A systematic review of the measurement properties of patient reported outcome measures used for adults with an ankle fracture

McKeown, Rebecca; Ellard, David R; Rabiu, Abdul-Rasheed; Karasouli, Eleni; Kearney, Rebecca S.

doi:10.1186/s41687-019-0159-5

Cited by 18 publications

(18 citation statements)

References 34 publications

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“…This questionnaire was developed in 1984 to evaluate patients’ function with ankle fractures [ 15 ]. A recent systematic review assessing patient-reported outcome measures used for adults with an ankle fracture found that OMAS has sufficient levels of reliability, internal consistency and construct validity [ 22 ]. The Short Form (SF-36) Survey is the most widely used health-related quality of life measure in research to date because of its history, reliability and validity [ 23 , 24 ].…”

Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Khojaly

Niocaill

Shahab

et al. 2021

Trials

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Background Postoperative management regimes vary following open reduction and internal fixation (ORIF) of unstable ankle fractures. There is an evolving understanding that extended periods of immobilisation and weight-bearing limitation may lead to poorer clinical outcomes. Traditional non-weight-bearing cast immobilisation may prevent loss of fixation, and this practice continues in many centres. The purpose of this trial is to investigate the safety and efficacy of immediate weight-bearing (IWB) and range of motion (ROM) exercise regimes following ORIF of unstable ankle fractures with a particular focus on functional outcomes and complication rates. Methods A pragmatic randomised controlled multicentre trial, comparing IWB in a walking boot and ROM within 24 h versus non-weight-bearing (NWB) and immobilisation in a cast for 6 weeks, following ORIF of all types of unstable adult ankle fractures (lateral malleolar, bimalleolar, trimalleolar with or without syndesmotic injury) is proposed. All patients presenting to three trauma units will be included. The exclusion criteria will be skeletal immaturity and tibial plafond fractures. The three institutional review boards have granted ethical approval. The primary outcome measure will be the functional Olerud-Molander Ankle Score (OMAS). Secondary outcomes include wound infection (deep and superficial), displacement of osteosynthesis, the full arc of ankle motion (plantar flexion and dorsal flection), RAND-36 Item Short Form Survey (SF-36) scoring, time to return to work and postoperative hospital length of stay. The trial will be reported in accordance with the CONSORT statement for reporting a pragmatic trial, and this protocol will follow the SPIRIT guidance. Discussion Traditional management of operatively treated ankle fractures includes an extended period of non-weight-bearing. There is emerging evidence that earlier weight-bearing may have equivocal outcomes and favourable patient satisfaction but higher wound-related complications. These studies often preclude more complicated fracture patterns or patient-related factors. To our knowledge, immediate weight-bearing (IWB) following ORIF of all types of unstable ankle fractures has not been investigated in a controlled prospective manner in recent decades. This pragmatic randomised-controlled multicentre trial will investigate immediate weight-bearing following ORIF of all ankle fracture patterns in the usual care condition. It is hoped that these results will contribute to the modern management of ankle fractures. Trial registration ISRCTN Registry ISRCTN76410775. Retrospectively registered on 30 June 2019.

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Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Khojaly

Niocaill

Shahab

et al. 2021

Trials

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“…In Corney et al's study carried out with 243 patients applied to psychiatry clinic, Folate levels in the blood was screened and it was observed that deficiency in Folate levels was higher in endogen (29%) and neurotic (11%) depression [23].…”

Section: Discussionmentioning

confidence: 99%

“…A number of studies in the literature have shown that low Folate level decreases the response to the treatment with antidepressant. One of those studies concluded that 45% of patients with normal Folate level responded to the treatment while it was only 7% in those with low Folate level [23].…”

Section: Discussionmentioning

confidence: 99%

Analysing Biochemical Parameters and Developing Risk Prediction Models in Patients with Schizophrenia and Bipolar Disorder

Kuzay

Polat

Konar

2021

EUROPEAN J MED ED TE

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Objectives: The aim of this study is to analyze biochemical parameters and develop risk prediction models in patients with schizophrenia and bipolar disorder.Methods: Biochemical values of 65 schizophrenia and 65 bipolar disorder patients were statistically compared by analyzing thyroid function tests (TSH, T3 and T4), 25-0H vitamin D3, calcium, ferritin, iron, folate, vitamin B12, and magnesium levels. Risk analysis of the control group was evaluated in line with the obtained findings.Results: Male patients diagnosed with schizophrenia were observed to have lower T3 level than that of control group (p<0.001). Vitamin B12 value and Ferritin levels of male patients diagnosed with bipolar disorder were higher than those of control group (p<0.05), while their T3 levels were lower comparing to control group (p<0.001). Female patients diagnosed with schizophrenia were observed to have higher Ferritin levels (p<0.05) and lower T3 levels comparing to control group (p<0.001). When female patients diagnosed with bipolar disorder were compared with control group, their Ferritin levels and T4 levels were observed to be higher (p<0.05). Conclusion:Unless an intervention is made by detecting vitamin deficiency, the treatment may fail with psychotropic medications. In psychotic symptoms, in addition to antipsychotic treatment, replacement of low serum vitamin level may have positive effects on recovery. Therefore, serum vitamin B12, T3, T4 and TSH hormones, and ferritin levels can be recommended to be used as routine screening tests especially in the first applications of psychiatric patients with cognitive disorders.

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“…In advance of the meeting, we will identify available guidance or existing consensus on how best to measure short-listed outcome domains. Where there is no existing consensus for potential outcome measures, the core research team will review key evidence sources to determine measurement quality [ 66 ], acceptability, and feasibility.…”

Section: Methodsmentioning

confidence: 99%

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Pearson

Tutton

Joeris

et al. 2021

Trials

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Background Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce—with patient partners and other key stakeholders—a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. Methods The study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. Discussion Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

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A systematic review of the measurement properties of patient reported outcome measures used for adults with an ankle fracture

Cited by 18 publications

References 34 publications

Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Analysing Biochemical Parameters and Developing Risk Prediction Models in Patients with Schizophrenia and Bipolar Disorder

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

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