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1.  Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials 
Empiric data and theoretical arguments suggest an alternative randomized clinical trial (RCT) design, called expertise-based RCT, has enhanced validity, applicability, and ethical integrity compared with conventional RCT. Little is known, however, about whether physicians will participate in an expertise-based RCT. In a cross-sectional survey of Canadian orthopaedic surgeons, we evaluated preference for and willingness to participate in an expertise-based versus a conventional RCT if given the opportunity to participate in a trial investigating the effectiveness of high tibial osteotomy versus unicompartmental knee arthroplasty. Using an electronic survey (©2005 SurveyMonkey.com), we invited all 767 members of the Canadian Orthopaedic Association (2005) to participate; 276 surgeons completed the questionnaire (37.5% response rate). One hundred two surgeons (53.4%) were willing to participate in an expertise-based RCT compared with 35 surgeons (18.3%) willing to participate in a conventional RCT. Ninety-seven surgeons (52.4%) strongly or moderately preferred the expertise-based design compared with 25 (13.5%) who preferred the conventional design. For the clinical example we presented, the majority of Canadian orthopaedic surgeons were willing to participate in and preferred the expertise-based design. The expertise-based randomized clinical trial design may overcome some of the barriers to conducting clinical trials in orthopaedic surgery and improve the validity of their conclusions.
doi:10.1007/s11999-008-0273-9
PMCID: PMC2505251  PMID: 18446421
2.  Effectiveness guidance document (EGD) for acupuncture research - a consensus document for conducting trials 
Background
There is a need for more Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Effectiveness Guidance Documents (EGD) are targeted to clinical researchers. The aim of this EGD is to provide specific recommendations for the design of prospective acupuncture studies to support optimal use of resources for generating evidence that will inform stakeholder decision-making.
Methods
Document development based on multiple systematic consensus procedures (written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders including patients, clinicians and payers were involved.
Results
Recommendations focused mainly on randomized studies and were developed for the following areas: overall research strategy, treatment protocol, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.
Conclusion
The present EGD, based on an international consensus developed with multiple stakeholder involvement, provides the first systematic methodological guidance for future CER on acupuncture.
doi:10.1186/1472-6882-12-148
PMCID: PMC3495216  PMID: 22953730
Comparative effectiveness research; Effectiveness guidance document; Acupuncture
3.  EBM 
The purpose of this paper is to explore new perspectives about difficulties academicians may have communicating with clinicians, obtaining subjects, and gaining compliance for their research. Sackett et al1 defined evidence-based medicine (EBM) as an integration of best research evidence, clinical expertise, and patient values. However, Guyatt et al2 places clinical observation and experience last in the evidence hierarchy with the randomized controlled trial held as the standard for clinical intervention. The hierarchical discourse of medical knowledge produces opposition rather than collaboration between researcher, clinician, and patient. Foucault gave new perspectives describing how power circulates through individuals within organizational discourse.3 Drawing on literature and experience, this paper describes how the hierarchical model of power in the research community obstructs new areas of knowledge, and how clinicians create resistance. Alleviating perceptions of dominance and creating connections produces cohesion within medical communities.
doi:10.1111/j.1365-2753.2008.01043.x
PMCID: PMC2614924  PMID: 19018888
evidence-based medicine; epistemology; clinician; power; Foucault
4.  Managing the Personal Side of Health: How Patient Expertise Differs from the Expertise of Clinicians 
Background
When patients need health information to manage their personal health, they turn to both health professionals and other patients. Yet, we know little about how the information exchanged among patients (ie, patient expertise) contrasts with the information offered by health professionals (ie, clinician expertise). Understanding how patients’ experiential expertise contrasts with the medical expertise of health professionals is necessary to inform the design of peer-support tools that meet patients’ needs, particularly with the growing prevalence of largely unguided advice sharing through Internet-based social software.
Objective
The objective of our study was to enhance our understanding of patient expertise and to inform the design of peer-support tools. We compared the characteristics of patient expertise with that of clinician expertise for breast cancer.
Methods
Through a comparative content analysis of topics discussed and recommendations offered in Internet message boards and books, we contrasted the topic, form, and style of expertise shared in sources of patient expertise with sources of clinician expertise.
Results
Patient expertise focused on strategies for coping with day-to-day personal health issues gained through trial and error of the lived experience; thus, it was predominately personal in topic. It offered a wealth of actionable advice that was frequently expressed through the narrative style of personal stories about managing responsibilities and activities associated with family, friends, work, and the home during illness. In contrast, clinician expertise was carried through a prescriptive style and focused on explicit facts and opinions that tied closely to the health care delivery system, biomedical research, and health professionals’ work. These differences were significant between sources of patient expertise and sources of clinician expertise in topic (P < .001), form (P < .001), and style (P < .001).
