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PubMed2005

Use of standards in the review of medical devices.

In keeping with its mandate to provide the least burdensome means of product regulation, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health uses many different standards to facilitate the review of premarket submissions of medical devices. The benefits of using standards in this manner include providing a set of common requirements and test protocols to the device manufacturer, thus reducing the manufacturer's need to "reinvent the wheel" for each new bench test to ensure safety and effectiveness of the device. With the current trend toward international harmonization of standards, tests performed in accordance with an international standard may be acceptable to several countries. However, there are instances in which the FDA does not agree with certain provisions in a standard. This article aims to clarify the approaches taken by the FDA to balance or resolve issues that arise when there is disagreement regarding the acceptability of a particular standard. One approach begins with the recognition of only some provisions of a standard, or more commonly, excluding those parts of a standard that are unacceptable to the FDA for regulatory or scientific validity reasons. Other approaches include working with the standards development organizations to revise the standard to include language more agreeable to all parties involved. Specific examples will be presented on medical devices, such as electrocardiogram cables and connectors, and noninvasive blood pressure monitors.

Device Approval↗

PubMed2006

The development of national competency standards for the midwife in Australia.

OBJECTIVE: to develop and validate national competency standards for midwives in Australia. This study was part of a commissioned national research project to articulate the scope of practice of Australian midwives and to develop national competency standards to assist midwives to deliver safe and competent midwifery care. DESIGN: a multi-method, staged approach was used to collect data through a literature review, workshop consultations, interviews, surveys and written submissions in order to develop national competency standards for Australian midwives. Subsequently, direct observation of practice in a range of settings ensured validation of the competencies. SETTING: maternity-care settings in each state and territory in Australia. PARTICIPANTS: midwives, other health professionals and consumers of midwifery care. FINDINGS: The national competency standards for the midwife were developed through research and consultation before being validated in practice. KEY CONCLUSIONS: the national competency standards are currently being implemented into education, regulation and practice in Australia. These will be minimum competency standards required of all midwives who seek authority to practise as a midwife in Australia. It is expected that all midwives will demonstrate that they are able to meet the competency standards relevant to the position they hold. IMPLICATIONS FOR PRACTICE: the competency standards establish a national standard for midwives and reinforce responsibility and accountability in the provision of quality midwifery care through safe and effective practice. In addition, individual midwives may use the competency standards as the basis of their ongoing professional development plans.

Australia↗

PubMed1999

Using standardized patients to train and evaluate dietetics students.

Faced with a dwindling number of clinical sites for training dietetics students, we incorporated a standardized patient scenario of a 17-year-old pregnant woman into a nutrition counseling course. A young woman was hired to be the patient and was trained extensively. Each student signed up for a 20-minute block of time to assess her and provide nutrition instruction, after which the standardized patient and course instructor provided individualized feedback to each student. Students then completed a brief questionnaire related to the standardized patient session. Overall, student response to the standardized patient session was positive, and students believed standardized patients should be included formally in undergraduate training. The students noted that the standardized patient session allowed them to be trained and evaluated objectively. Because of their ease in building rapport with the standardized patient, students reported that they were able to provide more in-depth education. They also appreciated the immediate and detailed performance review provided by the standardized patient and the instructor. We conclude that standardized patient sessions provide a great service to dietetics students, and plans to develop another standardized patient scenario that students can follow up throughout the continuum of care are underway.

Adolescent↗

PubMed1990

The advent of clinical standards for professional liability.

The development of clinically based written standards to reduce the frequency and severity of medical malpractice loss appears to be gaining in popularity among provider specialty groups and professional liability underwriters. To date, such standards have addressed problems in specialties such as obstetrics and anesthesia where dollar losses associated with malpractice claims have been high. Guidelines can be developed and used by providers on a purely voluntary basis or mandated on an involuntary basis by third parties such as malpractice insurance companies or legislators. Because the advent of risk-control standards is a relatively new phenomenon, formal scientific studies on the long-term benefits of such guidelines have not yet been published. However, it appears that sharp reductions of malpractice losses in specialties such as anesthesia have coincided with the implementation of formal written standards specifically designed for liability control. This has led some liability insurance carriers to decrease premiums associated with specialists following such standards. Many providers are understandably concerned about the potential use of written standards by plaintiff attorneys in medical malpractice suits. Although it is possible that such policies and guidelines could be admitted into evidence to show that a provider breached the legal duty or standard of care owed to a patient, it is uncertain whether these risk-control standards could ultimately pass the evidentiary rules of relevancy or materiality in a given lawsuit. It is clear, however, that the consensus-based process of creating clinical standards and guidelines specifically for controlling professional liability losses is itself a powerful and emerging standard for health care risk management programs.

