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Periodontology 2000, Vol.

37, 2005, 12–28 Copyright  Blackwell Munksgaard 2005


Printed in Denmark. All rights reserved PERIODONTOLOGY 2000

Evidence-based periodontology,
systematic reviews and research
quality
I A N N E E D L E M A N , D A V I D R. M O L E S & H E L E N W O R T H I N G T O N

Periodontology has a rich background of research The highest quality evidence will be used if it exists,
and scholarship. A simple MEDLINE search of ÔPeri- but if it does not, lower levels of evidence will be
odontal DiseasesÕ OR ÔPeriodontitisÕ alone from 1966 considered. Lower levels of evidence usually means
to 2003 brings up more than 45,000 hits. Therefore, research designs more prone to bias and therefore
efficient use of this wealth of research data needs to with less reliable data. However, the nature, strengths
be a part of periodontal practice. Evidence-based and weaknesses of the evidence will be made clear to
periodontology aims to facilitate such an approach, the reader. In addition, wherever possible, the data
accelerating the introduction of the best research into presentation supplies more clinically relevant infor-
patient care. mation, including the probability of achieving a cer-
This chapter will review the concepts of evidence- tain effect such as a benefit, and considering possible
based periodontology, introduce the systematic adverse effects.
review as a research tool and examine how evidence-
based periodontology can both inform on and benefit
healthcare in periodontology. Finally, we will exam- What evidence-based
ine the strengths and limitations of different research periodontology is not
designs and their appraisal. We hope that the infor-
mation in this chapter will provide a basic under- Evidence-based periodontology is not simply sys-
standing of the concepts that will be relevant to tematic reviews of randomized controlled trials,
reading and enjoying the other chapters in this vol- although this can be an important aspect. Evidence-
ume of Periodontology 2000. based periodontology is an approach to patient-care
and nothing more. The expectations that are some-
times laid on it can be inappropriate. It cannot pro-
What is evidence-based vide answers if research data do not exist (other than
periodontology? using expert opinion) and it cannot substitute for
highly developed clinical skills. Therefore, it can
Evidence-based periodontology is the application of never be cookbook healthcare or use statistics in
evidence-based health care to periodontology. A isolation to drive clinical care. Instead it is the com-
useful definition of evidence-based health care has prehensive integration of appropriate research evi-
been proposed by Muir Gray: ÔAn approach to dence, patient preference and clinical expertise
decision making in which the clinician uses the (Fig. 1).
best evidence available, in consultation with the This can be illustrated with data from a recent
patient, to decide upon the option which suits that systematic review on periodontal plastic surgery for
patient bestÕ (8). Therefore, evidence-based period- root surface coverage in localized Miller Class I and II
ontology is a tool to support decision making and defects (25). The data from the systematic review
integrating the best evidence available with clinical demonstrated that connective tissue grafts were sig-
practice. nificantly better than guided tissue regeneration in

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Evidence-based periodontology

and this might inform on the decision. However,


surprisingly, no data are available on patient views
on aesthetics comparing the two procedures.
Clinician’s Patient Therefore, this evidence-based approach to man-
skills preferences agement of recession has produced the best avail-
and views
able evidence, shown how precise this estimate
actually is, and highlighted the limitations of the
Evidence-based evidence, in this case the lack of data on some
periodontology outcomes that are relevant to the decision making
process.

Clinical relevance
Best evidence One of the barriers to the application of research
available
findings in clinical practice is the way that results are
often presented. Typically, a mean value will be
published, based on a statistical analysis comparing
Fig. 1. How evidence-based periodontology fits into experimental groups. Such a value in conjunction
healthcare. Reproduced with permission from Clarkson, with its associated 95% confidence interval is useful
J, Harrison, JE, Ismail, AI, Needleman, IG, Worthington, H, to determine whether there is a statistically signifi-
eds. Evidence Based Dentistry for Effective Practice.
cant difference between groups and will often be a
London: Martin Dunitz, 2003 (20).
requirement of a study designed for regulatory
approval. However, this type of analysis is not
reducing recession (mean difference 0.43 mm, designed to provide information about the probabil-
95%CI [0.62,0.23], chi square for heterogeneity 7.8 ity of achieving a certain outcome were the reader to
(df ¼ 5) P ¼ 0.17). This indicates that the pooled apply it in practice. Such an outcome could include
difference between six studies included in the review achieving a health benefit or preventing further dis-
is 0.43 mm, with a 95% confidence interval from 0.62 ease. For instance, in a meta-analysis from a sys-
to 0.23. The chi-square test indicates that there is no tematic review on guided tissue regeneration (GTR)
evidence of any heterogeneity between the studies for periodontal infrabony defects, the additional
(they could theoretically all be measuring the same benefit of using GTR over access flap surgery was a
difference). So, does this mean that only connective 1.1 mm gain in clinical attachment (21, 22). This
tissue grafts should be used in the treatment of should, however, not be interpreted as the additional
localized recession defects? Clearly, this would not be benefit to be expected every time that GTR is used
appropriate. The data show that both GTR and con- instead of access flap surgery.
nective tissue grafts can work. For the selected out- One approach to analysing and presenting data in a
come, which was recession reduction, connective more clinically useful format is to calculate the
tissue grafts produce 0.43 mm greater effect; the number needed to treat (NNT). This is the number of
result is both reasonably precise (judged by the patients that would need to be treated to achieve a
confidence interval) and the studies from which stated benefit (NNTb) or to avoid a stated harm
the data were taken were similar (no evidence of (NNTh). It is derived from a dichotomous outcome
heterogeneity). such as the proportion of sites achieving at least
However, recession reduction might not be the 2 mm gain in attachment. For the GTR meta-analysis,
only outcome of interest. The two surgical proce- and using this benefit, the NNTb is eight. In other
dures are very different. One requires the harvesting words, for every eight patients treated with GTR, you
of a soft tissue graft from the palate and the other can expect one to have at least 2 mm more gain in
does not. There are no data available examining clinical attachment than if you had used an access
patient preferences, but it is likely that some indi- flap (95% confidence interval [4,33]). For detailed
viduals will prefer a procedure that does not involve guidance regarding the use and calculation of
two surgical sites, even if it does not reduce the NNT the reader is recommended to the elec-
recession to the same extent. It is also possible that tronic journal ÔBandolierÕ: http://www.jr2.ox.ac.uk/
aesthetics are different following the two procedures bandolier/booth/painpag/NNTstuff/numeric.htm.

