Effectiveness Of Health Care Interventions Research Articles

Aversion to pragmatic randomised controlled trials: three survey experiments with clinicians and laypeople in the USA

ObjectivesPragmatic randomised controlled trials (pRCTs) are essential for determining the real-world safety and effectiveness of healthcare interventions. However, both laypeople and clinicians often demonstrate experiment aversion: preferring to implement either...

Effectiveness of Healthcare Interventions in Reducing Child Mortality

Effectiveness of Healthcare Interventions in Reducing Child Mortality

Modifications of the readiness assessment for pragmatic trials tool for appropriate use with Indigenous populations

BackgroundInequities in health access and outcomes exist between Indigenous and non-Indigenous populations. Embedded pragmatic randomized, controlled trials (ePCTs) can test the real-world effectiveness of health care interventions. Assessing readiness for ePCT, with tools such as the Readiness Assessment for Pragmatic Trials (RAPT) model, is an important component. Although equity must be explicitly incorporated in the design, testing, and widespread implementation of any health care intervention to achieve equity, RAPT does not explicitly consider equity. This study aimed to identify adaptions necessary for the application of the ‘Readiness Assessment for Pragmatic Trials’ (RAPT) tool in embedded pragmatic randomized, controlled trials (ePCTs) with Indigenous communities.MethodsWe surveyed and interviewed participants (researchers with experience in research involving Indigenous communities) over three phases (July-December 2022) in this mixed-methods study to explore the appropriateness and recommended adaptions of current RAPT domains and to identify new domains that would be appropriate to include. We thematically analyzed responses and used an iterative process to modify RAPT.ResultsThe 21 participants identified that RAPT needed to be modified to strengthen readiness assessment in Indigenous research. In addition, five new domains were proposed to support Indigenous communities’ power within the research processes: Indigenous Data Sovereignty; Acceptability – Indigenous Communities; Risk of Research; Research Team Experience; Established Partnership). We propose a modified tool, RAPT-Indigenous (RAPT-I) for use in research with Indigenous communities to increase the robustness and cultural appropriateness of readiness assessment for ePCT. In addition to producing a tool for use, it outlines a methodological approach to adopting research tools for use in and with Indigenous communities by drawing on the experience of researchers who are part of, and/or working with, Indigenous communities to undertake interventional research, as well as those with expertise in health equity, implementation science, and public health.ConclusionRAPT-I has the potential to provide a useful framework for readiness assessment prior to ePCT in Indigenous communities. RAPT-I also has potential use by bodies charged with critically reviewing proposed pragmatic research including funding and ethics review boards.

On the Remarkable Advancement of Assistive Robotics in Human-Robot Interaction-Based Health-Care Applications: An Exploratory Overview of the Literature

With the rapid advancement of technology, assistive robotic entities have arisen as indispensable instruments within diverse Human-Robot Interaction (HRI)-based health-care applications. By integrating Artificial Intelligence (AI) into these assistive robotic entities, they gain the capacity to autonomously perceive, engage in sophisticated reasoning, and execute actions within highly dynamic and complex environments. In light of these impressive achievements, this paper highlights a three-stage exploratory overview of the literature on the remarkable advancement of assistive robotics in HRI-based health-care applications. The first stage initiates an assessment of assistive robotics spanning historical epochs from ancient to modern times. Following this, the second stage comprehensively explores assistive robotics investigations in the realm of HRI-based health-care with its four sub-fields including rehabilitation, geriatric-care, pediatric-care, and nursing. Finally, the third stage entails a thorough analysis of the common challenges encountered in these pertinent investigations and provides a set of recommendations. This comprehensive paper not only provides an abundance of studies for each concept, method, and application in HRI, but it also presents their theoretical foundations, strengths, gaps, critical challenges, and recommendations. The results of the conducted exploratory overview shed light on the noteworthy prominence of assistive robotic entities within the HRI-based health-care field. The acquired findings emphasize the positive impact of such entities on human health, affirming their pivotal role in contributing to the advancement and effectiveness of health-care interventions. Furthermore, this paper provides an opportunity for scholars and researchers actively engaged in the pertinent field to obtain comprehensive additional insights, serving as a guiding resource for their academic endeavors.

