135 results on '"Sauvé M"'
Search Results
2. Factors associated with physical function among people with systemic sclerosis: A SPIN cohort cross-sectional study
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Dal Santo, T., Rice, D.B., Carrier, M.E., Virgili-Gervais, G., Levis, B., Kwakkenbos, L., Golberg, M., Bartlett, S.J., Gietzen, A., Gottesman, K., Guillot, G., Hudson, M., Hummers, L.K., Malcarne, V.L., Mayes, M.D., Mouthon, L., Richard, M., Sauvé, M., Wojeck, R.K., Geoffroy, M.C., Benedetti, A., Thombs, B.D., Dal Santo, T., Rice, D.B., Carrier, M.E., Virgili-Gervais, G., Levis, B., Kwakkenbos, L., Golberg, M., Bartlett, S.J., Gietzen, A., Gottesman, K., Guillot, G., Hudson, M., Hummers, L.K., Malcarne, V.L., Mayes, M.D., Mouthon, L., Richard, M., Sauvé, M., Wojeck, R.K., Geoffroy, M.C., Benedetti, A., and Thombs, B.D.
- Abstract
Contains fulltext : 298566.pdf (Publisher’s version ) (Closed access), Objectives: To compare physical function in systemic sclerosis (SSc, scleroderma) to general population normative data and identify associated factors. Methods: Scleroderma Patient-centered Intervention Network Cohort participants completed the Physical Function domain of the Patient-Reported Outcomes Measurement Information System Version 2 upon enrolment. Multivariable linear regression was used to assess associations of sociodemographic, lifestyle, and disease-related variables. Results: Among 2,385 participants, mean physical function T-score (43.7, SD = 8.9) was ∼2/3 of a standard deviation (SD) below the US general population (mean = 50, SD = 10). Factors associated in multivariable analysis included older age (-0.74 points per SD years, 95% CI -0.78 to -1.08), female sex (-1.35, -2.37 to -0.34), fewer years of education (-0.41 points per SD in years, -0.75 to -0.07), being single, divorced, or widowed (-0.76, -1.48 to -0.03), smoking (-3.14, -4.42 to -1.85), alcohol consumption (0.79 points per SD drinks per week, 0.45-1.14), BMI (-1.41 points per SD, -1.75 to -1.07), diffuse subtype (-1.43, -2.23 to -0.62), gastrointestinal involvement (-2.58, -3.53 to -1.62), digital ulcers (-1.96, -2.94 to -0.98), moderate (-1.94, -2.94 to -0.93) and severe (-1.76, -3.24 to -0.28) small joint contractures, moderate (-2.10, -3.44 to -0.76) and severe (-2.54, -4.64 to -0.44) large joint contractures, interstitial lung disease (-1.52, -2.27 to -0.77), pulmonary arterial hypertension (-3.72, -4.91 to -2.52), rheumatoid arthritis (-2.10, -3.64 to -0.56) and idiopathic inflammatory myositis (-2.10, -3.63 to -0.56). Conclusion: Physical function is impaired for many individuals with SSc and associated with multiple disease factors., 12 maart 2024, 10 p.
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- 2024
3. Modelling mixed mode fracture of mortar joints in masonry buildings
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Bisoffi-Sauve, M., Morel, S., and Dubois, F.
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- 2019
- Full Text
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4. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND)
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Kwakkenbos, L., Carrier, M.E., Welling, J.J.K.C., Turner, K.A., Cumin, J., Pépin, M.R., Ende, C.H.M. van den, Schouffoer, A.A., Hudson, M., Breda, W. van, Sauvé, M., Mayes, M.D., Malcarne, V.L., Nielson, W.R., Nguyen, C., Boutron, I., Rannou, F., Thombs, B.D., Mouthon, L., and Organizational Psychology
- Subjects
Cohort multiple RCT ,Keywords Feasibility trial ,General Neuroscience ,General Medicine ,Occupational therapy ,Tele-rehabilitation ,General Biochemistry, Genetics and Molecular Biology ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,Scleroderma ,Experimental Psychopathology and Treatment ,All institutes and research themes of the Radboud University Medical Center ,Internet intervention ,Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5] ,Systemic sclerosis ,General Agricultural and Biological Sciences ,Physical therapy - Abstract
Purpose The Scleroderma Patient-centered Intervention Network (SPIN) online hand exercise program (SPIN-HAND), is an online self-help program of hand exercises designed to improve hand function for people with scleroderma. The objective of this feasibility trial was to evaluate aspects of feasibility for conducting a full-scale randomized controlled trial of the SPIN-HAND program. Materials and Methods The feasibility trial was embedded in the SPIN cohort and utilized the cohort multiple randomized controlled trial (cmRCT) design. In the cmRCT design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about trials conducted using the cohort. When trials were conducted in the cohort, participants randomized to the intervention were informed and consented to access the intervention. Participants randomized to control were not informed that they have not received an intervention. All participants eligible and randomized to participate in the trial were included in analyses on an intent-to-treat basis. Cohort participants with a Cochin Hand Function Scale score ≥ 3/90 and an interest in using an online hand-exercise intervention were randomized (1:1 ratio) to be offered as usual care plus the SPIN-HAND Program or usual care for 3 months. User satisfaction was assessed with semi-structured interviews. Results Of the 40 randomized participants, 24 were allocated to SPIN-HAND and 16 to usual care. Of 24 participants randomized to be offered SPIN-HAND, 15 (63%) consented to use the program. Usage of SPIN-HAND content among the 15 participants who consented to use the program was low; only five (33%) logged in more than twice. Participants found the content relevant and easy to understand (satisfaction rating 8.5/10, N = 6). Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly. The required technical support was minimal. Conclusions Trial methodology functioned as designed, and the SPIN-HAND Program was feasibly delivered; however, the acceptance of the offer and use of program content among accepters were low. Adjustments to information provided to potential participants will be implemented in the full-scale SPIN-HAND trial to attempt to increase offer acceptance.
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- 2022
5. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Self-Management (SPIN-SELF) Program.
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Kwakkenbos, L, Østbø, N, Carrier, M-E, Nielson, WR, Fedoruk, C, Levis, B, Henry, RS, Pope, J, Frech, T, Gholizadeh, S, Johnson, SR, Piotrowski, P, Jewett, LR, Gordon, J, Chung, L, Bilsker, D, Tao, L, Turner, KA, Cumin, J, Welling, J, Fortuné, C, Leite, C, Gottesman, K, Sauvé, M, Reyna, TSR, Hudson, M, Larche, M, van Breda, W, Suarez-Almazor, ME, Bartlett, SJ, Malcarne, VL, Mayes, MD, Boutron, I, Mouthon, L, Benedetti, A, Thombs, BD, SPIN Investigators, Kwakkenbos, L, Østbø, N, Carrier, M-E, Nielson, WR, Fedoruk, C, Levis, B, Henry, RS, Pope, J, Frech, T, Gholizadeh, S, Johnson, SR, Piotrowski, P, Jewett, LR, Gordon, J, Chung, L, Bilsker, D, Tao, L, Turner, KA, Cumin, J, Welling, J, Fortuné, C, Leite, C, Gottesman, K, Sauvé, M, Reyna, TSR, Hudson, M, Larche, M, van Breda, W, Suarez-Almazor, ME, Bartlett, SJ, Malcarne, VL, Mayes, MD, Boutron, I, Mouthon, L, Benedetti, A, Thombs, BD, and SPIN Investigators
- Abstract
BACKGROUND: The Scleroderma Patient-centered Intervention Network (SPIN) developed an online self-management program (SPIN-SELF) designed to improve disease-management self-efficacy in people with systemic sclerosis (SSc, or scleroderma). The aim of this study was to evaluate feasibility aspects for conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF Program. METHODS: This feasibility trial was embedded in the SPIN Cohort and utilized the cohort multiple RCT design. In this design, at the time of cohort enrollment, cohort participants consent to be assessed for trial eligibility and randomized prior to being informed about the trial. Participants in the intervention arm are informed and provide consent, but not the control group. Forty English-speaking SPIN Cohort participants from Canada, the USA, or the UK with low disease-management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale [SEMCD] score ≤ 7) who were interested in using an online self-management program were randomized (3:2 ratio) to be offered the SPIN-SELF Program or usual care for 3 months. Program usage was examined via automated usage logs. User satisfaction was assessed with semi-structured interviews. Trial personnel time requirements and implementation challenges were logged. RESULTS: Of 40 SPIN Cohort participants randomized, 26 were allocated to SPIN-SELF and 14 to usual care. Automated eligibility and randomization procedures via the SPIN Cohort platform functioned properly, except that two participants with SEMCD scores > 7 (scores of 7.2 and 7.3, respectively) were included, which was caused by a system programming error that rounded SEMCD scores. Of 26 SPIN Cohort participants offered the SPIN-SELF Program, only 9 (35%) consented to use the program. Usage logs showed that use of the SPIN-SELF Program was low: 2 of 9 users (22%) logged into the program only once (median = 3), and 4 of 9 (44%) accessed none or only 1 of the 9 program's modules (median = 2)
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- 2022
6. Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: The Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial
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Kwakkenbos, C.M.C., Carrier, M.E., Welling, J.J.K.C., Levis, B., Levis, A.W., Sauvé, M., Turner, K.A., Tao, L.X., Aguila, K., Carboni-Jiménez, A., Cañedo-Ayala, M., Harb, S., Ende, C.H.M. van den, Hudson, M., Breda, W. van, Nguyen, C., Boutron, I., Rannou, F., Thombs, B.D., Mouthon, L., Kwakkenbos, C.M.C., Carrier, M.E., Welling, J.J.K.C., Levis, B., Levis, A.W., Sauvé, M., Turner, K.A., Tao, L.X., Aguila, K., Carboni-Jiménez, A., Cañedo-Ayala, M., Harb, S., Ende, C.H.M. van den, Hudson, M., Breda, W. van, Nguyen, C., Boutron, I., Rannou, F., Thombs, B.D., and Mouthon, L.
