| Literature DB >> 24965222 |
Adrienne Stevens1, Larissa Shamseer2, Erica Weinstein3, Fatemeh Yazdi1, Lucy Turner1, Justin Thielman1, Douglas G Altman4, Allison Hirst5, John Hoey6, Anita Palepu7, Kenneth F Schulz8, David Moher9.
Abstract
OBJECTIVE: To assess whether the completeness of reporting of health research is related to journals' endorsement of reporting guidelines.Entities:
Mesh:
Year: 2014 PMID: 24965222 PMCID: PMC4070413 DOI: 10.1136/bmj.g3804
Source DB: PubMed Journal: BMJ ISSN: 0959-8138

Fig 1 Schematic depicting relation among evaluation of reporting guideline, studies contained within it, and determination of comparison groups according to journal endorsement status

Fig 2 PRISMA flow diagram for selecting reporting guidelines for health research. RG=reporting guideline

Fig 3 PRISMA flow diagram for selecting evaluations of relevant reporting guidelines. RG=reporting guideline; SR=systematic review
Characteristics of included evaluations for BMJ economics, CONSORT extension for abstracts, CONSORT extension for harms, CONSORT extension for herbal interventions, and PRISMA reporting guidelines
| Author, year* | Country of corresponding author | Sources of funding; role of funder; authors’ source(s) of support | Content focus | Specific medical or scientific specialty† | Extent of guideline assessed‡ |
|---|---|---|---|---|---|
| Herman, 2005122§ | United States | Government agency: grant from National Center for Complementary and Alternative Medicine; not reported; not reported (authors declare no competing interests) | Complementary medicine | Unspecified | All items |
| Jefferson, 1998123 | United Kingdom | Not reported; not reported; not reported | Unspecified | Unspecified | Subset of items¶ |
| Ghimire, 2014146 | South Korea | Not reported; not reported; not reported (authors declare no competing interests) | Unspecified | Oncology | Subset of items¶ |
| Haidich, 2011124§ | Greece | Not reported; not reported; not reported | Drug therapies | Several medical specialties†† | All items |
| Turner, 2011125§ | Canada | Government agency: National Center for Complementary and Alternative Medicine, National Institutes of Health; not reported; authors declare no competing interests | Complementary medicine | Unspecified | Subset of items‡‡ |
| Peron, 2014141 | France | Not reported; not reported; charitable foundation: Nuovo-Soldati Foundation (authors declare no competing interests) | Drugs therapies | Oncology | Subset of items¶ |
| Cornelius, 2013142 | United Kingdom | Government agency: National Institute for Health Research Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London; not reported; not reported (authors declare no competing interests) | Drug therapies | Neurosciences | Subset of items¶ |
| Lee, 2008126 | Canada | Government agency: Canadian Institutes of Health Research Chronic Disease New Emerging Team grant (joint sponsorship from Canadian Diabetes Association, Kidney Foundation of Canada, Heart and Stroke Foundation of Canada, and two other Canadian Institutes of Health Research Institutes); not reported; not reported | Drug therapies | Clinical neurology | Subset of items¶ |
| Ernst, 2011127 | United Kingdom | Not reported; not reported; not reported | Complementary medicine | Medicine, general and internal | Subset of items |
| PRISMA, 2009 | |||||
| Tunis, 2013143§ | Canada | No funding; not applicable; not reported (authors state no competing interests; authors have declared financial activities not related to article) | Unspecified | Radiology, nuclear medicine, and medical imaging | All items |
| Panic, 2013145§ | Italy | Not reported; funder had no role in work; Academic: ERAWEB, Charitable: Fondazione Veronesi (authors declare no competing interests) | Unspecified | Gastroenterology and hepatology | All items |
| Fleming, 2013144§ | United Kingdom | Not reported; not reported; not reported. | Unspecified | Dentistry, oral surgery, and medicine | All items |
*All included evaluations were published as full reports.
†2011 journal impact factor categories used for classification.
‡If authors of evaluations deemed particular guidance item to be “not applicable” to literature they were assessing, those items were excluded from analysis; for evaluations with zero or one studies in one comparison arm, those evaluations were removed from synthesis because that one arm would determine direction of effect.
§Included in quantitative analysis.
¶As determined by authors of this review when comparing with published guidance.
**Official extension of CONSORT reporting guideline; “official” defined as at least one author from original CONSORT reporting guideline on authorship of extension.
††Cardiac and cardiovascular systems, hematology, immunology, infectious diseases, obstetrics and gynecology, oncology, psychiatry, respiratory system, and rheumatology.
