The quality of subgroup analyses in chronic pain randomized controlled trials: a methodological review.
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ABSTRACT:
SUBMITTER: AminiLari M
PROVIDER: S-EPMC8019964 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:AimsThis study aimed to investigate the reporting of subgroup analyses in heart failure (HF) randomized controlled trials (RCTs) and to determine the strength and credibility of subgroup claims.Methods and resultsAll primary HF RCTs published in nine high-impact journals from 1 January 2008 to 31 December 2017 were included. Multivariable regression analysis was used to identify factors that may favour the reporting of results in specific subgroups. Strength of the subgroup effect claimed was classified into (i) strong, (ii) likely, or (iii) suggestive. Credibility of subgroup claim was scored using a pre-specified 10 pointer criteria. Of the 261 HF RCTs studied, 107 (41%) reported subgroup analyses. Twenty-five (23%) RCTs claimed a subgroup effect for the primary outcome of which six (24%) made a strong claim, eight (32%) claimed a likely effect, and 11 (44%) suggested a possible subgroup effect. Seven of the 25 RCTs did not employ interaction testing for subgroup claims of the primary outcome. Three out of 10 pre-specified credibility criteria were satisfied by half of the trials. Fourteen trials justified the choice of subgroups, and 10 explicitly stated they were underpowered to detect differences within subgroups. Source of funding did not influence the frequency of reporting subgroup analyses (OR 0.53, 95% CI 0.78-3.62, P = 0.52).ConclusionsAppropriate credibility criteria were rarely met even by HF RCTs that held strong subgroup claims. Subgroup analyses should be pre-specified, be adequately powered, present interaction terms, and be replicated in independent data before being integrated into clinical decision making.
| S-EPMC7835611 | biostudies-literature
Project description:Several studies reported that Tai Chi showed potential effects for chronic pain, but its role remains controversial. This review assessed the evidence regarding the effects of Tai Chi for chronic pain conditions. 18 randomized controlled trials were included in our review. The aggregated results have indicated that Tai Chi showed positive evidence on immediate relief of chronic pain from osteoarthritis (standardized mean difference [SMD], -0.54; 95% confidence intervals [CI], -0.77 to -0.30; P < 0.05). The valid duration of Tai Chi practice for osteoarthritis may be more than 5 weeks. And there were some beneficial evidences regarding the effects of Tai Chi on immediate relief of chronic pain from low back pain (SMD, -0.81; 95% CI, -1.11 to -0.52; P < 0.05) and osteoporosis (SMD, -0.83; 95% CI, -1.37 to -0.28; P = 0.003). Therefore, clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.
| S-EPMC4850460 | biostudies-other
Project description:OBJECTIVE: To evaluate the frequency, validity, and relevance of statistically significant (P<0.05) sex-treatment interactions in randomized controlled trials in Cochrane meta-analyses. DESIGN: Meta-epidemiological study. DATA SOURCES: Cochrane Database of Systematic Reviews (CDSR) and PubMed. ELIGIBILITY CRITERIA FOR STUDY SELECTION: Reviews published in the CDSR with sex-treatment subgroup analyses in the forest plots, using data from randomized controlled trials. DATA EXTRACTION: Information on the study design and sex subgroup data were extracted from reviews and forest plots that met inclusion criteria. For each statistically significant sex-treatment interaction, the potential for biological plausibility and clinical significance was considered. RESULTS: Among the 41 reviews with relevant data, there were 109 separate treatment-outcome analyses ("topics"). Among the 109 topics, eight (7%) had a statistically significant sex-treatment interaction. The 109 topics included 311 randomized controlled trials (162 with both sexes, 46 with males only, 103 with females only). Of the 162 individual randomized controlled trials that included both sexes, 15 (9%) had a statistically significant sex-treatment interaction. Of four topics where the first published randomized controlled trial had a statistically significant sex-treatment interaction, no meta-analyses that included other randomized controlled trials retained the statistical significance and no meta-analyses showed statistical significance when data from the first published randomized controlled trial were excluded. Of the eight statistically significant sex-treatment interactions from the overall analyses, only three were discussed by the CDSR reviewers for a potential impact on different clinical management for males compared with females. None of these topics had a sex-treatment interaction that influenced treatment recommendations in recent guidelines. UpToDate, an online physician-authored clinical decision support resource, suggested differential management of men and women for one of these sex-treatment interactions. CONCLUSION: Statistically significant sex-treatment interactions are only slightly more frequent than what would be expected by chance and there is little evidence of subsequent corroboration or clinical relevance of sex-treatment interactions.
