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BMC Complementary Medicine and Therapies May 2024Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a...
BACKGROUND
Pragmatic acupuncture trials (PATs) are a research tool for assessing the effectiveness of acupuncture treatments in a real-world setting. This study aimed to provide a comprehensive methodological analysis of PATs using the PRECIS-2(PRagmatic Explanatory Continuum Indicator Summary-2) tool to determine their pragmatism.
METHODS
The MEDLINE, EMBASE, Cochrane Central Register for Controlled Trials, CINAHL, Allied and Complementary Medicine Database, China National Knowledge Infrastructure, VIP, WANFANG, Taiwan Periodical Literature Database, KoreaMed, KMbase, Research Information Service System, Oriental Medicine Advanced Searching Integrated System, CiNii and ClinicalTrials.gov were searched. The search included randomised controlled trials (RCTs) and protocols of RCTs that investigated all types of acupuncture and used self-declared pragmatic design. Two authors independently collected the basic information and characteristics of the studies and assessed their pragmatism using the nine PRECIS-2 domains and the additional domain of control.
RESULTS
A total of 93 studies were included. The means of eligibility, recruitment, organisation, primary outcome, primary analysis, and control domains were statistically larger than three and were shown to be pragmatic. The means of setting, flexibility:delivery, and follow-up domains were not greater than three and were shown to be non-pragmatic. For flexibility:adherence domain was inappropriate for assessment owing to insufficient information in the studies.
CONCLUSIONS
PATs were pragmatic in the domain of eligibility, recruitment, organisation, primary outcome, primary analysis, and control and were not pragmatic in the domain of setting, flexibility:delivery, and follow-up. Future PATs need to strengthen the pragmatism in the setting, flexibility:delivery, and follow-up domains and to describe the flexibility:adherence domain in more detail.
TRIAL REGISTRATION
CRD42021236975.
Topics: Humans; Acupuncture Therapy; Pragmatic Clinical Trials as Topic; Randomized Controlled Trials as Topic; Research Design
PubMed: 38702632
DOI: 10.1186/s12906-024-04473-7 -
Frontiers in Medicine 2021Pragmatic trials inform clinical decision with better generalizability and can bridge different streams of medicine. This study collated the expectations regarding...
Pragmatic trials inform clinical decision with better generalizability and can bridge different streams of medicine. This study collated the expectations regarding pragmatic trial design of integrative medicine (IM) for diabetes and kidney diseases among patients and physicians. Dissonance between users' perspective and existing pragmatic trial design was identified. The association between risk of bias and pragmatism of study design was assessed. A 10-group semi-structured focus group interview series [21 patients, 14 conventional medicine (ConM) and 15 Chinese medicine (CM) physicians] were purposively sampled from private and public clinics in Hong Kong. Perspectives were qualitatively analyzed by constant comparative method. A systematic search of four databases was performed to identify existing IM pragmatic clinical trials in diabetes or kidney disease. Primary outcomes were the pragmatism, risk of bias, and rationale of the study design. Risk of bias and pragmatism were assessed based on Cochrane risk-of-bias tool and PRECIS-2, respectively. The correlation between risk of bias and pragmatism was assessed by regression models with sensitivity analyses. The subtheme on the motivation to seek IM service was analyzed, covering the perceived limitation of ConM effect, perceived benefits of IM service, and assessment of IM effectiveness. Patients expected IM service to retard disease progression, stabilize concomitant drug dosage, and reduce potential side effects associated with ConM. In the systematic review, 25 studies from six countries were included covering CM, Korean medicine, Ayurvedic medicine, and western herbal medicine. Existing study designs did not include a detailed assessment of concomitant drug change and adverse events. Majority of studies either recruited a non-representative proportion of patients as traditional, complementary, and integrative medicine (TCIM) diagnosis was used as inclusion criteria, or not reflecting the real-world practice of TCIM by completely dropping TCIM diagnosis in the trial design. Consultation follow-up frequency is the least pragmatic domain. Increase in pragmatism did not associate with a higher risk of bias. Existing IM pragmatic trial design does not match the patients' expectation in the analysis of incident concomitant drug change and adverse events. A two-layer design incorporating TCIM diagnosis as a stratification factor maximizes the generalizability of evidence and real-world translation of both ConM and TCIM.
PubMed: 34513860
DOI: 10.3389/fmed.2021.668913 -
Exploration of Targeted Anti-tumor... 2023Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population,...