‡‡Evaluation’s authors indicated subset was assessed but authors of this review determined smaller subset was analyzed when comparing with published guidance.
Characteristics of included evaluations for QUOROM, STARD, STRICTA, and STROBE reporting guidelines
| Author, year* | Country of corresponding author | Sources of funding; role of funder; authors’ source(s) of support | Content focus | Specific medical or scientific specialty† | Extent of guideline assessed‡ |
|---|---|---|---|---|---|
| Hind, 2007128§ | United Kingdom | Not reported; not reported; not reported (authors declare they previously worked for UK NHS Health Technology Assessment Programme (source of included reports)) | Therapeutic interventions (generic) | Unspecified | Subset of items |
| Biondi-Zoccai, 2006129 | Italy | No funding; not applicable; not reported (authors declare no competing interests) | Drug therapies | Urology and nephrology | All items |
| Poolman, 2007130 | Canada, Netherlands | Not reported; not reported; academic: Canadian Institutes of Health Research Canada Research Chair; Industry: Merck Sharp and Dohme Netherlands, Biomet Netherlands, Zimmer Netherlands; other: Stichting Wetenschappelijk Onderzoek Orthopaedische Chirurgie Fellowship, Anna Fonds Foundation, Nederlandse Vereniging voor Orthopedische Traumatologie Fellowship | Surgery | Orthopedics | All items |
| Freeman, 2009131§ | United Kingdom | Government agency: European Commission funds allocated to Safe Activities For Everyone Network of Excellence under 6th Framework; not reported; not reported | Biochemical and laboratory research methods | Obstetrics and gynecology | All items |
| Mahoney, 2007132§ | United States | Industry: LifeScan Inc; not reported; study funder | Diagnostic (glucose monitoring) | Endocrinology and metabolism | All items |
| Selman, 2011133§ | United Kingdom | Not reported; not reported; other: charitable foundation (Wellbeing of Women) and Medical Research Council/Royal College of Obstetricians and Gynaecologists Clinical Research Training Fellowship (authors declare no competing interests) | Diagnostic studies | Obstetrics and gynecology | Subset of items¶ |
| Smidt, 2006134§ | Netherlands | Government agency: ZonMW; funder did not play role in study or manuscript**; authors declare no competing interests. | Diagnostic studies | Medicine, general and internal | Subset of items¶ |
| Coppus, 2006135 | Netherlands | Government agency: VIDI-program of ZonMW and charitable foundation: Scientific foundation of the Maxima Medical Center; | Diagnostic studies | Reproductive biology | Subset of items§ |
| Johnson, 2007136 | United Kingdom | Not reported; not reported; not reported (authors declare no competing interests) | Diagnostic studies | Ophthalmology | Subset of items |
| Krzych, 2009137 | Poland | Self financed; not applicable; not reported | Diagnostic studies | Cardiac and cardiovascular systems | Subset of items†† |
| Paranjothy, 2007138 | United Kingdom | No funding; not reported; authors state no information to disclose | Diagnostic studies | Ophthalmology | All items |
| Hammerschlag, 2011139§ | United States | Not reported; not reported; personnel support from Oregon College of Oriental Medicine research department and Helfgott Research Institute of National College of Natural Medicine | Complementary Medicine | Unspecified | Subset of items¶ |
| Parsons, 2011147§ | United Kingdom | Not reported; not reported; not reported | Surgery | Orthopedics | All items |
| Delaney, 2010140 | United States | Industry: Biomedical Excellence for Safer Transfusion collaborative (industry sponsored); not reported; authors declare no competing interests | Platelet transfusion | Hematology | Subset of items¶ |
*All included evaluations were published as full reports.
†2011 journal impact factor categories used for classification.
‡If authors of evaluations deemed particular guidance item to be “not applicable” to literature they were assessing, those items were excluded from analysis; for evaluations with zero or one studies in one comparison arm, those evaluations were removed from synthesis because that one arm would determine direction of effect.
§Included in quantitative analysis.
¶As determined by authors of this review when comparing with published guidance.
**Specifically, funding agency did not play role in design or conduct of study; collection, management, analysis, or interpretation of data; or preparation, review, or approval of manuscript.
††Authors of evaluations indicated subset was assessed, but authors of this review determined smaller subset was analyzed when comparing with published guidance.
