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At least 1,405 records · Page 78Linked to original sources
PubMed2000

Efficiency of drag sampling for estimating population sizes of Ixodes pacificus (Acari: Ixodidae) nymphs in leaf litter.

Drag sampling is a commonly used method to obtain relative estimates of the density of questing nymphal Ixodes scapularis Say and I pacificus Cooley & Kohls ticks, which are primary vectors of Lyme disease spirochetes to humans in North America. However, the efficiency of drag sampling in determining absolute population densities of questing nymphs has not been evaluated previously. Therefore, we assessed the efficiency of a single drag-sampling occasion to estimate the total population size of questing I pacificus nymphs in a leaf-litter habitat in California. Repeated daily removal sampling was carried out in four areas, each covering 300 m2, on 17 occasions over a 23-d period in the spring of 1999. In total, 573 I. pacificus nymphs were collected, of which 55 (9.6%) were collected on the initial sampling occasion and 20 (3.5%) on the last occasion. The total population size of questing nymphs, i.e., the intersection with the horizontal axis of a linear regression of daily nymphal catch rates on the number of nymphs caught previously, was estimated to be 936. Thus, the efficiency of the initial sampling occasion to estimate the total population size was 5.9% (4.8, 5.0, 5.8, and 9.1%, respectively, for the four individual sampling areas). Further, the overall mean efficiencies of the two, five, and 10 first removal sampling occasions to estimate the absolute nymphal density was 5.2, 4.7, and 4.3%, respectively, and 13 sampling occasions were required to collect 50% of the estimated total nymphal population.

Animals↗
PubMed1998

On the influence of sample size on the prognostic accuracy and reproducibility of renal transplant biopsy.

INTRODUCTION: The minimal specimen size necessary for accurate interpretation of a renal biopsy has not been identified. We attempted such a determination by three different analyses of a collection of biopsies performed in renal transplants. METHODS: First, we studied the influence of three lesions (glomerulosclerosis, arteriolar hyalinosis, interstitial fibrosis/tubular atrophy) in 199 baseline biopsies, obtained at time of transplantation, on transplant outcome. Secondly, we compared the results from the three lesions in baseline biopsy with those from 114 subsequent core biopsies in the same patients. Thirdly, we compared the two baseline biopsies obtained in 118 paired kidneys in cadaver transplantation where both kidneys were used. RESULTS: For statistically significant prediction of outcome from glomerulosclerosis, we found that a specimen containing at least 25 glomeruli was needed in the baseline biopsy. Arteriolar hyalinosis predicted outcome independent of sample size, but became less important than percentage glomerulosclerosis in predicting outcome if only samples containing more than 25 glomeruli were considered. Interstitial fibrosis/tubular atrophy did not predict the outcome of a kidney, independent of sample size. When comparing baseline with subsequent core biopsies, or with paired baseline biopsies, at least 14 glomeruli were necessary to allow even moderate reproducibility of glomerulosclerosis (Cohen's kappa > 0.25) and to allow statistical significance (P < 0.05). The reproducibility of arteriolar hyalinosis was not dependent on sample size but was reproducible in 80% of paired baseline biopsies, and in 67% of the comparison of the baseline with core biopsy. Both precision and significance was lost if sample numbers were reduced by including only larger samples. There was no reproducibility in any study of interstitial fibrosis/tubular atrophy when comparing either baseline with subsequent biopsy, or paired baseline biopsies. SUMMARY: Much larger biopsy samples are necessary than has generally been assumed in order for glomerulosclerosis rates to be reproducible or predictive of outcome. Arteriolar hyalinosis is prognostically important and shows good reproducibility independent of sample size. Interstitial fibrosis/tubular atrophy appear useless as predictors, being of no prognostic importance and lacking reproducibility. Our finding clarifies some of the discrepancies found by different investigators regarding the importance of renal biopsy in predicting prognosis. Preliminary, our data indicate that samples containing fewer than 25 glomeruli are unreliable in determining outcome based on glomerulosclerosis. The importance of our findings which are based only on chronic lesions, with respect to acute changes, is unknown.

Adolescent↗
PubMed2001

A venue-based method for sampling hard-to-reach populations.

