Thomas 2017.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 8 weeks Time frame: March to July 2016
Participants	Study characteristics Setting: single centre (Jewish General Hospital HD unit, Montreal) Country: Canada Inclusion criteria: patients on HD who speak English or French and had depression and/or anxiety symptoms as indicated by scores of ≥ 6 on the PHQ‐9 and/or GAD‐7 scales Exclusion criteria: significant cognitive impairment (determined by an abnormal score on the Mini‐Cog); current psychosis; or acute suicidal ideation with intent Baseline characteristics Number (analysed/randomised): intervention group (17/21); control group (15/20) Mean age ± SD (years): intervention group (66 ± 13); control group (64 ± 14) Sex (M/F): intervention group (14/7); control group (13/7) Dialysis type: HD Mean dialysis vintage ± SD (years): intervention group (5 ± 7); control group (3 ± 3) Comorbidities CVD: not reported Diabetes: intervention group (11/21); control group (15/20) Hypertension: intervention group (16/21); control group (16/20) Depression (clinician diagnosis): intervention group (21/21); control group (20/20)
Interventions	Intervention classification Non‐pharmacological intervention Indication: study reporting fatigue Intervention group Mindfulness meditation Control group Treatment‐as‐usual without intervention Co‐interventions Both control and intervention groups received Psychoeducational literature on anxiety and depression
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available (fatigue was reported as an adverse event) Proportion of participants screened as eligible who enrolled: assessed at 8 weeks Proportion of participants who completed the 8‐week trial in the intervention arm (completed ≥ 13 sessions and stayed with the intervention until week 8): assessed at 8 weeks Patient's satisfaction of the intervention provided "How much they enjoyed” each mindfulness practice (scale of 1 to 10, estimated their frequency of independent meditative practice over the last week, and assess the improvement in "courage”, “hope”, “dignity”, “self‐confidence"): assessed at 8 weeks Adverse events: assessed at 8 weeks: (including fatigue post‐dialysis) Intervention tolerability 10‐point Likert scale: assessed at 8 weeks Change in depression PHQ‐9 (Appendix 3): assessed during 8‐week follow‐up Change in anxiety GAD‐7 (Appendix 3): assessed during 8‐week follow‐up Hospitalisation: assessed at 8 weeks
Notes	Additional information Funding: Hoffman‐La Roche Ltd and Lundbeck Canada Inc. S.R. is supported by the Canadian Institute of Health Research Fellowship Award and Fonds de Recherche Santé Québec Chercheur‐ Boursier Clinicien Junior Investigator Award. This study was also supported by charitable donations to the Jewish General Hospital Division of Geriatric Psychiatry Conflicts of interest/disclosures: none Trial registration identification number: NCT02686333 A priori published protocol was reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The interventionists randomised the participant codes to the intervention group or the control group, using a simple 1:1 computer‐generated sequence." Comment: A computer‐generated sequence is considered as low risk of bias. No imbalance between intervention groups was apparent
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not reported. However, interventions were different and investigators/participants could be aware of the treatment assigned
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Participants completed questionnaires with an independent assessor who then assigned each of them an anonymous code.The interventionists, who were not involved in the recruitment process and patient assessment, randomised the participant codes to the intervention group or the control group, using a simple 1:1 computer‐generated sequence." [...] "This study was a randomised, controlled, assessor‐blinded trial conducted in an urban haemodialysis unit. Both the assessor and the statistical associate were blinded to randomisation allocation." Comment: Fatigue was assessed as an adverse event. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. Other subjective outcomes were assessed. Not sure if the outcome assessment was blinded
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Of missed sessions, 55% were due to logistic issues (switches in the location or time of assigned haemodialysis shifts) and 45% were due to refusals (most common reasons given were “too tired” or “too ill” on the given day). Five patients dropped out early in treatment (<2 sessions) for “feeling too medically ill” (n=1), “feeling already improved” (n=1), and “lack of interest” (n=3). One patient stopped after five sessions when they were transferred to home peritoneal dialysis therapy." Comment: 17/21 participants in the intervention group and 15/20 participants in the control group participants completed the study (> 5% lost to follow‐up, with difference between groups). Reasons for discontinuations seemed to be not related to the treatment allocation
Selective reporting (reporting bias)	High risk	Information about the protocol and the statistical analysis plan were reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was not reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	High risk	There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding (pharmaceutical company) could influence the data analysis and authors did not have conflicts of interest