Evidence-based dentistry: Part IV. Research design and levels of evidence. Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – the PRioRiTy (Prioritising Recruitment in Randomised Trials) study Health and mental health social workers need information literacy skills. Online Alcohol Assessment and Feedback for Hazardous and Harmful Drinkers: Findings From the AMADEUS-2 Randomized Controlled Trial of Routine Practice in Swedish Universities Ten years of evidence to guide physiotherapy interventions: Physiotherapy Evidence Database (PEDro) Reporting quality of randomised controlled trials published in prosthodontic and implantology journals. International Journal of Implant Dentistry Prioritization of Research Addressing Management Strategies for Ductal Carcinoma In Situ Acquisition of psychomotor skills in dentistry: an experimental teaching method. Large simple trials in psychiatry: providing reliable answers to important clinical questions. Comparative Effectiveness Research: A Report From the Institute of Medicine Failed appointments in an orthodontic clinic. Multidisciplinary Rectal Cancer Management: 2nd European Rectal Cancer Consensus Conference (EURECA-CC2). Impact of Length or Relevance of Questionnaires on Attrition in Online Trials: Randomized Controlled Trial Clinical research in implant dentistry: study design, reporting and outcome measurements: consensus report of Working Group 2 of the VIII European Workshop on Periodontology. Online Cognitive Behavioral Therapy for Bulimic Type Disorders, Delivered in the Community by a Nonclinician: Qualitative Study An Online Spaced-Education Game Among Clinicians Improves Their Patients’ Time to Blood Pressure Control: A Randomized Controlled Trial Development of a Self-Help Web-Based Intervention Targeting Young Cancer Patients With Sexual Problems and Fertility Distress in Collaboration With Patient Research Partners The Ins and Outs of an Online Bipolar Education Program: A Study of Program Attrition Medline search validity for randomised controlled trials in different areas of dental research Evaluation of an audience response system in a preclinical operative dentistry course. Online vs live methods for teaching difficult airway management to anesthesiology residents Publication of statistically significant research findings in prosthodontics & implant dentistry in the context of other dental specialties.
Previous papers in this series on evidence -based dentistry have discussed the first 2 steps in seeking answers to clinical problems formulating a clear question and strategically search ing for evidence . The next step , critical appraisal of the evidence , is made easier if one underst and s the basic concepts of clinical research design . The strongest design , especially for questions related to therapeutic or preventive interventions , is the r and omized , controlled trial . Questions relating to diagnosis , prognosis and causation are often studied with observational , rather than experimental , research design s. The strongest study design should be used whenever possible . Rules have been established to grade research evidence . This paper , the fourth in the series , presents an overview of research methodology most commonly used in the dental literature Background Despite the problem of inadequate recruitment to r and omised trials , there is little evidence to guide research ers on decisions about how people are effectively recruited to take part in trials . The PRioRiTy study aim ed to identify and prioritise important unanswered trial recruitment questions for research . The PRioRiTy study - Priority Setting Partnership ( PSP ) included members of the public approached to take part in a r and omised trial or who have represented participants on r and omised trial steering committees , health professionals and research staff with experience of recruiting to r and omised trials , people who have design ed , conducted , analysed or reported on r and omised trials and people with experience of r and omised trials methodology . Methods This partnership was aided by the James Lind Alliance and involved eight stages : ( i ) identifying a unique , relevant prioritisation area within trial methodology ; ( ii ) establishing a steering group ( iii ) identifying and engaging with partners and stakeholders ; ( iv ) formulating an initial list of uncertainties ; ( v ) collating the uncertainties into research questions ; ( vi ) confirming that the questions for research are a current recruitment challenge ; ( vii ) shortlisting questions and ( viii ) final prioritisation through a face-to-face workshop . Results A total of 790 survey respondents yielded 1693 open-text answers to 6 questions , from which 1880 potential questions for research were identified . After merging duplicates , the number of questions was reduced to 496 . Questions were combined further , and those that were su bmi tted by fewer than 15 people and /or fewer than 6 of the 7 stakeholder groups were excluded from the next round of prioritisation result ing in 31 unique questions for research . All 31 questions were confirmed as being unanswered after checking relevant , up-to- date research evidence . The 10 highest priority questions were ranked at a face-to-face workshop . The number 1 ranked question was “ How can r and omised trials become part of routine care and best utilise current clinical care pathways ? ” The top 10 research questions can be viewed at www.priority research .ie . Conclusion The prioritised questions call for a collective focus on normalising trials as part of clinical care , enhancing communication , addressing barriers , enablers and motivators around participation and exploring greater public involvement in the research process In recent years , social work has moved in parallel with medicine and the health sciences to use evidence -based criteria to determine the actions of practitioners ( Institute of Medicine , 2001 ; Parker-Oliver & Demiris , 2006 ) . Consequently , social workers employed in health and mental health setting s are compelled to use evidence -based practice s in their work . For many practitioners , evidence -based practice means the application of empirically based service models and a trend toward interventions demonstrated to be effective in changing behavior and ameliorating clients ' problems . However , social workers , including those in medical and mental health services , are often not involved in the research that informs these practice s , and their ability to shape promoted practice s is virtually nonexistent . Health and mental health social workers increasingly view evidence -based practice as prescriptive , with research ers in centers of scholarship developing research for practitioners . This situation has exacerbated the rift between research ers and social workers who are expected to carry out empirically supported practice s , although they are not involved in the production of research or even in the synthesis of evidence that supports particular practice s and rejects others . People with research expertise and the re sources to conduct empirical inquiry are generally located in academic institutions and do not necessarily call on practitioners themselves to critically examine evidence -based practice models . When these prescribed practice s move from the rarified conditions under which r and omized controlled trials are conducted into agency setting s , they confront real-world organizational realities , Real-world " intrusions " may limit fidelity to the model produced by this " gold st and ard " of research . As a result , technology transfer , or reliability for replication of evidence -based practice s , may be compromised . Perhaps most disheartening is how this situation encourages passivity among people in the field to engage in research or remain fluent with current research . Continuing knowledge development is a shared responsibility