| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 8
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"After the clinicians performed a clinical assessment of hospitalised patients, the list of nominated patients was sent to us one day before the concert; we randomised the names of patients, thus ensuring that no bias was introduced when dividing the patients into two groups". Method of randomisation not described. |
| Allocation concealment (selection bias) |
Unclear risk |
Not described. |
| Blinding (performance bias and detection bias)
Subjective outcomes |
Unclear risk |
Study did not address subjective outcomes. |
| Blinding (performance bias and detection bias)
Objective outcomes |
Unclear risk |
This is one of a series of studies. At the beginning of the report it is stated that: "they were all done as controlled, blind or double‐blind studies" but it is unclear from the report who was blinded in this particular study. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
"Initially, this study aimed to recruit 30 to 40 patients. The complexity of the clinic, including unforeseen problems with staff resources in taking blood samples, and the nature of the disease that can unpredictably incapacitate some patients to move from the ward reduced the total number studied to 17 patients. In spite of some patients' willingness to come from the ward to the ground floor where the concert was taking place, some patients felt unwell before the event or might have fallen asleep. Some patients changed their minds about participating, even after having signed the consent form." |
| Selective reporting (reporting bias) |
Unclear risk |
Not known. |
| Protection from contamination? |
Low risk |
"contol group formed by patients who remained on the ward at the time of the live performance" |