- Abstract
Item does not contain fulltext, Background: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional health outcomes (secondary) in people with SSc with at least mild hand function limitations. Methods: The pragmatic, two-arm, parallel-group cohort multiple randomized controlled trial was embedded in the SPIN Cohort. Cohort participants with Cochin Hand Function Scale (CHFS) scores ≥ 3 and who indicated interest in using the SPIN-HAND Program were randomized (3:2 ratio) to an offer of program access or to usual care (targeted N = 586). The SPIN-HAND program consists of 4 modules that address (1) thumb flexibility and strength; (2) finger bending; (3) finger extension; and (4) wrist flexibility and strength. The primary outcome analysis compared CHFS scores 3 months post-randomization between participants offered versus not offered the program. Secondary outcomes were CHFS scores 6 months post-randomization and functional health outcomes (Patient-Reported Outcomes Measurement Information System profile version 2.0 domain scores) 3 and 6 months post-randomization. Results: In total, 466 participants were randomized to intervention offer (N = 280) or usual care (N = 186). Of 280 participants offered the intervention, 170 (61%) consented to access the program. Of these, 117 (69%) viewed at least one hand exercise instruction video and 77 (45%) logged into the program website at least 3 times. In intent-to-treat analyses, CHFS scores were 1.2 points lower (95% CI - 2.8 to 0.3) for intervention compared to usual care 3 months post-randomization and 0.1 points lower (95% CI - 1.8 to 1.6 points) 6 months post-randomization. There were no statistically significant differences in other outcomes. Conclusion: The offer to use the SP
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- 2022
7. Effects of a support group leader education program jointly developed by health professionals and patients on peer leader self-efficacy among leaders of scleroderma support groups: A two-arm parallel partially nested randomised controlled trial
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Thombs, B.D., Levis, B., Carrier, M.E., Dyas, L., Nordlund, J., Tao, L.X., Aguila, K., Bourgeault, A., Konrad, V., Sauvé, M., Connolly, K., Henry, R.S., Ostbo, N., Levis, A.W., Kwakkenbos, C.M.C., Malcarne, V.L., El-Baalbaki, G., Hudson, M., Wurz, A., Culos-Reed, S.N., Platt, R.W., Benedetti, A., Thombs, B.D., Levis, B., Carrier, M.E., Dyas, L., Nordlund, J., Tao, L.X., Aguila, K., Bourgeault, A., Konrad, V., Sauvé, M., Connolly, K., Henry, R.S., Ostbo, N., Levis, A.W., Kwakkenbos, C.M.C., Malcarne, V.L., El-Baalbaki, G., Hudson, M., Wurz, A., Culos-Reed, S.N., Platt, R.W., and Benedetti, A.
- Abstract
Contains fulltext : 284227.pdf (Publisher’s version ) (Open Access), Background: More people with rare diseases likely receive disease education and emotional and practical support from peer-led support groups than any other way. Most rare-disease support groups are delivered outside of the health care system by untrained leaders. Potential benefits may not be achieved and harms, such as dissemination of inaccurate information, may occur. Our primary objective was to evaluate the effects of a rare-disease support group leader education program, which was developed collaboratively by researchers, peer support group leaders, and patient organization leaders, compared to waitlist control, on peer leader self-efficacy among scleroderma support group leaders. Methods: The trial was a pragmatic, two-arm partially nested randomised controlled trial with 1:1 allocation into intervention or waitlist control. Eligible participants were existing or candidate peer support group leaders affiliated with a scleroderma patient organization. Leader training was delivered in groups of 5-6 participants weekly for 13 weeks in 60-90 min sessions via the GoToMeeting® videoconferencing platform. The program included 12 general leader training modules and one module specific to scleroderma. Primary outcome was leader self-efficacy, measured by the Support Group Leader Self-efficacy Scale (SGLSS) immediately post-intervention. Secondary outcomes were leader self-efficacy 3 months post-intervention; emotional distress, leader burnout, and volunteer satisfaction post-intervention and 3 months post-intervention; and program satisfaction among intervention participants post-intervention. Results: One hundred forty-eight participants were randomised to intervention (N = 74) or waitlist (N = 74). Primary outcome data were provided by 146 (99%) participants. Mean number of sessions attended was 11.4 (standard deviation = 2.6). Mean program satisfaction score (CSQ-8) was 30.3 (standard deviation = 3.0; possible range 8-32). Compared to waitlist control, leader self
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- 2022
8. Barriers and facilitators to physical activity for people with scleroderma: A Scleroderma Patient-centered Intervention Network Cohort study
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Harb, S., Peláez, S., Carrier, M.E., Kwakkenbos, C.M.C., Bartlett, S.J., Hudson, M., Mouthon, L., Sauvé, M., Welling, J.J.K.C., Shrier, I., Thombs, B.D., Harb, S., Peláez, S., Carrier, M.E., Kwakkenbos, C.M.C., Bartlett, S.J., Hudson, M., Mouthon, L., Sauvé, M., Welling, J.J.K.C., Shrier, I., and Thombs, B.D.
- Abstract
Item does not contain fulltext, Objective: To support physical activity among people with systemic sclerosis (SSc; scleroderma), we sought to determine the (1) prevalence and importance of barriers and (2) likelihood of using possible facilitators. Methods: We invited 1,707 participants from an international SSc cohort to rate the (1) importance of 20 barriers (14 medical; 4 social or personal; 1 lifestyle; 1 environmental); and (2) likelihood of using 91 corresponding barrier-specific and 12 general facilitators. Results: Among 721 respondents, 13 barriers were experienced by ≥25% of participants, including 2 (fatigue, Raynaud's) rated 'important' or 'very important' by ≥50% of participants, 7 (joint stiffness and contractures, shortness of breath, gastrointestinal problems, difficulty grasping, pain, muscle weakness and mobility limitations, low motivation) by 26-50%, and 4 by <26%. Overall, 23 (18 medical-related) of 103 facilitators were rated by ≥75% as 'likely' or 'very likely' to use among those who experienced corresponding barriers; these facilitators focused on adapting exercise (e.g., using controlled, slow movement), taking care of one’s body (e.g., stretching), keeping warm (e.g., wearing gloves), and protecting skin (e.g., covering ulcers). Among those who had previously tried the facilitator, all facilitators were rated by ≥50% as 'likely' or 'very likely' to use; among those with the barrier who had not tried the facilitator, only 12 of 103 were rated by >50% as 'likely' or 'very likely'. Conclusion: Medical-related physical activity barriers were common and considered important. Facilitators considered as most likely to be used involved adapting exercise, taking care of one’s body, keeping warm, and protecting skin.
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- 2022
9. Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: The Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial
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Kwakkenbos, L., Carrier, M.E., Welling, J.J.K.C., Levis, B., Levis, A.W., Sauvé, M., Turner, K.A., Tao, L.X., Aguila, K., Carboni-Jiménez, A., Cañedo-Ayala, M., Harb, S., Ende, C.H.M. van den, Hudson, M., Breda, W. van, Nguyen, C., Boutron, I., Rannou, F., Thombs, B.D., Mouthon, L., Kwakkenbos, L., Carrier, M.E., Welling, J.J.K.C., Levis, B., Levis, A.W., Sauvé, M., Turner, K.A., Tao, L.X., Aguila, K., Carboni-Jiménez, A., Cañedo-Ayala, M., Harb, S., Ende, C.H.M. van den, Hudson, M., Breda, W. van, Nguyen, C., Boutron, I., Rannou, F., Thombs, B.D., and Mouthon, L.
- Abstract
Contains fulltext : 286758.pdf (Publisher’s version ) (Open Access), Background: Systemic sclerosis (scleroderma; SSc) is a rare autoimmune connective tissue disease. Functional impairment of hands is common. The Scleroderma Patient-centered Intervention Network (SPIN)-HAND trial compared effects of offering access to an online self-guided hand exercise program to usual care on hand function (primary) and functional health outcomes (secondary) in people with SSc with at least mild hand function limitations. Methods: The pragmatic, two-arm, parallel-group cohort multiple randomized controlled trial was embedded in the SPIN Cohort. Cohort participants with Cochin Hand Function Scale (CHFS) scores ≥ 3 and who indicated interest in using the SPIN-HAND Program were randomized (3:2 ratio) to an offer of program access or to usual care (targeted N = 586). The SPIN-HAND program consists of 4 modules that address (1) thumb flexibility and strength; (2) finger bending; (3) finger extension; and (4) wrist flexibility and strength. The primary outcome analysis compared CHFS scores 3 months post-randomization between participants offered versus not offered the program. Secondary outcomes were CHFS scores 6 months post-randomization and functional health outcomes (Patient-Reported Outcomes Measurement Information System profile version 2.0 domain scores) 3 and 6 months post-randomization. Results: In total, 466 participants were randomized to intervention offer (N = 280) or usual care (N = 186). Of 280 participants offered the intervention, 170 (61%) consented to access the program. Of these, 117 (69%) viewed at least one hand exercise instruction video and 77 (45%) logged into the program website at least 3 times. In intent-to-treat analyses, CHFS scores were 1.2 points lower (95% CI - 2.8 to 0.3) for intervention compared to usual care 3 months post-randomization and 0.1 points lower (95% CI - 1.8 to 1.6 points) 6 months post-randomization. There were no statistically significant differences in other outcomes. Conclusion: The offer to use the SP
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- 2022
10. POS1497-PARE POST-TRIAL SURVEY OF PARTICIPANTS OF A PHASE 3 CLINICAL TRIAL IN SSC-ILD
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Galetti, I., primary, Brown, E., additional, Kennedy, A., additional, Riggs, R. J., additional, Roennow, A., additional, Sauvé, M., additional, Welling, J., additional, Finnern, H., additional, Gilbert, A., additional, Gahlemann, M., additional, and Sauter, W., additional
- Published
- 2021
- Full Text
- View/download PDF
11. Barriers and facilitators to physical activity for people with scleroderma: A Scleroderma Patient-centered Intervention Network (SPIN) Cohort study
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Harb, S., Peláez, S., Carrier, M.E., Kwakkenbos, L., Bartlett, S.J., Hudson, M., Mouthon, L., Sauvé, M., Welling, J.J.K.C., Shrier, I., Thombs, B.D., Harb, S., Peláez, S., Carrier, M.E., Kwakkenbos, L., Bartlett, S.J., Hudson, M., Mouthon, L., Sauvé, M., Welling, J.J.K.C., Shrier, I., and Thombs, B.D.
