Electronic Health Record Nudges and Health Care Quality and Outcomes in Primary Care: A Systematic Review.

Importance: Nudges have been increasingly studied as a tool for facilitating behavior change and may represent a novel way to modify the electronic health record (EHR) to encourage evidence-based care. Objective: To evaluate the association between EHR nudges and health care outcomes in primary care settings and describe implementation facilitators and barriers. Evidence Review: On June 9, 2023, an electronic search was performed in PubMed, Embase, PsycINFO, CINAHL, and Web of Science for all articles about clinician-facing EHR nudges. After reviewing titles, abstracts, and full texts, the present review was restricted to articles that used a randomized clinical trial (RCT) design, focused on primary care settings, and evaluated the association between EHR nudges and health care quality and patient outcome measures. Two reviewers abstracted the following elements: country, targeted clinician types, medical conditions studied, length of evaluation period, study design, sample size, intervention conditions, nudge mechanisms, implementation facilitators and barriers encountered, and major findings. The findings were qualitatively reported by type of health care quality and patient outcome and type of primary care condition targeted. The Risk of Bias 2.0 tool was adapted to evaluate the studies based on RCT design (cluster, parallel, crossover). Studies were scored from 0 to 5 points, with higher scores indicating lower risk of bias. Findings: Fifty-four studies met the inclusion criteria. Overall, most studies (79.6%) were assessed to have a moderate risk of bias. Most or all descriptive (eg, documentation patterns) (30 of 38) or patient-centeredness measures (4 of 4) had positive associations with EHR nudges. As for other measures of health care quality and patient outcomes, few had positive associations between EHR nudges and patient safety (4 of 12), effectiveness (19 of 48), efficiency (0 of 4), patient-reported outcomes (0 of 3), patient adherence (1 of 2), or clinical outcome measures (1 of 7). Conclusions and Relevance: This systematic review found low- and moderate-quality evidence that suggested that EHR nudges were associated with improved descriptive measures (eg, documentation patterns). Meanwhile, it was unclear whether EHR nudges were associated with improvements in other areas of health care quality, such as effectiveness and patient safety outcomes. Future research is needed using longer evaluation periods, a broader range of primary care conditions, and in deimplementation contexts.

Days at Home After Traumatic Brain Injury: Moving Beyond Mortality to Evaluate Patient-Centered Outcomes Using Population Health Data.

BACKGROUND AND OBJECTIVES: Administrative data are invaluable for assessing outcomes at the population level. However, there are few validated patient-centered outcome measures that capture morbidity following traumatic brain injury (TBI) using these data. We sought to characterize and validate days at home (DAH) as a measure to quantify population-level outcomes after moderate to severe TBI. We additionally assessed the earliest feasible outcome assessment period for patients with TBI using this outcome measure. METHODS: This multicenter retrospective cohort study used linked health administrative data sources to identify adults with moderate to severe TBI presenting to trauma centers in Ontario, Canada, between 2009 and 2021. DAH at 180 days (DAH180 days) reflects the total number of days spent alive and at home excluding the days spent institutionalized across care settings. Construct validity was determined using hierarchical quantile regression to assess the associations between clinical and injury covariates with DAH180 days. Predictive validity was assessed using Spearman rank correlation. We estimated minimally important difference (MID) in DAH180 days to aid with outcome measure interpretability. RESULTS: There were 6,340 patients who met inclusion criteria. Median DAH180 days was 70 days (interquartile range 0-144). Mortality occurred in 2,162 (34.1%) patients within 90 days following injury. Patients in the lower DAH180 days group were more commonly older (absolute standardized difference [ASD] = 0.68) with higher preinjury health resource utilization (ASD = 0.36) and greater injury severity (ASD = 0.81). Increased baseline health resource utilization (-10.1 days, 95% CI -17.4 to -2.8, p = 0.0041), older age (-4.6 days, 95% CI -5.7 to -3.4, p < 0.001), higher cranial injury severity (-84.6 days, 95% CI -98.3 to -71.0, p < 0.001), and major extracranial injuries (-14.2 days, 95% CI -19.5 to -8.93, p < 0.001) were significantly associated with fewer DAH180 days. DAH180 days was positively correlated with DAH at up to 3 years (r = 0.91, 95% CI 0.90-0.92) and negatively correlated with direct health care expenditure (rs = -0.89, 95% CI -0.88 to -0.90). The average MID estimated from anchor-based and distribution-based methods was 18 days. DISCUSSION: We validate DAH180 days as a potentially useful outcome measure with construct, predictive, and face validity in a population with moderate to severe TBI. Given the intensity of acute care requirements for patients with TBI, our work highlights DAH180 days as a feasible and sufficiently responsive outcome measure.

