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Validity of lumbar spinal stenosis outcome measures used in clinical studies: A systematic analysis of randomized and observational clinical trials [Meeting Abstract]

Wertli, M M; Rossi, D R L; Burgstaller, J M; Rasmussen-Barr, E; Weiser, S; Held, U; Steurer, J; Brunner, F
Background: Questionnaires are used to assess the outcome of clinical studies. Validation studies in a specific patient population assures that patient relevant complaints are assessed. Compared to low back pain, patients with lumbar spinal stenosis express different clinical signs and symptoms. Therefore, outcome measures validated in low back pain populations may not assess the relevant complaints in patients with LSS. The aim of the current study was to analyze outcome measures used in studies on LSS patients and whether they were validated for this population. Methods: Based on systematic reviews and meta-analysis published between 2006 and January 2016, all randomized (RCT) and observational studies (OS) on patients with LSS were analyzed. All information on outcome measures was extracted. Referenced validation studies were retained in full text analyzed. We assessed the quality of each validation study based on previously published quality criteria: minimal number of patients, construct validity, internal consistency, criterion validity, reproducibility, responsiveness, floor and ceiling effect, and interpretability. Results: Overall, 97 studies were analyzed (46 RCT, 50 OS, 1 combined) that used 33 different outcome measures (8 pain measures, 25 functional outcome measures). The most frequently used pain measure was the Visual Analogue Scale (VAS), the most frequently used disability measures were the Oswestry Disability Index (ODI) and the Spinal Stenosis Measure. One-fifth of the measures were validated in LSS patients. Out of the 97 studies, 30 studies (31%) used no validated outcome measure and 67 (69%) used at least one validated outcome measure. For most validation studies (n = 7), we found poor methodological quality (Table 1). Conclusion: The systematic analysis of RCT and OS showed that one-third of the studies used no validated outcome measure to assess clinical outcomes. Further, the methodological quality of many validation studies was poor. (Table Presented)
EMBASE:618721931
ISSN: 1432-0932
CID: 2751142

The start back screening tool in secondary care: Do psychological subscale scores differ among patients with acute, subacute and chronic spine pain [Meeting Abstract]

Lis, A; Brennan, T; Joo, L; Weiser, S
BACKGROUND CONTEXT: The STarT Back Screening Tool (SBST) provides a method of identifying obstacles to recovery in patients with spine pain and has been validated in primary care. Although primary care populations include patients with acute, subacute, and chronic pain, differences in SBST profiles among these groups are not known. Such differences may have implications for targeted interventions. For example, anxiety may be higher in the acute stage when the injury is new, while depression may be higher in the chronic stage due to failed treatment. This study reports on differences in SBST psychological subscale scores in patients with acute (<4 weeks), subacute (4-12 weeks) and chronic (>12 weeks) spine pain seeking outpatient Physical Therapy (PT). This study is a first step in determining the usefulness of the SBST in different spine pain groups. PURPOSE: To compare SBST psychological profiles in patients with acute, subacute and chronic spine pain. STUDY DESIGN/SETTING: Cross-sectional/Outpatient Physical Therapy Clinic. PATIENT SAMPLE: Patients with spine pain seeking PT from January to December 2013. OUTCOME MEASURES: Data was extracted from a clinical database. The 5 SBST psychological subscale scores and age, gender and pain duration were collected for this study. METHODS: MANOVA analysis was used to compare the 5 items of the SBST across study groups. Because the sample sizes of the 3 groups were unbalanced, and did not have normal distributions, a univariate analysis was conducted to confirm if significant findings by MANOVA reflected a true difference by group. As cut-off scores have not been established for patients in secondary care, we analyzed the items of the SBST psychological subscale as both continuous and categorical variables (using previously validated cutoff scores). A Non-parametric Kruskal Wallis-H test was used for continuous SBST scores and Chi-square test were used for dichotomized scores. Statistical analysis was done using SPSS v.23. RESULTS: The sample included 384 patients; 10% acute (n=38), 25% subacute (n=97) and 65% chronic (n=249). Fifty-five percent were female and 45% male; mean age was 51 years (SD=16). No significant group differences were found on demographic variables. MANOVAshowed that the SBST subscale significantly differed between patients groups (p<.0005). The Kruskal Wallis-H test showed a statistically significant difference in catastrophyzing (p<.005) among study groups, with acute patients showing less catastrophyzing (mean=0.92, 95% CI: 0.29-1.54) than the other two groups (Subacute mean=2.71, 95% CI: 2.06-3.36 and Chronic mean=3.11, 95%CI: 2.71- 3.51). The Chi-square analysis showed that catastrophyzing and anxiety were different among study groups (p<.05). In both cases, the acute patients had lower scores than the other two groups. CONCLUSIONS: SBST psychological profiles were similar among patients with acute, subacute and chronic pain. However, catastrophyzing was higher in the subacute and chronic groups than in the acute group in both analyses. This suggests that interventions aimed at reducing catastrophyzing thoughts should be initiated in acute care prophylactically. Although anxiety showed the same pattern as catastrophyzing in the Chi-square analysis, cutoff scores that have not yet been validated for this population were used, limiting the validity of this finding. The SBST may be useful for identifying risk factors in the study groups. However, future prospective studies are needed to validate existing cut-off scores in all groups before conclusions can be drawn
EMBASE:617916393
ISSN: 1529-9430
CID: 2704472

