Systematic review of clinical outcome reporting in randomised controlled trials of burn care

Young, Amber; Davies, Anna; Bland, Sophie; Brookes, Sara; Blazeby, Jane M

doi:10.1136/bmjopen-2018-025135

Cited by 29 publications

(33 citation statements)

References 197 publications

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“…Therefore, the quality of each study will not add any additional value to this review. This is consistent with other systematic review of outcomes reported in different medical and surgical conditions 28–30…”

Section: Methods and Designsupporting

confidence: 93%

CORE-Kids: a protocol for the development of a core outcome set for childhood fractures

Marson¹,

Manning²,

James³

et al. 2020

BMJ Open

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IntroductionLimb fractures in children are common yet there are few trials that compare treatments for these injuries. There is significant heterogeneity in the outcomes reported in the paediatric orthopaedic literature, which limits the ability to compare study results and draw firm conclusions. The aim of the CORE-Kids Study is to develop a core outcome set for use in research studies of childhood limb fractures. A core outcome set will provide a minimum set of outcomes to be measured in all trials to minimise the heterogeneity of outcomes reported and minimise reporting bias. A core outcome set ensures that outcomes are reported that are relevant to families as well as clinicians. The core outcome set will include additional upper and lower limb modules.MethodsThe development of the core outcome set will require four phases to evaluate:What are the outcomes that are relevant to professionals?What are the outcomes that are relevant to families?What are the most important of these outcomes?Which outcomes should be included in the core outcome set?This will be completed through a systematic review of trials to identify the outcomes domains that are relevant to trialists. A series of semi-structured interviews will be completed with families to identify the outcome domains that are relevant to families. These outcome domains will be used in a three-round Delphi Study to analyse the importance of these outcome domains to a range of stakeholders including parents, clinicians and researchers. Following this, the core outcome set will be decided at a consensus meeting.Ethics and disseminationEthical approval has been awarded HRA/REC IRAS number 262503. Date of approval 06/08/2019. Dissemination will be through scientific literature and international societies.Trial registrationCore Outcome Measures in Effectiveness Trials Initiative, registration number: 1274. Date of registration 13/12/2018.PROSPERO registration numberCRD42018106605.

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Section: Methods and Designsupporting

confidence: 93%

CORE-Kids: a protocol for the development of a core outcome set for childhood fractures

Marson¹,

Manning²,

James³

et al. 2020

BMJ Open

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“…What is more, both experimental and especially clinical studies on burn treatment used different outcome issues or different definitions, respectively, to assess the same outcome issues, while results were evaluated at different time points after the injury [ 71 , 73 ]. In addition, like all reviews of clinical studies in burns, we had to face the heterogeneity of basic parameters including epidemiology, comorbidity, as well as type, degree, TBSA and localization of the burn.…”

Section: Discussionmentioning

confidence: 99%

“…In addition, like all reviews of clinical studies in burns, we had to face the heterogeneity of basic parameters including epidemiology, comorbidity, as well as type, degree, TBSA and localization of the burn. Young and colleagues, in a recent systematic review of burn treatment, suggested the development of a core outcome set (COS) enabling the comparison of results of studies on burn treatment [ 73 ]. This basic problem when designing trials in burn patients applies also for HBO: Only two clinical studies were randomized including a total of 16 [ 24 ] and 15 patients [ 25 ], respectively.…”

Section: Discussionmentioning

confidence: 99%

The History and Development of Hyperbaric Oxygenation (HBO) in Thermal Burn Injury

