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2022, vol. 79, br. 10, str. 1010-1019
Tehnike randomizacije i veličina klastera u klaster randomizovanim studijama sprovedenim u osnovnim i srednjim školama
aUniverzitet u Prištini sa privremenim sedištem u Kosovskoj Mitrovici, Medicinski fakultet, Katedra za Preventivnu medicinu 
bUniverzitet u Beogradu, Medicinski fakultet, Institut za medicinsku statistiku i informatiku

e-adresamirjana.kostic@med.pr.ac.rs
Ključne reči: slučajni izbor, metod; istraživanje; istraživanje, dizajn; uzorak, veličina; škole
Sažetak
Uvod/Cilj. Formiranje grupa u istraživanjima tako da budu slične u svim karakteristikama izuzev ishoda, obezbeđuje se postupkom slučajne raspodele. Cilj ove studije bio je da ispita učestalost tehnika slučajne raspodele i njihov uticaj na postizanje ravnoteže na početku istraživanja u studijama sa grupama formiranim pomenutom metodom, koje su sprovedene u školama. Metode. Pretraživanjem bibliografske baze podataka Medline ukupan broj prikupljenih radova je bio 343, od kojih je 81 ispunilo kriterijume za uključenje u studiju. Svaku publikaciju su pregledala dva nezavisna istraživača, podaci su ekstrahovani i analizirani. Rezultati. Najčešće primenjena tehnika slučajne raspodele bila je stratifikacija koja je opisana u 28 (34,6%) studija. U studijama u koji-ma je primenjena prosta metoda slučajne raspodele nije bilo statistički značajne razlike u broju ispitanika i klastera kao i veličini klastera između ispitivanih grupa. U studijama u kojima su primenjene tehnike restriktivne slučajne raspodele postoji statistički značajna razlika u broju ispitanika i klastera između grupa, ali ne i u veličini klastera. Zaključak. Iako u veličini klastera ne postoji razlika između ispitivanih grupa kako na nivou celog uzorka tako i u odnosu na tehnike slučajne raspodele, trebalo bi sprovesti dodatna istraživanja na većem uzorku kako bi se utvrdio uticaj primenjenih tehnika slučajne raspodele na prisustvo ravnoteže na početku istraživanja kada je u pitanju veličina klastera.

Introduction

Randomized controlled studies in which randomization is conducted at the level of clusters, where all subjects within the same cluster, such as hospitals or general practitioners, are subjected to the same treatment, are called cluster randomized trials (CRTs) [1]. Clusters may be groups of subjects, hospitals, schools, geographic regions, etc.

Compared with individually randomized studies, cluster randomized studies are of a more complex design and require more subjects to achieve adequate statistical power and the application of a more complex method of analysis [2]. Compared with an individually randomized trial testing the same hypothesis, cluster randomization requires a significantly larger sample size [3].

The main result of a such design application is that the outcome for one patient cannot be considered independently from other patients (as in individual randomized studies). Patients in the same cluster will probably have similar outcomes [4].

The formation of study groups so as to be similar in all characteristics except in the outcome is achieved through randomization. Baseline balance among groups shall ensure that all differences obtained at the end of the trial are attributed to the effect of study treatment, not the existing differences.

In cluster-randomized studies, it is necessary to achieve balance, both at the level of individual subjects and at the level of clusters [5]. Due to cluster size, a large number of clusters are often difficult to randomize into every study group, while a small number of clusters is not enough to provide adequate balance among study groups [6]. Furthermore, the necessary number of cases depends on the size of the clusters: 100 clusters each containing 10 probands lead to greater statistical power than 10 clusters of 100 probands each [7]. Regarding the use of the randomization method in CRTs, some authors believe that adequate balance cannot be achieved by the application of simple randomization, especially if the number of randomized clusters is small [8]. That is the main reason why a matched or stratified design of the study is used [6], although certain authors [2][6][9] favor stratification when studies of such design are in question.

