Page 108 - International guidelines for groin hernia management

Hernia

Registry, HerniaMed, Club Hernie, EuraHS, Dutch Hernia • The EQ-VAS, which provides a simple snapshot of
Registry, Evereg and AHSQC). patients’ self-reported health.
Large registries have the theoretical advantage of being
The EQ-5D Index gives a general overview of patients’
able to capture information on rare adverse outcomes and
self-reported quality of life on five dimensions: health,
disseminate that information to the surgical community at
anxiety and depression, ability to self-care, ability to carry
large. RCTs, which are often performed at expert centers,
out usual activities, and experience of pain or discomfort.
may lack this feature. Registries also can inform regulatory
Patients’ scores on these questions are combined to give an
agencies and the public about important outcome differ-
index ranging from - 0.594 to 1.0 (best possible score).
ences between healthcare facilities.
A problem with this approach is that IH patients gen-
Accurate, complete and valid data entry is crucial. A
erally do not have major problems with anxiety, depression
voluntary registry or a system lacking validity checks is at
or ability to self-care, dimensions included in the Index.
high risk for selection bias and input bias. Registry estab-
What they do have is a specific local problem, that this
lishment and maintenance is costly and a stable funding
generic health questionnaire will not identify or measure.
source must be assured prior to registry development.
At least two studies have shown clearly that generic
What constitutes a good registry?
instruments have poor discriminatory powers for distin-
Reasonable construct validity for a registry requires a
guishing between satisfied and dissatisfied hernia repair
robust system of data collection, follow-up and validation, 81, 177
patients. For unclear reasons, the NHS has failed to
agreed upon at the national level, and practical for the
adopt a condition-specific IH questionnaire. Outcome-
structure of the healthcare system in which it is imbedded.
specific disease measures for hernia surgery such as the
To deter risk-averse patient selection, predefined risk 81
Carolinas comfort score exist and have been validated.
adjustment models are suggested.
Groin hernia repair outcome reporting is inconsistent
Healthcare systems’ structures vary broadly worldwide
and poorly defined, limiting meta-analyses, which them-
resulting in problems designing international registries. In
selves do not control for the differing definitions of
many countries, routine follow-up is not done due to
assessed outcomes. A recent study published in the journal
clinical and financial constraints. Additionally, patients
Hernia assessed type, frequency and definition of clinician-
experiencing adverse events may not present to their
observed and assessed outcomes and PROMs for instru-
original healthcare provider, making adverse event data 178
ment validity and frequency of domain reporting. Forty
collection more difficult.
RCTs (10,810 patients) and seven meta-analyses (17,280
Time burdens, financial constraints, resource limitations 178
patients) were included in the review. No single PROM
and other factors place tremendous pressures on healthcare
was reported by any study. There were 58 different clini-
systems and their personnel worldwide. Quality data entry
cian-observed outcomes, with recurrence (n = 47, 100%),
into registry databases may increase workload since many
wound infection (n = 33, 70.2%), hematoma (n = 31,
of these data points are already in the medical record. A
77.5%) and seroma formation (n = 22, 46.8%) being most
method of minimizing data entry duplication would be to
frequently reported. All studies measured patients’ views,
ensure that registry data entry occurs during the recording
although only 12 (30.0%) used validated instruments. The
of clinical data entry. This, of course, would require local
SF36 was the most commonly used multidimensional valid
and national coordination. International registries could
PROM (n = 7), and a visual analogue scale assessing pain
incorporate this feature as well.
(n = 32) was the most frequently used one-dimensional
Patient Reported Outcomes
scale. Non-validated questionnaires assessed 25 other
Patient Reporting of Outcome Measures (PROMs) is
aspects of patients’ health. Two meta-analyses defined
another method of measuring outcomes. The United
recurrence, and three defined chronic pain; although neither
Kingdom’s National Health Service (NHS) has used
ensured that included RCTs adhered to the definitions.
PROMs since April, 2009 to assess the quality of all NHS- These results suggest that a standardized core outcome
funded care from patients’ perspectives. 176 PROMs mea-
set is needed for hernia surgery to improve outcome
sures patients’ health status or health-related quality of life
reporting and evidence synthesis.
at a single point in time. Data are collected from short, self-
completed questionnaires. For surgeries, health status
information is gathered pre and postprocedure. Two gen-
Chapter 27
eric measures are used to assess patients’ self-reported
outcomes following groin hernia surgery.
Dissemination and Implementation
• The EQ-5D Index, a general measure of patients’
quality of life M. Pawlak, A. Wijsmuller and H. Eker
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