Assessment of Patient Safety in a Low-Resource Health Care System: Proposal for a Multimethod Study.

BACKGROUND: The high prevalence of adverse events (AEs) globally in health care delivery has led to the establishment of many guidelines to enhance patient safety. However, patient safety is a relatively nascent concept in low- and middle-income countries (LMICs) where health systems are already overburdened and underresourced. This is why it is imperative to study the nuances of patient safety from a local perspective to advocate for the judicious use of scarce public health resources. OBJECTIVE: This study aims to assess the status of patient safety in a health care system within a low-resource setting, using a multipronged, multimethod approach of standardized methodologies adapted to the local setting. METHODS: We propose purposive sampling to include a representative mix of public and private, rural and urban, and tertiary and secondary care hospitals, preferably those ascribed to the same hospital quality standards. Six different approaches will be considered at these hospitals including (1) focus group discussions on the status quo of patient safety, (2) Hospital Survey on Patient Safety Culture, (3) Hospital Consumer Assessment of Healthcare Providers and Systems, (4) estimation of incidence of AEs identified by patients, (5) estimation of incidence of AEs via medical record review, and (6) assessment against the World Health Organization's Patient Safety Friendly Hospital Framework via thorough reviews of existing hospital protocols and in-person surveys of the facility. RESULTS: The abovementioned studies collectively are expected to yield significant quantifiable information on patient safety conditions in a wide range of hospitals operating within LMICs. CONCLUSIONS: A multidimensional approach is imperative to holistically assess the patient safety situation, especially in LMICs. Our low-budget, non-resource-intensive research proposal can serve as a benchmark to conduct similar studies in other health care settings within LMICs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/50532.

How well did the consensus methods apply in the guideline development of traditional Chinese medicine: a web-based survey in China.

BACKGROUND AND OBJECTIVE: Consensus methods are crucial in developing clinical guidelines. Different methods, such as the Delphi and nominal group techniques, are commonly used, but there is a lack of detailed instructions on how to implement them effectively. The survey aims to explore the opinions and attitudes of the chair, panel and working group on the critical elements of the consensus methods during guideline development. METHODS: We used a cross-sectional design to conduct this study and sent a structured questionnaire to stakeholders, including the chair, panel members, and working group participants, through the popular mobile phone application WeChat.We selected participants using a combination of purposive and snowball sampling. The questionnaire gathered information on demographics, experiences, opinions, and concerns regarding consensus methods and guideline development. RESULTS: The sample comprised 290 participants representing 31 provinces or municipalities. Among them, the most significant number of respondents (n = 107, 36.9%) were from Beijing. Most participants, specifically 211 (72.76%), held senior professional titles, while 186 (64.14%) adhered to ongoing guidelines. The Delphi method was the most commonly used consensus method (n = 132, 42.31%), but the respondents had only a preliminary understanding of it (n = 147, 47.12%). The consensus process also revealed the insufficiency of involving pharmacoeconomists, patients, and nurses. CONCLUSIONS: Consensus methods have to be standardised and used consistently in the guideline development process. The findings of this study offer insights into diverse roles and more effective ways to apply the consensus process during guideline development.

Guía metodológica: Pertinencia de Datos Poblacionales sobre Discapacidad para la Kinesiología / Methodological Guide: Relevance of Population-based Data on Disability for Physical Therapy

Introducción. El Estudio Nacional de la Discapacidad y Dependencia (ENDIDE) y el III Estudio Nacional de la Discapacidad (ENDISC) son investigaciones de relevancia en Chile que utilizan la estadística para comprender la situación de las personas con discapacidad en el país. Estos estudios recopilan datos cuantitativos y cualitativos sobre la discapacidad, permitiendo obtener información actualizada sobre su prevalencia, tipos de discapacidad, acceso a servicios y barreras enfrentadas. La utilización de la estadística en estos estudios es crucial para identificar necesidades, diseñar políticas inclusivas y evaluar el impacto de las intervenciones en la calidad de vida de las personas con discapacidad en Chile. Es relevante comprender las metodologías y pertinencia de estos datos para el desarrollo de la kinesiología, según indica la Convención sobre los Derechos de las Personas con discapacidad.

