Postsurgical pain outcome assessment Patient utilities in chronic musculoskeletal pain: how useful is the standard gamble method? The Bournemouth Questionnaire: a short-form comprehensive outcome measure. II. Psychometric properties in neck pain patients. Outcome measures in chronic low back pain Assessment of pain quality in chronic neuropathic and nociceptive pain clinical trials with the Neuropathic Pain Scale. The CONECSI trial: Results of a randomized controlled trial of a multidisciplinary cognitive behavioral program for coping with chronic neuropathic pain after spinal cord injury Accurately measuring the quality and effectiveness of cervical spine surgery in registry efforts: determining the most valid and responsive instruments. Idiographic outcome analyses of the clinical significance of two interventions for patients with musculoskeletal pain. Using the "TOPS," an outcomes instrument for multidisciplinary outpatient pain treatment. Psychometric properties of a generic health measure in patients with neck pain The Validity of the Neuropathic Pain Scale for Assessing Diabetic Neuropathic Pain in a Clinical Trial The prevalence and impact of chronic pain with neuropathic pain symptoms in the general population. The use of a responder analysis to identify differences in patient outcomes following a self-care intervention to improve cancer pain management Comparing the psychometric properties of the Checklist of Nonverbal Pain Behaviors (CNPI) and the Pain Assessment in Advanced Dementia (PAIN-AD) instruments. Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study What is an acceptable outcome of treatment before it begins? Methodological considerations and implications for patients with chronic low back pain Comparative reliability and validity of chronic pain intensity measures
& NA ; Reliable and valid measures of pain are essential for conducting clinical trials of pain treatments . Perhaps the most important aspect of a pain measure 's validity is its sensitivity , or ability to detect changes in pain over time and due to treatment . Several factors may affect a measure 's sensitivity , including the complexity of the rating task for the measure , the number of pain intensity levels assessed by the measure , the dimension of pain assessed ( e.g. pain intensity vs. pain relief ) , and the number of individual ratings ( e.g. single rating vs. composite score ) used to create the measure . The purpose of this study was to compare the relative sensitivity of three measures of outcome and a composite made up of all three measures for detecting analgesic effects in two sample s of persons participating in a r and omized controlled trial . One hundred and twenty‐three patients who had undergone knee surgery and 124 women who had undergone a laparotomy were given one of three medications in the day after their surgery : morphine , ketorolac , or placebo . Two measures of pain intensity ( a visual analog scale ( VAS ) and a 4‐point verbal rating scale ( VRS ) ) were administered at baseline , and these measures plus a 5‐point VRS of pain relief were administered at 16 additional time points up to 24 h following surgery . As predicted , we found variability in the sensitivity of the outcome measures used in these studies , with the 4‐point VRS showing less sensitivity than the VAS or relief ratings . However , contrary to our prediction , a composite measure of outcome made up of all three measures was not consistently superior to the individual measures for detecting treatment effects . Finally , we found that pain relief ratings were related to , but also distinct from , change in pain intensity as measured by changes in pain intensity ratings from baseline to each postmedication assessment point . These findings have important implication s for the assessment of pain in clinical trials The main goal of current pain management approaches is to increase the patients ' quality of life by improving pain coping skills and by reducing the levels of disability in daily life , often despite persistent pain . Direct measurement of quality of life is of crucial importance in economic evaluation research , in which not only is the estimation of financial costs and benefits included , but so is the evaluation of costs and benefits in terms of changes in health states . The purpose of this study is to compare the psychometric qualities of two instruments for assessing patients ' utilities , the  rating scale ( RS )  and the st and ard gamble ( SG ) . Such instruments are design ed for their application in economic evaluation research , but have seldomly been used in chronic pain trials . Both methods provide a single measure between 0 and 1 . The relationship between these utility measures and descriptive and domain-specific quality of life measures was examined in 133 fibromyalgia patients and 148 patients with chronic non-specific low back pain .  