Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale

PURPOSE: To compare the sensitivity to change and the responsiveness to intervention of the PROMIS Pain Interference short forms, Brief Pain Inventory (BPI), 3-item PEG scale, and SF-36 Bodily Pain subscale in a sample of patients with persistent musculoskeletal pain of moderate severity. METHODS: Standardized response means, standardized effect sizes, and receiver operating curve analyses were used to assess change between baseline and 3-month assessments in 250 participants who participated in a randomized clinical effectiveness trial of collaborative telecare management for moderate to severe and persistent musculoskeletal pain. RESULTS: The BPI, PEG, and SF-36 Bodily Pain measures were more sensitive to patient-reported global change than the PROMIS Pain Interference short forms, especially for the clinically improved group, for which the change detected by the PROMIS short forms was not statistically significant. The BPI was more responsive to the clinical intervention than the SF-36 Bodily Pain and PROMIS Pain Interference measures. Post hoc analyses exploring these findings did not suggest that differences in content or rating scale structure (number of response options or anchoring language) adequately explained the observed differences in the detection of change. CONCLUSIONS: In this clinical trial, the BPI and PEG measures were better able to detect change than the SF-36 Bodily Pain and PROMIS Pain Interference measures

Comparative Responsiveness of the PROMIS Pain Interference Short Forms with Legacy Pain Measures: Results from Three Randomized Clinical Trials

The PROMIS Pain Interference (PROMIS-PI) scales are reliable and publicly accessible; however, little is known about how responsive they are to detect change in clinical trials and how their responsiveness compares to legacy measures. The study purpose was to evaluate responsiveness for the PROMIS-PI scales and to compare their responsiveness with legacy pain measures. We used data from three clinical trials totaling 759 participants. The clinical trials included patients with chronic low back pain (n= 261), chronic back or osteoarthritis pain (n = 240), and a history of stroke (n= 258). At both baseline and follow-up, participants completed PROMIS-PI scales and legacy pain measures (Brief Pain Inventory Interference scale, Pain/Enjoyment/General Activity (PEG) scale, SF-36 Bodily Pain scale, and Roland-Morris Disability Questionnaire). We measured global ratings of pain change, both prospectively and retrospectively, as anchors to identify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. The PROMIS-PI scales had largely comparable responsiveness with the Brief Pain Inventory Interference scale and PEG. The four PROMIS-PI short forms had comparable responsiveness. For all pain questionnaires, responsiveness varied based on the study population and whether pain improved or worsened

Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials

Minimally important difference (MID) refers to the smallest meaningful difference that carries implications for patient care. Minimally important differences are necessary to help interpret patient-reported pain outcomes in research and clinical practice. The PROMIS pain interference scales were validated across diverse samples; however, more information about their MIDs could improve their interpretability. The purpose of this study was to estimate MIDs for 4 fixed-length PROMIS pain interference scales, including the 6-item Pain Short Form and the 4-, 6-, and 8-item pain interference scales used in the PROMIS profile instruments. Data were analyzed from 3 randomized controlled trials (N = 759). The 3 samples, respectively, consisted of patients with chronic low back pain (n = 261), chronic back pain or hip/knee osteoarthritis pain (n = 240), and a history of stroke (n = 258). For each sample, anchor- and distribution-based approaches were used to estimate MIDs. Standard error of measurement and effect sizes were used as distribution-based MID estimates. Anchor-based MID estimates were established by mapping PROMIS pain interference scores onto established anchor measures, including the Brief Pain Inventory, and retrospective and prospective global ratings of change. The distribution- and anchor-based MID estimates showed convergence. For the pain samples, MID estimates ranged from 2 to 3 T-score points. For the nonpain sample, MID estimates ranged from 3.5 to 4.5 T-score points. The MID estimates were comparable across the 4 fixed-length scales. These MIDs can be used to evaluate treatment effects in research and clinical care and to calculate estimates for powering clinical trials

Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials

The PROMIS depression scales are reliable and valid measures that have extensive normative data in general population samples. However, less is known about how responsive they are to detect change in clinical settings and how their responsiveness compares to legacy measures. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples

Minimally Important Differences and Severity Thresholds are Estimated for the PROMIS Depression Scales from Three Randomized Clinical Trials

BACKGROUND: Patient Reported Outcomes Measurement Information Systems (PROMIS) scales are increasingly being used to measure symptoms in research and practice. The purpose of this study was to determine the minimally important difference (MID) and severity thresholds (cut-points) for the four fixed-length PROMIS depression scales. METHODS: The study sample was adult participants in three randomized clinical trials (N=651). MID was estimated using multiple distribution- and anchor-based approaches including assessing correspondence between Patient Health Questionnaire (PHQ-9) and PROMIS depression scores. RESULTS: The best MID estimate was a PROMIS depression T-score of 3.5 points with most methods producing an MID in the 3 to 4 point range across all three samples. MID estimates were similar for all four PROMIS scales. A PHQ-9 1-point change equated to a PROMIS 1.25-point T-score change. PROMIS T-scores of 55, 60, 65, and 70 appeared to be reasonable thresholds for mild, moderate, moderately severe, and severe depression, respectively. LIMITATIONS: The study sample was predominantly male veterans with either chronic pain (2 trials) or previous stroke (1 trial). The severity of depression was mild to moderate. CONCLUSION: A T-score of 3 to 4 points is a reasonable MID for PROMIS depression scales and can be used to assess treatment effects in both practice and research as well to calculate sample sizes for clinical trials. Severity cut-points can help interpret the meaning of scores and action thresholds for treatment decisions

