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Table 1 Key research questions and associated hypotheses

From: A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

Area of key
research question
Hypotheses developed Level of analysis
Safety All designated staff in the PoCT practices meet the required competency level to perform PoCT Practice staff level
  All PoCT practices obtain QC results within the acceptable performance range Practice level
  In terms of accuracy, all PoCT practice results meet the required QA performance levels for the pathology laboratories Practice level
  In terms of precision, PoCT practice results meet the required QA performance levels for the pathology laboratories Practice level
  Results obtained from PoCT devices for each patient closely agree with results obtained for the same patient from pathology laboratory testing Test level
  All intervention practices meet the standards for PoCT in GP and obtain accreditation Practice level
  The number of serious adverse events reported in PoCT patients per person-year is the same as or fewer than the number of serious adverse events reported in control patients per person-year Patient level
  The proportion of PoCT patients who experience one or more serious adverse events is the same as or less than the proportion of control patients who experience one or more serious adverse events Patient level
Clinical effectiveness The proportion of PoCT patients who have pathology results within the target range is the same as or greater than the proportion of control patients who have pathology results within the target range Patient level
  The proportion of total tests within the target range in PoCT practices is the same as or greater than the proportion of total tests within the target range in control practices Test (within patient) level
  The number of general practitioner visits for PoCT patients per person-year is different than the number of general practitioner visits for control patients per person-year Patient level
  PoCT patients report the same or greater improvement in compliance with disease management as directed by medical staff as control patients Time of questionnaire administration (within patient) level
Satisfaction The average change in attitudes in GPs from PoCT practices is different to the average change in attitudes in GPs from control practices Time of questionnaire administration (within GP) level
  The average change in attitudes in patients from PoCT practices is different to the average change in attitudes in patients from control practices Time of questionnaire administration (within patient) level
  Device operators report a change in average attitudes Time of questionnaire administration (within device operator) level
  Pathology providers report a change in average attitudes Time of questionnaire administration (within pathology provider) level
  The average level of satisfaction with regard to PoCT assisting with disease management in intervention GPs is different to the average level of satisfaction with disease management in control GPs GP level
  The average level of satisfaction with regard to work flow in intervention GPs is different to the average level of satisfaction with regard to work flow in control GPs GP level
  The average level of satisfaction with testing in intervention GPs is different to the average level of satisfaction with testing in control GPs GP level
  The average level of satisfaction with regard to the collection process in intervention patients is different to the average level of satisfaction with regard to the collection process in control patients Patient level
  The average level of confidence in the process in intervention patients is different to the average level of confidence in the process in control patients Patient level
  The average level of confidence in the results in intervention patients is different to the average level of confidence in the results in control patients Patient level
  The average level of satisfaction with regard to transport in intervention patients is different to the average level of satisfaction with regard to transport in control patients Patient level
  The average level of satisfaction with regard to loss of work time in intervention patients is different to the average level of satisfaction with regard to loss of work time in control patients Patient level
  The average level of satisfaction with regard to disease compliance in intervention patients is different to the average level of satisfaction with regard to disease compliance Patient level
  Device operators are satisfied with PoCT Device Operator level
  Pathology providers are satisfied with PoCT Pathology Provider level
Cost effectiveness The value of the resources used in PoCT is different from that of those used in pathology laboratory testing Patient level