Stigma and health outcomes in multiple sclerosis: a systematic review.

BACKGROUND: Stigma is increasingly recognised as contributing to disability in MS. This systematic review aimed to answer the following question: To what extent is stigma associated with psychological and physical health outcomes in MS? METHODS: The inclusion criteria were: scientific publication of original quantitative research in adults with MS and/or Clinically Isolated Syndrome; outcome measures including a measurement of stigma and psychological and/or physical health; peer reviewed articles in the English language. Pubmed, PsycINFO and Science Direct were searched in November 2023. The Joanna Briggs Institute Critical Appraisal Tool was used to assess the methodological quality and risk of bias in all of the identified studies. The following data was extracted: (1) author and publication year, (2) country, (3) design, (4) sample size and demographics, (5) stigma measure, (6) psychological and/or physical health outcomes, 8) key findings. RESULTS: 18 Studies were identified, reporting in total 22,021 adult participants with multiple sclerosis, with individual sample sizes ranging from 33 to 6,670. The review consistently identified stigma to be significantly associated with adverse psychological and physical health outcomes in all 18 identified studies. Over half of all identified studies investigated depression and stigma and over half investigated quality of life and stigma, and a significant association was demonstrated for both of these variables with stigma in all of these studies. DISCUSSION: Limitations are that most studies were Western with primarily white participants. Only variables studied could be reported and therefore only a selective perspective of stigma in MS could be explored. A meta-analysis was not feasible, due to the variety of stigma definitions and measures employed. A model of stigma in MS is presented and possible interventions to manage stigma in MS are discussed. A need for international action to develop a consensus measure of MS stigma and determine the trajectory and causal dynamics of MS stigma is highlighted.

Development of a core outcome set of clinical research on the integration of traditional Chinese and Western medicine for spinal metastases: a study protocol.

BACKGROUND: In recent years, the incidence of spinal metastasis (SM) has been increasing steadily. In response to this serious public health problem, researchers have made progress by using the integration of traditional Chinese and Western medicine. However, considerable heterogeneity in the definition and measurement of outcomes across clinical research studies, along with the lack of uniform measurement standards for study data, makes it difficult for researchers to compare different treatments. Therefore, it is crucial to accurately evaluate clinical research on the integration of traditional Chinese and Western medicine for SM. METHODS: This study protocol outlines a comprehensive research programme based on the Core Outcome Set Standards Protocol Items. The study consists of four phases: a literature review, semistructured interviews, a two-round modified Delphi survey, a consensus meeting. Phase 1 involves a comprehensive literature review to extract outcomes used in current clinical studies of integrated traditional Chinese and Western medicine or Western medicine for the treatment of SM. A semistructured interview format will be used to survey patients and caregivers in phase 2 to collect suggestions from the patient perspective. Phase 3 involves a two-round modified Delphi survey to complete a prioritisation evaluation of outcomes to generate a candidate list for core outcome set (COS). Finally, phase 4 involves a face-to-face consensus meeting to review and establish the COS. ETHICS AND DISSEMINATION: Conducted in response to the current dilemma of SM, the study was endorsed by the Spine Oncology Group of the Orthopaedic Surgeons Branch of the Chinese Physicians' Association. It will be developed and reported through a rigorous process, with the results of the study to be published in a peer-reviewed journal.Registration: COMET Registry: COMET 2938; https://www.comet-initiative.org/Studies/Details/2938.

