Comparison of the University of California-Los Angeles Shoulder Scale and the Simple Shoulder Test with the shoulder pain and disability index: single-administration reliability and validity. Standardized Reporting of Clinical Practice Guidelines: A Proposal from the Conference on Guideline Standardization Protocol for the ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial: a pragmatic multi-centre randomised controlled trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults Development and Initial Validation of a Parent Report Measure of the Behavioral Development of Infants at Risk for Autism Spectrum Disorders The Social Communication Intervention Project: a randomized controlled trial of the effectiveness of speech and language therapy for school-age children who have pragmatic and social communication problems with or without autism spectrum disorder. Driving up the Quality and Relevance of Research Through the Use of Agreed Core Outcomes Shoulder disability questionnaire design and responsiveness of a functional status measure. Diagnosis and relation to general health of shoulder disorders presenting to primary care. Challenges in Evaluating Psychosocial Interventions for Autistic Spectrum Disorders Application of Platelet-Rich Plasma to Disorders of the Knee Joint Factor structure and psychometric properties of the revised Home Situations Questionnaire for autism spectrum disorder: The Home Situations Questionnaire-Autism Spectrum Disorder Systematic comparison of study quality criteria. Italian version of ASES questionnaire for shoulder assessment: cross-cultural adaptation and validation Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: a randomized clinical trial. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial The feasibility and validity of ambulatory self-report of psychotic symptoms using a smartphone software application Implementing PRISMA-P: recommendations for prospective authors Research Diagnostic Criteria for Temporomandibular Disorders: A Calibration and Reliability Study Effectiveness of Manual Physical Therapy for Painful Shoulder Conditions: A Systematic Review Analgesic efficacy of a lecithin-vehiculated diclofenac epolamine gel in shoulder periarthritis and lateral epicondylitis: a placebo-controlled, multicenter, randomized, double-blind clinical trial. Use of Condition-Specific Patient-Reported Outcome Measures in Clinical Trials among Patients with Wrist Osteoarthritis: A Systematic Review Comparison of customized versus standard exercises in rehabilitation of shoulder disorders Interventions on Bullying and Cyberbullying in Schools: A Systematic Review
BACKGROUND AND PURPOSE Shoulder scales are often used to evaluate treatment efficacy , yet little is known about the psychometric properties of these scales . Only one scale has undergone psychometric scrutiny : the Shoulder Pain and Disability Index ( SPADI ) . This study compared 2 shoulder measures -the University of California-Los Angeles ( UCLA ) Shoulder Scale and the Simple Shoulder Test (SST)-with the SPADI . SUBJECTS One hundred ninety-two patients with shoulder disorders were recruited from one physician 's office to complete the self-report sections of the 3 scales . METHODS Cronbach alpha values and st and ard errors of measurement ( SEM ) were calculated for each of the multi-item subscales . Validity was examined through calculation of correlation coefficients among the 3 scales . Factor analysis was completed to assess the underlying constructs of the SPADI and the SST . RESULTS Cronbach alpha values ranged from.85 to.95 . The SEM values for the multi-item scales ranged from 4.75 to 11.65 . Evidence for validity to reflect function was indicated by the correlation between the SST and the SPADI disability subscale . The factor analysis of the SPADI revealed loading on 1 factor , whereas the SST loaded on 2 factors . CONCLUSION AND DISCUSSION All scales demonstrated good internal consistency , suggesting that all items for each scale measure the same construct . However , the SEMs for all scales were high . Factor loading was inconsistent , suggesting that patients may not distinguish between pain and function 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 Background Proximal humeral fractures , which occur mainly in older adults , account for approximately 4 to 5 % of all fractures . Approximately 40 % of these fractures are displaced fractures involving the surgical neck . Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory . In particular it is not clear whether surgery gives better outcomes than non-surgical management . Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision . Methods / Design We aim to undertake a pragmatic UK-based multi-centre r and omised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus st and ard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck . The choice of surgical intervention is left to the surgeon , who must use techniques that they are fully experienced with . This will avoid ' learning curve ' problems . We will promote good st and ards of non-surgical care , similarly insisting on care-provider competence , and emphasize the need for comparable provision of rehabilitation for both groups of patients .We aim to recruit 250 patients from a minimum of 18 NHS trauma centres throughout the UK . These patients will be followed-up for 2 years . The primary outcome is the Oxford Shoulder Score , which will be collected via question naires completed by the trial participants at 6 , 12 and 24 months . This is a 12-item condition-specific question naire providing a total score based on the person 's subjective assessment of pain and activities of daily living impairment . We will also collect data for other outcomes , including general health measures and complications , and