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Needleman et al.

bias and therefore vary in their reliability and will be


Evidence-based periodontology vs. discussed further below.
traditional periodontology
High quality research and the use of evidence are The components of evidence-based
fundamental to both evidence-based periodontology periodontology
and traditional periodontology. The differences
between these approaches emanate from how An overview of the components is given in Fig. 2.
research informs clinical practice. Evidence-based Evidence-based periodontology starts with the
periodontology uses a more transparent approach to recognition of a knowledge gap. From the know-
acknowledge both the strengths and the limitations ledge gap comes a focussed question that leads on
of the evidence. An appreciation of the level of to a search for relevant information. Once the rele-
uncertainty or imprecision of the data is essential in vant information is located, the validity of the
order to offer choices to the patient regarding research needs to be considered in two broad areas.
treatment options. Evidence-based periodontology Firstly, is the science good (internal validity)? Inter-
also attempts to gather all available data and to nal validity focuses on the methodology of research.
minimize bias in summarizing the data. These Secondly, can the findings be generalized outside of
aspects are key to decision making and are high- the study (external validity)? External validity might
lighted in Table 1. be affected by the way treatment was performed. For
Furthermore, evidence-based periodontology instance, if the time spent on treatment was exten-
acknowledges explicitly the type or level of research sive it might not be practical to provide this therapy
on which conclusions are drawn. The research hier- outside of a research study. Another example could
archy is discussed in more detail later in this chapter. relate to the use of many specific inclusion criteria
However, one aspect that influences the reliability of in a trial which could make it difficult to generalize
the data is the control of bias. Bias is a collective term the findings to a wider group of patients. The
for factors that systematically distort the results of question the reader should ask is whether their types
research away from the truth. Different research of patients are so different from the study that it is
designs offer different possibilities for the control of

Recognize clinical knowledge gap


Table 1. Comparison of evidence-based periodon-
tology vs. traditional periodontology
Evidence-based Traditional
periodontology periodontology Develop into a focussed question

Similarities
• High value of clinical
skills and experience
Search for evidence
• Fundamental importance
of integrating evidence
with patient values Reject
Differences if invalid Evaluate the evidence
• Uses best evidence • Unclear basis or poor
available of evidence
• Systematic appraisal • Unclear or absent
of quality of evidence appraisal of quality Integrate into practice
of evidence
• More objective, more • More subjective, more
transparent and less opaque and more
biased process biased process
• Greater acceptance • Greater tendency to Evaluate the effects
of levels of uncertainty black and white
Fig. 2. The steps of evidence-based periodontology.
conclusions
Reproduced with permission from Clarkson, J, Harrison,
Reproduced with permission from Clarkson, J, Harrison, JE, Ismail, AI, JE, Ismail, AI, Needleman, IG, Worthington, H, eds. Evi-
Needleman, IG, Worthington, H, eds. Evidence Based Dentistry for Effective dence Based Dentistry for Effective Practice. London:
Practice. London: Martin Dunitz, 2003 (20).
Martin Dunitz, 2003 (20).

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Evidence-based periodontology

reasonable to expect differences in outcomes. After Therefore, having reviewed the data, it is clear that
locating and appraising the research, the results there is good evidence to indicate that connective
then need to be applied clinically, or at least inclu- tissue grafts have a greater effect on change in
ded in a range of options. Finally, the results in recession than guided tissue regeneration, although
clinical practice need to be evaluated to reveal there are several limitations to this evidence. Clinical
whether the adopted technique achieved the recommendation is tempered by the lack of data on
expected outcome. aesthetics and adverse effects and the possible
The example of gingival recession mentioned ear- exaggeration of benefit through publication bias. This
lier can be used to illustrate this approach. The information can then inform on the case presenta-
uncertainty might relate to whether to change from tion to the patient and a choice of options discussed
using connective tissue grafts for recession defects to and agreed. The outcome of treatment can then be
guided tissue regeneration and can be translated into evaluated to see whether the desired endpoint was
a focussed question. Here the patient or problem achieved and this helps to refine the case presenta-
group could be refined more closely to localized tion discussion in future.
recession defects and perhaps Miller Class I or II, as
we might reasonably expect these lesions to respond
differently from more advanced lesions. The inter- Systematic reviews
vention is guided tissue regeneration and the com-
parison, connective tissue grafts. The outcomes would One important element of evidence-based period-
include change in recession or possibly the chance of ontology is the systematic review. Systematic reviews
achieving complete root coverage. Since the proce- are a research design termed Ôresearch synthesisÕ.
dure is primarily for aesthetics, a patient-centred That is, they use research methodology to pool data
assessment of aesthetics should be an outcome. As from multiple studies that address a particular
always, there must be a consideration of adverse hypothesis. A systematic review can be defined as a
effects and these might include pain, postoperative review of a clearly formulated question that attempts
infection, and severe bleeding postoperatively. to minimize bias using systematic and explicit
Reassembling this structure into a focussed methods to identify, select, critically appraise and
question would lead to ÔIn patients with localized summarize relevant research.
Miller Class I or II recession defects, what is the The description of systematic reviews as providing
effect of guided tissue regeneration vs. connective the highest level of evidence is widespread but also
tissue grafts on change in recession, chance of raises expectations that may or may not be fulfilled. A
complete defect coverage and aesthetics and what realistic understanding of what a systematic review
are the adverse effects?’ For this particular research can provide is important for the appropriate use of
question, the randomized controlled trial is best able this type of evidence (Table 2). More detailed infor-
to address the change in recession outcome. For the mation on systematic reviews exist (5, 19), and guides
other outcomes, other research designs might have to conducting them are freely available (1, 13).
been used, such as observational studies. Preferably, As with all research, a systematic review starts from
we would like to find a systematic review that will an hypothesis. This is derived from a focussed ques-
have completed the searching and study appraisal tion which is set to answer a particular area of
for us. uncertainty. For instance, for the systematic review
The search quickly identifies a systematic review on smoking and periodontal therapy in the chapter by
(25). The review has a research question that is Labriola et al. in this volume, the focussed question
appropriate to our question and demonstrates a was: ‘‘In patients with chronic periodontitis, what is
statistically superior effect of connective tissue grafts the effect of smoking or smoking cessation on the
compared with guided tissue regeneration. The response to nonsurgical periodontal therapy in terms
review also acknowledges certain limitations. In of clinical and patient-centred outcomes?’’(14). The
terms of the validity of the meta-analysis, the question has set the types of patients (individuals
reviewers urge caution as publication bias could be with chronic periodontitis undergoing nonsurgical
affecting the overall result, but this could not be therapy), type of exposure (cigarette smoking) and
tested due to the low number of studies. Publication types of outcomes (clinical and patient-centred) to be
bias is discussed later in this chapter. Another limi- investigated, each aspect being defined in more detail
tation was that there were no data on aesthetics or within the protocol. As this is a prognostic research
adverse effects. question, where exposure (smoking) cannot be

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Needleman et al.

