and those who stated their status was somewhat better or somewhat worse. This approach is based on each patient's perception. It considers that the definition of MCID is the minimal difference each patient can perceive as meaningful.
Using the distribution-based method, we found that the MCIDs of the PCS and MCS were 5 and 5 by half the SD, and 6 and 5 by standard error of the measurement. In the anchor-based method, the MCIDs of the PCS and MCS for improvement/deterioration were 4 (area under the curve, 0.82)/-2 (area under the curve, 0.79) and 4 (area under the curve, 0.72)/ (area under the curve, 0.68), respectively.
Since both anchor-based and distribution-based MCID estimates of the SF-36 in patients with musculoskeletal tumors were so similar, we have confidence in the estimates we made, which were about 5 points for both the PCS and the MCS subscales of the SF-36. This suggests that interventions improving SF-36 by less than that amount are unlikely to be perceived by patients as clinically important. Therefore, those interventions may not justify exposing patients to risk, cost, or inconvenience. When applying new interventions to orthopaedic oncology patients going forward, it will be important to consider these MCIDs for evaluation purposes.
Level III, diagnostic study.
Purpose The Patient-Reported Outcomes Measurement Information System Upper Extremity Computer Adaptive Test (UE CAT) has recently been made available by the National Institutes of Health to measure ...physical function outcomes in the upper extremity. We hypothesized that the UE CAT would psychometrically outperform the Disabilities of the Arm, Shoulder, and Hand (DASH) and the Patient-Reported Outcomes Measurement Information System Physical Function Computer Adaptive Test (PF CAT) in a hand patient population. Methods The UE CAT, PF CAT, and DASH were each electronically administered to all adult patients who presented to a tertiary hand and upper extremity (nonshoulder) orthopedic clinic. Patient responses were retrospectively studied to determine the validity, reliability, and floor/ceiling effects of all 3 instruments using the Rasch Partial Credit Model. Responder burden and Pearson correlations were calculated for each instrument. Results A total of 379 patients completed the UE CAT, PF CAT, and the DASH. On average, 6 UE CAT, 9 PF CAT, and 30 DASH questions were administered to each patient. All 3 instruments were each highly correlated with each other. Floor effects were low and similar between all instruments; however, ceiling effects were higher in the UE CAT (10.82%) than in the PF CAT (1.32%) or DASH (5.28%). High person reliability (PR) and item reliability (IR) were found for all 3 metrics: UE CAT (α = 0.99; PR = 0.91; IR = 0.94); PF CAT (α = 0.95; PR = 0.89; IR = 0.96); and DASH (α = 0.97; PR = 0.95; IR = 0.99). The UE CAT questions had the best item-fit: only 1 of 15 UE CAT items had poor fit in contrast to 4 of 30 DASH items and 7 of 33 PF CAT items. Conclusions The psychometric properties of the UE CAT compare favorably with the PF CAT and the DASH in nonshoulder upper extremity patients. The relatively large ceiling effect found in the UE CAT could be improved with item bank expansion to include items at the upper end of function. Clinical Relevance The UE CAT is a useful patient-reported outcome measure that merits further investigation.
A multicenter, prospective review of surgical patients with adult spine deformity.
Assessment of the incidence, risk factor, and impact of radiographical and implant-related complications (RIC) on ...health-related quality of life measures.
This study provides assessment of the incidence of RIC in adult spinal deformity surgery and impact of these complications on need for reoperation. Risk factors for development of RIC are also assessed, as well as the impact of these complications on health-related quality of life (HRQOL) outcomes measures.
A multicenter, prospective database of surgical patients with adult spinal deformity was reviewed. All patients with complete 2-year follow-up were included. HRQOL was measured using the Oswestry Disability Index, General Health Survey (36-Item Short Form Health Survey SF-36), and Scoliosis Research Society-22 (SRS-22r) at baseline, 6 weeks, 1 year, and 2 years postoperatively. Univariate testing was performed as appropriate. Multivariate logistic regression modeling was used to determine independent predictors of RIC. Multivariate repeated-measures mixed models were used to examine HRQOL, accounting for confounders.
A total of 245 patients met inclusion criteria. The incidence of RIC was 31.7% and 52.6% of those patients required reoperation. Rod breakage accounted for 47% of the implant-related complications, and proximal junctional kyphosis accounted for 54.5% of radiographical complications. Univariate analysis identified the following potential risk factors for RIC: weight, American Society of Anesthesiologists score, revision, stopping the fusion in the lower thoracic spine, worse SRS-Schwab classification modifiers (pelvic tilt++, pelvic incidence minus lumbar lordosis++, sagittal vertical axis++), higher T1 spinopelvic inclination, and higher T1 slope. Independent predictors of RIC as identified on multivariate logistic regression included American Society of Anesthesiologists (odds ratio: 1.75, P = 0.029) and sagittal vertical axis modifier ++ (odds ratio 3.43, P = 0.0001). The RIC and no RIC groups each experienced significant improvement over time, as measured on the Oswestry Disability Index (P = 0.0001), SF-36 (P = 0.0001), and SRS-22r (P = 0.0001). However, the rate of improvement over time was less for patients with RIC (SRS-22r P = 0.043, SF-36 P = 0.0001).
