Re: Re: Effectiveness of NFP

[Guest guest]

Hello,

has anybody of you access to " Human Reproduction Update " ?

It would be helpful if I could get the paper below:

Gemzell-sson K, ns L. Mechanisms of action of mifepristone

and levonorgestrel when used for emergency contraception.

Hum Reprod Update. 2004 Jul-Aug;10(4):341-8. Epub 2004 Jun 10. Review.

PMID: 15192056 [PubMed - indexed for MEDLINE]

Thanks in advance

--

Mikolajczyk, MD

Department of Public Medicine

School of Public Health

University of Bielefeld

PO-Box 100131

D-33501 Bielefeld

Germany

Phone: +49 (0)521 106-4262

Fax: +49 (0)521 106-2968

[Guest guest]

Dear Karel:

You might be interested in the two recent effectiveness studies conducted by the

town University Institute for Reproductive Health. They report the

effectiveness of the Standard Days Method and the TwoDay methods of NFP. These

studies include " Correct Use " and " Typical Use " results and rates of

intercourse.

1. Arevalo M, Jennings V, Sinai I. Efficacy of a new method of family planning:

the Standard Days Method. Contraception. 2000;65:333-338.

2. Arevalo M, Jennings V, Nikula M, Sinai I. Efficacy of the new TwoDay Method

of family planning. Fertility and Sterility. 2004;82:885-892.

You also might be interested in one of the latest publications by Trussell

-- in which he defines terms for effectiveness studies.

Trussell mentioned that there are many factors that can influence contraceptive

effectiveness, including the age of the users, the frequency of intercourse, the

expertise of the investigators, user characteristics, and the inherent efficacy

of the methods. For example methods that require little behavior change on the

part of the user, like sterilization or the IUD, will show very consistent

efficacy rates as determined by different investigators with different subjects.

Whereas methods that require modification of behaviors, like NFP or use of

condoms, will have a lot more variability in efficacy rates between various

efficacy studies. Efficacy rates can also be influenced by methodological

problems in conducting efficacy studies and by the bias of the investigators.

Trussell J. Contraceptive failure in the United States. Contraception.

2004;70:89-96.

J. Fehring

Professor of Nursing

Marquette University

Re: Effectiveness of NFP

Dear et al.,

your discussion about methodological aspects of NFP research is very

helpful. The problems with conceptualization of " typical use " index

show how complex the issue is. In the future it is necessary to

determine te magnitude of effect of different variables on " typical

use " : for example age of users, coital frequency, inherent

effectiveness of the method, if fertility was proved (nulliparous

women), motivation (spacers/limiters). We can use these variables and

characteristics as predictors in complex statistical model

with " typical use " as a dependet variable.

I think it is necessary to focus our research projects on the concept

of " motivation to pregnancy avoidance " or " attitudes to

pregnancy/child " . How we can measure it (i.e. operationalization)?

Etc.

Moreover, I think it is necessary to improve our concept of " method

effectiveness " and use the concept of " perfect use index " See:

Trussell J. Methodological pitfalls in the analysis of contraceptive

failure. Stat Med. 1991 Feb;10(2):201-20.

Trussell J, Grummer-Strawn L. Contraceptive failure of the ovulation

method of periodic abstinence. Fam Plann Perspect. 1990 Mar-Apr;22

(2):65-75.

As Trussell et al. claim, in the magnitude of published reports on

NFP effectiveness the " method effectiveness " was calculated wrongly.

See:

Lamprecht V, Trussell J.

Natural family planning effectiveness: evaluating published reports.

Adv Contracept. 1997 Jun-Sep;13(2-3):155-65.

To my knowledge only two NFP studies mention the " perfect use index " :

3,0 for Billings method in WHO study and 0,5 for STM method in

Germany (NFP working group). All (?) other studies mention

the " method effectiveness " , i. e. cycles with imperfect use (or

without information about coital frequency) are also included. What

do you think of it?

I think it would be extremely helpful to publish directions and

recommendations for future NFP effectiveness studies: i. e. basic

definitions, how to calculate perfect use index (to include only

cycles with at least one unprotected intercourse during the infertile

period, with abstinence in fertile time), how to calculate life-

table, how to interpret published results etc...

And the same case is the area of psychological research of NFP use...

Best wishes!

Karel Skocovsky

> Dear a,

>

> I think that simply changing the terminology is unacceptable. In

> communicating with others we would have always to repeat that we

are

> using a specific definition. Otherwise it would be a sort of a

> scientific deceit.

>

> Further I do not think, that deriving intentions from behaviour is

a

> valid approach, reflecting the complexity of human life. In my

opinion

> the term of " achieving related behaviour " or yours " pregnancy

seeking

> behaviour " is misleading and should not be used.

