Protocol for the development of a tool to map systemic sclerosis pain sources, patterns, and management experiences: a Scleroderma Patient-centered Intervention Network patient-researcher partnership.

INTRODUCTION: Systemic sclerosis (SSc) is a rare, complex autoimmune rheumatic disease with multiple factors that contribute to pain. People with SSc emphasize the effect pain has on their quality of life, but no studies have systematically examined the frequency and relative importance of different SSc pain sources, patterns of pain from different sources, and pain management experiences. Our objectives are to (1) develop a tool, jointly with researchers, health care providers, and patients, to map sources of pain in SSc, determine patterns of pain from different sources, and understand pain management experiences; and (2) administer the final tool version to participants in the large multinational Scleroderma Patient-centered Intervention Network (SPIN) Cohort. METHODS: First, we will use validated pain assessment tools as templates to develop an initial version of our pain assessment tool, and we will obtain input from patient advisors to adapt it for SSc. The tool will include questions on pain sources, pain patterns, pain intensity, pain management techniques, and barriers to pain management in SSc. Second, we will conduct nominal group technique sessions with people living with SSc and health care providers who care for people with SSc to further refine the tool. Third, we will conduct individual usability testing sessions with SPIN Cohort participants. Once the tool has been finalized, we will administer it to individuals in the multinational SPIN Cohort, which currently includes over 1,300 active participants from 54 sites in 7 countries. We will perform unsupervised clustering using the KAy-Means for MIxed LArge data (KAMILA) method to identify participant subgroups with similar profiles of pain sources (present or absent) and to evaluate predictors of subgroup membership. We will use latent profile analysis to identify subgroups of participants with similar profiles based on pain intensity scores for each pain source and evaluate predictors. DISCUSSION: Once completed, our pain assessment tool will allow our team and other researchers to map sources of pain in SSc and to understand pain management experiences of people living with SSc. This knowledge will provide avenues for studies on the pathophysiology of pain in SSc and studies of interventions to improve pain management.

Researcher and patient experiences of co-presenting research to people living with systemic sclerosis at a patient conference: content analysis of interviews.

BACKGROUND: Patient engagement in research is important to ensure research questions address problems important to patients, that research is designed in a way that can effectively answer those questions, and that findings are applicable, relevant, and credible. Yet, patients are rarely involved in the dissemination stage of research. This study explored one way to engage patients in dissemination, through co-presenting research. METHODS: Semi-structured, one-on-one, audio-recorded interviews were conducted with researchers and patients who co-presented research at one patient conference (the 2022 Canadian National Scleroderma Conference) in Canada. A pragmatic orientation was adopted, and following verbatim transcription, data were analyzed using conventional content analysis. RESULTS: Of 8 researchers who were paired with 7 patients, 5 researchers (mean age = 28 years, SD = 3.6 years) and 5 patients (mean age = 45 years, SD = 14.2 years) participated. Researcher and patient perspectives about their experiences co-presenting and how to improve the experience were captured across 4 main categories: (1) Reasons for accepting the invitation to co-present; (2) Degree that co-presenting expectations were met; (3) The process of co-presenting; and (4) Lessons learned: recommendations for co-presenting. CONCLUSIONS: Findings from this study suggest that the co-presenting experience was a rewarding and enjoyable way to tailor research dissemination to patients. We identified a patient-centred approach and meaningful and prolonged patient engagement as essential elements underlying co-presenting success.

Involving patients throughout the entire research process is important to ensure research effectively addresses problems important to patients and that findings are applicable, relevant, and credible. Yet, patients are rarely involved in the dissemination of research. We explored one way to engage patients in dissemination, through co-presenting research. We conducted one-on-one interviews with 5 researchers and 5 patients who co-presented research at a patient conference in Canada. Both researchers and patients indicated that the co-presenting experience was rewarding and enjoyable and a useful way to tailor dissemination to patients. We found that a patient-centred approach and meaningful and prolonged patient engagement were essential elements underlying co-presenting success.

Results from a living systematic review of the prevalence of mood and anxiety disorders and factors associated with symptoms in systemic sclerosis.

