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A Critical Analysis of the Exercise Prescription and Return to Activity Advice That Is Provided in Patient Information Leaflets Following Lumbar Spine Surgery.

ABSTRACT: Background and objectives: Lumbar spine surgery may be considered if pharmacologic, rehabilitation and interventional approaches cannot provide sufficient recovery from low back-related pain. Postoperative physiotherapy treatment in England is often accompanied by patient information leaflets, which contain important rehabilitation advice. However, in order to be an effective instrument for patients, the information provided in these leaflets must be up to date and based on the best available evidence and clinical practice. This study aims to critically analyse the current postoperative aspects of rehabilitation (exercise prescription and return to normal activity) that are provided in patient information leaflets in England as part of an evaluation of current practice following lumbar spine surgery. Materials and Methods: Patient information leaflets from English National Health Service (NHS) hospitals performing lumbar spine surgery were sourced online. A content analysis was conducted to collect data on postoperative exercise prescription and return to normal activities. Results: Thirty-two patient information leaflets on lumbar surgery were sourced (fusion, n = 11; decompression, n = 15; all lumbar procedures, n = 6). Many of the exercises prescribed within the leaflets were not based on evidence of clinical best practice and lacked a relationship to functional activity. Return to normal activity advice was also wide ranging, with considerable variation in the recommendations and definitions provided. Conclusions: This study highlights a clear variation in the recommendations of exercise prescription, dosage and returning to normal activities following lumbar spine surgery. Future work should focus on providing a consistent and patient-centred approach to recovery.

SUBMITTER: Low M

PROVIDER: S-EPMC6681378 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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A Critical Analysis of the Exercise Prescription and Return to Activity Advice That Is Provided in Patient Information Leaflets Following Lumbar Spine Surgery.

Low Matthew M Burgess Louise C LC Wainwright Thomas W TW

Medicina (Kaunas, Lithuania) 20190707 7

<i>Background and objectives:</i> Lumbar spine surgery may be considered if pharmacologic, rehabilitation and interventional approaches cannot provide sufficient recovery from low back-related pain. Postoperative physiotherapy treatment in England is often accompanied by patient information leaflets, which contain important rehabilitation advice. However, in order to be an effective instrument for patients, the information provided in these leaflets must be up to date and based on the best avail ...[more]

PMID: 31284666

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Project description:BackgroundNocebo effects ('negative placebo' effects) experienced by clinical trial participants can arise from an underlying condition or through communication about side effects in the participant information leaflets (or elsewhere). Misattributing nocebo effects to the medicinal intervention can lead to participants experiencing harmful nocebo effects and may result in distortion of adverse effect reporting. However, little is known about how information on potential side effects is provided to trial participants. There is increasing concern that the way in which potential side effects in clinical trials are described to patients in participant information leaflets (PIL) can in itself cause harm by either increased anxiety, poor adherence or inducing the side effect itself. In this study, we aimed to explore these concerns and identify the way in which potential side effects from investigational medicinal products used in trials are presented in written information to potential participants.MethodsTrials were identified from the International Standard Randomised Controlled Trials Number (ISRCTN) clinical trial registry (a primary registry of the WHO International Clinical Trials Registry Platform (ICTRP)). Eligible studies were placebo-controlled clinical trials of investigational medicinal products (IMP) in adults conducted in the UK. We assessed readability using the Flesch Reading Ease scale, Gunning-Fog Index and Flesch-Kincaid Grade. Data extracted from the PILs were divided into 8 predefined qualitative themes for analysis in NVivo11.ResultsMost of the patient information leaflets were ranked as 'fairly difficult to read' or 'difficult to read' according to the Flesch Reading Ease scale. All studies presented information about adverse events, whereas only a third presented information about intervention benefits. Where intervention or study benefits were presented, they were usually after adverse events (21/33, 64%).DiscussionParticipant information leaflets scored poorly on ease of readability and had more content relating to adverse effects than any potential beneficial effects. The way in which adverse events were presented was heterogeneous in terms of their likelihood and severity and the amount and level of detail provided. By comparison, potential benefits from the intervention and/or study were described less often, by shorter text, and only after information about harms.

Project description:PurposeTo characterize the inter- and intraobserver variability of qualitative, non-disk contour degenerative findings of the lumbar spine at magnetic resonance (MR) imaging.Materials and methodsThe case accrual method used to perform this institutional review board-approved, HIPAA-compliant retrospective study was the random selection of 111 interpretable MR examination cases of subjects from the Spine Patient Outcomes Research Trial. The subjects were aged 18-87 years (mean, 53 years +/- 16 [standard deviation]). Four independent readers rated the cases according to defined criteria. A subsample of 40 MR examination cases was selected for reevaluation at least 1 month later. The following findings were assessed: spondylolisthesis, disk degeneration, marrow endplate abnormality (Modic changes), posterior anular hyperintense zone (HIZ), and facet arthropathy. Inter- and intraobserver agreement in rating the data was summarized by using weighted kappa statistics.ResultsInterobserver agreement was good (kappa = 0.66) in rating disk degeneration and moderate in rating spondylolisthesis (kappa = 0.55), Modic changes (kappa = 0.59), facet arthropathy (kappa = 0.54), and posterior HIZ (kappa = 0.44). Interobserver agreement in rating the extent of Modic changes was moderate: kappa Values were 0.43 for determining superior anteroposterior extent, 0.47 for determining superior craniocaudal extent, 0.57 for determining inferior anteroposterior extent, and 0.48 for determining inferior craniocaudal extent. Intraobserver agreement was good in rating spondylolisthesis (kappa = 0.66), disk degeneration (kappa = 0.74), Modic changes (kappa = 0.64), facet arthropathy (kappa = 0.69), and posterior HIZ (kappa = 0.67). Intraobserver agreement in rating the extent of Modic changes was moderate, with kappa values of 0.54 for superior anteroposterior, 0.60 for inferior anteroposterior, 0.50 for superior craniocaudal, and 0.60 for inferior craniocaudal extent determinations.ConclusionThe interpretation of general lumbar spine MR characteristics has sufficient reliability to warrant the further evaluation of these features as potential prognostic indicators.

Dataset Information

A Critical Analysis of the Exercise Prescription and Return to Activity Advice That Is Provided in Patient Information Leaflets Following Lumbar Spine Surgery.

Publications

A Critical Analysis of the Exercise Prescription and Return to Activity Advice That Is Provided in Patient Information Leaflets Following Lumbar Spine Surgery.

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