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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES MEDICAL ACADEMY

Paulius Dobožinskas

IMPACT OF THE “FAST TRACK”

PROTOCOL IMPLEMENTATION ON THE

HIP FRACTURE MANAGEMENT

Doctoral dissertation Biomedical Sciences,

Medicine (06 B)

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The doctoral dissertation was prepared at the Lithuanian University of Health Sciences.

The dissertation is defended extramurally. Scientific Consultant

Prof. Dr. Šarūnas Tarasevičius (Lithuanian University of Health Sciences, Medical Academy, Biomedical Sciences, Medicine - 06B)

Dissertation is defended at the Medical Research Council of the Medical Academy of Lithuanian University of Health Sciences

Chairperson

Prof. Dr. Rūta Jolanta Nadišauskienė (Lithuanian University of Health Sciences, Biomedical Sciences, Medicine - 06B)

Members:

Prof. Habil. Dr. Virgilijus Ulozas (Lithuanian University of Health Sci-ences, Biomedical SciSci-ences, Medicine - 06B)

Prof. Dr. Mindaugas Kiudelis (Lithuanian University of Health Sciences, Biomedical Sciences, Medicine - 06B)

Prof. Dr. Pranas Šerpytis (Vilnius University, Biomedical Sciences, Med-icine - 06B)

Prof. Dr. Annette W-Dahl (Lund University (Sweden), Biomedical Sci-ences, Medicine - 06B)

The dissertation will be defended at the open session of the Medical Re-search Council of Lithuanian University of Health Sciences on the 30th of June 2016, at 01:00 p.m. in the Museum of History of Lithuanian Medicine and Pharmacy.

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LIETUVOS SVEIKATOS MOKSLŲ UNIVERSITETAS MEDICINOS AKADEMIJA

Paulius Dobožinskas

PACIENTŲ, PATYRUSIŲ

PROKSIMALINĖS ŠLAUNIKAULIO

DALIES LŪŽIUS, GYDYMO

IR PAGALBOS VALDYMO

OPTIMIZAVIMAS ĮDIEGUS SKUBAUS

PACIENTŲ STACIONARIZAVIMO IR

GYDYMO PROTOKOLĄ

Daktaro disertacija Biomedicinos mokslai, medicina (06B) Kaunas, 2016

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Disertacija rengta Lietuvos sveikatos mokslų universiteto Medicinos akademijoje.

Disertacija ginama eksternu. Mokslinis konsultantas

Prof. dr. Šarūnas Tarasevičius (Lietuvos sveikatos mokslų universitetas, biomedicinos mokslai, medicina – 06B)

Disertacija ginama Lietuvos sveikatos mokslų universiteto Medicinos akademijos medicinos mokslo krypties taryboje:

Pirmininkas

Prof. dr. Rūta Jolanta Nadišauskienė (Lietuvos sveikatos mokslų universitetas, biomedicinos mokslai, medicina – 06B)

Nariai:

Prof. habil. dr. Virgilijus Ulozas (Lietuvos sveikatos mokslų universitetas, biomedicinos mokslai, medicina – 06B)

Prof. dr. Mindaugas Kiudelis (Lietuvos sveikatos mokslų universitetas, biomedicinos mokslai, medicina – 06B)

Prof. dr. Pranas Šerpytis (Vilniaus universitetas, biomedicinos mokslai, medicina – 06B)

Prof. dr. Annette W-Dahl (Lundo univeristetas (Švedija), biomedicinos mokslai, medicina – 06B)

Disertacija bus ginama viešame Medicinos krypties tarybos posėdyje 2016 m. birželio 30 d. 13 val. Lietuvos sveikatos mokslų universiteto Lietuvos medicinos ir farmacijos istorijos muziejuje.

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CONTENTS

ABBREVIATIONS ... 7

INTRODUCTION ... 8

THE AIM AND OBJECTIVES OF THE STUDY ... 10

ACTUALITY, ORIGINALITY AND PRACTICAL VALUE OF THE STUDY ... 11

1. LITERATURE REVIEW ... 12

1.1 Epidemiology of hip fracture ... 12

1.2 Hip fracture classification ... 15

1.3. Principles of hip fracture treatment ... 16

1.4 Hip fracture management ... 19

1.4.1 Fast track schemes and surgery timing in patients with hip fractures ... 19

1.4.2 Periods of patients care ... 21

1.4.3 Evidence-based perioperative treatment guidelines ... 27

1.5 Health-related quality of life in patients with hip fracture ... 30

2. PATIENTS AND METHODS ... 33

2.1 Hip fracture patients care evaluation ... 34

2.1.1 Patients care related data collection ... 34

2.1.2 Introduction of fast track protocol ... 35

2.2 Hip fracture patients function and health-related quality of life evaluation ... 37

2.2.1. Data registration during the preoperative period ... 39

2.2.2. Patients care during postoperative period ... 40

2.2.3. Patient data registration at 4-months follow-up after femoral neck fracture ... 41

2.3 Statistical data analysis ... 43

3. RESULTS ... 44

3.1.1 Procedures performance analysis ... 45

3.1.2 Time to surgery and length of stay analysis ... 46

3.2 Patients’ hip joint functioning and health-related quality of life after femoral neck fracture (Functional outcome study) ... 47

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3.2.1 Patient characteristics and baseline data ... 47

3.2.2 Comparison of mortality rate ... 49

3.2.3 Hip joint functioning and health-related quality of life result at the 4-month follow-up ... 50

4. DISCUSSION ... 54

4.1 Management of medical procedures after fast-track introduction ... 54

CONCLUSIONS... 62 PRACTICAL RECOMMENDATIONS ... 63 REFERENCES ... 64 LIST OF PUBLICATIONS ... 75 PUBLICATIONS ... 76 SUMMARY IN LITHUANIAN ... 92 SUPPLEMENTS... 111 ACKNOWLEDGMENTS ... 124 CURRICULUM VITAE ... 126

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ABBREVIATIONS

A&E – Accident and Emergency Department ASA – American Society of Anesthesiologists BMD – Bone Mass Density

DVT – Deep vein thrombosis ECG – Electrocardiography

EQ-5D – The 5 Dimension Scale of the Euro-QoL EQ VAS – EuroQol-visual analogue scale

FNF – Femoral Neck Fracture FTP – Fast Track Protocol

HRQL – Health-related Quality of Life ICP – Integrated Care Pathway

LOS – Length of Stay

NHIF – National Health Insurance Fund NHP – Nottingham Health Profile

p – Level of Significance QoL – Quality of Life

RCT – Randomized Controlled Trials SD – Standard Deviation

SF-36 – Short Form-36

SPMSQ – Short Portable Mental Status Questionnaire THA – Total Hip Arthroplasty

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INTRODUCTION

The number of hip fractures is increasing together with rising average life expectancy in the majority of countries [27, 32]. These fractures represent not only a health problem, but an important economic and social issue for the country as well. Thus, it is of importance to use all available resources efficiently to ensure the most efficient, highest quality and evidence-based care for this group of patients. The audit procedures of medical institutions and care procedures have been recognized as the most efficient instrument to improve the quality of treatment.

We found no long-term prospective clinical trials conducted in Lithua-nia and investigating the quality of care of hip fracture patients. In order to perform systemic analysis of hip fracture patients care and discover factors negatively affecting outcome it is necessary to assess the current situation in the field, identify problems and implement necessary changes seeking the im-provement in overall care process. Subsequently the additional investigation should be performed to investigate the effect of implemented changes on the outcome, and this process should be continuous for all the time.