Background. The National Study on Disability and Dependency (ENDIDE) and the III National Study on Disability (ENDISC) are relevant investigations in Chile that use statistics to understand the situation of people with disabilities in the country. These studies collect quantitative and qualitative data on disability, allowing to obtain updated information on its prevalence, types of disability, access to services and barriers faced. The use of statistics in these studies is crucial to identify needs, design inclusive policies and assess the impact of explosions on the quality of life of people with disabilities in Chile. It is important to understand the methodologies and relevance of these data for the development of kinesiology, as indicated by the Convention on the Rights of Persons with Disabilities.

Bodies of concern? A qualitative exploration of eating, moving and embodiment in young mothers.

In some countries, including the United Kingdom, young mothers' pregnant and postnatal bodies remain an area of concern for policy and practice, with interventions developed to support improved health behaviours including diet and physical activity. This article explores what young women themselves think and feel about eating and moving during and after pregnancy. Semi-structured interviews with 11 young mothers were conducted within two voluntary organisations. Data were analysed using thematic analysis with the theoretical lens of embodiment, which provided an understanding of how young women's eating and moving habits related to how they felt about their bodies in the world. Four themes situated in different experiences of being and having a body were identified: pregnant body, emotional body, social body and surveilled body. Stress and low mood impacted eating habits as young women responded to complex circumstances and perceived judgement about their lives. Food choices were influenced by financial constraints and shaped by the spaces and places in which young women lived. Whilst young women were busy moving in their day-to-day lives, they rarely had the resources to take part in other physical activity. Holistic approaches that focus on how women feel about their lives and bodies and ask them where they need support are required from professionals. Interventions that address the structural influences on poor diet and inequalities in physical activity participation are necessary to underpin this. Approaches that over-focus on the achievement of individual health behaviours may fail to improve long-term health and risk reinforcing young women's disadvantage.

Fragility of cardiovascular outcome trials (CVOTs) examining nutrition interventions among patients with diabetes mellitus: a systematic review of randomized controlled trials.

PURPOSE: There is controversy regarding the optimal statistical method to interpret how robust is a statistically significant result. The fragility index (FI) and the reverse fragility index (RFI) are quantitative measures that can facilitate the appraisal of a clinical trial's robustness. This study was performed to evaluate the FI and RFI of randomized controlled trials (RCTs) examining nutritional interventions in patients with diabetes mellitus, focusing on cardiovascular outcomes. METHODS: A systematic search was conducted and relevant RCTs were identified in three databases. RCTs examining nutritional interventions (supplements or dietary patterns) in patients with DM with dichotomous primary endpoints involving cardiovascular outcomes were eligible. Data were extracted to compose 2 × 2 event tables and the FI and RFI were calculated for each comparison, using Fisher's exact test. Risk of bias (RoB) of the included RCTs was assessed with the Cochrane RoB 2.0 tool. RESULTS: A total of 14,315 records were screened and 10 RCTs were included in the analyses. The median FI of the paired comparisons was 3 (IQR: 2-4) and the median RFI was 8 (IQR: 4.5-17). RoB and heterogeneity were low. CONCLUSIONS: RCTs examining nutritional interventions and cardiovascular outcomes among patients with diabetes mellitus appear to be statistically fragile. Τhe FI and the RFI can be reported and interpreted as an additional perspective of a trial's robustness. HIGHLIGHTS: • In the evidence-healthcare era, assessing how robust statistically significant results are remains a matter of controversy. • Recently, the fragility index (FI) and reverse fragility index (RFI) were proposed to assess the robustness of randomized controlled trials (RCTs) with 2 × 2 comparisons. • When applying the FI and RFI, RCTs examining nutritional interventions and cardiovascular outcomes among patients with diabetes mellitus (DM) appear to be statistically fragile. • Τhe FI and the RFI can be reported and interpreted as an additional perspective of a trial's robustness. • RCTs implementing nutrition interventions among patients with DM can improve their methodology.

[Selection and application of explanatory and pragmatic randomized controlled trials in clinical research of acupuncture].

In the view of the controversy that there is no efficacy difference between true and sham acupuncture in acupuncture randomized controlled trials (RCTs), it is analyzed that one of the reasons is that many clinical studies do not properly understand the design of RCT research and interpret the research results. Starting from the concept and coverage of explanatory RCT and pragmatic RCT, this study lists the application examples of two types of RCTs in the field of acupuncture from five aspects: research purpose and trial environment, subject selection, intervention measures, control measures and outcome evaluation, so as to provide some ideas for their application in clinical trials.

