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Made available in DSpace on 2020-12-10T20:03:52Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-03-15 Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) Study Design. Cross-sectional study. Objective. To investigate the equivalence of electronic and paper version of self-report questionnaires for the assessment of disability, pain, fear of movement, depression, and physical activity of patients with chronic low back pain (LBP). Summary of Background Data. Paper and electronic versions of self-report questionnaires are commonly used for assessment of patients with LBP. However, the equivalence of self-report questionnaires commonly used for assessment of patients with chronic LBP remains unclear. Methods. Seventy-nine individuals with chronic LBP seeking physiotherapy care were recruited. Participants attended the clinic twice with an interval of 1 week and completed the self-reported questionnaires in a random order. The following questionnaires were administered: Roland Morris Disability Questionnaire (RMDQ); 11-point numerical rating scale (NRS); Tampa Scale for Kinesiophobia (TSK); Center for Epidemiological Studies-Depression (CES-D), and Baecke Habitual Physical Activity Questionnaire (BPAQ). To investigate the equivalence between the two questionnaire versions, intraclass correlation coefficient with 95% confidence interval and Bland-Altman plotting was used. Results. The paper and electronic versions of the RMDQ, TSK, and CES-D showed good reliability and the showed moderate reliability. In contrast, the NRS showed poor reliability between the electronic and paper versions. Conclusion. Our findings support that the electronic version of the RMDQ, TSK, CES-D, and BPAQ can be administered in clinical and research settings for assessment of patients with chronic LBP. Nevertheless, electronic version of the NRS for assessment of pain intensity should not be used interchangeably in clinical practice in patients with chronic LBP. Univ Estadual Paulista, Dept Fisioterapia, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Fed Minas Gerais UFMG, Dept Phys Therapy, Belo Horizonte, MG, Brazil Univ Estadual Paulista, Dept Educ Fis, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Estadual Paulista, Dept Fisioterapia, Fac Ciencias & Tecnol, Presidente Prudente, Brazil Univ Estadual Paulista, Dept Educ Fis, Fac Ciencias & Tecnol, Presidente Prudente, Brazil FAPESP: 2017/21336-8 FAPESP: 2016/03826-5 FAPESP: 2017/12246-5

OBJECTIVES/HYPOTHESIS The aim of the study was to investigate the healing rates, the restoration of hearing, and the time for complete healing of paper patching versus watchful waiting for traumatic tympanic membrane perforations (TTMPs). STUDY DESIGN Systematic review with meta analysis. METHODS Publications were selected by a search on "PubMed," "Embase," and "Web of Science." A meta-analysis of risk ratios for paper patching (intervention arm) and watchful waiting (control arm) was performed. RESULTS Five studies describing 393 TTMPs were included in the quantitative meta-analysis. TTMP healing rates ranged between 84.2% and 95.2% in the intervention arm and between 76.7% and 84.8% in the control arm. The pooled risk ratio of healed TTMPs was significantly higher in the intervention arm than in the control arm (risk ratio: 1.12, 95% confidence interval: 1.04-1.21). CONCLUSIONS TTMPs have high healing potential with and without intervention. The healing rate of paper patching was superior to that of watchful waiting alone. LEVEL OF EVIDENCE NA Laryngoscope, 131:2091-2097, 2021.

To compare the Disabilities of the Arm, Shoulder, and Hand (DASH) patient-reported outcome measure as administered by tablet computer to the traditional paper format.In a prospective, randomized study design, 223 consecutive adult patients who presented to the clinic of a single hand surgeon at a tertiary medical center were randomized by visit time to receive the DASH by either paper or tablet computer. Test completeness, time to completion, DASH score, and diagnostic and demographic data were collected and compared between the two cohorts. In total, 120 participants took the DASH using the tablet and 103 using paper.43% of the paper surveys had at least one question that was omitted, compared with 13% in the tablet group; 14% of the paper surveys were not scoreable ( 27 questions answered) compared with 4% of the tablet surveys. The mean time to complete was 3.1 minutes for the paper version of the DASH and 4.3 minutes for the tablet version. Among our study population, there was no influence of age, sex, or diagnosis category on the time required to complete either version of the test. The mean DASH score was 45 for the paper version and 32 for the tablet version.The use of digital data entry methods in the arena of health care outcomes research is increasing. Administration of the DASH via a tablet computer resulted in more complete data, slightly increased responder burden, and a lower DASH score. This finding may have important implications for the use of this metric in an electronic format in future research endeavors.Diagnostic II.