| S-EPMC5122320 | biostudies-literature
Project description:OBJECTIVES:To systematically assess the evidence of Craniosacral Therapy (CST) for the treatment of chronic pain. METHODS:PubMed, Central, Scopus, PsycInfo and Cinahl were searched up to August 2018. Randomized controlled trials (RCTs) assessing the effects of CST in chronic pain patients were eligible. Standardized mean differences (SMD) and 95% confidence intervals (CI) were calculated for pain intensity and functional disability (primary outcomes) using Hedges' correction for small samples. Secondary outcomes included physical/mental quality of life, global improvement, and safety. Risk of bias was assessed using the Cochrane tool. RESULTS:Ten RCTs of 681 patients with neck and back pain, migraine, headache, fibromyalgia, epicondylitis, and pelvic girdle pain were included. CST showed greater post intervention effects on: pain intensity (SMD?=?-0.32, 95%CI?=?[-?0.61,-0.02]) and disability (SMD?=?-0.58, 95%CI?=?[-?0.92,-0.24]) compared to treatment as usual; on pain intensity (SMD?=?-0.63, 95%CI?=?[-?0.90,-0.37]) and disability (SMD?=?-0.54, 95%CI?=?[-?0.81,-0.28]) compared to manual/non-manual sham; and on pain intensity (SMD?=?-0.53, 95%CI?=?[-?0.89,-0.16]) and disability (SMD?=?-0.58, 95%CI?=?[-?0.95,-0.21]) compared to active manual treatments. At six months, CST showed greater effects on pain intensity (SMD?=?-0.59, 95%CI?=?[-?0.99,-0.19]) and disability (SMD?=?-0.53, 95%CI?=?[-?0.87,-0.19]) versus sham. Secondary outcomes were all significantly more improved in CST patients than in other groups, except for six-month mental quality of life versus sham. Sensitivity analyses revealed robust effects of CST against most risk of bias domains. Five of the 10 RCTs reported safety data. No serious adverse events occurred. Minor adverse events were equally distributed between the groups. DISCUSSION:In patients with chronic pain, this meta-analysis suggests significant and robust effects of CST on pain and function lasting up to six months. More RCTs strictly following CONSORT are needed to further corroborate the effects and safety of CST on chronic pain. PROTOCOL REGISTRATION AT PROSPERO:CRD42018111975.
| S-EPMC6937867 | biostudies-literature
Project description:ObjectiveTo determine the proportion of patients with neuropathic pain who achieve a clinically meaningful improvement in their pain with the use of different pharmacologic and nonpharmacologic treatments.Data sourcesMEDLINE, EMBASE, the Cochrane Library, and a gray literature search.Study selectionRandomized controlled trials that reported a responder analysis of adults with neuropathic pain-specifically diabetic neuropathy, postherpetic neuralgia, or trigeminal neuralgia-treated with any of the following 8 treatments: exercise, acupuncture, serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), topical rubefacients, opioids, anticonvulsant medications, and topical lidocaine.SynthesisA total of 67 randomized controlled trials were included. There was moderate certainty of evidence that anticonvulsant medications (risk ratio of 1.54; 95% CI 1.45 to 1.63; number needed to treat [NNT] of 7) and SNRIs (risk ratio of 1.45; 95% CI 1.33 to 1.59; NNT = 7) might provide a clinically meaningful benefit to patients with neuropathic pain. There was low certainty of evidence for a clinically meaningful benefit for rubefacients (ie, capsaicin; NNT = 7) and opioids (NNT = 8), and very low certainty of evidence for TCAs. Very low-quality evidence demonstrated that acupuncture was ineffective. All drug classes, except TCAs, had a greater likelihood of deriving a clinically meaningful benefit than having withdrawals due to adverse events (number needed to harm between 12 and 15). No trials met the inclusion criteria for exercise or lidocaine, nor were any trials identified for trigeminal neuralgia.ConclusionThere is moderate certainty of evidence that anticonvulsant medications and SNRIs provide a clinically meaningful reduction in pain in those with neuropathic pain, with lower certainty of evidence for rubefacients and opioids, and very low certainty of evidence for TCAs. Owing to low-quality evidence for many interventions, future high-quality trials that report responder analyses will be important to strengthen understanding of the relative benefits and harms of treatments in patients with neuropathic pain.
