Systematic review and pooled analysis of randomized controlled trials in countries of the Gulf Cooperation Council (GCC): Methods and quality assessment

Khalid S. Alraddadi; Fayzah H. Al-Adwani; Rajaa M. Al-Raddadi; Sultan H. Alamri; Iman K. Ramadan; Ahmad A. Mirza

doi:10.15537/smj.2023.44.4.20220664

References

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1. Chung JH,
2. Lee SW.
Assessing the quality of randomized controlled urological trials conducted by Korean medical institutions. Korean J Urol 2013; 54: 289–296.
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1. Sackett DL,
2. Rosenberg WM,
3. Gray JA,
4. Haynes RB,
5. Richardson WS.
Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312: 71–72.
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1. Uetani K,
2. Nakayama T,
3. Ikai H,
4. Yonemoto N,
5. Moher D.
Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement. Intern Med 2009; 48: 307–313.
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1. You YN,
2. Cho MR,
3. Park JH,
4. Park GC,
5. Song MY,
6. Choi JB, et al.
Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia. Trials 2017; 18: 205.
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5.↵
1. Lim SM,
2. Shin ES,
3. Lee SH,
4. Seo KH,
5. Jung YM,
6. Jang JE.
Tools for assessing quality and risk of bias by levels of evidence. J Korean Med Assoc 2011; 54: 419–429.
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1. Mokdad AH,
2. Jaber S,
3. Aziz MI,
4. AlBuhairan F,
5. AlGhaithi A,
6. AlHamad NM, et al.
The state of health in the Arab world, 1990-2010: an analysis of the burden of diseases, injuries, and risk factors. Lancet 2014; 383: 309–320.
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7.↵
1. Saquib N,
2. Ibrahim AY,
3. Saquib J.
Behavioral trials in the Arab Gulf States: A scoping review. SAGE Open Med 2019; 7: 2050312119846787.
OpenUrl
8.↵
1. Higgins JPT,
2. Churchill R,
3. Chandler J,
4. Cumpton MS
1. Higgins JPT,
2. Altman DG,
3. Sterne JAC.
Assessing risk of bias in included studies. In: Higgins JPT, Churchill R, Chandler J, Cumpton MS, eds. Cochrane Handbook for Systematic Reviews of Intervantions version 5.2.0. Cochrane; 2017.
9.↵
1. Rajab AM,
2. Hamza A,
3. Aldairi RK,
4. Alaloush MM,
5. Saquib J,
6. Saquib N.
Systematic review on the quality of randomized controlled trials from Saudi Arabia. Contemp Clin Trials Commun 2019; 16: 100441.
OpenUrl
10.↵
1. AlKabba AF,
2. Hussein G,
3. Kasule OH,
4. Jarallah J,
5. Alrukban M,
6. Alrashid A.
Teaching and evaluation methods of medical ethics in the Saudi public medical colleges: cross-sectional questionnaire study. BMC Med Educ 2013; 13: 1–8.
OpenUrl CrossRef PubMed
11.
1. Latif R.
Medical and biomedical research productivity from the Kingdom of Saudi Arabia (2008-2012). J Family Community Med 2015; 22: 25–30.
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1. Al-Bishri J.
Evaluation of biomedical research in Saudi Arabia. Saudi Med J 2013; 34: 954–959.
OpenUrl
13.↵
1. Page MJ,
2. McKenzie JE,
3. Bossuyt PM,
4. Boutron I,
5. Ho mann TC,
6. Mulrow CD, et al.
The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372: n71.
OpenUrl FREE Full Text
14.↵
1. Chung W,
2. Lee KW,
3. Hwang IH,
4. Lee DH,
5. Kim SY.
Quality assessment of randomized controlled trials in the Journal of the Korean Academy of Family Medicine. Korean J Fam Med 2009; 30:626–631.
OpenUrl
15.↵
1. Keech A,
2. Pike R,
3. Granger R,
4. Gebski V.
Interpreting the results of a clinical trial. Med J Aust 2007; 186: 318–319.
OpenUrl PubMed
16.↵
1. Schulz KF,
2. Chalmers I,
3. Hayes RJ,
4. Altman DG.
Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273: 408–412.
OpenUrl CrossRef PubMed Web of Science
17.
1. Moher D,
2. Pham B,
3. Jones A,
4. Cook DJ,
5. Jadad AR,
6. Moher M, et al.
Does quality of reports of randomized trials affect estimates of intervention efficacy reported in metaanalyses? Lancet 1998; 352: 609–613.
OpenUrl CrossRef PubMed Web of Science
18.
1. Wood L,
2. Egger M,
3. Gluud LL,
4. Schulz KF,
5. Jüni P,
6. Altman DG, et al.
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008; 336: 601–605.
OpenUrl Abstract/FREE Full Text
19.
1. Kunz R,
2. Vist G,
3. Oxman AD.
Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2007: MR000012.
20.↵
1. Kunz R,
2. Oxman AD.
The unpredictability paradox: rovicw of empirical comparisons of randomized and non-randomized clinical trials. BMJ 1998; 317: 1185–1190.
OpenUrl Abstract/FREE Full Text
21.↵
1. Morissette K,
2. Tricco AC,
3. Horsley T,
4. Chen MH,
5. Moher D.
Blinded versus unblinded assessments of risk of bias in studies included in a systematic review. Cochrane Database Syst Rev 2011; 2011: MR000025.
OpenUrl
22.↵
1. Hartling L,
2. Ospina M,
3. Liang Y,
4. Dryden DM,
5. Hooton N,
6. Krebs Seida J, et al.
Risk of bias versus quality assessment of randomised controlled trials: cross sectional study. BMJ 2009; 339: b4012.
OpenUrl Abstract/FREE Full Text
23.↵
1. Alfahmi H,
2. Aldawood L,
3. Baz B,
4. Elrggal M,
5. Alsharif HY,
6. Alkahtani SA.
Quality of methodological reporting of randomized clinical trials of sodium-glucose cotransporter-2 (sglt2) inhibitors. Arch Pharma Pract 2017; 8: 78–81.
OpenUrl
24.↵
1. Zhang D,
2. Yin P,
3. Freemantle N,
4. Jordan R,
5. Zhong N,
6. Cheng KK.
An assessment of the quality of randomised controlled trials conducted in China. Trials 2008; 9: 22.
OpenUrl CrossRef PubMed
25.↵
1. Schulz KF,
2. Grimes DA.
Allocation concealment in randomised trials: defending against deciphering. Lancet 2002; 359: 614–618.
OpenUrl CrossRef PubMed Web of Science
26.↵
1. Prescott RJ,
2. Counsell CE,
3. Gillespie WJ,
4. Grant AM,
5. Russell IT,
6. Kiauka S, et al.
Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999; 3: 1–143.
OpenUrl CrossRef PubMed