In the majority of developed countries hip fracture patients are treated ac-cording well-defined algorithms/protocols that are valid either in the insti-tution or nationwide. These protocols usually describe the care procedures which hip fracture patients should receive from admission to the medical fa-cilities until discharge [19, 42, 47, 55, 56, 72]. The major aim of the introduc-tion of such protocol is to create and standardize care pathways that would ensure the most efficient patient’s care from admission until discharge. One of the most important aims of implementation of these protocols is to decrease waiting time for surgery for hip fracture patients and to start postoperative procedures as early as possible.

There are some differences in hip fracture care models in different coun-tries. These differences are based on distinct health care systems, cultural differences, thus care models that are effective in one country might not im-prove outcome in another [29, 99]. Direct treatment protocol transfer from

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one country to another without a detailed audit of care procedures in receiving country probably will be a failure. Thus in the beginning a comparative care pathways analysis with other countries and audit procedures of their results should be performed seeking the best possible care and outcome improve-ment after impleimprove-mentation of the protocol.

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THE AIM AND OBJECTIVES OF THE STUDY

Aim of the research project – to investigate the changes in care

man-agement and outcome after “Fast track” protocol introduction for patients with hip fractures.

Tasks of the research project:

1. To assess the impact of the Fast track protocol introduction on qual-ity of patients care in A&E (Accident and Emergency department) and hip fracture management.

2. To evaluate changes in time periods from patients hospital admission to surgery and length of stay after Fast track protocol introduction. 3. To compare mortality rate before and after Fast track protocol

intro-duction.

4. To compare functional results and health-related quality of life (HRQL) for patients with hip fracture before and after Fast track protocol introduction.

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ACTUALITY, ORIGINALITY AND PRACTICAL VALUE

OF THE STUDY

Hip fracture patients were recognized as an upcoming challenge for ma-jority health care systems in the world. With increasing population life expec-tancy and a higher proportion of elderly patients in the community, additional economic resources are required for the short and long-term care of those patients. Taking into account that economic resources for health care are lim-ited different approaches are needed to reduce economic pressure together not interfering with the quality of patients care.

Our study investigates the effect of the introduction of the new type of managementin terms of new patient’s care protocols implementation in daily practice seeking to determine if it is linked with possible changes in outcome. To our knowledge, Lithuania was the first country in Baltic countries and probably in Eastern Europe implementing new protocols in the scientifically proven way.

We found that Fast track protocol introduction reduced the length of stay and waiting time for surgery. It is obvious that such changes in care probably have saved a certain amount of economic resources without having any neg-ative effect on the outcome. Also, these changes in care management for hip fracture patients did not require any additional personnel, making possible financial savings even more evident.

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1. LITERATURE REVIEW

1.1 Epidemiology of hip fracture

The number of hip fractures has doubled in the last 30-40 years in many countries [5]. The projections indicate that the number of hip fractures occur-ring in the world each year will rise from 1.66 million in 1990 to 6.26 million by 2050 [27].

The data from different studies show geographic, ethnic and gender vari-ations in the incidence of hip fractures. Hip fractures are recognized to be a major global public health problem in many Western nations. The highest hip fracture rates are seen in North Europe and the US, but the recent trends show that these fracture rates have either stabilized or decreased in the last two decades [27, 31, 32]. The lowest rate is in Latin America and black pop-ulations in Africa. Asian countries, such as Kuwait, Iran, China, and Hong Kong, show intermediate hip fracture rates [31-33, 53]. In the year 2050, it is predicted that 70% of over 6-milion fractures will occur in these populations [18]. Also, it has been reported that by 2050 half of hip fractures will occur in Asia [32]. The age-standardized hip fracture rates across different countries are presented in Table 1.1.1.

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Table 1.1.1. The incidence of hip fracture in different countries (per 100000

population).

Continent Country Men Women

Africa Morocco 57.7 79.9 Cameroon 43.7 52.1 Asia Korea 137 262 Malaysia 87.4 212.5 Japan 99.6 368 Kuwait 216.6 316 Hong Kong 50 110 Taiwan 233.4 496.8

South America Brazil 59.3 168.4

Argentina 137 405 Venezuela 37 98 Europe Switzerland 137.8 346 England 143.6 418.2 Greece 201.7 469.9 Sweden 302.7 709.5 Norway 352 763.6 Austria 567 759 The Netherlands 308 669

North America United States 197.2 553.5

United States,

Minnesota 201.6 511.5

Oceania New Zealand,

Maori 197 516

Non-Maori 288 827

Australia 187.8 504.2

New South Wales 191.8 475.1

Source: Dhanwal D.K., Dennison E.M, Harvey N.C, Cooper C. Epidemiology of hip frac-ture: worldwide geographic variation [32].

Such countries as Japan, Mexico, Ecuador, and Russia are still reporting about increasing number of hip fractures in their countries [3, 52, 59, 73]. However, recent data from Australia, Austria, Sweden, Finland, and Czech

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Republic reports significant decreases in fall-related hip fractures [17, 33, 54, 70]. It can be explained by a broad range of different approaches to pre-vention that have been introduced in those countries during the last decade including medical treatment and changes to improve patient safety.

Two thirds of all hip fractures are experienced by women because of older age in population and age-related osteoporosis in the postmenopausal period [92]. Female to male ratio of osteoporotic hip fractures in countries with a high incidence rate of osteoporosis is 2:1, but reaches 1:1 with increasing age [18]. They occur more frequently among white than black women. Also, rates of hip fracture in Asian women are lower than in white women [92]. It can be explained by differences in skeletal size, diet, exercise, exposure to trauma and falling tendency between races.

Hip fracture risk increases for adults aged 85 years or older and they have ten times greater risk to sustain a hip fracture than younger population (age 65-69) [50].There are reports of the reduction in the incidence of hip fractures in the younger elderly population. However, the increase of fractures for very old population (the hip fracture curve is shifting to the right) is also reported [5]. Osteoporosis and falls are major risk factors for hip fracture. Other im-portant risk factors for hip fractures are older age, female gender, ethnicity, low bone mass density (BMD), the frequency of falls, prior fractures, low body weight, excessive alcohol intake, smoking, cognitive impairment, and vitamin D deficiency or insufficiency [18, 50].

Aging and trends in hip fracture rates in Lithuania. Population aging

is a long-term problem that began several decades ago in the EU. With the decreasing number of births and increasing life expectancy, Lithuanian pop-ulation is also aging. In 2011, the life expectancy for Lithuanian males was 68.5 years, the life expectancy for females was 79.1 years. At the beginning of 2012, 22.1% of the population was older than 60 compared with 19.2% in 2001 [59].

Over the past ten years, the number of elderly people increased by 28.8 thousand in Lithuania. The population size of elderly women is 1.8 times higher than male [59].

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Table 1.1 2. Population by age (5 years age groups) Total by age 2006 2007 2008 2009 2010 2012 50-54 207628 210103 214652 223756 234458 245756 55-59 181105 187456 192278 192974 192189 194715 60-64 172141 164640 157658 156326 162712 171612 65-69 164802 163563 164157 161651 155401 147221 70-74 143074 143891 142750 142750 143045 141290 75-79 113606 115005 116095 115723 115222 116419 80-84 66427 69110 72243 75670 77729 81303 85 and older 33903 35702 37911 40435 43004 48316

Source: Lithuanian Department of Statistics, 2010 [59].