Initial enthusiasm for the potential of pharmacogenomics (PGx) to transform medical practice has been tempered by the reality that the process of biomarker discovery, validation, and clinical qualification has been disappointingly slow, with a limited number of PGx tests entering the marketplace since the initial publication of the human genome sequence. Reasons for the delays include the complexity of the underlying science as well as clinical, economic, and organizational barriers to the effective delivery of personalized health care. Nevertheless, payers are interested in using PGx services to ensure that drug use is safer and more effective, particularly in the settings of medications that are widely used, have significant risks of serious adverse events, have poor or highly variable drug response, or are very expensive. However, public and private payers have specific evidence requirements for new health care technologies that must be met prior to obtaining favorable coverage and reimbursement status. These evaluation criteria are frequently more rigorous than the current level of evidence required for regulatory approval of new PGx tests or PGx-related drug labeling. To support payer decision-making, researchers will need to measure the impact of PGx testing on clinical and economic outcomes and demonstrate the net benefit of PGx testing as compared to usual care. By linking payer information needs with the current PGx research agenda, there is the opportunity to develop the data required for informed decision-making. This strategy will increase the likelihood that PGx services will be both reimbursed and used appropriately in clinical practice.

Background: Daily documentation and maintenance of medical record quality is a crucial issue in orthopaedic surgery. The purpose of the present study was to determine whether the introduction of a handheld computer could improve both the quantitative and qualitative aspects of medical records. Methods: A series of consecutive patients who were admitted for the first time to a thirty-six-bed orthopaedic ward of an academic teaching hospital for a planned operation or any other treatment of an acute injury or chronic condition were randomized to daily documentation of their clinical charts on a handheld computer or on conventional paper forms. The electronic documentation consisted of a specially designed software package on a handheld computer for bedside use with structured decision trees for examination, obtaining a history, and coding. In the control arm, chart notes were compiled on standard paper forms and were subsequently entered into the hospital's information system. The number of documented ICD (International Classification of Diseases) diagnoses was the primary end point for sample size calculations. All patient charts were reread by an expert panel consisting of two surgeons and the surgical quality assurance manager. These experts assigned quality ratings to the different documentation systems by scrutinizing the extent and accuracy of the patient histories and the physical findings as assessed by daily chart notes. Results: Eighty patients were randomized to one of the two documentation arms, and seventy-eight (forty-seven men and thirty-one women) of them were eligible for final analysis. Documentation with the handheld computer increased the median number of diagnoses per patients from four to nine (p < 0.0001), but it produced some overcoding for false or redundant items. Documentation quality ratings improved significantly with the introduction of the handheld device (p < 0.01) with respect to the correct assessment of a patient's progress and translation into ICD diagnoses. Various learning curve effects were observed with different operators. Study physicians assigned slightly better practicability ratings to the handheld device. Conclusions: The preliminary data from this study suggest that handheld computers may improve the quality of hospital charts in orthopaedic surgery. Level of Evidence: Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). See Instructions to Authors for a complete description of levels of evidence.

To examine the influence of evidence-based guidance on health care decisions, a study of the use of seven different sources and types of evidence-based guidance was carried out in senior health professionals in England with responsibilities either for directing and purchasing health care based in the health authorities, or providing clinical care to patients in trust hospitals or in primary care.Postal survey.Three health settings: 46 health authorities, 162 acute and/or community trust hospitals, and 96 primary care groups in England.566 subjects (46 directors of public health, 49 directors of purchasing, 375 clinical directors/consultants in hospitals, and 96 lead general practitioners).Knowledge of selected evidence-based guidance, previous use ever, beliefs in quality, usefulness, and perceived influence on practice.A usable response rate of 73% (407/560) was achieved; 82% (334/407) of respondents had consulted at least one source of evidence-based guidance ever in the past. Professionals in the health authorities were much more likely to be aware of the evidence-based guidance and had consulted more sources (mean number of different guidelines consulted 4.3) than either the hospital consultants (mean 1.9) or GPs in primary care (mean 1.8). There was little variation in the belief that the evidence-based guidance was of "good quality", but respondents from the health authorities (87%) were significantly more likely than either hospital consultants (52%) or GPs (57%) to perceive that any of the specified evidence-based guidance had influenced a change of practice. Across all settings, the least used route to accessing evidence-based guidance was the Internet. For several sources an effect was observed between use ever, the health region where the health professional worked, and the region where the guidance was produced or published. This was evident for some national sources as well as in those initiatives produced locally with predominantly local distribution networks.The evidence-based guidance specified was significantly more likely to be seen to have contributed to the decisions of public health specialists and commissioners than those of consultants in hospitals or of GPs in a primary care setting. Appropriate information support and dissemination systems that increase awareness, access, and use of evidence-based guidance at the clinical interface should be developed.

