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The Bone & Joint Journal
Vol. 106-B, Issue 4 | Pages 394 - 400
1 Apr 2024
Kjærvik C Gjertsen J Stensland E Dybvik EH Soereide O

Aims. The aims of this study were to assess quality of life after hip fractures, to characterize respondents to patient-reported outcome measures (PROMs), and to describe the recovery trajectory of hip fracture patients. Methods. Data on 35,206 hip fractures (2014 to 2018; 67.2% female) in the Norwegian Hip Fracture Register were linked to data from the Norwegian Patient Registry and Statistics Norway. PROMs data were collected using the EuroQol five-dimension three-level questionnaire (EQ-5D-3L) scoring instrument and living patients were invited to respond at four, 12, and 36 months post fracture. Multiple imputation procedures were performed as a model to substitute missing PROM data. Differences in response rates between categories of covariates were analyzed using chi-squared test statistics. The association between patient and socioeconomic characteristics and the reported EQ-5D-3L scores was analyzed using linear regression. Results. The median age was 83 years (interquartile range 76 to 90), and 3,561 (10%) lived in a healthcare facility. Observed mean pre-fracture EQ-5D-3L index score was 0.81 (95% confidence interval 0.803 to 0.810), which decreased to 0.66 at four months, to 0.70 at 12 months, and to 0.73 at 36 months. In the imputed datasets, the reduction from pre-fracture was similar (0.15 points) but an improvement up to 36 months was modest (0.01 to 0.03 points). Patients with higher age, male sex, severe comorbidity, cognitive impairment, lower income, lower education, and those in residential care facilities had a lower proportion of respondents, and systematically reported a lower health-related quality of life (HRQoL). The response pattern of patients influenced scores significantly, and the highest scores are found in patients reporting scores at all observation times. Conclusion. Hip fracture leads to a persistent reduction in measured HRQoL, up to 36 months. The patients’ health and socioeconomic status were associated with the proportion of patients returning PROM data for analysis, and affected the results reported. Observed EQ-5D-3L scores are affected by attrition and selection bias mechanisms and motivate the use of statistical modelling for adjustment. Cite this article: Bone Joint J 2024;106-B(4):394–400


The Bone & Joint Journal
Vol. 106-B, Issue 1 | Pages 69 - 76
1 Jan 2024
Tucker A Roffey DM Guy P Potter JM Broekhuyse HM Lefaivre KA

Aims. Acetabular fractures are associated with long-term morbidity. Our prospective cohort study sought to understand the recovery trajectory of this injury over five years. Methods. Eligible patients at a level I trauma centre were recruited into a longitudinal registry of surgical acetabular fractures between June 2004 and August 2019. Patient-reported outcome measures (PROMs), including the 36-Item Short Form Health Survey (SF-36) physical component summary (PCS), were recorded at baseline pre-injury recall and six months, one year, two years, and five years postoperatively. Comparative analyses were performed for elementary and associated fracture patterns. The proportion of patients achieving minimal clinically important difference (MCID) was determined. The rate of, and time to, conversion to total hip arthroplasty (THA) was also established. Results. We recruited 251 patients (253 fractures), with a 4:1 male to female ratio and mean age of 46.1 years (SD 16.4). Associated fracture patterns accounted for 56.5% of fractures (n = 143). Trajectory analysis showed all timepoints had significant disability versus baseline, including final follow-up (p < 0.001). Elementary fractures had higher SF-36 PCS at six months (p = 0.023) and one year (p = 0.007) compared to associated fractures, but not at two years (p = 0.135) or five years (p = 0.631). The MCID in SF-36 PCS was observed in 37.3% of patients (69/185) between six months and one year, 26.9% of patients (39/145) between one and two years, and 23.3% of patients (20/86) between two and five years, highlighting the long recovery potential of these injuries. A significant proportion of patients failed to attain the MCID after five years (38.1%; 40/105). Conversion to THA occurred in 13.1% of patients (11/110 elementary and 22/143 associated fractures). Approximately two-thirds of THAs (21/33 patients; 63.6%) were performed within two years of index surgery. Conclusion. Acetabular fractures significantly impact physical function. Recovery trajectory is often elongated beyond one year, with two-thirds of our patients displaying persistent clinically relevant long-term disability. Cite this article: Bone Joint J 2024;106-B(1):69–76


