Physical Impairment Index: Reliability, Validity, and Responsiveness in Patients with Acute Low Back Pain Performance of a Patient Reported Outcomes Measurement Information System (PROMIS) Short Form in Older Adults with Chronic Musculoskeletal Pain. Addressing methodological challenges in implementing the nursing home pain management algorithm randomized controlled trial Depression and osteoarthritis. Scoping review of systematic reviews of complementary medicine for musculoskeletal and mental health conditions Validation of Self-Report Pain Scales in Children Effectiveness of manual therapies: the UK evidence report An empirical evaluation of the SF-12, SF-6D, EQ-5D and Michigan Hand Outcome Questionnaire in patients with rheumatoid arthritis of the hand Editorial: an author's checklist for measure development and validation manuscripts. Assessment of study quality for systematic reviews: a comparison of the Cochrane Collaboration Risk of Bias Tool and the Effective Public Health Practice Project Quality Assessment Tool: methodological research. Reporting of Sex Effects by Systematic Reviews on Interventions for Depression, Diabetes, and Chronic Pain NICE guidance on long-term sickness and incapacity. Primary care clinician adherence to guidelines for the management of chronic musculoskeletal pain: results from the study of the effectiveness of a collaborative approach to pain. Musculoskeletal Pain and Vitamin D Deficiency in Children: A Pilot Follow-up Study of Vitamin D Therapy in Musculoskeletal/Orthopedic Conditions. Reliability and Validity of 6 Measures of Pain, Function, and Disability for Ankle Arthroplasty and Arthrodesis Effects of Feldenkrais method on chronic neck/scapular pain in people with visual impairment: a randomized controlled trial with one-year follow-up. Musculoskeletal pain is associated with incident mobility disability in community-dwelling elders.
Study Design . Cohort study of patients with acute low back pain undergoing physical therapy .  Objectives . Examine the reliability and validity of the Physical Impairment Index in a group of patients with acute low back pain and determine the responsiveness and minimum detectable change of the index and its component tests . Summary of the Background Data . The Physical Impairment Index was originally described as a reliable and valid means of assessing physical impairment in patients with low back pain . The psychometric properties of the index have not been reported in patients with acute low back pain , nor has its responsiveness been examined . Methods . Seventy-eight patients with acute ( <3 weeks duration ) low back pain participating in a clinical trial were assessed at baseline and after 4 weeks .  Interrater reliability of the index was examined in a subgroup of 20 patients . Validity was examined through correlations with concurrent measures of pain , disability , and psychosocial variables . Changes in the index over 4 weeks were used to assess responsiveness and minimum detectable change . Results . Interrater reliability of the index was high ( intraclass correlation coefficient = 0.89 ) , and its validity was generally supported by the pattern of correlations . The index was more responsive to change than any of its component tests but was less responsive than the Oswestry disability score . The minimum detectable change on the index was approximately 1 point . Conclusions . The Physical Impairment Index appears to be a reliable and valid measure of physical impairment for patients with acute low back pain and may be useful as an adjunct outcome measure for studies involving these patients . Further research on patients with chronic pain is needed before it can be advocated for outcomes research with this population OBJECTIVE To assess reliability , validity , and responsiveness of a 29-item short-form version of the Patient Reported Outcomes Measurement Information System ( PROMIS ) and a novel “ impact score ” calculated from those measures . DESIGN Prospect i ve cohort study . SETTING Rural primary care practice s. SUBJECTS Adults aged ≥ 55 years with chronic musculoskeletal pain , not currently receiving prescription opioids . METHODS Subjects completed the PROMIS short form at baseline and after 3 months . Patient subsets were compared to assess reliability and responsiveness . Construct validity was tested by comparing baseline scores among patients who were or were not applying for Worker 's Compensation ; those with higher or lower catastrophizing scores ; and those with or without recent falls . Responsiveness was assessed with mean score changes , effect sizes , and st and ardized response means . RESULTS Internal consistency was good to excellent , with Cronbach 's alpha between 0.81 and 0.95 for all scales . Among patients who rated their pain as stable , test-retest scores at 3 months were around 0.70 for most scales . PROMIS scores were worse among patients seeking or receiving worker 's compensation , those with high catastrophizing scores , and those with recent falls . Among patients rating pain as “ much less ” at 3 months , absolute effect sizes for the various scales ranged from 0.24 ( Depression ) to 1.93 ( Pain Intensity ) . CONCLUSIONS Results indicate that the PROMIS short 29-item form may be useful for the study of patients with chronic musculoskeletal pain . Our findings also support use of the novel “ impact score ” recommended by the National Institutes of Health ( NIH ) Task Force on Research St and ards for Chronic Low Back Pain Background Unrelieved pain among nursing home ( NH ) residents is a well-documented problem . Attempts have been made to enhance pain management for older adults , including those in NHs . Several evidence -based clinical guidelines have been published to assist providers in assessing and managing acute and chronic pain in older adults . Despite the proliferation and dissemination of these practice guidelines , research has shown that intensive systems-level implementation strategies are necessary to change clinical practice and patient outcomes within a health-care setting . One promising approach is the embedding of guidelines into explicit protocol s and algorithms to enhance decision making . Purpose The