Process

Questions

Question 1

Introduce myself and purpose: How do you do? I was a student of Lanzhou University, was doing a review about microwave tissue coagulation in the treatment of cervical ectropion. Purpose of my study was to compare the effects of variety randomisation methods. I had searched out a paper that published in (time, journal) written by you. Could you please tell me what method to be used in this trial?

Question 2

If the subject cannot describe the method clearly, change the question like this: could you please tell me when a new participant enrolled, how did you decide which group the participant should be allocated to?

Question 3

If there was any problem about the first author, the second author or others should be interviewed.

Question 4

Next two questions aim to understand the category of support source for investigated study, I selected one of them or both: (1) Was your study funded by government or any other source? (2) Was your study for new drug development?

Question 5

Judgment should be made immediately for whether it was a real RCT or not. If it be judged as real RCT, next questions aim to understand the status of allocation concealment: (1) Do you know allocation concealment? If so, please clarify. (2) Did you use any method to mask allocation sequence? If any, please clarify.

Question 6

Next question aims to understand the validity of blinding particularly pay attention to whether the detector was blinded or not: Please tell me who were blinded in your trial?

Question 7

We said "thank you" to author.

Question 8

Finally, We needed to judge whether the subject knew well the trial principle or not: if anyone persisted in the method of randomisation as correct but actually wrong or ineligible, it should be judged didn't know; if anyone claimed that "I knew we performed not good enough" or "it was impossible to perform a completely correct RCT" and so on, it should be judged as knew well about the principle of trial but violated knowingly claimed the non‐RCT as RCT.

Question 9

Put all of record in the form.

Study

Song 1994

Methods

Randomization method not stated.
Parallel, single centre, single blinded study.
Number of women randomised: n = 300;
Number of women analysed: n = 300.
Units of comparison: individuals.
Source of funding: unclear.

RCT duration: from Jan 1991 to May 1992

Participants

Inclusion criteria: women with cervical ectropion. Macroscopic examination: discriminating acute with chronic cervicitis.
Age: MTC group (n = 154): 19 to 57 years (mean age 33);
Laser group (n = 146): 28 to 54 years (mean age 35).
Average gravidity: MTC group: 2.2; laser group: 1.9.
Average parity: MTC group: 1.0; laser group: 1.0.
Grade II: MTC group: 32; laser group: 43;
Grade III: MTC group: 122; laser group: 103.
Symptom: unclear.
Exclusion criteria: excluded women with cervical intraepithelial neoplasia (CIN1, 2, 3), cancer in situ or early cervical cancer which were diagnosed through Papanicolaou test and/or histological examination or colposcopy. Excluded women with vaginal or cervical infection.
Source of participants: medical outpatients.

Interventions

Treatment: MTC;
Control: CO2 laser.
Timing of treatment: during 3 to 7 days after menstrual period (once).

Outcomes

Efficacy: cure rate (according to appearance of cervix).
Adverse effect: bleeding during operation, bellyache during operation, bleeding post‐operation, topical infection bleeding post‐operation.
The follow‐up period: 8‐12 weeks.

Note

Location: China

Setting: Department of Gynaecology and Obstetrics of Chaoyang Hospital

Funding: unclear

Study

Wang 2003

Methods

Randomisation: random digits table;
Parallel, single centre, no blinding.
Number of women randomised: n = 120;
Number of women analysed: n = 120.
Units of comparison: individuals.
Source of funding: unclear.

RCT duration: from Aug 2001 to Oct 2001.

Participants

Inclusion criteria: women with cervical ectropion.
Age: MTC group (n = 60): unclear;
Laser group (n = 60): unclear.
Grade I: MTC group: 8; laser group: 9;
Grade II: MTC group: 27; laser group: 28;
Grade III: MTC group: 25; laser group: 23;
Simple pattern: MTC group: 42; laser group: 43;
Granular pattern or Mammilla pattern: MTC group: 18; laser group: 17.
Symptom: unclear.
Exclusion criteria: Excluded women with cervical intraepithelial neoplasia (CIN1, 2, 3), cancer in situ or early cervical cancer. Excluded women with vaginal or cervical infection.
Source of participants: not stated.

Interventions

Treatment: MTC;

Control: CO₂ laser.
Timing of treatment: during 3 to 7 days after menstrual period (once).

Outcomes

Efficacy: Cure rate (According to appearance of cervix);
Adverse effect: vaginal discharge post‐treatment.
The follow‐up period: 2,3,4,6,8,12 weeks.

Note

Location: China.

Setting: Shiyan Maternal and Child Health Hospital, Hubei.

Funding: unclear.

Study

Xu 2004

Methods

Randomisation: random digits table;
Parallel, single centre, no blinding.
Number of women randomised: n = 120;
Number of women analysed: n = 120.
Units of comparison: individuals.
Source of funding: Unclear.
RCT duration: from Jun 2000 to May 2002.

Participants

Inclusion criteria: women with cervical ectropion. Papanicolaou test: Grade I or II.
Age: 23 to 50 years (mean age 33).
Grade I: MTC group: 15; Laser group: 13;
Grade II: MTC group: 27; Laser group: 28;
Grade III: MTC group: 19; Laser group: 18.
Symptom: unclear.
Exclusion criteria: not reported.
Source of participants: medical outpatient.

Interventions

Treatment: MTC (once);
Control: interferon‐alpha suppository (aoping suppository): 6000 U once/two days; duration: 6‐10 days. (Repeat it after next menstrual period).
Timing of treatment: during 3 to 7 days after menstrual period.

Outcomes

Efficacy: cure rate (according to appearance of cervix);
Adverse effect: vaginal discharge post‐treatment.
The follow‐up period: 8,to 12 weeks.

Note

Location: China

Setting: Department of Gynaecology and Obstetrics of The First Hospital of Nanping, Fujian.

Funding: unclear

Study ID

Song 1994

Xu 2004

Wang 2003

Design

Parallel single‐centre.

Parallel single‐centre.

Parallel single‐centre.

Adequate sequence generation?

Yes.

Yes(random number table).

Yes(random number table).

Allocation concealment?

Yes(envelopes).

No.

No.

Blinding?

Yes (Single: participants).

No.

No.

Incomplete outcome data addressed?

Unclear.

Unclear.

Unclear.

Free of selective reporting?

Unclear.

Unclear.

Unclear.

Free of other bias?

Unclear.

Unclear.

Unclear.

Power calculation

Unclear.

Unclear.

Unclear.