Clinical Competence↗

PubMed1997

Preferred placement of the feet during quiet stance: development of a standardized foot placement for balance testing.

OBJECTIVE: To establish a standardized stance position for balance testing based on average preferred foot placement, and to compare this to existing standards. DESIGN: Cross-sectional study. BACKGROUND: It has been shown that the orientation of the feet can have a marked influence on the results obtained during balance testing, prompting the need for standardized foot positioning. Unfortunately, current recommendations do not appear to address concerns about the potential effects of 'uncomfortable' or 'unnatural' foot positions on the control of stabilizing reactions. METHODS: The present study identifies the central tendency and variance of the preferred stance width and foot angle, measured from foot tracings in 262 subjects (89 male, 173 female) ranging in age from 19 to 97 years. RESULTS: Results revealed a great degree of variability in preferred stance width and angle across subjects, although mean differences due to gender or age (</= 50 versus > 60) were small. The average preferred foot position was 0.17 m between heel centres, with an angle of 14 degrees between the long axes of the feet. Existing standards for stance position lie well outside the range of preferred foot placement. CONCLUSIONS: The wide range of preferred foot placements clearly highlights the need for standardization during balance testing. A standard based on average preference would reduce potential effects of 'uncomfortable' or 'unnatural' foot positions, in comparison to existing standards. RELEVANCE: The development of a standardized stance position for balance testing is necessary since foot placement can influence stabilizing reactions. The present results provide a standardization based on average preferred foot placement, which will minimize between-subject variability and reduce the abnormal constraints that are placed on subjects by existing standards.

Journal Article↗

PubMed2003

[Effects of kinesthetic mobilization in comparison with standard mobilization on respiratory function after coronary artery bypass and other relevant factors].

Presently no relevant nursing data exist in Germany on the effect of mobilization according to kinaesthetic principles on the physiological system, on locomotion and the sensory system. The effect of two different versions of mobilization was measured in a unicentric, open, randomized study with two parallel groups from December 1999 to October 2000 in the intermediate ICU for patients after heart surgery at Ulm University Hospital. The aim was, to show superiority of kinaesthetic mobilization, compared to empirically developed standard mobilization on patients after aortal coronary bypass surgery, with reference to respiratory function. The two protocols of mobilization were carefully coordinated with precise plans of action and timing. A total of 104 subjects were randomized to the two groups. In the kinaesthetic mobilization group (n = 52) median age was 67.5 years, ten (19.2%) were female and 42 (80.8%) were male. In the standard mobilization group (n = 52) median age was 69 years, eight (15.4%) were female and 44 (84.6%) were male. The main outcome variable was the respiratory minute volume 30 minutes after the second mobilization minus the respiratory minute volume prior to the second mobilization. The median change in respiratory minute volume was 0.4 ltr/min. (-5.1 to 3) in the group with kinaesthetic mobilization and median 0.3 ltr/min (-6.0 to +9.1) in the standard mobilization group. Superiority of kinaesthetic mobilization compared to standard mobilization could not be proven (p = 0.38). Also in the secondary outcome variables the kinaesthetic mobilization showed no superiority over standard mobilization. The respiratory minute volume data within points of measure show that subjects in the kinaesthetic group have less extreme results (> 12 ltr.). In the area < 5 ltr. there is a similar tendency. This may point out that regulation between movement of body, respiration and circulatory system occurs more continuous in kinaesthetic mobilization than the standard mobilization. A similar tendency was seen in the secondary outcomes variables. Subjectively nurses noted that kinaesthetic mobilization was less strenuous than standard mobilization, even though subjects in the kinaesthetic group showed more mobility restriction (37%) than in the standard group (15%). From before to after the first mobilization the percentage of subjects needing less pain medication was higher in the kinaesthetic group (35%), compared to the standard group (19%). There were no serious adverse events in either group. The concept of kinaesthetic mobilization showed no negative effect on subjects compared to empirically developed standard mobilization. There was no diagnosis of pneumonia and none of instabile sternum on any of the subjects in this study. Also, there was no negative effect on the sternum due to the light support arms gave to sitting up and rotating movements in the area of thorax and pelvis on subjects in the kinaesthetic group. The subjects early trust in their own varied movement and the possible effects of kinaesthetic mobilization in later phases of recuperation was not explored in this study.