Constructing scientifically sound samples of hard-to-reach populations, also known as hidden populations, is a challenge for many research projects. Traditional sample survey methods, such as random sampling from telephone or mailing lists, can yield low numbers of eligible respondents while non-probability sampling introduces unknown biases. The authors describe a venue-based application of time-space sampling (TSS) that addresses the challenges of accessing hard-to-reach populations. The method entails identifying days and times when the target population gathers at specific venues, constructing a sampling frame of venue, day-time units (VDTs), randomly selecting and visiting VDTs (the primary sampling units), and systematically intercepting and collecting information from consenting members of the target population. This allows researchers to construct a sample with known properties, make statistical inference to the larger population of venue visitors, and theorize about the introduction of biases that may limit generalization of results to the target population. The authors describe their use of TSS in the ongoing Community Intervention Trial for Youth (CITY) project to generate a systematic sample of young men who have sex with men. The project is an ongoing community level HIV prevention intervention trial funded by the Centers for Disease Control and Prevention. The TSS method is reproducible and can be adapted to hard-to-reach populations in other situations, environments, and cultures.

Adolescent↗
PubMed2005

Evaluation of the Center for Disease Control and Prevention's HIV behavioral surveillance of men who have sex with men: sampling issues.

BACKGROUND: The Centers for Disease Control and Prevention is embarking on a program of biannual venue-based time-space sampling surveys to monitor prevalence and incidence of HIV among men who have sex with men (MSM). GOAL: We examine the efficacy of the suggested methodology in terms of population coverage, sample period, range of venues, and representativeness. STUDY: The 2002 Urban Men's Health Study (N = 879) is a telephone interview of a household probability sample of adult MSM living in San Francisco. RESULTS: A 6-month bar/club sample would capture 79% of the adult MSM population and yield an accurate estimate of HIV prevalence. Using a longer sample period or sampling other less-frequented venues yields marginal improvement. Risk behavior, when broadly defined, is overestimated. CONCLUSIONS: The National HIV Behavioral Surveillance of MSM protocol may be satisfactory for sampling urban MSM within defined limits, but could be conducted at significantly less cost by reducing the types of venues and fielding time. However, bias in the venue sample with respect to risk behavior and other key correlates argues for validity checks based on household probability samples conducted at infrequent intervals.

Centers for Disease Control and Prevention, U.S.↗
PubMed1995

Development of sample size models for national general practice surveys.

The most cost-effective method to measure the morbidity managed and treatments provided in general practice is from records of a cluster of consultations (encounters) from each general practitioner (GP) in a random sample. A cluster sampling method is proposed for future surveys for analysis of encounter-based general practice data. The sample sizes needed to measure the most common problems managed and drugs prescribed were estimated using ratio-estimator models for cluster sample surveys. Morbidity and treatment rates were estimated from the Australian Morbidity and Treatment Survey in General Practice 1990-1991 (AMTS). The 20 most common problems in the AMTS were managed at estimated rates of 1.5 to 9.5 per 100 encounters. The 20 most common drugs were prescribed at estimated rates of 0.7 to 3.6 per 100 problems. These rates were used to determine precision as a percentage of each true value for future surveys, that is, as relative precision. If we want to be 95 per cent confident that these rates will be within 5 per cent of each true rate, sample sizes of 552 to 5675 GPs are needed. If we fix the sample size at 1000 GPs, relative precision lies within 12 per cent of these rates. If the sample size is increased to 1500 GPs, relative precision improves only marginally. The differences in sample size for each of the most frequent morbidity and treatment data are largely due to their variable distributions and relatively infrequent occurrence in general practice. A sample size of 1000 GPs will enable measurement of the most common morbidity and treatments at 95 per cent confidence.

Australia↗
PubMed2004

An incidence density sampling program for nested case-control analyses.

BACKGROUND: The nested case-control design can be a very efficient approach to an epidemiological investigation. In order to obtain unbiased estimates of relative risk, controls should be selected by incidence density sampling, which involves matching each case to a sample of those who are at risk at the time of case occurrence. METHODS: This paper presents a simple computer program for incidence density sampling. This program was evaluated using data derived from a cohort study of mortality among workers employed in the nuclear weapons industry. Controls were selected for cases via incidence density sampling; an estimate of the exposure-mortality association was obtained via conditional logistic regression. After 100 iterations of this procedure, the average effect estimate was compared to the risk estimate obtained via proportional hazards regression. The same methods were used to evaluate a program for incidence density sampling that was proposed previously by Pearce in 1989. RESULTS: Relative risk estimates obtained from nested case-control analyses conducted using the incidence density sampling program reported in this paper are unbiased. In contrast, the program for incidence density sampling proposed by Pearce tended to produce biased relative risk estimates; the magnitude of bias increased with increasing numbers of controls selected per case. CONCLUSIONS: The computer program described in this paper offers a simple approach to incidence density sampling for nested case-control analyses with exact matching on attained age and appropriate enumeration of the pool of eligible controls for each case. This method overcomes problems of bias inherent in a previously proposed program for incidence density sampling.

