Chronic venous disorder registry: A new perspective

Abstract

Chronic venous disorder is one of the most prevalent medical conditions in the US that carries significant economic and health burden. The knowledge into venous pathophysiology, how it develops, and the true quality of life benefits of various treatment options are largely unknown. A truly meaningful clinical data capture system specifically for venous disorder may provide answers to the paucity of data. We describe a modern system to capture research and best practice data using the state of art information technology.

Keywords

chronic venous disorder registry endovenous thermal ablation saphenous veins venous insufficiency

Introduction

Chronic venous disorders (CVD) represent a common malady, causing significant morbidity worldwide.¹ In the US, an estimated 15–25% of adult Americans are affected by the disorder with considerable economical impact.¹ The population-based costs in the US for the treatment of CVD have been estimated to be over one billion dollars a year.² The pathophysiologic abnormalities leading to the development of venous reflux as well as the true quality of life benefits of various treatments options are largely unknown,³ despite its prevalence. This illustrates both the youth of phlebology as a specialty, and a true paucity of meaningful data as it pertains to managing CVD. As the US healthcare environment has recently evolved in terms of electronic accessibility of patient data, opportunities have emerged. We describe a modern system to capture research and best practice data to answer some of the aforementioned concerns and share the steps to bring it to fruition. There is no better time to consider a paradigm shift in meaningful documentation. This overview will explore the possibility of meaningful data collection using state of art information technology in phlebology.

Background

The current political climate for healthcare has been shaped by the increase in healthcare expenditures which surpassed $2.3 trillion in 2008 and accounted for 16.2% of the nation’s Gross Domestic Product (GDP).⁴ This spending is among the highest of all industrialized countries and is yet accompanied by subpar quality outcomes.⁴ Major legislation in recent years is intended to reign in costs and improve efficiency. It is apparent that the US government is committed to confront the issues facing healthcare and rising costs. Two bills passed in 2009 and 2010 framed the current position. The first bill, “The American Recovery and Reinvestment Act (ARRA)” of 2009 set forth guidelines to build upon the concept of electronic health records (EHR) and the personal health record (PHR). The second bill, entitled “Patient Protection and Affordable Care Act” of 2010 led to the creation of the Patient-Centered Outcomes Research Institute (PCORI), a non-profit organization focused on relative health outcomes, clinical effectiveness, and appropriateness of different medical treatments. The new regulatory requirements afford an opportunity to shape medical issues currently in debate now and potentially those in the future while supporting the advancement of medical specialties (such as phlebology) using statistical rather than anecdotal or market-driven evidence. Compared to other disease states, little is known about venous pathophysiology; yet, most practitioners caring for vein patients would agree that there is an abundance of ignorance as it applies to arbitrary decisions of insurance companies. The rise in utilization for varicose vein procedures for CVD has grown by over 250% over the past decade as patients gained greater access to care with lesser invasive treatment options.³ The combination of a healthcare crisis and perceived excess utilization have led to heightened scrutiny of the specialty especially by the insurance companies. As a result, unilateral efforts employed by payers to reign in consumption have included: arduous medical necessity guidelines,³ exclusions for treatment of varicose veins and CVD, arbitrary cuts in contracted reimbursement, and limited provider eligibility for reimbursement. In this current climate, medical decisions are often being made by non-healthcare providers. A considerable argument may be made to suggest that now is the time for practitioners caring for vein patients to address many unanswered questions, and in doing so, providing a solid scientific platform to guide medical decision making.

The practice of medicine and quality initiatives will have an ever greater influence on provider reimbursement. Whether it is patient reported outcomes, comparative effectiveness, or the Physician Quality Reporting System (PQRS), all clinical work and result will be measured. The question becomes, do we wish to rely on existing authorities to evaluate our work, or should we collectively lead this process capturing clinical evidence about our specialty?

The problem with the “legacy” registry

Unfortunately, legacy or traditional registries are not the answer and have suffered for many years with inaccuracies and inefficiencies rooted primarily in the fact that data are self-reported through manual abstraction process from paper records that are highly variable in terms of content and quality. Data collection inefficiencies, poor data quality, and high latency in reporting have affected many aspects of healthcare delivery that depend on data and are costly to establish and maintain. These and other problems caused by the use of paper records, and manual data abstraction, are the reasons the US government has made significant investments to enhance adoption of EHR systems. Moreover, additional limitations of legacy registry include (1) standardization of data elements and definition across registry that address the same disease or treatment areas, (2) uniform method of patient identity management, (3) interoperation with EHR, (4) standardization of methodologies for sampling, data quality assurance, and risk adjustment, (5) standardization of linkage methods, (6) ensuring high provider participation across these programs, and (7) guaranteeing that providers and data users are confident that registries are sustainable.

