A review of reporting of participant recruitment and retention in RCTs in six major journals

Toerien, Merran; Brookes, Sara; Metcalfe, Chris; Salis, Isabel O C de; Tomlin, Zelda; Peters, Tim J.; Sterne, Jonathan A C; Donovan, Jenny

doi:10.1186/1745-6215-10-52

Cited by 148 publications

(169 citation statements)

References 21 publications

Supporting

Mentioning

159

Contrasting

Unclassified

Order By: Relevance

“…have looked at how often reports of RCTs include quantitative data for the recruitment process (5)(6)(7)(8). One of the comprehensive reviews of these investigated the recruitment process in 172 reports of RCTs published in 4 highimpact medical journals between 1999 and 2000.…”

Section: Simsek and Yazicimentioning

confidence: 99%

See 1 more Smart Citation

Incomplete reporting of recruitment information in clinical trials of biologic agents for the treatment of rheumatoid arthritis: A review

Şimşek

Yazıcı

2012

Arthritis Care & Research

View full text Add to dashboard Cite

Objective. It is important to evaluate how a randomized controlled trial (RCT) sample was assembled from the general patient population in order to determine whether a patient differs from those who participated in the trial in a meaningful way. The aim of this study is to assess the adequacy of reporting of the recruitment process of rheumatoid arthritis (RA) patients participating in RCTs with biologic agents. Methods. We searched PubMed for all reports of RCTs involving etanercept, infliximab, adalimumab, golimumab, certolizumab, abatacept, tocilizumab, and rituximab in RA patients. Data recorded were eligibility fraction, enrollment fraction, recruitment fraction, and number of patients needed to be screened (NNS) in order to randomize 1 participant. Results. Of the 66 trials included in the analysis, 23 (35%) reported the number of individuals assessed by investigators for eligibility, and 18 (27%) reported the number eligible for participation. Of the studies that reported quantitative recruitment information, the median eligibility fraction was 80.6% (interquartile range [IQR] 71.8 -91.1%) and the median enrollment fraction was 100% (IQR 88.4 -100%). The median NNS was found to be 1.28 (IQR 1.18 -1.43). Conclusion.A substantial majority of RCTs conducted in RA patients with biologic agents did not provide sufficient information about the patient recruitment process, which makes assessments of external validity difficult. The rate of reporting of the recruitment process in this study was found to be lower as compared to similar studies conducted in different specialties.

show abstract

Section: Simsek and Yazicimentioning

confidence: 99%

“…We also analyze the association between recruitment rates and trial characteristics. A number of publications have studied the reporting process of RCTs in various subspecialties of medicine (5)(6)(7)(8). However, no study, to the best of our knowledge, has investigated RCTs focusing on RA alone to date.…”

Section: Introductionmentioning

confidence: 99%

Incomplete reporting of recruitment information in clinical trials of biologic agents for the treatment of rheumatoid arthritis: A review

Şimşek

Yazıcı

2012

Arthritis Care & Research

View full text Add to dashboard Cite

show abstract

“…8,[14][15][16][17][18] While some stages were well reported, others were depicted incompletely. In cases of trials published in major journals, 85-90% reported the enrollment fraction, whereas only 40-60% reported the eligibility fraction.…”

Section: Discussionmentioning

confidence: 99%

External Validity of Knee Osteoarthritis Clinical Trials: A Systematic Review

Koog¹

2015

Arch Rheumatol

View full text Add to dashboard Cite

“…Učestalost dijagrama toka je obrađena u okviru sistematskog pregleda randomizovanih kontrolnih studija o toku ispitanika [9]. Autori ovog istraživanja beleže učestalost grafičkog prikaza toka studije u 2/3 izveštaja što pokazuju i naši rezultati kada su u pitanju ogledi sa klaster randomizacijom.…”