Most references to "leadership" and "learning" as sources of quality improvement in medical care reflect an implicit commitment to the decision technology of "clinical judgement". All attempts to sustain this waning decision technology by clinical guidelines, care pathways, "evidence based practice", problem based curricula, and other stratagems only increase the gap between what is expected of doctors in today's clinical situation and what is humanly possible, hence the morale, stress, and health problems they are increasingly experiencing. Clinical guidance programmes based on decision analysis represent the coming decision technology, and proactive adaptation will produce independent doctors who can deliver excellent evidence based and preference driven care while concentrating on the human aspects of the therapeutic relation, having been relieved of the unbearable burdens of knowledge and information processing currently laid on them. History is full of examples of the incumbents of dominant technologies preferring to die than to adapt, and medicine needs both learning and leadership if it is to avoid repeating this mistake.

To identify the desirable characteristics of review criteria for quality improvement and to determine how they should be selected.Review criteria are the elements against which quality of care is assessed in quality improvement. Use of inappropriate criteria may impair the effectiveness of quality improvement activities and resources may be wasted in activities that fail to facilitate improved care.A two round modified Delphi process was used to generate consensus amongst an international panel of 38 experts. A list of 40 characteristics of review criteria, identified from literature searches, was distributed to the experts who were asked to rate the importance and feasibility of each characteristic. Comments and suggestions for characteristics not included in the list were also invited.The Delphi process refined a comprehensive literature based list of 40 desirable characteristics of review criteria into a more precise list of 26 items. The expert consensus view is that review criteria should be developed through a well documented process involving consideration of valid research evidence, possibly combined with expert opinion, prioritisation according to health outcomes and strength of evidence, and pilot testing. Review criteria should also be accompanied by full clear information on how they might be used and how data might be collected and interpreted.The desirable characteristics for review criteria have been identified and will be of use in the development, evaluation, and selection of review criteria, thus improving the cost effectiveness of quality improvement activities in healthcare settings.

Aim—To identify and describe current methods of making health related research evidence accessible to general practice staV in the Northern and Yorkshire Region. Method—A postal survey questionnaire of general practice staV in the Northern and Yorkshire Region. Results—At least one completed questionnaire was obtained from 70% of the general practices surveyed, and the individual response rate to the survey was 45%. Just under 60% of all respondents reported having no access to the NHS internet and just under 50% also reported having no access to the internet. All respondents in this survey reported greater access to paper based information than to electronic databases. However, this research provides evidence of diVerential access to information resources between diVerent professions in general practice with GPs clearly having easier access than other professions to both paper based resources and electronic databases. 70% of all respondents said that they would need to be trained to use either a computer, the internet, or to search databases if the opportunity for easy access to any of these information services was available. Conclusions—At the time of this survey, general practices seemed to be struggling to set up the infrastructure and develop the skills that are necessary to make best use of available research evidence. In addition, there is a need for further investigation into the reasons why diVerent professions working in the same practice setting have diVerential access to information resources available in primary care. (Quality in Health Care 2001;10:83‐89)

Objectives - The purpose of this study is to demonstrate to what extent an evidence based decision model can improve physicians' decisions and whether a selective use of the decision model is feasible. Methods - Four experienced vascular surgeons were asked to make a treatment decision for 137 "paper patient" cases with asymptomatic abdominal aneurysms. Their decisions were compared with the optimal treatment as calculated by a computerised evidence based decision analytical model. Results - Surgeons agreed with the model's advice based on life expectancy in 81% of the cases, and decided to operate in only 12% of the cases for which there was no agreement. Surgeons' decisions differed from the decision model's calculated optimal treatment, in particular for older patients with aneurysms of intermediate size and with many risk factors, and for younger patients with small aneurysms and few risk factors. Not all these decisions, however, were reported to be more difficult. Conclusion - Use of a decision analytical model might lead to more appropriate decisions and a better quality of care. Selective use of the decision tool for difficult decisions only would be more efficient but is not yet feasible because reported decision difficulty is not strongly related to disagreement with the decision tool.