The Bone & Joint Journal
Vol. 100-B, Issue 5 | Pages 640 - 645
1 May 2018
Frietman B Biert J Edwards MJR

Aims. The aim of this study was to record the incidence of post-traumatic osteoarthritis (OA), the need for total hip arthroplasty (THA), and patient-reported outcome measures (PROMS) after surgery for a fracture of the acetabulum, in our centre. Patients and Methods. All patients who underwent surgery for an acetabular fracture between 2004 and 2014 were included. Patients completed the 36-Item Short Form Health Survey (SF-36) and the modified Harris Hip Score (mHHS) questionnaires. A retrospective chart and radiographic review was performed on all patients. CT scans were used to assess the classification of the fracture and the quality of reduction. Results. A total of 220 patients were included, of which 55 (25%) developed post-traumatic OA and 33 (15%) underwent THA. A total of 164 patients completed both questionnaires. At a mean follow-up of six years (2 to 10), the mean SF-36 score for patients with a preserved hip joint was higher on role limitations due to physical health problems than for those with OA or those who underwent THA. In the dimension of bodily pain, patients with OA had a significantly better score than those who underwent THA. Patients with a preserved hip joint had a significantly better score on the function scale of the mHHS and a better total score than those with OA or who underwent THA. Conclusion. Of the patients who were treated surgically for an acetabular fracture (with a mean follow-up of six years), 15% underwent THA at a mean of 2.75 years postoperatively. Patients with a THA had a worse functional outcome than those who retain their native hip joint. We recommend using PROMS and CT scans when reviewing these patients. Cite this article: Bone Joint J 2018;100-B:640–5


The Bone & Joint Journal
Vol. 101-B, Issue 6 | Pages 715 - 723
1 Jun 2019
Jayakumar P Teunis T Williams M Lamb SE Ring D Gwilym S

Aims. The purpose of this study was to identify factors associated with limitations in function, measured by patient-reported outcome measures (PROMs), six to nine months after a proximal humeral fracture, from a range of demographic, injury, psychological, and social variables measured within a week and two to four weeks after injury. Patients and Methods. We enrolled 177 adult patients who sustained an isolated proximal humeral fracture into the study and invited them to complete PROMs at their initial outpatient visit within one week of injury, between two and four weeks, and between six to nine months after injury. There were 128 women and 49 men; the mean age was 66 years (. sd. 16; 18 to 95). In all, 173 patients completed the final assessment. Bivariate analysis was performed followed by multivariable regression analysis accounting for multicollinearity using partial R. 2. , correlation matrices, and variable inflation factor. Results. Many variables within a week of injury and between two and four weeks after injury correlated with six- to nine-month PROMs in bivariate analysis. Kinesiophobia measured within a week of injury (Tampa Scale for Kinesiophobia-11: partial R. 2. = 0.14; p = 0.000) and self-efficacy measured between two and four weeks (Pain Self-efficacy Questionnaire-2: partial R. 2. = 0.266; p < 0.001) were the strongest predictors of limitations (measured by Patient Reported Outcome Measurement Information System Upper Extremity Physical Function Computer Adaptive Test (PROMIS UE)) at six to nine months in multivariable analysis. Similar findings were observed with other types of PROM. Regression models accounted for a substantial amount of variance in all PROMs at both timepoints (e.g. 66% of the overall variance within one week, and 70% within two to four weeks for PROMIS UE at six to nine months). . Conclusion. Recovery from a proximal humeral fracture appears to be enhanced by overcoming fears of movement or reinjury within a week after injury and greater self-efficacy (developing resilience and more effective coping strategies) within a month. Such factors are modifiable using enhanced communication skills and cognitive behavioural treatments. These findings could be a catalyst for the routine assessment and treatment of psychological and social factors in the management of patients with fractures. Cite this article: Bone Joint J 2019;101-B:715–723


Bone & Joint Research
Vol. 5, Issue 4 | Pages 153 - 161
1 Apr 2016
Kleinlugtenbelt YV Nienhuis RW Bhandari M Goslings JC Poolman RW Scholtes VAB

Objectives. Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods. A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results. In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties. Conclusion. According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties. Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153–161. DOI: 10.1302/2046-3758.54.2000462


Bone & Joint Open
Vol. 5, Issue 8 | Pages 621 - 627
1 Aug 2024
Walter N Loew T Hinterberger T Alt V Rupp M

Aims

Fracture-related infections (FRIs) are a devastating complication of fracture management. However, the impact of FRIs on mental health remains understudied. The aim of this study was a longitudinal evaluation of patients’ psychological state, and expectations for recovery comparing patients with recurrent FRI to those with primary FRI.