Today in the US, at least 30% of practices use an EHR. As part of the American Reinvestment and Recovery Act (ARRA), the Office of the National Coordinator for Health IT (ONCHIT) has started providing incentive payments to practices and hospitals that have adopted EHR. This program is predicted to accelerate adoption from the current 5% increase annually to perhaps 8–10%. At this rate, within five years, it would be realistic to anticipate over 70–80% of all ambulatory practices and hospitals will have a comprehensive EHR system. These incentives provide an ideal opportunity for interested practitioners to establish a clinical registry. Not all EHR are equal or capable of participation. Some EHR systems offer wonderful scheduling and billing software, yet become weak when it comes to medical documentation. Providers should seek systems that offer ease in documentation and an ability for automated data transfer. In the context of this digital transformation, providers can take advantage of the lower cost and higher quality of data that will come from EHR, as opposed to traditional paper records.

The solution

As the US healthcare moves toward a more accountable and quality-based model, an EHR-based patient-centered registry could be the answer to the aforementioned dilemma and serves as a possible foundation for providers to gain better insight into their operations, ultimately helping their bottom line. When EHR templates are combined to a single form, a standard and unified document is formed. This super-template allows for quick navigation to appropriate fields for each and every visit. Efficient data collection may be captured by many members of a healthcare team including the staff, the physician, and others with output tailored to the specific date of service. Patient reported outcome data may be captured seamlessly through dedicated computer tablets or kiosks that walk patients through generic and disease-specific queries with little to no provider input. Patient attestation is a critical component and a requirement for the query to be validated.

Clinical registries have become an increasingly useful tool in understanding comparative effectiveness of treatments for particular diseases or conditions. Registries have also traditionally been a key component of understanding the epidemiology of disease. A final key benefit to clinical registries has been their use in better characterizing the care process to find opportunities for quality of care improvement. To be effective, clinical registries require high-quality data that are available in a timely fashion and accurately reflect the clinical process being measured. In phlebology, venous disease-related benchmark metrics collected in the outpatient setting may be utilized to track patients over time. Though not a policing tool, feedback may be shared with participating practices on how well they are providing evidence-base care on a continuous basis. This will not only allow the practitioners to transparently demonstrate safe patient care but may have a future impact with payer incentives and reimbursement. Data may be submitted to the Center for Medicare & Medicaid Services’ (CMS) PQRS or other pay-for-performance initiatives on a voluntary basis. The ultimate goal for the registry is for it to gain acceptance by professional and regulatory communities nationwide by collecting high-quality data that can measure long-term outcomes which in turn will help assess the appropriateness and effectiveness of vein care including patient reported outcome measures. The clinical benchmarked data further allows medical organizations and professionals the opportunity to improve or shape the quality and appropriateness of their local care environment. These patterns may be used to lead and step up to educate the legislative bodies and inform the public about how proper assessment of patient care should be performed. Quality tools produced from this effort will allow states, payers, and purchasers of care to have on hand the critical, transparent metrics with which to evaluate the quality of care as the US shifts from a fee-for-service reimbursement model to one more focused on outcomes-based care and commensurate reimbursement.

Currently, reliance on claims and billing data is misplaced and the use of a vein registry and other similar datasets will assist federal and state agencies in determining appropriate care and reimbursement models. This will ensure high-quality and effective vein care delivery to patients, driven by physician oversight and leadership, and offers the opportunity for true transparency that is desired and that protects the interest of all stakeholders-government, payers, hospitals, physicians and most importantly, the patients. In order to rely on registries for performance measurement, both providers and users of performance measurement data need to have faith that the registries to which they submit data will be sustainable over time. Potential solutions include advocating for models that provide sufficient incentive for participation so that high-quality registries with sustainable business models emerge. Additional models include registry participation as a component of professional certification, third-party vendor contribution, and web-based platforms with social medial element.

What are the data priorities for patients with varicose veins?

