Stalberg 2008.
Methods | Study design: Prospective randomised controlled clinical trial Duration of study: rolling, with final outcome assessment administered following the first postoperative consultation of each patient. Recruitment: All patients referred to single surgeon for thyroid or parathyroid surgery during the study were randomised into the study (those older than the age limits subsequently excluded). |
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Participants | Description: Patients referred for thyroid or parathyroid surgery. Setting: Peri‐operative surgical setting for head and neck surgery, tertiary referral centre, Australia Inclusions: Aged 18 to 65, able to access to the Internet at work as well as at home (authors link Internet access at work to being of working age and so exclude those people above retirement age). Patients randomised until number meeting inclusion criteria (≤ 65 years of age) was 50 in intervention group and 50 in control group. Two participants in intervention group and one in the control group did not proceed to surgery leaving 48 in intervention group and 49 in control group. |
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Interventions | Co‐intervention: all participants in the study received a standardised approach to information including a detailed discussion of the indications, risks and complications of thyroid/parathyroid surgery, a hand drawn diagram detailing the proposed procedure, copy of the Royal Australasian College of Surgeons brochure entitled "Patient Guide on Surgery of the Thyroid Gland and Parathyroid Glands". All participants were given a typed sheet entitled 'If you have further questions about your operation' which emphasised the need for participants to have any outstanding issues or questions addressed or explained before the date of surgery. Intervention: On the typed sheet, the sheet listed in order ‐ surgeon's email address, office telephone number, office fax number and office mailing address and participants were informed by the surgeon that e‐mail was the preferred mode of communication. Control: On the typed sheet the email address was not present and participants did not receive the verbal statement about email being the preferred method of communication. |
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Outcomes | Numbers, age and sex distribution of patients using any form of communication with the surgeon in the perioperative period outside of the routine booked consultations (via patient files at end of study period). Method of communication used (via patient files at end of study period). Number of emails per patient, content of the emails, origin of the email (patient, relative etc) (emails printed out and placed in patient file and examined at end of study period). Patient satisfaction (via questionnaire administered during the first post‐operative consultation). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Investigator confirmed 'sealed envelopes with equal numbers of envelopes containing “email” or “no email”. Envelopes were handed out to every patient at consultation and after exclusion of patients based on age limits, randomisation was terminated when 50 patients had been acquired in each group.' |
Allocation concealment (selection bias) | Low risk | Investigator confirmed 'Envelopes were opened by the surgeon at the time of consultation after the provision of information session' |
Blinding (performance bias and detection bias) All outcomes | High risk | Investigators were not blind to the group assignment of participants. Investigators had access to the patient notes which contained the randomisation. It was not possible to blind patients to allocation owing to the nature of the intervention. |
Incomplete outcome data (attrition bias) All outcomes. | High risk | An intention to treat analysis was carried out for all outcomes other than patient satisfaction. An intention to treat analysis could not be carried out on the patient satisfaction outcome as the patients not proceeding to surgery did not complete the post‐operative questionnaire. Additionally, the response rate to the questionnaire was 76% (Intervention: 77%, Control: 76%) and there is no exploration of non‐responders. |
Selective reporting (reporting bias) | Low risk | There is no evidence of selective outcome reporting. |
Other bias | High risk | Baseline comparability: study states 'no statistically significant difference between the 2 groups with respect to either age distribution or sex distribution (P = 0.18)' Validation of measures: Confirmation obtained from investigator that patient satisfaction questionnaire was not validated. Validation not relevant for other outcomes. Reliability of measures: both response and recall bias are possible with a self‐completed patient questionnaire. Other outcomes measured via collation of emails from each participant. Authors use age as a proxy for Internet access at work which may exclude those aged over 65 and still working. No rationale is given for why both work and home Internet access was required for participation. Contamination: Study states that control participants would still have had access to the surgeon's email address, which was available on the appointment card as well as on the Australian Endocrine Surgeons Web site, although attention was not specifically drawn to it. |