| S-EPMC8115961 | biostudies-literature
Project description:To identify the efficacy of auricular acupressure on pain and disability for chronic LBP by systematic review.A search of randomized controlled trials was conducted in four English medical electronic databases and three Chinese databases. Two reviewers independently retrieved related studies, assessed the methodological quality, and extracted data with a standardized data form. Meta-analyses were performed using all time-points meta-analysis.A total of 7 trials met the inclusion criteria, of which 4 had the low risk of bias. The findings of this study showed that, for the immediate effect, auricular acupressure had large, significant effects in improving pain within 12 weeks. As for the follow-up effect, the pooled estimates also showed promising effect at 4-week follow-up after 4-week intervention (standardized mean difference = -1.13, 95% CI (-1.70, -0.56), P < 0.001). But, for the disability level, the therapeutic effect was not significant (mean difference = -1.99, 95% CI (-4.93, 0.95), P = 0.18). No serious adverse effects were recorded.The encouraging evidence of this study indicates that it is recommended to provide auricular acupressure to patients with chronic low back pain. However, a more accurate estimate of the effect will require further rigorously designed large-scale RCTs on chronic LBP for improving pain and disability.
| S-EPMC5539928 | biostudies-other
Project description:Chronic pain has been estimated to affect 60% of patients with diabetes and is strongly associated with reduced activity tolerance. We systematically reviewed randomized controlled trials (RCTs) that explored interventions to improve physical activity among patients with diabetes to establish whether co-morbid chronic pain was captured at baseline or explored as an effect modifier and if trials reported a component designed to target chronic pain.We searched CINAHL, Cochrane Central Registry of Controlled Trials, EMBASE, ERIC, MEDLINE, SPORTDiscus and PsycInfo from inception of each database to March 2012 for RCTs that enrolled patients with diabetes and randomly assigned them to an intervention designed to promote physical activity. Two reviewers independently selected trials and abstracted data. We identified 136 trials meeting our inclusion criteria, only one of which that reported capturing chronic pain measures at baseline. No trial reported on specific interventions to address chronic pain as a competing demand, or as an effect modifier.Only 1 trial identified that aimed to promote physical activity among patients with diabetes reported that co-morbid chronic pain was captured at baseline. No trials reported exploring chronic pain as an effect modifier or targeting it as part of its intervention.
| S-EPMC3737137 | biostudies-literature
Project description:Autogenic training (AT) is frequently used as therapeutic approach in multimodal pain therapy. The aim of this systematic review and meta-analysis is to investigate the efficacy of AT in individuals suffering from chronic pain in comparison to passive and active control groups. A comprehensive literature search in Medline, Web of Science, PsycInfo, and PubPsych and manual searches (last search April 7, 2021) were conducted to locate randomized controlled trials (RCTs). Treatment guidelines and references of relevant articles and previous reviews were checked. ProQuest Dissertations and Theses Full Text database, DART-Europe E-theses Portal, Networked Digital Library of Theses and Dissertations (NDLTD), and the Theses Database of the German National Library were screened to identify any unpublished material. A total of 13 eligible studies (k = 15 comparisons) including 576 participants were identified. Random-effects meta-analyses revealed a significantly positive, moderate effect of AT on the primary outcome pain compared to passive control groups (g = 0.58, 95% CI [0.36; 0.79], k = 9, I2 = 0%). In comparison with other psychological interventions, no difference was found (g = - 0.05, 95% CI [- 0.30; 0.20], k = 6, I2 = 0%). Sensitivity analyses proved the robustness of findings. Overall risk-of-bias judgment was 'some concerns' in the majority of studies. Beneficial effects of AT on pain reduction were demonstrated, but findings are prone to bias. Furthermore, high methodological quality RCTs are needed to strengthen the promising evidence of AT for individuals with chronic pain.
