Interventions to improve outdoor mobility among people living with disabilities: A systematic review.

Background: Around 15% of the global population live with some form of disabilities and experience worse health outcomes, less participation in the community and are part of fewer activities outside the home. Outdoor mobility interventions aim to improve the ability to move, travel and orient outside the home and could influence the number of activities outside the home, participation and quality of life. However, outdoor mobility interventions may also lead to harm like falls or injuries or have unforeseen effects which could lead to mortality or hospitalization. Objectives: To assess the efficacy of interventions aiming to improve outdoor mobility for adults living with disabilities and to explore if the efficacy varies between different conditions and different intervention components. Search Methods: Standard, extensive Campbell search methods were used, including a total of 12 databases searched during January 2023, including trial registries. Selection Criteria: Only randomized controlled trials were included, focusing on people living with disabilities, comparing interventions to improve outdoor mobility to control interventions as well as comparing different types of interventions to improve outdoor mobility. Data Collection and Analysis: Standard methodological procedures expected by Campbell were used. The following important outcomes were 1. Activity outside the home; 2. Engagement in everyday life activities; 3. Participation; 4. Health-related Quality of Life; 5. Major harms; 6. Minor harms. The impact of the interventions was evaluated in the shorter (≤6 months) and longer term (≥7 months) after starting the intervention. Results are presented using risk ratios (RR), risk difference (RD), and standardized mean differences (SMD), with the associated confidence intervals (CI). The risk of bias 2-tool and the GRADE-framework were used to assess the certainty of the evidence. Main Results: The screening comprised of 12.894 studies and included 22 studies involving 2.675 people living with disabilities and identified 12 ongoing studies. All reported outcomes except one (reported in one study, some concerns of bias) had overall high risk of bias. Thirteen studies were conducted in participants with disabilities due to stroke, five studies with older adults living with disabilities, two studies with wheelchair users, one study in participants with disabilities after a hip fracture, and one study in participants with cognitive impairments. Skill training interventions versus control interventions (16 studies) The evidence is very uncertain about the benefits and harms of skill training interventions versus control interventions not aimed to improve outdoor mobility among all people living with disabilities both in the shorter term (≤6 months) and longer term (≥7 months) for Activity outside the home; Participation; Health-related Quality of Life; Major harms; and Minor harms, based on very low certainty evidence. Skill training interventions may improve engagement in everyday life activities among people with disabilities in the shorter term (RR: 1.46; 95% CI: 1.16 to 1.84; I 2 = 7%; RD: 0.15; 95% CI: -0.02 to 0.32; I 2 = 71%; 692 participants; three studies; low certainty evidence), but the evidence is very uncertain in the longer term, based on very low certainty evidence. Subgroup analysis of skill training interventions among people living with disabilities due to cognitive impairments suggests that such interventions may improve activity outside the home in the shorter term (SMD: 0.44; 95% CI: 0.07 to 0.81; I 2 = NA; 118 participants; one study; low certainty evidence). Subgroup analysis of skill training interventions among people living with cognitive impairments suggests that such interventions may improve health-related quality of life in the shorter term (SMD: 0.49; 95% CI: 0.12 to 0.88; I 2 = NA; 118 participants; one study; low certainty evidence). Physical training interventions versus control interventions (five studies) The evidence is very uncertain about the benefits and harms of physical training interventions versus control interventions not aimed to improve outdoor mobility in the shorter term (≤6 months) and longer term (≥7 months) for: Engagement in everyday life activities; Participation; Health-related Quality of Life; Major harms; and Minor harms, based on very low certainty evidence. Physical training interventions may improve activity outside the home in the shorter (SMD: 0.35; 95% CI: 0.08 to 0.61; I 2 = NA; 228 participants; one study; low certainty evidence) and longer term (≥7 months) (SMD: 0.27; 95% CI: 0.00 to 0.54; I 2 = NA; 216 participants; one study; low certainty evidence). Comparison of different outdoor mobility interventions (one study) The evidence is very uncertain about the benefits and harms of outdoor mobility interventions of different lengths in the shorter term (≤6 months) and longer term (≥7 months) for Activity outside the home; Engagement in everyday life activities; Participation; Health-related Quality of Life; Major harms; and Minor harms, based on very low certainty evidence. No studies explored the efficacy of other types of interventions. Authors' Conclusions: Twenty-two studies of interventions to improve outdoor mobility for people living with disabilities were identified, but the evidence still remains uncertain about most benefits and harms of these interventions, both in the short- and long term. This is primarily related to risk of bias, small underpowered studies and limited reporting of important outcomes for people living with disabilities. For people with disabilities, skill training interventions may improve engagement in everyday life in the short term, and improve activity outside the home and health-related quality of life for people with cognitive impairments in the short term. Still, this is based on low certainty evidence from few studies and should be interpreted with caution. One study with low certainty evidence suggests that physical training interventions may improve activity outside the home in the short term. In addition, the effect sizes across all outcomes were considered small or trivial, and could be of limited relevance to people living with disabilities. The evidence is currently uncertain if there are interventions that can improve outdoor mobility for people with disabilities, and can improve other important outcomes, while avoiding harms. To guide decisions about the use of interventions to improve outdoor mobility, future studies should use more rigorous design and report important outcomes for people with disabilities to reduce the current uncertainty.

