Outcome Measures for Spinal Surgery




© Springer-Verlag Berlin Heidelberg 2016
João Luiz Pinheiro-Franco, Alexander R. Vaccaro, Edward C. Benzel and H. Michael Mayer (eds.)Advanced Concepts in Lumbar Degenerative Disk Disease10.1007/978-3-662-47756-4_14


14. Outcome Measures for Spinal Surgery



Elizabeth P. Norheim , Steven D. Glassman  and Leah Yacat Carreon 


(1)
Norton Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY 40202, USA

(2)
Department of Orthopaedic Surgery, University of Louisville School of Medicine and the Norton Leatherman Spine Center, Louisville, KY, USA

 



 

Elizabeth P. Norheim



 

Steven D. Glassman



 

Leah Yacat Carreon (Corresponding author)



Keywords
Comparative Effectiveness Research (CER)Cost per Quality-Adjusted Life Year Gained (Cost/QALY)Incremental Cost-Effectiveness Ratio (ICER)Minimum Clinically Important Difference (MCID)Patient-Reported Outcome (PRO)Quality-Adjusted Life Year (QALY)Substantial Clinical Benefit (SCB)



Abbreviations

CER

Comparative Effectiveness Research

Cost/QALY

Cost per Quality-Adjusted Life Year Gained

EQ-5D

European Quality of Life-5 Dimensions

HRQOL

Health-Related Quality of Life

ICER

Incremental Cost-Effectiveness Ratio

MCID

Minimum Clinically Important Difference

NDI

Neck Disability Index

ODI

Oswestry Disability Index

PRO

Patient Reported Outcome

QALY

Quality-Adjusted Life Year

RMDQ

Roland-Morris Disability Questionnaire

SCB

Substantial Clinical Benefit

SF-12

Short Form-12

SF-36

Short Form-36

SF-6D

Short Form-6 Dimensions

SPORT

Spine Outcomes Research Trial

SRS-22R

Scoliosis Research Society-22 Revised

VAS

Visual Analogue Scale



14.1 Introduction


The past two decades have seen major advancements in the use of an evidence-based approach to medical treatment, including in the field of spinal surgery. Historically, there has been a lack of patient-reported outcomes (PRO) data to guide surgical decision making. Prior parameters of success in spinal surgery—such as fusion rates, physician assessment, and complications—did not necessarily correlate with clinical outcomes [13].

More recently functional outcomes, patient satisfaction, and healthcare costs have become the major focus of spinal surgery research. Newer PRO measures are at the forefront and provide valid data that better reflects the change in overall health status of an individual after treatment. By quantifying health-related quality of life (HRQOL) changes experienced by the patient, these outcome measures allow for a more relevant assessment of treatment effectiveness.


14.2 Outcome Measures Categories


Health-related quality of life (HRQOL) measures assess, through self-reported means, how a patient’s physical and mental health is affected over time by a disease process or disability. They can also quantify response to treatment for the specific disease or disability. There are several types of HRQOL measures. These include generic measures, disease-specific measures, pain scales, and health utility scales.


14.2.1 Generic Measures


Generic measures apply to a variety of disease and treatment groups and seek to evaluate multidimensional aspects of health-related function [4]. Originally described by Ware in 1992 to survey health status in the Medical Outcomes Study (MOS) [5], the Medical Outcomes Short Form-36 (SF-36) is the most well known and widely used of these generic outcomes tools. The SF-36 is a 36-item self-administered questionnaire that explores physical and mental health through eight health concepts or domains. These domains include physical functioning, social functioning, general health, mental health, role emotional, role physical, bodily pain, and vitality. From the SF-36 two summary scores can be measured: a physical composite summary score (PCS) and a mental composite summary score (MCS). Using norm-based scoring, all domain scales have a mean of 50 and a standard deviation of 10 based on the general 1998 US population [5]. The SF-36 has been found to be a valid and reliable measure in different disease states, including patients with low back pain [6, 7]. In contrast to other surveys, the SF-36 presents a considerable respondent burden. There are shorter versions available, such as the SF-12 [8] and SF-8 [9], but all items must be answered in order to calculate the PCS and MCS. In addition, the shorter versions do not provide scores across the eight health domains. Lastly, the SF-36, SF-12, and SF-8 require a license to administer and cannot be easily scored in clinic.

Although generic measures translate the effects of treatments across multiple diseases and populations into a numerical value, they do have some limitations. A major disadvantage is that they can miss important components of health evaluation as related to specific diseases or treatments.


