ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/ SCCT/SCMR/SIR 2008 Key Data Elements and Definitions for Cardiac Imaging: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Cardiac I Echocardiographic guidance and assessment of percutaneous repair for mitral regurgitation with the Evalve MitraClip: lessons learned from EVEREST I. Stepwise introduction of a bone-conserving osseointegrated hip arthroplasty using RSA and a randomized study: II. Clinical proof of concept—40 patients followed for 2 years Multicenter comparison of two clinical decision rules for the use of radiography in acute, high-risk knee injuries. Two-year migration results of the ReCap hip resurfacing system—a radiostereometric follow-up study of 23 hips Stepwise introduction of a bone-conserving osseointegrated hip arthroplasty using RSA and a randomized study: I. Preliminary investigations—52 patients followed for 3 years Enhanced implant stability with a chemically modified SLA surface: a randomized pilot study. Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study The next critical role of orthopedic registries Patient-matched instruments versus standard instrumentation in total knee arthroplasty: a prospective randomized study Standardized Reporting of Clinical Practice Guidelines: A Proposal from the Conference on Guideline Standardization ACC/AHA Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: Executive Summary--a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Pacemaker Implantation). Radiostereometric analysis of keeled versus pegged glenoid components in total shoulder arthroplasty: a randomized feasibility study Editorial: Standards of Reporting: The CONSORT, QUORUM, and STROBE Guidelines Patient-specific Total Knee Arthroplasty Required Frequent Surgeon-directed Changes Introducing new technology: a stepwise algorithm. Comparison of Clinical and Radiographic Outcomes of Platform-Switched Implants with a Rough Collar and Platform-Matched Implants with a Smooth Collar: A 1-Year Randomized Clinical Trial.
The American College of Cardiology ( ACC ) and the American Heart Association ( AHA ) support their members ’ goal to improve the prevention and care of cardiovascular diseases through professional education , research , development of guidelines and st and ards , and by fostering policy that supports optimal patient outcomes . The ACC and AHA recognize the importance of the use of clinical data st and ards for patient management , to assess outcomes , and conduct research , and the importance of defining the processes and outcomes of clinical care , whether in r and omized trials , observational studies , registries , or quality improvement initiatives . Hence , clinical data st and ards strive to define and st and ardize data relevant to clinical topics in cardiology , with the primary goal of assisting data collection by providing a platform OBJECTIVE Percutaneous mitral repair is rapidly developing as an alternative to cardiac surgery in select patients . The Evalve percutaneous E2E system uses the MitraClip to replicate the surgical suture-based approach . This procedure requires real-time echocardiographic guidance in a unique and significant collaboration between echocardiographer and interventionalist . transesophageal echocardiography ( TEE ) is used as the primary imaging modality to guide this procedure and is essential to its success . METHODS In EVEREST I , the US multicenter phase I safety and feasibility trial , 47 patients with 3 or 4 + mitral regurgitation ( MR ) were enrolled . The trial involved a st and ardized echocardiographic imaging protocol with a st and ardized anatomic-based vocabulary , predetermined st and ard TEE views , preprocedural strategy meetings , and display of echocardiographic aids to optimize communication and procedural efficiency during placement of the clip . RESULTS TEE guidance facilitated the creation of a double-orifice mitral valve in all 47 patients enrolled ( 100 % ) , and 40 patients were discharged with 1 or more clips ( 85 % ) . At discharge , successful placement of a clip and < or= 2 + MR was present in 34 patients ( 74 % ) . The st and ardized approach contributed to a reduction in the time to perform the procedure over the course of the trial at both initial and new sites . CONCLUSIONS TEE is essential to the guidance of percutaneous MitraClip E2E repair . A streamlined approach to echocardiographic guidance , using predetermined st and ardized views , a common anatomic-based vocabulary , preprocedural strategy meetings , and a display of echocardiographic aids in the catheterization laboratory shortens the procedure time and allows for efficient percutaneous repair Background We have developed a bone-conserving commercially pure titanium hip replacement system using osseointegration principles : a metaphyseal loading proximal femoral component affixing into the retained neck and