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Keywords

[1] 1.↵
Chung JH,
Lee SW.
Assessing the quality of randomized controlled urological trials conducted by Korean medical institutions. Korean J Urol 2013; 54: 289–296.
OpenUrl

[2] Chung JH,

[3] Lee SW.

[4] 2.↵
Sackett DL,
Rosenberg WM,
Gray JA,
Haynes RB,
Richardson WS.
Evidence based medicine: what it is and what it isn’t. BMJ 1996; 312: 71–72.
OpenUrl FREE Full Text

[5] Sackett DL,

[6] Rosenberg WM,

[7] Gray JA,

[8] Haynes RB,

[9] Richardson WS.

[10] 3.↵
Uetani K,
Nakayama T,
Ikai H,
Yonemoto N,
Moher D.
Quality of Reports on Randomized Controlled Trials Conducted in Japan: Evaluation of Adherence to the CONSORT Statement. Intern Med 2009; 48: 307–313.
OpenUrl PubMed

[11] Uetani K,

[12] Nakayama T,

[13] Ikai H,

[14] Yonemoto N,

[15] Moher D.

[16] 4.↵
You YN,
Cho MR,
Park JH,
Park GC,
Song MY,
Choi JB, et al.
Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia. Trials 2017; 18: 205.
OpenUrl

[17] You YN,

[18] Cho MR,

[19] Park JH,

[20] Park GC,

[21] Song MY,

[22] Choi JB, et al.