Real-world effectiveness and costs of vertical oscillatory pressure manipulation for low back pain

IntroductionReal-world evidence studies using routinely collected data, such as patient clinical records, are innovative ways of generating insight into the effectiveness of healthcare interventions. This study examined the effectiveness of vertical oscillatory pressure (VOP) on selected clinical outcomes for patients with low back pain (LBP) using routinely collected data.MethodsRetrospective analysis was carried out on the medical records of patients diagnosed with LBP in a tertiary hospital in south-west Nigeria over a 10-year period. Clinical outcomes (pain intensity and functional disability) in patients who received VOP (<i>n</i> = 201) for their LBP were compared with controls that had traditional physiotherapy (TP) (<i>n</i> = 138) in a routine clinical setting. Total costs of intervention were estimated in terms of direct and indirect costs.ResultsThere were significant differences within group (from baseline to 4th and 8th week of intervention) for the VOP group in pain intensity (<i>p</i> = 0.001) and functional disability (<i>p</i> = 0.001). However, TP group showed no significant differences in pain intensity and functional disability across baseline and week 8 of the study. There was a significant difference in pain intensity (2.95 ± 1.38 vs. 4.16 ± 2.48; <i>p</i> = 0.013) between VOP and TP at week eight. A higher direct and indirect costs associated with VOP compared with TP (both <i>p</i> = 0.042).ConclusionsThe findings of this study suggest that VOP is an effective intervention for LBP in the ‘real-world’. VOP is more effective compared to TP on its effect on pain intensity over time.

Benefits of Participation in Clinical Trials: An Umbrella Review.

Participation in randomised clinical trials (RCTs) entails taking part in the discovery of effects of health care interventions. The question of whether participants' outcomes are different to those of non-participants remains controversial. This umbrella review was aimed at assessing whether there are health benefits of participation in RCTs, compared to non-participation. After prospective registration (PROSPERO CRD42021287812), we searched the Medline, Scopus, Web of Science and Cochrane Library databases from inception to June 2022 to identify relevant systematic reviews with or without meta-analyses. Data extraction and study quality assessment (AMSTAR-2) were performed by two independent reviewers. Of 914 records, six systematic reviews summarising 380 comparisons of RCT participants with non-participants met the inclusion criteria. In two reviews, the majority of comparisons were in favour of participation in RCTs. Of the total of comparisons, 69 (18.7%) were in favour of participation, reporting statistically significant better outcomes for patients treated within RCTs, 264 (71.7%) comparisons were not statistically significant, and 35 (9.5%) comparisons were in favour of non-participation. None of the reviews found a harmful effect of participation in RCTs. Our findings suggest that taking part in RCTs may be beneficial compared to non-participation.

Designing and conducting adaptive trials to evaluate interventions in health services and implementation research: practical considerations

Randomised controlled clinical trials are widely considered the preferred method for evaluating the efficacy or effectiveness of interventions in healthcare. Adaptive trials incorporate changes as the study proceeds, such as...

Activating people to partner in health and self-care: use of the Patient Activation Measure.

Summary Patient activation is a behavioural concept and is at the heart of personalised care. It is defined as an individual’s knowledge, skill and confidence for managing their health and health care.Evidence indicates that patient activation scores can predict health behaviour and are closely linked to various clinical outcomes: reduced unnecessary emergency department visits, hospital admissions and re‐admissions. Patients with lower activation levels (25–40% of the population) are less likely to adopt healthy behaviour, and more likely to have poorer clinical outcomes and higher rates of hospitalisation.Effective interventions can improve a patient’s activation level, and positive change in activation equates to positive change in self‐care behaviour. But to improve patient activation, we must first measure it using a robust evidence‐based tool such as the Patient Activation Measure (PAM) survey.Armed with the patient’s PAM score, providers can tailor their care and help patients achieve better self‐care, which can improve outcomes of care and reduce unnecessary health care utilisation.The PAM is also useful for population segmentation and risk stratification — to target interventions and health strategies to meet the needs of patients who are at different points along the activation continuum, to measure the performance of health care systems, and to evaluate the effectiveness of health care interventions.The role of patient activation requires further serious consideration if we are to improve the long‐term health and wellbeing of all Australians. The PAM tool is a feasible and cost‐effective solution for achieving the Quadruple Aim — improving population health, the cost‐efficiency of the health system, and patient and provider experience.

