Interrater and Intrarater Reliability in the Measurement of Kyphosis in Postmenopausal Women With Osteoporosis Radiographic measures of thoracic kyphosis in osteoporosis: Cobb and vertebral centroid angles Clinical measurement of the thoracic kyphosis. A study of the intra-rater reliability in subjects with and without shoulder pain Prediction of thoracic kyphosis using the Debrunner kyphometer. Development and validation of the Liverpool infant bronchiolitis severity score: a research protocol. Use of Condition-Specific Patient-Reported Outcome Measures in Clinical Trials among Patients with Wrist Osteoarthritis: A Systematic Review Measurement of Thoracic and Lumbar Fracture Kyphosis: Evaluation of Intraobserver, Interobserver, and Technique Variability A new skin-surface device for measuring the curvature and global and segmental ranges of motion of the spine: reliability of measurements and comparison with data reviewed from the literature Postural taping decreases thoracic kyphosis but does not influence trunk muscle electromyographic activity or balance in women with osteoporosis. Rehabilitation using manual mobilization for thoracic kyphosis in elderly postmenopausal patients with osteoporosis. AMSTAR is a reliable and valid measurement tool to assess the methodological quality of systematic reviews. Standardized Reporting of Clinical Practice Guidelines: A Proposal from the Conference on Guideline Standardization Minimally invasive management of thoraco-lumbar fractures: combined percutaneous fixation and balloon kyphoplasty. Factors That Can Affect the External Validity of Randomised Controlled Trials Effect of back-strengthening exercise on posture in healthy women 49 to 65 years of age. The Evidence Project risk of bias tool: assessing study rigor for both randomized and non-randomized intervention studies Bias in Systematic Reviews? The Bournemouth Questionnaire: a short-form comprehensive outcome measure. II. Psychometric properties in neck pain patients. The effectiveness of surgery for stress incontinence in women: a systematic review. Evaluating the role of quality assessment of primary studies in systematic reviews of cancer practice guidelines Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Validity and reliability of criterion based clinical audit to assess obstetrical quality of care in West Africa The Cannabis Use Problems Identification Test (CUPIT): development, reliability, concurrent and predictive validity among adolescents and adults.
Study Design . A reliability study was performed using repeated r and om measurements involving three observers , 26 subjects and three instruments . Objectives . To determine the most reliable , cost‐effective , noninvasive , and clinical ly feasible method of measuring spinal kyphosis .  Summary of Background Data . The most clinical ly useful , noninvasive and reliable method of measuring postural deformity in spinal osteoporosis ( kyphosis ) remains unqualified . Despite traditional use of costly , invasive roentgenographs for the evaluation of spinal kyphosis , the reliability of this method remains question able . Methods . Twenty‐six postmenopausal women with known bone mineral density and a diagnosis of osteoporosis were recruited from the Osteoporosis Program at Women 's College Hospital , Toronto , Canada . Noninvasive measurements of thoracic kyphosis were obtained by three trained examiners using the DeBrunner 's kyphometer and the flexicurve ruler . The intrarater and interrater reliability of and between each method was compared , using roentgenographic films obtained in the sagittal plane . Spinal posture was classified according to the method of Itoi ( 1990 ) . Statistical computations were performed using SAS statistical software . Results . Consistent measurements were obtained with the  DeBrunner 's kyphometer  and the flexicurve ruler by each observer , according to the results of critical two‐way analysis of variance ( Intraclass Correlation Coefficient 2,1 ) . Measurements in two subgroups , healthy backs ( n = 11 ) and rounded backs ( n= 13 ) , showed consistent use of each noninvasive instrument with some examiner preference for specific tools . There was marginally better intrarater and interrater reliability using the DeBrunner 's kyphometer compared with that obtained with the flexicurve ruler . Two‐way analysis of variance ( Intraclass Correlation Coefficient 2,1 ) of collapsed data showed no significant difference in the reliability of the kyphometer , flexicurve ruler , or roentgenographs in the measurement of thoracic kyphosis . Conclusions . The flexicurve ruler and DeBrunner 's kyphometer had the closest agreement in the measurement of spinal kyphosis . The kyphometer demonstrated the least variation in intrarater and interrater reliability when compared with the flexicurve ruler and roentgenographs . The flexicurve ruler permits qualitative assessment of posture , however , and is the most costeffective instrument . The results of this study challenge the traditional belief that roentgenographic analysis is the best method for evaluating spinal kyphosis . The DeBrunner 's kyphometer and flexible ruler may represent viable , cost‐effective and noninvasive alternatives to roentgenographic evaluation of spinal kyphosis ObjectiveS everal measures can quantify thoracic kyphosis from radiographs , yet their suitability for people with osteoporosis remains uncertain . The aim of this study was to examine the validity and reliability of the vertebral centroid and Cobb angles  in people with osteoporosis . Design and patients  Lateral radiographs of the thoracic spine  were captured in 31 elderly women with osteoporosis .  Thoracic kyphosis was measured globally ( T1–T12 ) and regionally ( T4–T9 ) using Cobb and vertebral centroid angles . Multisegmental curvature was also measured by fitting polynomial functions to the thoracic curvature profile . Canonical and Pearson correlations were used to examine correspondence ; agreement between measures was examined with linear regression . Results Moderate to high intra- and inter-rater reliability was achieved ( SEM = 0.9–4.0 ° ) . Concurrent validity of the simple measures was established against multisegmental curvature ( r = 0.88–0.98 ) . Strong association was observed between the Cobb and centroid angles globally ( r = 0.84 ) and regionally ( r = 0.83 ) . Correspondence between measures was moderate for the Cobb method r = 0.72 ) , yet stronger for the centroid method ( r = 0.80 ) . The Cobb angle was 20 % greater for regional measures due to the influence of endplate tilt . Conclusions Regional Cobb and centroid angles are valid and reliable measures of thoracic kyphosis in people with osteoporosis . However , the Cobb angle is biased by endplate tilt , suggesting that the centroid angle is more appropriate for this population Background Clinical sagittal plane assessment of the thoracic kyphosis angle is considered an