In many Western European countries the rates of hip fractures appear to be decreasing [32]. According to the health statistics, a growing number of hip fractures has been documented in Lithuania [99]. Number of hip fractures increased from 2780 in the year 2000 to 5334 in the year 2009.

1.2 Hip fracture classification

The hip fracture should be suspected in patients with a history of a fall that led to a painful hip, inability to walk or difficulty of standing an externally rotated limb. Subsequent radiographs of the pelvis confirm the diagnosis. Hip fracture is a general description of several different types of proximal femoral fractures. Proximal femoral fractures according to the fractured part of the bone can be classified radiographically into two main types: intracapsular and extracapsular [76]. Intracapsular fractures are fractures of the femoral neck. Extracapsular fractures are divided into trochanteric (trochanteric or lesser trochanteric fractures) and subtrochanteric fractures (fractures of the trochanteric area that extend distally within 5 cm below the lesser trochanter). The most commonly used classification system for femoral neck fractures is the Garden classification. The fractures are divided into four types according to the degree of displacement [41]. This classification is used as a valuable tool for fracture healing prognosis if osteosynthesis is performed.

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The proportions of intracapsular hip fractures and intertrochanteric hip fractures are about the same and comprise about 90% of all fractures of the femur. The part of intracapsular fractures is slightly greater (53-60%) than that of intertrochanteric fractures [92]. Subtrochanteric fractures account for the remaining 10% [106].

Hip fracture classification plays an important role when selecting the best treatment method.

1.3. Principles of hip fracture treatment

The primary goal of treatment is to return the patient to the level of func-tion one had before the fracture. The timing of surgery is important. In gen-eral, the operation should be performed as soon as possible after the trauma, usually within 24 or 48 hours after admission. Such an interval allows ade-quate time to address any medical problems and prepare patients for surgical intervention. Unacceptable waiting times for surgery increase the risk of post-operative medical complications and mortality rate.

Hip fractures were managed using conservative methods based on traction and bed rest before operative treatment involving the use of various implants was introduced in the 1950s [45].

Conservative treatment approaches are now rarely used because of poor outcome and prolonged hospital stay [45, 76]. The method of surgery treat-ment is chosen according to the type of hip fracture and general patient status (age, mobility before the fracture, mental ability, and ability to participate in a postoperative rehabilitation program). Patients with femoral neck fractures are treated operatively with either osteosynthesis or hip replacement. Patients younger than 60 years with intracapsular undisplaced femoral neck fractures should be treated with internal fixation [8].

There are no well-defined algorithms regarding the treatment method that should be used for patients with displaced femoral neck fractures. There is currently insufficient evidence to decide if either osteosynthesis or arthro-plasty should be performed. However, several recent studies showed that

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ar-throplasty appears to be superior to internal fixation, concerning complication rates, as a treatment for displaced femoral neck fractures. O. Leonardson et al. (2010) in a ten-year randomized study of 450 patients investigated hip frac-ture patients treated with internal fixation or replacement [58]. At ten years follow-up, there were 99 failures (45.6%) after internal fixation compared to 17 (8.8%) after hip replacement. The rate of mortality was 75% for ten years and did not differ significantly between both groups. Patient-reported pain and function were similar in both groups at five and ten years but was superior at one-year follow-up for the hip replacement group. Authors concluded that hip replacement should remain the treatment of choice for displaced intracap-sular fractures of the femoral neck. Since hip replacement leads to a better patient-reported outcome during the first year, it should be used even for el-derly patients with a short remaining life expectancy to achieve more efficient reduction of pain and better quality of life.

In a meta-analysis of 14 randomized studies with 2,289 patients comparing primary arthroplasty with osteosynthesis for displaced femoral neck fractures, authors found that primary arthroplasty led to significantly fewer method-re-lated hip complications and reoperations, compared to internal fixation. There was no significant difference in mortality between the two groups at 30 days and one year. The majority of studies showed better function and less pain after the primary arthroplasty. Authors concluded that primary arthroplasty should be used in most patients with displaced femoral neck fracture. The healthy, lucid individual, 70–80 years old, should be given a total hip arthro-plasty. The older, impaired or institutionalized patient would benefit from a hemiarthroplasty [86].

Most of these studies observe and compare the number of complications, mortality, and functional outcome regarding the type of treatment. Howev-er, there is a shortage of the information regarding patients quality of life on the treatment method used. In a recent study of Leonardsson et al. (2013), three treatment methods were evaluated with respect to patient-reported pain, health-related quality of life, and satisfaction with the surgical result [57]. Both patients below and patients above seventy years of age treated with total hip

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arthroplasty reported less pain and were more satisfied compared with those treated with internal fixation or hemiarthroplasty. The differences between total hip arthroplasty and hemiarthroplasty in patients below seventy years of age did not reach the significance. The authors concluded that total hip arthroplasty as a treatment for femoral neck fractures was associated with less pain and greater satisfaction at short-term follow-up, as compared to internal fixation and hemi-arthroplasty, both in patients younger and older than seventy years [57].

Various types of plates, screws, and nails are available for fixing extra-capsular fractures. At present, the sliding hip screw is the most efficient de-vice. Subtrochanteric fractures may also be fixed with a sliding hip screw, but these are increasingly being treated with an intramedullary nail [76]. Intra-medullary nailing of pertrochanteric femoral fractures has grown in popular-ity over the past two decades likely because this procedure is associated with a low risk for postoperative morbidity and a fast recovery of function [43].

In a prospective, randomized multicenter study with 684 patients with an intertrochanteric or subtrochanteric fracture and one year of follow-up the aim was to assess whether the use of the intramedular nail, as compared with a sliding hip screw, resulted in less postoperative pain, improved functional mobility, and reduced surgical complication rates [66]. Authors reported that nails and sliding hip screws were similar regarding pain, function, and reop-eration rates twelve months after treatment of intertrochanteric and subtro-chanteric fractures.

In another study from Norwegian Hip Fracture Register, 2716 patients with transverse/reverse oblique trochanteric and subtrochanteric fractures were observed [65]. The aim was to compare results after patients’ treatment with intramedular nails and sliding hip screw (SHS). 12 months postopera-tively patients with transverse/reverse oblique trochanteric and subtrochan-teric fractures operated with an SHS had a higher reoperation rate compared to those operated with an IM nail. Small differences regarding pain, satisfac-tion, quality of life, and mobility was also in favor of IM nailing.

The Parker MJ et al. (2004) compared intramedullary nails with extramed-ullary implants for extracapsular hip fractures in adults [77]. A 43 randomised

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and quasi-randomised controlled trials comparing nails with extramedullary implants for extracapsular hip fractures were included. Authors concluded that current evidence supports the continued use of the sliding hip screw for fixing the more common types of extracapsular hip fractures. This may not be the case for some of the more recently developed designs of intramedullary nails or specific fracture types, but further research is required to confirm this.

1.4 Hip fracture management

Hip fractures are associated with increased mortality, morbidity, and a high financial burden. Patients who sustain hip fractures are usually elderly and have multiple co-morbidities. Because of these reasons they are at high risk of pre- and postoperative complications. The main complications during hos-pitalization following hip fracture involve pressure ulcers formation, urinary tract and respiratory infections, thrombosis, cardiac events and perioperative delirium. These complications appear in approximately 20% of the patients [28]. They can lead to death or poor outcome. All these negative compli-cations can be avoided if appropriate pre- and postoperative management, incorporating all necessary care elements, ideally by a multidisciplinary team are introduced [18].