Impact of organizational context on patient outcomes in a proactive primary care program:a longitudinal observational study

BackgroundThe effectiveness of health care interventions is co-determined by contextual factors. Unknown is the extent of this impact on patient outcomes. Therefore, the aim of this study is to explore which characteristics of general practices are associated with patient outcomes in a proactive primary care program, the U-PROFIT 2.0.MethodsA longitudinal observational study was conducted from January 2016 till October 2017. Two questionnaires were send out, one to collect characteristics of general practices such as practice neighbourhood socio-economic status, general practice versus healthcare centre (involving multiple primary care professionals), and professional- frail older patient ratio per practice of general practitioners and practice nurses. Regarding delivering the program, the practice or district nurse who delivered the program, number of years since the start of the implementation, and choice of age threshold for frailty screening were collected. Patient outcomes collected by the second questionnaire and send to frail patients were daily functioning, hospital admissions, emergency department visits, and general practice out-of-hours consultations. Linear and generalized linear mixed models were used.ResultsA total of 827 frail older people were included at baseline. Delivery of the program by a district nurse compared to a practice nurse was significantly associated with a decrease in daily functioning on patient-level (β = 2.19; P = < 0.001). Duration since implementation of 3 years compared to 9 years was significantly associated with less out-of-hours consultations to a general practice (OR 0.11; P = 0.001). Applying frailty screening from the age of 75 compared to those targeted from the age of 60 showed a significant increase in emergency visits (OR 5.26; P = 0.03).ConclusionThree associations regarding the organizational context 1) the nurse who delivered the program, 2) the number of years the program was implemented and 3) the age threshold for defining a frail patient are significant and clinically relevant for frail patients that receive a proactive primary care program. In general, contextual factors need more attention when implementing complex primary care programs which can result in better balanced choices to enhance effective proactive care for older people living in the community.

Can Multi-Attribute Utility Instruments Adequately Capture Net Health Gains in Vision-Related Quality of Life (QoL)?

Background: Health states/outcomes evaluation is an integral part of medical economics. Generic utility instruments compare quality of life (QoL) effects of healthcare interventions across a wide spectrum of diseases and patient populations. This study seeks to determine whether these generic instruments are sensitive to ocular diseases, where expected QoL effects of treatment are patient comfort and symptoms relief, rather than additional quality-adjusted life years (QALYs). Methods: Targeted search and systematic review of refereed studies on dry eye therapy with omega-3 fatty acids (omega-3s) were performed across four databases to identify clinical effectiveness parameters and outcomes. An alternative utility instrument for measuring comparative vision/opthalmic-related QoL effects of pharmaceutical-grade fish oils is used for illustration. Results: Most studies utilise common parametric indices of omega-3 therapy in dry eye. VisQoL appears sufficiently sensitive and customisable to a QoL impact assessment of omega-3s. Clinical outcomes and covariates can be matched to VisQoL in capturing aspects of vision functioning that are vital for patient daily performance and well-being, U = x / n. In contrast, generic measures tend to be content-insensitive to changes in vision/opthalmic-related QoL. Conclusions: Relevance, reliability and validity of multi-attribute utility measures in ocular conditions, like dry eye, can be assessed in terms of four key factors addressed by VisQoL: (a) sensitivity to ocular condition; (b) correlation with clinical parametric data; (c) customisability based on presenting symptoms; and (d) suitability to comparative investigations of intervention effectiveness relative to vision-related QoL.

Comparison of Gilteritinib and Salvage Chemotherapy in FLT3-Mutated Acute Myeloid Leukemia on the Number Needed to Treat for Various Clinical Outcomes: A Secondary Analysis of the Admiral Trial

