Errors
and Omissions in Experimental Trials - 2b
CRITICISMS
AND COMMENTS [cont.]
DR R. M.
GRAINGER
The third review of this book in the Australian
Dental Journal, by DR R. M. GRAINGER, Division of Dental Research, Faculty of
Dentistry University of Toronto, was as follows:
Those whose work has been so unfairly criticized
might well ask P. R. N. Sutton if he feels his own work is proof that the
unimpeachable study can be done(26), or if he would welcome similar scrutiny of
his publications.
While we do not claim to be able to answer every
question to P R. N. Sutton's satisfaction (or even our own), in order to help
set the record as straight as possible(27) the following are specific comments
on points raised by P. R. N. Sutton in his discussion of the Brantford Study.
No attempt is made to rationalize why specific workers directed or restricted
their research efforts or discussion in any areas other than to comment that
they no doubt accomplished as much as they could under the circumstances in
which they had to work.
Item 1: Reference to Hutton et al. (1951). The numbers of children
of the same age examined in the years 1944 and 1945 were very similar with the
exception of the nine-year age group. From the unpublished data released at
annual meetings in Brantford the number of children examined in 1944 was 239,
and in 1945, 319; making a total of 558 (not 608). The data in Table I (Hutton et al.) were apparently combined by
pooling the two years' results not by averaging the averages. However, the
point is rather academic(28).
Item 2 : Reference to Ontario Health
Department report. The date of water-fluoridation in Tables I and 11 was given
as 1946 through a typographical error but was twice correctly stated to be
June, 1945, in the text referring to the Table. The small error in percentage
reduction for seven-year-olds was also conceded. These points do not seriously
underline the usefulness of the work(29).
Item 3: Re late commencement of
National Health and Welfare study and detection of caries protection for young
individuals born prior to commencement of fluoridation. Despite the fact that
the Department of National Health and Welfare began its control study nearly
three years after fluoridation began, much worthwhile information was obtained
and the effect of late commencement, if any, was to result in underestimation
of the fluoride protection(30).
Item 4: Reason for selection of control
cities. It seems clear that Brown (1951) gave adequate reasons for selecting
Sarnia and Brantford(31).
Item 5: Re superior dental care in
Brantford. The difference in level of dental care between the cities is factual
as recorded by Brown (1952). This variation of numbers of teeth classified as
F. rather than D. or M. does not fundamentally influence the DMF rate(32).
Item 6: Comparability of rates. As
stated under item 5, the dental condition of the children in Sarnia and
Brantford differed in 1948 because a lower level of dental treatment in Sarnia
resulted in higher tooth mortality. The tooth mortality rates thus differed but
it does not follow that the DMF rates differed(33). Brown's statement (1951)
"by 1948 the Brantford data were not greatly different from those in
Sarnia" is obviously referring to DMF rates and hence quite valid(34). The
differences in oral hygiene are also only remotely related to the DMF rates
under discussion(35).
Item 7: Concentration of fluorides. The
fluoride content of the Brantford water supply was raised to approximately 1
ppm in June, 1945, and raised to 1.2 in February, 1949(36) The Stratford water
fluoride content is believed to have been in the order of 1.3 to 1.6 ppm since
1917 when the wells were drilled. Naturally no analysis for fluoride was
available prior to the beginning of the interest in fluoridation and early
techniques for analysis were not as reliable as present methods(37). These
facts have been recorded in the writings of the primary workers (Hutton et al., 1951; and Brown et al., 1951, 1952, 1953, 1954, 1956)
and the differences in amounts from other writers night seem less
"strange" if they were merely acknowledged to be minor
misquotations(38).
Item 8: Re statement by Brown et al. (1956). The statement is
substantially correct with the exception that Brown's observational period did
not begin until 1948 hence is less than 10 years(39). The decrease in mean df
rates for the 9-11 years group in Sarnia between years 1948 and 1954 (Brown, 1956),
did not continue into 1955(40). There was a highly significant decrease over
the period 1948 to 1955 (2.37 to 1.93) in Brantford and no significant decrease
in Sarnia (2.50 to 2.31)(41). In the same periods the mean df rates for this
age [in] Stratford remained nearly equal (1.66 and 1.65) and increased for
other ages (42).
Item 9: Re Table II: Ontario Department
of Health Report. The printing of dashes rather than percentages for the
control cities was to avoid confusing the table With "negative reductions"
and in the case of the 9 to 11 df figure to avoid emphasising what was
considered to be a spurious decrease(43). This judgment was borne out by the
1955 figures(44).
Item 10: Differences in reported rates
between examiners. Different examiners give characteristically higher or lower
rates upon examining the same individuals due to differences in skill, training
the physical condition. Thus the differences quoted are no reflection on the
design of the experiment or the care taken in the work. The strength of the
double examinations comes through corroboration of caries trends in Brantford
over the years and not through interchangeability of data(45).
