bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation in clinical practice: problems, precedents and principles
Authors: Mclntyre Neil 
Published: December 2007

Abstract‘Audit’ is now in widespread use in our National Health Service, but there is little documentation of improvement resulting from audit. If it is to be used to identify mistakes in clinical practice, we must be prepared to admit them, or to have our work evaluated by others; such openness is uncommon. Understandably, doctors are concerned about possible litigation, under‐ mining of their authority, and/or interference with their methods of practice. Furthermore, few are willing to comment adversely on the work of others.There is confusion about the best method(s) of audit. Outcome and process audit serve different purposes. Outcome audit measures the effect of care on patients' health, but in individual cases a poor outcome may result after impeccable medical care and a good outcome after poor care. Outcome audit requires a large patient group, is costly, and is of value for a limited number of conditions. Appropriate standards are needed to judge the results; it may be fallacious to compare outcomes in different settings, and with different patient groups. Furthermore, outcome audit is of little value for auditing the care given by individual doctors, and this limits its value in clinical education.Process audit deals with the appropriateness of clinical actions, on the assumption that they affect outcome. It can detect poor performance when outcome audit would be unlikely to identify poor outcome. For common or well‐defined problems, process audit can make use of clear criteria, for example agreed protocols, and this may have immediate benefit for individual patients. When there is no agreed protocol the overall quality of care can still be audited against relatively explicit criteria, if there is agreement on the relevant ‘principles of clinical practice’, i.e. the rules which should guide the clinical management of individual patients. Clearly these should cover the collection, recording and analysis of patient data; planning for diagnosis, monitoring, treatment and patient education, and steps to be taken when there is uncertainty about the best course of action. Performance in these areas can be assessed by reviewing the patients' notes, but most clinical records are inadequate for this purpose.Process audit can be applied to all clinical problems, and is the method of choice for assessing the actions of individuals. Its educational value is self‐ evident. It allows the identification of deficiencies, and the provision of feedback to correct them. Furthermore, it provides for a continuum of audit through the undergraduate and postgraduate years of a doctor's training.
Acquisition and use of clinical data for audit and research
Authors: MRCP Jeremy Wyatt DM 
Published: December 2007

AbstractAcquisition of adequate patient data for clinical management is hard enough, but higher quality patient data are needed for clinical audit and research. This article discusses some of the problems of using routine clinical data for audit and research, aspects of data quality, sources of audit or research data and their problems, methods for improving data quality, the benefits and problems of computer‐based systems and current trends in the capture and processing of clinical data.
Meta‐analysis or best‐evidence synthesis?
Authors: Eysenck H.J. 
Published: December 2007

AbstractThis article examines the usefulness of meta‐analysis, and articulates many of the criticisms that have been made of its workings. An attempt is made to outline the precautions that have to be taken before a scientifically useful and meaningful meta‐analysis can be carried out. The problems encountered include heterogeneity of samples, conditions, interventions and end‐points; narrow focus; curvilinearity of regression; lack of independence of determinants; synergistic interactions; contradictory experimental results. It is suggested that best‐evidence synthesis, or theorydirected analysis, might be a safer option.
Case mix adjustment in comparative audit
Authors: Hayes Catriona , Murray Gordon D. 
Published: December 2007

AbstractThere is increasing pressure to measure and publicize the quality of health care, with, for example, hospital ‘league tables’; appearing regularly in the lay press. Equally, there is increasing recognition that such simplistic presentations of data can be seriously misleading, as differences in case mix mean that they do not compare like with like.We discuss what is required of a statistical model if it is to be used to make comparisons of clinical performance which are adjusted for case mix. Outcome measures must be well defined and relevant, and the risk factors used in the model must reflect the patient's potential prognosis rather than aspects of his or her clinical care. In addition, the calibration of the statistical model is crucial.We review a number of established clinical scoring systems and demonstrate that they fail to meet all of the required criteria. Of particular concern is the fact that these scoring systems are susceptible to biases which could actually mask differences in performance. We highlight areas where further research is required, with the aim of stimulating progress in this field.
Systematic reviews of randomized controlled trials: the need for complete data
Authors: Clarke Michael J. , Stewart Lesley A. 
Published: December 2007

