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A Scoping Review of Peer Navigation Programs for People Living with HIV: Form, Function and Effects.AIDS and Behavior Dec 2022This scoping review maps recent research into peer navigation programs for people living with HIV. Four databases were systematically searched in June 2020. Results were... (Review)
Review
This scoping review maps recent research into peer navigation programs for people living with HIV. Four databases were systematically searched in June 2020. Results were screened according to defined criteria and were not restricted to any design, outcome or country. Six papers drew from randomised control trials, five from quasi-experimental or pragmatic trials, and four panel, eight qualitative, three mixed method and one cross-sectional designs were included for review. Programs incorporated health systems navigation and social support. Authors provided strong theoretical bases for peers to enhance program effects. Studies primarily reported program effects on continuum of care outcomes. Further research is required to capture the role HIV peer navigators play in preventing disease and promoting quality of life, mental health, and disease self-management in diverse settings and populations. Peer programs are complex, social interventions. Future work should evaluate detailed information about peer navigators, their activities, the quality of peer engagement as well as employee and community support structures to improve quality and impact.
Topics: Humans; Quality of Life; Cross-Sectional Studies; HIV Infections; Peer Group; Social Support
PubMed: 35672548
DOI: 10.1007/s10461-022-03729-y -
JAMA May 2022Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and...
IMPORTANCE
Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use.
OBJECTIVE
To develop international, consensus-based, PRO-specific ethical guidelines for clinical research.
EVIDENCE REVIEW
The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance.
FINDINGS
Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans.
CONCLUSIONS AND RELEVANCE
The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.
Topics: Biomedical Research; Consensus; Delphi Technique; Ethics, Clinical; Humans; Morals; Patient Reported Outcome Measures; Practice Guidelines as Topic; Research Design; Research Report
PubMed: 35579638
DOI: 10.1001/jama.2022.6421 -
Cancer Treatment Reviews Jun 2022Research on therapeutic strategies for patients with unknown primary cancer (CUP) has been underwhelming. This paper summarized and evaluated the CUP therapeutic... (Review)
Review
BACKGROUND
Research on therapeutic strategies for patients with unknown primary cancer (CUP) has been underwhelming. This paper summarized and evaluated the CUP therapeutic research over the previous five years. Based on this evaluation, recommendations for clinical trial designs are made to improve the impact of CUP research on patients.
METHODS
Published and ongoing research were evaluated. PubMed was searched from January 1, 2015, to November 1, 2021. The start date of 2015 was chosen to identify research published after ESMO issued new diagnostic and therapeutic guidelines. The US National Library of Medicine indexed ongoing clinical trials.
FINDINGS
Of the 244 CUP studies indexed in PubMed, 11.9% were prospective studies, and 4.9% were clinical trials. The review protocol deemed 65 publications eligible for full-text review. Eleven studies evaluating therapeutic regimens were retained. The two prospective studies and non-randomized trials showed promising outcomes for site-specific treatments. Randomized clinical trials were less promising; however, the trials had recruitment challenges resulting in biased accrual and the inability to keep pace with advancing diagnostics and therapeutics. Most of the 35 ongoing studies were phase II single-arm trials assessing immune checkpoint inhibitors (ICI) or site-specific therapies among CUP patients with suspected favorable prognoses.
CONCLUSION
Our evaluation suggests two prospective clinical trial designs that addressed recent study design and recruitment challenges. A visionary approach uses a multi-arm, multistage randomized trial to address rapid advancements in diagnosis and therapy. A pragmatic approach utilizes a single-arm trial with historical controls to overcome comparison group and recruitment challenges.
Topics: Humans; Immune Checkpoint Inhibitors; Prospective Studies; Research Design
PubMed: 35569387
DOI: 10.1016/j.ctrv.2022.102407 -
World Neurosurgery May 2022Classic randomized controlled trials (RCTs) form the cornerstone for medical guidelines and protocols. However, in neurosurgery, RCTs are not always applicable to...
BACKGROUND
Classic randomized controlled trials (RCTs) form the cornerstone for medical guidelines and protocols. However, in neurosurgery, RCTs are not always applicable to everyday clinical practice. Pragmatic controlled trials aim to incorporate real-life data with the preservation of the methodologic quality. This study is a systematic literature review of all pediatric neurosurgical RCTs published between 2000 and 2020 and an analysis of their pragmatism.
METHODS
An electronic database search was performed in PubMed, EMBASE, and the Cochrane Library to identify all relevant trials. Pragmatism was evaluated retrospectively on 9 domains: eligibility, recruitment, setting, organization, flexibility (delivery and adherence), follow-up, primary outcome, and primary analysis.