What data should be captured for patients with varicose veins? Based on the clinical practice guideline of the American Venous Forum and the Society for Vascular Surgery published in 2011, the Clinical Etiology Anatomy and Pathology (CEAP) classification should be used to categorize patients with chronic venous disease and that the treatment outcome should be assessed using the revised Venous Clinical Severity Score (VCSS).⁵ A multispecialty group of experts in superficial venous disease have collaborated to develop a master dataset of data elements to be collected that includes comprehensive demographic, anatomic duplex parameters, treatment option, and procedure complication considerations (Tables 1–5). Expanded demographic information, risk factors for varicose veins and thrombosis, physical exam findings, duplex ultrasound findings, and venous severity tools are all considered to be important elements to capture in the medical vein practice. Once a master set and an EHR dataset become synchronous, meaningful data may be routinely shared via digital means as it is entered without need for duplicate entry. Standardization of data transfer may employ a commonly available digital format such as the continuity of care document (CCD) which is an Extensible Markup Language (XML)-based markup standard intended to specify the encoding, structure, and semantics of clinical document summary for exchange. Avoiding duplicate data entry is a critical feature to harness with any system moving forward. The process of interfacing and synchronizing an EHR with a master database is essential to the success of any method of data collection.

Table 1.

Demographics.

Demographics	VV risk	VTE (PE + DVT) risk	Vein treatment history (more than one may be chosen)
DOB/gender	Occupation	Family Hx of VTE
1. Ethnicity: Are you Hispanic, Latino/a, or of Spanish origin (one or more categories may be selected):	1. Prolonged sitting or standing	1. Biological mother	1. Medical Compression (>20 mmHg)
a. ___ No, not of Hispanic, Latino/a, or Spanish origin.	2. Active movement ½ of the day	2. Biological father	2. Small vein sclero
b. ___ Yes, Mexican, Mexican-American, Chicano/a	3. Biological siblings	3. Large vein sclero
c. ___ Yes, Puerto Rican	Family History	a. Male	4. Endovenous laser obliteration
d. ___ Yes, Cuban	1. Biological mother	b. Female	5. Ambulatory phlebectomy
e. ___ Yes, Another Hispanic, Latino/a or Spanish origin	2. Biological father	6. Endovenous radiofrequency obliteration
3. Biological siblings	Biological Children	7. Surgical stripping
2. Race: What is your race? (one or more categories may be selected.)	a. Male	1. Male	8. High ligation
a. ___ White	b. Female	2. Female	9. Lower extremity deep vein and/or IVC stent
b. ___Black or African-American	10. IVC filter placement
c. ___ American-Indian or Alaska Native	Multiparity (2 or more)	Prior Hx of VTE:
d. ___Asian-Indian	1. Yes	1. When was the last VTE event:
e. ___ Chinese	2. No	2. Was the last VTE event an idiopathic event, secondary event, or not sure:
f. ___ Filipino	3. How long were you treated with anticoagulation (months):
g. ___ Japanese	HRT/BCP	4. Are you still on anticoagulation now
h. ___ Korean	1. ____ Yes (if yes, then complete part a and b.)	a. Yes _____
i. ___ Vietnamese	a. Name of drug:	b. No _____
j. ___ Other Asian	b. Length of use (years):
k. ___ Native Hawaiian	2. ____ No	Recent Surgery (<3 months)
l. ___ Guamanian or Charmorro	1. Yes
m. ___ Samoan	2. No
n. ___ Other Pacific Islander
3. Primary language: How well do you speak English? (respondents 5 years or older)	Obesity (defined as BMI 25 or more)	Recent immobilization (<3 months) including hospitalization
a. ___ Very well	1. Yes	1. Yes
b. ___ Well	2. No	2. No
c. ___ Not well
d. ___ Not at all	History of superficial thrombophlebitis	HRT/BCP
1. Yes	1. Name HRT/BC medication:
2. No	2. Length of use (years):
4. Disability Status:
a. Are you deaf or do you have serious difficulty hearing? Yes or No: ____
b. Are you blind or do you have serious difficulty seeing, even when wearing glasses? Yes or No: ____	Leg injury (open surgery/fracture)	Genetic risk factors
c. Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, or making decisions? Yes or No: ____	1. Yes 2. No	1. Factor V Leiden mutation 2. Prothrombin gene 20210 mutation
d. Do you have serious difficulty walking or climbing stairs? Yes or No: ____
e. Do you have difficulty dressing or bathing? Yes or No: ____	3. Protein S deficiency
4. Protein C deficiency
Prior history of lower extremity DVT	5. Anti-thrombin III deficiency
5. Geographic Region:	1. Yes (if yes, select a or b below)
1. West 2. Midwest 3. Northeast 4. South	a. Right leg b. Left leg c. Both	Age and gender appropriate cancer screening (within last 2 years)
		1. Yes
	2. No	2. No
May-Thurner’s Syndrome	Autoimmune disease history
6. Zip Code=	1. Yes	1. Crohn
2. No	2. Ulcerative colitis
7. BMI=	3. SLE
Height (English or metric)=	Klippel-Trenaunay Syndrome	4. RA
Weight (English or metric)=	1. Yes	5. Sjorgren
2. No	6. Antiphosphlipid antibody syndrome
8. Sex	7. Any blood dyscrasias
a. Male	a. Yes (if yes, then which one?)
b. Female	b. No
9. Employment status:	Recent (<2 weeks) long travel (more than 4 hrs)
a. Yes	1. Yes
b. No	2. No