Aged↗

PubMed2002

Panel expertise for an Angoff standard setting procedure in progress testing: item writers compared to recently graduated students.

INTRODUCTION: An earlier study showed that an Angoff procedure with > or = 10 recently graduated students as judges can be used to estimate the passing score of a progress test. As the acceptability and feasibility of this approach are questionable, we conducted an Angoff procedure with test item writers as judges. This paper reports on the reliability and credibility of this procedure and compares the standards set by the two different panels. METHODS: Fourteen item writers judged 146 test items. Recently graduated students had assessed these items in a previous study. Generalizability was investigated as a function of the number of items and judges. Credibility was judged by comparing the pass/fail rates associated with the Angoff standard, a relative standard and a fixed standard. The Angoff standards obtained by item writers and graduates were compared. RESULTS: The variance associated with consistent variability of item writers across items was 1.5% and for graduate students it was 0.4%. An acceptable error score required 39 judges. Item-Angoff estimates of the two panels and item P-values correlated highly. Failure rates of 57%, 55% and 7% were associated with the item writers' standard, the fixed standard and the graduates' standard, respectively. CONCLUSION: The graduates' and the item writers' standards differed substantially, as did the associated failure rates. A panel of 39 item writers is not feasible. The item writers' passing score appears to be less credible. The credibility of the graduates' standard needs further evaluation. The acceptability and feasibility of a panel consisting of both students and item writers may be worth investigating.

Curriculum↗

PubMed2002

Prospective randomized comparison of cooled radiofrequency versus standard radiofrequency energy for ablation of typical atrial flutter.

In patients with atrial flutter, conventional RF ablation may not result in complete isthmus block. This prospective, randomized study tested the hypothesis that the cooled RF ablation is safe and facilitates the achievement of isthmus block with fewer RF applications than with standard ablation for typical atrial flutter. Isthmus ablation was performed in 59 patients (40 men, 64 +/- 14 years) with type I atrial flutter using standard RF (n = 31) or cooled RF (n = 28) catheters with crossover after 12 unsuccessful RF applications. The endpoint was bidirectional isthmus block or a total of 24 unsuccessful RF applications. After the first 12 RF applications, 17 (55%) of 31 standard RF and 22 (79%) of 28 cooled RF patients had bidirectional isthmus block (P < 0.05). After the remaining patients crossed over to the alternate RF ablation system and underwent up to 12 more RF applications, bidirectional isthmus block had been demonstrated in 27 (87%) of 31 standard RF and 25 (89%) of 28 cooled RF patients (P = NS). Isthmus block was not achieved within 24 RF applications in four standard and three cooled RF patients. Mean measured tip temperatures for cooled RF were lower than for standard RF (38.5 degrees C +/- 6.98 degrees C vs 57.2 degrees C +/- 7.42 degrees C, P < 0.0001). Peak temperatures were also lower for cooled RF compared to standard RF (45.7 degrees C +/- 22.7 degrees C vs 63.4 degrees C +/- 9.87 degrees C, P < 0.0001). Importantly, mean power delivered was significantly higher for cooled than for standard RF (42.3 +/- 9.48 vs 34.0 +/- 14.0 W, P < 0.0001). There were no serious complications for either ablation system. During a 12.8 +/- 3.76-month follow-up, there were two atrial flutter recurrences in the cooled RF group and four in the standard RF group (P = NS). In patients with type I atrial flutter, ablation with the cooled RF catheter is as safe as, and facilitates creation of bidirectional isthmus block more rapidly than, standard RF ablation.

Atrial Flutter↗

PubMed2000

Standardized units of RBCs: is it time for implementation?

