| Literature DB >> 35735900 |
Rob A De Bie1, Arie C Verburg2, Carla Agasi-Idenburg3, Edith H C Cup4, Carolien Dekker1, Johanna M Van Dongen5, Edwin Geleijn6, Marissa H G Gerards7, Maud Graff8, Ron Van Heerde9, Hanneke Kalf4, Marly Kammerer4, Renée A Kool10, Anja De Kruif11, Hinke M Kruizenga12, Marike Van der Leeden13, Ton A F Lenssen14, Willemijn M Meijer15, Raymond Ostelo16, Amber Ronteltap17, Marike Van der Schaaf13, Sonja Van Oers18, Marian A E De van der Schueren19, Anne I Slotegraaf19, Cindy Veenhof20, Thomas J Hoogeboom21, Philip Van der Wees21.
Abstract
OBJECTIVE: To report the study protocol and baseline characteristics of a prospective cohort study to evaluate longitudinal recovery trajectories of patients recovering from COVID-19 who have visited a primary care allied health professional.Entities:
Mesh:
Year: 2022 PMID: 35735900 PMCID: PMC9422882 DOI: 10.2340/jrm.v54.2506
Source DB: PubMed Journal: J Rehabil Med ISSN: 1650-1977 Impact factor: 3.959
Fig. 1Study flowchart patient inclusion and data collection.
PIF, Patient information form; IC, Informed consent; PROMs, Patient reported outcome measures
Overall outcome measures and endpoints for the prospective cohort study on allied healthcare for patients recovering from COVID-19 in primary care
| Profession | Domain | Measure | Baseline | End of treatment | 3 months | 6 months | 9 months | 12 months |
|---|---|---|---|---|---|---|---|---|
| Primary outcome measures | ||||||||
| Total cohort | Participation | USER-P | × | × | × | × | ||
| Quality of life | EQ-5D-5L | × | × | × | × | |||
| Fatigue | FSS | × | × | × | × | |||
| Physical functioning | PROMIS FF Short Form 10b | × | × | × | × | |||
| Costs | Cost questionnaire | × | × | × | × | |||
| Secondary outcome measures | ||||||||
| Total cohort | Psychological well-being | HADS | × | × | × | × | × | × |
| PT/ET | Physical functioning | PROMIS FF Short Form 10b | × | × | × | × | ||
| PT/ET | Activities | PSFS | × | × | ||||
| PT/ET | Exercise capacity | 6MWT | × | × | ||||
| PT/ET | Muscle strength | 5TSTS | × | × | ||||
| DI | Nutritional status | BMI | × | × | ||||
| DI | Global assessment | PG-SGA SF | × | × | ||||
| SLT | Voice problems | VHI | × | × | ||||
| SLT | Swallowing problems | DHI | × | × | ||||
| OT | Activities | COPM | × | × | × | |||
| OT | Functioning | AMPS | × | × | ||||
| OT | Cognitive functioning | CoCo-P | × | × | × | |||
USER-P: Utrecht Scale for Evaluation of Rehabilitation Participation; EQ-5D-5L: EuroQol-5 Dimensions-5 Levels; FSS: Fatigue Severity Scale; PROMIS: Patient-Reported Outcomes Measurement Information System FF Short Form 10b; HADS: Hospital Anxiety and Depression Scale; PSFS: Patient Specific Functioning Scale; 6MWT: 6-minute walk test; SPPB: Short Physical Performance Battery; SWT: Shuttle Walk Test – incremental and endurance; 5TSTS: 5 times sit-to-stand test; HHD: Hand Held Dynamometer; BMI: body mass index; SARC-F: Strength, Assistance with walking, Rise from a chair, Climb stairs and Falls; VAS: visual analogue scale; BSC: Bristol Stool Chart; BIA: bio-electrical impedance analysis; PG-SGA: Patient-Generated Subjective Global Assessment short form; VHI: Voice Handicap Index; MPT: Maximum Phonation Time; DHI: Dysphagia Handicap Index; MSS: maximum swallowing speed; COPM: Canadian Occupational Performance Measure; PRO-ergo: Patient Reported Outcome-ergo; AMPS: Assessment of Motor and Process Skills; PRPP: Perceive, Recall, Plan, Perform; CoCo-P: Cognitive Complaints – Participation; Physical Therapist (PT) Exercise Therapist (ET) Dieticians (DI) Speech and Language therapists (SLT) Occupational Therapist (OT).
Description of the prospective cohort study on allied healthcare for patients recovering from COVID-19 in primary care at baseline provided by allied health professionals
| Total prospective cohort | |
|---|---|
| Patients, | 1451 |
| Treatment trajectories, | 1708 |
| Physical therapy/exercise therapy | 1005 |
| Occupational therapy | 364 |
| Dietary care | 224 |
| Speech and language therapy | 115 |
| Allied healthcare professionals, | 896 |
| Sex, | |
| Male | 475 (32.7) |
| Female | 825 (56.9) |
| Missing | 151 (10.4) |
| Age, mean ± SD | 49.1 ± 13.0 |
| Referring physician, | |
| General practitioner | 1061 (73.1) |
| Pulmonologist | 113 (8.7) |
| Internist | 8 (0.6) |
| Rehabilitation physician | 34 (2.6) |
| Elderly care physician | 9 (0.7) |
| Direct access to allied healthcare | 10 (0.8) |
| Other referral | 59 (4.6) |
| Unknown | 1 (0.1) |
| Missing | 156 (10.8) |
| COVID-19 severity, | |
| Mild/moderate | 974 (67.1) |
| Severe | 268 (18.5) |
| Critical | 38 (3.0) |
| Missing | 171 (11.8) |
| Admission to hospital for COVID-19 infection, | |
| Hospitalized including IC-treatment | 87 (6.0) |
| Hospitalized | 210 (16.3) |
| Not hospitalized | 988 (76.9) |
| Missing | 166 (11.4) |
n: number; SD: standard deviation; IC: Intensive Care.
Primary outcome measures of the participating patients at baseline
| Outcome measure | Baseline |
|---|---|
| USER-P | |
| Frequency scale | 27.5 (10.4) |
| Restrictions scale | 65.8 (19.3) |
| Satisfaction scale | 39.4 (16.3) |
| EQ-VAS, mean (SD) | |
| 55.6 (17.8) | |
| FSS, median (IQR) | |
| 5.8 [5.1-6.3] | |
| PROMIS, T-score (IQR) | |
| 37.9 (33.5-41.5) | |
| HADS anxiety, mean (SD) | |
| 7.1 (4.5) | |
| HADS depression, mean (SD) | |
| 7.3 (4.2) |
USER-P: Utrecht Scale for Evaluation of Rehabilitation Participation EQ-VAS: EuroQol Visual Analogue Scale FSS: Fatigue Severity Scale PROMIS: Patient-Reported Outcomes Measurement Information System; HADS: Hospital Anxiety and Depression Scale; SD: standard deviation; IQR: interquartile range.
All 3 scales have a score range of 0–100, with higher scores reflecting better participation (higher frequency, less restrictions, higher satisfaction).
Data were not fully available for all patients: the n within the table depicts the number of patients with available data.
PROMIS instruments are always expressed as a score relative to the mean of a group (T-score). A T-score is a standardized score. In this process, the mean score in a population is assigned the value 50. The standard deviation (SD) is set equal to 10 points. In a normal distribution, 95% of the scores of people in the population are between the mean plus or minus 2 SD, in this case between the values 30 and 70. Values below 30 or above 70 therefore occur in less than 5% of the population.