Item 11: Significant fluctuations in
controls. The important point is that for the controls the inter-year changes
were upward trends or mere fluctuations (even though in some cases calculated
to be beyond change), whereas in Brantford the change took the form of a highly
significant continual downward trend(46).
Item 12: Larger percentage changes in
control. There is no definite explanation as to why rates increased in
Stratford and also in Sarnia over the ten years, but this may be a reflection
of a general post-war increase in dental caries which has been seen in other
areas. However, it is significant that in the various fluoridation experiments,
e.g. in Brantford, Newburgh, Grand Rapids, etc., the shift has always been
significantly downward in the fluoridated cities whereas the control city rates
have remained about the same or in the case of Stratford, increased(47).
Item 13: Smaller percentage decrease
after longer fluoridation. As pointed out by Sutton himself on page 168 (middle
paragraph) the fluoride protection for permanent teeth of the children aged six
to seven seemed to occur within two or three years after fluoridation began.
Thereafter the yearly DMF rates were subject to random fluctuation and the
differences in percentage decrease of 69 per cent and 51 per cent are most
likely a reflection of this inter-year variation(48).
Item 14: The quotation from the Ontario
Government Report is taken out of context from a series of summary statements.
The previous statement was to the effect that in Brantford there had been a
significant decrease of about 60 per cent in DMF rates. In the statement
following, as picked out by Sutton, it was stated that "no change"
occurred in Stratford and Sarnia(49). It should be clear enough from the
context that the words "no similar downward change" were inferred(50).
Item 15: Possible weighting effect. The
critic is referring to a possible shift in age distribution within the group,
e.g. a possible sampling shift within the six to eight-year age group so that
certain years had disproportionately higher or lower numbers of eight-year-olds
and hence higher or lower average caries scores. This is rather remote in that
selection methods used by Dr Brown were the same each year, moreover very large
shifts in age distribution would be needed to produce the significant
differences to which P N. R. Sutton refers(51).
Commentary on the Review by Dr R. M. Grainger
Commentary on the Review by Dr R. M. Grainger
(26) Dr R. M. Grainger raises the
question as to whether "the unimpeachable study can be done". This
is, of course, unlikely. It is precisely for this reason that all papers (and
these include my own) which set out to present new knowledge should be
examined, in order to reduce the chance that findings which are not soundly
based will be accepted at their face value. This is particularly necessary in
those studies which may involve the health of the public.
(27) The result of Dr Grainger's
attempt "to help set the record as straight as possible" will be
judged after considering his other remarks.
(28) Item 1, Reference to Hutton et al. (1951); The numbers of children
of the same age examined in the years 1944 and 1945 were very similar with the
exception of the nine-year age group. From the unpublished data released at
annual meetings in Brantford the number of children examined in 1944 was 239,
and in 1945, 319; making a total of 558 (not 608). The data in Table I (Hutton et al.) were apparently combined by
pooling the two years' results not by averaging the averages. However, the
point is rather academic.
Comment.
The phrase "making total of 558 (not 608)" suggests that the figure
608 was an error in this monograph. This is not the case, in fact this figure
was not mentioned. It was published by the authors of this study, Hutton et al., in 1951 (Table 1, column 2). Dr
Grainger, therefore, is suggesting that the total 558 children (derived from
the unpublished figures of 239 and 319) is correct, and that the figure of 608
children examined, published by the authors of the study, is incorrect. It
should be noted that, five years after this figure of 608 was first published,
in Table II, column 2, of their final report Hutton et al. (1956) again published their figure of 608. In both the
tables in which it appears it has been used in computing the def and the DMF
rates. Also, if one accepted Dr Grainger's figure of 558 as the correct number of
nine-year-old children examined in these two years, the impossible situation
would also have to be accepted in which the number of these children with
decayed, missing or filled teeth, which Hutton et al. (1951) gave as 595, would exceed the number of children
examined.
(29) Item 2: Reference to Ontario
Health Department report. The date of water-fluoridation in Tables I and II was
given as 1946 through a typographical error but was twice correctly stated to
be June, 1945, in the text referring to the Table. The small error in
percentage reduction for seven-year-olds was also conceded. These points do not
seriously undermine the usefulness of the work.
Comment.
The "small" error in percentage reduction, which, Dr Grainger said
"was also conceded", was the showing of 51 per cent instead of 66 per
cent (p. 167). Dr Grainger does not mention here the substitution of dashes for
figures in the two cases of reduction in the caries rate in the control cities
(pp. 4, 37, 44). Several types of errors are present in Tables I and 11: (a)
two omissions, which Dr Grainger implied-Item 9 of this review(43)-were made
deliberately; (b) two typographical errors; (c) two arithmetical errors (Table
I, age 7, "% Reduction Since 1944-45" in the caries attack rates should
be 66, not 51, and in Table II, age 10, the "% Reduction Since 1944"
in the caries attack rates should be 18, not 61); and if, as appears likely,
the figures given by Dr Grainger in Item 1, of this review(28), are incorrect
and were used, (d) four incorrect mean figures.
