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Psychoanalysis, science and clinical practice.

The question of the relationship between psychoanalysis and science, and the place of psychoanalysis in clinical practice is reviewed. A commonly held view that the central question is whether or not psychoanalysis is scientific is challenged. It is argued instead that psychoanalysis, science and clinical practice are epistemologically independent fields and attempts to subsume one within the other are unproductive. Psychoanalysis may have as much to say concerning the epistemological basis of science as science has to say concerning the epistemological basis of psychoanalysis. Only a proper appreciation of this enables the question of the relationship between psychoanalysis and clinical practice to be adequately examined.

Australia↗

Realities of diagnosing Helicobacter pylori infection in clinical practice: a case for non-invasive indirect methodologies.

BACKGROUND: The current, arbitrarily defined gold standard for the diagnosis of H. pylori infection requires histologic examination of two specially stained antral biopsy specimens. However, routine histology is potentially limited in general clinical practice by both sampling and observer error. The current study was designed to examine the diagnostic performance of invasive and non-invasive H. pylori detection methods that would likely be available in general clinical practice. METHODS: The diagnostic performance of rotating clinical pathology faculty using thiazine staining was compared with that of an expert gastrointestinal pathologist in 38 patients. In situ hybridization stains of adjacent biopsy cuts were also examined by the expert pathologist for further comparison. Receiver operator characteristic (ROC) analysis was performed to evaluate whether the diagnostic performance of the expert pathologist differed depending upon the histologic method employed. A similar analysis was made to evaluate the diagnostic performance of pathology trainees relative to the expert. In the absence of an established invasive gold standard, non-invasive testing methods (rapid serum antibodies, formal Elisa antibodies and carbon-14 urea breath testing) were evaluated in 74 patients by comparison with a gold standard defined using a combination of diagnostic tests. RESULTS: Using either rapid urease testing of biopsy specimens or urea breath testing as the gold standard for comparison, the diagnostic performance of the rotating clinical pathology faculty was inferior to that of the expert gastrointestinal pathologist especially with regard to specificity (e.g., 69 percent for the former versus 88 percent, with the latter relative to rapid urease testing). Although interpretation of in situ hybridization staining by the expert appeared to have an even higher specificity, ROC analysis failed to show a difference. The mean ROC areas for thiazine and in situ hybridization staining for trainee pathologists relative to the expert were 0.88 and 0.94, respectively. In untreated patients, urea breath testing had a sensitivity and specificity of 100 percent as compared with thiazine staining with a sensitivity of 83 percent and a specificity of 97 percent. Post-therapy, breath testing had a sensitivity of 100 percent but a specificity of only 86 percent as compared with invasive testing with a sensitivity and specificity of 100 percent. Rapid serum antibody testing and formal Elisa antibody testing agreed in 93 percent of cases (Kappa 0.78) with the rapid test being correct in three of the four disagreements. CONCLUSIONS: The current study illustrates a number of realities regarding H. pylori diagnosis. There is no diagnostic gold standard in general clinical practice. Accurate interpretation of specially stained slides is a learned activity with a tendency towards overdiagnosis early on. Urea breath testing is likely to be the diagnostic method of choice for untreated patients in general clinical practice although antibody testing is almost as accurate. Rapid antibody tests are at least as accurate as formal Elisa antibody tests. Urea breath testing is useful for confirming cure after therapy, but false-positive results may occur in some patients.

Biopsy↗

Clinical practice guidelines: moving into the 21st century.

Clinical practice guidelines affect every aspect of healthcare. Practitioners, third-party payors, regulatory bodies, governments, and accrediting agencies increasingly use these guidelines, which are developed by a wide variety of organizations. The majority of guidelines are based on consensus and a nonsystematic literature review, but some, including those developed by the Agency for Health Care Policy and Research, are evidence based. Both types of guidelines have distinct advantages and limitations. Consensus-based guidelines are less time consuming to develop but may lack crucial information and result in a wide variety of outcomes; whereas, the type of evidence used to develop strength-of-evidence ratings for evidence-based guidelines may result in ambiguous recommendations and cause ethical concerns. Outcomes research on the use of guidelines and issues related to their timeliness need to be addressed. Studies that include a wide variety of outcome indicators and care variables and contributions of clinicians are needed to develop practice guidelines that are clinically useful and improve patient care.

Forecasting↗

Knowing the score: using predictive scoring systems in clinical practice.

