Evaluation of an ICU-specific Questionnaire for Patient-reported Outcome Measures

Study Overview
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Brief Summary
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An ICU-specific questionnaire for patient reported outcome measures (PROM) after critical care will be tested in a study of 650 patients recruited six months to three years after discharge from the ICU, and 150 controls who have not been critically ill, matched for age and sex. The questionnaire is sent by mail after an invitation letter followed by a phone call and returned in a pre-stamped envelope. It is then scanned and data imported digitally. Medical data from the ICU-stay can be added. Further analyses after comparison with the control population and item reduction will follow.

Detailed Description
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ICU-patients were interviewed in a semi-structured way, providing detailed information on symptoms and difficulties in all areas of everyday life. The interviews were recorded, transcribed, and the issues were categorized into 13 hypothesised domains.All issues were then rephrased into questions, with care taken to maintain only one issue per question, and adequate scales for frequency, intensity and duration was used. The time frame is usually the last month. This intensive care specific questionnaire for patient reported outcome measures (PROM) after critical care will be tested in a study of 650 patients recruited six months to three years after discharge from the ICU, and 150 controls who have not been critically ill, matched for age and sex. The questionnaire is sent by mail after an invitation letter followed by a phone call and returned in a pre-stamped envelope. It is then scanned and data imported digitally. Medical data from the ICU-stay can be added. Further analyses after comparison with the control population and item reduction will follow.

Official Title
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Evaluation of an Intensive Care Specific Questionnaire for Patient-reported Outcome

Conditions
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Intensive Care Unit Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients treated in an intensive care unit at Sahlgrenska University for more than 72 hours and survived are included between 6 months and tre years after discharge from ICU. Control persons from the Swedish Population Registry matched for sex and gender are also included. Exclusion Criteria: Patient with acute neurological/neurosurgical conditions and/or anoxic/hypoxic brain damage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critical care survivors<br>Former ICU-patients recruited six months to three years after discharge from the ICU | |
| Matched controls<br>Control patients who have not been critically ill, matched for age and sex. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome measured with an ICU-specific questionnaire | An ICU-specific questionnaire will be used which has been developed from interviews of former ICU-patients | Six months to 3 years after intensive care |