Dr Grainger contends that the points
which he mentioned "do not seriously undermine the usefulness of the
work"; but the occurrence, on one page alone, of all the errors and
omissions which have just been mentioned certainly undermines confidence in the
care taken in the preparation of this official report by the anonymous
"statisticians" of the Division of Medical Statistics, Ontario
Department of Health.
(30) Item 3: Re late commencement of
National Health and Welfare Study and detection of caries protection for young
individuals born prior to commencement of fluoridation. Despite the fact that
the Department of National Health and Welfare began its control study nearly
three years after fluoridation began, much worthwhile information was obtained
and the effect of late commencement, if any, was to result in underestimation
of the fluoride protection.
Comment.
Dr Grainger does not state the nature of this "worthwhile
information" but, whatever it was, it could not compensate for the lack of
a pre-fluoridation caries assessment in this study. Its late commencement could
be justified only if it was known that the caries rates in Brantford had not
been affected by the ingestion of fluorides prior to the baseline examination
(p. 168). However, the results from the City Health Department study, if taken
at their face value, indicated that there had been marked and erratic changes:
at first a considerable rise in the DMF rates after about one year of
fluoridation, followed by a marked fall during the second year. It is
surprising, therefore, that, out of all the cities in Canada, Brantford was
chosen as the location of two long-term studies, for it should have been
obvious that the value of the second study would be severely limited by the
fact that the very important data showing the pre-fluoridation caries rates
could never be obtained.
(31) Item 4: Reason for selection of
control cities. It seems clear that Brown (1951) gave adequate reasons for
selecting Sarnia and Brantford.
Comment.
As Dr Grainger notes, this paragraph refers to the selection of the control
cities, which were Sarnia and Stratford-not "Sarnia and Brantford".
The sole reference to the selection of control cities which Brown (1951) gave
is as follows: "The Ontario Dental Division, under Dr Frank Kohli,
volunteered assistance, as did Dr G. L. Anderson, Medical Officer of Health for
Sarnia, and Dr H. B. Kenner, Medical Officer of Health for Stratford, and both
these cities entered the study as controls. (The water of Sarnia is
fluorine-free, and that of Stratford contains 1.3 ppm. of fluorine from a
natural source.)" Dr Grainger considers that "Brown (1951) gave
adequate reasons" for the selection of the control cities-but few would
agree with him.
(32) Item 5: Re superior dental care in
Brantford. The difference in level of dental care between the cities is factual
as recorded by Brown (1952). This variation of numbers of teeth classified as
F. rather than D. or M. does not fundamentally influence the DMF rate.
Comment.
Increased dental care usually includes some prophylactic treatments and, as
noted by Doctors Blayney and Hill (18). even regular examinations may be
accompanied by "more emphasis on the teaching of oral health." This
statement by Dr Grainger implies that he considers that such increased dental
care has no influence on the total DMF rate.
(33) Item 6: Comparability of rates. As
stated under Item 5, the dental condition of the children in Sarnia and
Brantford differed in 1948 because a lower level of dental treatment in Sarnia
resulted in higher tooth mortality. The tooth mortality rates thus differed but
it does not follow that the DMF rates differed.
Comment.
It does not state "that the DMF rates differed; it points out, as its
title states, the "Doubtful comparability of rates" owing to the
delay in setting up this study. Dr Grainger's comments suggest either that he
has not understood the meaning of the first sentence of the paragraph, or that
he is seeking to distract attention from the presence of this important
deficiency in the study-its late commencement.
(34) Brown's statement (1951) "by
1948 the Brantford data were not greatly different from those in Sarnia"
is obviously referring to DMF rates and hence quite valid.
Comment.
This quotation does not appear in Brown (1951) but a similar statement was made
by Brown et al. in 1953 and 1954 (b)
and is given on page 169. The fact that it was "obviously referring to DMF
rates" was not questioned. The implications of this remark were discussed.
(35) The differences in oral hygiene are
only remotely related to the DMF rates under discussion.
Comment.
Brown et al. (1954b) said that
"marked differences in oral hygiene as between the test and control groups
might conceivably affect the findings". Such "marked
differences" were reported-but were disregarded.
(36) Item 7: Concentration of
fluorides. The fluoride content of the Brantford water supply was raised to
approximately 1 ppm in June, 1945, and raised to 1.2 in February, 1949
Comment.
This statement of Dr Grainger is welcome because it provides the answer to the
question: Which of the statements regarding the concentrations of fluorides in
the Brantford water, which were reported on page forty-two, are accurate and
which ones are not?
(37) The Stratford water fluoride
content is believed to have been in the order of 1.3 to 1.6 ppm since 1917 when
the wells were drilled. Naturally no analysis for fluoride was available prior
to the beginning of the interest in fluoridation and early techniques for
analysis were not as reliable as present methods.
