Pharmacotherapy for the Prevention of Chronic Pain after Surgery in Adults: An Updated Systematic Review and Meta-analysis.

BACKGROUND: Chronic postsurgical pain can severely impair patient health and quality of life. This systematic review update evaluated the effectiveness of systemic drugs to prevent chronic postsurgical pain. METHODS: The authors included double-blind, placebo-controlled, randomized controlled trials including adults that evaluated perioperative systemic drugs. Studies that evaluated same drug(s) administered similarly were pooled. The primary outcome was the proportion reporting any pain at 3 or more months postsurgery. RESULTS: The authors identified 70 new studies and 40 from 2013. Most evaluated ketamine, pregabalin, gabapentin, IV lidocaine, nonsteroidal anti-inflammatory drugs, and corticosteroids. Some meta-analyses showed statistically significant-but of unclear clinical relevance-reductions in chronic postsurgical pain prevalence after treatment with pregabalin, IV lidocaine, and nonsteroidal anti-inflammatory drugs. Meta-analyses with more than three studies and more than 500 participants showed no effect of ketamine on prevalence of any pain at 6 months when administered for 24 h or less (risk ratio, 0.62 [95% CI, 0.36 to 1.07]; prevalence, 0 to 88% ketamine; 0 to 94% placebo) or more than 24 h (risk ratio, 0.91 [95% CI, 0.74 to 1.12]; 6 to 71% ketamine; 5 to 78% placebo), no effect of pregabalin on prevalence of any pain at 3 months (risk ratio, 0.88 [95% CI, 0.70 to 1.10]; 4 to 88% pregabalin; 3 to 80% placebo) or 6 months (risk ratio, 0.78 [95% CI, 0.47 to 1.28]; 6 to 68% pregabalin; 4 to 69% placebo) when administered more than 24 h, and an effect of pregabalin on prevalence of moderate/severe pain at 3 months when administered more than 24 h (risk ratio, 0.47 [95% CI, 0.33 to 0.68]; 0 to 20% pregabalin; 4 to 34% placebo). However, the results should be interpreted with caution given small study sizes, variable surgical types, dosages, timing and method of outcome measurements in relation to the acute pain trajectory in question, and preoperative pain status. CONCLUSIONS: Despite agreement that chronic postsurgical pain is an important topic, extremely little progress has been made since 2013, likely due to study designs being insufficient to address the complexities of this multifactorial problem.

Health-related quality of life at healing in individuals with chronic venous or mixed-venous leg ulceration: a longitudinal assessment.

AIMS: To identify factors associated with longitudinal changes in health-related quality of life in community-dwelling individuals with venous or mixed-venous leg ulcers. BACKGROUND: Most care focuses primarily on healing; this research may additionally lead to strategies to improve quality of life. DESIGN: Data from four studies (2000-2009) were combined (2012) to examine quality of life in community-dwelling individuals referred for care of chronic leg wounds. METHODS: Data collection occurred at baseline, 3, 6, 9 and 12 months or at healing and included a comprehensive clinical assessment and measures of pain (McGill), functional autonomy (EQ-5D™ ) and quality of life (SF-12TM ). Physical Component Summary and Mental Component Summary scores (SF-12TM ) were categorized by whether or not there was an improvement (≥3 points) over time. Multivariable logistic regression modelling was used to identify factors associated with improvement. RESULTS/FINDINGS: Mean age of this sample (n = 519) was 67·5 years, 55·9% were women. Median time to healing was 70 days. Mean Physical Component Summary score increased from 37·0-41·5; factors associated with improvement included independent mobility, family history, problems with usual activities, fewer comorbidities and higher baseline pain. Mean Mental Component Summary score improved from 50·5-53·7; factors associated with improvement included anxiety or depression at baseline and living with others. CONCLUSION: Chronic leg ulceration has a substantial, negative impact on health-related quality of life. Ascertaining characteristics associated with changes in quality of life will contribute to the development of comprehensive strategies for prevention, care and improved quality of life.

Factors associated with health-related quality of life in chronic leg ulceration.

