Dong 2020.
Study characteristics | ||
Methods | Design: RCT Date of study: December 2016 to December 2019 Power calculation: not calculated Inclusion criteria: meets the Severe Acute Pancreatitis diagnostic criteria in the 2013 Chinese Guidelines for the Diagnosis and Treatment of Acute Pancreatitis, aged 70 years or older, expected hospital stay >2 weeks and provision of written informed consent. Exclusion criteria: the exclusion criteria were history of severe acute pancreatitis, coma, complicated with mental disorders or disorders, dementia, low immune function (such as neutrophil deficiency) and end‐stage disease. |
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Participants | Sample size: 106 Country: China Setting: Affiliated Hospital of Jiangnan University, Age: mean age in intervention group 75.87 [+/‐ 4.32], mean age in control group 76.23 [+/‐ 4.58] Sex: male, 32 (64%) in intervention group, male 34 (65%), in control group Co‐morbidity: not reported Dementia: excluded Frailty: not reported |
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Interventions | Intervention: all patients received 1. Directional communication plan 2. Cognitive therapy activity plan 3. Early activity plan The following schemes are implemented as needed based on the evaluation results 4. Pain improvement program 5. Sleep improvement program 6. Assisted feeding plan 7. Rehydration program 8. Constipation improvement plan 9. Hearing/vision improvement program 10. Hypoxic improvement program 11. Aspiration pneumonia prevention program 12. Urine‐related infection prevention program 13. Delirium improvement program14. Dementia improvement program 15. Multiple medication management plan Control: Routine nursing programmes and procedures. |
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Outcomes | Outcomes reported: ‐ Incident delirium using CAM ‐ Inpatient mortality ‐ Length of hospital admission (days) ‐ ADL using Barthel Index (pre and post 2‐week intervention period only) Outcomes from study not reported: None Frequency of outcomes assessment: pre and post 2 week intervention period |
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Notes | Funding source:this work was supported by the Translational Medicine Specialty of Wuxi Municipal Health Committee (ZM006). Declarations of interest: No conflicts of interest to declare Delirium not excluded at enrolment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of random number table to determine if subjects for test group or control |
Allocation concealment (selection bias) | Unclear risk | Method of allocation not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel described |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Three participants in intervention group died, no data presented on them, even at baseline |
Selective reporting (reporting bias) | High risk | No protocol available. Length of stay was not pre‐specified in methods. Incomplete reporting for cognition and self‐care as categories used are not referenced or specified as data derived. |
Other bias | Low risk | No evidence of other bias |