1.4.1 Fast track schemes and surgery timing in patients with hip fractures The current evidence for optimal surgical timing is entirely observation-al, and the results from different studies are controversial on mortality, most postoperative complications, the length of hospital stay, and return to liv-ing status. Most hospitals have adopted well-defined hip fracture patients’ care pathways [19, 72, 85]. Those care pathways are created to standardize delivery of healthcare and clinical management of the patient and to help health professionals make decisions about health care in specific clinical cir-cumstances and improve patients care and outcomes. Created care protocols include a detailed description of procedures and strategies for hip fracture pa-tients’ and their management from their arrival at the hospital until discharge.

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The majority of care pathways in this patient group are focused on fast track

schemes for admission and further surgery to shorten the time from

admis-sion to surgery [34, 37, 56]. The first guideline for a fast-track surgical pro-gram for patients with hip fractures became available in 2005 [35].

There is no accepted definition as to what constitutes early surgery, but most studies have used a period between 24 and 72 hours [18]. Several national insti-tutions and International Osteoporosis Foundation recommend that hip-fracture patients should undergo surgery on the day of admission or no later than 24 h after admission [67, 74, 88, 91]. The most common reasons for operative delay include administrative (such as the unavailability of the operating room and/or surgical personnel) and medical-related causes (e. g. investigation and stabiliza-tion of the patient’s preoperative medical condistabiliza-tion) [88].Thus, surgery should proceed as soon as patient’s clinical status is medically optimized, avoiding possible administrative reasons for the delay. Orosz GM. et al. (2004) inves-tigated the association of hip fracture surgery timing with function and other outcomes. A total of 1206 patients aged 50 years or older admitted with hip fracture during 29 months were included in the study.The authors reported that early surgery was not associated with improved function or mortality, but it was associated with reduced pain and length of stay (LOS) and probably less major complications among patients medically stable at admission. Authors conclud-ed that additional research is neconclud-edconclud-ed on whether functional outcomes may be improved. However in the meantime, patients with hip fracture who are medi-cally stable should receive early surgery when possible [75].

A systematic review and meta-analysis of 16 observational studies in-vestigated a total of 13 478 patients analyzing the impact of surgery timing on patient outcome after hip fracture [89]. Five of these studies reported adjusted measures for mortality (721 deaths in 4208 patients). Early surgery (i.e., with-in the cut-off limits of 24, 48 or 72 h) was associated with a reduction with-in mor-tality of 19%. Unadjusted data indicated that early surgery also reduced rates of in-hospital pneumonia (RR 0.59, 95% CI 0.37–0.93, p = 0.02) and pressure sores (RR 0.48, 95% CI 0.34–0.69, p< 0.001) [44]. These results suggest that reducing surgical delays may reduce mortality and complications.

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Also, there is a study showing that preoperative waiting time increased the risk of periprosthetic infection in patients with femoral neck fracture [104].

1.4.2 Periods of patients care

All hip fracture patients care processes can be divided into the following periods: pre-hospital care, pre-operative preparation, surgical management, post-operative management and immediate rehabilitation (Figure 1.4.2.1).

Figure 1.4.2.1. Periods of care in hip fracture patients

In Pre-hospital period patients with suspected hip fracture are

clas-sified as severe and should be transferred to the hospital from the site of injury as quickly as possible. The important first step in hip fracture patients’ care is transportation to the hospital. Patient with suspected hip fracture must be immobilized, and oxygen, as well as infusion therapy, should be initialized. Immobilization of the fracture during transportation reduces hip joint pain and prevents dislocation. It was also reported that minimizing pain by immobilization and analgesics reduces the occurrence of delirium [69]. The administration of oxygen after the trauma prevents confusion and local tissue hypoxia [9, 25, 44]. The use of infusion thera-py in the ambulance improves the hemodynamic of patients and stops the catabolic process [95].

For the faster patient management and to reduce a preoperative period a notification call from ambulance during transportation to the hospital should

Pre-operative period Pre-hospital period Surgery period HIP FRACTURE Postoperative period Rehabilitation period

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be considered. Such a notification system is established in Sweden where medical personnel calls the orthopedic surgeon in charge to inform that they have a patient with a proximal femoral fracture arriving within a stated time. The specialist then informs the X-ray and the orthopedic departments. At the admission to the hospital, the ambulance personnel directly takes the patient to the X-ray unit and then to the orthopedic ward, bypassing the A&E department. However, this is not the case in Lithuania. In the Hospi-tal of Lithuanian University of Health Sciences Kaunas klinikos patients with proximal femoral fractures spend approximately two hours in the A&E department [98]. Eliminating the stay in A&E would ensure faster patient journey to the orthopedic ward shortening the time patients spend on hard surfaces, thus reducing the risk of pressure ulcers [49, 61].

An interventional study by Larsson G. et Holgers K-M. (2011) examined whether a well defined algorithm for pre-hospital, preoperative treatment for patients with suspected hip fracture can lead to a reduction of waiting time, less postoperative pain, fewer complications and shorter length of stay. In their study, the intervention included an ambulance nurse tele-phone call to the orthopedic surgeon as soon as he/she encountered a pa-tient with a suspected hip fracture. The papa-tient was then given pain relief treatment, and blood tests and ECG were administered and results sent to A&E department. Patients also received infusion and oxygen therapy. For pressure ulcer prophylaxis, a special pillow was placed under the injured leg. When the ambulance arrived at A&E, the patient was transferred to the bed and received a specialist consultation. Ambulance staff then trans-ported the patient to Radiology and delivered patient’s blood tests to the lab. This patient bypassed A&E and was admitted more quickly to the or-thopedic unit. Results from the fast-track group were compared to results from a control group, who had been admitted to A&E in the usual way. In a studied group, authors found that there were fewer complications and shorter length of stay compared to the control group. This concluded that fast-track care for hip fracture patients could minimize complications, and decrease the overall length of stay [56].

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Pre-operative period.

Patients arriving in A&E with suspected hip fracture are vulnerable to pres-sure sores and dehydration. They should spend the shortest possible time in A&E and be admitted to a ward where they can receive appropriate treatment. In 1995, the UK Audit Commission suggested that admission to the ward from A&E should be within 1 hour, for elderly patients with hip fractures [34].

During a stay at A&E department, it is recommended to perform an ap-propriate X-ray of the hip, pelvis, and chest. Intravenous fluids should be started if it was not done during transportation, a blood sample should be sent for analysis, ECG should be recorded, pain should be assessed at regular intervals, and a urinary catheter needs to be placed. Once the fracture has been confirmed, an urgent referral or transferal to an orthopedic ward must be carried out, the geriatric team should be notified, and an initial orthopedic assessment can be performed [18].

The main principles of preoperative management

Guidelines regarding preoperative management involve a multidisci-plinary care provided by a team of specialists including orthopedic surgeons, orthopedic nurses, geriatricians, and anesthesiologists.

1. Vital signs must be assessed every 4 or 6 hours, including blood pres-sure, pulse, temperature, orientation, and confusion assessment. 2. Bed rest is important and should include heel protectors, anti-embolic

compression devices and use of pressure relief mattresses and an over-head trapeze if available.

3. Foot and ankle exercises every 1-2 hours, and incentive spirometry (sustained maximal inspiration with visual feedback on a spirometer) every hour when awake.

4. Assessment of cardiac and thrombotic risk should also be performed to evaluate the need for a beta blocker and statin.