>

> I still think that we can talk about pregnancy rates, but we should

> stratify them by the use categories:

>

> - ...% were using the method always according to the rules, in this

> group there were ... pregnancies, there were on average ... acts of

> intercourse per cycle in this group, with such variation between

> different couples and such between different cycles of the same

couples,

>

> - ...% had intercourse in the fertile time according to the rules

in one

> of ... cycles, in this group there were y1 pregnancies, there were

on

> average ... acts of intercourse per cycle in this group, with such

> variation between different couples and such between different

cycles of

> the same couples

>

> (in fact we would be interested in a more detailed subgroup

analysis)

>

> This is one piece of information, the other is why the behaviour

between

> these groups differed, there also a stratified analysis could be

done.

>

>

>

[Guest guest]

, how exactly is method effectiveness obtained? For example, is

ambiguity of fertility a user or method problem? I was thinking it was method

but I must be wrong.

Of course I am not very schooled in research and little qualified to engage in

this discussion, but I find the subject thought provoking and like to throw out

thoughts for you more scholarly listers to answer. You are all so nice to be

patient with me. In fact I have been thinking about this user effectiveness

issue for as long as I have known about NFP and especially since being

introduced to the list and reading the series of articles discussing this by Joe

Stanford and Bob Kambic.

KJ

a:

Just as Dr. Stanford -- is reluctant* to describe 'intentions' to achieve or avoid pregnancy as " on " or " off " --- why is there agreement that 'behaviors' to achieve or avoid are as well " on " or " off " . *By reluctant I mean he has evidence to indicate that intentions are not necessarily either to achieve or avoid but that for some there is a process to go from avoiding to achieving.

I think that there are many reasons that couples could have intercourse (coitus) on days that they know are fertile, including:

1. confusing patterns of fertility and infertility

2. confusing or extensive instructions on what is the fertile time or not coupled with extensive instructions as to when to have intercourse

3. passion or desire overrides the intention

4. frustration with too many days of fertility as defined by a method

5. the couple is too tired and exhausted to bother with charting and what the charts have to say about fertility --- i.e., 4-5 young children, unable to take temp in morning, not sure if all mucus observations were made

I think that it is fair to provide couples with Correct Use effectiveness and Typical Use effectiveness, i.e., the pregnancy rates they can expect with a method of family planning when it is used correctly; and the pregnancy rates when couples do not always follow the instructions. And I think that most couples can understand the concepts of " Correct Use " and " Typical Use. " They are the ones that need to decide on what methods to use.

You are right in saying that there are differences between contraceptive methods and natural methods -- on many other outcomes -- that researchers could study and couples should know about when deciding on methods of child spacing. The theology of the body certainly could give us directions as to what some of those outcomes could be.

Thanks for your Alaska insights! And willingness to share them.

J. Fehring

Marquette University

Re: Effectiveness of NFP

Thanks Joe and for the comments. Joe, what you describe below seems prophetic to me. That is the whole point of NFP, we are trying to reconnect the person to his body and the body with itself!

Contraception is irrational behavior, pure and simple and the irrationality has resulted in many other evils. Quite honestly sometimes I think that most of today's evils can be traced to contraception! NFP confronts that irrationality, that's why it is so earth shattering.

If an NFP couple engages in coitus during a known fertile time, I don't believe they are irrational enough to think that pregnancy is not a distinct possiblity. Current use effectiveness rates and rules assume such irrationality.

Not being a researcher, I not sure I can speak to the concerns raised by , but I'm not advocating scientific deceit, merely re-education. If all NFP researchers were united in a perspective it would seem that eventually there would be a watershed, but I'm sure in the short run there would be difficulties to overcome.

I do not see how a subject (or other researchers) could object to describing coitus during the fertile time as pregnancy seeking or achieving related behavior if that were the term and description set out at the beginning of the research project. It is simply descriptive of reality and demonstrates that the couple is rational!

a J

Re: Effectiveness of NFP

> a

> what you describe below and in your other post is exactly how the

> Creighton Model System has classified pregnancies since the early

> 1970s. Interestingly, at the time it generated enormous

> controversy

> in the NFP community. In the Creighton Model evaluations, what

> you

> call pregnancy seeking behavior is called achieving related

> behavior,

> and the converse, avoiding related behavior. (It was before my

> time, but I have read much of the documents from the time.)

> Volumes

> were written at the time. Suffice it to say that many people took

> offense at " achieving related behavior " as being perceived as a

> way

> to " explain away " pregnancies that they thought should be listed

> as

> " unintended. " The problems revolved around lack of clarity and/or

> agreement about the differences between intention and behavior.

> Joe

>

> >I left off " marked " or " charted " before fertile and infertile

> days

> >in this sentence: " Coitus on fertile days is defined as

> pregnancy

> >seeking behavior, coitus on infertile days is defined as behavior

> >not intended to result in pregnancy. " meaning that when the

> couple

> >marks a day as fertile and has coitus, this is defined as an

> >intention to acheive pregnancy and vice versa.