Conclusion
Patients offer other patients substantial expertise that differs significantly from the expertise offered by health professionals. Our findings suggest that experienced patients do not necessarily serve as “amateur doctors” who offer more accessible but less comprehensive or detailed medical information. Rather, they offer valuable personal information that clinicians cannot necessarily provide. The characteristics of patient expertise and the resulting design implications that we identified will help informaticians enhance the design of peer-support tools that will help meet patients’ diverse information needs.
doi:10.2196/jmir.1728
PMCID: PMC3222167  PMID: 21846635
Health knowledge; attitudes; practice; social support; community networks; peer group; consumer health informatics; online communities; patient expertise; personalized health
5.  Sentence retrieval for abstracts of randomized controlled trials 
Background
The practice of evidence-based medicine (EBM) requires clinicians to integrate their expertise with the latest scientific research. But this is becoming increasingly difficult with the growing numbers of published articles. There is a clear need for better tools to improve clinician's ability to search the primary literature. Randomized clinical trials (RCTs) are the most reliable source of evidence documenting the efficacy of treatment options. This paper describes the retrieval of key sentences from abstracts of RCTs as a step towards helping users find relevant facts about the experimental design of clinical studies.
Method
Using Conditional Random Fields (CRFs), a popular and successful method for natural language processing problems, sentences referring to Intervention, Participants and Outcome Measures are automatically categorized. This is done by extending a previous approach for labeling sentences in an abstract for general categories associated with scientific argumentation or rhetorical roles: Aim, Method, Results and Conclusion. Methods are tested on several corpora of RCT abstracts. First structured abstracts with headings specifically indicating Intervention, Participant and Outcome Measures are used. Also a manually annotated corpus of structured and unstructured abstracts is prepared for testing a classifier that identifies sentences belonging to each category.
Results
Using CRFs, sentences can be labeled for the four rhetorical roles with F-scores from 0.93–0.98. This outperforms the use of Support Vector Machines. Furthermore, sentences can be automatically labeled for Intervention, Participant and Outcome Measures, in unstructured and structured abstracts where the section headings do not specifically indicate these three topics. F-scores of up to 0.83 and 0.84 are obtained for Intervention and Outcome Measure sentences.
Conclusion
Results indicate that some of the methodological elements of RCTs are identifiable at the sentence level in both structured and unstructured abstract reports. This is promising in that sentences labeled automatically could potentially form concise summaries, assist in information retrieval and finer-grained extraction.
doi:10.1186/1472-6947-9-10
PMCID: PMC2657779  PMID: 19208256
6.  Physicians' Reports of Focused Expertise in Clinical Practice 
Little is known about the prevalence of focused expertise (special areas of expertise within a clinical field) among physicians, yet such expertise may influence how care is delivered. We surveyed general internists, pediatricians, cardiologists, infectious disease specialists, and orthopedic surgeons to describe the prevalence of focused expertise and identify associated physician and practice characteristics. About one quarter of generalists and three quarters of specialists reported a focused expertise within their primary specialty. Hospital-based physicians more often reported such expertise, and physicians reimbursed by capitation less often reported expertise. Learning how focused expertise affects processes and outcomes of care will contribute to decisions about physician training and staffing of medical groups.
doi:10.1046/j.1525-1497.2000.08003.x
PMCID: PMC1495463  PMID: 10886476
physician training; primary care; specialty care; manpower
7.  Placebo for depression: we need to improve the quality of scientific information but also reject too simplistic approaches or ideological nihilism 
BMC Medicine  2014;12:105.
The placebo response plays a major role in psychiatry, particularly in depression. A new network meta-analysis investigates whether the effects of placebo vary in studies comparing fluoxetine and venlafaxine, two widely prescribed antidepressants. Even though data from this article indicate that the effects of placebos do not differ, publication bias cannot be ruled out. The authors use their finding to criticise the paradigm of evidence-based medicine, questioning whether there is anything certain in psychiatry and, more precisely, in the field of antidepressant treatment for major depression. This study stimulates the debate about validity of scientific knowledge in medicine and highlights the importance of considering things from a different perspective. However, the authors’ view should be considered with caution. As clinicians, we make decisions every day, integrating individual clinical expertise and patients’ preferences and values with the best, up-to-date research data. The quality of scientific information must be improved, but we still think that valid conclusions to help clinical practice can be drawn from a critical and cautious use of the best available, if flawed, evidence.
Please see related articles: http://www.biomedcentral.com/1741-7015/11/230 and http://www.biomedcentral.com/1741-7015/12/106.
doi:10.1186/1741-7015-12-105
PMCID: PMC4070084  PMID: 24962638
Antidepressants; Major depressive disorder; Meta-analysis; Placebo; Publication bias
8.  Clinician Assessment of the Driving Competence of Patients with Dementia 
OBJECTIVES
To determine the validity and reliability of clinician ratings of the driving competence of patients with mild dementia.
DESIGN
Observational study of a cross-section of drivers with mild dementia based on chart review by clinicians with varying types of expertise and experience.
SETTING
Outpatient dementia clinic.
