[ { "key": "FQVT44P5", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/FQVT44P5", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/FQVT44P5", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "U.S. Food and Drug Administration", "numChildren": 0 }, "data": { "key": "FQVT44P5", "version": 1, "itemType": "webpage", "title": "Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw fomr FDA-Regulated Clinical Trials", "creators": [ { "creatorType": "author", "firstName": "", "lastName": "U.S. Food and Drug Administration" } ], "abstractNote": "", "websiteTitle": "", "websiteType": "WebContent", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126489.pdf", "accessDate": "2010-09-22T14:39:03Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [], "collections": [ "39MN9HRZ" ], "relations": {}, "dateAdded": "2010-09-22T14:39:03Z", "dateModified": "2010-09-22T15:01:51Z" } }, { "key": "8PVGTNNJ", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/8PVGTNNJ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/8PVGTNNJ", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "McGuinness", "parsedDate": "2008", "numChildren": 0 }, "data": { "key": "8PVGTNNJ", "version": 1, "itemType": "journalArticle", "title": "Of rowing boats, ocean liners and tests of the ANOVA homogeneity of variance assumption", "creators": [ { "creatorType": "author", "firstName": "Keith A.", "lastName": "McGuinness" } ], "abstractNote": "Abstract: \"One of the assumptions of analysis of variance (ANOVA) is that the variances of the groups being compared are approximately equal. This assumption is routinely checked before doing an analysis, although some workers consider ANOVA robust and do not bother and others avoid parametric procedures entirely. Two of the more commonly used heterogeneity tests are Bartlett's and Cochran's, although, as for most of these tests, they may well be more sensitive to violations of the ANOVA assumptions than is ANOVA itself. Simulations were used to examine how well these two tests protected ANOVA against the problems created by variance heterogeneity. Although Cochran's test performed a little better than Bartlett's, both tests performed poorly, frequently disallowing perfectly valid analyses. Recommendations are made about how to proceed, given these results.\"", "publicationTitle": "Austral Ecology", "publisher": "", "place": "", "date": "06/2008", "volume": "27", "issue": "6", "section": "", "partNumber": "", "partTitle": "", "pages": "681-688", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1111/j.1442-9993.2002.tb00217.x", "citationKey": "", "url": "http://onlinelibrary.wiley.com/doi/10.1111/j.1442-9993.2002.tb00217.x/abstract", "accessDate": "2010-08-19T14:11:11Z", "PMID": "", "PMCID": "", "ISSN": "14429985", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "CrossRef", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Analysis of Variance" }, { "tag": "a02" } ], "collections": [ "SEXT6Z3R" ], "relations": {}, "dateAdded": "2010-09-15T03:51:49Z", "dateModified": "2010-09-15T03:51:49Z" } }, { "key": "4Z4MHAWX", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/4Z4MHAWX", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/4Z4MHAWX", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Data Analysis and Story Library", "numChildren": 0 }, "data": { "key": "4Z4MHAWX", "version": 1, "itemType": "webpage", "title": "Nambeware Polishing Times", "creators": [ { "creatorType": "author", "name": "Data Analysis and Story Library" } ], "abstractNote": "Excerpt: \"Nambe Mills manufactures a line of tableware made from sand casting a special alloy of several metals. After casting, the pieces go through a series of shaping, grinding, buffing, and polishing steps. In 1989 the company began a program to rationalize its production schedule of some 100 items in its tableware line. The total grinding and polishing times listed here were a major output of this program. Number of cases: 59. Variable Names: 1. BOWL: Bowl (1) or not (0); 2. CASS: Casserole (1) or not (0); 3. DISH: Dish (1) or not (0); 4. TRAY: Tray (1) or not (0); 5. DIAM: Diameter of item, or equivalent (inches); 6. TIME: Grinding and polishing time (minutes); 7. PRICE: Retail price ($). Note: Items not classed as bowl, casserole, dish, or tray are plates.\"", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://lib.stat.cmu.edu/DASL/Datafiles/nambedat.html", "accessDate": "2009-12-01T19:51:14Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [ { "tag": "Analysis of Variance" }, { "tag": "a02" } ], "collections": [ "SEXT6Z3R" ], "relations": {}, "dateAdded": "2010-09-15T03:51:49Z", "dateModified": "2010-09-15T03:51:49Z" } }, { "key": "79EAAN7T", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/79EAAN7T", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/79EAAN7T", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Howell", "numChildren": 0 }, "data": { "key": "79EAAN7T", "version": 1, "itemType": "webpage", "title": "Multiple Comparisons with Repeated Measures", "creators": [ { "creatorType": "author", "firstName": "David C.", "lastName": "Howell" } ], "abstractNote": "Excerpt: \"One of the commonly asked questions on listservs dealing with statistical issue is 'How do I use SPSS (or whatever software is at hand) to run multiple comparisons among a set of repeated measures?' This page is a (longwinded) attempt to address that question. I will restrict myself to the case of one repeated measure (with or without a between subjects variable), but the generalization to more complex cases should be apparent.\"", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://www.uvm.edu/~dhowell/StatPages/More_Stuff/RepMeasMultComp/RepMeasMultComp.html", "accessDate": "2009-12-01T19:47:29Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [ { "tag": "Analysis of Variance" }, { "tag": "a02" } ], "collections": [ "SEXT6Z3R" ], "relations": {}, "dateAdded": "2010-09-15T03:51:49Z", "dateModified": "2010-09-15T03:51:49Z" } }, { "key": "TCCIZJFJ", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/TCCIZJFJ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/TCCIZJFJ", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "UCLA Academic Technology Services", "numChildren": 0 }, "data": { "key": "TCCIZJFJ", "version": 1, "itemType": "webpage", "title": "Coding systems for categorical variables in regression analysis", "creators": [ { "creatorType": "author", "firstName": "", "lastName": "UCLA Academic Technology Services" } ], "abstractNote": "Excerpt: \"Categorical variables require special attention in regression analysis because, unlike dichotomous or continuous variables, they cannot by entered into the regression equation just as they are. For example, if you have a variable called race that is coded 1 = Hispanic, 2 = Asian 3 = Black 4 = White, then entering race in your regression will look at the linear effect of race, which is probably not what you intended. Instead, categorical variables like this need to be recoded into a series of variables which can then be entered into the regression model. There are a variety of coding systems that can be used when coding categorical variables. Ideally, you would choose a coding system that reflects the comparisons that you want to make. In Chapter 3 of the Regression with SAS Web Book we covered the use of categorical variables in regression analysis focusing on the use of dummy variables, but that is not the only coding scheme that you can use. For example, you may want to compare each level to the next higher level, in which case you would want to use \"forward difference\" coding, or you might want to compare each level to the mean of the subsequent levels of the variable, in which case you would want to use \"Helmert\" coding. By deliberately choosing a coding system, you can obtain comparisons that are most meaningful for testing your hypotheses.