Ross 2004.

Methods	Study design: Randomised controlled trial. Duration of study: 1 year Recruitment: Initial approach involved sending a recruitment letter explaining the study was sent to eligible patients. Secondary approach involved a research assistant approaching patients in the waiting room of the practice, asking them if they would be interested in reading their medical records online in the context of a study.
Participants	Description: Heart failure patients attending a speciality clinic. Setting: Speciality clinic for heart failure, University of Colorado Hospital, US. Majority of patients in the practice have New York Heart Association Class II or Class III symptoms of heart failure. Inclusions: followed in the practice, speak English and 18 years of age or older. Participants needed to have used a web browser before. Exclusions; physicians, nurses, physician assistants and nurse practitioners as not typical users. In total 394 patients were approached to participate, 312 received the mailing prior to the recruitment period and 82 presented to the clinic during the recruitment period without receiving the mailing. Of these, 287 declined access to online medical records, 144 returned the baseline survey before declining. In total 107 (27% of eligible) participants were randomised; 54 into the intervention group, 53 into the control group.
Interventions	Intervention: SPPARO (System Providing Patients Access to Records Online). Three components to SPPARO; medical record, educational guide and messaging system. Participants given user identification and password and a written user guide to the system. The messaging system allowed patients to exchange secure messages with the nursing staff in the practice. Patients were reminded to call the research assistant if they had problems using SPPARO. Control: Patients in control group continued to receive standard care in the practice and were offered use of SPARRO after the study was completed as an incentive to participate. Co‐interventions: all participants will have seen the guide in one form or another as the educational guide is an online version of the printed materials that all patients in the heart failure practice receive at their first visit. Periodic messages were sent by the research staff to all participants ‐ they were informed about upcoming surveys and encouraged to contact the research assistant if they had a change of address or telephone number
Outcomes	Not all outcomes were relevant to the review but are listed here for completeness. Primary outcome: Self‐efficacy (as assessed by the self‐efficacy domain of the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 6 months and 12 months). Other outcomes: Health status (as assessed by the KCCQ at baseline, 6 months and 12 months). Patient satisfaction with doctor‐patient communication (as assessed using the Art of Medicine Questionnaire at baseline, 6 months and 12 months). Adherence to medications (assessed using the questions derived from Morisky measured at baseline, 6 months and 12 months). General adherence to medical regimens (assessed using the General Adherence Scale from the Medical Outcomes Study (MOS) measured at baseline, 6 months and 12 months). Mortality (from chart review, nursing staff and telephone and mail contact with the homes of patients throughout the study). Emergency department visits and hospitalisations at the University of Colorado Hospital (from chart review throughout the study period). Outcomes relevant to review: Dates that participants used SPPARO and components of SPPARO used (measured in patient hit days throughout the study period). Electronic messages and phone messages from participants (via SPARRO system and for phone via review of written medical record and staff logs throughout the study period). Content of messages sent through SPPARO (categorised throughout the study period). Nursing staff time spent answering messages via SPPARO (nurses kept weekly log throughout the study period).
Notes	This intervention is multifaceted. Only the outcomes relating to the use of secure messaging will be of relevance to this review.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	As initial questionnaires were received patients were consecutively assigned identification numbers that were linked to either intervention or control group according to a predefined computer‐generated randomisation scheme. Randomisation was restricted so that equal numbers of patients were assigned to the intervention and control groups in blocks of 10.
Allocation concealment (selection bias)	Low risk	Sequential sealed envelopes were used.
Blinding (performance bias and detection bias) All outcomes	Low risk	Investigators (PI and data analyst) were blind to group allocation. Participants were blind to group allocation when they completed the baseline questionnaire: 'when patients completed the initial questionnaire they were blinded to their enrolment status.' Staff administering the service were blind to group allocation: 'physicians and practice staff not told which patients were enrolled into the study. They could become aware of a patient's enrolment status, however, if a patient directly mentioned using it, or if a patient sent an electronic message using SPPARO.'
Incomplete outcome data (attrition bias) All outcomes.	Low risk	Participant attrition is acknowledged and reasons for drop‐outs are given. An intention to treat analysis is not carried out, however statistical methods are used to account for missing participants in the analysis for the scored questionnaire items (repeated measures analysis) across all outcomes. Repeated measures analysis involved using baseline data for censored individuals and using association data from uncensored individuals to provide an estimate. This implicitly assumed that the associations observed among the baseline, 6‐month, and 12‐month measures in the uncensored subjects would have been observed in the censored subjects.
Selective reporting (reporting bias)	High risk	All outcomes are addressed in the results section of this study, however not all values are reported, for example; P value is provided for the number of messages sent per patient but the actual number of messages is not presented. Categories of messages sent using SPPARO are presented graphically for the whole sample and not by group. Information in the text states that there was no significant difference between groups for category of message but the P values are not presented, nor the data for category by group.
Other bias	Low risk	Baseline comparability: Baseline demographic statistics are presented for both intervention and control groups, but then the overall sample is compared statistically to the decliners group rather than by group assignment. The authors state in the results that 'at baseline, the intervention and control groups did not differ in their socio‐economic characteristics, or in their health status as assessed by the KCCQ symptom score.' Validity of measures: Authors 'used previously validated survey instruments where available.' KCCQ for self‐efficacy required a change of 7.7 on the scaled score as the minimally clinically significant difference in this measure. This was based on a validation study of the KCCQ which found mean difference in self‐efficacy score during and 3 months after hospitalisation for congestive heart failure was 15.4 points, for this study criterion of clinical significance set to be half this difference. Art of Medicine questionnaire, Morisky and MOS tools are validated. No information given on how messages were categorised or how the categories were devised. Reliability of measures: Potential response and recall bias: all questionnaire were self‐administered. Phone messages were tracked by asking nurses to keep logs and by referring to medical record. This may introduce some unreliability. Generalisability: study investigators identified 288 patients who did not enrol in the primary study and of these144 completed a 'decliners survey'. There was found to be no difference in socioeconomic characteristics and health status assessed by the KCCQ symptom score between decliners and participants. Therefore the study population is a good representation of the practice population.