Ibuprofen for acute postoperative pain in children.

BACKGROUND: Children often require pain management following surgery to avoid suffering. Effective pain management has consequences for healing time and quality of life. Ibuprofen, a frequently used non-steroidal anti-inflammatory drug (NSAID) administered to children, is used to treat pain and inflammation in the postoperative period. OBJECTIVES: 1) To assess the efficacy and safety of ibuprofen (any dose) for acute postoperative pain management in children compared with placebo or other active comparators. 2) To compare ibuprofen administered at different doses, routes (e.g. oral, intravenous, etc.), or strategies (e.g. as needed versus as scheduled). SEARCH METHODS: We used standard Cochrane search methods. We searched CENTRAL, MEDLINE, Embase, CINAHL and trials registries in August 2023. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in children aged 17 years and younger, treated for acute postoperative or postprocedural pain, that compared ibuprofen to placebo or any active comparator. We included RCTs that compared different administration routes, doses of ibuprofen and schedules. DATA COLLECTION AND ANALYSIS: We adhered to standard Cochrane methods for data collection and analysis. Our primary outcomes were pain relief reported by the child, pain intensity reported by the child, adverse events, and serious adverse events. We present results using risk ratios (RR) and standardised mean differences (SMD), with the associated confidence intervals (CI). We used GRADE to assess the certainty of the evidence. MAIN RESULTS: We included 43 RCTs that enroled 4265 children (3935 children included in this review). We rated the overall risk of bias at the study level as high or unclear for 37 studies that had one or several unclear or high risk of bias judgements across the domains. We judged six studies as having a low risk of bias across all domains. Ibuprofen versus placebo (35 RCTs) No studies reported pain relief reported by the child or a third party, or serious adverse events. Ibuprofen probably reduces child-reported pain intensity less than two hours postintervention compared to placebo (SMD -1.12, 95% CI -1.39 to -0.86; 3 studies, 259 children; moderate-certainty evidence). Ibuprofen may reduce child-reported pain intensity, two hours to less than 24 hours postintervention (SMD -1.01, 95% CI -1.24 to -0.78; 5 studies, 345 children; low-certainty evidence). Ibuprofen may result in little to no difference in adverse events compared to placebo (RR 0.79, 95% CI 0.51 to 1.23; 5 studies, 384 children; low-certainty evidence). Ibuprofen versus paracetamol (21 RCTs) No studies reported pain relief reported by the child or a third party, or serious adverse events. Ibuprofen likely reduces child-reported pain intensity less than two hours postintervention compared to paracetamol (SMD -0.42, 95% CI -0.82 to -0.02; 2 studies, 100 children; moderate-certainty evidence). Ibuprofen may slightly reduce child-reported pain intensity two hours to 24 hours postintervention (SMD -0.21, 95% CI -0.40 to -0.02; 6 studies, 422 children; low-certainty evidence). Ibuprofen may result in little to no difference in adverse events (0 events in each group; 1 study, 44 children; low-certainty evidence). Ibuprofen versus morphine (1 RCT) No studies reported pain relief or pain intensity reported by the child or a third party, or serious adverse events. Ibuprofen likely results in a reduction in adverse events compared to morphine (RR 0.58, 95% CI 0.40 to 0.83; risk difference (RD) -0.25, 95% CI -0.40 to -0.09; number needed to treat for an additional beneficial outcome (NNTB) 4; 1 study, 154 children; moderate-certainty evidence). Ibuprofen versus ketorolac (1 RCT) No studies reported pain relief or pain intensity reported by the child, or serious adverse events. Ibuprofen may result in a reduction in adverse events compared to ketorolac (RR 0.51, 95% CI 0.27 to 0.96; RD -0.29, 95% CI -0.53 to -0.04; NNTB 4; 1 study, 59 children; low-certainty evidence). AUTHORS' CONCLUSIONS: Despite identifying 43 RCTs, we remain uncertain about the effect of ibuprofen compared to placebo or active comparators for some critical outcomes and in the comparisons between different doses, schedules and routes for ibuprofen administration. This is largely due to poor reporting on important outcomes such as serious adverse events, and poor study conduct or reporting that reduced our confidence in the results, along with small underpowered studies. Compared to placebo, ibuprofen likely results in pain reduction less than two hours postintervention, however, the efficacy might be lower at two hours to 24 hours. Compared to paracetamol, ibuprofen likely results in pain reduction up to 24 hours postintervention. We could not explore if there was a different effect in different kinds of surgeries or procedures. Ibuprofen likely results in a reduction in adverse events compared to morphine, and in little to no difference in bleeding when compared to paracetamol. We remain mostly uncertain about the safety of ibuprofen compared to other drugs.