A critical analysis of research methods and experimental models to study intracanal medicaments.

In order to ensure predictable decontamination of the root canal system, chemo-mechanical preparation of the root canal space is sometimes supplemented with the use of intracanal medication. As microbial control of the root canal space is fundamental to the resolution of apical periodontitis, root canal disinfection strategies haven been researched intensively. The use of intracanal medication as a supplementary step to the chemo-mechanical preparation of the root canal space is one of them. Because of the costs and limitations of clinical research it is relevant and common practice to first evaluate alternative or new root canal disinfection modalities in laboratory studies. This involves the simulation of a root canal infection in a laboratory model, on which different disinfection strategies can be tested. When modelling the infected root canal, different levels of infection can be discriminated: suspended bacteria, microbial biofilms and infected dentine. This review describes the experimental models associated with these infection levels and critically appraises their value and methodological details. Suggestions for relevant research methods and experimental models are given, as well as some good practices for laboratory-based microbiological studies.

On the path to reclaiming Indigenous midwifery: Co-creating the Maternal Infant Support Worker pilot program.

OBJECTIVE: The aim of the Maternal Infant Support Worker (MiSW) pilot program was to implement a virtual training program for lay maternal-infant health providers in remote First Nations communities in Northwestern Ontario, Canada. METHODS: The MiSW pilot program was administered jointly by a community college and a university and consisted of a 20-week virtual course followed by a 9-month mentored work placement in the community. RESULTS: The MiSW pilot program was delivered successfully; 11 of 13 participants received a certificate from a community college. MiSWs provided culturally and linguistically appropriate care to women, infants, and families in their respective communities. MiSWs provided doula support in their communities-a first for our region since the policy of forced evacuation for birth was implemented. MiSWs developed a community of practice for ongoing education, as well as to support each other in their work. CONCLUSION: The MiSW pilot program demonstrated that it is possible to provide a virtual training program and then provide continued virtual mentorship as the participants work in their First Nations communities. By prioritizing Indigenous voices above those of the research team, we were able to gain the trust of the MiSWs and maintain engagement with communities.

Strategies for evaluating self-efficacy and observed success in the practice of yoga postures for therapeutic indications: methods from a yoga intervention for urinary incontinence among middle-aged and older women.

BACKGROUND: Most clinical investigations involving yoga lack adequate description of the specific yoga elements, including physical postures. Few studies have measured self-efficacy regarding the performance of yoga postures or assessed observed success in performing postures. METHODS: We developed and piloted several tools to evaluate self-efficacy and observed success in practicing yoga in the context of a randomized feasibility trial of an Iyengar-based yoga intervention for urinary incontinence in ambulatory women ≥50 years. At the end of the 12-week yoga intervention involving twice weekly group yoga classes and once weekly home practice, participants rated their self-efficacy in performing each of the included 15 yoga postures on a 5-point Likert scale. During the 12th week, an expert yoga consultant observed participants and rated their competency in performing postures on a 5-point scale. Participants completed a questionnaire about self-efficacy in adhering to home yoga practice. We examined the distribution of and correlations between scores on the above measures. RESULTS: Among 27 participants (mean age 65 years), the range of means for self-efficacy ratings for individual postures was 3.6 to 4.5. The range of means for observed competency ratings for individual postures was 3.3 to 5.0. Mean self-efficacy rating for confidence in adhering to the assigned once-weekly home yoga practice was 2.8 (range 1 to 5). Posture self-efficacy was inversely correlated with participant age (p = 0.01) and positively correlated with self-reported physical function (p = 0.03) and mobility (p = 0.01). No significant correlations were found between posture self-efficacy scale scores and expert-observed yoga competency ratings or practice adherence self-efficacy scores. CONCLUSIONS: These measures hold promise for advancing yoga research and practice by describing methods to: 1) measure self-efficacy in performing specific yoga postures; 2) use an expert observer to assess participants' competence in performing yoga postures; and 3) measure self-efficacy in adhering to home practice. These proposed measures can be used to describe specific components of yoga interventions, to assess whether study participants are able to learn to practice physical aspects of yoga and/or maintain this practice over time, as well as to investigate relationships between self-efficacy and competency in performing yoga postures to achieve specific health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02342678, January 21, 2015.