goal of the article is to describe several issues that arose in the design and conduct of a study that compared the effectiveness of pain management algorithms coupled with a comprehensive adoption program versus the effectiveness of education alone in improving evidence -based pain assessment and management practice s , decreasing pain and depressive symptoms , and enhancing mobility among NH residents . Methods The study used a cluster-r and omized controlled trial ( RCT ) design in which the individual NH was the unit of r and omization . The Roger ’s Diffusion of Innovations theory provided the framework for the intervention . Outcome measures were surrogate-reported usual pain , self-reported usual and worst pain , and self-reported pain-related interference with activities , depression , and mobility . Results The final sample consisted of 485 NH residents from 27 NHs . The investigators were able to use a staggered enrollment strategy to recruit and retain facilities . The adaptive r and omization procedures were successful in balancing intervention and control sites on key NH characteristics . Several strategies were successfully implemented to enhance the adoption of the algorithm . Limitations /Lessons The investigators encountered several method ological challenges that were inherent to both the design and implementation of the study . The most problematic issue concerned the measurement of outcomes in persons with moderate to severe cognitive impairment . It was difficult to identify valid , reliable , and sensitive outcome measures that could be applied to all NH residents regardless of the ability to self-report . Another challenge was the inability to incorporate advances in implementation science into the ongoing study Conclusions Method ological challenges are inevitable in the conduct of an RCT . The need to optimize internal validity by adhering to the study protocol is compromised by the emergent logistical issues that arise during the course of the study Depression is significant among patients with arthritis and musculoskeletal illnesses . However , the impact of depression on osteoarthritis has not been extensively studied . This article highlights the close links between these 2 prevalent chronic conditions , and the associated individual and societal burden . Results from a large clinical trial of depressed older patients with arthritis showed that a focused , collaborative depression care intervention not only decreased depression but also improved arthritis-associated outcomes , such as pain severity and arthritis-related limitations in daily activities . Relative to patients given usual care , patients receiving intervention also reported better health status and higher quality of life . Analyses of the depression interventions uncovered a reciprocal interrelation between depression and pain . Higher severity of either depression or pain decreased the benefits of systematic depression treatment and was associated with worse pain and depression outcomes . Current approaches to management of depression and arthritis do not reflect readily-available evidence -based treatment . A pilot study using a combined approach to address both depression and pain problems among elderly patients with depression and osteoarthritis suggested that benefits for depression , pain , and functional outcomes are strengthened by providing both  pain and depression care management . An integrated depression and pain program using evidence d-based pharmacologic and nonpharmacologic treatments is needed to achieve optimal depression and pain outcomes . Currently , a r and omized trial is under way to evaluate effectiveness of a combined pain and depression intervention using pharmacologic and nonpharmacologic therapies . Key intervention components in these 2 innovative and integrated depression and pain programs can guide clinicians to treat both depression and pain with more focus and intensity Objective To identify potentially effective complementary approaches for musculoskeletal (MSK)–mental health ( MH ) comorbidity , by synthesis ing evidence on effectiveness , cost-effectiveness and safety from systematic review s ( SRs ) . Design Scoping review of SRs . Methods We search ed literature data bases , registries and reference lists , and contacted key authors and professional organisations to identify SRs of r and omised controlled trials for complementary medicine for MSK or MH . Inclusion criteria were : published after 2004 , study ing adults , in English and scoring > 50 % on Assessing the Method ological Quality of Systematic Review s ( AMSTAR ) ; quality appraisal checklist ) . SRs were synthesis ed to identify research priorities , based on moderate/good quality evidence , sample size and indication of cost-effectiveness and safety . Results We included 84 MSK SRs and 27 MH SRs . Only one focused on MSK – MH comorbidity . Meditative approaches and yoga may improve MH outcomes in MSK population s. Yoga and tai chi had moderate/good evidence for MSK and MH conditions . SRs reported moderate/good quality evidence ( any comparator ) in a moderate/large population for :  low back pain ( LBP )  ( yoga , acupuncture , spinal manipulation/mobilisation , osteopathy ) , osteoarthritis ( OA ) ( acupuncture , tai chi ) , neck pain  ( acupuncture , manipulation/manual therapy ) , myofascial trigger point pain ( acupuncture ) , depression ( mindfulness-based stress reduction ( MBSR ) , meditation , tai chi , relaxation ) , anxiety ( meditation/MBSR , moving meditation , yoga ) , sleep disorders ( meditative/mind – body movement ) and stress/distress ( mindfulness ) . The majority of these complementary approaches had some evidence of safety — only three had evidence of harm . There was some evidence of cost-effectiveness for spinal manipulation/mobilisation and acupuncture for LBP , and manual therapy/manipulation for neck pain , but few SRs review ed cost-effectiveness and many found no data . Conclusions Only one SR studied MSK – MH comorbidity . Research priorities for complementary medicine for both MSK and MH ( LBP , OA , depression , anxiety and sleep problems ) are yoga , mindfulness and tai chi . Despite the large number of SRs and the prevalence of