Editorial
information
Editors:
Toni
Belfield, consumer editor, UK
David Grimes, USA
Metin
Gülmezoglu, Turkey
Frans Helmerhorst, co-ordinating
editor, The Netherlands
Regina Kulier, Austria
Paul
O'Brien, Ireland
Editors
who left the group:
Alisson Bigrigg, UK
Michel
Boulvain, Belgium
Alba DiCenso, Canada
Anne Eisinga,
UK
Tina Mackie, UK
Olav Meirik, Norway
Review
Group Co-ordinator
Anja Helmerhorst, The
Netherlands
Trial Search Co-ordinator
Carol Manion,
USA
Web Master
Marcel Lens, The Netherlands
Senior
IT Specialist
Roger Melet, The Netherlands
Junior IT
Specialist
Chris Helmerhorst, The Netherlands
Hany
Abdel-Aleem, Egypt
Catharine Aicken, UK
Rebecca
Allen, USA
Miguel Arguinzoniz, Spain
Ayodele
Arowojolu, Nigeria
Myat Arrowsmith, UK
Deborah Bartz,
USA
Brandi Batchelor, USA
Katrin Ba-Thike,
Myanmar
Margaret Beksinska, South Africa
Patrizia
Bianchi-Movarekhi, Italy
Kelly Blanchard, USA
Kitty
Bloemenkamp, The Netherlands
Lynn Borgatta, USA
Marieke
Both, The Netherlands
Michel Boulvain, Belgium
Dalia
Brahmi, USA
Aldo Campana, Italy
Boonsri Chanrachakul,
Tailand
Mario Chen-Mok, Costa Rica
Linan Cheng,
China
Lynley Cook, New Zealand
Frances Cowan,
UK
Kathryn Curtis, USA
Andrea Dalve-Endres,
USA
Catherine D'Arcangues, France
Philip Darney,
USA
Gabriel De Candolle, Switzerland
Justin Diedrich,
USA
Beverly Draper, South Africa
Eleanor Drey,
USA
Alison Edelman, USA
John Ehiri, USA
Hokehe
Eko, Nigeria
Ekpereonne Esu, Nigeria
Enrique Ezcurra,
Cuba
Anis Fekih, Tunisia
Annabeth Fraser,
USA
C.P.Gang,China
Maria Gallo, USA
Sara Garner,
UK
Kristina Gemzell-Danielsson, Sweden
Anna Glasier,
UK
Elizabeth Griffith, Australia
David Grimes,
USA
Diederik Grobbee, The Netherlands
John
Guillebaud, UK
Metin Gülmezoglu, Turkey
Vera
Halpern, Russia
Jannifer Hapgood, South Africa
Cynthia
Harper, USA
Jennifer Hayes, USA
Frans Helmerhorst,
The Netherlands
Janet Hiller, Australia
Margaret
Hoffman, South Africa
Justus Hofmeyr, South Africa
David
Hubacher, USA
David Hughes, UK
LI Hui, China
Fiona
Jenner, Australia
Jeffrey Jensen, USA
LaShawn Jones,
USA
Bliss Kaneshiro, USA
Nathalie Kapp, USA
Jos
Kleijnen, The Netherlands
Sheila Krishnan, USA
Regina
Kulier, Austria
Maureen Kuyoh, Kenya
Tess Lawrie,
South Africa
Stuart Logan, UK
Patricia Lohr,
USA
Laureen Lopez, USA
Nicola Low, UK
Nandita
Maitra, India
Anu Manchikanti, USA
Diana Mansour,
UK
Caroline Marfleet, UK
Monika Mueller,
Switserland
Win May, Thailand
Karen Meckstroth,
USA
Suzanne Medema, The Netherlands
Olav Meirik,
Norway
Anne Meremikwu, Nigeria
Martin Meremikwu,
Nigeria
Stuart Morris, UK
Chelsea Morroni, South
Africa
Kavita Nanda, USA
Juan Manuel Nardin,
Argentina
Sara Newmann, USA
Mark Nichols, USA
Paul
O'Brien, Ireland
Chioma Oringanje, Nigeria
Gilda
Piaggio, Uruguay
Bert Peterson, USA
Chelsea Polis,
USA
Domerudee Preechapornprasert, Tailand
Tanya
Proctor, UK
Patama Promsonthi, Tailand
Asha Pun,
Nepal
Marjolein Raps, The Netherlands
Elizabeth
Raymond, USA
Jasper Radder, The Netherlands
Regina-Maria
Renner, Switzerland
Angela Robinson, UK
Sonia Saxena,
UK
Lale Say, Turkey
Kate Schaffer, USA
Sicco
Scherjon, The Netherlands
Kenneth Schulz, USA
Sara
Ellis Simonsen, USA
Mandisa Singata, South
Africa
Jennifer Smit, South Africa
Marieke Snel, The
Netherlands
Marieke Snieders, The Netherlands
Nancy
Stanwood, USA
Markus Steiner, USA
Jody Steinauer,
USA
Carolyn Summerbell, UK
Eeke Thomee, The
Netherlands
Elizabeth Tolley, USA
Cathy
Toroitich-Ruto, Kenya
Sarah Truitt, USA
James
Trussell, USA
David Turok, USA
Margaret Usher-Patel,
UK
Toos Van den Berk, The Netherlands
Lize Van der
Merwe, South Africa
Carla Van der Wijden, The
Netherlands