> >kj

> >

>

> --

> ______________________________

> ph B. Stanford, MD, MSPH

> Health Research Center

> Dept. Family & Prev. Med.

> University of Utah

> jstanford@...

[Guest guest]

I got the text. thank you

Mikolajczyk, MD wrote:

> Hello,

>

> has anybody of you access to " Human Reproduction Update " ?

> It would be helpful if I could get the paper below:

>

> Gemzell-sson K, ns L. Mechanisms of action of mifepristone

> and levonorgestrel when used for emergency contraception.

> Hum Reprod Update. 2004 Jul-Aug;10(4):341-8. Epub 2004 Jun 10. Review.

> PMID: 15192056 [PubMed - indexed for MEDLINE]

>

> Thanks in advance

>

>

>

>

> --

> Mikolajczyk, MD

> Department of Public Medicine

> School of Public Health

> University of Bielefeld

> PO-Box 100131

> D-33501 Bielefeld

> Germany

> Phone: +49 (0)521 106-4262

> Fax: +49 (0)521 106-2968

>

>

> *

[Guest guest]

Dear a (in Alaska):

I would like to preface my remarks with the statement that I am no expert when

it comes to family planning effectiveness studies. I do know something about

research since I attempt to teach graduate and undergraduate nursing students

about research methods and designs -- and usually put them to sleep in the

process. I have conducted and published an effectiveness study (CrM) and

currently am in the middle of another (i.e., mucus plus monitor). I would

classify myself as somebody who is struggling to understand efficacy studies and

what all the terms mean.

To attempt to answer your question, I think that the terms " method "

effectiveness and " use " effectiveness are older terms when it comes to

effectiveness studies. The newer terms or more standardized terms are:

1. Perfect (or Correct) Use -- as defined by following the directions for use

or following correctly a specific set of rules -- and the failure rates as a

result (or i.e., pregnancy rates)show how effective methods can be. This is

close to or the same as method-related pregnancy (those that occur despite

following the rules for avoiding pregnancy) that is advocated by some NFP

experts.

2. Typical use - as defined by inconsistent or incorrect use - reflect how

effective a method is during actual use.

3. Imperfect use - is defined by methods are used incorrectly or

inconsistently.

I take these definitions from --- Trussell, J. Contraceptive failure in the

United States. Contraception, 2004;70:89-96. Trussell believes (and has

emphatically explained in many articles) that it is not correct or a good idea

to calculate " method " and " use " failures separately.

I use these definitions because they are the same ones found in the Book

Contraceptive Technology (Hatcher, et al). This book is used by many health

professionals as an expert reference book for contraceptive efficacy. The

pregnancy rates as found in this book are then included (referenced) in many

professional textbooks (nursing and medical) and in many articles. They are

also the efficacy rates that you will find in the lay consumer literature.

A clinical prospective efficacy study of a NFP method or contraceptive method

would determine " Perfect " use by classifying an unintended pregnancy as a

pregnancy as a result of perfect or correct use. This classification would be

given usually only after an analysis of the chart, an interview, and a

confirmation of the pregnancy.

Please note -- that when clinical (efficacy) studies or clinical trials are

conducted on contraceptive methods(and NFP methods) an artificial process or

condition is set up -- that includes consent, monitoring the participants,

collecting data, asking for intentions, eliminating women that do not fit your

sample, etc, etc. Therefore, the results of these types of studies do not

always give a good picture of " typical " or " average " use pregnancy rates -

especially for behaviorally dependent methods. Typical use or average use

pregnancy rates are probably best determined through survey studies of

participants who are not closely monitored. As Trussell stated in his article

" pregnancy rates during typical use reflect how effective methods are for the

average person who does not always use methods correctly or consistently. "

Hence he relies on the National Survey of Family Growth for some of his

effectiveness data.

To confuse the issue at tad more -- there are efficacy studies that are called

or classified as Theoretical efficacy studies. They are based on applying the

rules of the given NFP methods to already established data sets (that have

indicators for the fertile phase) and then determining probabilities of

pregnancy when the method either fails to cover the fertile phase.

I probably have confused you and others on this list more with my babblings --

than if I would not have responded. Well -- at least -- I might have solved

your insomnia!

Keep warm.

J. Fehring

Professor

From the Lower 48!

Re: RE: Effectiveness of NFP

, how exactly is method effectiveness obtained? For example, is

ambiguity of fertility a user or method problem? I was thinking it was method

but I must be wrong.

Of course I am not very schooled in research and little qualified to engage in

this discussion, but I find the subject thought provoking and like to throw out

thoughts for you more scholarly listers to answer. You are all so nice to be

patient with me. In fact I have been thinking about this user effectiveness

issue for as long as I have known about NFP and especially since being

introduced to the list and reading the series of articles discussing this by Joe

Stanford and Bob Kambic.

