Background and Purpose. Assessment of the quality of randomized controlled trials (RCTs) is common practice in systematic reviews. However, the reliability of data obtained with most quality assessment scales has not been established. This report describes 2 studies designed to investigate the reliability of data obtained with the Physiotherapy Evidence Database (PEDro) scale developed to rate the quality of RCTs evaluating physical therapist interventions. Method. In the first study, 11 raters independently rated 25 RCTs randomly selected from the PEDro database. In the second study, 2 raters rated 120 RCTs randomly selected from the PEDro database, and disagreements were resolved by a third rater; this generated a set of individual rater and consensus ratings. The process was repeated by independent raters to create a second set of individual and consensus ratings. Reliability of ratings of PEDro scale items was calculated using multirater kappas, and reliability of the total (summed) score was calculated using intraclass correlation coefficients (ICC [1,1]). Results. The kappa value for each of the 11 items ranged from .36 to .80 for individual assessors and from .50 to .79 for consensus ratings generated by groups of 2 or 3 raters. The ICC for the total score was .56 (95% confidence interval=.47–.65) for ratings by individuals, and the ICC for consensus ratings was .68 (95% confidence interval=.57–.76). Discussion and Conclusion. The reliability of ratings of PEDro scale items varied from “fair” to “substantial,” and the reliability of the total PEDro score was “fair” to “good.”

Reliability of the PEDro Scale for Rating Quality of Randomized Controlled Trials

Background
Exercise therapy is widely used as an intervention in low-back pain.

Objectives
To evaluate the effectiveness of exercise therapy in adult non-specific acute, subacute and chronic low-back pain versus no treatment and other conservative treatments.

Search methods
The Cochrane Central Register of Controlled Trials (Issue 3, 2004), MEDLINE, EMBASE, PsychInfo, CINAHL databases to October 2004; citation searches and bibliographic reviews of previous systematic reviews.

Selection criteria
Randomized controlled trials evaluating exercise therapy for adult non-specific low-back pain and measuring pain, function, return-to-work/absenteeism, and/or global improvement outcomes.

Data collection and analysis
Two reviewers independently selected studies and extracted data on study characteristics, quality, and outcomes at short, intermediate, and long-term follow-up.

Main results
Sixty-one randomized controlled trials (6390 participants) met inclusion criteria: acute (11), subacute (6) and chronic (43) low-back pain (1 unclear). Evidence was found of effectiveness in chronic populations relative to comparisons at all follow-up periods; pooled mean improvement was 7.3 points (95% CI, 3.7 to 10.9) for pain (out of 100), 2.5 points (1.0 to 3.9) for function (out of 100) at earliest follow-up. In studies investigating patients (i.e. presenting to healthcare providers) mean improvement was 13.3 points (5.5 to 21.1) for pain, 6.9 (2.2 to 11.7) for function, representing significantly greater improvement over studies where participants included those recruited from a general population (e.g. with advertisements). There is some evidence of effectiveness of graded-activity exercise program in subacute low-back pain in occupational settings, though the evidence for other types of exercise therapy in other populations is inconsistent. There was evidence of equal effectiveness relative to comparisons in acute populations [pain: 0.03 points (95% CI, -1.3 to 1.4)].

Limitations: This review largely reflects limitations of the literature, including low quality studies with heterogeneous outcome measures, inconsistent and poor reporting, and possibility of publication bias.

Authors' conclusions
Exercise therapy appears to be slightly effective at decreasing pain and improving function in adults with chronic low-back pain, particularly in healthcare populations. In subacute low-back pain there is some evidence that a graded activity program improves absenteeism outcomes, though evidence for other types of exercise is unclear. In acute low-back pain, exercise therapy is as effective as either no treatment or other conservative treatments.

Exercise therapy for treatment of non-specific low back pain.

This systematic review found that 2 features of exercise therapy for chronic nonspecific low back pain seem to be responsible for success: close supervision and an individually designed program.

/pdf/systematic-review-strategies-for-using-exercise-therapy-to-10cpdv9r0w.pdf

Systematic Review: Strategies for Using Exercise Therapy To Improve Outcomes in Chronic Low Back Pain

https://www.oarsijournal.com/article/S1063-4584(07)00234-8/pdf

OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence.

Patients with low back pain were most likely to benefit from spinal manipulation if they met at least 4 of the following criteria: symptom duration less than 16 days, no symptoms distal to the knee...