Background —Consumer involvement in clinical guidelines has long been advocated although there are few empirical accounts of attempts to do so. It is therefore not surprising that there is a lack of clarity about how and when to involve consumers and what to expect from them within the process of guideline development. Methods —The North of England evidence based guideline development programme has used four different methods of consumer involvement. Results —When individual patients were included in a guideline development group they contributed infrequently and had problems with the use of technical language. Although they contributed most in discussions of patient education, their contributions were not subsequently acted on. In a “one off” meeting with a group of patients there were again reported problems with medical terminology and the group were most interested in sections on patient education and self management. However, their understanding of the use of scientific evidence in order to contribute to a more cost effective health care remained unclear. In a workshop it was possible to explain the technical elements of guideline development to patients who could then engage with such a process and make relevant suggestions as a consequence. However, this was relatively resource intensive. A patient advocate within a guideline development group felt confidence to speak, was used to having discussions with health professionals, and was familiar with the medical terminology. Conclusions —Consumers should be involved in all stages of guideline development. While this is possible, it is not straightforward. There is no one right way to accomplish this and there is a clear need for further work on how best to achieve it.

Student peer assessment (SPA) has been used intermittently in medical education for more than four decades, particularly in connection with skills training. SPA generally has not been rigorously tested, so medical educators have limited evidence about SPA effectiveness.Seventy-one first-year medical students were stratified by previous test scores into problem-based learning tutorial groups, and then these assigned groups were randomized further into intervention and control groups. All students received evidence-based medicine (EBM) training. Only the intervention group members received SPA training, practice with assessment rubrics, and then application of anonymous SPA to assignments submitted by other members of the intervention group.Students in the intervention group had higher mean scores on the formative test with a potential maximum score of 49 points than did students in the control group, 45.7 and 43.5, respectively (P = 0.06).SPA training and the application of these skills by the intervention group resulted in higher scores on formative tests compared to those in the control group, a difference approaching statistical significance. The extra effort expended by librarians, other personnel, and medical students must be factored into the decision to use SPA in any specific educational context.SPA has not been rigorously tested, particularly in medical education. Future, similarly rigorous studies could further validate use of SPA so that librarians can optimally make use of limited contact time for information skills training in medical school curricula.

BACKGROUND: Most studies on bariatric surgery outcomes are performed as clinical trials or reflect the clinical experience in single centers. The status of bariatric surgery in Germany has been examined with the cooperation of clinics and hospitals at the Institute of Quality Assurance in Surgery at the Otto-von-Guericke University of Magdeburg (Germany) since January 1, 2005. METHODS: In this prospective multicenter observational study, the data obtained for all primary bariatric procedures, including all repeated operations, performed on consecutive patients with morbid obesity at participating hospitals from 2005 to 2007 were prospectively collected using an internet online data registry. Perioperative characteristics such as the spectrum of diagnostic measurements, type of surgical procedures, and short-and long-term out comes were investigated. RESULTS: During the study period 3,123 surgical procedures were performed. In 2005 and 2006, gastric banding (GB) was the operation performed most frequently, followed by the Roux-en-Y gastric bypass (RYGBP). In 2007, a RYGBP was carried out in 42.1% of all bariatric procedures. Among all patients, 74.4% were female. The mean BMI ranged from 48.5 kg/m(2) in 2005 to 48.0 kg/m(2) in 2007. Follow-up data after 12 months were available for 63.8% of the patients operated in 2005 and 2006. The mortality was 0.1% (30 days) and 0.16% (overall). CONCLUSION: As indicated by the worldwide trend, there is an ongoing change from GB to sleeve gastrectomy (SG) and malabsorptive procedures. The BMI of German bariatric surgical patients is substantially higher than that of patients from most other countries. There were no differences in overall outcomes during follow-up as compared to published studies.