Introduction/background: FMS-like receptor tyrosine kinase-3 (FLT3) mutations are common in acute myeloid leukemia (AML) and are associated with poor prognosis. Historically, patients with relapsed/refractory (R/R) FLT3 mutation-positive (FLT3mut+) AML experienced dismal survival outcomes. Gilteritinib, a highly potent and selective FLT3 inhibitor, was recently approved as the first targeted therapy for patients with R/R FLT3mut+ AML, and has the potential to bring significant clinical benefits to these patients. The randomized, phase 3 ADMIRAL trial (NCT02421939; Perl, et al. 2019) was the first head-to-head study that evaluated 120-mg/day gilteritinib versus salvage chemotherapy in R/R FLT3mut+ AML patients. The ADMIRAL trial demonstrated that gilteritinib was superior to salvage chemotherapy based on significantly longer median overall survival (OS) and higher response rates, including complete remission/complete remission with partial hematological recovery (CR/CRh), composite CR (CRc), and hematopoietic stem cell transplantation (HSCT) rate. Based on these results, the current study estimated the number needed to treat (NNT) with gilteritinib, compared with salvage chemotherapy, in order to evaluate its clinical benefit with CR/CRh, CRc, 1-year OS, and HSCT rates. Methods: NNT is an established and easily interpretable measure to assess the effectiveness of healthcare interventions. The clinical event estimates (ie, CR/CRh rate, CRc rate, 1-year OS, and HSCT rate) of gilteritinib and salvage chemotherapy among R/R FLT3mut+ AML patients were obtained from the ADMIRAL trial. CR/CRh was defined as the combined rate of CR and CRh. CRc was defined as the combination of CR, CR with incomplete hematologic recovery, and CR with incomplete platelet recovery. OS was defined as time from randomization to death due to any cause. The NNT is calculated as the inverse of the absolute rate difference between the event rates of gilteritinib and salvage chemotherapy. Positive NNT values represent treatment benefit, with lower values indicating greater benefit of gilteritinib over salvage chemotherapy. The 95% confidence interval (CI) of the NNT was derived from the 95% CI of the event rate difference. Results: In the ADMIRAL trial, patients assigned to gilteritinib had significantly higher CR/CRh rates (34.0% vs 15.3%) and CRc rates (54.3% vs 21.8%) than patients assigned to salvage chemotherapy. The NNT for CR/CRh and CRc was 5.35 (95% CI: 3.66, 9.98) and 3.08 (95% CI: 2.38, 4.36), suggesting that treating five and three patients with gilteritinib instead of salvage chemotherapy would result in one additional patient achieving CR/CRh and CRc, respectively. With respect to the survival outcome, patients randomized to gilteritinib had significantly prolonged OS compared to those randomized to salvage chemotherapy (median OS: 9.3 vs 5.6 months; hazard ratio: 0.64); rates of 1-year survival were 37.1% versus 16.7%, respectively. The NNT comparing gilteritinib with salvage chemotherapy was 4.90 (95% CI: 3.29, 9.64) for 1-year OS, which suggests that treating approximately five patients with gilteritinib instead of salvage chemotherapy would lead to one additional survivor at the end of the first year. Lastly, more patients underwent HSCT in the gilteritinib arm versus the salvage chemotherapy arm (25.5% vs 15.3%); the corresponding NNT was estimated at 9.82 (95% CI: 5.40, 54.59) for gilteritinib versus salvage chemotherapy. Conclusion: The results demonstrated that treatment with gilteritinib compared with salvage chemotherapy leads to more R/R FLT3mut+ AML patients achieving CR/CRh, CRc, and proceeding to HSCT, as well as more patients remaining alive at 1 year. This NNT analysis supports the superior clinical benefit of gilteritinib versus salvage chemotherapy in R/R FLT3mut+ AML patients. Disclosures Pandya: Astellas Pharma, Inc.: Current Employment. Qi:BMS: Other: Employee of Analysis Group Inc., which received consulting fees; Astellas Pharma, Inc.: Research Funding. Yang:Analysis Group Inc.: Current Employment; Takeda Pharmaceutical Company Ltd: Research Funding. Garnham:Astellas Pharma, Inc.: Current Employment. Shah:Astellas: Current Employment. Zeidan:Taiho: Consultancy, Honoraria; Celgene / BMS: Consultancy, Honoraria, Research Funding; Cardinal Health: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria, Research Funding; Trovagene: Consultancy, Honoraria, Research Funding; Otsuka: Consultancy, Honoraria; CCITLA: Other; ADC Therapeutics: Research Funding; Seattle Genetics: Consultancy, Honoraria; Aprea: Research Funding; MedImmune/Astrazeneca: Research Funding; Astex: Research Funding; Daiichi Sankyo: Consultancy, Honoraria; Astellas: Consultancy, Honoraria; Acceleron: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Research Funding; Incyte: Consultancy, Honoraria, Research Funding; Jazz: Consultancy, Honoraria; Agios: Consultancy, Honoraria; Boehringer-Ingelheim: Consultancy, Honoraria, Research Funding; Epizyme: Consultancy, Honoraria; Leukemia and Lymphoma Society: Other; Ionis: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Research Funding; BeyondSpring: Consultancy, Honoraria; Cardiff Oncology: Consultancy, Honoraria, Other.