KJ

[Guest guest]

Ha, Ha, fooled you. I am currently in Texas, visiting family. Eighty degrees

today!

No, your answer was helpful. I learned the old terms " method " and " user " . I

understood method effectiveness to mean the effectiveness of avoiding pregnancy

when all the rules were followed which you say now is called perfect or correct

use. I guess I was thinking that ambiguity can impact perfect use but then

realized that each method has its own way of dealing with ambiguity. Aslong as

you are following the rules for the particular method regarding ambiguity, an

ensuing pregnancy would not impact perfect use rate, correct? But ambiguity can

impact perfect use in the sense that if the rules aren't correct for the

ambiguity, that would impact the perfect use rate, right?

I'm not getting the difference between typical and imperfect use though.

Your point about how the study affects behavior is one that I was wondering

about in reading 's " passion " post (just teasing R) which I am going to

think about a little more because it seems related to the point I was trying to

make. Like, if you impose a contraceptive research model, does that encourage

contraceptive type thinking in nfp users involved in the study and does it

perpetuate contraceptive type thinking across the industry in subtle ways?

KJ

Dear a (in Alaska):

I would like to preface my remarks with the statement that I am no expert when it comes to family planning effectiveness studies. I do know something about research since I attempt to teach graduate and undergraduate nursing students about research methods and designs -- and usually put them to sleep in the process. I have conducted and published an effectiveness study (CrM) and currently am in the middle of another (i.e., mucus plus monitor). I would classify myself as somebody who is struggling to understand efficacy studies and what all the terms mean.

To attempt to answer your question, I think that the terms " method " effectiveness and " use " effectiveness are older terms when it comes to effectiveness studies. The newer terms or more standardized terms are:

1. Perfect (or Correct) Use -- as defined by following the directions for use or following correctly a specific set of rules -- and the failure rates as a result (or i.e., pregnancy rates)show how effective methods can be. This is close to or the same as method-related pregnancy (those that occur despite following the rules for avoiding pregnancy) that is advocated by some NFP experts.

2. Typical use - as defined by inconsistent or incorrect use - reflect how effective a method is during actual use.

3. Imperfect use - is defined by methods are used incorrectly or inconsistently.

I take these definitions from --- Trussell, J. Contraceptive failure in the United States. Contraception, 2004;70:89-96. Trussell believes (and has emphatically explained in many articles) that it is not correct or a good idea to calculate " method " and " use " failures separately.

I use these definitions because they are the same ones found in the Book Contraceptive Technology (Hatcher, et al). This book is used by many health professionals as an expert reference book for contraceptive efficacy. The pregnancy rates as found in this book are then included (referenced) in many professional textbooks (nursing and medical) and in many articles. They are also the efficacy rates that you will find in the lay consumer literature.

A clinical prospective efficacy study of a NFP method or contraceptive method would determine " Perfect " use by classifying an unintended pregnancy as a pregnancy as a result of perfect or correct use. This classification would be given usually only after an analysis of the chart, an interview, and a confirmation of the pregnancy.

Please note -- that when clinical (efficacy) studies or clinical trials are conducted on contraceptive methods(and NFP methods) an artificial process or condition is set up -- that includes consent, monitoring the participants, collecting data, asking for intentions, eliminating women that do not fit your sample, etc, etc. Therefore, the results of these types of studies do not always give a good picture of " typical " or " average " use pregnancy rates - especially for behaviorally dependent methods. Typical use or average use pregnancy rates are probably best determined through survey studies of participants who are not closely monitored. As Trussell stated in his article " pregnancy rates during typical use reflect how effective methods are for the average person who does not always use methods correctly or consistently. " Hence he relies on the National Survey of Family Growth for some of his effectiveness data.

To confuse the issue at tad more -- there are efficacy studies that are called or classified as Theoretical efficacy studies. They are based on applying the rules of the given NFP methods to already established data sets (that have indicators for the fertile phase) and then determining probabilities of pregnancy when the method either fails to cover the fertile phase.

I probably have confused you and others on this list more with my babblings -- than if I would not have responded. Well -- at least -- I might have solved your insomnia!

Keep warm.

J. Fehring

Professor

From the Lower 48!

Re: RE: Effectiveness of NFP

, how exactly is method effectiveness obtained? For example, is ambiguity of fertility a user or method problem? I was thinking it was method but I must be wrong.

Of course I am not very schooled in research and little qualified to engage in this discussion, but I find the subject thought provoking and like to throw out thoughts for you more scholarly listers to answer. You are all so nice to be patient with me. In fact I have been thinking about this user effectiveness issue for as long as I have known about NFP and especially since being introduced to the list and reading the series of articles discussing this by Joe Stanford and Bob Kambic.

KJ