In a systematic review of CRTs in the field of primary health care, published 1997-2000, Eldridge et al. [10] quote that in 54% of studies, matching and stratification were applied during randomization. In a systematic review of group randomized trials in the field of cancer prevention, published 2002-2006, Murray et al. [11] quote that simple randomization is applied in 40% of studies, matching is applied in 20% of studies, stratification in 35% of studies, while a combination of matching and stratification is applied in 5.3% of studies. In a systematic review of Rutterford et al. [12] that included 300 CRTs published 2000-2008, the stratification method is applied in 39% of studies, simple randomization in 37% of studies, while matching is applied in 19% of studies, and minimization in 5% of studies.

The aim of this study was to investigate the frequency of randomization methods and their relation with the size of the cluster in terms of achieving baseline balance in CRTs conducted in schools.

Methods

A literature search of the Medline bibliographic database was conducted until March 31, 2020, using following key words in the title of the paper: "cluster randomised trial", "cluster randomized trial", " randomised cluster trial", "randomized cluster trial", "field randomised trial", "field randomized trial", "randomised field trial", "randomized field trial", "community based randomised trial", "community based randomized trial", "randomised community based trial", "randomized community based trial", "community randomised trial", "community randomized trial", "randomised community trial", "randomized community trial", "group randomised trial", "group randomized trial", "randomised group trial", "randomized group trial", "place based randomised trial" "place based randomized trial", "randomised place based trial", "randomized place based trial", "randomised place trial", "randomized place trial", "place randomised trial", "place randomized trial", "prevention randomised trial", "prevention randomized trial", "randomised prevention trial", "randomized prevention trial", "randomised prevention trial". Study inclusion criteria were: prospective CRTs that include two study groups, with schools as randomization units and students as observation units. Exclusion criteria were: studies in which randomization is not performed at the level of clusters, cluster randomized studies in which randomization units are not schools, and pilot trials. After reading through the published titles and abstracts, all the ones which met the inclusion criteria were downloaded in extenso. The total number of collected articles in the full text was 343, out of which 81 (Appendix 1) were eligible for inclusion [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70][71][72][73][74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89][90][91][92]. Each publication was reviewed by two independent reviewers and data about randomization methods, the number of subjects and clusters at the beginning of the trial were extracted. The size of the cluster was obtained by dividing the total number of randomized subjects by the number of randomized clusters (Figure 1).

Figure 1 Identification of cluster randomized trials from PubMed citations indexed in March 2020.

Data analysis

For primary data analysis, descriptive methods and methods for testing statistical hypotheses were used. The measure of central tendency (median), a measure of variability [interquartile range (IQR)], and relative numbers were used from descriptive statistical methods. Statistical hypotheses were tested by the Wilcoxon test. Statistical data analysis was performed using IBM SPSS Statistics 21 (SPSS Inc., Chicago, IL, USA). The criterion for statistical significance was p < 0.05.

Results

The most often applied randomization method was the method of stratification reported in 28 (34.6%) studies. The following were simple randomization reported in 18 (22.2%) studies, matching in 12 (14.8%) studies, and block randomization in 8 (9.9%) studies. In 9 (11.1%) studies, it was not reported which randomization methods were used. The frequency of other randomization methods was less than 5% (Table 1).

Table 1. Randomization methods in cluster randomized trials conducted in schools as randomization units (n = 81)

Allocation techniques n (%)
Stratification 28 (34.6)
Simple randomization 18 (22.2)
Matching 12 (14.8)
Not reported 9 (11.1)
Block randomization 8 (9.9)
Balanced randomization 3 (3.7)
Matching and stratification 1 (1.2)
Block and stratification 1 (1.2)
Restricted randomization 1 (1.2)

When the entire sample was considered, there was a statistically significant difference in the number of subjects and clusters between the intervention and control group, while there was no statistically significant difference in the size of clusters between groups.

Table 2. The association of randomization methods and cluster size at baseline

Cluster size at baseline (n = 72) Intervention group* Control group* p**
Number of participants 813 (394–2.710) 823 (380–2.864) 0.020
Number of clusters 12.5 (7.75–34) 12 (8–31) 0.001
Cluster size 59.2 (33.8–160.4) 62.5 (33.9–158) 0.736
Baseline simple randomization studies (n = 18)
Number of participants 314 (113–691) 314 (108–718) 0.088
Number of clusters 10 (6–13) 10 (7–12) 0.953
Cluster size 45 (28.9–62.8) 42.6 (24.9–65) 0.365
Baseline restricted randomization studies (n = 54)
Number of participants 1,115 (669.5–4.253) 1,093 (628.5–4.299) 0.012
Number of clusters 20 (10–35) 16 (10–33.5) < 0.001
Cluster size 76.8 (41.8–168.7) 74.7 (40.3–178) 1.000

*number of subjects and clusters in trial arms; **Wilcoxon test
Note: Values are given as median and IQR (interquartile range 25–75 percentiles).