‡‡Unofficial extension of CONSORT reporting guideline.
Validity assessment for evaluations with studies enabling endorsing versus non-endorsing journal comparison
| Author, year | Relevant studies for assessment (endorsing | Year of publication of assessed studies | Journals that published assessed studies | Two or more assessors for completeness of reporting* | No of items assessed as reported in methods section* | Comprehensive search strategy* | Balance of studies per journal in comparison groups*† |
|---|---|---|---|---|---|---|---|
| Herman, 2005122‡ | 2 | 2003-04 | 1 | Unclear | High | Low | High |
| Jefferson, 1998123 | 1 | 1997-98§ | 1 | Unclear | Unclear | High | High |
| Ghimire, 2014146 | 74 | 2010-12 | 2 | High | Unclear | Low | Low |
| Haidich, 2011124‡ | 25 | 2006 | 2 | High | High | High | Low |
| Turner, 2011125‡ | 5 | 2009 | 5 | Low | High | Low | Low |
| Peron, 2013141 | 43 | 2007-11 | 2 | Unclear | High | Low | Low |
| Cornelius, 2013142 | 1 | 2009 | 1 | High | High | High | High |
| Lee, 2008126 | 1 | 2005 | 1 | High | High | High | High |
| Ernst, 2011127 | 1 | 2009 | 1 | Unclear | High | Low | High |
| Tunis, 2013143‡ | 13 | 2010-11 | 1 | High | High | Low | Low |
| Panic, 2013145‡ | 30 | Jan-Oct 2012 | 6 | High | High | Low | Unclear |
| Fleming, 2013144‡ | 20 | 2009-11 | 2 | High | High | Low | Low |
| Biondi-Zoccai, 2006128 | 1 | 2004 | 1 | High | High | Low | High |
| Poolman, 2007130 | 1 | 2006 | 1 | High | Unclear | Low | High |
| STARD, 2003 | |||||||
| Freeman, 2009131‡ | 3 | 2004-05 | 2 | Unclear | High | High | High |
| Mahoney, 2007132‡ | 6 | 2003-05 | 4 | High | High | Low | High |
| Selman, 2011133‡ | 14 | 2003-06 | 6 | High | Low | Low | Low |
| Smidt, 2006134‡ | 95 | 2004 | 7 | High | High | Low | Low |
| Coppus, 2006135 | 8 | 2004 | 1 | Low | High | Unclear | High |
| Johnson, 2007136 | 1 | 2005 | 1 | High | High | Low | High |
| Krzych, 2009137 | 4 | 2004-06 | 2 | Unclear | High | Low | High |
| Paranjothy, 2007138 | 1 | 2005-06 | 1 | High | High | Low | High |
| Hammerschlag, 2011139‡ | 17 | 2002-05 | 3 | Low | High | Low | Unclear |
| Parsons, 2011147‡ | 9 | 2008-10 | 2 | Low | Unclear | Low | Low |
| Delaney, 2010140 | 1 | 2008 | 1 | High | Unclear | Low | High |
*High=high validity; low=low validity; unclear=unclear validity.
†Assessed once authors’ data reorganized into comparison groups.
‡Included in quantitative synthesis.
§Estimated based on information provided in article.
Validity assessment for evaluations with studies enabling the after versus before journal comparison
| Author, year | Relevant studies for assessment (after | Year of publication of assessed studies | Journals that published assessed studies | Two or more assessors for completeness of reporting* | No of items assessed as reported in methods section* | Comprehensive search strategy* | Balance of studies per journal in comparison groups*† | Sampling took place in period following publication of reporting guideline*† |
|---|---|---|---|---|---|---|---|---|
| Jefferson, 1998123 | 1 | 1997-98 | 1 | Unclear | Unclear | High | High | Low |
| Ghimire, 2014146 | 74 | 2010-12 | 2 | High | Unclear | Low | Low | Low |
| Lee, 2008126 | 1 | 2005 | 1 | High | High | High | High | Low |
| PRISMA, 2009 | ||||||||
| Panic, 2013145‡ | 27 | 2012 | 6 | High | High | Low | Low | Unclear |
| Fleming, 2013144‡ | 14 | 2009-11 | 1 | High | High | Low | High | Low |
| Hind, 2007128‡ | 13 | 2005 | 1 | Low | High | Low | High | High |
| Smidt, 2006134‡ | 95 | 2004 | 7 | High | High | Low | Unclear | Low |
| Selman, 2011133 | 3 | 2005-06 | 1 | High | Low | Low | Low | High |
| STRICTA, 2002 | ||||||||
| Hammerschlag, 2011139‡ | 11 | 2003-05 | 2 | Low | High | Low | Unclear | Low |
| Parsons, 2011147‡ | 9 | 2008-10 | 2 | Low | Unclear | Low | Low | Low |
*High=high validity; low=low validity; unclear=unclear validity.
†Assessed once authors’ data reorganized into comparison groups.
‡Included in quantitative synthesis.
§Estimated based on information provided in article.
Journal endorsement information for evaluations assessing BMJ economics, CONSORT extension for abstracts, CONSORT extension for harms, CONSORT extension for herbal interventions, and PRISMA reporting guidelines
| Author, year | Endorsing journals that published assessed studies | Extent of endorsement | Date of endorsement provided |
|---|---|---|---|
| Herman, 2005122* † | BMJ | Submit checklist | By journal, email |
| Jefferson, 1998123 | BMJ | Submit checklist | By journal, email |
| Ghimire, 2014146 | Lancet | Suggests use | By journal, email |
| Haidich, 2011124*† | Annals of Internal Medicine | Submit checklist | By journal, email |
