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RMD Open Jun 2024To understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative...
Synthesis of guidance available for assessing methodological quality and grading of evidence from qualitative research to inform clinical recommendations: a systematic literature review.
OBJECTIVE
To understand (1) what guidance exists to assess the methodological quality of qualitative research; (2) what methods exist to grade levels of evidence from qualitative research to inform recommendations within European Alliance of Associations for Rheumatology (EULAR).
METHODS
A systematic literature review was performed in multiple databases including PubMed/Medline, EMBASE, Web of Science, COCHRANE and PsycINFO, from inception to 23 October 2020. Eligible studies included primary articles and guideline documents available in English, describing the: (1) development; (2) application of validated tools (eg, checklists); (3) guidance on assessing methodological quality of qualitative research and (4) guidance on grading levels of qualitative evidence. A narrative synthesis was conducted to identify key similarities between included studies.
RESULTS
Of 9073 records retrieved, 51 went through to full-manuscript review, with 15 selected for inclusion. Six articles described methodological tools to assess the quality of qualitative research. The tools evaluated research design, recruitment, ethical rigour, data collection and analysis. Seven articles described one approach, focusing on four key components to determine how much confidence to place in findings from systematic reviews of qualitative research. Two articles focused on grading levels of clinical recommendations based on qualitative evidence; one described a qualitative evidence hierarchy, and another a research pyramid.
CONCLUSION
There is a lack of consensus on the use of tools, checklists and approaches suitable for appraising the methodological quality of qualitative research and the grading of qualitative evidence to inform clinical practice. This work is expected to facilitate the inclusion of qualitative evidence in the process of developing recommendations at EULAR level.
Topics: Humans; Qualitative Research; Research Design; Evidence-Based Medicine; Practice Guidelines as Topic
PubMed: 38886002
DOI: 10.1136/rmdopen-2023-004032 -
The Cochrane Database of Systematic... Jun 2024Osteoarthritis (OA) affecting the first metatarsophalangeal joint (hallux rigidus) is common and painful. Several non-surgical treatments have been proposed; however,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Osteoarthritis (OA) affecting the first metatarsophalangeal joint (hallux rigidus) is common and painful. Several non-surgical treatments have been proposed; however, few have been adequately evaluated. Since the original 2010 review, several studies have been published necessitating this update.
OBJECTIVES
To determine the benefits and harms of non-surgical treatments for big toe OA.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search was February 2023.
SELECTION CRITERIA
We included randomised trials that compared any type of non-surgical treatment versus placebo (or sham), no treatment (such as wait-and-see) or other treatment.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. The major outcomes were pain, function, quality of life, radiographic joint structure, adverse events and withdrawals due to adverse events. The primary time point was 12 weeks. We used GRADE to assess the certainty of evidence.