Studies where a simple randomization method was applied demonstrated the absence of a statistically significant difference between study groups in the number of subjects and clusters, as well as in the size of clusters, while studies with restrictive randomization methods demonstrated a statistically significant difference between study groups in the number of subjects and clusters but not in the size of clusters (Table 2).

Discussion

The results of this trial show the possible presence of bias during randomization. The difference in the number of subjects and clusters between study groups during randomization is slight but statistically significant. According to the literature, there is a much greater probability of not achieving the balance between trial arms, especially if the number of clusters is small [93] like in the studies from this research. Without withstanding the aforementioned, there was no statistically significant difference in the number of subjects and clusters between study groups in studies where simple randomization was applied, which leads to the conclusion that the baseline balance was achieved although the randomization method, otherwise not recommended in CRTs, was applied.

In the bibliography, restrictive randomization methods are recommended for CRTs because they may improve the chances of achieving balanced study groups [94]. Author Lewsey [95] quotes that, when CRTs are in question, matching and stratification are especially popular methods, and also quotes that the most commonly used factors of stratification are the size of the cluster, cluster-level socio-economic status, geographic location, and categorized levels of individual-level prognostic factors. On the other hand, this trial showed a significant difference in the number of subjects and clusters between trial arms in studies that applied certain restrictive randomization methods. The number of subjects and clusters was significantly higher in intervention groups.

Although CRTs are of complex design, in certain cases, they are the only choice, for instance, if the nature of the intervention requires it to be performed in the entire community or to prevent contamination if subjects from both study groups come from the same population. The application of adequate randomization methods in these studies has a great impact on the quality of the trial. Several authors [6][2][9] recommend stratification, which is the most frequently applied method in one-third of all studies in this research. We can find a similar result in the research of Varnell et al. [96], while in the systematic review of CRTs in the field of oral health, stratification was reported to be the most frequently used randomization method in 48% of studies [97].

Although certain authors [6][12] believe that balance in CRTs cannot be achieved by application of simple randomization, its frequency of 22.2% in this trial is rather high. In the bibliography, there is a trial where simple randomization was applied in more than half of the studies covered by systematic review [98], but there are also trials where the frequency of this method is similar to our results [97].

As for individually randomized controlled trials, the goal of randomization in group randomized trials is to achieve a balance of baseline covariates. In contrast to individually randomized trials, another form of baseline balance applies to group randomized trials, namely, baseline balance of group sample size [99]. In the case of CRTs, the most efficient design is achieved when the sizes of clusters are equal [100]. The results of this trial showed that there were no differences in the size of clusters between study groups. However, the possible presence of bias can be seen through the presence of differences in the number of subjects and clusters in the randomization process. The difference already existing between subjects and clusters at baseline may increase if a loss of subjects and/or clusters occurs during the study. For this reason, we believe that additional investigation is necessary.

The limitation of this study is that it included only studies conducted in schools as randomization units. There is a heterogenicity between trials that has not been investigated, which also represents a limitation of this trial. Moreover, the only balance measuring factor we took into consideration was the size of the cluster that represents a number of subjects and clusters in trial arms, without the presence of balance in prognostic factors.

Conclusion

The most frequently applied randomization method is stratification, although the frequency of simple randomization is also high. In studies where a simple randomization method was applied, there was no difference in the number of subjects and clusters between study groups, unlike in studies where some restrictive randomization methods were applied. Even though there was no difference in the size of clusters between study groups, either with respect to the entire sample or the randomization method applied, additional research should be conducted on a larger sample in order to determine the effects of the randomization method on achieving baseline balance, when cluster size is in question.

Dodatak

Acknowledgement

In memory of Professor Goran Trajković who helped us with the basic idea of this research.