for an economic evaluation . Additionally , we plan a systematic collection of reasons for non- inclusion of eligible patients who were not recruited into the trial , and their baseline characteristics , treatment preferences and intended treatment . Discussion This article presents the protocol for a multi-centre r and omised controlled trial . It gives extensive details of , and the basis for , the chosen methods , and describes the key measures taken to avoid bias and to ensure validity . Trial Registration Current Controlled Trials IS RCT We developed and evaluated a new parent report instrument — Parent Observation of Early Markers Scale (POEMS)—to monitor the behavioral development of infants at risk for autism spectrum disorder ( ASD ) because they have older affected siblings . Parents of 108 at-risk infants ( 74 males , 34 females ) completed the POEMS from child age 1–24 months . The POEMS had acceptable psychometric properties and promising predictive validity . Most concerning items were social and communication deficits , and intolerance to waiting . Results provide preliminary evidence that prospect i ve parent report measures can help to detect early ASD symptoms in infants at biological risk . We invite research ers to join us in multi-center studies of the POEMS BACKGROUND Children who show disproportionate difficulty with the pragmatic as compared with the structural aspects of language are described as having pragmatic language impairment ( PLI ) or social communication disorder ( SCD ) . Some children who have PLI also show mild social impairments associated with high-functioning autism or autism spectrum disorder ( ASD ) . There is little robust evidence of effectiveness of speech- language interventions which target the language , pragmatic or social communication needs of these children . AIMS To evaluate the effectiveness of an intensive manualized social communication intervention ( SCIP ) for children who have PLI with or without features of ASD . METHODS & PROCEDURES In a single-blind RCT design , 88 children with pragmatic and social communication needs aged 5;11 - 10;8 , recruited from UK speech and language therapy services , were r and omly assigned in a 2:1 ratio to SCIP or to treatment-as-usual . Children in the  SCIP  condition received up to 20 sessions of direct intervention from a specialist research speech and language therapist working with supervised assistants . All therapy content and methodology was derived from an intervention manual . A primary outcome measure of structural language and secondary outcome measures of narrative , parent-reported pragmatic functioning and social communication , blind-rated perceptions of conversational competence and teacher-reported ratings of classroom learning skills were taken pre-intervention , immediately post-intervention and at 6-month follow-up . Analysis was by intention to treat . OUTCOMES & RESULTS No significant treatment effect was found for the primary outcome measure of structural language ability or for a measure of narrative ability . Significant treatment effects were found for blind-rated perceptions of conversational competence , for parent-reported measures of pragmatic functioning and social communication , and for teacher-reported ratings of classroom learning skills . CONCLUSIONS & IMPLICATION S There is some evidence of an intervention effect on blind and parent/teacher-reported communication outcomes , but not st and ardized language assessment outcomes , for 6 - 11-year-old children who have pragmatic and social communication needs . These findings are discussed in the context of the increasingly central role of service user outcomes in providing evidence for an intervention . The substantial overlap between the presence of PLI and ASD ( 75 % ) across the whole cohort suggests that the intervention may also be applicable to some verbally able children with ASD who have pragmatic communication needs There is a growing recognition that insufficient attention has been paid to the selection of the outcomes to measure in clinical trials and clinical audit . Outcomes need to be relevant to patients , clinicians , purchasers and policy-makers if the findings of research are to influence practice and future research . In addition , st and ardization of outcomes is needed to combine data from different studies to allow evidence synthesis and to compare data sets . Inconsistent choice of outcome measures means that many meta-analyses are unable to include data from all the relevant studies . For example , the five most accessed Cochrane review s in 2009 , together with the top cited review in that year , all described inconsistencies in the outcomes reported in eligible trials . A call for the st and ardization of outcomes is a regular conclusion of systematic review s. Furthermore , outcome reporting bias , defined as the bias arising from selecting outcomes for publication based on the results , affects many r and omized trials and ‘ is an under-recognized problem that affects the conclusions in a substantial proportion of Cochrane review s ’ . That bias is likely to affect systematic review s more widely as well as affecting individual studies when considered on their own . Similar problems occur with clinical audit , highlighting the importance of establishing national audits that use and report the same outcomes for all participants . All these issues could be addressed with the development and application of agreed st and ardized sets of outcomes that have been termed ‘ core outcome sets ’ . These should be measured and reported , as a minimum , in all relevant clinical trials and national clinical audits for a specific condition . Adopting a core outcome set does not imply that a particular study , review or audit should be restricted