Diclofenac for acute postoperative pain in children.

BACKGROUND: Many children undergo various surgeries, which often lead to acute postoperative pain. This pain influences recovery and quality of life. Non-steroidal anti-inflammatory drugs (NSAIDs), specifically cyclo-oxygenase (COX) inhibitors such as diclofenac, can be used to treat pain and reduce inflammation. There is uncertainty regarding diclofenac's benefits and harms compared to placebo or other drugs for postoperative pain. OBJECTIVES: To assess the efficacy and safety of diclofenac (any dose) for acute postoperative pain management in children compared with placebo, other active comparators, or diclofenac administered by different routes (e.g. oral, rectal, etc.) or strategies (e.g. 'as needed' versus 'as scheduled'). SEARCH METHODS: We used standard, extensive Cochrane search methods. We searched CENTRAL, MEDLINE, and trial registries on 11 April 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) in children under 18 years of age undergoing surgery that compared diclofenac (delivered in any dose and route) to placebo or any active pharmacological intervention. We included RCTs comparing different administration routes of diclofenac and different strategies. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Our primary outcomes were: pain relief (PR) reported by the child, defined as the proportion of children reporting 50% or better postoperative pain relief; pain intensity (PI) reported by the child; adverse events (AEs); and serious adverse events (SAEs). We presented results using risk ratios (RR), mean differences (MD), and standardised mean differences (SMD), with the associated confidence intervals (CI). MAIN RESULTS: We included 32 RCTs with 2250 children. All surgeries were done using general anaesthesia. Most studies (27) included children above age three. Only two studies had an overall low risk of bias; 30 had an unclear or high risk of bias in one or several domains. Diclofenac versus placebo (three studies) None of the included studies reported on PR or PI. We are very uncertain about the benefits and harms of diclofenac versus placebo on nausea/vomiting (RR 0.83, 95% CI 0.38 to 1.80; 2 studies, 100 children) and any reported bleeding (RR 3.00, 95% CI 0.34 to 26.45; 2 studies, 100 children), both very low-certainty evidence. None of the included studies reported SAEs. Diclofenac versus opioids (seven studies) We are very uncertain if diclofenac reduces PI at 2 to 24 hours postoperatively compared to opioids (median pain intensity 0.3 (interquartile range (IQR) 0.0 to 2.5) for diclofenac versus median 0.7 (IQR 0.1 to 2.4) in the opioid group; 1 study, 50 children; very low-certainty evidence). None of the included studies reported on PR or PI for other time points. Diclofenac probably results in less nausea/vomiting compared to opioids (41.0% in opioids, 31.0% in diclofenac; RR 0.75, 95% CI 0.58 to 0.96; 7 studies, 463 participants), and probably increases any reported bleeding (5.4% in opioids, 16.5% in diclofenac; RR 3.06, 95% CI 1.31 to 7.13; 2 studies, 222 participants), both moderate-certainty evidence. None of the included studies reported SAEs. Diclofenac versus paracetamol (10 studies) None of the included studies assessed child-reported PR. Compared to paracetamol, we are very uncertain if diclofenac: reduces PI at 0 to 2 hours postoperatively (SMD -0.45, 95% CI -0.74 to -0.15; 2 studies, 180 children); reduces PI at 2 to 24 hours postoperatively (SMD -0.64, 95% CI -0.89 to -0.39; 3 studies, 300 children); reduces nausea/vomiting (RR 0.47, 95% CI 0.25 to 0.87; 5 studies, 348 children); reduces bleeding events (RR 0.57, 95% CI 0.12 to 2.62; 5 studies, 332 participants); or reduces SAEs (RR 0.50, 95% CI 0.05 to 5.22; 1 study, 60 children). The evidence certainty was very low for all outcomes. Diclofenac versus bupivacaine (five studies) None of the included studies reported on PR or PI. Compared to bupivacaine, we are very uncertain about the effect of diclofenac on nausea/vomiting (RR 1.28, 95% CI 0.58 to 2.78; 3 studies, 128 children) and SAEs (RR 4.52, 95% CI 0.23 to 88.38; 1 study, 38 children), both very low-certainty evidence. Diclofenac versus active pharmacological comparator (10 studies) We are very uncertain about the benefits and harms of diclofenac versus any other active pharmacological comparator (dexamethasone, pranoprofen, fluorometholone, oxybuprocaine, flurbiprofen, lignocaine), and for different routes and delivery of diclofenac, due to few and small studies, no reporting of key outcomes, and very low-certainty evidence for the reported outcomes. We are unable to draw any meaningful conclusions from the numerical results. AUTHORS' CONCLUSIONS: We remain uncertain about the efficacy of diclofenac compared to placebo, active comparators, or by different routes of administration, for postoperative pain management in children. This is largely due to authors not reporting on clinically important outcomes; unclear reporting of the trials; or poor trial conduct reducing our confidence in the results. We remain uncertain about diclofenac's safety compared to placebo or active comparators, except for the comparison of diclofenac with opioids: diclofenac probably results in less nausea and vomiting compared with opioids, but more bleeding events. For healthcare providers managing postoperative pain, diclofenac is a COX inhibitor option, along with other pharmacological and non-pharmacological approaches. Healthcare providers should weigh the benefits and risks based on what is known of their respective pharmacological effects, rather than known efficacy. For surgical interventions in which bleeding or nausea and vomiting are a concern postoperatively, the risks of adverse events using opioids or diclofenac for managing pain should be considered.

