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Clinically important changes in health-related quality of life for patients with chronic obstructive pulmonary disease: an expert consensus panel report.

OBJECTIVE: Without clinical input on what constitutes a significant change, health-related quality of life (HRQoL) measures are less likely to be adopted by clinicians for use in daily practice. Although standards can be determined empirically by within-person change studies based on patient self-reports, these anchor-based methods incorporate only the patients' perspectives of important HRQoL change, and do not reflect an informed clinical evaluation. The objective of this study was to establish clinically important difference standards from the physician's perspective for use of 2 HRQoL measures among patients with chronic obstructive pulmonary disease (COPD). DESIGN: We assembled a 9-person expert panel of North American physicians familiar with the use of the Chronic Respiratory Questionnaire (CRQ), a disease-specific HRQoL measure, or the generic Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36, Version 2.0) among patients with COPD. RESULTS: Using 2 rounds of the Delphi process, 1 in-person meeting, and an iterative improvement process for circulating and correcting the final report, the expert panel established small, moderate, and large clinically important change levels for the CRQ and SF-36. CONCLUSIONS: For this expert physician panel, levels for detecting clinically important differences on the CRQ were equal to or slightly higher than previous studies based on patient-reported differences. Clinically important differences on the SF-36, Version 2.0, were noticeably larger than previous estimates based on cross-sectional differences between clinically defined patient groups.

Health Status Indicators↗

A taxonomy for classification of stroke rehabilitation services.

OBJECTIVE: To develop a taxonomy for use in measuring stroke rehabilitation services. DESIGN: A cross-sectional study using facility-level survey data and extant data files. SETTING: Veterans Administration medical centers (VAMCs). VARIABLES: (1) A list of rehabilitation characteristics, including personnel, physical facilities, coordination of care, and hospital characteristics; and (2) a classification or typology of VAMCs according to the type of postacute stroke care on-site. MAIN OUTCOME MEASURES: Data sources included extant Veterans Administration (VA) computerized databases, VA central office administrative files, and 2 mailed surveys to VA rehabilitation medicine services and stroke acute care services. The rehabilitation taxonomy was derived using 2 methods that assess face and construct validity, respectively: (1) an expert panel rating, using a modified Delphi process, of the clinical importance of each of the rehabilitation characteristics; and (2) a comparison of rehabilitation characteristics across the different types of VAMCs. Variables were included in the final taxonomy if the expert panel reached consensus that the variable was clinically important, or if there were statistically significant differences in these characteristics across the different types of medical centers. RESULTS: Of 67 possible rehabilitation characteristics, a multidisciplinary expert panel reached consensus about the likely clinical importance of 21 rehabilitation characteristics, 11 of which showed statistically significant differences across different types of VAMCs. An additional 9 variables that lacked expert panel consensus differed significantly among the different medical centers. These 30 variables represent a preliminary taxonomy of key rehabilitation characteristics. Among the 20 variables that varied significantly across the different types of medical centers, 18 showed a pattern with the greatest amount of resources and organizational sophistication being found in VAMCs with rehabilitation units, followed by medical centers with geriatric units, and the least amount of resources and organizational sophistication was seen in medical centers whose postacute care services were limited to nursing home or intermediate care. CONCLUSION: Thirty rehabilitation characteristics had face validity and/or construct validity, and can be considered to represent a preliminary taxonomy for measuring stroke rehabilitation services. This study also shows that there are significant differences among hospitals in resources and organization of care deemed to be important for stroke patients.

Aged↗

Qualitative review of intensive care unit quality indicators.