at all levels of the social work profession ( Lewis , 2003 ) , and current education and practice structures are not encouraging practitioners to be partners in this process . We assert that people closest to direct services are best positioned to point out practice realities that distort programs . Although practice s may be supported by high-level empirical evidence , they may not prove effective or even feasible under real-world conditions . Originally , evidence -based practice was proposed for physicians to make use of the convergence of an explosion of information and technology , so that clinicians could use the growing body of research available through online data bases . Ultimately , other health professionals were supposed to formulate clinical questions , critically assess empirical studies , and decide on the best approaches to bring to a dialogue with clients . The clients were meant to be active partners in decision making about their own care . The institution of the Cochrane Collaboration ( http://www : cochrane.org./index.htm ) and the Campbell Collaboration ( http://www . campbellcollaboration.org/ ) formalized this process , and both apply rigorous , transparent st and ards to their review s of research studies . Although they are meant to serve policymakers , health workers , and people who use services , the extent to which medical social workers consult their readily available Web sites is unclear . Unlike nursing , speech therapy or rehabilitation therapy , or other health professions that have produced a burgeoning literature on information literacy skills as a central concern for educators ( Jacobs , Rosenfeld , & Haber , 2003 ; Nail-Chiwetalu & Bernstein Ratner , 2007 ) , the social work literature is for the most part silent in this area . With the exception of two recent texts that promote a bottom-up approach to evidence -based practice ( Courneyer , 2004 ; Gibbs , 2003 ) and Gary Holden 's remarkable informatics Web site for social workers ( http://www : nyu . Background Previous research on the effectiveness of online alcohol interventions for college students has shown mixed results . Small benefits have been found in some studies and because online interventions are inexpensive and possible to implement on a large scale , there is a need for further study . Objective This study evaluated the effectiveness of national provision of a brief online alcohol intervention for students in Sweden . Methods Risky drinkers at 9 colleges and universities in Sweden were invited by mail and identified using a single screening question . These students ( N=1605 ) gave consent and were r and omized into a 2-arm parallel group r and omized controlled trial consisting of immediate or delayed access to a fully automated online assessment and intervention with personalized feedback . Results After 2 months , there was no strong evidence of effectiveness with no statistically significant differences in the planned analyses , although there were some indication of possible benefit in sensitivity analyses suggesting an intervention effect of a 10 % reduction ( 95 % CI –30 % to 10 % ) in total weekly alcohol consumption . Also , differences in effect sizes between universities were seen with participants from a major university ( n=365 ) reducing their weekly alcohol consumption by 14 % ( 95 % CI –23 % to –4 % ) . However , lower recruitment than planned and differential attrition in the intervention and control group ( 49 % vs 68 % ) complicated interpretation of the outcome data . Conclusions Any effects of current national provision are likely to be small and further research and development work is needed to enhance effectiveness . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 02335307 ; http://www.is rct n.com/IS RCT N02335307 ( Archived by WebCite at http://www.webcitation.org/6ZdPUh0R4 ) Clinicians are increasingly using evidence from high- quality clinical research to guide clinical decision making . Recent articles in this journal have examined research evidence to assist in clinical decisions as diverse as the prescription of running shoes,1 exercise therapy in the treatment of chronic disease2 and the use of protective equipment to prevent concussion.3 The most valid information about the effectiveness of healthcare interventions is provided by r and omised controlled trials and systematic review s of r and omised controlled trials.4 The Physiotherapy Evidence Data base ( PEDro ; http://www.pedro.org.au ) provides easy access to r and omised controlled trials and systematic review s of physiotherapy interventions . PEDro also includes links to evidence -based clinical practice guidelines . October 2009 marked the 10th anniversary of the launch of PEDro . PEDro is freely available on the internet . The data base indexes citation details , author abstract s and , where available , links to full text for r and omised controlled trials , systematic review s and practice guidelines in physiotherapy . Although the PEDro data base is design ed primarily for health professionals , a subsite , called Physiotherapy Choices ( http://www.physiotherapychoices.org.au ) , provides information in lay terms directly to consumers of physiotherapy services . As of August 2009 , more than 15 000 records ( 12 408 trials , 2060 review s and 603 guidelines ) have been indexed on PEDro . Each record is coded according to the subdiscipline(s ) of physiotherapy it addresses . PEDro now includes 615 r and omised controlled trials and 102 The purpose of this study was to examine the reporting quality of r and omised controlled trials ( RCTs ) published in prosthodontic and implantology journals . Thirty issues of nine journals in prosthodontics and implant dentistry were search ed for RCTs , covering the years 2005 - 2012 : The Journal of Prosthetic Dentistry , Journal of Oral Rehabilitation , The International Journal of Prosthodontics , The International Journal of Periodontics & Restorative Dentistry , Clinical Oral Implants Research , Clinical Implant Dentistry & Related Research , The International Journal of Oral & Maxillofacial Implants , Implant Dentistry and Journal of Dentistry . The reporting quality was assessed using a modified Consoli date d St and ards of Reporting Trials ( CONSORT ) statement checklist . Data were analysed using descriptive statistics followed by univariable and multivariable examination of statistical associations ( α = 0·05 ) . A total of 147 RCTs were identified with a mean CONSORT score of 69·4 ( s.d . = 9·7 ) . Significant differences were found among journals with the Journal of Oral Rehabilitation achieving the highest score ( 80·6 , s.d . = 5·5 ) followed by Clinical Oral Implants Research ( 73·7 , s.d . = 8·3 ) . Involvement of a statistician/ method ologist was significantly associated with increased CONSORT scores . Overall , the reporting quality of RCTs in major prosthodontic and implantology journals requires improvement . This is of paramount importance considering that optimal reporting of RCTs is an important prerequisite for clinical decision-making The International Journal of Implant Dentistry is a peer- review ed open access journal published under the SpringerOpen br and . The journal is dedicated to promoting the exchange and discussion of all research areas relevant to implant dentistry in the form of systematic literature or invited review s , prospect i ve and retrospective clinical studies , clinical case reports , basic laboratory and animal research , and articles on material research and engineering . Ductal carcinoma in situ ( DCIS ) is a condition in which abnormal cells line the milk ducts of the breast but have not invaded the underlying breast tissue . Approximately 55000 new cases of DCIS were expected to occur among U.S. women in 2013 , which accounted for approximately 24 % of all new breast cancer diagnoses ( 1 ) . Although the annual incidence of DCIS is less than that of