The legal implications of clinical practice guidelines

In the past several years, considerable attention has been focused on clinical practice guidelines. They are developed to foster improved clinical care and to increase clinical efficiency. The legal implications of developing and following guidelines are not yet clear. The author argues that properly formulated guidelines could reduce the burdens of preventing and resolving malpractice claims.     

Enhancing clinical practice: The role of practice guidelines.

Health service researchers believe that significant practice variations occur, in part, because there is no strong consensus on best practices for managing a specific condition. The Agency for Health Care Policy and Research supports the development of science-based clinical guidelines, performance measures, and standards of quality. Since 1992, it has published 6 clinical guidelines and is supporting development of more than 20 others. Each has a consumer version, in English and Spanish, to educate patients and describe care options. Widespread use of these guidelines will improve the quality of health care by assisting providers in making more informed decisions, thereby reducing unnecessary health care practices; will reduce some costs; and will provide feedback on knowledge gaps that merit the attention and support of researchers and policymakers. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Attributes of clinical guidelines that influence use of guidelines in general practice: observational study

OBJECTIVE: To determine which attributes of clinical practice guidelines influence the use of guidelines in decision making in clinical practice. DESIGN: Observational study relating the use of 47 different recommendations from 10 national clinical guidelines to 12 different attributes of clinical guidelines-for example, evidence based, controversial, concrete. SETTING: General practice in the Netherlands. SUBJECTS: 61 general practitioners who made 12 880 decisions in their contacts with patients. MAIN OUTCOME MEASURES: Compliance of decisions with clinical guidelines according to the attribute of the guideline. RESULTS: Recommendations were followed in, on average, 61% (7915/12 880) of the decisions. Controversial recommendations were followed in 35% (886/2497) of decisions and non-controversial recommendations in 68% (7029/10 383) of decisions. Vague and non-specific recommendations were followed in 36% (826/2280) of decisions and clear recommendations in 67% (7089/10 600) of decisions. Recommendations that demanded a change in existing practice routines were followed in 44% (1278/2912) of decisions and those that did not in 67% (6637/9968) of decisions. Evidence based recommendations were used more than recommendations for practice that were not based on research evidence (71% (2745/3841) v 57% (5170/9039)). CONCLUSIONS: People and organisations setting evidence based clinical practice guidelines should take into account some of the other important attributes of effective recommendations for clinical practice.     

The place of renal scintigraphy in the diagnosis of renal artery stenosis. Fifteen years of clinical experience

BACKGROUND: Renal scintigraphy with radiolabeled pentetic acid (diethylenetriamine pentaacetic acid [DTPA]) or, more recently, mertiatide (mercaptoacetyltriglycine [MAG3]), with or without captopril challenge, is widely recommended as a diagnostic test for renal artery stenosis. OBJECTIVES: To address (1) whether the diagnostic accuracy has been improved by the use of captopril and the introduction of mertiatide and (2) whether a renal scan that shows abnormalities is a useful criterion to select patients for renal arteriography. PATIENTS AND METHODS: A standard diagnostic protocol, using both scintigraphy and arteriography, was followed in 505 consecutive high-risk hypertensive patients who were evaluated for renovascular hypertension at the University Hospital Dijkzigt, Rotterdam, the Netherlands, from 1978 to 1992. RESULTS: Renal artery stenosis (> or = 50%) was present in 263 patients. When the single-kidney fractional uptake was used as a diagnostic criterion, a specificity of 0.90 was obtained at a cutoff value of 35% for the worst kidney in scintigraphy using pentetic acid without captopril challenge (n = 225) and at a cutoff value of 37% after captopril challenge (n = 280). This was associated with sensitivity levels of 0.65 and 0.68, respectively. The difference between the uptake of pentetic acid with and without captopril challenge in the 85 patients who were studied under both circumstances was no more accurate as a predictor of renal artery stenosis. In the 93 patients who were studied with mertiatide as well as with pentetic acid, both after captopril challenge, the diagnostic accuracy was no better with mertiatide than with pentetic acid; mertiatide failed to offer any advantage not only when the single-kidney fractional uptake was used as a criterion, but also with the use of other scintigraphic parameters (eg, time to peak, time to pyelum, overall shape of renographic curve, and kidney size). CONCLUSIONS: The diagnostic accuracy of renal scintigraphy has not been improved by the introduction of mertiatide or by the use of captopril. The usefulness of scintigraphy as a diagnostic test for the presence of renal artery stenosis remains questionable. The physician will always confront either a substantial number of arteriograms that do not show abnormalities when renal scintigraphy is omitted as a screening step or a substantial number of missed diagnoses when a renal scan that shows abnormalities is used as a prerequisite for arteriography.     