Methods

A prospective longitudinal study was conducted at a level 1 trauma centre from January 2020 to December 2022. In total, 56 patients treated for FRI were enrolled. The ICD-10 symptom rating (ISR) and an expectation questionnaire were assessed at five timepoints: preoperatively, one month postoperatively, and at three, six, and 12 months.


Aims

Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance.

Methods

We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs.


Bone & Joint Open
Vol. 4, Issue 4 | Pages 273 - 282
20 Apr 2023
Gupta S Yapp LZ Sadczuk D MacDonald DJ Clement ND White TO Keating JF Scott CEH

Aims

To investigate health-related quality of life (HRQoL) of older adults (aged ≥ 60 years) after tibial plateau fracture (TPF) compared to preinjury and population matched values, and what aspects of treatment were most important to patients.

Methods

We undertook a retrospective, case-control study of 67 patients at mean 3.5 years (SD 1.3; 1.3 to 6.1) after TPF (47 patients underwent fixation, and 20 nonoperative management). Patients completed EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, Lower Limb Function Scale (LEFS), and Oxford Knee Scores (OKS) for current and recalled prefracture status. Propensity score matching for age, sex, and deprivation in a 1:5 ratio was performed using patient level data from the Health Survey for England to obtain a control group for HRQoL comparison. The primary outcome was the difference in actual (TPF cohort) and expected (matched control) EQ-5D-3L score after TPF.


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 274 - 282
1 Feb 2022
Grønhaug KML Dybvik E Matre K Östman B Gjertsen J

Aims

The aim of this study was to investigate if there are differences in outcome between sliding hip screws (SHSs) and intramedullary nails (IMNs) with regard to fracture stability.

Methods

We assessed data from 17,341 patients with trochanteric or subtrochanteric fractures treated with SHS or IMN in the Norwegian Hip Fracture Register from 2013 to 2019. Primary outcome measures were reoperations for stable fractures (AO Foundation/Orthopaedic Trauma Association (AO/OTA) type A1) and unstable fractures (AO/OTA type A2, A3, and subtrochanteric fractures). Secondary outcome measures were reoperations for A2, A3, and subtrochanteric fractures individually, one-year mortality, quality of life (EuroQol five-dimension three-level index score), pain (visual analogue scale (VAS)), and satisfaction (VAS) for stable and unstable fractures. Hazard rate ratios (HRRs) for reoperation were calculated using Cox regression analysis with adjustments for age, sex, and American Society of Anesthesiologists score.


Bone & Joint Open
Vol. 2, Issue 10 | Pages 825 - 833
8 Oct 2021
Dailey HL Schwarzenberg P Webb, III EB Boran SAM Guerin S Harty JA

Aims

The study objective was to prospectively assess clinical outcomes for a pilot cohort of tibial shaft fractures treated with a new tibial nailing system that produces controlled axial interfragmentary micromotion. The hypothesis was that axial micromotion enhances fracture healing compared to static interlocking.

Methods

Patients were treated in a single level I trauma centre over a 2.5-year period. Group allocation was not randomized; both the micromotion nail and standard-of-care static locking nails (control group) were commercially available and selected at the discretion of the treating surgeons. Injury risk levels were quantified using the Nonunion Risk Determination (NURD) score. Radiological healing was assessed until 24 weeks or clinical union. Low-dose CT scans were acquired at 12 weeks and virtual mechanical testing was performed to objectively assess structural bone healing.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 247 - 255
1 Feb 2021
Hassellund SS Williksen JH Laane MM Pripp A Rosales CP Karlsen Ø Madsen JE Frihagen F

Aims

To compare operative and nonoperative treatment for displaced distal radius fractures in patients aged over 65 years.