to only those outcomes . Rather , the expectation is that , as a minimum , core outcomes will always be collected and reported to allow the results of trials to be compared , contrasted and combined as appropriate . The adoption of core outcomes would have implication s across all areas of research in health and health care , reduce heterogeneity between trials , and lead to research that is more likely to have measured relevant outcomes . Importantly , they would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information . In addition , they will increase the efficiency and value of research . An important rationale for core outcome sets is that outcomes currently reported for trials do not consistently reflect endpoints that are meaningful for patients . Examples exist where trials failed to include all outcomes important to patients and where involvement of patients has identified an outcome that might not have been considered by practitioners on their own . Despite increasing recognition of the importance of incorporating patients ’ opinions , their involvement has been limited . Recent regulatory guidance in the USA requires documented evidence of patient input during the development of instruments to measure  patient reported outcomes ( PROs ) . However , measurement of PROs in clinical trials is hampered by the multiplicity and heterogeneity of tools currently available . Many generic , disease and domain-specific instruments have been developed and vali date d , each containing multiple scales and items . As a result , synthesis of PRO data from trials is difficult and review s aim ing to summarize treatment effect according to PROs may fail . There is synergy between the development of core outcome sets for trials and work to select up to seven outcomes that are important to patients for inclusion in Summary of Findings tables in systematic review s. Developed by the GRADE group ( http://www . grade workinggroup.org ) , Cochrane review s have featured such tables since 2008 , and they play a key role in presenting research in guidelines , such as those produced by the World Health Organization ( WHO ) . The development of core outcome sets needs to be accelerated and undertaken in ways that maximize efficiency . The COMET ( Core Outcome Measures in Effectiveness Trials , http://www.comet-initiative.org ) Initiative in the UK brings together research ers interested in the development and application of core outcome sets . These include key participants in a collaboration of research ers in rheumatology who have done the most notable work to date in this area . The COMET Initiative was launched in January 2010 , with a second meeting in July 2011 . Attendees included trialists , systematic review ers , patients , clinicians , journal editors , research funders , policy-makers , people responsible for trials registries and regulators . Data on individual studies , both published and ongoing , are being included in a free , publically available internet-based re source . This will be up date d periodically , to minimize the risk of duplication . Seventy-eight published or ongoing studies have already been entered into the repository . In addition , published review s of outcomes used in clinical trials or studies examining patients ’ views , will be entered The Shoulder Disability Question naire ( SDQ ) is a measure covering 16 items design ed to evaluate functional status limitation in patients with shoulder disorders . The responsiveness of the SDQ was evaluated for 180 patients with soft tissue shoulder disorders , without underlying systemic disorders . These patients participated in a r and omized placebo-controlled trial , in which ultrasound and electrotherapy appeared to be ineffective as adjuvants to st and ardized exercise therapy . At baseline and at 6-week follow-up , patients completed the  SDQ  and rated severity of shoulder pain and their chief complaint , while a research physiotherapist rated severity of symptoms and restriction of mobility . At the 6-week follow-up , patients also rated overall change since baseline . According to the calibrated responsiveness ratio ( CRR ) and the area under the receiver-operator characteristic curve ( AUC ) the SDQ discriminates accurately between self-rated clinical ly stable and improved subjects . The presented results suggest that the SDQ is as responsive as the compared outcome measures , and therefore is ready for use in clinical trials OBJECTIVES To prospect ively evaluate the incidence , spectrum of disease and relation to general health of shoulder disorders in primary care . METHODS Patients presenting with shoulder pain to two large general practice s in the Cambridge area over a 1-month period were invited to participate . After consulting their general practitioner , patients were administered a demographic information question naire , a shoulder pain and disability index ( SPADI ) and a short form 36 ( SF-36 ) health survey . Subsequent review in a clinic held by a rheumatology registrar every 2 weeks was undertaken . RESULTS The sex- and age-st and ardized incidence of shoulder pain was 9.5 per 1000 ( 95 % confidence interval 7.9 to 11.2 per 1000 ) . Rotator cuff tendinopathy was found in 85 % , signs of impingement in 74 % , acromioclavicular joint disease in 24 % , adhesive capsulitis in 15 % and referred pain in 7 % . On the SPADI the mean disability subscale score was 45 ( 95 % confidence interval 41 to 50 ) and the mean pain score was 58 ( 95 % confidence interval 53 to 62 ) ( range 0 to 100 ) . Evaluation of general health status using the SF-36 showed the difference between population norms and those with shoulder pain was significant in six of the eight domains , being especially marked ( greater than 20 point reduction ) for emotional role , physical