Dashti‐Khavidaki 2013.

Study characteristics
Methods	Study design Cluster RCT Study dates Duration of follow‐up: 6 months Time frame: October 2010 to October 2011
Participants	Study characteristics Setting: single centre (HD ward of Imam Khomeini Hospital, affiliated to Tehran University of Medical Sciences) Country: Iran Inclusion criteria: aged 18 and 90 years; HD for at least 3 months; 3 times/week for 4 hours in each session using polysulfone membrane and bicarbonate buffer Exclusion criteria: positive history of dementia or other conditions that impair answering the questionnaire; unable to speak Persian Baseline characteristics Number (analysed/randomised): intervention group (26/45); control group (34/47) Mean age ± SD (years): intervention group (55.4 ± 15.7); control group (48.6 ± 14.7) Sex (M/F): intervention group (14/12); control group (22/12) Dialysis type: HD Mean dialysis vintage ± SD (years): intervention group (7.75 ± 6.93); control group (5.7 ± 6.65) Comorbidities CVD: not reported Diabetes: not reported Hypertension: not reported Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group Pharmacist‐led pharmaceutical care in addition to the standard care Control group Standard care: brief medication review by nurses and monthly visits by nephrology fellow and attending physicians Co‐interventions Not reported
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available QoL SF‐36: assessed at baseline and at 6 months Physical function Role‐physical Role‐emotional Social function Pain General health Emotional well‐being (mental health) Energy/fatigue (vitality) Laboratory data (Hb and ferritin levels, TSAT, serum calcium, phosphate, intact PTH, albumin, LDL‐cholesterol): assessed at baseline and at 6 months Calcium‐phosphate product: assessed at baseline and at 6 months Clinical data: assessed at baseline and at 6 months Death: assessed until the end of treatment Kidney transplant: assessed until the end of treatment Hospitalisation: assessed until the end of treatment
Notes	Additional information Funding: This study was part of a Pharm. D thesis supported by Tehran University of Medical Sciences Conflicts of interest/disclosures: none Trial registration identification number: not reported A priori published protocol: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Sequence generation methods were not reported in sufficient detail to permit judgement
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 participants and/or investigators could be aware of the treatment assigned
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "SF‐36 was completed by patients and was read for patients who were unable to read." Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. 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. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	High risk	Quote: "Of these 92 patients, 45 and 47 patients assigned to the case and control groups respectively. Twenty‐six patients in the case group and 34 subjects in the control group completed the study." Comment: 26/45 participants in the intervention group and 34/47 participants in the control group completed the study (> 5% lost to follow‐up, with differences between group). 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 not reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was 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	Low risk	There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. The study seemed to be free from other source of bias