BACKGROUND: Individuals with chronic leg ulceration may have significantly impaired health-related quality of life (HRQOL) due to pain, impaired mobility, poor sleep, depression, restricted work capacity, and social isolation. The study purpose was to examine the associations among sociodemographic and clinical factors and HRQOL in a large sample of community-dwelling adults being treated for leg ulcers. METHODS: Data are from the cross-sectional baseline assessment of the Canadian Bandaging Trial, a multi-center, randomized controlled trial conducted to assess time to healing with two forms of high-compression bandaging. All participants received a comprehensive, standardized clinical assessment, and completed the 12-item Short Form (SF-12) and McGill Pain Questionnaire. SF-12 data were compared to age- and sex-adjusted norms, and multivariable logistic regression was used to identify factors associated with whether individuals were below, or at/above their normative values on the physical and mental component summary (PCS, MCS). RESULTS: Of 424 individuals enrolled over a 50-month period, 407 (96 %) completed the SF-12. Mean age was 65 ± 17 years, and 55 % were women. Mean PCS was 39.1 ± 9.9 with 91 (22.4 %) scoring at/above the mean value for their age and sex; equivalent values for the MCS were 51.4 ± 9.9 and 209 (51.4 %). Higher levels of pain, younger age, larger size and longer duration of ulcer, and limited mobility were associated with poorer HRQOL. CONCLUSIONS: Findings confirm the considerable burden of illness associated with leg ulcers. Given the chronic and recurring nature of the condition, strategies focused on improving HRQOL and healing are needed for this vulnerable population.

Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain.

BACKGROUND: Chronic wounds are managed almost entirely by community nurses. Almost all individuals with leg ulcers report acute pain usually related to dressing change. Little is known about pain after healing. The purpose of this study was to explore the course of pain from baseline to time of healing of leg ulcers (venous or mixed etiology). In order to understand this phenomenon and develop implications for nursing practice, objectives included: 1) Measure incidence and prevalence of pain at baseline and healing; 2) Describe characteristics associated with leg ulcer pain at baseline; 3) Identify predictors of leg ulcer pain at healing. METHODS: Data were from one randomized controlled trial (2004-2008) of 424 individuals with leg ulcers in the community receiving evidence-informed nursing management. The primary outcome was pain at the time of healing. Predictive factors included demographic, circumstance of living, clinical and ulcer characteristics. Multivariable logistic regression identified the subset of predictors of pain at healing. Odds ratios (OR) and 95% confidence intervals (CI) are reported. RESULTS: Eighty-two percent of participants reported pain at baseline and 32% at healing. Five percent with no pain at baseline reported pain at healing. Thirty-seven percent reported moderate to severe pain at baseline and 11% at healing. Twenty percent of all those who healed reported pain interfered with work moderately to extremely at time of healing. Being female (OR=1.64, 95% CI 1.00, 2.68, p=0.05), use of short-stretch vs. four-layer bandages (OR=1.73, 95% CI 1.06, 2.82, p=0.03), lower SF-12 PCS (OR=0.97, 95% CI 0.94, 0.99, p=0.02) and MCS (OR=0.98, 95% CI 0.95-1.00, p=0.04) scores, use of non-steroidal anti-inflammatory drugs (OR=2.28, 95% CI 1.06, 4.88, p=0.03), and tender pain (OR=2.17, 95% CI 1.29, 3.66, p=<0.01) were associated with pain at time of healing. CONCLUSIONS: Pain is an issue on admission for chronic wounds and at healing, yet 58% with moderate to severe pain on admission were not taking pain medication(s). Future studies should examine the role of pain at healing and at subsequent ulcer recurrence. Mobility and other factors that may contribute to pain at time of healing should also be assessed. Community nurses are encouraged to consider pain when planning care on admission and also after wound healing, when most patients are discharged from care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00202267.

Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial.

BACKGROUND: Venous leg ulcers, affecting approximately 1% of the population, are costly to manage due to poor healing and high recurrence rates. We evaluated an evidence-informed leg ulcer care protocol with two frequently used high compression systems: 'four-layer bandage' (4LB) and 'short-stretch bandage' (SSB). METHODS: We conducted a cost-effectiveness analysis using individual patient data from the Canadian Bandaging Trial, a publicly funded, pragmatic, randomized trial evaluating high compression therapy with 4LB (n = 215) and SSB (n = 209) for community care of venous leg ulcers. We estimated costs (in 2009-2010 Canadian dollars) from the societal perspective and used a time horizon corresponding to each trial participant's first year. RESULTS: Relative to SSB, 4LB was associated with an average 15 ulcer-free days gained, although the 95% confidence interval [-32, 21 days] crossed zero, indicating no treatment difference; an average health benefit of 0.009 QALYs gained [-0.019, 0.037] and overall, an average cost increase of $420 [$235, $739] (due to twice as many 4LB bandages used); or equivalently, a cost of $46,667 per QALY gained. If decision makers are willing to pay from $50,000 to $100,000 per QALY, the probability of 4LB being more cost effective increased from 51% to 63%. CONCLUSIONS: Our findings differ from the emerging clinical and economic evidence that supports high compression therapy with 4LB, and therefore suggest another perspective on high compression practice, namely when delivered by trained registered nurses using an evidence-informed protocol, both 4LB and SSB systems offer comparable effectiveness and value for money.

