Research Topics
| Kenneth F SchulzSummaryAffiliation: Family Health International Country: USA Publications
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Detail Information
Publications
The methodology for developing a prospective meta-analysis in the family planning communityDavid K Turok
Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah, USA
Trials 12:104. 2011..This paper describes the process of creating a PMA collaboration to evaluate the impact of misoprostol on ease of intrauterine device (IUD) insertion in nulliparous women...
Resources for authors of reports of randomized trials: harnessing the wisdom of authors, editors, and readersDavid Moher
Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, USA
Trials 12:98. 2011..We invite authors, editors, and readers worldwide to nominate examples of well reported items for the database...
The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trialGilda Piaggio
UNDP UNFPA WHO World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland
BMC Med Res Methodol 3:19. 2003....
The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trialsD Moher
University of Ottawa, Thomas C, Chalmers Centre for Systematic Reviews, Ottawa, Canada
BMC Med Res Methodol 1:2. 2001..In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results...
Helping editors, peer reviewers and authors improve the clarity, completeness and transparency of reporting health researchDavid Moher
BMC Med 6:13. 2008..As such, they are not able to judge the merits of the results and interpret them. The EQUATOR Network is a new initiative aimed at improving the clarity and transparency of reporting health research...
Transparent and accurate reporting increases reliability, utility, and impact of your research: reporting guidelines and the EQUATOR NetworkIveta Simera
Centre for Statistics in Medicine, University of Oxford, Oxford, UK
BMC Med 8:24. 2010..This paper outlines EQUATOR's goals and activities and offers suggestions for organizations and individuals involved in health research on how to strengthen research reporting...
[Failures in sample size calculation in randomized trial: mandatory and mystical]Kenneth F Schulz
Family Health International, Research, Triangle Park, NC 27709, USA
Z Arztl Fortbild Qualitatssich 100:129-35. 2006
[CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)]Kenneth F Schulz
Family Health International, Research Triangle Park, NC 27709, USA
Zhong Xi Yi Jie He Xue Bao 8:604-12. 2010..com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials...
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trialsKenneth F Schulz
Family Health International, Research Triangle Park, NC 27709, USA
BMC Med 8:18. 2010..com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials...
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trialsKenneth F Schulz
Family Health International, Research Triangle Park, NC 27709, USA
Trials 11:32. 2010..com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials...
[Epidemiological methods 7: secrecy of randomization in randomized studies: how one defends against decisions]Kenneth F Schulz
Family Health International, P.O. Box 13950, Research Triangle Park, NC 27709, USA
Z Arztl Fortbild Qualitatssich 101:499-505. 2007
Multiplicity in randomised trials II: subgroup and interim analysesKenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 365:1657-61. 2005..Investigators and readers, however, need to grasp that the estimated treatment effects are prone to exaggeration, a random high, with early stopping...
Sample size calculations in randomised trials: mandatory and mysticalKenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 365:1348-53. 2005..Unbiased trials with imprecise results trump no results at all. Clinicians and patients deserve guidance now...
[Epidemiological methods 8: blinded randomized trial: what one covers up is what one obtains]Kenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Z Arztl Fortbild Qualitatssich 101:630-7. 2007
Case-control studies: research in reverseKenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:431-4. 2002..Devotion of meticulous attention to these points enhances the validity of the results and bolsters the reader's confidence in the findings...
Sample size slippages in randomised trials: exclusions and the lost and waywardKenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:781-5. 2002..Unfortunately, some explanations for mishandling exclusions intuitively appeal to readers, disguising the seriousness of the issues. Creative mismanagement of exclusions can undermine trial validity...
Generation of allocation sequences in randomised trials: chance, not choiceKenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:515-9. 2002..Investigators should devote appropriate resources to the generation of properly randomised trials and reporting their methods clearly...
Unequal group sizes in randomised trials: guarding against guessingKenneth F Schulz
Family Health International, PO Box 13950Research Triangle Park, NC 27709, USA
Lancet 359:966-70. 2002..Simple randomisation contributes the unpredictability whereas permuted-block randomisation contributes the balance, but avoids the perfect balance that can result in selection bias...
Allocation concealment in randomised trials: defending against decipheringKenneth F Schulz
Family Health International, PO Box 13950, 27709, Research Triangle Park, NC, USA
Lancet 359:614-8. 2002..Hypothesis tests of baseline characteristics, however, are superfluous and could be harmful if they lead investigators to suppress reporting any baseline imbalances...