Fifteen years experience with finger arterial pressure monitoring: assessment of the technology

We review the Finapres technology, embodied in several TNO-prototypes and in the Ohmeda 2300 and 2300e Finapres NIBP. Finapres is an acronym for FINger Arterial PRESsure, the device delivers a continuous finger arterial pressure waveform. Many papers report on the accuracy of the device in comparison with intra-arterial or with noninvasive but intermittent blood pressure measurements. We compiled the results of 43 such papers and found systolic, diastolic and mean accuracies, in this order, ranging from -48 to 30 mmHg, from -20 to 18 mmHg, and from -13 to 25 mmHg. Weighted for the number of subjects included pooled accuracies were -0.8 (SD 11.9), -1.6 (8.3) and -1.6 (7.6) mmHg respectively. Subdividing the pooled group according to criteria such as reference blood pressure, place of application, and prototype or commercial device we found no significant differences in mean differences or SD. Measurement at the finger allows uninterrupted recordings of long duration. The transmission of the pressure pulse along the arm arteries, however, causes distortion of the pulse waveform and depression of the mean blood pressure level. These effects can be reduced by appropriate filtering, and upper arm 'return-to-flow' calibration to bring accuracy and precision within AAMI limits. For the assessment of beat-to-beat changes in blood pressure and assessment of blood pressure variability Finapres proved a reliable alternative for invasive measurements when mean and diastolic pressures are concerned. Differences in systolic pressure are larger and reach statistical significance but are not of clinical relevance. Finger arteries are affected by contraction and dilatation in relation to psychological and physical (heat, cold, blood loss, orthostasis) stress. Effects of these phenomena are reduced by the built-in Physiocal algorithm. However, full smooth muscle contraction should be avoided in the awake patient by comforting the patient, and covering the hand. Arterial state can be monitored by observing the behaviour of the Physiocal algorithm. We conclude that Finapres accuracy and precision usually suffice for reliable tracking of changes in blood pressure. Diagnostic accuracy may be achieved with future application of corrective measures.     

The development of clinical practice guidelines for treatment of peptic acid diseases in a VA ambulatory care clinic

The costly treatment of peptic acid diseases at a Veterans Affairs ambulatory care clinic prompted the development of clinical practice guidelines (CPGs) for the disorders. A committee consisting of a clinical pharmacist, the chiefs of ambulatory care and medicine, and a gastroenterologist guided the process. A consensus-style conference format involving medical staff and residents, pharmacists, and other health providers was chosen to develop the CPGs. Before the conference each participant received a list of key issues and literature on practice guidelines, and on peptic acid diseases and their treatment. At the conference the participants were divided into four groups; each group discussed specific key issues using a modified nominal group process. Recommendations from each group were made to the entire conference. Final recommendations were compiled into what was adopted and readily received as the CPGs for the institution.     

IQ-memory discrepancies in normal and clinical samples.

The potential utility of IQ—Memory Index discrepancy scores derived from the Wechsler Adult Intelligence Scale—Revised (WAIS—R) and the Wechsler Memory Scale—Revised (WMS—R; D. Wechsler, 1987) was examined in a clinical sample, whose scores were then compared to those of subjects from the WMS—R standardization sample. The clinical sample included patients with diagnoses associated with memory deficits. Discrepancy scores between Full-Scale IQ and the Delayed Memory Index differentiated the groups, but material-specific discrepancies between IQ scores and immediate recall memory scores did not. The largest mean discrepancy and the greatest prevalence of scores beyond a criterion score of 15 were found in patients with presumed Alzheimer's disease. Issues related to limitations in the application of such discrepancy scores are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Nursing Informatics 1997 postconference on patient guidelines and clinical practice guidelines: the state of our knowledge and a vision

This study involved 329 patients who had either a Caesarean section or a hysterectomy. A comparison has been made between 70 patients who were never catheterized and 251 who had a urethral catheter perioperatively. The absence of recognized urinary tract infections in those without a catheter was significant when compared with the 21 urinary infections identified in the catheterized group (p<0.05). The absence of urinary tract infections in the uncatheterized group clearly demonstrates the benefit of avoiding catheterization when possible.     