Nicolette Van Gemund, The Netherlands
Paul
Van Look, Belgium
Clarine Van Oel, The Netherlands
Huib
Van Vliet, The Netherlands
Jantien Visser, The
Netherlands
Kirsten Vogelsong, USA
Dilys Walker,
USA
Carolyn Westhoff, USA
Mark Wildhagen, The
Netherlands
Hajo Wildschut, The
Netherlands
Shangchun Wu, China
Zou Yan,
China
Mingming Zhang, China
The following people
are contributing to protocols not yet published in the
Cochrane Library:
David Turok et al, USA
Misoprostol
for cervical priming prior to IUD insertion in nulliparous
women
Handsearchers:
Susan
Carr, UK
Nancy Graham, UK
David Grimes, USA
Nancy
Kennedy, Australia
Laureen Lopez, USA
Pauline McGough,
UK
Marjan Loep, The Netherlands (passed away February
2005)
Paul O'Brien, Ireland
Peer Referees:
Jeff
Andrews, USA
Lisa Askie, Australia
Pim Assendelft,
The Netherlands
Catherine d' Arcangues, France
Richard
Anderson, UK
Toni Belfield, UK
Jesse Berlin,
USA
Alison Bigrigg, UK
Michel Boulvain,
Belgium
Walli Bounds, UK
Peter Bowen Simpkins, UK
Lynn
Borgatta, USA
Vivian Brache, Dominican Republic
Sharon
Cameron, UK
Linan Cheng, China
Christine Clar,
Germany
Kurus Coyaji, India
John Collins, USA
Ton
de Craen, The Netherlands
Mitch Creinin, USA
Miriam
Cremer, USA
Kathryn Curtis, USA
Phil Darney, USA
Sally
Davies, UK
Olaf Dekkers, The Netherlands
Cor De Kroon,
The Netherlands
Alba DiCenso, Canada
Alison Edelman,
USA
Lindsay Edouard, Canada
Jan Jaap Erwich, The
Netherlands
Tim Farley, UK
Paul Feldblum, USA
Marcus
Filshie, UK
Ian Fraser, Australia
Mary Lyn Gaffield,
USA
Sandra Garcia, Mexico
David Griffin, UK
David
Grimes, USA
John Guillebaud, UK
Metin Gulmezoglu,
Turkey
Jennifer Hayes, USA
Neveen Hamdy, UK
Johan
Hamerlynck, Belgium
David Handelsman, Australia
Philip
Hannaford, UK
Tim Hargreave, UK
David Healy,
Australia
Frans Helmerhorst, The Netherlands
Paula
Hillard, USA
Justus Hofmeyr, South Africa
Kristine
Hopkins, USA
Pak Chung Ho, Hong Kong
Victoria
Jennings, USA
Frank Willem Jansen, The Netherlands
Jeff
Jensen, USA
Ad Kaptein, The Netherlands
Nathalie Kapp,
USA
Andrew Kaunitz, USA
Marc Keirse, Belgium
Kathy
Kennedy, USA
Jos Kleinen, The Netherlands
Cor de
Kroon, The Netherlands
Ali Kubba, UK
Regina Kulier,
Austria
Miriam Labbok, USA
Conchita Le Fur,
UK
Patricia Lohr, USA
Laureen Lopez, USA
Tapani
Luukkainen, Finland
Nandita Maitra, India
Alex
Macario, USA
Evan Maijo-Wilson, USA
Mike Mbizvo,
Zimbabwe
Susan McIntyre, USA
Olav Meirik,
Norway
Suneeta Mittal, India
John Newton, UK
Mark
Nichols, USA
Kerstin Nilsson, Sweden
Paul O'Brien,
Ireland
David Paintin, UK
Bert Peterson, USA
Kresten
Rubeck Petersen, Denmark
Amy Pollack, USA
Marius
Rademaker, New Zealand
Ann Robbins, USA
Cecilia Pyper,
UK
Jasper Radder, The Netherlands
Tina Raine,
USA
Michael Rosenberg, USA
Patrick Rowe, UK
Sam
Rowlands, UK
Lale Say, Turkey
James Shelton, USA
Erik
Schaff, USA
Ken Schulz, UK
James Scott, USA
James
Shelton, USA
Nick Simpson, UK
Phillip Stubblefield,
USA
Allan Templeton, UK
James Trussell, USA
David
Turok,USA
Jan Vandenbroucke, Belgium
Jos Van
Roosmalen,The Netherlands
Robin Van der Weiden, The
Netherlands
Carla Van der Wijden, The
Netherlands
Christopher Viscomi, USA
Jantien Visser,
The Netherlands
Kirsten Vogelsong, USA
Helena Von
Herzen, Finland
Philip Wiffen, UK
Beverly Winikoff,
USA
Frederick Wu, UK
Special
advisers:
Ward Cates jr., USA
Marc Keirse,
Belgium
Frits Rosendaal, The Netherlands
Felicia
Stewart, USA
James Trussell, USA
Jan Vandenbroucke,
Belgium
Ann Webb, UK
Supporting
Cochrane Centre
Dutch
Cochrane Centre
Acknowledgements
David
Paintin who was a peer reviewer for our group has retired
because of his respectable age.