This study identified that nearly one-third of patients undergoing adult spinal deformity surgery experienced a radiographical or implant-related complication, and that just more than one-half of these patients experiencing complication required a reoperation within 2 years of surgery. These complications significantly affected HRQOL measures. Baseline patient characteristics and parameters of the SRS-Schwab classification can be used to help identify those patients at greater risk.
3.
Purpose
While open TLIF (O-TLIF) remains the mainstay approach, minimally invasive TLIF (MI-TLIF) may offer potential advantages of reduced trauma to paraspinal muscles, minimized perioperative blood ...loss, quicker recovery and reduced risk of infection at surgical sites. This meta-analysis was conducted to provide an updated assessment of the relative benefits and risks of MI-TLIF versus O-TLIF.
Methods
Electronic searches were performed using six databases from their inception to December 2014. Relevant studies comparing MI-TLIF and O-TLIF were included. Data were extracted and analysed according to predefined clinical end points.
Results
There was no significant difference in operation time noted between MI-TLIF and O-TLIF cohorts. The median intraoperative blood loss for MI-TLIF was significantly lower than O-TLIF (median: 177 vs 461 mL; (weighted mean difference) WMD, −256.23; 95 % CI −351.35, −161.1;
P
< 0.00001). Infection rates were significantly lower in the minimally invasive cohort (1.2 vs 4.6 %; relative risk (RR), 0.27; 95 %, 0.14, 0.53;
I
2
= 0 %;
P
= 0.0001). VAS back pain scores were significantly lower in the MI-TLIF group compared to O-TLIF (WMD, −0.41; 95 % CI −0.76, −0.06;
I
2
= 96 %;
P
< 0.00001). Postoperative ODI scores were also significantly lower in the minimally invasive cohort (WMD, −2.21; 95 % CI −4.26, −0.15;
I
2
= 93 %;
P
= 0.04).
Conclusions
In summary, the present systematic review and meta-analysis demonstrated that MI-TLIF appears to be a safe and efficacious approach compared to O-TLIF. MI-TLIF is associated with lower blood loss and infection rates in patients, albeit at the risk of higher radiation exposure for the surgical team. The long-term relative merits require further validation in prospective, randomized studies.
Abstract Background The duration of untreated depression (DUD) might have a substantial impact on the clinical outcomes; however, there are important knowledge gaps including the effects on ...disability and potential differences between first-episode and recurrent episodes of depression. Methods We recruited 121 outpatients with first episode and recurrent major depression, and conducted prospective clinical assessments over six months. Clinical outcomes included response to antidepressant therapy, remission and changes in disability. Results Patients with a DUD of six months or shorter were more frequently young, unemployed and had higher levels of physical illnesses than those with a longer DUD (all p <0.05). A shorter DUD was associated with significantly higher odds of response at 12 weeks (adjusted odds ratio 2.8; 95% CI: 1.2–6.8) and remission at 24 weeks (4.1; 95% CI: 1.6–10.5) after adjusting for relevant confounders. Changes in disability ratings were analyzed with growth curve analysis and showed steeper declines among those with a shorter DUD. The associations of DUD on clinical outcomes were evident both in patients with first-episode and recurrent depression. Limitations Naturalistic design. Self-rated assessment of disability. Findings from subgroup analyses should be replicated in larger sample size. Conclusions A shorter duration of untreated depression is associated with more favorable outcomes for major depression, including depression-related disability. This association seems to work both at the first and recurrent episodes, which might have direct implications for both primary and secondary prevention.
Background: Platelet-rich plasma (PRP) has been shown to be a general stimulation for repair and 1-year results showed promising success percentages.
Purpose: This trial was undertaken to determine ...the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a 2-year follow-up.
Study Design: Randomized controlled trial; Level of evidence, 1.
Methods: The trial was conducted in 2 Dutch teaching hospitals. One hundred patients with chronic lateral epicondylitis were randomly assigned to a leukocyte-enriched PRP group (n = 51) or the corticosteroid group (n = 49). Randomization and allocation to the trial group were carried out by a central computer system. Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique. The primary analysis included visual analog scale (VAS) pain scores and Disabilities of the Arm, Shoulder and Hand (DASH) outcome scores.