- Abstract
02 februari 2021, Item does not contain fulltext, Objective: To support physical activity among people with systemic sclerosis (SSc; scleroderma), we sought to determine the (1) prevalence and importance of barriers and (2) likelihood of using possible facilitators. Methods: We invited 1,707 participants from an international SSc cohort to rate the (1) importance of 20 barriers (14 medical; 4 social or personal; 1 lifestyle; 1 environmental); and (2) likelihood of using 91 corresponding barrier-specific and 12 general facilitators. Results: Among 721 respondents, 13 barriers were experienced by ≥25% of participants, including 2 (fatigue, Raynaud's) rated 'important' or 'very important' by ≥50% of participants, 7 (joint stiffness and contractures, shortness of breath, gastrointestinal problems, difficulty grasping, pain, muscle weakness and mobility limitations, low motivation) by 26-50%, and 4 by <26%. Overall, 23 (18 medical-related) of 103 facilitators were rated by ≥75% as 'likely' or 'very likely' to use among those who experienced corresponding barriers; these facilitators focused on adapting exercise (e.g., using controlled, slow movement), taking care of one’s body (e.g., stretching), keeping warm (e.g., wearing gloves), and protecting skin (e.g., covering ulcers). Among those who had previously tried the facilitator, all facilitators were rated by ≥50% as 'likely' or 'very likely' to use; among those with the barrier who had not tried the facilitator, only 12 of 103 were rated by >50% as 'likely' or 'very likely'. Conclusion: Medical-related physical activity barriers were common and considered important. Facilitators considered as most likely to be used involved adapting exercise, taking care of one’s body, keeping warm, and protecting skin.
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- 2021
12. CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): Checklist with explanation and elaboration
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Kwakkenbos, L., Imran, M., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., Thombs, B.D., Kwakkenbos, L., Imran, M., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., and Thombs, B.D.
- Abstract
Contains fulltext : 234331.pdf (Publisher’s version ) (Open Access)
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- 2021
13. Effects of non-pharmacological and non-surgical interventions on health outcomes in systemic sclerosis: Protocol for a living systematic review
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Discepola, M.N., Carboni-Jiménez, A., Kwakkenbos, L., Henry, R.S., Boruff, J., Krishnan, A., Boström, C., Culos-Reed, N., Hudson, M., Leader, D.M., Mattsson, M., Mouthon, L., Wojeck, R.K., Jimenez, E.Y., Sauvé, M., Welling, J.J.K.C., Guillot, G., Benedetti, A., Thombs, B.D., Discepola, M.N., Carboni-Jiménez, A., Kwakkenbos, L., Henry, R.S., Boruff, J., Krishnan, A., Boström, C., Culos-Reed, N., Hudson, M., Leader, D.M., Mattsson, M., Mouthon, L., Wojeck, R.K., Jimenez, E.Y., Sauvé, M., Welling, J.J.K.C., Guillot, G., Benedetti, A., and Thombs, B.D.
- Abstract
Contains fulltext : 233404.pdf (Publisher’s version ) (Open Access), Introduction: Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease with a high level of burden, a significant impact on the ability to carry out daily activities, and a considerable negative impact on health-related quality of life. Non-pharmacological interventions could be provided to potentially improve mental and physical health outcomes. However, the effectiveness of non-pharmacological interventions on health and well-being among individuals with SSc has not been well established. The proposed living systematic review aims to identify and evaluate randomised controlled trial (RCT) evidence on the effectiveness of non-pharmacological and non-surgical interventions on mental and physical health outcomes and on the delivery of such services in SSc. Methods and analysis: Eligible studies will be RCTs that examine non-pharmacological and non-surgical interventions aimed at improving health outcomes among individuals with SSc or the delivery of services intended to improve healthcare or support of people with SSc (eg, support groups). All RCTs included in a previous systematic review that sought studies published between 1990 and March 2014 will be evaluated for inclusion. Additional trials will be sought from January 2014 onwards using a similar, augmented search strategy developed by a health sciences librarian. We will search the MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library and Web of Science databases and will not restrict by language. Two independent reviewers will determine the eligibility of identified RCTs and will extract data using a prespecified standardised form in DistillerSR. Meta-analyses will be considered if >=2 eligible RCTs report similar non-pharmacological interventions and comparable health outcomes. We will conduct a qualitative synthesis for interventions that cannot be synthesised via meta-analysis. Ethics and dissemination: We will post initial and ongoing results via a website, publish results periodically vi
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- 2021
14. Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)
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Imran, M., Kwakkenbos, L., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., Thombs, B.D., Imran, M., Kwakkenbos, L., McCall, S.J., McCord, K.A., Fröbert, O., Hemkens, L.G., Zwarenstein, M., Relton, C., Rice, D.B., Langan, S.M., Benchimol, E.I., Thabane, L., Campbell, M.K., Sampson, M., Erlinge, D., Verkooijen, H.M., Moher, D., Boutron, I., Ravaud, P., Nicholl, J., Uher, R., Sauvé, M., Fletcher, J., Torgerson, D., Gale, C., Juszczak, E., and Thombs, B.D.
- Abstract
Contains fulltext : 234358.pdf (Publisher’s version ) (Open Access), Objectives: Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist. Methods: The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist. Results: 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report. Conclusion: Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using
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- 2021
15. Validation of the COVID-19 Fears Questionnaires for Chronic Medical Conditions: A Scleroderma Patient-centered Intervention Network COVID-19 Cohort study
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Wu, Y., Kwakkenbos, L., Henry, R.S., Tao, L.X., Harb, S., Bourgeault, A., Carrier, M.E., Levis, B., Sun, Y., Bhandari, P.M., Carboni-Jiménez, A., Gagarine, M., He, C., Krishnan, A., Negeri, Z.F., Neupane, D., Mouthon, L., Bartlett, S.J., Benedetti, A., Thombs, B.D., Culos-Reed, N., El-Baalbaki, G., Hebblethwaite, S., Patten, S.B., Varga, J., Bustamante, L., Duchek, D., Ellis, K., Rice, D.B., Dyas, L., Fortune, C., Gietzen, A., Guillot, G., Lewis, N., Nielsen, K., Richard, M., Sauvé, M., Welling, J.J.K.C., Wu, Y., Kwakkenbos, L., Henry, R.S., Tao, L.X., Harb, S., Bourgeault, A., Carrier, M.E., Levis, B., Sun, Y., Bhandari, P.M., Carboni-Jiménez, A., Gagarine, M., He, C., Krishnan, A., Negeri, Z.F., Neupane, D., Mouthon, L., Bartlett, S.J., Benedetti, A., Thombs, B.D., Culos-Reed, N., El-Baalbaki, G., Hebblethwaite, S., Patten, S.B., Varga, J., Bustamante, L., Duchek, D., Ellis, K., Rice, D.B., Dyas, L., Fortune, C., Gietzen, A., Guillot, G., Lewis, N., Nielsen, K., Richard, M., Sauvé, M., and Welling, J.J.K.C.
- Abstract
Contains fulltext : 226380.pdf (publisher's version ) (Closed access), Objective: Fear associated with medical vulnerability should be considered when assessing mental health among individuals with chronic medical conditions during the COVID-19 pandemic. The objective was to develop and validate the COVID-19 Fears Questionnaire for Chronic Medical Conditions. Methods: Fifteen initial items were generated based on suggestions from 121 people with the chronic autoimmune disease systemic sclerosis (SSc; scleroderma). Patients in a COVID-19 SSc cohort completed items between April 9 and 27, 2020. Exploratory factor analysis (EFA) and item analysis were used to select items for inclusion. Cronbach's alpha and Pearson correlations were used to evaluate internal consistency reliability and convergent validity. Factor structure was confirmed with confirmatory factor analysis (CFA) in follow-up data collection two weeks later. Results: 787 participants completed baseline measures; 563 of them completed the follow-up assessment. Ten of 15 initial items were included in the final questionnaire. EFA suggested that a single dimension explained the data reasonably well. There were no indications of floor or ceiling effects. Cronbach's alpha was 0.91. Correlations between the COVID-19 Fears Questionnaire and measures of anxiety (r = 0.53), depressive symptoms (r = 0.44), and perceived stress (r = 0.50) supported construct validity. CFA supported the single-factor structure (χ2(35) = 311.2, p < 0.001, Tucker-Lewis Index = 0.97, Comparative Fit Index = 0.96, Root Mean Square Error of Approximation = 0.12). Conclusion: The COVID-19 Fears Questionnaire for Chronic Medical Conditions can be used to assess fear among people at risk due to pre-existing medical conditions during the COVID-19 pandemic.