Utilization of Methods for Pain Treatment and Management Among Older Adults with Chronic Pain.

BACKGROUND: Older adults have a high prevalence of chronic pain, which can have a substantial effect on their health and quality of life. Patients' use of effective pain relief methods is a central part of the treatment and management of chronic pain. The utilization of pain relief methods and their perceived effectiveness are important knowledge for treating and managing chronic pain for clinicians and older adults. However, this has been poorly investigated. AIM: We aimed to survey the methods used by older people to treat and manage chronic pain as well as their perceived effectiveness. METHODS: A total of 2,000 questionnaires were sent to a random sample of people aged 65 years of age or older living in Sweden and 1,141 questionnaires were returned in usable condition. A total of 433 participants reported having chronic pain and completed the Pain Management Inventory to map the use and perceived effectiveness of used treatment and management methods. RESULTS: The prevalence of chronic pain was 38% and the most used pain treatment methods were passive approaches, i.e., rest (60%), distractions (53%), non-prescribed medicine (49%), and prescribed medicine (44%). A total of 72% of respondents used either prescribed or non-prescribed medicine. The most used active treatment was physical activity (52%). The perceived effectiveness varied to a large extent for each method, and, on average, no treatment method seemed to be more effective than any other. CONCLUSIONS: Knowledge about the actual use of pain treatment methods and the varied perceived effectiveness can guide clinicians in recommending new approaches or alternatives to manage chronic pain in older adults. How used methods are aligned with current clinical recommendations could be further explored in the future.

Are European clinical trial funders policies on clinical trial registration and reporting improving? A cross-sectional study.

Objectives: Assess the extent to which the clinical trial registration and reporting policies of 25 of the world's largest public and philanthropic medical research funders meet best practice benchmarks as stipulated by the 2017 WHO Joint Statement, and document changes in the policies and monitoring systems of 19 European funders over the past year. Design Setting Participants: Cross-sectional study, based on assessments of each funder's publicly available documentation plus validation of results by funders. Our cohort includes 25 of the largest medical research funders in Europe, Oceania, South Asia, and Canada. Interventions: Scoring all 25 funders using an 11-item assessment tool based on WHO best practice benchmarks, grouped into three primary categories: trial registries, academic publication, and monitoring, plus validation of results by funders. Main outcome measures: How many of the 11 WHO best practice items each of the 25 funders has put into place, and changes in the performance of 19 previously assessed funders over the preceding year. Results: The 25 funders we assessed had put into place an average of 5/11 (49%) WHO best practices. Only 6/25 funders (24%) took the PI's past reporting record into account during grant application reviews. Funders' performance varied widely from 0/11 to 11/11 WHO best practices adopted. Of the 19 funders for which 2021(2) baseline data was available, 10/19 (53%) had strengthened their policies over the preceding year. Conclusions: Most medical research funders need to do more to curb research waste and publication bias by strengthening their clinical trial policies.