| The Lancet | Submit checklist | By journal, email | |
| Turner, 2011125*† | The American Journal of Gastroenterology | Submit checklist | By journal, email |
| American Journal of Kidney Diseases | Suggests use | By journal, email | |
| Applied Health Economics and Health Policy | Suggests use | By journal, email | |
| JAMA | Submit checklist | Not provided | |
| Phytomedicine | Suggests use | Not provided | |
| Peron, 2014141 † | Lancet | Submit checklist | By journal, email |
| Lancet Oncology | Submit checklist | By journal, email | |
| Cornelius, 2013142 † | Lancet | Submit checklist | By journal, email |
| Lee, 2008126 | BMJ | Submit checklist | By journal, email |
| Ernst, 2011127 † | Annals of Internal Medicine | Suggests use | Not provided |
| Tunis, 2013143*† | Radiology | Suggests use | Unknown based on information given |
| Panic, 2013145* | Alimentary Pharmacology and Therapeutics | Extent of endorsement at time of author’s analysis unknown (all journals) | Provided by author (all journals) |
| American Journal of Gastroenterology | |||
| BMC Gastroenterology | |||
| Colorectal Disease | |||
| Diseases of the Colon and Rectum | |||
| Gut | |||
| Gut Pathogens | |||
| Hepatitis Monthly | |||
| HPB | |||
| Fleming, 2013144* | American Journal of Orthodontics and Dentofacial Orthopedics | Submit checklist | By journal, email |
| Angle Orthodontist | Suggests use | Not provided | |
| European Journal of Orthodontics | Submit checklist | By journal, email | |
| Journal of Orthodontics | Suggests use | By journal, email | |
*Evaluations included in quantitative analysis.
†Endorsing versus non-endorsing journals comparison only.
Journal endorsement information for evaluations assessing QUOROM, STARD, STRICTA, and STROBE reporting guidelines
| Author, year | Endorsing journals that published assessed studies | Extent of endorsement | Date of endorsement provided |
|---|---|---|---|
| Hind, 2007128*† | UK NHS Health Technology Assessment Programme | Submit checklist | By evaluation |
| Biondi-Zoccai, 2006129‡ | Clinical Cardiology | Unknown based on information given | Unknown based on information given |
| Poolman, 2007130‡ | BMJ | Suggests use | Not provided |
| Freeman, 2009131*‡ | American Journal of Obstetrics and Gynecology | Submit checklist | Unknown based on information given |
| Molecular Diagnosis§ | Suggests use | Not provided | |
| Mahoney, 2007132*‡ | Archives of Disease in Childhood (including Fetal and Neonatal Edition) | Suggests use | Unknown based on information given |
| Clinical Biochemistry | Suggests use | Not provided | |
| Emergency Medicine Journal | Suggests use | Unknown based on information given | |
| Journal of the Medical Association of Thailand | Suggests use | Not provided | |
| Selman, 2011133*¶ | American Journal of Obstetrics and Gynecology† | Submit checklist | Unknown based on information given |
| Cancer† | Suggests use | Not provided | |
| Clinical Radiology† | Suggests use | Not provided | |
| Journal of the Medical Association of Thailand† | Suggests use | Not provided | |
| Obstetrics and Gynecology | Suggests use | By journal, email | |
| Radiology† | Suggests use | By journal website | |
| Smidt, 2006134* | Annals of Internal Medicine | Suggests use | Journal website or by evaluation (all journals) |
| BMJ | Suggests use | ||
| Clinical Chemistry | Submit checklist | ||
| JAMA | Suggests use | ||
| The Lancet | Submit checklist | ||
| Neurology | Submit checklist | ||
| Radiology | Suggests use | ||
| Coppus, 2006135‡ | Human Reproduction | Journal no longer endorses guideline | |
| Johnson, 2007136‡ | Ophthalmic and Physiologic Optics | Submit checklist | By journal, email |
| Krzych, 2009137‡ | Clinical Chemistry** | Submit checklist | Reported in another evaluation |
| Heart | Suggests use | Not provided | |
| Paranjothy, 2007138‡ | British Journal of Ophthalmology | Suggests use | Not provided |
| Hammerschlag, 2011139* | Acupuncture in Medicine | Suggests use | By journal, email |
| Journal of Alternative and Complementary Medicine | Suggests use | By journal, email | |
| Medical Acupuncture† | Suggests use | By journal, email | |
| Parsons, 2011147* | Clinical Orthopaedics and Related Research | Suggests use | By journal, email |
| The Journal of Bone and Joint Surgery (American) | Suggests use | By journal, email | |
| Delaney, 2010140‡ | Annals of Surgery | Suggests use | Not provided |
*Evaluations included in quantitative analysis.
†After versus before journal endorsement comparison only.
‡Endorsing versus non-endorsing journals comparison only.
§Now published as Molecular Diagnosis and Therapy.
¶In quantitative analysis for endorsing versus non-endorsing journals only.
**Reported in another included evaluation.