Dealing with Bad Risk in Cost-Effectiveness Analysis: The Cost-Effectiveness Risk-Aversion Curve.

Cost-effectiveness analysis has been advocated and is widely used to inform policy and decision makers in setting priorities for resource allocation. Since the costs and effects of health care interventions are uncertain, much research interest has focused on handling uncertainty in cost-effectiveness analysis. The most widely used method to summarize uncertainty in cost-effectiveness analysis is the cost-effectiveness acceptability curve, which estimates the probability that an intervention is cost effective for a wide range of threshold ratios. However, by estimating the uncertainty associated with incremental costs and effects, information about the uncertainty associated with the costs and effects of the individual programs is lost, which may be important to inform risk-averse decision makers. In the present paper, we suggest to penalize the expected net monetary benefit (NMB) of a program for its downside risk (i.e. bad risk), which preserves the uncertainty of the individual programs and rank orders programs according to their risk-adjusted NMB. The cost-effectiveness risk-aversion curve (CERAC) is introduced, which estimates the net benefit-to-risk ratio for a wide range of threshold rations. The CERAC is a helpful additional tool to inform decision and policy makers who are risk averse, and can easily be constructed using the results of a cost-effectiveness analysis.

Assessing context suitability (generalizability, external validity, applicability or transferability) of findings in evidence syntheses in healthcare-An integrative review of methodological guidance.

Evidence syntheses provide the basis for evidence-based decision making in healthcare. To judge the certainty of findings for the specific decision context evidence syntheses should consider context suitability (ie, generalizability, external validity, applicability or transferability). Our objective was to determine the status quo and to provide a comprehensive overview of existing methodological recommendations of Health Technology Assessment (HTA) and Systematic Review (SR) producing organizations in assessing context suitability of evidence on effectiveness of health care interventions. Additionally, we analyzed similarities and differences between the recommendations. In this Integrative Review we performed a structured search for methods documents from evidence synthesis producing organizations that include recommendations on appraising context suitability in effectiveness assessments. Two reviewers independently selected documents according to predefined eligibility criteria. Data were extracted in standardized and piloted tables by one reviewer and verified by a second reviewer. We performed a thematic analysis to identify and summarize the main themes and categories regarding recommended context suitability assessments. We included 14 methods documents of 12 organizations in our synthesis. Assessment approaches are very heterogeneous both regarding the general concepts (eg, integration in the evidence synthesis preparation process) and the content of assessments (eg, assessment criteria). Some heterogeneity seems to be justified because of the need to tailor the assessment to different settings and medical areas. However, most differences were inexplicable. More harmonization is desirable and appears possible.

Effects of healthcare interventions on psychosocial factors of patients with multimorbidity: A systematic review and meta-analysis

PurposeA systematic review and meta-analysis was conducted to assess the types of healthcare intervention programs offered to patients with multimorbidity and their effects on key psychosocial factors. MethodsFor this systematic review and meta-analysis, we searched databases like Cochrane Library, PubMed, Embase, CINAHL RISS, KISS, etc. for studies published between January 1, 2009, and April 30, 2019. In total, 8,248 studies in English or Korean were reviewed. We included only randomized controlled trials or quasi-experimental studies that applied healthcare interventions and had major effects on the psychosocial factors in adult patients with multimorbidity. Methodological quality was assessed using Cochrane collaboration risk of bias tool. Meta-analysis was performed using the Review Manager 5.3 version to estimate the effect size. ResultsWe identified six randomized controlled trials and 1446 subjects were enrolled. The results reveal that healthcare interventions have an effect on self-rated health (SMD = 0.53 95 % CI: 0.26, 0.79, p < .001), reducing anxiety (SMD = −0.19 95 % CI: −0.36, −0.01, p = .030) and depression (SMD = −0.27 95 % CI: −0.44, −0.10, p = .002), and improving self-efficacy (SMD = 0.21 95 % CI: 0.06, 0.35, p = .005) for patients with multimorbidity. However, there was no significant effect on quality of life. ConclusionHealthcare interventions had significant positive effects on self-rated health, anxiety, depression, and self-efficacy of patients with multimorbidity. These results are expected to serve as basic data for the development of a community-based integrated healthcare intervention program and health policy, especially for the vulnerable older population with multimorbidity.

