Article type
Abstract
Background and Aims:
Organizational factors have impact on the quality of rehabilitation services. Yet, a common framework to address these factors has been lacking. Recently, the International Classification of Service Organization in Rehabilitation (ICSO-R 2.0) launched 23 categories covering the Provider and Delivery dimensions. ICSO-R 2.0 was developed to provide a prerequisite for rehabilitation service organization assessment and implementation projects. This framework is too extensive to be applied as standardized information in clinical trials and the categories are too broad for analytical purposes. Hence, the present project aimed to identify and specify a reporting set of key organizational factors in clinical trials and facilitate analysis of organizational factors in future meta-analysis.
Methods:
A 2-step procedure was conducted:
Step 1: Identification of important categories based on a Delphi survey with international stakeholders, 2 systematic literature reviews (1 topic review and 1 review of randomized controlled trials), and focus group interviews with users in Germany, Indonesia, and Norway.
Step 2: Necessary reduction of categories and proposal of reporting specifications based on discussion and voting among key researchers, stakeholders, and users.
Results:
All categories except location of provider emerged from Step 1. In Step 2, the number of categories was reduced to 8 in the initial voting process. Subsequently, categories already sufficiently covered by existing reporting guidelines for clinical trials and categories without value sets applicable in statistical analysis and meta-analysis were excluded. Thus, in a minimum reporting set, we recommend that context and setting of services should be reported, specifying if the services/intervention are taking place in a “hospital,” “community,” or “other context”; if the setting is “primary level” or “secondary level of specialization”; if the setting is “inpatient,” “outpatient,” “in-home,” or “telerehabilitation”; and if the setting is “acute,” “subacute,” or “long-term” rehabilitation services. Quality assurance and management should be reported with “Yes” (the relevant quality assurance systems are described in the Methods) or “No” (when no adequate description).
Conclusion:
We advise that the suggested key organizational factors should be reported as part of the Methods section in clinical trials and tested as a categorization of intervention in metanalysis.
Organizational factors have impact on the quality of rehabilitation services. Yet, a common framework to address these factors has been lacking. Recently, the International Classification of Service Organization in Rehabilitation (ICSO-R 2.0) launched 23 categories covering the Provider and Delivery dimensions. ICSO-R 2.0 was developed to provide a prerequisite for rehabilitation service organization assessment and implementation projects. This framework is too extensive to be applied as standardized information in clinical trials and the categories are too broad for analytical purposes. Hence, the present project aimed to identify and specify a reporting set of key organizational factors in clinical trials and facilitate analysis of organizational factors in future meta-analysis.
Methods:
A 2-step procedure was conducted:
Step 1: Identification of important categories based on a Delphi survey with international stakeholders, 2 systematic literature reviews (1 topic review and 1 review of randomized controlled trials), and focus group interviews with users in Germany, Indonesia, and Norway.
Step 2: Necessary reduction of categories and proposal of reporting specifications based on discussion and voting among key researchers, stakeholders, and users.
Results:
All categories except location of provider emerged from Step 1. In Step 2, the number of categories was reduced to 8 in the initial voting process. Subsequently, categories already sufficiently covered by existing reporting guidelines for clinical trials and categories without value sets applicable in statistical analysis and meta-analysis were excluded. Thus, in a minimum reporting set, we recommend that context and setting of services should be reported, specifying if the services/intervention are taking place in a “hospital,” “community,” or “other context”; if the setting is “primary level” or “secondary level of specialization”; if the setting is “inpatient,” “outpatient,” “in-home,” or “telerehabilitation”; and if the setting is “acute,” “subacute,” or “long-term” rehabilitation services. Quality assurance and management should be reported with “Yes” (the relevant quality assurance systems are described in the Methods) or “No” (when no adequate description).
Conclusion:
We advise that the suggested key organizational factors should be reported as part of the Methods section in clinical trials and tested as a categorization of intervention in metanalysis.