Outcome scores have been promoted as adjuncts to clinical decision making, especially when further care is thought to be futile. The Pediatric Risk of Mortality score is used to calculate the risk of mortality for patients admitted to pediatric intensive care units. In this article the Pediatric Risk of Mortality score in evaluated for its ability to contribute to individual patient care decisions in the context of clinical practice. Through analysis several features of the Pediatric Risk of Mortality score were identified that require discretion if the score is to be used in decisions involving individual patients. These features include variability and bias introduced in data collection and data presentation. Also, outcome scores do not allow for the incorporation of patient and family values into the decision process. Outcome scores can provide some adjunctive information to clinicians, but they should be used with caution when making patient care decisions. Use of Pediatric Risk of Mortality scores in clinical practice must be tempered with a knowledge of the limitations of the scores, individual patient variability, the conditions under which the scores have been validated and collected and, most importantly, an awareness that outcome scores do not take into account the caregiver and patient values that are inherent in any treatment decision.

Child↗

The use of rheumatoid arthritis health-related quality of life patient questionnaires in clinical practice: lessons learned.

OBJECTIVE: The utilization of health-related quality of life (HRQOL) patient questionnaires by clinical rheumatologists is limited. Yet, considerable literature exists defining the value of such data. In an effort to understand this apparent paradox, we performed a literature review and conducted a survey to describe what has been learned over the past 2 decades concerning the use of these measures in clinical care and explore the reasons for their underutilization. METHODS: A panel of rheumatologists with extensive clinical experience was convened to review the relevant literature pertaining to the use of HRQOL patient instruments in clinical practice. Additionally, a survey of all American College of Rheumatology practicing clinicians was conducted to assess the use of and beliefs about these measures. RESULTS: The literature provided evidence to support the use of HRQOL patient measures in clinical practice. Forty-seven percent of the responding rheumatologists stated that none of their patients complete HRQOL patient questionnaires. The majority of respondents (63%) reported that such information is "somewhat valuable." The most frequently reported reason for the underutilization was that such instruments "require too much staff time." CONCLUSIONS: The literature supports the potential value of HRQOL patient questionnaires in clinical practice. Few rheumatologists routinely gather such information as part of patient care. Reasons for this discrepancy between utility and use are given along with recommendations intended to help increase their utilization in clinical care.

Arthritis, Rheumatoid↗

Effects of feedback of information on clinical practice: a review.

OBJECTIVE: To establish what is known about the role of feedback of statistical information in changing clinical practice. DESIGN: Review of 36 studies of interventions entailing the use of statistical information for audit or practice review, which used a formal research design. SUBJECTS: Papers identified from computer searches of medical and health service management publications, of which 36 describing studies of interventions designed to influence clinical care and including information feedback from clinical or administrative data systems were reviewed. MAIN OUTCOME MEASURES: Evidence for effect of information feedback on change in clinical practice. RESULTS: Information feedback was most likely to influence clinical practice if it was part of strategy to target decision makers who had already agreed to review their practice. A more direct effect was discernable if the information was presented close to the time of decision making. The questions of the optimum layout and quantity of information were not addressed; the 36 papers were insufficient for defining good formats for information to be used for audit or quality assurance. CONCLUSIONS: Given the cost of information processing and the current emphasis on closing the audit loop in the health services, it is important that the use of information in the audit process should be critically evaluated.

Clinical Medicine↗

Benefit/risk assessment of SERM therapy: clinical trial versus clinical practice settings.

Benefit/risk assessment (B/rA) can be used in a variety of circumstances encompassing clinical practice and research settings. Subsequent to the reporting of the results from the Breast Cancer Prevention Trial (BCPT), methodology was developed to perform B/rA for the use of the selected estrogen receptor modulator (SERM), tamoxifen. Although the methodology was specifically developed and applied to the use of tamoxifen, it is a generalized procedure that can be readily modified and applied to other forms of therapy including other SERMs. Recently, the methodology has been incorporated into the Study of Tamoxifen and Raloxifene (STAR) trial, a randomized clinical trial designed to compare the chemopreventive effects of two SERMs--tamoxifen and raloxifene. The B/rA of SERMs is complex because SERMs are known to exhibit properties that can reduce or increase the incidence of several health outcomes. This paper summarizes the uses of B/rA in the clinical practice and clinical trial settings and describes the constraints of the methodology as it is being applied to the assessment of therapy with SERMs.

Antineoplastic Agents↗

A comparison of clinical practice guideline appraisal instruments.