PARTICIPANTS
Fifty dementia subjects from a longitudinal study of driving and dementia.
MEASUREMENTS
Each clinician reviewed information from the clinic charts and the first study visit. The clinician then rated the drivers as safe, marginal, or unsafe. A professional driving instructor compared these ratings with total driving scores on a standardized road test and categorical ratings of driving competence. Clinicians also completed a visual analog scale assessment of variables that led to their determinations of driving competence.
RESULTS
Accuracy of clinician ratings ranged from 62% to 78% for the instructor’s global rating of safe versus marginal or unsafe. In general, there was moderate accuracy and interrater reliability. Accuracy could have been improved in the least-accurate raters by greater attention to dementia duration and severity ratings, as well as less reliance on the history and physical examination. The most accurate predictors were clinicians specially trained in dementia assessment, who were not necessarily the most experienced in their years of clinical experience.
CONCLUSION
Although a clinician may be able to identify many potentially hazardous drivers, accuracy is insufficient to suggest that a clinician’s assessment alone is adequate to determine driving competence in those with mild dementia.
doi:10.1111/j.1532-5415.2005.53265.x
PMCID: PMC3292185  PMID: 15877559
dementia; driving; Alzheimer’s disease
9.  Totally laparoscopic versus conventional ileoanal pouch procedure – design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative proctocolectomy- LapConPouch-Trial 
BMC Surgery  2006;6:13.
Background
Restorative proctocolectomy is increasingly being performed minimal invasively but a totally laparoscopic technique has not yet been compared to the standard open technique in a randomized study.
Methods/design
This is a two armed, single centre, expertise based, preoperatively randomized, patient blinded study. It is designed as a two-group parallel superiority study. Power calculation revealed 80 patients per group in order to recruit the 65 patients to be analysed for the primary endpoint. The primary objective is to investigate intra-operative blood loss and the need for blood transfusions. We hypothesise that intra-operative blood loss and the need for peri-operative blood transfusions are significantly higher in the conventional group. Additionally a set of surgical and non-surgical parameters related to the operation will be analysed as secondary objectives. These will include operative time, complications, postoperative pain, lung function, postoperative length of hospital stay, a cosmetic score and pre-and postoperative quality of life.
Discussion
The trial will answer the question whether there is indeed an advantage in the laparoscopic group in regard to blood loss and the need for blood transfusions. Moreover, it will generate data on the safety and potential advantages and disadvantages of the minimally invasive approach.
doi:10.1186/1471-2482-6-13
PMCID: PMC1676020  PMID: 17125500
10.  Open versus endovascular repair of abdominal aortic aneurysm: a survey of Canadian vascular surgeons 
Canadian Journal of Surgery  2008;51(2):142-149.
Objective
The aim of this survey was to determine Canadian vascular surgeons' experience with elective endovascular aortic repair (EVAR) and traditional open repair and their interest in participating in an expertise-based randomized controlled trial (RCT) as opposed to a conventional RCT comparing these 2 procedures.
Methods
A single-page questionnaire was developed and sent by fax, email or post to all vascular surgeons in Canada. Nonresponders were recontacted on 2 additional occasions to improve the response rate. The questionnaire had 2 sections. The first inquired about current and past practice patterns, including experience in both open and endovascular techniques. The second investigated the surgeons' belief in the value of open as opposed to endovascular repair and the value of expertise-based RCT methodology; it also canvassed their interest in participating in a future trial. Definitions of expertise in open and endovascular repair were drawn from the published literature. Criteria to determine the feasibility of conducting an expertise-based RCT were established a priori.
Results
The questionnaire was sent to 259 surgeons who appeared in multiple vascular surgery databases, and the overall response rate was 56% (95% confidence interval [CI] 50%–62%). The mean career experience was 406 cases (standard deviation [SD] 359) for conventional open abdominal aortic aneurysm (AAA) repair and 24 cases (SD 48) for endovascular repair. Of the responding surgeons, 51% (95% CI 41%–60%) ranked conventional open repair as “probably superior.” Respondents were equally interested in participating in an RCT using either expertise-based methodology (54%, 95% CI 44%–63%) or conventional design (51%, 95% CI 41%–60%).
Conclusion
Uncertainty exists among vascular surgeons in Canada as to the role of endovascular surgery in the repair of AAA. A national RCT comparing open with endovascular repair in the elective setting is potentially feasible with either expertise-based or conventional design. Increases in the number of surgeons who are willing to participate and have expertise in EVAR, in addition to high recruitment rates among eligible patients, will be necessary to make such a trial feasible in Canada.
PMCID: PMC2386348  PMID: 18377756
11.  International clinical trials setting for rare cancers: organisational and regulatory constraints—the EORTC perspective 
ecancermedicalscience  2013;7:321.