Mean utility score at baseline was 0.43 with the RS and 0.78 for the SG . The correlation between both methods was found to be poor ( r = 0.21 ) . Both measures appeared to be fairly stable in a 2-week test-retest period ( intra class correlation coefficient ( ICC ) = 0.74 and 0.77 ) . Scores on the description of patient 's own health on six domains , global assessment of change and domain specific measures correlated moderately with the RS scores and low with the SG . Multiple regression analyses demonstrated that 32 % of the variance in RS values and only 13 % of the variance in SG utilities could be explained by domain-specific measures . These results suggest an acceptable construct validity for the RS but insufficient construct validity for the SG . Valuations of ones own health appear only partially to be related to the assessment of the pain-specific measures and measures of distress . It can be concluded that the RS and domain-specific measures assess partly different , but nevertheless complementary aspects of health-related quality of life . It is therefore recommended to include in economic evaluation studies both domain-specific measures and valuation measures . Finally , in chronic musculoskeletal pain patients , RS scores were found to be more responsive in detecting significant changes in preferences than SG scores . For use in patients with chronic musculoskeletal pain , the RS is preferred to the SG for establishing accurate decisions about the impact of new interventions on their health outcomes OBJECTIVE To modify an existing outcome measure ( Bournemouth Question naire [ BQ ] ) for use in patients with nonspecific neck pain and test its psychometric properties . DESIGN Prospect i ve longitudinal study in which the question naire was administered on 3 occasions ( pretreatment , retest , and posttreatment ) . SETTING Anglo-European College of Chiropractic outpatient clinic and 8 field chiropractic practice s. METHOD Seven core items relating to the biopsychosocial model of pain were included in the original question naire ( back BQ ) . The wording of one of these items ( disability in activities of daily living ) was modified to include activities likely to be affected by neck pain . Testing of the neck BQ was carried out in 102 patients with nonspecific neck pain . RESULTS The instrument demonstrated high internal consistency on 3 administrations ( Cronbach 's alpha = 0.87 , 0.91 , 0.92 ) . All 7 items were retained on the basis that they each significantly contributed to the total score ( item-corrected total score correlations > 0.43 ) and to the instrument 's responsiveness to clinical change ( item change-corrected total change score correlations > 0.42 ) . The instrument was reliable in test-retest administrations in stable subjects ( ICC = 0.65 ) . The instrument demonstrated acceptable construct validity and longitudinal construct validity with established external measures . The treatment effect size of the instrument was found to be high ( 1.67 ) . CONCLUSION The neck BQ covers the salient dimensions of the biopsychosocial model of pain , is quick and easy to complete , and has been shown to be reliable , valid , and responsive to clinical ly significant change in patients with nonspecific neck pain . Its use as an outcome measure in clinical trials and outcomes research is recommended The purpose of this prospect i ve , single site cohort quasi-experimental study was to determine the responsiveness of the numerical rating scale ( NRS ) , Rol and –Morris disability question naire ( RMDQ ) , Oswestry disability index ( ODI ) , pain self-efficacy question naire ( PSEQ ) and the patient-specific functional scale ( PSFS ) in order to determine which would best measure clinical ly meaningful change in a chronic low back pain ( LBP ) population . Several patient-based outcome instruments are currently used to measure treatment effect in the chronic LBP population . However , there is a lack of consensus on what constitutes a “ successful ” outcome , how an important improvement/deterioration has been defined and which outcome measure(s ) best captures the effectiveness of therapeutic interventions for the chronic LBP population . Sixty-three consecutive patients with chronic LBP referred to a back exercise and education class participated in this study ; 48 of the 63 patients had complete data . Five question naires were administered initially and after the 5-week back class intervention . Also at 5 weeks , patients completed a global impression of change as a reflection of meaningful change in patient status . Score changes in the five different question naires were subjected to both distribution- and anchor-based methods : st and ard error of measurement ( SEM ) and receiver operating characteristic ( ROC ) curves to define clinical improvement . From these methods , the minimal clinical ly important difference ( MCID ) defined as the smallest difference that patients and clinicians perceive to be worthwhile is presented for each instrument . Based on the SEM , a point score change of 2.4 in the NRS , 5 in the RMDQ , 17 in the ODI , 11 on the PSEQ , and 1.4 on the PSFS corresponded to the MCID . Based on ROC curve analysis , a point score change of 4 points for both the NRS and RMDQ , 8 points for the ODI , 9 points for the PSEQ and 2 points for the PSFS corresponded to the MCID . The ROC analysis demonstrated that both the PSEQ and PSFS are responsive to clinical ly important change over time . The NRS was found to be least responsive . The exact value of the MCID is not a fixed value and is dependent on the assessment method used to calculate the score change . Based on ROC curve analysis the PSFS and PSEQ were more responsive than the other scales in measuring change in patients with chronic LBP following participation in a back class programme . However , due to the small sample size , the lack of observed worsening of symptoms over time , the single centre and intervention studied these results which need to be interpreted with caution UNLABELLED Although a number of measures of pain qualities exist , little research has examined the potential for these measures to identify the unique effects of pain treatments on different pain qualities . We examined the utility of the Neuropathic Pain Scale ( NPS ) for assessing changes in pain qualities after open label lidocaine patch 5 % in 3 sample s of patients : patients with peripheral neuropathic pain , low back pain , and osteoarthritis . With one exception ( " cold " pain in subjects with low back pain ) , each of the NPS items showed significant change after open label lidocaine patch . In addition , significantly larger changes were observed for the NPS items reflecting global pain intensity and pain unpleasantness and for items assessing sharp and deep pain than for items assessing cold , sensitive , and itchy pain . The pattern of changes in pain qualities did not differ across the 3 diagnostic groups , but it did differ from the patterns of changes in pain qualities associated with other analgesic treatments . The results support the potential utility of the NPS for assessing the patterns of changes in pain qualities that can be observed after pain treatment . PERSPECTIVE Pain clinical trials that include measures of pain qualities , such as the NPS , might identify distinct patterns of treatment effects on those pain qualities . This research might be used to help clinicians target analgesics to match the specific qualities associated with a patient 's pain and to better underst and the mechanisms of analgesic effects in drug development programs Summary A multidisciplinary cognitive behavioral program might have beneficial effects on people with chronic neuropathic spinal cord injury pain . ABSTRACT Many people with spinal cord injury ( SCI ) rate chronic neuropathic pain as one of the most difficult problems to manage . The aim of the CONECSI ( COping with NEuropathiC Spinal cord Injury pain ) trial was to evaluate a multidisciplinary cognitive behavioral treatment program for persons with chronic neuropathic pain after SCI . The intervention consisted of educational , cognitive , and behavioral elements .  A total of 61 people were r and omized to either the intervention group or the waiting list control group in 4 Dutch rehabilitation centers . Primary outcomes were pain intensity and pain‐related disability ( Chronic Pain Grade question naire ) , and secondary outcomes were mood ( Hospital Anxiety and Depression Scale ) , participation in activities ( Utrecht Activities List ) , and life satisfaction ( Life Satisfaction Question naire ) . Measurements were performed at baseline , and at 3 , and 6 months follow‐up . The primary statistical technique was r and om coefficient analysis . The analyses showed significant changes over time on both primary ( t1–t2 ) , and 2 out of 4 secondary outcomes ( both t1–t2 and t1–t3 ) . Significant intervention effects ( Time * Group interactions ) were found for anxiety and participation in activities , but not for the primary outcomes . Subsequent paired t tests showed significant changes in the intervention group