Blinding in randomised trials: hiding who got whatKenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:696-700. 2002..Unfortunately, many articles do not contain proper reporting. If an article claims blinding without any accompanying clarification, readers should remain sceptical about its effect on bias reduction...
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trialsKenneth F Schulz
Family Health International, Research Triangle Park, North Carolina 27709, USA
Ann Intern Med 152:726-32. 2010..Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience...
Clinical research in obstetrics and gynecology: a Baedeker for busy cliniciansDavid A Grimes
Family Health International, Research Triangle Park, North Carolina 27709, USA
Obstet Gynecol Surv 57:S35-53. 2002
Twenty micrograms vs. >20 microg estrogen oral contraceptives for contraception: systematic review of randomized controlled trialsMaria F Gallo
Family Health International, Research Triangle Park, NC 27709, USA
Contraception 71:162-9. 2005..While health care providers and women might select COCs containing 20 microg EE based on theoretical improvements in safety profile from the reduced dose of estrogen, no evidence is available to support this choice...
False alarms and pseudo-epidemics: the limitations of observational epidemiologyDavid A Grimes
Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, and FHI 360, Research Triangle Park, North Carolina 27599 7570, USA
Obstet Gynecol 120:920-7. 2012....
The landscape and lexicon of blinding in randomized trialsKenneth F Schulz
Family Health International, Box 13950, Research Triangle Park, NC 27709, USA
Ann Intern Med 136:254-9. 2002
Fertility awareness-based methods for contraception: systematic review of randomized controlled trialsDavid A Grimes
Family Health International, Research Triangle Park, NC 27709, USA
Contraception 72:85-90. 2005..The efficacy and acceptability of these methods are unclear...
Bias and causal associations in observational researchDavid A Grimes
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:248-52. 2002..Differentiation between spurious, indirect, and causal associations can be difficult. Criteria such as temporal sequence, strength and consistency of an association, and evidence of a dose-response effect lend support to a causal link...
Multiplicity in randomised trials I: endpoints and treatmentsKenneth F Schulz
Family Health International, PO Box 13950, Research Triangle Park, NC 27709 USA
Lancet 365:1591-5. 2005..In these cases, adjustments somewhat rescue scattershot analyses. Readers need to be aware of the potential for under-reporting of analyses...
The Good Clinical Practice guideline: a bronze standard for clinical researchDavid A Grimes
Family Health International, Research Triangle Park, NC, USA
Lancet 366:172-4. 2005
Steroid hormones for contraception in men: systematic review of randomized controlled trialsDavid A Grimes
Family Health International, P O Box 13950, Research Triangle Park, NC 27709, USA
Contraception 71:89-94. 2005..To avoid bias, future trials need to pay more attention on the methodological requirements for randomized controlled trials. Trials with adequate power would also be helpful...
Clinical research in obstetrics and gynecology: more tips for busy cliniciansDavid A Grimes
Family Health International, Research Triangle Park, North Carolina, USA
Obstet Gynecol Surv 60:S53-69. 2005
Descriptive studies: what they can and cannot doDavid A Grimes
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:145-9. 2002..Hypotheses about causation from descriptive studies are often tested in rigorous analytical studies...
Biphasic versus triphasic oral contraceptives for contraceptionHubertus A A M van Vliet
Family Health International, Research Triangle Park, NC 27709, USA
Contraception 65:321-4. 2002..This suggests that the choice of progestin may be more important that the phasic regimen in determining bleeding patterns...
Immediate start of hormonal contraceptives for contraceptionLaureen M Lopez
Clinical Sciences, FHI 360, Research Triangle Park, North Carolina, USA
Cochrane Database Syst Rev 12:CD006260. 2012..The immediate-start approach may improve women's access to, and continuation of, hormonal contraception...
Cochrane systematic reviews of IUD trials: lessons learnedDavid A Grimes
Family Health, International, P O Box 13950, Research Triangle Park, NC 27796, USA
Contraception 75:S55-9. 2007..Intrauterine devices (IUDs) are the most widely used reversible contraceptives in the world today, and decisions about their use should reflect the best available evidence...
Combination estrogen-progestin contraceptives and body weight: systematic review of randomized controlled trialsMaria F Gallo
Family Health International, Research Triangle Park, North Carolina, USA
Obstet Gynecol 103:359-73. 2004..CONCLUSION: Available evidence is insufficient to determine the effect of combination contraceptives on weight, but no large effect is evident...
