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Journal of Clinical Epidemiology Jun 2024To generate a bank of items describing application and interpretation errors that can arise in pairwise meta-analyses in systematic reviews of interventions.
OBJECTIVES
To generate a bank of items describing application and interpretation errors that can arise in pairwise meta-analyses in systematic reviews of interventions.
STUDY DESIGN AND SETTING
MEDLINE, Embase, and Scopus were searched to identify studies describing types of errors in meta-analyses. Descriptions of errors and supporting quotes were extracted by multiple authors. Errors were reviewed at team meetings to determine if they should be excluded, reworded, or combined with other errors, and were categorized into broad categories of errors and subcategories within.
RESULTS
Fifty articles met our inclusion criteria, leading to the identification of 139 errors. We identified 25 errors covering data extraction/manipulation, 74 covering statistical analyses, and 40 covering interpretation. Many of the statistical analysis errors related to the meta-analysis model (eg, using a two-stage strategy to determine whether to select a fixed or random-effects model) and statistical heterogeneity (eg, not undertaking an assessment for statistical heterogeneity).
CONCLUSION
We generated a comprehensive bank of possible errors that can arise in the application and interpretation of meta-analyses in systematic reviews of interventions. This item bank of errors provides the foundation for developing a checklist to help peer reviewers detect statistical errors.
Topics: Humans; Meta-Analysis as Topic; Systematic Reviews as Topic; Data Interpretation, Statistical; Research Design
PubMed: 38552725
DOI: 10.1016/j.jclinepi.2024.111331 -
Journal of Oral and Maxillofacial... Jun 2024Temporomandibular joint (TMJ) surgery is being increasingly performed globally with considerable success leading to improved quality of life for patients affected with...
PURPOSE
Temporomandibular joint (TMJ) surgery is being increasingly performed globally with considerable success leading to improved quality of life for patients affected with disabling temporomandibular disorders. One of the most unusual phenomena noted during maxillofacial surgery due to stimulation of the trigeminal nerves is the Trigeminocardiac reflex (TCR), which causes sudden bradycardia and hypotension causing alarm and distress to the surgical and anesthetic team. The purpose of this systematic review is to identify the frequency and discuss the pathophysiology of the TCR especially during TMJ surgery.
METHODS
The authors performed a systematic review by searching PubMed, Embase, Ovid, and Cochrane databases between 1946 and 2023 to identify studies that reported on the development of TCR during TMJ surgery. Non-English publications and those with inadequate details were excluded.
RESULTS
Thirty-six papers reporting on the development of the TCR during oral and maxillofacial procedures were noted. Six papers reported specifically on TCR during TMJ surgery. A total of 25 subjects developed TCR during TMJ surgery. The mean age of the subjects was 31 (standard deviation 17.16) years. Twenty-three subjects (92%) developed bradycardia while 2 subjects (8%) developed asystole. All subjects recovered. The most common stimulant noted in these papers leading to TCR was manipulation and distraction of the TMJ.
CONCLUSION
Although TCR is uncommon, it can occur during TMJ surgery, and it behooves the surgeon and anesthesia team to be aware of the potential for TCR to ensure adequate and timely treatment.
Topics: Humans; Bradycardia; Intraoperative Complications; Oral Surgical Procedures; Reflex, Trigeminocardiac; Temporomandibular Joint; Temporomandibular Joint Disorders
PubMed: 38547928
DOI: 10.1016/j.joms.2024.03.005 -
Frontiers in Neuroscience 2024Interpersonal synchronization involves the alignment of behavioral, affective, physiological, and brain states during social interactions. It facilitates empathy,...
INTRODUCTION
Interpersonal synchronization involves the alignment of behavioral, affective, physiological, and brain states during social interactions. It facilitates empathy, emotion regulation, and prosocial commitment. Mental disorders characterized by social interaction dysfunction, such as Autism Spectrum Disorder (ASD), Reactive Attachment Disorder (RAD), and Social Anxiety Disorder (SAD), often exhibit atypical synchronization with others across multiple levels. With the introduction of the "second-person" neuroscience perspective, our understanding of interpersonal neural synchronization (INS) has improved, however, so far, it has hardly impacted the development of novel therapeutic interventions.
