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Boulware LE, Barnes GJ II, Wilson RF, et al. Value of the Periodic Health Evaluation. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Apr. (Evidence Reports/Technology Assessments, No. 136.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Value of the Periodic Health Evaluation.

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Executive Summary

Introduction

The periodic health evaluation (PHE) consists of one or more visits with a health care provider to assess patients' overall health and risk factors for preventable disease, and it is distinguished from the annual physical exam by its incorporation of tailored clinical preventive services and laboratory testing as part of health risk assessment. By promoting prevention, management of chronic conditions, and enhancing the patient-provider relationship, the PHE may improve patient outcomes and the public's health. However, it could also induce unnecessary costs and patient harms by promoting the use of non-recommended services. Early studies of the PHE, performed before the adoption of current preventive services guidelines, were costly and demonstrated minimal improvement in clinical outcomes, leading to concern regarding the PHE's value and to the promotion of episodic, targeted delivery of preventive services in the context of ongoing clinical care. More recent clinical trials have reported scattered benefits of the PHE. Thus, despite its continued practice, the value of PHE in improving health and healthcare costs has been largely unclear.

Private and public health insurance coverage for preventive services in the U.S. has gradually increased over time. However, increases are typically for one recommended service at a time, rather than a comprehensive set of preventive services. Recent legislation will provide coverage for a “Welcome to Medicare Visit” for new enrollees, incorporating a range of diagnostic and screening tests. Lack of clear evidence to support or refute its use, and recent legislation to cover preventive services on a wide scale provide the basis for this systematic review of the evidence to elucidate the value of the PHE.

Methods

The American College of Physicians posed preliminary questions regarding the PHE. We convened a panel of three internal and eight external technical experts to provide input into the refinement of questions to be addressed. We also recruited peer reviewers representing stakeholder organizations to give feedback on the draft report.

We address the following Key Questions concerning the value of the PHE for adults:

1.

What definitions are used for the adult PHE in studies of its value?

2.

What is the evidence that a PHE, delivered at different patient ages or different frequencies, is associated with benefits (i.e., improved outcomes) compared to care without a PHE (e.g., usual care)?

Outcomes include:

a.

Delivery of recommended clinical preventive services.

b.

Patient attitudes/perceptions (e.g., knowledge, satisfaction).

c.

Behavioral outcomes (e.g., tobacco cessation, adherence).

d.

Proximal/intermediate clinical outcomes (e.g., cholesterol lowering, disease management).

e.

Distal clinical outcomes (e.g., death, or myocardial infarction).

f.

Economic outcomes (e.g., cost savings, health care utilization).

g.

Public health (e.g., improvements in family and community health).

3.

What is the evidence that a PHE, delivered at different patient ages or different frequencies, is associated with harms (i.e., worse outcomes) compared to care without a PHE (e.g., usual care)?

Outcomes include:

a.

Delivery of non-recommended clinical preventive services.

b.

Patient attitudes/perceptions (e.g., worry).

c.

Behavioral outcomes (e.g., continuation of risky behaviors).

d.

Proximal/intermediate clinical outcomes (e.g., complications from testing).

e.

Distal clinical outcomes (e.g., events such as death).

f.

Economic outcomes (e.g., induced costs, increased health care utilization).

g.

Public health (e.g., declines in family and community health).

4.

What system-based interventions improve the receipt or delivery of the PHE (e.g., insurance premium reductions or provider reminders)?

We searched MEDLINE®, the Cochrane databases, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and we hand-searched 24 journals and bibliographies from pertinent articles through February, 2006. We used pre-specified, standard criteria to select studies. Pairs of reviewers screened the literature for relevant article titles. For articles promoted to abstract review, two investigators independently reviewed abstracts and excluded them if they: 1) had no useful information applying to the Key Questions; 2) were not written in English; 3) included subjects only 18 years or younger ; 4) contained no original data; or 5) had no comparison group. Titles and abstracts were promoted to further review if either of two reviewers did not exclude them. For articles promoted to final review, two reviewers sequentially performed full data abstraction for each article, including information on study design, location and setting, dates of performance, follow up length, enrollment, eligibility criteria, participant characteristics, components of the PHE, interventions, and outcomes.