Development of a checklist for people communicating evidence-based information about the effects of healthcare interventions: a mixed methods study

ObjectivesTo make informed decisions about healthcare, patients and the public, health professionals and policymakers need information about the effects of interventions. People need information that is based on the best...

Study within a trial protocol: Same-day consent vs. delayed consent in a randomized trial.

Randomized trials are designed to evaluate the effects of health care interventions. The recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered research that will not adequately answer the original research question. We aim to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial. This SWAT is designed as an observational study. However, the host trial is a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification program in patients with peripheral arterial disease. For this trial and SWAT, same-day consent is defined as the patient giving consent on the same day, after the investigator has fully explained the predesigned information leaflet for the host trial. Delayed consent is defined as the patient feeling they still need further time to consider their decision to participate or not. The SWAT was registered on the Northern Ireland Network for Trials Methodology Research.

Spatial dynamics and socioeconomic factors correlated with American cutaneous leishmaniasis in Pernambuco, Brazil from 2008 to 2017.

INTRODUCTION: American cutaneous leishmaniasis (ACL) is a public health problem and has been associated with country’s territory. We aimed to analyze the spatial dynamics and socioeconomic factors correlated to the incidence of ACL in Pernambuco, Brazil from 2008 to 2017. METHODS: A cross-sectional, ecological study was conducted in the Brazilian municipalities. Patient data were obtained from the Health Hazard Notification System (SINAN); indicators and incidence for the total period and for quinquennium were obtained. Socioeconomic factors were analyzed to evaluate the association between the incidence of ACL and presence of bathroom and running water, garbage collection availability, inadequate water supply, sanitation, rural population, per capita income, and vulnerability to poverty. Spatial analysis considered the gross incidence; the Bayesian local empirical method and Moran spatial autocorrelation index were applied using Terra View and QGIS. RESULTS: The incidence of ACL reduced (0.29/100,000 inhabitants per year). Individuals with ACL were young adults (30.3%), men (60.2%), brown skinned (62.9%), rural residents (70.6%), and less educated (46.7%); had autochthonous transmission (78.8%); developed the cutaneous form (97.2%); had evolution to cure (82.7%); and were diagnosed using the clinical epidemiological criterion (70.5%). ACL occurred in the large part of the state and showed heterogeneous distribution, with persistence of two high priority intervention clusters covering Health Regions I, II, III, IV, and XII. CONCLUSIONS: Spatial analysis and epidemiological indicators complement each other. The combination of these methods can improve the understanding on ACL occurrence, which will help subsidize planning and enhance the quality and effectiveness of healthcare interventions.

Spin in the reporting, interpretation, and extrapolation of adverse effects of orthodontic interventions: protocol for a cross-sectional study of systematic reviews

