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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Abstract

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 organisations will allow SPIN to develop, rigourously test and effectively disseminate psychosocial and rehabilitation interventions for people with SSc.

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Most cited references 35

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The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review.

Kurt Kroenke, Robert L Spitzer, Janet B W Williams … (2010)

Depression, anxiety and somatization are the most common mental disorders in primary care as well as medical specialty populations; each is present in at least 5-10% of patients and frequently comorbid with one another. An efficient means for measuring and monitoring all three conditions would be desirable. Evidence regarding the psychometric and pragmatic characteristics of the Patient Health Questionnaire (PHQ)-9 depression, generalized anxiety disorder (GAD)-7 anxiety and PHQ-15 somatic symptom scales are synthesized from two sources: (1) four multisite cross-sectional studies (three conducted in primary care and one in obstetric-gynecology practices) comprising 9740 patients, and (2) key studies from the literature that have studied these scales. The PHQ-9 and its abbreviated eight-item (PHQ-8) and two-item (PHQ-2) versions have good sensitivity and specificity for detecting depressive disorders. Likewise, the GAD-7 and its abbreviated two-item (GAD-2) version have good operating characteristics for detecting generalized anxiety, panic, social anxiety and post-traumatic stress disorder. The optimal cutpoint is > or = 10 on the parent scales (PHQ-9 and GAD-7) and > or = 3 on the ultra-brief versions (PHQ-2 and GAD-2). The PHQ-15 is equal or superior to other brief measures for assessing somatic symptoms and screening for somatoform disorders. Cutpoints of 5, 10 and 15 represent mild, moderate and severe symptom levels on all three scales. Sensitivity to change is well-established for the PHQ-9 and emerging albeit not yet definitive for the GAD-7 and PHQ-15. The PHQ-9, GAD-7 and PHQ-15 are brief well-validated measures for detecting and monitoring depression, anxiety and somatization. Copyright 2010. Published by Elsevier Inc.

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Effect of a self-management program on patients with chronic disease.

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For patients with chronic disease, there is growing interest in "self-management" programs that emphasize the patients' central role in managing their illness. A recent randomized clinical trial demonstrated the potential of self-management to improve health status and reduce health care utilization in patients with chronic diseases. To evaluate outcomes of a chronic disease self-management program in a real-world" setting. Before-after cohort study. Of the 613 patients from various Kaiser Permanente hospitals and clinics recruited for the study, 489 had complete baseline and follow-up data. The Chronic Disease Self-Management Program is a 7-week, small-group intervention attended by people with different chronic conditions. It is taught largely by peer instructors from a highly structured manual. The program is based on self-efficacy theory and emphasizes problem solving, decision making, and confidence building. Health behavior, self-efficacy (confidence in ability to deal with health problems), health status, and health care utilization, assessed at baseline and at 12 months by self-administered questionnaires. At 1 year, participants in the program experienced statistically significant improvements in health behaviors (exercise, cognitive symptom management, and communication with physicians), self-efficacy, and health status (fatigue, shortness of breath, pain, role function, depression, and health distress) and had fewer visits to the emergency department (ED) (0.4 visits in the 6 months prior to baseline, compared with 0.3 in the 6 months prior to follow-up; P = 0.05). There were slightly fewer outpatient visits to physicians and fewer days in hospital, but the differences were not statistically significant. Results were of about the same magnitude as those observed in a previous randomized, controlled trial. Program costs were estimated to be about $200 per participant. We replicated the results of our previous clinical trial of a chronic disease self-management program in a "real-world" setting. One year after exposure to the program, most patients experienced statistically significant improvements in a variety of health outcomes and had fewer ED visits.

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Barriers to participation in randomised controlled trials: a systematic review.

S. Ross, A. Grant, C. Counsell … (1999)

A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2013

Publication date (Electronic): 6 August 2013

Volume: 3

Issue: 8

Electronic Location Identifier: e003563

Affiliations

[1 ]Lady Davis Institute for Medical Research, Jewish General Hospital , Montréal, Québec, Canada

[2 ]Department of Psychiatry, Montréal, Québec, Canada

[3 ]Department of Educational and Counselling Psychology , Montréal, Québec, Canada

[4 ]Department of Medicine, McGill University , Montréal, Québec, Canada

[5 ]Division of Rheumatology, Geffen School of Medicine at the University of California , Los Angeles, California, USA

[6 ]Southern California Chapter, Scleroderma Foundation , Los Angeles, California, USA

[7 ]University of Michigan Scleroderma Program , Ann Arbor, Michigan, USA

[8 ]Department of Psychology, San Diego State University , San Diego, California, USA

[9 ]San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology , San Diego, California, USA

[10 ]University of Texas Health Science Center Houston , Houston, Texas, USA

[11 ]Université Paris Descartes , Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France

[12 ]Pôle de Médecine Interne, Hôpital Cochin , Paris, France

[13 ]Pôle Ostéo-articulaire, Hôpital Cochin , Paris, France

[14 ]IFR Handicap INSERM , Paris, France

[15 ]Scleroderma Societies of Canada and Ontario , Hamilton, Ontario, Canada

[16 ]Beryl & Richard Ivey Rheumatology Day Programs, St Joseph's Health Care , London, Ontario, Canada

[17 ]Occupational Therapy Graduate Program, University of New Mexico , Albuquerque, New Mexico, USA

[18 ]INSERM U738 , Paris, France

[19 ]University Paris Descartes , Paris, France

[20 ]Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique , Paris, France

[21 ]Biomedical Ethics Unit, McGill University , Montréal, Québec, Canada

[22 ]Department of Rheumatology, Sint Maartenskliniek , Ubbergen, Gelderland, The Netherlands

[23 ]Internal Medicine, Midwestern University , Downers Grove, Illinois, USA

[24 ]Department of Oncology, McGill University , Montréal, Québec, Canada

[25 ]School of Psychology, University of Minho , Braga, Portugal

[26 ]Federation of European Scleroderma Associations , Froyennes, Belgium

[27 ]College of Nursing, University of New Mexico , Albuquerque, New Mexico, USA

[28 ]Medicine, Division of Rheumatology, University of Western Ontario, St Joseph's Health Care , London, Ontario, Canada

[29 ]Department of Mathematics and Statistics, McGill University , Montréal, Québec, Canada

[30 ]University of Texas MD Anderson Cancer Center , Houston, Texas, USA

[31 ]School of Physical and Occupational Therapy, McGill University , Montréal, Québec, Canada

[32 ]McGill University Health Center, Clinical Epidemiology Montréal , Montréal, Québec, Canada

[33 ]Desautels Faculty of Management, McGill University , Montréal, Québec, Canada

[34 ]Department of Epidemiology, Biostatistics, and Occupational Health, McGill University , Montréal, Québec, Canada

[35 ]Department of Psychology, McGill University , Montréal, Québec, Canada

[36 ]School of Nursing, McGill University , Montréal, Québec, Canada

Author notes

[Correspondence to ] Dr Brett D Thombs; brett.thombs@ 123456mcgill.ca

Article

Publisher ID: bmjopen-2013-003563

DOI: 10.1136/bmjopen-2013-003563

PMC ID: 3740254

PubMed ID: 23929922

SO-VID: e84eb2b3-f67d-4d34-bbfe-bb2cabfa5680

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This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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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Abstract

Introduction

Methods and analysis

Ethics and dissemination

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Most cited references 35

The Patient Health Questionnaire Somatic, Anxiety, and Depressive Symptom Scales: a systematic review.

Effect of a self-management program on patients with chronic disease.

Barriers to participation in randomised controlled trials: a systematic review.

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