OBJECTIVE: To identify and compare clinical practice guideline appraisal instruments. METHODS: Appraisal instruments, defined as instruments intended to be used for guideline evaluation, were identified by searching MEDLINE (1966-99) using the Medical Subject Heading (MeSH) practice guidelines, reviewing bibliographies of the retrieved articles, and contacting authors of guideline appraisal instruments. Two reviewers independently examined the questions/statements from all the instruments and thematically grouped them. The 44 groupings were collapsed into 10 guideline attributes. Using the items, two reviewers independently undertook a content analysis of the instruments. RESULTS: Fifteen instruments were identified, and two were excluded because they were not focused on evaluation. All instruments were developed after 1992 and contained 8 to 142 questions/statements. Of the 44 items used for the content analysis, the number of items covered by each instrument ranged from 6 to 34. Only the instrument by Cluzeau and colleagues included at least one item for each of the 10 attributes, and it addressed 28 of the 44 items. This instrument and that of Shaneyfelt et al. are the only instruments that have so far been validated. CONCLUSIONS: A comprehensive, concise, and valid instrument could help users systematically judge the quality and utility of clinical practice guidelines. The current instruments vary widely in length and comprehensiveness. There is insufficient evidence to support the exclusive use of any one instrument, although the Cluzeau instrument has received the greatest evaluation. More research is required on the reliability and validity of existing guideline appraisal instruments before any one instrument can become widely adopted.

Humans↗

A survey of clinical practice of lung transplantation in North America.

OBJECTIVES: The clinical practice of lung transplantation (LT) varies widely among transplant centers. The objective of this study was to determine the practice patterns of North American lung transplant programs in specific areas that are considered controversial by most lung transplant practitioners. METHODS: The Transplant/Immunology Network of the American College of Chest Physicians (ACCP) designed a survey and distributed it through the ACCP using a Web-based survey tool. The survey was divided into the following two sections: (1) patient selection issues; and (2) posttransplant management. Additional questions were asked about graft preservation, retransplantation, and living donor operations. A single 64-question survey was sent to each lung transplant program in the United Sates registered in the United Network of Organ Sharing database as of September 2001 and to each of the five active Canadian programs. RESULTS: The survey was conducted in September and October 2002. Fifty of 65 active centers completed the survey, for a response rate of 77%. The data are presented in graphic format as a percentage of respondents. CONCLUSION: This survey provides a large, time-sensitive database summarizing the clinical practice of LT in North America. In general, the survey responses demonstrated a remarkable degree of consistency around patient selection criteria, but much greater variance in posttransplant management of lung transplant recipients. These findings may reflect the fact that a published selection criteria guideline exists, but no similar documents have been designed for postoperative management. Hopefully, postoperative areas with widely divergent approaches to management will foster future collaborative studies aimed at identifying the most appropriate practices.

Data Collection↗

Prescribing all phosphodiesterase 5 inhibitors to a patient with erectile dysfunction--a realistic and feasible option in everyday clinical practice--outcomes of a simple treatment regime.

OBJECTIVE: In clinical practice, to apply and evaluate outcomes of a treatment regime, in which the patient had the opportunity to try all the available phosphodiesterase 5 (PDE5) inhibitors. METHODS: Patients eligible for treatment with PDE5 inhibitors were prescribed 8 tablets with a shorter-acting substance (four tablets sildenafil 100mg and four tablets vardenafil 20mg) and eight tablets with a long-acting substance (tadalafil 20mg). Outcomes of the regime were recorded. RESULTS: Of the 186 patients, 64 (34%) had not been treated previously (naïve), and 122 (66%) were undergoing treatment for their erectile dysfunction. The overall treatment response was 89% (165 of 186 patients); 78% (n=145 of 186 patients) tested all three substances. No significant difference in choice between long- and shorter-acting medications in the overall material was observed. Two thirds of the naïve patients (n=64) preferred a shorter-acting substance (p<0.01). Every fifth man requested both a shorter- and a long-acting medication to accommodate his need. CONCLUSION: If patients are given the opportunity in clinical practice to try all three available PDE5 inhibitors, the overall response rate is very high, almost 90%. No significant difference in patient preference between long- and shorter-acting drugs was observed. Treatment choice was based mainly on efficacy or duration of effect.

3',5'-Cyclic-GMP Phosphodiesterases↗

Guidelines on radioiodine therapy for differentiated thyroid carcinoma: impact on clinical practice.