Rare diseases are a serious public health problem that presents unique challenges to many countries. There is no internationally accepted definition for rare diseases. Patients suffering from rare cancers often face challenges, including late or incorrect diagnoses, difficulties finding clinical expertise and accessing appropriate treatments, and uncertainty in clinical decision making, with difficult and rare access for these patients to clinical trials. Treatment choice is difficult as little information is available in the literature. In such situations, clinicians will base treatment decisions on retrospective data or case report series with a lower scientific level of evidence than that obtained from randomised controlled clinical trials. The only way forward is clinical trials organisation, but to perform it within rare indications we are always faced with many methodological, regulatory, and organisational challenges, besides stakeholders’ different views, which are not usually concurrent. The aims of the European Organisation for Research and Treatment of Cancer (EORTC) are to develop, conduct, coordinate, and stimulate translational and clinical research in Europe to improve the management of cancer and related problems by increasing survival but also patient quality of life. In particular, extensive and comprehensive research in the field of rare cancers is beyond the means of individual European hospitals and can be best accomplished through the multidisciplinary multinational efforts of basic scientists and clinicians. In this paper, we will present an overview of the clinical research scene for rare cancers and will try to propose possible steps to improve the current situation.
doi:10.3332/ecancer.2013.321
PMCID: PMC3660157  PMID: 23717342
rare cancer; clinical trials; international collaboration
12.  Advancing the evidence base in cancer: psychosocial multicenter trials 
Trials  2012;13:171.
Background
The diagnosis and treatment of cancer is associated with significant distress and psychosocial morbidity. Although psychosocial interventions have been developed in an attempt to improve psychosocial outcomes in cancer patients and survivors, there is continued debate about whether there is adequate high-level evidence to establish the effectiveness of these interventions. The evidence base is limited as a result of numerous challenges faced by those attempting to conduct psychosocial intervention trials within the health system. Barriers include insufficient participant recruitment, difficulty generalizing from single-trial studies, difficulty in building and managing research teams with multidisciplinary expertise, lack of research design expertise and a lack of incentives for researchers conducting intervention research. To strengthen the evidence base, more intervention studies employing methodologically rigorous research designs are necessary.
Methods
In order to advance the evidence base of interventions designed to improve psychosocial outcomes for cancer patients and survivors, we propose the formation of a collaborative trials group that conducts multicenter trials to test the effectiveness of such interventions.
Results
Establishment of such a group would improve the quality of the evidence base in psychosocial research in cancer patients, by increasing support for conducting intervention research and providing intervention research training opportunities. A multidisciplinary collaborative group conducting multicenter trials would have the capacity to overcome many of the barriers that currently exist.
Conclusions
A stronger evidence base is necessary to identify effective psychosocial interventions for cancer patients. The proposed formation of a psycho-oncology collaborative trials group that conducts multicenter trials to test the effectiveness of psychosocial interventions would assist in achieving this outcome.
doi:10.1186/1745-6215-13-171
PMCID: PMC3522541  PMID: 22992443
Cancer; Oncology; Multicenter trials; Psychosocial aspects; Intervention studies
13.  Pelvic Girdle Pain during or after Pregnancy: a review of recent evidence and a clinical care path proposal 
Facts, Views & Vision in ObGyn  2011;3(3):221-227.
The pregnant patient is a vulnerable subject, and even more so when a serious fetal condition is diagnosed. (Invasive) fetal therapy should only be offered when there is a good chance that the life of the fetus will be saved, or irreversible damage by the disease or disability is prevented. Following diagnosis of a potentially treatable condition, the patient needs to be referred to a center with sufficient expertise in diagnosis and all therapeutic options. Preferences of the physician towards one or another antenatal intervention is not at stake prior to that moment. When fetal therapy is justified­­, it should be offered with full respect for maternal choice and individual assessment and perception of potential­­ risks, and should be at the location where there is sufficient expertise. For therapies of unproven benefit, the absence of evidence must be disclosed, and therapy should only be undertaken with full voluntary consent of the mother. These ought to be undertaken within well designed and approved trials and only by experts in the treatment modality. Potential risks and eventual morbidities in case of therapeutic failure should be part of the counselling, neither­­ should fetal therapy be presented as an alternative to termination of pregnancy
PMCID: PMC3991449  PMID: 24753868
Fetal therapy; fetal surgery; fetoscopy; prenatal diagnosis; trial; informed consent; termination of ­pregnancy
14.  Use of the Crohn’s disease activity index in clinical trials of biological agents 
The Crohn’s disease activity index (CDAI) has been commonly used to assess the effects of treatment with different agents in Crohn’s disease (CD). However, these studies may be compromised, if the results compared to a placebo or standard therapy group (in the absence of a placebo) substantially differ from the expected response. In addition, significant concerns have been raised regarding the reliability and validity of the CDAI. Reproducibility of the CDAI may be limited as significant inter-observer error has been recorded, even if measurements are done by experienced clinicians with expertise in the diagnosis and treatment of CD. Finally, many CDAI endpoints are open to subjective interpretation and have the potential for manipulation. This is worrisome as there is the potential for significant financial gain, if the results of a clinical trial appear to provide a positive result. Physicians caring for patients should be concerned about the positive results in clinical trials that are sponsored by industry, even if the trials involve respected centers and the results appear in highly ranked medical journals.