VTE: venous thromboembolism; DVT: deep venous thrombosis; PE: pulmonary embolism; HRT: hormone replacement therapy; BC: birth control; SLE: systemic lupus erythematosus; RA: rheumatoid arthritis.

Table 2.

Duplex findings.

Anatomic region	Right lower extremity					Peak reflux velocity (mm/s)	Anatomic region	Left lower extremity				Reflux duration (s)	Peak reflux velocity (mm/s)
Anatomic region	R	O	N	Diameter (mm)	Reflux duration (s)	Peak reflux velocity (mm/s)	Anatomic region	R	O	N	Diameter (mm)	Reflux duration (s)	Peak reflux velocity (mm/s)
1-Reticular veins	1-Reticular veins
2j-SFJ	2j-SFJ
2-GSV Above knee	2-GSV Above knee
2a-AASV	2a-AASV
2p-PASV	2p-PASV
3-GSV Below knee	3-GSV Below knee
4j-SPJ	4j-SPJ
4-SSV	4-SSV
5a-Tributaries AK	5a-Tributaries AK
5b-Tributaries BK	5b-Tributaries BK
9-EIV	9-EIV
11-CFV	11-CFV
12-PFV	12-PFV
13-FV	13-FV
14-PopV	14-PopV
15-Crural vein (AT, PT, Per)	15-Crural vein (AT, PT, Per)
16-Muscular (Gastrocnemius., Soleal)	16-Muscular (Gastrocnemius, Soleal)
17-IP AK (cm above knee)	17-IP AK (cm above knee)
18-IP BK (cm above ankle)	18-IP BK (cm above ankle)
Patient position for scan	Supine
Standing
Reverse Trendelenburg
Time of day for scan	8 am–11 am
11 am–2 pm
2 pm–6 pm

R: reflux; 0: obstruction; N: neither; SFJ: saphenofemoral junction; GSV: greater saphenous vein; AASV: anterior accessory saphenous vein; PASV: posterior accessory saphenous vein; SPJ: saphenopopliteal junction; SSV: short saphenous vein; AK: above knee; BK: below knee; EIV: external iliac vein; CFV: common femoral vein; PFV: profunda femoral vein; FV: femoral vein; PopV: popliteal vein; AT: anterior tibial vein; PT: posterior tibial vein; Per: peroneal vein; IP: incompetent perforator vein.

Table 3.

Treatment options.