The past decade has witnessed significant advances in our understanding of the biology of prostate cancer. Androgen ablation/androgen receptor inhibition remains as the mainstay of treatment for advanced prostate cancer. Our understanding of the biology of prostate cancer has increased exponentially owing to advances in molecular biology. With this knowledge many intriguing issues have come to light, which clinicians and scientists alike strive to answer. These include why prostate cancer is so common, what drives the development of prostate cancer at a molecular level, why prostate cancer appears refractory to many families of cytotoxic chemotherapeutics, and why prostate cancer preferentially metastasizes to bone. Two clinical forms of prostate cancer have been identified: indolent organ confined disease, which elderly men often die of, and aggressive metastatic disease. A method of distinguishing between these two forms of the disease at an organ-confined stage remains elusive. Understanding the mechanisms of castrate resistance is a further issue of clinical importance. New trials of treatments, including molecular agents that target prostate cancer from a range of angles, have been instituted over the past 10-15 years. We can look at these trials not only as a chance to investigate the effectiveness of new treatments but also as an opportunity to further understand the complex biology of this disease.

Background Decisions concerning drug safety and efficacy are generally based on pivotal evidence provided by clinical trials. Unfortunately, finding the relevant clinical trials is difficult and their results are only available in text-based reports. Systematic reviews aim to provide a comprehensive overview of the evidence in a specific area, but may not provide the data required for decision making. Methods We review and analyze the existing information systems and standards for aggregate level clinical trials information from the perspective of systematic review and evidence-based decision making. Results The technology currently used has major shortcomings, which cause deficiencies in the transfer, traceability and availability of clinical trials information. Specifically, data available to decision makers is insufficiently structured, and consequently the decisions cannot be properly traced back to the underlying evidence. Regulatory submission, trial publication, trial registration, and systematic review produce unstructured datasets that are insufficient for supporting evidence-based decision making. Conclusions The current situation is a hindrance to policy decision makers as it prevents fully transparent decision making and the development of more advanced decision support systems. Addressing the identified deficiencies would enable more efficient, informed, and transparent evidence-based medical decision making.

The clinical utility of genetic tests is determined by the outcomes following test use. Like other measures of value, it is often contested. Stakeholders may have different views about benefits and risks and about the importance of social versus health outcomes. They also commonly disagree about the evidence needed to determine whether a test is effective in achieving a specific outcome. Questions may be presented as factual disagreements, when they are actually debates about what information matters or how facts should be interpreted and used in clinical decision-making. Defining the different issues at stake is therefore an important element of policy-making. Key issues include evidence standards for test use, and in particular, the circumstances under which prospective controlled data should be required, as well as evidence on feasibility, cost and equitable delivery of testing; the goals of population-based screening programs, and in particular, the role of social outcomes in evaluating test value; and the appropriate uses and funding of tests that inform non-medical actions. Addressing each of these issues requires attention to stakeholder values and methods for effective deliberation that incorporate consumer as well as health professional perspectives.