that were not seen in the control group : decrease of pain intensity , pain‐related disability , anxiety , and increase of participation in activities . This study implies that a multidisciplinary cognitive behavioral program might have beneficial effects on people with chronic neuropathic SCI pain BACKGROUND CONTEXT There is a growing dem and to measure the real-world effectiveness and value of care across all specialties and disease states . Prospect i ve registries have emerged as a feasible way to capture real-world care across large patient population s. However , the proven validity of more robust and cumbersome patient-reported outcome instruments ( PROi ) must be balanced with what is feasible to apply in large-scale registry efforts . Hence , commercial registry efforts that measure quality and effectiveness of care in an attempt to guide quality improvement , pay for performance , or value-based purchasing should incorporate measures that most accurately represent patient-centered improvement . PURPOSE We set out to establish the relative validity and responsiveness of common PROi in accurately determining effectiveness of cervical surgery for neck and arm pain in registry efforts . STUDY DESIGN Prospect i ve cohort study . PATIENT SAMPLE Eighty-eight patients undergoing primary anterior cervical discectomy and fusion ( ACDF ) for neck and arm pain . OUTCOME MEASURES Patient-reported outcome measures for pain ( numeric rating scale for neck pain [ NRS-NP ] and arm pain [ NRS-AP ] ) , disability ( neck disability index [ NDI ] ) , general health ( short-form 12-item survey physical component summary [ SF-12 PCS ] and mental component summary [ SF-12 MCS ] ) , and quality of life ( Euro-Qol-5D [ EQ-5D ] ) were assessed . METHODS Eighty-eight patients undergoing primary ACDF for neck and arm pain were entered into a Web-based prospect i ve registry . Baseline and 12-month patient-reported outcomes ( NRS-NP , NRS-AP , NDI , SF-12 PCS , SF-12 MCS , and EQ-5D ) were assessed . Patients were also asked whether they experienced a level of improvement after ACDF that met their expectation ( meaningful improvement ) . To assess the validity of NRS-NP , NRS-AP , and NDI ( measures of pain and disability ) to discriminate between meaningful and nonmeaningful improvement and the validity of SF-12 PCS , SF-12 MCS , and EQ-5D ( measures of general health and quality of life ) to discriminate between meaningful and nonmeaningful improvement , receiver-operating characteristic curves were generated for each outcome instrument . The greater the area under the curve ( AUC ) , the more valid the discriminator . The difference between st and ardized response means ( SRMs ) in patients reporting meaningful improvement versus not was calculated to determine the relative responsiveness of each outcome instrument to changes in  pain and QOL after surgery . RESULTS For pain and disability , both NDI ( AUC=0.75 ) and NRS-AP ( AUC=0.74 ) were valid discriminators of meaningful improvement . Numeric rating scale for neck pain ( AUC=0.69 ) was a poor discriminator . Neck disability index was also most responsive to postoperative improvement ( SRM difference 0.78 ) , followed by NRS-AP ( SRM difference 0.59 ) and NRS-NP ( SRM difference 0.46 ) . For general health and quality of life , SF-12 PCS ( AUC=0.79 ) was the only valid discriminator of meaningful improvement . Euro-Qol-5D ( AUC=0.68 ) and SF-12 MCS ( AUC=0.44 ) were poor discriminators . Short-form 12 physical component summary ( SRM difference 1.08 ) was also most responsive compared with EQ-5D ( SRM difference 0.89 ) and SF-12 MCS ( SRM difference 0.01 ) . CONCLUSIONS For pain and disability , NDI is the most valid and responsive measure of improvement after surgery for neck and arm pain . Numeric rating scale for neck pain and NRS-AP are poor substitutes for NDI when measuring effectiveness of care in registry efforts . For health-related quality of life , only SF-12 PCS could accurately discriminate meaningful improvement after cervical surgery and was found to be most valid and responsive . Large-scale registry efforts aim ed at measuring effectiveness of cervical spine surgery should use NDI and SF-12 to accurately assess improvements in pain , disability , and quality of life UNLABELLED This study adopted a perspective of the individual to define domains of everyday life for the analysis of clinical ly meaningful change . The purpose was to compare the clinical significance of two interventions for patients with musculoskeletal pain , applying an idiographic outcome measure , The Patient Goal Priority Question naire , in combination with the Jacobson and Truax methodology [ ( 1991 ) . CLINICAL SIGNIFICANCE A statistical approach to defining meaningful change in psychotherapy research . Journal of Consulting and Clinical Psychology , 67 ( 3 ) , 300 - 307 ] for determination of clinical significance . The concurrent validity of the outcome variables behavioral performance , satisfaction with behavioral performance , and fulfilled pre-treatment expectations was also studied . Eighty-two patients , r and omized to either individually tailored behavioral medicine treatment ( experimental group ) or physical exercise therapy ( control group )  were evaluated at baseline and 3 months post-treatment regarding behavioral treatment goals . The experimental intervention had high impact on participants ' performance of their highest ranked everyday life activities , and result ed in larger proportions of clinical ly significant outcomes compared with controls . The concurrent validity of the outcomes was high for those reporting clinical ly significant changes , but more generally , there was a moderate agreement across outcome categories . The individual should be the unit for analyses of clinical significance to enhance the ecological validity of the construct . Further development of idiographic outcome measures is necessary , as is the inclusion in pain intervention research OBJECTIVE To assess the reliability of an augmented SF-36 instrument , the Treatment Outcomes in Pain Survey  ( "  TOPS  " ) , in patients treated in two pain management programs , and present norms for initial values and treatment-related improvements . DESIGN Prospect i ve case series at two sites with longitudinal follow-up . SETTING Multidisciplinary , comprehensive outpatient pain treatment centers in university hospitals in Salt Lake City and Boston . PATIENTS Nine hundred and forty seven adult out patients with a range of socioeconomic , demographic , and ethnic characteristics , all referred for evaluation and treatment of chronic pain . INTERVENTIONS Usual practice multidisciplinary pain treatment . OUTCOMES MEASURES TOPS prior to pain treatment and 5-week nominal follow-up . Means and st and ard deviations of baseline and follow-up results . Psychometric results for reliability ( Cronbach alpha ) , validity ( item discriminant validity , validity coefficients ) , and related statistical precision measures for group and individual design s. RESULTS Several measures were precise enough to permit following individual patients in st and ard clinic treatment , of which the Total Pain Experience dimension was the most powerful . Similar psychometrics were observed in the Boston and Salt Lake City sites . The Pain Symptom , Objective Family/Social Disability , Objective Work Disability , and Upper Body Functional Limitations scales were vali date d. DISCUSSION The TOPS was design ed to satisfy several models of clinical pain treatment . It successfully monitored treatment based on those models . Not all patients improve with treatment , but most do . The TOPS can be administered in a variety of ways , but we found paper and pencil administration with computer scanning of results quick and efficient for making the data available to clinicians as part of treatment . CONCLUSIONS The accuracy of the TOPS is sufficient to monitor the response of individual patients during multidisciplinary treatment of chronic pain . The TOPS provides needed documentation ( e.g. , to third-party payors ) of the aggregate value of multidisciplinary outpatient treatment of chronic pain as well as its benefit for individual patients Objective : To examine the reliability , validity and responsiveness of the generic Current Perceived Health 42 ( CPH42 ) Profile in Chinese patients with neck pain in Hong Kong . Design : A prospect i ve observational study . Setting : Physiotherapy outpatient departments . Subjects : Two sample s with 472 consecutive adult patients with neck pain from seven physiotherapy outpatient departments in Hong Kong . Methods : Subjects were requested to complete the CPH42 Profile , and their pain intensity was measured using the 11-point numerical rating scale ( NRS ) . They were observed and measured at the beginning of physiotherapy , at seven days , at week 3 and at week 6 after treatment began . Results : The CPH42 Profile had very good test – retest reliability and internal consistency ( intraclass correlation coefficient 0.91 , Cronbach 's alpha 0.90 ) . Validity was confirmed by a moderate correlation with the NRS at the beginning of treatment and week 6 ( rank correlation 0.41–0.53 ) . Moreover , a significant difference in scores was found between those who had sought medical consultation and /or had taken medication because of neck pain