Compression therapy	Thermal ablation		Chemical ablation	Oral pharmacological therapy
Strength	Tumescence volume (cc)=		Volumes/Sclerosant % = Gas (RA, CO₂:O₂, CO₂)	Narcotics 1. Yes 2. No
1. <20 mmHg	Tumescence mix/%=		1. RA
2. 20–30 mmHg	Device:		2. CO₂:O₂
3. 30–40 mmHg	1. Laser		3. O₂	Anti-inflammatory
4. 40–50 mmHg	a. Wavelength=		1. NSAIDS
5. 50 mmHg	b. Total time of laser activation (sec)=		Foam Mix (1:2-1:5)	2. COX II Inhibitor
c. Tip		1. 1:2
Style	i. Bare tip		2. 1:3	Calcium dobesilate
1. Panty/full	ii. Jacketed fiber		3. 1:4	1. Yes
2. Capri	d. Total energy (J)		4. 1:5	2. No
3. Thigh	e. Treatment length (CM)
4. Calf/knee Stiffness	f. Source of reflux i. SFJ ii. SPJ		Consistency	Micronized purified flavonoid fraction, i.e., oxerutin, flavonoids
1. Circular knit	iii. Thigh perforator		1. Foam	1. Yes
2. Flat knit	iv. Calf perforator		2. Liquid	2. No
	g. Distance from junction (cm)=		Anatomic Class	Pentoxyfylline
		1. Small veins	1. Yes
Wrap			2. Residual varices	2. No
1. Unna boot	2. Radio Frequency		3. Recurrent varices
2. Short stretch	a. Number of cycles=		4. GSV primary rx	Anti-oxidant oral vitamins
b Total time of RF activation (sec)=		5. SSV primary rx	1. Ascorbic Acid
Custom vs. RTW	c. Temperature c°=		6. Recanalization rescue (indicate length of time)	2. Alpha-tocopherol
1. Brand=	d. Treatment length (cm)=		a. Length of time:
e. Source of reflux
Circaid-like device	i. SFJ		Rutin
1. Brand=	ii. SPJ		1. Yes
iii. Thigh perforator		2. No
Specialized Ulcer Kit	iv. Calf perforator
1. Brand=	g. Distance from junction (cm)=		Rucus aculeatus
		1. Yes
Moderate Sedation	Anatomic Vein Treated		2. No
1. Yes	Left Leg	Right Leg
2. No	1. GSV	1. GSV	Retreated (weeks):
2. SSV	2. SSV
3. AASV	3. AASV	Hesperidin Methchalocone
4. PASV	4. PASV	1. Yes
5. IP AK	5. IP AK	2. No
6. IP BK	6. IP AK
		Green tea polyphenol
		1. Yes
		2. No

RTW: ready to wear; RA: room air; SFJ: saphenofemoral junction; GSV: greater saphenous vein; AASV: anterior accessory saphenous vein; PASV: posterior accessory saphenous vein; SPJ: saphenopopliteal junction; SSV: short saphenous vein; AK: above knee; BK: below knee; EIV: external iliac vein; CFV: common femoral vein; PFV: profunda femoral vein; FV: femoral vein; PopV: popliteal vein; IP: incompetent perforator vein.

Table 4.

Treatment options.

Phlebectomy	Pin stripping/S&L	Venous ulcer care
No. of incisions=	Tumescence volume (cc)=	Compression specifics (wrap,- short stretch, Unna boot)
Wrap:
Length of vein removed (cm)=	Tumescence Mix/%=	1. Unna Boot
2. Short Stretch
Anesthesia	Device (PIN stripper, Codman Stripper, other)
1. General	1. PIN Stripper	Skin substitute (apligraf, other)
2. Tumescent	2. Codman Stripper	1. Apligraf
3. Other – Please name:	2. Dermagraf
Anatomic region	3. Integra
1. AK medial	Duplex guidance (Y/N)	4. Others (Please provide name of
2. AK lateral	1. Yes	graft)____
3. AK posterior	2. No	Skin graft
4. AK anterior	1. Yes
5. BK medial	Suture used (Vicryl, Silk, other)	2. No
6. BK lateral	1. Silk
7. BK posterior	2. Vicryl	Wound supplies (Please provide
8. BK anterior	3. Other____	name)____
Accessory saphenous ligation (Y/N)	Wound size (cm²)=
1. Yes
2. No	Wound duration (weeks)=
Flush ligation (Y/N)	Concomitant vein treatment (Y/N)
1. Yes	1. Yes
2. No	2. No
Selective ligation (distance from SFJ in cm)=
Inversion (Y/N)
1. Yes
2. No
Distal point of strip (BK, AK, Ankle)
1. Below knee
2. Above knee
3. Ankle
Vein breakage (Y/N)
1. Yes
2. No
Vein diameter (mm)=
1. Proximal thigh=
2. Mid thigh=
3. Below knee level=
Vein depths (mm)
1. Proximal thigh=
2. Mid thigh=
3. Knee level=
4. Below knee level=
Presence of phlebitis in stripped vein (Y/N)
1. Yes
2. No
Previous treatment of stripped vein (Y/N)
1. Yes
2. No
Simultaneous adjunctive treatment and type (Y/N)
1. Yes
2. No
General anesthesia (Y/N)
1. Yes
2. No
IV Sedation (Y/N)
1. Yes
2. No
Oral sedation (Y/N)
1. Yes
2. No
Proximal incision suture (silk, vicryl, other)
1. Silk
2. Vicryl
3. Others
Distal incision suture (silk, vicryl, other)
1. Silk
2. Vicryl
3. Other

RTW: ready to wear; SFJ: saphenofemoral junction; GSV: greater saphenous vein; AASV: anterior accessory saphenous vein; PASV: posterior accessory saphenous vein; SPJ: saphenopopliteal junction; SSV: short saphenous vein; AK: above knee; BK: below knee; EIV: external iliac vein; CFV: common femoral vein; PFV: profunda femoral vein; FV: femoral vein; PopV: popliteal vein; IP: incompetent perforator vein.

