Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Nassar, 2018

SR and meta-analysis of observational and randomized studies.

Literature search up to August 3^rd, 2017.

A: Eghbali-Babadi, 2017

B: Fumagalli, 2013

C: Fumagalli, 2006

D: Malacarne, 2011

Study design:

A: Randomized trial
B: Randomized crossover study
C: Cohort study
D: pre-post intervention study

Setting and Country:

A: Iran, cardiac surgery ICU

B: Italy. 2ICUs
C: Italy, cardiology ICU
D: Italy (1ICU)

Source of funding and conflicts of interest:

Supported, in part, by the Brazilian Ministry of Health through the Program

of Institutional Development of the Brazilian Unified Health System

(PROADI-SUS).

Drs. Robinson’s and Falavigna’s institutions received funding from the

Brazilian Ministry of Health. Dr. Falavigna disclosed that he is an associate

of a consulting and training company in Health Economics field called

“HTAnalyze (www.htanalyze.com),” which provides services for both the public and private sectors. The remaining authors have disclosed that they do not have any potential conflicts of interest.

Inclusion criteria SR:

1) Studies comparing flexible versus restrictive visiting policies

in the ICU;

2) Studies evaluating at least one of the following outcomes:

2.1) Patient-related outcomes: ICU mortality, ICU-acquired

infections, delirium, ICU length of stay, length of mechanical

ventilation, need for sedatives, anxiety, depression,

and satisfaction;

2.2) Family member–related outcomes: anxiety, depression,

posttraumatic stress disorder (PTSD), and satisfaction;

2.3) ICU professional–related outcomes: burnout, workload,

and satisfaction.

Exclusion criteria SR:

n.r.

4/7 studies included

Important patient characteristics at baseline:

N, mean age

A: XX patients, XX yrs

B:

C:

….

Sex:

A: % Male

B:

C:

….

Groups comparable at baseline?

Describe intervention:

A: Flexible visitation: 30-40 min in the morning, beyond the usual time period.

B: Flexible visitation: 24h/day

C: Flexible visitation: 6h/day

D: Flexible visitation: 3h/day

Describe  control:

A: Restricted visitation: Usual (not described in the article).

B: Restrictive visitation: 1h/day, divided into 2 periods of 30 min each.

C: Restrictive visitation: 2h/day

D: Restrictive vistation: 1h/day

End-point of follow-up:

n.r.

For how many participants were no complete outcome data available?

(intervention/control)

n.r.

ICU length of stay

n.r.

Sleep

n.r.

Pain

n.r.

Anxiety/stress

Defined as the results on he HADS.

Effect measure: SMD [IQR]

A: n.r.
B: -6.23 [-6.97 - -5.60]
C: -1.00 [-1.57 - -0.43]
D: n.r.

Delirium

Defined as delirium incidence intervention/control (%):

A: 20.6% / 44.1%

B: n.r.
C: n.r.
D: n.r.

Mortality

Defined as mortality rate intervention/control (%)

A: n.r.
B: n.r.
C: 1.8% / 5.2%
D: 28.7% / 24.5%

Author’s conclusion

Although flexible family visitation models appear to be beneficial for patients’ and family members’ outcomes, its possible impact on ICU professionals burnout demand attention and adoption of prevention strategies. Randomized trials aiming

to evaluate outcomes involving the three components of the

patient-family-staff triad are still needed. Nonetheless, educating health professionals and family members and improving the structure of the work environment are actions required to achieve the potential benefits of flexible family visitation

policies.

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Jaberi, 2020

Type of study:

double‑blind randomized controlled trial

Setting and country:

Hospital in Iran.

Funding and conflicts of interest:

The research and Technology of Rafsanjan University

of Medical Sciences supported financially the research

project.

Inclusion criteria:

The inclusion criteria for patients were age higher than 18 years, having informed consent

to participate in the study, candidates for teaching round,

having cognitive ability to answer questions, being alert, and no history of hospitalization in CICU. The inclusion

criteria for family members include being over 18 years of age, being a prime family member (mother, father, sister or brother child, and spouse and grandparents),

having a wish and request to attend beside the patients, no history of known mental illness, and no history of

presence during the teaching round.