[23] 5.↵
Lim SM,
Shin ES,
Lee SH,
Seo KH,
Jung YM,
Jang JE.
Tools for assessing quality and risk of bias by levels of evidence. J Korean Med Assoc 2011; 54: 419–429.
OpenUrl

[24] Lim SM,

[25] Shin ES,

[26] Lee SH,

[27] Seo KH,

[28] Jung YM,

[29] Jang JE.

[30] 6.↵
Mokdad AH,
Jaber S,
Aziz MI,
AlBuhairan F,
AlGhaithi A,
AlHamad NM, et al.
The state of health in the Arab world, 1990-2010: an analysis of the burden of diseases, injuries, and risk factors. Lancet 2014; 383: 309–320.
OpenUrl CrossRef PubMed

[31] Mokdad AH,

[32] Jaber S,

[33] Aziz MI,

[34] AlBuhairan F,

[35] AlGhaithi A,

[36] AlHamad NM, et al.

[37] 7.↵
Saquib N,
Ibrahim AY,
Saquib J.
Behavioral trials in the Arab Gulf States: A scoping review. SAGE Open Med 2019; 7: 2050312119846787.
OpenUrl

[38] Saquib N,

[39] Ibrahim AY,

[40] Saquib J.

[41] 8.↵
Higgins JPT,
Churchill R,
Chandler J,
Cumpton MS
Higgins JPT,
Altman DG,
Sterne JAC.
Assessing risk of bias in included studies. In: Higgins JPT, Churchill R, Chandler J, Cumpton MS, eds. Cochrane Handbook for Systematic Reviews of Intervantions version 5.2.0. Cochrane; 2017.

[42] Higgins JPT,

[43] Churchill R,

[44] Chandler J,

[45] Cumpton MS

[46] Higgins JPT,

[47] Altman DG,

[48] Sterne JAC.

[49] 9.↵
Rajab AM,
Hamza A,
Aldairi RK,
Alaloush MM,
Saquib J,
Saquib N.
Systematic review on the quality of randomized controlled trials from Saudi Arabia. Contemp Clin Trials Commun 2019; 16: 100441.
OpenUrl

[50] Rajab AM,

[51] Hamza A,

[52] Aldairi RK,

[53] Alaloush MM,

[54] Saquib J,

[55] Saquib N.

[56] 10.↵
AlKabba AF,
Hussein G,
Kasule OH,
Jarallah J,
Alrukban M,
Alrashid A.
Teaching and evaluation methods of medical ethics in the Saudi public medical colleges: cross-sectional questionnaire study. BMC Med Educ 2013; 13: 1–8.
OpenUrl CrossRef PubMed

[57] AlKabba AF,

[58] Hussein G,

[59] Kasule OH,

[60] Jarallah J,

[61] Alrukban M,

[62] Alrashid A.

[63] 11.
Latif R.
Medical and biomedical research productivity from the Kingdom of Saudi Arabia (2008-2012). J Family Community Med 2015; 22: 25–30.
OpenUrl

[64] Latif R.

[65] 12.↵
Al-Bishri J.
Evaluation of biomedical research in Saudi Arabia. Saudi Med J 2013; 34: 954–959.
OpenUrl

[66] Al-Bishri J.

[67] 13.↵
Page MJ,
McKenzie JE,
Bossuyt PM,
Boutron I,
Ho mann TC,
Mulrow CD, et al.
The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372: n71.
OpenUrl FREE Full Text

[68] Page MJ,

[69] McKenzie JE,

[70] Bossuyt PM,

[71] Boutron I,

[72] Ho mann TC,

[73] Mulrow CD, et al.

[74] 14.↵
Chung W,
Lee KW,
Hwang IH,
Lee DH,
Kim SY.
Quality assessment of randomized controlled trials in the Journal of the Korean Academy of Family Medicine. Korean J Fam Med 2009; 30:626–631.
OpenUrl

[75] Chung W,

[76] Lee KW,

[77] Hwang IH,

[78] Lee DH,

[79] Kim SY.

[80] 15.↵
Keech A,
Pike R,
Granger R,
Gebski V.
Interpreting the results of a clinical trial. Med J Aust 2007; 186: 318–319.
OpenUrl PubMed

[81] Keech A,

[82] Pike R,

[83] Granger R,

[84] Gebski V.