et al. 2021

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Background and Objectives: Hyperbaric oxygenation (HBO) denotes breathing of 100% oxygen under elevated ambient pressure. Since the initiation of HBO for burns in 1965, abundant experimental and clinical work has been done. Despite many undisputedly positive and only a few controversial results on the efficacy of adjunctive HBO for burn injury, the method has not yet been established in clinical routine. Materials and Methods: We did a retrospective analysis of the literature according to PRISMA—guidelines, from the very beginning of HBO for burns up to present, trying to elucidate the question why HBO is still sidelined in the treatment of burn injury. Results: Forty-seven publications (32 animal experiments, four trials in human volunteers and 11 clinical studies) fulfilled the inclusion criteria. Except four investigators who found little or no beneficial action, all were able to demonstrate positive effects of HBO, most of them describing less edema, improved healing, less infection or bacterial growth and most recently, reduction of post-burn pain. Secondary enlargement of burn was prevented, as microvascular perfusion could be preserved, and cells were kept viable. The application of HBO, however, concerning pressure, duration, frequency and number of treatment sessions, varied considerably. Authors of large clinical studies underscored the intricate measures required when administering HBO in severe burns. Conclusions: HBO unquestionably has a positive impact on the pathophysiological mechanisms, and hence on the healing and course of burns. The few negative results are most likely due to peculiarities in the administration of HBO and possibly also to interactions when delivering the treatment to severely ill patients. Well-designed studies are needed to definitively assess its clinical value as an adjunctive treatment focusing on relevant outcome criteria such as wound healing time, complications, length of hospital stay, mortality and scar quality, while also defining optimal HBO dosage and timing.

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“…In burns, the potential of exercise to induce positive effects on energy expenditure, muscle mass and insulin sensitivity has also been investigated, albeit largely in the post-discharge phase and predominantly in paediatric patients [ 16 , 18 , 20 , 23 , 24 , 61 ]. However, the use of exercise for these purposes in adults as part of inpatient care continues to be a largely unexplored, yet promising, area of future research [ 62 ]. Our data shows that metabolic outcomes are not consistently used as therapeutic exercise targets and that more guidance is needed to reach consensus about the role exercise can play in the metabolic management of burn patients.…”

Section: Discussionmentioning

confidence: 99%

Status of adult inpatient burn rehabilitation in Europe: are we neglecting metabolic outcomes?

et al. 2021

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Background Hypermetabolism, muscle wasting and insulin resistance are challenging yet important rehabilitation targets in the management of burns. In the absence of concrete practice guidelines, however, it remains unclear how these metabolic targets are currently managed. This study aimed to describe the current practice of inpatient rehabilitation across Europe. Methods An electronic survey was distributed by the European Burn Association to burn centres throughout Europe, comprising generic and profession-specific questions directed at therapists, medical doctors and dieticians. Questions concerned exercise prescription, metabolic management and treatment priorities, motivation and knowledge of burn-induced metabolic sequelae. Odds ratios were computed to analyse associations between data derived from the responses of treatment priorities and knowledge of burn-induced metabolic sequelae. Results Fifty-nine clinicians with 12.3 ± 9 years of professional experience in burns, representing 18 out of 91 burn centres (response rate, 19.8%) across eight European countries responded. Resistance and aerobic exercises were only provided by 42% and 38% of therapists to intubated patients, 87% and 65% once out-of-bed mobility was possible and 97% and 83% once patients were able to leave their hospital room, respectively. The assessment of resting energy expenditure by indirect calorimetry, muscle wasting and insulin resistance was carried out by only 40.7%, 15.3% and 7.4% respondents, respectively, with large variability in employed frequency and methods. Not all clinicians changed their care in cases of hypermetabolism (59.3%), muscle wasting (70.4%) or insulin resistance (44.4%), and large variations in management strategies were reported. Significant interdisciplinary variation was present in treatment goal importance ratings, motivation and knowledge of burn-induced metabolic sequelae. The prevention of metabolic sequelae was regarded as the least important treatment goal, while the restoration of functional status was rated as the most important. Knowledge of burn-induced metabolic sequelae was linked to higher importance ratings of metabolic sequelae as a therapy goal (odds ratio, 4.63; 95% CI, 1.50–14.25; p < 0.01). Conclusion This survey reveals considerable non-uniformity around multiple aspects of inpatient rehabilitation across European burn care, including, most notably, a potential neglect of metabolic outcomes. The results contribute to the necessary groundwork to formulate practice guidelines for inpatient burn rehabilitation.

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Systematic review of clinical outcome reporting in randomised controlled trials of burn care

Cited by 29 publications

References 197 publications

CORE-Kids: a protocol for the development of a core outcome set for childhood fractures

CORE-Kids: a protocol for the development of a core outcome set for childhood fractures

The History and Development of Hyperbaric Oxygenation (HBO) in Thermal Burn Injury

Status of adult inpatient burn rehabilitation in Europe: are we neglecting metabolic outcomes?

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