function and physical role . CONCLUSION Shoulder pain , most commonly due to rotator cuff tendinopathy , is associated with significantly reduced health when measured by both specific and generic means . Effort towards prevention and early intervention in these complaints is warranted In 2002 , the National Institutes of Health sponsored a meeting concerning method ological challenges of research in psychosocial interventions in Autism Spectrum Disorders . This paper provides a summary of the presentations and the discussion s that occurred during this meeting . Recommendations to federal and private agencies included the need for r and omized clinical trials of comprehensive interventions for autism as the highest , but not the sole priority . Ongoing working groups were proposed to address psychosocial interventions with a focus on relevant statistics , st and ardized documentation and methods of diagnosis , development of outcome measures , establishment of st and ards in research ; and the need for innovative treatment design s , including application of design s from other research areas to the study of interventions in ASD Importance : The promising therapeutic potential and regenerative properties of platelet-rich plasma ( PRP ) have rapidly led to its widespread clinical use in musculoskeletal injury and disease . Although the basic scientific rationale surrounding PRP products is compelling , the clinical application has outpaced the research . Objective : The purpose of this article is to examine the current concepts around the basic science of PRP application , different preparation systems , and clinical application of PRP in disorders in the knee . Evidence Acquisition : A systematic search of PubMed for studies that evaluated the basic science , preparation and clinical application of platelet concentrates was performed . The search used terms , including platelet-rich plasma or PRP preparation , activation , use in the knee , cartilage , ligament , and meniscus . Studies found in the initial search and related studies were review ed . Results : A comprehensive review of the literature supports the potential use of PRP  both nonoperatively and intraoperatively , but highlights the absence of large clinical studies and the lack of st and ardization between method , product , and clinical efficacy . Conclusions and Relevance . In addition to the call for more r and omized , controlled clinical studies to assess the clinical effect of PRP , at this point , it is necessary to investigate PRP product composition and eventually have the ability to tailor the therapeutic product for specific indications Previously , we adapted the Home Situations Question naire to measure behavioral non-compliance in everyday setting s in children with pervasive developmental disorders . In this study , we further revised this instrument for use in autism spectrum disorder and examined its psychometric properties ( referred to as the Home Situations Question naire-Autism Spectrum Disorder ) . To cover a broader range of situations and improve reliability , we prepared seven new items describing situations in which children with autism spectrum disorder might display non-compliance . Parents completed ratings of 242 children with autism spectrum disorder with accompanying disruptive behaviors ( ages 4–14 years ) participating in one of two r and omized clinical trials . Results from an exploratory factor analysis indicated that the Home Situations Question naire-Autism Spectrum Disorder consists of two 12-item factors : Socially Inflexible ( α = 0.84 ) and Dem and Specific ( α = 0.89 ) . One-to-two-week test – retest reliability was statistically significant for all scored items and also for subscale totals . The pattern of correspondence between the Home Situations Question naire-Autism Spectrum Disorder and parent-rated problem behavior , clinician-rated repetitive behavior , adaptive behavior , and IQ provided evidence for concurrent and divergent validity of the Home Situations Question naire-Autism Spectrum Disorder . Overall , the results suggest that the Home Situations Question naire-Autism Spectrum Disorder is an adequate measure for assessing non-compliance in a variety of situations in this population , and use of its two subscales will likely provide a more refined interpretation of ratings Approaches for the systematic review and evaluation of chemical toxicity are currently being reconsidered , with a specific focus on the evaluation of individual studies and their integration into the overall body of evidence . This renewed interest has arisen , in part , as a result of several prominent review s of these approaches by special committees of the National Research Council ( NRC ) , among others . We conducted a critical evaluation of several available frameworks for evaluating study quality . We assessed the criteria separately for human , animal , and in vitro studies as well as for systematic review s. We then evaluated commonalities across disciplines . We also considered the potential implication s of applying criteria frameworks and how they bear on fundamental risk assessment questions . We found that the available frameworks within each discipline differed in terms of their intended purpose and level of guidance for decision making . All the frameworks across disciplines shared common themes , however , including the adequate reporting of specific details of study conditions and design / protocol , selection and r and omization of study groups ( where applicable ) , outcome assessment methods and applicability ( e.g. , validity and reliability ) , avoidance of selective reporting , and the consideration of potential confounders or bias . We identified the most informative study quality considerations , which will enable research