Dataset Information

Lack of standardization in dry needling dosage and adverse event documentation limits outcome and safety reports: a scoping review of randomized clinical trials.

ABSTRACT:

Objectives

Examine: (1) whether variability in dry needling (DN) dosage affects pain outcomes, (2) if effect sizes are clinically important, and (3) how adverse events (AE) were documented and whether DN safety was determined.

Methods

Nine databases were searched for randomized controlled trials (RCTs) investigating DN in symptomatic musculoskeletal disorders. Methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) scale. Included RCTs met PEDro criteria #1 and scored > 7/10. Data extraction included DN dosage, pain outcome measures, dichotomous AE reporting (yes/no), and AE categorization. Clinically meaningful differences were determined using the minimum clinically important difference (MCID) for pain outcomes .

Results

Out of 22 identified RCTs, 11 demonstrated significant between-group differences exceeding the MCID, suggesting a clinically meaningful change in pain outcomes. Nine documented whether AE occurred. Only five provided AEs details and four cited a standard means to report AE.

Discussion

There was inconsistency in reporting DN dosing parameters and AE. We could not determine if DN dosing affects outcomes, whether DN consistently produces clinically meaningful changes, or establish optimal dosage. Without more detailed reporting, replication of methods in future investigations is severely limited. A standardized method is lacking to report, classify, and provide context to AE from DN. Without more detailed AE reporting in clinical trials investigating DN efficacy, a more thorough appraisal of relative risk, severity, and frequency was not possible. Based on these inconsistencies, adopting a standardized checklist for reporting DN dosage and AE may improve internal and external validity and the generalizability of results.

SUBMITTER: Kearns GA

PROVIDER: S-EPMC10013441 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Lack of standardization in dry needling dosage and adverse event documentation limits outcome and safety reports: a scoping review of randomized clinical trials.

Kearns Gary A GA Brismée Jean-Michel JM Riley Sean P SP Wang-Price Sharon S Denninger Thomas T Vugrin Margaret M

The Journal of manual & manipulative therapy 20220523 2

<h4>Objectives</h4>Examine: (1) whether variability in dry needling (DN) dosage affects pain outcomes, (2) if effect sizes are clinically important, and (3) how adverse events (AE) were documented and whether DN safety was determined.<h4>Methods</h4>Nine databases were searched for randomized controlled trials (RCTs) investigating DN in symptomatic musculoskeletal disorders. Methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) scale. Included RCTs met PEDro crite ...[more]

PMID: 35607259

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Project description:Background/Objectives: The current study aimed to characterize the adverse reactions associated with dry needling (DN) treatments reported by Polish physiotherapists, with a secondary objective of investigating whether the level of DN experience influences the occurrence of these adverse effects. Methods: A total of 102 Polish physiotherapists, all with regular DN practice, participated in an ad hoc online survey. The participants were categorized by their level of experience in DN treatment: 44 with 0-2 years, 43 with 3-6 years, and 15 with more than 7 years of experience. The survey consisted of 27 questions focused on both mild and severe adverse effects resulting from DN treatments. Results: The results showed that in the short term (over the past week), minor bleeding was the most commonly reported mild adverse effect (70%), followed closely by slightly pain during treatment (68%). Slight pain following treatment was also reported by 52% of respondents. No significant relationship was found between experience with dry needling (DN) and the reporting of mild adverse effects, with the exception of tingling (X(2) = 10.958; p = 0.004). In the retrospective analysis of the past month, most respondents reported experiencing bleeding between one and three times (49%), while bruising occurred one to three times in 44% of cases. Similarly, 44% of respondents noted pain after treatment one to three times, and 47% experienced pain during DN at this frequency. A significant interaction with DN experience was observed in the frequency of drowsiness reported over the past month (X(10) = 19.735; p = 0.032). Conclusions: Severe adverse effects were extremely rare in clinical practice: pneumothorax and shock were each reported by 3% of respondents, nerve palsy by 14%, infection by 2%, and hospitalization by 1%. In conclusion, this study suggests that most adverse effects are mild, typically involving bleeding and slight pain during or after treatment. Additionally, DN experience does not appear to be a significant factor influencing the type or prevalence of these adverse effects.