MAIN RESULTS
This update includes six trials (547 participants). The mean age of participants ranged from 32 to 62 years. Trial durations ranged from 4 to 52 weeks. Treatments were compared in single trials as follows: arch-contouring foot orthoses versus sham inserts; shoe-stiffening inserts versus sham inserts; intra-articular injection of hyaluronic acid versus saline (placebo) injection; arch-contouring foot orthoses versus rocker-sole footwear; peloid therapy versus paraffin therapy; and sesamoid mobilisation, flexor hallucis longus strengthening and gait training plus physical therapy versus physical therapy alone. Certainty of the evidence was limited by the risk of bias and imprecision. Meta-analysis was not performed due to the heterogeneity of interventions. We reported numerical data for the 12-week time point for the three trials that used a placebo/sham control group. Arch-contouring foot orthoses versus sham inserts One trial (88 participants) showed that arch-contouring foot orthoses probably lead to little or no difference in pain, function, or quality of life compared to sham inserts (moderate certainty). Mean pain (0-10 scale, 0 no pain) with sham inserts was 3.9 points compared to 3.5 points with arch-contouring foot orthoses; a difference of 0.4 points better (95% (CI) 0.5 worse to 1.3 better). Mean function (0-100 scale, 100 best function) with sham inserts was 73.3 points compared to 65.5 points with arch-contouring foot orthoses; a difference of 7.8 points worse (95% CI 17.8 worse to 2.2 better). Mean quality of life (-0.04-100 scale, 100 best score) with sham inserts was 0.8 points compared to 0.8 points with arch-contouring foot orthoses group (95% CI 0.1 worse to 0.1 better). Arch-contouring foot orthoses may show little or no difference in adverse events and withdrawal due to adverse events compared to sham inserts (low certainty). Adverse events (mostly foot pain) were reported in 6 out of 41 people with sham inserts and 4 out of 47 people with arch-contouring foot orthoses (RR 0.58, 95% CI 0.18 to 1.92). Withdrawals due to adverse events were reported in 0 out of 41 people with sham inserts and 1 out of 47 people with arch-contouring foot orthoses (Peto OR 6.58, 95% CI 0.13 to 331). Shoe-stiffening inserts versus sham inserts One trial (100 participants) showed that shoe-stiffening inserts probably lead to little or no difference in pain, function, or quality of life when compared to sham inserts (moderate certainty). Mean pain (0-100 scale, 0 no pain) with sham inserts was 63.8 points compared to 70.1 points with shoe-stiffening inserts; a difference of 6.3 points better (95% CI 0.5 worse to 13.1 better). Mean function (0-100 scale, 100 best function) with sham inserts was 81.0 points compared to 84.9 points with shoe-stiffening inserts; a difference of 3.9 points better (95% CI 3.3 worse to 11.1 better). Mean quality of life (0-100 scale, 100 best score) with sham inserts was 53.2 points compared to 53.3 points with shoe-stiffening inserts; a difference of 0.1 points better (95% CI 3.7 worse to 3.9 better). Shoe-stiffening inserts may show little or no difference in adverse events and withdrawal due to adverse events, compared to sham inserts (low certainty). Adverse events (mostly foot pain, blisters, and spine/hip pain) were reported in 31 out of 51 people with sham inserts and 29 out of 49 people with shoe-stiffening inserts (RR 0.94, 95% CI 0.42 to 2.08). Withdrawals due to adverse events were reported in 1 out of 51 people with sham inserts and 2 out of 49 people with shoe-stiffening inserts (Peto OR 2.08, 95% CI 0.19 to 22.23). Hyaluronic acid versus placebo One trial (151 participants) showed that a single intra-articular injection of hyaluronic acid probably leads to little or no difference in pain or function compared to placebo (moderate certainty). Mean pain (0-100 scale, 0 no pain) with placebo was 72.5 points compared to 68.2 points with hyaluronic acid; a difference of 4.3 points better (95% CI 2.1 worse to 10.7 better). Mean function (0-100 scale, 100 best function) was 83.4 points with placebo compared to 85.0 points with hyaluronic acid; a difference of 1.6 points better (95% CI 4.6 worse to 7.8 better). Hyaluronic acid may provide little or no difference in quality of life (0-100 scale, 100 best score) which was 79.9 points with placebo compared to 82.9 points with hyaluronic acid; a difference of 3.0 better (95% CI 1.4 worse to 7.4 better; low certainty). There may be fewer adverse events with hyaluronic acid compared to placebo. Adverse events (mostly pain at the injection site) were reported in 43 out of 76 people with placebo compared with 27 out of 75 people with hyaluronic acid (RR 0.64, 95% CI 0.44 to 0.91; low certainty). No participants withdrew from either group due to adverse events. The effects on radiographic joint structure were not reported in any study.