comorbidity , more high- quality , large r and omised controlled trials in comorbid population s are needed BACKGROUND AND OBJECTIVES : The Faces Pain Scale – Revised ( FPS-R ) and Color Analog Scale ( CAS ) are self-report pain scales commonly used in children but insufficiently vali date d in the emergency department setting . Our objectives were to determine the psychometric properties ( convergent validity , discriminative validity , responsivity , and reliability ) of the FPS-R and CAS , and to determine whether degree of validity varied based on age , sex , and ethnicity . METHODS : We conducted a prospect i ve , observational study of English- and Spanish-speaking children ages 4 to 17 years . Children with painful conditions indicated their pain severity on the FPS-R and CAS before and 30 minutes after analgesia . We assessed convergent validity ( Pearson correlations , Bl and -Altman method ) , discriminative validity ( comparing pain scores in children with pain against those without pain ) , responsivity ( comparing pain scores pre- and postanalgesia ) , and reliability ( Pearson correlations , repeatability coefficient ) . RESULTS : Of 620 patients analyzed , mean age was 9.2 ± 3.8 years , 291(46.8 % ) children were girls , 341(55 % ) were Hispanic , and 313(50.5 % ) were in the younger age group ( < 8 years ) . Pearson correlation was 0.85 , with higher correlation in older children and girls . Lower convergent validity was noted in children < 7 years of age . All subgroups based on age , sex , and ethnicity demonstrated discriminative validity and responsivity for both scales . Reliability was acceptable for both the FPS-R and CAS . CONCLUSIONS : The FPS-R and CAS overall demonstrate strong psychometric properties in children ages 4 to 17 years , and between subgroups based on age , sex , and ethnicity . Convergent validity was question able in children < 7 years old Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions . Methods The conclusions are based on the results of systematic review s of r and omized clinical trials ( RCTs ) , widely accepted and primarily UK and United States evidence -based clinical guidelines , plus the results of all RCTs not yet included in the first three categories . The strength/ quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs . Results By September 2009 , 26 categories of conditions were located containing RCT evidence for the use of manual therapy :  13 musculoskeletal conditions , four types of chronic headache and nine non-musculoskeletal conditions . We identified 49 recent relevant systematic review s and 16 evidence -based clinical guidelines plus an additional 46 RCTs not yet included in systematic review s and guidelines .Additionally , brief references are made to other effective non-pharmacological , non-invasive physical treatments . Conclusions Spinal manipulation/mobilization is effective in adults for : acute , subacute , and chronic low back pain ; migraine and cervicogenic headache ; cervicogenic dizziness ;  manipulation/mobilization is effective for several extremity joint conditions ; and thoracic manipulation/mobilization is effective for acute/subacute neck pain . The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration , and for manipulation/mobilization for mid back pain , sciatica , tension-type headache , coccydynia , temporom and ibular joint disorders , fibromyalgia , premenstrual syndrome , and pneumonia in older adults . Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation , or for Stage 1 hypertension when added to an antihypertensive diet . In children , the evidence is inconclusive regarding the effectiveness for otitis media and enuresis , and it is not effective for infantile colic and asthma when compared to sham manipulation . Massage is effective in adults for  chronic low back pain and chronic neck pain . The evidence is inconclusive for knee osteoarthritis , fibromyalgia , myofascial pain syndrome , migraine headache , and premenstrual syndrome . In children , the evidence is inconclusive for asthma and infantile colic Background The aim of this study was to assess the psychometric properties , namely acceptability , validity , reliability , interpretability and responsiveness of the EuroQol EQ-5D ( EQ-5D visual analogue ( VAS ) and EQ-5D ( utility ) ) , Short Form 12 Dimensions ( SF-12 ) , SF-6D and Michigan H and Outcome Question naire ( MHQ ) in patients with rheumatoid arthritis ( RA ) of the h and . Methods The empirical investigation was based upon data from a r and omised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the h and s and /or wrists . Participants completed the EQ-5D , SF-12 and MHQ at baseline and at 4 and 12 months follow up . Acceptability was measured using completion rates over time ; construct validity using the “ known groups ” approach , based on pain troublesomeness ; convergent validity using spearman ’s rho correlation ( ρ ) ; reliability using internal consistency ( Cronbach ’s alpha ) ; interpretability using minimal important differences ( MID ) ; and responsiveness using effect sizes and st and ardised response means ( SRM ) stratified by level of self-rated improvement in h and and wrist function or level of self-rated benefit and satisfaction from trial treatments . Results At baseline , the study population had a mean age of 62.4 years , a mean MHQ score of 52.1 and included 76 % women . The EQ-5D ( utility ) had the highest completion rates across time points . All instruments discriminated between pre-specified groups based on pain troublesomeness . Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D ( ρ = 0.65 ) and SF-6D ( ρ = 0.63 ) utility scores . The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months , whilst minimal important differences varied considerably across PROMs . Conclusions The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the h and . The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purpose A recent special issue of the Journal of Pediatric Psychology included papers focused on evidence -based assessment across several broad domains of assessment in pediatric psychology ( e.g. , adherence , pediatric pain , and quality of life ) . In one of these papers , Holmbeck et al. ( 2008 ) review ed strengths and limitations of existing measures of psychosocial adjustment and psychopathology , concluding that many measures lacked supporting psychometric data ( e.g. , basic indices of reliability and validity ) that would permit a complete evaluation of these measures . Given that measure development and validation papers are frequently published in JPP ( Brown , 2007 ) , it is important that we attend to guiding psychometric principles when developing and disseminating data on new measures to be employed with pediatric population s ( Nunnally & Bernstein , 1994 ) . Thus , the purpose of this paper is to present and describe a checklist for authors to use when su bmi tting measure development papers to JPP . This checklist is included in the Appendix and is also included at the following link on the JPP website : http://www.oxfordjournals.org/our_journals/jpepsy/for _ authors /measure%20development%20checklist.pdf Findings presented by Holmbeck et al. ( 2008 ) indicated that 34 of the 37 measures review ed met pre-established “ evidence -based assessment ” ( EBA ) criteria for “ well-established ” measures ( Cohen et al. , 2008 ) . To be considered “ well-established , ” a measure had to have been presented in at least two peer- review ed journal articles by different investigatory teams , have demonstrated adequate levels of reliability and validity , and be accompanied by supporting information ( e.g. , a measure manual ) . Although most measures that we review ed met these criteria , we also found that most of the 34 “ well-established ” measures were hampered by at least one major psychometric flaw and /or lacked important psychometric data . We concluded that a more fine-grained EBA classification system is needed . One important distinction in this literature relates to differences between empirically supported assessment and evidence -based assessment . This type of distinction was first discussed in the literature on clinical interventions ( e.g. , Spring , 2007 ) . An empirically supported intervention is one that has demonstrated efficacy in r and omized clinical trials or clinic-based effectiveness trials . An evidence -based intervention has empirical support in the manner just described , but also “ integrates research evidence , clinical expertise , and patient preferences and characteristics … empirically-supported treatments  ( ESTs )  are an important component of evidence -based practice ( EBP ) , but EBP can not be reduced to ESTs ” ( Spring , 2007 , p.611 ) . Applying these terms to the field of assessment and measure development efforts , an empirically supported assessment measure would be one that demonstrates satisfactory psychometric characteristics , broadly defined . To be evidence based , the measure should also demonstrate utility in clinical setting s , be useful in making diagnoses , be sensitive to treatment effects , and /or provide incremental validity above and beyond other similar measures . Although papers in the special issue of JPP frequently referred to “ evidence -based assessment ” ( Cohen et al. , 2009 ) , the articles included in the issue tended to evaluate the degree to which the measures were empirically-supported rather than evidence based . To be “ evidence -based , ” our review s would have needed to integrate an evaluation of clinical utility , diagnostic utility , and treatment sensitivity with the empirical psychometric data presented in each review . As noted , the published review s were more likely to focus on the latter rather than on the former . As suggested by Mash and Hunsley ( 2005 ) , detailed EBA profiles would provide a complete evaluation of evidence across each of several psychometric and clinical ly relevant dimensions , including : ( a ) internal consistency , ( b ) test – retest reliability , ( c ) the availability of normative data , ( d ) content validity , ( e ) construct validity , ( f ) convergent and discriminant validity , ( g ) criterion-related validity , ( h ) incremental validity , ( i ) clinical utility , ( j ) diagnostic utility , and ( k ) treatment sensitivity . The focus on incremental validity and clinical and diagnostic utility raises the bar from a focus on “ empirical support ” ( i.e. , where the focus would tend to be primarily on psychometric data ) to a broad focus on the “ evidence base ” for a measure . In developing the checklist that is the focus of this article , we attempted to provide a list of criteria relevant to establishing the evidence base ( and not just empirical support ) for a measure . In addition to shifting the focus from providing “ empirical support ” for a measure to providing an “ evidence base ” for our instruments , a checklist for measure development papers would permit JPP review ers to evaluate such papers in the same way that review ers of r and omized clinical trials make use of the Consoli date d St and ards of Reporting Trials ( CONSORT ) checklist and flowchart ( Altman et al. , 2001 ) . The CONSORT checklist contains reporting st and ards with respect to method ological features of and the manner in which results are reported in clinical trials . Moreover , authors are required to provide a flowchart that describes details of sample recruitment and attrition during the course of the study . Thus , a checklist for measure development papers would serve two interrelated purpose s : ( a ) it would provide guidance to authors as they embark on the measure development process and would provide a list of criteria authors can use as they develop an evidence base for their measures , and ( b ) it would begin to st and ardize the manner in which psychometric and other assessment -related data are presented in measure development papers for this journal . Before providing a more detailed overview of the checklist , it is important to note that this checklist is rather exhaustive ( see Appendix ) . As such , it represents what would “ ideally ” be expected for a measure development or validation manuscript rather than minimal criteria for such papers . No one paper can provide a complete evaluation of all important psychometric and clinical ly relevant dimensions that will establish once- and -for-all the