AbstractIf the relative effectiveness of different treatments that might be used in clinical practice is to be evaluated reliably, it is very important that the evaluation is carried out in an appropriate manner. This is especially true where the differences between treatments are expected to be moderate, and so easily obscured by the play of chance or systematic bias. Although such differences are often of considerable clinical importance, they can be difficult to assess and require a large amount of randomized evidence. This evidence can be obtained through prospective randomized controlled trials, meta‐analysis of results from past randomized trials, or ideally a combination of the two, with prospective trials contributing to future meta‐analyses. Whichever technique is adopted, all possible biases must be minimized through the collection of as much randomized evidence as possible. In meta‐analyses, this is best achieved by ensuring that all relevant trials, and all randomized participants in these trials, are included in the analysis. The gold standard for this might be a meta‐analysis of individual patient data, in which details for each participant in every trial are collected and analysed centrally. This approach requires considerable time and effort. However, it will add to the analyses that can be performed and will remove many of the problems associated with a reliance on published data alone and some of the problems that can arise from the use of aggregate data. This paper sets out some of the reasons for this and some of the techniques used for individual patient data‐based meta‐analysis.
Clinical audit in the National Health Service: fact or fiction?
Authors: Miles A. , Bentley P. , Polychronis A. , Price N. , Grey J. 
Published: December 2007

AbstractIt is increasingly recognized that the repeated rhetorical emphasis from 1989 to date on achieving measurable benefits to patients from audit, in the face of inattention to the development of methodologies with which to realize such benefits in operational practice, has represented a serious deficiency in strategic planning and direction and a consequent failure to establish functional clinical audit within the NHS. A grand revision of strategy is therefore necessary, and this should begin with the development of a research‐based method of audit, the training of clinicians and audit support staff in its use and a subsequent trial of its effectiveness prior to its implementation within the NHS. Only then will measurable improvements become possible, value for money be assured and clinicians' attitudes to audit change.
Monitoring outcomes in routine practice: defining appropriate measurement criteria
Authors: Long Andrew F. , Dixon Paul 
Published: December 2007

AbstractWith the development of an internal market for health care, ‘purchasing for outcomes’ has become an important if somewhat rhetorical catchphrase. While there is emerging understanding about how it can be pursued, doubts are being expressed over an outcomes rather than a process emphasis. This debate has been confused by a failure to differentiate the role and importance of monitoring outcomes at an individual patient care level from those at an aggregate population/purchaser level.The clinical need to collect outcomes data on individual patient care within routine care settings places additional requirements on measurement development and selection. Traditional measurement criteria, stressing reliability, validity and responsiveness to change, must be supplemented by criteria of feasibility of use, clinical utility and acceptability. One option is to select domains or items of interest from longer instruments initially designed for research, carefully selected in relation to the purposes of measurement. Further measurement criteria must be addressed which stress the relevance of the proposed instrument to the condition and to the participants in the clinical interaction: in particular, patient‐centredness and sensitivity to the setting.Monitoring the outcomes of individual patient care within routine clinical practice poses considerable challenges to researchers who are developing instruments and to clinicians who collect and use the data. A shift in emphasis is required towards more context‐specific tests, addressing relevance to lay perceptions, to clinical use and to the condition and setting under review. The content validity, the responsiveness to patient‐relevant and clinically relevant change and, of course, reliability must have greater primacy. In this way, outcome data which measure the quality of clinical practice and which provide appropriate criteria for research into effectiveness can be generated.
User involvement in clinical audit: a review of developments and issues of good practice*
Authors: Kelson Marcia 
Published: December 2007

AbstractThere have been considerable political and organizational moves to involve ‘consumers’ (patients, carers, service users, potential users, local communities and the public at large) in the provision, planning and monitoring of health services. Such developments beg the question ‘what constitutes good practice in user involvement?’. Taking user views into account relates not only to obtaining feedback on ’hotel’ aspects of care (issues such as food and cleanliness) but also to the potential for patient input to clinical audit and the standards by which care itself is measured.Recent policy statements specifically advocate involving users in the process and product of clinical audit. In practice, ‘involvement’ has meant anything from passing on information to full and active participation in partnership with professionals. This paper outlines some of the issues raised in the published literature on user involvement in clinical audit. Suggesting that real involvement refers to users as active participants, not passive recipients, the paper documents the increasing policy commitment to user involvement and considers issues that influence how the rhetoric is put into practice.
The French clinical guidelines and medical references programme: development of 48 guidelines for private practice over a period of 18 months
Authors: Maisonneuve Hervé , Cordier Hélèns , Durocher Alain , Matillon Yves 
Published: December 2007