How Well Do You Expect to Recover, and What Does Recovery Mean, Anyway? Qualitative Study of Expectations After a Musculoskeletal Injury

Carroll, Linda J; Lis, Angela; Weiser, Sherri; Torti, Jacqueline
BACKGROUND: Expecting to recover from a musculoskeletal injury is associated with actual recovery. Expectations are potentially modifiable, although it is not well understood how injured persons formulate expectations. A better understanding of this may lead to better knowledge about how interventions might be implemented, what to intervene on and when to intervene. OBJECTIVES: The objectives of this study were to explore what 'recovery' meant to participants, whether they expected to 'recover', and how they formed these expectations. METHODS: This qualitative study used interpretive phenomenological analysis. Eighteen semi-structured interviews were conducted with persons seeking treatment for recent musculoskeletal injuries. RESULTS: Recovery was conceptualized as either complete cessation of symptoms/pain-free return to function or return to function despite residual symptoms. Expectations were driven by desire for a clear diagnosis; belief (or disbelief) in the clinician's prognosis; prior experiences; others' experiences and attitudes; information from other sources such as the internet; and a sense of self as resilient. CONCLUSIONS: Expectations appear to be embedded in both hopes and fears suggesting that clinicians should address both when negotiating realistic goals and educating patients. This is particularly relevant for cases of non-specific musculoskeletal pain where diagnoses are unclear and treatment may not completely alleviate pain.
PMID: 26586855
ISSN: 1538-6724
CID: 1848792

A conservative care approach to the rehabilitation of patients with spine pain

Chapter by: Lis, Angela; Weiser, Sherri
in: Spinal disorders and treatments : the NYU-HJD comprehensive textbook by Errico, Thomas J; Cheriyan, Thomas; Varlotta, Gerard P [Eds]
New Delhi : Jaypee Brothers, 2015
pp. 178-186
ISBN: 9351524957
CID: 2709222

Fear-avoidance beliefs-a moderator of treatment efficacy in patients with low back pain: a systematic review