AIM
Coronavirus disease 2019 (COVID-19) became pandemic on 11th March 2020 and it deeply stressed the healthcare system. Cancer patients represent a vulnerable population, so many recommendations have been approved to ensure optimal management. Clinical research was notably impacted by COVID too. This review aims to analyze the challenges occurred during a pandemic for the management of enrolled patients (enrollment, use of telemedicine visits, study procedures) and for the clinical trials system (from feasibility to selection visit, site initiation visit, monitorings, use of e-signature, deviations and discontinuations).
METHODS
The studies included in the present review were selected from PubMed/Google Scholar/ScienceDirect databases.
RESULTS
During the first phase of pandemic many clinical trials were suspended in accrual and, as the pandemic progressed, recommendations were established to guarantee the safety and the continuity of care of enrolled patients. In addition, lot of new strategies was found during the pandemic to reduce the negative consequences on clinical trial performance and to guarantee new opportunities of care in the respect of good clinical practice (GCP) in a bad scenario.
CONCLUSIONS
Among all modifiers, investigators would prefer to maintain the positive ones such as pragmatic and simplified trial designs and protocols, reducing in-person visits when not necessary and to minimizing sponsor and contract research organizations (CROs) visits.
PubMed: 38023994
DOI: 10.37349/etat.2023.00183 -
Pain Physician Sep 2023Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Extensive research into potential sources of thoracic pain with or without referred pain into the chest wall has demonstrated that thoracic facet joints can be a potential source of pain confirmed by precise, diagnostic blocks.The objective of this systematic review and meta-analysis is to evaluate the effectiveness of medial branch blocks and radiofrequency neurotomy as a therapeutic thoracic facet joint intervention.
METHODS
Systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies of medial branch blocks and the radiofrequency neurotomy in managing thoracic pain utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was performed. A comprehensive literature search of multiple databases of RCTs and observational studies of medial branch blocks and radiofrequency neurotomy in managing chronic thoracic pain were identified from 1996 to December 2022 with inclusion of manual searches of the bibliography of known review articles and multiple databases. Methodologic quality and risk of bias assessment was also conducted. Evidence was synthesized utilizing principles of quality assessment and best evidence synthesis, with conventional and single meta-analysis. The primary outcome measure of success was 3 months of pain reduction for medial branch blocks and 6 months for radiofrequency thermoneurolysis for a single treatment. Short-term success was defined as up to 6 months and long-term was more than 6 months.
RESULTS
This literature search yielded 11 studies meeting the inclusion criteria, of which 3 were RCTs and 8 were observational studies. Of the 3 RCTs, 2 of them assessed medial branch blocks and one trial assessed radiofrequency for thoracic pain. The evidence for managing thoracic pain with qualitative analysis and single-arm meta-analysis and GRADE system of appraisal, with the inclusion of 2 RCTs and 3 observational studies for medial branch blocks was Level II. For radiofrequency neurotomy, with the inclusion of one RCT of 20 patients in the treatment group and 5 observational studies, the evidence was Level III in managing thoracic pain.
LIMITATIONS
There was a paucity of literature with RCTs and real-world pragmatic controlled trials. Even observational studies had small sample sizes providing inadequate clinically applicable results. In addition, there was heterogeneity of the available studies in terms of their inclusion and exclusion criteria, defining their endpoints and the effectiveness of the procedures.
CONCLUSION
This systematic review and meta-analysis show Level II evidence of medial branch blocks and Level III evidence for radiofrequency neurotomy on a long-term basis in managing chronic thoracic pain.
KEY WORDS
Chronic spinal pain, thoracic facet or zygapophysial joint pain, facet joint nerve blocks, medial branch blocks, controlled comparative local anesthetic blocks, diagnostic accuracy, radiofrequency neurotomy.
Topics: Humans; Nerve Block; Pain Management; Chronic Pain; Denervation; Anesthesia, Local; Chest Pain; Zygapophyseal Joint; Treatment Outcome
PubMed: 37774177
DOI: No ID Found -
Journal of Medical Internet Research Aug 2023Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video... (Review)
Review
BACKGROUND
Video recordings of patients may offer advantages to supplement patient assessment and clinical decision-making. However, little is known about the practice of video recording patients for direct care purposes.
OBJECTIVE
We aimed to synthesize empirical studies published internationally to explore the extent to which video recording patients is acceptable and effective in supporting direct care and, for the United Kingdom, to summarize the relevant guidance of professional and regulatory bodies.