Comment.
This statement is most revealing for it indicates that the wells at Stratford
have been analyzed to determine their fluoride content only since "the
beginning of the interest in fluoridation". If this is the case, the
statements of Brown et al, (1953,
1956), concerning the "continuous" use of water containing fluorides
in concentrations of 1.3 ppm or 1.6 ppm since 1917 are not founded on data and
are, therefore, merely different guesses.
(38) These facts have been recorded in
the writings of the primary workers (Hutton et
al., 1951; and Brown et al.,
1951, 1952, 1953, 1954, 1956) and the differences in amounts from other writers
might seem less "strange" if they were merely acknowledged to be
minor misquotations.
Comment.
It was pointed out that the "facts" regarding fluoride concentrations
were stated differently in these papers. In regard to the concentration in the
Stratford supply, a comparison of the statements made by Brown et al., in 1953 and 1956 suggests that
the concentration of fluorides in this supply may have increased from 1.3 to
1.6 in this three year period. The important admission that the fluoride
concentration in Stratford was obtained only relatively recently, is not
contained in any of the six "writings of the primary workers"
mentioned by Dr Grainger. Therefore his statement is not correct.
As Dr Grainger suggests, it is not
unlikely that the statements regarding fluoride concentration of the
"other writers", the New Zealand Commission of Inquiry (1957) and the
Ontario Department of Health (1956), were "minor misquotations".
(39) Item 8 Re statement by Brown et al (1956). The statement is
substantially correct with the exception that Brown's observational period did
not begin until 1948, hence is less than 10 years.
Comment.
Dr Grainger suggests that the phrase "more than ten years" is
incorrect. It was inserted into the quotation of a statement by Brown et al. (1956), but enclosed in square
brackets to indicate that it was not a part of the quotation. However, in the
sentence which immediately precedes that quotation Brown et al. (1956) said: "Brantford has had more than 10 years of
experience with 1 part per million of fluoride in its water supply. During that
time... "It is clear that they were not referring to "Brown's
observational period" of about seven years, but to the period of
fluoridation in Brantford which commenced in June 1945 (Hutton et al., 1951; p. 173) and was,
therefore, "more than 10 years".
(40) The decrease in mean df rates for
the 9-11 years group in Sarnia between the years 1948 and 1954 (Brown, 1954),
did not continue into 1955.
Comment.
The 1955 rate of 2.31 df was still below the 1948 and the
1951 figures of 2.50 and 2.41 respectively.
(41) There was a highly significant
decrease over the period 1948 to 1955 (2.37 to 1.93) in Brantford and no
significant decrease in Sarnia (2.50 to 2.31).
Comment.
The decrease mentioned by Dr Grainger (2.37 to 1.93) was
reported in Brantford between 1948 and 1954 (Brown et al., 1954b) not "over the period 1948 to 1955". In
1955 this rate rose to 1.99 (Brown et al.,
1956), and the difference between 1948 and 1955 was no longer said to be
"highly significant" (Brown, 1955)
The rates quoted by Dr Grainger for
Brantford are for the years 1948 and 1954 (see 63). It should be noted that it
was between these two years that the maximum "decrease" was reported
in the rates in that test city (2.37 to 1.93). Furthermore, in mentioning
Sarnia, instead of giving the figures for the same period (1948-54), 2.50 to
2.11, he cited the figures 2.50 to 2.31, which cover a different period
(1948-55) and do not reveal (Brown, 1955) the significant "decrease",
in the rate in this control city, which was shown in the previous report (Brown
et al., 1954b). By the use of these
figures, the reviewer exaggerates the contrast between the test city and this
control. Thus, this statement by Dr Grainger is both inaccurate and misleading.
(42) In the same periods the mean df
rates for this age [in] Stratford remained nearly equal (1.66 and 1.65) and
increased for other ages.
Comment.
The rates for the four examinations were: 1.66, 1.76, 1.58, 1.65 (Brown, 1955).
(Throughout this monograph caries rates have been given in the form in which
they appear in the original papers although it is recognized that, in cases
such as these, the practice of showing caries rates with two places of decimals
is, probably, not warranted.) Dr Grainger mentions the least variable of the
ten caries rates in the control cities-that for the deciduous teeth of children
aged nine to eleven years in Stratford. He omits to mention the DMF rates which
show the remarkable situation, in this control city, in which each of the
inter-year changes occurring in this age group, and in five out of the six inter-year
changes in the rates of the "other ages", were said by Brown (1955)
to be statistically significant.
(43) Item 9: Re Table 11, Ontario
Department of Health Report. The printing of dashes rather than percentages for
the control cities was to avoid confusing the table with "negative
reductions" and in the case of the 9 to 11 df figure to avoid emphasizing
what was considered to be a spurious decrease.
Comment.