Wertli, Maria M; Rasmussen-Barr, Eva; Held, Ulrike; Weiser, Sherri; Bachmann, Lucas M; Brunner, Florian
BACKGROUND CONTEXT: Psychological factors are believed to influence the development of chronic low back pain. To date, it is not known how fear-avoidance beliefs (FABs) influence the treatment efficacy in low back pain. PURPOSE: To summarize the evidence examining the influence of FABs measured with the Fear-Avoidance Belief Questionnaire or the Tampa Scale of Kinesiophobia on treatment outcomes in patients with low back pain. STUDY DESIGN/SETTING: This is a systematic review. PATIENT SAMPLE: Patients with low back pain. OUTCOME MEASURES: Work-related outcomes and perceived measures including return to work, pain, and disability. METHODS: In January 2013, the following databases were searched: BIOSIS, CINAHL, Cochrane Library, Embase, OTSeeker, PeDRO, PsycInfo, PubMed/Medline, Scopus, and Web of Science. A hand search of the six most often retrieved journals and a bibliography search completed the search. STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS: research studies that included patients with low back pain who participated in randomized controlled trials (RCTs) investigating nonoperative treatment efficacy. Out of 646 records, 78 articles were assessed in full text and 17 RCTs were included. Study quality was high in five studies and moderate in 12 studies. RESULTS: In patients with low back pain of up to 6 months duration, high FABs were associated with more pain and/or disability (4 RCTs) and less return to work (3 RCTs) (GRADE high-quality evidence, 831 patients vs. 322 in nonpredictive studies). A decrease in FAB values during treatment was associated with less pain and disability at follow-up (GRADE moderate evidence, 2 RCTs with moderate quality, 242 patients). Interventions that addressed FABs were more effective than control groups based on biomedical concepts (GRADE moderate evidence, 1,051 vs. 227 patients in studies without moderating effects). In chronic patients with LBP, the findings were less consistent. Two studies found baseline FABs to be associated with more pain and disability and less return to work (339 patients), whereas 3 others (832 patients) found none (GRADE low evidence). Heterogeneity of the studies impeded a pooling of the results. CONCLUSIONS: Evidence suggests that FABs are associated with poor treatment outcome in patients with LBP of less than 6 months, and thus early treatment, including interventions to reduce FABs, may avoid delayed recovery and chronicity. Patients with high FABs are more likely to improve when FABs are addressed in treatments than when these beliefs are ignored, and treatment strategies should be modified if FABs are present.
PMID: 24614254
ISSN: 1529-9430
CID: 1360902

Catastrophizing-a prognostic factor for outcome in patients with low back pain: a systematic review

Wertli, Maria M; Eugster, Rebekka; Held, Ulrike; Steurer, Johann; Kofmehl, Reto; Weiser, Sherri
BACKGROUND CONTEXT: Psychological factors including catastrophizing thoughts are believed to influence the development of chronic low back pain (LBP). PURPOSE: To assess the prognostic importance of catastrophizing as a coping strategy in patients with LBP. STUDY DESIGN: This is a systematic review. PATIENT SAMPLE: This study included patients with LBP. OUTCOME MEASURES: Work-related outcomes and perceived measures including return to work, pain, and disability. METHODS: In September 2012, the following databases were searched: BIOSIS, CINAHL, Cochrane Library, Embase, OTSeeker, PeDRO, PsycInfo, Medline, Scopus, and Web of Science. To ensure completeness of the search, a hand search and a search of bibliographies were conducted and all relevant references included. All observational studies investigating the prognostic value of catastrophizing in patients with LBP were eligible. Included were studies with 100 and more patients and follow-up of at least 3 months. Excluded were studies with poor methodological quality, short follow-up duration, and small sample size. RESULTS: A total of 1,473 references were retrieved, and 706 references remained after the removal of duplicates. For 77 references, the full text was assessed and 19 publications based on 16 studies were included. Of four studies that investigated work-related outcomes, two found catastrophizing to be associated with work status. Most studies that investigated self-reported outcome measures (n=8, 66%) found catastrophizing to be associated with pain and disability at follow-up in acute, subacute, and chronic LBP patients. In most studies that applied cutoff values, patients identified as high catastrophizers experienced a worse outcome compared with low catastrophizers (n=5, 83%). CONCLUSIONS: There is some evidence that catastrophizing as a coping strategy might lead to delayed recovery. The influence of catastrophizing in patients with LBP is not fully established and should be further investigated. Of particular importance is the establishment of cutoff levels for identifying patients at risk.
PMID: 24607845
ISSN: 1529-9430
CID: 1360892

The role of fear avoidance beliefs as a prognostic factor for outcome in patients with nonspecific low back pain: a systematic review