Testing for genetic variation in drug response, in order to improve the safety and efficacy of drug therapy, is both intuitively appealing and scientifically grounded. The impact on health care could be significant, given the potentially disruptive effect of pharmacogenomic testing on clinical practice, reimbursement policies, research and development, and perhaps most significantly, on the approach of patients to their own health care, as argued by Carlson in this issue [1]. But as with many scientific innovations, transformation into medical applications has proven complicated. Though many gene variants are known to play a role, drug response is a complex phenomenon, influenced by factors such as diet, co-morbidities, and even other drugs. Thus, the predictive value of many potential pharmacogenomic tests remains small, and their clinical utility is generally not yet established. These considerations lead Garrison to argue that the impact of pharmacogenomics is likely to be moderate – an evolution or refinement rather than a revolution – and as with most new healthcare technologies, change will take decades to fully work through the healthcare system [2]. Given these uncertainties, it is not yet possible to forecast the public health impact of pharmacogenomics. It is clear, however, that important scientific, social, and policy issues need to be addressed to optimize the potential benefits to patients and the public's health. These include careful consideration of incentives – such as research funding, partnership development, and reimbursement mechanisms – and oversight. The needs and expectations of both clinicians and patients must be considered, and unanticipated consequences, such as the potential ‘nocebo’ effect described by Haga and colleagues [3], must be considered. And as with other genomic research, limitations in study design or analysis may lead to overly simplistic interpretations of population differences in drug response, with potential adverse consequences for how tests and drugs are used [4]. The papers in this special issue illustrate the broad range of scientific, ethical, and social issues to be considered as the field develops. Pharmacogenomics has different potential applications and the settings that offer the greatest opportunities are difficult to predict. To some extent, opportunities will be influenced by the nature of the scientific and clinical challenge. Given the adverse effects and variable responses associated with cancer chemotherapy and the somatic genetic variation inherent in the biology of cancer, it is not surprising that some of the most promising applications of pharmacogenomics are found in oncology [5, 6]. In general, though, the benefits of pharmacogenomics may relate most to issues of service delivery. Patients receiving ‘state of the art’ care from clinicians, involving close follow-up, monitoring for adverse effects, and appropriate dose adjustments and drug changes, may be least likely to benefit from pharmacogenomic guidance. But if patients receiving less than ideal care stand to receive the greatest benefit, we are faced with the conundrum that these patients are typically the least likely to have access to ‘fancy’ new technologies. The good news is that testing costs for many well-known pharmacogenomic variants as well as genome-wide scanning are dropping dramatically. And logistical aspects of actual testing have evolved to the point of direct patient access and ‘mail-in’ testing. These observations underscore the importance of rigorous health services research to explore the potential for pharmacogenomics to be truly cost-saving, or at a minimum, cost-effective. In this context, how might pharmacogenomics improve public health specifically? Two examples, one involving drug safety and the other drug effectiveness, provide useful examples. Warfarin is a widely used drug with a narrow therapeutic index: approximately 3–10% of warfarin users experience a serious bleeding event each year, and some of these events are fatal. Testing for variants in the CYP2C9 and VKORC1 genes identifies individuals with lower warfarin dosing requirements and could provide a means to prescribe the drug more safely [7]. Even a small reduction in bleeding episodes could have a positive effect on public health. However, the ability of testing to improve outcomes beyond those achieved in a ‘state of the art’ anticoagulation clinic has not been shown to date, and indeed may prove to be challenging. Therefore, evaluation of pharmacogenomic applications in diverse patient populations and settings will be important to determine where they provide most value. The populations likely to benefit the most may also be the most challenging to collaborate with because of logistical issues, cultural barriers, and difficulties conducting research studies in real-world settings. Research partnerships that promote community participation and shared governance may be an important component of successful pharmacogenomic research. In addition to reducing adverse events, pharmacogenomics might also improve the efficacy of drug treatment. Tamoxifen is a widely used adjuvant treatment to prevent the recurrence of early stage breast cancer. Tamoxifen is actually a ‘pro-drug’ – that is, it needs to be activated via the body's metabolic enzymes. Studies have indicated that variants of CYP2D6 may be associated with the risk of breast cancer recurrence: women with a low-activity variant of CYP2D6 have less active metabolites of tamoxifen and thus may have lower effectiveness [8]. There is no effective approach to monitoring women for their response to tamoxifen over time. Fortunately, there is a good drug alternative, aromatase inhibitors, which have been shown to be at least equally efficacious, but these are significantly more expensive than tamoxifen. The clinical and patient impact of breast cancer recurrence is obviously significant, and CYP2D6 testing with tamoxifen therapy would appear to be an ideal application of pharmacogenomics, especially in resourcelimited situations. Several questions must be resolved: Is the genetic association with disease recurrence (and/or survival) valid? And what level of evidence would be required to recommend testing? Does genetic testing provide a means to optimize the use of a less expensive drug in a cost-effective manner, and if so, will clinicians and patients find this an acceptable approach? As with drug safety, effective strategies for community-based research are needed. The promise of pharmacogenomics will not be realized without effective leadership. Despite rapid growth of the pharmacogenomic literature, research addressing clinical outcomes is still very limited [9]. And with costs dropping, collaborative effort is needed to minimize the dangers of premature translation. For example, analysis of a test marketed as a means to reduce the risk of hearing loss from aminoglycosides indicated little scientific evidence of benefit, lack of cost effectiveness, and a potential for net harm [10]. Leadership is needed to assure oversight mechanisms that either prevent such tests from reaching the marketplace or assure that clinicians and consumers are well informed of their limitations when they do. At the same time, reimbursement policies that provide appropriate incentives for development are needed, with reasonable standards for clinical utility [11]. Perhaps most important, infrastructures will be required to assure adequate evaluation of pharmacogenomic testing in a range of routine clinical settings so that meaningful evaluation of the risks and benefits (both clinical and social) can occur. Robust partnerships between industry and academia [12], careful attention to research ethics [13], and methods to incorporate patient perspectives [14] will all be important in this effort. If researchers, health care leaders, policy makers, and test developers can work cooperatively and in concert with patients to achieve these goals, benefits to public health are likely.