than those who did not . The responsiveness measured from the beginning of treatment to week 3 and week 6 ( st and ard response means of 0.33 and 0.36 ) was comparable to the respective changes in pain intensity . Conclusion : The CPH42 Profile has been shown to demonstrate good reliability and validity , and it is sensitive to changes in severity over time . It is suitable for use as an outcome measure for evaluation of patients with neck pain Objectives : In controlled trials of analgesics for the treatment of neuropathic pain , the primary outcome variable is most often a measure of global pain intensity . However , because neuropathic pain is associated with a variety of pain sensations , the effects of analgesic treatments on different sensations could go undetected if specific pain qualities are not assessed . This study sought to evaluate the utility of assessing the multiple components of neuropathic pain in an analgesic clinical trial . Methods : One hundred fifty-nine subjects with diabetes-related foot pain were r and omly assigned to receive an active analgesic ( controlled-release oxycodone ) or matching placebo for 6 weeks . A multidimensional measure of neuropathic pain , the Neuropathic Pain Scale ( NPS ) , was administered before , during , and after study treatment . Results : Relative to placebo , the opioid analgesic produced statistically significantly greater decreases in global pain intensity , pain unpleasantness , and sharp , dull , and deep pain sensations . Responder analyses indicated a higher rate of responding to the opioid condition , relative to placebo , for intense , unpleasant , deep , and surface pain . The opioid analgesic did not significantly reduce hot , cold , itchy , or sensitive pain sensations compared with placebo in either analysis . Conclusions : These findings support the utility of the NPS for characterizing the multidimensional nature of the neuropathic pain experience and for detecting changes in neuropathic pain with treatment OBJECTIVE We performed a prevalence estimate of chronic pain with neuropathic pain ( NeP ) symptoms to determine its frequency and associations with morbidity . DESIGN We conducted a telephone-based survey based upon a r and om sampling of both urban and rural households of the general population in one Canadian province to determine NeP prevalence and its impact upon financial well-being and quality of life . OUTCOME MEASURES Telephonic use of the DN4 question naire ( DN4Q ) , used to identify NeP symptoms in those patients with chronic pain , was vali date d within selected clinical population s of chronic pain . Epidemiological data was obtained for all subjects . EuroQoL (EQ)-5D data estimating quality of life was measured . RESULTS Chronic pain was present in 35.0 % of the surveyed population of 1,207 subjects , with NeP symptoms present in 17.9 % . The NeP group had significantly more pain  , was female predominant , had a greater belief of being economically disadvantaged , suffered from more restrictions in mobility and in usual activities , and had overall lower EQ-5D utility scores compared with subjects with non-NeP. DN4Q validation demonstrated that pain entities not normally defined as NeP are recorded as such using the DN4Q , and that a spectrum of NeP features may occur across a host of painful conditions . CONCLUSION Despite limitations of the DN4Q , symptoms of NeP may be more prevalent in the general population than expected and has a greater impact upon patients ' lives than non-NeP. Limitations of the DN4Q may relate to the concept of a spectrum of NeP existent amongst heterogenous NeP and non-NeP syndromes Abstract Previously , we demonstrated , in a r and omized clinical trial , the effectiveness of a psychoeducational intervention to decrease pain intensity scores and increase patients ’ knowledge of cancer pain management with a sample of oncology patients with pain from bone metastasis . In the present study , we evaluated for changes in mood states ( measured using the Profile of Mood States ) , quality of life ( QOL ; measured using the Medical Outcomes Study Short Form‐36 ( SF‐36 ) ) , and pain ’s level of interference with function ( measured using the Brief Pain Inventory ( BPI ) ) from baseline to the end of the intervention first between the  intervention and the st and ard care groups and then within the intervention group based on the patients ’ level of response to the intervention ( i.e. , patients were classified as non‐responders , partial responders , or responders ) . No differences were found in any of these outcome measures between patients in the st and ard care and intervention groups . However , when patients in