Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments

Context Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs. Objective To investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs. Data Sources and Study Selection We selected the 3 most recent meta-analyses of patented pharmacological treatments published January 2009 through October 2009 in each general medicine journal with an impact factor of at least 10; in high-impact journals in each of the 5 specialty medicine areas with the greatest 2008 global therapeutic sales (oncology, cardiology, respiratory medicine, endocrinology, and gastroenterology); and in the Cochrane Database of Systematic Reviews. Data Extraction Two investigators independently extracted data on disclosed study funding, author-industry financial ties, and author employment from each meta-analysis, from RCTs included in each meta-analysis, and on whether meta-analyses reported disclosed COIs of included RCTs. Results Of 29 meta-analyses reviewed, which included 509 RCTs, only 2 meta-analyses (7%) reported RCT funding sources; and 0 reported RCT author-industry ties or employment by the pharmaceutical industry. Of 318 meta-analyzed RCTs that reported funding sources, 219 (69%) were industry funded; and 91 of 132 (69%) that reported author financial disclosures had 1 or more authors with pharmaceutical industry financial ties. In 7 of the 29 meta-analyses reviewed, 100% of included RCTs had at least 1 form of disclosed COI (pharmaceutical industry funding, author-industry financial ties, or employment), yet only 1 of these 7 meta-analyses reported RCT funding sources, and 0 reported RCT author-industry ties or employment. Conclusion Among a group of meta-analyses of pharmacological treatments published in high-impact biomedical journals, information concerning primary study funding and author COIs for the included RCTs were only rarely reported. JAMA. 2011;305(10):1008-1017 www.jama.co

Depression Screening and Patient Outcomes in Cancer: A Systematic Review

Several practice guidelines recommend screening for depression in cancer care, but no systematic reviews have examined whether there is evidence that depression screening benefits cancer patients. The objective was to evaluate the potential benefits of depression screening in cancer patients by assessing the (1) accuracy of depression screening tools; (2) effectiveness of depression treatment; and (3) effect of depression screening, either alone or in the context of comprehensive depression care, on depression outcomes.Data sources were CINAHL, Cochrane, EMBASE, ISI, MEDLINE, PsycINFO and SCOPUS databases through January 24, 2011; manual journal searches; reference lists; citation tracking; trial registry reviews. Articles on cancer patients were included if they (1) compared a depression screening instrument to a valid criterion for major depressive disorder (MDD); (2) compared depression treatment with placebo or usual care in a randomized controlled trial (RCT); (3) assessed the effect of screening on depression outcomes in a RCT.There were 19 studies of screening accuracy, 1 MDD treatment RCT, but no RCTs that investigated effects of screening on depression outcomes. Screening accuracy studies generally had small sample sizes (median = 17 depression cases) and used exploratory methods to set sample-specific cutoff scores that varied substantially across studies. A nurse-delivered intervention for MDD reduced depressive symptoms moderately (effect size = 0.37).The one treatment study reviewed reported modest improvement in depressive symptoms, but no evidence was found on whether or not depression screening in cancer patients, either alone or in the context of optimal depression care, improves depression outcomes compared to usual care. Depression screening in cancer should be evaluated in a RCT in which all patients identified as depressed, either through screening or via physician recognition and referral in a control group, have access to comprehensive depression care

New directions for patient-centred care in scleroderma : the Scleroderma Patient-centred Intervention Network (SPIN)