PURPOSE: The purpose of this study was to (1) conduct a systematic review of the literature to identify interventions that improve patient outcomes in the intensive care unit (ICU); (2) evaluate potential measures of quality based on the impact, feasibility, variability, and the strength of evidence to support each measure and to categorize these measures as outcome, process, access, or complication measures; and (3) select a list of candidate quality measures that can be broadly applied to improve ICU care. METHODS: We identified and independently reviewed all studies in Medline (1965-2000) and The Cochrane Library (Issue 3, 2001) that met the following criteria: design: observational studies, experimental trials, or systematic reviews; population: critically ill adults; and intervention: process or structure measure that was associated with improved patient outcomes: morbidity, mortality, complications, errors, costs, length of stay (LOS), and patient reported outcomes. Studies were grouped into categories by the type of outcome that was improved by the intervention. Potential quality measures were evaluated for: impact on morbidity, mortality, and costs; feasibility of the measure; and variability in the measure. We evaluated the strength of evidence for each intervention used to improve outcomes and using the Delphi method, assigned an over-all recommendation for each quality measure. RESULTS: A total of 3,014 citations were identified. Sixty-six studies that met selection criteria reported on a variety of interventions that were associated with improved patient outcomes. We identified 6 outcome measures: ICU mortality rate, ICU LOS greater than 7 days, average ICU LOS, average days on mechanical ventilation, suboptimal management of pain, and patient/family satisfaction; 6 process measures: effective assessment of pain, appropriate use of blood transfusions, prevention of ventilator-associated pneumonia, appropriate sedation, appropriate peptic ulcer disease prophylaxis, and appropriate deep venous thrombosis prophylaxis; 4 access measures: rate of delayed admissions, rate of delayed discharges, cancelled surgical cases, and emergency department by-pass hours; and 3 complication measures: rate of unplanned ICU readmission, rate of catheter-related blood stream infections, and rate of resistant infections. CONCLUSIONS: Further work is needed to create operational definitions and to pilot test the selected measures. The value of these measures will be determined by our ability to evaluate our current performance and implement interventions designed to improve the quality of ICU care.

Adrenergic beta-Antagonists↗

Guidelines for the recurrence of pediatric cancer.

OBJECTIVES: To provide practice guidelines to assist patients and parents in coping with a return of disease. DATA SOURCES: Delphi studies, review, and research articles. CONCLUSIONS: When a child's cancer recurs, the patient and parents are at risk of physical and psychologic difficulties. Guidelines to assist patients and parents to cope have shown positive response. IMPLICATIONS FOR NURSING PRACTICE: Practice guidelines to assist patients and parents cope with a return of cancer can help health care professionals develop interventions for particular families.

Adaptation, Psychological↗

Research in Nurse Education Today: do we meet our aims and scope?

All issues of Nurse Education Today between January 1996 and July 2001 were examined manually and categorized as 'research' or other forms of scholarship. A total of 356 articles were reviewed and 193 of these were considered to be some form of research. The prevalence of well known methods of data collection was noted and broad trends identified. Questionnaires, reflective diaries, Delphi surveys, focus groups and individual interviews formed the backbone of methods used in educational research. There was a marked absence of experimental work. Proportionally more UK based papers avoided inferential analysis than those from overseas. We show that 'research' in Nurse Education Today has become rather narrow. It rarely incorporates 'user' (client/patient) perspectives, and rarely (especially in the UK) uses more than one site for study. More papers which undertake comparison of nurse education between countries, which employ samples from more than one country, and which address the impact of findings from an international perspective should be sought in order to enhance this aspect of the diversity of the journal.

Nursing Research↗

[Criteria of quality of structure in rehabilitation units with inpatient treatment].

The structure of a rehabilitation unit is an important feature of the quality of care. Adequate and qualitatively good structures provide the basis for appropriate therapy offers and treatment and eventually, a better health for rehabilitants. The quality of structures is generally recorded without any evaluation of the aspects in particular. The definition of standards is the basis for such an evaluation. The project presented is aimed at the definition of relevant structural standards for rehab units with inpatient treatment for musculoskeletal, cardiac, neurological, gastroenterological, oncological, pneumological and dermatological diseases. Here, the distinction between basal criteria which have to be fulfilled by every rehab unit with inpatient treatment and criteria important for a well-aimed assignment of patients with specific needs ("assignment criteria") should be made. Apart from the documentation of structural attributes, the structural quality of a rehab unit can be described individually as well as in comparison with other units. Relevant structural criteria were defined in expert meetings by means of a modified Delphi-technique with five inquiries. Overall, 199 "basal criteria" and "assignment criteria" were defined. All criteria can be assigned to the two domains general structural characteristics (general characteristics and equipment of rooms; medical/technical equipment; therapy, education, care; staff) and process-related structures (conceptual frames; internal quality management; internal communication and personnel development). The structural standards are applicable to units for musculoskeletal, cardiac, neurological, oncological, gastroenterological, dermatological and pneumological rehabilitation financed by the two main providers of rehabilitation, the statutory pension insurance scheme and the statutory health insurance scheme for all other five indications. The definition of structural standards agreed by experts in a formal consensus process, provides comprehensive and concrete requirements for German rehab units with inpatient medical rehabilitation. If the two main providers of rehabilitation both use the standards this can be regarded as a hallmark on the path to a unitary programme for quality management. The results enable units to analyse their weak points not just on an individual basis but allow also for a comparison between units, along with contributing to optimizing the structural quality of rehab units.