Methods

A total of 100 patients were randomized in this non-inferiority trial, comparing cast immobilization with operation with a volar locking plate. Patients with displaced AO/OTA A and C fractures were eligible if one of the following were found after initial closed reduction: 1) dorsal angulation > 10°; 2) ulnar variance > 3 mm; or 3) intra-articular step-off > 2 mm. Primary outcome measure was the abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) after 12 months. Secondary outcome measures were the Patient-Rated Wrist and Hand Evaluation (PRWHE), EuroQol-5 dimensions 5-level questionnaire (EQ-5D-5L), range of motion (ROM), grip strength, “satisfaction with wrist function” (score 0 to 10), and complications.


The Bone & Joint Journal
Vol. 102-B, Issue 6 | Pages 766 - 771
1 Jun 2020
Coughlin TA Nightingale JM Myint Y Forward DP Norrish AR Ollivere BJ

Aims

Hip fractures in patients < 60 years old currently account for only 3% to 4% of all hip fractures in England, but this proportion is increasing. Little is known about the longer-term patient-reported outcomes in this potentially more active population. The primary aim is to examine patient-reported outcomes following isolated hip fracture in patients aged < 60 years. The secondary aim is to determine an association between outcomes and different types of fracture pattern and/or treatment implants.

Methods

All hip fracture patients aged 18 to 60 years admitted to a single centre over a 15-year period were used to identify the study group. Fracture pattern (undisplaced intracapsular, displaced intracapsular, and extracapsular) and type of operation (multiple cannulated hip screws, angular stable fixation, hemiarthroplasty, and total hip replacement) were recorded. The primary outcome measures were the Oxford Hip Score (OHS), the EuroQol five-dimension questionnaire (EQ-5D-3L), and EQ-visual analogue scale (VAS) scores. Preinjury scores were recorded by patient recall and postinjury scores were collected at a mean of 57 months (9 to 118) postinjury. Ethics approval was obtained prior to study commencement.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 48 - 54
1 Jan 2020
Gwilym S Sansom L Rombach I Dutton SJ Achten J Costa ML

Aims

Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment.

Methods

This was a multicentre, two-arm, open-label, parallel-group randomized controlled feasibility trial. Patients with a fracture of the distal radius aged 16 years and over were recruited from four centres in the UK and randomized (1:1) to receive a Woodcast or fibreglass cast. Data were collected on participant recruitment and retention, clinical efficacy, safety, and patient acceptability.


The Bone & Joint Journal
Vol. 102-B, Issue 2 | Pages 155 - 161
1 Feb 2020
McMahon SE Diamond OJ Cusick LA

Aims

Complex displaced osteoporotic acetabular fractures in the elderly are associated with high levels of morbidity and mortality. Surgical options include either open reduction and internal fixation alone, or combined with total hip arthroplasty (THA). There remains a cohort of severely comorbid patients who are deemed unfit for extensive surgical reconstruction and are treated conservatively. We describe the results of a coned hemipelvis reconstruction and THA inserted via a posterior approach to the hip as the primary treatment for this severely high-risk cohort.

Methods

We have prospectively monitored a series of 22 cases (21 patients) with a mean follow-up of 32 months (13 to 59).


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 42 - 47
1 Jan 2020
Jayakumar P Teunis T Vranceanu AM Williams M Lamb S Ring D Gwilym S

Aims

Patient engagement in adaptive health behaviours and interactions with their healthcare ecosystem can be measured using self-reported instruments, such as the Patient Activation Measure (PAM-13) and the Effective Consumer Scale (ECS-17). Few studies have investigated the influence of patient engagement on limitations (patient-reported outcome measures (PROMs)) and patient-reported experience measures (PREMs). First, we assessed whether patient engagement (PAM-13, ECS-17) within two to four weeks of an upper limb fracture was associated with limitations (the Quick Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH), and Patient-Reported Outcome Measurement Information System Upper Extremity Physical Function computer adaptive test (PROMIS UE PF) scores) measured six to nine months after fracture, accounting for demographic, clinical, and psychosocial factors. Secondly, we assessed the association between patient engagement and experience (numerical rating scale for satisfaction with care (NRS-C) and satisfaction with services (NRS-S) six to nine months after fracture.