Table 2. The potential of systematic reviews


What a high quality systematic review can do
• Find and summarize all available studies.
– A comprehensive search will identify all relevant studies up to the point of the date of the completion of the search.
This should give the reader greater confidence that bias in selecting studies has been minimized.
• Provide an objective assessment of the quality or research and in particular the degree of protection from bias within
the original studies.
– Components of methodological quality that have evidence of affecting bias can be evaluated. It may be much harder
to evaluate the impact of other ÔqualityÕ issues if there is no consensus on how to measure them. An example could be
the quality of the treatment provided.
• Estimate research effects across multiple studies with meta-analysis.
– Meta-analysis is valid only if studies are similar in their research question and design.
– Meta-analysis can estimate uncertainty and precision of the effect.
– Meta-analysis may generate hypotheses for differential effects across subgroups of the population tested.
• If the effect is consistent across multiple studies (with small differences in design), then it may more readily possible to
generalise the results to clinical practice than the results from a single study.
• Overcome limitations of underpowered studies in detecting a true difference if such a true difference really exists.

What a high quality systematic review cannot do


• It cannot be used in isolation to dictate clinical practice.
• It is a synthesis of available research and must be used in context with clinical judgement and patient preference.
• Produce strong conclusions if the research base is weak in quality.
– The value of the review will then be to present a comprehensive objective summary of the strength of the data and to
identify the design of research to answer important gaps.
• Overcome limitations of narrowly designed clinical research.
– If the clinical studies only investigate the effect of an intervention in highly selected individuals, the conclusions
cannot be generalised outside of these conditions. However, the objective communication of any limitations in the
research base will help to set the degree of uncertainty and indicate the priorities for future research.
• Exclude relevant studies.
– Although the majority of hits from the search will be excluded, this is due to the deliberate strategy of achieving high
sensitivity (likelihood of finding all relevant studies) but low precision (likelihood of only finding relevant studies).
Therefore, it is common to find that more than 90% of the search records are totally irrelevant to the question and
must be excluded. The alternative approach of aiming for high precision also carries a high risk of missing relevant
studies, although it will appear as if few studies are being excluded.
• Be a miracle research design.
– All research has strengths and limitations/weaknesses. Systematic reviews are no different from other research
designs in this respect.

randomized, the cohort study is the research design reports, and contacting researchers, industry and
of choice to incorporate into this investigation. journals for unpublished data.
These components help in the design of the search The search strategy aims for high sensitivity, i.e. the
strategy that aims to be comprehensive. Usually, greatest chance of finding all relevant studies. The
searching of multiple electronic databases is carried downside of this approach is low precision, i.e. in
out together with searching other sources. The most addition to the relevant studies, the search will
commonly searched databases include MEDLINE identify many irrelevant hits (probably more than
(strong on English-language studies), EMBASE 90% of hits from the search will not be relevant). For
(strong on other European languages), and CENTRAL example, in a systematic review on systemic anti-
(the Cochrane Collaboration register of trials microbials, the search identified 1,300 hits. Screening
records). Searching only electronic databases can of the title and abstracts (if available) indicated that
miss important data, as records on the database may 158 papers might be relevant. Once the full text of the
not be appropriately coded. To supplement the studies had been reviewed, 25 trials were judged
electronic search, other approaches are used. relevant and could be included (9). At first sight,
Typically, this will include checking for publications rejecting 1,275/1,300 studies would appear to be
in the bibliographies of retrieved studies and review wasting potentially useful data. However, the delib-
articles, hand-searching of journals for missed erately inclusive search identifies a large number of

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Evidence-based periodontology

irrelevant papers, including veterinary medicine, in the mid 1980s (3) and set up an Oral Health Group
review papers, duplicate reporting of research and as part of the Cochrane Collaboration in 1994. The
laboratory studies. The systematic review screens the editorial base of the Oral Health group subsequently
search findings against prestated criteria. These cri- moved to Manchester University in 1997 with Bill
teria aim to exclude studies irrelevant to answering Shaw and Helen Worthington as co-ordinating edi-
the question, but do not attempt to exclude on the tors (http://www.cochrane-oral.man.ac.uk/). The
basis of the quality of the study. Instead, the quality of first Cochrane systematic review in periodontology
relevant studies is critically appraised using objective was published in 2001 and researched the effect of
criteria that could influence the study outcome. guided tissue regeneration for infrabony defects (21).
The dimension of quality can be incorporated into Many individuals have been active in the critical
a systematic review in a number of ways. If the analysis of the periodontal literature. These include
studies are similar enough to be combined in a meta- Jan Egelberg, Loma Linda University, Noel Claffey,
analysis, the impact of quality on the overall result Trinity College Dublin, and Gary Greenstein, Uni-
can be estimated (through sensitivity analyses or versity of Medicine and Dentistry of New Jersey.
meta-regression). If meta-analysis is not possible, the There have been many notable events in evidence-
quality of studies can be summarized in narrative based periodontology. The 1996 World Workshop in
tables, in particular for those elements designed to Periodontology held by the American Academy of
protect against bias. Whilst this may not be as Periodontology included elements of evidence-based
powerful as the use of meta-analysis, it will highlight healthcare, supported by Michael Newman at UCLA
limitations to be placed upon the conclusions. Fol- (2). The 2002 European Workshop on Periodontology
lowing pooling of the data with meta-analysis or became the first international workshop to use rig-
qualitative methods, the conclusions from the orous systematic reviews to inform the consensus.
investigation can be drawn and related to the data The workshop was organized by the European Acad-
derived from the review. emy of Periodontology for the European Federation of
The systematic review will not be appropriate for Periodontology, under the chairmanship of Professor
some questions. For instance, to address the ques- Klaus Lang. Sixteen focussed and rigorous systematic
tion, ÔWhich indices have been used to measure gin- reviews formed the basis of intense consensus dis-
givitis?Õ a descriptive survey will be more appropriate. cussions. A similar approach was used subsequently
However, systematic methods should be adopted for by the American Academy of Periodontology for the
some aspects, in particular to ensure that the search Contemporary Science Workshop in 2003.
is both comprehensive and contemporary. This Many other groups are now using similar methods
might form an important initial stage to answering a in healthcare and research. Most recently, the Inter-
question such as ÔWhich gingivitis indices have been national Center for Evidence-Based Oral Health was
validated?Õ This is a research question answerable by launched in 2003 (http://www.eastman.ucl.ac.uk/
a systematic review. iceboh) to produce high quality evidence-based
research with an emphasis on, but not limited to,
periodontology and implants and to provide generic
The development of evidence- training in systematic reviews and research methods.
based periodontology
Evidence-based periodontology is built upon devel-
opments in clinical research design throughout the
Study designs and critical appraisal
18th, 19th and 20th centuries (15, 20, 23, 28).
Different study designs
Evidence-based medicine has only been known for
just over a decade and the term was coined by the Different clinical research questions require evalua-
clinical epidemiology group at McMaster University tion through different study designs. A study to
in Canada (4). determine the effectiveness of surgical therapy com-
The influence of the McMaster group spread far. pared with nonsurgical debridement deals with the
One of the earliest to take up the challenge in peri- effectiveness of a treatment option and would be best
odontology (in fact in oral health research overall) answered by a randomized controlled trial (RCT) or,
was Alexia Antczak Bouckoms in Boston, USA. Ant- ideally, a systematic review of RCTs. However, it must
czak Bouckoms and colleagues challenged the be noted that although RCTs and systematic reviews
methods and quality of periodontal clinical research of RCTs may well be the Ôgold standardÕ upon which