METHODS
To evaluate the potential of INS-based treatments for mental disorders, we performed two systematic literature searches identifying studies that directly target INS through neurofeedback (12 publications; 9 independent studies) or brain stimulation techniques (7 studies), following PRISMA guidelines. In addition, we narratively review indirect INS manipulations through behavioral, biofeedback, or hormonal interventions. We discuss the potential of such treatments for ASD, RAD, and SAD and using a systematic database search assess the acceptability of neurofeedback (4 studies) and neurostimulation (4 studies) in patients with social dysfunction.
RESULTS
Although behavioral approaches, such as engaging in eye contact or cooperative actions, have been shown to be associated with increased INS, little is known about potential long-term consequences of such interventions. Few proof-of-concept studies have utilized brain stimulation techniques, like transcranial direct current stimulation or INS-based neurofeedback, showing feasibility and preliminary evidence that such interventions can boost behavioral synchrony and social connectedness. Yet, optimal brain stimulation protocols and neurofeedback parameters are still undefined. For ASD, RAD, or SAD, so far no randomized controlled trial has proven the efficacy of direct INS-based intervention techniques, although in general brain stimulation and neurofeedback methods seem to be well accepted in these patient groups.
DISCUSSION
Significant work remains to translate INS-based manipulations into effective treatments for social interaction disorders. Future research should focus on mechanistic insights into INS, technological advancements, and rigorous design standards. Furthermore, it will be key to compare interventions directly targeting INS to those targeting other modalities of synchrony as well as to define optimal target dyads and target synchrony states in clinical interventions.
PubMed: 38529267
DOI: 10.3389/fnins.2024.1286130 -
The Journal of Manual & Manipulative... Mar 2024Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an... (Review)
Review
BACKGROUND
Disorders of the cervical spine are some of the costliest musculoskeletal conditions to manage globally. Joint mobilization and manipulation have been shown to be an effective treatment for neck pain. However, the generalizability and clinical translation depends on the nature of the trial designs that inform its use. The extent to which randomized control trials (RCTs) assessing manual therapy treatments for cervical spine disorders fall on the efficacy (explanatory) -effectiveness (pragmatic) spectrum often informs how the findings are translated into clinical practice.
OBJECTIVE
The aim of this systematic review was to determine where RCTs of manual therapy for neck disorders fall on the efficacy-effectiveness spectrum.
METHODS
A search of three electronic databases including PubMed, CINAHL, and CENTRAL were completed for trials published from inception to May 2023. RCTs in which joint mobilization or manipulation were used to treat cervical spine disorders were assessed on the effectiveness-efficacy spectrum using the Rating of Included Trials on the Efficacy-Effectiveness Spectrum (RITES) tool and risk of bias using the Revised Cochrane Risk of Bias tool.
RESULTS
A total of 174 trials met eligibility. RITES domain two trial setting (71.3% vs 16.1%), domain three flexibility of intervention(s) (62.1% vs 23%), and domain four clinical relevance of experimental and comparison intervention(s) (51.7% vs 29.3%) all favored efficacy over effectiveness. Domain one participant characteristic(s) had a slightly greater emphasis on effectiveness compared to efficacy (36.8% vs 44.8%). Most studies (96%) had at least some risk of bias.
CONCLUSION
Over half of the RCTs assessing the treatment effect of joint mobilization and manipulation for neck pain favor efficacy (explanatory) over effectiveness (pragmatic) designs. Future RCTs on this topic should consider a greater emphasis on pragmatic trial design components in order to better reflect real-world translation to clinical practice.
PubMed: 38525785
DOI: 10.1080/10669817.2024.2327127 -
Systematic Reviews Mar 2024Manual therapy (MT) is frequently used in combination with management of osteoarthritis of the knee, but there is no consensus on the exact efficacy of this treatment... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Manual therapy (MT) is frequently used in combination with management of osteoarthritis of the knee, but there is no consensus on the exact efficacy of this treatment strategy. The purpose of this systematic review and meta-analysis was to evaluate the pain relief and safety of MT for treatment of knee osteoarthritis (KOA).
METHODS
Randomized controlled trials evaluating MT in patients with KOA in major English and Chinese journals were searched in the following databases: Wanfang, China Science and Technology Journal Database (VIP database), China National Knowledge Infrastructure (CNKI), PubMed, Embase, Web of Science, and the Cochrane Library databases through June 2023. The methodological quality and quality of evidence of the included studies were assessed using Cochrane's risk-of-bias 2 (ROB 2) tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool. Data analysis was performed using Stata version 15.0 software. After use of Galbraith plots to exclude studies that could lead to heterogeneity, random effects models were used to analyze the remaining data and test the consistency of the findings. We used meta-regression to assess the effect of treatment period, patient age, and sex ratio on outcomes. Funnel plots and Egger's test were used to evaluate publication bias. Sensitivity analyses were used to determine the reliability of the results.