Germany↗

[Evolution of a quality assurance programme for physiotherapy schools - results of the first quality inspections].

In cooperation with the Hochrhein-Institute for Research in Rehabilitation (HRI), the Association for Assuring the Quality of Education in Physiotherapy Schools in Germany (ISQ) has developed a quality assurance programme for physiotherapy schools. It aims at assessing the quality of physiotherapy schools in Germany, and to award a quality seal based on compliance with defined criteria. First, a catalogue of quality features and criteria relevant for education in physiotherapy was developed. It is based on the analysis of questionnaires that had been sent to all German physiotherapy schools, to selected physiotherapists and leading physiotherapists in hospitals, to competent federal authorities, and to three school-classes with group discussions. The persons addressed named 360 different quality features. They were collected in a catalogue, revised in a multi-stage Delphi procedure, and approved consensually. The final criteria were transformed into basic quality requirements, and formulated as a check-list. Assessment of the quality features is carried out by trained visitors. In addition, the satisfaction of students is assessed with a questionnaire. The results of the interviews and the questionnaires are fed back to the schools in a quality report. Schools meeting all basic quality requirements are awarded the seal of quality. The seal is valid for three years. Since January 2003, this procedure is available for all schools in Germany. Until September 2002, a pretest of visitations and student questionnaires had been carried out with 31 member schools of the ISQ; according to the resulting quality reports, none of these schools would instantly be awarded the quality seal. In all, more than half of the schools do not meet 10 of the 42 basic criteria. Fundamental deficiencies have been found in the documentation pertaining to supervision of practical training. In terms of training, further training and professional development of their teachers and associated professors, needs for improvement could be shown in more than 66 % of all visited schools. Only 9 of 31 schools could produce a written syllabus. Additionally, the requirements of teachers conferences and equipment of libraries were not met by the majority. A general problem among the schools is inadequate documentation in many fields.

Clinical Competence↗

[Early rehabilitation care in the hospital--definition and indication. Results of the expert group "Early Rehabilitation Care in the Hospital"].

As a result of the continuing development in recent medicine, and improvements of emergency services, an increasing number of patients are surviving serious disease and injury. This has increased the need for rehabilitation, starting already during the acute hospital stay. Early identification and rehabilitation may reduce overall costs and help patients to regain independence earlier. Since the eighties specialized early post-acute rehabilitation units have been increasingly implemented in German hospitals. With book 9 of the German Social Code (SGB IX) coming into effect in July 2001, early post-acute rehabilitation care in hospitals became accepted as a social right. However, the specifics of early rehabilitation care have not been defined. There is a lack of generally accepted indication criteria for early rehabilitation services. Similarly, the aims, objectives and methods need to be specified. It was the objective of a group of interested experts from different fields and backgrounds to achieve an interdisciplinary consensus in terms of conceptual definitions and terminology for all early rehabilitation care services in the acute hospital. The development of the definitions and criteria was achieved by using a modified Delphi-technique. By publishing this paper the group is providing information about its activities and results. Examples of typical cases from the various fields of early rehabilitation care were identified and described. Furthermore, the report points out a number of other problems in the area of early rehabilitation care, which have yet to be solved.

Persons with Disabilities↗

[Guideline: "Treatment of acute perioperative and posttraumatic pain". Updating from the S2- to the S3-level: a preliminary report].

