Search terms

Unless otherwise stated, search terms are free text terms; MeSH = Medical subject heading (Medline medical index term); exp = exploded MeSH; the dollar sign ($) stands for any character(s); the question mark (?) = to substitute for one or no characters; tw = text word; pt = publication type; sh = MeSH; adj = adjacent.

A) Diabetes mellitus, general

1 exp diabetes mellitus/
2 diabet$.tw.
3 IDDM.tw.
4 NIDDM.tw.
5 MODY.tw.
6 insulin$ secret$ dysfunc$.tw.
7 impaired glucose toleran$.tw.
8 exp glucose intolerance/
9 glucose intoleran$.tw.
10 exp insulin resistance/
11 insulin$ resist$.tw.
12 (non insulin$ depend$ or noninsulin$ depend$ or
non insulin?depend$ or noninsulin?depend$).tw.
13 (insulin? depend$ or insulin?depend$).tw
14 metabolic$ syndrom$.tw.
15 (pluri metabolic$ syndrom$ or plurimetabolic$ syndrom$).tw.
16 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15
17 exp diabetes insipidus/
18 diabet$ insipidus.tw.
19 17 or 18
20 16 not 19

B) Controlled trials*

21 randomized‐controlled trial.pt.
22 controlled‐clinical trial.pt.
23 randomized‐controlled‐trials.sh.
24 random allocation.sh.
25 double‐blind method.sh.
26 single‐blind method.sh.
27 21 or 22 or 23 or 24 or 25 or 26
28 animal.sh.
29 human.sh.
30 28 not 29
31 27 not 30

C) Glycaemic index or glycaemic load

32 (diet adj5 glyc?emic$).tw.
33 Glycemic Index/ or glyc?emic index.tw.
34 (all bran or wholegrain or pasta or oat$ or apple$ or appricot$ or bean$ or lentil$ or wheat bran or barley porridge or raw oats or basmati rice).ti, ab.
35 (gi adj10 (diet or food or carbohydrate$)).tw.
36 (food adj5 glyc?emic$).tw.
37 (carbohydrate$ adj5 (blood glucose or blood sugar) adj5 (low or less$ or high$)).tw.
38 (puls$ adj10 (diet or food)).tw.
39 lentil$.tw.
40 or/32‐39
41 dietary carbohydrates/
42 blood glucose.sh,rn,rw.
43 41 and 42
44 40 or 43

D) Systematic reviews, meta‐analyses, health‐technology assessment reports
45 exp meta‐analysis/
46 exp Review Literature/
47 meta‐analysis.pt.
48 systematic review$.tw.
49 search$.tw.
50 medline.tw.
51 cochrane database of systematic reviews.jn.
52 45 or 46 or 47 or 48 or 49 or 50 or 51
53 letter.pt.
54 comment.pt.
55 editorial.pt.
56 historical‐article.pt.
57 53 or 54 or 55 or 56
58 52 not 57
59 exp Technology Assessment, Biomedical/
60 HTA.tw.
61 (health technology adj6 assessment$).tw.
62 (biomedical adj6 technology assessment$).tw.
63 60 or 61 or 62
64 58 or 63

65 31 or 64
66 20 and 44
67 65 and 66

* Robinson KA, Dickersin K. Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. International Journal of Epidemiology 2002;31:150‐3.

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1: Pioglitazone
I2: Rosiglitazone
C1: Placebo

Randomised controlled clinical trial (RCT)

Non‐inferiority / equivalence trial

Controlled clinical trial

Design: parallel, crossover, factorial RCT

Design: crossover study

Design: factorial study

Crossover study: wash‐out phase

Crossover study: carryover effect tested

Crossover study: period effect tested

Method of randomisation

Unit of randomisation (individuals, cluster ‐ specify)

Randomisation stratified for centres

Randomisation ratio

Concealment of allocation

Stated blinding (open; single, double, triple blind)

Actual blinding: participant

Actual blinding: caregiver / treatment administrator

Actual blinding: outcome assessor

Actual blinding: others

Blinding checked: participant

Blinding checked: caregiver / treatment administrator

Primary endpoint defined

[n] of primary endpoint(s)

[n] of secondary endpoints

Total [n] of endpoints

Prior publication of study design

Outcomes of prior / current publication identical

Power calculation

[n] participants per group calculated

Non‐inferiority trial: interval for equivalence specified

Intention‐to‐treat analysis (ITT)

Per‐protocol‐analysis

ITT defined

Analysis stratified for centres

Missing data: last‐observation‐carried‐forward (LOCF)