invasive breast cancer , exp and ed use of screening mammography has led to a dramatic increase in the diagnosis of DCIS ( 32.5 cases per 100000 women ) ( 2 ) . There is considerable uncertainty about the optimal clinical management of DCIS because of the lack of reliable methods for distinguishing DCIS that would never become symptomatic from DCIS that is likely to progress to life-threatening invasive cancer ( 3 ) . Current treatment options for DCIS include mastectomy , breast-conserving surgery ( BCS ) , and BCS plus radiation therapy ( 2 , 46 ) . There are limited r and omized , controlled trials ( RCTs ) on which to base decisions about the tradeoffs among DCIS treatment options , and the existing trials may not capture all relevant patient-centered outcomes . For example , 4 large RCTs comparing BCS alone with BCS plus radiation therapy all show similar , very high overall survival regardless of treatment ( 710 ) . The addition of radiation therapy significantly reduces the risk for local recurrence ; approximately one half of all recurrences are DCIS rather than invasive cancer ( 5 , 11 ) . The long-term benefit of preventing the recurrence of an asymptomatic condition that may or may not progress to cancer is difficult to quantify . In other conditions where screening may detect early cancer or cancer precursors that may not progress to a life-threatening stage , such as early-stage prostate cancer , active surveillance or watchful waiting ( an observation strategy ) is an acceptable option for some patients . A similar strategy may be acceptable for some women diagnosed with DCIS , although no studies have compared management strategies that involve no immediate treatment ( that is , observation or active surveillance ) versus immediate treatments . The most important potential benefit of treatment of DCIS is the reduction in the number of deaths due to invasive breast cancer . For many women with a DCIS diagnosis , this may be an unrealized benefit . Some proportion of DCIS may never progress to life-threatening invasive cancer , so these women only have the adverse outcomes of diagnosis and treatments . Both active management strategies and surveillance approaches present tradeoffs relevant to patient-centered outcomes , such as symptoms , function , and well-being . Given the clinical importance of DCIS , the diversity of available treatment strategies , variety of patient-centered outcomes of interest , and areas of uncertainty , we sought to create a prioritized research agenda for the Patient-Centered Outcomes Research Institute ( PCORI ) that would incorporate different stakeholders ' perspectives . A central goal of PCORI is to engage stakeholders in its work in a meaningful way . Between September 2012 and January 2013 , PCORI undertook a broad effort tosolicit research topics to consider for targeted funding from patients , caregivers , research ers , and results of previous prioritization processes by groups , such as the Institute of Medicine . In April 2013 , PCORI 's Assessment of Prevention , Diagnosis , and Treatment Options program , together with the program 's external advisory panel , have identified DCIS management as an important topic with unmet research needs . Then , PCORI tasked the Duke University Evidence Synthesis Group ( ESG ) to work with various stakeholders to identify and prioritize the future research that is most needed by patients and other decision makers on this topic . Methods Overview of Prioritization Approach Our approach to prioritizing future research and developing recommendations for targeted future funding by PCORI included several steps ( Figure 1 ) . These included appraisal s of recent systematic review s to preliminarily identify important evidence gaps , transformation of evidence gaps into research questions and organization of the questions within a comprehensive analytic framework , engagement of stakeholders to identify additional gaps and prioritize research needs or questions , scans of recently published and ongoing studies relevant to the stakeholders ' list of prioritized research needs , and identification of potential study design s to address prioritized research questions . Figure 1 . Overview of prioritization process Adapted from reference 12 . ESG = Evidence Synthesis Group ; PCORI = Patient-Centered Outcomes Research Institute . Identification of Evidence Gaps We used an iterative process to identify evidence gaps for DCIS management . First , we identified and appraised recent published systematic review s , clinical practice guidelines , and future research needs documents to develop an initial list of evidence gaps . This list was neither exhaustive nor prioritized . Next , we organized these gaps according to the population s , interventions , comparators , outcomes , timing , and setting of interest and transformed them into research questions informed by the criteria . Selection and Engagement of Stakeholders We convened a group of 9 stakeholders , including clinical experts and research ers in DCIS management strategies , representatives from federal and nongovernmental funding agencies , representatives from relevant professional societies , health care decision makers and policymakers , and representatives from related consumer and patient advocacy groups ( Table 1 of the Supplement ) . Within each of these categories , we sought to identify a person who was either familiar with the clinical area and its current uncertainties or brought a specific method ological expertise to the stakeholder panel . The University of Minnesota Evidence -based Practice Center , which did a comparative effectiveness review on DCIS management in 2009 ( 13 ) , and PCORI 's patient engagement group provided input on potential stakeholders . Each potential stakeholder completed a disclosure statement and was screened for conflicts of interest . We solicited and received stakeholder input at various points in the process through group discussion s via teleconferences detailing the process and outlining existing evidence gaps , Web-based surveys to obtain priority ranking of topics , and e-mail communications to solicit or provide further clarification of research gaps from teleconferences . Supplement . Supplementary Data for Prioritization of Research Addressing the Management of DCIS Development of an Analytic Framework On the basis of the exp and ed list of 30 evidence gaps and informed by an analytic framework in a recent evidence synthesis on DCIS ( 13 ) , we constructed an analytic framework that depicted the identified knowledge gaps within the context of the population s , interventions , comparators , outcomes , timing , and setting criteria ( Figure 2 ) . This framework shows that women diagnosed with DCIS may have pretreatment evaluations . After these evaluations , women may undergo several management strategies . These management strategies affect patient-centered outcomes ( such as development of comorbid conditions , DCIS recurrence , invasive cancer , and sexual functioning ) . Throughout the analytic framework , population factors ( such as socioeconomic , family history , and genetic factors ) and effects of decisional uncertainty about management strategies were highlighted as potential modifiers . Figure 2 . Analytic framework . DCIS = ductal carcinoma in situ ; FRN = future research need ; MRI = magnetic resonance imaging . Prioritization of Future Research After expansion of the identified research priorities , stakeholders were invited to rank the revised future research needs online . The survey used a forced-ranking prioritization method described by the Agency for Healthcare Research and Quality Evidence -based Practice Center 's Future Research Needs projects ( 14 ) , whereby participants were given 10 votes that could be allocated to any identified research priorities , with a maximum of 3 votes per item . The stakeholders were not given specific