This astonishing explanation, for the printing of dashes in this table, implies
that these omissions were made deliberately because the results did not conform
to those expected. Why should a decrease of 0.44 df (18 per cent) in the test
city be accepted and published, but a very similar one of 0.39 df (16 per cent)
in a caries rate in the control city of Sarnia be considered
"spurious" and not published-a dash being shown in the appropriate
position in the table? By printing these dashes, the "statisticians"
of the Ontario Department of Health could have misled their Minister into
thinking that there were no changes in these caries rates in Sarnia and
Stratford (particularly as the Summary of the report said so) but that there
had been a decrease of eighteen per cent in the corresponding rate in Brantford
due to fluoridation.
Talk of "negative reductions"
cannot disguise the fact that nothing is more calculated to confuse a table
than (as Dr Grainger implies) the deliberate omission by
"statisticians" of figures giving the percentage changes in rates
(one of which was said to be significant).
(44) This judgement was borne out by
the 1955 figures.
Comment.
Dr Grainger tries to justify this "judgment" by implying that these
so-called "spurious" decreases were not seen in the 1955 figures.
However, small "decreases" were still shown in that year, the
"reduction" in Sarnia being 7.6 per cent.
In any case, this so-called
"judgment", regarding the omission of data, has no place in the
preparation of an unbiased report.
(45) Item 10: Differences in reported
rates between examiners. Different examiners give characteristically higher or
lower rates upon examining the same individuals due to differences in skill,
training the physical condition [sic]. Thus the differences quoted are no
reflection on the design of the experiment or the care taken in the work. The strength
of the double examinations comes through corroboration of caries trends in
Brantford over the years and not through interchangeability of data.
Comment.
Dr Grainger refers to the differences between examiners in the assessment of
caries rates. This important matter has already been considered. The aim of the
paragraph mentioned was to show that, as the rates obtained by the examiners in
the two Brantford studies were different, data from the City Health Department
study could not be used to decrease "the deficiency in the data of the
National Health and Welfare study, owing to its late commencement"
The admission, which is implicit in Dr
Grainger's remark, that "interchangeability of data" was not
permissible between the two studies in Brantford confirms the point made. The
degree of reliance which can be placed on the "corroboration of caries
trends in Brantford over the years" must be considered in the light of the
widely divergent results obtained in these studies, which were discussed in the
second paragraph of page three.
(46) Item 11: Significant fluctuations
in controls. The important point is that for the controls the inter-year
changes were upward trends or mere fluctuations (even though in some cases
calculated to be beyond change) [sic], whereas in Brantford the change took the
form of a highly significant continual downward trend.
Comment.
It was pointed out that in the control city of Stratford five out of the six
comparisons made between the permanent teeth rates of successive years were said
by Brown et al. (1954b) to be
significant changes (four of them being at the three standard error level). In
the permanent teeth rates in the other control city, Sarnia, there were four
highly significant and one significant change in the nine comparisons made.
Brown et al. (1953, 1954b) and Brown
(1955) said that the odds relating to the occurrence by chance or sampling
variation of a difference of the magnitude of three standard errors (such as
were reported in eight of these changes) "are 369 to I against".
Therefore, when Dr Grainger terms these unexplained changes "mere
fluctuations" he is rejecting that remark of Brown et al. and denying the meaning of statistical significance.
Dr Grainger neglected to mention that
the "highly significant continual downward trend" in the caries rates
in Brantford occurred only in children who were aged twelve to fourteen years.
In the two other age groups, in both the deciduous and the permanent
dentitions, there was an upward trend in the caries rates in the fluoridated
city during the last year of the study, the rise from 0.44 DMF to 0.69 DMF, in
the youngest age group, being said to be a highly significant rise (Brown,
1955). Therefore this statement by Dr Grainger, that there was a
"continual downward trend" in Brantford, is incorrect and is
misleading.
(47) Item 12. Larger percentage changes
in control. There is no definite explanation as to why rates increased in
Stratford and also in Sarnia over the ten years but this may be a reflection of
a general post-war increase in dental caries which has been seen in other
areas. However, it is significant that in the various fluoridation experiments
e.g. in Brantford, Newburgh, Grand Rapids, etc., the shift has always been
significantly downward in the fluoridated cities whereas the control city rates
have remained about the same or in the case of Stratford, increased.
Comment.
Dr Grainger's statement, that the "rates increased in Stratford and also
in Sarnia over the ten years", is inaccurate for, as he pointed out in his
Item eight (39), "Brown's observational period did not begin until 1948,
hence is less than 10 years." Sarnia was first examined in March 1948 and
Stratford in October of that year (Brown, 1952). Therefore the caries rates of
the children in both those towns were known for a period of about seven years,
not one of ten years. Furthermore, in the deciduous teeth in Sarnia, the
younger age group showed a higher rate in 1955 than in 1948, but in the older
children the final rate was lower than the initial one. In this city the DMF
rate rose between 1948 and 1953 but between that year and 1955 there was a
decrease in this rate in each of the three age groups.
