Patient-Centered Outcomes in Surgical and Orthodontic Treatment

Abstract

Patient-centered health care has two characteristics: it is closely congruent with and responsive to the patient's wants, needs, and preferences, and it considers the psychological, social, cultural, and economic dimensions of the patient in addition to physical findings. The ultimate benefit to the patient has always been a primary concern of clinicians providing coordinated orthodontic and orthognathic surgical treatment. However, in the past 10 years, a much greater emphasis has been placed in both medicine and dentistry on the patient as a coparticipant in decision making and the process of treatment. In addition, it has been realized the success of treatment must be defined not just in terms of the objective findings of clinicians, but also in the context of the patient's perceptions of what was achieved.

This article discusses the impact of the new emphasis on patient-centered care on clinical practice and research in orthodontics and orthognathic surgery and provides two examples of how patient-centered outcomes can be assessed and used to improve the quality of care in these patients.

An emphasis on patient-centered care ^1,2 affects several aspects of the clinical management of patients treated for dentofacial disharmony, whether the treatment is orthodontics alone or in combination with orthognathic surgery.

Patient-Centered Clinical Practice

Disclosing Information to Patients

Patients increasingly expect to be informed not only about their diagnoses, but also about details of the problem, treatment options, and prognosis. In the treatment of dentofacial disharmony and particularly in the decision between orthodontic camouflage and surgical correction, treatment simulations created by computer software of alternative treatment outcomes help clinicians decide which movements of jaws and teeth would be best. Recent studies show that, in most circumstances, sharing these simulations with the patients and allowing them a role in the treatment-planning process significantly improves communication without creating undue risk.^3,4

The art of patient-centered care involves skilled assessment of the role the patient desires in the treatment process. Individual patients differ with respect to the amount of detail they wish to know and the degree to which they wish to participate in decision making. Some patients will desire complete details, whereas others will not wish to exercise their right to know. Interpersonal communication skills are extremely important because a patient's perception of the clinician's ability to relate to them as an individual mediates the patient's (parent's) treatment acceptance, willingness to participate in the decision-making process, and adherence to treatment.⁵

Patient-Clinician Relationships

Quill⁶ describes the ideal modern patient-clinician relationship as a contract under which both parties have unique responsibilities; the relationship is consensual, not obligatory; both parties must be willing to negotiate; and both parties must benefit.⁶ The incorporation of a patient's review that includes the patient's perspective, values, and preferences in clinical encounters will complement the clinician-centered diagnostic evaluation.^7,8 This requires a deliberative clinician who will openly communicate and actively listen so the patient's perspective can be incorporated.

Decision Making

Providing information to the patient enables him or her to participate in treatment decisions. As orthognathic surgery has become more patient-centered, the patient has become a coparticipant in the treatment-planning process, with the patient helping to decide what treatment option will be used. This approach removes the clinician from the authoritarian role. It has several advantages, but it undoubtedly requires more time because it requires exploring the desired outcome with the patient. Conversely, informed consent problems almost always revolve around a treatment outcome different from what the patient really desired, often because the wrong treatment plan (from the patient's perspective) was chosen.⁹

Medical Law and Informed Consent

Before the 1970s, the courts judged disclosure of information to patients according to a clinician-centered standard, the performance of a “reasonable medical practitioner” similarly situated.¹⁰ In 1972, the case of Canterbury versus Spence emphasized a patient-centered standard.¹¹ After this landmark case, approximately half the states adopted an informed consent doctrine that stressed what a reasonable patient had the right to know.¹² In the discussion of risk associated with a treatment, patients should be given information not only on what percentage of patients experienced an event, but also how other patients perceived that event. For example, a small percentage of patients have root resorption associated with orthodontic camouflage of dentofacial disharmonies, and a greater number have some neurosensory alterations associated with surgical correction. It is important to tell the patients not only what percentage of those treated will have these problems, but what difference it makes if the problem arises. This requires the practitioner to have a sound knowledge of outcomes as seen through the perspective of the patient.

Quality Assessment

Historically, quality assurance meant providers followed processes of care considered important by their peers. By the late 1980s, outcomes of care began to be widely emphasized over process measures, but providers remained the evaluators. In the 1990s, it has become relatively common to have patients, often through surveys, serve as judges of quality of care. Quality assurance is no longer limited to peer review, but includes patients' perspectives as well.