METHODS
Five electronic databases (MEDLINE, Embase, APA PsycINFO, CENTRAL, and HMIC) were searched from 2012 to 2022. Eligible studies evaluated an intervention involving video recording of adult patients (≥18 years) to support diagnosis, care, or treatment. All study designs and countries of publication were included. Websites of UK professional and regulatory bodies were searched to identify relevant guidance. The acceptability of video recording patients was evaluated using study recruitment and retention rates and a framework synthesis of patients' and clinical staff's perspectives based on the Theoretical Framework of Acceptability by Sekhon. Clinically relevant measures of impact were extracted and tabulated according to the study design. The framework approach was used to synthesize the reported ethico-legal considerations, and recommendations of professional and regulatory bodies were extracted and tabulated.
RESULTS
Of the 14,221 abstracts screened, 27 studies met the inclusion criteria. Overall, 13 guidance documents were retrieved, of which 7 were retained for review. The views of patients and clinical staff (16 studies) were predominantly positive, although concerns were expressed about privacy, technical considerations, and integrating video recording into clinical workflows; some patients were anxious about their physical appearance. The mean recruitment rate was 68.2% (SD 22.5%; range 34.2%-100%; 12 studies), and the mean retention rate was 73.3% (SD 28.6%; range 16.7%-100%; 17 studies). Regarding effectiveness (10 studies), patients and clinical staff considered video recordings to be valuable in supporting assessment, care, and treatment; in promoting patient engagement; and in enhancing communication and recall of information. Observational studies (n=5) favored video recording, but randomized controlled trials (n=5) did not demonstrate that video recording was superior to the controls. UK guidelines are consistent in their recommendations around consent, privacy, and storage of recordings but lack detailed guidance on how to operationalize these recommendations in clinical practice.
CONCLUSIONS
Video recording patients for direct care purposes appears to be acceptable, despite concerns about privacy, technical considerations, and how to incorporate recording into clinical workflows. Methodological quality prevents firm conclusions from being drawn; therefore, pragmatic trials (particularly in older adult care and the movement disorders field) should evaluate the impact of video recording on diagnosis, treatment monitoring, patient-clinician communication, and patient safety. Professional and regulatory documents should signpost to practical guidance on the implementation of video recording in routine practice.
TRIAL REGISTRATION
PROSPERO CRD42022331825: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=331825.
Topics: Humans; Aged; Patient Participation; Empirical Research; Communication; Narration; Clinical Decision-Making
PubMed: 37585249
DOI: 10.2196/46478 -
The Cochrane Database of Systematic... Sep 2022People diagnosed with borderline personality disorder (BPD) frequently present to healthcare services in crisis, often with suicidal thoughts or actions. Despite this,... (Review)
Review
BACKGROUND
People diagnosed with borderline personality disorder (BPD) frequently present to healthcare services in crisis, often with suicidal thoughts or actions. Despite this, little is known about what constitutes effective management of acute crises in this population and what type of interventions are helpful at times of crisis. In this review, we will examine the efficacy of crisis interventions, defined as an immediate response by one or more individuals to the acute distress experienced by another individual, designed to ensure safety and recovery and lasting no longer than one month. This review is an update of a previous Cochrane Review examining the evidence for the effects of crisis interventions in adults diagnosed with BPD.
