Objective:

To describe the focus of randomised and controlled clinical trials addressing consumers and communication.

Methods:

. An alphanumeric coding scheme was used to facilitate the coding and analysis of the 2545 trials in the Specialised Register which consists predominantly of relevant trials identified and retrieved from the Cochrane Controlled Trials Register. Coding commenced in January 02, with each trial coded by the scope, intervention and outcome, with most trials having more than one category for intervention or outcome. Data on the number of trials coded for each of the scope, interventions or outcomes was compiled after searching for the appropriate alphanumeric code in the relevant Procite field.

Results:

By 14 Feb 02, the first 598 trials in the Register had been coded. The new coding system enabled us to identify the proportion of trials by existing scope areas:

* Communication enhancement (19%)
* Health care decision making which includes education and support of the patient (76%)
* Participation in health care planning, policy and research (5%)
* Communication techniques and media (27%)
* Placebo effects (<1%)

Other major features of the Register are:

Interventions:

a) Direction of communication: the majority of communication interventions are directed to the consumer by the health care provider as patient education (48%), skills training (21%) or counseling (15%).
b) Interventions where the direction of communication is between consumers strongly favour provider-led or initiated group activities (10%), or family support (8%), compared with self help groups (2%).
c) Setting of the intervention: one third of interventions are hospital based, one fifth take place in the patient's home, and nearly half of the studies were undertaken in the USA.

Outcomes:

a) Most outcome measures related to health behavior, particularly "compliance" (35%) or measured the patient's psychological health (28%).
b) Knowledge acquisition and retention of information by consumers were measured as outcomes in one third of trials.

Conclusions:

The new coding system has immediate benefits in analyzing the Register and identifying gaps in research. This analysis revealed a widely held 'deficit' model in consumer-provider communication, whereby the aim is to increase consumers' knowledge and compliance in order to improve their health and well being. Conversely, little attention is paid to the possibility that health care providers may learn from consumers during clinical consultations or by working with them in planning services, policy or research. Where attention is paid to communication from consumers to providers it is set in a provider centred framework of inviting feedback, history taking or patient profiling (usually highly structured by the provider) or the consumer asking questions. A consumer focused agenda for trials would give greater priority to providers listening (not just history taking or responding to questions) and learning from consumers. The small number of trials of consumer participation in health care planning, policy and research probably reflects less enthusiasm for trialists in this area, which faces political and methodological challenges. Until these are overcome, doubts about the value and methods will continue.