Two reviewers independently judged individual studies' quality on several aspects of external and internal validity, including descriptions of: inclusion/exclusion criteria; subjects' baseline characteristics; handling of withdrawals; the intervention; adequacy of length of study follow up; outcomes; randomization and blinding (for RCTs); and the statistical analysis. At the completion of the article review, we summarized the magnitude of effects in RCTs by reporting Cohen's d (95% confidence interval (CI)) for mean differences and proportions. We considered effect sizes ranging from 0 to 0.25 to represent “small” effects, from 0.26 to 0.8 to represent “medium” sized effects, and greater than 0.8 to represent “large” effects. We also graded the quantity, quality and consistency of the “best available evidence” (comprised of studies least likely to present biased findings) addressing Key Questions 2 through 4 by adapting an evidence-grading scheme recommended by the GRADE Working Group (classifying bodies of evidence pertaining to each outcome as “high”, “medium,” “low,” or “very low” grade). Evidence grading incorporated assessments of studies' quality, consistency in the direction of reported results for an outcome, sparseness of data, probability of bias, and reported strength of association between the PHE and outcomes.

Results

We screened 6523 articles for eligibility at the title review level and reviewed 2021 at the abstract level, and 819 at the article inclusion/exclusion level. Of these, 54 articles were promoted for full review, representing 36 studies reporting multiple outcomes or follow up dates. All studies addressed Key Question 1, 36 studies addressed Key Question 2, no studies addressed Key Question 3, and five studies addressed Key Question 4.

Identified Studies

We identified a total of 36 studies containing information applicable to the Key Questions. A description of study characteristics is listed in Table 1. The most common study design was cross-sectional (14 studies), followed by randomized controlled trials (RCTs) (11) and cohort studies (7). Overall, the literature was characterized by complexity and heterogeneity in several dimensions. Studies were conducted over a period of several decades (19 from 1990 and later, 9 between 1970-1989, and 4 before 1970) (Table 1). Practice settings for the studies were also diverse, with 16 studies taking place in private offices, four in hospital outpatient clinics, and seven in academic practices. Studies reflected a range of health plans as well, with four studies in Medicare or Medicaid populations, 10 in non-U.S. national health plans, four in employer health plans, and two in staff-model HMOs. While 25 studies were performed in the U.S., we also identified relevant studies from the United Kingdom, Canada, Taiwan, Japan, Denmark and Sweden.

Key Question 1. What Definitions are Used for the Adult PHE in Studies of its Value?

Definitions of the PHE were heterogeneous. While central elements used to define the PHE included the clinical history and risk assessment of patients and a physical examination, the specific composition of these central elements varied among studies. The most frequently cited types of history and risk assessment performed were assessment of dietary, alcohol/substance abuse, and tobacco smoking risks; the least frequently cited types of risk assessment included assessment of calcium and folic acid intake. In many cases, the physical examination was referred to with no specific clarification of what components were included. When specified, the most frequently cited components of the examination were assessment of blood pressure, weight and height, breast examination, gynecological examination, and rectal examination; the least frequently cited components included neurological and foot examinations.

Key Question 2. What is the Evidence that a PHE, Delivered at Different Patient Ages or Different Frequencies, is Associated with Benefits Compared to Care Without a PHE?

Studies addressing Key Question 2 reported on the association of receipt of the PHE with: a) delivery/receipt of seven preventive services; b) seven proximal clinical outcomes; c) three distal clinical outcomes; and d) economic outcomes.

Delivery/receipt of clinical preventive services. The PHE consistently improved delivery/receipt of the gynecological examination/Pap smear, cholesterol screening, and fecal occult blood testing. The magnitude of the PHE's effects on receipt of the gynecological examination/Pap smear based on 2 RCTs ranged from small (Cohen's d (95% CI): 0.07 (0.07, 0.07)) to large (Cohen's d (95% CI):1.71 (1.69,1.73)). The strength and consistency of evidence pertaining to gynecological examination/Pap smear was graded “high.” The magnitude of the PHE's effects on receipt of cholesterol screening based on one RCT and four observational studies ranged from small effects in the RCT (Cohen's d (95% (CI): 0.02 (0.00,0.04)) to large associations in observational studies. The strength and consistency of evidence pertaining to cholesterol screening was graded “medium.” The magnitude of the PHE's effects on receipt of fecal occult blood testing based on 2 RCTs was large (Cohen's d (95% CI): 1.19 (1.17, 1.21) and 1.07 (1.05, 1.08). The strength and consistency of evidence pertaining to fecal occult blood testing was graded “high.” Effects of the PHE were mixed among studies assessing delivery/receipt of preventive counseling, immunizations, and mammography. The strength and consistency of the evidence regarding these outcomes ranged from “low” (mammography and counseling) to “medium” (immunizations).

Proximal clinical outcomes. One study reported the PHE had a positive effect on patient “worry,' with smaller increases in health worry (13% increase in baseline worry score) among persons receiving the PHE compared to persons receiving usual care (23% increase in baseline worry score) at 24 months follow up. The strength and consistency of the evidence from this study was graded “medium.” Among the best available evidence, the PHE had mixed effects on disease detection, health habits, health status, blood pressure, serum cholesterol, and body mass index. The strength and consistency of the evidence assessing these outcomes ranged from “low” (serum cholesterol) to “medium” (disease detection, health habits, blood pressure, and body mass index).