The suggestion that there has been
"a general post-war increase in dental caries" is not supported by these
studies, for such a rise it was not seen in any of the unfluoridated control
cities considered. In Muskegon and Oak Park there was no definite trend. At the
time when (as a result of their being fluoridated) these cities ceased to serve
as controls, the rates for the children of some ages were higher, and for other
ages they were lower, than during the initial examination. The trend in
Kingston cannot be investigated owing to the method of presenting the data in
the Newburgh study. The contention that "the shift has always been
significantly downward in the fluoridated cities" can be accepted only if
the many deficiencies pointed out in this monograph are ignored and the figures
from these trials accepted at their face value.
(48) Item 13: Smaller percentage
decrease after longer fluoridation. As pointed out by Sutton himself on page
168 (middle paragraph) the fluoride protection for permanent teeth of the
children aged six to seven seemed to occur within two or three years after
fluoridation began. Thereafter the yearly DMF rates were subject to random
fluctuation and the differences in percentage decrease of 69 per cent and 51
per cent are most likely a reflection of this inter-year variation.
Comment.
No specific mention was made of "the children aged six to seven" when
pointing out the reductions in the DMF rates which were reported to have
occurred in the early years of the City Health Department study (Hutton et al., 1951). Some implications of this
reported early decrease in caries rates were discussed on pages two and
thirty-eight.
When he makes the remark that "the
differences in percentage decrease of 69 per cent and 51 per cent are most
likely a reflection of this inter-year variation", Dr Grainger shows that
he could not have noted that the increase in the DMF rate in these children, in
the fluoridated city, from 0.44 in 1954 to 0.69 in 1955 (so that the
"percentage decrease" dropped from 69 per cent to 51 per cent), was
shown by Brown (1955) to be, statistically speaking, a highly significant (three
standard error level) rise in the rate in the test city during the final year
of the study. Therefore, when he makes this suggestion, he is expressing an
opinion which contradicts the notation given by Brown (1955), in his Table IV,
which indicates that the rise in rates which produced this percentage
"decrease" is statistically significant at the three standard error
level.
Dr Grainger may be right-but if he is,
Brown's (1955) indication of statistical significance in this case is
incorrect, and the methods used in the National Health and Welfare study for
calculating statistical significance must be questioned. In consequence, all
statements made in the study regarding significant changes in the caries rates,
both in the test city and its controls, become doubtful.
It is of interest to note that the
"1955 Report" from this study was released in two different
publications. The first, a booklet, was dated November 1955, and was
"prepared by H. K. Brown . . . with the assistance of H. R. McLaren... G.
H. Josie... and Barbara J. Stewart". The second publication is a paper by
Brown, McLaren, Josie and Stewart published in 1956 in the Canadian Journal of
Public Health, no reference being made to the previous publication. The ten
tables and the two figures in the body of these reports are the same and the
text of both is practically identical. However, there is one important
difference: that part of the discussion dealing with the unexplained rise
(shown as significant) in the DMF rate of children aged six to eight years in
Brantford (and also in the control city with the "optimum"
concentration of fluorides in its water), was omitted from the later report
(Brown et al., 1956).
The questions should be asked: Why was this very important small section of the original report omitted when it was published in the Journal? Why, in both these 1955 reports, was the smaller percentage "decrease" between the initial and the final caries rates of the youngest age group in Brantford not published?
The questions should be asked: Why was this very important small section of the original report omitted when it was published in the Journal? Why, in both these 1955 reports, was the smaller percentage "decrease" between the initial and the final caries rates of the youngest age group in Brantford not published?
(49-50) Item 14 The quotation from the
Ontario Government Report is taken out of context from a series of summary
statements. The previous statement was to the effect that in Brantford there
had been a significant decrease of about 60 per cent in DMF rates. In the
statement following, as picked out by Sutton, it was stated that "no
change" occurred in Stratford and Sarnia(49). It should be clear enough
from the context at the words "no similar downward change" were
inferred(50)
Comment.
The charge that the quotation mentioned was "taken out of context" is
meaningless unless it implies that the sense of the original statement has been
altered. So that the reader can judge this matter, the whole of paragraph three
(the "previous statement" referred to by Dr Grainger) and paragraph
four are reproduced. The quotation given on page 176, which was the one
criticized, is shown here in italic type to distinguish it from its context.
The evidence produced by the
investigators of the Brantford City Health Department and of the Department of
National Health and Welfare, independently show that since the introduction of
the fluorine in the water there has been a significant decrease, amounting to
approximately 60 per cent in the number of decayed, missing and filled teeth
suffered by Brantford school children.
At the same time, it has been established that there has been no change in the already
low dental caries attack rates in Stratford which has 1.2 ppm of natural
fluoride in its domestic water, or in the relatively high rates for Sarnia
which has had virtually no fluoride in its water."