Time to clinical stability in patients hospitalized with community-acquired pneumonia: implications for practice guidelines

CONTEXT: Many groups have developed guidelines to shorten hospital length of stay in pneumonia in order to decrease costs, but the length of time until a patient hospitalized with pneumonia becomes clinically stable has not been established. OBJECTIVE: To describe the time to resolution of abnormalities in vital signs, ability to eat, and mental status in patients with community-acquired pneumonia and assess clinical outcomes after achieving stability. DESIGN: Prospective, multicenter, observational cohort study. SETTING: Three university and 1 community teaching hospital in Boston, Mass, Pittsburgh, Pa, and Halifax, Nova Scotia. PATIENTS: Six hundred eighty-six adults hospitalized with community-acquired pneumonia. MAIN OUTCOME MEASURES: Time to resolution of vital signs, ability to eat, mental status, hospital length of stay, and admission to an intensive care, coronary care, or telemetry unit. RESULTS: The median time to stability was 2 days for heart rate (< or =100 beats/min) and systolic blood pressure (> or =90 mm Hg), and 3 days for respiratory rate (< or =24 breaths/min), oxygen saturation (> or =90%), and temperature (< or =37.2 degrees C [99 degrees F]). The median time to overall clinical stability was 3 days for the most lenient definition of stability and 7 days for the most conservative definition. Patients with more severe cases of pneumonia at presentation took longer to reach stability. Once stability was achieved, clinical deterioration requiring intensive care, coronary care, or telemetry monitoring occurred in 1% of cases or fewer. Between 65% to 86% of patients stayed in the hospital more than 1 day after reaching stability, and fewer than 29% to 46% were converted to oral antibiotics within 1 day of stability, depending on the definition of stability. CONCLUSIONS: Our estimates of time to stability in pneumonia and explicit criteria for defining stability can provide an evidence-based estimate of optimal length of stay, and outline a clinically sensible approach to improving the efficiency of inpatient management.     

Early treatment of acute myocardial infarct: implementation of therapy guidelines in routine clinical practice, MITRA pilot phase

Intracellular pH has been shown to be an important physiological parameter in cell cycle control and differentiation, aspects that are central to the spermatogenic process. However, the pH regulatory mechanisms in spermatogenic cells have not been systematically explored. In this work, measuring intracellular pH (pHi) with a fluorescent probe (BCECF), membrane potential with a fluorescent lipophilic anion (bisoxonol), and net movement of acid using a pH-stat system, we have found that rat round spermatids regulate pHi by means of a V-type H(+)-ATPase, a HCO3- entry pathway, a Na+/HCO3- dependent transport system, and a putative proton conductive pathway. Rat spermatids do not have functional base extruder transport systems. These pH regulatory characteristics seem specially designed to withstand acid challenges, and can generate sustained alkalinization upon acid exit stimulation.     

Current data of the science and medical practice: evaluation of the discrepancies

Eleven patients with hepatic metastases from colorectal cancer survived more than 5 years after the resection were reviewed. There were 3 (27.3%) disease-free survivors, the longest survival period was 7 years and 2 months. Compared with 41 survivors of less than 5-year duration after resection, it was shown that close follow-up after resection of the primary cancer, detecting early subclinical hepatic metastases, preoperative lower level of CEA, tumor less or equal to 5 cm in size, single metastatic nodule and radical resection were important factors influening long-term survival (P < 0.05). It is of the opinion that early diagnosis, early resection and re-resection after detecting subclinical local recurrence and metastases play important role in improving long-term response.     

The use of empiric clinical data in the evaluation of practice guidelines for unstable angina