Wertli, Maria M; Rasmussen-Barr, Eva; Weiser, Sherri; Bachmann, Lucas M; Brunner, Florian
BACKGROUND CONTEXT: Psychological factors including fear avoidance beliefs are believed to influence the development of chronic low back pain (LBP). PURPOSE: The purpose of this study was to determine the prognostic importance of fear avoidance beliefs as assessed by the Fear Avoidance Beliefs Questionnaire (FABQ) and the Tampa Scale of Kinesiophobia for clinically relevant outcomes in patients with nonspecific LBP. DESIGN/SETTING: The design of this study was a systematic review. METHODS: In October 2011, the following databases were searched: BIOSIS, CINAHL, Cochrane Library, Embase, OTSeeker, PeDRO, PsycInfo, PubMed/Medline, Scopus, and Web of Science. To ensure the completeness of the search, a hand search and a search of bibliographies was conducted and all relevant references included. A total of 2,031 references were retrieved, leaving 566 references after the removal of duplicates. For 53 references, the full-text was assessed and, finally, 21 studies were included in the analysis. RESULTS: The most convincing evidence was found supporting fear avoidance beliefs to be a prognostic factor for work-related outcomes in patients with subacute LBP (ie, 4 weeks-3 months of LBP). Four cohort studies, conducted by disability insurance companies in the United States, Canada, and Belgium, included 258 to 1,068 patients mostly with nonspecific LBP. These researchers found an increased risk for work-related outcomes (not returning to work, sick days) with elevated FABQ scores. The odds ratio (OR) ranged from 1.05 (95% confidence interval [CI] 1.02-1.09) to 4.64 (95% CI, 1.57-13.71). The highest OR was found when applying a high cutoff for FABQ Work subscale scores. This may indicate that the use of cutoff values increases the likelihood of positive findings. This issue requires further study. Fear avoidance beliefs in very acute LBP (<2 weeks) and chronic LBP (>3 months) was mostly not predictive. CONCLUSIONS: Evidence suggests that fear avoidance beliefs are prognostic for poor outcome in subacute LBP, and thus early treatment, including interventions to reduce fear avoidance beliefs, may avoid delayed recovery and chronicity.
PMID: 24412032
ISSN: 1529-9430
CID: 1019412

Influence of catastrophizing on treatment outcome in patients with nonspecific low back pain: a systematic review

Wertli, Maria M; Burgstaller, Jakob M; Weiser, Sherri; Steurer, Johann; Kofmehl, Reto; Held, Ulrike
STUDY DESIGN: Systematic review. OBJECTIVE: The aim of this study was to assess the effect of catastrophizing on treatment efficacy and outcome in patients treated for low back pain. SUMMARY OF BACKGROUND DATA: Psychological factors including catastrophizing thoughts are thought to increase the risk for chronic low back pain. The influence of catastrophizing is debated. METHODS: In September 2012, the following databases were searched: BIOSIS, CINAHL, Cochrane Library, EMBASE, OTseeker, PeDRO, PsycINFO, MEDLINE, Scopus, and Web of Science. For 50 of 706 references, full text was assessed. Results based on 11 studies were included in this analysis. RESULTS: In the 11 studies, a total of 2269 patients were included. Seven studies were of good and 4 of moderate methodological quality. Heterogeneity in study settings, treatments, outcomes, and patient populations impeded meta-analysis. Catastrophizing at baseline was predictive for disability at follow-up in 4 studies and for pain in 2 studies. Three studies found no predictive effect of catastrophizing. A mediating effect was found in all studies (n = 5) assessing the impact of a decrease in catastrophizing during treatment. A greater decrease was associated with better outcome. Most studies that investigated the moderating effects on treatment efficacy found no effect (n = 5). However, most studies did not look for a direct interaction between the treatment and catastrophizing thoughts. No study investigated the influence of catastrophizing on work-related outcomes including return to work. CONCLUSION: Catastrophizing predicted degree of pain and disability and mediated treatment efficacy in most studies. The presence of catastrophizing should be considered in patients with persisting back pain. Limited evidence was found for the moderating effects on treatment efficacy. Future research should aim to clarify the role of catastrophizing as a moderator of outcome and investigate its importance for work-related outcomes.Level of Evidence: 1.
PMID: 24253796
ISSN: 0362-2436
CID: 799902

Identifying determinants of low back pain behaviors [Meeting Abstract]