BACKGROUND: Current practice for the preparation of RBCs from whole blood for transfusion results in poorly standardized contents of RBC Hb. The principle of apheresis, metering the anticoagulant into the collected blood, which is pumped into an empty container, allows variation in the collected volume according to properties of the donor. STUDY DESIGN AND METHODS: The total Hb mass of each person in a representative group of Swedish blood donors was evaluated by using Hb concentration and blood volume (BV), with the latter calculated from each donor's weight and height. The number of blood units that could be collected without exceeding 13 percent of the BV was estimated at a standardized content of RBC Hb set at 40, 45, and 50 g. RESULTS: With Hb standards of 45 and 50 g per unit of RBCs, it would be possible to collect 1 unit, but not more, from 93 female donors in the study; with 40 g of Hb as the standard, 2 units could be collected from 6 percent of the donors. Using a standard of 40 g of Hb, it would be possible to collect 2 units or more from 95 percent of 121 male donors. The corresponding figures at Hb standards of 45 and 50 g were 81 and 50 percent, respectively, of the male donors. The largest number of units that could be collected would thus be obtained at a 40-g Hb standard. However, the greatest total mass of RBC Hb would have been obtained at 45 g. Even the yield of plasma would reach a maximum at this RBC Hb standard. CONCLUSION: Depending on the donor's Hb and BV, it is possible to collect either 1 or 2 units of RBCs without exceeding 13 percent of any donor's BV, provided the collected volume of blood in each unit is less than the current standard. Such practice would allow better use of the donor population. Two-unit blood collections may reduce donor exposure in transfusions. Applying a standard at 45 g of RBC Hb per unit was found to permit the collection of maximum RBC Hb and plasma in the evaluated population of Scandinavian donors. Perhaps it is time to discuss a change in current rules for the preparation of RBCs for transfusion.

Blood Donors↗

PubMedDate not supplied

Latent trait standardization of the benzodiazepine dependence self-report questionnaire using the Rasch scaling model.

The aim of the present study was to obtain standardized scores that correspond with the raw scores on the four Rasch scales of the Benzodiazepine Dependence-Self Report Questionnaire (Bendep-SRQ). The eligible normative group for standardization of the Bendep-SRQ scales consisted of 217 general practice (GP) patients, all using benzodiazepines. Two standardization methods were used and compared: "classical standardization," which transforms raw scores into standard scores on the unit normal distribution, and "latent trait standardization," which transforms raw scores into latent trait scores. The latter requires the Rasch model with the additional assumption of a normally distributed latent trait, which held true for the scales "problematic use," "lack of compliance," and "withdrawal," but not for "preoccupation." The observed unequal item spacing on the "preoccupation" scale was hypothesized to induce a response tendency of nondeviation, causing a local violation of the assumption of a normally distributed latent trait. Nevertheless, comparison of the results of the two standardization methods revealed such a high degree of resemblance, that latent trait standardization could be used for "preoccupation" just as well as classical standardization. The presented standard scores and corresponding percentile ranks make raw Bendep-SRQ scores clinically interpretable in relation to the normative GP sample. Incorporation of the Rasch scaling methodology into the development of the Bendep-SRQ marks the adoption of the item response theory in the field of applied test methodology. In this process, it appears that equal item spacing has to be taken into account to prevent local violations of the Rasch model with the additional assumption of a normally distributed latent trait.

Adolescent↗

PubMed2001

Pectus excavatum repair: experience with standard and minimal invasive techniques.