ers to implement more objective and st and ardized methods for evaluating studies and , ultimately , improve risk assessment methods The patient-oriented measures , represented by self-administered question naire , have become an important aspect of clinical outcome assessment . To be used with different language groups and in different countries , question naires must be translated and adapted to new cultural characteristics and then vali date d by a widely accepted process to evaluate reliability and validity , fundamental characteristic for each measure . The aim of the study is to perform the cross-cultural adaptation and to assess the Italian version instrument reliability and validity . The study design is a cross-cultural adaptation and cross-sectional study of a sample of patients affected by shoulder disorder with a sub sample followed prospect ively for retest reliability . The American Shoulder and Elbow Surgeons St and ardized Shoulder Assessment Form was culturally adapted for Italian-speaking people , following the simplified Guillemin criteria . Reliability and validity were assessed in a cross-sectional study of 50 consecutive patients affected by shoulder disorder . A sub- sample of 20 patients was followed prospect ively for retest reliability . The results were compared with other vali date d patient-oriented measures . The ASES scales showed a high correlation with other patient-oriented measures , as hypothesized , and it also showed good values with regard to reproducibility , consistency and validity , to the original versions published in English . These findings suggest that the evaluation capacities of the Italian version of ASES are equivalent to those of English language version IMPORTANCE Disruptive behavior is common in children with autism spectrum disorder . Behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale r and omized trials . OBJECTIVE To evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior . DESIGN , SETTING , AND PARTICIPANTS This 24-week r and omized trial compared  parent training ( n = 89 ) to parent education ( n = 91 ) at 6 centers ( Emory University , Indiana University , Ohio State University , University of Pittsburgh , University of Rochester , Yale University ) . We screened 267 children ; 180 children ( aged 3 - 7 years ) with autism spectrum disorder and disruptive behaviors were r and omly assigned ( 86 % white , 88 % male ) between September 2010 and February 2014 .  INTERVENTIONS Parent training ( 11 core , 2 optional sessions ; 2 telephone boosters ; 2 home visits ) provided specific strategies to manage disruptive behavior . Parent education ( 12 core sessions , 1 home visit ) provided information about autism but no behavior management strategies . MAIN OUTCOMES AND MEASURES Parents rated disruptive behavior and noncompliance on co- primary outcomes : the Aberrant Behavior Checklist-Irritability subscale ( range , 0 - 45 ) and the Home Situations Question naire-Autism Spectrum Disorder ( range , 0 - 9 ) . On both measures , higher scores indicate greater severity and a 25 % reduction indicates clinical improvement . A clinician blind to treatment assignment rated the Improvement scale of the Clinical Global Impression ( range , 1 - 7 ) , a secondary outcome , with a positive response less than 3 . RESULTS At week 24 , the Aberrant Behavior Checklist-Irritability subscale declined 47.7 % in parent training ( from 23.7 to 12.4 ) compared with 31.8 % for parent education ( 23.9 to 16.3 ) ( treatment effect , -3.9 ; 95 % CI , -6.2 to -1.7 ; P < .001 , st and ardized effect size = 0.62 ) . The Home Situations Question naire-Autism Spectrum Disorder declined 55 % ( from 4.0 to 1.8 ) compared with 34.2 % in parent education ( 3.8 to 2.5 ) ( treatment effect , -0.7 ; 95 % CI , -1.1 to -0.3 ; P < .001 , st and ardized effect size = 0.45 ) . Neither measure met the prespecified minimal clinical ly important difference . The proportions with a positive response on the Clinical Global Impression-Improvement scale were 68.5 % for parent training vs 39.6 % for parent education ( P < .001 ) . CONCLUSIONS AND RELEVANCE For children with autism spectrum disorder , a 24-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes , although the clinical significance of the improvement is unclear . The rate of positive response judged by a blinded clinician was greater for parent training vs parent education . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01233414 Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability .  Physiotherapy is often the first choice of treatment although its effectiveness is still under debate . Systematic review s in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome . Methods / Design This r and omized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement , involving 90 participants aged 18 - 75 . Participants are recruited from outpatient physiotherapy clinics , general practitioners , and orthopaedic surgeons in Germany . Eligible participants will be r and omly allocated to either individualized physiotherapy or to a st and ard exercise protocol using central r and omization . The control group will perform the st and ard exercise protocol aim ing to restore muscular deficits in strength , mobility , and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements . Participants of the intervention group will perform the st and ard exercise protocol as a home program , and will additionally be treated with individualized physiotherapy based on clinical examination results , and guided by a decision tree . After the intervention phase both groups will continue their home program for another 7 weeks . Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients ' global impression of change , the generic patient-specific scale , the average weekly pain score , and patient satisfaction with treatment . Additionally , the fear avoidance beliefs question naire , the pain catastrophizing scale , and patients ' expectancies of treatment effect are assessed . Participants ' adherence to the protocol , use of additional treatments for the shoulder , direct and indirect costs , and sick leave due to shoulder complaints will be recorded in a shoulder log-book . Discussion To our knowledge this is the first trial comparing individualized physiotherapy based on a defined decision making process to a st and ardized exercise protocol . Using high- quality method ologies , this trial will add evidence to the limited body of knowledge about the effect of physiotherapy in patients with SIS.Trial registration Current Controlled Trials IS RCT Background Semi-structured interview scales for psychosis are the gold st and ard approach to assessing psychotic and other symptoms . However , such assessment s have limitations such as recall bias , averaging , insensitivity to change and variable interrater reliability . Ambulant , real-time self-report assessment devices may hold advantages over interview measures , but it needs to be shown that the data thus collected are valid , and the collection method is acceptable , feasible and safe . We report on a monitoring system for the assessment of psychosis using smartphone technology . The primary aims were to : i ) assess validity through correlations of item responses with those on widely accepted interview assessment s of psychosis , and ii ) examine compliance to the procedure in individuals with psychosis of varying severity . Methods A total of 44 participants ( acute or remitted DSM-4 schizophrenia and related disorders , and prodromal ) completed 14 branching self-report items concerning key psychotic symptoms on a touch-screen mobile phone when prompted by an alarm at six pseudo-r and om times , each day , for one week . Face to face PANSS and CDS interviews were conducted before and after the assessment period blind to the ambulant data . Results Compliance as defined by completion of at least 33 % of all possible data -points over seven days was 82 % . In the 36 compliant participants , 5 items ( delusions , hallucinations , suspiciousness , anxiety , hopelessness ) showed moderate to strong ( rho 0.6 - 0.8 ) associations with corresponding items from interview rating scales . Four items showed no significant correlation with rating scales : each was an item based on observable behaviour . Ambulant ratings showed excellent test-retest reliability and sensitivity to change . Conclusions Ambulatory monitoring of symptoms several times daily using smartphone software applications represents a feasible and valid way of assessing psychotic phenomena for research and clinical management purpose s. Further evaluation required over longer assessment periods , in clinical trials and service setting Systematic review s have become very popular . A recent estimate suggests that 22 new systematic review s are published daily [ 1 ] . One reason for this interest is that they serve many purpose s. For example , the influential Institute of Medicine has indicated that a systematic review is an essential component when developing clinical practice guidelines within the USA [ 2 ] . Some granting agencies are now advocating for the use of systematic review s as an evidence -based rationale for the conduct of a proposed r and omized trial [ 3 ] . And journals are now dem and ing the use of systematic review s to provide readers with context of the results of a clinical trial [ 4 ] . For systematic review s to be useful , they need to be reported in the highest possible quality thus facilitating their accurate use across a wide spectrum of stakeholders , including patients . Unfortunately , surveys of the published literature indicate that the quality of reporting is not optimal . For example , there is evidence indicating that reporting biases , particularly selective outcome reporting , is prevalent . An early example of differences between outcomes reported in protocol s and the paired completed review was an examination of 47 Cochrane review s in which 43 ( 91 % ) contained a major change , such as the addition or deletion of outcomes  , between the protocol and the full publication [ 5 ] . More recently , in an examination of 485 Cochrane protocol - review pairs , 38 % ( 95 % CI 23 to 54 % ) were found to have discrepant outcomes ( i.e. , added , omitted , or changed the priority ) between the protocol and completed review [ 6 ] . The vast majority of these discrepancies were without attribution with more significant outcomes being up grade d or added . Whether or not , and to what extent , these examples reflect reporting biases is not clear . However , they represent inconsistencies that should be avoided by authors . The gold st and ard for identifying reporting biases is a comparison of the completed review with its paired protocol . Such an examination is difficult with systematic review s as too few of them report working from a protocol , although a growing number of funders are now requiring them . Perhaps , systematic review ers do not report or use protocol s because there has been little guidance on how to report them until recently . To help facilitate the use of reporting systematic review protocol s , the three of us and several colleagues developed Preferred Reporting Items for Systematic Review and Meta- Analysis Protocol s ( PRISMA -P ) [ 7 ] . This is a reporting guideline consisting of a 17-item checklist , to help prospect i ve authors in the preparation and reporting of a scientifically rigorous systematic review protocol . We also prepared a pedagogical explanation and elaboration document to facilitate its use [ 8 ] . Readers appear