\"", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://www.ats.ucla.edu/stat/sas/webbooks/reg/chapter5/sasreg5.htm", "accessDate": "2009-12-01T19:49:00Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [ { "tag": "Analysis of Variance" }, { "tag": "a02" } ], "collections": [ "SEXT6Z3R" ], "relations": {}, "dateAdded": "2010-09-15T03:51:49Z", "dateModified": "2010-09-15T03:51:49Z" } }, { "key": "C857GMDM", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/C857GMDM", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/C857GMDM", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Kermit and Lengard", "numChildren": 0 }, "data": { "key": "C857GMDM", "version": 1, "itemType": "webpage", "title": "Assessing the Performance of a Sensory Panel - Panelist monitoring and tracking", "creators": [ { "creatorType": "author", "firstName": "Martin", "lastName": "Kermit" }, { "creatorType": "author", "firstName": "Valerie", "lastName": "Lengard" } ], "abstractNote": "Abstract: \"Sensory science uses the human senses as instruments of measures. This study presents univariate and multivariate data analysis methods to assess individual and group performances in a sensory panel. Green peas were evaluated by a trained panel of 10 assessors for six attributes over two replicates. A consonance analysis with Principal Component Analysis (PCA) is run to get an overview of the panel agreement and detect major individual errors. The origin of the panelist errors is identi⬚ed by a series of tests based on ANOVA: sensitivity, reproducibility, crossover and panel agreement, complemented with an eggshell-correlation test. One assessor is identi⬚ed with further need for training in attributes pea fl⬚avour, sweetness, fruity and off-fl⬚avour, showing errors in sensitivity, reproducibility and crossover. Another assessor shows poor performance for attribute mealiness and to some extent also fruity ⬚avour. Only one panelist performs well to very well in all attributes. The speci⬚city and complementarity of the series of univariate tests are explored and veri⬚ed with the use of a PCA model. Keywords: Sensory panel performance; ANOVA; Agreement error; Sensitivity; Reproducibility; Crossover; Eggshell plot.\"", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://www.camo.com/resources/casestudies/PMT.pdf", "accessDate": "2009-12-01T06:00:00Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [ { "tag": "Analysis of Variance" }, { "tag": "a02" } ], "collections": [ "SEXT6Z3R" ], "relations": {}, "dateAdded": "2010-09-15T03:51:49Z", "dateModified": "2010-09-15T03:51:49Z" } }, { "key": "NMNSCQAA", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/NMNSCQAA", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/NMNSCQAA", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Gunnes et al.", "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "NMNSCQAA", "version": 1, "itemType": "journalArticle", "title": "Assessing quality of life in a randomized clinical trial: Correcting for missing data", "creators": [ { "creatorType": "author", "firstName": "Nina", "lastName": "Gunnes" }, { "creatorType": "author", "firstName": "Taral", "lastName": "Seierstad" }, { "creatorType": "author", "firstName": "Steinar", "lastName": "Aamdal" }, { "creatorType": "author", "firstName": "Paal", "lastName": "Brunsvig" }, { "creatorType": "author", "firstName": "Anne-Birgitte", "lastName": "Jacobsen" }, { "creatorType": "author", "firstName": "Stein", "lastName": "Sundstrom" }, { "creatorType": "author", "firstName": "Odd", "lastName": "Aalen" } ], "abstractNote": "BACKGROUND:Health-related quality of life is a topic of current interest. This paper considers a randomized phase III study of radiation therapy with concurrent chemotherapy (docetaxel) versus radiation therapy alone in non-small cell lung cancer, stage III A/B. Longitudinal data on quality of life have been obtained through repeated administration of a multi-item questionnaire (EORTC QLQ-C30) developed by the European Organisation for Research and Treatment of Cancer. Missingness in the data is owing to patients having failed to complete the questionnaire at some of the scheduled filling-in times.METHODS:We have analysed a monotone (in terms of missingness) subset of the data as regards estimation of the mean score of a summary measure of self-reported quality of life in a hypothetical drop-out-free population at different points in time. Missingness is a difficult issue of great importance. We have therefore chosen to compare three different methods that are relatively easy to implement: the linear-increments method, the inverse-probability-weighting method and the Markov-process method. Single imputation has been applied in a supplementary analysis to fill in for all the non-consecutive missing score values prior to the execution of the estimation procedure.RESULTS:For the response in focus, the observed mean score at a certain time is larger than the estimated mean scores, which implies that the true mean score is easily overestimated unless the missingness is appropriately adjusted for. Comparison of the treatment arms shows a significant difference in mean score at the end of treatment.CONCLUSIONS:Use of proper methodology developed for analysing data subject to missingness is necessary to reduce potential estimation bias. The quality of life of patients receiving radiation therapy with concurrent chemotherapy (docetaxel) appears somewhat worse than that of patients receiving radiation therapy alone in the period during which treatment is given. The conclusions are robust for the choice of statistical methods.", "publicationTitle": "BMC Medical Research Methodology", "publisher": "", "place": "", "date": "2009", "volume": "9", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "28", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2288-9-28", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2288/9/28", "accessDate": "2009-05-20T12:56:31Z", "PMID": "", "PMCID": "", "ISSN": "1471-2288", "archive": "", "archiveLocation": "", "shortTitle": "Assessing quality of life in a randomized clinical trial", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Analysis of Variance" }, { "tag": "a02" } ], "collections": [ "SEXT6Z3R" ], "relations": {}, "dateAdded": "2010-09-15T03:51:49Z", "dateModified": "2010-09-15T03:51:49Z" } }, { "key": "BNCF7JGP", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/BNCF7JGP", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/BNCF7JGP", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Argaud et al.", "parsedDate": "2007", "numChildren": 0 }, "data": { "key": "BNCF7JGP", "version": 1, "itemType": "journalArticle", "title": "Changeovers of vasoactive drug infusion pumps: impact of a quality improvement program", "creators": [ { "creatorType": "author", "firstName": "Laurent", "lastName": "Argaud" }, { "creatorType": "author", "firstName": "Martin", "lastName": "Cour" }, { "creatorType": "author", "firstName": "Olivier", "lastName": "Martin" }, { "creatorType": "author", "firstName": "Marc", "lastName": "Saint-Denis" }, { "creatorType": "author", "firstName": "Tristan", "lastName": "Ferry" }, { "creatorType": "author", "firstName": "Agnes", "lastName": "Goyatton" }, { "creatorType": "author", "firstName": "Dominique", "lastName": "Robert" } ], "abstractNote": "Abstract: \"BACKGROUND: Hemodynamic instability following the changeover of vasoactive infusion pump (CVIP) is a common problem in the intensive care unit. Several empiric methods are used to achieve CVIP. We hypothesized that the variation in these procedures could generate some morbidity. We sought to assess the effects of the standardization of practice, as a quality improvement program, on the CVIP-induced incidents. MATERIALS AND METHODS: We performed a prospective before-and-after intervention study including all adult patients with a diagnosis of cardiovascular failure who received a continuous infusion of vasoactive drugs or inotropic drugs. After a baseline preimplementation period (phase 1), a standardized 'quick change method' of CVIP using two syringe drivers was implemented in our intensive care unit (phase 2). Endpoints (rate and distribution of incidents: variations of systolic blood pressure >20 mmHg or heart rate >20 beats/min, and arrhythmias) were registered in both 3-month phases. RESULTS: We studied a total of 913 CVIP events (phase 1, 435 events; phase 2, 478 events) from 43 patients. Patient characteristics were not significantly different among phases, with a majority of the patients having septic shock. The frequency of incidents was significantly (P < 0.0001) reduced in phase 2 (5.9%, n = 28) versus phase 1 (17.8%, n = 78). This effect was observed whichever catecholamine was used. More than 98% of incidents were blood pressure variations, with a similar distribution of the nature of incidents in both phases. CONCLUSION: The present study illustrates that adverse events are common following CVIP, and illustrates the positive impact of a quality improvement program to enhance inpatient safety related to this current process of care.\"", "publicationTitle": "Critical Care", "publisher": "", "place": "", "date": "2007", "volume": "11", "issue": "6", "section": "", "partNumber": "", "partTitle": "", "pages": "R133", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/cc6209", "citationKey": "", "url": "http://ccforum.com/content/11/6/R133", "accessDate": "2009-11-30T14:45:16Z", "PMID": "", "PMCID": "", "ISSN": "1364-8535", "archive": "", "archiveLocation": "", "shortTitle": "Changeovers of vasoactive drug infusion pumps", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Adverse events" }, { "tag": "a02" } ], "collections": [ "65U6MJAX" ], "relations": {}, "dateAdded": "2010-09-15T03:44:36Z", "dateModified": "2010-09-15T03:44:36Z" } }, { "key": "SPTRGCXT", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/SPTRGCXT", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/SPTRGCXT", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "McKay et al.", "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "SPTRGCXT", "version": 1, "itemType": "journalArticle", "title": "A review of significant events analysed in general practice: implications for the quality and safety of patient care", "creators": [ { "creatorType": "author", "firstName": "John", "lastName": "McKay" }, { "creatorType": "author", "firstName": "Nick", "lastName": "Bradley" }, { "creatorType": "author", "firstName": "Murray", "lastName": "Lough" }, { "creatorType": "author", "firstName": "Paul", "lastName": "Bowie" } ], "abstractNote": "Abstract: \"BACKGROUND: Significant event analysis (SEA) is promoted as a team-based approach to enhancing patient safety through reflective learning. Evidence of SEA participation is required for appraisal and contractual purposes in UK general practice. A voluntary educational model in the west of Scotland enables general practitioners (GPs) and doctors-in-training to submit SEA reports for feedback from trained peers. We reviewed reports to identify the range of safety issues analysed, learning needs raised and actions taken by GP teams. METHOD: Content analysis of SEA reports submitted in an 18 month period between 2005 and 2007.RESULTS:191 SEA reports were reviewed. 48 described patient harm (25.1%). A further 109 reports (57.1%) outlined circumstances that had the potential to cause patient harm. Individual 'error' was cited as the most common reason for event occurrence (32.5%). Learning opportunities were identified in 182 reports (95.3%) but were often non-specific professional issues not shared with the wider practice team. 154 SEA reports (80.1%) described actions taken to improve practice systems or professional behaviour. However, non-medical staff were less likely to be involved in the changes resulting from event analyses describing patient harm (p < 0.05). CONCLUSION: The study provides some evidence of the potential of SEA to improve healthcare quality and safety. If applied rigorously, GP teams and doctors in training can use the technique to investigate and learn from a wide variety of quality issues including those resulting in patient harm. This leads to reported change but it is unclear if such improvement is sustained.\"", "publicationTitle": "BMC Family Practice", "publisher": "", "place": "", "date": "2009", "volume": "10", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "61", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2296-10-61", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2296/10/61", "accessDate": "2009-10-11T15:11:58Z", "PMID": "", "PMCID": "", "ISSN": "1471-2296", "archive": "", "archiveLocation": "", "shortTitle": "A review of significant events analysed in general practice", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Adverse events" }, { "tag": "a02" } ], "collections": [ "65U6MJAX" ], "relations": {}, "dateAdded": "2010-09-15T03:44:36Z", "dateModified": "2010-09-15T03:44:36Z" } }, { "key": "QTWDHMD6", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/QTWDHMD6", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/QTWDHMD6", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/932/items/9J9N8VIS", "type": "application/json" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "QTWDHMD6", "version": 1, "parentItem": "9J9N8VIS", "itemType": "note", "note": "Mark