We aimed to synthesize evidence on (1) the prevalence of mood and anxiety disorders and (2) factors associated with symptoms in systemic sclerosis (SSc). We searched MEDLINE, CINAHL, EMBASE, Cochrane CENTRAL, and PsycINFO via an ongoing living systematic review with automated monthly searches. We identified 6 eligible studies through March 1, 2023. Based on 3 studies (N = 93 to 345), current or 30-day major depressive disorder prevalence was 4% (95% confidence interval [CI] 2%, 6%) in a sample of Canadian outpatients (N = 345), 18% (95% CI 12%, 27%) in a study of Indian outpatients (N = 93), 10% (95% CI 4%, 21%) for French patient conference attendees (N = 51), and 29% (95% CI 18%, 42%) for French inpatients (N = 49). Current or 30-day prevalence of any anxiety disorder was 49% (95% CI 36%, 62%) for French conference attendees and 51% (95% CI 38%, 64%) for French inpatients; current or 30-day prevalence of generalized anxiety disorder was 3% for Indian outpatients (95% CI 1%, 9%; N = 93). In 3 studies (N = 114 to 376) that examined factors associated with depressive symptoms, higher education and being married or living as married were associated with lower symptoms and pulmonary involvement, breathing problems, and tender joint counts with higher symptoms; age and disease severity markers were not associated. Only 1 study (N = 114) assessed factors associated with anxiety symptoms and found no statistically significant associations. Limitations included heterogeneous populations and assessment methods, small samples, and substantial risk of bias concerns. Mood and anxiety disorder prevalence appear high in SSc, but estimates vary, and existing studies have important limitations. Future research should assess mood and anxiety prevalence and factors associated with symptoms using large representative samples and validated classification and assessment methods.Review registration: PROSPERO (CRD 42021251339).

Transparency and completeness of reporting of depression screening tool accuracy studies: A meta-research review of adherence to the Standards for Reporting of Diagnostic Accuracy Studies statement.

OBJECTIVES: Accurate and complete study reporting allows evidence users to critically appraise studies, evaluate possible bias, and assess generalizability and applicability. We evaluated the extent to which recent studies on depression screening accuracy were reported consistent with Standards for Reporting of Diagnostic Accuracy Studies (STARD) statement requirements. METHODS: MEDLINE was searched from January 1, 2018 through May 21, 2021 for depression screening accuracy studies. RESULTS: 106 studies were included. Of 34 STARD items or sub-items, the number of adequately reported items per study ranged from 7 to 18 (mean = 11.5, standard deviation [SD] = 2.5; median = 11.5), and the number inadequately reported ranged from 3 to 17 (mean = 10.1, SD = 2.5; median = 10.0). There were eight items adequately reported, seven partially reported, 11 inadequately reported, and four not applicable in ≥50% of studies; the remaining four items had mixed reporting. Items inadequately reported in ≥70% of studies related to the rationale for index test cut-offs examined, missing data management, analyses of variability in accuracy results, sample size determination, participant flow, study registration, and study protocol. CONCLUSION: Recently published depression screening accuracy studies are not optimally reported. Journals should endorse and implement STARD adherence.

Sample size and precision of estimates in studies of depression screening tool accuracy: A meta-research review of studies published in 2018-2021.

OBJECTIVES: Depression screening tool accuracy studies should be conducted with large enough sample sizes to generate precise accuracy estimates. We assessed the proportion of recently published depression screening tool diagnostic accuracy studies that reported sample size calculations; the proportion that provided confidence intervals (CIs); and precision, based on the width and lower bounds of 95% CIs for sensitivity and specificity. In addition, we assessed whether these results have improved since a previous review of studies published in 2013-2015. METHODS: MEDLINE was searched from January 1, 2018, through May 21, 2021. RESULTS: Twelve of 106 primary studies (11%) described a viable sample size calculation, which represented an improvement of 8% since the last review. Thirty-six studies (34%) provided reasonably accurate CIs. Of 103 studies where 95% CIs were provided or could be calculated, seven (7%) had sensitivity CI widths of ≤10%, whereas 58 (56%) had widths of ≥21%. Eighty-four studies (82%) had lower bounds of CIs <80% for sensitivity and 77 studies (75%) for specificity. These results were similar to those reported previously. CONCLUSION: Few studies reported sample size calculations, and the number of included individuals in most studies was too small to generate reasonably precise accuracy estimates.

Inclusion of currently diagnosed or treated individuals in studies of depression screening tool accuracy: a meta-research review of studies published in 2018-2021.

OBJECTIVES: Screening is done to improve health outcomes by identifying and effectively treating individuals with unrecognized conditions. Depression screening has been proposed to identify previously unrecognized depression cases. Including individuals already diagnosed or treated for depression in screening test accuracy studies could exaggerate accuracy and the yield of new cases from screening. The present study investigated (1) the proportion of depression screening tool accuracy primary studies published in 2018-2021 that excluded individuals with a confirmed depression diagnosis or who were already undergoing treatment; and (2) whether this has improved since the last review of studies published in 2013-2015, which found that five of 89 (5.6%) primary studies appropriately excluded such individuals. METHODS: MEDLINE was searched from January 1, 2018 through May 21, 2021 for primary studies on depression screening tool accuracy. RESULTS: Eighteen of 106 (17.0%; 95% Confidence Interval [CI], 11.0% to 25.3%) primary studies excluded currently diagnosed or treated individuals. This was 11.4% (95% CI, 2.8% to 20.0%) greater than in similar studies published in 2013-2015. CONCLUSION: There has been an improvement since 2015, but the proportion of studies that exclude individuals already known to have depression remains low. This may bias research findings intended to inform clinical practice.