Table 5.

Procedure complications.

Serious Rx complications	Minor Rx complications
DVT – Endovenous heat induced thrombosis (EHIT)	1. EHIT type II 2. EHIT type III 3. EHIT type IV	Superficial thrombophlebitis in untreated vessels requiring treatment: defined as warmth, erythema and induration involving any saphenous, truncal or branch varicosities	1. Yes 2. No
DVT – Proximal/distal/muscular	1. Gastroc
	2. Soleal
	3. Peroneal
	4. Posterior tibial
	5. Anterior tibial
	6. Popliteal
	7. Femoral
	8. Deep femoral
Pulmonary embolus diagnosis	1. V/Q
	2. Spiral CT
	3. Pulmonary angiography
Pulmonary embolus location	1. Right upper lobe	1. Left upper lobe
	2. Right middle lobe	2. Left lower lobe
	3. Right lower lobe	3. Main left PA
	4. Main right PA
Stroke/TIA diagnosis	1. CTA
	2. MRA
	3. Cerebral angiography
Skin necrosis – >10 cm²	1. Yes
Skin necrosis – >10 cm²	2. No
Death	1. Yes
Death	2. No
Allergy/Anaphylaxis	1. Yes
Allergy/Anaphylaxis	2. No
Skin burn	1. Full thickness
	2. Subcutaneous injury
	3. Leave a mark
Paresthesia	1. Numbness
	2. Tingling
	3. Pain
Loss of limb	1. Yes
Loss of limb	2. No
Arterial compromise	1. Arterial embolism
	2. Arterial-venous fistula
	3. Pseudoaneurysm
	4. Arterial perforation
Cellulitis	1. Yes
Cellulitis	2. No
Fiber breakage/instrument complication	1. Yes
Fiber breakage/instrument complication	2. No

DVT: deep venous thrombosis; EHIT: endovenous heat induced thrombus; V/Q: ventilation/perfusion scan; CTA: computed tomographic angiography; MRA: magnetic resonance angiography; PA: pulmonary artery.

Comparative effectiveness research and patient reported outcome

Medical procedures have advanced dramatically over the past decade. As new devices and treatments are introduced, there is often no clear benefit, e.g., enhanced safety, lower cost, enhanced outcomes, and etc., over existing treatment options. As aforementioned, the answer to this uncertainty is comparative effectiveness research (CER).^3,6,7 An essential part of this effort is the creation of the Federal Coordinating Council for Comparative Effectiveness Research which encourages, “the development and use of clinical registries, clinical data networks, and electronic health data to be used to generate or obtain outcomes data.” It also oversees the budget which supports efforts to conduct or support research that compares clinical outcomes.^3,6 CER will undoubtedly impact future payment to healthcare providers. It will become an ever more critical component in our patient care decision making, and offers an opportunity to justify value in the work we do.

The complexity, cost, and time involved in administering randomized trials leave policy makers actively seeking alternatives to help facilitate and compare effectiveness for a variety of medical conditions and interventions. Practice-based evidence (PBE) research is the ideal alternative, permitting prospective, observational review of a variety of interventions with the heterogeneity seen in daily practice. As an example, patients with symptomatic varicose veins or complications of venous hypertension often have a dramatic improvement in their vitality following successful surgical intervention.⁸

Given the climate of healthcare in the United States, there is little value in gathering clinical effectiveness data without the patient’s voice. It is the patient’s perspective, not physician interpretation or surrogate outcomes that ultimately matter.⁹ When the patient’s voice is captured through a validated health-related quality of life (HRQL) tool, combined with patient-specific features, the outcomes most important to the patient are assessed and documented. Ideally patients will complete both generic and disease-specific tools. Patients may complete surveys on-line or on kiosks or tablets within the confines of the practice. There are logistical issues to consider when collecting patient reported outcome (PRO), yet the right tools coupled with a patient friendly medium should ease the administrative burden as patients and staff become familiar with the process.