doi:10.3748/wjg.14.4127
PMCID: PMC2725371  PMID: 18636655
Crohn’s disease; Crohn’s disease activity index; Clinical trials; Infliximab; Adalimumab; Corticosteroids; Azathioprine
15.  Towards evidence‐based medicine for paediatricians 
To give the best care to patients and families, paediatricians need to integrate the highest‐quality scientific evidence with clinical expertise and the opinions of the family.1Archimedes seeks to assist practising clinicians by providing “evidence‐based” answers to common questions which are not at the forefront of research but are at the core of practice. In doing this, we are adapting a format that has been successfully developed by Kevin Macaway‐Jones and the group at the Emergency Medicine Journal—“BestBets”.
A word of warning. The topic summaries are not systematic reviews, although they are as exhaustive as a practising clinician can produce. They make no attempt to statistically aggregate the data, nor search the grey, unpublished literature. What Archimedes offers are practical, best evidence‐based answers to practical, clinical questions.
The format of Archimedes may be familiar. A description of the clinical setting is followed by a structured clinical question. (These aid in focusing the mind, assisting searching2 and gaining answers.3) A brief report of the search used follows—this has been carried out in a hierarchical way, to search for the best‐quality evidence to answer the question (http://www.cebm.net/levels_of_evidence.asp). A table provides a summary of the evidence and key points of the critical appraisal. For further information on critical appraisal and the measures of effect (such as number needed to treat), books by Sackett et al4 and Moyer et al5 may help. To pull the information together, a commentary is provided. But to make it all much more accessible, a box provides the clinical bottom lines.
Electronic‐only topics that have been published on the BestBets site (www.bestbets.org) and may be of interest to paediatricians include:
Are meningeal irritation signs reliable in diagnosing meningitis in children?
Is immobilisation effective in Osgood‐Schlatter's disease?
Do all children presenting to the emergency department with a needlestick injury require PEP for HIV to reduce HIV transmission?
Readers wishing to submit their own questions—with best evidence answers—are encouraged to review those already proposed at www.bestbets.org. If your question still has not been answered, feel free to submit your summary according to the Instructions for Authors at www.archdischild.com. Three topics are covered in this issue of the journal.
Is lumbar puncture necessary for evaluation of early neonatal sepsis?
Does the use of calamine or antihistamine provide symptomatic relief from pruritus in children with varicella zoster infection?
Is supplementary iron useful when preterm infants are treated with erythropoietin?
Is more research needed?
“More research is needed” is a phrase you might have read before. But is more research really needed? Two situations are offered to us in Archimedes this month where clinical questions are, as yet, unanswered. Is iron supplementation really necessary for premature infants treated with erythropoietin, and do antihistamines and calamine lotion help in children with chicken pox? How can we decide if these questions really do “need” research? It may be worth thinking of how likely benefits and harms may be, what the importance of these outcomes are and finally, how much would you consider reasonable to pay for the answer? For example, what chance is there that antihistamines work in chickenpox? What is the chance that side effects will occur? What is the relative severity of side effects versus the delight of being itch free? If we pay for research and spend hours and hours of time pressing through the increasing regulatory frameworks for clinical trials to define the answer to this question, what will be the opportunity cost? What would we fail to do by looking at this? The same questions can be asked of iron supplementation in premature infants, the salvage treatment of relapsing systemic histocytosis or the promotion of car‐seat use in low‐income families. Such value judgements are important; they will have different answers from different perspectives; they will be subject to political influences from pressure groups; being aware of them might stop us from frequently expounding “more research is needed”.
References
1Moyer VA, Ellior EJ. Preface. In: Moyer VA, Elliott EJ, Davis RL, et al, eds. Evidence based pediatrics and child health, Issue 1. London: BMJ Books, 2000.
2Richardson WS, Wilson MC, Nishikawa J, et al. The well‐built clinical question: a key to evidence‐based decisions. ACP J Club 1995;123:A12–13.
3Bergus GR, Randall CS, Sinift SD, et al. Does the structure of clinical questions affect the outcome of curbside consultations with specialty colleagues? Arch Fam Med 2000;9:541–7.
4Sackett DL, Starus S, Richardson WS, et al. Evidence‐based medicine. How to practice and teach EBM. San Diego: Harcourt‐Brace, 2000.
5Moyer VA, Elliott EJ, Davis RL, et al, eds. Evidence based pediatrics and child health, Issue 1. London: BMJ Books, 2000.
doi:10.1136/adc.2006.105379
PMCID: PMC2083019
16.  Facilitating physician referrals on the World Wide Web: representation and appropriate utilization of clinical expertise. 
