An Electronic Clinical Decision Support System for the Management of Low Back Pain in Community Pharmacy: Development and Mixed Methods Feasibility Study

Background People with low back pain (LBP) in the community often do not receive evidence-based advice and management. Community pharmacists can play an important role in supporting people with LBP as pharmacists are easily accessible to provide first-line care. However, previous research suggests that pharmacists may not consistently deliver advice that is concordant with guideline recommendations and may demonstrate difficulty determining which patients require prompt medical review. A clinical decision support system (CDSS) may enhance first-line care of LBP, but none exists to support the community pharmacist–client consultation. Objective This study aimed to develop a CDSS to guide first-line care of LBP in the community pharmacy setting and to evaluate the pharmacist-reported usability and acceptance of the prototype system. Methods A cross-platform Web app for the Apple iPad was developed in conjunction with academic and clinical experts using an iterative user-centered design process during interface design, clinical reasoning, program development, and evaluation. The CDSS was evaluated via one-to-one user-testing with 5 community pharmacists (5 case vignettes each). Data were collected via video recording, screen capture, survey instrument (system usability scale), and direct observation. Results Pharmacists’ agreement with CDSS-generated self-care recommendations was 90% (18/20), with medicines recommendations was 100% (25/25), and with referral advice was 88% (22/25; total 70 recommendations). Pharmacists expressed uncertainty when screening for serious pathology in 40% (10/25) of cases. Pharmacists requested more direction from the CDSS in relation to automated prompts for user input and page navigation. Overall system usability was rated as excellent (mean score 92/100, SD 6.5; 90th percentile compared with similar systems), with acceptance rated as good to excellent. Conclusions A novel CDSS (high-fidelity prototype) to enhance pharmacist care of LBP was developed, underpinned by clinical practice guidelines and informed by a multidisciplinary team of experts. User-testing revealed a high level of usability and acceptance of the prototype system, with suggestions to improve interface prompts and information delivery. The small study sample limits the generalizability of the findings but offers important insights to inform the next stage of system development. </jats:sec

Efficacy, tolerability, and dose-dependent effects of opioid analgesics for low back pain : a systematic review and meta-analysis

IMPORTANCE Opioid analgesics are commonly used for low back pain, however, to our knowledge there has been no systematic evaluation of the effect of opioid dose and use of enrichment study design on estimates of treatment effect. OBJECTIVE To evaluate efficacy and tolerability of opioids in the management of back pain; and investigate the effect of opioid dose and use of an enrichment study design on treatment effect. DATA SOURCES Medline, EMBASE, CENTRAL, CINAHL, and PsycINFO (inception to September 2015) with citation tracking from eligible randomized clinical trials (RCTs). STUDY SELECTION Placebo-controlled RCTs in any language. DATA EXTRACTION AND SYNTHESIS Two authors independently extracted data and assessed risk of bias. Data were pooled using a random effects model with strength of evidence assessed using the grading of recommendations assessment, development, and evaluation (GRADE). MAIN OUTCOMES AND MEASURES The primary outcome measurewas pain. Pain and disability outcomes were converted to a common 0 to 100 scale, with effects greater than 20 points considered clinically important. RESULTS Of 20 included RCTs of opioid analgesics (with a total of 7925 participants), 13 trials (3419 participants) evaluated short-term effects on chronic low back pain, and no placebo-controlled trials enrolled patients with acute low back pain. In half of these 13 trials, at least 50% of participants withdrew owing to adverse events or lack of efficacy. There was moderate-quality evidence that opioid analgesics reduce pain in the short term; mean difference (MD), −10.1 (95%CI, −12.8 to −7.4). Meta-regression revealed a 12.0 point greater pain relief for every 1 log unit increase in morphine equivalent dose (P = .046). Clinically important pain relief was not observed within the dose range evaluated (40.0-240.0-mg morphine equivalents per day). There was no significant effect of enrichment study design. CONCLUSIONS AND RELEVANCE For people with chronic low back pain who tolerate the medicine, opioid analgesics provide modest short-term pain relief but the effect is not likely to be clinically important within guideline recommended doses. Evidence on long-term efficacy is lacking. The efficacy of opioid analgesics in acute low back pain is unknown

Investigating the primary care management of low back pain : a simulated patient study

A limitation of existing studies of primary care for low-back-pain (LBP) is that they are not based upon direct observation of the clinical encounter and so may under or over-estimate the extent of evidence practice gaps. This was a cross-sectional observational study which observed the management recommendations for LBP provided in primary care using a simulated patient approach. Trained actors requested an over-the-counter medicine or asked for management advice for one of two simulated patient scenarios; non-specific LBP (NSLBP) or vertebral compression fracture. Visits were audio-recorded to allow data capture, validation and review. We evaluated concordance with key recommendations provided in evidence-based LBP guidelines on pain medicines, patient self-care advice and referral. Visits were conducted across 534 pharmacies comprising 336 non-specific scenarios and 198 fracture scenarios. Recommendations for pain medicines, but not patient self-care advice and referral, were typically consistent with guidelines. For the NSLBP scenario the concerns were: infrequent provision of reassurance of favourable outcome (8%), advice to stay active (5%), advice to avoid bed rest (0%), advice to use superficial heat (24%) and excessive endorsement of referral (57.4%) and imaging (22.7%). For the fracture scenario the concerns were a low rate of prompt medical referrals (50.0%) and low endorsement of rest (1.0%). Perspective: We observed primary-care that aligned closely with some aspects, but was at odds with other aspects, of evidence-based LBP guidelines. Problems included inadequate self-care advice and failing to appropriately recommend imaging or prompt medical review where indicated. These results can inform implementation strategies to improve primary-care management of LBP