Background: The 39 item Parkinson's disease questionnaire (PDQ-39) is the most widely used patient reported rating scale in Parkinson's disease. However, several fundamental measurement assumptions necessary for confident use and interpretation of the eight PDQ-39 scales have not been fully addressed. Methods: Postal survey PDQ-39 data from 202 people with Parkinson's disease (54% men; mean age 70 years) were analysed regarding psychometric properties using traditional and Rasch measurement methods. Results: Data quality was good ( mean missing item responses, 2%) and there was general support for the legitimacy of summing items within scales without weighting or standardisation. Score reliabilities were adequate (Cronbach's alpha 0.72-0.95; test-retest 0.76-0.93). The validity of the current grouping of items into scales was not supported by scaling success rates ( mean 56.2%), or factor and Rasch analyses. All scales represented more health problems than that experienced by the sample ( mean floor effect 15%) and showed compromised score precision towards the less severe end. Conclusions: Our results provide general support for the acceptability and reliability of the PDQ-39. However, they also demonstrate limitations that have implications for the use of the PDQ-39 in clinical research. The grouping of items into scales appears overly complex and the meaning of scale scores is unclear, which hampers their interpretation. Suboptimal targeting limits measurement precision and, therefore, probably also responsiveness. These observations have implications for the role of the PDQ-39 in clinical trials and evidence based medicine. PDQ-39 derived endpoints should be interpreted and selected cautiously, particularly regarding small but clinically important effects among people with less severe problems.

Background: Paraneoplastic neurological syndromes (PNS) are defined by the presence of cancer and exclusion of other known causes of the neurological symptoms, but this criterion does not separate “true” PNS from neurological syndromes that are coincidental with a cancer. Objective: To provide more rigorous diagnostic criteria for PNS. Methods: An international panel of neurologists interested in PNS identified those defined as “classical” in previous studies. The panel reviewed the existing diagnostic criteria and recommended new criteria for those in whom no clinical consensus was reached in the past. The panel reviewed all reported onconeural antibodies and established the conditions to identify those that would be labelled as “well characterised”. The antibody information was obtained from published work and from unpublished data from the different laboratories involved in the study. Results: The panel suggest two levels of evidence to define a neurological syndrome as paraneoplastic: “definite” and “possible” . Each level can be reached combining a set of criteria based on the presence or absence of cancer and the definitions of “classical” syndrome and “well characterised” onconeural antibody. Conclusions: The proposed criteria should help clinicians in the classification of their patients and the prospective and retrospective analysis of PNS cases.

Objective: To evaluate the results of surgical treatment options for chronic subdural haematoma in contemporary neurosurgery according to evidence based criteria. Methods: A review based on a Medline search from 1981 to October 2001 using the phrases “subdural haematoma” and “subdural haematoma AND chronic”. Articles selected for evaluation had at least 10 patients and less than 10% of patients were lost to follow up. The articles were classified by three classes of evidence according to criteria of the American Academy of Neurology. Strength of recommendation for different treatment options was derived from the resulting degrees of certainty. Results: 48 publications were reviewed. There was no article that provided class I evidence. Six articles met criteria for class II evidence and the remainder provided class III evidence. Evaluation of the results showed that twist drill and burr hole craniostomy are safer than craniotomy; burr hole craniostomy and craniotomy are the most effective procedures; and burr hole craniostomy has the best cure to complication ratio (type C recommendation). Irrigation lowers the risk of recurrence in twist drill craniostomy and does not increase the risk of infection (type C recommendation). Drainage reduces the risk of recurrence in burr hole craniostomy, and a frontal position of the drain reduces the risk of recurrence (type B recommendation). Drainage reduces the risk of recurrence in twist drill craniostomy, and the use of a drain does not increase the risk of infection (type C recommendation). Burr hole craniostomy appears to be more effective in treating recurrent haematomas than twist drill craniostomy, and craniotomy should be considered the treatment of last choice for recurrences (type C recommendation). Conclusions: The three principal techniques—twist drill craniostomy, burr hole craniostomy, and craniotomy—used in contemporary neurosurgery for chronic subdural haematoma have different profiles for morbidity, mortality, recurrence rate, and cure rate. Twist drill and burr hole craniostomy can be considered first tier treatment, while craniotomy may be used as second tier treatment. A cumulative summary of data shows that, overall, the postoperative outcome of chronic subdural haematoma has not improved substantially over the past 20 years.