AUTHORS' CONCLUSIONS
The existing evidence regarding the benefits and harms of non-surgical treatments for big toe OA is limited. There is moderate-certainty evidence, based upon three single placebo/sham-controlled trials, that there are no clinically important benefits of arch-contouring foot orthoses, shoe-stiffening inserts, or a single intra-articular injection of hyaluronic acid. Further placebo-controlled trials are needed to evaluate the effectiveness of non-surgical treatments for big toe OA.
Topics: Humans; Randomized Controlled Trials as Topic; Middle Aged; Foot Orthoses; Adult; Hallux Rigidus; Quality of Life; Shoes; Osteoarthritis; Bias; Hyaluronic Acid
PubMed: 38884172
DOI: 10.1002/14651858.CD007809.pub3 -
Journal of Bodywork and Movement... Jul 2024
Topics: Humans; Exercise Therapy; Osteoarthritis, Knee; Physical Therapy Modalities; Systematic Reviews as Topic
PubMed: 38876615
DOI: 10.1016/j.jbmt.2024.02.031 -
Endocrine Practice : Official Journal... Jun 2024Data are scant on the impact of metformin use in gestational diabetes mellitus/diabetes in pregnancy on long-term outcomes in children and mothers beyond 5 years of... (Review)
Review
OBJECTIVE
Data are scant on the impact of metformin use in gestational diabetes mellitus/diabetes in pregnancy on long-term outcomes in children and mothers beyond 5 years of childbirth. This systematic review and meta-analysis aimed to evaluate the long-term impact of metformin use in pregnancy on children and their mothers.
METHODS
Electronic databases were searched for studies evaluating metformin compared with insulin for managing gestational diabetes mellitus/diabetes in pregnancy. The primary outcome was the change in body mass index (BMI) in children at the ages of 5 to 11 years. The secondary outcomes were alterations in other anthropometric measures, obesity, and changes in the levels of lipids and adipocytokines in children and mothers.
RESULTS
Children at the age of 9 years born to mothers who were treated with metformin during pregnancy had similar BMI (mean difference [MD], 1.09 kg/m [95% confidence interval {CI}, -0.44 to 2.62]; P = .16; I = 16%), waist circumference-to-height ratio (MD, 0.13 [95% CI, -0.05 to 0.30]; P = .16; I = 94%), dual-energy X-ray absorptiometry (DXA) total fat mass (MD, 0.68 kg [95% CI, -2.39 to 3.79]; P = .66; I = 70%), DXA total fat percent (MD, 0.04% [95% CI, -3.44 to 3.51]; P = .98; I = 56%), DXA total fat-free mass (MD, 0.81 kg [95% CI, -0.96 to 2.58]; P = .37; I = 55%), magnetic resonance imaging visceral adipose tissue volume (MD, 80.97 cm [95% CI, -136.47 to 298.41]; P = .47; I = 78%), and magnetic resonance spectroscopy liver fat percentage (MD, 0.27% [95% CI, -1.26 to 1.79]; P = .73; I = 0%) to those born to mothers who were treated with insulin. Serum adiponectin, leptin, alanine aminotransferase, and ferritin were comparable among groups. In children between the ages of 9 and 11 years, the occurrence of obesity, diabetes, or challenges in motor and social development were comparable between the 2 groups. After 9 years of childbirth, BMI and the risk of developing diabetes were similar between the 2 groups of women.
CONCLUSION
Metformin use in pregnancy did not show any adverse effects compared with insulin on long-term outcomes in children and their mothers.
PubMed: 38876183
DOI: 10.1016/j.eprac.2024.05.017 -
The Knee Jun 2024Adding corticosteroids to intraoperative periarticular injections (PAIs) have become a current trend in total knee arthroplasty (TKA). Periarticular corticosteroid... (Review)
Review
BACKGROUND
Adding corticosteroids to intraoperative periarticular injections (PAIs) have become a current trend in total knee arthroplasty (TKA). Periarticular corticosteroid injections (PACSIs) intend to improve postoperative pain and function. However, preoperative corticosteroid injections for symptomatic arthritis increase the rates of prosthetic joint infection (PJI) when given months prior to TKA. The aim of this systematic review was to determine whether the addition of corticosteroids to PAIs during TKA improves patient outcomes and whether such practice increases the risk of PJI?