Bias↗
PubMedDate not supplied

A two-stage sampling method for clinical surveillance of individuals in care for HIV infection in the United States.

OBJECTIVES: The goals of this study were two-fold: (1) to describe methods for drawing a population-based sample of individuals in care for HIV infection and (2) to compare data from the sample with data from existing surveillance systems that describe care for HIV. METHODS: The authors implemented a two-stage sampling method, using local HIV/AIDS surveillance data as a sampling frame of HIV care providers in three states. At selected providers, medical records of a random sample of patients were abstracted. RESULTS: The medical records of a number of patients, ranging from 253 to 374 individuals per state, were abstracted. The demographics of sampled individuals and of individuals reported to the local HIV/AIDS surveillance program were similar; however, differences existed in the proportion of individuals receiving HIV care consistent with treatment guidelines between the sample and a contemporary facility-based supplemental surveillance project. The median design effect for outcomes collected in the sample was 1.8 (range=0.5-29.6). CONCLUSIONS: This survey method is feasible for collecting population-based data on patients in care for HIV. Sample size and some design elements should be changed in future studies to increase precision of estimates and usefulness of data for local planning and evaluation.

Adolescent↗
PubMedDate not supplied

Multi-matrix sampling: an approach to evaluation of health education programs.

Sampling is often used in evaluation as an economical and efficient means of estimating population parameters. Among the approaches to sampling traditionally used, few provide the apparent flexibility of multi-matrix sampling. The current paper proposes multi-matrix sampling as an alternative to traditional sampling approaches for evaluation of health education programs. A comparison is made between examinee sampling and multi-matrix sampling. No significant differences were found between the estimates of mean test performance provided by the two sampling plans following completion of the fifth grade unit of the School Health Curriculum Project. The advantages and disadvantages of multi-matrix sampling are examined, and potential applications of this technique are illustrated.

Curriculum↗
PubMed2005

A random sampling approach for robust estimation of tissue-to-plasma ratio from extremely sparse data.

his study was performed to develop a new nonparametric approach for the estimation of robust tissue-to-plasma ratio from extremely sparsely sampled paired data (ie, one sample each from plasma and tissue per subject). Tissue-to-plasma ratio was estimated from paired/unpaired experimental data using independent time points approach, area under the curve (AUC) values calculated with the naïve data averaging approach, and AUC values calculated using sampling based approaches (eg, the pseudoprofile-based bootstrap [PpbB] approach and the random sampling approach [our proposed approach]). The random sampling approach involves the use of a 2-phase algorithm. The convergence of the sampling/resampling approaches was investigated, as well as the robustness of the estimates produced by different approaches. To evaluate the latter, new data sets were generated by introducing outlier(s) into the real data set. One to 2 concentration values were inflated by 10% to 40% from their original values to produce the outliers. Tissue-to-plasma ratios computed using the independent time points approach varied between 0 and 50 across time points. The ratio obtained from AUC values acquired using the naive data averaging approach was not associated with any measure of uncertainty or variability. Calculating the ratio without regard to pairing yielded poorer estimates. The random sampling and pseudoprofile-based bootstrap approaches yielded tissue-to-plasma ratios with uncertainty and variability. However, the random sampling approach, because of the 2-phase nature of its algorithm, yielded more robust estimates and required fewer replications. Therefore, a 2-phase random sampling approach is proposed for the robust estimation of tissue-to-plasma ratio from extremely sparsely sampled data.

Algorithms↗
PubMed2001

Measurement of children's exposure to pesticides: analysis of urinary metabolite levels in a probability-based sample.