essential component of the postural examination of patients presenting with upper body pain syndromes . Cervical headaches and conditions involving the shoulder , such as subacromial pain syndrome , have all been associated with an increase in the thoracic kyphosis . Concomitantly a decrease in the thoracic kyphosis as a result of a stretching and strengthening rehabilitation programme is believed to be associated with a reduction in symptoms and pain and improvement in function . Clinicians generally measure the sagittal plane kyphosis angle visually . There is no certainty that this method is reliable or is capable of measuring angular changes over time or in response to intervention . As such a simple and reliable clinical method of measuring the thoracic kyphosis would enable clinicians to record this information . The aim of this investigation was to determine the intra-tester reliability of measuring the thoracic kyphosis angle using a clinical method Methods Measurements were made in 45 subjects with and 45 subjects without upper body symptoms . Measurements were made with the subjects in relaxed st and ing . Two gravity dependent inclinometers were used to measure the kyphosis . The first was placed over the region of the 1st and 2nd thoracic spinous processes . The other , over the region of the 12th thoracic and 1st lumbar spinous processes . The angle produced by each inclinometer was measured 3 times in succession . Each set of 3 measurements was made on two occasions ( separated by a minimum of 30 minutes and additional data collection involving 46 further measurements of posture and movement on the same and an additional subject before the thoracic kyphosis measurements were re-measured ) by one rater . The reliability of the measurements was analyzed using 2-way ANOVA intraclass correlation coefficients ( ICC ) , 95 % confidence intervals ( CI ) and st and ard error of measurement ( SEM ) for precision , for a single measurement [ ICC(single ) ] and the average of 3 measures [ ICC(average ) ] . The assessor remained ' blinded ' to data input and the measurements were staggered to reduce examiner bias . Results The measurement of the thoracic kyphosis as used in this investigation was found to have excellent intra-rater reliability for both subjects with and without symptoms . The ICC(single ) results for the subjects without symptoms were , .95 ; ( 95 % CI .91-.97 ) . The corresponding ICC(average ) results were ; .97 ; ( 95 % CI .95-.99 ) . The results for the subjects with symptoms were ; 93 ; ( 95 % CI .88-.96 ) , for ICC(single ) and for ICC(average ) ; .97 ; ( 95 % CI .94-.98 ) . The SEM results for subjects without and with symptoms were 1.0 ° and 1.7 ° , respectively . Conclusions The findings of this immediate test-retest reliability study suggest that the clinical measurement of the thoracic kyphosis using gravity dependent inclinometers demonstrates excellent intra-rater reliability . Additional research is required to determine the inter-rater reliability of this method .Trial registration National Research Register : The Debrunner kyphometer is an accepted tool for detecting and evaluating  thoracic kyphosis .  This prospect i ve study was conducted to create a mathematical formula that provides , with high approximation , the roentgenographic angle of thoracic kyphosis ( T4-T12 ) using only the kyphometer . Several clinical ( kyphometer value , age , and sex ) and radiographic ( Cobb angle [ T4-T12 ] ) parameters from 90 consecutively screened adolescents ( 44 male and 46 female ) were correlated using simple and multiple linear regression analyses . The reliability of measurement using the Debrunner kyphometer was high . The kyphometer value was strongly correlated with the roentgenographically measured thoracic Cobb angle ( simple linear regression analysis ; probability range , 0.0026 to 0.0002 ) . There was no correlation between age or sex and thoracic kyphosis . The predicted kyphosis angle using the kyphometer and the mathematic formula was 44.66 degrees + /- 2.68 degrees , ( range 27 to 62 degrees ) , and the real roentgenographic kyphosis angle was 47.5 degrees + /- 3.53 degrees , ( range , 24 to 70 degrees ) . The kyphometer and formula were more reliable and accurate when kyphosis less than 50 degrees was measured . In this study , the authors constructed a mathematical formula that accurately provides the roentgenographic T4-T12 kyphosis angle in adolescents using only the Debrunner kyphometer with a deviation of less than 3 degrees . The authors recommend that all physicians engaged in kyphosis screening programs use the kyphometer combined with the recently constructed simple mathematic formula . This method will reduce the cost of school screening programs , overdiagnoses , and unnecessary exposure of adolescents to irradiation AIM To develop and vali date a  bronchiolitis severity scoring instrument  for use by nurses and other healthcare professions . BACKGROUND Bronchiolitis is a viral lower respiratory tract infection of infancy . In industrialized countries , admission rates have increased over the last decade with up to 3 % of all infants born being admitted to hospital . A small number of these hospitalized infants will require admission to critical care for either invasive or non-invasive ventilation . During the seasonal epidemic , the number of unplanned admissions to critical care with bronchiolitis substantially increases . DESIGN We will use a mixed methods study design . METHODS We will use scale development and psychometric methods to develop a scoring instrument and to test the instrument for content , construct and criterion validity and reliability in several different clinical locations . This study protocol has been review ed and approved by the NHS National Research Ethics Service , January 2011 . DISCUSSION There is an urgent need to develop a valid and reliable severity scoring instrument sensitive to clinical changes in the infant , to facilitate clinical decision-making and help st and ardize patient care . Furthermore , a valid and reliable scoring instrument could also be used as a proxy patient-reported outcome measure to evaluate the efficacy of clinical interventions in r and omized controlled trials Background . This paper aim ed to identify condition-specific patient-reported outcome measures used in clinical trials among people with wrist osteoarthritis and summarise empirical peer- review ed evidence supporting their reliability , validity , and responsiveness to change . Methods . A systematic review of r and omised controlled trials among people with wrist osteoarthritis was undertaken . Studies reporting reliability , validity , or responsiveness were identified using a systematic reverse citation trail audit procedure . Psychometric properties of the instruments were examined against predefined criteria and summarised . Results . Thirteen clinical trials met inclusion criteria . The