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Needleman et al.

to base decisions on the effectiveness of interven- Montenegro et al. (18) conducted a systematic
tions, they are not necessarily appropriate, or ethical, review of the quality of RCTs of periodontal ther-
to answer all questions. An RCT would obviously not apy, published in Journal of Periodontology, Journal
be helpful in answering the question posed on the of Clinical Periodontology or Journal of Periodontal
epidemiological evidence of plaque in the etiology of research over a 3-year period from 1996 to 1998.
periodontitis. For such questions regarding prognosis From the electronic search, 283 papers were poss-
or etiology, cohort studies would be more appropri- ibly relevant and 177 studies met the inclusion
ate. Table 3 illustrates the types of study designs criteria of being an RCT, performed on humans and
most suitable for different types of research questions for which a full text article was available. Screening
arising in periodontology. The most appropriate and data abstraction were performed independently
source of information will depend upon the type of and in duplicate to minimise error and bias. The
study design being sought. evaluation was not performed blind to author
affiliation identity of the RCTs as the evidence
suggests that this has a minimal impact on out-
Critical appraisal: Why, what and how? come (16). In view of the empirical data described
above, the quality components chosen were those
Why critically appraise?
demonstrated to be important for protection from
Evidence-based periodontology, as its name implies, bias: adequacy of method of generation of the
is periodontology that is based on evidence, but not random sequence, adequacy of method of con-
just any so-called evidence. Richards wrote a toolbox cealing the allocation sequence from the patient
article for the journal Evidence-based Dentistry enti- recruitment, examiner blinding (where it was
tled ÔNot all evidence is created equalÕ (24). We have judged possible to achieve), and handling of losses
already seen in this chapter that the quality of evi- and withdrawals.
dence may vary according to study design and that The results indicated that 29/177 (17%) of RCTs
this has led to the concept that there can be a hier- employed a clearly adequate method of generating
archy of evidence. One hierarchy is illustrated in the random number sequence, and that 12/177 (7%)
Table 4 and is specific to studies on therapy, pre- of studies described adequate allocation conceal-
vention, etiology, and harm. Other suggested levels ment (Fig. 3). Furthermore, where examiner blinding
for different types of research question can be found was possible, 97/177 (55%) of studies reported an
at the Center for Evidence-Based Medicine: (http:// adequate method. Clear accounting for study sub-
www.cebm.net/levels_of_evidence.asp#levels). jects was present in 100/177 (55%) of reports. Since
The publication of research in a high-ranking the study was conducted on trial reports, it is not
journal may not be an absolute guarantee of quality. clear how much of the inadequacy was due to
Within the medical literature there are methodolo- incomplete reporting rather than inadequate study
gical studies which have empirically shown that methods. If the data do reflect study conduct, then
quality is not merely a hypothetical concept but also bias and exaggeration of the effect of the test inter-
affects study outcomes. As examples of this, the re- ventions could be a problem with some trials in
views of Schulz et al. (26), Moher et al. (17) and Juni periodontology.
et al. (12) showed that in studies in which there was Similar results were found when investigating
inadequate concealment of treatment allocation, the RCTs of oral implants (6). This study searched for
treatment effects were exaggerated by about 40% RCTs up to the end of 1999 in multiple databases.
compared to trials of higher quality. Seventy-four publications were located and 43 RCTs
were quality assessed as many studies were pre-
Quality assessment of trials in periodontology and
sented in multiple publications. Although the
implantology
methods and criteria were a little different for this
Two recent studies have investigated the methodo- study compared with the quality appraisal of peri-
logical quality of RCTs in periodontology and odontal studies, the results are broadly comparable.
implantology as assessed by their publications. Both A clearly adequate method of randomization/con-
studies targeted RCTs for investigation due to the cealment of allocation was present in 1/43 (2%)
importance of the RCT in providing evidence for papers. Blinding was described in 12/43 (28%)
the effect of interventions and also because of the studies and the reasons for withdrawals and losses
empiric data indicating the effect of key domains of to follow-up were specified in 33/43 (77%) of
methodology on bias. reports.

18
Table 3. Study designs and the types of questions they address
Definition of study design Used for (examples given in italics)
Experimental studies
Randomized-controlled trial: parallel group design – a group of Evaluating the effectiveness of an intervention
participants (or other unit of analysis, e.g. teeth) is randomized into Randomized controlled trial comparing the effectiveness of surgical therapy
different treatment groups. These groups are followed up for the and nonsurgical debridement.
outcomes of interest

Randomized-controlled trial: split-mouth design – each patient is


his/her own control. A pair of similar teeth, or groups of teeth
(quadrants), may be selected and randomly allocated to different
treatment groups.

Non-randomized controlled trial – allocation of participants under Controlled trial comparing two methods of treating periodontal intrabony
the control of the investigator, but the method falls short of defects using pairs of sites where the LHS is always group A and the RHS group B.
genuine randomization.
Observational studies
Cohort: a longitudinal study, identifying groups of participants Measuring the incidence of a disease; looking at the causes of disease;
according to their exposure/intervention status. Groups are followed determining prognosis.
forward in time to measure the development of different outcomes. Cohort study looking at the progress of periodontitis over time and relating this to
external factors such as smoking or plaque.

Case-Control: a study that identifies groups of participants Identifying potential risk factors for a disease; looking at the possible causes of
according to their disease/outcome status. Groups are investigated/ disease.
questioned to determine their exposure status Case-control study looking at the prevalence of periodontitis and relating this to
factors such as genetic markers.