The Minnesota Children's Pesticide Exposure Study is a probability-based sample of 102 children 3-13 years old who were monitored for commonly used pesticides. During the summer of 1997, first-morning-void urine samples (1-3 per child) were obtained for 88% of study children and analyzed for metabolites of insecticides and herbicides: carbamates and related compounds (1-NAP), atrazine (AM), malathion (MDA), and chlorpyrifos and related compounds (TCPy). TCPy was present in 93% of the samples, whereas 1-NAP, MDA, and AM were detected in 45%, 37%, and 2% of samples, respectively. Measured intrachild means ranged from 1.4 microg/L for MDA to 9.2 microg/L for TCPy, and there was considerable intrachild variability. For children providing three urine samples, geometric mean TCPy levels were greater than the detection limit in 98% of the samples, and nearly half the children had geometric mean 1-NAP and MDA levels greater than the detection limit. Interchild variability was significantly greater than intrachild variability for 1-NAP (p = 0.0037) and TCPy (p < 0.0001). The four metabolites measured were not correlated within urine samples, and children's metabolite levels did not vary systematically by sex, age, race, household income, or putative household pesticide use. On a log scale, mean TCPy levels were significantly higher in urban than in nonurban children (7.2 vs. 4.7 microg/L; p = 0.036). Weighted population mean concentrations were 3.9 [standard error (SE) = 0.7; 95% confidence interval (CI), 2.5, 5.3] microg/L for 1-NAP, 1.7 (SE = 0.3; 95% CI, 1.1, 2.3) microg/L for MDA, and 9.6 (SE = 0.9; 95% CI, 7.8, 11) microg/L for TCPy. The weighted population results estimate the overall mean and variability of metabolite levels for more than 84,000 children in the census tracts sampled. Levels of 1-NAP were lower than reported adult reference range concentrations, whereas TCPy concentrations were substantially higher. Concentrations of MDA were detected more frequently and found at higher levels in children than in a recent nonprobability-based sample of adults. Overall, Minnesota children's TCPy and MDA levels were higher than in recent population-based studies of adults in the United States, but the relative magnitude of intraindividual variability was similar for adults and children.

Adolescent↗
PubMed1998

Bilateral sequential inferior petrosal sinus sampling with corticotrophin-releasing hormone stimulation in the diagnosis of Cushing's disease.

OBJECTIVE: The demonstration of a central to peripheral ACTH gradient in a hypercortisolaemic patient is diagnostic of Cushing's disease. We tried to determine whether single blood samples for ACTH obtained sequentially from each of the inferior petrosal sinuses following human corticotrophin-releasing hormone (hCRH) stimulation can reliably establish such a gradient. DESIGN: Prospective study. PATIENTS: Seventeen patients with clinical and biochemical features of Cushing's syndrome. METHODS: After the administration of hCRH, the patients underwent bilateral sequential inferior petrosal sinus sampling, with a single blood sample obtained from each of the inferior petrosal sinuses sequentially, along with a peripheral venous sample. The petrosal sinus catheter was withdrawn immediately after obtaining a blood sample. Patients did not require indwelling catheters in the petrosal sinuses, nor heparinisation. RESULTS: Bilateral sequential inferior petrosal sinus sampling correctly identified a pituitary source of ACTH, as shown by a central to peripheral ACTH ratio >2, in all patients in whom the procedure was successfully carried out. All patients underwent transsphenoidal pituitary surgery resulting in remission. CONCLUSIONS: The simplified method of inferior petrosal sinus sampling, using a single sequential sample from each of the inferior petrosal sinuses, following initial hCRH stimulation, is as accurate as the more complex test using multiple bilateral simultaneous inferior petrosal sinus samples. It avoids the use of indwelling cerebral venous catheters and is therefore unlikely to cause brain stem damage.

Adult↗
PubMed2004

[Estimate methods used with complex sampling designs: their application in the Cuban 2001 health survey].