Exclusion criteria:

Exclusion criteria

include cancelling of continued being in research by

the patients or families and the occurrence of any acute

situation for the patient and family.

N total at baseline:

Intervention: 30

Control: 30

Important prognostic factors²:

age

I: 60.63 ± 15.27

C: 63.47 ± 12.89

Sex:

I: 46.7% M

C: 56.7% M

Groups comparable at baseline?

Yes

In the intervention group, the selected family member

presented and participated in the round. After completion of the rounds, the STAI and patient’s satisfaction about quality of round questionnaire were completed for patients in both groups by a researcher fellow, via face‑to‑face interview.

In the control group the teaching round performed without family member’s presence. After completion of the rounds, the STAI and patient’s satisfaction about quality of round questionnaire were completed for patients in both groups by a researcher fellow, via face‑to‑face interview.

Length of follow-up:

Post-intervention

Loss-to-follow-up:

n.r.

Incomplete outcome data:

n.r.

Length of ICU stay
n.r.

Sleep and sedation/agitation score

n.r.

Pain

n.r.

Anxiety/stress

Measured with STAI (range 20-80, lower score means better outcome.

I: 45.30 (SD 8.34)

C: 51.10 (SD 7.76)

Delirium

n.r.

Mortality

n.r.

Author’s conclusion

The results of the present study revealed that FCR

was able to correct patients’ STAI score and their

satisfaction about various clinical aspects of round.

Therefore, by implementing this program while taking

advantage of other benefits, it is possible to improve

patient’s outcomes. Due to the differing conditions

and characteristics of adult patients for the presence

of family members during medical rounds and the

limited number of studies available for comparison

other aspects of patient outcomes, further clinical trials are recommended.

Limitations
Although the researchers tried to minimize the impact of confounding factors by matching the samples of the three groups based on the STAI scores in pretest, repeatedly, the study is suggested in larger and more specialized samples. On the other hand, STAI questions may not be a familiar scale for the elderly that constitute the majority of the research samples, so researchers tried to complete the questionnaire by interview.

Rosa, 2019

Type of study:

cluster-crossover randomized clinical trial

Setting and country:

36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil

Funding and conflicts of interest:

n.r..

Inclusion criteria:

atients 18 years or older admitted to participating ICUs were consecutively included

Exclusion criteria:

he exclusion criteria were coma (Richmond Agitation-Sedation Scale19 score ≤−4) lasting longer than 96 hours from initial screening assessment or presence of any of the following characteristics at screening assessment: delirium (positive Confusion Assessment Method for the ICU [CAM-ICU] screening),20 brain death, exclusive palliative care, inability to communicate, predicted ICU length of stay less than 48 hours, unlikely to survive longer than 24 hours, prisoner status, unavailability of a family member to participate in ICU visits, and previous enrollment in the study.

N total at baseline:

Intervention: 20

Control: 20

Important prognostic factors²:

age

I: 58.4 ± 18.3

C: 58.6 ± 18.2

Sex:

I: 53.5% M

C: 52.1% M

Groups comparable at baseline?

Yes

The flexible visitation model included both flexibility of ICU visiting hours and family education. One or 2 close family members were allowed to visit the patient for up to 12 hours per day; however, only 1 relative was enrolled in the study. These family members had to attend at least 1 structured meeting in which they received education about the ICU environment, common procedures, multidisciplinary work, infection control, palliative care, and delirium. These structured meetings were conducted by trained clinicians using a face-to-face format at least 3 times per week. Additionally, family members had access to an information brochure and website (http://www.utivisitas.com.br) designed to help them understand the various processes and emotions associated with an ICU stay and improve cooperation without increasing ICU staff workload. Patients were also allowed to receive social visits at specific time intervals according to local rules. Social visits were offered to friends or family members who did not qualify for flexible visitation. Implementation of the flexible visitation model is shown in eFigure 1 in Supplement 2.

In the restricted visitation model, visitors were allowed as before randomization, according to local hours (median, 1.5 hours/d [interquartile range {IQR}, 1.0 to 2.0]; up to 4.5 hours/d). Visitors were not required to attend educational meetings.