Patient reported outcome data have tangible meaning. Over the past two decades, quality-adjusted life-years (QALYs) have gained popularity in measuring the value of healthcare outcome.^10,11 In a simplistic approach, the positive change in patient perceived health state multiplied by the duration of the effect, e.g., degree of symptom relief after vein treatment multiplied by duration of effect equates to the number of QALYs gained. Once QALYs have been determined, they may be applied to the costs associated with a given procedure to determine the cost/QALY.¹² This ratio may then be applied to compare any medical intervention, e.g., total hip replacement vs. superficial vein surgery, etc. A number of governments have begun to use QALYs to assist in resource allocation, and share-specific methodologies used to determine cost effectiveness for a given treatment option, etc.¹¹ This process serves to benchmark existing modalities, and when coupled with patient-specific data, may help to identify which patients stand to gain more with superficial venous surgery.

Although large-scale statistics are absent in the field of managing superficial venous disease, a recent study from Finland studied the impact of superficial venous surgery in 143 patients concluded that superficial venous surgery improved HRQL and was cost-effective.¹⁰ Calculating costs/QALY is not as simple as it may seem. There are many variables to be considered. Comparative effectiveness is meaningless if patient reported data are not accurately collected. Interestingly, in the Institute of Medicine’s 2009 report on national priorities for comparative effectiveness research, there is no mention of the common condition of CVD. It is clear that commercial insurers have viewed venous disease as a common condition and one that has grown more costly given heightened utilization of services over the past decade. PRO statistics are critical in the field of venous disease, as commonly reported surrogate outcomes such as demonstration of vein closure on duplex evaluation are truly meaningless to patients, who instead are most concerned with the impact of venous disease on their quality of life. Given the current healthcare environment, practitioners must take initiative and begin gathering data to demonstrate the value of venous treatments to patients. If care providers ask their patients to complete user-friendly questionnaires from the patients’ own perspective, the value of venous intervention can be ascertained.^13–16

Generic HRQL considerations

The concept of health-related quality of life queries has continued to evolve since the 1980s.¹² Surveys employ either visual analog scales (VAS) or questionnaires in an effort to identify the patient perceived health state at a given time. The tool should be cognitively undemanding and require no more than a few minutes to complete. The Short-Form-6D (SF-6D) requires patients to grade their perceived state of health for features of physical function, role participation, social function, bodily pain, mental health, and vitality. Many of the tools have been translated, tested, and validated in dozens of countries. It is known that cultural differences exist and as such it is important to use a survey that is validated for that culture. Each value reported from a questionnaire is culturally weighted for mathematical interpretation and resulting value between zero (dead) and 1 (best possible health). The mathematic translation of HRQL tools enables a comparison over time and permits more complex analysis including that of cost effectiveness for a given intervention.^14–17 The generic HRQL tools generally require a licensing process, yet many already have the intended query in a tablet friendly format. A number of tools have been used to assess generic HRQL in patients with CVD, yet much more may be gleaned from a practice-based evidence approach and comparing PRO following a venous intervention.

Disease-specific queries

Disease-specific tools are used to assess specific features of the medical condition in question. PRO questions are geared to specific features of patients with varicose veins and CVD. Commonly recognized and validated HRQLs in patients with CVD include the Aberdeen Varicose Vein Questionnaire (AVVQ), the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ), the Venous Insufficiency Epidemiological and Economic Study (VEINES-QOL/Sym), and the Specific Quality-of-life and Outcome Response-Venous (SQOR-V).^14–17 Many of these tools have been compared head to head and each has its respective merits and weaknesses. As with the generic HRQL tools, there is commonly a licensing fee associated with the use of a specific survey. The SQOR-V, however, has no fee attached and has been designed for a more sensitive assessment of HRQL in patients with CEAP classes C1–3.¹⁷

Conclusion

The practice-based clinical registry holds enormous potential as a powerful tool to help measure, manage, and improve patient care. For a registry to fulfill its potential, stakeholders must work together to overcome the current limitations in function and flexibility.

Declarations

All authors have no relevant financial interest/arrangement in regards to the preparation and/or subsequent publication of this paper.

Footnotes

Acknowledgement

The authors wish to acknowledge the contribution from Drs. Mike Hogarth and Alan Hirsch in preparation of this manuscript.

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