prioritization criteria to use but rather were told to decide , on the basis of their perspectives , which were the most important unanswered research questions in DCIS management . Only the priorities in the top tier ( n= 10 ) moved on to the final stage of horizon scan and study design determination . Stakeholders were informed of the final ranking of future research priorities . Horizon Scan of Studies Potentially Relevant to Top-Tier Research Questions We performed 2 data base search es to identify recently published and ongoing studies relevant to the top-tier future research questions result ing from the stakeholder forced-ranking prioritization exercise . We search ed PubMed to identify relevant literature published since 2008 and Clinical Trials.gov for ongoing studies . Members of the ESG team review ed the titles and abstract s identified by search ing PubMed for applicability to the top-tier research questions ; full texts were then obtained and screened for all citations passing the title- and - abstract screening . At both the title- and - abstract and full-text screening stages , articles were included if they met all of the following criteria : presented original data or secondary analysis of data from an RCT , prospect i ve or retrospective observational study , or relevant modeling study ; included data for a pretreatment evaluation or management strategy of interest ; included women with DCIS ; and had a stated objective that could be categorized according to our identified list of research priorities . We search ed Clinical Trials.gov using the keywords ductal carcinoma in situ and DCIS . A member of the ESG team review ed all study abstract s result ing from the search and coded them as potentially relevant to 1 or more of the identified research priorities . We then abstract ed study type ( such as Acquisition of psychomotor skills is one of the most important educational tasks in dental education ; yet , there has been little systematic research in this area . This investigation compared a traditional method of teaching psychomotor skills with an experimental method . The investigation was conducted in a pre clinical restorative dentistry laboratory course . Eighty-eight freshman students were r and omly assigned to an experimental ( n = 44 ) or control group ( n = 44 ) ; instructors ( n = 4 ) were r and omly assigned to each group . The control group was taught using the traditional method used at the University of North Carolina School of Dentistry at Chapel Hill ; the experimental group was taught using a guided systematic approach that relied on detailed checklists and exhaustive faculty feedback . Dependent variables measured were quality of performance on laboratory practical examinations , time required to complete practical examinations , and time required to complete the course . Results suggest that this experimental approach has promise for psychomotor skill teaching and learning in dentistry The need for reliable evidence for medical interventions has long been recognised and the history of attempts to produce this evidence is thoroughly documented in the James Lind library ( http://www.jameslindlibrary .org/ ) . The status of r and omised controlled trials as the most reliable method for evaluating the effects of treatments is now well established . Although the basic principles of the r and omised trial have a long developmental history , it is often considered that the first modern medical r and omised controlled trial came was the UK Medical Research Council trial of  streptomycin  in the treatment of tuberculosis ( Medical Research Council , 1948 ) . In the years following this trial , many r and omised trials were conducted on a number of key questions in a number of disease areas including psychiatry and mental health . Many of these were funded by national public bodies , particularly Join the dialogue on health care reform . Comment on the perspectives published in Annals and offer ideas of your own . All thoughtful voices should be heard . On 30 June 2009 , another milestone was achieved in progress toward a national system to promote medical research that focuses on decision making by physicians and patients . The first steps occurred in late 2007 and early 2008 with a seminal article ( 1 ) and an Institute of Medicine ( IOM ) report that called for a national initiative of research that would support better decision making about interventions in health care ( 2 ) . One of us was a coeditor of the IOM report . A third milestone was reached when both presidential c and i date s endorsed this concept . A fourth milestone came when the president signed into law the American Recovery and Reinvestment Act of 2009 ( ARRA ) ; this act allotted $ 1.1 billion to support this form of research , which had become known as comparative effectiveness research ( CER ) . The legislation created a federal council on CER and asked the IOM to elicit input from a broad array of stakeholders on which research topics should have the highest-priority for funding through the ARRA and to then develop a list of the highest-priority topics for the Secretary of Health and Human Services to consider . By law , the Federal Coordinating Council and the IOM committee to set priorities for comparative effectiveness research reported to the Secretary on 30 June 2009 . This issue contains both this article , which is a commentary on the IOM committee report ( 3 ) by the committee 's cochairs , and a perspective on better research methods for CER ( 4 ) . Definition of CER The IOM committee quickly settled on a working definition of CER , which consisted of the elements of earlier definitions reduced to 2 sentences : CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent , diagnose , treat and monitor a clinical condition , or to improve the delivery of care . The purpose of CER is to assist consumers , clinicians , purchasers , and policy makers to make informed decisions that will improve health care at both the individual and population levels . Two key elements that are embedded in this definition are the direct comparison of effective interventions and their study in patients who are typical of day-to-day clinical care . These features would ensure that the research would provide information that decision makers need to know , as would a third feature , research design ed to identify the clinical characteristics that predict which intervention would be most successful in an individual patient . The same research design would also help policymakers by identifying sub population s of patients that are more likely to benefit from one intervention than the other . High-Priority Research Topics The IOM committee sought advice from a broad range of stakeholders and received it in 3 forms : approximately 90 letters ; 54 oral presentations at a day-long hearing in Washington , DC ; and a Web-based nomination form . Overall , the committee received more than 2606 nominations from 1758 individual responders within 3 weeks . In a 3-step voting process , the committee identified 100 high-priority topics , which it ranked in quartiles . At each stage , the committee sought to have a balanced portfolio of topics . Table 5 - 1 in the report ( available at www.iom.edu/cerpriorities ) lists the 100 highest-ranked topics . Establishing a Sustainable National Program of CER The U.S. Congress is currently debating legislation that would guarantee health insurance to more Americans while reforming the U.S. health system . A key aim of the legislation is to moderate the rate at which the cost of health care increases while improving the quality of care . Many leaders believe that reaching this goal will require a sustained effort to produce better evidence to inform decision making . Government officials have characterized the $ 1.1 billion allocated to CER as a down payment on a national program of CER . As of this writing , the House of Representatives