Methods for Heart Rate Variability Biofeedback (HRVB): A Systematic Review and Guidelines.

Heart Rate Variability Biofeedback (HRVB) has been widely used to improve cardiovascular health and well-being. HRVB is based on breathing at an individual's resonance frequency, which stimulates respiratory sinus arrhythmia (RSA) and the baroreflex. There is, however, no methodological consensus on how to apply HRVB, while details about the protocol used are often not well reported. Thus, the objectives of this systematic review are to describe the different HRVB protocols and detect methodological concerns. PsycINFO, CINALH, Medline and Web of Science were searched between 2000 and April 2021. Data extraction and quality assessment were based on PRISMA guidelines. A total of 143 studies were finally included from any scientific field and any type of sample. Three protocols for HRVB were found: (i) "Optimal RF" (n = 37), each participant breathes at their previously detected RF; (ii) "Individual RF" (n = 48), each participant follows a biofeedback device that shows the optimal breathing rate based on cardiovascular data in real time, and (iii) "Preset-pace RF" (n = 51), all participants breathe at the same rate rate, usually 6 breaths/minute. In addition, we found several methodological differences for applying HRVB in terms of number of weeks, duration of breathing or combination of laboratory and home sessions. Remarkably, almost 2/3 of the studies did not report enough information to replicate the HRVB protocol in terms of breathing duration, inhalation/exhalation ratio, breathing control or body position. Methodological guidelines and a checklist are proposed to enhance the methodological quality of future HRVB studies and increase the information reported.

Effectiveness of Procedural Sedation and Analgesia in Pediatric Emergencies. A Cross-Sectional Study.

INTRODUCTION: Pain is defined as an unpleasant emotional and sensory experience associated with bodily harm or with situations that cause fear and anxiety. However, it is often undertreated in pediatric emergency departments. This study aims to assess the effectiveness of sedation-analgesia techniques, level of satisfaction among health care professionals and relatives, and agreement between the satisfaction of health care professionals and relatives. METHODS: A cross-sectional design was conducted. Sociodemographic and clinical variables were recorded, together with those for effectiveness using the Face, Legs, Activity, Cry, and Consolability scale and the Wong-Baker FACES scale, and the satisfaction using the 10-point Likert scale. Stata 16.1 was used for data analysis. RESULTS: A total of 94 procedures were registered. The results suggested that these techniques were effective or mildly effective in only half of the cases. Satisfaction was considered good across the board, and the agreement between health care professionals (ie, pediatric nurses and pediatricians) was considered substantial. However, the agreement between health care professionals and relatives was moderate. DISCUSSION: Our results suggested that the adequate management of pain in pediatric emergency departments is still a challenge, despite the availability of international guidelines. Future research lines should be focused on analyzing possible causes of the inefficacy of some sedation-analgesia techniques and the causes of the differences between the perspectives of health care professionals and relatives. These research lines may be useful to improve quality of care and pediatric patient comfort.

Adherence to literature search reporting guidelines in leading rheumatology journals' systematic reviews: umbrella review protocol.

Literature searches are important components of systematic reviews. They are not only informative of the retrieval process, but they also set the data to be analyzed and influence additional components of systematic reviews. Despite the available guidelines, several studies have shown that the quality of reporting in systematic reviews is deficient in several medical fields. Systematic reviews may not comply completely with those guidelines despite explicitly stating they do. This protocol intends to answer to what extent systematic reviews published in rheumatology journals have complied with the PRISMA's search strategy guidelines published in 2009. The objective of the study is to analyze the compliance with the PRISMA (2009) search strategy guidelines among systematic reviews published in leading rheumatology journals. Inclusion criteria for this umbrella review protocol are systematic reviews (with or without meta-analyses) that mention having followed the PRISMA statement (2009) in their methods section, and published in journals listed in the Rheumatology category of the Journal of Citations Report 2020. Exclusion criteria are articles published before 2009; retraction letters, notes, expressions of concern; systematic reviews using PRISMA 2020. Databases to be consulted are Web of Science, PubMed and Scopus, from inception to present. Data summaries will be presented in graphs, figures, tables and network maps. A narrative synthesis will be described. This protocol complies with guidelines such as PRISMA 2020, PRISMA-A, PRISMA-P, PRISMA-S, PRESS, and JBI Manual for evidence synthesis, as long as it is suitable for umbrella review protocols. Articles in any language will be considered.

Gastrointestinal and eating problems in women with Ehlers-Danlos syndromes.