RESULTS
A total of 25 studies, with 2376 participants, were included in this review. The overall methodological quality of the included studies was limited. Our findings suggest that MT has a positive impact on pain relief outcomes in KOA patients. The meta-analysis showed that MT was superior to usual care (SMD = 2.04, 95% CI 0.94, 3.14, I = 96.3%; low evidence quality) and exercise (SMD = 1.56, 95% CI 0.41, 2.71, I = 96.3%; low evidence quality) for reducing pain. In terms of improvement in visual analogue scale (VAS) scores, MT treatment beyond 4 weeks (SMD = 1.56, 95% CI 0.41, 2.71, I = 96.3%) may be superior to treatments less than or equal to 4 weeks (SMD = 1.24, 95% CI 0.56, 1.95, I = 94.7%). No serious adverse events associated with MT were reported.
CONCLUSIONS
MT may be effective at reducing pain in patients with KOA and may be more effective after a 4-week treatment period. Compared with usual care and exercise therapy, MT may be superior at reducing KOA pain in the short term (9 weeks), but its long-term efficacy requires careful consideration of evidence-based outcomes. MT appears to be safe for KOA patients, though clinicians should inform patients of the potential risk of MT-related adverse events.
Topics: Humans; Osteoarthritis, Knee; Reproducibility of Results; Pain; Pain Management; Musculoskeletal Manipulations
PubMed: 38504373
DOI: 10.1186/s13643-024-02467-7 -
Musculoskeletal Science & Practice Jun 2024Cervical and thoracic thrust or non-thrust manipulations have shown to be effective in patients with neck pain, but there is a lack of studies comparing both... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cervical and thoracic thrust or non-thrust manipulations have shown to be effective in patients with neck pain, but there is a lack of studies comparing both interventions in patients with neck pain.
OBJECTIVE
To investigate the effects of cervical thrust or non-thrust manipulations compared to thoracic or cervicothoracic manipulations for improving pain, disability, and range of motion in patients with neck pain.
DESIGN
Systematic review and meta-analysis.
METHOD
Searches were performed in PubMed, PEDro, Cochrane Library, CINHAL, and Web of Science databases from inception to May 22, 2023. Randomized clinical trials comparing cervical thrust or non-thrust manipulations to thoracic or cervicothoracic manipulations were included. Methodological quality was assessed with PEDro scale, and the certainty of evidence was evaluated using GRADE guidelines.
RESULTS
Six studies were included. Meta-analyses revealed no differences between cervical thrust or non-thrust manipulations and thoracic or cervicothoracic manipulations in pain intensity, disability, or cervical range of motion in any plane. The certainty of evidence was downgraded to very low for pain intensity, to moderate or very low for disability and to low or very low for cervical range of motion.
CONCLUSION
There is moderate to very low certainty evidence that there is no difference in effectiveness between cervical thrust or non-thrust manipulations and thoracic or cervicothoracic manipulations for improving pain, disability, and range of motion in patients with neck pain.
PROSPERO REGISTRATION
CRD42023429933.
Topics: Humans; Neck Pain; Range of Motion, Articular; Female; Cervical Vertebrae; Male; Adult; Thoracic Vertebrae; Manipulation, Spinal; Middle Aged; Pain Measurement
PubMed: 38492291
DOI: 10.1016/j.msksp.2024.102927 -
The Cochrane Database of Systematic... Mar 2024Stoma reversal is associated with a relatively high risk of surgical site infection (SSI), occurring in up to 40% of cases. This may be explained by the presence of... (Review)
Review
BACKGROUND
Stoma reversal is associated with a relatively high risk of surgical site infection (SSI), occurring in up to 40% of cases. This may be explained by the presence of microorganisms around the stoma site, and possible contamination with the intestinal contents during the open-end manipulation of the bowel, making the stoma closure site a clean-contaminated wound. The conventional technique for stoma reversal is linear skin closure (LSC). The purse-string skin closure (PSSC) technique (circumferential skin approximation) creates a small opening in the centre of the wound, enabling free drainage of contaminants and serous fluid. This could decrease the risk of SSI compared with LSC.