Review on comparability of 'classical' and 'contemporary' research methods in the context of Ayurveda.

Recent discussions on Ayurvedic research almost always end up with a note of discontent about its current methodology and demands for radically different versions. Reinforcement of "classical methods (of the glorious past)" is being envisaged as an alternative. If research is systematic enquiry to bring out truth, its core construct applies to formation of knowledge anywhere in the world, any time, may it be ancient or modern. As a part of debating on the necessity of an alternative, this article tries to check the comparability of 'classical method' (as available from Darsanas and Ayurveda) with 'contemporary method' through examining how much the two systems correspond in relation to the basic construct and terminology of research, under nine domains. The domains include most of the cardinal aspects of research process such as philosophical constructs, research paradigm, basic approaches on reasoning, definition and classification of research, research process based on nature of relationship, planning of interventional research, technical terminology, research reporting and research fallacies. More than sixty technical terms related to classical method are selected and explored for their conformity with contemporary language of research. Meaningful agreement was obtained which suggested that the two systems are comparable. Leaving a space for more systematic, methodical and extensive critical comparison, this review concluded on a suggestion that, one who proposes radical changes in research methodology, may consider the comparability of the two systems, and rethink on an extremist demand for a total reconstruction. Instead, the modus operandi of revising Ayurvedic research may emphasise on prioritizing its preferences and practices.

Assessment of the quality of reporting in studies of acupuncture for patients with cancer using the STRICTA guidelines.

INTRODUCTION: There has been a burgeoning of research evaluating acupuncture for various symptoms of cancer and the side-effects associated with its treatment. A systematic review was conducted to examine the quality of reporting in published studies of acupuncture in cancer according to the STRICTA (STandards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. METHODS: Systematic review of published research of acupuncture for symptoms of cancer and the side-effects associated with its treatment. Databases searched were: Medline, CINAHL, Cochrane (all databases), Scopus, and PubMed from their inception to December 2014. Clinical trials, pilot/feasibility studies, observational studies, and case studies were included. Only full journal papers published in English were included. The quality of reporting was evaluated using STRICTA guidelines. Each included paper was assessed by two independent reviewers, with disagreements adjudicated by a third reviewer. RESULTS: 88 papers were identified which met the inclusion criteria. The median number of STRICTA items reported in trials with a control or comparator arm (n=47) was 14 out of 17 (range 8 to 17, IQR 4). For studies without a control or comparator arm the median was 11 out of a possible 15 (range 5 to 15, IQR 3). Key weaknesses in reporting included details of other components of treatments, and details of the acupuncturist administering treatments. CONCLUSIONS: Despite the widespread use of the STRICTA guidelines in acupuncture research, adherence remains poor for a few specific items. Further research is required to explore the reasons why authors fail to report those items, and to develop strategies to improve the adherence to the guidelines.

Lessons from Outside and Within: Exploring Advancements in Methodology for Naturopathic Medicine Clinical Research.

INTRODUCTION: Naturopathy is a mixture of both traditional and complementary medicine. It incorporates a broad set of health care practices that may or may not be traditional to that country or conventional medicine and are not fully integrated into the dominant health care system. Research required to evaluate or substantiate naturopathic medicine may not fall under the testing of randomized clinical trials, which opens up discussions on what is the best practice for research in naturopathic medicine. DISCUSSION: Not only do advances in health research methodology offer important opportunities to progress naturopathic research, there are also areas where the unique characteristics of naturopathic philosophy and practice can impact other areas of health research. Some of the new advances in health research methodology involve whole-system research, pragmatic trials, template for intervention description and replication protocols for complex interventions, patient-centered care models, and the pragmatic-explanatory continuum indicator summary tool for designing pragmatic trials. Discussion and critique of these health-related methodologies shows that these research methods are more suited for the philosophy and treatment options that naturopathy is based on. CONCLUSIONS: Successful implementation of naturopathic research methodologies, and translation and dissemination of research will require a substantial paradigm shift in which naturopathic practitioners adopt a greater level of responsibility for developing an evidence base for naturopathic medicine.

[The specific methodological features of scientific research in the field of balneotherapy]. / Metodologicheskie osobennosti provedeniia nauchnykh issledovanii v oblasti bal'neoterapii.