BACKGROUND/PURPOSE: The Nuss procedure is a minimally invasive pectus repair that helps avoid cartilage resection and osteotomy. This report compares outcomes in patients undergoing a standard pectus repair to patients with the Nuss procedure. METHODS: One hundred three children (ages 5 to 20 years) with severe pectus excavatum underwent repair. Patients were evaluated for type of repair performed, associated anomalies, cardiopulmonary function, operating time, analgesia requirements, complications, length of hospital stay, hospital and operative charges, and cosmetic result. Statistical analysis was performed using the Mann-Whitney rank sum test. RESULTS: There were 68 patients (average age, 12.6 years) in the standard group and 35, (average age, 9.5 years) in the Nuss group. Associated anomalies were found in 6 standard group and 2 Nuss group patients. Average operating time in Nuss was 3.3 hours and in open procedures, 4.7 hours. Postoperative complications occurred in 13 (20%) standard repair patients and 15 (43%) after the Nuss. In the standard group, 14 patients received intrathecal and 3 received epidural analgesia, while 35 (52%) required an intravenous patient-controlled anesthetic device (PCA; average, 1.8 days). In the Nuss group, 25 patients (71%) received epidural anesthesia (average, 3 days), and 31 (89%) utilized PCA (average 3.8 days). Four (6%) standard patients and 8 Nuss patients (29%) required reoperation. Length of stay averaged 4.0 days (range 2 to 30) in the standard group and 4.8 days (range, 2 to 11) in the Nuss group. Average operating room charge was $8,325 in the standard group and $9,480 in the Nuss group. Average hospital charge was $4,137 for the standard patient and $4,044 for the Nuss group. Analgesic requirements and length of hospital stay were increased (P <.05). The complication rate and operative and hospital charges were similar between groups. CONCLUSIONS: Although the Nuss repair is associated with shorter operating time, smaller incisions, and less dissection, early results indicate few other advantages. Drawbacks of the Nuss procedure include high complication and reoperation rates and lack of efficacy in older teenagers and those with connective tissue disorders. Long-term follow-up will be necessary to determine final cosmetic and functional outcomes and define the overall risks and benefits of this procedure as compared with the standard technique.

Adolescent↗

PubMed2004

A comparison of high-dose and standard-dose epinephrine in children with cardiac arrest.

BACKGROUND: When efforts to resuscitate a child after cardiac arrest are unsuccessful despite the administration of an initial dose of epinephrine, it is unclear whether the next dose of epinephrine (i.e., the rescue dose) should be the same (standard) dose or a higher dose. METHODS: We performed a prospective, randomized, double-blind trial to compare high-dose epinephrine (0.1 mg per kilogram of body weight) with standard-dose epinephrine (0.01 mg per kilogram) as rescue therapy for in-hospital cardiac arrest in children after failure of an initial, standard dose of epinephrine. The trial included 68 children, and Utstein-style reporting guidelines were used. The primary outcome measure was survival 24 hours after the arrest. RESULTS: The rate of survival at 24 hours was lower in the group assigned to a high dose of epinephrine as rescue therapy than in the group assigned to a standard dose: 1 of the 34 patients in the high-dose group survived for 24 hours, as compared with 7 of the 34 patients in the standard-dose group (unadjusted odds ratio for death with the high dose, 8.6; 97.5 percent confidence interval, 1.0 to 397.0; P=0.05). After adjustment by multiple logistic-regression analysis for differences in the groups at the time of arrest, the high-dose group tended to have a lower 24-hour survival rate (odds ratio for death, 7.9; 97.5 percent confidence interval, 0.9 to 72.5; P=0.08). The two treatment groups did not differ significantly in terms of the rate of return of spontaneous circulation (which occurred in 20 patients in the high-dose group and 21 of those in the standard-dose group; odds ratio, 1.1; 97.5 percent confidence interval, 0.4 to 3.0). None of the patients in the high-dose group, as compared with four of those in the standard-dose group, survived to hospital discharge. Among the 30 patients whose cardiac arrest was precipitated by asphyxia, none of the 12 who were assigned to high-dose epinephrine were alive at 24 hours, as compared with 7 of the 18 who were assigned to a standard dose (P=0.02). CONCLUSIONS: We did not find any benefit of high-dose epinephrine rescue therapy for in-hospital cardiac arrest in children after failure of an initial standard dose of epinephrine. The data suggest that high-dose therapy may be worse than standard-dose therapy.

Asphyxia↗

PubMed2006

Bicalutamide 150 mg in addition to standard care for patients with early non-metastatic prostate cancer: updated results from the Scandinavian Prostate Cancer Period Group-6 Study after a median follow-up period of 7.1 years.

