Holloway 2007.
| Methods | Design: RCT over 5 sessions | |
| Participants | Country: England, UK Setting: semi‐rural GP practice Health status: mild to moderate asthma Diagnosis criteria: not described Total sample: 85 participants (46 in control group and 39 in intervention group) Mean age, years: 49.3 ± 14.2 (control group) and 50.2 ± 14.0 (intervention group) Gender: 18 men and 28 women (control group), 18 men and 21 women (intervention group) Inclusion criteria: participants aged 16‐70 years; able to understand, read and write English, with a commitment to participate for possibly 8 attendances; willing to give written informed consent and with no serious comorbidity Exclusion criteria: not described |
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| Interventions | Intervention group: 5 x 60‐min individual sessions on the Papworth method from a respiratory physiotherapist. The Papworth method consisted of 5 components: breathing training, education, relaxation training, integration of 'appropriate' breathing and relaxation techniques into daily living activities and home exercises (audiotape or CD containing reminders of the breathing and relaxation techniques) Control group: no additional treatment Assessments took place at baseline and at 6 and 12 months after baseline |
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| Outcomes | QoL as measured by the SGRQ, which assesses impaired respiratory symptoms and QoL related to these Hypocapnic symptoms as assessed by the NQ HADS Lung function (VC, FEV1, FVC, PEFR) Capnography |
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| Notes | Funding: this study was not sponsored but was undertaken as part fulfilment of a PhD degree at University College London. A study author's post was funded by Cancer Research UK Register number: not described |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was undertaken by a computer‐generated number sequence assigning consecutive participant ID numbers a 1 or a 2 to denote intervention or control condition |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement of 'low risk' or 'high risk” |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants and personnel, and the outcome is likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Some outcomes were participant‐rated, which could introduce high risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups (7 from the intervention group and 6 from the control group), with similar reasons for missing data across groups |
| Selective reporting (reporting bias) | Low risk | The study protocol is available, and all of the study's prespecified (primary and secondary) outcomes that are of interest in the review have been reported in the prespecified way |
| Other bias | Low risk | The study appears to be free of other sources of bias |