Marjan
Loep passed away February 5, 2005. Marjan Loep used to work
for the Dutch Cochrane Centre in Amsterdam and was a great
support to all of us in the office in Leiden.
Cochrane
Health Promotion and Public Health Field have awarded a
bursary of Aust.$ 3000 to our reviewer Janet Hiller from
the University of Adelaide to update her review: Education
for contraceptive use by women after childbirth.
Roger
Melet helped us to get the Fertility Regulation Group off
the ground and contributed greatly to the technical
development of the group till August 1998 as our first
group co-ordinator. Marjan Loep from the Dutch Cochrane
Centre has assisted in coordinating work. Clarine van Oel
boosted the methodoligical developments of the group during
the time she was working as review group coordinator.
Editorial
board members Olav Meirik, Alisson Bigrigg, Tina Mackie,
Alba DiCenso and Michel Boulvain discontinued their work.
Their activities for the Fertility Regulation Group are
greatly acknowledged.
To
our great regret we announce that our Honourable
Boardmember Charlotte Ellertson passed away March 2004.
SOURCES
OF SUPPORT
External
World Health Organization (WHO),
Geneva, Switzerland
Ministry of Foreign / Developing
Affairs, The Hague, The Netherlands
Consumer
involvement
Role
of consumers is to
Ensure that work undertaken by the
Cochrane groups have a consumer perspective which brings
knowledge and recognition of consumer issues and concerns
to the Cochrane process in order that information,
research and service delivery result in improved outcomes
for women and men.
Ensure that consumer perspectives
in the Cochrane reviews are known about and influence
future practice through effective and known about
dissemination processes.
Ensure that the consumer
perspective input into the Cochrane process is informed,
is systematic and builds on the work developed and
promoted by the Cochrane Consumer Network.
Involvement
of other users
None
at the moment
Conflict
of interest
General
information and guidelines are described in section 2.1 of
the Cochrane Manual and section 2.2 of the Cochrane
Reviewers' Handbook (in this Library). The Fertility
Regulation Group is an independent group. None of the
sponsors have a direct or indirect influence of the
editorial activities.
The
conflict of interest of the editorial board: F.M.
Helmerhorst has supervised studies sponsored or assigned by
various pharmaceutical companies that manufacture oral
contraceptives. M.Gulmezoglu is working in an international
research institution (WHO), which contributes to the
development and evaluation of fertility regulation methods.
D. Grimes has consulted with or served on a speakers bureau
for Berlex Laboratories, Schmid, ALZA, Ortho-McNeil,
GynoPharma, G.D.Searle and Organon, all of which have
marketed or plan to market IUDs. He served as a
court-appointed expert to the Claimant's Committee in the
A.H. Robins (distributor of the Dalkon Shield) bankruptcy
proceedings.
The
collaborative work up of reviewers, referees and members of
the editorial board and the 'comments and criticism'
section of reviews may prevent conflict of interest. Any
forwarded conflict of interest will be circulated among all
members of the editorial board. Decision of the Board will
be taken by majority. If no majority will be reached, the
Dutch Cochrane Centre will be requested for assistance.
Background
Exploratory
meeting held on 21/22 June 1996
Registration with the
Collaboration on 13 June, 1997 as the Cochrane Fertility
Regulation Review Group.
Name changed from Cochrane
Fertility Regulation Review Group into Cochrane Fertility
Regulation Group in the autumn of 1998.