Methods

A total of 744 adults with an isolated fracture of the proximal humerus, elbow, or distal radius completed PROMs. Due to multicollinearity of patient engagement and psychosocial variables, we generated a single variable combining measures of engagement and psychosocial factors using factor analysis. We then performed multivariable analysis with p < 0.10 on bivariate analysis.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 55 - 63
1 Jan 2020
Hagberg K Ghassemi Jahani S Kulbacka-Ortiz K Thomsen P Malchau H Reinholdt C

Aims

The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis.

Methods

In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years’ follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 17 - 25
1 Jan 2020
Trickett RW Mudge E Price P Pallister I

Aims

The aim of this study was to develop a psychometrically sound measure of recovery for use in patients who have suffered an open tibial fracture.

Methods

An initial pool of 109 items was generated from previous qualitative data relating to recovery following an open tibial fracture. These items were field tested in a cohort of patients recovering from an open tibial fracture. They were asked to comment on the content of the items and structure of the scale. Reduction in the number of items led to a refined scale tested in a larger cohort of patients. Principal components analysis permitted further reduction and the development of a definitive scale. Internal consistency, test-retest reliability, and responsiveness were assessed for the retained items.


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 478 - 483
1 Apr 2019
Borg T Hernefalk B Hailer NP

Aims

Displaced, comminuted acetabular fractures in the elderly are increasingly common, but there is no consensus on whether they should be treated non-surgically, surgically with open reduction and internal fixation (ORIF), or with acute total hip arthroplasty (THA). A combination of ORIF and acute THA, an approach called ’combined hip procedure’ (CHP), has been advocated and our aim was to compare the outcome after CHP or ORIF alone.

Patients and Methods

A total of 27 patients with similar acetabular fractures (severe acetabular impaction with or without concomitant femoral head injury) with a mean age of 72.2 years (50 to 89) were prospectively followed for a minimum of two years. In all, 14 were treated with ORIF alone and 13 were treated with a CHP. Hip joint and patient survival were estimated. Operating times, blood loss, radiological outcomes, and patient-reported outcomes were assessed.


The Bone & Joint Journal
Vol. 100-B, Issue 7 | Pages 959 - 965
1 Jul 2018
Mackenzie SP Carter TH Jefferies JG Wilby JBJ Hall P Duckworth AD Keating JF White TO

Aims

The Edinburgh Trauma Triage Clinic (TTC) streamlines outpatient care through consultant-led ‘virtual’ triage of referrals and the direct discharge of minor fractures from the Emergency Department. We compared the patient outcomes for simple fractures of the radial head, little finger metacarpal, and fifth metatarsal before and after the implementation of the TTC.

Patients and Methods

A total of 628 patients who had sustained these injuries over a one-year period were identified. There were 337 patients in the pre-TTC group and 289 in the post-TTC group. The Disabilities of the Arm, Shoulder and Hand Score (QuickDASH) or Foot and Ankle Disability Index (FADI), EuroQol-5D (EQ-5D), visual analogue scale (VAS) pain score, satisfaction rates, and return to work/sport were assessed six months post-injury. The development of late complications was excluded by an electronic record evaluation at three years post-injury. A cost analysis was performed.


The Bone & Joint Journal
Vol. 100-B, Issue 6 | Pages 693 - 702
1 Jun 2018
Jayakumar P Overbeek CL Vranceanu A Williams M Lamb S Ring D Gwilym S

Aims

Outcome measures quantifying aspects of health in a precise, efficient, and user-friendly manner are in demand. Computer adaptive tests (CATs) may overcome the limitations of established fixed scales and be more adept at measuring outcomes in trauma. The primary objective of this review was to gain a comprehensive understanding of the psychometric properties of CATs compared with fixed-length scales in the assessment of outcome in patients who have suffered trauma of the upper limb. Study designs, outcome measures and methodological quality are defined, along with trends in investigation.

Materials and Methods

A search of multiple electronic databases was undertaken on 1 January 2017 with terms related to “CATs”, “orthopaedics”, “trauma”, and “anatomical regions”. Studies involving adults suffering trauma to the upper limb, and undergoing any intervention, were eligible. Those involving the measurement of outcome with any CATs were included. Identification, screening, and eligibility were undertaken, followed by the extraction of data and quality assessment using the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria. The review is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria and reg

istered (PROSPERO: CRD42016053886).