OBJECTIVES
To assess the effects of crisis interventions in adults diagnosed with BPD in any setting.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, nine other databases and three trials registers up to January 2022. We also checked reference lists, handsearched relevant journal archives and contacted experts in the field to identify any unpublished or ongoing studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) comparing crisis interventions with usual care, no intervention or waiting list, in adults of any age diagnosed with BPD.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
We included two studies with 213 participants. One study (88 participants) was a feasibility RCT conducted in the UK that examined the effects of joint crisis plans (JCPs) plus treatment as usual (TAU) compared to TAU alone in people diagnosed with BPD. The primary outcome was self-harm. Participants had an average age of 36 years, and 81% were women. Government research councils funded the study. Risk of bias was unclear for blinding, but low in the other domains assessed. Evidence from this study suggested that there may be no difference between JCPs and TAU on deaths (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.06 to 14.14; 88 participants; low-certainty evidence); mean number of self-harm episodes (mean difference (MD) 0.30, 95% CI -36.27 to 36.87; 72 participants; low-certainty evidence), number of inpatient mental health nights (MD 1.80, 95% CI -5.06 to 8.66; 73 participants; low-certainty evidence), or quality of life measured using the EuroQol five-dimension questionnaire (EQ-5D; MD -6.10, 95% CI -15.52 to 3.32; 72 participants; very low-certainty evidence). The study authors calculated an Incremental Cost Effectiveness Ratio of GBP -32,358 per quality-adjusted life year (QALY), favouring JCPs, but they described this result as "hypothesis-generating only" and we rated this as very low-certainty evidence. The other study (125 participants) was an RCT conducted in Sweden of brief admission to psychiatric hospital by self-referral (BA) compared to TAU, in people with self-harm or suicidal behaviour and three or more diagnostic criteria for BPD. The primary outcome was use of inpatient mental health services. Participants had an average age of 32 years, and 85% were women. Government research councils and non-profit foundations funded the study. Risk of bias was unclear for blinding and baseline imbalances, but low in the other domains assessed. The evidence suggested that there is no clear difference between BA and TAU on deaths (RR 0.49, 95% CI 0.05 to 5.29; 125 participants; low-certainty evidence), mean number of self-harm episodes (MD -0.03, 95% CI -2.26 to 2.20; 125 participants; low-certainty evidence), violence perpetration (RR 2.95, 95% CI 0.12 to 71.13; 125 participants; low-certainty evidence), or days of inpatient mental health care (MD 0.70, 95% CI -14.32 to 15.72; 125 participants; low-certainty evidence). The study suggested that BA may have little or no effect on the mean number of suicide attempts (MD 0.00, 95% CI -0.06 to 0.06; 125 participants; very low-certainty evidence). We also identified three ongoing RCTs that met our inclusion criteria. The results will be incorporated into future updates of this review.
AUTHORS' CONCLUSIONS
A comprehensive search of the literature revealed very little RCT-based evidence to inform the management of acute crises in people diagnosed with BPD. We included two studies of two very different types of intervention (JCP and BA). We found no clear evidence of a benefit over TAU in any of our main outcomes. We are very uncertain about the true effects of either intervention, as the evidence was judged low- and very low-certainty, and there was only a single study of each intervention. There is an urgent need for high-quality, large-scale, adequately powered RCTs on crisis interventions for people diagnosed with BPD, in addition to development of new crisis interventions.
Topics: Adult; Borderline Personality Disorder; Crisis Intervention; Female; Hospitalization; Humans; Male; Quality of Life; Self-Injurious Behavior
PubMed: 36161394
DOI: 10.1002/14651858.CD009353.pub3 -
Frontiers in Neurology 2020Given the limited healthcare resources in low and middle income countries (LMICs), effective rehabilitation strategies that can be realistically adopted in such...
Given the limited healthcare resources in low and middle income countries (LMICs), effective rehabilitation strategies that can be realistically adopted in such settings are required. A systematic review of literature was conducted to identify pragmatic solutions and outcomes capable of enhancing stroke recovery and quality of life of stroke survivors for low- and middle- income countries. PubMed, HINARI, and Directory of Open Access Journals databases were searched for published Randomized Controlled Trials (RCTs) till November 2018. Only completed trials published in English with non-pharmacological interventions on adult stroke survivors were included in the review while published protocols, pilot studies and feasibility analysis of trials were excluded. Obtained data were synthesized thematically and descriptively analyzed. One thousand nine hundred and ninety six studies were identified while 347 (65.22% high quality) RCTs were found to be eligible for the review. The most commonly assessed variables (and outcome measure utility) were activities of daily living [75.79% of the studies, with Barthel Index (37.02%)], motor function [66.57%; with Fugl Meyer scale (71.88%)], and gait [31.12%; with 6 min walk test (38.67%)]. Majority of the innovatively high technology interventions such as robot therapy (95.24%), virtual reality (94.44%), transcranial direct current stimulation (78.95%), transcranial magnetic stimulation (88.0%) and functional electrical stimulation (85.00%) were conducted in high income countries. Several traditional and low-cost interventions such as constraint-induced movement therapy (CIMT), resistant and aerobic exercises (R&AE), task oriented therapy (TOT), body weight supported treadmill training (BWSTT) were reported to significantly contribute to the recovery of motor function, activity, participation, and improvement of quality of life after stroke. Several pragmatic, in terms of affordability, accessibility and utility, stroke rehabilitation solutions, and outcome measures that can be used in resource-limited settings were found to be effective in facilitating and enhancing post-stroke recovery and quality of life.