RESULTS
Of the 1862 studies included, 15 met the inclusion criteria. On average, studies scored between equally pragmatic/explanatory and rather pragmatic (M = 3.59, standard deviation [SD] = 0.56). Lowest ratings were seen for setting (M = 2.80, SD = 1.66) and eligibility (M = 3.20, SD = 1.66). Highest scores of pragmatism were given to analysis (M = 4.67, SD = 0.82) and intervention organization (M = 4.60, SD = 1.06). There was no significant difference between studies based on number of patients included, main subject, or publication year.
CONCLUSIONS
Pediatric neurosurgical RCTs scored reasonably well on overall pragmatism. In the future, there will be a greater need for pragmatic controlled trials in pediatric neurosurgery to bridge the divide between real-life data and reliable methodological quality. There is an opportunity to develop further applications of pragmatism tailored to surgical interventions.
Topics: Child; Databases, Factual; Humans; Neurosurgery; Neurosurgical Procedures; PubMed
PubMed: 35505562
DOI: 10.1016/j.wneu.2021.09.124 -
BMC Nursing Apr 2022The Covid-19 pandemic has produced unprecedented challenges across all aspects of health and social care sectors globally. Nurses and healthcare workers in care homes...
BACKGROUND
The Covid-19 pandemic has produced unprecedented challenges across all aspects of health and social care sectors globally. Nurses and healthcare workers in care homes have been particularly impacted due to rapid and dramatic changes to their job roles, workloads, and working environments, and residents' multimorbidity. Developed by the World Health Organisation, Psychological First Aid (PFA) is a brief training course delivering social, emotional, supportive, and pragmatic support that can reduce the initial distress after disaster and foster future adaptive functioning.
OBJECTIVES
This review aimed to synthesise findings from studies exploring the usefulness of PFA for the well-being of nursing and residential care home staff.
METHODS
A systematic search was conducted across 15 databases (Social Care Online, Kings Fund Library, Prospero, Dynamed, BMJ Best Practice, SIGN, NICE, Ovid, Proquest, Campbell Library, Clinical Trials, Web of Knowledge, Scopus, Ebsco CINAHL, and Cochrane Library), identifying peer-reviewed articles published in English language from database inception to 20th June 2021.
RESULTS
Of the 1,159 articles screened, 1,146 were excluded at title and abstract; the remaining 13 articles were screened at full text, all of which were then excluded.
CONCLUSION
This review highlights that empirical evidence of the impact of PFA on the well-being of nursing and residential care home staff is absent. PFA has likely been recommended to healthcare staff during the Covid-19 pandemic. The lack of evidence found here reinforces the urgent need to conduct studies which evaluates the outcomes of PFA particularly in the care home staff population.
PubMed: 35468786
DOI: 10.1186/s12912-022-00866-6 -
International Journal of Language &... Jul 2022It is widely acknowledged that children with developmental language disorder (DLD) predominantly have difficulties in the areas of grammar and vocabulary, with preserved...
BACKGROUND
It is widely acknowledged that children with developmental language disorder (DLD) predominantly have difficulties in the areas of grammar and vocabulary, with preserved pragmatic skills. Consequently, few studies focus on the pragmatic skills of children with DLD, and there is a distinct lack of studies examining the effectiveness of pragmatic interventions.
AIMS
To carry out a systematic review of the literature on pragmatic interventions for children with DLD.
METHODS & PROCEDURES
This systematic review was registered with PROSPERO (ID = CRD42017067239). A systematic search in seven databases yielded 1031 papers, of which 11 met our inclusion criteria. The included papers focused on interventions for children with DLD (mean = 3-18 years), enhancing oral language pragmatic skills, published between January 2006 and May 2020, and were based on a group-study design such as randomized control trial or pre-post-testing. Study participants were monolingual speakers. The quality of papers was appraised using the Cochrane Risk of bias tool for randomized controlled trials.
OUTCOMES & RESULTS
There was a high degree of variability between the included intervention studies, especially regarding intensity, intervention targets and outcomes. The evidence suggested that pragmatic intervention is feasible for all models of delivery (individual, small and large group) and that interventions for pragmatic language are mostly focused on encouragement of conversation and narrative skills observed through parent-child interaction or shared book-reading activities.
CONCLUSIONS & IMPLICATIONS
This study highlights the importance of promoting and explicitly teaching pragmatic skills to children with DLD in structured interventions. A narrative synthesis of the included studies revealed that in addition to direct intervention, indirect intervention can also contribute to improving oral pragmatic skills of children with DLD.