Evaluation of Outcomes

The patient-centered focus in the clinical setting has prompted an expansion in the research setting to include other softer outcomes in addition to traditional clinical indicators. Such outcomes as dental or skeletal stability, function, physiological responses, and oral health assessments, which predominate the literature and ongoing clinical research, are clinician centered. These are, of course, important measures for gaining an understanding of growth, biological mechanisms, and treatment effectiveness. However, concentrating on these objective measures gives an incomplete picture of the treatment outcome because the perspective of those whose daily experiences are in part shaped by their skeletal disharmonies and/or malocclusion is not included. Orthodontists and oral and maxillofacial surgeons are not alone in incomplete evaluations of this type. As Jesse Parker pointed out, “Modern medicine [… and dentistry] has privileged objective features of illness [… malocclusion and skeletal disharmony] over its subjective and experiential features.”¹³

Gathering Data to Evaluate Patient-Centered Outcomes: Methodological Considerations

To obtain the patient's perspective, data relating to the process and outcome of orthodontic and orthognathic surgical treatment important to and/or valued by patients (and parents) must be obtained.¹⁴ This includes an understanding of (1) what patients want, expect, feel, perceive, and believe about their problem and treatment; (2) how the information presented to them and their experiences during the treatment process affect their perceptions; and (3) their satisfaction with and valuation of the clinical result of treatment. If the patient's perspective on health outcomes is important, we should measure it directly from the perspective of the patient. Patient self-reports are an essential component of patient-centered outcomes because patient perceptions do not necessarily correlate with clinical measures.¹⁵ For example, both the decision to seek orthodontic or surgical treatment and the choice of treatment reflect the patient's subjective evaluation of the functional and esthetic problems more than the absolute degree of the problem.¹⁶

Unfortunately, asking the patient is neither simple nor straightforward. Assessing the patient's perspective presents some interesting methodological challenges. The methodological and practical issues of obtaining information about patient-centered outcomes include all the concerns related to the more objective measures, such as cephalometrics, bite force, or peer assessment rating (PAR) scores. Patient-centered measures must be evaluated relative to their comprehensiveness, practicality, responsiveness, reproducibility, validity, and depth of coverage. In addition, it must be kept in mind that patient-based assessments include possible response bias.

Practitioners should expect to see the following issues addressed when they read reports on patient-centered outcomes.

Comprehensiveness and Practicality

The information-gathering process should include sufficient questions to ensure the desired information is obtained, but this must be balanced against the limits of patient cooperation. It is essential to remember that patients, unlike machines and probes, get tired, become irritable, and lose patience and interest. The process should be fast, easy to administer, inexpensive, readily performed on a serial basis (before and after treatment), and provide quantifiable data. If a questionnaire is used, patients from a wide variety of educational backgrounds should be able to complete it with minimal instructions. The impact of developmental stage, cultural background, and socioeconomic status on the interpretation or understanding of the questions needs to be carefully considered.¹⁷

Responsiveness

The process should be able to detect subtle but clinically relevant differences among patients, as well as changes over time. Orthognathic surgery involves a relatively long process that includes more than just treatment: a decision phase to seek treatment, a deliberation phase about treatment options, actual treatment phases, and an adjustment phase after treatment. The phases of treatment to be included and the definition of the clinically significant differences should be established before the development of the instrument so testing can verify the desired sensitivity of the instrument.

Reliability

The measurement process should provide the same information on a given patient repeatedly if the characteristic or concept of interest is stable. Generally, objective measures are evaluated using a test-retest approach in which data for the same subject or sample are obtained on separate occasions. There are two problems in using test-retest methods for self-report instruments. These are subject sensitization (the first administration of the instrument may influence the responses on the subsequent administration) and memory/recall variability (a lack of agreement between two test scores may be caused by the subject's recall or response style). Other approaches, in addition to test-retest, can be used to establish the reliability of a self-report instrument. For example, redundant items can be incorporated in an instrument and the internal consistency evaluated during the development of an instrument.

If an interviewer administers the assessment, a script should be used by the interviewer to ensure consistency of presentation to all subjects. Interinterviewer reproducibility must also be considered if multiple interviewers are involved because interviewer style can significantly affect subjective reporting.