In highly integrated and increasingly complex health care systems, the identification and proper utilization of clinical staff expertise are key factors for efficiently delivering high quality patient care. To achieve these capabilities on an enterprise-wide scale, we have embarked on a multi-phased project to develop World Wide Web (WWW)-based physician referral capabilities for two large teaching hospitals. Currently, users may search for information concerning the education, training, board certifications, and self-designated clinical interests of staff members. Address, phone number, email address, and a photo are also presented. Our experience indicates that institutional changes are required to successfully deploy and maintain online physician referral services and that accurate and equitable representation of clinical expertise and the incorporation of referral guidelines require an incremental introduction of a carefully planned program that addresses the needs of clinicians, administrators, and health care policy-makers.
PMCID: PMC2233105  PMID: 8947760
17.  Hematologist/Oncologist Disease-Specific Expertise and Survival: Lessons from Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL) 
Cancer  2011;118(7):1827-1837.
Background
The impact of physicians’ disease-specific expertise on patient outcome is unknown. While previous studies suggest a survival advantage for cancer patients cared for at high volume centers, these observations may simply reflect referral bias or better access to advanced technologies, clinical trials, and multidisciplinary support at large centers.
Methods
We evaluated time to first treatment(TTFT) and overall survival(OS) of patients with newly diagnosed chronic lymphocytic leukemia/small lymphocytic lymphoma(CLL) at a single academic center based on whether they were cared for by a hematologist/oncologist who sub-specializes in CLL(CLL hematologist) or a hematologist/oncologist with expertise in other areas(non-CLL hematologist).
Results
Among 1309 newly diagnosed patients with CLL cared for between 1999–2009, 773(59%) were cared for by CLL hematologists and 536 were cared for by non-CLL hematologists. Among early stage patients(Rai 0-I), median TTFT(9.2 vs. 6.1 years; p<0.001) and OS(10.5 years vs. 8.8 years; p<0.001) were superior for patients cared for by CLL hematologists. For all patients, OS was superior for patients cared for by CLL hematologists(10.5 years vs. 8.4 years; p=0.001). Physician’s disease-specific expertise remained an independent predictor of OS after adjusting for age, stage, sex, and lymphocyte count. Patients seen by a CLL hematologist were also more likely participate in clinical trials(48% vs. 16%; p<0.001).
Conclusion
Physician disease-specific expertise appears to influence outcome in patients with CLL. To the greatest extent possible, patients should be cared for by a hematologist/oncologist expert in the care of their specific malignancy. When not possible, practice guidelines developed by disease-specific experts should be followed.
doi:10.1002/cncr.26474
PMCID: PMC3893049  PMID: 22009554
chronic lymphocytic lymphoma(CLL); small lymphocytic lymphoma (SLL); prognosis; physician expertise
18.  THE EFFICACY OF HYPNOTIC ANALGESIA IN ADULTS: A REVIEW OF THE LITERATURE 
This article both summarizes the previous reviews of randomized, controlled trials of hypnotic analgesia for the treatment of chronic and acute pain in adults, and reviews similar trials which have recently been published in the scientific literature. The results indicate that for both chronic and acute pain conditions: (1) hypnotic analgesia consistently results in greater decreases in a variety of pain outcomes compared to no treatment/standard care; (2) hypnosis frequently out-performs non-hypnotic interventions (e.g. education, supportive therapy) in terms of reductions in pain-related outcomes; and (3) hypnosis performs similarly to treatments that contain hypnotic elements (such as progressive muscle relaxation), but is not surpassed in efficacy by these alternative treatments. Factors that may influence the efficacy of hypnotic analgesia interventions are discussed, including, but not limited to, the patient's level of suggestibility, treatment outcome expectancy, and provider expertise. Based upon this body of literature, suggestions are offered for practitioners who are using, or would like to use, hypnosis for the amelioration of pain problems in their patients or clients.
doi:10.1002/ch.370
PMCID: PMC2753288  PMID: 20161034
pain; chronic pain; acute pain; hypnosis; hypnotic analgesia
19.  Computerised therapy for depression with clinician vs. assistant and brief vs. extended phone support: study protocol for a randomised controlled trial 
Trials  2012;13:151.
Background
Computerised cognitive behaviour therapy (cCBT) involves standardised, automated, interactive self-help programmes delivered via a computer. Randomised controlled trials (RCTs) and observational studies have shown than cCBT reduces depressive symptoms as much as face-to-face therapy and more than waiting lists or treatment as usual. cCBT’s efficacy and acceptability may be influenced by the “human” support offered as an adjunct to it, which can vary in duration and can be offered by people with different levels of training and expertise.
Methods/design
This is a two-by-two factorial RCT investigating the effectiveness, cost-effectiveness and acceptability of cCBT supplemented with 12 weekly phone support sessions are either brief (5–10 min) or extended (20–30 min) and are offered by either an expert clinician or an assistant with no clinical training. Adults with non-suicidal depression in primary care can self-refer into the study by completing and posting to the research team a standardised questionnaire. Following an assessment interview, eligible referrals have access to an 8-session cCBT programme called Beating the Blues and are randomised to one of four types of support: brief-assistant, extended-assistant, brief-clinician or extended-clinician.