interested in the guidance . Since its publication a little more than a year ago , it has been downloaded about 45,000 times and cited ( Google scholar ) nearly 100 times . This journal and others have endorsed PRISMA -P. Here , we describe how the journal intends to implement it . All protocol su bmi ssions to the journal should use continuous line numbering in their manuscript . Authors should also include a completed PRISMA -P checklist indicating whether or not the requested item information is reported ( by completing the check mark ) . If the item is checked , authors should then specify the line number ( or range of line numbers ) where this information is described . Manuscripts accepted for publication will have the completed PRIMSA-P checklist ( on su bmi ssion ) included as an Appendix to their publication , which must be referenced within the main text ( Additional file 1 ) . Prospect i ve authors can download a Word version of the PRISMA -P checklist , which includes the two added columns , from the journal ’s website ( URL to be added)or the PRISMA website ( ttp://www . prisma -statement.org/Extensions/ Protocol s.aspx ) . If PRISMA -P was used to help report the protocol , it should be cited or the PRISMA -P URL ( http://www . prisma -statement.org/Extensions/ Protocol s.aspx ) on the PRISMA website should be reported . About half of what the journal publishes are protocol s of systematic review s. We want to ensure they are published to the highest possible quality . Endorsement and implementation of reporting guidelines appears to improve the completeness of reporting . For example , a systematic review examining the completeness of reporting in more than 16,000 r and omized trials in journals that endorsed the CONSORT statement , compared to journals that did not , found more complete reporting [ 9 ] . Similarly , examining 300 systematic review s published in February 2014 found that mention of PRISMA was associated with better reporting [ 1 ] . There is always a tension between an optimal implementation strategy and ensuring minimal barriers to su bmi ssion for prospect i ve authors . We believe the journal has achieved a good balance with this strategy . Protocol s su bmi tted for publication consideration from now on that do not include a completed checklist , including the two aforementioned columns , will be returned to the authors with instructions about the journal ’s systematic review protocol implementation strategy and invited to resu bmi t their continuously line numbered manuscript and appropriately completed checklist Abstract The aim of this study was to investigate the reliability between different examiners when using the axis I of the Research Diagnostic Criteria for Temporom and ibular Disorders ( RDC/TMD ) . The hypothesis was that the st and ardized RDC/TMD examination protocol enables calibrated examiners to evaluate all examination items reliably . After calibration training by the RDC/TMD calibration team including the calibration of palpation pressure and the performance of the st and ardized examination protocol , four examiners , blinded to the patients ’ medical histories examined 24 subjects in a r and omized sequence . One experienced examiner was the st and ard ( hierarchical calibration ) . The recorded measurements strictly followed the RDC/TMD . Intraclass correlation coefficients ( ICC ) , bias and precision were calculated to estimate interrater reliability . Acceptable ( 0.75≥ICC>0.4 ) to excellent ( ICC>0.75 ) reliability was found for 20 of the 23 ( 87 % ) examinations . Only sub-retrom and ibular muscle palpation and joint sound vibration recordings on lateral excursion showed poor- results ( ICC≤0.4 ) . The RDC/TMD examination protocol enables calibrated examiners to perform most ( 87 % ) examination items with satisfactory reliability . Therefore multi-site studies based on the RDC/TMD examination protocol may become feasible , keeping in mind the unsatisfactory reliability of 13 % of the items ( clicking during laterotrusion to the ipsilateral side , palpation of the posterior and subm and ibular region ) Abstract Multiple disease-specific systematic review s on the effectiveness of physical therapy intervention for shoulder dysfunction have been inconclusive . To date , there have been two systematic review s that examined manual therapy specifically but both considered effects within diagnoses . The purpose of this systematic review was to identify the effectiveness of manual therapy to the glenohumeral joint across all painful shoulder conditions . A search of MEDLINE , CINAHL , Web of Science , and Cochrane Central Register of R and omized Controlled Trials for articles date d 1996 to June 2009 was performed . Inclusion for review were  manual therapy performed to the glenohumeral joint only ; non-surgical painful shoulder disorders ; subjects 18 - 80 years ; and outcomes of range of motion , pain , function , and /or quality of life . Quality assessment was performed using the PEDro scale with subsequent data extraction . Seventeen related articles were found with seven fitting the inclusion criteria . The average PEDro score was 7.86 , meeting the cutoff score for high quality . Significant heterogeneity in outcome measures prohibited meta- analysis . Five studies demonstrated benefits utilizing manual therapy for mobility , and four demonstrated a trend towards decreasing pain values . Functional outcomes and quality -of-life measures varied greatly among all studies . Manual therapy appears to increase either active or passive mobility of the shoulder . A trend was found favoring manual therapy for decreasing pain , but the effect on function and quality of life remains inconclusive . Future research utilizing consistent outcome measurements is necessary Diclofenac