OBJECTIVES: To look at the individual features of three different methods used to estimate simple parameters--means, totals, and percentages, as well as their standard errors--and of logistic regression models, and to describe how such methods can be used for analyzing data obtained from complex samples. METHODS: Data from Cuba's Second National Survey of Risk Factors and Non-Communicable Chronic Ailments [Segunda Encuesta Nacional de Factores de Riesgo y Afecciones Crónicas No Transmisibles], which was conducted in 2001, were studied. A complex, stratified multi-stage cluster sampling design was used. Cuba's 14 provinces and the municipality of Isla de la Juventud served as the strata, while the clusters consisted of sampled geographic areas (SGA), blocks, and sectors. Samples were weighted in inverse proportion to their probability of being selected, and estimates were performed by sex and age group (15-34, 35-54, 55-74, and 75 or more years). Taylor approximations were used to estimate variances. Three statistical methods were compared: conventional analysis, which assumes all data were obtained through simple random sampling; weighted analysis, which only takes into account the weight of the samples when performing estimates; and adjusted analysis, which looks at all aspects of the sampling design (namely, the disparity in the probability of being included in the sample and the effect of clustering on the data). RESULTS: The point estimates obtained with the three different types of analytic methods were similar. Standard error (SE) estimates for the prevalence of overweight and of arterial hypertension that were obtained by conventional analysis were underestimated by 19.3% and by more than 11.5%, respectively, when such estimates were compared to those obtained with the other two analytic methods. On the other hand, weighted analysis generated SE values that were much smaller than those obtained with the other two types of analyses. The same pattern was noted when odds ratios were calculated using the different methods. CONCLUSIONS: Analytic methods that take into account the way the data are structured as well as the study design give a more realistic picture of the problem under study and provide more exact estimates of the study parameters and their SE than conventional analytic methods. Because data from epidemiologic and public health research are often obtained through complex sampling designs, the methods described in this paper and the statistical packages that utilize them should be used more widely.

Cuba↗
PubMed2001

Use of sample size for estimating efficacy of a vaccine against an infectious disease.

OBJECTIVE: To determine the sample size necessary to evaluate the efficacy of a vaccine in a population. PROCEDURE: An equation was coded into a computer spreadsheet to compare the traditional sample size calculation with that needed when evaluating the efficacy of a vaccine applied in a population. RESULTS: The traditional approach used to conservatively estimate sample size necessary to detect a given difference in group proportions potentially greatly underestimates the number of animals needed for vaccine efficacy (VE) trials. In VE trials, it is necessary to estimate the effect of population-level vaccination prior to estimating sample size. In VE trials, as incidence proportion in the population or herd decreases or VE decreases, necessary sample size increases. CONCLUSIONS AND CLINICAL RELEVANCE: In designing a clinical or field trial, such as one to evaluate the efficacy of a vaccine against an infectious disease in a population, one needs to approach sample size calculations in a nontraditional manner. The proportion of the population vaccinated, disease transmission dynamics, and VE will affect the incidence in the nonvaccinated and vaccinated groups and, hence, sample size. Thus, estimation of the effect of the vaccination on the population must be made prior to calculating sample size. Otherwise, sample size and the power to identify VE will be insufficient.

Animal Diseases↗
PubMed2001

Evaluation of self-collected cervicovaginal cell samples for human papillomavirus testing by polymerase chain reaction.

As human papillomavirus (HPV) becomes accepted as the central cause of cervical cancer, longitudinal studies are shifting focus away from causality to a more detailed investigation of the natural history of HPV infections. These studies commonly require repeated samples for HPV testing over several years, usually collected during a pelvic exam, which is inconvenient to the participants and costly to the study. To alleviate the inconvenience and cost of repeated clinic visits, it has been proposed that women collect cervicovaginal cells themselves, hopefully increasing participation in the natural history studies. We evaluated the technical feasibility of self-collection of cervicovaginal cells using a Dacron swab for HPV DNA detection. We compared the self-collected swab sample and two clinician-administered swab samples (one from the endocervix and another from the ectocervix) from a total of 268 women participating in a case-control study of adenocarcinoma and squamous cell carcinomas of the uterine cervix (111 cases and 157 controls). HPV DNA was detected and genotyped using an L1 consensus PCR assay. The overall agreement between the clinician- and self-collected swabs was excellent [88.1%; kappa = 0.73 (95% confidence interval (CI), 0.61-0.85)]. The correlation was highest between the two clinician-administered swabs [kappa = 0.81 (95% CI, 0.69-0.93)] but was still excellent when comparing either clinician-administered swab to the self-administered sample [kappa = 0.75 (95% CI, 0.63-0.87) and 0.67 (95% CI, 0.55-0.79) for ectocervix and endocervix, respectively]. The type-specific agreement between samples was higher for high-risk, or cancer-associated, HPV genotypes than for low risk, noncancer-associated HPV genotypes when comparing the self-administered swab sample to the clinician-administered swab sample (kappa = 0.78 for high-risk versus 0.66 for low-risk HPV infections, t = -1.45, P = 0.15). The decrease in agreement for low risk types was largely attributable to an increased detection of these types in the self-administered sample (McNemar's chi2 = 6.25, P = 0.01 for clinician- versus self-administered swab comparisons). The agreement did not vary significantly by age, menopausal status, case status, or clinic center. We have demonstrated that a self-collected Dacron swab sample of cervicovaginal cells is a technically feasible alternative to clinician-administered cervical cell collection in natural history studies of HPV and cervical cancer.