Section: Diskusijaunclassified

A systematic review of the usage of flow diagram in cluster randomized trials

Kostić¹,

Ilić²,

Bukumirić³

et al. 2014

Praxis Med

View full text Add to dashboard Cite

Dijagram toka studije predstavlja sastavni deo usklađenih standarda o izveštavanju (CONSORT). Preporučuje se njegova primena u izveštavanju ogleda sa klaster randomizacijom. Cilj rada je da se predstavi učestalost korišćenja dijagrama toka u klaster randomizovanim studijama u skladu sa standardima o izveštavanju. Urađeno je pretraživanje Medline-a i za analizu izdvojeno 474 studija sa klaster randomizacijom. Studije su pregledane u cilju otkrivanja upotrebe grafičkog prikaza, primene standarda o izveštavanju i vremena publikovanja studije. U zavisnosti od trajanja, studije su podeljene na one koje su prikazale završena istraživanja i one čije je izvođenje još uvek u toku. Učestalost dijagrama toka je bila statistički značajno veća u studijama koje su se pridržavale standarda (86,2%) u odnosu na studije koje nisu koristile CONSORT smernice (71,4%), i u studijama koje su prikazale završena istraživanja (81,2 %) u odnosu na studije koje su predstavljale pilot projekte (54,3%). Primena CONSORT-a je zabeležena u 145 (31%) literaturnih jedinica. Broj klaster randomizovanih studija dobijenih pretraživanjem MEDLINE-a niskom cluster randomized trial [ti] i cluster randomised trial [ti] i primena CONSORT-a u izveštajima klaster randomizovanih studija linearno rastu tokom vremena (p<0,001). Učestalost primene dijagrama toka je veća u izveštajima klaster randomizovanih studija koji su rađeni u skladu sa standardima o izveštavanju.Klјučne reči: grafički prikaz toka studije, CONSORT, meta-analiza, klaster randomizovani ogledi. UVODKlaster randomizovane studije, u kojima su klasteri umesto pojedinaca nasumično raspoređeni u inerventne i kontrolne grupe su sve popularnije i naročito česte u primarnoj zdravstvenoj zaštiti [1].Klasteri predstavljaju jedinice randomizacije, a čla-novi klastera jedinice opservacije. Ta razlika između jedinica randomizacije i jedinica opservacije razlikuje klaster randomizovane studije od ostalih tipova randomizovanih studija, sa svim statističkim i praktičnim posledicama [2]. Klastere mogu da čine grupe pojedinaca, bolnice, škole, geografska područja.U poređenju sa individualno randomizovanim studijama, klaster randomizovane studije su složenijeg dizajna, zahtevaju više učesnika za dobijanje adekvatne statističke snage, i zahtevaju složeniju analizu [3].Grupa istraživača i urednika je usaglasila smernice u vidu usklađenih standarda o izveštavanju iz kliničkih ogleda. Prve smernice pod nazivom CONSORT objavljene su 1996. godine [4], a njihova poslednja revizija koja sadrži detaljna uputstva o izveštavanju klaster randomizovanih studija uradjena je 2010. godine [5]. CON-SORT smernice sadrže listu stavki koje bi trebalo da budu uključene u izveštaj studije i dijagram za prikaz toka ispitanika od početka istraživanja do konačne analize. [5] U izveštavanju klaster randomizovanih studija neophodno je pored toka ispitanika u dijagramu prikazati i tok klastera. Dijagram toka jasno prikazuje da li je bilo gubitaka klastera tokom izvođenja studije što je od značaja u proceni pristrasnosti i generalizovanju r...

show abstract

A review of reporting of participant recruitment and retention in RCTs in six major journals

Cited by 148 publications

References 21 publications

Incomplete reporting of recruitment information in clinical trials of biologic agents for the treatment of rheumatoid arthritis: A review

Incomplete reporting of recruitment information in clinical trials of biologic agents for the treatment of rheumatoid arthritis: A review

External Validity of Knee Osteoarthritis Clinical Trials: A Systematic Review

A systematic review of the usage of flow diagram in cluster randomized trials

Contact Info

Product

Resources

About