Validity

The measurement process should provide accurate and generalizable information. For example, a questionnaire intended to measure the satisfaction of orthognathic surgical patients with the outcome and process of treatment should have the following types of validity: construct validity, the questionnaire measures the concept or abstract idea that it claims to measure; content validity, the questions are relevant to the concept; concurrent validity, the scores obtained are congruent with the expected results in a select group (for example, orthognathic patients who express dissatisfaction should have low scores on scales that evaluate perceptions of esthetics, occlusion, or function); and correlational validity, the scores from a newly developed instrument are related to scores from a previously validated and reliable instrument if one exists.¹⁸ In addition, the findings should be free from measurement and selection biases. Response biases represent an additional complexity that must be considered in self-report measures.¹⁹ For example, we have reported that self-image as a motivation for orthognathic surgical treatment patients is associated with both impression management and self-deceptive positivity, but that adjusting for the psychological distress of the patient removes this association.²⁰

Coverage

Patients undergoing orthognathic surgery represent diverse age ranges and developmental stages, and because of the length of treatment time, a patient may move from one developmental stage to another. The valuation and importance, and perhaps even the interpretation, of specific aspects of outcome and process at the age of 16 years may be considerably different from that at the age of 45 years. Researchers must give careful attention to the psychometric and population-appropriate properties of a questionnaire. Cognitive and social development may have significant impact on the development of self-report questionnaires. Not all self-report instruments can be used across a wide age range, and responses may not be similar across different instruments even though the instruments purport to measure the same construct.

Using Patient-Centered Outcomes to Improve Orthognathic Treatment

This section provides examples of how patient perspectives can be obtained using qualitative and quantitative approaches in a patient-centered assessment and used to improve the quality of patient care.

Both qualitative and quantitative approaches are used in obtaining patient-reported outcomes. Qualitative techniques are particularly useful in the development of patient-centered outcome measures. These include one-on-one in-depth interviews, focus groups, and small-scale telephone or mail surveys sent to only small samples.²¹ More traditional quantitative methods, usually self-administered questionnaires, are used when reliable, generalizable results are desired. Decision analysis is another relatively new quantitative research technique that can explicitly factor patients' values and preferences into decisions about the usefulness or cost-effectiveness of treatment strategies.²²

Qualitative Research Example: Outpatient Versus Hospital Orthognathic Surgery

Four orthognathic surgical patients who underwent surgery in an ambulatory care center and three caretakers (two parents and one spouse) participated in separate minifocus group discussions about the ambulatory care setting and recovery. The intent of these discussions was to identify concerns different from those of patients who are hospitalized.

The 1½ hour discussions of the two groups are summarized in Table 1. Both groups independently identified the same positive and negative aspects of the process and short-term recovery. These remarks reflect a consistent theme that information and communication before surgery often is not sufficient, and individualized postsurgical follow-up is extremely important. As noted by D'Angelica et al,²³ even patients generally satisfied with the communication with their surgeons before surgery and in the hospital can be less than optimally prepared for problems that occur later. Helping the patient express and resolve feelings of surprise or anxiety during the postoperative phase will likely increase overall satisfaction with treatment. Given the significant relationship that exists between communication and patient satisfaction, it is essential the clinician's education prepare him/her to work interpersonally with patients.²⁴

Table 1. Themes From Minifocus Group Discussions.

Positive themes from patients and caregivers Ambulatory care center setting: convenient, home-like, personal attention Preparation: thorough, detailed, attending and staff responsive to questions Follow-up: telephone calls by surgeon and care center helpful and reassuring

Negative theme from patients Icepack: scary, anxiety producing … “couldn't see; didn't know what was touching my face”

Negative themes from patients and caregivers Swelling and bruising: extent surprising, not prepared emotionally for presentation… “I knew (it) would happen but did not know how much” … “Amazing how much you can swell” Food preparation: monotonous, more difficult than anticipated

Quantitative Research Example: Perceptions of Surgical Outcomes

At the University of North Carolina, we have looked at specific outcomes using a set of four questionnaires (Postsurgical Perceptions; Problems With Facial Sensation; Problems With Occlusion and Function; and Satisfaction) that were developed as part of an NIH grant (Psychosocial ν Clinical responses to orthognathic surgery; Ceib Phillips, P.I. DE 10028). These were completed by 225 patients who were at least 1 year postsurgery and had rigid fixation. The demographic characteristics and surgical procedure distribution for these patients are shown in Figure 1.