Outcome measures used in adolescent sport-related concussion research: a scoping review.

OBJECTIVES: To provide an overview of the outcome measures currently used after sports-related concussion (SRC) in adolescents, categorising by the constructs they assess, follow-up duration and their feasibility of use. DESIGN: Scoping review. DATA SOURCES: We searched three electronic databases (MEDLINE, EMBASE and CINAHL). We also undertook citation tracking of the included articles and searched for ongoing or unpublished trials using ClinicalTrials.gov and Theses Global. ELIGIBILITY CRITERIA: Studies tracking concussion recovery in adolescent athletes. RESULTS: 15 782 records were identified. After initial title and abstract screening, we retrieved 87 studies for full-text screening, with 75 studies fulfilling the eligibility criteria and included in the review, comprising 13 107 participants (9480 male, 3615 female and 12 unreported), ranging in age from 5 to 19 years. 46 different outcome measures were used, with Post-Concussion Symptom Scale (n=42) and Immediate Post-Concussion Assessment and Cognitive Testing (n=21) the most common. Most outcome measures quantified aspects of sensorimotor function including balance, oculomotor function and cognition. Follow-up duration ranged from 7 days to 1 year. 60% of studies ceased follow-up assessments within 6 weeks post-SRC. CONCLUSIONS: Adolescent SRC literature uses a wide range of outcome measures. Most research quantifies cognitive/fatigue domains in the acute/subacute stages post-SRC, using male participants. Other key domains such as anxiety/mood, migraine and key modifiers (cervical and sleep disturbance) are less well represented in the literature. Many of the outcome measures used in current research are associated with high cost and require highly qualified examiners, creating barriers to their implementation in some adolescent sporting environments. STUDY REGISTRATION: https://doi.org/10.17605/OSF.IO/N937E.

Active Visual Art Therapy and Health Outcomes: A Systematic Review and Meta-Analysis.

Importance: Art therapy has a long-standing tradition in patient treatment. As scientific interest in its use has recently grown, a comprehensive assessment of active visual art therapy is crucial to understanding its potential benefits. Objective: To assess the association of active visual art therapy with health outcomes across patient groups and comparators. Data Sources: The systematic literature search included the Cochrane Library, Embase, MEDLINE, CINAHL, ERIC, American Psychological Association PsycArticles, American Psychological Association PsycInfo, PSYNDEX, the German Clinical Trials Register, and ClinicalTrials.gov. No filters regarding language were applied. The search covered all dates before March 2021. Data analysis was conducted from April 24 to September 8, 2023. Study Selection: Randomized clinical trials with any type of patient population comparing the intervention with any control not using active visual art therapy were included. Two researchers independently screened the abstracts and full texts. Data Extraction and Synthesis: Data extraction followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and study quality was evaluated using the Cochrane Risk of Bias tool. Data were synthesized using narrative summaries, forest plots, and random effects meta-analyses. Main Outcome and Measures: In line with the protocol, all outcome measures of the included studies were extracted. Results: The search identified 3104 records, of which 356 outcomes of 69 studies were included, with a total of approximately 4200 participants, aged 4 to 96 years, in the review. The meta-analyses included 50 studies and 217 outcomes of 2766 participants. Treatment indications included mental, neurological, and other somatic disorders, and prevention. Most outcome measures focused on depression, anxiety, self-esteem, social adjustment, and quality of life. Art therapy was associated with an improvement in 18% of the 217 outcomes compared with the controls (1%), while 81% showed no improvement. The standardized mean difference in the change from baseline of the meta-analyses of 0.38 (95% CI, 0.26-0.51) and posttest analysis of 0.19 (95% CI, 0.12-0.26) also indicated an improvement of outcomes associated with art therapy. Overall study quality was low. Conclusions and Relevance: In this systematic review and meta-analysis of randomized clinical trials, visual art therapy was associated with therapeutic benefits for some outcomes, although most studies were of low quality. Further good-quality studies are needed to provide additional insights for its best possible integration into routine care.