A sample size of 35 per group (total 140) is sufficient to detect a moderate effect size with 90% power on our primary outcome measure (Work and Social Adjustment Scale); assuming a 30% attrition rate, 200 patients will be randomised. Secondary outcome measures include the Beck Depression and Anxiety Inventories and the PHQ-9 and GAD-7. Data on clinical outcomes, treatment usage and patient experiences are collected in three ways: by post via self-report questionnaires at week 0 (randomisation) and at weeks 12 and 24 post-randomisation; electronically by the cCBT system every time patients log-in; by phone during assessments, support sessions and exit interviews.
Discussion
The study’s factorial design increases its efficiency by allowing the concurrent investigation of two types of adjunct support for cCBT with a single sample of participants. Difficulties in recruitment, uptake and retention of participants are anticipated because of the nature of the targeted clinical problem (depression impairs motivation) and of the studied interventions (lack of face-to-face contact because referrals, assessments, interventions and data collection are completed by phone, computer or post).
Trial registration
Current Controlled Trials ISRCTN98677176
doi:10.1186/1745-6215-13-151
PMCID: PMC3495903  PMID: 22925596
Cognitive behaviour therapy; Internet; Guided self-help
20.  Adult ADHD and comorbid depression: A consensus-derived diagnostic algorithm for ADHD 
Objective:
Many patients present to their physician with depression as their primary symptom. However, depression may mask other comorbid disorders. This article presents diagnostic criteria and treatment recommendations (and monitoring) pertaining to the diagnosis of adult attention deficit hyperactivity disorder (ADHD), which may be missed in patients who present with depressive symptoms, or major depressive disorder (MDD). Other co-occurring conditions such as anxiety, substance use, and bipolar disorder are briefly discussed.
Methods:
A panel of psychiatrist-clinicians with expertise in the area of child and adolescent ADHD and mood disorders, adult mood disorders, and adult ADHD was convened. A literature search for recommendations on the diagnosis and treatment of co-occurring conditions (MDD, anxiety symptoms, and substance use) with adult ADHD was performed. Based on this, and the panel’s clinical expertise, the authors developed a diagnostic algorithm and recommendations for the treatment of adult ADHD with co-occurring MDD.
Results:
Little information exists to assist clinicians in diagnosing ADHD co-occurring with other disorders such as MDD. A three-step process was developed by the panel to aid in the screening and diagnosis of adult ADHD. In addition, comorbid MDD, bipolar disorder, anxiety symptoms, substance use and cardiovascular concerns regarding stimulant use are discussed.
Conclusion:
This article provides clinicians with a clinically relevant overview of the literature on comorbid ADHD and depression and offers a clinically useful diagnostic algorithm and treatment suggestions.
PMCID: PMC2695217  PMID: 19557108
ADHD; adult; treatment; diagnosis; substance use disorder; depression
21.  Prediction of persistent shoulder pain in general practice: Comparing clinical consensus from a Delphi procedure with a statistical scoring system 
BMC Family Practice  2011;12:63.
Background
In prognostic research, prediction rules are generally statistically derived. However the composition and performance of these statistical models may strongly depend on the characteristics of the derivation sample. The purpose of this study was to establish consensus among clinicians and experts on key predictors for persistent shoulder pain three months after initial consultation in primary care and assess the predictive performance of a model based on clinical expertise compared to a statistically derived model.
Methods
A Delphi poll involving 3 rounds of data collection was used to reach consensus among health care professionals involved in the assessment and management of shoulder pain.
Results
Predictors selected by the expert panel were: symptom duration, pain catastrophizing, symptom history, fear-avoidance beliefs, coexisting neck pain, severity of shoulder disability, multisite pain, age, shoulder pain intensity and illness perceptions. When tested in a sample of 587 primary care patients consulting with shoulder pain the predictive performance of the two prognostic models based on clinical expertise were lower compared to that of a statistically derived model (Area Under the Curve, AUC, expert-based dichotomous predictors 0.656, expert-based continuous predictors 0.679 vs. 0.702 statistical model).
Conclusions
The three models were different in terms of composition, but all confirmed the prognostic importance of symptom duration, baseline level of shoulder disability and multisite pain. External validation in other populations of shoulder pain patients should confirm whether statistically derived models indeed perform better compared to models based on clinical expertise.
doi:10.1186/1471-2296-12-63
PMCID: PMC3141514  PMID: 21718463
22.  Protocol of an expertise based randomized trial comparing surgical Venae Sectio versus radiological Puncture of Vena Subclavia for insertion of Totally Implantable Access Port in oncological patients 
Trials  2008;9:60.
Background
Totally Implantable Access Ports (TIAP) are being extensively used world-wide and can be expected to gain further importance with the introduction of new neoadjuvant and adjuvant treatments in oncology. Two different techniques for the implantation can be selected: A direct puncture of a central vein and the utilization of a Seldinger device or the surgical Venae sectio. It is still unclear which technique has the optimal benefit/risk ratio for the patient.