epolamine ( 2-hydroxyethyl-pyrrolidine ) ( DHEP ) is a diclofenac salt endowed with enhanced cutaneous permeation . To optimize its absorption after topical application , a lecithin-enriched DHEP 1.3 % gel has been developed ( DHEP lecithin gel ) and investigated in patients with shoulder periarthritis and lateral epicondylitis in a placebo-controlled , multicenter double-blind clinical trial . One hundred fifty-eight patients were r and omized to a 10-day treatment with DHEP lecithin gel or placebo ( 5 g t.i.d . applied on the painful area ) . The efficacy criteria were pain measured by visual analog scale ( VAS ) while performing a specific st and ardized movement , intake of rescue medication ( paracetamol ) , and the disabilities of the arm , shoulder and h and ( DASH ) question naire . VAS scores indicated a consistently higher analgesic activity of DHEP lecithin gel . At day 3 , pain was reduced by -20.1 + /- 20.2 and -9.9 + /- 12.7 mm in the DHEP lecithin gel- and placebo-treated patients , respectively ( p < 0.001 ) ; at day 6 of treatment , DHEP lecithin gel induced a pain reduction of -33.2 + /- 26.1 mm , while the reduction achieved with placebo was only -21.2 + /- 18.8 mm ( p < 0.001 ) . The mean changes in DASH question naire indicated that DHEP lecithin gel was more effective than placebo in improving patient well-being and reducing difficulties in performing the activities most severely impaired by rheumatism , while no difference was observed between the two treatments in consumption of rescue medication . In conclusion , these results indicate that DHEP lecithin gel is a topically effective analgesic product in patients with shoulder periarthritis or lateral epicondylitis and provide further evidence on the use of topical nonsteroidal anti-inflammatory drugs as an optimal approach to the treatment of localized musculoskeletal disorders 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 Objective ( s ) : ( 1 ) To compare the effectiveness of customized exercises with that of st and ard exercises for the treatment of patients with shoulder disorders . ( 2 ) To determine whether four weeks or eight weeks would be needed to see improvement in outcome measures . Design : A single-blinded r and omized clinical trial . Setting : An outpatient physical therapy clinic affiliated with an academic institution . Subjects : Thirty patients with shoulder disorders were tested and treated between February 2003 and December 2004 . Interventions : Patients were r and omized to a customized or st and ard exercise group . Each patient first underwent a st and ardized physical therapy assessment . Based on the results of the assessment , a classification was determined and a classification-specific exercise programme was instructed to the patients in the customized exercise group . The st and ard exercise group , regardless of classification , received preselected st and ard exercises . Both groups were followed for eight weeks . Main measures : Shoulder range of motion , strength , pain intensity and function were assessed three times ( weeks 0 , 4 and 8) . Results : There were no significant differences between the customized and st and ard exercise groups in measures of shoulder range of motion , strength , pain intensity and function after four or eight weeks of exercise . Patients in both groups had significant improvements in shoulder strength , pain intensity and function . Significant improvements occurred at week 8 , but not at week 4 . Conclusion : The customized shoulder exercises did not provide additional benefit to our shoulder patients than the st and ard exercises Background : bullying ( and cyberbullying ) is a widespread phenomenon among young people and it is used to describe interpersonal relationships characterized by an imbalance of power . In this relationships often show aggressive behavior and intentional " harm doing " repeated over time . The prevalence of bullying among youth has been reported to vary widely among countries ( 5.1%-41.4 % ) and this behavior seems generally higher among student boys than girls . Several school interventions have been developed to reduce bullying , but reported inconsistent results possibly related to limitations in the study design or to other method ological shortcomings . Aims : evaluating r and omized-controlled trials ( RTCs ) conducted between 2000 and 2013 to assess the effectiveness of  school interventions on  bullying  and cyberbullying  . Methods : a systematic search of the scientific literature was conducted on Pubmed / Medline and Ebsco online data bases . We also contacted experts in the field of preventive bullying research . Results : 17 studies met the inclusion criteria . The majority of studies did not show positive effects in the long term ; the interventions focused on the whole school were more effective in reducing bullying than interventions delivered through classroom curricula or social skills training alone . Conclusion : while there is evidence that programs aim ed at reducing bullying can be effective in the short term , their long-term effectiveness has not been established , and there are important differences in the results based on gender , age and socio-economic status of participants . Internal inconsistency in the findings of some studies , together with the wide variability of experimental design s and lack of common st and ardized measures in outcome evaluation , are important limitations in this field of research
They have been shown to be valid , reliable , and responsive , with a low administration burden .
BACKGROUND The aim of this study was to perform a st and ardized and systematic evaluation of the available evidence on multi-item shoulder-specific patient-reported outcome measures that are applicable to a wide spectrum of disorders .