Fig 4 Completeness of reporting summary plot for BMJ economics checklist, endorsing versus non-endorsing journals. Summary plots in this and other related figures were generated in Comprehensive Meta-analysis. In brief, summary effect estimates for each checklist are shown, and those estimates were previously calculated in Review Manager. For example, checklist item “economic importance of question” was assessed in only one evaluation, which had 13 studies (2 studies from endorsing journal and 11 studies from non-endorsing journals; appendix 7) that provided information on whether study had reported on that checklist item. Appendix 7 shows analyses for each checklist item conducted in Review Manager

Fig 5 Completeness of reporting summary plot for CONSORT extension for harms checklist, endorsing versus non-endorsing journals

Fig 6 Completeness of reporting summary plot for PRISMA checklist, endorsing versus non-endorsing journals. Although all evaluations assessed all items, one evaluation was excluded from analysis of two checklist items because of zero or one studies for analysis

Fig 7 Completeness of reporting summary plot for STARD checklist, endorsing versus non-endorsing journals. Effect estimate for checklist item “Test methods: definition of cut-offs of index test and reference standard” was not estimable during quantitative analysis because of zero events in each arm (one evaluation in analysis)

Fig 8 Completeness of reporting summary plot for STRICTA checklist, endorsing versus non-endorsing journals

Fig 9 Completeness of reporting summary plot for STROBE checklist, endorsing versus non-endorsing journals. Effect estimate for checklist item “Methods: missing data” was not estimable during quantitative analysis because of zero events in each arm
Analysis by mean summed score of items for reporting guideline checklists, endorsing versus non-endorsing journals*
| Reporting guideline† | No of evaluations‡ | No of studies (total) | Effect estimate (99% CI) |
|---|---|---|---|
| CONSORT extension for harms, 2004 | 1§ | 25 | Mean difference 0.04 (–1.50 to 1.58) |
| PRISMA, 2009 | 3¶ | 63 | Standardized mean difference 0.53 (0.02 to 1.03) |
| STARD, 2003 | 3 | 23 | Standardized mean difference 0.52 (–0.11 to 1.16) |
| STRICTA, 2002 | 1†† | 17 | Mean difference 1.42 (–0.04 to 2.88) |
| STROBE, 2007 | 1§ | 9 | Mean difference 1.55 (–3.19 to 6.29) |
*Individual forest plots depicting these summary data are shown in appendix 7.
†QUOROM (two evaluations) was not estimable because of one study in one comparison arm per assessed evaluation.
‡Only evaluations that calculated summed score for report were included.
§All checklist items summed.
¶Subset of items was summed for one evaluation.
**Subset of items was summed for two of three evaluations.
††Subset of items was summed.