Cross-sectional: a study (survey) undertaken on a defined population Measuring the prevalence of a disease or risk factor in a defined population at a
at a single point in time (snap-shot). Subjects are observed on just specific time.
one occasion and are not followed up. A cross-sectional study to determine the current periodontal treatment needs in
a specific population.
Evidence-based periodontology

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Needleman et al.

Table 4. Center for Evidence-Based Medicine hier- 60%

archy of evidence for studies on therapy, prevention,


etiology or harm (http://www.cebm.net/levels_of_ 50%

evidence.asp#levels)
40%
Level Type of evidence
Ia Systematic review (with homogeneity*) of 30%

randomized controlled trials (RCT).


20%
1b Individual RCT (with narrow confidence
interval, see notes below).
10%

2a Systematic review (with homogeneity*) of


cohort studies. 0%
Randomization Allocation Examiner blinding Accounting for all
2b Individual cohort study (including low quality method concealment subjects

RCT; e.g. < 80% follow-up).


Fig. 3. Quality of reporting of randomized controlled tri-
2c ÔOutcomesÕ research; Ecological studies. als in periodontology (18). Percentage of studies with
adequate method.
3a Systematic review (with homogeneity*) of
case-control studies.
3b Individual case-control study. possible impact of studies. The importance of sev-
4 Case-series (and poor quality cohort and eral of the quality issues that we have described has
case-control studies§) not been thoroughly appreciated until relatively
5 Expert opinion without explicit critical recently. Therefore, it is unfair to judge the past
appraisal, or based on physiology, bench from the standpoint of current knowledge. In
research or Ôfirst principles. addition, the pressure on page numbers in paper-
based journals can restrict detail. Hopefully this
Users can add a minus-sign Ô–Õ to denote the level of that
fails to provide a conclusive answer because of: aspect will be alleviated by initiatives in electronic
EITHER a single result with a wide Confidence Interval publication.
(such that, for example, an absolute risk reduction in an Guidelines are available to help the publication of
RCT is not statistically significant but whose confidence
intervals fail to exclude clinically important benefit or clinical research. These guidelines are well accepted
harm); by high impact biomedical journals and offer guid-
OR a Systematic Review with troublesome (and statisti- ance not only to authors but also to editors and
cally significant) heterogeneity.
reviewers. These guidelines include CONSORT
Such evidence is inconclusive.
*A systematic review that is free of worrisome variations (Consolidated Standards of Reporting Trials) for
(heterogeneity) in the directions and degrees of results reporting randomized controlled trials and STARD
between individual studies. Not all systematic reviews (Standards for Reporting of Diagnostic Accuracy) for
with statistically significant heterogeneity need be wor-
risome, and not all worrisome heterogeneity need be reporting studies on diagnostic tests (http://consort-
statistically significant. As noted above, studies display- statement.org/). In addition, three guidelines for
ing worrisome heterogeneity should be tagged with a Ô–Õ
at the end of their designated level. reporting systematic reviews are available: QUOROM
§ Poor quality cohort study: one that failed to clearly de- (Quality of Reporting of Meta-analyses) (http://
fine comparison groups and/or failed to measure expo- consort-statement.org/), MOOSE (Meta-analysis Of
sures and outcomes in the same (preferably blinded),
objective way in both exposed and nonexposed individ- Observational Studies in Epidemiology) (27), and
uals and/or failed to identify or appropriately control QUADAS (Quality Assessment of studies of Diagnos-
known confounders and/or failed to carry out a suffi-
ciently long and complete follow-up of patients. Poor tic Accuracy included in Systematic reviews) (29). For
quality case-control study: one that failed to clearly define clarification, it should be remembered that system-
comparison groups and/or failed to measure exposures atic reviews are termed meta-analyses by some in
and outcomes in the same (preferably blinded), objective
way in both cases and controls and/or failed to identify or North America, whereas the term meta-analysis is
appropriately control known confounders. usually reserved only for the statistical combining of
data which may or may not be part of a systematic
review.
Improving the quality of reporting of
The format of these guidelines is similar. Each
clinical research in periodontology
presents a checklist of items for incorporation into
The adequacy of reporting of clinical research is the research report. The selection of items is evi-
crucial if the reader is to evaluate the quality and dence-based as far as possible and otherwise derived

20
Evidence-based periodontology

(a)
PAPER Item Description Reported
SECTION on
And topic Page #
TITLE & 1 How participants were allocated to interventions
ABSTRACT (e.g., "random allocation", "randomized", or
"randomly assigned").
INTRODUCTION 2 Scientific background and explanation of rationale.
Background
METHODS 3 Eligibility criteria for participants and the settings
Participants and locations where the data were collected.
Interventions 4 Precise details of the interventions intended for
each group and how and when they were actually
administered.
Objectives 5 Specific objectives and hypotheses.
Outcomes 6 Clearly defined primary and secondary outcome
measures and, when applicable, any methods
used to enhance the quality of measurements
(e.g., multiple observations, training of assessors).
Sample size 7 How sample size was determined and, when
applicable, explanation of any interim analyses
and stopping rules.
Randomization -- 8 Method used to generate the random allocation
sequence sequence, including details of any restrictions
generation (e.g., blocking, stratification).
Randomization -- 9 Method used to implement the random allocation
allocation sequence (e.g., numbered containers or central
concealment telephone), clarifying whether the sequence was
concealed until interventions were assigned.
Randomization -- 10 Who generated the allocation sequence, who
Implementation enrolled participants, and who assigned
participants to their groups.
Blinding 11 Whether or not participants, those administering
(masking) the interventions, and those assessing the
outcomes were blinded to group assignment.
When relevant, how the success of blinding was
evaluated.
Statistical 12 Statistical methods used to compare groups for
methods primary outcome(s). Methods for additional
analyses, such as subgroup analyses and
adjusted analyses.
RESULTS 13 Flow of participants through each stage (a
diagram is strongly recommended). Specifically,
Participant flow for each group report the numbers of participants
randomly assigned, receiving intended treatment,
completing the study protocol, and analyzed for
the primary outcome. Describe protocol deviations
from study as planned, together with reasons.
Recruitment 14 Dates defining the periods of recruitment and
follow-up.
Baseline data 15 Baseline demographic and clinical characteristics
of each group.
Numbers 16 Number of participants (denominator) in each
analyzed group included in each analysis and whether the
analysis was by ‘intention-to-treat’. State the
results in absolute numbers when feasible (e.g.,
10/20, not 50%).
Outcomes and 17 For each primary and secondary outcome, a
estimation summary of results for each group, and the
estimated effect size and its precision (e.g. 95%
confidence interval).
Ancillary 18 Address multiplicity by reporting any other
analyses analyses performed, including subgroup analyses
and adjusted analyses, indicating those pre-
specified and those exploratory.
Adverse events 19 All important adverse events or side effects in
each intervention group.
DISCUSSION 20 Interpretation of the results, taking into account
Interpretation study hypotheses, sources of potential bias or
imprecision and the dangers associated with
multiplicity of analyses and outcomes.
Generalisability 21 Generalisability (external validity) of the trial
findings.
Overall evidence 22 General interpretation of the results in the context
of current evidence.
Fig. 4. a) CONSORT Checklist of items to include when reporting a randomized trial. b) CONSORT Flow chart. Available
from: http://www.consort-statement.org/.