Systemic sclerosis (SSc), or scleroderma, is a chronic multisystem autoimmune disorder characterised by thickening and fibrosis of the skin and by the involvement of internal organs such as the lungs, kidneys, gastrointestinal tract, and heart. Because there is no cure, feasibly-implemented and easily accessible evidence-based interventions to improve health-related quality of life (HRQoL) are needed. Due to a lack of evidence, however, specific recommendations have not been made regarding non-pharmacological interventions (e.g. behavioural/psychological, educational, physical/occupational therapy) to improve HRQoL in SSc. The Scleroderma Patient-centred Intervention Network (SPIN) was recently organised to address this gap. SPIN is comprised of patient representatives, clinicians, and researchers from Canada, the USA, and Europe. The goal of SPIN, as described in this article, is to develop, test, and disseminate a set of accessible interventions designed to complement standard care in order to improve HRQoL outcomes in SSc.The initial organisational meeting for SPIN was funded by a Canadian Institutes of Health Research (CIHR) Meetings, Planning, and Dissemination grant to B.D. Thombs (KPE-109130), Sclerodermie Quebec, and the Lady Davis Institute for Medical Research of the Jewish General Hospital, Montreal, Quebec. SPIN receives finding support from the Sclemderma Society of Ontario, the Scleroderma Society of Canada, and Sclerodermie Quebec. B.D. Thombs and M. Hudson are supported by New Investigator awards from the CIHR, and Etablissement de Jeunes Chercheurs awards from the Fonds de la Recherche en Sante Quebec (FRSQ). M. Baron is the director of the Canadian Scleroderma Research Group, which receives grant folding from the CIHR, the Scleroderma Society of Canada and its provincial chapters, Scleroderma Society of Ontario, Sclerodermie Quebec, and the Ontario Arthritis Society, and educational grants from Actelion Pharmaceuticals and Pfizer. M.D. Mayes and S. Assassi are supported by the NIH/NIAMS Scleroderma Center of Research Translation grant no. P50-AR054144. S.J. Motivala is supported by an NIH career development grant (K23 AG027860) and the UCLA Cousins Center for Psychoneuroimmunology. D. Khanna is supported by a NIH/NIAMS K23 AR053858-04) and NIH/NIAMS U01 AR057936A, the National Institutes of Health through the NIH Roadmap for Medical Research Grant (AR052177), and has served as a consultant or on speakers bureau for Actelion, BMS, Gilead, Pfizer, and United Therapeutics

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

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 nterventions 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.(undefined

Supporting people with Scleroderma: understanding different perspectives about coping and social support