OBJECTIVES
To assess the effects of purse-string skin closure compared with linear skin closure in people undergoing stoma reversal.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, two other databases, and three trials registers on 21 December 2022. We also checked references, searched for citations, and contacted study authors to identify additional studies.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) comparing PSSC and LSC techniques in people undergoing closure of stoma (loop ileostomy, end ileostomy, loop colostomy, or end colostomy) created for any indication.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected eligible studies, extracted data, evaluated the methodological quality of the included studies, and conducted the analyses. The most clinically relevant outcomes were SSI, participant satisfaction, incisional hernia, and operative time. We calculated odds ratios (ORs) for dichotomous data and mean differences (MDs) for continuous data, each with its corresponding 95% confidence interval (CI). We used the GRADE approach to rate the certainty of the evidence.
MAIN RESULTS
Nine RCTs involving 757 participants were eligible for inclusion. Eight studies recruited only adults (aged 18 years and older), and one study included people aged 12 years and older. The participants underwent elective reversal of either ileostomy (82%) or colostomy (18%). We considered all studies at high risk of performance and detection bias (lack of blinding) and four studies at unclear risk of selection bias related to random sequence generation. PSSC compared with LSC likely reduces the risk of SSI (OR 0.17, 95% CI 0.09 to 0.29; I = 0%; 9 studies, 757 participants; moderate-certainty evidence). The anticipated absolute risk of SSI is 52 per 1000 people who have PSSC and 243 per 1000 people who have LSC. The likelihood of being very satisfied or satisfied with stoma closure may be higher amongst people who have PSSC compared with people who have LSC (100% vs 89%; OR 20.11, 95% CI 1.09 to 369.88; 2 studies, 122 participants; low-certainty evidence). The results of the analysis suggest that PSSC compared with LSC may have little or no effect on the risk of incisional hernia (OR 0.51, 95% CI 0.07 to 3.70; I = 49%; 4 studies, 297 participants; very low-certainty evidence) and operative time (MD -2.67 minutes, 95% CI -8.56 to 3.22; I = 65%; 6 studies, 460 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
PSSC compared with LSC likely reduces the risk of SSI in people undergoing reversal of stoma. People who have PSSC may be more satisfied with the result compared with people who have LSC. There may be little or no difference between the skin closure techniques in terms of incisional hernia and operative time, though the evidence for these two outcomes is very uncertain.
Topics: Adult; Humans; Incisional Hernia; Surgical Stomas; Skin; Surgical Wound Infection; Ileostomy
PubMed: 38470607
DOI: 10.1002/14651858.CD014763.pub2 -
Alternative Therapies in Health and... Mar 2024In recent years, Tiaoshen acupuncture in Traditional Chinese Medicine (TCM) has been employed for treating patients with insomnia, but the clinical efficacy remains to...
BACKGROUND
In recent years, Tiaoshen acupuncture in Traditional Chinese Medicine (TCM) has been employed for treating patients with insomnia, but the clinical efficacy remains to be substantiated.
OBJECTIVE
To assess the efficacy and safety of acupuncture in treating insomnia using the Tiaoshen method in TCM.
DESIGN
A systematic review and meta-analysis was conducted.
SETTING
The research was conducted in Shenzhen.
METHODS
Electronic databases, including Chinese National Knowledge Infrastructure (CNKI), Wanfang, SinoMed, Weipu, PubMed, Web of Science, EMBASE, and Cochrane databases, were retrieved up to September 15, 2023. Randomized controlled trials (RCTs) meeting inclusion criteria were screened. Quality assessment of included articles was performed using the Cochrane Risk of Bias tool. Valid data were then extracted and analyzed via meta-analysis using Review Manager 5.3. The study was registered in the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY), 2023100051.
RESULTS
A total of 13 articles were included, comprising 849 patients with insomnia (diagnosed as chronic insomnia or primary insomnia). Meta-analysis results indicated that acupuncture with the Tiaoshen method could decrease the Pittsburgh Sleep Quality Index (PSQI) score [RR=-3.03, 95% CI (-3.73, -2.33), P < .00001], hyperarousal (HAS) scale score [RR=-7.75, 95% CI (-12.29, -3.22), P < .0008], and fatigue scale-14 (FS-14) score [RR=-2.11, 95% CI (-2.83, -1.38), P < .00001] compared with superficial acupuncture on non-effective acupoints or conventional acupuncture manipulation. Additionally, acupuncture with the Tiaoshen method demonstrated safety. However, the funnel plot suggested the presence of publication bias.
