scholarly journals Estimating Responders to Treatment Using Five Indices of Significant Individual Change

Author(s):  
Ron D. Hays ◽  
Mary E. Slaughter ◽  
Karen L. Spritzer ◽  
Patricia M. Herman

Abstract Background: Identifying how many individuals significantly improve (“responders”) provides important supplementary information beyond group mean change about the effects of treatment options. This supplemental information can enhance interpretation of clinical trials and observation studies. This study provides a comparison of five ways of estimating the significance of individual change.Methods: Secondary analyses of the Impact Stratification Score (ISS) for chronic low back pain which was administered at two timepoints in two samples: 1) three months apart in an observational study of 1,680 patients undergoing chiropractic care; and 2) 6 weeks apart in a randomized trial of 720 active-duty military personnel with low back pain. The ISS is the sum of the PROMIS-29 v2.1 physical function, pain interference and pain intensity scores and has a possible range of 8 (least impact) to 50 (greatest impact). The five methods of evaluating individual change compared were: 1) standard deviation index; 2) standard error of measurement (SEM); 3) standard error of estimate; 4) standard error of prediction; and 5) reliable change index.Results: Internal consistency reliability of the ISS at baseline was 0.90 in Sample 1 and 0.92 in Sample 2. Effect size of change on the ISS was -0.16 in Sample 1 and -0.59 in Sample 2. The denominators for the five methods in Sample 1 (Sample 2) were 7.6 (8.4) for the standard deviation index, 2.4 (2.4) for the SEM, 2.3 (2.3) for the standard error of estimation, and 3.3 (3.4) for the standard error of prediction and the reliable change index. The amount of change on the ISS needed for significant individual change in both samples was about 15-16 for the standard deviation index, 5 for the SEM and for the standard error of estimation, and 7 for the standard error of prediction and reliable change index. The percentage of people classified as responders ranged from 1% (standard deviation index in Sample 1) to 57% (SEM and standard error of estimate in Sample 2).Conclusions: The standard error of prediction and reliable change index estimates of significant change are consistent with retrospective ratings of change of at least moderately better in prior research. These two are less likely than other methods to classify people as responders who have not actually gotten better.

2021 ◽  
Author(s):  
Ron D. Hays ◽  
Mary E. Slaughter ◽  
Patricia M. Herman

Abstract Background: Identifying how many individuals significantly improve (“responders”) provides important supplementary information beyond group mean change about the effects of treatment options. This supplemental information can enhance interpretation of clinical trials and observation studies. This study provides a comparison of five ways of estimating the significance of individual change.Methods: Secondary analyses of the Impact Stratification Scale (ISS) selected for chronic low back pain was administered at two timepoints three months apart in an observational study of 1,680 patients undergoing chiropractic care. The (ISS is the sum of the PROMIS-29 v2,1 physical function, pain interference and pain intensity scores and has a possible range of 8 (least impact) to 50 (greatest impact). The five methods of evaluating individual change compared were: 1) standard deviation index; 2) confidence interval around the standard error of measurement (SEM); 3) standard error of estimate; 4) standard error of prediction; and 5) reliable change index.Results: Internal consistency reliability of the ISS at baseline was 0.90. Effect size of change on the ISS was -0.16 using the SD (7.6) at baseline. The denominators for the five methods were 7.6 for the standard deviation index, 2.4 for the confidence interval around the SEM, 2.3 for the standard error of estimation, and 3.3 for the standard error of prediction and the reliable change index. The amount of change on the ISS needed for significant individual change was 15 for the standard deviation index, 5 for the confidence interval around the SEM and for the standard error of estimation, and 7 for the standard error of prediction and reliable change index. The percentage of people classified as responders ranged from 1% (standard deviation index) to 22% (standard error of prediction and reliable change index).Conclusions: The standard error of prediction and reliable change index estimates of significant change are consistent with retrospective ratings of change of at least moderately better in prior research. These two are less likely than other methods to classify people as responders who have not actually gotten better.


2018 ◽  
Vol 24 (1) ◽  
pp. 577-580
Author(s):  
Komal Mushtaq ◽  
Shoaib Waqas ◽  
Hafiz Muhammad Asim

Chronic low back pain (CLBP) can be managed by multidisciplinary team approach especially physiotherapy and rehabilitation. In this study, effectiveness of spinal manual therapy (maitland grade I and II mobilization) for CLBP management was assessed. Methods: All subjects in the study were provided maitland grade I and II spinal mobilization for 20 minutes each. A similar treatment frequency was applied and consisted on three sessions per week for 2 continuous weeks. Numeric pain rating scale (NPRS) was applied to assess the pain severity levels before treatment and after treatment. Data were normally distributed and therefore, change in pain intensity was measured by “t” test using SPSS version 23.0. Results: The calculated mean pain score on NPRS before treatment was 3.90 (standard deviation, 0.3038) and after treatment it was 1.65 (standard deviation, 0.8638). The calculated t-value was 12.08 (p value=0.000). Conclusion: These results clearly demonstrate that the maitland G1 and G2 spinal mobilization can be exploited as an effective treatment choice for chronic low back pain.