metaphysis only , leaving the femoral canal untouched . The acetabular cup closely fits a dual-geometry cavity , avoiding stress protection at the dome . Patients and methods After extensive laboratory and clinical pilot trial investigations , the surface-engineered implants were su bmi tted to a prospect i ve r and omized controlled clinical trial involving 40 patients ( 40 hips ) , in which they were compared to the cemented Spectron femoral component and cementless Trilogy cup as control implant . The following clinical measures were used to monitor progress at regular intervals for the first 2 postoperative years : radiostereometric analysis ( RSA ) , Harris Hip Score , pain score , WOMAC , and SF-36 . Results After 2 years of follow-up , no statistically significant differences were seen between the groups concerning rotation or translation along the cardinal axes . The patients receiving the Gothenburg osseointegrated titanium ( GOT ) system had significantly higher Harris Hip Score at 6 months , suggesting more rapid recovery . WOMAC , SF-36 and pain analysis were similar for the first 2 postoperative years . Interpretation Our RSA data suggest that osseointegration was achieved for all patients receiving the GOT hip system . This bone-conserving prosthesis may provide a good alternative , especially for young and active patients STUDY OBJECTIVE Two separate clinical decision rules , one developed in Ottawa and the other in Pittsburgh , for the use of radiography in acute knee injuries have been previously vali date d and published . In this study , the rules were prospect ively vali date d and compared in a new set of patients . METHODS A prospect i ve , blinded , multicenter trial was conducted in the emergency departments of three urban teaching hospitals . A convenience sample of 934 patients with knee pain requiring radiographs was enrolled . A st and ardized data form was completed for each patient , comprising the 10 clinical variables included in the two rules . St and ard knee radiographs were then taken in each patient . The rules were interpreted by the primary investigator on the basis of the data sheet and the final radiologist radiograph reading . RESULTS In the 745 patients in whom the Pittsburgh rules could be applied there were 91 fractures ( 12.2 % ) . The use of the Pittsburgh rule missed one fracture , yielding a sensitivity of 99 % ( 95 % confidence interval [ CI ] , 94 % to 100 % ) ; the specificity was 60 % ( 95 % CI , 56 % to 64 % ) . The Ottawa inclusion criteria were met by 750 patients , with 87 fractures ( 11.6 % ) . The Ottawa rule missed three fractures , for a sensitivity of 97 % ( 95 % CI , 90 % to 99 % ) ; specificity was 27 % ( 95 % CI , 23 % to 30 % ) . CONCLUSION Prospect i ve validation and comparison found the Pittsburgh rule for knee radiographs to be more specific without loss of sensitivity compared with the Ottawa rule There has been renewed interest for metal-on-metal hip resurfacing due to improved design and manufacturing of implants , better material s , and enhanced implant fixation . In contrast to conventional total hip replacements , only a few clinical hip resurfacing trials using radiostereometry ( RSA ) have been reported , and solely for the Birmingham hip resurfacing arthroplasty . The purpose of this RSA trial was to describe the migration pattern of a  new hip resurfacing system ( ReCap ) within the first two years after primary surgery . Twenty-six patients underwent total hip replacement .  The patients were followed-up for up to 24 months and were evaluated with the use of radiostereometric measurements .  The prosthesis showed mean translations and rotation close to zero . Maximum translation was seen along the transverse axis in the medial direction ( 0.13 mm ) . No statistically significant translation or rotation was seen at two-years follow-up , ( t-test , p < 0.05 , translation or rotation ) Background We developed a total hip system using osseointegration guidelines , a metaphyseal-loading proximal femoral replacement in the retained neck and a dual-geometry titanium shell in the acetabulum . Patients and methods A r and omized controlled clinical trial was undertaken in 52 patients ( 53 hips ) , using the cemented Spectron stem and cementless Harris-Galante II cup as control implants  ( 24 patients in experimental group , 29 control patients ) . Clinical measures of Harris Hip Score ( HHS ) , pain score and radiostereometric analysis ( RSA ) at regular intervals for up to three years were used to monitor progress . Results No statistically significant differences were found in HHS and pain score ; the stability of the cementless experimental implant was also comparable to that of the cemented controls by RSA . 