5. Low-molecular-weight heparins should be commenced unless contra-indicated.

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7. A normal diet is allowed until six hours before surgery. Water, lemon-ade, and clear carbohydrate-enriched drinks may be considered until two hours before surgery if permitted by the anesthetics’ team.

8. Nutritional status should be assessed, and supplementation provided for patients with poor nutrition, or those who are at-risk of poor nu-trition.

9. A bowel regimen can be commended and such medications as hyp-notics, antihistamines, anticholinergic and benzodiazepines, should be avoided.

10. Low-dose haloperidol prophylaxis should be considered for high-de-lirium-risk patients who have no contraindication to neuroleptics. 11. An antiemetic regimen should be started if needed.

12. Continuous oxygen therapy administered at 2 l/minute or higher flows to keep oxygen saturation > 93%.

13. Brochures may be handed over to the patient and his or her family on hip fracture care, including aspects of rehabilitation and discharge planning [18].

Surgery period

The American Society of Anesthesiologists (ASA) Physical Status Classifica-tion System is used for assessing the fitness of patients before surgery. The ASA classification is based on the presence of comorbid illnesses and their severity. Type of anesthesia for hip fracture surgery is chosen according to this classifi-cation. General or regional (spinal or epidural) anesthesia could be considered. Study of 18,817 patients from the Scottish Hip Fracture Audit database showed a very small but statistically significant lower absolute mortality in patients who re-ceived general versus regional anesthesia [46]. Parker MJ et al. in Cochran review compared different types of anesthesia for surgical repair of hip fractures (proxi-mal femoral fractures) in adults. Twenty-two trials, involving 2567 predominant-ly female and elderpredominant-ly patients, comparing regional anesthesia with general anes-thesia were included. Pooled results from eight trials showed regional anesanes-thesia to be associated with a decreased mortality at one month (56/811 (6.9%) versus

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86/857 (10.0%)); however, this was not significant. Later results from six tri-als for three-month mortality tri-also showed a clinically relevant reduction (86/726 (11.8%) versus 98/765 (12.8%) although it was not significant. Regional anesthe-sia was associated with a reduced risk of deep venous thrombosis (39/129 (30%) versus 61/130 (47%). Regional anesthesia was also associated with a reduced risk of acute postoperative confusion (11/117 (9.4%) versus 23/120 (19.2%). Overall, there was insufficient evidence available from trials comparing regional versus general anesthesia to rule out clinically important differences. Regional anesthe-sia may reduce acute postoperative confusion, but no strong conclusions can be drawn for mortality or other outcomes [78].

Postoperative period

The main objectives of postoperative care are adequate pain control, de-lirium prevention, anemia management, oxygen support, early mobilization, consideration for nutritional support, particularly for patients with malnu-trition, urinary catheter management, pressure ulcers prevention, transitions management [50]. In the recommendations of Cassim B et al. (2013) it is recommended that the patient should be seen daily by the orthopedic surgeon and a physician or geriatrician to identify possible early complications and frequent communication between the teams is obligatory [18]. After the sur-gery, the patient can then be started on clear fluids and later the diet should be prescribed according to tolerance. The diet should include additional supple-mentation for malnourished patients.

Oxygen therapy can be administered through a nasal catheter when the patient is at rest and during the first four nights postoperatively. The patient should turn, cough and breathe deeply every 1-2 hours while awake. Transfu-sion may take place to keep the hemoglobin> 10 g/dl.

Prophylactic antibiotics should be continued for 24 hours postoperatively (cefazolin 1 g eight-hourly).

Assessment should be made of the patient’s vital signs every 4-6 hours, in-cluding blood pressure, pulse, temperature, pain, pulse oximetry, orientation, and confusion, as well as neurovascular checks. Fluid intake and the amount

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of urine should be recorded. The standardized pain regimen and anticoagu-lation therapy should be continued. The duration of the anticoaguanticoagu-lation will need to be individualized and may be from 2 to 6 weeks.

The bowel regimen must be continued, with the aim of a bowel movement by postoperative day two and every 48 hours after that. The urine catheter may be removed on the first postoperative day. If retention is suspected, this should be confirmed using either an immediate ultrasound bladder scan or single catheterization when residual urine volume> 300 ml. If the second ep-isode of retention occurs, then scheduled intermittent catheterization should be done every 4 to 6 hours, or continuous catheterization for 1-2 days. It is important to screen and treat urinary tract infections, if present. A skin care program should be implemented for patients with established incontinence.

Activity should comprise the patient walking from the bed to the chair twice a day starting on the first postoperative day. Pain relief drugs are recommend-ed before mobilization. Further activity depends on the patient’s weight-bear-ing status. Occupational and Physiotherapy should be commenced on day one postoperatively.

Use of adaptive devices, such as glasses and hearing aids, should be en-sured, as well as regular orientation. Calm reassurance, the family presence or a sitter should be used to assist with agitation.

Rehabilitation or social services consultation can take place for discharge planning. An assessment of recurrent fall risk should be carried out, and addi-tional investigation of the severe osteoporosis cause should be implemented. A detailed referral is necessary on discharge, including written instructions and follow-up arrangements [18].

Morbidity, mortality and loss of function of hip fracture patients can be reduced by a structured acute management plan and appropriate control of risk factors.

Evidence from the UK-wide audits suggests that patient outcomes and bed utilization are better when coordinated interdisciplinary care is available. This is confirmed by some controlled clinical trials and emerging evidence from managed care. Managed care can offer: early preoperative optimiza-tion, avoidance of unnecessary operative delay, incorporation of elements of

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good practice (e.g. in pressure area care, analgesia and fluid balance); early discharge planning and rehabilitation goal setting; attention to medically re-versible causes such as poor nutrition, iatrogenic problems, delirium, sepsis and medical co-morbidity [71].

Rehabilitation

Studies conducted during the recovery period are heterogeneous. The dif-ferences in treatment settings, interventions, and outcomes studied provide no clear evidence for best treatment practices [4]. Most studies investigated the effectiveness of hip fracture rehabilitation using six different approach-es (clinical pathway, early supported discharge, interdisciplinary care, occu-pational therapy/physical therapy, exercise, discharge setting), in 3 types of setting (acute care hospital, inpatient rehabilitation, and outpatient rehabili-tation) [23]. Systematic review shows that measures and methods for char-acterizing rehabilitation interventions and settings are not well standardized, making it difficult to reach evidence-based conclusions about best practices in hip fracture rehabilitation in the elderly [23].

1.4.3 Evidence-based perioperative treatment guidelines

There are established evidence-based perioperative treatment guidelines for best practice for elderly hip fracture patients care [4].To be included in clinical recommendations, studies had to be rated as Level 1 or 2. Level 1 evidence study should include one or more high quality randomized con-trolled trials (RCT) or systematic reviews while Level 2 evidence study should include one or more high-quality observational studies. The over-view of clinical recommendations by Beaupre LA (2005) are presented in Table 1.4.3.1.

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Table1.4.3.1.Evidence-based clinical recommendations for patients with

hip fracture.