most common patient-reported outcome was the disabilities of the arm , shoulder , and h and question naire ( DASH ) . The DASH , the  Michigan H and Outcomes Question naire ( MHQ ) , the  Patient Evaluation Measure ( PEM ) , and the  Patient-Reported Wrist Evaluation ( PRWE ) had evidence supporting their reliability , validity , and responsiveness . A post-hoc review of excluded studies revealed the AUSCAN Osteoarthritis H and Index as another suitable instrument that had favourable reliability , validity , and responsiveness . Conclusions . The DASH , MHQ , and AUSCAN Osteoarthritis H and Index instruments were supported by the most favourable empirical evidence for validity , reliability , and responsiveness . The PEM and PRWE also had favourable empirical evidence reported for these elements . Further psychometric testing of these instruments among people with wrist osteoarthritis is warranted Study Design . Statistical analysis of various measurement techniques for thoracolumbar burst fracture kyphosis on lateral radiograph . Objective . To determine the most reliable measurement technique . Summary of Background Data . The treatment of thoracic and lumbar burst fractures involves many factors , including the degree of result ant kyphosis . Although various methods have been described , no study has directly compared these methods for reliability and reproducibility . Methods . Fifty lateral radiographs of thoracic and lumbar burst fractures were r and omly selected and measured on two separate occasions by three spine surgeons using five different measurement techniques .  Radiograph quality , fracture type , and the center beam location were determined . Statistical analysis included analysis of variance for repeated measures and analysis of variance using a generalized linear model . Results . Intraclass correlation coefficients were most consistent for Method 1 ( rho = 0.83–0.94 ) followed by Method 4 ( rho = 0.65–0.89 ) and Method 5 ( rho = 0.73–0.85 ) . Intraobserver agreement ( % of repeated measures within 5 ° of the original measurement ) ranged between 72 % and 98 % for all techniques for all three observers , with Method 1 showing the best agreement ( 84%–98 % ) . Paired comparisons between observers varied considerably with interobserver reliability correlation coefficients ranging from 0.52 to 0.93 . Method 1 showed the highest interobserver reliability coefficient ( 0.81 , range 0.71–0.93 ) followed by Method 5 ( 0.71 , range 0.68–0.75 ) . Method 1 also had the highest percentage of agreement within categories ( 90 % within 5 ° ) . Conclusions . Method 1 ( measuring from the superior endplate of the vertebral body one level above the injured vertebral body to the inferior endplate of the vertebral body one level below ) showed the best intraobserver and interobserver reliability overall There is an increasing awareness of the risks and dangers of exposure to radiation associated with repeated radiographic assessment of spinal curvature and spinal movements . As such , attempts are continuously being made to develop skin-surface devices for use in examining the progression and response to treatment of various spinal disorders . However , the reliability and validity of measurements recorded with such devices must be established before they can be recommended for use in the research or clinical environment . The aim of this study was to examine the reliability of measurements using a newly developed skin-surface device , the Spinal Mouse .  Twenty healthy volunteers ( mean age 41±12 years , nine males , 11 females ) took part . On 2 separate days , spinal curvature was measured with the Spinal Mouse during st and ing , full flexion , and full extension ( each three times by each of two examiners ) . Paired t-tests , intraclass correlation coefficients ( ICC ) , and st and ard errors of measurement ( SEM ) with 95 % confidence intervals were used to characterise between-day and interexaminer reliability for : st and ing sacral angle , lumbar lordosis , thoracic kyphosis , and ranges of motion ( flexion , extension ) of the thoracic spine , lumbar spine , hips , and trunk . The between-day reliability for segmental ranges of flexion was also determined for each motion segment from T1 - 2 to L5-S1 . The majority of parameters measured for the ‘ global regions ’ ( thoracic , lumbar , or hips ) showed good between-day reliability . Depending on the parameter of interest , between-day ICCs ranged from 0.67 to 0.92 for examiner 1 ( average 0.82 ) and 0.57 to 0.95 for examiner 2 ( average 0.83 ) ; for 70 % of the parameters measured , the ICCs were greater than 0.8 and generally highest for the lumbar spine and whole trunk measures . For lumbar spine range of flexion , the SEM was approximately 3 ° . The ICCs were also good for the interexaminer comparisons , ranging from 0.62 to 0.93 on day 1 ( average 0.81 ) and 0.70 to 0.94 on day 2 ( average 0.86 ) , although small systematic differences were sometimes observed in their mean values . The latter were still evident even if both examiners used the same skin markings . For segmental ranges of flexion , the ICCs varied between vertebral levels but overall were lower than for the global measures ( average for all levels in all analyses , ICC 0.6 ) . For each examiner , the average between-day SEM over all vertebral levels was approximately 2 ° . For ‘ global ’ regions of the spine , the Spinal Mouse delivered consistently reliable values for st and ing curvatures and ranges of motion which compared well with those reported in the literature . This suggests that the device can be reliably implemented for in vivo studies of the sagittal profile and range of motion of the spine . As might be expected for the smaller angles being measured , the segmental ranges of flexion showed lower reliability . Their usefulness with regard to the interpretation of individual results and the detection of ‘ real change ’ on an individual basis thus remains question able . Nonetheless , the group mean values showed few between-day differences , suggesting that the device may still be of use in providing clinical ly interesting data on segmental motion when examining groups of individuals with a given spinal pathology or undergoing some type of intervention BACKGROUND Greater thoracic kyphosis is associated with increased biomechanical loading of the spine which is potentially problematic in individuals with osteoporotic vertebral fractures . Conservative interventions that reduce thoracic kyphosis warrant further investigation . This study aim ed to investigate the effects of therapeutic postural taping on thoracic posture . Secondary aims explored the effects of taping on trunk muscle activity and balance . METHODS Fifteen women with osteoporotic vertebral fractures participated in this within-participant design study . Three taping conditions were r and omly applied : therapeutic taping , control taping and no taping .  