OBJECTIVE: To determine the applicability to emergency department (ED) clinical practice of a nationally disseminated practice guideline on the disposition of patients with a diagnosis of unstable angina, and to determine the potential impact of the guideline on hospital admissions and demand for intensive care beds. DESIGN: Application of guideline criteria for ED disposition decisions to a validation sample derived from a prospective clinical trial. SETTING: Five hospitals, including 2 urban general teaching hospitals, 2 urban tertiary care university hospitals, and 1 suburban university-affiliated community hospital. PATIENTS: A consecutive sample of 457 patients who presented with symptoms suggestive of acute cardiac ischemia and who had "unstable angina" or "rule out unstable angina" diagnosed by ED physicians. Greater than 90% of eligible patients were enrolled in the clinical trial; follow-up data sufficient for assignment of a definitive diagnosis were obtained for 99% of subjects. MAIN OUTCOME MEASURES: Acute myocardial infarction and unstable angina, based on blind review of initial and follow-up clinical data, including cardiac enzyme levels and electrocardiograms. After completion of the trial, without knowledge of final diagnosis or outcome, the investigators classified patients into risk groups specified by the unstable angina guideline. RESULTS: Of subjects with an ED diagnosis of unstable angina, only 6% (n=28) met the guideline's criteria corresponding to low risk for adverse events and were therefore suitable for discharge directly to home. Fifty-four percent (n=247) met the intermediate-risk criteria; 40% (n=182) met the high-risk criteria and were identified as requiring admission to an intensive care unit. Actual ED disposition differed from guideline recommendations in 2 major areas: only 4% (1/28) of low-risk patients were discharged to home with outpatient follow-up, and only 40% (72/182) of high-risk patients were admitted to an intensive care unit. CONCLUSIONS: Although the guideline was intended to reduce hospitalization by identifying a low-risk group, the small size of this group among ED patients suggests that little reduction in hospitalization can be expected. Indeed, the guideline may increase demand for the limited number of intensive care beds to accommodate patients with unstable angina considered high-risk but currently placed elsewhere. These results emphasize the need to use empiric data from target clinical settings to assess the likely actual impact of guidelines on clinical care prior to national dissemination.     

The use of clinical practice guidelines (CPGs) to evaluate practice and control costs in ventriculoperitoneal shunt management

Radical resection of ductal adenocarcinoma of the pancreas affords the only realistic chance of cure. Despite some reports, in particular from Japan, suggesting an improvement in the long-term prognosis, this is true only in subgroups of selected patients. In actual fact, the overall long-term survival of resected patients is still below 10%. How meaningful is a more extended resection? The lack of randomized prospective trials involving a sufficient number of cases does not enable us to make any final conclusions. The only controlled data, recently reported by an Italian multicenter study, suggested that extended lymphadenectomy improved prognosis not in the whole population of resected patients, but only in a subgroup of patients with lymph node involvement. No definitive judgments can be made without further prospective controlled clinical trials involving a greater number of patients. The suspicion arises that surgery alone, even when extensive, may not be the best treatment for pancreatic ductal cancer.     

The development of practice guidelines for the treatment of severe plaque form psoriasis

OBJECTIVE: To develop and introduce evidence-based guidelines for the selection of 5 commonly used treatment modalities--UV-B, photochemotherapy, methotrexate, acitretin, and cyclosporine--for adult patients with severe plaque form psoriasis. PATIENTS AND SETTING: Patients, residents, and dermatologists from the Department of Dermatology of the Academic Medical Center of the University of Amsterdam, Amsterdam, the Netherlands, were involved in this process. DESIGN: The development process started with a questionnaire to evaluate how patients with severe psoriasis were treated. A systematic literature review was set up to provide evidence-based estimates of effectiveness, adverse effects, and dropout rates. In 2 meetings, the opinion leaders and intended users discussed the results of the questionnaire and systematic review as well as the clinical considerations in the treatment choices. Guidelines were then made regarding the sequence of selection of 5 modalities in the concept of rotational therapy. These guidelines were introduced. Their use was analyzed for 6 months. RESULTS: Before the guidelines, there was no uniform approach. In the systematic review, 665 studies concerning the treatments were found. Exclusion rates were high. No studies of methotrexate therapy could be included. Photochemotherapy showed the highest average proportion of patients with clearance (70% [6947/9925]) and good response (83% [8238/9925]), followed by UV-B (67.9% [620/913]) and cyclosporine (64% [1030/1609]) therapy. In the second internal meeting, the following sequence for the treatments was defined: UV-B, photochemotherapy, methotrexate, acitretin, and cyclosporine. In 78% (69/88) of patients treated after the introduction, the guidelines were followed to determine the treatment choice. CONCLUSIONS: Guidelines for treating severe plaque form psoriasis can be successfully developed, introduced, and implemented and were considered to improve clinical care.     

Improving the relationship between the randomized clinical trial and real-world clinical practice.

I comment on the article by Krause (see record 2011-19228-002), which discusses a number of ways for clinical psychotherapy outcome researchers to make the results of randomized controlled trials (RCT) more useful to practicing psychotherapists primarily by making the distributions of raw data from those studies available to the public. In this way, it would be possible for psychotherapists to determine which treatment of an RCT (experimental or control) would be best for a specific patient. Problems with this proposal are discussed and an alternative model that integrates psychotherapy outcome data from group means and clinical case studies is offered. (PsycINFO Database Record (c) 2011 APA, all rights reserved)