21
Needleman et al.

(b) Assessed for though deliberate deception is always a possibility,


eligibility (n= ... )
the majority of problems that arise are in fact unin-
Enrollment Excluded (n = ... ) tentional. Most methodological errors may be classi-
Not meeting
inclusion criteria
fied as being the result of bias, confounding, or
(n = ... ) chance. Therefore, for the purpose of this chapter,
Refused to participate
(n = ... ) quality will be discussed in relation to these meth-
Other reasons (n = ... ) odological issues. Other aspects of study conduct may
Randomized (n = ... ) well be critical to the validity of a study but will not be
considered in this chapter as they will be specific for a
Allocated to intervention Allocated to intervention
particular study. Such factors could include how well
Allocation

(n = ... ) (n = ... )
Received allocated Received allocated treatment or supportive maintenance was provided.
intervention (n = ... ) intervention (n = ... )
Did not receive allocated Did not receive allocated
intervention intervention
(give reasons) (n = ... ) (give reasons) (n = ... ) Bias
Follow up

Lost to follow up (n = ... ) Lost to follow up (n = ... ) Bias is a systematic error. It leads to results which are
(give reasons) (give reasons)
Discontinued intervention
consistently wrong in one or another direction. Bias
Discontinued intervention
(n = ... ) (give reasons) (n = ... ) (give reasons) leads to an incorrect estimate of the effect of a risk
factor or exposure (e.g. smoking) on the development
Analysis

Analysed (n = ... ) Analysed (n = ... )


Excluded from analysis
of a disease or outcome of interest (e.g. response to
Excluded from analysis
(give reasons) (n = ... ) (give reasons) (n = ... ) periodontal therapy). The observed effect will be
Fig. 4. Continued. either above or below the true value. Many types of
bias have been identified, however, the main types
by a Delphi approach to consensus. In addition to the relate to:
checklist, a chart is used to illustrate the flow of pa- • how subjects were selected for inclusion in a study
tients through the study. The checklist and chart for (selection bias);
CONSORT are illustrated in Fig. 4a, b. The checklist • provision of care (performance bias);
should accompany the manuscript in its journal • assessment of outcomes (detection/measurement
submission but not be part of the final paper. The bias);
intention with the chart, however, is that it should be • occurrence and handling of patient attrition
published as part of the paper. Whilst the checklist (attrition bias).
has numerous items, each can be concisely ad- Selection bias occurs when there is a systematic
dressed and is unlikely to be the main cause for difference between the characteristics of the subjects
excessive length of a publication. selected for a study and the characteristics of those
At the time of writing, oral health journals that have who were not. For instance, selection bias will often
adopted CONSORT as editorial policy and their dates occur with volunteers (self-selection bias). People
of adoption are: British Dental Journal (1999), Journal who volunteer to participate in a study tend to be
of Orthodontics (2000), International Journal of End- different from the general population. Similarly, it is
odontics (2003) and Journal of Dental Research (2004). important to consider whether people might have
The British Dental Journal is the only one that has selectively withdrawn from the study before its
adopted QUOROM (2002). completion (attrition bias). They may have with-
drawn at random, or because of some factor related
to the study, e.g. the treatment they were receiving
What should be appraised?
was ineffective or uncomfortable in comparison with
Given that some evidence is ÔbetterÕ than other evi- the alternative treatment. It is necessary to decide
dence, it seems reasonable to place greater emphasis whether the results of the investigation were likely to
on ÔgoodÕ than on ÔpoorÕ quality evidence when mak- have been compromised if one group of subjects had,
ing clinical decisions. The problem arises as to how on average, a shorter follow-up as a result of more
exactly we decide what constitutes good quality evi- people dropping-out.
dence. This process is critical appraisal. The validity of The avoidance of selection bias is a major concern
published evidence is potentially affected by the in the design of case-control studies. In this type of
quality of every stage of the experimental process study it is essential to ensure that controls are rep-
from aims and objectives, through design, execution, resentative of the population from which the cases
analysis, interpretation, and finally publication. Al- originated. Suppose a group of researchers is con-