the intervention group were categorized using a responder analysis approach , significant differences in the various outcome measures were found among the three respondent groups . Differences in the physical and mental component summary scores on the SF‐36 and the interference items on the BPI , among the three respondent groups , were not only statistically significant but also clinical ly significant . The use of responder analysis in analgesic trials may help to identify unique subgroups of patients and lead to the development of more effective psychoeducational interventions OBJECTIVE To examine and compare the psychometric properties of two common observational pain assessment tools used in persons with dementia . DESIGN In a cross-sectional descriptive study nursing home ( NH ) residents  were videotaped at rest and during a structured movement procedure . Following one training session and one practice session , two trained graduate nursing research assistants independently scored the tapes using the two pain observation tools . SETTING Fourteen NHs in Western Washington State participating in a r and omized controlled trial of an intervention to enhance pain assessment and management .  PARTICIPANTS Sixty participants with moderate to severe pain were identified by nursing staff or chosen based on the pain items from the most recent Minimum Data Set assessment . MEASURES  Checklist of Nonverbal Pain Indicators ( CNPI ) and the Pain Assessment in Advanced Dementia ( PAINAD ) , demographic and pain-related data ( Minimum Data Set ) , nursing assistant reports of participants ' usual pain intensity , and Pittsburgh Agitation Scale . RESULTS Internal consistency for both tools was good except for the CNPI at rest for one rater . Inter-rater reliability for pain presence was fair ( K = 0.25 for CNPI with movement ; K = 0.31 for PAINAD at rest ) to moderate ( K = 0.43 for CNPI at rest ; K = 0.54 for PAINAD with movement ) . There were significant differences in mean CNPI and PAINAD scores at rest and during movement , providing support for construct validity . However , both tools demonstrated marked floor effects , particularly when participants were at rest . CONCLUSIONS Despite earlier studies supporting the reliability and validity of the CNPI and the PAINAD , findings from the current study indicate that these measures warrant further study with clinical users , should be used cautiously both in research and clinical setting s and only as part of a comprehensive approach to pain assessment Background Pelvic Girdle Pain ( PGP ) is an important cause of disability and economic cost worldwide . There is a need for effective preventative and management strategies . Emerging studies measure a variety of outcomes rendering synthesis and translation to clinical practice difficult . A Core Outcome Set ( COS ) can address this problem by ensuring that data are relevant , useful and usable for making well-informed healthcare choices . The aim of this study is to develop a consensus-based PGP-COS , including agreement on methods ( e.g. instruments ) for measuring the construct outcomes in the COS for use in research and clinical practice . Furthermore , as there is uncertainty as to whether incorporating stakeholder interviews in addition to conducting a systematic review to determine an initial list of outcomes for the Delphi survey , or , whether using different rating scales in a Delphi survey impacts on the final COS , we propose to embed two method ological studies within the PGP-COS development process to address these questions . Methods The PGP-COS study will include five phases : ( 1 ) A systematic review of the literature and semi-structured interviews with 15 patients ( three countries ) to form the initial list of outcomes for the Delphi survey ; ( 2 ) A 3-round Delphi including patients , clinicians , research ers and service providers ; ( 3 ) A systematic review of methods for measuring the outcomes in the preliminary PGP-COS identified in the Delphi survey ; ( 4 ) A face-to-face consensus meeting to agree on the final PGP-COS and methods for measuring the COS ; ( 5 ) Global dissemination . To address the method ological questions , we will assess the number and type of outcomes , in the final PGP-COS , that were exclusively derived from the interviews . Secondly , we will r and omise Delphi survey participants to either a 5-point or 9-point importance rating scale , and examine potential differences in ‘ important ’ ratings between the groups . Discussion There is currently no COS for measuring/monitoring PGP in trials and clinical practice . A PGP-COS will ensure that relevant outcomes are measured using appropriate