BackgroundTitles and abstracts are the most read sections of biomedical papers. It is therefore important that abstracts transparently report both the beneficial and adverse effects of health care interventions and do not mislead the reader. Misleading reporting, interpretation, or extrapolation of study results is called “spin”. In this study, we will assess whether adverse effects of orthodontic interventions were reported or considered in the abstracts of both Cochrane and non-Cochrane reviews and whether spin was identified and what type of spin.MethodsEligibility criteria were defined for the type of study designs, participants, interventions, outcomes, and settings. We will include systematic reviews of clinical orthodontic interventions published in the five leading orthodontic journals and in the Cochrane Database. Empty reviews will be excluded. We will manually search eligible reviews published between 1 August 2009 and 31 July 2019. Data collection forms were developed a priori. All study selection and data extraction procedures will be conducted by two reviewers independently. Our main outcomes will be the prevalence of reported or considered adverse effects of orthodontic interventions in the abstract of systematic reviews and the prevalence of “spin” related to these adverse effects. We will also record the prevalence of three subtypes of spin, i.e., misleading reporting, misleading interpretation, and misleading extrapolation-related spin. All statistics will be calculated for the following groups: (1) all journals individually, (2) all journals together, and (3) the five leading orthodontic journals and the Cochrane Database of Systematic Reviews separately. Generalized linear models will be developed to compare the various groups.DiscussionWe expect that our results will raise the awareness of the importance of reporting and considering of adverse effects and the presence of the phenomenon of spin related to these effects in abstracts of systematic reviews of orthodontic interventions. This is important, because an incomplete and inadequate reporting, interpretation, or extrapolation of findings on adverse effects in abstracts of systematic reviews can mislead readers and could lead to inadequate clinical practice. Our findings could result in policy implications for making judgments about the acceptance for publication of systematic reviews of orthodontic interventions.

What matters most to patients following percutaneous coronary interventions? A new patient-reported outcome measure developed using Rasch analysis.

IntroductionMeasuring patient reported outcomes can improve the quality and effectiveness of healthcare interventions. The aim of this study was to identify the final set of items that can be included in a patient-reported outcome measure to assess recovery of patients following percutaneous coronary interventions.MethodsA consecutive sample of 200 patients registered in the Victorian Cardiac Outcomes Registry participated in a telephone survey 30 days following their percutaneous cardiac procedure. Rasch analysis was used to select the best set of items to form a concise and psychometrically sound patient-reported outcome measure. Key measurement properties assessed included overall fit to the Rasch measurement model, unidimensionality, response formats (thresholds), targeting, internal consistency and measurement invariance.ResultsFive items were identified as being reliable and valid measures of patient-reported outcomes: pain or discomfort, shortness of breath, confidence in performing usual activities, feeling unhappy and having trouble sleeping. Data showed overall fit to a Rasch model of expected item functioning (χ2 16.99; p = 0.07) and all items demonstrated unidimensionality (t-test less than 0.05 threshold value). Internal consistency was acceptable (equivalent Cronbach’s α 0.65) given there are only five items, but there was a ceiling effect (mean logit score -1.24) with compromised score precision for patients with better recovery.ConclusionsWe identified a succinct set of items that can be used in a patient-reported outcome measure following percutaneous coronary interventions. This patient-report outcome measure has good structural validity and acceptable internal consistency. While further psychometric evaluations are recommended, the items identified capture the patient’s perspective of their recovery following a percutaneous coronary intervention.

Impact of methodological choices on a meta-analysis of real-world evidence comparing non-vitamin-K antagonist oral anticoagulants with vitamin K antagonists for the treatment of patients with non-valvular atrial fibrillation

Objective: The aim of this study was to investigate the impact of methodological choices in a meta-analysis of real-world evidence (RWE) comparing three non-vitamin-K antagonist oral anticoagulants with vitamin K antagonists (VKAs) for the treatment of patients with non-valvular atrial fibrillation (NVAF).Methods: The meta-analysis was based on a systematic review of RWE studies enrolling incident and prevalent patients aged ≥18 years with NVAF and receiving either rivaroxaban, dabigatran, apixaban or a VKA. Five different scenarios were considered to explore the impact of the initial meta-analysis assumptions: (1) using studies that involved only incident patients; (2) excluding studies that only reported crude values and did not consider any adjustment; (3) including all studies independently of possible database overlap; (4) using studies with data on different dosages for rivaroxaban and dabigatran; and (5) assigning quality weights to studies to assess quality of reporting. These scenarios were run on three outcomes: ischemic stroke (IS), myocardial infarction (MI) and intracranial hemorrhage (ICH).Results: Across all scenarios, rivaroxaban was associated with significantly lower risks of IS and ICH than VKAs. In most scenarios, dabigatran was associated with significantly lower risks of IS and ICH. In all scenarios, apixaban was associated with a significantly lower risk of ICH.Conclusions: Sensitivity analyses showed the impact of similar assumptions was different depending on the outcome and the drug considered. The development of recommendations and guidelines for the inclusion of RWE in meta-analyses could prove useful in evaluating the effectiveness of health care interventions.