Core outcome domains for lichen sclerosus: a CORALS initiative consensus statement.

BACKGROUND: Lichen sclerosus (LS) is a chronic inflammatory condition mainly affecting genital skin. It causes distressing symptoms that impact daily quality of life (QoL). It causes progressive anatomical changes and a potential risk of cancer. Published randomized controlled trials are of varying methodological quality and difficult to combine in meta-analyses. This is partly due to lack of agreed outcome measures to assess treatment response. Identification of core outcome sets (COSs), which standardize key outcomes to be measured in all future trials, is a solution to this problem. OBJECTIVES: To obtain international agreement on which outcome domains should be measured in interventional trials of genital LS. METHODS: Recommended best practice for COS domain development was followed: (i) identification of potential outcome domains: a long list was generated through an up-to-date LS literature search, including information collected during the LS priority-setting partnership; (ii) provisional agreement of outcome domains: a three-stage multi-stakeholder international electronic-Delphi (e-Delphi) consensus study; (iii) final agreement of outcome domains: online consensus meeting with international stakeholders including anonymized voting. RESULTS: In total, 123 participants (77 patients, 44 health professionals, 2 researchers) from 20 countries completed three rounds of the e-Delphi study. Eleven outcome domains were rated as 'critical' and were discussed at the online consensus meetings. The first set of consensus meetings involved 42 participants from 12 countries. Consensus was met for 'symptoms' (100% agreed) and 'QoL - LS-specific' (92% agreed). After the second set of meetings, involving 29 participants from 12 countries, 'clinical (visible) signs' also met consensus (97% agreed). CONCLUSIONS: The international community has agreed on three key outcome domains to measure in all future LS clinical trials. We recommend that trialists and systematic reviewers incorporate these domains into study protocols with immediate effect. CORALS will now work with stakeholders to select an outcome measurement instrument per prioritized core domain.

Effect of motor control exercises versus graded activity in patients with chronic nonspecific low back pain: a randomized controlled trial.

BACKGROUND: Motor control exercises to improve control and coordination of trunk muscles and graded activity under the principles of cognitive-behavioral therapy are 2 commonly used exercise therapies, yet there is little evidence to support the use of one intervention over the other. OBJECTIVE: The objective of this study was to compare the effectiveness of motor control exercises and graded activity for patients with chronic nonspecific low back pain. DESIGN: This study was a prospectively registered randomized controlled trial with outcome assessment and statistical analyses conducted blind to group. SETTING: The study was conducted in primary care settings. PATIENTS: The participants were 172 patients with chronic (>12 weeks) nonspecific low back pain. INTERVENTIONS: Patients were randomly assigned to receive either motor control exercises or graded activity. There was no attempt to subclassify patients to match them to a treatment. Patients in both groups received 14 sessions of individualized, supervised exercise therapy. MEASUREMENTS: Primary outcomes were average pain over the previous week (numeric rating scale) and function (Patient-Specific Functional Scale); secondary outcomes were disability (24-item Roland-Morris Disability Questionnaire), global impression of change (Global Perceived Effect Scale), and quality of life (36-Item Short-Form Health Survey questionnaire [SF-36]). Outcome measures were collected at baseline and at 2, 6, and 12 months after intervention. RESULTS: A linear mixed models analysis showed that there were no significant differences between treatment groups at any of the time points for any of the outcomes studied. For example, the effect for pain at 2 months was 0.0 (-0.7 to 0.8). LIMITATIONS: Clinicians could not be blinded to the interventions. CONCLUSION: results of this study suggest that motor control exercises and graded activity have similar effects for patients with chronic nonspecific low back pain.