PubMed: 32695058
DOI: 10.3389/fneur.2020.00337 -
JAMA Oncology Sep 2022The log-rank test is considered the criterion standard for comparing 2 survival curves in pivotal registrational trials. However, with novel immunotherapies that often... (Meta-Analysis)
Meta-Analysis
Log-Rank Test vs MaxCombo and Difference in Restricted Mean Survival Time Tests for Comparing Survival Under Nonproportional Hazards in Immuno-oncology Trials: A Systematic Review and Meta-analysis.
IMPORTANCE
The log-rank test is considered the criterion standard for comparing 2 survival curves in pivotal registrational trials. However, with novel immunotherapies that often violate the proportional hazards assumptions over time, log-rank can lose power and may fail to detect treatment benefit. The MaxCombo test, a combination of weighted log-rank tests, retains power under different types of nonproportional hazards. The difference in restricted mean survival time (dRMST) test is frequently proposed as an alternative to the log-rank under nonproportional hazard scenarios.
OBJECTIVE
To compare the log-rank with the MaxCombo and dRMST in immuno-oncology trials to evaluate their performance in practice.
DATA SOURCES
Comprehensive literature review using Google Scholar, PubMed, and other sources for randomized clinical trials published in peer-reviewed journals or presented at major clinical conferences before December 2019 assessing efficacy of anti-programmed cell death protein-1 or anti-programmed death/ligand 1 monoclonal antibodies.
STUDY SELECTION
Pivotal studies with overall survival or progression-free survival as the primary or key secondary end point with a planned statistical comparison in the protocol. Sixty-three studies on anti-programmed cell death protein-1 or anti-programmed death/ligand 1 monoclonal antibodies used as monotherapy or in combination with other agents in 35 902 patients across multiple solid tumor types were identified.
DATA EXTRACTION AND SYNTHESIS
Statistical comparisons (n = 150) were made between the 3 tests using the analysis populations as defined in the original protocol of each trial.
MAIN OUTCOMES AND MEASURES
Nominal significance based on a 2-sided .05-level test was used to evaluate concordance. Case studies featuring different types of nonproportional hazards were used to discuss more robust ways of characterizing treatment benefit instead of sole reliance on hazard ratios.
RESULTS
In this systematic review and meta-analysis of 63 studies including 35 902 patients, between the log-rank and MaxCombo, 135 of 150 comparisons (90%) were concordant; MaxCombo achieved nominal significance in 15 of 15 discordant cases, while log-rank did not. Several cases appeared to have clinically meaningful benefits that would not have been detected using log-rank. Between the log-rank and dRMST tests, 137 of 150 comparisons (91%) were concordant; log-rank was nominally significant in 5 of 13 cases, while dRMST was significant in 8 of 13. Among all 3 tests, 127 comparisons (85%) were concordant.
CONCLUSIONS AND RELEVANCE
The findings of this review show that MaxCombo may provide a pragmatic alternative to log-rank when departure from proportional hazards is anticipated. Both tests resulted in the same statistical decision in most comparisons. Discordant studies had modest to meaningful improvements in treatment effect. The dRMST test provided no added sensitivity for detecting treatment differences over log-rank.
Topics: Antibodies, Monoclonal; Humans; Ligands; Neoplasms; Proportional Hazards Models; Survival Analysis; Survival Rate
PubMed: 35862037
DOI: 10.1001/jamaoncol.2022.2666 -
Frontiers in Cardiovascular Medicine 20232-dimensional Speckle-Tracking Echocardiography, to obtain longitudinal layer specific strain (LSS), has recently emerged as a novel and accurate non-invasive imaging... (Review)
Review
The clinical application of longitudinal layer specific strain as a diagnostic and prognostic instrument in ischemic heart diseases: A systematic review and meta-analysis.
BACKGROUND
2-dimensional Speckle-Tracking Echocardiography, to obtain longitudinal layer specific strain (LSS), has recently emerged as a novel and accurate non-invasive imaging technique for diagnosis as well as for prediction of adverse cardiac events. This systematic review and meta-analysis aimed to give an overview of the possible clinical implication and significance of longitudinal LSS.
METHODS
We conducted a systematic review and meta-analysis with all the studies involving layer specific strain in patients with ischemic heart disease (IHD). Of 40 eligible studies, 9 met our inclusion criteria. Studies that were included either investigated the prognostic value ( = 3) or the diagnostic value ( = 6) of longitudinal LSS.