Enhancing the Classification of Congenital Heart Defects for Outcome Association Studies in Birth Defects Registries.

INTRODUCTION: Traditional strategies for grouping congenital heart defects (CHDs) using birth defect registry data do not adequately address differences in expected clinical consequences between different combinations of CHDs. We report a lesion-specific classification system for birth defect registry-based outcome studies. METHODS: For Core Cardiac Lesion Outcome Classifications (C-CLOC) groups, common CHDs expected to have reasonable clinical homogeneity were defined. Criteria based on combinations of Centers for Disease and Control-modified British Pediatric Association (BPA) codes were defined for each C-CLOC group. To demonstrate proof of concept and retention of reasonable case counts within C-CLOC groups, Texas Birth Defect Registry data (1999-2017 deliveries) were used to compare case counts and neonatal mortality between traditional vs. C-CLOC classification approaches. RESULTS: C-CLOC defined 59 CHD groups among 62,262 infants with CHDs. Classifying cases into the single, mutually exclusive C-CLOC group reflecting the highest complexity CHD present reduced case counts among lower complexity lesions (e.g., 86.5% of cases with a common atrium BPA code were reclassified to a higher complexity group for a co-occurring CHD). As expected, C-CLOC groups had retained larger sample sizes (i.e., representing presumably better-powered analytic groups) compared to cases with only one CHD code and no occurring CHDs. DISCUSSION: This new CHD classification system for investigators using birth defect registry data, C-CLOC, is expected to balance clinical outcome homogeneity in analytic groups while maintaining sufficiently large case counts within categories, thus improving power for CHD-specific outcome association comparisons. Future outcome studies utilizing C-CLOC-based classifications are planned.

Inhibition moderates the effect of attentional bias modification for reducing residual depressive symptoms: A randomized sham-controlled clinical trial.

OBJECTIVES: Residual symptoms represent risk factor for relapse. Attention bias modification (ABM) may reduce clinical and sub-clinical depressive symptoms, indicating that is may be of relevance when preventing relapse. Current evidence suggests that executive functions may moderate the outcome of interventions targeting depressive symptoms. METHODS: We assessed inhibition and shifting as indicators of executive functioning by means of the Color-Word Interference Test (i.e., "Stroop task"). These baseline characteristics were investigated as moderator of the effect of ABM on depression symptoms in a double-blinded randomized sham-controlled trial of ABM including patients with a history of recurrent depression (N = 301). Inclusion and follow-ups took place from January 2015 to October 2016. The trial was retrospectively registered #NCT02658682 January 2016. RESULTS: The moderation analysis was based on the interaction term ABM x Stroop. Scaled inhibition scores ≤10.8, but not shifting ability, moderated the effect of ABM compared to sham on clinician-rated depression (HDRS). The difference from the 15th to the 85th percentile of the inhibition score was about 1 HDRS-point, indicating a small effect size. No moderation was found when self-reported depression and AB were the outcome. Post-hoc power calculation indicates risk of Type-II error. CONCLUSION: When targeting depressive symptoms, ABM seems to be somewhat more effective in patients with weak inhibitory control. This suggests that evaluating the level of inhibition in individual patients could provide some information when making decisions about prescribing ABM to reduce residual symptoms, but the clinical implications of this is uncertain due to an overall small effect size attributable to ABM. Future studies should examine whether inhibitory control still is a relevant moderator when comparing ABM to treatment options other than the sham control condition.

Core outcome sets for trials of interventions to prevent and to treat multimorbidity in adults in low and middle-income countries: the COSMOS study.