METHODS
A systematic review of the current literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines screened 1025 abstracts. Thirteen studies meeting specific eligibility criteria were included for further analysis.
RESULTS
Among the studies comparing the PACSIs versus nonsteroidal PAIs, 36% showed a significant reduction in postoperative pain scores, 20% showed significant improvement in range of motion (ROM), and 16% showed a significant reduction in total morphine equivalence (TME). While 100% of the studies comparing PACSI to saline or no injections showed significant improvement in pain, ROM and TME. In total, there were 3 infections in 576 TKA cases receiving PACSIs and 2 infections in 534 cases not receiving a PACSI. However, studies were not powered specifically to assess for infection.
CONCLUSIONS
The addition of corticosteroids to intraoperative PAIs do not demonstrate a significant benefit in the majority of studies, and tend to not have an effect on PJI risk; however, studies were not specifically powered to assess PJI risk.
PubMed: 38876084
DOI: 10.1016/j.knee.2024.05.009 -
Frontiers in Immunology 2024To evaluate the methodological quality, report quality, and evidence quality of meta-analysis (MA) and systematic review (SR) on the efficacy of probiotics in the...
BACKGROUND
To evaluate the methodological quality, report quality, and evidence quality of meta-analysis (MA) and systematic review (SR) on the efficacy of probiotics in the treatment of rheumatoid arthritis (RA).
METHODS
Databases were used to identify eligible SRs/MAs until February 12, 2024. The methodological quality of the studies was assessed using AMSTAR-2 tool, the quality of the literature reports was scored using PRISMA checklists, and the quality of the evidence was graded using GRADE system.
RESULTS
Seven reviews including 21 outcomes were included. Methodological quality of the included reviews was of general low, and the entries with poor scores were 2, 4, and 7. By PRISMA checklists, there were some reporting deficiencies, and quality problems were mainly reflected in the reporting registration and protocol, comprehensive search strategy and additional analysis. GRADE results elevated the quality of evidence to be low or very low overall.
CONCLUSIONS
Probiotics may have a therapeutic effect on RA, based on the evidence provided by the SRs/MAs in this overview. Nevertheless, there is still a lack of conclusive evidence due to methodological limitations in the included research. To make trustworthy judgments regarding the efficacy of probiotics in the treatment of RA, more large-scale, high-quality randomized controlled trials are still required.
Topics: Probiotics; Arthritis, Rheumatoid; Humans; Systematic Reviews as Topic; Treatment Outcome; Meta-Analysis as Topic
PubMed: 38873605
DOI: 10.3389/fimmu.2024.1397716 -
Minerva Dental and Oral Science Jun 2024The aim of this article is to summarize, compare, and assess possible association in individuals with or without rheumatoid arthritis (RA) for periodontitis.
INTRODUCTION
The aim of this article is to summarize, compare, and assess possible association in individuals with or without rheumatoid arthritis (RA) for periodontitis.
EVIDENCE ACQUISITION
Three study repositories were searched for quantitative studies examining the relationship between periodontal disease and rheumatoid arthritis between 2000 and December 2022. Quality was evaluated using the Newcastle Ottawa Scale (NOS). The standardized mean difference (SMD), with a random effect model and a P value of 0.05 as the significance level, was utilized as a summary statistic measure.
EVIDENCE SYNTHESIS
Fourteen papers were included in the descriptive synthesis. Thirteen were qualified for meta-analysis. Our findings suggest a link between the two conditions in terms of clinical attachment levels (CAL), tooth loss, Plaque Index, and probing depth. The estimated SMD for CAL was found to be 0.68 (95% CI: 0.15-1.21) (P<0.01). For tooth loss, the forest plot analysis revealed an SMD of 1.62 (95% CI: 0.48-2.76) (P=0.005). Similarly, for pocket depth, the SMD was 0.53; CI: 0.07-0.99 (P>0.05). The pooled estimates for plaque index were 0.29; CI: 0.03-0.61 (P>0.05). The funnel plot showed a symmetric distribution with the absence of systematic heterogeneity.