There is currently a political enthusiasm for the development and use of clinical guidelines despite, paradoxically, there being relatively few healthcare issues that have a sound research evidence base. As decisions have to be made even where there is an undetermined evidence base and that limiting recommendations to where evidence exists may reduce the scope of guidelines, thus limiting their value to practitioners, guideline developers have to rely on various different sources of evidence and adapt their methods accordingly. This paper outlines a method for guideline development which incorporates a consensus process devised to tackle the challenges of a variable research evidence base for the development of a national clinical guideline on risk assessment and prevention of pressure ulcers.To inform the recommendations of the guideline a formal consensus process based on a nominal group technique was used to incorporate three strands of evidence: research, clinical expertise, and patient experience.The recommendations for this guideline were derived directly from the statements agreed in the formal consensus process and from key evidence-based findings from the systematic reviews. The existing format of the statements that participants had rated allowed a straightforward revision to "active" recommendations, thus reducing further risk of subjectivity entering into the process.The method outlined proved to be a practical and systematic way of integrating a number of different evidence sources. The resultant guideline is a mixture of research based and consensus based recommendations. Given the lack of available guidance on how to mix research with expert opinion and patient experiences, the method used for the development of this guideline has been outlined so that other guideline developers may use, adapt, and test it further.

To develop and evaluate an information service in which a "clinical informaticist" (a GP with training in evidence-based medicine) provided evidence-based answers to questions posed by GPs and nurse practitioners.Descriptive pilot study with systematic recording of the process involved in searching for and critically appraising literature. Evaluation by questionnaire and semi-structured interview.General practice.34 clinicians from two London primary care groups (Fulham and Hammersmith).Number and origin of questions; process and time involved in producing summaries; satisfaction with the service.All 100 clinicians in two primary care groups were approached. Thirty four agreed to participate, of whom 22 asked 60 questions over 10 months. Participants were highly satisfied with the summaries they received. For one third of questions the clinicians stated they would change practice in the index patient, and for 55% the participants stated they would change practice in other patients. Answering questions thoroughly was time consuming (median 130 minutes). The median turnaround time was 9 days; 82% of questions were answered within the timeframe specified by the questioner. Without the informaticist, one third of questions would not have been pursued.The clinical informaticist service increased access to evidence for busy clinicians. Satisfaction was high among users and clinicians stated that changes in practice would occur. However, uptake of the service was lower than expected (22% of those offered the service). Further research is needed into how this method of increasing access to evidence compares with other strategies, and whether it results in improved health outcomes for patients.

Evidence based guidelines are regarded as an appropriate basis for providing effective health care, but few guidelines incorporate the views of users such as carers.To develop guidelines to assist primary health care teams (PHCTs) in their work with carers within South Asian communities.The guidelines were drawn up by a development group consisting of members of teams in areas with South Asian communities (Leicester and Bradford). The teams were invited to make their recommendations based on a systematic review of literature on minority ethnic carers and the findings of a study of the needs and experiences of local South Asian carers. A grading system was devised to enable the teams and a group of expert peer reviewers to assess the quality of evidence in support of each recommendation.The teams agreed seven recommendations, graded according to available evidence and strength of opinion. External peer review supported the PHCTs' interpretation of evidence and their recommendations. The recommendations included consideration of communication and information for carers, coordination of care within teams, and recognition by team members of the roles of carers and their cultural and religious beliefs.There are particular steps that PHCTs can take to improve their support of South Asian carers. It is possible to develop guidelines that take users' views into account and incorporate evidence from qualitative studies.