2010 ◽  
Vol 22 (03) ◽  
pp. 255-262
Author(s):  
Masood Mazaheri ◽  
Mahyar Salavati ◽  
Hossein Negahban ◽  
Mohamad Parnianpour

As balance is the foundation for all voluntary motor skills, considerable research has been conducted to evaluate postural control in patients with low back pain (LBP). Although reliability is a population-specific property, to the authors' knowledge, there has been no study to determine the test-retest reliability of the center of pressure (COP) measures in the general population of LBP patients. As many as 11 patients with a history of nonspecific LBP randomly completed postural measurements with three levels of difficulty (rigid surface-eyes open, rigid surface-eyes closed, and foam surface-eyes closed) in two sessions. The COP data were used to calculate standard deviation of amplitude, phase plane portrait, standard deviation of velocity, mean total velocity, and area (95% confidence ellipse). Relative reliability of these measures was assessed using intraclass correlation coefficient (ICC) and absolute reliability using standard error of measurement (SEM), and coefficient of variation (CV). Among different COP parameters, the mean total velocity in all conditions of postural difficulty showed the highest reliability, with the ICC range of 0.73–0.80, SEM range of 0.09–0.32 cm/s, and CV range of 5.7–8.2%. Therefore, the mean total velocity may be an optimal COP parameter to be used for quantification and assessment of balance performance in LBP patients.


2000 ◽  
Vol 6 (3) ◽  
pp. 364-364 ◽  
Author(s):  
NANCY R. TEMKIN ◽  
ROBERT K. HEATON ◽  
IGOR GRANT ◽  
SUREYYA S. DIKMEN

Hinton-Bayre (2000) raises a point that may occur to many readers who are familiar with the Reliable Change Index (RCI). In our previous paper comparing four models for detecting significant change in neuropsychological performance (Temkin et al., 1999), we used a formula for calculating Sdiff, the measure of variability for the test–retest difference, that differs from the one Hinton-Bayre has seen employed in other studies of the RCI. In fact, there are two ways of calculating Sdiff—a direct method and an approximate method. As stated by Jacobson and Truax (1991, p. 14), the direct method is to compute “the standard error of the difference between the two test scores” or equivalently [begin square root](s12 + s22 − 2s1s2rxx′)[end square root] where si is the standard deviation at time i and rxx′ is the test–retest correlation or reliability coefficient. Jacobson and Truax also provide a formula for the approximation of Sdiff when one does not have access to retest data on the population of interest, but does have a test–retest reliability coefficient and an estimate of the cross-sectional standard deviation, i.e., the standard deviation at a single point in time. This approximation assumes that the standard deviations at Time 1 and Time 2 are equal, which may be close to true in many cases. Since we had the longitudinal data to directly calculate the standard error of the difference between scores at Time 1 and Time 2, we used the direct method. Which method is preferable? When the needed data are available, it is the one we used.


2018 ◽  
Vol 11 (1) ◽  
pp. 046-052
Author(s):  
Fitra Puspita Sari

The incidence of low back pain is about 80% of the population have sufferedfrom low back pain. Data of low back pain patients within 6 months (April to September2016) as many as 72 visits in Poly Saraf RSUD Bengkulu City. The purpose of the studyto determine the effect of stretching on the reduction of the scale of pain in low back painpatients in Poly Saraf RSUD Bengkulu City. The type of research is pre-experiment withone group pre-test post-test design. Respondents were lower back pain patients as manyas 32 people taken with purposive sampling technique. Data collection was done byinterview using numerical pain scale. The result showed that the average of pain scalebefore stretching was 4.81 with a standard deviation of 0.592, the pain scale afterstretching was 3.34 with a standard deviation of 0.701. Stretching exercises have asignificant effect on decreasing the scale of low back pain (p = 0.000 ≤ α 5%). It isdesirable for nurses to apply stretching exercises as an initial measure to lower the scaleof low back pain.


Author(s):  
Sarah Tinitali ◽  
Terry Haines ◽  
Kelly-Ann Bowles

Objective To determine a methodology for the analysis of real-time driving posture data in the low back pain population. Background The strength of the relationship between driving posture and low back pain is yet to be defined due to the lack of studies in the field using validated and repeatable posture measurement tools. Reliable and validated real-time measurement tools are now available, yet reliable methods of analysis of these data are yet to be established. Method Ten occupational drivers completed a typical work shift while wearing an inertial motion sensor system (dorsaVi ViMove). Real-time lumbar flexion data were extracted, with test–retest reliability of mean lumbar flexion, peak lumbar flexion, and standard deviation of lumbar flexion analysed at different times across a work shift, and in different sections within a drive. Results Mean lumbar flexion was highly repeatable over numerous drives in one day, with greater test–retest reliability if the first five minutes of driving data were excluded. Peak lumbar flexion had acceptable test-retest reliability over numerous drives in one day, while standard deviation of lumbar flexion was not a repeatable measure. Conclusion Mean lumbar flexion was a reliable outcome for characterising driving posture in drivers with low back pain. Peak lumbar flexion may be used if appropriate to the individual study. Standard deviation of lumbar flexion is not a reliable posture outcome. Application This paper provides a reliable methodology for analysis of real-time driving posture data in occupational drivers with low back pain.