Design
A single-center, expertise based randomized, controlled superiority trial to compare two different TIAP implantation techniques. 100 patients will be included and randomized pre-operatively. All patients aged 18 years or older scheduled for primary elective implantation of a TIAP under local anesthesia who signed the informed consent will be included. The primary endpoint is the primary success rate of the randomized technique. Control Intervention: Venae Sectio will be employed to insert a TIAP by a surgeon; Experimental intervention: Punction of V. Subclavia will be used to place a TIAP by a radiologist. Duration of study: Approximately 10 months, follow up time: 90 days.
Organisation/Responsibility
The PORTAS 2 – Trial will be conducted in accordance with the protocol and in compliance with the moral, ethical, and scientific principles governing clinical research as set out in the Declaration of Helsinki (1989) and Good Clinical Practice (GCP). The Center of Clinical Trials at the Department of Surgery, University Hospital Heidelberg is responsible for design and conduct of the trial including randomization and documentation of patients' data. Data management and statistical analysis will be performed by the independent Institute for Medical Biometry and Informatics (IMBI), University of Heidelberg.
Trial Registration
The trial is registered at ClinicalTrials.gov (NCT00600444).
doi:10.1186/1745-6215-9-60
PMCID: PMC2579421  PMID: 18950491
23.  “Evidence-Based Dentistry in Oral Surgery: Could We Do Better?” 
Evidence-based Dentistry (EBD), like Evidence-based Medicine (EBM), was born in order to seek the “best available research evidence” in the field of dentistry both in research and clinical routine.
But evidence is not clearly measurable in all fields of healthcare: in particular, while drug effect is rather independent from clinician’s characteristics, the effectiveness of surgical procedures is strictly related to surgeon’s expertise, which is difficult to quantify. The research problems of dentistry have a lot in common with other surgical fields, where at the moment the best therapeutic recommendations and guidelines originates from an integration of evidence-based medicine and data from consensus conferences.
To cope with these problems, new instruments have been developed, aimed at standardizing clinical procedures (CAD-CAM technology) and at integrating EBM achievements with the opinions of expert clinicians (GRADE System).
One thing we have to remember however: it is necessary to use the instruments developed by evidence-based medicine but is impossible to produce sound knowledge without considering clinical expertise and quality of surgical procedures simultaneously. Only in this way we will obtain an evidence-based dentistry both in dental research and clinical practice, which is up to third millennium standards.
doi:10.2174/1874210601004020077
PMCID: PMC2945005  PMID: 20871758
EBD; Oral surgery; Surgeon's expertise; Third Millennium research; GRADE System.
24.  Diverse Eastern and Western Approaches to the Management of Gastric Cancer 
Gastrointestinal Cancer Research : GCR  2007;1(2 Suppl 1):S10-S15.
There are still remarkable disparities in the treatment of gastric cancer between the East and the West. Treatment outcomes for this disease have improved in Japan due to early detection, endoscopic treatment, and increased surgical expertise with D2 resection. Similar improvements have been seen in Korea, whereas gastric cancer remains a virulent disease in Western countries. In the field of adjuvant therapy, baseline surgical quality and outcomes were quite different between studies conducted in Japan and Western countries, and Japanese oncologists have not accepted the Western results. In Japan, more radical surgery than standard D2 dissection failed to demonstrate any superiority in two recent randomized trials, whereas a significant survival benefit of adjuvant chemotherapy using S-1 was obtained in the large, nationwide randomized trial. These results will change Japanese practice guidelines and approaches in designing clinical trials in this field. Several disparities are also evident in the results of chemotherapy trials for advanced gastric cancer. In Western studies, two triplet regimens have already demonstrated significant prolongation of survival; however, these benefits seem to be marginal and the regimens may be replaced by newer treatments. Studies testing newer treatments in 1,300 patients in Japan are anticipated to produce median survival duration of more than 12 months. Several molecular targeting agents are being investigated in international trials based on promising results in preliminary studies, discussion of which is beyond the scope of this paper. Although various disparities between regions must be overcome, it is time to pursue further benefits by incorporating new agents into treatment approaches for patients with gastric cancer.
PMCID: PMC2661560  PMID: 19343155
25.  The effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols 
BMC Neurology  2011;11:87.
Background
Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized approach or individualized therapy in patients with homonymous hemianopia post stroke.
Methods/Design
This study is a double-blind randomized controlled, multicenter trial. A standardised scanning rehabilitation program (Neuro Vision Technology (NVT) program) of 7 weeks at 3 times per week, is compared to individualized therapy recommended by clinicians.
Discussion
The results of the trial will provide information that could potentially inform the allocation of resources in visual rehabilitation post stroke.
Trial Registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12610000494033
doi:10.1186/1471-2377-11-87
PMCID: PMC3152517  PMID: 21767413

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