Dr Grainger suggests that the writers
of this report, when they used the expression "no change", really
meant "no similar downward change". However, as they were members of
the Division of Medical Statistics and, presumably, were trained in the very
precise science, of statistics, it is unlikely that they would use such an
inexact expression. Also, the term "downward change" is a rather
clumsy substitute for the word "decrease" which was used in the
previous paragraph (para. 3 above). Both these points suggest that Dr
Grainger's interpretation is incorrect.
(51) Item 15 Possible weighting effect.
The critic is referring to a possible shift in age distribution within the
group, e.g. a possible sampling shift within the six to eight-year age group so
that certain years had disproportionately higher or lower numbers of
eight-year-olds and hence higher or lower average caries scores. This is rather
remote in that selection methods used by Dr Brown were the same each year;
moreover very large shifts in age distribution would be needed to produce the
significant differences to which P N. R. Sutton refers.
Comment.
After reading Dr Grainger's remarks it may be supposed that it was said that
the inter-year significant changes in caries rates, reported from the control
cities, were due to a "weighting" effect. However, if the original
paragraph is consulted, it will be found that it is headed "Unexplained
Significant changes in controls." A "weighting" effect was
mentioned as a possible explanation for these unexplained changes. This
suggestion was made following the failure of the authors (Brown, 1951, 1952;
Brown et al., 1953, 1954b, 1956) to
advance even a suggestion why these changes occurred. Dr Grainger's comment
leaves these significant changes in the caries rates of the control cities as
the authors of this study left them - unexplained.
This reviewer has made it clear that
the statements regarding the "continuous" use of water containing
fluorides in concentrations of 1.3 or 1.6 ppm since 1917 in Stratford are not
based on data (comment 37); and that the misleading omission of figures from
the Ontario Department of Health Report (1956) was made deliberately (comment
43). However it has been seen that, although Dr Grainger said (27) that his aim
was "to help set the record as straight as possible", most of his
comments, if they had been accepted at their face value, would have had the
reverse effect.
MR
J. FERRIS FULLER
Apart from the reviews already quoted
above, the only published criticism known to the author is that contained in
the Book Reviews section of the January 1960 issue of the New Zealand Dental
Journal. This was contributed by MR J. FERRIS FULLER, a member of the Dental
Research Committee of the New Zealand Medical Research Council and a member of
the Fluoridation Committee of the Department of Health, whose submissions to
the New Zealand Commission of Inquiry (1957) are mentioned in over twenty
paragraphs of its report.
Mr
Fuller's review stated:
"Everyone is out of step except
our Albert," or so the author would have us conclude. Altogether an
extraordinary book; clever but unfortunate; skilfully contrived and
yet-stripped of its finery-rather slender. It could be ignored if the matter
rested within the Sciences; but since by the very nature of the subject it
takes us into the public forum, some of the errors must be stated..
Part I of Fluoridation: Errors and
Omissions in Experimental Trials (Chapter 19 here) is a reprint of a paper by
Sutton and Amies (see footnote on page 136) that appeared recently in the
Medical Journal of Australia criticising the Brantford-Sarnia-Stratford study
in Canada(52). But the authors have omitted to read the literature(53), and
their criticisms therefore are not based on the known facts. This is a serious
matter especially when the comments come from two critics who exalt themselves
above fellow scientists of at least equivalent status in other parts of the
world. They accuse the Canadian workers of failing to devise a randomisation
procedure that would eliminate bias(54), of deliberately omitting vital
information in some of the tables(55), and finally of displaying bias in the
presentation of results(56). Their comments are based on a report of the Ontario
Department of Health (1956) to the Ontario Minister of Health, a report
obviously written in simple abbreviated terms for public consumption(57).
Sutton and Amies failed to read two official publications readily
available(58), namely, a 51-page booklet "A suggested methodology for
fluoridation surveys in Canada" and the 35-page detailed report of the
Department of Health and Welfare, of November, 1955 These two booklets together
show that great care was taken to introduce a well-designed randomisation procedure(59),
that examiner variability was eliminated as far as humanly possible by the
employment of one examiner only throughout the whole period of the study(60),
and that the information alleged to have been omitted is in fact shown in
detail in the tables in the 1955 report(61), together with the standard error
for each of the indices used. In short, the more important criticisms that
appear so damaging are in fact without foundation. Thus, when the authors say
that "what must be eventually a statistical study does not appear to have
been designed as such" and "no attempt at statistical evaluation has
been considered" their comments are absurd and, indeed, irresponsible(62).
The full official report on the Brantford study was available in New Zealand, incidentally,
when the Commission of Inquiry held its hearings(63), and three of its tables
are included in the published report of the Commission.
