Foglio 2001.
Study characteristics | ||
Methods |
Study design: RCT. 1 year after completing an original PRP (Time point T2), participants with COPD and asthma were randomised to either Intervention Group (Repeat the PRP (termed PRP2)) or to Control Group (Do not repeat PRP). At the end of PRP2, participants in the intervention group only were assessed (Time point T3). 1 year after completing PRP2, participants in both intervention and control groups were assessed (Time point T4). Total duration of study: 1 year Details of any run‐in period: Participants were stable as assessed by stability in blood gas values and free from exacerbations in the 4 weeks prior to entry into the study. No changes made to routine therapy in the week preceding inclusion into the study. Number of study centres and location: Single site. Italy Study setting: Day hospital Withdrawals: 11 participants in intervention group and 10 participants in control group did not perform evaluations at 1 year (T4) (personal/transport/family reasons). 2 participants in intervention group and 2 participants in control group were excluded due to other pathologies. Not clear how many of these withdrawn participants had asthma diagnosis Date of study: Not stated |
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Participants |
Number recruited: Number of participants with asthma randomly assigned at T2 to intervention group 14, control group 17. Number completed: Data not available from information provided by authors regarding how many participants with asthma randomised at T2 completed PRP2 Mean (SD) age: Intervention group 58.8 (6.4) years, Control group 58.1 (7.6) years. (Data only available for the age of participants with asthma who had complete dataset at T2 and T4.) Age range: Intervention group 50 to 68 years, Control group 49 to 71 years. (Data only available for the age of participants with asthma who had complete dataset at T2 and T4.) Gender (M/F): Intervention group 3/5. Control group 3/7. (Data only available for the gender of participants with asthma who had complete dataset at T2 and T4.) Mean (SD) BMI: Not stated Severity of condition: Not stated Diagnostic criteria: “Asthma was characterised by dyspnoea with wheezing, variable airflow limitation with reversible obstruction and bronchial hyperresponsiveness in absence of smoking history.” Baseline lung function: Mean (SD) % predicted FEV1 asthma participants only: Intervention group 73.25 (17.28)%, Control group 92.4 (22.33)% Smoking history: Not stated Asthma treatment: All participants with asthma received inhaled steroids and bronchodilators. Inclusion criteria: Not specifically stated Exclusion criteria: Other organ failure or cancer. Unable to co‐operate |
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Interventions |
Intervention: Multidisciplinary outpatient 8‐week PRP which included optimisation of pharmacologic treatment, supervised exercise training (aerobic and resistance training), patient and family education, nutritional programme and psychological counselling when appropriate Comparison: Usual care Concomitant medications: All participants with asthma received inhaled steroids and bronchodilators. Excluded medications: None stated |
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Outcomes |
Primary outcomes: No specified primary outcomes. The following were measured: Exercise capacity (incremental CPET on cycle ergometer and 6MWD). Dyspnoea (BDI and TDI). Quality of life (SGRQ). Exacerbations. Hospitalisations. Mortality rate. Lung volumes and FRC. Arterial blood gas levels. Maximal inspiratory pressure. Secondary outcomes: No specified secondary outcomes Time points reported: Baseline (T2), completion of pulmonary rehabilitation (T3 ‐ intervention group only) and 1 year (T4) Data reported as endpoint rather than as change from baseline. |
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Notes |
Funding: None stated Notable conflicts of interest: None stated Other: Only data at T2 and T4 for asthma participants were eligible for the review. 1 of the authors (L Bianchi) provided us with all available raw data for all participants through email correspondence. Data for 6MWD represented as change from baseline, and corrected for error in original publication. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No detail provided on how the random sequence was generated. |
Allocation concealment (selection bias) | Unclear risk | Not stated whether allocation was concealed. |
Blinding of participants and personnel (performance bias) Subjectively reported outcomes | High risk | Rehab programme‐ not able to blind participants or personnel delivering it. |
Blinding of participants and personnel (performance bias) Not subjectively reported outcomes | High risk | Rehab programme‐ not able to blind participants or personnel delivering it. |
Blinding of outcome assessment (detection bias) Subjectively reported outcomes | Unclear risk | Not clear who collected questionnaire data. |
Blinding of outcome assessment (detection bias) Not subjectively assessed outcomes | Low risk | “The technicians who collected data were blinded to a patient’s allocation to PRP2 or the control group.” “All measurements were performed and recorded under the supervision of a nurse not involved in the study.” |
Incomplete outcome data (attrition bias) All outcomes | High risk | High numbers of dropouts and no ITT. “Eleven patients in group 1 and 10 patients in group 2 did not perform evaluations at T4 due to personal, transport, or familial problems.” |
Selective reporting (reporting bias) | Unclear risk | No protocol available. |
Other bias | Unclear risk | Baseline imbalance in 6MWD at baseline between groups. Participants had already completed pulmonary rehabilitation a year previously, not clear how this affects generalisability |