Distal clinical and economic outcomes. The PHE had mixed effects on costs, disability, hospitalization, and mortality. The strength and consistency of the evidence ranged from “medium” (costs, disability, mortality) to “high” (hospitalization).

Key Question 3. What is the Evidence that a PHE, Delivered at Different Patient Ages or Different Frequencies, is Associated with Harms Compared to Care Without a PHE?

We identified no studies focused on the delivery of non-recommended preventive services or the inducement of poor health outcomes as a result of the PHE.

Key Question 4. What System-based Interventions Improve the Receipt or Delivery of the PHE?

Among the best available evidence, two interventions (scheduling of appointments for the PHE and offering a free PHE) improved delivery of the PHE with medium to large positive effects. One study demonstrated a 29% improvement in attendance at the PHE for persons provided with a scheduled appointment versus an open invitation to the PHE, and one study demonstrated a 22% increase in attendance at the PHE with offering a free PHE versus a small fee. The strength and consistency of this evidence was graded “medium.”

Limitations

The PHE was described with great heterogeneity, limiting inferences regarding which aspects of the PHE are most influential on outcomes. Few large-scale RCTs assessed the effect of the PHE, with some of the largest trials performed among select populations prior to guidelines of the U.S. Preventive Services Task Force (USPSTF) in 1989, limiting their generalizability. Outcomes in some categories (e.g., counseling) were heterogeneous, limiting inferences regarding these outcomes. Little evidence addressed the PHE's effect on intermediate outcomes (e.g. blood glucose control, diabetes management). Evidence regarding the cost-effectiveness of the PHE was similarly sparse. Many outcomes were reported among a few RCTs, leaving open the possibility that individual study designs heavily influenced the direction of multiple outcomes. The feasibility of isolating the effect of the PHE on long-term outcomes is unclear given the periodic (or one-time) delivery of the PHE in studies and given multiple other episodes of patient care that typically occur outside of the PHE.

Our review is also subject to potential publication bias, in that investigators may have been more likely to publish articles reporting the PHE improved outcomes. In addition, observational studies in this review are subject to unaddressed residual confounding of results.

Recommendations for Future Research

Studies are needed to assess whether the PHE could encourage delivery of inappropriate preventive services or inflict harms on patients and to clarify the effect of the PHE on health habits, patient attitudes, health status, other intermediate outcomes such as clinical morbidity or worker productivity, and broad public health outcomes such as communicable disease containment or improvements in family health. Work to elucidate the magnitude and duration of effects of the PHE on outcomes is also needed. Studies elucidating the PHE's effect on both direct and indirect costs, long-term changes in quality of life, and clinical morbidity can be used in cost-effectiveness models, which are needed to more fully integrate findings regarding potential harms and benefits of the PHE.

Studies are needed of the frequency and intensity of the PHE required to achieve clinical improvements (or to induce harms) studies also are needed to assess differences in the PHE's effect when delivered in different health care systems or by different providers. Such studies would enhance knowledge regarding mechanisms through which the PHE can be delivered most efficiently.

Additional, well-designed studies are needed to strengthen the evidence for or against system-level interventions to enhance receipt of the PHE.

Conclusions

The best available evidence suggests delivery of some recommended preventive services are improved by the PHE and may be more directly affected by the PHE than proximal or long-term clinical outcomes and costs. It may be difficult to entirely isolate the effect of receipt of the PHE on intermediate clinical outcomes which require ongoing management such as blood pressure or long-term outcomes such as mortality. Thus, studies linking the PHE with improved delivery of preventive services may provide the best evidence of its value. Since appropriate implementation of preventive services has been demonstrated to improve health in evidence which provides the basis for USPSTF recommendations, findings of increased delivery of preventive services in the setting of the PHE may provide adequate justification for implementation of the PHE. While achieving consistency in the definition and delivery of the PHE stands as an important remaining challenge, efforts to clarify the presumed long-term benefits of receiving multiple preventive services in the context of the PHE versus other types of ambulatory visits are needed to fully elucidate the value of the PHE.

Mechanisms through which improvements in care attributed to the PHE occur are unclear. The PHE may have a stronger effect on the delivery of preventive services which are performed by clinicians at the time of the office visit (e.g., fecal occult blood testing) versus preventive services requiring patients to schedule appointments outside of the office (e.g., mammography).

Future studies assessing the value of the PHE should incorporate diverse study populations and should seek to carefully define systems of “usual care” with which the PHE is to be compared, capture outcomes in a standardized fashion, and more clearly assess the PHE's cost-effectiveness. The development of computerized models may be most helpful in assessing the long-term value of the PHE.

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