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Table 1 Included studies and their characteristics

From: Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review

First author

Year

Country

Intervention arm (number)

Control arm (number)

Type of cluster

Type of patients

Type of intervention

Primary outcome

Clusters

Patients

Clusters

Patients

Sehgal [28]

2002

USA

21

85

23

84

Individual providers

Prevalent only

2 and 3

Change in Kt/V and achievement of facility Kt/V goal

McClellan [29]

2004

USA

21

2237

20

2044

HD units

Prevalent and incident

1, 2, and 3

Proportion of patients whose urea reduction ratio was ≥65%

Leon [40]

2006

USA

21

86

23

94

HD units

Prevalent only

3

Serum albumin level

Pradel [51]

2008

USA

14

107

14

107

Shifts in HD unit

Prevalent and incident

3

See ¥

Locatelli [53]

2009

EU**

NR*

321

NR

278

Nephrology Unit

Prevalent and incident

2

Proportions of patients with hemoglobin > 11 g/dL, serum ferritin > 100 μg/L, hypochromic red cell count < 10%, or transferrin saturation > 20%

Sullivan [48]

2009

USA

14

145

14

134

Shifts in HD unit

Prevalent only

3

Serum phosphorus level

Bond [49]

2011

USA

38

3157

39

3135

HD units

Prevalent and incident

2 and 3

Change in influenza vaccination rates

Kauric-Klein [54]

2012

USA

NR

59

NR

59

HD Units

Prevalent only

3

Changes in systolic blood pressure over time (primary outcome not explicitly stated)

Sullivan [50]

2012

USA

11

92

12

75

HD units

Prevalent and incident

3

Number of transplant process steps completed

Bennett [55]

2013

AUS/NZ

2

38

2

41

HD units

Prevalent and incident

2

Rate of referral to dietetic services for nutrition support

Karavetian [56]

2013

Lebanon

1

37

1

24

Shifts in HD unit

Prevalent and incident

3

Patient knowledge score£

Weisbord [57]

2013

USA

9

100

9

120

Shifts in HD unit

Prevalent and incident

2

Changes in scores on pain, erectile dysfunction and depression surveys

Rosenblum [58]

2014

USA

216

4609

216

4551

HD units

Prevalent and incident

2 and 4

Positive blood culture rate

Wileman [30]

2014

UK

6

45

6

45

Shifts in HD unit

Prevalent and incident

3

Serum phosphate level

Karavetian [31]

2015

Lebanon

6

88

6

96

Shifts in HD unit

Prevalent and incident

3

Serum phosphorus level

Bennett [32]

2016

AUS/NZ

15

171

15

171

HD units

Prevalent and incident

3 and 4

30-s sit-to-stand test

Graham-Brown [33]

2016

UK

3

NA***

3

NA***

Shifts in HD unit

Prevalent only

4

Left ventricular mass

Howren [34]

2016

USA

11

61

11

58

Shifts in HD unit

Prevalent and incident

3

Unclear: Mean interdialytic weight gain across for periods or Fluid nonadherent as defined by an interdialytic weight gain > 2.5 kg over a 4-week period

Wileman [35]

2016

UK

6

49

6

40

Shifts in HD unit

Prevalent and incident

3

Interdialytic weight gain

Hymes [36]

2017

USA

20

1245

20

1225

HD units

Prevalent and incident

2 and 4

Positive blood culture rate

Patzer [37]

2017

USA

67

4203

20

1225

HD units

Prevalent and incident

1, 2, and 3

Facility level transplant referral rate

Patzer [38]

2017

USA

NA***

NA***

NA***

NA***

HD units

Prevalent and incident

1, 2, and 3

Co-primary outcomes of (i) change in proportion of patients waitlisted and (ii) disparity reduction in proportion of patients waitlisted in a dialysis facility after 1 year

Brunelli [39]

2018

USA

20

826

20

845

HD units

Prevalent and incident

4

Positive blood culture rate

Delmas [41]

2018

Switzerland

NR

NR

NR

NR

HD Units

Prevalent only

1

Nurse quality of working life

Griva [42]

2018

Singapore

14

101

14

134

Shifts in HD unit

Prevalent only

3

Serum potassium/phosphate levels and interdialytic weight gains

Huang [43]

2018

China

1

46

1

44

Shifts in HD unit

Prevalent and incident

3

Blood pressure monitored before each hemodialysis

Milazi [44]

2018

AUS/NZ

3

60

3

60

Shifts in HD unit

Prevalent and incident

3

Serum phosphate level

Song [52]

2018

USA

NA***

NA***

NA***

NA***

HD units

Prevalent only

3 and 5

Patient and surrogate self-reported preparedness for end-of-life decision making

Sullivan [45]

2018

USA

20

1041

20

836

HD units

Prevalent and incident

3

Placement on kidney transplant waiting list

Waterman [46]

2018

USA

10

133

10

120

HD units

Prevalent and incident

3

Patients’ readiness to allow someone to be a living donor

Dember [47]

2019

USA

133

1938

133

2532

HD units

Incident only

4

Death

  1. NR not reported, USA United States of America, EU European Union, UK United Kingdom, AUS/NZ Australia/New Zealand, NA not applicable, g/dL grams per deciliter, μg/L micrograms per liter, Kt/V fractional urea clearance represented by K = dialyzer clearance of urea, t = dialysis time, V = distribution volume of urea
  2. *Locatelli et al. did not report the number of clusters randomized to each arm; however, the authors reported a total of 53 nephrology units participated in the trial
  3. **Included countries from Bulgaria, Croatia, Poland, Romania, and Serbia and Montenegro
  4. ***This was a study protocol of an ongoing trial and thus the final sample size used (or to be used) in the analysis was not available
  5. We defined patients as “prevalent” if they were on hemodialysis for at least 6 months and “incident” if they are newly starting or started hemodialysis less than 6 months prior to baseline
  6. ¥Study assessed three distinct behaviors to explore patients’ readiness to pursue living donor kidney transplant: (1) considering living donor kidney transplant, (2) talking with family or friends about living donor kidney transplant, and (3) asking someone to be a kidney transplant donor
  7. £Patient knowledge questionnaire was utilized to assess patients’ knowledge of kidney disease, renal diet, phosphate binders, and vitamin D therapy
  8. 1 = educational/ quality improvement interventions targeted at health professionals (e.g., transplant education and engagement activities targeting health professionals, etc.); 2 = quality improvement interventions targeted at organization of health care or health services delivery (e.g., nutrition screening, change in catheter exit-site care, etc.); 3 = patient health promotion or educational intervention (e.g., education about benefits of resistance exercise program, dietary counseling, education on avoiding foods with phosphorus additives, etc.); 4 = direct patient therapeutic intervention (e.g., intradialytic resistance training, antimicrobial barrier caps for catheters, etc.); and 5 = other