bill proposes a national program of CER , and the Senate Finance Committee white paper does likewise . Accordingly , the IOM committee made several recommendations aim ed at a sustainable , trustworthy national CER initiative . The Appendix provides the full text of these recommendations . Governance The 2008 IOM committee recommended establishing a national program with authority , overarching responsibility , sustained re sources , and adequate capacity to ensure production of credible , unbiased information about what is known and what is not known about clinical effectiveness ( 2 ) . The current committee exp and ed this recommendation by calling upon the secretary of the Department of Health and Human Services to establish a mechanismsuch as a coordinating advisory bodywith the authority to strategize , organize , monitor , evaluate , and report on the implementation and impact of the CER Program . The committee recognized that many agencies of the federal government are engaged in research that fits some or all of the key elements of CER . To make the best use of the funds allocated for CER , these agencies should be jointly accountable for spending CER funds on research that reflects the same conceptualization of CER . Therefore , these disparate efforts should use a single definition of CER and the same definitions of outcomes and measures of function and illness . This form of cross-agency coordination is compatible with each agency focusing on the form of research with which it has the greatest experience . Active Involvement of Consumers in CER The 2009 ARRA created a means for coordinating federal CER efforts : the Federal Coordinating Council . Seeking to complement the functions of the Council , the IOM committee focused on the potential contribution of consumers of health care to CER and recommended involving them at all levels of the national CER initiative . The recommendation is as follows : The CER Program should fully involve consumers , patients and their caregivers in key aspects of CER , including strategic planning , priority setting , research proposal development , peer review , and dissemination . The concept that animates this recommendation is a radical but logical departure from past practice : When a principal aim of research is to inform decision makers , listen to the decision makers . Meaningful participation will require consumers to learn more about research , just as they will teach research ers about how to frame their investigations to satisfy the needs of consumers who are also decision makers . This approach has precedent . For example , the National Institute for Health and Clinical Effectiveness in the United Kingdom teaches decision making to consumers who participate in the institute 's program . Methodology of CER Remembering that the purpose of CER is to inform decision making , consider the principal forms of clinical research . Systematic review s of the literature summarize a body of evidence . Over the past 2 decades , they have become indispensable to expert panels that formulate practice guidelines or policymakers who make insurance coverage decisions . These macro decision makers are starting to use decision models for the same purpose s ( 5 ) . Two broad categories of research are the starting point for systematic review s : observational research and r and omized trials . Large established data bases provide an opportunity to link current health care practice s to the outcome of care . These data bases are representative of critical groups often omitted from r and omized trials , but they contain limited data ; of note , they seldom specify the rationale for medical decisions . These observational research methods have many advantagesspeed , real-world decisions , large numbers of decisions and outcomes , and low costbut they can not escape a key limitation : Characteristics of the patient that drive real-life clinical decisions may also influence clinical outcomes , leading to uncertainty about whether they or the intervention itself causes the outcomes . Overcoming the limitations of observational research is the most important frontier of research on study methods . To overcome these limitations , research ers often r and omly assign patients to different interventions . This simple action eliminates much of the uncertainty that plagues the interpretation of observational research . However , we have too often used the conceptual elegance of r and omization to answer the wrong questions . We ask , Does this work ? when our readers want to know , Is this better than that ? Thus , too often , r and omized trials are so-called efficacy studies : They are design ed to create near-ideal circumstances to see whether the intervention can possibly work . To this end , research ers exclude many types of patients from efficacy trials and often compare the intervention with a placebo . In these respects , efficacy trials are unlike the conditions that physicians and patients face in daily practice . Another article in this issue ( 4 ) describes several exciting new methods for making r and omized trials more suitable for CER . The examples of observational research and new r and omized trial methods are the basis for the IOM committee 's strong recommendation that a national CER program should support research in the methods of clinical research . The Infrastructure for Observational Research The committee believes that very large collection s of the electronic records of patients can be a valuable re source for CER . Using these data sets , it is possible to compare the outcomes of using several effective interventions in a population that is representative of daily care , 2 features that are aligned with the goals of CER . The great numbers of patients in these data sets also makes it possible to study subgroups with precision and perhaps identify key predictors of response to an intervention , both of which would facilitate decision making at the individual and population BACKGROUND The aim of this study was to retest the hypotheses of Reekie and Devlin ( 1998 ) by conducting a similar r and omized controlled trial in an orthodontic clinic in the Netherl and s. It was hypothesized that a reminder would reduce the failed attendance rate and that the form of the reminder would be irrelevant . METHODS All patients with appointments in the orthodontic clinic at the Academic Centre of Dentistry Amsterdam during a 3-week period were divided into 4 groups . Three groups received a reminder 1 day before the appointment , either by telephone , mail , or short message service ( SMS , a service used to send and receive short text messages to and from cell phones ) . A control group did not receive a reminder . In a follow-up study , r and om sub sample s in each group were interviewed by telephone . Subjects were asked how they felt about receiving a reminder and which reminder they preferred . RESULTS The hypothesis that a reminder would reduce the failed attendance rate was not confirmed . Also , no differences were found between the 4 conditions , indicating that the form of the reminder is irrelevant . However , most of the interviewed participants felt positive or very positive about receiving a reminder . There was a significant preference for a reminder by mail ( 56.3 % ) , followed by a telephone reminder ( 26.0 % ) and a reminder by SMS ( 17.7 % ) . No less than 20 % of the interviewed participants felt negative or very negative about the reminders and considered them to be a waste of time and money . CONCLUSIONS The hypothesis that reminders are useful in the prevention of failed appointments was not confirmed . This study underlines the importance of replication studies . It demonstrates that every research result , whether it is generated by evidence -based or tradition-based research , should be interpreted with care and should be replicated in other studies before the results can be generalized