WHAT THIS PAPER ADDS
What is already known on the subject? An increasing number of studies have shown that difficulties in acquiring pragmatic language is not only present in children with autism. What this study adds to existing knowledge? Interventions for pragmatic language in children with DLD are mostly focused on encouragement of conversation and narrative skills, very often through parent-child interaction or shared book-reading activities. Interventions that target language pragmatic are feasible for all models of delivery (individual, small and large group). What are the potential or actual clinical implications of this work? The efficacy of the existing studies varies, and it is difficult to give recommendations regarding the intensity and duration of the specific intervention. In addition to offering pragmatic intervention directly from a specialist, pragmatic interventions can also be carried out indirectly if the intervention is under the continuous supervision of a specialist.
Topics: Communication; Humans; Language Development Disorders; Linguistics; Parent-Child Relations; Randomized Controlled Trials as Topic; Vocabulary
PubMed: 35445482
DOI: 10.1111/1460-6984.12716 -
BMJ Open Apr 2022(1) To summarise the literature on the impact of paediatric weight management interventions on health outcomes in preschool age children with overweight or obesity and... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
(1) To summarise the literature on the impact of paediatric weight management interventions on health outcomes in preschool age children with overweight or obesity and (2) to evaluate the completeness of intervention description and real-world applicability using validated tools.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
MEDLINE, Embase, CINAHL, Cochrane Library and PsychInfo were searched between 10 March 2015 and 21 November 2021.
ELIGIBILITY CRITERIA
Randomised controlled trials addressing weight management in preschool children (2-6 years) with overweight or obesity.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently extracted key information from each study and assessed risk of bias. Random-effects meta-analysis was performed where there was evidence for homogeneous effects. The certainty of evidence was assessed by the Grading of Recommendations Assessment, Development and Evaluation.
RESULTS
Of the 16 908 studies retrieved, 9 trials (1687 participants) met the inclusion criteria. These interventions used motivational interviewing (MI) or multicomponent educational interventions related to health behaviour approaches and were 6-12 months in duration. All studies contained some risk of bias. A difference was found in the intervention groups compared with controls for body mass index (BMI) z score (mean difference -0.10, 95% CI -0.12 to -0.09; eight trials, 1491 participants; p<0.001; I 68%), though there was substantial heterogeneity. There were no subgroup effects between studies using MI compared with studies using multicomponent interventions. The certainty of the evidence was considered low. The trials were reported in sufficient detail and were considered pragmatic.
CONCLUSIONS
Paediatric weight management interventions delivered to the parents of young children with obesity result in small declines in BMI z score. The results should be interpreted cautiously as they were inconsistent and the quality of the evidence was low.
PROSPERO REGISTRATION NUMBER
CRD42020166843.
Topics: Body Mass Index; Child; Child, Preschool; Humans; Obesity; Overweight; Parents; Quality of Life
PubMed: 35383062
DOI: 10.1136/bmjopen-2021-053523 -
Journal of Medical Internet Research Apr 2022Digital health refers to the proper use of technology for improving the health and well-being of people and enhancing the care of patients through the intelligent... (Review)
Review
BACKGROUND
Digital health refers to the proper use of technology for improving the health and well-being of people and enhancing the care of patients through the intelligent processing of clinical and genetic data. Despite increasing interest in well-being in both health care and technology, there is no clear understanding of what constitutes well-being, which leads to uncertainty in how to create well-being through digital health. In an effort to clarify this uncertainty, Brey developed a framework to define problems in technology for well-being using the following four categories: epistemological problem, scope problem, specification problem, and aggregation problem.
OBJECTIVE
This systematic scoping review aims to gain insights into how to define and address well-being in digital health.
METHODS
We followed the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. Papers were identified from 6 databases and included if they addressed the design or evaluation of digital health and reported the enhancement of patient well-being as their purpose. These papers were divided into design and evaluation papers. We studied how the 4 problems in technology for well-being are considered per paper.
RESULTS
A total of 117 studies were eligible for analysis (n=46, 39.3% design papers and n=71, 60.7% evaluation papers). For the epistemological problem, the thematic analysis resulted in various definitions of well-being, which were grouped into the following seven values: healthy body, functional me, healthy mind, happy me, social me, self-managing me, and external conditions. Design papers mostly considered well-being as healthy body and self-managing me, whereas evaluation papers considered the values of healthy mind and happy me. Users were rarely involved in defining well-being. For the scope problem, patients with chronic care needs were commonly considered as the main users. Design papers also regularly involved other users, such as caregivers and relatives. These users were often not involved in evaluation papers. For the specification problem, most design and evaluation papers focused on the provision of care support through a digital platform. Design papers used numerous design methods, whereas evaluation papers mostly considered pre-post measurements and randomized controlled trials. For the aggregation problem, value conflicts were rarely described.