Skin patch and vaginal ring versus combined oral contraceptives for contraceptionLaureen M Lopez
Behavioral and Biomedical Research, Family Health International, P O Box 13950, Research Triangle Park, North Carolina, USA, 27709
Cochrane Database Syst Rev 3:CD003552. 2010..Ring users generally had fewer adverse events than COC users but more vaginal irritation and discharge. High losses to follow up can affect the validity of the results...
Steroidal contraceptives: effect on carbohydrate metabolism in women without diabetes mellitusLaureen M Lopez
Clinical Sciences, FHI 360, Research Triangle Park, North Carolina, USA
Cochrane Database Syst Rev 4:CD006133. 2012..These issues have been raised primarily with contraceptives containing estrogen...
Surrogate end points in clinical research: hazardous to your healthDavid A Grimes
Family Health International, Research Triangle Park, North Carolina, USA
Obstet Gynecol 105:1114-8. 2005..The clinical maxim that "a difference to be a difference must make a difference" applies to research as well. Clinical research should focus on outcomes that matter...
Cohort studies: marching towards outcomesDavid A Grimes
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:341-5. 2002..Strengths of a cohort study include the ability to calculate incidence rates, relative risks, and 95% CIs. This format is the preferred way of presenting study results, rather that with p values...
Making sense of odds and odds ratiosDavid A Grimes
Family Health International, Research Triangle Park, North Carolina 27709, USA
Obstet Gynecol 111:423-6. 2008..Because of the difficulty in understanding odds ratios, their use should probably be limited to case-control studies and logistic regression, for which odds ratios are the proper measures of association...
Compared to what? Finding controls for case-control studiesDavid A Grimes
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 365:1429-33. 2005..Although no ideal control group exists, readers need to think carefully about how representative the controls are. Poor choice of controls can lead to both wrong results and possible medical harm...
Oral contraceptives for functional ovarian cystsDavid A Grimes
Clinical Sciences, FHI 360, PO Box 13950, Research Triangle Park, North Carolina, USA, NC 27709
Cochrane Database Syst Rev 9:CD006134. 2011..This became a common clinical practice in the early 1970s...
Steroidal contraceptives: effect on bone fractures in womenLaureen M Lopez
Clinical Sciences, FHI, P O Box 13950, Research Triangle Park, North Carolina, USA, 27709
Cochrane Database Syst Rev 7:CD006033. 2011..Age-related decline in bone mass increases the risk of fracture, especially of the spine, hip, and wrist. Concern about bone health influences the recommendation and use of these effective contraceptives globally...
The public health impact of legal abortion: 30 years laterWillard Cates
Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina, Chapel Hill, NC, USA
Perspect Sex Reprod Health 35:25-8. 2003
An overview of clinical research: the lay of the landDavid A Grimes
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:57-61. 2002..By contrast, p values address only chance. Testing null hypotheses at a p value of 0.05 has no basis in medicine and should be discouraged...
Refining clinical diagnosis with likelihood ratiosDavid A Grimes
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 365:1500-5. 2005..When combined with an accurate clinical diagnosis, likelihood ratios from ancillary tests improve diagnostic accuracy in a synergistic manner...
Nonhormonal drugs for contraception in men: a systematic reviewLaureen M Lopez
Family Health International, Research Triangle Park, North Carolina 27709, USA
Obstet Gynecol Surv 60:746-52. 2005....
Biphasic versus monophasic oral contraceptives for contraception: a Cochrane reviewHubertus A A M van Vliet
Family Health International, P.O.Box 13950, Research Triangle Park, North Carolina 27709, USA
Hum Reprod 17:870-3. 2002..Since no clear rationale exists for biphasic pills and since extensive evidence is available for monophasic pills, the latter are preferred...
Immediate post-partum insertion of intrauterine devicesDavid A Grimes
Behavioral and Biomedical Research, Family Health International, P O Box 13950, Research Triangle Park, North Carolina, USA, 27709
Cochrane Database Syst Rev 5:CD003036. 2010..The popularity of immediate post-partum IUD insertion in countries as diverse as China, Mexico, and Egypt support the feasibility of this approach. Early follow up may be important in identifying spontaneous IUD expulsions...