Angle of thoracic kyphosis was measured after each condition . Force plate-derived balance parameters and trunk muscle electromyographic activity ( EMG ) were recorded during three static st and ing tasks of 40s duration . RESULTS There was a significant main effect of postural taping on thoracic kyphosis ( p=0.026 ) , with a greater reduction in thoracic kyphosis after taping compared with both control tape and no tape . There were no effects of taping on EMG or balance parameters . CONCLUSIONS The results of this study demonstrate that the application of postural therapeutic tape in a population with osteoporotic vertebral fractures induced an immediate reduction in thoracic kyphosis . Further research is needed to investigate the underlying mechanisms associated with this decrease in kyphosis OBJECTIVE To explore the feasibility and effects of rehabilitation using manual mobilization of the thoracic spine in elderly female patients with osteoporosis . METHODS Forty-eight postmenopausal patients with osteoporosis ( age 76 -/+ 7 years ) were r and omly assigned to 3 months rehabilitation ( 18 sessions including manual mobilization , taping and exercises , n = 29 ) or control ( wait-list , n = 19 ) . The primary outcome was thoracic kyphosis degree ( Spinal-Mouse ) . Secondary outcomes were back pain ( visual analogue scale ) and quality of life ( Qualeffo-41 ) . Explanatory outcomes were compliance with rehabilitation , complications , and patients ' and therapists ' perceptions regarding the rehabilitation programme . RESULTS Thoracic kyphosis improved significantly following rehabilitation compared with controls ( intention-to-treat analysis , p = 0.017 ) ; and in patients who were compliant with rehabilitation ( n = 15 ) compared with those who were non-compliant ( p = 0.002 ) and controls ( p = 0.001 ) . Mental health worsened slightly in the rehabilitation group ( p = 0.029 ) , but not significantly compared with controls . Neither patients nor physical therapists reported serious adverse effects . CONCLUSION Three months of rehabilitation with manual mobilization can attenuate thoracic kyphosis in elderly patients with osteoporosis . Its impact on back pain and quality of life remains unclear and needs further investigation OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess  systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review Evidence -based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice ( 1 - 3 ) . In many cases , guidelines encapsulate the most current knowledge about best practice s. Rigorously developed guidelines can translate complicated research findings into actionable recommendations for clinical care ( 4 ) . Over the past decade , a plethora of guidelines has been created and published by a multitude of organizations at substantial cost . Despite the enormous energies invested in guideline authoring , the quality of individual guidelines varies considerably . In its l and mark report , the Institute of Medicine ( IOM ) defined 8 desirable attributes of clinical practice guidelines : validity , reliability and reproducibility , clinical applicability , clinical flexibility , clarity , documentation , development by a multidisciplinary process , and plans for review ( 5 ) . However , critical information that would attest to validity or would document fulfillment of the other IOM criteria is regularly absent from published guidelines . In an evaluation of 279 guidelines developed by U.S. medical specialty societies , Shaneyfelt and colleagues ( 6 ) found that guidelines published in the peer- review ed medical literature do not adhere to established method ologic st and ards . Likewise , Grilli and colleagues ( 7 ) found that of 431 guidelines produced by specialty societies , 82 % did not apply explicit criteria to grade the scientific evidence that supported their recommendations , 87 % did not report whether a systematic literature search was performed , and 67 % did not describe the type of professionals involved in guideline development . Systematic review s of guidelines for drug therapy ( 8) , management of depression ( 9 ) , and osteoporosis ( 10 ) have confirmed marked variation in quality . Both nonadherence to method ologic st and ards and failure to document development activities contribute to this variation . We convened the Conference on Guideline St and ardization ( COGS ) to define a st and ard for guideline reporting that would promote guideline quality and facilitate implementation . The proposed st and ard provides a checklist of components necessary for evaluation of validity and usability . The checklist is intended to minimize the quality defects that arise from failure to include essential information and to promote development of recommendation statements that are more easily implemented . In contrast to other instruments that have been developed for post hoc evaluation of guideline quality , the COGS checklist is intended to be used prospect ively by developers to improve their product by improving documentation . The COGS panel used a systematic and rigorous process to define content of the proposed st and ard and to achieve consensus . The COGS panel also included a wide variety of perspectives , deliberately bringing together representatives from medical specialty societies , government agencies , and private groups that develop guidelines ; journal editors and the National Guideline Clearinghouse ( NGC ) , which disseminate guidelines ; guideline implementers , including managed care representatives and informaticians ; and academicians . Methods We actively sought people with diverse background s from wide-ranging geographic areas to participate in the meeting . Selection criteria for participants were 1 ) activity in a wide variety of guidelines initiatives , 2 ) recognition as leaders in their field , and 3 ) willingness to collaborate . To maximize interaction , the number of participants in the Conference was limited . We set as a task for the panelists the specification and definition of a set of necessary guideline components that should be considered for reporting in all evidence -based practice guidelines . We defined necessary items as those that establish the validity of the guideline recommendations or facilitate practical application of the recommendations . We noted that many additional items might be considered appropriate components in guidelines , but sought to define a minimal set of essential elements . We assembled a list of c and i date guideline components from the IOM Provisional Instrument for Assessing Clinical Guidelines ( 5 ) , the NGC ( 11 ) , and the Guideline Elements Model ( 12 ) , a hierarchical model of guideline content that was created from a systematic review of published guideline descriptions . These items were supplemented with items highlighted in the literature , for example , structured abstract ( 13 ) and conflict of interest ( 14 ) . We applied