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- 2020
16. The Scleroderma Patient-Centered Intervention Network Self-Management Program: Protocol for a randomized feasibility trial
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Carrier, M.E., Kwakkenbos, L., Nielson, W.R., Fedoruk, C., Nielsen, K., Milette, K., Pope, J., Frech, T., Gholizadeh, S., Hummers, L., Johnson, S.R., Piotrowski, P., Jewett, L.R., Gordon, J.K., Chung, L., Bilsker, D., Turner, K.A., Cumin, J., Welling, J.J.K.C., Fortune, C., Leite, C., Gottesman, K., Sauvé, M., Rodríguez-Reyna, T.S., Hudson, M., Larché, M., Breda, W. van, Suarez-Almazor, M.E., Bartlett, S.J., Malcarne, V.L., Mayes, M.D., Boutron, I., Mouthon, L., Wigley, F.M., Thombs, B.D., Carrier, M.E., Kwakkenbos, L., Nielson, W.R., Fedoruk, C., Nielsen, K., Milette, K., Pope, J., Frech, T., Gholizadeh, S., Hummers, L., Johnson, S.R., Piotrowski, P., Jewett, L.R., Gordon, J.K., Chung, L., Bilsker, D., Turner, K.A., Cumin, J., Welling, J.J.K.C., Fortune, C., Leite, C., Gottesman, K., Sauvé, M., Rodríguez-Reyna, T.S., Hudson, M., Larché, M., Breda, W. van, Suarez-Almazor, M.E., Bartlett, S.J., Malcarne, V.L., Mayes, M.D., Boutron, I., Mouthon, L., Wigley, F.M., and Thombs, B.D.
- Abstract
Contains fulltext : 219726.pdf (publisher's version ) (Open Access), Background: Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. Objective: The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. Methods: The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. Results: Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. Conclusions: The SPIN-SELF program is a self-h
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- 2020
17. Protocol for a partially nested randomized controlled trial to evaluate the effectiveness of the Scleroderma Patient-centered Intervention Network Support Group Leader EDucation (SPIN-SSLED) Program
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Thombs, B.D., Aguila, K., Dyas, L., Carrier, M.E., Fedoruk, C., Horwood, L., Canedo-Ayala, M., Sauvé, M., Kwakkenbos, L., Malcarne, V.L., El-Baalbaki, G., Pelaez, S., Connolly, K., Hudson, M., Platt, R.W., Elrod, S., Fortune, C., Gottesman, K., Nielsen, K., Guillot, G., Rozee, K., Gielzen, A., Richard, M., and Stephens, N.
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medicine.medical_specialty ,Education, Continuing ,medicine.medical_treatment ,Medicine (miscellaneous) ,Personal Satisfaction ,Burnout, Psychological ,Peer support ,Burnout ,Psychological Distress ,Peer Group ,Support group ,Scleroderma ,law.invention ,Experimental Psychopathology and Treatment ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Patient Education as Topic ,Randomized controlled trial ,Feasibility trial ,law ,Intervention (counseling) ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,030203 arthritis & rheumatology ,lcsh:R5-920 ,Scleroderma, Systemic ,business.industry ,Patient education ,Support groups ,Self Efficacy ,3. Good health ,Test (assessment) ,Leadership ,Self-Help Groups ,Physical therapy ,Systemic sclerosis ,Job satisfaction ,lcsh:Medicine (General) ,business - Abstract
Background Some people with rare diseases rely on peer-led support groups for disease-specific education and emotional and practical support. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease. Many people with SSc cannot access support groups, and, when support groups exist, they may not be sustained due to challenges that could be addressed via leader training. The Scleroderma Patient-centered Intervention Network (SPIN), along with SSc patient organization partners, developed a training program for SSc patient support group leaders, the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program. We recently completed a feasibility trial in which we successfully delivered the program to two groups of support group leaders who reported a high level of satisfaction with the program and its delivery. The primary objective of the full-scale SPIN-SSLED trial is to evaluate the effect of the program on support group leaders’ self-efficacy for carrying out their leadership role. Secondary objectives include evaluating effects on leader burnout, leader satisfaction (participation efficacy), and emotional distress. Methods/design The SPIN-SSLED trial is a pragmatic randomized controlled trial (RCT) in which 180 support group leaders will be randomly allocated to training groups of 6 participants each or to a waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups, but not in the waitlist control. Participants allocated to the training program will receive the 13-module SPIN-SSLED Program, delivered via webinar over the course of 3 months in weekly 60–90-min sessions. The primary outcome is leader self-efficacy, measured by the Scleroderma Support Group Leader Self-efficacy Scale post-intervention. Secondary outcomes are leader self-efficacy at 3 months post-intervention, and leader burnout, volunteer job satisfaction (participation efficacy), and emotional distress post-intervention and at 3 months post-intervention. Discussion The SPIN-SSLED trial will test whether a training program for SSc patient support group leaders increases the self-efficacy of group leaders to carry out leadership tasks. The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases. Trial registration ClinicalTrials.gov, NCT03965780. Registered on 29 May 2019.
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- 2019
18. Mild hypoxia disrupts recollection, not familiarity
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Yonelinas, A. P., Quamme, J. R., Widaman, K. F., Kroll, N. E. A., Sauvé, M. J., and Knight, R. T.
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- 2004
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19. PARE0009 COMMUNITY ADVISORY BOARD INPUT CAN MAKE LAY SUMMARIES OF CLINICAL TRIAL RESULTS MORE UNDERSTANDABLE
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Welling, J., primary, Roennow, A., additional, Sauvé, M., additional, Brown, E., additional, Galetti, I., additional, Gonzalez, A., additional, Portales Guiraud, A. P., additional, Kennedy, A., additional, Leite, C., additional, Riggs, R. J., additional, Zheng, A., additional, Perkovic Popovic, M., additional, Gilbert, A., additional, Moros, L., additional, Sroka-Saidi, K., additional, Schindler, T., additional, and Finnern, H., additional
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- 2020
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20. Performance of the Patient-Reported Outcomes Measurement Information System-29 in scleroderma: A Scleroderma Patient-centered Intervention Network Cohort Study [Correction]
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Kwakkenbos, L., Thombs, B.D., Khanna, D., Carrier, M.E., Baron, M., Furst, D.E., Gottesman, K., Hoogen, F.H.J. van den, Malcarne, V.L., Mayes, M.D., Mouthon, L., Nielson, W.R., Poiraudeau, S., Riggs, R., Sauvé, M., Wigley, F.M., Hudson, M., Bartlett, S.J., Kwakkenbos, L., Thombs, B.D., Khanna, D., Carrier, M.E., Baron, M., Furst, D.E., Gottesman, K., Hoogen, F.H.J. van den, Malcarne, V.L., Mayes, M.D., Mouthon, L., Nielson, W.R., Poiraudeau, S., Riggs, R., Sauvé, M., Wigley, F.M., Hudson, M., and Bartlett, S.J.
- Abstract
05 juni 2019, Item does not contain fulltext, In the original article [https://doi.org/10.1093/rheumatology/kex055], the SPIN Investigators were not listed; instead they were listed in the supplementary data file. They have now been moved to the Acknowledgements section of the main article so that they can be tagged for inclusion as collaborators in PubMed.
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- 2019
21. Addressing challenges to patient-centered care in a rare disease context: The Scleroderma Patient-centered Intervention Network (SPIN)
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Thombs, B.D., Kwakkenbos, L., Carrier, M.E., Rice, D.B., Fedoruk, C., Turner, K.A., Cañedo-Ayala, M., Carboni-Jiménez, A., Tao, L.X., Harb, S., Gholizadeh, S., Aguila, K., Sauvé, M., Thombs, B.D., Kwakkenbos, L., Carrier, M.E., Rice, D.B., Fedoruk, C., Turner, K.A., Cañedo-Ayala, M., Carboni-Jiménez, A., Tao, L.X., Harb, S., Gholizadeh, S., Aguila, K., and Sauvé, M.
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Contains fulltext : 219611.pdf (Publisher’s version ) (Open Access)
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- 2019
22. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND)
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Kwakkenbos, L., Carrier, M.E., Boutron, I., Welling, J.J.K.C., Sauvé, M., Ende, C.H.M. van den, Schouffoer, A.A., Hudson, M., Nguyen, C., Rannou, F., Thombs, B.D., Mouthon, L., Kwakkenbos, L., Carrier, M.E., Boutron, I., Welling, J.J.K.C., Sauvé, M., Ende, C.H.M. van den, Schouffoer, A.A., Hudson, M., Nguyen, C., Rannou, F., Thombs, B.D., and Mouthon, L.
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Contains fulltext : 219625.pdf (Publisher’s version ) (Open Access)
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- 2019
23. A simple, inexpensive, life-saving way to perform iterative laparotomy in patients with severe intra-abdominal sepsis
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Doyon, A., Devroede, G., Viens, D., Saito, S., Rioux, A., Echavé, V., Sauvé, M., Martin, M., and Poisson, J.
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- 2001
24. Curiethérapie prostatique transpérinéale par iode 125 avec dosimétrie prévisionnelle : analyse des résultats dosimétriques pré- et post-implantation
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Simonian-Sauve, M, Smart, C, Mailleux, H, Rosello, R, Bladou, F, and Salem, N
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- 2003
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25. The association of sociodemographic and disease variables with hand function: A Scleroderma Patient-centered Intervention Network cohort study
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Kwakkenbos, L., Sanchez, T.A., Turner, K.A., Mouthon, L., Carrier, M.E., Hudson, M., Ende, C.H.M. van den, Schouffoer, A.A., Welling, J.J.K.C., Sauvé, M., and Thombs, B.D.