Appendix 1

Table 3. Trials included in the analysis

Study Publication year Study power Randomization methods Intervention group Control group Intervention group Control group
number of participants randomized number of participants randomized number of clusters randomized number of clusters randomized
Pereira et al. [13] 2012 Described Stratification 176,843 171,240 388 375
Barreto et al. [14] 2011 Described in previous report Stratification 176,843 171,240 388 375
Stephenson et al. [15] 2008 Described Stratification 4,516 4,250 14 13
Cunha et al. [16] 2008 Described Stratification 72,980 79,458
Henderson et al. [17] 2007 Described Balanced 2,080 2,135 13 12
Cooper et al. [18] 2006 Described Block randomization 1,164 1,209 34 34
Rodrigues et al. [19] 2005 Described in previous report Stratification 176,843 171,240 386 375
Madsen et al. [20] 2013 Described Not reported 82 74 4 3
Sancho-Garnier et al. [21] 2012 Described Stratification 798 567 39 31
Tol et al. [22] 2012 Described Simple randomization 199 200 12 12
James-Burdumy et al. [23] 2012 Not reported Block randomization 6,400 4,590 20 16
Ezendam et al. [24] 2012 Described in previous report Stratification 485 398 11 9
Hartmann et al. [25] 2010 Not reported Simple randomization 16 11
Walsh et al. [26] 2010 Described Stratification 2,270 2,461
Hunter et al. [27] 2010 Described Block randomization 1,115 1,376 11 11
Wen et al. [28] 2010 Described Matching 1,339 1,004 2 2
Berg et al. [29] 2009 Described Stratification 375 378 17 17
Wolfe et al. [30] 2009 Not reported Stratification 968 754 10 10
Ringwalt et al. [31] 2009 Described Matching 3,990 4,348 20 10
Tol et al. [32] 2008 Described Simple randomization 237 258 7 7
Martínez Vizcaíno et al. [33] 2008 Described Simple randomization 691 718 10 10
Naldi et al. [34] 2007 Described in previous report Stratification 5,676 5,554 62 60
Martiniuk et al. [35] 2007 Described Block and stratification 403 380 12 12
Rapp et al. [36] 2006 Described Simple randomization 605 629 16 16
Martiniuk et al. [37] 2003 Described Simple randomization 197 271 8 11
Aveyard et al. [38] 2001 Described in previous report Balanced 4,660 4,641 27 26
Priest et al. [39] 2014 Described Stratification 8,859 7,386 34 34
Halliday et al. [40] 2014 Described Stratification 2,710 2,523 51 50
Isensee et al. [41] 2014 Described Stratification 2,437 2,335 26 22
Ebenezer et al. [42] 2013 Described Block randomization 813 808 49 49
Martínez-Vizcaíno et al. [43] 2014 Described in previous report Simple randomization 769 823 10 10
Bere et al. [44] 2014 Described Not reported 585 1,365
Primack et al. [45] 2014 Described Stratification 554 578 31 33
Barreto et al. [46] 2014 Described in previous report Stratification 176,843 172,240 388 375
Muhumuza et al. [47] 2014 Described Stratification 2,523 3,036 6 6
Tol et al. [48] 2014 Described Stratification 153 176 7 7
Santos et al. [49] 2014 Described Block randomization 340 347 10 10