| S-EPMC8548271 | biostudies-literature
Project description:ObjectiveTo determine the proportion of chronic low back pain patients who achieve a clinically meaningful response from different pharmacologic and nonpharmacologic treatments.Data sourcesMEDLINE, EMBASE, Cochrane Library, and gray literature search.Study selectionPublished randomized controlled trials (RCTs) that reported a responder analysis of adults with chronic low back pain treated with any of the following 15 interventions: oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs), exercise, acupuncture, spinal manipulation therapy, corticosteroid injections, acetaminophen, oral opioids, anticonvulsants, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors, cannabinoids, oral muscle relaxants, or topical rubefacients.SynthesisA total of 63 RCTs were included. There was moderate certainty that exercise (risk ratio [RR] of 1.71; 95% CI 1.37 to 2.15; number needed to treat [NNT] of 7), oral NSAIDs (RR = 1.44; 95% CI 1.17 to 1.78; NNT = 6), and SNRIs (duloxetine; RR = 1.25; 95% CI 1.13 to 1.38; NNT = 10) provide clinically meaningful benefits to patients with chronic low back pain. Exercise was the only intervention with sustained benefit (up to 48 weeks). There was low certainty that spinal manipulation therapy and topical rubefacients benefit patients. The benefit of acupuncture disappeared in higher-quality, longer (> 4 weeks) trials. Very low-quality evidence demonstrated that corticosteroid injections are ineffective. Patients treated with opioids had a greater likelihood of discontinuing treatment owing to an adverse event (number needed to harm of 5) than continuing treatment to derive any clinically meaningful benefit (NNT = 16), while those treated with SNRIs (duloxetine) had a similar likelihood of continuing treatment to attain benefit (NNT = 10) as those discontinuing the medication owing to an adverse event (number need to harm of 11). One trial each of anticonvulsants and topical NSAIDs found similar benefit to that of placebo. No RCTs of acetaminophen, cannabinoids, muscle relaxants, selective serotonin reuptake inhibitors, or tricyclic antidepressants met the inclusion criteria.ConclusionExercise, oral NSAIDs, and SNRIs (duloxetine) provide a clinically meaningful reduction in pain, with exercise being the only intervention that demonstrated sustained benefit after the intervention ended. Future high-quality trials that report responder analyses are required to provide a better understanding of the benefits and harms of interventions for patients with chronic low back pain.
| S-EPMC7822613 | biostudies-literature
Project description:BACKGROUND: We conducted in two parts a systematic review of randomized controlled trials (RCTs) on electronic symptom reporting between patients and providers to improve health care service quality. Part 1 reviewed the typology of patient groups, health service innovations, and research targets. Four innovation categories were identified: consultation support, monitoring with clinician support, self-management with clinician support, and therapy. OBJECTIVE: To assess the methodological quality of the RCTs, and summarize effects and benefits from the methodologically best studies. METHODS: We searched Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and IEEE Xplore for original studies presented in English-language articles between 1990 and November 2011. Risk of bias and feasibility were judged according to the Cochrane recommendation, and theoretical evidence and preclinical testing were evaluated according to the Framework for Design and Evaluation of Complex Interventions to Improve Health. Three authors assessed the risk of bias and two authors extracted the effect data independently. Disagreement regarding bias assessment, extraction, and interpretation of results were resolved by consensus discussions. RESULTS: Of 642 records identified, we included 32 articles representing 29 studies. No articles fulfilled all quality requirements. All interventions were feasible to implement in a real-life setting, and theoretical evidence was provided for almost all studies. However, preclinical testing was reported in only a third of the articles. We judged three-quarters of the articles to have low risk for random sequence allocation and approximately half of the articles to have low risk for the following biases: allocation concealment, incomplete outcome data, and selective reporting. Slightly more than one fifth of the articles were judged as low risk for blinding of outcome assessment. Only 1 article had low risk of bias for blinding of participants and personnel. We excluded 12 articles showing high risk or unclear risk for both selective reporting and blinding of outcome assessment from the effect assessment. The authors' hypothesis was confirmed for 13 (65%) of the 20 remaining articles. Articles on self-management support were of higher quality, allowing us to assess effects in a larger proportion of studies. All except one self-management interventions were equally effective to or better than the control option. The self-management articles document substantial benefits for patients, and partly also for health professionals and the health care system. CONCLUSION: Electronic symptom reporting between patients and providers is an exciting area of development for health services. However, the research generally is of low quality. The field would benefit from increased focus on methods for conducting and reporting RCTs. It appears particularly important to improve blinding of outcome assessment and to precisely define primary outcomes to avoid selective reporting. Supporting self-management seems to be especially promising, but consultation support also shows encouraging results.
| S-EPMC3510713 | biostudies-other