[85] 16.↵
Schulz KF,
Chalmers I,
Hayes RJ,
Altman DG.
Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273: 408–412.
OpenUrl CrossRef PubMed Web of Science

[86] Schulz KF,

[87] Chalmers I,

[88] Hayes RJ,

[89] Altman DG.

[90] 17.
Moher D,
Pham B,
Jones A,
Cook DJ,
Jadad AR,
Moher M, et al.
Does quality of reports of randomized trials affect estimates of intervention efficacy reported in metaanalyses? Lancet 1998; 352: 609–613.
OpenUrl CrossRef PubMed Web of Science

[91] Moher D,

[92] Pham B,

[93] Jones A,

[94] Cook DJ,

[95] Jadad AR,

[96] Moher M, et al.

[97] 18.
Wood L,
Egger M,
Gluud LL,
Schulz KF,
Jüni P,
Altman DG, et al.
Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008; 336: 601–605.
OpenUrl Abstract/FREE Full Text

[98] Wood L,

[99] Egger M,

[100] Gluud LL,

[101] Schulz KF,

[102] Jüni P,

[103] Altman DG, et al.

[104] 19.
Kunz R,
Vist G,
Oxman AD.
Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2007: MR000012.

[105] Kunz R,

[106] Vist G,

[107] Oxman AD.

[108] 20.↵
Kunz R,
Oxman AD.
The unpredictability paradox: rovicw of empirical comparisons of randomized and non-randomized clinical trials. BMJ 1998; 317: 1185–1190.
OpenUrl Abstract/FREE Full Text

[109] Kunz R,

[110] Oxman AD.

[111] 21.↵
Morissette K,
Tricco AC,
Horsley T,
Chen MH,
Moher D.
Blinded versus unblinded assessments of risk of bias in studies included in a systematic review. Cochrane Database Syst Rev 2011; 2011: MR000025.
OpenUrl

[112] Morissette K,

[113] Tricco AC,

[114] Horsley T,

[115] Chen MH,

[116] Moher D.

[117] 22.↵
Hartling L,
Ospina M,
Liang Y,
Dryden DM,
Hooton N,
Krebs Seida J, et al.
Risk of bias versus quality assessment of randomised controlled trials: cross sectional study. BMJ 2009; 339: b4012.
OpenUrl Abstract/FREE Full Text

[118] Hartling L,

[119] Ospina M,

[120] Liang Y,

[121] Dryden DM,

[122] Hooton N,

[123] Krebs Seida J, et al.

[124] 23.↵
Alfahmi H,
Aldawood L,
Baz B,
Elrggal M,
Alsharif HY,
Alkahtani SA.
Quality of methodological reporting of randomized clinical trials of sodium-glucose cotransporter-2 (sglt2) inhibitors. Arch Pharma Pract 2017; 8: 78–81.
OpenUrl

[125] Alfahmi H,

[126] Aldawood L,

[127] Baz B,

[128] Elrggal M,

[129] Alsharif HY,

[130] Alkahtani SA.

[131] 24.↵
Zhang D,
Yin P,
Freemantle N,
Jordan R,
Zhong N,
Cheng KK.
An assessment of the quality of randomised controlled trials conducted in China. Trials 2008; 9: 22.
OpenUrl CrossRef PubMed

[132] Zhang D,

[133] Yin P,

[134] Freemantle N,

[135] Jordan R,

[136] Zhong N,

[137] Cheng KK.

[138] 25.↵
Schulz KF,
Grimes DA.
Allocation concealment in randomised trials: defending against deciphering. Lancet 2002; 359: 614–618.
OpenUrl CrossRef PubMed Web of Science

[139] Schulz KF,

[140] Grimes DA.

[141] 26.↵
Prescott RJ,
Counsell CE,
Gillespie WJ,
Grant AM,
Russell IT,
Kiauka S, et al.
Factors that limit the quality, number and progress of randomised controlled trials. Health Technol Assess 1999; 3: 1–143.
OpenUrl CrossRef PubMed

[142] Prescott RJ,

[143] Counsell CE,

[144] Gillespie WJ,

[145] Grant AM,

[146] Russell IT,

[147] Kiauka S, et al.

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Methods and quality assessment

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Methods and quality assessment

References

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