RESULTS
The pooled meta-analysis showed that longitudinal LSS is a significant diagnostic marker for coronary artery disease (CAD) in patients with IHD. Endocardial LSS was found to be a good diagnostic marker for CAD in IHD patients (OR: 1.28, CI95% [1.11-1.48], < 0.001, per 1% decrease). Epicardial (OR: 1.34, CI95% [1.14-1.56], < 0.001, per 1% decrease), Mid-Myocardial (OR: 1.24, CI95% [1.12-1.38], < 0.001, per 1% decrease) and endocardial (OR: 1.21, CI95% [1.09-1.35], < 0.001, per 1% decrease) LSS all entailed diagnostic information regarding CAD, with epicardial LSS emerging as the superior diagnostic marker for CAD in patients with SAP. Endocardial LSS proved to be the better diagnostic marker of CAD in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). LSS was shown to be a good prognostic maker of adverse cardiac events in IHD patients. Two studies found endocardial circumferential strain to be the good predictor of outcome in CAD patients and when added to baseline characteristics. Epicardial LSS emerged as best predictor in acute coronary syndrome (ACS) patients.
CONCLUSION
In patients with SAP, epicardial LSS was the stronger diagnostic marker while in NSTE-ACS patients, endocardial LSS was the stronger diagnostic marker. In addition, endocardial circumferential strain is the better predictor of adverse outcome in CAD patients whilst in ACS patients, epicardial LSS was found to be a better predictor of outcome.
PubMed: 37051064
DOI: 10.3389/fcvm.2023.980626 -
PloS One 2023To systematically evaluate the empirical evidence on the impact of community-based health insurance (CBHI) on healthcare utilization and financial risk protection in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
To systematically evaluate the empirical evidence on the impact of community-based health insurance (CBHI) on healthcare utilization and financial risk protection in low- and middle-income countries (LMIC).
METHODS
We searched PubMed, CINAHL, Cochrane CENTRAL, CNKI, PsycINFO, Scopus, WHO Global Index Medicus, and Web of Science including grey literature, Google Scholar®, and citation tracking for randomized controlled trials (RCTs), non-RCTs, and quasi-experimental studies that evaluated the impact of CBHI schemes on healthcare utilization and financial risk protection in LMICs. We assessed the risk of bias using Cochrane's Risk of Bias 2.0 and Risk of Bias in Non-randomized Studies of Interventions tools for RCTs and quasi/non-RCTs, respectively. We also performed a narrative synthesis of all included studies and meta-analyses of comparable studies using random-effects models. We pre-registered our study protocol on PROSPERO: CRD42022362796.
RESULTS
We identified 61 articles: 49 peer-reviewed publications, 10 working papers, 1 preprint, and 1 graduate dissertation covering a total of 221,568 households (1,012,542 persons) across 20 LMICs. Overall, CBHI schemes in LMICs substantially improved healthcare utilization, especially outpatient services, and improved financial risk protection in 24 out of 43 studies. Pooled estimates showed that insured households had higher odds of healthcare utilization (AOR = 1.60, 95% CI: 1.04-2.47), use of outpatient health services (AOR = 1.58, 95% CI: 1.22-2.05), and health facility delivery (AOR = 2.21, 95% CI: 1.61-3.02), but insignificant increase in inpatient hospitalization (AOR = 1.53, 95% CI: 0.74-3.14). The insured households had lower out-of-pocket health expenditure (AOR = 0.94, 95% CI: 0.92-0.97), lower incidence of catastrophic health expenditure at 10% total household expenditure (AOR = 0.69, 95% CI: 0.54-0.88), and 40% non-food expenditure (AOR = 0.72, 95% CI: 0.54-0.96). The main limitations of our study are the limited data available for meta-analyses and high heterogeneity persisted in subgroup and sensitivity analyses.
CONCLUSIONS
Our study shows that CBHI generally improves healthcare utilization but inconsistently delivers financial protection from health expenditure shocks. With pragmatic context-specific policies and operational modifications, CBHI could be a promising mechanism for achieving universal health coverage (UHC) in LMICs.
Topics: Humans; Developing Countries; Community-Based Health Insurance; Delivery of Health Care; Health Expenditures; Universal Health Insurance; Insurance, Health
PubMed: 37368882
DOI: 10.1371/journal.pone.0287600