CONCLUSIONS
Acupuncture with the Tiaoshen method could enhance sleep quality and efficiency. Due to the low quality of some literature, further high-quality RCTs are needed to improve the level of evidence.
PubMed: 38466061
DOI: No ID Found -
Journal of Integrative and... Jun 2024This review aimed to describe the quality and comprehensiveness of adverse event (AE) reporting in clinical trials incorporating manual therapy (MT) as an intervention...
This review aimed to describe the quality and comprehensiveness of adverse event (AE) reporting in clinical trials incorporating manual therapy (MT) as an intervention for extremity conditions using the Consolidated Standards of Reporting Trials (CONSORT)-Harms extension as the benchmark. The secondary aim was to determine whether the quality of AE reporting improved after the availability of the CONSORT reporting checklist. Systematic review. A literature search was conducted using multiple databases to identify trials where MT was used to treat extremity conditions. Studies that reported AEs were identified and evaluated using the CONSORT-Harms extension. The frequency of trials reporting study AEs before and after the publication of the updated 2010 CONSORT statement was calculated, along with the categorization of how study AEs were reported. Of the 55,539 studies initially identified, 220 trials met all inclusion criteria. Eighty trials (36.4%) reported AE occurrence. None of the studies that reported AEs adhered to all 10 criteria proposed by the 2010 CONSORT-Harms extension. The most commonly reported criterion was number four, which clarified how AE-related information was collected (30% of trials). The least reported criterion was number six, which describes the participant withdrawals for each arm due to AEs and the experience with the allocated treatment (1.3% of trials). The nomenclature used to describe AEs varied substantially. Fifty-nine of 76 trials (33.3%) were published after the updated CONSORT Harms-checklist was available, compared to 21 of 44 trials (46.7%) published before it was available. Reporting of AEs in trials investigating MT for extremity conditions is poor. Every included trial lacked adherence to all 10 criteria proposed by the CONSORT-Harms Extension. The quality and comprehensiveness of AE reporting did not improve after the most recent CONSORT update recommending AE reporting. Clinicians must obtain informed consent before performing any intervention, including MT, which requires disclosing potential risks, which could be better known with improved tracking, analyzing, and reporting of AEs. The authors recommend improved adherence to best practices for adequately tracking and reporting AEs in future MT trials.
Topics: Humans; Checklist; Clinical Trials as Topic; Extremities; Musculoskeletal Manipulations
PubMed: 38452161
DOI: 10.1089/jicm.2023.0009 -
Chiropractic & Manual Therapies Mar 2024The cost of spine-related pain in the United States is estimated at $134.5 billion. Spinal pain patients have multiple options when choosing healthcare providers,...
BACKGROUND
The cost of spine-related pain in the United States is estimated at $134.5 billion. Spinal pain patients have multiple options when choosing healthcare providers, resulting in variable costs. Escalation of costs occurs when downstream costs are added to episode costs of care. The purpose of this review was to compare costs of chiropractic and medical management of patients with spine-related pain.
METHODS
A Medline search was conducted from inception through October 31, 2022, for cost data on U.S. adults treated for spine-related pain. The search included economic studies, randomized controlled trials and observational studies. All studies were independently evaluated for quality and risk of bias by 3 investigators and data extraction was performed by 3 investigators.
RESULTS
The literature search found 2256 citations, of which 93 full-text articles were screened for eligibility. Forty-four studies were included in the review, including 26 cohort studies, 17 cost studies and 1 randomized controlled trial. All included studies were rated as high or acceptable quality. Spinal pain patients who consulted chiropractors as first providers needed fewer opioid prescriptions, surgeries, hospitalizations, emergency department visits, specialist referrals and injection procedures.
CONCLUSION
Patients with spine-related musculoskeletal pain who consulted a chiropractor as their initial provider incurred substantially decreased downstream healthcare services and associated costs, resulting in lower overall healthcare costs compared with medical management. The included studies were limited to mostly retrospective cohorts of large databases. Given the consistency of outcomes reported, further investigation with higher-level designs is warranted.
Topics: Adult; Humans; Chiropractic; Emergency Room Visits; Musculoskeletal Pain
PubMed: 38448998
DOI: 10.1186/s12998-024-00533-4