Intervention Outcome(s) assessed Recommendations evidenceLevel of

Preoperative Preoperative traction

Analgesic use, ease of

fracture reduction Preoperative traction demonstrates no benefit 1

Pressure sore

prevention Incidence of pressure sores

Pressure-reducing mattresses appear to be beneficial in reducing pressure sores development 1

Surgical delay Mortality, major complications, decubitus

ulcer, preoperative pain

Surgery should be performed once patient is medically stable, within 24h if possible

2

Perioperative Conservative management

Nonunion, leg shortening and deformity

Operative treatment is better than conservative

treatment 1

Surgical management Intertrochanteric

Operative details (length of surgery, blood loss, transfusion requirements) Fixation complications (nonunion, reoperations) Anatomical restoration (limb shortening, deformity)

Function, pain, mortality

Sliding hip screw fixation should be considered standard of treatment Short femoral nails (i.e., short Gamma) should not be used (increased risk of postoperative fracture around implant)

Long femoral nails may be superior to sliding screw fixation for treatment of reverse obliquity and subtrochanteric fractures Ender’s nails should not be used

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Subcapital

Operative details (length of surgery, blood loss, transfusion requirements) Fixation complications (nonunion, reoperations) Anatomical restoration (limb shortening, deformity)

Function, pain, mortality

Screws are better than pins for nondisplaced fractures

Cemented arthroplasties are superior to

noncemented

Bipolar implants have no advantages over unipolar implants. Choice of hemiarthroplasty versus internal fixation is dependent upon patient factors/surgeon preference, but displaced fractures should be treated with hemiarthroplasty or total hip arthroplasty

1

Anesthetic Mortality, morbidity Regional anesthesia should be used whenever

possible 1 Deep vein thrombosis (DVT) prophylaxis Mortality, morbidity (DVT, pulmonary embolus) Prophylaxis in the form of any heparin or fondiparinux for 10 days postoperatively, or mechanical pumping should be used

Vitamin K antagonists may be used for 10 days postoperatively with a target international normalized ratio of 2.5 (2.0 to 3.0 acceptable) DVT prophylaxis should be commenced preoperatively if surgery is delayed 1 1 1 Antibiotic prophylaxis Morbidity (wound infection, urinary and respiratory tract infections)

Antibiotics should be used preoperatively for all

patients 1

Intervention Outcome(s) assessed Recommendations Level of

evidence

Table1.4.3.1.Evidence-based clinical recommendations for patients with

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Postoperative wound drainage

Morbidity (Wound infection, wound healing, transfusions, dressing changes, reoperation)

Postoperative drains may

not be required 1

Urinary tract

management Urinary retention

Intermittent catheterization is superior to indwelling catheterization 1 Perioperative pain http://www.ncbi. nlm.nih.gov/ pmc/articles/ PMC3421108/ figure/Fig1/

Pain, analgesic use

Epidural pain

management may reduce myocardial ischemia also to reducing perioperative and postoperative pain

1 Early postoperative (up to 7 days) Nutritional assessment and treatment Mortality, morbidity, function, maintenance of lean body mass

Nutrition should be assessed

Protein supplementation should be considered for malnourished patients

1

Multidisciplinary care

Function, morbidity

Length of stay, mortality

Effectiveness of multidisciplinary care compared with usual care is unclear

Presence of mild or moderate dementia should not preclude inclusion in a rehabilitation program

1,2

1

1.5 Health-related quality of life in patients with hip fracture

The health-relatedquality of life covers physical, mental, and social well-being.There is no disease or population-specific measures or well-de-fined recommendations for evaluating patient quality of life after hip frac-tures.A range of scales and outcome measures are used in different studies. The most commonly used tools to measure quality of life in patients with

Intervention Outcome(s) assessed Recommendations Level of

evidence

Table1.4.3.1.Evidence-based clinical recommendations for patients with

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femoral neck fractures (FNFs) are the Short Form-36 (SF-36), the Notting-ham Health Profile (NHP) and the Euro-QoL (EQ-5D) [14, 51, 101, 102]. Ti-dermark J et al (2007) evaluated the internal and external responsiveness and overlap of changes in scores on different health-related questionnaires and preferred to use the EQ-5D in the global health status evaluation for patients with hip fracture because of its better responsiveness compared to NHP and the SF-36 [93], Hip fracture patients often are old with many co- morbidities, having dementia syndrome, thus to use self-administered questioners some-times is rather complicated.For those reasons researchers stated that assessing QoL in hip fracture patient through self-administered questionnaires is sub-ject to considerable bias due to non-response [11].

Patients with fractures are associated with poor health-related quality of life which is directly related to fracture type: worsed QoL is observed for hip fracture patients, following by vertebral and wrist fracture patients [12, 79, 94]. A consid-erable loss in the HRQL occurred during the first 4 postoperative months while at the 1-year follow up the patients’ HRQL was almost similar to that at four months with some improvement in the 2nd year, but not to baseline values [10, 62]. It has been reported that lower EQ-5D index at discharge depends on the need of care prior to fracture, low Mini-Mental Status, treatment method (internal fixation versus arthroplasty), lower pre-fracture Barthel Index, and Geriatric Depression Scale scores [15]. The quality of life was found to be depended on comorbidity, mobility, activities of daily life, independence, and fracture complaints [62].

Comparing HRQL results between countries, it is important to take into ac-count the differences between the nations in general. Molzahg AE et al. (2011) investigated HRQL in 7,401 adults with a mean age of 73.1 years [67]. Testing was simultaneously performed in 22 centres: Melbourne, Australia; Paris, France; Geneva, Switzerland; Bath, England; Edinburgh, Scotland; Seattle, USA; Beer Sheena, Israel; Barcelona, Spain; Tokyo, Japan; Guangzhou, China; Hong Kong; Istanbul, Turkey; Vilnius, Lithuania; Prague, Czech Republic; Budapest, Hun-gary; Victoria, Canada; Oslo, Norway; Umea, Sweden; Copenhagen, Denmark; Leipzig, Germany; Porto Alleger, Brazil and Montevideo, Uruguay. Testing results showed that there were differences in HRQL between people living in

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medium and high-development countries. The authors reported that Lithuanian and Hungary people rated their quality of life worse. Authors explained this find-ing that both Hungary and Lithuania were experiencfind-ing a ‘post-communist syn-drome’ characterized by a lack of feeling of citizenship, lack of identification with community and withdrawal into a family that may affect their QoL [67].

A similar finding was reported by Borgström F et al. (2011) who also showed significant variations in the quality of life ratings between different countries [1]. His study involved 2737 patients from nine countries and the HRQL after bone fractures were investigated. He reported that the quality of life loss during the four months of the study was greatest for hip fracture pa-tients, followed by vertebral and wrist fracture patients. Also, significant vari-ations between the countries were observed. The biggest loss in HRQL after the fracture was seen in Lithuania, followed by Italy, Russia, and Mexico. A smaller loss in the quality of life was in Austria and Sweden.

In another report Borgstrom F. et al (2013) in The International Costs and Utilities Related to Osteoporotic Fractures Study (ICUROS) presented costs in relation to quality of life after the fractures in 11 countries (Australia, Austria, Estonia, France, Italy, Lithuania, Mexico, Russia, Spain, UK and the USA) [12]. The quality of life was measured using the EQ-5D questionnaire. In the study par-ticipated 2808 patients (1273 hip fracture patients). A regression analysis showed that there were significant differences in the QoL loss between countries. For all fracture types and countries, the QoL reduced significantly after fracture com-pared to pre-fracture QoL. The mean decrease was largest for patients with hip fracture followed by vertebral and distal forearm fracture. The QoL after frac-ture was higher in the US compared to other countries.The QoL loss after a hip fracture was significantly lower in Austria (which was set as a reference in the regression analysis) compared to all countries except Sweden and Spain. For hip fracture, mean QoL just after fracture fell below 0.05 in Italy, Mexico, Lithuania, Russia, and Spain. At four months, the average quality of life had significantly in-creased, although it was still below the pre-fracture level. Additionally, the results suggest that there are significant differences in the magnitude of the quality of life reduction after hip fracture between countries [12].