OBJECTIVE: The Early Prostate Cancer (EPC) programme is evaluating the efficacy and tolerability of bicalutamide following standard care (radiotherapy, radical prostatectomy or watchful waiting) in patients with localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N + ) non-metastatic prostate cancer. Herein we report the latest findings after a median follow-up period of 7.1 years from the Scandinavian Prostate Cancer Group (SPCG)-6 study, one of three trials in the EPC programme. MATERIAL AND METHODS: A total of 1218 patients were randomized on a 1:1 basis to either bicalutamide 150 mg/day (n=607) or placebo (n=611) following standard care; 81.4% were followed conservatively (watchful waiting). The primary endpoints were objective progression-free survival (PFS) and overall survival (OS). RESULTS: In patients with localized disease there was no significant difference in PFS [hazard ratio (HR) 0.85; 95% CI 0.69-1.06; p=0.15] and a trend towards decreased OS with bicalutamide plus standard care compared with standard care alone (HR 1.23; 95% CI 0.96-1.58; p=0.11). In patients with locally advanced disease, bicalutamide significantly improved PFS, reducing the risk of progression by 53% compared with standard care alone (HR 0.47; 95% CI 0.37-0.59; p<0.001). The median time to progression was 8.8 years for bicalutamide plus standard care and 7.1 years for standard care alone. There was a significant improvement in OS with bicalutamide plus standard care, with a reduction in the risk of death of 35% versus standard care alone (HR 0.65; 95% CI 0.50-0.85; p=0.001). CONCLUSION: This analysis of the SPCG-6 study showed that bicalutamide plus standard care offers significant PFS and OS benefits for patients with locally advanced disease, but not for those with localized disease.

Aged↗

PubMed2002

Role of JCAHO standards and clinical practice guidelines in promoting appropriate antimicrobial use.

The role of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) standards and clinical practice guidelines in promoting appropriate antimicrobial use and the development of such standards and guidelines are described. JCAHO is committed to continuously improve the safety and quality of patient care. Reducing antimicrobial resistance in health systems often requires change, something that many health care practitioners are reluctant to embrace. Current JCAHO standards suggest that the use of clinical practice guidelines be considered, but guideline use is not required. JCAHO's standards development process is lengthy and involved. Therefore, it is easier to effect change by modifying the statements of intent that accompany the standards than the standards themselves. Concerns about antimicrobial resistance can be addressed through performance measurement. In July 2002, core measures of patient care processes and outcomes will be implemented for the first time. JCAHO requires hospital laboratories to be accredited, which increases the stature of the laboratory in the eyes of hospital administration. JCAHO laboratory standards directly relate to clinical practice guidelines, antimicrobial resistance, and NCCLS (formerly known as the National Committee for Clinical Laboratory Standards) and support efforts to reduce inappropriate antimicrobial use. Hospital laboratories play a vital role in effecting change in antimicrobial use. JCAHO laboratory standards for clinical practice guidelines and quality control support efforts to reduce inappropriate antimicrobial use. Hospitals have been reluctant to require the use of clinical practice guidelines in JCAHO standards, although guidelines promote appropriate antimicrobial use and reduce antimicrobial resistance. Pharmacists should work with laboratory staff and JCAHO to effect the changes needed to stem antimicrobial resistance.

Anti-Infective Agents↗

PubMed2001

Setting standards in the evaluation of community-based health promotion programmes--a unifying approach.

Community-based health promotion often emphasizes elements of empowerment, participation, multidisciplinary collaboration, capacity building, equity and sustainable development. Such an emphasis may be viewed as being in opposition to equally powerful notions of evidence-based decision making and accountability, and with funders' and government decision-makers' preoccupation with measuring outcomes. These tensions may be fuelled when community practitioners and lay participants feel evaluations are imposed upon them in a manner that fails to appreciate the uniqueness of their community, its programme, and practitioners' skills and experience. This paper attempts to provide an approach that depicts evaluation as being mutually beneficial to both funders/government and practitioners. First, a values stance for health promotion, termed a 'salutogenic' orientation, is proposed as a foundation for the evaluation of community-based health promotion. Secondly, we discuss possible objects of interest, the first component of an evaluation. We then discuss the spirit of the times and its implications for community-based health promotion. Finally, we address the key question of setting standards. A typology of standards is presented. Arbitrary, experiential and utility standards are based on perceived needs and priorities of practitioners, lay participants or professional decision-makers. Historical, scientific and normative standards are driven by empirical, objective data. Propriety and feasibility standards are those wherein the primary concern is for consideration of resources, policies, legislation and administrative factors. The 'model' standards approach is presented as an exemplar of a combined approach that incorporates elements of each of the other standards. We argue that the 'optimal' standard for community-based health promotion depends on the setting and the circumstances. There is no 'magic bullet', 'one-size-fits-all' or 'best' standard. Further, we argue that standards should be set from an inclusive, salutogenic orientation. This approach offers a means of creating a situation in which policy-makers and funders are more supportive of evaluation designs that fit with community realities, and community stakeholders are more capable and consistent in rigorously evaluating community-based health promotion programmes and policies.