INTRODUCTION: The burden of multimorbidity is recognised increasingly in low- and middle-income countries (LMICs), creating a strong emphasis on the need for effective evidence-based interventions. Core outcome sets (COS) appropriate for the study of multimorbidity in LMICs do not presently exist. These are required to standardise reporting and contribute to a consistent and cohesive evidence-base to inform policy and practice. We describe the development of two COS for intervention trials aimed at preventing and treating multimorbidity in adults in LMICs. METHODS: To generate a comprehensive list of relevant prevention and treatment outcomes, we conducted a systematic review and qualitative interviews with people with multimorbidity and their caregivers living in LMICs. We then used a modified two-round Delphi process to identify outcomes most important to four stakeholder groups (people with multimorbidity/caregivers, multimorbidity researchers, healthcare professionals and policymakers) with representation from 33 countries. Consensus meetings were used to reach agreement on the two final COS. REGISTRATION: https://www.comet-initiative.org/Studies/Details/1580. RESULTS: The systematic review and qualitative interviews identified 24 outcomes for prevention and 49 for treatment of multimorbidity. An additional 12 prevention and 6 treatment outcomes were added from Delphi round 1. Delphi round 2 surveys were completed by 95 of 132 round 1 participants (72.0%) for prevention and 95 of 133 (71.4%) participants for treatment outcomes. Consensus meetings agreed four outcomes for the prevention COS: (1) adverse events, (2) development of new comorbidity, (3) health risk behaviour and (4) quality of life; and four for the treatment COS: (1) adherence to treatment, (2) adverse events, (3) out-of-pocket expenditure and (4) quality of life. CONCLUSION: Following established guidelines, we developed two COS for trials of interventions for multimorbidity prevention and treatment, specific to adults in LMIC contexts. We recommend their inclusion in future trials to meaningfully advance the field of multimorbidity research in LMICs. PROSPERO REGISTRATION NUMBER: CRD42020197293.

Endpoints and outcomes for localized scleroderma/morphea: a scoping literature review.

BACKGROUND: Current treatment for localized scleroderma (LS) has been shown to halt disease activity, but little is still known about patient experiences with these treatments, nor is there consensus about optimal measurement strategies for future clinical trials. OBJECTIVE: Conduct a scoping review of the literature for the types of outcomes and measures (i.e. clinician-, patient-, and caregiver-reported) utilized in published treatment studies of LS. METHODS: Online databases were searched for articles related to the evaluation of treatment efficacy in LS with a special focus on pediatrics. RESULTS: Of the 168 studies, the most common outcomes used were cutaneous disease activity and damage measured via clinician-reported assessments. The most frequently cited measure was the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT). Few patient-reported outcome measures (PROMs) were used. LIMITATIONS: Some studies only vaguely reported the measures utilized, and the review yielded a low number of clinical trials. CONCLUSION: In addition to evaluating disease activity with clinician-reported measures, the field could obtain critical knowledge on the patient experience by including high-quality PROMs of symptoms and functioning. More clinical trials using a variety of outcomes and measures are necessary to determine the most suitable course of treatment for LS patients.

Report From the Second Global Scientific Conference on Clinical Trial Design and Outcome Measures for RDH12-Associated Inherited Retinal Degeneration.

Translational Relevance: A multi-stakeholder, patient centric approach will be critical to the design of future successful clinical trials with outcome measures relevant to the RDH12-IRD population.

Pozelimab for CHAPLE disease: results from in-trial interviews and clinical outcome assessments.

BACKGROUND: CD55 deficiency with hyper-activation of complement, angiopathic thrombosis, and protein-losing enteropathy (CHAPLE) disease is ultra-rare (< 100 children or young adults worldwide) and potentially fatal. The study used mixed-methods approaches to assess how pozelimab impacts the signs and symptoms of CHAPLE disease from the patient perspective by combining within-trial interviews and clinical outcome assessments (COAs) (ClinicalTrials.gov, NCT04209634). METHODS: Interviews conducted with patients/caregivers at screening and week 24 assessed the signs and symptoms of CHAPLE disease, including those which were most bothersome, and evaluated the change. Patients/caregivers and clinicians completed the COAs; interview data contextualized the meaningfulness of change. RESULTS: Ten patients (aged 3-19 years) were enrolled; caregivers contributed to nine interviews. Abdominal pain, diarrhea, facial and peripheral edema, nausea, and vomiting are the core signs and symptoms of CHAPLE disease (≥ 90% patients experienced pre-treatment); the most bothersome signs and symptoms were abdominal pain (n = 9) and facial edema (n = 1). All core signs and symptoms were reported as resolved at week 24 interviews. Severity on global assessments changed from "mild" to "very severe" at baseline to "no signs or symptoms" at week 24. Interview results were generally consistent with sign- or symptom-specific COA scores. CONCLUSIONS: Patients with CHAPLE disease treated with pozelimab for 24 weeks experienced complete resolution of core signs and symptoms. Mixed-methods approaches can contextualize the patient experience (how patients feel and function) in rare disease trials. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04209634, registered December 24, 2019, https://classic. CLINICALTRIALS: gov/ct2/show/NCT04209634 .