The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies.

OBJECTIVE: To determine the relative effectiveness of evidence-informed practice using two high compression systems: four-layer (4LB) and short-stretch bandaging (SSB) in community care of venous leg ulcers. DESIGN AND SETTING: Pragmatic, multi-centre, parallel-group, open-label, randomized controlled trial conducted in 10 centres. Cognitively intact adults (≥18 years) referred for community care (home or clinic) with a venous ulceration measuring ≥0.7cm and present for ≥1 week, with an ankle brachial pressure index (ABPI) ≥0.8, without medication-controlled Diabetes Mellitus or a previous failure to improve with either system, were eligible to participate. METHODS: Consenting individuals were randomly allocated (computer-generated blocked randomization schedule) to receive either 4LB or SSB following an evidence-informed protocol. Primary endpoint: time-to- healing of the reference ulcer. SECONDARY OUTCOMES: recurrence rates, health-related quality of life (HRQL), pain, and expenditures. RESULTS: 424 individuals were randomized (4LB n = 215; SSB n = 209) and followed until their reference ulcer was healed (or maximum 30 months). An intent-to-treat analysis was conducted on all participants. Median time to ulcer healing in the 4LB group was 62 days [95% confidence interval (CI) 51 to 73], compared with 77 days (95% CI 63 to 91) in the SSB group. The unadjusted Kaplan-Meier curves revealed the difference in the distribution of cumulative healing times was not significantly different between group (log rank χ2 = 0.001, P = 0.98) nor ulcers recurrence (4LB, 10.1%; SSB, 13.3%; p = 0.345). Multivariable Cox Proportional Hazard Modeling also showed no significant between-bandage differences in healing time after controlling for significant covariates (p = 0.77). At 3-months post-baseline there were no differences in pain (no pain: 4LB, 22.7%; SSB, 26.7%; p = 0.335), or HRQL (SF-12 Mental Component Score: 4LB, 55.1; SSB, 55.8; p = 0.615; SF-12 Physical Component Score: 4LB, 39.0; SSB, 39.6; p = 0.675). The most common adverse events experienced by both groups included infection, skin breakdown and ulcer deterioration. CONCLUSIONS: The Canadian Bandaging Trial revealed that in the practice context of trained RNs using an evidence-informed protocol, the choice of bandage system (4LB and SSB) does not materially affect healing times, recurrence rates, HRQL, or pain. From a community practice perspective, this is positive news for patient-centred care allowing individual/family and practitioner choice in selecting compression technologies based on circumstances and context. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00202267.

Healthcare Use for Pain in Women Waiting for Gynaecological Surgery.

Background. Pain while waiting for surgery may increase healthcare utilization (HCU) preoperatively. Objective. Examine the association between preoperative pain and HCU in the year prior to gynecological surgery. Methods. 590 women waiting for surgery in a Canadian tertiary care centre were asked to report on HCU in the year before surgery. Pain was assessed using the Brief Pain Inventory. Results. 33% reported moderate to severe pain intensity and interference in the week before surgery. Sixty-one percent (n = 360) reported a total of 2026 healthcare visits, with 21% (n = 126) reporting six or more visits in the year before surgery. After controlling for covariates, women with moderate to severe (>3/10) pain intensity/interference reported higher odds of overall HCU (≥3 pain-related visits to family doctor or specialist in the past year or ≥1 to emergency/walk-in clinic) compared to women with no or mild pain. Lower body mass index (BMI < 30 versus ≥30) and anxiety and/or depression were associated with emergency department or walk-in visits but not visits to family doctors or specialists. Conclusions. There is a high burden of pain in women awaiting gynecological surgery. Decisions about resource allocation should consider the impact of pain on individuals and the healthcare system.

Pain in Canadian Veterans: analysis of data from the Survey on Transition to Civilian Life.