Missing data: other methods

LOCF defined

[n] of screened participants (I1/ I2 / C1 / total)

[n] of randomised participants (I1/ I2 / C1 / total)

I1: 400
I2: 350
C1: 700
Total: 1450

[n] of participants finishing the study (I1/ I2 / C1 / total)

[n] of patients analysed (I1/ I2 / C1 / total)

Description of discontinuing participants

Drop‐outs (reasons explained)

Withdrawals (reasons explained)

Losses‐to‐follow‐up (reasons explained)

[n] of participants who discontinued (I1/ I2 / C1 / total)

[%] discontinuation rate (I1/ I2 / C1 / total)

Discontinuation rate similar between groups

[%] crossover between groups

Differences [n] calculated to analysed patients

[n] of subgroups

Subgroups: pre‐defined

Subgroups: post‐hoc

[n] of statistical comparisons

Adjustment for multiple outcomes / repeated measurements

Baseline characteristics: clinically relevant differences

Treatment identical (apart from intervention)

Timing of outcomes' measurement comparable between groups

Compliance measured

Other important covariates measured (specify)

Co‐morbidities measured

Co‐medications measured

Specific doubts about study quality

Funding: commercial

Funding: non‐commercial

Publication status: peer review journal

Publication status: journal supplement

Publication status: abstract

Publication status: other

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1: Pioglitazone
I2: Rosiglitazone
C1: Placebo

[n] (I1/ I2 / C1 / total)

Sex [n,%] (I1/ I2 / C1 / total)

Age [years] mean (SD) (I1/ I2 / C1 / total)

I1: 43 (12)
I2: 41 (11)
C: 45 (12)
Total: 42 (10)

Ethnic groups [%] (I1/ I2 / C1 / total)

Duration of disease [years] mean (SD) (I1/ I2 / C1 / total)

Body mass index [kg/m2] mean (SD) (I1/ I2 / C1 / total)

Pharmaco‐naive patients [n,%] (I1/ I2 / C1 / total)

Co‐morbidity [%] (I1/ I2 / C1 / total)

Co‐medication [%] (I1/ I2 / C1 / total)

HbA1c [%] mean (SD) (I1/ I2 / C1 / total)

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear
I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1: Pioglitazone
I2: Rosiglitazone
C1: Placebo

[n] of participants who died

[n] adverse events (I1/ I2 / C1 / total)

[%] adverse events (I1/ I2 / C1 / total)

[n] serious adverse events (I1/ I2 / C1 / total)

[%] serious adverse events (I1/ I2 / C1 / total)

[n] drop‐outs due to adverse events (I1/ I2 / C1 / total)

I1: 3/40
I2: 5/30
C1: 6/50
Total: 14/120

[%] drop‐outs due to adverse events (I1/ I2 / C1 / total)

[n] hospitalisation (I1/ I2 / C1 / total)

[%] hospitalisation (I1/ I2 / C1 / total)

[n] out‐patient treatment (I1/ I2 / C1 / total)

[%] out‐patient treatment (I1/ I2 / C1 / total)

[n] hypoglycaemic episodes (I1/ I2 / C1 / total)

[%] hypoglycaemic episodes (I1/ I2 / C1 / total)

[n] severe hypoglycaemic episodes (I1/ I2 / C1 / total)

[%] severe hypoglycaemic episodes (I1/ I2 / C1 / total)

[n] nocturnal hypoglycaemic episodes (I1/ I2 / C1 / total)

[%] nocturnal hypoglycaemic episodes (I1/ I2 / C1 / total)

[n] with symptoms (I1/ I2 / C1 / total)

[%] with symptoms (I1/ I2 / C1 / total)

Symbols & abbreviations: Y = yes; N = no; ? = unclear I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1: Pioglitazone
I2: Rosiglitazone
C1: Placebo

All‐cause mortality: [n] of participants who died
(I1/ I2 / C1 / total)"

I1: 2/200
I2: 1/300
C1: 2/500
Total: 5/1000

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear I = intervention; C = control

Characteristic

Study a

Study b

Study c

Study d

Study e

Intervention 1 (I1) / intervention 2 (I2) / control 1 (C1)

I1: Pioglitazone
I2: Rosiglitazone
C1: Placebo

Weight change [kg] at 12 weeks (mean/SD)
(I1/ I2 / C1 / total)

I1: ‐2.5 (1.2)
I2: ‐1.3 (0.8)
C1: +0.3 (0.4)
Total: ‐1.2 (0.9)

Notes

Symbols & abbreviations: Y = yes; N = no; ? = unclear; I = intervention; C = control