Wilkinson 2008.
| Study characteristics | ||
| Methods | RCT. Prospective pilot study to investigate the feasibility of a video link to support patients on the transplantation waiting list and their families. |
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| Participants | Patients on the transplantation list, at least 16 years of age, with a confirmed diagnosis of CF and willing to have an ISDN line installed in their home. Number randomised: 16, median age 27 years (range 21 – 41). Number of participants completed the intervention: 7 (4 on telemedicine and 3 in the control arm). Of those who did not complete the study four patients died, three patients received a transplant, one withdrew following randomisation and one was too unwell to continue. |
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| Interventions | Telemedicine additional to standard care: the participants were provided with an ISDN line to their home and a videoconferencing unit was connected to their home television set. Participants were also given a micro‐spirometer, pulse‐oximeter and a supply of single use clinical thermometers. Contact was made, on a weekly basis, at a time agreed by the patient and assessor (senior physiotherapist or nurse consultant). The topics which were discussed included: non‐invasive ventilation; haemoptysis; physiotherapy and amount of sputum; mobility; difficulties with any clinical procedures; appetite and weight; and any other problems as appropriate. Control group: standard medical care. |
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| Outcomes | 1. 'Cystic Fibrosis Quality of Life Questionnaire'. 2. 'Beck Anxiety Inventory'. 3. 'Beck Depression Inventory'. 4. Seven‐point questionnaire which included the number of visits to the cystic fibrosis clinic, general practitioner (GP), courses of intravenous antibiotics, length of hospital inpatient stay and how many visits were made either to a hospital or to the GP. 5. 'Borg Anxiety Scale', which was completed before and after each clinic attendance and after telemedicine link‐up. 6. Coping of carers: COPE questionnaire (Carver 1997). Patients and their caregivers were asked to complete a telemedicine satisfaction questionnaire on completion of the study. |
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| Notes | Authors were contacted for detailed quantitative data on outcome measures, but we did not receive a response within the time updating the review. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomised by a physiotherapist distributing a pre‐prepared sealed envelope, which was made by a third party not involved with recruitment (Wilkinson 2008, p. 183). |
| Allocation concealment (selection bias) | Low risk | Participants and investigator could not foresee assignments because the authors reported that they used sequentially numbered sealed envelopes (Wilkinson 2008, p.183). |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Due to the nature of the intervention the participants and teams providing the intervention could been blinded, but he authors provided no information on blinding of outcome assessment. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | The authors reported a high number of dropouts. The number of dropouts for each group is unclear. Reasons for dropouts were reported: 4 patients died, 3 patients received transplant, 1 withdrew, and 1 was too unwell to continue (Wilkinson 2008, p. 183). |
| Selective reporting (reporting bias) | High risk | Means and SDs for all outcome parameters for intervention and control group were not reported in the published article. |
ACT: airway clearance techniques BEH: nutritional and behavioural intervention BMI: body mass index CCT: controlled clinical trial CF: cystic fibrosis CFK: CF knowledge CPT: chest physiotherapy CTL: control condition FEV1: forced expiratory volume at one second FVC: forced vital capacity HLOC: health locus of control KG: kilogram ITT: intention‐to‐treat LOC: locus of control Mean FEF25-75%: forced expiratory flow during the middle of the maneuver NIH: National Institute of Health PEFR: peak expiratory flow rate PFT: pulmonary functioning POI: primary outcome indicator POMS: profile of mood states QOL: quality of life RCT: randomised controlled trial RDA: recommended daily allowance REE: resting energy expenditure RISCS: role play inventory of situations and coping skills SD: standard deviation SES: socioeconomic status STAI: state trait anxiety inventory STAIC: state trait anxiety inventory (children)