CONCLUSIONS
Although our data suggest a link between periodontal disease and rheumatoid arthritis, larger population-based investigations are needed to validate this connection. Case-control studies must pave the way to more rigorous investigations with well-defined populations and clinical outcomes as primary outcome measures.
PubMed: 38869834
DOI: 10.23736/S2724-6329.23.04891-X -
International Journal of Paediatric... Jun 2024Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood, and temporomandibular joints (TMJs) are involved in 39%-78% of patients. (Review)
Review
BACKGROUND
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood, and temporomandibular joints (TMJs) are involved in 39%-78% of patients.
AIM
The aim of this systematic review was to assess the effectiveness of conservative approaches in improving TMJ arthritis in children and adolescents affected by JIA.
DESIGN
PubMed, Scopus, and Web of Science were systematically searched from the inception until February 25, 2024, to identify observational studies presenting participants with a diagnosis of JIA affecting the TMJ, rehabilitative approaches for TMJ arthritis as interventions, and clinical or radiological assessment of TMJ arthritis as outcome.
RESULTS
Of 478 papers suitable for title/abstract screening, 13 studies were included. The studies evaluated the effectiveness of intra-articular (IA) corticosteroid (CS) injections, IA infliximab injections, arthrocentesis alone or in combination with IACS injections, occlusal splint, functional appliance, and physiotherapy. The effectiveness of IACS injections was shown in eight studies. IA infliximab injections did not appear to significantly improve TMJ arthritis.
CONCLUSION
Results of this systematic review suggested that conservative treatments, especially IACS injections, might be effective in improving TMJ arthritis in patients affected by JIA. Further studies with a higher level of evidence and more representative samples should be conducted.
PubMed: 38863137
DOI: 10.1111/ipd.13225 -
Journal of ISAKOS : Joint Disorders &... Jun 2024Orthobiologics has seen a renaissance over the last decade as an adjunct therapy during osteotomy due to the limited inherent regenerative potential of damaged... (Review)
Review
IMPORTANCE
Orthobiologics has seen a renaissance over the last decade as an adjunct therapy during osteotomy due to the limited inherent regenerative potential of damaged intraarticular tissues.
AIM OR OBJECTIVE
This systematic review aims to present the latest evidence regarding using orthobiologics with simultaneous high tibial osteotomy (HTO) for knee osteoarthritis. The results of this study may guide surgeons to improve their clinical results and clear the air regarding confusion over whether or not to add orthobiologics to HTO in clinical practice backed by scientific evidence.
EVIDENCE REVIEW
According to PRISMA guidelines a systematic search for relevant literature was performed in the PubMed (MEDLINE), Scopus, EMBASE, and Cochrane Library databases of all studies published in English from January 1990 to May 2023. The following search terms were entered into the title, abstract, and keyword fields: "knee" or "osteotomy" AND "valgus" or "varus" AND "regenerative medicine" or "PRP" or "mesenchymal stem cells" or "stem cells" or "BMAC" or "bone marrow" or "growth factors" or "umbilical cord blood-derived mesenchymal stem cell" or "stromal vascular fraction". The AMSTAR-2 checklist was used to confirm the quality of the systematic review. Randomised controlled trials (RCTs), prospective and retrospective comparative cohort studies, case-control studies, and case series were included. Studies that reported clinical outcomes in patients treated with knee osteotomy for varus/valgus knee with concomitant adjunction of regenerative treatment [Platelet-rich plasma (PRP), Adipose-derived stem cells (ADSC), Human Umbilical Cord Blood-Derived (HUCBD), Mesenchymal Stem Cells (MSC), bone marrow aspirate concentrate (BMAC), stromal vascular fraction (SVF)] were included. The outcome measures extracted from the studies were the KOOS score, Lysholm score, Subjective IKDC, WOMAC Score, KSS, Tegner, HSS, radiographic tibiofemoral angle, posterior tibial slope and complications. The current systematic review is registered in the PROSPERO Registry (CRD42023439379).