Weiner, S S; Gibbons, M W; Weiser, S; Vieira, D L
BACKGROUND CONTEXT: Nonspecific low back pain (LBP) remains a large public health problem despite attempts to minimize its impact. Evidence- based guidelines (EBG) are well defined and their efficacy demonstrated, yet clinical adherence is inconsistent. Various explanations for non-adherence to the evidence include clinician beliefs that guidelines are incongruent with patient expectations and clinician desire to satisfy patients' request for non-guideline care. PURPOSE: This study systematically explored the low back pain literature to synthesize what is known about patient expectations of care, and investigated the knowledge, beliefs and attitudes of patients with LBP regarding seeking care and how they use this information to guide their health care choices. The purpose was to explore patient perceptions on topics related to LBP including natural history, red flags, management, and attitudes about patient-clinician shared decision making. STUDY DESIGN/SETTING: This pilot study is a mixed methods design combining a systematic review with qualitative study design. Subjects were recruited at the New York University Langone Medical Center (NYULMC) Spine Center. PATIENT SAMPLE: Ten adult volunteer subjects with recurrent chronic LBP seeking care from a spine specialist were recruited at the NYULMC Spine Center. OUTCOME MEASURES: Domains related to patient attitudes and beliefs, and their impact on health care consumption for managing LBP were extracted from the admissible evidence. These domains were then compared with coded and synthesized interview data to either support or refute the patient narrative. METHODS: Literature review: A systematic literature search was performed with a NYULMC clinical librarian. Two researchers systematically screened the references using pre-defined inclusion-exclusion criteria. Structured interviews: Subjects with recurrent chronic LBP were recruited for a semi structured interview developed by a multidisciplinary team of LBP experts. Themes were extracted using !
EMBASE:71177499
ISSN: 1529-9430
CID: 628002

Predictors of short-term work-related disability among active duty US Navy personnel: a cohort study in patients with acute and subacute low back pain

Hiebert, R; Campello, MA; Weiser, S; Ziemke, GW; Fox, BA; Nordin, M
BACKGROUND CONTEXT: Musculoskeletal disorders of the spine in the US military account for the single largest proportion of the absence of sickness causes leading to early termination. We explored if selected psychological and physical factors were associated with poor outcome after episodes of low back pain (LBP). PURPOSE: To identify clinical, demographic, and psychological factors predictive of work duty status after a complaint of LBP. STUDY DESIGN: A prospective clinical cohort of US Navy personnel treated for LBP. PATIENT SAMPLE: Eligible cases were active duty US Navy or Marine Corps personnel presenting to an emergency clinic or primary care clinic with a complaint of LBP, where the index episode of LBP was no more than 12 weeks duration before enrollment. OUTCOME MEASURES: The subject's work status (full duty, light duty, sick in quarters [SIQ], limited duty, or medically released to full duty) was abstracted from the subject's electronic medical record at approximately 4 weeks and then again 12 weeks after study enrollment. Work status in this study population is assigned by a Navy health-care provider at the time of a clinical visit and based on the health-care provider's determination of medical fitness for duty. This study collapsed work status into two groups, "full duty" (consisting of "full duty" and "medically released to full duty") and "not at full duty" (consisting of "light duty," "SIQ," and "limited duty"). METHODS: Volunteers completed a baseline questionnaire consisting of recommended well-validated measures, including attitudes and beliefs about LBP and work (Fear-Avoidance Beliefs Questionnaire [FABQ] and the Tampa Scale of Kinesiophobia), distress (the Pain Catastrophizing Scale), clinical depression (The Center for Epidemiologic Studies Depression scale), a numeric pain intensity scale, self-perceived disability (Oswestry Disability Index), and general health status (12-Item Short Form Health Survey). Navy health-care providers conducted a back pain-specific medical evaluation. Associations are expressed as multivariate-adjusted prevalence ratios (PRs) estimated using Poisson regression. RESULTS: Two hundred fifty-three participants were enrolled. Work status outcome was collected for 239 participants. Predictors of "not at full duty" at 4 weeks after enrollment included having back pain for 4 weeks or less before study enrollment (PR, 2.69; 95% CI, 1.21-5.97) and increased FABQ Work subscale score (PR, 1.05; 95% CI, 1.01-1.08). The sole predictor of work status at 12 weeks after enrollment was increased FABQ Physical Activity (FABQ Physical) subscale score (PR=1.14; 95% CI, 1.00-1.30). CONCLUSIONS: The findings that fear-avoidance beliefs were predictive of subsequent work status among active duty service personnel in this study population (after adjusting for clinical, demographic, and psychological covariates) suggest the clinical utility of addressing these factors during treatment of back pain episodes in the military. These findings reflect the important role that psychological factors may play in the return to work process in an active duty military population.
PMID: 22227177
ISSN: 1529-9430
CID: 167274