evidence base for a measure . Instrument refinement is part of a measure development process that gradually builds an evidence base for a scale ( see Smith & McCarthy , 1995 , for suggestions on measure refinement ) . Indeed , the validation of any measure is a cumulative process that occurs across many different types of research studies and across research programs BACKGROUND The Cochrane Collaboration is strongly encouraging the use of a newly developed tool , the Cochrane Collaboration Risk of Bias Tool ( CCRBT ) , for all review groups . However , the psychometric properties of this tool to date have yet to be described . Thus , the objective of this study was to add information about psychometric properties of the CCRBT including inter-rater reliability and concurrent validity , in comparison with the Effective Public Health Practice Project Quality Assessment Tool ( EPHPP ) . METHODS Both tools were used to assess the method ological quality of 20 r and omized controlled trials included in our systematic review of the effectiveness of knowledge translation interventions  to improve the management of cancer pain . Each study assessment was completed independently by two review ers using each tool . We analysed the inter-rater reliability of each tool 's individual domains , as well as final grade assigned to each study . RESULTS The EPHPP had fair inter-rater agreement for individual domains and excellent agreement for the final grade . In contrast , the CCRBT had slight inter-rater agreement for individual domains and fair inter-rater agreement for final grade . Of interest , no agreement between the two tools was evident in their final grade assigned to each study . Although both tools were developed to assess ' quality of the evidence ' , they appear to measure different constructs . CONCLUSIONS Both tools performed quite differently when evaluating the risk of bias or method ological quality of studies in knowledge translation interventions for cancer pain . The newly introduced CCRBT assigned these studies a higher risk of bias . Its psychometric properties need to be more thoroughly vali date d , in a range of research fields , to underst and fully how to interpret results from its application Differences in disease prevalence , clinical manifestations , and health outcomes exist between men and women . Sources for this variation range from biological differentiation at the cellular level to behavioral differences influenced by societal gender norms . Typically , biologically based differences between men and women are called sex differences , whereas gender differences describe health differences related , at least in part , to societal constructs of gender ( 13 ) . For example , biological events unique to women , such as pregnancy and menopause , are probably associated with sex differences in occurrence of certain conditions or in response to some medical therapies ( 48 ) . Gender differences probably exist in health-related perceptions and behaviors for women and men with medical conditions that are prevalent for both sexes ( for example , heart disease and chronic pain ) ( 9 –16 ) . Although sex and gender differences are theoretically distinct , they remain difficult to disentangle when differences between men and women in health outcomes and treatment effectiveness are being examined . For this reason , and for brevity , we hereafter refer to sex and gender differences collectively as sex effects . In the past 2 decades , recognition of the importance of sex effects for health outcomes and treatment heterogeneity has been growing . Beginning in 1993 , the National Institutes of Health has issued policies requiring the inclusion of women and minorities in all clinical research and trial design s with valid analysis of sex effects or differences between racial and ethnic groups ( 17 , 18 ) . Since then , the inclusion of women in clinical trials has increased ( 19 , 20 ) , and sex effects have been identified for medications , such as nicotine replacement therapy , analgesics , and aspirin ( 13 , 14 , 21 ) . Recently , sex effects in adverse reactions led to sex-specific dosage recommendations for a widely used sedative ( 7 ) . Despite this progress , representation of women in clinical studies remains inadequate for many conditions ( 22 ) . Further , published clinical trials infrequently report sex effects or discuss the appropriateness of sex-specific analyses ( 19 , 20 , 23 ) . To advance the clinical evidence base and improve health outcomes for women , clinical research must include adequate numbers of women , appropriately conduct sex-specific analyses , and consistently report sex effects . Systematic review s ( SRs ) are a key source of information for clinicians , research ers , and guideline panels . By synthesizing the overall body of evidence for key clinical and research questions , SRs could potentially make a unique contribution to the evaluation of sex effects . To our knowledge , however , the reporting of sex effects by SRs has not been previously examined . Here , we use evidence mapping to systematic ally evaluate the reporting of sex effects by SRs examining a diverse set of interventions for chronic conditions common to women ( that is , depression , diabetes , and chronic pain ) . Evidence mapping is an emerging approach that describes key characteristics of studies for a broad area of medicine ( 2426 ) . Our evidence map addresses the volume and characteristics of eligible SRs , including the representation of women in primary studies , whether and how review s reported sex effects , and findings about sex effects . Methods This work was part of a larger report for the Veterans Health Administration ( VHA ) Evidence -based Synthesis Program ( ESP ) . The complete technical report is available online ( www.hsrd . research .va.gov/publications/esp ) and includes additional information on our methods . We focused on SRs to determine the reporting of sex effects , provide high-level information about the volume of current clinical evidence , and summarize information about actual sex effects . Prioritization of Conditions for Inclusion We used forced-ranking prioritization ( 27 ) with our VHA stakeholders to