The German guidelines for the treatment of acute perioperative and posttraumatic pain from 1999 have been revised during the last three years and will be published at the end of 2006 as a guideline on S3-level. 20 medical societies evaluate with the instruments of the centre of evidence based medicine of Oxford (CEBM) the available randomised controlled trials, systematic reviews and existing guidelines and consent in final Delphi rounds the detailed recommendations (grades A - C). Comprehensive information of the patients (pain level, therapeutic possibilities), measurement and documentation of pain, interdisciplinary management of therapy and complete consideration of all operative, pain therapeutic, medicinal, psychologic, physiotherapeutical and physical procedures are central aims of the actual guideline.

Acute Disease↗

The swine-influenza decision.

We analyzed the economic aspects of mass immunization against swine-like influenza in 1976-1977, and have used the Delphi technic for estimating the likelihood and characteristics of an epidemic. If an epidemic occurs and no preventive efforts are made, total costs could exceed $6 billion for the whole population and $3 billion for those in the high-risk group. Expected net benefits from immunization vary with (1) the target population, (2) costs of vaccine administration and (3) vaccine acceptance rates. With an epidemic probability of 0.10 and with costs of purchasing and administering the vaccine each estimated at $0.50 per person in the target population, maximum net benefits cannot be obtained by an offer of vaccine to the entire population. Economic considerations do not require limitation of vaccination to high-risk groups. If the program is restricted to adults 25 years of age and over, and if acceptance rates exceed 59 per cent, the program is economically justifiable.

Adult↗

Robustness in practice--the regional planning of health services.

Earlier work has criticized the dominant tendencies in operational research contributions to health services planning as characterized by optimization, implausible demands for data, depoliticization, hierarchy and inflexibility. This paper describes an effort which avoids at least some of these pitfalls. The project was to construct a planning system for a regional health council in Ontario, Canada, which would take account of the possible alternative future states of the health-care system's environment and would aim to keep options for future development open. The planning system devised is described in the paper. It is based on robustness analysis, which evaluates alternative initial action sets in terms of the useful flexibility they preserve. Other features include the explicit incorporation of pressures for change generated outside the health-care system, and a satisficing approach to the identification of both initial action sets and alternative future configurations of the health-care system. It was found possible to borrow and radically 're-use' techniques or formulations from the mainstream of O.R. contributions. Thus the 'reference projection' method was used to identify inadequacies in performance which future health-care system configurations must repair. And Delphi analysis, normally a method for generating consensus, was used in conjunction with cluster analysis of responses to generate meaningfully different alternative futures.

Health Planning Councils↗

Combined evidence-based literature analysis and consensus guidelines for stocking of emergency antidotes in the United States.

STUDY OBJECTIVE: To develop guidelines for the stocking of antidotes at hospitals that accept emergency admissions using combined evidence-based and consensus methods. METHODS: Study participants were 12 medical care providers from disciplines that are affected by insufficient stocking of emergency antidotes (clinical pharmacology, critical care, clinical pharmacy, emergency medicine, hospital pharmacy, internal medicine, managed care pharmacy, clinical toxicology, pediatrics, poison control centers, pulmonary medicine, regulatory medicine). Selection of individuals for the study panel was based on evidence of previous antidote research or perspective regarding the purchase and use of antidotes. The literature regarding each antidote was systematically amassed using pre-1966 literature files, current MEDLINE searches, the reference lists of major medical textbooks, and citations solicited from the consensus panel. Articles relevant to 4 defined core questions were included. These articles formed the basis of an evidence-based analysis performed by the principal investigator. After literature analysis, a literature summary and proposed guidelines for antidote stocking were submitted to the panel. Consensus was formed by electronic iterative presentation of alternatives to each panel member using a modified Delphi method. All panel members participated in 5 rounds of guideline analysis of 20 antidotes. RESULTS: Of the 20 antidotes, 16 antidotes were ultimately recommended for stocking (N -acetylcysteine, atropine, Crotalid snake antivenin, calcium gluconate and chloride, cyanide antidote kit, deferoxamine, digoxin immune Fab, dimercaprol, ethanol, fomepizole, glucagon, methylene blue, naloxone, pralidoxime, physostigmine, sodium bicarbonate), 2 were not recommended for stocking (black widow antivenin, ethylenediamine tetraacetic acid), and consensus could not be reached for 2 antidotes (flumazenil, physostigmine). CONCLUSION: These guidelines provide a tool to be used in revising or creating policies and procedures with regard to the stocking of antidotes in hospitals that accept emergency patients.