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Experimental Psychopathology and Treatment ,All institutes and research themes of the Radboud University Medical Center ,Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5] - Abstract
Contains fulltext : 196552.pdf (Publisher’s version ) (Open Access) Objectives: Impaired hand function in systemic sclerosis (SSc) is a primary cause of disability and contributes diminished health-related quality of life. The objective of the present study was to evaluate sociodemographic, lifestyle, and disease-related factors independently associated with hand function in SSc. Methods: Patients enrolled in the Scleroderma Patient-centered Intervention Network Cohort who completed baseline study questionnaires between March 2014 and September 2017 were included. Hand function was measured using the Cochin Hand Function Scale (CHFS). Multiple linear regression analysis was used to identify independent correlates of impaired hand function. Results: Among 1193 participants (88% female), the mean CHFS score was 13.3 (SD=16.1). Female sex (standardised regression coefficient, beta =.05), current smoking (beta=.07), higher BMI (beta=.06), diffuse SSc (beta=0.14), more severe Raynaud's scores (beta=.23), more severe finger ulcer scores (beta=.23), moderate (beta=0.19) or severe small joint contractures (beta=.20), rheumatoid arthritis (beta=0.07), and idiopathic inflammatory myositis (beta=0.06) were significantly associated with higher CHFS scores (more impaired hand function). Consumption of 1-7 alcoholic drinks per week (beta=-0.07) was associated with lower CHFS scores (less impaired hand function) compared to no drinking. Conclusions: Multiple factors are associated with hand function in SSc. The presence of moderate or severe small joint contractures, the presence of digital ulcers, and severity of Raynaud's phenomenon had the largest associations. Effective interventions are needed to improve the management of hand function in patients with SSc. 7 p.
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- 2018
26. Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data
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Kwakkenbos, L., Imran, M., McCord, K.A., Sampson, M., Fröbert, O., Gale, C., Hemkens, L.G., Langan, S.M., Moher, D., Relton, C., Zwarenstein, M., Benchimol, E.I., Boutron, I., Campbell, M.K., Erlinge, D., Jawad, S., Ravaud, P., Rice, D.B., Sauvé, M., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Juszczak, E., Thombs, B.D., Kwakkenbos, L., Imran, M., McCord, K.A., Sampson, M., Fröbert, O., Gale, C., Hemkens, L.G., Langan, S.M., Moher, D., Relton, C., Zwarenstein, M., Benchimol, E.I., Boutron, I., Campbell, M.K., Erlinge, D., Jawad, S., Ravaud, P., Rice, D.B., Sauvé, M., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Juszczak, E., and Thombs, B.D.
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Contains fulltext : 194062.pdf (publisher's version ) (Open Access), Introduction: Randomised controlled trials (RCTs) conducted using cohorts and routinely collected health data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. The development of an extension of the CONsolidated Standards of Reporting Trials (CONSORT) statement for RCTs using cohorts and routinely collected health data is being undertaken with the goal of improving reporting quality by setting standards early in the process of uptake of these designs. To develop this extension to the CONSORT statement, a scoping review will be conducted to identify potential modifications or clarifications of existing reporting guideline items, as well as additional items needed for reporting RCTs using cohorts and routinely collected health data. Methods and analysis: In separate searches, we will seek publications on methods or reporting or that describe protocols or results from RCTs using cohorts, registries, electronic health records and administrative databases. Data sources will include Medline and the Cochrane Methodology Register. For each of the four main types of RCTs using cohorts and routinely collected health data, separately, two investigators will independently review included publications to extract potential checklist items. A potential item will either modify an existing CONSORT 2010, Strengthening the Reporting of Observational Studies in Epidemiology or REporting of studies Conducted using Observational Routinely collected health Data item or will be proposed as a new item. Additionally, we will identify examples of good reporting in RCTs using cohorts and routinely collected health data. Ethics and dissemination: The proposed scoping review will help guide the development of the CONSORT extension statement for RCTs conducted using cohorts and routinely collected health data.
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- 2018
27. The Scleroderma Patient-Centered Intervention Network Cohort: Baseline clinical features and comparison with other large scleroderma cohorts
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Dougherty, D.H., Kwakkenbos, L., Carrier, M.E., Salazar, G.A., Assassi, S., Baron, M., Bartlett, S.J., Furst, D.E., Gottesman, K., Hoogen, F.H.J. van den, Malcarne, V.L., Mouthon, L., Nielson, W.R., Poiraudeau, S., Sauvé, M., Boire, G., Bruns, A., Chung, L., Denton, C.P., Dunne, J.V., Fortin, P.R., Frech, T., Gill, A., Gordon, J.K., Herrick, A.L., Hinchcliff, M., Hudson, M., Johnson, S.R., Jones, N., Kafaja, S., Larché, M., Manning, J.B., Pope, J., Spiera, R.F., Steen, V., Sutton, E., Thorne, J.C., Wilcox, P.G., Thombs, B.D., Mayes, M.D., Dougherty, D.H., Kwakkenbos, L., Carrier, M.E., Salazar, G.A., Assassi, S., Baron, M., Bartlett, S.J., Furst, D.E., Gottesman, K., Hoogen, F.H.J. van den, Malcarne, V.L., Mouthon, L., Nielson, W.R., Poiraudeau, S., Sauvé, M., Boire, G., Bruns, A., Chung, L., Denton, C.P., Dunne, J.V., Fortin, P.R., Frech, T., Gill, A., Gordon, J.K., Herrick, A.L., Hinchcliff, M., Hudson, M., Johnson, S.R., Jones, N., Kafaja, S., Larché, M., Manning, J.B., Pope, J., Spiera, R.F., Steen, V., Sutton, E., Thorne, J.C., Wilcox, P.G., Thombs, B.D., and Mayes, M.D.
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Contains fulltext : 194824.pdf (publisher's version ) (Closed access), Objectives: The Scleroderma Patient-centered Intervention Network (SPIN) Cohort is a web-based cohort designed to collect patient-reported outcomes at regular intervals as a framework for conducting trials of psychosocial, educational, self-management and rehabilitation interventions for patients with SSc. The aim of this study was to present baseline demographic, medical and patient-reported outcome data of the SPIN Cohort and to compare it with other large SSc cohorts. Methods: Descriptive statistics were used to summarize SPIN Cohort characteristics; these were compared with published data of the European Scleroderma Trials and Research (EUSTAR) and Canadian Scleroderma Research Group (CSRG) cohorts. Results: Demographic, organ involvement and antibody profile data for SPIN (N = 1125) were generally comparable with that of the EUSTAR (N = 7319) and CSRG (N = 1390) cohorts. There was a high proportion of women and White patients in all cohorts, though relative proportions differed. Scl70 antibody frequency was highest in EUSTAR, somewhat lower in SPIN, and lowest in CSRG, consistent with the higher proportion of interstitial lung disease among dcSSc patients in SPIN compared with in CSRG (48.5 vs 40.3%). RNA polymerase III antibody frequency was highest in SPIN and remarkably lower in EUSTAR (21.1 vs 2.4%), in line with the higher prevalence of SSc renal crisis (4.5 vs 2.1%) in SPIN. Conclusion: Although there are some differences, the SPIN Cohort is broadly comparable with other large prevalent SSc cohorts, increasing confidence that insights gained from the SPIN Cohort should be generalizable, although it should be noted that all three cohorts include primarily White participants.
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- 2018
28. Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data
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Kwakkenbos, L., Juszczak, E., Hemkens, L.G., Sampson, M., Fröbert, O., Relton, C., Gale, C., Zwarenstein, M., Langan, S.M., Moher, D., Boutron, I., Ravaud, P., Campbell, M.K., McCord, K.A., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Benchimol, E.I., Erlinge, D., Sauvé, M., Torgerson, D., Thombs, B.D., Kwakkenbos, L., Juszczak, E., Hemkens, L.G., Sampson, M., Fröbert, O., Relton, C., Gale, C., Zwarenstein, M., Langan, S.M., Moher, D., Boutron, I., Ravaud, P., Campbell, M.K., McCord, K.A., Staa, T.P. van, Thabane, L., Uher, R., Verkooijen, H.M., Benchimol, E.I., Erlinge, D., Sauvé, M., Torgerson, D., and Thombs, B.D.
- Abstract
Contains fulltext : 197751.pdf (publisher's version ) (Open Access), Background: Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data. Methods: The development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial "long list" of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the "long list" and generate a "short list" of key items. In phase 4, these items will serve as the basis fo
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- 2018
29. Randomized feasibility trial of the Scleroderma Patient-centered Intervention Network hand exercise program (SPIN-HAND): Study protocol
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Carrier, M.E., Kwakkenbos, L., Boutron, I., Welling, J.J.K.C., Sauvé, M., Ende, C.H.M. van den, Schouffoer, A.A., Hudson, M., Thombs, B.D., Mouthon, L., Carrier, M.E., Kwakkenbos, L., Boutron, I., Welling, J.J.K.C., Sauvé, M., Ende, C.H.M. van den, Schouffoer, A.A., Hudson, M., Thombs, B.D., and Mouthon, L.
- Abstract
Item does not contain fulltext, Background: Significant functional impairment of the hands is nearly universal in systemic sclerosis (SSc, scleroderma). Hand exercises may improve hand function, but developing, testing and disseminating rehabilitation interventions in SSc is challenging. The Scleroderma Patient-centered Intervention Network (SPIN) was established to address this issue and has developed an online hand exercise program to improve hand function for SSc patients (SPIN-HAND). The aim of the proposed feasibility trial is to evaluate the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-HAND intervention. Design and methods: The SPIN-HAND feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with at least mild hand function limitations (Cochin Hand Function Scale >=3) and an indicated interest in using an online hand-exercise intervention will be randomized with a 1:1 ratio to be offered to use the SPIN-HAND program or usual care for 3 months. The primary aim is to evaluate the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-HAND program. Discussion: The SPIN-HAND exercise program is a self-help tool that may improve hand function in patients with SSc. The SPIN-HAND feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-HAND program. Trial registration: ClinicalTrials.gov Identifier: NCT03092024.
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- 2018
30. Performance of the Patient-Reported Outcomes Measurement Information System-29 in scleroderma: A Scleroderma Patient-centered Intervention Network Cohort Study
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Kwakkenbos, L., Thombs, B.D., Khanna, D., Carrier, M.E., Baron, M., Furst, D.E., Gottesman, K., Hoogen, F.H.J. van den, Malcarne, V.L., Mayes, M.D., Mouthon, L., Nielson, W.R., Poiraudeau, S., Riggs, R., Sauvé, M., Wigley, F.M., Hudson, M., Bartlett, S.J., Kwakkenbos, L., Thombs, B.D., Khanna, D., Carrier, M.E., Baron, M., Furst, D.E., Gottesman, K., Hoogen, F.H.J. van den, Malcarne, V.L., Mayes, M.D., Mouthon, L., Nielson, W.R., Poiraudeau, S., Riggs, R., Sauvé, M., Wigley, F.M., Hudson, M., and Bartlett, S.J.