Nonspecific side effects of oral contraceptives: nocebo or noise?David A Grimes
Family Health International, Research Triangle Park, NC 27709, USA
Contraception 83:5-9. 2011..When in doubt, clinicians should err on the side of optimism...
Uses and abuses of screening testsDavid A Grimes
Family Health International, PO Box 13950, Research Triangle Park, NC 27709, USA
Lancet 359:881-4. 2002..However, inappropriate application or interpretation of screening tests can rob people of their perceived health, initiate harmful diagnostic testing, and squander health-care resources...
Statistical methods for assessing the influence of study characteristics on treatment effects in 'meta-epidemiological' researchJonathan A C Sterne
MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, UK
Stat Med 21:1513-24. 2002..We show that both within- and between meta-analysis heterogeneity may be of importance in the analysis of meta-epidemiological studies, and that confounding exists between the effects of publication status and trial quality...
Reducing publication bias through trial registrationLisa N Abaid
Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina 27599 7570, USA
Obstet Gynecol 109:1434-7. 2007..Trial registration and the development of comprehensive, computerized databases will promote transparency in research and help reduce publication bias...
The CONSORT Statement: revised recommendations for improving the quality of reports of parallel-group randomized trials 2001David Moher
University of Ottawa, Thomas C. Chalmers Centre for Systematic Reviews, Ontario
Explore (NY) 1:40-5. 2005..In sum, the CONSORT statement is intended to improve the reporting or an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results...
The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trialsDavid Moher
Thomas C Chalmers Centre for Systematic Reviews, University of Ottawa, Ottawa, Ontario, Canada
Clin Oral Investig 7:2-7. 2003..In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results...
Guidelines for reporting health research: the EQUATOR network's survey of guideline authorsIveta Simera
Centre for Statistics in Medicine, Oxford, United Kingdom
PLoS Med 5:e139. 2008
Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyondDavid Moher
Chalmers Research Group, Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, Ontario K1H 8L1, Canada
CMAJ 171:349-50. 2004
Turning a blind eye: testing the success of blinding and the CONSORT statementDouglas G Altman
BMJ 328:1135; author reply 1136. 2004
Reducing publication bias of prospective clinical trials through trial registrationLisa N Abaid
Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC 27599 7570, USA
Contraception 76:339-41. 2007..Contraception endorses the views of the ICMJE and will now require registration of all prospective trials...
CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaborationSally Hopewell
UK Cochrane Centre, Oxford, United Kingdom
PLoS Med 5:e20. 2008..Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract...
Reporting the clinical importance of randomized controlled trialsDavid Moher
CMAJ 166:711-2; author reply 712. 2002
CONSORT for reporting randomised trials in journal and conference abstractsSally Hopewell
UK Cochrane Centre, Summertown Pavilion, Oxford OX2 7LG, UK
Lancet 371:281-3. 2008
Interpreting the number needed to treatKenneth F Schulz
JAMA 288:831; author reply 831-2. 2002
[The CONSORT statenent: Revised Recommendations For Improving the Quality of Reports of Parallel-Group Randomized Trials]David Moher
Zhongguo Zhong Xi Yi Jie He Za Zhi 25:658-61. 2005
Peer review of statistics in medical research. Reporting power calculations is importantDouglas G Altman
BMJ 325:491; author reply 491. 2002
Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatmentsIsabelle Boutron
INSERM U738, AP HP, Hopital Bichat Claude Bernard, and Université Paris 7 Denis Diderot, Paris, France
Ann Intern Med 148:W60-6. 2008..The conduct of randomized, controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports...
Allocation concealment in clinical trialsKenneth F Schulz
JAMA 288:2406-7; author reply 2408-9. 2002
CONSORT statement requires closer examinationDouglas G Altman
BMJ 325:1364. 2002
Reflections on medical journalsDavid Moher
Ann Intern Med 137:1011-2; author 1011-2. 2002
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological studyLesley Wood
Department of Social Medicine, University of Bristol, Bristol BS8 2PR
BMJ 336:601-5. 2008..To examine whether the association of inadequate or unclear allocation concealment and lack of blinding with biased estimates of intervention effects varies with the nature of the intervention or outcome...
Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaborationIsabelle Boutron
INSERM U738, AP HP, Hopital Bichat Claude Bernard, and Université Paris 7 Denis Diderot, Paris, France
Ann Intern Med 148:295-309. 2008..This extension, in conjunction with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs performed in this field...