3 revisions were required for migration in the experimental group and 1 was required for component dislocation in the control group . Interpretation Our findings indicate the practicality of osseointegration of titanium implants , but suggest that current performance is inadequate for clinical introduction . However , the stable fixation achieved in the retained neck in the majority of patients is indicative of osseointegration . This finding will encourage technical and design improvements for enhancement of clinical osseointegration and should also encourage further study . Periprosthetic osteolysis might be avoided by the establishment and maintenance of direct implant-bone connection : “ osseointegration ” PURPOSE Chemical modification to a s and blasted , large-grit , acid-etched ( SLA ) implant surface has been shown to enhance the rate of osseointegration . The goal of the present study was to examine changes in stability for implants with a chemically modified SLA surface and to compare their outcomes to those of control implants . MATERIAL S AND METHODS A r and omized controlled trial was conducted with 31 patients . Each patient received 2 implants with the same physical properties but with surfaces that were chemically different . The control implants had a st and ard SLA surface , while the test implants had a chemically modified surface . Resonance frequency analysis was assessed weekly over the first 6 weeks following implant placement . RESULTS All implants proved clinical ly successful , allowing for restoration . Most implants were placed in the m and ible ( 50 of 62 ) . A shift in implant stability from decreasing stability to increasing stability ( P < .001 ) , occurred after 2 weeks for the test implants and after 4 weeks for the control implants . CONCLUSION The findings from this pilot study provide clinical support for the potential for chemical modification of the SLA surface to alter biologic events during the osseointegration process and demonstrate levels of short-term clinical success similar to those observed for implants with an SLA surface Purpose The aim of this study was to compare radiological results of total knee arthroplasties ( TKAs ) performed with patient-specific computed tomography (CT)-based instrumentation and conventional technique . The main study hypothesis was that CT-based patient-specific instrumentation ( PSI ) increases the accuracy of TKA . Methods A prospect i ve , r and omized controlled trial was carried out between January and December 2011 . A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and r and omly assigned to an experimental or control group . The experimental group comprised 52 patients operated on with the aid of the Signature ™ CT-based implant positioning system .  The control group consisted of 60 patients operated on using conventional instrumentation .  The radiographic evaluation of implant positioning and overall coronal alignment was performed 12 months after the surgery by using st and ing anteroposterior radiographs of the entire lower limb and st and ard lateral radiographs . Results Of the 112 patients initially enrolled for the study , 95 were included in the subsequent analyses . There were no statistically significant differences between groups in respect to coronal and sagittal component positioning and overall coronal alignment , except for frontal tibial component positioning . For this parameter , better results were obtained in the control group , with borderline statistical significance . Conclusions Our study did not reveal superiority of the CT-based PSI system over conventional instrumentation . Further high- quality investigations of patient-specific systems are absolutely indispensable to assess their utility for TKA . In our opinion , the surgeon applying PSI technology is required to have advanced knowledge and considerable experience with the conventional method There is an urgent need for the introduction of new implant technology in orthopedic surgery to be conducted in a more controlled manner than in the past . Inadequate regulation and lack of effective post-market surveillance have meant that patients have not been protected from potentially harmful implants and procedures . Compounding the problem is a lack of question ing , a lack of critical appraisal , and lack of a requirement for clinical evidence by both surgeons and manufacturers before large-scale introduction of new technology to the market . There is a long and growing history of failed innovation , demonstrated by the failure or recall of individual products such as Boneloc ( bone cement ) , The Capital Hip ( total hip arthroplasty ) , and the ASR hip system ( total hip arthroplasty ) among others , as well as whole classes of devices such as large-head metal-on-metal bearings . This demonstrates simple , yet severe flaws in the mechanisms that should protect patients from increased risk associated with introduction of new technology . Insufficient or inadequate pre clinical data , a lack of clinical data from timely RSA ( radiostereometric analysis ) studies , and limited larger , multicenter cohort studies prior to general release all increase the risk to patients . The 510k process , where the majority of so-called innovative new design s have been cleared or approved by FDA - or CE-notified bodies for clinical use , is based on similarities to previously used implants . In the 510k process , there is no requirement for specific clinical evidence , so manufactures have not obtained clinical data . Registry post-market surveillance has proven to be a powerful method for detection of increased risk of implant failure , but this is not available in all countries . When registries do identify poor-performing devices , regulators and manufacturers are often slow to respond . The main problem with the current approach to the introduction of new technology is the inability to identify unanticipated failures before wider release ( Bauer 1992 ) . It is 20 years since the stepwise introduction of new implants was first described ( Malchau 1995 ) . The basic concept of this approach is that the smallest possible numbers of patients ( after sufficient pre clinical testing ) are exposed to the implant prior to general release . Stepwise introduction uses a combination of ( 1 ) outcome measurements with high-precision metrics in small cohorts , such as RSA , and ( 2 ) limited clinical introduction in a larger cohort , prospect ively monitoring outcomes and revisions . Adoption of this concept would certainly have reduced the large number of poor-performing new implants introduced in recent years . The concept has , however , never been implemented due to lack of support from surgeons , manufacturers , and regulatory authorities . Now trends have changed , with increasing focus on implementing an effective approach to pre-release clinical assessment . The ongoing work and discussion s in the International Society of Arthroplasty Registries ( ISAR ) , the reports from the Australian Orthopaedic Association total joint registry , and the actions taken in the UK to put a “ beyond compliance ” program into action will facilitate a more cautious market introduction . In addition , the Arthroplastywatch project ( www.arthroplastywatch.com ) is in action : data are collected on the web through a specially developed search routine . Based on examination in several steps using medical and statistical expertise , a caution could be warranted or a warning declared . These combined initiatives say one thing : that close monitoring of new implants by well-established registries during a phase of controlled introduction must be a universal requirement . We propose a structured model for clinical trials involving 4 levels : ( 1 ) a pure observational study using reoperation data from multiple registries , as shown in several papers by the Nordic Arthroplasty Register Association ( NARA ) ; ( 2 ) patient-reported outcome measures , either from national implant registries or from other registries for specific studies ; ( 3 ) radiographic data plus other parameters such as blood levels of metal ions , based on specific needs for a new technology ; and ( 4 ) options for r and omized studies with use of , for example , RSA in the evaluation . The cornerstone in this structural model should be the exp and ed use of existing and future registries with a high degree of coverage and completeness . While registries have a strong tradition in arthroplasty surgery , this is not as well developed in other areas of orthopedic surgery . It is the responsibility of orthopedic surgeons and their professional bodies to support and implement registries where they can be of benefit . The arthroplasty registry experience has shown that it is possible to use registries to effectively monitor the introduction of new technology . Without this registry-based surveillance , identification of many of the failed innovations would have been delayed or might even have gone unrecognized . It is encouraging that registries in fracture surgery are now emerging , where implants are inserted in large and increasing numbers . Finally , implant performance is potentially confounded by the technical difficulty of inserting the implant , the knowledge and abilities of the surgeon inserting them , and the complexity of the cases . Many registries monitor performance at the surgeon level . This together with continuous education and training in how to use new implants should be an integral part of the process of a more cautious market introduction . If training is linked in with the stepwise introduction , it will be possible to identify the need for and the extent of training . Our proposed regulatory change to require registry-based monitoring of new implants during the phase of limited introduction must be accompanied by a change in the way we think and act as orthopedic surgeons . In the training of future orthopedic surgeons , emphasis must be placed on developing a healthy skepticism to innovation , on recognizing the need for evidence -based introduction , and on building a culture holding the view that reporting to a registry is imperative . The registries will then be able to offer back data to enable surgeons to choose the best clinical practice . To increase innovation and to ensure that innovation is effective and beneficial , the role of registries should be exp and ed . The registries should not undertake the role of a regulatory authority , but in compliance with the industry and the orthopedic community they should ensure that a more cautious approach is used when new technology is introduced . This could lead to a better balance between the inborn conservatism that a registry represents and the continuous need for innovation . The independence , infrastructure , and expertise of the registries can be used more fully to optimize how new implants are introduced . All stakeholders need to join to ensure that first and foremost , we do no harm Summary Background Optimal positioning of implants and restoration of neutral mechanical axis are two primary surgical goals in total knee arthroplasty ( TKA ) . Despite modern instruments and improved surgical techniques , malalignment remains an important cause of early failure after TKA . The aim of this prospect i ve r and omized study was to compare the value of a new patient-matched instrument system ( PMI ) ( SignatureTM ; Biomet , Inc , Warsaw , Indiana ) to that of st and ard TKA surgical instrumentation ( STD ) in terms of coronal mechanical alignment , time of operation and blood loss . Patients and methods A total of 38 patients waiting for primary TKA were enrolled and r and omized into two groups ( 19 PMI and 19 STD ) . Magnetic resonance imaging was performed in all patients in the PMI group , and specific instruments for the femur and tibia were design ed preoperatively . All patients were operated on using the st and ard medial parapatellar approach with no use of tourniquet . Mechanical axis , time for the operation , and blood loss were evaluated . Results Patients in both groups had comparable age , body mass index , preoperative mechanical axis , Knee Society Score , and level of hemoglobin . Postoperative results showed that the PMI group fell significantly closer to neutral mechanical axis ( STD : 2.7 ± 1.7 , PMI : 1.7 ± 0.9 ; P = 0.013 ) with no outliers and a reduced time for the operation . There was no difference in the evaluation blood loss . Conclusions The use of PMI can contribute in achieving better mechanical axis with reduction in outliers and decreased operation time . Due to small differences between PMI and st and ard instruments , additional research are needed to confirm these preliminary results , and to discover potential benefits and functional improvements in the long-term outcome 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 The publication of major studies dealing with the natural history of bradyarrhythmias and tachyarrhythmias and major advances in the technology of pacemakers and implantable cardioverter-defibrillators ( ICDs ) has m and ated this revision of the 1991 ACC/AHA Guidelines for Implantation of Pacemakers and Antiarrhythmia Devices . This executive summary appears in the April 7 , 1998 issue of Circulation . The full text of the guidelines , including the ACC/AHA Class I , II , and III recommendations , is published in the April 1998 issue of the Journal of the American College of Cardiology . Reprints of both the executive summary and the full text are available from both organizations . Following extensive review of the medical literature and related documents previously published by the American College of Cardiology , the American Heart Association , and the North American Society for Pacing and Electrophysiology , the writing committee developed recommendations that are evidence based whenever possible . Evidence supporting current recommendations is ranked as level A if the data were derived from multiple r and omized clinical trials involving a large number of individuals . Evidence was ranked as level B when data were derived from a limited number of trials involving comparatively small numbers of patients or from well- design ed data analysis of nonr and omized studies or observational data registries . Evidence was ranked as level C when consensus of expert opinion was the primary source of recommendation . The committee emphasizes that for certain conditions for which no other therapies are available , the indications for device therapies are based on years of clinical experience as well as expert consensus and are thus well supported , even though the evidence was ranked as level C. These guidelines include exp and ed sections on selection of pacemakers and ICDs , optimization of technology , cost , and follow-up of implanted devices . The follow-up sections are relatively brief because in many instances the type and frequency of follow-up examinations Background This study aim ed to assess differences in the fixation and functional outcomes between pegged and keeled all-polyethylene glenoid components for st and ard total shoulder arthroplasty . Methods Patients were r and omized to receive a  keeled or pegged all-polyethylene glenoid component .  