- Abstract
Contains fulltext : 175251.pdf (publisher's version ) (Closed access), Objective. The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses seven health-related quality of life domains plus pain intensity. The objective was to examine PROMIS-29v2 validity and explore clinical associations in patients with SSc. Methods. English-speaking SSc patients in the Scleroderma Patient-centered Intervention Network Cohort from 26 sites in Canada, the USA and the UK completed the PROMIS-29v2 between July 2014 and November 2015. Enrolling physicians provided medical data. To examine convergent validity, hypotheses on the direction and magnitude of correlations with legacy measures were tested. For clinical associations, t-tests were conducted for dichotomous variables and PROMIS-29v2 domain scores. Effect sizes (ESs) were labelled as small (<0.25), small to moderate (0.25-0.45), moderate (0.46-0.55), moderate to large (0.56-0.75) and large (>0.75). Results. There were 696 patients (87% female), mean (s.d.) disease duration 11.6 (8.7) years, 57% with limited cutaneous subtype. Validity indices were consistent with seven of nine hypotheses (|r| =0.51-0.87, P < 0.001), with minor divergence for two hypotheses. Gastrointestinal involvement was associated with significantly worse outcomes for all eight PROMIS-29v2 domains (moderate or moderate to large ES in six of eight). Presence of joint contractures was associated with significant decrements in seven domains (small or small to moderate ESs). Skin thickening, diffuse cutaneous subtype and presence of overlap syndromes were significantly associated (small or small to moderate ESs) with five or six domains. Conclusion. This study further establishes the validity of the PROMIS-29v2 in SSc and underlines the importance of gastrointestinal symptoms and joint contractures in reduced health-related quality of life.
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- 2017
31. Validation of the Self-Efficacy for Managing Chronic Disease Scale: A Scleroderma Patient-Centered Intervention Network cohort study
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Riehm, K.E., Kwakkenbos, L., Carrier, M.E., Bartlett, S.J., Malcarne, V.L., Mouthon, L., Nielson, W.R., Poiraudeau, S., Nielsen, K., Baron, M., Frech, T., Hudson, M., Pope, J., Sauvé, M., Suarez-Almazor, M.E., Wigley, F.M., and Thombs, B.D.
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Experimental Psychopathology and Treatment - Abstract
Contains fulltext : 161749.pdf (Publisher’s version ) (Closed access) Objective: Self-management programs for patients with chronic illnesses, including rheumatic diseases, seek to enhance self-efficacy for performing health management behaviors. No measure of self-efficacy has been validated for patients with systemic sclerosis (SSc; scleroderma). The objective of this study was to assess the validity and internal consistency reliability of the Self-Efficacy for Managing Chronic Disease (SEMCD) scale in SSc. Methods: English-speaking SSc patients enrolled in the Scleroderma Patient-centered Intervention Network Cohort who completed the SEMCD scale at their baseline assessment between March 2014 and June 2015 were included. Patients were enrolled from 21 sites in Canada, the US, and the UK. Confirmatory factor analysis (CFA) was used to evaluate the factor structure of the SEMCD scale. Cronbach's alpha was calculated to assess internal consistency reliability. Hypotheses on the direction and magnitude of Pearson's correlations with psychological and physical outcome measures were formulated and tested to examine convergent validity. Results: A total of 553 patients were included. CFA supported the single-factor structure of the SEMCD scale (Tucker Lewis Index = 0.99, comparative fit index = 0.99, root mean square error of approximation = 0.10). Internal consistency was high (alpha = 0.93), and correlations with measures of psychological and physical functioning were moderate to large (|r| = 0.48-0.67, P
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- 2016
32. Using optimal test assembly methods for shortening patient-reported outcome measures: Development and validation of the Cochin Hand Function Scale-6: A Scleroderma Patient-Centered Intervention Network cohort study
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Levis, A.W., Harel, D., Kwakkenbos, L., Carrier, M.E., Mouthon, L., Poiraudeau, S., Bartlett, S.J., Khanna, D., Malcarne, V.L., Sauvé, M., Ende, C.H.M. van den, Poole, J.L., Schouffoer, A.A., Welling, J.J.K.C., and Thombs, B.D.
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Experimental Psychopathology and Treatment - Abstract
Contains fulltext : 161748.pdf (Publisher’s version ) (Closed access) Objective: To develop and validate a short form of the Cochin Hand Function Scale (CHFS), which measures hand disability, for use in systemic sclerosis, using objective criteria and reproducible techniques. Methods: Responses on the 18-item CHFS were obtained from English-speaking patients enrolled in the Scleroderma Patient-Centered Intervention Network Cohort. CHFS unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit to CHFS items. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible form length between 1 and 17 items. The final short form selected was the form with the least number of items that maintained statistically equivalent convergent validity, compared to the full-length CHFS, with the Health Assessment Questionnaire (HAQ) disability index (DI) and the physical function domain of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29). Results: There were 601 patients included. A 6-item short form of the CHFS (CHFS-6) was selected. The CHFS-6 had a Cronbach's alpha of 0.93. Correlations of the CHFS-6 summed score with HAQ DI (r = 0.79) and PROMIS-29 physical function (r = -0.54) were statistically equivalent to the CHFS (r = 0.81 and r = -0.56). The correlation with the full CHFS was high (r = 0.98). Conclusion: The OTA procedure generated a valid short form of the CHFS with minimal loss of information compared to the full-length form. The OTA method used was based on objective, prespecified criteria, but should be further studied for viability as a general procedure for shortening patient-reported outcome measures in health research. 10 p.
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- 2016
33. The Promis-29 in systemic sclerosis: Associations with clinical characteristics in the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
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Kwakkenbos, L., Thombs, B.D., Bartlett, S.J., Carrier, M.E., Hudson, M., Mouthon, L., Malcarne, V.L., Sauvé, M., and Khanna, D.
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Experimental Psychopathology and Treatment - Abstract
Item does not contain fulltext 5 p.
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- 2015
34. Construct validity of the Promis-29 in systemic sclerosis: Results from the Scleroderma Patient-Centered Intervention Network (SPIN) Cohort
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Kwakkenbos, L., Thombs, B.D., Bartlett, S.J., Carrier, M.E., Hudson, M., Mouthon, L., Malcarne, V.L., Sauvé, M., and Khanna, D.
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Experimental Psychopathology and Treatment - Abstract
Item does not contain fulltext 2 p.
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- 2015
35. Vehicle routing and scheduling with time windows
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Desrosiers, J., Soumis, F., Desrochers, M., Sauvé, M., Cottle, R. W., editor, Dixon, L. C. W., editor, Korte, B., editor, Todd, M. J., editor, Allgower, E. L., editor, Cunningham, W. H., editor, Dennis, J. E., Jr., editor, Eaves, B. C., editor, Fletcher, R., editor, Goldfarb, D., editor, Hiriart-Urruty, J.- B., editor, Iri, M., editor, Jeroslow, R. G., editor, Johnson, D. S., editor, Lemarechal, C., editor, Lovasz, L., editor, McLinden, L., editor, Powell, M. J. D., editor, Pulleyblank, W. R., editor, Rinnooy Kan, A. H. G., editor, Ritter, K., editor, Sargent, R. W. H., editor, Shanno, D. F., editor, Trotter, L. E., Jr., editor, Tuy, H., editor, Wets, R. J. B., editor, Beale, E. M. L., editor, Dantzig, G. B., editor, Kantorovich, L. V., editor, Koopmans, T. C., editor, Tucker, A. W., editor, Wolfe, P., editor, Gallo, Giorgio, editor, and Sandi, Claudio, editor
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- 1986
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36. SAT0465 Construct Validity of the Promis-29 in Systemic Sclerosis: Preliminary Results from the Scleroderma Patient-Centered Intervention Network (Spin) Cohort
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Kwakkenbos, L., primary, Thombs, B.D., additional, Bartlett, S., additional, Hudson, M., additional, Mouthon, L., additional, Malcarne, V., additional, Sauvé, M., additional, and Khanna, D., additional
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- 2015
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37. The Scleroderma Patient-centered Intervention Network (SPIN) Cohort: Protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context
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Kwakkenbos, L., Jewett, L.R., Baron, M., Bartlett, S.J., Furst, D.E., Gottesman, K., Khanna, D., Malcarne, V.L., Mayes, M.D., Mouthon, L., Poiraudeau, S., Sauvé, M., Nielson, W.R., Poole, J.L., Assassi, S., Boutron, I., Ells, C., Ende, C.H.M. van den, Hudson, M., Impens, A., Körner, A., Leite, C., Maia, A., Mendelson, C., Pope, J., Steele, R.J., Suarez-Almazor, M.E., Ahmed, S., Coronado-Montoya, S., Delisle, V.C., Gholizadeh, S., Jang, Y., Levis, B., Milette, K., Mills, S.D., Razykov, I., Fox, R.S., Thombs, B.D., Kwakkenbos, L., Jewett, L.R., Baron, M., Bartlett, S.J., Furst, D.E., Gottesman, K., Khanna, D., Malcarne, V.L., Mayes, M.D., Mouthon, L., Poiraudeau, S., Sauvé, M., Nielson, W.R., Poole, J.L., Assassi, S., Boutron, I., Ells, C., Ende, C.H.M. van den, Hudson, M., Impens, A., Körner, A., Leite, C., Maia, A., Mendelson, C., Pope, J., Steele, R.J., Suarez-Almazor, M.E., Ahmed, S., Coronado-Montoya, S., Delisle, V.C., Gholizadeh, S., Jang, Y., Levis, B., Milette, K., Mills, S.D., Razykov, I., Fox, R.S., and Thombs, B.D.
