Figures
- FIGURE 1
PRISMA flow diagram.
Tables
- TABLE 1
Use of Cochrane risk of bias tool to assess quality of randomised controlled trials
Study Random sequence generation Allocation concealment Selective reporting Blinding subject and personnel Blinding outcome assessment Incomplete outcome data Other source of bias Maher et al.
(2020) [38]Low Low Low Low Low Low Unclear Moor et al. (2020) [30] Low Low Low High High Low Unclear - TABLE 2
Use of Newcastle–Ottawa tool to assess the quality of cohort studies
Study Representativeness of exposed cohort Selection of non-exposed cohort Ascertainment of all-cause Outcome not present at the start of study Comparability of cohort Assessment of outcome Adequate follow-up duration Adequate follow-up rate Score Quality Russell et al. (2016) [31] 1 0 1 1 2 0 1 1 7 Good Johannson et al. (2017) [20] 1 0 1 1 1 1 1 1 7 Good Veit et al. (2020) [32] 1 0 1 1 2 1 1 1 8 Good Edwards et al. (2020) [39] 0 0 1 1 2 1 1 1 7 Good Moor et al. (2019) [45] 1 0 1 1 0 1 1 1 6 Fair Moor et al. (2018) [40] 1 0 1 1 2 1 1 1 8 Good Moor et al. (2020) [46] 1 0 1 1 0 1 1 1 6 Fair Broos et al. (2017) [41] 1 0 1 1 2 1 1 1 8 Good Marcoux et al. (2019) [28] 1 0 1 1 2 1 1 1 8 Good Noth et al. (2021) [43] 1 1 1 1 2 1 1 1 9 Good Moor et al. (2020) [42] 1 0 1 1 2 1 1 1 8 Good - TABLE 3
Characteristics of included studies on home monitoring in interstitial lung disease (ILD) patients
Study Setting/design Sample size and characteristics Disease group Clinic measures/frequency Home measures/frequency Study length Outcome Quality Results Moor et al. (2020) [30] NL/RCT n=90
Age (mean±sd): 71±6.9 years
Intervention (n=46)
Male: 39 (85%)
Age (mean): 70 years
Control (n=44)
Male: 43 (98%)
Age (mean): 72 yearsIPF Spirometry, K-BILD, PESaM, EQ-5D-5L, HADS, VAS, GRC, EQ-VAS (baseline, and at 12 and 24 weeks) FVC (Once daily)
K-BILD, PESaM, EQ-5D-5L, HADS, VAS, GRC, EQ-VAS (weekly)24 weeks Investigate whether a home monitoring programme improves HRQOL and medication use for patients with IPF Moderate (1) Improved psychological well-being compared to standard care alone (mean difference 1.04 points; 95% CI 0.09–2.00; p=0.032)
(2) Mean change in FVC was not significantly different between hospital-based group (−87.9 mL; range −209 to 33.2 mL) and home monitoring group (−7.9 mL; range −96 to 69.4 mL; p=0.25)
(3) Correlation between home and hospital spirometry was high at all time-points (r=0.97, p<0.001 at baseline and 12 weeks; r=0.96, p<0.001 at 24 weeks)
(4) Correlation between slopes was moderately strong (r=0.58; p<0.001)Maher et al. (2020) [38] RCT n=253
Intervention (n=127)
Age (mean): 70 years (range 61.0–76.0)
Male: 70 (55%)
Placebo (n=126)
Age (mean): 69 years (range 63.0–74.0)
Male: 69 (55%)Unclassifiable ILD Spirometry
6MWD, UCSD-SOBQ, Leicester Cough Questionnaire, SGRQ (baseline and at 24 weeks)FVC (once daily) 24 weeks The mean change in FVC measured by daily home-based spirometry, change in FVC measured by site spirometry, change in 6MWD, change in UCSD-SOBQ Good (1) The primary end-point was not adequately analysed due to technical issues resulting in variability in home-based spirometry measurements
(2) Mean FVC decline measured by clinic spirometry was less in pirfenidone than placebo group (treatment difference 95.3 mL; 95% CI 35.9–154.6, p=0.002)Russell et al. (2016) [31] UK/PCS n=50
Male: 45 (90%)
Age (mean±sd): 66.7±7.9 yearsIPF Spirometry baseline, and at 3, 6 and 12 months FEV1, FVC (once daily) Median: 279 days, range 13–490 days Feasibility and reliability of measuring daily FVC Good (1) Daily FVC measurement was most predictive for disease progression and mortality when measured at 3 months (hazard ratio 1.04; 95% CI 1.02–1.06; p≤0.001), 6 months (HR 1.02; 95% CI 1.01–1.03; p<0.001), and 12 months (HR 1.012; 95% CI 1.007–1.01; p=0.001); 28 days did not yield a positive correlation
(2) Regular home measurement of FVC is feasible and reliable