We used model-based radiostereometric analysis ( RSA ) to assess glenoid fixation and subjective outcome measures to assess patient function . Follow-up examinations were completed at 6 weeks and 6 , 12 and 24 months after surgery . Modifications to the RSA surgical , imaging and analytical techniques were required throughout the study to improve the viability of the data . Results Stymied enrolment result ed in only 16 patients being included in our analyses . The RSA data indicated statistically greater coronal plane migration in the keeled glenoid group than in the pegged group at 12 and 24 months . Functional outcome scores did not differ significantly between the groups at any follow-up . One patient with a keeled glenoid showed high component migration after 24 months and subsequently required revision surgery 7 years postoperatively . Conclusion Despite a small sample size , we found significant differences in migration between glenoid device design s. Although clinical ly these findings are not robust , we have shown the feasibility of RSA in total shoulder arthroplasty as well as the value of a high-precision metric to achieve objective results in a small group of patients St and ards of scientific reporting have evolved from the very beginning of scientific reporting . Virtually all journals now publish instructions for authors and most medical journals adhere to certain st and ards of publication . Such st and ards have been promoted by international groups such as the International Committee of Medical Journal Editors ( ICMJE ) and Committee on Publication Ethics ( COPE ) . The ICMJE has published general st and ards for crafting scientific articles : the “ Uniform Requirements for Manuscripts Su bmi tted to Biomedical Journals : Writing and Editing for Biomedical Publication ” [ 7 ] . These guidelines include suggestions not only for manuscript preparation , but also guidelines for ethical issues related to publishing . COPE , however , focuses on ethical issues [ 1 ] . CORR adheres to these guidelines ; authors may find links to these guidelines in our online Instructions for Authors . Such guidelines , as important as they are , lack sufficient detail to ensure all important information is included . Therefore , in addition to these general guidelines for preparing a manuscript , numerous international groups have published guidelines to ensure various sorts of studies contain all essential information . These include the CONSORT ( Consoli date d St and ards of Reporting Trials ) guidelines for r and omized trials [ 2 , 3 , 8 ] , QUORUM ( Quality of Reporting of Meta-analyses ) [ 6 ] and MOOSE ( Meta- analysis Of Observational Studies in Epidemiology ) [ 13 ] for meta-analyses , and STROBE ( Strengthening the Reporting of Observational Studies in Epidemiology ) for various sorts of observational studies ( the majority of clinical studies in surgical disciplines ) [ 12 , 15 ] . In essence , these guidelines tell investigators and authors what information is required to ensure readers ( and review ers ) can properly evaluate the study . Despite these st and ards , most reports of clinical studies lack such critical information . I suspect this is less by intent than lack of awareness of what information is required . In addition , although many journals , including CORR require a Level of Evidence [ 5 , 10 , 16 ] for studies involving patients , most clinical articles published in surgical journals have a relatively low level ; prospect i ve , r and omized trials are uncommon ( and often impractical ) , and even sufficiently large retrospective cohort studies to control for confounding variables may be unachievable for many conditions or treatments in single institutions . In the absence of high levels of evidence , systematic review s [ 9 , 11 , 17 ] and meta-analyses [ 4 ] have become increasingly common . My search of PubMed for articles limited to meta- analysis yielded 276 articles from 1950–1989 , 2116 from 1990–1994 , 3736 from 1995–1999 , 7920 from 2000–2004 , and 9313 from 2005 to 2009 . Most of these analyses undoubtedly collected information from lower level studies , thereby incurring the limitations of the individual studies . Virtually all systematic and meta-analyses we have recently published noted missing and variably reported data . In contrast to medical disciplines , surgical disciplines do not have the advantage of being able to conduct tightly design ed prospect i ve , r and omized , blinded , controlled trials . ( A PubMed search limited to r and omized controlled trials suggested The Journal of Bone and Joint Surgery and CORR had together published 556 RCTs and although I did not individually check these for quality , they reflect a small fraction of the articles both journals publish . ) For the foreseeable future , most of our information will arise from observational studies rather than prospect i ve trials . In this setting , it is especially important that each article contain all relevant information for future systematic review s and meta-analyses . The STROBE guidelines [ 12 ] provide authors with lists of critical information for reporting three sorts of observational studies : cohort ( longitudinal studies typically reporting outcomes of treatment in one or more cohorts ) , case-control ( studies identifying factors in outcomes ) , and cross-sectional studies ( studies to identify prevalence of factors or characteristics in a population at a single time ) . CORR now requires authors to adhere to CONSORT guidelines for r and omized clinical trials , QUORUM guidelines for meta-analyses , and STROBE guidelines for observational clinical studies . Authors will be able to download from our Instructions to Authors convenient templates for the various sorts of articles we publish ; these templates contain the information required . In addition , we request authors read and follow the guidelines in the Cochrane H and book for Systematic Review s of Interventions 4.2.6 [ 14 ] . Adherence to these st and ards will enhance our ability to answer key clinical questions in more definitive ways than we have in the past , and to answer more questions Background Patient-specific instrumentation potentially improves surgical precision and decreases operative time in total knee arthroplasty ( TKA ) but there is little supporting data to confirm this presumption . Questions / purpose sWe asked whether patient-specific instrumentation would require infrequent intraoperative changes to replicate a single surgeon ’s preferences during TKA and whether patient-specific instrumentation guides would fit securely . Methods We prospect ively evaluated the plan and surgery in 60 patients treated with 66 TKAs performed with patient-specific instrumentation and recorded any changes . A subset of six postoperative radiographic changes to the femoral and tibial components ( implant size , coronal and sagittal alignment ) was analyzed to determine if surgeon intervention was beneficial . Each guide was evaluated to determine fit . We compared patient demographics and implant sizing in the patient-specific instrumentation group with a control group in which traditional instrumentation was used . Results We recorded 161 intraoperative changes in 66 knee arthroplasties ( 2.4 changes/knee ) performed with patient-specific instrumentation . The predetermined implant size was changed intraoperatively in 77 % of femurs and 53 % of tibias . We identified a subset of 95 intraoperative changes that could be radiographically evaluated to determine if our changes were an improvement or detriment to reaching goal alignment . Eighty-two of the 95 changes ( 86 % ) made by the surgeon were an improvement to the recommended alignment or size of patient-specific instrumentation . The guide did not fit securely on eight femurs ( 12 % ) and three tibias ( 5 % ) . Tourniquet time and blood loss were not improved with patient-specific instrumentation . Conclusions We caution surgeons against blind acceptance of patient-specific instrumentation technology without supportive data .Level of Evidence Level III , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence In this issue of Spine , a novel method for managing chronic discogenic low back pain with a thermal intradiscal catheter is reported . This study raises some general questions regarding the introduction of new treatment techniques and devices . Decisions about medical treatment should be based on a careful appraisal of the best evidence available . A step-wise introduction is necessary to increase the use of evidence -based decision making in the implementation of new surgical techniques and implants while exposing as few patients as possible to the potential risk of failure . The development of the total hip arthroplasty procedure , for example , could have been different if the introduction of new devices and techniques had been done more carefully and performed in a step-wise manner . Inferior properties could have been revealed earlier , thus reducing the number of failures and allowing for necessary improvements . It is also desirable , therefore , that members of this profession agree on a st and ardized way to introduce new surgical techniques and implants in the field of spinal disorders . Based on the results of Swedish reports and practice , the following schedule for step-wise clinical introduction