AIM: For the examination of the impact on clinical practice of the guidelines for differentiated thyroid carcinoma (DTC), treatment data from the ongoing Multicenter Study Differentiated Thyroid Carcinoma (MSDS) were analyzed. PATIENTS, METHODS: Patients were randomized to adjuvant external beam radiotherapy (RTx) or no RTx in addition to standard therapy in TNM stages pT4 pN0/1/x M0/x (UICC, 5th ed. 1997). All patients were to receive the same treatment regimen consisting of thyroidectomy, ablative radioiodine therapy (RIT), and a diagnostic 131I whole-body scintigraphy (WBS) 3-4 months after RIT. RESULTS: Of 339 eligible patients enrolled between January 2000 and March 2004, 273 could be analyzed. Guideline recommendations by the German Society for Nuclear Medicine from 1999 and 1992 were complied with within 28% and 82% with regard to the interval between surgery and RIT (4 vs. 4-6 weeks), in 33% and 84% with regard to 131I activity for RIT (1-3 vs. 1-4 GBq; +/- 10%), and in 16% and 60% with regard to 131I activity for WBS (100-300 vs. 100-400 MBq; +/- 10%). CONCLUSIONS: The 1999 guideline revision appears to have had little impact on clinical practice. Further follow-up will reveal if guideline compliance had an effect on outcomes.

Combined Modality Therapy↗

Litigation and defensive clinical practice: quantifying the problem.

OBJECTIVE: To assess the evidence for claims about a rise in defensive clinical practice, particularly within maternity care; to describe an attempt to quantify the extent of defensive practice; and to identify areas for further research. DESIGN: Review of existing literature and a large scale postal survey. PARTICIPANTS: Over 2000 midwives and obstetricians, mostly based in Scotland. FINDINGS: Several claims have been made about the incidence of litigation, and its apparent effects on clinical practice. These effects, referred to as defensive practice, include both risk avoidance and risk-reduction strategies. Fears about recruitment to and retention within high-risk specialties have been expressed, especially in the USA. A majority of those midwives and obstetricians surveyed believed that litigation has caused a rise in defensiveness, and there was some agreement between the two groups about what constitutes defensive practice. However, there were discrepancies between the examples of defensive practice given by practitioners and what they admitted their own response to be. CONCLUSIONS: Defensiveness is believed to be fairly commonplace, but because of difficulties in defining and quantifying the concept of defensiveness it is unclear what the exact implications for clinical practice may be. Further research is required to establish this.

Data Collection↗

[Evaluation of the clinical practice of Informed Consent in clinical trials].

On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT) the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160) of the CTs approved by the Ethical Committee of Clinical Research (CEIC) of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.

Clinical Trials as Topic↗

Adoption of a ventilator-associated pneumonia clinical practice guideline.

CONCEPTUAL FRAMEWORK: The Academic Center for Evidence-based Practice (ACE) Star Model was used to implement an evidence-based clinical practice guideline (CPG) in order to decrease ventilator-associated pneumonia (VAP) incidence rates and ventilator days. The goal was to interrupt person-to-person transmission of bacteria and bacterial colonization using low-cost, evidence-based strategies to prevent VAP. DISCOVERY: Two geographically proximate medical centers, inclusive of five intensive care units located in the southwestern region of the United States had significant variations in their VAP rates. EVIDENCE SUMMARY: Using the U.S. Preventive Services Task Force grading criteria, the results of 69 studies were used to establish a clinical practice guideline to prevent ventilator-associated pneumonia. TRANSLATION: A clinical practice guideline was developed for the prevention of VAP and included five nursing activities: (a) head-of-bed elevation; (b) oral care; (c) ventilator tubing condensate removal; (d) hand hygiene; and (e) glove use. The effect of the CPG, inclusive of an educational intervention, was measured using an observational, prospective, quasi-experimental design. INTEGRATION: A multidisciplinary education team developed a self-learning packet, educational materials, and storyboards for the staff as dissemination strategies. Strategies also included e-mail, one-on-one teaching with clinicians, and feedback on guideline adoption and VAP rate reports. EVALUATION: Observation data were collected to evaluate adoption of the CPG while caring for 106 ventilated patients. VAP rates changed at both hospitals although the change was not statistically significant. Additionally, the ICU length of stay declined at both facilities, causing cost savings. DISCUSSION: These results support the idea that adoption of evidence-based practices contributes to decreased VAP rates. For a successful program, ICU leaders should emphasize strategies that routinize adoption of evidence-based CPGs.

Adolescent↗

Compliance and outcomes in locally advanced head and neck cancer patients treated with alternating chemo-radiotherapy in clinical practice.