Process indicators outshine outcome measures: assessing hospital quality of care in breast cancer treatment in China.

Reporting the results of quality indicators can narrow the gap in the quality of care between hospitals. While most studies rely on outcome indicators, they may not accurately measure the quality of care. Process indicators are not only strongly associated with treatment outcomes, but are also more sensitive to whether patients are treated accurately, enabling timely intervention. Our study aims to investigate whether process indicators provide a more reasonable assessment of hospital quality of care compared to outcome indicators. Data were sourced from the Specific Disease Medical Service Quality Management and Control System in China. A total of 113,942 patients with breast cancer treated in 298 hospitals between January 2019 and April 2023 were included in this retrospective study. The rankability of 11 process indicators was calculated and used as a weight to create a new composite indicator. The composite indicators and outcome measures were compared using the O/E ratio categories. Finally, in order to determine the impact of different years on the results, a sensitivity analysis was conducted using bootstrap sampling. The rankability ( ρ ) values of the eleven process indicators showed significant differences, with the highest ρ value for preoperative cytological or histological examination before surgery (0.919). The ρ value for the outcome indicator was 0.011. The rankability-weighting method yielded a comprehensive score ( ρ  = 0.883). The comparison with categorical results of the outcome indicator has different performance classifications for 113 hospitals (37.92%) for composite scores and 140 (46.98%) for preoperative cytological or histological examinationbefore surgery. Process indicators are more suitable than outcome indicators for assessing the quality of breast cancer care in hospitals. Healthcare providers can use process indicators to identify specific areas for improvement, thereby driving continuous quality improvement efforts.

A randomized, double-blind, placebo-controlled trial to evaluate the effect of nabiximols oromucosal spray on clinical measures of spasticity in patients with multiple sclerosis.

BACKGROUND: Spasticity is a common and potentially debilitating symptom of multiple sclerosis (MS) with a highly variable presentation. Understanding, quantifying, and managing MS-associated spasticity (MSS) is a challenge for research and in clinical practice. The tetrahydrocannabinol:cannabidiol oromucosal spray nabiximols has demonstrated beneficial effects in the treatment of MSS in clinical studies as well as real-world observational studies, and is approved for the treatment of MSS in 29 countries globally. Most randomized studies evaluated the efficacy of nabiximols using the change in average daily spasticity scores reported by patients using the spasticity Numeric Rating Scale as a primary endpoint. This study, RELEASE MSS1 (NCT04657666), was conducted using a prespecified primary endpoint of change in spastic muscle tone (Modified Ashworth Scale Lower Limb Muscle Tone-6 [MAS LLMT-6]) to corroborate the efficacy of nabiximols as adjunctive therapy observed with the patient-measured spasticity Numeric Rating Scale primary endpoint in the previous pivotal studies. METHODS: This was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-treatment, 2-period, crossover trial. Because of the prevalence and functional impact of lower limb spasticity on the individual patient's overall experience of MS spasticity, the MAS LLMT-6 was derived from the clinician-rated MAS. The MAS LLMT-6 is the average transformed MAS score of 6 muscle groups (knee flexors, knee extensors, and ankle plantar flexors; all assessed bilaterally). Secondary measures included MAS LLMT-4 scores, defined as the average of the 4 individual MAS-transformed scores of knee flexors and knee extensors bilaterally. Patients had a diagnosis of MS and an untransformed MAS score of at least 2 in ≥2 of 6 LLMT-6 muscle groups despite current treatment with ≥1 of the following oral antispasticity agents: baclofen, tizanidine, or dantrolene. Eligible participants were randomly assigned to 1 of 2 treatment sequences. Each treatment sequence consisted of two treatment periods, each consisting of a 14-day dose titration phase followed by a 7-day dose maintenance phase. RESULTS: Of 68 patients enrolled, 33 were assigned to nabiximols followed by placebo and 35 were assigned to placebo followed by nabiximols. Least squares mean changes in MAS LLMT-6 scores from baseline to day 21 were -0.23 for nabiximols and -0.26 for placebo; the least squares mean treatment difference in MAS LLMT-6 scores for nabiximols versus placebo was 0.04, which was not statistically significant (P = 0.7152). Mean changes in MAS LLMT-4 scores from baseline to day 21 also were not significantly different between the nabiximols and placebo groups. Safety results in this study were consistent with the known safety profile of nabiximols in patients with MSS. CONCLUSION: Despite the established efficacy of nabiximols in MSS observed using patient-reported measures, the primary endpoint was not met in this study. The findings from this study reflect and emphasize some of the challenges in the evaluation and treatment of MS spasticity. CLINICAL TRIAL REGISTRATION NUMBER (CLINICALTRIALS.GOV): : NCT04657666.