of new implants is suggested ( Figure 1 ) : The initial step is a pre clinical testing and is beyond the scope of this discussion . The first clinical step is the open prospect i ve and preferably r and omized trial that includes a minimum of patients but yields a relevant evaluation . The strict rules of prospect i ve , r and omized trials should be adhered to . In this first clinical phase , methods associated with high accuracy , such as radiostereometric analysis ( RSA ) , are required . Within 6 to 24 months , this method has the potential to identify implants/ methods that provide inferior fixation and increased polyethylene wear . Results from this first step determine whether further clinical evaluation is worthwhile . It should be noted and stressed that all types of complications can not be predicted and that further follow-up study is necessary . If favorable results are obtained in the first step , the second step , a multicenter trial exposing the new procedure to a broader aspect in the orthopedic community , can be initiated . In the first step , there is a risk for susceptibility and performance bias because the inventors themselves often perform this introductory investigation . The protocol in the multicenter trial must be prepared carefully and agreed on by all participating inventors . A sufficient number of patients should be included to allow adequate statistical analysis . The ultimate goal for step two is to make even the multicenter trial r and omized by using well-documented methods /implants as the gold st and ard . The final step in the evaluation , step three , is to include a continuous control group by using register studies based on large cohorts to reveal early or unusual and potential clinical catastrophic complications . In a rather small and closed community such as Sweden , the register should be nationwide and include all units in a specific field . When applying the principles for step-wise introduction to the investigation of chronic discogenic low back pain with a  thermal intradiscalcatheterbySaal  and Saal , oneobserves that the current study falls between the pre clinical step and step one . The lack of r and omization toward either conservative or surgical intervention is a definite limitation of the study , and before this method is introduced to a larger study group , a r and omized trial must be considered . A multicenter trial exposing the new procedure to a broader aspect of the orthopedic community is recommended before using it in general orthopedic practice . The length of the follow-up period was very short in this study , and no long-term clinical conclusions can be drawn based on the results PURPOSE The aim of this study was to evaluate and compare the clinical and radiographic outcomes of single implants with a platform-switched rough collar ( PSRC ) and a platform-matched smooth collar ( PMSC ) . MATERIAL S AND METHODS Twenty-six patients missing a tooth in the anterior maxilla ( through the premolars ) were r and omly assigned to the PSRC or the PMSC group . All implants were placed in a flapless approach and restored with an early loading protocol . Clinical measurements were performed at surgery , loading , and at 3 , 6 , and 12 months after loading . In addition , radiographic evaluations were carried out using st and ardized periapical radiographs and cone beam computed tomography . Patient satisfaction surveys were completed , and microbial analysis with DNA probes was performed . RESULTS The implant survival rate was 100 % for both groups . The mean marginal bone level ( MBL ) was significantly higher in the PSRC group compared to the PMSC group at all time points . From the 2-week postoperative visit to 1 year postloading , the mean MBL change in the PSRC group was 0.21 ± 0.56 mm and in the PMSC group it was 0.74 ± 0.47 mm . Soft tissue profiles were stable over time , with no significant differences between groups . There were no significant differences between groups in the number of microbial species seen . Patients in both groups were highly satisfied with postoperative and postprosthetic experiences . CONCLUSION In this study , the PSRC method preserved marginal bone by a mean of 0.53 mm more than the st and ard PMSC protocol . Within the limitations of the present study , it can be concluded that the PSRC protocol may be beneficial in marginal bone preservation . Longitudinal studies are needed to verify the long-term effects of this approach
INTERPRETATION The guidelines have improved method ological reporting in RSA studies , but adherence to these guidelines is still relatively low .
BACKGROUND AND PURPOSE Guidelines for st and ardization of  radiostereometry ( RSA )  of implants were published in 2005 to facilitate comparison of outcomes between various research groups .
In this systematic review , we determined how well studies have adhered to these guidelines .