Chang.", "tags": [], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "VMQ92Q6T", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/VMQ92Q6T", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/VMQ92Q6T", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/932/items/9J9N8VIS", "type": "application/json" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "numChildren": 0 }, "data": { "key": "VMQ92Q6T", "version": 1, "parentItem": "9J9N8VIS", "itemType": "note", "note": "Includes bibliographical references and index.", "tags": [], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "ENBFDQTD", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/ENBFDQTD", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/ENBFDQTD", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Graffy et al.", "parsedDate": "2010", "numChildren": 0 }, "data": { "key": "ENBFDQTD", "version": 1, "itemType": "journalArticle", "title": "Trials within trials? Researcher, funder and ethical perspectives on the practicality and acceptability of nesting trials of recruitment methods in existing primary care trials", "creators": [ { "creatorType": "author", "firstName": "Jonathan", "lastName": "Graffy" }, { "creatorType": "author", "firstName": "Peter", "lastName": "Bower" }, { "creatorType": "author", "firstName": "Elaine", "lastName": "Ward" }, { "creatorType": "author", "firstName": "Paul", "lastName": "Wallace" }, { "creatorType": "author", "firstName": "Brendan", "lastName": "Delaney" }, { "creatorType": "author", "firstName": "Ann-Louise", "lastName": "Kinmonth" }, { "creatorType": "author", "firstName": "David", "lastName": "Collier" }, { "creatorType": "author", "firstName": "Julia", "lastName": "Miller" } ], "abstractNote": "Abstract: \"BACKGROUND: Trials frequently encounter difficulties in recruitment, but evidence on effective recruitment methods in primary care is sparse. A robust test of recruitment methods involves comparing alternative methods using a randomized trial, 'nested' in an ongoing 'host' trial. There are potential scientific, logistical and ethical obstacles to such studies. METHOD: Telephone interviews were undertaken with four groups of stakeholders (funders, principal investigators, trial managers and ethics committee chairs) to explore their views on the practicality and acceptability of undertaking nested trials of recruitment methods. These semi-structured interviews were transcribed and analyzed thematically. RESULTS: Twenty people were interviewed. Respondents were familiar with recruitment difficulties in primary care and recognised the case for 'nested' studies to build an evidence base on effective recruitment strategies. However, enthusiasm for this global aim was tempered by the challenges of implementation. Challenges for host studies included increasing complexity and management burden; compatibility between the host and nested study; and the impact of the nested study on trial design and relationships with collaborators. For nested recruitment studies, there were concerns that host study investigators might have strong preferences, limiting the nested study investigators' control over their research, and also concerns about sample size which might limit statistical power. Nested studies needed to be compatible with the main trial and should be planned from the outset. Good communication and adequate resources were seen as important. CONCLUSIONS: Although research on recruitment was welcomed in principle, the issue of which study had control of key decisions emerged as critical. To address this concern, it appeared important to align the interests of both host and nested studies and to reduce the burden of hosting a recruitment trial. These findings should prove useful in devising a programme of research involving nested studies of recruitment interventions.\"", "publicationTitle": "BMC Medical Research Methodology", "publisher": "", "place": "", "date": "2010", "volume": "10", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "38", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2288-10-38", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2288/10/38", "accessDate": "2010-05-06T17:28:30Z", "PMID": "", "PMCID": "", "ISSN": "1471-2288", "archive": "", "archiveLocation": "", "shortTitle": "Trials within trials?", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "49TKJQDU", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/49TKJQDU", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/49TKJQDU", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Sanders et al.", "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "49TKJQDU", "version": 1, "itemType": "journalArticle", "title": "Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study", "creators": [ { "creatorType": "author", "firstName": "Kerrie", "lastName": "Sanders" }, { "creatorType": "author", "firstName": "Amanda", "lastName": "Stuart" }, { "creatorType": "author", "firstName": "Elizabeth", "lastName": "Merriman" }, { "creatorType": "author", "firstName": "Meaghan", "lastName": "Read" }, { "creatorType": "author", "firstName": "Mark", "lastName": "Kotowicz" }, { "creatorType": "author", "firstName": "Doris", "lastName": "Young" }, { "creatorType": "author", "firstName": "Roderick", "lastName": "Taylor" }, { "creatorType": "author", "firstName": "Ian", "lastName": "Blair-Holt" }, { "creatorType": "author", "firstName": "Alistair", "lastName": "Mander" }, { "creatorType": "author", "firstName": "Geoffrey", "lastName": "Nicholson" } ], "abstractNote": "Abstract: \"BACKGROUND: Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. METHODS: The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for three to five consecutive years. A variety of recruitment strategies were employed to attract potential participants. RESULTS: Of the 2,317 participants randomised onto the study, 74% (n= 1716/ 2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods. CONCLUSIONS: The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected.\" Trial registration: ISRCTN83409867 and ACTR12605000658617.", "publicationTitle": "BMC Medical Research Methodology", "publisher": "", "place": "", "date": "2009", "volume": "9", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "78", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2288-9-78", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2288/9/78", "accessDate": "2009-11-30T05:15:00Z", "PMID": "", "PMCID": "", "ISSN": "1471-2288", "archive": "", "archiveLocation": "", "shortTitle": "Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "3NTT5VDC", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/3NTT5VDC", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/3NTT5VDC", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Dyas et al.", "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "3NTT5VDC", "version": 1, "itemType": "journalArticle", "title": "Strategies for improving patient recruitment to focus groups in primary care: a case study reflective paper using an analytical framework", "creators": [ { "creatorType": "author", "firstName": "Jane", "lastName": "Dyas" }, { "creatorType": "author", "firstName": "Tanefa", "lastName": "Apeky" }, { "creatorType": "author", "firstName": "Michelle", "lastName": "Tilling" }, { "creatorType": "author", "firstName": "A", "lastName": "Siriwardena" } ], "abstractNote": "Abstract: \"BACKGROUND: Recruiting to primary care studies is complex. With the current drive to increase numbers of patients involved in primary care studies, we need to know more about successful recruitment approaches. There is limited evidence on recruitment to focus group studies, particularly when no natural grouping exists and where participants do not regularly meet. The aim of this paper is to reflect on recruitment to a focus group study comparing the methods used with existing evidence using a resource for research recruitment, PROSPeR (Planning Recruitment Options: Strategies for Primary Care). METHODS: The focus group formed part of modelling a complex intervention in primary care in the Resources for Effective Sleep Treatment (REST) study. Despite a considered approach at the design stage, there were a number of difficulties with recruitment. The recruitment strategy and subsequent revisions are detailed. RESULTS: The researchers' modifications to recruitment, justifications and evidence from the literature in support of them are presented. Contrary evidence is used to analyse why some aspects were unsuccessful and evidence is used to suggest improvements. Recruitment to focus group studies should be considered in two distinct phases; getting potential participants to contact the researcher, and converting those contacts into attendance. The difficulty of recruitment in primary care is underemphasised in the literature especially where people do not regularly come together, typified by this case study of patients with sleep problems. CONCLUSIONS: We recommend training GPs and nurses to recruit patients during consultations. Multiple recruitment methods should be employed from the outset and the need to build topic related non-financial incentives into the group meeting should be considered. Recruitment should be monitored regularly with barriers addressed iteratively as a study progresses.\"", "publicationTitle": "BMC Medical Research Methodology", "publisher": "", "place": "", "date": "2009", "volume": "9", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "65", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2288-9-65", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2288/9/65", "accessDate": "2009-09-29T03:04:36Z", "PMID": "", "PMCID": "", "ISSN": "1471-2288", "archive": "", "archiveLocation": "", "shortTitle": "Strategies for improving patient recruitment to focus groups in primary care", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "M99BD62Q", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/M99BD62Q", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/M99BD62Q", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Herber et al.", "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "M99BD62Q", "version": 1, "itemType": "journalArticle", "title": "Recruitment rates and reasons for community physicians' non-participation in an interdisciplinary intervention study on leg ulceration", "creators": [ { "creatorType": "author", "firstName": "Oliver", "lastName": "Herber" }, { "creatorType": "author", "firstName": "Wilfried", "lastName": "Schnepp" }, { "creatorType": "author", "firstName": "Monika", "lastName": "Rieger" } ], "abstractNote": "Abstract: \"BACKGROUND: This article describes the challenges a research team experienced recruiting physicians within a randomised controlled trial about leg ulcer care that seeks to foster the cooperation between the medical and nursing professions. Community-based physicians in North Rhine-Westphalia, Germany, were recruited for an interdisciplinary intervention designed to enhance leg ulcer patients' self-care agency. The aim of this article is to investigate the success of different recruitment strategies employed and reasons for physicians' non-participation. METHODS: The first recruitment phase stressed the recruitment of GPs, the second the recruitment of specialists. Throughout the recruitment process data were collected through phone conversations with GP practices who indicated reasons for non-participation. RESULTS: Despite great efforts to recruit physicians, the recruitment rate reached only 26 out of 1549 contacted practices (1.7%) and 12 out of 273 (4.4%) practices during the first and second recruitment phase respectively. The overall recruitment rate over the 16-month recruitment period was 2%. With a target recruitment rate of n = 300, only 45 patients were enrolled in the study, not meeting study projections. Various reasons for community physicians' non-participation are presented as stated spontaneously during phone conversations that might explain low recruitment rates. The recruitment strategy utilised is discussed against the background of factors associated with high participation rates from the international literature. CONCLUSION: Time, money, and effort needed during the planning and recruitment phase of a study must not be underestimated to avoid higher than usual rates of refusal and lack of initial contact. Pilot studies prior to a study start-up may provide some evidence on whether the target recruitment rate is feasible. TRIAL REGISTRATION: Current Controlled Trials ISRCTN42122226.\"", "publicationTitle": "BMC Medical Research Methodology", "publisher": "", "place": "", "date": "2009", "volume": "9", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "61", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2288-9-61", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2288/9/61", "accessDate": "2009-11-30T14:00:58Z", "PMID": "", "PMCID": "", "ISSN": "1471-2288", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "HT7HKFSS", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/HT7HKFSS", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/HT7HKFSS", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Taylor et al.", "parsedDate": "1984-05-24", "numChildren": 0 }, "data": { "key": "HT7HKFSS", "version": 1, "itemType": "journalArticle", "title": "Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer", "creators": [ { "creatorType": "author", "firstName": "KM", "lastName": "Taylor" }, { "creatorType": "author", "firstName": "RG", "lastName": "Margolese" }, { "creatorType": "author", "firstName": "CL", "lastName": "Soskolne" } ], "abstractNote": "Abstract: \"We studied the reasons surgical principal investigators chose not to enter patients in a large, multicenter trial sponsored by a cooperative group. In 1976 the National Surgical Adjuvant Project for Breast and Bowel Cancers (NSABP) initiated a clinical trial to compare segmental mastectomy and postoperative radiation, or segmental mastectomy alone, with total mastectomy. Because the low rates of accrual were threatening to close the trial prematurely, we mailed a questionnaire to the 94 NSABP principal investigators, asking why they were not entering eligible patients in the trial. A response rate of 97 per cent was achieved. Physicians who did not enter all eligible patients offered the following explanations: (1) concern that the doctor-patient relationship would be affected by a randomized clinical trial (73 per cent), (2) difficulty with informed consent (38 per cent), (3) dislike of open discussions involving uncertainty (22 per cent), (4) perceived conflict between the roles of scientist and clinician (18 per cent), (5) practical difficulties in following procedures (9 per cent), and (6) feelings of personal responsibility if the treatments were found to be unequal (8 per cent). Further investigation into the behavioral aspects of the investigator-patient relationship is particularly pressing, since fear of change in this relationship was the most common reason given for not entering eligible patients in the trial.