Table 1.

Key research questions and associated hypotheses

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