Freeman et al. [50] 2013 Described Stratification 20 20
O'Leary-Barrett et al. [51] 2013 Not reported Not reported 1,529 1,114 11 8
Lewis et al. [52] 2013 Not reported Matching 7 7
Peskin et al. [53] 2014 Described Balanced 598 847 5 5
Coleman et al. [54] 2012 Described Matching 647 626 4 4
Peterson et al. [55] 2009 Described Matching 1,058 1,093 25 25
Telford et al. [56] 2013 Not reported Not reported 394 314 13 16
Telford-2013 et al. [57] 2013 Not reported Simple randomization 394 314 13 16
LaBrie et al. [58] 2008 Not reported Not reported 603 559 12 8
Sloboda [59] 2009 Described Not reported 10,028 7,292 41 42
Gmel et al. [60] 2012 Described Matching and stratification 973 885 57 56
Waters et al. [61] 2018 Described Simple randomization 3,433 3,601 12 11
Mallick et al. [62] 2018 Described Stratification 223 231 5 5
Kittayapong et al. [63] 2017 Described Not reported 1,297 1,017 5 5
Marcano-Olivier et al. [64] 2019 Described Simple randomization 86 90
Nawi et al. [65] 2015 Described Simple randomization 47 50 4 2
Rathleff et al. [66] 2015 Described Simple randomization 62 59 2 2
Sutherland et al. [67] 2016 Described Block randomization 837 631 5 5
Baker-Henningham et al. [68] 2019 Described Not reported 108 112 7 7
Halliday et al. [69] 2020 Described Stratification 4,850 4,721 29 29
Nsangi et al. [70] 2020 Described Stratification 6,383 6,256 60 60
Chang Wu et al. [71] 2018 Described Simple randomization 365 565 7 9
Morgan et al. [72] 2018 Not reported Matching 118 79 34 26
Bundy et al. [73] 2017 Described in previous report Simple randomization 113 108 6 6
Rozi et al. [74] 2019 Described Stratification 738 589 10 8
Andersen et al. [75] 2015 Described Stratification 2,381 1,786 53 44
Gerald et al. [76] 2019 Described Matching 224 169 10 10
Penalvo et al. [77] 2015 Described Stratification 12 12
Schonfeld et al. [78] 2015 Not reported Block randomization 692 702 12 12
Sutherland et al. [79] 2016 Described Block randomization 696 537 5 5
Kaufman et al. [80] 2016 Described Stratification 565 661 13 13
Sanchez et al. [81] 2019 Described Not reported 3,243 3,148 38 34
Dalma et al. [82] 2019 Described Stratification 6,831 5,587 36 30
Valente et al. [83] 2020 Described Simple randomization 3,340 3,318 38 34
Andrade et al. [84] 2016 Described Matching 700 740 10 10
Vik et al. [85] 2015 Described Matching 1,713 1,681 31 31
Chard et al. [86] 2019 Not reported Stratification 2,021 1,972 50 50
D ziaugyt_e et al. [87] 2017 Described Simple randomization 112 94 2 2
Okely et al. [88] 2017 Described Matching 771 747 12 12
Asdigian et al. [89] 2017 Not reported Simple randomization 314 321 6 7
Peterson et al. [90] 2016 Described Matching 1,058 1,093 25 25
Bauer et al. [91] 2020 Described Matching 639 723 8 8
Potter et al. 2016 Not reported Restricted 1,775 1,469
Praena-Crespo et al. [92] 2016 Described Simple randomization 2,856 2,864 47 50