BACKGROUND AND AIMS: To evaluate the feasibility in clinical practice of alternating chemo-radiotherapy in locally advanced head and neck cancer patients. PATIENTS AND METHODS: From August 1993 to April 1998 at the Division of Medical Oncology of Parma, 48 consecutive patients were observed, and 38 (79%) started the Merlano chemo-radiotherapy. The characteristics of the patients were: males (32, 84%); median age, 57 years; PS <2 (32, 84%). The primary sites were the oropharynx (18, 47%), oral cavity (8, 21%), hypopharynx (7, 19%), larynx (5, 13%); stage IV disease was present in 29 (76%) patients. Twenty-five (66%) patients were married, and 24 (63%) resided outside of the city. RESULTS: The compliance was very low: 21 patients (55%) performed all the programmed cycles of chemotherapy, whereas only 5 patients (13%) performed the chemo-radiotherapy at full doses without any delay. The objective responses were 3 (8%) complete and 21 (55%) complete plus partial responses. Failures were 2 (5%) stable disease and 2 (5%) progressive disease, and the response was not assessable in 10 (26%). The median duration of the response was 8 months. The median overall survival and the time to progression were 18 and 13 months, respectively; the 5-year overall and relapse-free survival were 36% and 26%, respectively. Nine (24%) patients were still alive as of August 30, 2001, 8 (21%) of them without progression. Twenty-six patients (68%) died with a local-regional relapse. One patient (3%) died for a second cancer. Grade 3-4 hematologic toxicity was leukopenia (n = 25, 66%) and thrombocytopenia (n = 9, 24%); grade 3-4 non-hematologic toxicity was diarrhea (n = 3, 8%) and mucositis (n = 2, 5%). Two patients (5%) died for intestinal infarction and perforation possibly related to treatment. CONCLUSIONS: Compliance to the chemo-radiotherapy was very poor. The response rate was lower than that reported in clinical trials, whereas overall survival was comparable. The alternating chemo-radiotherapy is a very complex treatment that cannot be easily applied in clinical practice; a careful selection of patients is mandatory not only considering oncologic and medical criteria, but also the level of awareness of the patient and his family.

Adult↗

Assessing the clinical effectiveness of preventive maneuvers: analytic principles and systematic methods in reviewing evidence and developing clinical practice recommendations. A report by the Canadian Task Force on the Periodic Health Examination.

This paper examines a process for evaluating clinical effectiveness and developing recommendations in which systematic methods are used to review evidence from published clinical research and to reach sound conclusions about appropriate medical policy. The methodology addresses four important components of the analytic process: (1) the criteria that must be satisfied for a clinical practice to be considered effective; (2) proper methods for reviewing evidence from published clinical research to determine whether a clinical practice meets these criteria (including methods for performing comprehensive literature reviews, for judging the quality of individual studies, and for synthesizing or pooling the results of multiple studies); (3) theoretical and practical concerns in translating the results of the scientific review into sound clinical practice recommendations; and (4) the importance of documentation, guidelines, and other safeguards to minimize the effect the reviewers themselves have on the objectivity and consistency of the analytic methods.

Epidemiologic Methods↗

Practice analysis survey: revalidation of advanced clinical practice in orthopaedic physical therapy.

The first orthopaedic physical therapy practice analysis survey was completed in 1983. Another practice analysis survey was conducted in 1993 to identify the advance practice of clinicians who practice in orthopaedic physical therapy settings. Since 10 years elapsed, a new practice analysis study was conducted to identify the practice of orthopaedic clinical specialists. The purpose of this report is to describe the results of this survey. Orthopaedic physical therapists, both specialists and nonspecialists, participated in group interviews, subject matter expert meetings, and a national practice survey to delineate important knowledges and responsibilities. The survey was.sent to a stratified convenience sample of 1,000 orthopaedic physical therapists, of which 325 were orthopaedic clinical specialists. The three-part survey contained 180 items. A total of 420 respondents, of which 241 were orthopaedic clinical specialists, rated the importance and application level for the items. The results of this study provide evidence for a core body of knowledge required by clinicians practicing with advanced skills in orthopaedic physical therapy and create the framework for the Orthopaedic Physical Therapy Specialty Exam.

Clinical Competence↗

Quality, clinical practice improvement, and the episode of care.

To improve routine clinical practice, we must measure patients treated in routine practice (effectiveness research), not in specially controlled circumstances (efficacy research). We describe a new study methodology, Clinical Practice Improvement (CPI), designed to develop data-driven, analytically-based protocols to achieve desirable outcomes at the lowest essential cost over the continuum of care. Measurement in CPI encompasses a comprehensive view of care management: patient characteristics, process steps, and outcomes. All three classes of data are considered simultaneously, providing a basis for meaningful analyses of significant associations between processes and outcomes. We present an example of a CPI pediatric asthma study.

Asthma↗