BACKGROUND: Little is known about the prevalence of chronic pain among Veterans outside the United States. OBJECTIVE: To describe the prevalence of chronic pain and associated sociodemographic, health behaviour, employment/income, disability, and physical and mental health factors in Canadian Veterans. METHODS: The 2010 Survey on Transition to Civilian Life included a nationally representative sample of 3154 Canadian Armed Forces Regular Force Veterans released from service between 1998 and 2007. Data from a telephone survey of Veterans were linked with Department of National Defence and Veterans Affairs Canada administrative databases. Pain was defined as constant/reoccurring pain (chronic pain) and as moderate/severe pain interference with activities. RESULTS: Forty-one percent of the population experienced constant chronic pain and 23% experienced intermittent chronic pain. Twenty-five percent reported pain interference. Needing help with tasks of daily living, back problems, arthritis, gastrointestinal conditions and age ≥ 30 years were independently associated with chronic pain. Needing help with tasks of daily living, back problems, arthritis, mental health conditions, age ≥ 30 years, gastrointestinal conditions, low social support and noncommissioned member rank were associated with pain interference. CONCLUSIONS: These findings provide evidence for agencies and those supporting the well-being of Veterans, and inform longitudinal studies to better understand the determinants and life course effects of chronic pain in military Veterans.

The Role of Preference on Outcomes of People Receiving Evidence-Informed Community Wound Care in Their Home or in a Nurse-Clinic Setting: A Cohort Study (n = 230).

This study followed a cohort of community-dwelling individuals receiving wound-care in a large urban-rural region. During a randomized control trial (RCT) evaluating outcomes of receiving care in a nurse-clinic or at home, many approached were willing to participate if they could choose their location of care. This provided a unique opportunity to enroll them as a "choice" cohort, following them in the same manner as the trial participants but allowing them to select their setting of care. The objective was to investigate the role of preference and location of care on care outcomes, including satisfaction with care, healing, health-related quality of life (HRQL), pain, and resource use. This is a secondary analysis of a prospective cohort of 126 individuals enrolled in an RCT to receive care at home or in a nurse-clinic (Allocated group), and an additional 104 who received care at home or in a nurse-clinic based on their preference (Choice group). Mobile individuals with a leg ulcer of venous or mixed venous etiology, referred for community leg ulcer care, were eligible. Specially-trained nurses provided care to both groups using an evidence-informed protocol. Baseline data included socio-demographic, circumstance-of-living and a detailed wound assessment. Mean age of the cohort was 68 years. Satisfaction, healing, recurrence, pain, HRQL, and resource utilization did not differ between groups. If available, individuals should have an option of care venue given almost half of those approached indicated a clear preference for clinic or home. With outcomes being similar, health care planners and decision-makers, as well as individuals and their families, can feel confident that the setting of care will not impact the outcomes. However, larger studies in other contexts are needed to explore the interaction between choice and setting.

Guideline adaptation and implementation planning: a prospective observational study.

BACKGROUND: Adaptation of high-quality practice guidelines for local use has been advanced as an efficient means to improve acceptability and applicability of evidence-informed care. In a pan-Canadian study, we examined how cancer care groups adapted pre-existing guidelines to their unique context and began implementation planning. METHODS: Using a mixed-methods, case-study design, five cases were purposefully sampled from self-identified groups and followed as they used a structured method and resources for guideline adaptation. Cases received the ADAPTE Collaboration toolkit, facilitation, methodological and logistical support, resources and assistance as required. Documentary and primary data collection methods captured individual case experience, including monthly summaries of meeting and field notes, email/telephone correspondence, and project records. Site visits, process audits, interviews, and a final evaluation forum with all cases contributed to a comprehensive account of participant experience. RESULTS: Study cases took 12 to >24 months to complete guideline adaptation. Although participants appreciated the structure, most found the ADAPTE method complex and lacking practical aspects. They needed assistance establishing individual guideline mandate and infrastructure, articulating health questions, executing search strategies, appraising evidence, and achieving consensus. Facilitation was described as a multi-faceted process, a team effort, and an essential ingredient for guideline adaptation. While front-line care providers implicitly identified implementation issues during adaptation, they identified a need to add an explicit implementation planning component. CONCLUSIONS: Guideline adaptation is a positive initial step toward evidence-informed care, but adaptation (vs. 'de novo' development) did not meet expectations for reducing time or resource commitments. Undertaking adaptation is as much about the process (engagement and capacity building) as it is about the product (adapted guideline). To adequately address local concerns, cases found it necessary to also search and appraise primary studies, resulting in hybrid (adaptation plus de novo) guideline development strategies that required advanced methodological skills.Adaptation was found to be an action element in the knowledge translation continuum that required integration of an implementation perspective. Accordingly, the adaptation methodology and resources were reformulated and substantially augmented to provide practical assistance to groups not supported by a dedicated guideline panel and to provide more implementation planning support. The resulting framework is called CAN-IMPLEMENT.