Reducing the burden of chronic diseases has been identified as a health priority by National and International health organizations around the world, and community-based supportive interventions have been proposed as one possible way of achieving this goal. In general, receiving social support has been found to impact health and benefit many individuals with chronic disease who are engaged in disease management efforts. Scleroderma is a rare and complex rheumatic, autoimmune disease that affects the connective tissues and people who receive a diagnosis can experience a wide variety of challenges in their daily life. Because of the unique challenges that rare disease patients can experience related to the disease impact and navigating health care, people diagnosed with scleroderma may benefit from a variety of supportive interventions to help them better cope. However, no definitive conclusions can be drawn at this time about the unique support needs of people with scleroderma since qualitative investigations directly looking at coping and social support for scleroderma are limited. In the current dissertation research, two distinct focus group studies were conducted using a social constructionist framework. The purpose of Study 1 was to explore differing perspectives regarding the challenges experienced and strategies used while coping with scleroderma, through focus group discussions with people who have a diagnosis of scleroderma (4 focus groups, n=34) and health care professionals working with patients with scleroderma (1 focus group, n=8). The purpose of Study 2 was to perform an exploratory, follow-up investigation to Study 1 to deepen our understanding of patient perspectives about the influence of social support on the ability to cope with scleroderma (4 focus groups, N=19). Findings from Study 1 provided a deeper understanding of the unique challenges experienced by people with scleroderma while actively coping with the disease, including problems accessing information (e.g., from healthcare professionals), dealing with negative emotions (e.g., related to misunderstandings with loved ones), and accessing resources (e.g., effective scleroderma treatments). Study 1 also provided knowledge about helpful strategies to address those coping challenges (e.g., advocating for your needs and learning to problem solve). Next, findings from Study 2 showed that to better cope with their disease, individuals with scleroderma often relied on close social relationships to provide different types of support, such as emotional, informational, and instrumental support. In addition, different relational factors were identified that either enhanced or impeded the ability of people with scleroderma to rely on social support to cope with their disease, including different issues related to communication style, active engagement, and complementarity. Implications of the dissertation findings and future direction for research will be discussed.La réduction de la charge des maladies chroniques a été identifiée comme une priorité pour la santé par des organismes de santé nationaux et internationaux à travers le monde. Des interventions de soutiens communautaires ont été proposées comme un moyen possible d'atteindre cet objectif. Généralement, il a été prouvé que l'obtention de soutien social est bénéfique pour la santé de nombreuses personnes atteintes de maladies chroniques qui essayent de mieux gérer leur maladie. La sclérodermie est une maladie auto-immune, rhumatismale rare et complexe qui affecte les tissus conjonctifs. Les personnes qui reçoivent un diagnostic de sclérodermie peuvent éprouver une grande variété de défis tout au long de la vie. En raison des défis souvent uniques que les patients atteints de maladies rares peuvent rencontrer, les personnes diagnostiquées de la sclérodermie peuvent, eux aussi, bénéficier de diverses interventions de soutien communautaire. Cependant, aucune conclusion définitive ne peut être tirée pour le moment sur les besoins de soutien des personnes atteintes de la sclérodermie, car les enquêtes qualitatives portant directement sur l'adaptation et le soutien social pour la sclérodermie sont limitées.Dans la thèse actuelle, deux études distinctes, utilisant des groupes de discussion, ont été menées en utilisant un cadre constructionniste social. Le but de l'étude 1 était d'explorer différentes perspectives concernant les défis rencontrés et les stratégies utilisées pour faire face à la sclérodermie, à travers des groupes de discussion avec des personnes ayant un diagnostic de sclérodermie (4 groupes de discussion, n = 34) et des professionnels de la santé travaillant avec des patients avec la sclérodermie (1 groupe de discussion, n = 8). Le but de l'étude 2 était d'effectuer une enquête de suivi exploratoire à l'étude 1, pour approfondir notre compréhension des points de vue des personnes atteinte par la sclérodermie sur l'influence du soutien social sur la capacité à gérer la maladie (4 groupes de discussion, N = 19). Les résultats de l'étude 1 ont permis de mieux comprendre les défis uniques vécus par les personnes atteintes de la sclérodermie, notamment les problèmes d'accès à l'information (ex. par les professionnels de la santé), d'émotions négatives (ex. malentendus avec leurs proches) et d'accès aux ressources (ex. traitements efficaces pour la sclérodermie). Étude 1 a également fourni des connaissances sur les stratégies utiles pour répondre à ces défis d'adaptation (ex. défendre ses besoins activement et apprendre à faire de la résolution de problèmes). Ensuite, les résultats de l'étude 2 ont montré que pour mieux faire face à leur maladie, les individus atteints de la sclérodermie s'appuyaient souvent sur des relations sociales proche pour fournir différents types de soutien, tels qu'un soutien émotionnel, informatif et instrumental. En outre, différents facteurs relationnels ont été identifiés qui ont amélioré ou entravé la capacité des personnes atteintes de sclérodermie à s'appuyer sur le soutien social pour faire face à leur maladie, y compris différentes questions liées au style de communication, à l'engagement actif et à la complémentarité. Les implications des résultats de la dissertation et des suggestions pour des études dans le futur seront discutées

Effects of screening for psychological distress on patient outcomes in cancer:A systematic review

<p>Objective: Several practice guidelines recommend routine screening for psychological distress in cancer care. The objective was to evaluate the effect of screening cancer patients for psychological distress by assessing the (1) effectiveness of interventions to reduce distress among patients identified as distressed; and (2) effects of screening for distress on distress outcomes.</p><p>Methods: CINAHL, Cochrane, EMBASE, ISI, MEDLINE;PsycINFO, and SCOPUS databases were searched through April 6, 2011 with manual searches of 45 relevant journals, reference list review, citation tracking of included articles, and trial registry reviews through June 30, 2012. Articles in any language on cancer patients were included if they (1) compared treatment for patients with psychological distress to placebo or usual care in a randomized controlled trial (RCT); or (2) assessed the effect of screening on psychological distress in a RCT.</p><p>Results: There were 14 eligible RCTs for treatment of distress, and 1 RCT on the effects of screening on patient distress. Pharmacological, psychotherapy and collaborative care interventions generally reduced distress with small to moderate effects. One study investigated effects of screening for distress On psychological outcomes, and it found no improvement</p><p>Conclusion: Treatment studies reported modest improvement in distress symptoms, but only a single eligible study was found on the effects of screening cancer patients for distress, and distress did not improve in screened patients versus those receiving usual care. Because of the lack of evidence of beneficial effects of screening cancer patients for distress, it is premature to recommend or mandate implementation of routine screening. (C) 2013 Elsevier Inc. All rights reserved.</p>