\"", "publicationTitle": "N Engl J Med", "publisher": "", "place": "", "date": "May 24, 1984", "volume": "310", "issue": "21", "section": "", "partNumber": "", "partTitle": "", "pages": "1363-1367", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "", "citationKey": "", "url": "http://content.nejm.org/cgi/content/abstract/310/21/1363", "accessDate": "2009-11-30T14:04:14Z", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "HighWire", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "GEXQD23P", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/GEXQD23P", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/GEXQD23P", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Chang et al.", "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "GEXQD23P", "version": 1, "itemType": "journalArticle", "title": "Participant recruitment and retention in a pilot program to prevent weight gain in low-income overweight and obese mothers", "creators": [ { "creatorType": "author", "firstName": "Mei-Wei", "lastName": "Chang" }, { "creatorType": "author", "firstName": "Roger", "lastName": "Brown" }, { "creatorType": "author", "firstName": "Susan", "lastName": "Nitzke" } ], "abstractNote": "Abstract: \"Background: Recruitment and retention are key functions for programs promoting nutrition and other lifestyle behavioral changes in low-income populations. This paper describes strategies for recruitment and retention and presents predictors of early (two-month post intervention) and late (eight-month post intervention) dropout (non retention) and overall retention among young, low-income overweight and obese mothers participating in a community-based randomized pilot trial called Mothers In Motion. Methods: Low-income overweight and obese African American and white mothers ages 18 to 34 were recruited from the Special Supplemental Nutrition Program for Women, Infants, and Children in southern Michigan. Participants (n = 129) were randomly assigned to an intervention (n = 64) or control (n = 65) group according to a stratification procedure to equalize representation in two racial groups (African American and white) and three body mass index categories (25.0-29.9 kg/m2, 30.0-34.9 kg/m2, and 35.0-39.9 kg/m2). The 10-week theory-based culturally sensitive intervention focused on healthy eating, physical activity, and stress management messages that were delivered via an interactive DVD and reinforced by five peer-support group teleconferences. Forward stepwise multiple logistic regression was performed to examine whether dietary fat, fruit and vegetable intake behaviors, physical activity, perceived stress, positive and negative affect, depression, and race predicted dropout as data were collected two- month and eight-month after the active intervention phase. Results: Trained personnel were successful in recruiting subjects. Increased level of depression was a predictor of early dropout (odds ratio = 1.04; 95% CI = 1.00, 1.08; p = 0.03). Greater stress predicted late dropout (odds ratio = 0.20; 95% CI = 0.00, 0.37; p = 0.01). Dietary fat, fruit, and vegetable intake behaviors, physical activity, positive and negative affect, and race were not associated with either early or late dropout. Less negative affect was a marginal predictor of participant retention (odds ratio = 0.57; 95% CI = 0.31, 1.03; p = 0.06). CONCLUSIONS: Dropout rates in this study were higher for participants who reported higher levels of depression and stress.\" Trial registration: Current Controlled Trials NCT00944060", "publicationTitle": "BMC Public Health", "publisher": "", "place": "", "date": "2009", "volume": "9", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "424", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2458-9-424", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2458/9/424", "accessDate": "2009-11-30T05:33:31Z", "PMID": "", "PMCID": "", "ISSN": "1471-2458", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "B4SZAFBZ", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/B4SZAFBZ", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/B4SZAFBZ", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Anisimov and Fedorov", "parsedDate": "2007", "numChildren": 0 }, "data": { "key": "B4SZAFBZ", "version": 1, "itemType": "journalArticle", "title": "Modelling, prediction and adaptive adjustment of recruitment in multicentre trials", "creators": [ { "creatorType": "author", "firstName": "Vladimir V.", "lastName": "Anisimov" }, { "creatorType": "author", "firstName": "Valerii V.", "lastName": "Fedorov" } ], "abstractNote": "Abstract: \"This paper is focused on statistical modelling, prediction and adaptive adjustment of patient recruitment in multicentre clinical trials. We consider a recruitment model, where patients arrive at different centres according to Poisson processes, with recruitment rates viewed as a sample from a gamma distribution. A statistical analysis of completed studies is provided and properties of a few types of parameter estimators are investigated analytically and using simulation. The model has been validated using many real completed trials. A statistical technique for predictive recruitment modelling for ongoing trials is developed. It allows the prediction of the remaining recruitment time together with confidence intervals using current enrolment information, and also provision of an adaptive adjustment of recruitment by calculating the number of additional centres required to accomplish a study up to a certain deadline with a pre-specified probability. Results are illustrated for different recruitment scenarios.