In Part 2 of the book Sutton continues
in the same vein. He complains that misleading comments are made in some
reports, yet his own book contains many misleading statements. For example, he
claims that a proper evaluation of examination errors at Grand Rapids has not
been carried out(64), and he doubts the accuracy of caries attack rates in test
and control areas because X-ray examinations were incomplete or absent(65). It
is significant that he omits to refer to a report by Hayes, McAuley, and Arnold
published in the U.S. Public Health Report in December, 1956, which is a key
reference in this subject(66). This report met the specific point that
"some observers have suggested that X-rays are essential to determine the
efficacy of caries control measures" and an investigation was undertaken
"to determine whether or not supplementing direct observation with X-ray examinations
would affect the conclusions based on direct observation alone." The
conclusion was that supplementary X-ray examinations supported the clinical
findings and did not change the basic observation that substantial decreases in
dental caries occurred during the test period. The very standard errors that
Sutton demands for a proper statistical evaluation were available in this
report(67). He quotes a subsequent (1957) paper by McAuley that suits his book
and, in the light of his criticisms and allegations, this makes the omission of
any reference to the 1956 report more damaging(68). To borrow his own phrase,
omissions of this nature render his work "open to doubt." Sutton
criticises his overseas colleagues for their inability to examine children in control
towns prior to fluoridation(69). With personal experience of a study of this
nature he would appreciate that where on the one hand the interests of a large
number of people and their local bodies and institutions are concerned as
compared with only one or two examining personnel on the other, it is almost
impossible to operate a plan to the exactitude dreamed of at the statistician's
desk. In any event, the criticism is rather meaningless as far as the Grand
Rapids study(70) is concerned when we realise that the baseline examination in
the control city of Muskegon showed that caries prevalence in that city is of
the same order as in Grand Rapids.
In attacking the Evanston-Oak Park
study, Sutton bemoans the lack of information about the design of the study and
phrases such as "It is not clear...", "It is not
understood...", (It) was not stated..." give the lead to questions
and speculations that follow. But why not adopt the simple expedient of writing
to the workers concerned and so finding out instead of speculating? This
attitude is typical of the book(71). And typical also is the quibbling over
details that do not detract one iota from the part that fluoridation has played
in these areas in reducing dental decay(72). "The total tooth surfaces
considered... should be 58,325, not 58,352" says the author, and also...
the mean of these values for 1946... is 150.09, not 149.76"(73). Dear me,
Dr Sutton, how dreadful.
And then we come to the
Newburgh-Kingston study. Prominence is given to the different composition of
the waters at Newburgh as compared with the control city of Kingston(74), and
this is cited as the reason why the latter is unacceptable as a control. But
once again Sutton omits any reference to a key report, that by Dean, Arnold,
and Elvove of August, 1942, listing caries prevalence rates in communities
where the variables in the domestic water mentioned by Sutton varied to a
greater degree than between Newburgh and Kingston without caries prevalence
being markedly affected(75).
The author complains of bias in the manner
in which some results are presented but, as can be seen, he displays bias
himself in the choice of articles he quotes(76) and in his omission to read
others. It is not surprising, therefore, to see him fall into the familiar
pattern of the anti-fluoridationist. Those who question fluoridation are given
the familiar title of "eminent authorities," a distinction not
afforded anyone else(77). It is surprising, however, to see him serve his ends
by quoting Feltman's study on the use of fluoride tablets. This study lacks the
very control that one would expect Sutton to consider essential(78).
As one would expect, there are no bouquets for the
New Zealand Commission of Inquiry, one complaint being that "no mention
was made of the employment of a statistician to assist its members in
evaluating numerical data." Had the author inquired, he would have been
told that the Professor of Biochemistry on the Commission was well versed in
biometrics, and that scientific witnesses quickly discovered that tables were
unacceptable unless they contained complete details including standard errors,
so that he could evaluate data statistically for himself and the
Commission(79).
Finally, a warning to those reading this book, lest
they be misled by the polemics and the array of figures. Please note that
Sutton's conclusions in part 2 (which forms the greater part of the book) are
confined to variations in the prevalence of dental decay in control cities and
not to the cities where fluoride has been added(80). What of the places where
fluoridation has been adopted? Sutton does not dispute the fact that the
prevalence of dental decay has been substantially reduced in the fluoridation
cities of Grand Rapids, Newburgh, Brantford, and Evanston(81), nor does he
mention that these good results have been confirmed by several independent
studies in the U.S.A., and also in Tasmania, Brazil, Japan, Germany, Sweden,
and at Hastings in New Zealand(82). The validity of the results from Hastings,
incidentally, has been checked by the Applied Mathematics Laboratory of the New
Zealand Department of Scientific and Industrial Research(83).
The anti-fluoridationists will rejoice with fresh
ammunition to replenish their stocks; but it is unlikely that this work will
serve any useful purpose in scientific circles despite the author's rather
pretentious hopes. The performance is almost as old as Time: "The
mountains are in labour, there will be born a ridiculous mouse," said the
ancient poet.
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