- Abstract
Contains fulltext : 219695.pdf (publisher's version ) (Open Access), Introduction: Psychosocial and rehabilitation interventions are increasingly used to attenuate disability and improve health-related quality of life (HRQL) in chronic diseases, but are typically not available for patients with rare diseases. Conducting rigorous, adequately powered trials of these interventions for patients with rare diseases is difficult. The Scleroderma Patient-centered Intervention Network (SPIN) is an international collaboration of patient organisations, clinicians and researchers. The aim of SPIN is to develop a research infrastructure to test accessible, low-cost self-guided online interventions to reduce disability and improve HRQL for people living with the rare disease systemic sclerosis (SSc or scleroderma). Once tested, effective interventions will be made accessible through patient organisations partnering with SPIN. Methods and analysis: SPIN will employ the cohort multiple randomised controlled trial (cmRCT) design, in which patients consent to participate in a cohort for ongoing data collection. The aim is to recruit 1500-2000 patients from centres across the world within a period of 5 years (2013–2018). Eligible participants are persons ≥18 years of age with a diagnosis of SSc. In addition to baseline medical data, participants will complete patient-reported outcome measures every 3 months. Upon enrolment in the cohort, patients will consent to be contacted in the future to participate in intervention research and to allow their data to be used for comparison purposes for interventions tested with other cohort participants. Once interventions are developed, patients from the cohort will be randomly selected and offered interventions as part of pragmatic RCTs. Outcomes from patients offered interventions will be compared with outcomes from trial-eligible patients who are not offered the interventions. Ethics and dissemination: The use of the cmRCT design, the development of self-guided online interventions and partnerships with patient
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- 2013
38. A simple, inexpensive, life-saving way to perform iterative laparotomy in patients with severe intra-abdominal sepsis
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Doyon, A., primary, Devroede, G., additional, Viens, D., additional, Saito, S., additional, Rioux, A., additional, Echavé, V., additional, Sauvé, M., additional, Martin, M., additional, and Poisson, J., additional
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- 2008
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39. Neuroleptic malignant syndrome without the use of neuroleptics
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Heyland, D and Sauvé, M
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Drug Incompatibility ,Depressive Disorder ,Phenelzine ,Amitriptyline ,Humans ,Neuroleptic Malignant Syndrome ,Female ,Middle Aged ,Research Article - Published
- 1991
40. Tumor Necrosis Factor-[alpha]-Mediated Downregulation of the Cystic Fibrosis Transmembrane Conductance Regulator Drives Pathological Sphingosine-1-Phosphate Signaling in a Mouse Model of Heart Failure.
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Meissner A, Yang J, Kroetsch JT, Sauvé M, Dax H, Momen A, Noyan-Ashraf MH, Heximer S, Husain M, Lidington D, and Bolz SS
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- 2012
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41. French study of dose escalation from 66 to 80 GY with 3D-CRT in prostate cancer: results at 5 years
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Bey, P, Carrie, C, Ginestet, C, Aletti, P, Pommier, P, Cowen, D, Gonzague-Casabianca, L, Simonin-Sauve, M, Maingon, P, Naudy, S, Lagrange, J, and Marcie, S
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- 2003
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42. Definitive results of a phase II escalating dose multicentric study in prostate adenocarcinoma from 66 Gy up to 80 Gy
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Bey, P., Beckendorf, V., Carrie, C., Aletti, P., Ginestet, C., Madelis, G., Pommier, P., Cowen, D., Gonzague-Casabianca, L., and Simonian-Sauve, M.
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- 2001
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43. How can nurses improve the prevention of DVT in brain tumour patients?
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Hauyon A and Sauvé M
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- 2007
44. Tests d'évaluation des systèmes informatiques concernant le calcul de la dose en trois dimensions
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Simonian-Sauve, M and Smart, C
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- 1998
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45. Changes in work and adequacy of financial resources during COVID-19 among people with systemic sclerosis: A Scleroderma Patient-centered Intervention Network study.
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Adams C, Nassar EL, Carrier ME, Kwakkenbos L, Henry RS, Virgili-Gervais G, Hu S, Bartlett SJ, Fortuné C, Gietzen A, Gottesman K, Guillot G, Hudson M, Lawrie-Jones A, Lewis N, Malcarne V, Mayes MD, Patten SB, Richard M, Sauvé M, Varga J, Welling J, Wojeck R, Mouthon L, Benedetti A, and Thombs BD
- Abstract
Introduction/objective: We investigated (1) work status changes during COVID-19, (2) financial resource adequacy, (3) preferences for work requirements (e.g. remote, workplace, mixed) and (4) work requirements versus preferences, among people with systemic sclerosis., Methods: This was a cross-sectional study of participants in the Scleroderma Patient-centered Intervention Network COVID-19 Cohort, which enrolled participants from the ongoing Scleroderma Patient-centered Intervention Network Cohort and externally in April 2020. In August 2022, participants completed questions on work status, financial well-being using the Consumer Financial Protection Bureau Financial Well-Being Scale, work requirements and work requirement preferences., Results: A total of 298 participants with systemic sclerosis were included. Mean age was 58.6 years (SD = 11.4). There were 101 (34%) participants working at the start of the pandemic and still working in August 2022, 179 (60%) not working at the start of the pandemic and still not working, 10 (3%) who stopped working after April 2020 and 8 (3%) who started working. Mean financial well-being did not change from April 2020 to August 2022 (difference: 0.2 points; 95% confidence interval: -1.1 to 0.7). Working participants (N = 109) preferred flexible work requirements (N = 34, 31%) or working entirely remotely (N = 32, 29%), but most were required to work entirely at a workplace (N = 35, 32%) or combined workplace and remotely with a fixed schedule (N = 31, 28%)., Conclusion: Work status and financial well-being did not change substantively among people with systemic sclerosis during the pandemic. Flexible work policies may support people with systemic sclerosis to work., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© The Author(s) 2024.)
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- 2024
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46. The association of outdoor temperature and self-reported Raynaud's phenomenon severity among people with systemic sclerosis: a Scleroderma Patient-centered Intervention Network Cohort study.
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Virgili-Gervais G, Matthews B, Nassar EL, Carrier ME, Kwakkenbos L, Pauling JD, Bartlett SJ, Gietzen A, Gottesman K, Guillot G, Hudson M, Hummers LK, Lawrie-Jones A, Malcarne VL, Mayes MD, Richard M, Sauvé M, Wojeck RK, Mouthon L, Benedetti A, and Thombs BD
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- Humans, Female, Male, Middle Aged, Adult, Temperature, Aged, Cohort Studies, Seasons, Raynaud Disease epidemiology, Raynaud Disease etiology, Scleroderma, Systemic complications, Severity of Illness Index, Self Report
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Background: Raynaud's phenomenon is the earliest and most common systemic sclerosis manifestation. Episodes can be triggered by cold exposure and ambient temperature changes. Small studies have found that Raynaud's phenomenon outcomes were associated with season. We aimed to map the degree that differences in ambient temperature are associated with Raynaud's phenomenon outcomes across the temperature spectrum., Methods: People with Raynaud's phenomenon secondary to systemic sclerosis in the Scleroderma Patient-centered Intervention Network Cohort completed past-week Raynaud's phenomenon severity assessments (0-10 numerical rating scale) at enrolment and longitudinally at 3-month intervals. Mean daily temperature and feels like temperature, which incorporates wind chill and humidity, for the week before each assessment were extracted for each participant from a weather site close to the participant's recruiting centre via the Iowa Environmental Mesonet. We used linear mixed models with basis splines to flexibly model non-linear changes in Raynaud's phenomenon severity across the temperature spectrum. People with lived experience of systemic sclerosis contributed to the study design and interpretation., Findings: Between April 15, 2014 and Aug 1, 2023, we included data on 20 233 Raynaud's phenomenon severity assessments from 2243 participants. 1964 (88%) of 2243 participants were women, 279 (12%) were men, and 1813 (82%) were White. Mean age was 54·8 (SD 12·7) years. The maximum predicted Raynaud's phenomenon severity score was 6·8 points (95% CI 5·6-8·1), which occurred at -25°C. Severity scores decreased minimally from -15°C to 5°C (0·05-0·21 points per 5°C difference), then decreased in larger steps between 5°C and 25°C (0·37-0·54 points per 5°C difference). The minimum predicted score was at 25°C (2·6 points [95% CI 2·5-2·7]). Scores increased at temperatures above 25°C to 3·5 points (3·0-4·1) at 35°C and 5·6 points (4·5-6·8) at 40°C. Results were similar for feels like temperature., Interpretation: Raynaud's phenomenon severity is worst at very cold temperatures but also increases with very warm temperatures, presumably due to air conditioning. Clinical management and Raynaud's phenomenon intervention trial designs should consider temperature patterns., Funding: Scleroderma Society of Ontario, Scleroderma Canada, Sclérodermie Québec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, the Canadian Institutes of Health Research, the Arthritis Society, the Lady Davis Institute for Medical Research of the Jewish General Hospital, the Jewish General Hospital Foundation, and McGill University., Competing Interests: Declaration of interests JDP has received speaker honoraria or consultancy fees from Astra Zeneca, Boehringer Ingelheim, IsoMab, Janssen, Permeatus, and Sojournix Pharma. MDM has received research grants or contracts from Prometheus Biosciences, Mitsubishi Tanabe, Boehringer Ingelheim, EICOS, Corbus, and Horizon Pharma; consulting fees from Cabaletta Pharma; an honorarium from GSK Pharma; and was a member of a data safety monitoring board or advisory board with Mitsubishi Tanabe, Boehringer Ingelheim, and EICOS. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)
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- 2024
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47. Factors associated with physical function among people with systemic sclerosis: a SPIN cohort cross-sectional study.