PURPOSE: Ehlers-Danlos syndromes (EDS) are a group of heritable conditions in which abnormal collagen synthesis leads to features such as joint hypermobility, skin abnormalities, and tissue fragility. Gastrointestinal (GI) symptoms are common among those affected. These may negatively impact eating behaviors, leading to weight/nutritional problems. We aimed to compare GI symptoms, disordered eating, and body mass index (BMI) between EDS patients and healthy controls, and to explore the link between these variables in EDS patients. METHOD: In this cross-sectional study, women with EDS and healthy controls responded to an online survey assessing GI symptoms (heartburn/regurgitations, early satiety, nausea/vomiting, bloating, abdominal pain, dysphagia), food allergies/intolerances, disordered eating, history of eating disorders (ED), and BMI. We performed intergroup comparisons as well as multivariate analyses to explore the associations between disordered eating, GI symptoms, and BMI in the EDS group. RESULTS: Sixty-six women with EDS and 39 healthy controls were included in the study. The EDS patients showed significantly more GI symptoms and food allergies/intolerances, increased prevalence of ED history, higher risk of current ED, and lower BMI than the controls. In the EDS group, the risk for ED was associated with GI symptoms; restricted eating was associated with GI symptoms, food allergies/intolerances, and dysphagia; uncontrolled eating was associated with GI symptoms; and BMI was associated with GI symptoms and food allergies/intolerances. DISCUSSION: Our results are concordant with that of previous reports highlighting the high level of GI problems and disordered eating in women with EDS. In addition, and for the first-time, the association between both is evidenced in this specific population. LEVEL OF EVIDENCE III: Case-control analytic study.

Instruments to assess patient comfort during hospitalization: A psychometric review.

AIM: To analyse the psychometric properties and the utility of instruments used to measure patient comfort, physical, social, psychospiritual and/or environmental, during hospitalization. BACKGROUND: There are no systematic reviews nor psychometric reviews of instruments used to measure comfort, which is considered an indicator of quality in health care associated with quicker discharges, increased patient satisfaction and better cost-benefit ratios for the institution. DESIGN: Psychometric review. DATA SOURCES: MEDLINE, CINAHL, PsycINFO, Web of Knowledge, ProQuest Thesis&Dissertations, Google. REVIEW METHODS: We limited our search to studies published between 1990-2015. The psychometric analysis was performed using the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN), along with the Quality Criteria for Measurement Properties. The utility of the instruments was assessed according to their cost-efficiency, acceptability and educational impact. Protocol registration in PROSPERO, CRD42016036290. RESULTS: Instruments reviewed showed moderate methodological quality and their utility was poorly reported. Thus, we cannot recommend any questionnaire without reservations, but the Comfort Scale, the General Comfort Questionnaire and their adaptations in adults and older patients, the Psychosocial Comfort Scale and the Incomfort des Patients de Reanimation are the most recommendable instruments to measure comfort. CONCLUSIONS: The methodology of the studies should be more rigorous and authors should adequately report the utility of instruments. This review provides a strategy to select the most suitable instrument to assess patient comfort according to their psychometric properties and utility, which is crucial for nurses, clinicians, researchers and institutions.

Instruments to assess the patient comfort during hospitalization: a psychometric review protocol.

AIM: The aim of this study was to analyse the psychometric properties, outcomes and utility of instruments measuring the patient comfort during hospitalization. BACKGROUND: While there are numerous systematic reviews assessing the psychometric properties of healthcare instruments, none of them is devoted to evaluate the psychometric properties of instruments measuring comfort, which is considered an indicator of quality in health care and is associated to quicker discharges, increased patient satisfaction and stronger cost-benefit ratios for the institution. DESIGN: Psychometric Systematic review. METHODS: Searches will be performed on MEDLINE, CINAHL, PsycINFO, Web of Knowledge, ProQuest Thesis&Dissertations and grey literature and will be focused on questionnaires measuring patient comfort as a holistic experience in any healthcare setting. The assessment will take into account the theoretical model on which the instruments are built, evaluate the psychometric properties of each study according to the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) and will include the assessment of the quality of instruments outcomes and their cost-efficiency, acceptability and educational impact. The review protocol was registered in PROSPERO, CRD42016036290 and was supported by the Grant PSI2014-52962-P, Spanish Ministry of Economy and Competitiveness (July, 2015). DISCUSSION: The results of our psychometric review will categorise the instruments measuring the patient comfort according to their psychometric properties, methodological quality, outcomes and utility, to improve the quality of health care provided and the institution's benefits.

Effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent therapy in online and outdoor format in individuals with fibromyalgia: Study protocol of a randomized, controlled trial (On&Out study).