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2. PATIENTS AND METHODS

We performed two studies to evaluate changes in patients care, function and HRQL after the introduction of “Fast track” protocol in the Hospital of Lithuanian University of Health Sciences Kauno klinikos (Kauno klinikos).

In the “Hip fracture patients care evaluation study”, we performed an audit of care for patients with hip fractures in Kauno klinikos from the January 2nd, 2009,

to June 30th, 2010. From January 1st,2011, the Fast track protocol was introduced

in the hospital. The results of previous audit were compared to hip fracture patients care from the June 1st, 2011, to May 31st, 2012 when care for patients with hip

frac-tures was executed according to hip fracture patient care protocols and quality indi-cators.Significant differences in patient outcome due to patient care were identified.

Figure 2.1. The hip fracture patients care evaluation study

In the “The hip fracture patients function and health-related quality of life outcome study”, we investigated patients with FNF treated in the hospital from May 1st, 2008 to April 30th, 2010. All hip fracture patients admitted to

the hospital during that period were included in the study. The patients treat-ed with THA (total hip arthroplasty) were investigattreat-ed at four months after the fracture for hip joint functioning and HRQL. The factors affecting the functional status and HRQL of the patients during this period were identi-fied. From of April 30th, 2011 to October 31st, 2012 the same data regarding

patients functional outcome and HRQL at 4-months follow-up was collected and compared with the period before the protocol introduction.

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Figure 2.2. The hip fracture patients function and health-related quality

of life outcome study

The study was performed with the permission of Kaunas Regional Bio-medical Researches Ethical Committee (BE-2-8).

2.1 Hip fracture patients care evaluation Inclusion criteria:

1. Patients admitted to the hospital with a fresh (up to one week after the trauma) hip fracture.

2. Patients who agreed to participate in the study and signed the informed consent form.

Exclusion criteria:

1. Patients with more than one fracture.

2. Patients who refused to participate in the study. 2.1.1 Patients care related data collection

Before the introduction of “Fast track” protocol, we investigated hip frac-ture patients from the 2nd January 2009 to 30th June 2010. The following

med-ical documents were analyzed: sheet attached to an ambulatory card filled in by admission room personnel (Form No. 025-1/a), patient case history (Form No. 003/a).

Certain procedures are considered to be of great importance in hip fracture management. Information about the following procedures for hip fracture patients on their arrival to the hospital was collected: pain assessment and use

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of analgesics, infusion therapy, oxygen therapy, blood test sampling, electro-cardiography (ECG) registration and fractured hip immobilization.

Also, information about the time period from admission to the healthcare

in-stitution to surgery, the length of stay in the orthopedic department was collected. 2.1.2 Introduction of fast track protocol

Before the fast track introduction, some team meetings were conducted,

and problems in hip fracture patients care, fields of improvement identified, and necessary changes discussed. According to the results before “Fast track” introduction, the main issues were identified during patients stay in A&E de-partment and protocol regarding patient’s care changes in this dede-partment was developed. A certain number of procedures were recognized to be of importance at an early stage of hip fracture patient’s management and were modified accordingly for subsequent investigation. Table 2.1.2.1

Table 2.1.2.1. Audit of procedures in A&E.

Problems in patient care before

FTP introduction Planned changes in patients care

No evaluation of pain severity To measure pain severity to all patients using VAS Occasionally used pain reliever To use pain relievers for all patients if pain ›2 points Rarely used oxygen therapy To measure and use oxygen therapy if PaCoO2 <95% Rarely used fractured hip

immobilization To immobilize all hip fractures

Rarely used infusion therapy To administer infusion therapy for all patients Rarely used ECG registration To register ECG for all patients

Rarely used blood sampling To perform blood sampling to all patients

The study focused on the completion of all investigated procedures and their effect on the period from admission to surgery and length of stay (LOS). Just before the fast track protocol was introduced, all ambulance services were informed about the study and encouraged to transport more patients with suspected hip fracture to our institution.

Based on the results of hip fracture patients care before “Fast track” in-troduction the changes in management were initiated from 2011 January 1st.

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The introduced FTP included well-defined care in the A&E department and orthopedicward as well as the protocol for planning a surgery within 24 hours after admission. After the arrival of patients with a suspected hip fracture he/she was transported directly to the X-ray department. If the hip fracture diagnosis was confirmed, the patient was taken back to the A&E where pain evaluation was performed.

Pain in the fractured hip was evaluated using the self-reported pain

mea-surement scale, approved by the Lithuanian Health Minister in 2004 for the assessment of patients’ pain in health-care institutions. This scale is designed as a 10 cm line with numbers from 1 to 10 each centimeter. The patients were asked to evaluate the pain in their hip during hospitalization; 0 indicated no pain and 10 was the greatest pain the patient could imagine. Subsequently drug prescription, immobilization, infusion therapy, ECG and blood tests were performed. To detect the presence of intellectual impairment and to deter-mine its degree for hip fracture patients, we used Short Portable Mental Sta-tus Questionnaire (SPMSQ). It is easily administered and has been designed, tested, standardized and validated [81]. SPMSQ includes 10 questions, which assess orientation to time and place (data, day, place) and general and per-sonal knowledge (president, mother‘s maiden name, telephone number). One question assesses concentration and set- shifting (counting backward by 3s). If a patient makes 0-2 mistakes it is classified as intact intellectual function-ing, 3 – 4 errors - mild intellectual impairment, 5 – 7 errors moderate intel-lectual impairment, 8 – 10 errors severe intelintel-lectual impairment. It is allowed one more error for a subject with only a grade school education or education beyond high school.

Within two hours from admission, the patients were supposed to be

transported to the orthopedic ward. Within one hour in the orthopedic ward, the patient met an anesthetist, who decided on the timing surgery, with the aim of operating on the patient within the shortest possible time. Any reasons for delaying surgery should be clearly defined and recorded in the patient’s case history. Before FTP introduction hip replacement surgeries were per-formed only during working days and time from admission to surgery was

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not regulated. According to FTP hip replacement surgeries were performed from 8 until 22 o’clock 7 days a week, and patients were operated by the staff on call.

The data about interventions and other variables was collected and com-pared to hip fracture patients treated before and after FTP introduction in the hospital.

2.2 Hip fracture patients function and health-related quality of life evaluation

Inclusion criteria:

1. Patients admitted to the hospital with a fresh (up to 2 months after the trauma) hip fracture.

2. Patients 55 years and older. 3. Patients treated with THA.

4. Patients who agreed to participate in the study and signed the informed consent form.

Exclusion criteria:

1. Patients with fractures caused by complications or with failed treat-ment of a previous femoral neck fracture.

2. Patients with multiple fractures or pathological fractures. 3. Patients who refused to participate in the study.

All hip fracture patients admitted after 1st June 2011 were

treat-ed according to the requirements of “Fast track” protocol describtreat-ed in section 2.1.2. While the methods of investigation evaluating their function and quality of life were the same independently, they were treated before or after the “Fast track” protocol introduction.