14.2.2 Disease-Specific Measures


Disease-specific measures focus on the effects on HRQOL associated with a specific medical condition. Therefore, these disease-specific measures are more likely to detect the effects of a specific intervention on a disease process. The Oswestry Disability Index (ODI) [10, 11], Roland-Morris Disability Questionnaire (RMDQ) [12], Neck Disability Index (NDI) [13], and Scoliosis Research Society-22R (SRS-22R) [1417] are examples of spine-specific measures.

The ODI is a self-administered survey measuring “low back-specific function” on a ten-item scale with six response categories each [10, 11, 18]. Each item is scored from 0 to 5 and then transformed into a 0–100-point scale with the higher the score signifying a greater disability experienced by the patient. Patients scoring between 0 and 20 have minimal disability, between 21 and 40 have moderate disability, between 41 and 60 have severe disability, between 61 and 80 are crippled, and between 81 and 100 are bed-bound or exaggerating their symptoms. Relative to RMDQ, it has less of a floor effect and is better used in populations with more severe disability [12]. ODI can be easily administered, scored, and interpreted in the clinic. This allows it to help guide treatment decisions.

The RMDQ is a measure of function and daily activity limitations. There are 12 items answerable by yes or no, giving a score ranging from 0 to 24. A higher score reflects greater disability. Relative to ODI, it has less of a ceiling effect and is better used in evaluating populations with lesser disability [12, 19].

The NDI is a ten-item self-administered survey measuring disability in patients with neck pain. Each item is scored from 0 to 5 for a maximum score of 50 [13]. Similar to ODI and RMDQ, a higher score is associated with a greater disability. Some authors may use a percentage score when one section is missed or is not applicable to what is studied, in which case the range of scores would be from 0 to 100 %.

The SRS-22R is a 22-item questionnaire with five domains, including self-image, pain, activity, mental, and satisfaction, measuring disability specific to scoliosis patients [14, 16, 17]. Each domain is scored from 1 to 5, with higher scores indicating improved outcomes. For patients with either adolescent idiopathic scoliosis or adult spinal deformity, the SRS-22R is the most widely used outcome instrument to measure disease burden and the effect of treatment [2022].


14.2.3 Pain Scales


The visual analogue scale (VAS) [2326] and numeric rating scales [27, 28] are commonly used pain scales in which the patient subjectively interprets the pain experience and assigns a value to the measurement scale. The VAS is a 100-mm-long horizontal line anchored on the left with “no pain” and on the right with “worst pain experience.” Patients mark on the line the point that they feel best represents their current level of pain. The score is determined by measuring in millimeters from the left-hand side of the line to the point that the patient marks. Numeric rating scales are a variant of the VAS and ask patients to rate their pain levels using numeric values, such as from 0 being no pain at all to 10 being the worst pain imaginable [27]. Advantages of pain scales include a low respondent burden, ease of administration, and a universally accepted tool. Limitations include the difficulty in interpreting objectively the subjective nature of the measurement. Pain scales are also difficult to translate when patients’ pain is in flux and changes depending on the time of day, level of activity, or other extrinsic factors.


14.3 Health Utility Scales


Health utilities measure the impact of a disease on society by quantifying health status, or change in health status, weighted for societal preference. Societal impact could theoretically be evaluated by valuing change in SF-36 PCS or ODI score. However, these outcome measures do not give a value that can be directly used in economic analysis.

Utilities or health state values are measured using a single index score for each state of health. Scores range from 0 for death to 1 for perfect health. They are weighted for the relative desirability of the health state. Utility scores are combined with life years for use in economic analysis.

Standards for economic evaluations recommend using societal values (utilities or preferences) [29]. There are two common approaches to obtaining “societal health states values,” direct and indirect [30, 31]. Direct measurement of value for health states of a representative sample of the population uses methods such as standard gamble, time-trade-off, and visual analogue scale ratings [30]. In standard gamble, the subject is asked to choose between remaining in a state of ill health for a period of time, or undergoing a medical intervention with the gamble that it will either restore them to normal health or lead to death. As implied by the name, time-trade-off method asks respondents to choose between remaining in a state of ill health for a period of time or being restored to normal health but also having a shorter life expectancy. Visual analogue scale asks respondents to rate a state of ill health on a scale from 0 to 100, with 0 being dead and 100 being perfect health. Indirect measurement uses preference-based measurement systems such as the Quality of Well-Being Scale [32], the EuroQol EQ-5D [33], SF-6D [34], or the Health Utilities Index (HUI) [35].

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May 4, 2017 | Posted by in ORTHOPEDIC | Comments Off on Outcome Measures for Spinal Surgery

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