CONSORT Statement- Checklist Articles Title : Managing back pain in pregnancy using a support garment: a randomized trial Author:

SM Kalus, LH Kornman, JA Quinlivan Published in : BJOG.2008 Jan; 11568-75

PAPER SECTION And topic TITLE & ABSTRACT INTRODUCTION Background Item 1 2 Descriptor How participants were allocated to interventions (e.g., "random allocation", "randomized", or "randomly assigned"). Scientific background and explanation of rationale. Reported on Page # Yes Yes It did not explain about the the specific devices used in the trial (Belly Bra and Tubigrip) whether there were similar trials previously about those devices (the benefits and harms/side effects of them) This is to justify whether it was ethical enough to conduct this trial Yes Yes Yes, the authors provided the primary and secondary aims of this study however they did not provided the hypotheses. Yes

METHODS Participants Interventions Objectives

3 4 5

Eligibility criteria for participants and the settings and locations where the data were collected. Precise details of the interventions intended for each group and how and when they were actually administered. Specific objectives and hypotheses.

Outcomes

Sample size

Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors). How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules.

Randomization -Sequence generation

Method used to generate the random allocation sequence, including details of any restrictions (e.g., blocking, stratification)

Randomization -Allocation concealment Randomization -Implementation Blinding (masking)

10 11

Statistical methods

12

Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned. Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups. Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated. Statistical methods used to compare groups for primary outcome(s); Methods for additional analyses, such as subgroup

Yes There is not any interim analysis and stopping rules. And I think it is all right since the study period relatively short (3 weeks) Yes, It does not mention any restrictions method. Although the baseline characteristics in the two group in this study were similar. I think it is important to consider a restriction to ensure the comparable baseline since this trial was relatively small. In a large trial simple randomization can be trusted to distribute equal characteristics in both groups. 70 paragraph 1

Not mentioned Not blinded

Yes It described methods to compare groups for primary and secondary outcomes,

analyses and adjusted analyses. RESULTS Participant flow 13 Flow of participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons. Dates defining the periods of recruitment and follow-up. Baseline demographic and clinical characteristics of each group.

however it did not mention about methods for subgroup analysis and adjusted analysis Yes There is no description about protocol deviations from study

Recruitment Baseline data

14 15

Yes No, There is no table about the details of the baseline demographic and clinical characteristics of the sample in each group. It only mentions that there were no significant differences in the baseline data (age, height, parity, or gestational age) Yes They only included all the samples that completed the study in the outcome analysis. Although they mentioned in the method section that the analysis will be based on the intention to treat analysis, they did not include the samples that did not complete the study. Yes

Numbers analyzed

16

Number of participants (denominator) in each group included in each analysis and whether the analysis was by "intention-totreat". State the results in absolute numbers when feasible (e.g., 10/20, not 50%).

Outcomes and estimation Ancillary analyses

17

18

Adverse events DISCUSSION Interpretation

19 20

Generalizability Overall evidence

21 22

For each primary and secondary outcome, a summary of results for each group, and the estimated effect size and its precision (e.g., 95% confidence interval). Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those pre-specified and those exploratory. All important adverse events or side effects in each intervention group. Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes. Generalizability (external validity) of the trial findings. General interpretation of the results in the context of current evidence.

Yes

Not mentioned Yes

Not mentioned It does not explain to whom the findings will be applicable Yes

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