measurement instruments for patients with PGP globally . Core outcome set registration This PGP-COS was registered with COMET ( Core Outcome Measures for Effectiveness Trials ) in January 2017 ( http://www.comet-initiative.org/ studies /details/958 ) Underst and ing changes in patient-reported outcomes is indispensable for interpretation of results from clinical studies . As a consequence the term “ minimal clinical ly important difference ” ( MCID ) was coined in the late 1980s to ease classification of patients into improved , not changed or deteriorated . Several method ological categories have been developed determining the MCID , however , all are subject to weaknesses or biases reducing the validity of the reported MCID . The objective of this study was to determine the reproducibility and validity of a novel method for estimating low back pain ( LBP ) patients ’ view of an acceptable change ( MCIDpre ) before treatment begins . One-hundred and forty-seven patients with chronic LBP were recruited from an out-patient hospital back pain unit and followed over an 8-week period . Original and modified versions of the Oswestry disability index ( ODI ) , Bournemouth question naire ( BQ ) and numeric pain rating scale  ( NRSpain ) were filled in at baseline . The modified question naires determined what the patient considered an acceptable post-treatment outcome which allowed us to calculate the MCIDpre . Concurrent comparisons between the MCIDpre , instrument measurement error and a retrospective approach of establishing the minimal clinical ly important difference ( MCIDpost ) were made . The results showed the prospect i ve acceptable outcome method scores to have acceptable reproducibility outside measurement error . MCIDpre was 4.5 larger for the ODI and 1.5 times larger for BQ and NRSpain compared to the MCIDpost . Furthermore , MCIDpre and patients post-treatment acceptable change was almost equal for the NRSpain but not for the ODI and BQ . In conclusion , chronic LBP patients have a reasonably realistic idea of an acceptable change in pain , but probably an overly optimistic view of changes in functional and psychological/affective domains before treatment begins Reliable and valid measures of pain are essential for conducting research on chronic pain . The purpose of this longitudinal study was to compare the reliability and validity of several measures of pain intensity .  One hundred twenty-three patients with chronic pain were administered telephone interview versions of 0 - 10 scales of current , worst , least and average pain , immediately prior to beginning a multidisciplinary treatment program . The measures were administered again to these subjects 2 weeks ( n=108 ) , 1 month ( n=106 ) and 2 months ( n=105 ) after the end of treatment . The validity ( defined as ability to detect changes in pain intensity over the course of treatment up to the 2-month follow-up assessment ) and reliability ( defined as stability over time in the 2 months after treatment ) of these four measures and of composite combinations of these measures were examined . Contrary to prediction , the composite measures did not show a statistically significant superiority to the individual ratings in terms of their ability to detect change in pain intensity from pre-treatment to various points after treatment . The composite scores did , however , show greater stability than did the individual ratings after treatment . The practical conclusions of this study are ; ( 1 ) , individual 0 - 10 pain intensity ratings have sufficient psychometric strengths to be used in chronic pain research , especially research that involves group comparison design s with relatively large sample sizes , but , ( 2 ) , composites of 0 - 10 ratings may be more useful when maximal reliability is necessary , ( e.g. in studies with relatively small sample sizes , or in clinical setting s where monitoring of changes in pain intensity in individuals is needed )
Although a variety of pain and physical functioning outcome measures have been reported in the literature , few have demonstrate method ologically strong psychometric properties .
INTRODUCTION A range of outcome measures across various domains are used to evaluate change following an intervention in clinical trials on chronic neuropathic pain ( NeP ) .
However , to capture a real change in the variable of interest , the psychometric properties of a particular measure should demonstrate appropriate method ological quality .
Various outcome measures in the domains of pain and physical functioning have been used in the literature for NeP , for which individual properties ( eg , reliability/validity ) have been reported .