Project description:ObjectiveTo compare the effect of ultrasound (US)-guided dry needling (DN) with traditional DN in the treatment of pain and dysfunction for patients with knee osteoarthritis (KOA).DesignA double-blind, randomized controlled trial.MethodsPatients (25 male and 65 female), age 50-80 years diagnosed with KOA were recruited and randomly assigned to one of three groups in a 1:1:1 ratio for intervention: real US-guided DN with exercise therapy (G1), placebo US-guided DN with exercise therapy (G2), and exercise therapy solely (G3). G1 and G2 were blinded to the application of real or placebo US guidance by turning the monitor of US imaging out-of-view from participants' vantage points. The effectiveness of blinding was evaluated by asking the participants whether they had received real-US guided DN. The responses were assessed by Chi-square test. Visual Analogue Scale (VAS), Knee injury, and Osteoarthritis Outcome Score (KOOS) subscales (KOOS-pain, KOOS-symptoms, KOOS-quality-of-life (QoL)) were collected at baseline, 4 weeks, and 8 weeks by a blinded assessor. Data were analyzed by mixed model analysis of variance (ANOVA) with Bonferroni correction.ResultsEighty-four participants (61.26±5.57 years) completed the study. G1 achieved significant improvement in VAS at 8 weeks compared to G2 and G3 (G1 vs. G2: MD = -15.61, 95% CI [-25.49, -5.51], p = 0.001; G1 vs. G3: MD = -19.90, 95% CI [-29.71, -10.08], p< 0.001). G1 achieved significant improvement in KOOS-pain at 8 weeks compared to G2 and G3 (G1 vs. G2: MD = 9.76, 95% CI [2.38, 17.14], p = 0.006; G1 vs. G3: MD = 9.48, 95% CI [2.31, 16.66], p = 0.010). KOOS-symptoms and KOOS-QoL were not statistically significant between groups. G2 had no significant difference of the perceptions as G1 with p = 0.128. G2 were successfully blinded to placebo US-guided DN.ConclusionUS-guided DN with exercise therapy may be more effective than traditional DN with exercise therapy or exercise therapy alone in reduce pain of KOA.

Project description:BackgroundAutomated recognition and redaction of personal identifiers in free text can enable organisations to share data while protecting privacy. This is important in the context of pharmacovigilance since relevant detailed information on the clinical course of events, differential diagnosis, and patient-reported reflections may often only be conveyed in narrative form. The aim of this study is to develop and evaluate a method for automated redaction of person names in English narrative text on adverse event reports. The target domain for this study was case narratives from the United Kingdom's Yellow Card scheme, which collects and monitors information on suspected side effects to medicines and vaccines.MethodsWe finetuned BERT - a transformer-based neural network - for recognising names in case narratives. Training data consisted of newly annotated records from the Yellow Card data and of the i2b2 2014 deidentification challenge. Because the Yellow Card data contained few names, we used predictive models to select narratives for training. Performance was evaluated on a separate set of annotated narratives from the Yellow Card scheme. In-depth review determined whether (parts of) person names missed by the de-identification method could enable re-identification of the individual, and whether de-identification reduced the clinical utility of narratives by collaterally masking relevant information.ResultsRecall on held-out Yellow Card data was 87% (155/179) at a precision of 55% (155/282) and a false-positive rate of 0.05% (127/ 263,451). Considering tokens longer than three characters separately, recall was 94% (102/108) and precision 58% (102/175). For 13 of the 5,042 narratives in Yellow Card test data (71 with person names), the method failed to flag at least one name token. According to in-depth review, the leaked information could enable direct identification for one narrative and indirect identification for two narratives. Clinically relevant information was removed in less than 1% of the 5,042 processed narratives; 97% of the narratives were completely untouched.ConclusionsAutomated redaction of names in free-text narratives of adverse event reports can achieve sufficient recall including shorter tokens like patient initials. In-depth review shows that the rare leaks that occur tend not to compromise patient confidentiality. Precision and false positive rates are acceptable with almost all clinically relevant information retained.

Dataset Information

Lack of standardization in dry needling dosage and adverse event documentation limits outcome and safety reports: a scoping review of randomized clinical trials.

Objectives

Methods

Results

Discussion

Publications

Lack of standardization in dry needling dosage and adverse event documentation limits outcome and safety reports: a scoping review of randomized clinical trials.

Similar Datasets

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