BACKGROUND AND PURPOSE During the first decade of the 21st century a number of important European r and omized studies were published . In order to help shape clinical practice based on best scientific evidence from the literature , the International Conference on ' Multidisciplinary Rectal Cancer Treatment : Looking for an European Consensus ' ( EURECA-CC2 ) was organized in Italy under the endorsement of European Society of Medical Oncology ( ESMO ) , European Society of Surgical Oncology ( ESSO ) , and European Society of Therapeutic Radiation Oncology ( ESTRO ) . METHODS Consensus was achieved using the Delphi method . The document was available to all Committee members as a web-based document customized for the consensus process . Eight chapters were identified : epidemiology , diagnostics , pathology , surgery , radiotherapy and chemotherapy , treatment toxicity and quality of life , follow-up , and research questions . Each chapter was subdivided by a topic , and a series of statements were developed . Each member commented and voted , sentence by sentence thrice . Sentences upon which an agreement was not reached after voting round # 2 were openly debated during a Consensus Conference in Perugia ( Italy ) from 11 December to 13 December 2008 . A h and -held televoting system collected the opinions of both the Committee members and the audience after each debate . The Executive Committee scored percentage consensus based on three categories : " large consensus " , " moderate consensus " , and " minimum consensus " . RESULTS The total number of the voted sentences was 207 . Of the 207 , 86 % achieved large consensus , 13 % achieved moderate consensus , and only 3 ( 1 % ) result ed in minimum consensus . No statement was disagreed by more than 50 % of the members . All chapters were voted on by at least 75 % of the members , and the majority was voted on by > 85 % . CONCLUSIONS This Consensus Conference represents an expertise opinion process that may help shape future programs , investigational protocol s , and guidelines for staging and treatment of rectal cancer throughout Europe Background There has been limited study of factors influencing response rates and attrition in online research . Online experiments were nested within the pilot ( study 1 , n = 3780 ) and main trial ( study 2 , n = 2667 ) phases of an evaluation of a Web-based intervention for hazardous drinkers : the Down Your Drink r and omized controlled trial ( DYD- RCT ) . Objectives The objective was to determine whether differences in the length and relevance of question naires can impact upon loss to follow-up in online trials . Methods A r and omized controlled trial design was used . All participants who consented to enter DYD- RCT and completed the primary outcome question naires were r and omized to complete one of four secondary outcome question naires at baseline and at follow-up . These question naires varied in length ( additional 23 or 34 versus 10 items ) and relevance ( alcohol problems versus mental health ) . The outcome measure was the proportion of participants who completed follow-up  at each of two follow-up intervals : study 1 after 1 and 3 months and study 2 after 3 and 12 months . Results At all four follow-up intervals there were no significant effects of additional question naire length on follow-up . R and omization to the less relevant question naire result ed in significantly lower rates of follow-up in two of the four assessment s made ( absolute difference of 4 % , 95 % confidence interval [ CI ] 0%-8 % , in both study 1 after 1 month and in study 2 after 12 months ) . A post hoc pooled analysis across all four follow-up intervals found this effect of marginal statistical significance ( unadjusted difference , 3 % , range 1%-5 % , P = .01 ; difference adjusted for prespecified covariates , 3 % , range 0%-5 % , P = .05 ) . Conclusions Apparently minor differences in study design decisions may have a measurable impact on attrition in trials . Further investigation is warranted of the impact of the relevance of outcome measures on follow-up rates and , more broadly , of the consequences of what we ask participants to do when we invite them to take part in research studies . Trial registration IS RCT N Register 31070347 ; http://www.controlled-trials.com/IS RCT N31070347/31070347 Archived by WebCite at ( http://www.webcitation.org/62cpeyYaY AIMS The objective of this working group was to assess and make specific recommendations to improve the quality of reporting of clinical research in implant dentistry and discuss ways to reach a consensus on choice of outcomes . MATERIAL AND METHODS Discussion s were informed by three systematic review s on quality of reporting of observational studies ( case series , case-control and cohort ) and experimental research ( r and omized clinical trials ) . An additional systematic review provided information on choice of outcomes and analytical methods . In addition , an open survey among all workshop participants was utilized to capture a consensus view on the limits of currently used survival and success-based outcomes as well as to identify domains that need to be captured by future outcome systems . RESULTS The Workshop attempted to clarify the characteristics and the value in dental implant research of different study design s. In most areas , measurable quality improvements over time were identified . The Workshop recognized important aspects that require continued attention by clinical research ers , funding agencies and peer review ers to decrease potential bias . With regard to choice of outcomes , the limitations of currently used systems were recognized . Three broad outcome domains that need to be captured by future research were identified : ( i ) patient reported outcome measures , ( ii ) peri-implant tissue health and ( iii ) performance of implant supported restorations . Peri-implant tissue health can be measured by marginal bone level changes and soft tissue inflammation and can be incorporated in time to event analyses . CONCLUSIONS The Workshop recommended that collaboration between clinicians and epidemiologists/ clinical trials specialists should be encouraged . Aspects of design aim ed at limitation of potential bias should receive attention by clinical research ers , funding agencies and journal editors . Adherence to appropriate reporting guidelines such as STROBE and CONSORT are necessary st and ards . Research on outcome measure domains is an area of top priority and should urgently inform a proper process leading to a consensus on outcome measures in dental implant research Background Cognitive behavioral therapy is recommended in the National Institute for Clinical Excellence guidelines for the treatment of bulimia nervosa . In order to make this treatment option more accessible to patients , interactive online CBT programs have been developed that can be used in the user ’s own home , in privacy , and at their convenience . Studies investigating online CBT for bulimic type eating disorders have provided promising results and indicate that , with regular support from a clinician or trained support worker , online CBT can be effective in reducing bulimic symptoms . Two main factors distinguish this study from previous research in this area . First , the current study recruited a wide range of adults with bulimic type symptoms from the community . Second , the participants in the current study had used cCBT  with support from a non clinical support worker rather than a specialist eating disorder clinician . Objective To investigate participants ’ experiences of using an online self-help cognitive behavioral therapy ( CBT ) package ( Overcoming Bulimia Online ) for bulimia nervosa ( BN ) and eating disorders not otherwise specified ( EDNOS ) . Methods Eight participants with a mean age of 33.9 years took part in semi-structured interviews  . Interviews were transcribed and analyzed using