determine our conditions of interest . These stakeholders included representatives from the Health Services Research & Development Center for the Study of Healthcare Innovation , Implementation and Policy ; Health Services Research & Development Women 's Health Research Network ; Women 's Health Research in the Office of Research & Development ; Women 's Health Services ; and Mental Health Services . We initially selected 34 conditions ( Appendix Table 1 ) based on disease prevalence in women , disease burden in women , availability and breadth of effective treatments for men or women , and women veterans ' priorities for gender-specific care . Stakeholders ranked this initial set of conditions , discussed the rankings , and reranked conditions that initially received intermediate priority rankings . After 2 rounds of iterative prioritization , the following conditions were selected : depressive disorders , type 2 diabetes mellitus , and chronic pain ( that is , chronic low back pain , fibromyalgia , and chronic knee pain due to osteoarthritis ) . Appendix Table 1 . Conditions Presented to Stakeholders for Prioritization * Data Sources and Search es In collaboration with an expert reference librarian , we search ed PubMed and Cochrane Data base of Systematic Review s to identify eligible SRs published after 1 October 2009 through 31 October 2014 for depression , 13 February 2015 for diabetes , and 27 February 2015 for chronic pain . Search strategies used Medical Subject Headings and free-text terms for the conditions of interest , eligible interventions , and SRs ( Appendix Table 2 ) . We restricted the search to the past 6 years because SRs are typically out date d within 5 years of publication ( 28 ) , and our goal was to describe the current state of the clinical literature . In addition to electronic search ing , we screened published review s of review s for eligible articles . Appendix Table 2 . Search Strategies Study Selection and Quality Assessment Eligible SRs evaluated interventions in several broad categories ( that is , medications , behavioral interventions , supervised exercise , and quality improvement or organizational interventions ) . We also included condition-specific interventions , such as bariatric surgery for diabetes . Review s that evaluated mixed conditions or multiple interventions must have reported results separately for at least 1 eligible condition or intervention . We included review s of interventions in any setting , with any type of active or inactive comparator , and with any duration of follow-up . Detailed inclusion and exclusion criteria are provided in Appendix Table 3 . Appendix Table 3 . Detailed Inclusion and Exclusion Criteria for Review Eligibility Two investigators screened citations for eligibility , and citations that were considered to be relevant by either person were retained for full-text review . Full-text articles were review ed by 2 investigators , and disagreements were resolved through discussion or adjudicated by a third person . Formal assessment of review quality was beyond the scope of this project . However , we noted whether review s originated from organizations known for high- quality review s ( that is , Cochrane Collaboration , Agency for Healthcare Research and Quality Evidence -based Practice Centers , and VHA ESP ) . For review s reporting sex effects , we also assessed industry funding and whether statistical power was considered . Data Abstract ion Data were abstract ed by 1 investigator and review ed by a second person . Disagreements were resolved by discussion or by a third review er . Abstract ed data included the analysis method ( that is , qualitative synthesis , meta- analysis , network meta- analysis , or individual-patient data [ IPD ] meta- analysis ) ; clinical conditions ; interventions ; main outcomes ; number and design of primary studies ( for example , r and omized , controlled trials [ RCTs ] or observational cohorts ) ; proportion of women in the included primary studies ; and if sex effects were part of the study aims , analysis plan , or results . For review s reporting sex effects , we also recorded the number of primary studies used for sex-specific analyses , effect estimates , and the method used ( for example , metaregression , subgroup analysis , or IPD meta- analysis ) . All eligible review s on depressive disorders and chronic pain conditions were fully abstract ed . All diabetes review s of nonpharmacologic interventions were also fully abstract ed . For eligible diabetes medication review s ( n= 120 ) , we applied an additional prioritization procedure before full abstract ion . We prioritized review s that examined multiple classes of medications or evaluated a single class of medications when 6 or fewer eligible review s were identified . For SRs evaluating a single class ( > 6 eligible review s were identified ) , we used additional prioritization criteria ( for example , the most recent review published in a high-impact journal or work done by an organization known for high- quality review s ) . The remaining unselected but eligible review s ( n= 58 ) had a keyword text search for sex effects and were fully abstract ed only when this search yielded positive results ( n= 13 ) . Data Synthesis and Analysis of SRs We grouped eligible review s by intervention category and described the overall volume of clinical literature for interventions addressing each condition of interest . We also determined the number of review s reporting sex effects and summarized these results . Time trends for the proportion of these review s were examined for depression and diabetes . Examination of Primary RCTs for Selected Interventions We anticipated that some interventions for each condition would have few or no eligible SRs that addressed sex effects . Thus , for a subset of interventions for each condition , we evaluated primary RCTs to determine the feasibility of conducting a future review to evaluate sex effects . Specifically , we examined  quality improvement interventions and psychotherapy for depression ; diet , physical activity , and culturally tailored psychoeducation for diabetes ; behavioral interventions for chronic low back pain ; and exercise interventions