Length of follow-up:

Hospital discharge or death.

Loss-to-follow-up:

I: 0

C: 0

Incomplete outcome data:

I: 6 (30%)

C: 3 (15%)

Length of ICU stay

Effect measure: median number of days (range)
I: 5  (3-8)

I: 5  (3-8)

Sleep and sedation/agitation score

n.r.

Pain

n.r.

Anxiety/stress

n.r.

Delirium

n.r.

Mortality

n.r.

Author’s conclusion

Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium.

Limitations
This study has several limitations. First, although the study recruited a large number of ICUs, the sample was limited to 1 middle-income country. Therefore, flexible visitation may have different effects across distinct sociocultural contexts. Second, data on the characteristics of ICUs not enrolled in the study, and causes of participant losses to follow-up, were not collected. Third, cluster randomization was susceptible to recruitment bias, since participants were aware of the interventions. Some imbalance in number and causes of participant exclusion and follow-up losses might have resulted from this phenomenon. Nevertheless, baseline characteristics of participants were well balanced. Fourth, although this study used a washout period and sensitivity analyses did not show evidence of significant interaction between intervention effects and sequence of ICU interventions (flexible visitation in phase 1 or restricted visitation in phase 1), the risk of carryover effect still exists. Fifth, the effect of the educational component of the flexible visitation model on family members cannot be isolated from flexible visiting hours. Sixth, this study did not evaluate the effects of flexible visitation on long-term outcomes. The length of clinician follow-up may have been insufficient to properly assess burnout.

Nassar, 2018

Yes

Yes

Yes

Yes

Unclear

Yes

Yes

Yes

Unclear

Study reference

(first author, publication year)

Was the allocation sequence adequately generated? ^a

Definitely yes

Probably yes

Probably no

Definitely no

Was the allocation adequately concealed?^b

Definitely yes

Probably yes

Probably no

Definitely no

Blinding: Was knowledge of the allocated

interventions adequately prevented?^c

Were patients blinded?

Were healthcare providers blinded?

Were data collectors blinded?

Were outcome assessors blinded?

Were data analysts blinded?

Definitely yes

Probably yes

Probably no

Definitely no

Was loss to follow-up (missing outcome data) infrequent?^d

Definitely yes

Probably yes

Probably no

Definitely no

Are reports of the study free of selective outcome reporting?^e

Definitely yes

Probably yes

Probably no

Definitely no

Was the study apparently free of other problems that could put it at a risk of bias?^f

Definitely yes

Probably yes

Probably no

Definitely no

Overall risk of bias

If applicable/necessary, per outcome measure^g

LOW

Some concerns

HIGH

Jaberi, 2020

Definitely yes;

Reason: In this trial, 60 patients were assigned into two groups:

“family presence during rounds” and “family absence

during rounds” equally based on categories STAI levels in three categories of 20–40, 41–60, and 61–80, using the random minimization method.

No information;

Reason: No information was provided about the allocation concealment.

Probably yes;

Reason: To blinding, the members of round team, patients, and family members did not know exactly that

the impact of the family members presence on the level

of anxiety, and their satisfaction was considered by the

researchers.

Definitely yes;

Reason: Loss to follow-up was infrequent.

Definitely yes;

Reason: Predescribed outcome measures were reported.

Definitely yes;

Reason: No other problems reported.

LOW

Rosa, 2019

Definitely yes;

Reason: The ICUs were consecutively randomized in a 1:1 ratio using computer-generated randomization with random block sizes of 2, 4, and 6 and stratified by number of ICU beds (≤10 or >10).

Definiely yes;

Reason: ). A statistician blinded to cluster identity performed randomization

Definitely no;

Reason: Outcome assessors were not blinded to study interventions, except for infectious diseases specialists adjudicating infectious outcomes.

Definitely yes;

Reason: Loss to follow-up was infrequent.

Definitely yes;

Reason: Predescribed outcome measures were reported.

Definitely no;

Reason: cluster randomization was susceptible to recruitment bias, since participants were aware of the interventions.

Some concerns