Introduction: The On&Out study is aimed at assessing the effectiveness, cost-utility and physiological underpinnings of the FIBROWALK multicomponent intervention conducted in two different settings: online (FIBRO-On) or outdoors (FIBRO-Out). Both interventions have proved to be efficacious in the short-term but there is no study assessing their comparative effectiveness nor their long-term effects. For the first time, this study will also evaluate the cost-utility (6-month time-horizon) and the effects on immune-inflammatory biomarkers and Brain-Derived Neurotrophic Factor (BDNF) levels of both interventions. The objectives of this 6-month, randomized, controlled trial (RCT) are 1) to examine the effectiveness and cost-utility of adding FIBRO-On or FIBRO-Out to Treatment-As-Usual (TAU) for individuals with fibromyalgia (FM); 2) to identify pre-post differences in blood biomarker levels in the three study arms and 3) to analyze the role of process variables as mediators of 6-month follow-up clinical outcomes. Methods and analysis: Participants will be 225 individuals with FM recruited at Vall d'Hebron University Hospital (Barcelona, Spain), randomly allocated to one of the three study arms: TAU vs. TAU + FIBRO-On vs. TAU + FIBRO-Out. A comprehensive assessment to collect functional impairment, pain, fatigue, depressive and anxiety symptoms, perceived stress, central sensitization, physical function, sleep quality, perceived cognitive dysfunction, kinesiophobia, pain catastrophizing, psychological inflexibility in pain and pain knowledge will be conducted pre-intervention, at 6 weeks, post-intervention (12 weeks), and at 6-month follow-up. Changes in immune-inflammatory biomarkers [i.e., IL-6, CXCL8, IL-17A, IL-4, IL-10, and high-sensitivity C-reactive protein (hs-CRP)] and Brain-Derived Neurotrophic Factor will be evaluated in 40 participants in each treatment arm (total n = 120) at pre- and post-treatment. Quality of life and direct and indirect costs will be evaluated at baseline and at 6-month follow-up. Linear mixed-effects regression models using restricted maximum likelihood, mediational models and a full economic evaluation applying bootstrapping techniques, acceptability curves and sensitivity analyses will be computed. Ethics and dissemination: This study has been approved by the Ethics Committee of the Vall d'Hebron Institute of Research. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and various community engagement activities. Trial registration number NCT05377567 (clinicaltrials.gov).

Tools to assess the measurement properties of quality of life instruments: a meta-review.

OBJECTIVE: This meta-review aims to discuss the methodological, research and practical applications of tools that assess the measurement properties of instruments evaluating health-related quality of life (HRQoL) that have been reported in systematic reviews. DESIGN: Meta-review. METHODS: Electronic search from January 2008 to May 2020 was carried out on PubMed, CINAHL, PsycINFO, SCOPUS, WoS, Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) database, Google Scholar and ProQuest Dissertations and Theses. RESULTS: A total of 246 systematic reviews were assessed. Concerning the quality of the review process, some methodological shortcomings were found, such as poor compliance with reporting or methodological guidelines. Regarding the procedures to assess the quality of measurement properties, 164 (66.6%) of reviewers applied one tool at least. Tool format and structure differed across standards or scientific traditions (ie, psychology, medicine and economics), but most assess both measurement properties and the usability of instruments. As far as the results and conclusions of systematic reviews are concerned, only 68 (27.5%) linked the intended use of the instrument to specific measurement properties (eg, evaluative use to responsiveness). CONCLUSIONS: The reporting and methodological quality of reviews have increased over time, but there is still room for improvement regarding adherence to guidelines. The COSMIN would be the most widespread and comprehensive tool to assess both the risk of bias of primary studies, and the measurement properties of HRQoL instruments for evaluative purposes. Our analysis of other assessment tools and measurement standards can serve as a starting point for future lines of work on the COSMIN tool, such as considering a more comprehensive evaluation of feasibility, including burden and fairness; expanding its scope for measurement instruments with a different use than evaluative; and improving its assessment of the risk of bias of primary studies. PROSPERO REGISTRATION NUMBER: CRD42017065232.

Tools to assess the measurement properties of quality of life instruments: a meta-review protocol.

INTRODUCTION: Using specific tools to assess the measurement properties of health status instruments is recommended both to standardise the review process and to improve the methodological quality of systematic reviews. However, depending on the measurement standards on which these tools are developed, the approach to appraise the measurement properties of instruments may vary. For this reason, the present meta-review aims to: (1) identify systematic reviews assessing the measurement properties of instruments evaluating health-related quality of life (HRQoL); (2) identify the tools applied to assess the measurement properties of HRQoL instruments; (3) describe the characteristics of the tools applied to assess the measurement properties of HRQoL instruments; (4) identify the measurement standards on which these tools were developed or conform to and (5) compare the similarities and differences among the identified measurement standards. METHODS AND ANALYSIS: A systematic review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols Guidelines. Electronic search will be carried out on bibliographic databases, including PubMed, Cumulative Index to Nursing and Allied Health Literature, Psychological Information, SCOPUS, Web of Science, COSMIN database and ProQuest Dissertations & Theses Global, being limited by time (2008-2018) and language (English). Descriptive analyses of different aspects of tools applied to evaluate the measurement properties of HRQoL instruments will be presented; the different measurement standards will be described and some recommendations about the methodological and research applications will be made. ETHICS AND DISSEMINATION: Ethical approval is not necessary for systematic review protocols. The results will be disseminated by its publication in a peer-reviewed journal and presented at a relevant conference. PROSPERO REGISTRATION NUMBER: CRD42017065232.