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41.Isensee B, Hansen J, Maruska K, Hanewinkel R. Effects of a school-based prevention programme on smoking in early adolescence: A 6-month follow-up of the 'Eigenstandig werden' cluster randomised trial. BMJ Open. 2014;4(1):e004422.
42.Ebenezer R, Gunawardena K, Kumarendran B, Pathmeswaran A, Jukes MC, Drake LJ. Cluster-randomised trial of the impact of school-based deworming and iron supplementation on the cognitive abilities of schoolchildren in Sri Lanka's plantation sector. Trop Med Int Health. 2013;18(8):942-951.
43.Martínez-Vizcaíno V, Sánchez-López M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martínez M, Franquelo-Morales P. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: A cluster randomized trial. Int J Behav Nutr Phys Act. 2014;11:154.
44.Bere E, Klepp KI, Overby NC. Free school fruit: Can an extra piece of fruit every school day contribute to the prevention of future weight gain? A cluster randomized trial. Food Nutr Res. 2014;58. [Crossref]
45.Primack BA, Douglas EL, Land SR, Miller E, Fine MJ. Comparison of media literacy and usual education to prevent tobacco use: A cluster-randomized trial. J Sch Health. 2014;84(2):106-115.
46.Barreto ML, Pilger D, Pereira SM, Genser B, Cruz AA, Cunha SS. Causes of variation in BCG vaccine efficacy: Examining evidence from the BCG REVAC cluster randomized trial to explore the masking and the blocking hypotheses. Vaccine. 2014;32(30):3759-3764.
47.Muhumuza S, Olsen A, Katahoire A, Kiragga AN, Nuwaha F. Effectiveness of a pre-treatment snack on the uptake of mass treatment for schistosomiasis in Uganda: A cluster randomized trial. PLoS Med. 2014;11(5):e1001640.
48.Tol WA, Komproe IH, Jordans MJ, Ndayisaba A, Ntamutumba P, Sipsma H. School-based mental health intervention for children in war-affected Burundi: A cluster randomized trial. BMC Med. 2014;12:56.
49.Santos RG, Durksen A, Rabbanni R, Chanoine JP, Lamboo Miln A, Mayer T. Effectiveness of peer-based healthy living lesson plans on anthropometric measures and physical activity in elementary school students: A cluster randomized trial. JAMA Pediatr. 2014;168(4):330-337.
50.Freeman MC, Clasen T, Brooker SJ, Akoko DO, Rheingans R. The impact of a school-based hygiene, water quality and sanitation intervention on soil-transmitted helminth reinfection: A cluster-randomized trial. Am J Trop Med Hyg. 2013;89(5):875-883.
51.O'Leary-Barrett M, Topper L, Al-Khudhairy N, Pihl RO, Castellanos-Ryan N, Mackie CJ. Two-year impact of personalitytargeted, teacher-delivered interventions on youth internalizing and externalizing problems: A cluster-randomized trial. J Am Acad Child Adolesc Psychiatry. 2013;52(9):911-920.
52.Lewis KM, DuBois DL, Bavarian N, Acock A, Silverthorn N, Day J. Effects of positive action on the emotional health of urban youth: A cluster-randomized trial. J Adolesc Health. 2013;53(6):706-711.
53.Peskin MF, Markham CM, Shegog R, Baumler ER, Addy RC, Tortolero SR. Effects of the It's Your Game . . Keep It Real program on dating violence in ethnic-minority middle school youths: A group randomized trial. Am J Public Health. 2014;104(8):1471-1477.
54.Coleman KJ, Shordon M, Caparosa SL, Pomichowski ME, Dzewaltowski DA. The healthy options for nutrition environments in schools (Healthy ONES) group randomized trial: Using implementation models to change nutrition policy and environments in low-income schools. Int J Behav Nutr Phys Act. 2012;9:80.
55.Peterson AVJr, Kealey KA, Mann SL, Marek PM, Ludman EJ, Liu J. Group-randomized trial of a proactive, personalized telephone counseling intervention for adolescent smoking cessation. J Natl Cancer Inst. 2009;101(20):1378-1392.
56.Telford RD, Cunningham RB, Waring P, Telford RM, Olive LS, Abhayaratna WP. Physical education and blood lipid concentrations in children: The LOOK randomized cluster trial. PLoS One. 2013;8(10):e76124.
57.Telford RD, Cunningham RB, Telford RM, Daly RM, Olive LS, Abhayaratna WP. Physical education can improve insulin resistance: The LOOK randomized cluster trial. Med Sci Sports Exerc. 2013;45(10):1956-1964.