Antidotes↗

Energetics of the interaction between water and the helical peptide group and its role in determining helix propensities.

The alanine helix provides a model system for studying the energetics of interaction between water and the helical peptide group, a possible major factor in the energetics of protein folding. Helix formation is enthalpy-driven (-1.0 kcal/mol per residue). Experimental transfer data (vapor phase to aqueous) for amides give the enthalpy of interaction with water of the amide group as approximately -11.5 kcal/mol. The enthalpy of the helical peptide hydrogen bond, computed for the gas phase by quantum mechanics, is -4.9 kcal/mol. These numbers give an enthalpy deficit for helix formation of -7.6 kcal/mol. To study this problem, we calculate the electrostatic solvation free energy (ESF) of the peptide groups in the helical and beta-strand conformations, by using the delphi program and parse parameter set. Experimental data show that the ESF values of amides are almost entirely enthalpic. Two key results are: in the beta-strand conformation, the ESF value of an interior alanine peptide group is -7.9 kcal/mol, substantially less than that of N-methylacetamide (-12.2 kcal/mol), and the helical peptide group is solvated with an ESF of -2.5 kcal/mol. These results reduce the enthalpy deficit to -1.5 kcal/mol, and desolvation of peptide groups through partial burial in the random coil may account for the remainder. Mutant peptides in the helical conformation show ESF differences among nonpolar amino acids that are comparable to observed helix propensity differences, but the ESF differences in the random coil conformation still must be subtracted.

Alanine↗

Auditory brainstem response in dolphins.

We recorded the auditory brainstem response (ABR) in four dolphins (Tursiops truncatus and Delphinus delphis). The ABR evoked by clicks consists of seven waves within 10 msec; two waves often contain dual peaks. The main waves can be identified with those of humans and laboratory mammals; in spite of a much longer path, the latencies of the peaks are almost identical to those of the rat. The dolphin ABR waves increase in latency as the intensity of a sound decreases by only 4 microseconds/decibel(dB) (for clicks with peak power at 66 kHz) compared to 40 microseconds/dB in humans (for clicks in the sonic range). Low-frequency clicks (6-kHz peak power) show a latency increase about 3 times (12 microseconds/dB) as great. Although the dolphin brainstem tracks individual clicks to at least 600 per sec, the latency increases and amplitude decreases with increasing click rates. This effect varies among different waves of the ABR; it is around one-fifth the effect seen in man. The dolphin brain is specialized for handling brief, frequent clicks. A small latency difference is seen between clicks 180 degrees different in phase--i.e., with initial compression vs. initial rarefaction. The ABR can be used to test theories of dolphin sonar signal processing. Hearing thresholds can be evaluated rapidly. Cetaceans that have not been investigated can now be examined, including the great whales, a group for which data are now completely lacking.

Acoustic Stimulation↗

Histidine pKa shifts accompanying the inactivating Asp121----Asn substitution in a semisynthetic bovine pancreatic ribonuclease.

A semisynthetic RNase, RNase-(1-118).(111-124), consisting of a noncovalent complex between residues 1-118 of RNase (obtained from the proteolytic digestion of RNase A), and a synthetic 14-residue peptide containing residues 111-124 of RNase, exhibits 98% of the enzymatic activity of bovine pancreatic ribonuclease A (EC 3.1.27.5). The replacement of aspartic acid-121 by asparagine in this semisynthetic RNase to form the "D121N" analog reduces kcat/Km to 2.7% of the value for RNase A. In the present work, 1H NMR spectroscopy has been used to probe the ionization states of His12, His105, and His119 in this catalytically defective semisynthetic RNase. A comparison of the observed resonances of D121N with those previously determined by others for RNase A enabled us to assign the C2 proton NMR resonances to individual residues; the assignment of His119 was confirmed by titrating D121N with the fully deuterated peptide, [Asn121]-RNase-(111-124). The observed pKa values of His12, His105, and His119 decrease 0.18, 0.16, and 0.02 pH unit, respectively, as a result of the D121N replacement. Values calculated by using a finite difference algorithm to solve the Poisson-Boltzmann equation (the DELPHI program, version 3.0) and a refined 2.0-A coordinate set for the crystal structure of D121N differ significantly for active site residues His12 (delta pKa = -0.58) and His119 (delta pKa = -0.55) but not for His105 (delta pKa = -0.10). The elmination of bound water from the calculations reduced, but did not reconcile, these discrepancies (His12, delta pKa = -0.36; His119, delta pKa = -0.41).