22
Evidence-based periodontology

ducting a case-control study to assess the effect of


cigarette smoking on the development of aggressive
periodontitis. In our hypothetical example, cases are
patients referred to a dental hospital with aggressive
periodontitis and controls are non-dental patients
Step 1
admitted to a nearby hospital with chronic bronchi- Generate a true random sequence
tis. A standard questionnaire is administered to both - computer generated is best
- tossed coin is acceptable
cases and controls that includes questions on lifetime
Step 2
smoking habits. The researchers may find no evi- Allocation concealment
dence from this study of an association between - conceal the sequence for study recruitment
- sequentially numbered truly opaque envelopes/drug
cigarette smoking and aggressive periodontitis. Can containers, centrally kept randomization accessed by
we accept this conclusion? The problem with this telephone, e.g. pharmacy
study is that the choice of controls is biased, as the Fig. 5. The two stages of randomization.
prevalence of smoking among patients admitted with
chronic bronchitis is likely to be much higher than
among the general population resident in the catch- therapists remain masked (blinded) to the treatment
ment area of the hospitals from which the cases and allocation. The use of placebo, where appropriate,
controls originated. Consequently, the strength of greatly facilitates masking; placebo controlled trials
the association between smoking and aggressive are usually easy to organize in such a way as to leave
periodontitis will most likely be under-estimated in the therapist masked to the treatment allocation.
this study. However, if the interventions to be compared are
Randomized controlled trials are less likely to be quite dissimilar in their delivery (e.g. surgical vs.
affected by selection bias if the randomization is nonsurgical therapy), then masking becomes con-
properly conducted. Randomization is a two-stage siderably more challenging. Under these circum-
process. The first stage is the generation of a true stances the best available option might be to ensure
random sequence. Typically, this is achieved through that the therapist remains masked until the last
computer software or a random number table. Whilst possible moment to ensure that all therapy prior to
a tossed coin is theoretically acceptable, we suggest that point has been undertaken as even-handedly as
using a method that can be audited later on for the possible. So, for example, in a split-mouth study
purposes of quality assessment, such as a computer comparing scaling and root planning vs. scaling and
generated list. root planning plus an adjunctive locally delivered
The second stage of randomization is less well antimicrobial, it might be possible to complete the
understood or carried out. Once the random mechanical therapy at all appropriate sites prior to
sequence is generated, it must be concealed from the therapist finding out which particular sites are to
those selecting patients for a study until the indi- receive the adjunctive therapy. However, the risk of
vidual has been recruited into the trial. If not, carry-over effects of the local antibiotic affecting the
despite the sequence being random, the researcher scaling and root planning-only sites should not be
will be aware of whether the patient will be ignored.
entered into test or control group. This knowledge Measurement (information) bias occurs when the
provides the opportunity for selection bias, whether measurements of exposure and/or outcome are not
intentional or not. This second stage of randomi- valid (i.e. they do not measure correctly what they
zation is termed allocation concealment (see Fig. 5 are supposed to measure). Errors in measurement
for an outline of this process). The key question to may be introduced by the observer (observer bias),
ask is, Was the recruitment of patients into a trial by the study individual (responder bias), or by the
entirely unpredictable with respect to test or con- instruments (instrument bias) used to make the
trol group? measurements (e.g. a badly designed questionnaire).
Performance bias occurs when different study As a result of measurement errors, study partici-
groups do not receive therapy in the same fashion or pants will be misclassified in relation to their
to the same standard. This may occur if the people exposure and/or outcome status. This misclassifi-
providing the therapy are aware of which groups the cation has particularly serious implications if the
participants have been allocated to. Depending on errors in exposure measurement are related to the
the nature of the investigation, it may be either a participant’s outcome status. Ideally the person
relatively simple or a difficult task to ensure that undertaking the examination should be blinded

23
Needleman et al.

(masked). This is more important for measures in we are interested in, such as diet, smoking habits,
which there is the potential for subjectivity (e.g. health beliefs, etc., but are also independent risk
pocket depth, colour change) than for objective factors for many diseases.
measures (e.g. tooth loss). Confounding can be dealt with at the design stage
Bias is a consequence of defects in the design or of an investigation by:
execution of a study. Bias cannot be controlled dur- • Randomization – By randomly allocating subjects
ing the statistical analysis of the data and cannot be to study groups it is hoped that confounders are
eliminated by increasing the size of the study. distributed equally between the groups. This is
usually the most effective way of minimizing the
Publication bias
problem of confounding. If randomization is
Publication bias refers to the greater likelihood of done properly, it has the advantage that it con-
publication of studies with positive results than those trols for both known and unknown confounders
with neutral or negative results (5). The risk with this provided the sample size is sufficiently large.
type of bias is that interventions appear to perform • Restriction – This limits participation in a study to
better than they will in clinical practice. For instance, specific groups which are similar to each other
publication bias might mean that although several with respect to the confounder (e.g. if smoking is
studies were published and the data available to be likely to be a confounder then only nonsmokers
included in a meta- analysis, a larger number of will be included in the study).
studies were actually conducted but not published. • Matching – This selects comparison groups with
Of these ÔmissingÕ studies, some may show no dif- similar backgrounds (e.g. nonsmokers are matched
ference between the intervention group and the with other nonsmokers, while smokers are mat-
control group, or even the control group performing ched with other smokers).
better. If these additional studies had been published, Confounding can also be controlled for in the ana-
the results of the meta-analysis could have been lysis by:
different. Therefore, the sample of published studies • Stratification – Here the strength of the association
is a biased sample and does not represent the com- is measured separately in each well-defined sub-
plete population of all research on this question. group (e.g. in the smokers and the nonsmokers
Graphic and formal statistical tests are available to separately). The results are then pooled together
investigate publication bias but need approximately using basic statistical techniques to obtain an
10 or more studies to have adequate power. Figure 6 overall summary measure of the association Ôadjus-
illustrates this situation using hypothetical data. tedÕ or ÔcontrolledÕ for the effects of the confounder.
• Statistical modelling – These are more sophisti-
cated mathematical techniques that can simulta-
Confounding
neously take into consideration the effects of
Confounding is a term that describes the situation several possible confounders that have been
where an estimate of the association between an recorded by the investigators.
exposure and the disease is mixed up with the real It is only possible to control for confounders in the
effect of another exposure on the same disease, the analysis if data on them were collected during the
two exposures being correlated. It is a difficult con- study. Obviously, the extent to which confounding
cept that may be illustrated with the help of the fol- can be controlled for will depend on the accuracy of
lowing example. Suppose we find that coffee drinkers these data. However, in some situations it may be
have a poorer response to periodontal therapy than virtually impossible to gain complete and accurate
noncoffee drinkers. Does it mean that coffee drinking information on confounders. Some confounders
affects the response to therapy? The problem here is may be so difficult to assess that even attempting to
that there is an alternative explanation. Smoking may adjust for them in a statistical model will not com-
be an independent risk factor for poor treatment pletely control for their effect. For example, Hujoel
response and it is possible that people who drink et al. have argued that the confounding effect of
coffee are more likely to smoke than those who do smoking is virtually impossible to measure with
not. Perhaps the observed association is actually due sufficient precision in studies that attempt to look at
to smoking habits, not coffee drinking (Fig. 7). the association between periodontal diseases and
Age and sex are the most common confounding systemic health and that such studies may only
variables in health-related studies because these two provide valid results if they are restricted to non-
variables are not only associated with most exposures smokers (10).

24
Evidence-based periodontology

(a) (b)
50
study 1
study 2 45
study 3
study 4 40
study 5
35
study 6

1/standard error
study 7 30
study 8
study 9 25
study 10
20
study 11
study 12 15
study 13
study 14 10
study 15
5

Combined 0
–2 –1 0 1 –.4 –.2 0 .2 .4
mean mean difference
←Favours control
Favours intervention→

(c) (d)
study 1
50
study 2
study 3 45
study 1
study 2 40
study 4
study 3 35
study 5
1/standard error
study 6 30
study 4
study 7 25
study 8
study 9
study 5 20
study 10
study 11 15
study 12
study 13 10
study 14
study 15 5

Combined 0
–2 –1 0 1 –.4 –.2 0 .2 .4
mean mean difference
←Favours control Favours
intervention→