a 6-step thematic analysis process . Results Saturation was achieved , and 7 themes were identified in the data set . These were : ( 1 ) conceptualizing eating disorders , ( 2 ) help-seeking behavior , ( 3 ) aspects of the intervention , ( 4 ) motivation to use the online package , ( 5 ) privacy and secrecy with regard to their eating problems , ( 6 ) recovery and the future , and ( 7 ) participant engagement describing individuals ’ thoughts on taking part in the online research study . Conclusions Participants suggested that online CBT self-help represented a generally desirable and acceptable treatment option for those with bulimic type eating problems , despite some difficulties with motivation and implementation of some elements of the package . Trial Registration International St and ard R and omized Controlled Trial Number of the original RCT that this study is based on : IS RCT N41034162 ; http://www.controlled-trials.com/IS RCT N41034162 ( Archived by WebCite at http://www.webcitation.org/6Ey9sBWTV Background —Many patients with high blood pressure ( BP ) do not have antihypertensive medications appropriately intensified at clinician visits . We investigated whether an online spaced-education ( SE ) game among primary care clinicians can decrease time to BP target among their hypertensive patients . Methods and Results —A 2-arm r and omized trial was conducted over 52 weeks among primary care clinicians at 8 hospitals . Educational content consisted of 32 vali date d multiple-choice questions with explanations on hypertension management . Providers were r and omized into 2 groups : SE clinicians  were enrolled in the game , whereas control clinicians received identical educational content in an online posting . SE game clinicians were e-mailed 1 question every 3 days . Adaptive game mechanics resent questions in 12 or 24 days if answered incorrectly or correctly , respectively . Clinicians retired questions by answering each correctly twice consecutively . Posting of relative performance among peers fostered competition . Primary outcome measure was time to BP target ( < 140/90 mm Hg ) . One hundred eleven clinicians enrolled . The SE game was completed by 87 % of clinicians ( 48/55 ) , whereas 84 % of control clinicians ( 47/56 ) read the online posting . In multivariable analysis of 17 866 hypertensive periods among 14 336 patients , the hazard ratio for time to BP target in the SE game cohort was 1.043 ( 95 % confidence interval , 1.007–1.081 ; P=0.018 ) . The number of hypertensive episodes needed to treat to normalize one additional patient ’s BP was 67.8 . The number of clinicians needed to teach to achieve this was 0.43 . Conclusions —An online SE game among clinicians generated a modest but significant reduction in the time to BP target among their hypertensive patients . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00904007 Background The Internet should be suitable for delivery of interventions targeting young cancer patients . Young people are familiar with the technologies , and this patient group is small and geographically dispersed . Still , only few psycho-educational Web-based interventions are design ed for this group . Young cancer patients consider reproductive health , including sexuality , an area of great importance and approximately 50 % report sexual problems and fertility-related concerns following cancer treatment . Therefore , we set out to develop a self-help Web-based intervention , Fex-Can , to alleviate such problems . To improve its quality , we decided to involve patients and significant others as research partners . The first 18 months of our collaboration are described in this paper . The intervention will subsequently be tested in a feasibility study followed by a r and omized controlled trial . Objective The study aims to describe the development of a Web-based intervention in long-term collaboration with patient research partners ( PRPs ) . Methods Ten former cancer patients and two significant others participated in building the Web-based intervention , using a participatory design . The development process is described according to the design step in the holistic framework presented by van Gemert-Pijnen et al and evaluates the PRPs ’ impact on the content , system , and service quality of the planned intervention . Results The collaboration between the research group and the PRPs mainly took place in the form of 1-day meetings to develop the key components of the intervention : educational and behavior change content , multimedia ( pictures , video vignettes , and audios ) , interactive online activities ( eg , self-monitoring ) , and partial feedback support ( discussion forum , tailored feedback from experts ) . The PRPs influenced the intervention ’s content quality in several ways . By repeated feedback on prototypes , the information became more comprehensive , relevant , and underst and able . The PRPs gave suggestions concerning the number of exercises and pointed out texts and pictures needing revision ( eg , experienced as normative or stereotypical ) to increase the persuasiveness of the program . The system quality was improved by PRPs ’ feedback on design , technical malfunctions , and navigation on the website . Based on feedback about availability of professional support ( technical problems and program content ) , the organization for support was clarified , which increased service quality . The PRPs also influenced the research project on an overall level by suggesting modifications of inclusion criteria for the RCT and by question ing the implementation plan . Conclusions With suggestions and continuous feedback from PRPs , it was possible to develop a Web-based intervention with persuasive design , believed to be relevant and attractive for young persons with cancer who have sexual problems or fertility distress .  In the next step , the intervention will be tested in a feasibility study , followed by an RCT to test the intervention ’s effectiveness in reducing sexual problems and fertility distress . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 36621459 ; http://www.is rct n.com/IS RCT N36621459 ( Archived by WebCite at http://www.webcitation.org/6gFX40F6 T Background The science of eHealth interventions is rapidly evolving . However , despite positive outcomes , evaluations of eHealth applications have thus far failed to explain the high attrition rates that are associated with some eHealth programs . Patient adherence remains an issue , and the science of attrition is still in its infancy . To our knowledge , there has been no in-depth qualitative study aim ed at identifying the reasons for nonadherence to— and attrition from— online interventions . Objective This paper explores the predictors of attrition and participant-reported reasons for nonadherence to an online psycho-education program for people newly diagnosed with a bipolar disorder . Methods As part of an ongoing r and omized controlled trial ( RCT ) evaluating an online psycho-education program for people newly diagnosed with a bipolar disorder , we undertook an in-depth qualitative study to identify participants ’ reasons for nonadherence to , and attrition from , the online intervention as well as a quantitative study investigating predictors of attrition . Within the RCT , 370 participants were r and omly allocated to 1 of 2 active interventions or an attention control condition . Descriptive analyses and chi-square tests were used to explore the completion rates of 358 participants , and st and ard regression analysis was used to identify predictors of attrition . The data from interviews with a sub sample of 39 participants who did not complete the online program  were analyzed using “ thematic analysis ” to identify patterns in reported reasons for attrition . Results Overall , 26.5 % of the sample did not complete their assigned intervention . St and ard multiple regression analysis revealed