Results: The PRP group was more often successfully treated than the corticosteroid group (P < .0001). Success was defined as a reduction of 25% on VAS or DASH scores without a reintervention after 2 years. When baseline VAS and DASH scores were compared with the scores at 2-year follow-up, both groups significantly improved across time (intention-to-treat principle). However, the DASH scores of the corticosteroid group returned to baseline levels, while those of the PRP group significantly improved (as-treated principle). There were no complications related to the use of PRP.
Conclusion: Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly, exceeding the effect of corticosteroid injection even after a follow-up of 2 years. Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits.
Objective
Focal brain lesions can have important remote effects on the function of distant brain regions. The resulting network dysfunction may contribute significantly to behavioral deficits ...observed after stroke. This study investigates the behavioral significance of changes in the coherence of spontaneous activity in distributed networks after stroke by measuring resting state functional connectivity (FC) using functional magnetic resonance imaging.
Methods
In acute stroke patients, we measured FC in a dorsal attention network and an arm somatomotor network, and determined the correlation of FC with performance obtained in a separate session on tests of attention and motor function. In particular, we compared the behavioral correlation with intrahemispheric FC to the behavioral correlation with interhemispheric FC.
Results
In the attention network, disruption of interhemispheric FC was significantly correlated with abnormal detection of visual stimuli (Pearson r with field effect = −0.624, p = 0.002). In the somatomotor network, disruption of interhemispheric FC was significantly correlated with upper extremity impairment (Pearson r with contralesional Action Research Arm Test = 0.527, p = 0.036). In contrast, intrahemispheric FC within the normal or damaged hemispheres was not correlated with performance in either network. Quantitative lesion analysis demonstrated that our results could not be explained by structural damage alone.
Interpretation
These results suggest that lesions cause state changes in the spontaneous functional architecture of the brain, and constrain behavioral output. Clinically, these results validate using FC for assessing the health of brain networks, with implications for prognosis and recovery from stroke, and underscore the importance of interhemispheric interactions. ANN NEUROL 2010;67:365–375
Abstract Purpose We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician's clinical behavior, patient outcomes, and costs. Methods The ...IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat. Results The 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1-1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8-3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed. Conclusions Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended.
The choice of surgical approach for THA remains controversial. Some studies suggest that the direct anterior approach (DAA) leads to less muscle damage than the miniposterior approach (MPA), but ...there is little high-quality evidence indicating whether this accelerates recovery, or whether this approach-which may be technically more demanding-is associated with component malposition or more complications.
(1) Does the DAA result in faster return to activities of daily living than the MPA? (2) Does the DAA have superior patient-reported outcome measures than the MPA? (3) Does the DAA result in improved radiographic outcomes than the MPA? (4) Does the DAA have a higher risk of complications than the MPA?
Between March 1, 2013, and May 31, 2016, 116 patients undergoing primary unilateral THA were randomized to either the DAA or MPA; 15 patients withdrew after randomization, and one died 6 months after surgery from a stroke unrelated to the procedure. Recruitment stopped when 52 patients had been randomized into the DAA group and 49 in the MPA group (n = 101). After patient randomization, one high-volume surgeon performed all of the DAAs and three high-volume surgeons performed the MPA THAs. The groups did not differ in age (65 years; SD 11; range, 38-86 years), sex (52% women), or body mass index (mean 29 kg/m; SD 6 kg/m; range, 21-40 kg/m; all p > 0.40). Functional results included time to discontinue gait aids, discontinue all narcotics, and independence with various activities of daily living; accelerometer data evaluated activity level. Clinical and radiographic outcomes, Hip disability and Osteoarthritis Outcome Score, SF-12, and Harris hip scores to 1 year were also tabulated. The minimum followup was 365 days (mean ± SD, 627 ± 369 days).
There were slight differences in early functional recovery that favored the DAA versus the MPA: time to discontinue walker use (10 versus 15 days, p = 0.01) and time to discontinue all gait aids (17 versus 24 days, p = 0.04). There were no other differences in early functional milestones, although at 2 weeks after surgery, mean steps per day were 3897 (SD 2258; range, 737-11,010) for the DAA versus 2235 for the MPA (SD 1688; range, 27-7450; p < 0.01). There was no difference in activity monitoring at 1 year. There were no differences in patient-reported outcome scores between the groups. There was no difference in the radiographic parameters measured in the two groups, including leg length discrepancy, component position, or offset, and there was no subsidence observed in any hip. There was no difference in complications between the DAA and the MPA groups (8% four of 52 versus 10% five of 49; p = 0.33).
Both the DAA and MPA approaches provided excellent early recovery with a low risk of complications. Patients undergoing the DAA had a slightly faster recovery, as measured by milestones of function and quantified by activity monitor data, but no substantive differences were evident at 2 months. Because the DAA is the less studied approach, longer term (> 1 year) complications may yet accrue, will be important to quantify, and may offset early benefits.
Level I, therapeutic study.
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