/pdf/a-clinical-prediction-rule-to-identify-patients-with-low-2lhpme8wdl.pdf

A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely To Benefit from Spinal Manipulation: A Validation Study

Introduction. A structured and rigorous methodology was developed for the formulation of evidence-based clinical practice guidelines (EBCPGs), then was used to develop EBCPGs for selected rehabilitation interventions for the management of low back pain. Methods. Evidence from randomized controlled trials (RCTs) and observational studies was identified and synthesized using methods defined by the Cochrane Collaboration that minimize bias by using a systematic approach to literature search, study selection, data extraction, and data synthesis. Meta-analysis was conducted where possible. The strength of evidence was graded as level I for RCTs or level II for nonrandomized studies. Developing Recommendations. An expert panel was formed by inviting stakeholder professional organizations to nominate a representative. This panel developed a set of criteria for grading the strength of both the evidence and the recommendation. The panel decided that evidence of clinically important benefit (defined as 15% greater relative to a control based on panel expertise and empiric results) in patient-important outcomes was required for a recommendation. Statistical significance was also required, but was insufficient alone. Patient-important outcomes were decided by consensus as being pain, function, patient global assessment, quality of life, and return to work, providing that these outcomes were assessed with a scale for which measurement reliability and validity have been established. Validating the Recommendations. A feedback survey questionnaire was sent to 324 practitioners from 6 professional organizations. The response rate was 51%. Results. Four positive recommendations of clinical benefit were developed. Therapeutic exercises were found to be beneficial for chronic, subacute, and postsurgery low back pain. Continuation of normal activities was the only intervention with beneficial effects for acute low back pain. These recommendations were mainly in agreement with previous EBCPGs, although some were not covered by other EBCPGs. There was wide agreement with these recommendations from practitioners (greater than 85%). For several interventions and indications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stimulation), there was a lack of evidence regarding efficacy. Conclusions. This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing guidelines that incorporates clinicians' feedback and is widely acceptable to practicing clinicians. Further well-designed RCTs are warranted regarding the use of several interventions for patients with low back pain where evidence was insufficient to make recommendations.

Philadelphia Panel Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions for Low Back Pain

Introduction. A structured and rigorous methodology was developed for the formulation of evidence-based clinical practice guidelines (EBCPGs), then was used to develop EBCPGs for selected rehabilitation interventions for the management of low back, neck, knee, and shoulder pain. Methods. Evidence from randomized controlled trials (RCTs) and observational studies was identified and synthesized using methods defined by the Cochrane Collaboration that minimize bias by using a systematic approach to literature search, study selection, data extraction, and data synthesis. Meta-analyses were conducted where possible. The strength of evidence was graded as level I for RCTs or level II for nonrandomized studies. Developing Recommendations. An expert panel was formed by inviting stakeholder professional organizations to nominate a representative. This panel developed a set of criteria for grading the strength of both the evidence and the recommendation. The panel decided that evidence of clinically important benefit (defined as 15% greater relative to a control based on panel expertise and empiric results) in patient-important outcomes was required for a recommendation. Statistical significance was also required but was insufficient alone. Patient-important outcomes were decided by consensus as being pain, function, patient global assessment, quality of life, and return to work, providing that these outcomes were assessed with a scale for which measurement reliability and validity have been established. Validating the Recommendations. A feedback survey questionnaire was sent to 324 practitioners from 6 professional organizations. The response rate was 51%. Results. Eight positive recommendations of clinical benefit were developed. These recommendations were mainly in agreement with previous EBCPGs, although some were not covered by other EBCPGs. There was wide agreement with these recommendations from practitioners (greater than 75% agreement). For several interventions and indications (eg, thermotherapy, therapeutic ultrasound, massage, electrical stimulation, mechanical traction), there was a lack of evidence regarding efficacy. Conclusions. This methodology of developing EBCPGs provides a structured approach to assessing the literature and developing EBCPGs that incorporates clinicians' feedback and is widely acceptable to practicing clinicians. Further well-designed RCTs are warranted regarding the use of several interventions where evidence was insufficient to make recommendations.

/pdf/philadelphia-panel-evidence-based-clinical-practice-4eb8408r1z.pdf

John Albright

Papers

Philadelphia Panel Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions for Low Back Pain

Philadelphia Panel Evidence-Based Clinical Practice Guidelines on Selected Rehabilitation Interventions: Overview and Methodology