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Dal Santo T, Rice DB, Carrier ME, Virgili-Gervais G, Levis B, Kwakkenbos L, Golberg M, Bartlett SJ, Gietzen A, Gottesman K, Guillot G, Hudson M, Hummers LK, Malcarne VL, Mayes MD, Mouthon L, Richard M, Sauvé M, Wojeck RK, Geoffroy MC, Benedetti A, and Thombs BD
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- Humans, Female, Male, Cross-Sectional Studies, Middle Aged, Aged, Adult, Patient Reported Outcome Measures, Cohort Studies, Smoking epidemiology, Age Factors, Sex Factors, Life Style, Scleroderma, Systemic physiopathology
- Abstract
Objectives: To compare physical function in systemic sclerosis (SSc, scleroderma) to general population normative data and identify associated factors., Methods: Scleroderma Patient-centered Intervention Network Cohort participants completed the Physical Function domain of the Patient-Reported Outcomes Measurement Information System Version 2 upon enrolment. Multivariable linear regression was used to assess associations of sociodemographic, lifestyle, and disease-related variables., Results: Among 2385 participants, the mean physical function T-score (43.7, SD = 8.9) was ∼2/3 of a standard deviation (SD) below the US general population (mean = 50, SD = 10). Factors associated in the multivariable analysis included older age (-0.74 points per SD years, 95% CI -0.78 to -1.08), female sex (-1.35, -2.37 to -0.34), fewer years of education (-0.41 points per SD in years, -0.75 to -0.07), being single, divorced, or widowed (-0.76, -1.48 to -0.03), smoking (-3.14, -4.42 to -1.85), alcohol consumption (0.79 points per SD drinks per week, 0.45-1.14), BMI (-1.41 points per SD, -1.75 to -1.07), diffuse subtype (-1.43, -2.23 to -0.62), gastrointestinal involvement (-2.58, -3.53 to -1.62), digital ulcers (-1.96, -2.94 to -0.98), moderate (-1.94, -2.94 to -0.93) and severe (-1.76, -3.24 to -0.28) small joint contractures, moderate (-2.10, -3.44 to -0.76) and severe (-2.54, -4.64 to -0.44) large joint contractures, interstitial lung disease (-1.52, -2.27 to -0.77), pulmonary arterial hypertension (-3.72, -4.91 to -2.52), rheumatoid arthritis (-2.10, -3.64 to -0.56) and idiopathic inflammatory myositis (-2.10, -3.63 to -0.56)., Conclusion: Physical function is impaired for many individuals with SSc and is associated with multiple disease factors., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
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- 2024
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48. Minimal Detectable Changes of the Health Assessment Questionnaire-Disability Index, Patient-Reported Outcomes Measurement Information System-29 Profile Version 2.0 Domains, and Patient Health Questionnaire-8 in People With Systemic Sclerosis: A Scleroderma Patient-Centered Intervention Network Cohort Cross-Sectional Study.
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Alkan A, Carrier ME, Henry RS, Kwakkenbos L, Bartlett SJ, Gietzen A, Gottesman K, Guillot G, Lawrie-Jones A, Hudson M, Hummers LK, Malcarne VL, Mayes MD, Mouthon L, Richard M, Wojeck RK, Worron-Sauvé M, Benedetti A, and Thombs BD
- Abstract
Objective: Systemic sclerosis (SSc) is a rare, chronic autoimmune disorder associated with disability, diminished physical function, fatigue, pain, and mental health concerns. We assessed minimal detectable changes (MDCs) of the Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient-Reported Outcomes Measurement Information System-29 Profile version 2.0 (PROMIS-29v2.0) domains, and Patient Health Questionnaire (PHQ)-8 in people with SSc., Methods: Scleroderma Patient-Centered Intervention Network Cohort participants completed the HAQ-DI, PROMIS-29v2.0 domains, and PHQ-8 at baseline assessments from April 2014 until August 2023. We estimated MDC95 (smallest change that can be detected with 95% certainty) and MDC90 (smallest change that can be detected with 90% certainty) with 95% confidence intervals (CIs) generated via the percentile bootstrapping method resampling 1,000 times. We compared MDC estimates by age, sex, and SSc subtype., Results: A total of 2,571 participants were included. Most were female (n = 2,241; 87%), and 38% (n = 976) had diffuse SSc. Mean (±SD) age was 54.9 (±12.7) years and duration since onset of first non-Raynaud phenomenon symptom was 10.8 (±8.7) years. MDC95 estimate was 0.41 points (95% CI 0.40-0.42) for the HAQ-DI, between 4.88 points (95% CI 4.72-5.05) and 9.02 points (95% CI 8.80-9.23) for the seven PROMIS-29v2.0 domains, and 5.16 points (95% CI 5.06-5.26) for the PHQ-8. MDC95 estimates were not materially different across subgroups., Conclusion: MDC95 and MDC90 estimates were precise and similar across age, sex, and SSc subtype groups. HAQ-DI MDC95 and MDC90 were substantially larger than previous estimates of HAQ-DI minimal important difference from several small studies. Minimally important differences of all measures should be evaluated in large studies using anchor-based methods., (© 2024 The Author(s). Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)
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- 2024
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49. Moderators of Loneliness Trajectories in People with Systemic Sclerosis During the COVID-19 Pandemic: A SPIN COVID-19 Cohort Longitudinal Study.
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Rapoport CS, Choi AK, Kwakkenbos L, Carrier ME, Henry RS, Levis B, Bartlett SJ, Gietzen A, Gottesman K, Guillot G, Lawrie-Jones A, Mayes MD, Mouthon L, Richard M, Worron-Sauvé M, Benedetti A, Roesch SC, Thombs BD, and Malcarne VL
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- Humans, Male, Female, Longitudinal Studies, Middle Aged, Aged, Adult, Personal Satisfaction, Cohort Studies, COVID-19 psychology, COVID-19 epidemiology, Scleroderma, Systemic psychology, Loneliness psychology
- Abstract
Background: Many individuals with systemic sclerosis (SSc) are at heightened risk for COVID-19 related morbidity and isolation due to interstitial lung disease, frailty, and immunosuppressant use. Minimal research has explored loneliness predictors in individuals with chronic illnesses during COVID-19. This study evaluated moderators of loneliness trajectories in individuals with SSc during COVID-19., Methods: Longitudinal data were analyzed across 30 timepoints from April 2020 to May 2022 from 775 adults in the Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 Cohort. Hierarchical linear modeling evaluated cross-level moderators of loneliness trajectories, including marital status, baseline number of household members, number of virtual or telephone one-on-one or virtual group conversations, number of hours spent enjoying in-person household conversations or activities, and satisfaction with quality of in-person household conversations (all in the past week). Level-1 moderation analyses assessed effects of conversation, activity, and satisfaction means and slopes over time., Results: Baseline values were not statistically significant moderators of loneliness trajectories. Higher mean (averaged over time) virtual or telephone one-on-one and in-person household conversations, in-person household activity, and in-person household conversation satisfaction were associated with lower loneliness trajectories (ps < .05). The relationship between in-person household conversation satisfaction and loneliness trajectory was statistically significantly but minimally attenuated over time (p < .001)., Conclusions: For people with SSc, higher mean conversation, activity, and satisfaction variables were associated with lower levels of loneliness during the pandemic, but changes in these social variables were generally not predictive of changes in loneliness., (© 2024. International Society of Behavioral Medicine.)
- Published
- 2024
- Full Text
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50. The association of resilience and positive mental health in systemic sclerosis: A Scleroderma Patient-centered Intervention Network (SPIN) cohort cross-sectional study.
- Author
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Neyer MA, Henry RS, Carrier ME, Kwakkenbos L, Virgili-Gervais G, Wojeck RK, Wurz A, Gietzen A, Gottesman K, Guillot G, Lawrie-Jones A, Mayes MD, Mouthon L, Nielson WR, Richard M, Sauvé M, Harel D, Malcarne VL, Bartlett SJ, Benedetti A, and Thombs BD
- Subjects
- Humans, Mental Health, Cross-Sectional Studies, Pain, Fatigue etiology, Patient-Centered Care, Resilience, Psychological, Scleroderma, Systemic complications, Scleroderma, Systemic psychology, Psychological Tests
- Abstract
Objective: A previous study using Scleroderma Patient-centered Intervention Network (SPIN) Cohort data identified five classes of people with systemic sclerosis (also known as scleroderma) based on patient-reported somatic (fatigue, pain, sleep) and mental health (anxiety, depression) symptoms and compared indicators of disease severity between classes. Across four classes ("low", "normal", "high", "very high"), there were progressively worse somatic and mental health outcomes and greater disease severity. The fifth ("high/low") class, however, was characterized by high disease severity, fatigue, pain, and sleep but low mental health symptoms. We evaluated resilience across classes and compared resilience between classes., Methods: Cross-sectional study. SPIN Cohort participants completed the 10-item Connor-Davidson-Resilience Scale (CD-RISC) and PROMIS v2.0 domains between August 2022 and January 2023. We used latent profile modeling to identify five classes as in the previous study and multiple linear regression to compare resilience levels across classes, controlling for sociodemographic and disease variables., Results: Mean CD-RISC score (N = 1054 participants) was 27.7 (standard deviation = 7.3). Resilience decreased progressively across "low" to "normal" to "high" to "very high" classes (mean 4.7 points per step). Based on multiple regression, the "high/low" class exhibited higher resilience scores than the "high" class (6.0 points, 95% confidence interval [CI] 4.9 to 7.1 points; standardized mean difference = 0.83, 95% CI 0.67 to 0.98)., Conclusions: People with worse disease severity and patient-reported outcomes reported substantially lower resilience, except a class of people with high disease severity, fatigue, pain, and sleep disturbance but positive mental health and high resilience., Competing Interests: Declaration of competing interest The authors have no competing interests to report., (Copyright © 2023. Published by Elsevier Inc.)
- Published
- 2024
- Full Text
- View/download PDF
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