a modified Delphi approach to help focus group discussion . This approach has been widely applied for evaluation of expert opinion on appropriateness ( 15 ) and medical necessity ( 16 ) , for policy development ( 17 ) , and for prioritization ( 18 ) . The technique has been described in detail ( 19 ) . In brief , after we secured agreement to participate in the COGS panel , we gave all participants a bibliography of re sources regarding guideline quality and its appraisal , guideline implementation , and the modified Delphi consensus development approach . Panelists were asked to rate their agreement with the statement that [ Item name ] is a necessary component of practice guidelines on a 9-point scale . Rating an item with a 9 indicated strong agreement with the statement that this item was necessary . Rating an item with a 1 indicated strong disagreement with the statement and suggested that the item was absolutely unnecessary in a guideline . A rating of 5 indicated neutrality or indifference . We developed a password-protected Web site that panelists used to complete the first round of ratings online before the meeting . Online rating permitted accurate and efficient data capture and analysis . For each item , the median rating and the disagreement index ( defined as the Interpercentile Range divided by the Interpercentile Range Adjusted for Symmetry ) were calculated ( 19 ) . The disagreement index , which can be calculated for panels of any size , describes the dispersion of ratings more effectively than the mean absolute deviation from the median . Index values greater than 1 indicate disagreement . We displayed summary statistics for each item on a form that was individualized for each panelist . The COGS meeting was held on 26 and 27 April 2002 in New Haven , Connecticut . In a colloquy facilitated by 2 of the authors , each c and i date item was discussed to ensure that all participants agreed on its definition and potential contribution to the COGS checklist and to highlight empirical evidence of its value . When appropriate , additional items were added to the list . The group determined that in the second round of ratings , it would be valuable to rate each item 's necessity on 2 subscales : necessity to establish validity and necessity for practical application . The participants then rated each item on these 2 dimensions . Analysis We tallied the median score and the disagreement index for each item . We retained items with median scores of 7 or higher and disagreement indexes less than 1.0 on either scale as necessary guideline components on the checklist . To interpret necessity , the 9-point scale is divided into 3 ranges : items scoring 1 to 3 are considered unnecessary , items scoring 4 to 6 are neutral , and items scoring 7 to 9 are considered necessary ( 20 ) . In this study , the threshold of 7 was chosen because it represented the lowest rating at which the participants indicated that an item was necessary for inclusion in guidelines . Pilot Review To field test the proposed checklist , we surveyed organizations that were active in guideline development . We identified all organizations that met the NGC Web site criteria for guideline display on 12 July 2002 . From that list , we selected organizations that had developed 10 or more guidelines displayed on the NGC Web site . We excluded 1 ) organizations that participated in development of the COGS checklist [ because of potential bias ] and 2 ) government agencies and organizations based outside the United States ( for logistic reasons ) . A draft COGS checklist and a brief survey were sent to the people identified as being responsible for guideline development at each eligible organization . Results All 23 panelists su bmi tted first- and second-round ballots . During the discussion , participants suggested consideration of 10 new items in the second round of balloting and refined definitions of several items . Thirty-six discrete items were considered necessary to establish guideline validity ; they received ratings of 7 or greater and had disagreement indexes of less than 1 . Twenty-four items were considered necessary for practical application of the guideline , each with a disagreement index less than 1 . Several items were rated necessary on both dimensions . Overall , 44 discrete items were considered necessary . Closely related items were then consoli date d into 18 topics to create the COGS checklist for reporting clinical guidelines ( Table ) . Appendix Tables 1 and 2 present a complete listing of all items rated and their scores . Table . The COGS Checklist for Reporting Clinical Practice Guidelines Appendix Table 1 . Items Ranked Necessary for Guideline Validity , Median Ratings , Distribution of Ratings by Tertiles , and Disagreement Index Appendix Table 2 . Items Ranked Necessary for Guideline Usability , Median Ratings , Distribution of Ratings by Tertiles , and Disagreement Index Twenty-two organizations met eligibility criteria for evaluation of the draft checklist , and all completed the survey ( 100 % response rate ) . Sixteen organizations ( 73 % ) responded that they believed the checklist would be helpful for creating more comprehensive practice guidelines , and an additional 2 organizations ( 9 % ) responded that it might be helpful . Nineteen respondents ( 86 % ) indicated that documenting the proposed items would fit within their organizations ' guideline development methods . Fifteen ( 68 % ) stated that they would use the proposed checklist in guideline STUDY DESIGN Retrospective review of prospect ively collected data . BACKGROUND There is no consensus regarding the ideal treatment of thoraco-lumbar spine fractures without neurological compromise . Many surgical techniques have been described but none has proved its definite superiority . The main drawback of these procedures is directly related to the morbidity of the approach . As minimally invasive fixation combined with balloon kyphoplasty for treatment of thoraco-lumbar fractures is gaining popularity , its efficacy has yet to be established . PURPOSE The purpose of this study is to report operative data , clinical and radiological outcomes of patients undergoing minimally invasive management of thoraco-lumbar fracture at our institutions . METHODS Forty-one patients underwent percutaneous kyphoplasty and stabilization for treatment of single-level fracture of the thoracic or lumbar spine . All patients were neurologically intact . There were 20 males and 21 females with an average age of 50 years . RESULTS The mean follow-up was 15 months ( 3 - 90 months ) . The mean operative time was 102 minutes ( range 35 - 240 minutes ) and the mean blood loss was < 100mL. VAS was significantly improved from 6.7 to 0.7 at last follow-up . Vertebral kyphosis decreased by 16 ° to 7.8 ° postoperatively ( P<0.001 ) . Local kyphosis and percentage of collapse were also significantly improved from 8 ° to 5.6 ° and from 