58.LaBrie JW, Hummer JF, Neighbors C, Pedersen ER. Live interactive group-specific normative feedback reduces misperceptions and drinking in college students: A randomized cluster trial. Psychol Addict Behav. 2008;22(1):141-148.
59.Sloboda Z, Stephens RC, Stephens PC, Grey SF, Teasdale B, Hawthorne RD. The adolescent substance abuse prevention study: A randomized field trial of a universal substance abuse prevention program. Drug Alcohol Depend. 2009;102(1-3):1-10.
60.Gmel G, Venzin V, Marmet K, Danko G, Labhart F. A quasi-randomized group trial of a brief alcohol intervention on risky single occasion drinking among secondary school students. Int J Public Health. 2012;57(6):935-944.
61.Waters E, Gibbs L, Tadic M, Ukoumunne OC, Magarey A, Okely AD. Cluster randomised trial of a school-community child health promotion and obesity prevention intervention: Findings from the evaluation of fun 'n healthy in Moreland! BMC Public Health. 2017;18(1):92.
62.Mallick R, Kathard H, Borhan ASM, Pillay M, Thabane L. A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students. Trials. 2018;19(1):664.
63.Kittayapong P, Olanratmanee P, Maskhao P, Byass P, Logan J, Tozan Y. Mitigating diseases transmitted by Aedes mosquitoes: A cluster-randomised trial of permethrin-impregnated school uniforms. PLoS Negl Trop Dis. 2017;11(1):e0005197.
64.Marcano-Olivier M, Pearson R, Ruparell A, Horne P, Viktor S, Erjavec M. A low-cost behavioural nudge and choice architecture intervention targeting school lunches increases children's consumption of fruit: A cluster randomised trial. Int J Behav Nutr Phys Act. 2019;16(1):20.
65.Mohammed Nawi A, Che Jamaludin FI. Effect of internet-based intervention on obesity among adolescents in Kuala Lumpur: A school-based cluster randomised trial. Malays J Med Sci. 2015;22(4):47-56.
66.Rathleff MS, Roos EM, Olesen JL, Rasmussen S. Exercise during school hours when added to patient education improves outcome for 2 years in adolescent patellofemoral pain: A cluster randomised trial. Br J Sports Med. 2015;49(6):406-412.
67.Sutherland R, Campbell E, Lubans DR, Morgan PJ, Okely AD, Nathan N. 'Physical activity 4 everyone' school-based intervention to prevent decline in adolescent physical activity levels: 12 month (mid-intervention) report on a cluster randomised trial. Br J Sports Med. 2016;50(8):488-495.
68.Baker-Henningham H, Scott Y, Bowers M, Francis T. Evaluation of a violence-prevention programme with Jamaican primary school teachers: A cluster randomised trial. Int J Environ Res Public Health. 2019;16(15):2797.
69.Halliday KE, Witek-Mcmanus SS, Opondo C, Mtali A, Allen A, Bauleni A. Impact of school-based malaria case management on school attendance, health and education outcomes: A cluster randomised trial in southern Malawi. BMJ Glob Health. 2020;5(1):e001666.
70.Nsangi A, Semakula D, Oxman AD, Austvoll-Dahlgren A, Oxman M, Rosenbaum R. Effects of the informed health choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, 1-year follow-up: A cluster-randomised trial. Trials. 2020;21(1):27.
71.Wu PC, Chen CT, Lin KK, Sun CC, Kuo CN, Huang HM. Myopia Prevention and Outdoor Light Intensity in a School-based Cluster Randomized Trial. Ophthalmology. 2018;125(8):1239-1250.
72.Morgan L, Hooker JL, Sparapani N, Reinhardt VP, Schatschneider C, Wetherby AM. Cluster randomized trial of the classroom SCERTS intervention for elementary students with autism spectrum disorder. J Consult Clin Psychol. 2018;86(7):631-644.
73.Bundy A, Engelen L, Wyver S, Tranter P, Ragen J, Bauman A. Sydney playground project: A cluster-randomized trial to increase physical activity, play, and social skills. J Sch Health. 2017;87(10):751-759.
74.Rozi S, Zahid N, Roome T, Lakhdir MPA, Sawani S, Razzak A. Effectiveness of a school based smokeless tobacco intervention: A cluster randomized trial. J Community Health. 2019;44(6):1098-1110.
75.Andersen A, Krølner R, Bast LS, Thygesen LC, Due P. Effects of the X:IT smoking intervention: A school-based cluster randomized trial. Int J Epidemiol. 2015;44(6):1900-1908.
76.Gerald JK, Fisher JM, Brown MA, Clemens CJ, Moore MA, Carvajal SC. School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial. J Allergy Clin Immunol. 2019;143(2):755-764.