\" Copyright © 2007John Wiley & Sons, Ltd.", "publicationTitle": "Statistics in Medicine", "publisher": "", "place": "", "date": "2007", "volume": "26", "issue": "27", "section": "", "partNumber": "", "partTitle": "", "pages": "4958-4975", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1002/sim.2956", "citationKey": "", "url": "http://dx.doi.org/10.1002/sim.2956", "accessDate": "2009-11-30T13:58:09Z", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "Wiley InterScience", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "VV7MBF8H", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/VV7MBF8H", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/VV7MBF8H", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Kolata", "parsedDate": "2009-08-03", "numChildren": 0 }, "data": { "key": "VV7MBF8H", "version": 1, "itemType": "newspaperArticle", "title": "Lack of Study Volunteers Hobbles Cancer Fight", "creators": [ { "creatorType": "author", "firstName": "Gina", "lastName": "Kolata" } ], "abstractNote": "Excerpt: \"There are more than 6,500 cancer clinical trials seeking adult patients, according to clinicaltrials.gov, a trials registry. But many will be abandoned along the way. More than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result, Dr. Ramsey and his colleague John Scoggins reported in an editorial in the September 2008 issue of The Oncologist.\" Also see commentary about this article at www.the-scientist.com/community/posts/list/575.page.", "publicationTitle": "The New York Times", "publisher": "", "place": "", "date": "August 3, 2009", "volume": "", "issue": "", "edition": "", "section": "Health / Research", "pages": "", "ISSN": "0362-4331", "DOI": "", "citationKey": "", "url": "http://www.nytimes.com/2009/08/03/health/research/03trials.html", "accessDate": "2009-08-29T15:33:05Z", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "NYTimes.com", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "9MWKC7J8", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/9MWKC7J8", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/9MWKC7J8", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "CTriSoft International", "numChildren": 0 }, "data": { "key": "9MWKC7J8", "version": 1, "itemType": "webpage", "title": "ExpDesign Studio: Powerful. User-friendly. Affordable.", "creators": [ { "creatorType": "author", "firstName": "", "lastName": "CTriSoft International" } ], "abstractNote": "Excerpt: ExpDesign StudioTM is an integrated environment for designing experiments or clinical trials. It is a powerful and user-friendly statistical software product that has integrated 8 main components: Classical Design, Sequential Design, Multi-Stage Design, Dose-Escalation Design, Adaptive Design, Adaptive Trial Monitoring, Dose-Escalation Trial Monitoring modules, and Adaptive Trial Simulator. In addition, ExpDesign Randomizor can generate random variates from different distributions. ExpDesign Toolkit provides features for distributional calculation, confidence intervals, function and data plotting.", "websiteTitle": "", "websiteType": "", "date": "", "publisher": "", "place": "", "DOI": "", "citationKey": "", "url": "http://www.ctrisoft.net/", "accessDate": "2009-11-30T13:38:57Z", "shortTitle": "", "language": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "IG6SFESF", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/IG6SFESF", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/IG6SFESF", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Sherman et al.", "parsedDate": "2009", "numChildren": 0 }, "data": { "key": "IG6SFESF", "version": 1, "itemType": "journalArticle", "title": "Comparing recruitment strategies in a study of acupuncture for chronic back pain", "creators": [ { "creatorType": "author", "firstName": "Karen", "lastName": "Sherman" }, { "creatorType": "author", "firstName": "Rene", "lastName": "Hawkes" }, { "creatorType": "author", "firstName": "Laura", "lastName": "Ichikawa" }, { "creatorType": "author", "firstName": "Daniel", "lastName": "Cherkin" }, { "creatorType": "author", "firstName": "Richard", "lastName": "Deyo" }, { "creatorType": "author", "firstName": "Andrew", "lastName": "Avins" }, { "creatorType": "author", "firstName": "Partap", "lastName": "Khalsa" } ], "abstractNote": "Abstract: \"BACKGROUND: Meeting recruitment goals is challenging for many clinical trials conducted in primary care populations. Little is known about how the use of different recruitment strategies affects the types of individuals choosing to participate or the conclusions of the study. METHODS: A secondary analysis was performed using data from participants recruited to a clinical trial evaluating acupuncture for chronic back pain among primary care patients in a large integrated health care organization. We used two recruitment methods: mailed letters of invitation and an advertisement in the health plan's magazine. For these two recruitment methods, we compared recruitment success (% randomized, treatment completers, drop outs and losses to follow-up), participant characteristics, and primary clinical outcomes. A linear regression model was used to test for interaction between treatment group and recruitment method. RESULTS: Participants recruited via mailed letters closely resembled those responding to the advertisement in terms of demographic characteristics, most aspects of their back pain history and current episode and beliefs and expectations about acupuncture. No interaction between method of recruitment and treatment group was seen, suggesting that study outcomes were not affected by recruitment strategy. CONCLUSION: In this trial, the two recruitment strategies yielded similar estimates of treatment effectiveness. However, because this finding may not apply to other recruitment strategies or trial circumstances, trials employing multiple recruitment strategies should evaluate the effect of recruitment strategy on outcome.\" Trial registration: Clinical Trials.gov NCT 00065585.", "publicationTitle": "BMC Medical Research Methodology", "publisher": "", "place": "", "date": "2009", "volume": "9", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "69", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2288-9-69", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2288/9/69", "accessDate": "2009-10-28T14:16:12Z", "PMID": "", "PMCID": "", "ISSN": "1471-2288", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "9J9N8VIS", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/9J9N8VIS", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/9J9N8VIS", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Chang", "numChildren": 2 }, "data": { "key": "9J9N8VIS", "version": 1, "itemType": "book", "title": "Classical and adaptive clinical trial designs with ExpDesign Studio", "creators": [ { "creatorType": "author", "firstName": "Mark", "lastName": "Chang" } ], "abstractNote": "Excerpt: \"This book introduces pharmaceutical statisticians, scientists, researchers, and others to ExpDesign Studio software for classical and adaptive designs of clinical trials. It includes the Professional Version 5.0 of ExpDesign Studio software that frees pharmaceutical professionals to focus on drug development and related challenges while the software handles the essential calculations and computations. After a hands-on introduction to the software and an overview of clinical trial designs encompassing numerous variations, Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio: * Covers both classical and adaptive clinical trial designs, monitoring, and analyses * Explains various classical and adaptive designs including groupsequential, sample-size reestimation, dropping-loser, biomarker-adaptive, and response-adaptive randomization designs * Includes instructions for over 100 design methods that have been implemented in ExpDesign Studio and step-by-step demos as well as real-world examples * Emphasizes applications, yet covers key mathematical formulations * Introduces readers to additional toolkits in ExpDesign Studio that help in designing, monitoring, and analyzing trials, such as the adaptive monitor, graphical calculator, the probability calculator, the confidence interval calculator, and more * Presents comprehensive technique notes for sample-size calculation methods, grouped by the number of arms, the trial endpoint, and the analysis basis Written with practitioners in mind, this is an ideal self-study guide for not only statisticians, but also scientists, researchers, and professionals in the pharmaceutical industry, contract research organizations (CROs), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials.\"", "series": "", "seriesNumber": "", "volume": "", "numberOfVolumes": "", "edition": "", "date": "c2008", "publisher": "John Wiley", "place": "Hoboken, NJ", "originalDate": "", "originalPublisher": "", "originalPlace": "", "format": "", "numPages": "", "ISBN": "9780470276129 (cloth/cd)", "DOI": "", "citationKey": "", "url": "http://lccn.loc.gov/2008001358", "accessDate": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "Classical and adaptive clinical trial designs with ExpDesign Studio?", "language": "", "libraryCatalog": "unAPI", "callNumber": "RM301.27 .C47 2008615/.190113QV 771 C4565c 2008", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "KGI3D6GF", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/KGI3D6GF", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/KGI3D6GF", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Barnard et al.", "parsedDate": "2010", "numChildren": 0 }, "data": { "key": "KGI3D6GF", "version": 1, "itemType": "journalArticle", "title": "A systematic review of models to predict recruitment to multicentre clinical trials", "creators": [ { "creatorType": "author", "firstName": "Katharine", "lastName": "Barnard" }, { "creatorType": "author", "firstName": "Louise", "lastName": "Dent" }, { "creatorType": "author", "firstName": "Andrew", "lastName": "Cook" } ], "abstractNote": "Abstract: \"BACKGROUND: Less than one third of publicly funded trials managed to recruit according to their original plan often resulting in request for additional funding and/or time extensions. The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. The requirements of a useful model were identified as usability, based on experience, able to reflect time trends, accounting for centre recruitment and contribution to a commissioning decision. METHODS: A systematic review of English language articles using MEDLINE and EMBASE. Search terms included: randomised controlled trial, patient, accrual, predict, enrol, models, statistical; Bayes Theorem; Decision Theory; Monte Carlo Method and Poisson. Only studies discussing prediction of recruitment to trials using a modelling approach were included. Information was extracted from articles by one author, and checked by a second, using a pre-defined form. RESULTS: Out of 326 identified abstracts, only 8 met all the inclusion criteria. Of these 8 studies examined, there are five major classes of model discussed: the unconditional model, the conditional model, the Poisson model, Bayesian models and Monte Carlo simulation of Markov models. None of these meet all the pre-identified needs of the funder. CONCLUSIONS: To meet the needs of a number of research programmes, a new model is required as a matter of importance. Any model chosen should be validated against both retrospective and prospective data, to ensure the predictions it gives are superior to those currently used.\"", "publicationTitle": "BMC Medical Research Methodology", "publisher": "", "place": "", "date": "2010", "volume": "10", "issue": "1", "section": "", "partNumber": "", "partTitle": "", "pages": "63", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1186/1471-2288-10-63", "citationKey": "", "url": "http://www.biomedcentral.com/1471-2288/10/63", "accessDate": "2010-07-11T03:03:24Z", "PMID": "", "PMCID": "", "ISSN": "1471-2288", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "BioMed Central and More", "callNumber": "", "rights": "", "extra": "", "tags": [ { "tag": "Accrual problems" }, { "tag": "a02" } ], "collections": [ "8DNFTXWS" ], "relations": {}, "dateAdded": "2010-09-15T03:17:31Z", "dateModified": "2010-09-15T03:17:31Z" } }, { "key": "5AQ83WPS", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/5AQ83WPS", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/5AQ83WPS", "type": "text/html" }, "up": { "href": "https://api.zotero.org/groups/932/items/KHMGAMET", "type": "application/json" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } } }, "data": { "key": "5AQ83WPS", "version": 1, "parentItem": "KHMGAMET", "itemType": "attachment", "linkMode": "imported_url", "title": "HighWire Snapshot", "accessDate": "2009-05-25T05:13:08Z", "url": "http://content.nejm.org/cgi/content/full/360/21/2160", "note": "", "contentType": "text/html", "charset": "windows-1252", "filename": "2160.html", "md5": null, "mtime": null, "tags": [], "relations": {}, "dateAdded": "2009-05-25T05:13:08Z", "dateModified": "2009-05-25T05:13:08Z" } }, { "key": "KHMGAMET", "version": 1, "library": { "type": "group", "id": 932, "name": "PMeanReferences", "links": { "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences", "type": "text/html" } } }, "links": { "self": { "href": "https://api.zotero.org/groups/932/items/KHMGAMET", "type": "application/json" }, "alternate": { "href": "https://www.zotero.org/groups/pmeanreferences/items/KHMGAMET", "type": "text/html" } }, "meta": { "createdByUser": { "id": 25504, "username": "pmean", "name": "Steve Simon", "links": { "alternate": { "href": "https://www.zotero.org/pmean", "type": "text/html" } } }, "creatorSummary": "Steinbrook", "parsedDate": "2009-05-21", "numChildren": 1 }, "data": { "key": "KHMGAMET", "version": 1, "itemType": "journalArticle", "title": "Controlling Conflict of Interest -- Proposals from the Institute of Medicine", "creators": [ { "creatorType": "author", "firstName": "Robert", "lastName": "Steinbrook" } ], "abstractNote": "", "publicationTitle": "N Engl J Med", "publisher": "", "place": "", "date": "May 21, 2009", "volume": "360", "issue": "21", "section": "", "partNumber": "", "partTitle": "", "pages": "2160-2163", "series": "", "seriesTitle": "", "seriesText": "", "journalAbbreviation": "", "DOI": "10.1056/NEJMp0810200", "citationKey": "", "url": "http://content.nejm.org", "accessDate": "2009-05-25T05:13:07Z", "PMID": "", "PMCID": "", "ISSN": "", "archive": "", "archiveLocation": "", "shortTitle": "", "language": "", "libraryCatalog": "HighWire", "callNumber": "", "rights": "", "extra": "", "tags": [], "collections": [], "relations": {}, "dateAdded": "2009-05-25T05:13:07Z", "dateModified": "2009-05-25T05:13:07Z" } } ]