This review was undertaken for the objective of highlighting and assessing the approaches to obtaining, analysis, and reporting the results of randomized controlled trials (RCT) in balneotherapy. The review covers the following topics: the specific features of the organization of the controlled randomized studies in the field of balneotherapy, the main methodological approaches used for these purposes that should be taken into consideration at different stages of the planning and performance of the studies together with other issues including sample size calculation, sequence generation modes, the application of the distribution concealment technique, types of randomization, blinding of the outcome assessment, the choice of the comparator group, and endpoint selection. We emphasize the importance of the appropriate statistical analysis and the comprehensive reporting of the results of the investigations. Special attention is given to the current approaches to the estimation of the quality of RCTs and to the preparation of the systematic reviews. The examples of the analysis of the relevant publications presented in the review will hopefully help the researchers to take advantage of the currently available experience and improve the compliance of the locally conducted balneotherapeutic trials with the international criteria for the methodological quality.

A Guideline for Randomized Controlled Trials of Acupuncture.

Guidelines for clinical trials of acupuncture are scarce, particularly in their guidance on choosing an adequate control in an acupuncture trial. This guideline was developed to address the research methodology for clinical research in acupuncture which contains the essential elements to be considered in the design, preparation and reporting of an acupuncture RCT. Particularly, investigators focused on the control design because of the unique feature of acupuncture. As one size does not fit all, one single design cannot answer all research questions. Therefore, we recommend that the clinical questions be answered in different stages of trials by choosing the appropriate control or comparator. This concept is adapted from classical drug trials developed by the Food and Drug Administration (FDA) of USA in which trials are staged in four phages in order to address different research questions. From the points listed above, this guideline offers the specific recommendations in an acupuncture RCT.

Research methods in complementary and alternative medicine: an integrative review.

The scientific literature presents a modest amount of evidence in the use of complementary and alternative medicine (CAM). On the other hand, in practice, relevant results are common. The debates among CAM practitioners about the quality and execution of scientific research are important. Therefore, the aim of this review is to gather, synthesize and describe the differentiated methodological models that encompass the complexity of therapeutic interventions. The process of bringing evidence-based medicine into clinical practice in CAM is essential for the growth and strengthening of complementary medicines worldwide.

Survived so what? Identifying priorities for research with children and families post-paediatric intensive care unit.

The involvement of patients and the public in the development, implementation and evaluation of health care services and research is recognized to have tangible benefits in relation to effectiveness and credibility. However, despite >96% of children and young people surviving critical illness or injury, there is a paucity of published reports demonstrating their contribution to informing the priorities for aftercare services and outcomes research. We aimed to identify the service and research priorities for Paediatric Intensive Care Unit survivors with children and young people, their families and other stakeholders. We conducted a face-to-face, multiple-stakeholder consultation event, held in the Midlands (UK), to provide opportunities for experiences, views and priorities to be elicited. Data were gathered using write/draw and tell and focus group approaches. An inductive content analytical approach was used to categorize and conceptualize feedback. A total of 26 individuals attended the consultation exercise, including children and young people who were critical care survivors; their siblings; parents and carers; health professionals; academics; commissioners; and service managers. Consultation findings indicated that future services, interventions and research must be holistic and family-centred. Children and young people advisors reported priorities that focused on longer-term outcomes, whereas adult advisors identified priorities that mapped against the pathways of care. Specific priorities included developing and testing interventions that address unmet communication and information needs. Furthermore, initiatives to optimize the lives and longer-term functional and psycho-social outcomes of Paediatric Intensive Care Unit survivors were identified. This consultation exercise provides further evidence of the value of meaningful patient and public involvement in identifying the priorities for research and services for Paediatric Intensive Care Unit survivors and illuminates differences in proposed priorities between children, young people and adult advisors.

Research methods in complementary and alternative medicine: an integrative review / 中西医结合学报

The scientific literature presents a modest amount of evidence in the use of complementary and alternative medicine (CAM). On the other hand, in practice, relevant results are common. The debates among CAM practitioners about the quality and execution of scientific research are important. Therefore, the aim of this review is to gather, synthesize and describe the differentiated methodological models that encompass the complexity of therapeutic interventions. The process of bringing evidence-based medicine into clinical practice in CAM is essential for the growth and strengthening of complementary medicines worldwide.