that young age ( P= .004 ) , male gender ( P= .001 ) , and clinical recruitment setting ( P= .001 ) were significant predictors of attrition ( F7,330= 8.08 , P < .001 ) . Thematic analysis of interview data from the noncompleter sub sample revealed that difficulties associated with the acute phases of bipolar disorder , not wanting to think about one ’s illness , and program factors such as the information being too general and not personally tailored were the major reasons for nonadherence . Conclusions The dropout rate was equivalent to other Internet interventions and to face-to-face therapy . Findings from our qualitative study provide participant-reported reasons for discontinuing the online intervention , which , in conjunction with the quantitative investigations about predictors , add to underst and ing about Internet interventions . However , further research is needed to determine whether there are systematic differences between those who complete and those who do not complete eHealth interventions . Ultimately , this may lead to the identification of population subgroups that most benefit from eHealth interventions and to informing the development of strategies to improve adherence . Trial Registration ACTRN12608000411347 ; http://www.anzctr.org.au/ACTRN12608000411347.aspx ( Archived by WebCite at http://www.webcitation.org/5uX4uYwVN Objective To determine the validity of Medline search es for r and omised controlled trials in dental research ( RCT -Ds ) , using the medical subject headings ( MeSH-terms ) . Design The Medline data base was search ed for r and omised controlled trials in dental research ( RCT -Ds ) published in 1999 and with MeSH-terms corresponding to different areas of dental research . All RCT -Ds were manually examined for relevance to the different areas of dental research and cross-tabulated against the Medline search results . The sensitivity , specificity , positive ( precision ) and negative predictive values , as well as the accuracy of the search results were calculated . Results The highest validity in the Medline search es for RCT -Ds was seen for endodontics , followed by orthodontics , whereas the lowest validity was seen for pediatric dentistry and public health dentistry . For pediatric dentistry the MeSH-term search es had too low a sensitivity for adequate location of RCT -Ds . Conclusions MeSH-term search es on Medline are a useful tool for rapid location of RCT -Ds in most areas of dental research . However , there is a vast variation in the search validity . More refined search strategies are required to locate RCT -Ds in areas of dental research with low search validity Student performance was compared on written and psychomotor skill tests of freshman dental students receiving conventional lectures versus the same lectures containing interactive components using TurningPoint , a wireless audience response system ( ARS ) . The research design was a controlled crossover study with seventy-seven freshman dental students conducted in a pre clinical operative dentistry course . Two r and omized groups alternated the two study lectures , one with ARS and the other without ARS .  Student knowledge retention was measured through written examination using immediate posttest , as well as questions on the unit and final examinations . Psychomotor skill tests were given on both lecture topics . Statistically significant differences indicating superiority of ARS  were identified for performance on the immediate posttest and psychomotor skill test only for the lecture " Principles of Dental Bonding . " The other examinations/skill testing showed no significant difference . These results indicate that ARS is a promising teaching tool for dental education Objective To compare the effectiveness of traditional and online teaching methods for educating anesthesiology residents in the principles and practice of difficult airway management . Design Prospect i ve , r and omized , controlled trial . Setting University hospital . Participants Two r and omly selected groups , each containing 28 physicians enrolled from among residents in Anesthesiology and Intensive Care Medicine in Italy . Interventions Residents in Group 1 took a traditional 5-h course on the principles and practice of airway management , which included lectures , slide projection , and dummy demonstrations . The same material was presented to Group 2 in an exclusively online format , which could be individually accessed for a period of 36 h. In the online course , student-instructor interaction was provided through threaded discussion forums during three 30-min real-time question - and -answer sessions . Measurements and results Differences in baseline and post-course scores on written tests and practical skills tests were measured . Knowledge gains in Group 2 were slightly , but not significantly , greater compared with Group 1 both in written ( P=0.228 ) and practical skills ( P=0.376 ) tests . Semi-quantitative ratings of learner satisfaction were significantly higher in the online group ( P=0.014 ) . Almost all online students ( 93 % ) were logged in for at least 45 of the 90 min of real-time question - and -answer sessions . The four instructors spent an average of 144±10 min preparing answers and interacting with online students . Conclusions Online teaching formats may be a valid alternative for teaching residents the principles and practice of difficult airway management . Interaction with instructors seems to be an important element , but it may require substantial time commitments by instructors OBJECTIVES To assess the hypothesis that there is excessive reporting of statistically significant studies published in prosthodontic and implantology journals , which could indicate selective publication . METHODS The last 30 issues of 9 journals in prosthodontics and implant dentistry were h and - search ed for articles with statistical analyses . The percentages of significant and non-significant results were tabulated by parameter of interest . Univariable/multivariable logistic regression analyses were applied to identify possible predictors of reporting statistically significance findings . The results of this study were compared with similar studies in dentistry with r and om-effects meta-analyses . RESULTS From the 2323 included studies 71 % of them reported statistically significant results , with the significant results ranging from 47 % to 86 % . Multivariable modeling identified that geographical area and involvement of statistician were predictors of statistically significant results . Compared to interventional studies , the odds that in vitro and observational studies would report statistically significant results was increased by 1.20 times ( OR : 2.20 , 95 % CI : 1.66 - 2.92 ) and 0.35 times ( OR : 1.35 , 95 % CI : 1.05 - 1.73 ) , respectively . The probability of statistically significant results from r and omized controlled trials was significantly lower compared to various study design s ( difference : 30 % , 95 % CI : 11 - 49 % ) . Likewise the probability of statistically significant results in prosthodontics and implant dentistry was lower compared to other dental specialties , but this result did not reach statistical significant ( P>0.05 ) . CONCLUSIONS The majority of studies identified in the fields of prosthodontics and implant dentistry presented statistically significant results . The same trend existed in publications of other specialties in dentistry
Due to the low quality , small sample sizes or lack of adequate reporting of the outcome data , the evidence is inadequate to cl aim or refute a difference in postoperative sensitivity between different dental liners .
Since August 2009 , members of the Primary Care Dentistry Research Forum ( www.dentistry research .org ) have taken part in an online vote to identify questions in day-to-day practice that they felt most needed to be answered with conclusive research .