Long-term  sickness absence and incapacity benefits ( disability pension ) rates have increased across industrialised countries . Effective measures are needed to support return to work . The recommendations of this guidance were informed by the most appropriate available evidence of effectiveness and cost-effectiveness . Public health evidence was provided by research using a variety of study design s that attempted to determine the outcome of a particular intervention by evaluating status before and after the intervention had been effected , and was not limited to r and omised control trials . Where the evidence base was depleted or underdeveloped , expert witnesses were called to give their opinion on the best available evidence and emerging interventions . The process enabled challenge and contestability from stakeholder groups at different points as the guidance was developed . Forty-five heterogeneous studies were included in the review of interventions to reduce long-term sickness absence and transitions from short-term to long-term absence ( mainly covering the former and also mainly examining musculoskeletal conditions ) . The analysis of evidence was restricted to descriptive synthesis . Three general themes emerged from an analysis of the studies that were more likely to report positive results : early interventions ; multidisciplinary approaches ; and interventions with a workplace component . Two further review s were undertaken , one on interventions to reduce the re-occurrence of sickness absence , which identified seven studies on lower back pain , and concluded that early intervention and direct workplace input are important factors . The final evidence review focused on six studies of interventions for those in receipt of incapacity benefit . The evidence was that work-focused interviews coupled with access to tailored support are effective and cost-effective interventions . Practitioners should consider the impact of interventions and management options on work ability for patients of working age . Work ability should be considered a key outcome for future intervention studies OBJECTIVE We assessed primary care clinician-provided guideline -concordant care as documented in patients ' medical records , predictors of documented guideline -concordant care , and its association with pain-related functioning . Patients were participants in a r and omized trial of collaborative care for chronic musculoskeletal pain . The intervention featured patient and primary care clinician education , symptom monitoring and feedback to clinicians by the intervention team . METHODS To assess concordance with the evidence -based treatment guidelines upon which our intervention was based , we developed an 8-item chart review tool , the  Pain Process Checklist ( PPC ) . We then review ed electronic medical records for 365 veteran patients treated by 42 primary care clinicians over 12 months . Intervention status , demographic , and clinical variables were tested as predictors of PPC scores using generalized estimating equations ( GEE ) . GEE was also used to test whether PPC scores predicted treatment response ( ≥30 % decrease in Rol and -Morris Disability Question naire score ) . RESULTS Rates of documented guideline -concordant care varied widely among PPC items , from 94 % of patients having pain addressed to 17 % of patients on opioids having side effects addressed . Intervention status was unrelated to item scores , and PPC-7 totals did not differ significantly between intervention and treatment-as-usual patients ( 61.2 % , st and ard error [ SE ] = 3.3 % vs 55.2 % , SE = 2.6 % , P = 0.15 ) . In a multivariate model , higher PPC-7 scores were associated with receiving a prescription for opioids ( odds ratio [ OR ] = 1.07 , P = 0.007 ) and lower PPC-7 scores with patient age ( 10-year difference OR = 0.97 , P = 0.004 ) . Finally , intervention patients who received quantitative pain and depression assessment s were less likely to respond to treatment ( assessed vs not : 18 % vs 33 % , P = 0.008 , and 13 % vs 28 % , P = 0.001 , respectively ) . CONCLUSIONS As measured by medical record review , additional training and clinician feedback did not increase provision of documented guideline -concordant pain care , and adherence to guidelines by primary care clinicians did not improve clinical outcomes for patients with chronic musculoskeletal pain PURPOSE OF THE STUDY The prevalence of vitamin D deficiency in pediatric population s is high . In the present study we analyzed associations between vitamin D therapy and pain , mobility , fatigue , and daily functioning in children with musculoskeletal/orthopedic conditions suffering from chronic and recurrent pain , but also diagnosed with vitamin D deficiency . MATERIAL AND METHODS Children with different musculoskeletal/orthopedic conditions and vitamin D deficiency were prescribed to receive vitamin D over 6 months . Thirty-five children ( 18 males ; age 10.48 ± 3.87 years ) completed a 6-month follow-up . Self- and parent/proxy rating scales were used to evaluate pain , movement , fatigue , and daily functioning . RESULTS At a six-month follow-up assessment involving child- and parent-reported scores , worst pain intensity significantly decreased ( p ≤ 0.03 ) after vitamin D therapy , as well as functioning problems related to pain ( p ≤ 0.01 ) . The children reported better movement and balance with less fatigue . The parents reported better functioning in everyday activities of their children . CONCLUSION This pilot study showed that vitamin D therapy possibly reduces pain intensity and improves mobility and daily functioning in children with musculoskeletal/orthopedic disorders , chronic recurrent pain , and vitamin D deficiency . Further follow-up and r and omized studies are required in order to assess the validity of clinical recommendations Background : Patient-reported outcome measures are increasingly used evaluating clinical care . Many measures used to assess operative hindfoot interventions vary in content , and some have not been psychometrically vali date d in this population . The purpose of this study was to compare measurement properties of  6 lower-extremity patient-reported outcome