Fig. 6. Illustration of publication bias. a) Forest plot shape was produced, this indicates the possibility of
showing the results of a meta-analysis of 15 studies. A very missing studies. These studies would be expected to pro-
small improvement is indicated in favour of the test duce data points that lie somewhere within the shaded
intervention since the diamond shape (representing the area. c) Another Forest plot, including the data from these
95% confidence interval for the pooled result) does not extra, previously ÔmissingÕ studies. The 95% confidence
cross the zero (‘no-effect’) line. b) Funnel plot for these interval for the pooled result now crosses the line of no
studies. In the absence of publication bias, it is anticipated effect, indicating no evidence that the intervention is any
that the plot would form a funnel shape. As no funnel more effective than the control.

spurious association samples drawn from that population. The extent to


Coffee drinking Poor treatment response
which the sample results reflect the likely result in the
population is assessed by performing statistical sig-
association risk factor
nificance tests and, more importantly, by calculating
Smoking habits confidence intervals. A proper discussion of these
(confounder)
methods is beyond the scope of this chapter, but in
Fig. 7. An example of confounding. general, studies with small sample sizes will be more
prone to sampling error and will provide less robust
Chance estimates than studies with larger samples.
Chance (sampling error) plays a role in most studies
of humans since it is rarely if ever possible to include
Interpretation
an entire population in an investigation. We therefore
attempt to infer information about the population on It is worth noting that authors may also fail to
the basis of information obtained from representative interpret their experimental results correctly. So,

25
Needleman et al.

even if the study has been well conducted and Some reviewers have attempted to devise com-
appropriately analyzed, there is still the potential to posite scales that give scores for the various quality
draw incorrect conclusions from the results. domains (11). These scores are then summed to an
overall summary measure for the study as a whole.
There are problems with this approach. Many
How to critically appraise? quality items may not be based on empirical evi-
dence and the scores attached to each item will
When appraising quality it is necessary to consider inevitably be subjective. It is also doubtful whether a
those factors that may affect the outcome of a study. single summary score is likely to provide an
These will inevitably vary according to both the topic adequate overall assessment of the quality of a
of the original research and the study designs particular study. When different composite scales
employed, so it is not possible to devise a single are applied to the same studies, differing scores and
system that will be appropriate for every occasion. As rankings may occur. For these reasons, composite
a general rule, the aforementioned domains of bias, scales have largely gone out of favour. An alternative
confounding and chance will all have to be ap- approach is to appraise each quality component
praised. separately (12).

Table 5. Quality assessment checklist for randomized controlled trials in periodontology used by Montenegro
et al. (18)
Item Classification Definition
Randomization Adequate If generated by random number
table (computer generated or not);
tossed coin; and shuffled cards.
Unclear Study refers to randomization but
either does not adequately explain
the method or no method was reported.
Inadequate Methods include alternate assignment,
hospital number, and odd/even birth date.
Allocation concealment Adequate Methods included central randomization
(e.g. by telephone to a pharmacy or trial
office), pharmacy sequentially numbered/
coded containers, and sequentially
numbered opaque envelopes.
Unclear If the study referred to allocation
concealment but either did not
adequately explain the method or
no method was reported.
Inadequate Involved methods where randomization
could not be concealed, such as alternate
assignment, hospital number,
and odd/even birth date.
Blinding of patient, caregiver, Recorded as adequate, inadequate,
and examiner were considered unclear, or for examiner blinding,
separately not applicable if the study
design precluded the
possibility of blinding.
Withdrawals and drop outs Were all patients who entered the
trial properly accounted for at the end?
Where dropouts occurred, the use of
analyses to allow for losses (such as
intention to treat) was noted.

26
Evidence-based periodontology

For rigorous systematic reviews, independent concealment) and also topic specific factors deemed
reviewers usually undertake quality appraisal in important by the reviewers. Other checklists cover a
duplicate and checklists are frequently employed for broad range of types of research and can be
this purpose. Two such checklists that have been found on the excellent Critical Appraisal Skills
used previously are reproduced here as examples Programme website (http://www.phru.nhs.uk/casp/
(Tables 5 and 6) (7, 18). These checklists are based on appraisa.htm).
a combination of factors that have been shown The use of checklists with objective criteria helps
empirically to affect quality (such as allocation to safeguard the quality of the quality appraisal
process itself. The process of devising the check-
list helps to ensure that all relevant quality issues
are included in the assessment. Written, piloted
Table 6. Quality assessment checklist for systematic
reviews in dentistry used by Glenny et al. (7)
checklists reduce, but can never completely elim-
inate individual subjectivity in decisions. Having a
Question (possible categories)
written list means that it is more likely that the
A. Did review address a focused question? quality assessors will be both consistent and
(yes, no, can’t tell) repeatable.
B. Did authors look for appropriate papers? The results of the quality appraisal are used to
(yes, no, can’t tell) assess the value of the evidence and to aid clinicians
C. Do you think authors attempted to identify all and reviewers in their efforts to place the evidence
relevant studies? into context. This might be a part of the formal pro-
(yes, no, can’t tell) cess of undertaking a systematic review or the
D. Search for published and unpublished literature informal act of reading and assessing recently pub-
(yes, no, can’t tell) lished literature as part of everyday periodontal
E. Were all languages considered? practice.
(yes, no, can’t tell)
F. Was any hand searching carried out?
(yes, no, can’t tell) Conclusions
G. Was it stated that the inclusion criteria were
carried out by at least two reviewers? The principles of evidence-based healthcare provide
(yes, no, can’t tell) structure and guidance to facilitate the highest levels
H. Did reviewers attempt to assess the quality of the of patient care. There are numerous components to
included studies? evidence-based periodontology including the pro-
(yes, no) duction of best available evidence, the critical
I. If so did they include this in the analysis? appraisal and interpretation of the evidence, the
(yes, no, can’t tell, not applicable) communication and discussion of the evidence to
J. Was it stated that the quality assessment was individuals seeking care and the integration of the
carried out by at least two reviewers? evidence with clinical skills and patient values. This
(yes, no, not applicable) volume of Periodontology 2000 is mainly concerned
K. Are the results given in a narrative or pooled with the first component, i.e. the generation of best
statistical analysis? evidence and, alone, is not enough to practise evi-
(narrative, pooled, not applicable) dence-based healthcare. However, an understanding
L. If the results have been combined was it of the principles should help to underpin the latter
reasonable to do so? aspects. Evidence-based healthcare is not an easier
(yes, no, can’t tell, not applicable) approach to patient management, but should provide
M. Are the results clearly displayed? both clinicians and patients with greater confidence
(yes, no, not applicable) and trust in their mutual relationship.
N. Was an assessment of heterogeneity made and
reasons for variation discussed?
(yes, no, not applicable) References
O. Were results of review interpreted appropriately?
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