(3) Home spirometry showed high correlation with hospital-based spirometryJohannson et al. (2017) [20] USA/PCS n=25
Male: 21 (84%)
Age (mean±sd): 73.6±7.5 yearsIPF Spirometry baseline and at 24 weeks FEV1, FVC (three times per week) UCSD-SOBQ (weekly), dyspnoea-VAS (weekly) 24 weeks Feasibility and reliability of measuring FVC and dyspnoea Good (1) Weekly home measurement of FVC and dyspnoea in patients with IPF is reliable and feasible over 24 weeks
(2) Mean adherence to weekly home spirometry >90%Veit et al. (2020) [32] DE/PCS n=47
Male: 28 (59.6%)
Age (mean±sd): 62.7 ±11.5 yearsILD Spirometry, 6MWD, DLCO, FVC, K-BILD, SGRQ, VAS Cough (baseline, at 3 and 6 months) FVC (three times per day) 6 months Determine feasibility in different types of fibrotic non-IPF ILD and investigate the clinical impact of daily home spirometry in patients with progressive ILD with respect to disease progression Good (1) Adherence was higher within the first 3 months compared to the second 3 months (83.5±19.6% versus 78.4±22.3% of the days; p=0.0086)
(2) Correlation between hospital FVC values and the mean of the home FVC measurements was similarly strong at 3-month (r=0.95; p<0.0001) and 6-month visits (r=0.93; p<0.0001)Edwards et al. (2020) [39] IE/USA/PCS n=36
USA: Age (mean): 62 years
Ireland: Age (mean): 66 yearsPF FVC (once daily)
mMRC (once daily)
IPF-PROM (weekly)1 year Acceptability and utility of patientMpower Fair (1) 93% of respondents reported a positive impact on their well-being
(2) Good correlation between hospital-based and home-based spirometryMoor et al. (2019) [45] NL/PCS n=10
Male: 6 (60%)
Age (mean): 53 yearsSarcoidosis Spirometry, activity, PROM (baseline and at 1 month), patients’ KSQ, EQ-5D-5L, HADS, FAS
Satisfaction (interview)PEF, FEV1, FVC (daily)
VAS fatigue, dyspnoea, cough, well-being (weekly)4 weeks Evaluate feasibility of home monitoring programme and patient satisfaction programme Fair (1) Home spirometry measurements highly correlated with in-hospital measurements of FVC (r=0.97, p<0.001) and FEV1 (r=0.96, p<0.001)
(2) Mean adherence to daily spirometry was 94.6%; it was measured by dividing the total number of measurements by the total numbers of daysMoor et al. (2018) [40] NL/PCS n=10
Male: 9 (90%)
Age (mean): 71 yearsIPF Spirometry, patient-reported outcome (baseline and at 1 month), patients’ K-BILD, HADS, EuroQoL 5D-5 L Home spirometry (daily)
Patient-reported outcome (weekly)4 weeks Feasibility of a pre-developed home monitoring programme in IPF (home spirometry) Fair (1) Home-based spirometry showed similar results to hospital-based spirometry; measurements of home and hospital FVC were correlated (r=0.94; p<0.001) and FEV1 (r=0.97; p<0.001) were highly correlated
(2) Feasibility and potential barriers of home spirometry: 80% of patients reported easy to use and 90% said it was not burdensome; mean adherence was 98.8% to home monitoring programmeMoor et al. (2020) [46] NL/PCS n=50
(n=44 acceptable data)
Age range: 43–79 years
Male: 68%IPF Questionnaire (baseline and at 6 weeks) FVC (twice daily)
Patient-reported K-BILD online6 weeks Measure diurnal variation in FVC in patients with f-ILD using home spirometry, evaluate the relationship between FVC and activity, home-based FVC, home and hospital-based correlation Fair (1) Morning FVC was significantly higher than afternoon FVC (mean difference 36 mL, p<0.001); the mean difference between morning and afternoon FVC was similar for patients with IPF compared with all f-ILDs
(2) Daily step correlated with FVC (r=0.32, p=0.028, K-BILD total score (r=0.5, p<0.001))
(3) Home and hospital-based spirometry were correlated (r=0.98, p<0.0001)Broos et al. (2017) [41] NL/PCS n=21
Male: 13
Female: 8
Age (mean±sd): 43±11 years
76% diagnosed with Scadding stage II sarcoidosisSarcoidosis Clinic spirometry, SGRQ, SF-36, KSQ, MRC, FAS at baseline, 1 and 3 months FVC (daily)
MRC, FAS (weekly)3 months Detect early steroid treatment effects in newly treated
pulmonary sarcoidosisGood (1) Home spirometry in sarcoidosis is reliable