Heterogeneous Outcome Selection and Incomplete Prespecification of Outcomes in Systematic Reviews: A Case Study on Pressure Injury.

OBJECTIVE: To understand how reviewers select and prespecify outcomes for systematic reviews (SRs), the authors report on the outcomes used in SRs of pressure injury (PI) intervention and treatment and evaluate their completeness of prespecification. DATA SOURCES: The authors searched four electronic databases for SRs involving PI prevention and/or treatments. STUDY SELECTION: Inclusion criteria were SRs and meta-analyses evaluating interventions for preventing or treating PI. Studies without systematic search or risk-of-bias assessment, conference proceedings, and articles not in Chinese or English were excluded. DATA EXTRACTION: Two reviewers extracted and categorized the outcomes in domains, assessing outcome prespecification using a five-element framework. Data items included study characteristics, target population, type of interventions, and outcome variables. DATA SYNTHESIS: This review included 95 SRs that reported a total of 432 instances of 24 different outcome domains. An average of four outcome domains were reported per SR. The most frequently reported domains were PI healing, PI occurrence, and PI status. Of the 62 SRs that prespecified primary outcomes, 40 (64.52%) reported more than one primary outcome. Only 24 of the 432 instances (5.56%) were completely specified. Among the 24 outcome domains, 12 (50.00%) were listed as primary outcomes at least once. Primary outcomes were more completely specified than nonprimary outcomes. CONCLUSIONS: Systematic reviews of PI prevention and/or treatment report diverse, incompletely prespecified outcomes, highlighting the need for a core outcome set to standardize key clinical outcomes.

A standard set of outcome measures for the comprehensive assessment of oral health and occlusion in individuals with osteogenesis imperfecta.

BACKGROUND: Osteogenesis imperfecta (OI) is a group of inherited connective tissue disorders of varying severity characterized by bone fragility. The primary objective of this international multidisciplinary collaboration initiative was to reach a consensus for a standardized set of clinician and patient-reported outcome measures, as well as associated measuring instruments for dental care of individuals with OI, based on the aspects considered important by both experts and patients. This project is a subsequent to the Key4OI project initiated by the Care4BrittleBones foundation which aims to develop a standard set of outcome measures covering a large domain of factors affecting quality of life for people with OI. An international team of experts comprising orthodontists, pediatric dentists, oral and maxillofacial surgeons, and prosthetic dentists used a modified Delphi consensus process to select clinician-reported outcome measures (CROMs) and patient-reported outcome measures (PROMs) to evaluate oral health in individuals with OI. Important domains were identified through a literature review and by professional expertise (both CROMs and PROMs). In three focus groups of individuals with OI, important and relevant issues regarding dental health were identified. The input from the focus groups was used as the basis for the final set of outcome measures: the selected issues were attributed to relevant CROMs and, when appropriate, matched with validated questionnaires to establish the final PROMs which represented best the specific oral health-related concerns of individuals with OI. RESULTS: Consensus was reached on selected CROMs and PROMs for a standard set of outcome measures and measuring instruments of oral health in individuals with OI. CONCLUSIONS: Our project resulted in consensus statements for standardization oral health PROMs and CROMs in individuals with OI. This outcome set can improve the standard of care by incorporating recommendations of professionals involved in dental care of individuals with OI. Further, it can facilitate research and international research co-operation. In addition, the significant contribution of the focus groups highlights the relevance of dental and oral health-related problems of individuals with OI.