Adolescent↗
PubMed2000

[Arthropod diversity in leafy vegetable field and sampling technology].

Two sampling units (plant and quadrat) and two sampling methods (random and fixed) were adopted to compare the variation degree of the diversity of arthropod communities in different chinese cabbage fields. The results show that a lower variation degree was found when the random sampling method was adopted with quadrat (0.11 m2) as sampling unit at seedling stage and with plant as sampling unit from growing to mature stage. The community diversity was relatively steady, when the critical number of samples was more than 12 quatrats (0.11 m2) at seedling stage, 30 plants in growing period, and 20 plants at mature stage. The optimum sampling unit, sampling method and sampling number of arthropod diversity in leafy vegetable field were also determined.

Animals↗
PubMed1991

Efficiency of cohort sampling designs: some surprising results.

Cohort sampling designs are proposed which one would intuitively expect to be more efficient than nested case-control sampling. Two of these designs start with a nested case-control sample and distribute controls to sampled risk sets other than those for which they were picked. The third design has the goal of maximizing the number of distinct persons in a nested case-control sample. Simulation results show surprisingly little gain, and more often a loss in efficiency of these new designs relative to nested case-control sampling. This is due to the sampling-induced covariance between score terms. We conclude that the often stated intuition that nested case-control sampling does not make good use of sampled individuals' covariate histories is false.

Analysis of Variance↗
PubMed1991

Lot quality assurance sampling techniques in health surveys in developing countries: advantages and current constraints.

Traditional survey methods, which are generally costly and time-consuming, usually provide information at the regional or national level only. The utilization of lot quality assurance sampling (LQAS) methodology, developed in industry for quality control, makes it possible to use small sample sizes when conducting surveys in small geographical or population-based areas (lots). This article describes the practical use of LQAS for conducting health surveys to monitor health programmes in developing countries. Following a brief description of the method, the article explains how to build a sample frame and conduct the sampling to apply LQAS under field conditions. A detailed description of the procedure for selecting a sampling unit to monitor the health programme and a sample size is given. The sampling schemes utilizing LQAS applicable to health surveys, such as simple- and double-sampling schemes, are discussed. The interpretation of the survey results and the planning of subsequent rounds of LQAS surveys are also discussed. When describing the applicability of LQAS in health surveys in developing countries, the article considers current limitations for its use by health planners in charge of health programmes, and suggests ways to overcome these limitations through future research. It is hoped that with increasing attention being given to industrial sampling plans in general, and LQAS in particular, their utilization to monitor health programmes will provide health planners in developing countries with powerful techniques to help them achieve their health programme targets.

Developing Countries↗
PubMed1995

Sample size calculations in scleroderma: a rational approach to choosing outcome measurements in scleroderma trials.

Subjects with both diffuse and limited scleroderma were studied to calculate the baseline characteristics of several commonly used outcome measurements in order to provide parameters for sample size calculations for scleroderma clinical trials. From these estimates, outcome measurements were chosen as potentially responsive to change in clinical trials if their sample sizes were not prohibitively large. Forty-five patients with scleroderma were systematically assessed to determine the means and standard deviations whereby sample size calculations can be performed using this information. Examples of sample sizes were determined for the entire group, and for 2 subsets: those with diffuse scleroderma and those with diffuse disease of recent onset. Many baseline characteristics were significantly different in patients with diffuse compared to limited systemic sclerosis. The baseline values were different for the Health Assessment Questionnaire (HAQ) disability score, Functional Index, grip strength, oral aperture, finger-to-palm distance, skin score, and physician global assessment. Sample sizes can vary widely depending upon the outcome measurement chosen and the range of deltas used within the different scleroderma subsets. Sample size requirements for many outcome measures are extremely large due to marked variability in the baseline measures. Primary outcome measures in scleroderma trials should be chosen which have adequate power to detect a minimal clinically relevant change in the primary outcome measurements at the sample sizes employed. All other outcome measures should be ranked as secondary. Skin scores, global assessments, and grip strength measurements require smaller sample sizes than the other outcome measurements which were studied. Sample sizes in future trials will vary depending upon the proportion of patients with diffuse and limited scleroderma who are included.

Female↗