FINDINGS
Osteotomy for unicompartmental arthritis with adjunction of orthobiologics such as PRP, ADSC, HUCBD, MSC, BMAC, and SVF presents a consistent statistically significant clinical improvement compared to preoperative scores regardless of the treatment modality used and there were no notable complications associated with the use of these novel agents.
CONCLUSIONS AND RELEVANCE
Orthobiologics and knee osteotomies could improve outcomes in patients with knee osteoarthritis desiring Knee preservation surgeries. However, only a few studies are available on the topic to conclude anything with certainty, the patients included in the studies could not be disintegrated based on the grade of osteoarthritis (OA), type, dosage and frequency of administration of orthobiologic and type of additional surgical procedures used. Therefore, better-structured RCTs are required to implement this finding into routine Orthopaedic practice.
LEVEL OF EVIDENCE
Level 4.
PubMed: 38851324
DOI: 10.1016/j.jisako.2024.06.001 -
BMC Musculoskeletal Disorders Jun 2024Posttraumatic wrist osteoarthritis is an irreversible and often progressive condition. Many surgical treatments, used in (daily) practice, aim to relieve symptoms like...
BACKGROUND
Posttraumatic wrist osteoarthritis is an irreversible and often progressive condition. Many surgical treatments, used in (daily) practice, aim to relieve symptoms like pain and restore function. The aim of this systematic review is to assess the patient reported and functional outcomes of the most common surgical interventions in patients with posttraumatic wrist osteoarthritis. This overview can help clinicians select the best treatment and manage patient's expectations.
METHODS
A literature search was performed in Pubmed, Embase and Cochrane for articles published between 1990 and November 2022 according to the PRISMA guidelines. The study protocol has been registered in the PROSPERO database (CRD42017080427). Studies that describe patient reported outcomes (pain and Disability of Arm, Shoulder and Hand (DASH) -score) and functional outcomes (range of motion (ROM) and grip strength) after surgical intervention with a minimal follow-up of 1 year were included. The identified surgical procedures included denervation, proximal row carpectomy, interpositional- and total arthroplasty, and midcarpal-, radiocarpal- and total arthrodesis. The pre-and postoperative outcomes were pooled and presented per salvage procedure.
RESULTS
Data from 50 studies was included. Pain score improved after all surgeries except denervation. Flexion/extension decreased after radiocarpal arthrodesis, did not show significant changes after proximal row carpectomy, and improved for all other surgeries. DASH score improved after arthroplasty, proximal row carpectomy and midcarpal arthrodesis. Grip strength improved after interposition arthroplasty and partial arthrodesis.
CONCLUSION
Evidence from this review did not support the indication for denervation in this particular patient population. In patients with SLAC/SNAC II, proximal row carpectomy might be favourable to a midcarpal arthrodesis solely based on better FE ROM of the radiocarpal joint after proximal row carpectomy. In terms of radiocarpal mobility, total wrist arthroplasty might be preferred to radiocarpal arthrodesis in patients with osteoarthritis after a distal radius fracture. More uniform measurements of outcomes would improve the understanding of the effect of surgical treatments of the posttraumatic osteoarthritic wrist.
Topics: Humans; Osteoarthritis; Wrist Joint; Range of Motion, Articular; Patient Reported Outcome Measures; Salvage Therapy; Arthrodesis; Hand Strength; Treatment Outcome; Wrist Injuries; Recovery of Function; Denervation
PubMed: 38849773
DOI: 10.1186/s12891-024-07527-6