35 % to 16 % at last follow-up . Fifteen leaks have been identified , three of which were posterior ; all remained asymptomatic . No patient worsened his or her neurological condition postoperatively . CONCLUSION Percutaneous stabilization plus balloon kyphoplasty seems to be a safe and effective technique to manage thoraco-lumbar fractures without neurological impairment R and omised controlled trials ( RCTs ) must be internally valid ( i.e. , design and conduct must eliminate the possibility of bias ) , but to be clinical ly useful , the result must also be relevant to a definable group of patients in a particular clinical setting ( i.e. , they must be externally valid ) . Lack of external validity is the most frequent criticism by clinicians of RCTs , systematic review s , and guidelines , and is one explanation for the widespread underuse in routine practice of many treatments that have been shown to be beneficial in trials and are recommended in guidelines [ 1 ] . Yet medical journals , funding agencies , ethics committees , the pharmaceutical industry , and governmental regulators seem to give external validity a low priority . Admittedly , whereas the determinants of internal validity are intuitive and can generally be worked out from first principles , underst and ing of the determinants of the external validity of an RCT requires clinical rather than statistical expertise , and often depends on a detailed underst and ing of the particular clinical condition under study and its management in routine clinical practice . However , reliable judgments about the external validity of RCTs are essential if treatments are to be used correctly in as many patients as possible in routine clinical practice . The results of RCTs or systematic review s will never be relevant to all patients and all setting s , but they should be design ed and reported in a way that allows clinicians to judge to whom the results can reasonably be applied . Table 1 lists some of the important potential determinants of external validity , each of which is review ed briefly below . Many of the considerations will only be relevant in certain types of trials , for certain interventions , or in certain clinical setting s , but they can each sometimes undermine external validity . Moreover , the list is not exhaustive and requires more detailed annotation and explanation than is possible in this short review . Table 1 Main Issues That Can Affect External Validity and Should Be Addressed in Reports of the Results of R and omised Controlled Trials or Systematic Review s and Considered by Clinicians Some of the issues that determine external validity are relevant to the distinction between pragmatic trials and explanatory trials [ 2 ] , but it would be wrong to assume that pragmatic trials necessarily have greater external validity than explanatory trials . For example , broad eligibility criteria , limited collection of baseline data , and inclusion of centres with a range of expertise and differing patient population s have many advantages , but they can also make it very difficult to generalise the overall average effect of treatment to a particular clinical setting OBJECTIVE To evaluate the effect of back-strengthening exercise on posture in 60 healthy estrogen-deficient women . DESIGN The 60 study subjects were r and omly assigned to either an exercise or a control group , and various factors were assessed at time of enrollment in the study and at 2-year follow-up . MATERIAL AND METHODS The 32 women in the exercise group were instructed in progressive back-strengthening exercises , whereas the 28 women in the control group had no exercise prescription and were asked to continue their usual physical and dietary activities . At baseline and 2-year follow-up examinations ,  back extensor strength  was measured with a strain-gauge dynamometer , and lateral roentgenograms of the thoracic and lumbar areas of the spine were obtained to measure the angles of thoracic kyphosis , lumbar lordosis , and sacral inclination . The changes in radiographic measurements and back extensor strength were analyzed statistically . RESULTS Back extensor strength increased significantly in both the exercise and the control groups , but no radiographic measurements were significantly different between these groups . The significant increase in back extensor strength in both groups of healthy women suggested that the original grouping did not accurately reflect the amount of exercise . Thus , the 60 subjects were reclassified for comparison on the basis of increase in back extensor strength--27 with more than or equal to the mean increase of 21.1 kg and 33 with less than 21.1 kg . Furthermore , each of these groups of subjects was subdivided on the basis of degree of thoracic kyphosis . Among the subjects with substantial thoracic kyphosis , those with a significant increase in back extensor strength had a significant decrease in thoracic kyphosis ( -2.8 + /- 4.2 degrees ; P = 0.041 ) , whereas those with a small increase in strength had a nonsignificant increase in thoracic kyphosis ( 1.8 + /- 5.3 degrees ) . The increase in back extensor strength did not seem to affect mild degrees of kyphosis . CONCLUSION Increasing the back extensor strength in healthy estrogen-deficient women helps decrease thoracic kyphosis Background Different tools exist for assessing risk of bias of intervention studies for systematic review s. We present a tool for assessing risk of bias across both r and omized and non-r and omized study design s. The tool was developed by the Evidence Project , which conducts systematic review s and meta-analyses of behavioral interventions for HIV in low- and middle-income countries . Methods We present the eight items of the tool and describe considerations for each and for the tool as a whole . We then evaluate reliability of the tool by presenting inter-rater reliability for 125 selected studies from seven published review s , calculating a kappa for each individual item and a weighted kappa for the total count of items . Results The tool includes eight items , each of which is rated as being present ( yes ) or not present ( no ) and , for some items , not applicable or not reported . The items include ( 1 ) cohort , ( 2 ) control or comparison group , ( 3 ) pre-post intervention data , ( 4 ) r and om assignment of participants to the intervention , ( 5 ) r and om selection of participants for assessment , ( 6 ) follow-up rate of 80 % or more , ( 7 ) comparison groups equivalent on sociodemographics , and ( 8) comparison groups equivalent at baseline on outcome measures . Together , items (1)–(3 ) summarize the study design , while the remaining items consider other common elements of study rigor . Inter-rater reliability was moderate to substantial for all items , ranging from 0.41 to 0.80 ( median κ = 0.66 ) . Agreement between raters on the total count of items endorsed was also substantial ( κw = 0.66 ) . Conclusions Strengths of the tool include its applicability to a range of study design s , from r and omized trials to various types of observational and quasi-experimental studies . It is relatively easy to use and interpret and can be applied to a range of review topics without adaptation , facilitating comparability across review s. Limitations include the lack of potentially relevant items measured in other tools and potential threats to validity of some items . To date , the tool has been applied in over 30 review s. We believe it is a practical option for assessing risk of bias in systematic review s of interventions that include a range of study design At an orthodontic meeting in recent years , a colleague recounted to me that when a presenter had finished their presentation on a systematic review , the person beside leaned over and said to my colleague ‘ not another systematic review where it ’s not possible to draw any firm conclusions ’ . So an element of frustration was clear based on the screening of a large volume of evidence to arrive at such a low point for a conclusion . This , however , is now a familiar outcome for many orthodontic systematic review s. In this short editorial , I have attempted to give a brief outline of the proposed benefits of systematic review s but more importantly , to highlight , some issues we all need to bear in mind in their regard . The increasing focus on evidence -based healthcare , including orthodontics , has shunned the narrative review and spawned the systematic review . Aim ing to identify , evaluate and summarize the findings of all relevant studies on a specific topic , its exacting systematic approach should minimize bias and provide conclusions based on reliable findings . Meta-analyses of r and omized clinical trials with low risk of bias are considered the highest level of evidence available for evaluating the effects of an intervention . Systematic review s are also important tools in setting the research agenda via their recommendations for future research and authors can alert research ers to the most pertinent outcomes in clinical practice . But systematic review s like any other study type are not without their variability , both in dentistry in general and specifically in orthodontics . Large differences have also been observed in the quality of reporting of several characteristics between Cochrane and non-Cochrane systematic review s. A key question that must be asked when looking at all Cochrane review s is whether the review has been undertaken in a way to avoid bias and whether the data and results from the included studies are valid . Conclusions may be distorted if bias is introduced to the review process at any stage . For example , incomplete search ing for all relevant studies may lead to publication bias ; there is strong association between publication and studies reporting significant or positive findings in medicine and also within orthodontics . With regard to studies included within the review , these need to be assessed to ensure that they are undertaken and reported in a manner that is free of bias ( systematic error ) . Outcome reporting bias ( ORB ) may also be relevant , e.g. in a study identified as relevant to a review , where data exist on the outcome of interest but only selected findings have been given based on the results . Although systematic review s have emphasized ‘ assessment of method ological quality ’ of included studies , the Cochrane h and book recommends a focus on ‘ risk of bias assessment ’ instead . The justifications are four-fold : it targets whether the results of included studies should be credible ; despite being carried out to the highest st and ards , a study may have risk of bias due to , e.g. impracticality/impossibility of blinding of participants / study personnel ; some quality markers , e.g. a power calculation is unlikely to directly affect risk of bias ; it overcomes ambiguity between quality of reporting and quality of the underlying research 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 OBJECTIVE To determine the method ological quality of studies evaluating surgery for stress incontinence , the effectiveness of different procedures and the frequency of complications associated with each procedure . MATERIAL S AND METHODS Eleven r and omized controlled trials , 20 non-r and omized trials/ prospect i ve cohort studies and 45 retrospective cohort studies were review ed systematic ally . RESULTS The method ological quality of the 31 prospect i ve studies was generally poor . The considerable variation in inclusion criteria , surgical management and assessment of outcome precluded any statistical meta- analysis . Evidence as to the effectiveness of surgery for stress incontinence is weak ; therefore , any conclusions are speculative . It appears that colposuspension may be more effective and the effect more long-lasting than that following anterior colporrhaphy and needle suspension . There is little information on the value of sling procedures . Comparisons of different ways of performing each procedure show no significant differences in outcome but this may reflect the method ological weaknesses of the studies . Valid and reliable data on the frequency of complications following surgery are lacking so the safety of the procedures is unclear . Repeat operations to correct stress incontinence are less successful than first procedures but this finding may be subject to confounding . CONCLUSIONS There is an urgent need for some large , rigorous , prospect i ve studies of high quality . Until such studies have been completed , recommendations as to the best clinical practice can not be based on scientific evidence . Studies need to define cases according to widely accepted criteria , including st and ard measures of the severity of stress incontinence , and surgical terminology for the procedures performed needs to be st and ardized and outcomes need to be clearly defined , valid and reliable , not confined to short-term assessment and include patients ' views along with the surgeon 's assessment Background The purpose of this study was to evaluate the role of study quality assessment of primary studies in cancer practice guidelines . Methods Reliable and valid study quality  assessment scales were sought and applied to published reports of trials included in systematic review s of cancer guidelines . Sensitivity analyses were performed to evaluate the relationship between quality scores and pooled odds ratios ( OR ) for mortality and need for blood transfusion .  