Canada↗

PubMed1999

Application of the bootstrap procedure provides an alternative to standard statistical procedures in the estimation of the vitamin B-6 requirement.

The bootstrap procedure is a versatile statistical tool for the estimation of standard errors and confidence intervals. It is useful when standard statistical methods are not available or are poorly behaved, e.g., for nonlinear functions or when assumptions of a statistical model have been violated. Inverse regression estimation is an example of a statistical tool with a wide application in human nutrition. In a recent study, inverse regression was used to estimate the vitamin B-6 requirement of young women. In the present statistical application, both standard statistical methods and the bootstrap technique were used to estimate the mean vitamin B-6 requirement, standard errors and 95% confidence intervals for the mean. The bootstrap procedure produced standard error estimates and confidence intervals that were similar to those calculated by using standard statistical estimators. In a Monte Carlo simulation exploring the behavior of the inverse regression estimators, bootstrap standard errors were found to be nearly unbiased, even when the basic assumptions of the regression model were violated. On the other hand, the standard asymptotic estimator was found to behave well when the assumptions of the regression model were met, but behaved poorly when the assumptions were violated. In human metabolic studies, which are often restricted to small sample sizes, or when statistical methods are not available or are poorly behaved, bootstrap estimates for calculating standard errors and confidence intervals may be preferred. Investigators in human nutrition may find that the bootstrap procedure is superior to standard statistical procedures in cases similar to the examples presented in this paper.

Adult↗

PubMedDate not supplied

Assessment of validity of the national public health performance standards: the local public health performance assessment instrument.

The National Public Health Performance Standards Program (NPHPSP) has developed performance standards measurement instruments, based on the 10 "Essential Services of Public Health" that are being tested in several states. This article is a report on the face and content validity of the instrument designed for local public health systems. Judgments about the face validity of the standards were obtained in a survey of local public health systems that had used the instrument in a test state. The validity of each standard was addressed along the following dimensions: the importance of the standard as a measure of the Essential Service; its completeness as a measure; and its reasonableness for achievement. All standards for each Essential Service were then judged in terms of their completeness in measuring performance of that service. Respondents judged the standards to be highly valid measures of local public health system performance. Some respondents had reservations about whether standards related to "enforcing laws and regulations" were achievable. Holding local public health systems accountable for the activities of other agencies was a factor mentioned in conjunction with those standards. The NPHPSP standards have face and content validity for measuring local public health system performance. Further testing of their validity and reliability is continuing.

Analysis of Variance↗

PubMed1990

Practice standards: implications for the internist.

Pressure for national standards of medical practice is increasing from cost control initiatives, medical malpractice liability, and the desire to simplify complex practice problems. Good standards need to be academically sound, focused enough to be clinically useful, yet flexible enough to allow for the realities of practice. Standards have already been created by several professional societies, including anesthesiology and cardiology in internal medicine. Although physician education is primary, controlling the use of expensive new technologies is an unwritten but important secondary goal. While standards have reduced malpractice liability in some professional groups, some clinicians are concerned that standards will be too academic and unrealistic. Currently, third-party payers are watching the development of practice standards but are hesitant to use them as criteria for determination of reimbursement. The federal government has a major interest in practice standards as a means of both monitoring quality of care and controlling costs. A number of agencies are studying the development of standards and their implications for use. Recent articles questioning the usefulness of common diagnostic tests and even the routine physical examination have raised concern among internists that restriction of practice and reimbursement will follow. Some evolving standards, such as screening for breast cancer, seem to ignore the realities of clinical practice and may generate more cost than they save. Internists need to provide input as standards are developed to guarantee appropriateness and feasibility.

Costs and Cost Analysis↗