Evaluation of evidence supporting NICE recommendations to change people's lifestyle in clinical practice: cross sectional survey.

Objectives: To assess whether recommendations of individually oriented lifestyle interventions (IOLIs) in guidelines from the National Institute for Health and Care Excellence (NICE) were underpinned by evidence of benefit, and whether harms and opportunity costs were considered. Design: Cross sectional survey. Setting: UK. Data sources: NICE guidelines and supporting evidence. Eligibility criteria: All NICE pathways for IOLI recommendations (ie, non-drug interventions that healthcare professionals administer to adults to achieve a healthier lifestyle and improve health) were searched systematically on 26 August 2020. One author screened all retrieved pathways for candidate guidelines, while a second author verified these judgments. Two authors independently and in duplicate screened all retrieved guidelines and recommendations for eligibility, extracted data, and evaluated the evidence cited and the outcomes considered. Disagreements were noted and resolved by consensus. Results: Within 57 guidelines, 379 NICE recommendations were found for IOLIs; almost all (n=374; 99%) recommended the lifestyle intervention and five (1%) recommended against the intervention. Of the 379 recommendations, 13 (3%) were supported by moderate or high certainty evidence of a beneficial effect on patient relevant outcomes (n=7; 2%) or surrogate outcomes (n=13; 3%). 19 (5%) interventions considered psychosocial harms, 32 (8%) considered physical harms, and one (<1%) considered the opportunity costs of implementation. No intervention considered the burden placed on individuals by these recommendations. Conclusion: Few NICE recommendations of lifestyle interventions are supported by reliable evidence. While this finding does not contest the beneficial effects of healthy habits, guidelines recommending clinicians to try to change people's lifestyle need to be reconsidered given the substantial uncertainty about the effectiveness, harms, and opportunity costs of such interventions.

PROTOCOL: Interventions to improve outdoor mobility among adults with disability.

This is the protocol for a Campbell systematic review. The objectives are as follows: to assess the efficacy of interventions aiming to improve outdoor mobility for people with disability and to explore if the efficacy varies between different populations and different intervention components.

Interventions to minimize blood loss in very preterm infants-A systematic review and meta-analysis.

Blood loss in the first days of life has been associated with increased morbidity and mortality in very preterm infants. In this systematic review we included randomized controlled trials comparing the effects of interventions to preserve blood volume in the infant from birth, reduce the need for sampling, or limit the blood sampled. Mortality and major neurodevelopmental disabilities were the primary outcomes. Included studies underwent risk of bias-assessment and data extraction by two review authors independently. We used risk ratio or mean difference to evaluate the treatment effect and meta-analysis for pooled results. The certainty of evidence was assessed using GRADE. We included 31 trials enrolling 3,759 infants. Twenty-five trials were pooled in the comparison delayed cord clamping or cord milking vs. immediate cord clamping or no milking. Increasing placental transfusion resulted in lower mortality during the neonatal period (RR 0.51, 95% CI 0.26 to 1.00; participants = 595; trials = 5; I2 = 0%, moderate certainty of evidence) and during first hospitalization (RR 0.70, 95% CI 0.51, 0.96; 10 RCTs, participants = 2,476, low certainty of evidence). The certainty of evidence was very low for the other primary outcomes of this review. The six remaining trials compared devices to monitor glucose levels (three trials), blood sampling from the umbilical cord or from the placenta vs. blood sampling from the infant (2 trials), and devices to reintroduce the blood after analysis vs. conventional blood sampling (1 trial); the certainty of evidence was rated as very low for all outcomes in these comparisons. Increasing placental transfusion at birth may reduce mortality in very preterm infants; However, extremely limited evidence is available to assess the effects of other interventions to reduce blood loss after birth. In future trials, infants could be randomized following placental transfusion to different blood saving approaches. Trial registration: PROSPERO CRD42020159882.