Results Results found that that whether trials were classified as high or low quality depended on the scale used to assess them . Although the results of the sensitivity analyses found some variation in the ORs observed , the confidence intervals ( CIs ) of the pooled effects from each of the analyses of high quality trials overlapped with the CI of the pooled odds of all trials . Quality score was not predictive of pooled ORs studied here . Conclusions Had sensitivity analyses based on study quality been conducted prospect ively , it is highly unlikely that different conclusions would have been found or that different clinical recommendations would have emerged in the guidelines Background : Insomnia is a prevalent health complaint that is often difficult to evaluate reliably . There is an important need for brief and valid assessment tools to assist practitioners in the clinical evaluation of insomnia complaints . Objective : This paper reports on the clinical validation of the  Insomnia Severity Index ( ISI )  as a brief screening measure of insomnia and as an outcome measure in treatment research . The psychometric properties ( internal consistency , concurrent validity , factor structure ) of the ISI were evaluated in two sample s of insomnia patients . Methods : The first study examined the internal consistency and concurrent validity of the ISI  in 145 patients evaluated for insomnia at a sleep disorders clinic . Data from the ISI were compared to those of a sleep diary measure . In the second study , the concurrent validity of the  ISI  was evaluated in a sample of 78 older patients who participated in a r and omized-controlled trial of behavioral and pharmacological therapies for insomnia . Change scores on the  ISI  over time were compared with those obtained from sleep diaries and polysomnography .  Comparisons were also made between ISI scores obtained from patients , significant others , and clinicians . Results : The results of Study 1 showed that the  ISI  has adequate internal consistency and is a reliable self-report measure to evaluate perceived sleep difficulties . The results from Study 2 also indicated that the ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties with treatment . In addition , there is a close convergence between scores obtained from the ISI patient 's version and those from the clinician 's and significant other 's versions . Conclusions : The present findings indicate that the ISI is a reliable and valid instrument to quantify perceived insomnia severity . The ISI is likely to be a clinical ly useful tool as a screening device or as an outcome measure in insomnia treatment research Background In Mali and Senegal , over 1 % of women die giving birth in hospital . At some hospitals , over a third of infants are stillborn . Many deaths are due to subst and ard medical practice s. Criterion-based clinical audits ( CBCA ) are increasingly used to measure and improve obstetrical care in re source -limited setting s , but their measurement properties have not been formally evaluated . In 2011 , we published a systematic review of obstetrical CBCA highlighting insufficient considerations of validity and reliability . The objective of this study is to develop an obstetrical CBCA adapted to the West African context and assess its reliability and validity . This work was conducted as a sub- study within a cluster r and omized trial known as QUARITE . Methods Criteria were selected based on extensive literature review and expert opinion . Early 2010 , two auditors applied the CBCA  to identical sample s at 8 sites in Mali and Senegal ( n = 185 ) to evaluate inter-rater reliability . In 2010–11 , we conducted CBCA at 32 hospitals to assess construct validity ( n = 633 patients ) . We correlated hospital characteristics ( re source availability , facility perinatal and maternal mortality ) with mean hospital CBCA scores . We used generalized estimating equations to assess whether patient CBCA scores were associated with perinatal mortality . Results Results demonstrate substantial ( ICC = 0.67 , 95 % CI 0.54 ; 0.76 ) to elevated inter-rater reliability ( ICC = 0.84 , 95 % CI 0.77 ; 0.89 ) in Senegal and Mali , respectively . Re source availability positively correlated with mean hospital CBCA scores and maternal and perinatal mortality were inversely correlated with hospital CBCA scores . Poor CBCA scores , adjusted for hospital and patient characteristics , were significantly associated with perinatal mortality ( OR 1.84 , 95 % CI 1.01 - 3.34 ) . Conclusion Our CBCA has substantial inter-rater reliability and there is compelling evidence of its validity as the tool performs according to theory . Trial registration Current Controlled Trials IS RCT AIMS To describe the empirical construction and initial validation of the Cannabis Use Problems Identification Test ( CUPIT ) , a brief self-report screening instrument for detection of currently and potentially problematic cannabis use . DESIGN In a three-phase prospect i ve design an item pool of c and i date questions was generated from a literature review and extensive expert consultation . The CUPIT internal structure , cross-sectional and longitudinal psychometric properties were then systematic ally tested among heterogeneous past-year users . PARTICIPANTS Volunteer participants were 212 high-risk adolescents ( n = 138 ) and adults ( n = 74 ) aged 13 - 61 years from multiple community setting s. MEASUREMENTS The comprehensive assessment battery included several established measures of cannabis-related pathology for CUPIT validation , with DSM-IV/ICD-10 diagnoses of cannabis use disorders as criterion st and ard . FINDINGS Sixteen items loading highly on two subscales derived from principal components analysis exhibited good to excellent test-retest ( 0.89 - 0.99 ) and internal consistency reliability ( 0.92 , 0.83 ) , and highly significant ability to discriminate diagnostic subgroups along the severity continuum ( non-problematic , risky , problematic use ) . Twelve months later , baseline CUPIT scores demonstrated highly significant longitudinal predictive utility for respondents ' follow-up diagnostic group membership . Receiver operating characteristic ( ROC ) analysis identified a  CUPIT score of 12 to be the optimal cut-point for maximizing sensitivity for both currently diagnosable cannabis use disorder and those at risk of meeting diagnostic criteria in the following 12 months . CONCLUSIONS The CUPIT is a brief cannabis screener that is reliable , valid and acceptable for use across diverse community setting s and consumers of all ages . The CUPIT has clear potential to assist with achievement of public health goals to reduce cannabis-related harms in the community
The strongest levels of evidence for reliability exists in support of the Debrunner kyphometer , Spinal Mouse and Flexicurve index , and for validity supports the arcometer and Flexicurve index .
BACKGROUND A wide array of instruments are available for non-invasive thoracic kyphosis measurement .
Guidelines for selecting outcome measures for use in clinical and research practice recommend that properties such as validity and reliability are considered .
This systematic review reports on the reliability and validity of non-invasive methods for measuring  thoracic kyphosis .