Figure 1.

Demographic characteristics and distribution of surgical procedures of patients who completed the postsurgery questionnaires.

An important finding is that the memory of the immediate recovery stage and the stress produced in the life of the patient is still strong even more than 2 years after surgery (Fig 2), and many patients had problems coping with this stage of treatment. Although less than 10% of the patients reported hospital stay procedures had not been explained or they did not know what to expect after being released from the hospital, approximately 30% reported being unprepared for how they would feel emotionally after surgery. Patients were told it can take 4 weeks to feel as if they have returned to full presurgical levels of activity, even if they have returned to work. Nevertheless, 40% reported they were surprised at how long the recovery took and 10% were surprised at the discomfort experienced when participating in activities.

Figure 2.

Percentage of patients who expressed dissatisfaction with some aspects of the immediate recovery stage.

These findings point out the difficulty communicating to the patient the emotional aspects of recovery. Patients are often prepared for possible consequences or risks by citing percentages, but sufficient time should be taken during the presurgical consultation to ask a patient how they would cope with an unexpected happening or delay in returning to full activity. It is important for the clinician to know the patient can respond adaptively to unexpected events and has a positive support system.

These questionnaires also asked patients if they had current problems or problems in the past 2 weeks (Fig 3). A second important finding is that neurosensory changes are noticed by the patients more often than clinicians might expect. Almost three fourths of the patients, even more than 2 years postsurgery, reported experiencing an alteration in sensation, primarily in the chin and lips. More than 40% reported residual numbness that caused at least some problems, and 14% had pain associated with the alteration. Approximately one third reported loss of sensitivity to touch in the lips and having food particles on the chin or mouth without knowing it was a problem. At least 15% of the patients reported other problems related to the change in sensations. These included drooling with or without knowing it, cheek biting, and discomfort associated with eating or drinking cold food or drink. Surprisingly, the percentages do not seem to decline substantially in the more than 2-year postsurgery group from the 1- to 2-year postsurgery group.

Figure 3.

Percentage of patients who expressed a problem or concern related to altered sensation.

The percentage of patients who reported a specific problem (Fig 4) was greater than the percentage who reported being dissatisfied overall with treatment or, more specifically, were dissatisfied with their improvement in masticatory ability or improvement in appearance. Patients were quite pleased with the esthetic results of treatment and, even at more than 2 years postsurgery, reported receiving positive comments about their appearance since the surgery. Three fourths of the patients agreed that people whom they met for the first time reacted more positively than they had before the surgery (Fig 5). Interestingly, approximately 15% expected more of an improvement in their appearance than that achieved, even while reporting satisfaction with the final result.

Figure 4.

Percentage of patients who expressed dissatisfaction with specific aspects of treatment outcome.

Figure 5.

Percentage of patients who expressed positive feedback.

Future Work With Patient-Centered Outcomes

Patient perspectives and their application in improving the quality of care can be summarized as Barbara deLateur did in a recent Walter J. Zeiter Lecture¹³:

Though difficult to study, it is not impossible;

Though qualitative, it can be quantified;

Though subjective, it can be observed;

Though theoretical, it is certainly not impractical.

Important aspects of future developments in this area include:

1. The assessment of patient-centered and/or patient-based outcomes requires an interdisciplinary approach; thus, appropriate psychological, behavioral, and economic data, in addition to physical findings by orthodontists and surgeons, need to be included. It is important to involve experts in these areas, not just orthodontists and oral and maxillofacial surgeons, in evaluating the outcomes of treatment.

2. The research base for patient-centered outcomes should be broadened to include patients from community-based practices, as well as academic centers. This would involve a broader spectrum of patients and would increase the generalizability of the research findings. Little systematic data exist to support the assumption that academic center patient populations will provide findings that can be applied to other settings and other conditions.

3. It is important to obtain information from the patients' perspective for both the effectiveness of treatments (for example, is the patient's valuation/perspective of the treatment consistent across severity levels and in different regions of the country) and the appropriateness of treatment (does it make a difference to the patient, is the perceived impact the same for all patients). Data of this type are important not only to improve the quality of care, but also to document the value of surgical-orthodontic treatment in an era when insurance carriers and health maintenance organizations question its medical necessity and deny patients coverage for this type of care.