(2) Home and hospital spirometry were correlated (r=0.98; p<0.001)Marcoux et al. (2019) [28] NL/PCS n=20
Male: 16 (80%)
Age (mean±sd): 73±6.9 yearsIPF Clinic spirometry at baseline, 4 and 23 weeks
6MWD (baseline and at 12 weeks)FVC (3 manoeuvres daily) 12 weeks Test the 12-week feasibility of blinded daily handheld spirometry and physical activity monitoring in patients with IPF Good (1) The correlation for office-based and handheld FVC measurements was 0.99 (95% CI 0.97–0.99) and 0.95 (95% CI 0.91–0.98), respectively
(2) Mean adherence to home spirometry was 84%Noth et al. (2021) [43] NL/PCS n=346 diagnosed with IPF in the previous 3 years and had an FVC ≥80% predicted;
116 randomised to nintedanib, 230 randomised to placebo for 12 weeks, followed by an open-label period in which all subjects received nintedanib 150 mg twice daily for 40 weeksIPF Clinic spirometry at baseline and weeks 4, 8, 12, 16, 20, 24, 36 and 52 FVC (weekly) 1 year Investigate the feasibility and validity of home spirometry as a measure of lung function decline in patients with IPF Good (1) Over 52 weeks, mean adherence was 86%
(2) Strong correlations were observed between home- and clinic-measured FVC at all time-points (r=0.72 to 0.84), but correlations between home- and clinic-measured rates of change in FVC were weak (r=0.26 for rate of decline in FVC over 52 weeks); the correlations were weaker in subjects who provided more FVC readings per week, due to variability in change in FVC measured at home (greater number of outliers) and errors in measurementsMoor et al. (2020) [42] NE/PCS n=10
Female: 60%
Age (mean±sd): 60.3±9.9 yearsSystemic sclerosis-associated ILD Spirometry at baseline and 3 months
K-BILD, HADS, EQ-5D-5L (baseline and at 6 weeks)FVC (once daily) 3 months Investigate the feasibility of an online home monitoring application, and spirometry Good (1) Mean±sd adherence was 98.8±1.5%
(2) Strong adherence and acceptability; 90% found home monitoring pleasant and wanted to continue to use home monitoring application dailyIPF: idiopathic pulmonary fibrosis; CAT: COPD Assessment Test; EQ-5D-5L: EuroQoL Five-Dimensions Questionnaire; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; GRC: Global Rating Change; HRQOL: health-related quality of life; ILD: interstitial lung disease; 6MWD: 6-min walk distance; HADS: Hospital Anxiety and Depression Scale; IE: Ireland; K-BILD: The King's Brief Interstitial Lung Disease; NL: Netherlands; PESaM: Patient Experiences and Satisfaction with Medication questionnaire; PCS: prospective cohort study; RCT: randomised controlled trial; SGRQ: St George's Respiratory Questionnaire; UK: United Kingdom; US: United States; VAS: visual analogue scale; mMRC: Modified Medical Research Council; EQ-VAS: EuroQol-visual analogue scales; IPF-PROM: Idiopathic Pulmonary Fibrosis (IPF) Patient Reported Outcome Measure; KSQ: King's Sarcoidosis Questionnaire; PEF: peak expiratory flow; f-ILD: fibrosing interstitial lung disease; SF36: 36-Item Short Form; UCSD-SOBQ: The University of California, San Diego, Shortness of Breath Questionnaire.
- TABLE 4
The components and outcomes measured in the home monitoring intervention in this systematic review
Study Measurement parameters Data transmission Online platform/app Spirometer Quality check Oximetry Step count/6MWD Symptom report Downloaded by staff Real-time Diary card Moor et al. (2020) [30] ✓ ✓ ✓ ✓ ✓ Russell et al. (2016) [31] ✓ ✓ Johannson et al. (2017) [20] ✓ ✓ ✓ ✓ Moor et al. (2019) [45] ✓ ✓ ✓ ✓ ✓ ✓ Veit et al. (2020) [32] ✓ ✓ ✓ ✓ ✓ Moor et al. (2018) [40] ✓ ✓ ✓ ✓ ✓ Edwards et al. (2020) [39] ✓ ✓ ✓ ✓ ✓ ✓ ✓ Noth et al. (2020) [43] ✓ ✓ Moor et al. (2020) [42] ✓ ✓ ✓ ✓ ✓ ✓ Broos et al. (2017) [41] ✓ ✓ ✓ Marcoux et al. (2019) [28] ✓ ✓ ✓ ✓ ✓ Moor et al. (2020) [46] ✓ ✓ ✓ ✓ Maher et al. (2020) [38] ✓ ✓ ✓ ✓ ✓
Vol 7 Issue 4
Table of Contents
Home monitoring of physiology and symptoms to detect interstitial lung disease exacerbations and progression: a systematic review