CONCLUSIONS
Current practice has found pragmatic ways of circumventing or dealing with the problems of digital health for well-being. Major differences exist between the design and evaluation of digital health, particularly regarding their conceptualization of well-being and the types of users studied. In addition, we found that current methodologies for designing and evaluating digital health can be improved. For optimal digital health for well-being, multidisciplinary collaborations that move beyond the common dichotomy of design and evaluation are needed.
Topics: Caregivers; Delivery of Health Care; Humans
PubMed: 35377328
DOI: 10.2196/33787 -
Frontiers in Neurology 2022To investigate the available evidence on early supported discharge (ESD) and transitional care (TC) delivery service in patients with cerebrovascular disease.
OBJECTIVE
To investigate the available evidence on early supported discharge (ESD) and transitional care (TC) delivery service in patients with cerebrovascular disease.
METHODS
A systematic literature search was conducted to collect all available evidence on the use of ESD and TC services. We included cluster-randomized pragmatic trials or randomized controlled trials (RCTs) that recruited patients with stroke or transient ischemic attack to receive either conventional care or any care service intervention that included rehabilitation or support provided by professional medical personnel with the aim of accelerating and supporting home discharge. Relevant data were electronically searched through international databases (Cochrane Library, EMBASE, and PubMed) and incorporated into a summary grid to investigate research outcomes and provide a narrative synthesis. Furthermore, we compared the outcomes in terms of length of hospital stay, patient and caregiver outcomes, and mortality through meta-analysis.
RESULTS
We identified and included a total of 20 publications of various original randomized studies. There were 18 studies conducted in western countries and 2 in eastern countries. The meta-analysis revealed a tendency that ESD or TC could decrease the length of hospital stay more than the usual care [standardized mean difference (SMD) -0.13; 95% confidence interval (CI) -0.31 to 0.04 days; = 0.14]. Moreover, there was a tendency that ESD resulted in better activities of daily living (ADL) than usual care (SMD 0.29; 95% CI -0.04 to 0.61; = 0.08). Patient outcome based on modified Rankin scale (mRS) score (SMD -0.11; 95% CI -0.38 to 0.17; = 0.45] and mortality (odds ratio 0.80; 95% CI 0.56-1.17; = 0.25) did not reveal any significant difference. The Caregiver Strain Index revealed no difference.
CONCLUSION
We did not find a large effect size for the use of TC and ESD. When implementing the TC and ESD model from western to Asian countries, services should be prepared and implemented in accordance with national medical rehabilitation pathways for cerebrovascular disease.
PubMed: 35370909
DOI: 10.3389/fneur.2022.755316 -
The Journal of Allergy and Clinical... Jul 2022Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of...
Is Inhaler Technique Adequately Assessed and Reported in Clinical Trials of Asthma and Chronic Obstructive Pulmonary Disease Therapy? A Systematic Review and Suggested Best Practice Checklist.
BACKGROUND
Inhaled medications are central to treating asthma and chronic obstructive pulmonary disease (COPD), yet critical inhaler technique errors are made by up to 90% of patients. In the clinical research setting, recruitment of subjects with poor inhaler technique may give a false impression of both the benefits and the necessity of add-on treatments such as biologic therapies.
OBJECTIVE
To assess the frequency with which inhaler technique is assessed and reliably optimized before and during patient enrollment into randomized controlled trials (RCTs) addressing the efficacy of topical therapy, and the escalation of therapy for asthma and COPD.
METHODS
Systematic searches were conducted of PubMed and Embase for RCTs published in the past 10 years involving patients with a diagnosis of asthma or COPD undergoing escalation of baseline inhaled therapy (stepping up, changing, adding, switching, increasing, etc) or the introduction of biologic agents.
RESULTS
Searches highlighted 1,014 studies, 118 of which were eligible after the removal of duplicates as well as screening and full text review. Of these, only 14 (11.9%) included accessible information in the methods section or referred to such information in online supplements or protocols concerning assessment of participants' inhaler technique. We therefore developed the proposed Best Practice Inhaler Technique Assessment and Reporting Checklist.
CONCLUSIONS
Our study identifies a concerning lack of checking and correcting inhaler technique, or at least reporting that this was undertaken, before enrollment in asthma and COPD RCTs, which may affect the conclusions drawn. Mandating the use of a standardized checklist in RCT protocols and ensuring all published RCTs report checking and correcting inhaler technique before enrollment are important next steps.
Topics: Administration, Inhalation; Asthma; Checklist; Humans; Nebulizers and Vaporizers; Pulmonary Disease, Chronic Obstructive
PubMed: 35364340
DOI: 10.1016/j.jaip.2022.03.013