Author(s):  
Mahima Thakur ◽  
Sathish Rajamani

Background of the study: Among antenatal women, back pain could be present in the form of pelvic gridle pain between the gluteal fold and the posterior iliac crest or as a lumbar pain over and around the lumbar spine. Nursing management aims to minimize the discomfort and the antenatal mother’s quality of life. Aim of the study: to assess the effectiveness of stretching exercises in reducing low back pain among antenatal mothers. Methodology: The research design for the study was Quasi - Experimental Research Design test sampling technique adopted in the study was purposive sampling technique. The total sample consists 60 antenatal mothers in 30 experimental groups and in 30 control group. The study was conducted in selected four villages Babarpur, Baroli, Dadlana and Ganjbad in District Panipat Haryana. Data collection tool was numerical rating pain scale and modified Oswestry low back pain questionnaire to assess the back pain. Stretching exercises was given for two weeks on every alternative day. Data analysis was done with the help by the mean of descriptive and inferential statistics. Results: The post-test pain and its standard deviation score among subjects in experimental group was 4.67 + 1.626 and in control group the post-test pain score and its standard deviation score was 8.60 + 2.415. The mean difference was -3.93. The independent „t‟ test value was -7.399 for the degree of freedom 58. This was statistically significant at the ‘P’ value < 0.05. Conclusion: The stretching exercise was effective in reducing the back pain. (Personal care, walking, sitting, standing, sleeping, social life, employment, lifting)


2018 ◽  
Vol 43 (2) ◽  
pp. 227-232 ◽  
Author(s):  
Mary E Matsumoto ◽  
Joseph M Czerniecki ◽  
Ali Shakir ◽  
Pradeep Suri ◽  
Michael Orendurff ◽  
...  

Background: Low back pain is a common secondary disabling condition in the transfemoral amputee population. Transfemoral amputees are at risk of excessive lumbar lordosis; it has been suggested that increased lumbar lordosis may be associated with low back pain. However, the relationship between lumbar lordosis angle and low back pain has not yet been studied in this population. Objective: To determine whether the extent of lumbar lordosis is associated with low back pain in transfemoral amputees. Study design: Case–control observational study. Methods: Participants included eight transfemoral amputees without low back pain and nine transfemoral amputees with low back pain. Etiology of amputation was primarily trauma. All participants underwent lateral view radiographs of the lumbar spine, from which lumbar lordosis angle and sacral inclination angle were measured. Results: Lumbar lordosis angle mean ± standard deviation was 46.1° ± 12.4° in participants with low back pain and 51.0° ± 12.6° in those without. Sacral inclination angle mean ± standard deviation was 38.3° ± 8.7° in participants with low back pain and 39.1° ± 7.5° in those without. There was no significant difference in lumbar lordosis angle or sacral inclination angle between participants with and without low back pain. Conclusion: This study suggests that increased lumbar lordosis angle and sacral inclination angle are not significantly associated with low back pain in transfemoral amputees of a primarily traumatic etiology. Clinical relevance Low back pain (LBP) is a common, disabling condition in transfemoral amputees. In the clinical setting, increased lumbar lordosis is implicated in LBP. This study does not support an association between increased lumbar lordosis and LBP; further study is needed to understand the increased prevalence of LBP in this population.


2021 ◽  
Vol 4 (2) ◽  
pp. 99-105
Author(s):  
Rini Rahmayanti ◽  
Delvi Hamdayani ◽  
Fitri Wahyuni S

Low back pain is one of the complaints felt by some and almost all postpartum mothers since pregnancy. Low back pain occurs in 45-55% of mothers in the first week postpartum, continues at 8 weeks postpartum as much as 68% and 60% in the next 8 months. Persistent pain causes inhibition of maternal activities and reduces quality of life. One type of complementary therapy is cryotherapy cold therapy with ice. Cold therapy is a therapeutic modality that can absorb tissue temperature so that there is a decrease in tissue temperature through the conduction mechanism. The purpose of this study was to determine the effectiveness of cryoptherapy on low back pain in postpartum mothers during home care during the COVID-19 pandemic. This type of research is a pre-experimental design with One Group Pretest-Posttest with a sample of 22 early postpartum mothers (24 hours to 1 week after delivery). Data were analyzed using paired t test. The results showed that the average pain scale before being given cryotherapy was 6.82 with a standard deviation of 0.907, the average self-efficacy after being given cryotherapy was 3.96 with a standard deviation of 0.64. There was a difference in the mean value between before and after the cryotherapy intervention was given with p-value = 0.002 (p<0.05). It is hoped that health services can use cryotherapy as a therapy to reduce postpartum maternal back pain.  


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