measures  , and to evaluate their reliability and validity in light of patients ’ preferences . Methods : Cross-sectional survey of 42 preoperative and 100 postoperative patients completed 6 lower-extremity outcome measures  on 2 occasions : Foot Function Index ( FFI ) , Ankle Osteoarthritis Scale ( AOS ) , patient-reported items of the  American  Orthopaedic Foot & Ankle Society Question naire ( AOFAS ) , Lower Extremity Functional Scale ( LEFS ) , Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , and the Short Musculoskeletal Function Assessment ( SMFA ) , as well as measures of preference , and symptoms . Results : Internal consistency was good to excellent for all scales and subscales ( α = .84-.97 ; ICC [ 2,1 ] = .81-.96 ) . Correlations between scales ranged from .50 ( WOMACStiffness and FFIActivity Limitations ) to .92 ( LEFS and SMFAOverall , WOMACPain and AOSOverall , FFIOverall and AOFASOverall ) . Higher correlations occurred within instruments ( r = .97 AOSPain and AOSOverall ) and between similar subscales from different instruments ( r = .91 WOMACPain and AOSPain ) . Construct validity showed moderate to high correlations to global ratings of Pain , Stiffness , and difficulty performing Daily Activities . The highest correlations ( r > .75 ) occurred between Pain and AOSOverall ( r = .84 ) , stiffness and WOMACStiffness ( r = .81 ) , and Daily Activities and AOSDisability ( r = .87 ) . Patients rated instruments by preference . FFI , WOMAC , LEFS , and SMFA rated favorably for length . FFI , WOMAC , LEFS , and AOFAS rated high for underst and ability . FFI was rated by postoperative patients as most likely to capture change due to surgery . SMFA rated the best overall . Conclusions : Direct comparison of instruments revealed similarity between scales in construct validity and reliability . Patient preferences supported the use of these scales . Foot-specific instruments offered no clear advantage over lower-extremity instruments . Level of Evidence : Level II , prospect i ve comparative study OBJECTIVE To determine whether the Feldenkrais method is an effective intervention for chronic neck/scapular pain in patients with visual impairment . DESIGN R and omized controlled trial with an untreated control group . SETTING Low vision center . PARTICIPANTS Patients ( N=61 ) with visual impairment ( mean , 53.3 y ) and nonspecific chronic ( mean , 23.8 y ) neck/scapular pain . INTERVENTIONS Participants were r and omly assigned to the Feldenkrais method group ( n=30 ) or untreated control group ( n=31 ) . Patients in the treatment group underwent one 2-hour Feldenkrais method session per week for 12 consecutive weeks . MAIN OUTCOME MEASURES Blind assessment of perceived pain ( visual analog scale [ VAS ] ) during physical therapist palpation of the left and right occipital , upper trapezius , and levator scapulae muscle areas ; self-assessed degree of pain on the Visual , Musculoskeletal , and Balance Complaints question naire ; and the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain scale . RESULTS Patients undergoing Feldenkrais method reported significantly less pain than the controls according to the VAS and Visual , Musculoskeletal , and Balance Complaints question naire ratings at posttreatment follow-up and 1-year follow-up . There were no significant differences regarding the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain scale ratings . CONCLUSIONS Feldenkrais method is an effective intervention for chronic neck/scapular pain in patients with visual impairment BACKGROUND Identifying mobility disability risk factors may facilitate development of interventions promoting functional independence in older persons . We tested the hypothesis that musculoskeletal pain is associated with first occurrence of severe mobility disability . METHODS In a prospect i ve observational study at 40 community-based sites , 759 older Catholic clergy in the Rush Religious Orders Study without baseline dementia , stroke , Parkinson 's disease , or severe performance-based mobility disability ( defined as gait speed less than or equal to 0.4 m/s ) and at least one follow-up mobility evaluation were evaluated over a mean of 8.5 ( SD = 3.8 ) years . All participants were queried about musculoskeletal pain in the year before baseline and underwent annual assessment of mobility . RESULTS Using a proportional hazards model adjusted for age , sex , and education , the hazard for incident severe mobility disability was greater for participants reporting pain in the year before baseline ( odds ratio = 1.47 , 95 % confidence interval = 1.17 - 1.85 ) . Results were unchanged after adjusting for self-reported mobility disability , gait speed , depressive symptoms , body mass index , physical activity , chronic medical conditions , and analgesic use . Compared with no report of musculoskeletal pain , musculoskeletal pain in one or two areas was associated with a 30 % greater hazard for incident disability ( odds ratio = 1.31 , 95 % confidence interval = 1.00 - 1.70 ) . Musculoskeletal pain in three or more areas was associated with an 80 % greater hazard for incident disability ( odds ratio = 1.80 , 95 % confidence interval = 1.31 - 2.47 ) . In participants without baseline self-reported mobility disability ( n = 486 ) , musculoskeletal pain was associated with greater hazard for incident self-reported mobility disability ( odds ratio = 1.38 , 95 % confidence interval = 1.11 - 1.73 ) . CONCLUSION In older persons , musculoskeletal pain is associated with incident mobility disability
Our primary outcome was the measure ’s minimal important difference ( MID ) .
Conclusions In this focused evidence review , the most evidence on key psychometric properties in chronic musculoskeletal pain population s was found for the ODI , RMDQ , SF-36 BPS , NRS , and VAS .
Background Developing successful interventions for chronic musculoskeletal pain requires valid , responsive , and reliable outcome measures .
The Minneapolis VA Evidence -based Synthesis Program completed a focused evidence review on key psychometric properties of 17 self-report measures of pain severity and pain-related functional impairment suitable for clinical research on chronic musculoskeletal pain .