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      Stratification of spine patients based on self-reported clinical symptom classes: Evaluation of long-term outcomes and subsequent interventions

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          Abstract

          Background

          Prior work by our group developed a stratification tool based on four PROMIS domains for patients with low back pain (LBP). Our study aimed to evaluate the ability of our previously developed symptom classes to predict long-term outcomes, and determine whether there were differential treatment effects by intervention.

          Methods

          This was a retrospective cohort study of adult patients with LBP seen in spine clinics in a large health system between November 14, 2018 and May 14, 2019 who completed patient-reported outcomes as part of routine care at baseline and again at 12-months follow-up. Latent class analysis identified symptom classes based on PROMIS domain scores (physical function, pain interference, social role satisfaction, and fatigue) that were ≥1 standard deviation worse (meaningfully worse) than the general population. The ability of the profiles to predict long-term outcomes at 12-months was evaluated through multivariable models. Differences in outcomes by subsequent treatments (physical therapy, specialist visits, injections, and surgery) were investigated.

          Results

          There were 3,236 adult patients (average age 61.1 ± 14.2, 55.4% female) included in the study with three distinct classes identified: mild symptoms ( n = 986, 30.5%), mixed ( n = 798, 24.7%) with poor scores on physical function and pain interference but better scores on other domains, and significant symptoms ( n = 1,452, 44.9%). The classes were significantly associated with long-term outcomes, with patients with significant symptoms improving the most across all domains. Utilization differed across classes, with the mixed symptom class receiving more PT and injections and significant symptom class receiving more surgeries and specialist visits.

          Conclusions

          Patients with LBP have distinct clinical symptom classes which could be utilized to stratify patients into groups based on risk of future disability. These symptom classes can also be used to provide estimates of the effectiveness of different interventions, further increasing the clinical utility of these classes in standard care.

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          Most cited references42

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          The PHQ-9: validity of a brief depression severity measure.

          While considerable attention has focused on improving the detection of depression, assessment of severity is also important in guiding treatment decisions. Therefore, we examined the validity of a brief, new measure of depression severity. The Patient Health Questionnaire (PHQ) is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The PHQ-9 was completed by 6,000 patients in 8 primary care clinics and 7 obstetrics-gynecology clinics. Construct validity was assessed using the 20-item Short-Form General Health Survey, self-reported sick days and clinic visits, and symptom-related difficulty. Criterion validity was assessed against an independent structured mental health professional (MHP) interview in a sample of 580 patients. As PHQ-9 depression severity increased, there was a substantial decrease in functional status on all 6 SF-20 subscales. Also, symptom-related difficulty, sick days, and health care utilization increased. Using the MHP reinterview as the criterion standard, a PHQ-9 score > or =10 had a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Results were similar in the primary care and obstetrics-gynecology samples. In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity. These characteristics plus its brevity make the PHQ-9 a useful clinical and research tool.
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            Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation.

            A number of studies have computed the minimally important difference (MID) for health-related quality of life instruments. To determine whether there is consistency in the magnitude of MID estimates from different instruments. We conducted a systematic review of the literature to identify studies that computed an MID and contained sufficient information to compute an effect size (ES). Thirty-eight studies fulfilled the criteria, resulting in 62 ESs. For all but 6 studies, the MID estimates were close to one half a SD (mean = 0.495, SD = 0.155). There was no consistent relationship with factors such as disease-specific or generic instrument or the number of response options. Negative changes were not associated with larger ESs. Population-based estimation procedures and brief follow-up were associated with smaller ESs, and acute conditions with larger ESs. An explanation for this consistency is that research in psychology has shown that the limit of people's ability to discriminate over a wide range of tasks is approximately 1 part in 7, which is very close to half a SD. In most circumstances, the threshold of discrimination for changes in health-related quality of life for chronic diseases appears to be approximately half a SD.
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              Prevention and treatment of low back pain: evidence, challenges, and promising directions

              Many clinical practice guidelines recommend similar approaches for the assessment and management of low back pain. Recommendations include use of a biopsychosocial framework to guide management with initial non-pharmacological treatment, including education that supports self-management and resumption of normal activities and exercise, and psychological programmes for those with persistent symptoms. Guidelines recommend prudent use of medication, imaging, and surgery. The recommendations are based on trials almost exclusively from high-income countries, focused mainly on treatments rather than on prevention, with limited data for cost-effectiveness. However, globally, gaps between evidence and practice exist, with limited use of recommended first-line treatments and inappropriately high use of imaging, rest, opioids, spinal injections, and surgery. Doing more of the same will not reduce back-related disability or its long-term consequences. The advances with the greatest potential are arguably those that align practice with the evidence, reduce the focus on spinal abnormalities, and ensure promotion of activity and function, including work participation. We have identified effective, promising, or emerging solutions that could offer new directions, but that need greater attention and further research to determine if they are appropriate for large-scale implementation. These potential solutions include focused strategies to implement best practice, the redesign of clinical pathways, integrated health and occupational interventions to reduce work disability, changes in compensation and disability claims policies, and public health and prevention strategies.
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                Author and article information

                Contributors
                Journal
                N Am Spine Soc J
                N Am Spine Soc J
                North American Spine Society Journal
                Elsevier
                2666-5484
                22 February 2023
                June 2023
                22 February 2023
                : 14
                : 100205
                Affiliations
                [a ]Center for Outcomes Research and Evaluation, Neurological Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, United States
                [b ]Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, United States
                [c ]Center for Spine Health, Neurological Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, United States
                [d ]Department of Rehabilitation and Sports Therapy, Neurological Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, United States
                [e ]Department of Physical Medicine and Rehabilitation, Neurological Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, United States
                [f ]Center for Value-Based Care Research, Community Care, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, United States
                Author notes
                [* ]Corresponding author. Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, JJ3-603, Cleveland, OH 44195, USA. Tel.: (216)-308-5259; fax: (216)-636-1040. LapinB@ 123456ccf.org
                Article
                S2666-5484(23)00007-0 100205
                10.1016/j.xnsj.2023.100205
                10031537
                36970061
                c1b3c796-3229-4f83-ba7a-c95d064131bf
                © 2023 The Author(s)

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 9 December 2022
                : 14 February 2023
                : 14 February 2023
                Categories
                Clinical Studies

                low back pain,stratification,classification,latent class analysis,promis,symptom clusters,treatments,healthcare utilization

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