AbstractThe French medical profession and health insurance organizations have jointly committed themselves to a concept termed the ‘medical regulation’ of care. They decided to promote the quality of health care, judging that an approach based on quality was the best option for reducing the increase in health costs. The Clinical Guidelines and Medical References programme was entrusted to ANDEM (Agence Nationale pour le Développement de l'Évaluation Médicale).Fifty working groups (669 experts) and 50 reading groups (1643 experts) met from June 1994 to November 1995 to produce guidelines. Learned societies were involved to propose experts. Hospital practitioners, doctors who specialized in the topic in question and those who did not had equal representation in the groups. The method consisted of a review of the literature to determine the level of scientific evidence. ANDEM's Scientific Council suggested modifications to the groups and agreed to disseminate 48 of the 50 texts.Careful observation of the operation of the groups identified factors that can positively influence the nature of the discussions and help avoid conflict: an abundance of high‐quality literature, an understanding of clinical research methodology, the existence of guidelines from different institutions or different countries tending towards the same conclusions, good initial work carried out by the chairperson and the project manager, a limit to the number of questions asked of the group, the chairperson having good people skills and meeting‐management skills, and an absence of professional and financial consequences for the participants. Good management of working groups is an additional factor in ensuring success. The regulatory medical references programme has led to changes of behaviour within the medical profession.
Patient, physician and presentational influences on clinical decision making for breast cancer: results from a factorial experiment*
Authors: McKinlay John B. , Burns Risa B. , Durante Richard , Feldman Henry A. , Freund Karen M. , Harrow Brooke S. , Irish Julie T. , Kasten Linda E. , Moskowitz Mark A. 
Published: December 2007

AbstractThis study examines the influence of six patient characteristics (age, race, socioeconomic status, comorbiditics, mobility and presentational style) and two physician characteristics (medical specialty and years of clinical experience) on physicians' clinical decision making behaviour in the evaluation and treatment of an unknown and known breast cancer. Physicians' variability and certainty associated with diagnostic and treatment behaviour were also examined. Separate analyses explored the influence of these non‐medical factors on physicians' cognitive processes. Using a fractional factorial design, 128 practising physicians were shown two videotaped scenarios and asked about possible diagnoses and medical recommendations. Results showed that physicians displayed considerable variability in response to several patient‐based factors. Physician characteristics also emerged as important predictors of clinical behaviour, thus confirming the complexity of the medical decision‐making process.
Issues of cost and quality: barriers to an informed debate
Authors: PhD Caryl E. Carpenter , Cornman John M. , PhD A. Douglas Bender , MBA David B. Nash MD 
Published: December 2007

AbstractDebates over health reform in the United States are hampered by a poorly informed public and misunderstandings about the concepts of quality, cost containment and their relationship to each other. This paper explores the nature and persistence of barriers to an informed public discussion of reform proposals. Those barriers are: (1) multiple definitions of quality, cost and cost containment, (2) the impact of the media on those definitions, (3) a false assumption that cost containment automatically results in diminished quality, and (4) the perceived impact of managed care and for‐profit health firms on that assumption. We suggest a framework for building the understanding and knowledge base necessary to a reform of the nation's health care system.
Shortcomings of the randomized controlled trial: a view from the boondocks
Authors: MD Joseph Herman 
Published: December 2007

AbstractThe randomized controlled trial (RCT), despite its well‐known limitations, continues to be regarded as a gold standard in determining whether an intervention does more harm than good. Some recent evidence suggests that it tends to overvalue the modalities it tests. Moreover, the accuracy with which the disorder under consideration is diagnosed can be critical to the performance of a new intervention designed for it. When technological progress allows us to diagnose milder instances, some therapies, possibly useful in dire circumstances, will appear ineffective if most of a trial population is at low risk. Human individuality makes it impossible to duplicate a RCT. As a result, Popper's criterion of falsifrability may not be met and so the carrying out of a large‐scale therapeutic experiment may not be a scientific activity. Finally, it is doubtful whether group probabilities derived from RCTs can be safely applied to individuals. These and other reservations concerning the applicability of the RCT to clinical practice are discussed.
A model for the development of evidence‐based clinical guidelines at local level ‐ the Leicestershire Genital Chlamydia Guidelines Project
Authors: MRCGP Tim Stokes MPH , MFPHM Rashmi Shukla MRCP , FRCP Paul Schober , FRCGP Richard Baker MO 
Published: December 2007