Fig 10 Completeness of reporting summary plot for PRISMA checklist, after versus before journal endorsement. Although all evaluations assessed all items, one evaluation was excluded from analysis of one checklist item because of zero and one studies for comparison arms

Fig 11 Completeness of reporting summary plot for QUOROM checklist, after versus before journal endorsement

Fig 12 Completeness of reporting summary plot for STARD checklist, after versus before journal endorsement

Fig 13 Completeness of reporting summary plot for STRICTA checklist, after versus before journal endorsement

Fig 14 Completeness of reporting summary plot for STROBE checklist, after versus before journal endorsement. Effect estimate for checklist item “Methods: missing data” was not estimable during quantitative analysis because of zero events in each arm
Analysis by mean summed score for reporting guideline checklists, after versus before journal endorsement*
| Reporting guideline | No of evaluations† | No of studies (total) | Effect estimate (99% CI) |
|---|---|---|---|
| PRISMA, 2009 | 2‡ | 41 | Standardized mean difference 0.49 (–0.10 to 1.08) |
| STRICTA, 2002 | 1§ | 11 | Mean difference 1.82 (–2.49 to 6.13) |
| STROBE, 2007 | 1‡ | 9 | Mean difference 1.16 (–3.97 to 6.29) |
*Individual forest plots depicting these summary data are shown in appendix 7.
†Only evaluations that calculated summed score for report were included.
‡All checklist items were summed.
§Subset of items was summed.
Assessment of methodological quality within evaluations
| Author, year | Methodological quality assessment |
|---|---|
| Herman, 2005122 | Evaluated economic evaluations on four criteria: randomization; prospective economic data collection; comparison group was usual care; and study was not blinded or mandatory regarding participation. Both studies in endorsing arm met all four criteria compared with 5/11 studies in non-endorsing arm |
| Ernst, 2011127 | Assessed studies by using Cochrane risk of bias tool. Only study from endorsing journal was assessed as at moderate risk of bias. Studies from non-endorsing journals were assessed at high (n=2) or moderate (n=2) risk of bias |
| Tunis, 2013143 | Assessed reviews by using AMSTAR. Using data provided by author, studies (n=13) from only endorsing journal scored mean of 9.2 of 11 points, and studies (n=48) from non-endorsing journals scored 7.6 of 11 points |
| Panic, 2013145 | Assessed reviews by using AMSTAR. Data by item are not presented. Endorsing versus non-endorsing journals: using data provided by author, mean summed score from studies (n=30) from endorsing journals was 7.2 (range 2 to 9), and those (n=30) from non-endorsing journals scored 6.4 (range 1-9). After versus before journal endorsement: using data provided by author, mean summed score was 7.3 (range 3-9, n=27 articles) after journal endorsement and 6.0 (range 0-9, n=26 articles) before endorsement |
| Fleming, 2013144 | Authors assessed reviews by using AMSTAR tool but analyzed across all included studies162 |
| Biondi-Zoccai, 2006129 | Assessed studies by using the Oxman and Guyatt index (range of 1 (minimal flaws) to 7 (extensive flaws)). Only study from endorsing journal scored 2 on index; studies (n=6) from non-endorsing journals scored range of 1-6 points |
| Poolman, 2007130 | Used the Oxman and Guyatt index (maximum score 7 points). Only study from endorsing journal scored 7 points. Studies from non-endorsing journals (n=6) scored range of 1-6 points; four studies scoring 1 or 2 points are considered to have “major flaws” according to index |
| Freeman, 2009131 | Assessed eight aspects that authors state address internal and external validity of included studies: selective participant sampling; lack of reporting ethnicity and/or sensitization status of participants; lack of reporting number of replicates, if done, that were used for overall study outcome; lack of reporting failure rate; lack of including reported failure rate in analysis; difference in reported and adjusted accuracy; lack of controlling for presence of fetal DNA; and lack of known genotypes in study as control. Raw data provided in tabular form without summary in text. Studies (n=3) from endorsing journals ranged from 2 to 4 of 8 flaws. Studies (n=8) from non-endorsing journals ranged from 2 to 6 flaws, and information from one study was not interpretable |
| Krzych, 2009137 | Authors assessed studies by using QUADAS tool but analyzed across all included studies |