77.Peñalvo JL, Santos-Beneit G, Sotos-Prieto M, Bodega P, Oliva B, Orrit X. The SI! Program for cardiovascular health promotion in early childhood: A cluster-randomized trial. J Am Coll Cardiol. 2015;66(14):1525-1534.
78.Schonfeld DJ, Adams RE, Fredstrom BK, Weissberg RP, Gilman R, Voyce C. Cluster-randomized trial demonstrating impact on academic achievement of elementary social-emotional learning. Sch Psychol Q. 2015;30(3):406-420.
79.Sutherland RL, Campbell EM, Lubans DR, Morgan PJ, Nathan NK, Wolfenden L. The physical activity 4 everyone cluster randomized trial: 2-Year outcomes of a school physical activity intervention among adolescents. Am J Prev Med. 2016;51(2):195-205.
80.Kaufman ZA, DeCelles J, Bhauti K, Hershow RB, Weiss HA, Chaibva C. A sport-based intervention to increase uptake of voluntary medical male circumcision among adolescent male students: Results from the MCUTS 2 cluster-randomized trial in Bulawayo, Zimbabwe. Acquir Immune Defic Syndr. 2016;72(Suppl 4):S292-S298.
81.Sanchez ZM, Valente JY, Fidalgo TM, Leal AP, Medeiros PFP, Cogo-Moreira H. The role of normative beliefs in the mediation of a school-based drug prevention program: A secondary analysis of the #Tamojunto cluster-randomized trial. PLoS One. 2019;14(1):e0208072.
82.Dalma A, Petralias A, Tsiampalis T, Nikolakopoulos S, Veloudaki A, Kastorini CM. Effectiveness of a school food aid programme in improving household food insecurity: A cluster randomized trial. Eur J Public Health. 2020;30(1):171-178.
83.Valente JY, Cogo-Moreira H, Sanchez ZM. Decision-making skills as a mediator of the #Tamojunto school-based prevention program: Indirect effects for drug use and school violence of a cluster-randomized trial. Drug Alcohol Depend. 2020;206:107718.
84.Andrade S, Lachat C, Cardon G, Ochoa-Avilés A, Verstraeten R, Van Camp J. Two years of school-based intervention program could improve the physical fitness among Ecuadorian adolescents at health risk: Subgroups analysis from a cluster-randomized trial. BMC Pediatr. 2016;16:51.
85.Vik FN, Lien N, Berntsen S, De Bourdeaudhuij I, Grillenberger M, Manios Y. Evaluation of the UP4FUN intervention: A cluster randomized trial to reduce and break up sitting time in European 10-12-year-old children. PLoS One. 2015;10(3):e0122612.
86.Chard AN, Garn JV, Chang HH, Clasen T, Freeman MC. Impact of a school-based water, sanitation, and hygiene intervention on school absence, diarrhea, respiratory infection, and soil-transmitted helminths: Results from the WASH HELPS cluster-randomized trial. J Glob Health. 2019;9(2):020402.
87.Džiaugytė L, Aleksejūnienė J, Brukienė V, Pečiulienė V. Self-efficacy theory-based intervention in adolescents: A cluster randomized trial-focus on oral self-care practice and oral self-care skills. Int J Paediatr Dent. 2017;27(1):37-46.
88.Okely AD, Lubans DR, Morgan PJ, Cotton W, Peralta L, Miller J. Promoting physical activity among adolescent girls: The girls in sport group randomized trial. Int J Behav Nutr Phys Act. 2017;14(1):81.
89.Asdigian NL, Whitesell NR, Keane EM, Mousseau AC, Kaufman CE. Effects of the 'Circle of Life' HIV-prevention program on marijuana use among American Indian middle school youths: A group randomized trial in a Northern Plains tribe. Am J Drug Alcohol Abuse. 2018;44(1):120-128.
90.Bauer KW, Foster GD, Weeks HM, Polonsky HM, Davey A, Sherman S. Breakfast in the classroom initiative and students' breakfast consumption behaviors: A group randomized trial. Am J Public Health. 2020;110(4):540-546.
91.Peterson AVJr, Marek PM, Kealey KA, Bricker JB, Ludman EJ, Heffner JL. Does Effectiveness of Adolescent SmokingCessation Intervention Endure into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial. PLoS One. 2016;11(2):e0146459.
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Novododat članak: provera, normiranje i linkovanje referenci u toku.
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O članku

jezik rada: engleski
vrsta rada: originalan članak
DOI: 10.2298/VSP210708087P
primljen: 08.07.2021.
revidiran: 09.09.2021.
prihvaćen: 01.10.2021.
objavljen u SCIndeksu: 04.11.2022.
metod recenzije: dvostruko anoniman
Creative Commons License 4.0

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