Utilisation of standardised outcomes measures by clinical Physiotherapists working in Namibia: a nationwide cross-sectional study.

Introduction: The utilisation of standardised outcome measures (SOMs) is crucial for evaluating patients' health status. Physiotherapists are highly recommended to use SOMs routinely. Despite the well-documented benefits of using SOMs, the utilisation of SOMs in clinical practice is still problematic particularly in Africa. In Namibia, there is dearth of information about SOMs utilisation by physiotherapists and the associated factors. This study was aimed at determining the extent of routine utilisation of SOMs and the associated demographic and work-related factors among physiotherapists. Methods: A cross-sectional, nationwide, online survey was conducted and all registered qualified physiotherapists and intern physiotherapists working in public or private hospitals/clinics were invited to participate. Data was analysed using Statistical Package for the Social Sciences (SPSS) version 29.0. The Chi-square (χ2) and Fishers exact test investigated the relationship between the associated factors and routine SOMs utilisation. The alpha level was set at 0.05. Results: Of 230 participants who received the invitational link, 99 (43.0%) responded timeously to the call to participate. Although 97.9% (n=94) of the participants indicated having used at least one type of SOMs in the last six months, the frequency of utilisation varied. Routine utilisation, defined as 70%-100% of the time, was reported in only 49.0% of the participants. The Chi-square test only showed significant findings for gender (p=0.01) and clinical specialty (p=0.004). The odds of utilising SOMs were 4.13 greater among physiotherapists with a clinical specialty and 3.88 times greater for females than males. Conclusion: The rates for routine utilisation of SOMs by Namibian physiotherapists are unfavourable. Female gender and clinical specialty influenced the utilisation of SOMs in daily clinical practice. Cognisant of the study limitations, these results call for the need to improve the routine utilisation of the SOMs in Namibia.

Self-compassion-based online group psychotherapy for bereavement-related grief: The COMPACT feasibility trial.

OBJECTIVE: This study aimed to examine the feasibility and effectiveness of online group psychotherapy focused on self-compassion for individuals experiencing bereavement-related grief. METHOD: This single-arm feasibility trial involved participants aged 18 years or older who had experienced bereavement at least 6 months prior the five-week intervention. Outcomes were measured at baseline, immediately post-intervention, and 4 and 12 weeks later. The primary endpoint was the percentage of participants who completed four out of five sessions; the pre-defined feasibility criterion was 70%. Secondary endpoints included measures of grief, depression, anxiety, self-compassion, and resilience. RESULTS: The program was conducted in three courses with 18, 26, and 16 participants, respectively. The primary endpoint was met for 83.1% of participants (54/65). Cohen's d effect sizes ([95% CI] 12 weeks vs. baseline) for grief, depression, anxiety, self-compassion, and resilience were - 0.25 [-0.52, 0.03], -0.64 [-0.94, -0.34], -0.48 [-0.77, -0.19], 0.50 [0.21, 0.79], and - 0.07 [-0.34, 0.21], respectively. CONCLUSIONS: Online group psychotherapy focused on self-compassion for individuals with bereavement-related grief is feasible and effective for addressing grief and psychological distress. Randomized controlled trials are warranted to confirm the intervention's efficacy. TRIAL REGISTRATION NUMBER: UMIN000048554, registered 2 August 2022.