AbstractClinical guidelines can be effective in achieving health gain when they are validly developed, disseminated and implemented appropriately. There is, however, a potential conflict between the need for validity through use of expert resources available at a national level, and implementation, which is undertaken at local level and depends on the local relevance of the guideline. This paper presents a model by which valid guidelines for the management of a given disease (genital chlamydial infection) by general practitioners can be developed at local level using the resources available to a district health authority department of public health. The model has three elements. First, a district‐wide postal questionnaire survey was used to document current clinical practice. Secondly, a critical review of the evidence relating to the management of genital chlamydial infection as it relates to British general practice was performed. Thirdly, the information gained from the critical review and survey was used by a multidisciplinary group to develop evidence‐based guideline recommendations. It is argued that the Leicestershire Genital Chlamydia Guidelines compare favourably with other recently published national guidelines in terms of their development and content. Local guideline development of guidelines for selected topics can be practical and appropriate.
Depot neuroleptic usage in adults with learning disabilities
Authors: Gravestock S. 
Published: December 2007

AbstractMost previous surveys of depot neuroleptic usage have monitored the consumption of oral psychoactive medications by heterogeneous mental handicap hospital populations. The present study assessed the prevalence, patient, practice and service delivery factors associated with depot neuroleptic usage in community learning disabilities services. The total of 79 adult subjects receiving depot neuroleptics roughly represented 0–5% of local service users. Several significant differences emerged between the factors associated with usage in the 61 (77%) subjects with psychotic disorders and 18 (23%) other subjects. Fitting backward elimination regression models accounted for 67–75% of the depot dosage variance. Comparison of these results with data from previous depot research studies suggested several methodological, clinical, ethical and research issues for future consideration.
Progress in social‐independent functioning of young people with Down's syndrome
Authors: Sloper p. , Turner S. 
Published: December 2007

AbstractThe progress over a 5‐year period in the social‐independent functioning of 96 older children and teenagers with Down's syndrome was examined. A significant increase in scores on the Self‐Sufficiency Index was found, with considerable individual variability. Path analysis was used to trace the factors associated with current levels of self‐sufficiency and the degree of change over time. Earlier level of cognitive development was the strongest predictor of progress in self‐sufficiency, but family factors were also important, particularly mothers’ strategies for coping with child problems and mothers’ levels of social support. For a small number of children with the lowest developmental level, family factors were less important as their self‐sufficiency was more strongly limited by their severe disability. The results suggest that interventions aimed at changing maternal coping strategies and supplementing social support may benefit the development of social‐independent functioning in young people with Down's syndrome.
Genotypic variation, clinical and histological characteristics of chronic hepatitis C detected at blood donor screening
Authors: Bird G.L.A. , Spence E. , Hillan K.J. , MacSween R.N.M. , Frame D. , Yap P. , Dow B. , McOmish F. , Mills P.R. 
Published: December 2007

Summary. Since blood donor screening for the hepatitis C virus (HCV) began in 1991 a large number of seropositive subjects have been detected and several reports have suggested a high prevelance of liver disease. The aim of this study was to evaluate the severity of liver disease in HCV‐positive blood donors in terms of the clinical, biochemical and histological abnormalities and to investigate the relationships between these features and the mode of transmission, duration of infection and viral genotype. We evaluated 54 consecutive blood donors who were positive for HCV both on serological testing and polymerase chain reaction. Twenty‐three (43%) had a history of intravenous drug abuse and 17 (31%) had received blood transfusions. In only two (4%) was no risk factor identified. The mean duration of infection in those with a clear history of HCV exposure was 12 years. Eighty‐three percent were HCV genotypes 1 or 3. All had abnormal liver biopsies with chronic hepatitis and several patients had periportal or portal‐portal fibrous septa, but there was none with architectural distortion or cirrhosis. There was no correlation between severity of liver disease and duration of HCV infection, mode of transmission or viral genotype.In the majority of HCV carriers detected at donor screening there is a chronic hepatitis with bridging necrosis in one third, but the degree of fibrosis is minimal and cirrhosis was not present in our patients. The long period of infection of many patients suggests that irreversible liver injury does not necessarily develop at an early stage despite persistent infection.