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Fig 1.

CONSORT flow diagram.

Flow diagram of enrollment, follow-up and analysis in the study “Activity monitoring in ME/CFS”.

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Table 1.

Baseline characteristics of the study population, all patients and by severity.

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Fig 2.

Patient example.

Patient example with raw data for steps per 24 hours and resting heart rate, days 1–168.

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Fig 3.

Steps per 24 hours, by severity, by SF-36 physical function, and by combination of SF-36 physical function and DSQ-SF.

(A) Steps per 24 hours (mean, 95% CI) during follow-up, by severity categories; Mild, Moderate and Severe. (B) Steps per 24 hours (mean, 95% CI) during follow-up, by three categories based on baseline SF-36 PF. (C) Steps per 24 hours (mean, 95% CI) during follow-up, in two groups based on; SF-36 PF > 50 or DSQ-SF < 55, versus SF-36 PF < 50 and DSQ-SF > 55. The largest changes in mean steps between 4-week time periods, with difference highest versus lowest are indicated. General Linear Model (GLM) for repeated measures with p values for time effect and for interaction time-by-group are shown.

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Fig 4.

Correlations between baseline clinical data, PROMs, steps per 24 hours and resting heart rate.

Spearman’s correlation plot between baseline steps per 24 hour (mean, weeks 1–4), resting heart rate (mean, weeks 1–4), age, Body Mass Index. Short Form-36 Health Survey (SF-36); The raw scores (scale 0–100) for the six SF-36 domains (Mental health (SF36-MH), Physical function (SF-36 PF), Bodily pain (SF-36 BP), General health (SF-36 GH), Social function (SF-36 SF) and Vitality (SF-36 VF). Composite Autonomic Symptom Score-31 (COMPASS-31); sum and Compass orthostatic, DePaul Symptom Questionnaire–Short Form (DSQ-SF), and Function Level. Significant p-values are shown below Spearman’s rho, with no adjustments for multiple correlations.

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Fig 5.

Activity data: Resting heart rate by severity, steps per 24 hours measured with Fitbit and SenseWear.

(A) Resting heart rate, mean (min and max) levels, by three severity groups. (B) Steps per 24 hours measured for seven consecutive days by Fitbit and SenseWear, at baseline, 3 months and 6 months. (C) Bland-Altman plot showing difference (bias) between Fitbit and SenseWear devices for measured steps per 24 hours.

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Fig 6.

SF-36 subdomains (mean, 95% CI) during follow up; SF36 Physical Function (SF-36 PF) by severity categories, and by categories of baseline SF-36 PF.

(A) SF-36 domains during follow-up; MH: Mental Health, PF: Physical Function, BP: Bodily pain, GH: General health, SF: Social function and VT: Vitality. Raw scores, scale 0–100, lower scores denote lower function. (B) SF-36 Physical Function (mean, 95% CI) during follow up shown in separate panels, for the severity categories. (C) SF-36 Physical Function (mean, 95% CI) during follow-up by three categories based on the baseline level of SF-36 PF; < 30, 30–45, and > 45. General Linear Model (GLM) for repeated measures with p values for time effect and for interaction time-by-group are shown.

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Fig 7.

DSQ-SF and SF-36 Physical Function during follow-up, by ME/CFS categorized based on a combination of baseline SF-36 PF and DSQ-SF scores.

(A) DePaul Symptom Questionnaire–Short Form (DSQ-SF) score (mean, 95% CI) during follow-up, by categories based on baseline SF-36 Physical Function; < 30, 30–45, and > 45. (B) SF-36 Physical function score (mean, 95% CI) during follow-up, by two groups based on: SF-36 PF > 50 OR DSQ-SF < 55 versus SF-36 PF < 50 AND DSQ-SF > 55. (C) DSQ-SF score (mean, 95% CI), by two groups based on; SF-36 Physical Function >50 OR DSQ-SF < 55 versus SF-36 Physical Function < 50 AND DSQ-SF > 55. The largest changes in mean scores between 4-week time periods, with difference highest versus lowest, are indicated. General Linear Model (GLM) for repeated measures with p values for time effect and for interaction time-by-group are shown.

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Table 2.

Participant evaluation of the study.

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Table 2 Expand

Table 3.

Short Form-36 Health Survey, the domain “Physical Function” (SF-36 PF, raw scores, scale 0–100), in different ME/CFS studies.

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