Figueiras 2017.
Methods |
Study design: parallel RCT Recruitment: recruitment at three CCUs Allocation: not reported Blinding: care‐givers were blinded Randomisation: computer block randomisation Follow‐up(s): 4, 8, and 12 months Description: an inpatient individual psychological counselling with telephone follow‐ups |
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Participants |
Baseline characteristics Intervention group
Control group
Inclusion criteria
Exclusion criteria
Baseline imbalances: ‐ Physically demanding work (i.e. white vs. blue collar): unknown Severity of CHD: unknown |
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Interventions |
Intervention In‐hospital individual participant session (about 45 min) with health psychologist including:
Participants were mailed a manual with illness and recovery information Weekly phone calls were made in the first 4 weeks after discharge to discuss strategies to change behavior and recovery goals
Control group
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Outcomes | Proportion at work at < 6 months (short term): 4 months* Proportion at work at 6‐12 months (medium term): 8 months* *Provided by personal communication Hospital Anxiety & Depression Scale |
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Identification |
Sponsorship source: FEDER through COMPETE and FCT – Fundação para a Ciência e a Tecnologia – reference PTDC/PSI‐PCL/112503/2009 Country: Portugal Setting: single setting, inpatient/outpatient (phone calls) Possible conflicts of interest: none reported Ethics committee approval: “The study was approved by the Ethics Commissions of all hospitals involved and by the Portuguese Data Protection Authority (CNPD) and registered with the number n º17,523/2011 – ‘Programa Coração Saudável’” |
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Notes | RTW results were obtained through personal communication. It is unclear how many people actually responded to the follow‐ups. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “The randomisation sequence was generated using a computer block randomisation to allocate the patients either to the control or the Intervention group after the baseline assessment.” |
Allocation concealment (selection bias) | Unclear risk | Allocation and randomisation were conducted after the baseline assessment. No information regarding allocation concealment was provided. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: “Caregivers were blinded to the group assignment.” |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | None reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Participants not replying at all time‐points (loss‐to‐follow‐up) were similar in both groups. However, it is unclear how many actually responded regarding the RTW results. |
Selective reporting (reporting bias) | Unclear risk | No mention of an a priori published study protocol. Non‐significant results for RTW not provided in the published articles |
Other bias | Unclear risk | None identified |