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Exclusion criteria

Exclusion criteria

Figure 2.2.1. Flowchart of the patients function and health-related quality

of life outcome study

Remaining patients included to the outcome analysis:

Before FTP introduction n꞊82 After FTP introduction n꞊ 58

Total: 140

Outcome analysis at four month follow up:

Before FTP introduction n꞊ 119 After FTP introduction n꞊ 106

Total: 225

All hip fracture patients included:

Before FTP introduction n꞊133 After FTP introduction n꞊178

Total: 311

Deceased before the end of follow up:

Before FTP - 24 After FTP – 16

Other reasosns :(lost of follow

up,

additional surgery on fractured hip, patients with dementia) Before FTP - 13 After FTP – 32 Deceased in hospital: Before FTP - 8 After FTP - 9 Osteosynthesis Before FTP - 1 After FTP – 58 Conservative treatment: Before FTP - 5 After FTP – 5

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2.2.1. Data registration during the preoperative period

Within 24 hours after admission, each patient with an FNF was invited to participate in the study by a specially trained investigator. All data were collected and registered prospectively. The data were obtained from patients’ case histories (Form No 003/a), and patient interviews. The patients’ relatives were interviewed if difficulties were experienced when collecting informa-tion from the patient.

The patients’ personal data (name, surname, personal code, address, con-tact phone number) and any co-morbidity were obtained from case histories registered by medical personnel. The data were specified during an interview with the patients or their relatives.

Before the surgery standardized, Hip Fracture Register Form No. 1 was used to collect information. Permission to use the Swedish National Hip Frac-ture Register forms for research purposes in Kauno klinikos was obtained from the Swedish National Hip Fracture Register (written authorization was received from the authors). The Swedish National Hip Fracture Register consists of three forms for data collection (Supplement 1). The first form (Form No. 1) was used to collect information about the patient’s admission to the health-care institution, place of residence before the fracture, mobility, the fracture itself and surgery type, and the time and location of discharge. The second form (Form No. 2) included information collected during the fol-low-up visit at 4 months after the injury. The patient’s place of residence, mobility, pain and any additional hospital stay were recorded. Additional sur-gery, if performed during the follow-up period, was registered on Form No.3. English forms were translated into Lithuanian [98]. The Swedish National Hip Fracture Register Forms were filled in according to the guidelines.

The time and place of the hip fracture event, the time of hospitalization, the place of admission, the ability to walk, the use of walking aids before the trauma, ASA grade, the type of fracture and the day and time of surgery were recorded in the Hip Fracture Register Form No. 1. The type of fracture was diagnosed by a radiology specialist and anorthopedicsurgeon based on X-rays taken during the patients’ stay in the acute room.

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Patient’s intellectual impairment was evaluated already in A&E depart-ment using SPMSQ (Suppledepart-ment 3). The type of hip fracture was classified according hip fracture classification system by an orthopedic surgeon. All pa-tients were consulted by an anesthesiologist before surgery, and the physical status of each patient was determined according to the ASA physical status classification [104]. The ASA grading system classifies patients as:

• ASA I – a normal, healthy patient;

• ASA II – mild systemic disease with no functional limitations; • ASA III – severe systemic disease with definite functionallimitations; • ASA IV – severe systemic disease that is a constant threat to life; • ASA V – moribund patient who is not expected to survive 24 hours with or without surgery.

E. Emergency surgery.

2.2.2. Patients care during postoperative period

All hip fracture patients included in this study before and after FTP intro-duction were treated with THA. All surgeries were performed under spinal anesthesia. During the first 24 h after the surgery, the patients were treated in an intensive care ward for orthopedic patients. On the second day after the surgery, the patients were transferred to an orthopedic ward in the depart-ment. The measures are taken to avoid the development of pressure ulcers, thromboembolic and infection were by an approved scheme in an orthopedic department. Pressure ulcers prophylactic included position on a bed chang-ing every two hours, use of pressure relief devices and skin moisturizers.For deep venous thrombosis prophylaxis, low-molecular-weight heparin was in-jected before and after the surgery daily during the hospital stay. Compression stockings or bandage were recommended and used for the entire hospitaliza-tion period and two months after the surgery during day time. Prophylactic antibiotics (Cephalosporin group) were initialized 1 hour before the surgery (incision) and continued for two days after the surgery. Wound drainage sys-tem was removed on the second day after the surgery. An indwelling catheter was removed within 48 hours after surgery. Urinary retention, if occurred,

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was managed by straight catheterization. X-rays were taken on the second postoperative day, and the position of the prosthetic components was evalu-ated.

The patients were mobilized in their beds (with passive and active

exer-cises for legs and sitting position in the bed) on the first post-operative day. They started to walk using a walking frame on the second post-operative day. A rehabilitation specialist and a ward nurse assisted the patients with sitting down on their bed, standing up using a walking frame and walking a few steps on the second day after surgery. The patients were walking on the op-erated limb using a walking frame with some support from the rehabilitation specialist by the third postoperative day. For patients whose general condition was fairly good, the walking distance was increased daily. The rehabilitation program during the hospital stay was organized individually depending on each patient’s general condition. During weekends, walking exercises were supervised by orthopedic nurses. In general, it should be emphasized that there were no changes in routine practice.

2.2.3. Patient data registration at 4-months follow-up after femoral neck fracture

Functional status of the operated hip and quality of life were registered 120 days (± 7 days) after the trauma. This period was used according to the recommendations from the Swedish National Hip Fracture Register model.

At the date of follow-up information about any deceased patients was collected from the database of the National Health Insurance Fund (NHIF). Patients who survived had been contacted via the phone and were invited to visit Outpatient department of Kauno klinikos. If a patient could not or did not agree to come for a visit to the health-care institution, information was collected during the phone interview. Questionnaires for evaluating hip joint functioning and HRQL were sent by post with a request for each patient to fill in the questionnaire and send it back to the researcher. If a patient came to the institution for follow-up, all necessary information was collected during the interview.

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If a reply was not received within two weeks of sending the letter with the questionnaires to the patients, the patients were repeatedly contacted via the phone to ask for the reasons for the delay and to request completed question-naires. Patients who did not send the questionnaires after the second contact were classified as a refusal to participate in the study.

At the 4-month follow-up, the patients’ place of residence, ability to

walk, use of walking aids, complaints of pain in the operated hip joint and any additional hospital stays during the follow-up period were recorded in the

Standardized Hip Fracture Form No. 2. Hip pain according to Form No. 2

was grouped into the following: “patients with pain in the hip” (answers 1 – 5 in form No. 2) and “patients free from pain in the hip” (answers 6 – 7).

The EQ-5D questionnaire is a generic QoL instrument for use as a

mea-sure of health outcome [14]. It is designed for self-assessment and is suitable for postal surveys, in clinics and face-to-face interviews. It applies to a broad range of health conditions. Before we started our study, the Euro QoL Group was contacted to ask their permission to use the EQ-5D questionnaire. The Euro QoL Group responded by sending a Lithuanian version of the EQ-5D questionnaire with permission to use it for research purposes.

The EQ-5D consists of two components. The first element is the de-scriptive system that is a questionnaire covering five dimensions: self-care, pain, usual activities and psychological (anxiety/depression) status with three possible answers for each item. Each dimension is divided into three degrees of severity: no problem, some problems or major problems. The second com-ponent is an additional visual analog scale (VAS, 0 – 100), and it is used to assess general health status, with 100 indicating the best health status and 0 the worst health status.

Physical condition was assessed through questions on mobility, self-care and pain/discomfort, social status with a question about usual care, and psy-chological condition with a question about anxiety/depression. Patients were asked to evaluate their health state the day they were asking on a vertical visual analog scale (EQ-VAS), where the endpoints were labeled “Best imag-inable health state” and “Worst imagimag-inable health state”.

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