Dataset Information

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.

ABSTRACT:

Objectives

To review the reporting of monitoring and implementation of interventions in a selection of trials that assessed the effectiveness of manual therapy and exercise in the management of shoulder subacromial pain.

Design

A review of trials assessing the effectiveness of manual therapy and exercise in the management of patients with shoulder subacromial pain.

Methods

We included in our review a selection of 10 trials that were included in a Cochrane review and compared manual therapy and exercise intervention with another intervention. Trials were assessed independently by two reviewers using two checklists: the Template for Intervention Description and Replication (TIDieR) and the Health Behavior Change Consortium treatment fidelity (National Institutes of Health Behaviour Change Consortium/NIHBCC).

Results

TIDieR overall scores for individual trials ranged from 11.1% to 45% and fidelity scores ranged from 7% to 50%. On average, trials scored the following within each domain of NIHBCC: study design 51%; training of providers 8%; treatment delivery 15%; treatment receipt 14% and treatment enactment 2.5%.

Conclusions

Little information about the monitoring, implementation and reporting of interventions was provided by trials and that is a barrier for implementing or replicating these interventions. The lack of information regarding the implementation of interventions needs to be taken into account when assessing whether effectiveness of interventions was impacted by their design or due to deviations from the protocol within trials.

SUBMITTER: Ribeiro DC

PROVIDER: S-EPMC7888324 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.

Ribeiro Daniel C DC Spiers Kate K Thomas Laura L Leilua Kiriffi K Wilkes Matthew M Norton Shontal S Lamb Sarah E SE

BMJ open 20210216 2

<h4>Objectives</h4>To review the reporting of monitoring and implementation of interventions in a selection of trials that assessed the effectiveness of manual therapy and exercise in the management of shoulder subacromial pain.<h4>Design</h4>A review of trials assessing the effectiveness of manual therapy and exercise in the management of patients with shoulder subacromial pain.<h4>Methods</h4>We included in our review a selection of 10 trials that were included in a Cochrane review and compare ...[more]

PMID: 33593786

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Project description:ObjectivesThe aim of this study was to assess whether it was feasible to conduct a full trial comparing a tailored versus a standardised exercise programme for patients with shoulder subacromial pain.DesignTwo-arm, patient-blinded and assessor-blinded, randomised controlled feasibility trial.MethodsTwenty-eight participants with shoulder subacromial pain were randomly allocated into one of two intervention groups-tailored or standardised exercise. Participants in the tailored exercise programme received exercises and manual therapy tailored to their scapular and shoulder movement impairments. Participants in the standardised exercise programme received progressive strengthening exercise. The primary outcome measures were (1) the participant recruitment rate; (2) the proportion of participants enrolled from the total number screened; (3) drop-out rates; and (4) adherence to the rehabilitation programme. Other outcome measures were: (5) pain levels; (6) Patient-Specific Functional Scale; (7) the Shoulder Pain and Disability Index; and (8) pain self-efficacy. We compared changes in pain and disability scores between groups using a repeated mixed-model analysis of variance. Since this is a feasibility study, we did not adjust alpha for multiple comparisons, and considered 75% CI as the probability threshold at 3-month follow-up. Health-related quality of life was assessed using the Short-Form 12 and quality-adjusted life years (QALYs) were estimated.ResultsThe recruitment rate was 3 participants per month, the proportion of participants enrolled was 23%, the drop-out rate was 14% and the overall adherence to the rehabilitation programme was 85%. No between-group differences were found for most outcome measures. Adverse events (n=2, only in the tailored group) were minor in nature and included skin injury or pain following taping.ConclusionsOur feasibility trial showed that additional strategies are required for improving recruitment, enrolment and minimising drop-out of participants into the trial and making it feasible to conduct a full trial.Trial registration numberANZCTR: 12617001405303.

Project description:Background/objectiveMultimodality neurologic monitoring (MMM) is an emerging technique for management of traumatic brain injury (TBI). An increasing array of MMM-derived biomarkers now exist that are associated with injury severity and functional outcomes after TBI. A standardized MMM reporting process has not been well described, and a paucity of evidence exists relating MMM reporting in TBI management with functional outcomes or adverse events.MethodsProspective implementation of standardized MMM reporting at a single pediatric intensive care unit (PICU) is described that included monitoring of intracranial pressure (ICP), cerebral oxygenation and electroencephalography (EEG). The incidence of clinical decisions made using MMM reporting is described, including timing of neuroimaging, ICP monitoring discontinuation, use of paralytic, hyperosmolar and pentobarbital therapies, neurosurgical interventions, ventilator and CPP adjustments and neurologic prognostication discussions. Retrospective analysis was performed on the association of MMM reporting with initial Glasgow Coma Scale (GCS) and Pediatric Risk of Mortality III (PRISM III) scores, duration of total hospitalization and PICU hospitalization, duration of mechanical ventilation and invasive ICP monitoring, inpatient complications, time with ICP > 20 mmHg, time with cerebral perfusion pressure (CPP) < 40 mmHg and 12-month Glasgow Outcome Scale-Extended Pediatrics (GOSE-Peds) scores. Association of outcomes with MMM reporting was investigated using the Wilcoxon rank-sum test or Fisher's exact test, as appropriate.ResultsEighty-five children with TBI underwent MMM over 6 years, among which 18 underwent daily MMM reporting over a 21-month period. Clinical decision-making influenced by MMM reporting included timing of neuroimaging (100.0%), ICP monitoring discontinuation (100.0%), timing of extubation trials of surviving patients (100.0%), body repositioning (11.1%), paralytic therapy (16.7%), hyperosmolar therapy (22.2%), pentobarbital therapy (33.3%), provocative cerebral autoregulation testing (16.7%), adjustments in CPP thresholds (16.7%), adjustments in PaCO2 thresholds (11.1%), neurosurgical interventions (16.7%) and neurologic prognostication discussions (11.1%). The implementation of MMM reporting was associated with a reduction in ICP monitoring duration (p = 0.0017) and mechanical ventilator duration (p = 0.0018). No significant differences were observed in initial GCS or PRISM III scores, total hospitalization length, PICU hospitalization length, total complications, time with ICP > 20 mmHg, time with CPP < 40 mmHg, use of tier 2 therapy, or 12-month GOS-E Peds scores.ConclusionImplementation of MMM reporting in pediatric TBI management is feasible and can be impactful in tailoring clinical decisions. Prospective work is needed to understand the impact of MMM and MMM reporting systems on functional outcomes and clinical care efficacy.

Project description:BackgroundArthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression.MethodsWe did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011.FindingsBetween Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference -1·3 points (95% CI -3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5-5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8-6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group).InterpretationSurgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process.FundingArthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).

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Dataset Information

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.

Objectives

Design

Methods

Results

Conclusions

Publications

Monitoring, implementation and reporting of interventions in a selection of trials assessing exercise therapy for the management of shoulder subacromial pain: a cross-sectional investigation.

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