Animals↗

Tanford-Kirkwood electrostatics for protein modeling.

Solvent plays a significant role in determining the electrostatic potential energy of proteins, most notably through its favorable interactions with charged residues and its screening of electrostatic interactions. These energetic contributions are frequently ignored in computational protein design and protein modeling methodologies because they are difficult to evaluate rapidly and accurately. To address this deficiency, we report a revised form of the original Tanford-Kirkwood continuum electrostatic model [Tanford, C. & Kirkwood, J. G. (1957) J. Am. Chem. Soc. 79, 5333-5339], which accounts for the effects of solvent polarization on charged atoms in proteins. The Tanford-Kirkwood model was modified to increase its speed and to improve its sensitivity to the details of protein structure. For the 37 electrostatic self-energies of the polar side-chains in bovine pancreatic trypsin inhibitor, and their 666 interaction energies, the modified Tanford-Kirkwood potential of mean force differs from a computationally intensive numerical potential (DelPhi) by root-mean-square errors of 0.6 kcal/mol and 0.08 kcal/mol, respectively. The Tanford-Kirkwood approach makes possible a realistic treatment of electrostatics in computationally demanding protein modeling calculations. For example, pH titration calculations for ovomucoid third domain that model polar side-chain relaxation (including >2 x 10(23) rotamer conformations of the protein) provide pKa values of unprecedented accuracy.

Models, Theoretical↗

Definitions for public health nutrition: a developing consensus.

OBJECTIVES: To assess the level of agreement amongst a panel of public health nutrition leaders regarding the key descriptors used to define the field of public health nutrition. DESIGN: Cross-sectional survey requiring quantitative and qualitative responses representing the first round of a consensus development Delphi technique. SETTING: International. SUBJECTS: Expert panel of 24 public health nutrition leaders from nine countries in the European Union, the USA and Australia. RESULTS: All but one of the panel agreed it was important to have a consensus definition for public health nutrition to describe the field consistently. Opinion about the length and complexity of this definition tended to vary depending on the intended use of the definition. The large majority (18/24) supported the inclusion of specific reference to physical activity in a definition of public health nutrition, although there was not consensus (> 83% agreement as criterion) on this point. Consensus descriptors regarded as important in a definition of public health nutrition included: population-based, focus on health promotion, food and nutrition systems focus, wellness maintenance, primary prevention, applies public health principles, education, environmental and political descriptors. Treatment as a descriptor was rated as unimportant by a majority (14/24) of panellists, delineating public health nutrition from clinical practice. CONCLUSIONS: There is strong international agreement amongst public health nutrition leaders in Europe, the USA and Australia about a range of descriptors that can be used to define public health nutrition. The limitations of using word-for-word definitions between and within countries may be overcome by explicit use of the consensus descriptors identified in this process.

Cross-Sectional Studies↗

A high-precision, low cost system for evaluating finger-tapping tasks.

Finger-tapping test is extensively employed to assess motor asymmetry in brain damaged patients and also to study the relationship between handedness and performance in normal subjects. The aim of this study was to develop a computer based finger-tapping system that could provide quantitative measures of finger-tapping performance. The system is designed to be used in a standard personnel computer without the need of any other hardware. The software is written in Borland Delphi 6.0 for Microsoft Windows 98 and higher operating systems. Beginning with the Pentium processor, it could be possible to access a time-stamp counter. The time-stamp counter is a 64-bit machine specific register that is incremented by every clock cycle, and keeps an accurate count of every cycle that occurs on the processor. By using a computer with 1 GHz processor speed it is possible to reach a high precision time resolution of 1 mus in finger-tapping tests. Our future prospects for the system are to improve it with various tools such as synchronized recording of electromyography, tapping force monitoring, monitoring of finger angle, and the response to different stimulus parameters by adding appropriate hardware and procedure.

Adolescent↗