Development and application of control tools for use in optogenetics research

Thesis: S.M., Massachusetts Institute of Technology, School of Architecture and Planning, Program in Media Arts and Sciences, 2014.Cataloged from PDF version of thesis.Includes bibliographical references.Optogenetic actuators such as Channelrhodopsin-2 (ChR2) are seven-transmembrane proteins that function as light-gated ion channels. These naturally occurring proteins are found in green algae and serve as sensory photoreceptors controlling phototaxis. Operationally, they contain the light-isomerizable chromophore all-trans-retinal that, upon absorption of a photon at or around 473nm, a conformational change to 13-cis-retinal is induced. This change opens the channel allowing cations to flow through. In the absence of light, the 13-cis-retinal relaxes back to the resting all-trans-retinal conformation and the channel closes. When an actuators packaged into a lox-containing Adeno-associated virus is used in conjunction with a mouse that expresses the Cre recombinase enzyme in a specific cell type, cell specific expression of the opsin is achieved. When used with LEDs, lasers, or specifically fabricated light delivery tools, control of very specific neural networks is realized. This thesis provides a review of optogenetics and details the development and application of a novel wireless device to optically control neural circuits and behavior.by Patrick Erin Monahan III.S.M

High-performance genetically targetable optical neural silencing by proton pumps

The ability to silence the activity of genetically specified neurons in a temporally precise fashion would provide the opportunity to investigate the causal role of specific cell classes in neural computations, behaviours and pathologies. Here we show that members of the class of light-driven outward proton pumps can mediate powerful, safe, multiple-colour silencing of neural activity. The gene archaerhodopsin-3 (Arch)1 from Halorubrum sodomense enables near-100% silencing of neurons in the awake brain when virally expressed in the mouse cortex and illuminated with yellow light. Arch mediates currents of several hundred picoamps at low light powers, and supports neural silencing currents approaching 900 pA at light powers easily achievable in vivo. Furthermore, Arch spontaneously recovers from light-dependent inactivation, unlike light-driven chloride pumps that enter long-lasting inactive states in response to light. These properties of Arch are appropriate to mediate the optical silencing of significant brain volumes over behaviourally relevant timescales. Arch function in neurons is well tolerated because pH excursions created by Arch illumination are minimized by self-limiting mechanisms to levels comparable to those mediated by channelrhodopsins2, 3 or natural spike firing. To highlight how proton pump ecological and genomic diversity may support new innovation, we show that the blue–green light-drivable proton pump from the fungus Leptosphaeria maculans4 (Mac) can, when expressed in neurons, enable neural silencing by blue light, thus enabling alongside other developed reagents the potential for independent silencing of two neural populations by blue versus red light. Light-driven proton pumps thus represent a high-performance and extremely versatile class of ‘optogenetic’ voltage and ion modulator, which will broadly enable new neuroscientific, biological, neurological and psychiatric investigations.National Institutes of Health (U.S.) (NIH Director's New Innovator Award (DP2 OD002002-01))National Institutes of Health (U.S.) (grant 0835878)National Science Foundation (U.S.) (grant 0848804)McGovern Institute for Brain Research at MIT (Neurotechnology Award Program)National Institutes of Health (U.S.) (NIH 1K99MH085944)Alfred P. Sloan FoundationUnited States. Dept. of DefenseDr. Gerald Burnett and Marjorie BurnettSFN Research Award for Innovation in NeuroscienceMassachusetts Institute of Technology. Media LaboratoryBenesse FoundationWallace H. Coulter FoundationHelen Hay Whitney FoundationBrain & Behavior Research Foundatio

Randomized Clinical Trial of a Self-care and Communication Intervention for Parents of Adolescent/Young Adults Undergoing High-Risk Cancer Treatment: A Report From the Children's Oncology Group

Background: Parents of adolescents and young adults (AYAs) with cancer offer primary support to their children and often experience their own high levels of distress, affecting parent-AYA communication and quality of life. Objective: To reduce parent distress and improve communication during high-risk cancer treatment, we examined efficacy of a self-care and communication intervention for parents and indirect benefit for AYAs receiving a therapeutic music video (TMV) intervention. Methods: In this study, we conducted a multisite, randomized controlled trial with AYAs and parents enrolled as dyads (n = 110). Parents were randomized to intervention or low-dose control; all AYAs received TMV. Data collection occurred at baseline, 2 weeks post intervention (T2), and 90 days post intervention (T3). Results: There were no significant between-group differences on primary outcomes for parents or AYAs. We did find significant differences favoring the parent intervention group on parenting confidence at T2 and marginally better outcomes for family adaptability/cohesion at T3. Both groups exhibited significant within-group improvement for parent distress (state anxiety, T3; perceived stress, T2 and T3; mood, T3), state anxiety (T2) intervention only, and family strengths control group only. Qualitative data demonstrate the parent intervention raised self-awareness and parent confidence in the short term. Conclusion: Parents found their intervention helpful. Absence of significant results may be due to short intervention duration, need for tailored content, underpowered sample, and potential indirect parent benefit from AYA participation in TMV. The parent intervention did not provide an indirect benefit for AYAs. Implications for nursing: Parents identified their own need for communication and support from nurses. Nurses can optimize AYA care by attending to parent needs through supportive listening and encouraging self-care