First Editorial
Board Meeting was held in Amsterdam on October 8, 1997
The
Editorial Board has meetings twice a year.
The
editorial process refers to the refereeing of titles,
protocols and reviews written in the Cochrane Collaboration
format, before they are entered into the Cochrane Database
of Systematic Reviews (CDSR).
It has been established to
produce high quality reviews which are meaningful to both
health care decision makers and the consumers. The process
is designed to be positive, open and interactive with the
aim of modifying and revising protocols/reviews until they
are of a suitable quality for publication Those involved in
the editorial process are members of the editorial team and
external peer reviewers. External peer reviewers are either
members of the Review Group not involved in the review or
people from outside the Review Group. They either have
topical or methodological expertise relevant to the review.
The editorial process differs slightly for each stage of
the review (i.e.title. protocol and review) and they are
detailed separately below. The Fertility Regulation Group
(FRG) decided to bring together the best scientific
evidence available by drawing data from randomized
controlled trials (RCT) where possible, but other types of
evidence derived from observational studies would be taken
into consideration. In the period (until February 2000),
that our Group is waiting for quality control guidelines of
observational studies proclaimed by the Cochrane
Collaboration, reviews based on RCT's are preferable.
Scope
The
Cochrane Group on Fertility Regulation addresses the
process by which people regulate their fertility, family
size and spacing of births.
The Group reviews:
the
effectiveness and safety of fertility regulating methods
(including breast feeding, drugs, devices and termination
of unwanted pregnancy) and procedures
the
delivery of services (effectiveness, accessibility and
acceptability)
how
people obtain and use information
how
people make and implement choices about fertility
regulation and preserve their reproductive health
issues
relating to collaborative decision making and policy
development processes.
Possible
areas of overlap with other CRG's are discussed and
problems are being solved by mutual agreement.
TOPICS
Contraception related
reviews:
General (not specific to one
method)
Methods:
any method vs any other
method
Management issues related to contraceptive use
:
information, counselling
timing
(interval/antenatal/postnatal/postabortion)
materials
used (direct counselling, information)
prescription
policies (over-the -counter, healthworkers)
preprescription
screening (e.g. hypertension, cervical cancer, clotting
defects etc)
Combined contraceptive methods
Methods
type
of estrogen
dose of estrogen
type of progestogens
dose
of progestogens
mono- vs, biphasics vs, triphasics vs
sequential
route of delivery (oral, transdermal, vaginal,
per injection, etc)
regimen (eg 21/7, 22/6, etc pills per
month; 84/7 pills)
Management
Information,
counselling
prescription policies (over-the -counter,
healthworkers)
preprescription screening (e.g.
hypertension, cervical cancer, clotting defects
etc)
management of side effects
Progestogen only
contraceptive methods
Methods
long acting:
implantables
injectable progestogens (different types of
progestogens)
progestogen only pills,
ring
Management
information, counselling
prescription
policies (over-the -counter, healthworkers)
preprescription
screening (e.g. hypertension, cervical cancer, clotting
defects etc)
management of side effects
Intrauterine
devices
Methods
inert
copper
hormonal
impregnated
framed/frameless
Management
information,
counselling
timing of insertion
antibiotics use for
IUD insertion
screening for STIs before IUD
insertion
management of side effects
Barrier
methods
Methods
types
condoms (male/female),
spermicides, diaphragm, cervical caps
Management
information, counselling
side
effects
Natural
methods
Methods
types
Management
information,
counselling
side effects
Female sterilisation
Methods
abdominal /vaginal entry methods
techniques
anaesthetic methods
Management
information,
counselling, consent
side effects; postoperative pain
relief
Male contraceptive
methods
Methods
hormonal
immunological
sterilisation
Management
information,
counselling
side effects
Emergency
contraception
Methods
estrogen/progestogen
progestogen
only
estrogen
only
antiprogestogen
IUD
Management
prescription
policies (over-the-counter, medical prescription, school
nurses)
counselling, information (leaflets, peers
etc)
management of side effects
Contraception in
people with specific characteristics or history of (WHO
Eligibility Criteria (2000) :
diabetes or other
endocrinological disorders
hypertension
thromboembolic
disease
gynaecological cancer
nulliparity
sexworkers
smokers
perimenopausal
adolescents
previous
history of STI
Abortion
related reviews:
First trimester induced abortion
General
Methods
any method vs any other
method
Management issues related to abortion
counselling
and information
on abortion methods
on contraceptive
methods
surveillance and care after the procedure (e.g.
bath)
antibiotic use
oxytocics use
ultrasound
(routine/dates), (before/after)
contraceptive use
(immediate vs delayed/type)
routine counselling by eg.
psychiatrists
Medical vs medical methods for
abortion
Methods
type, dose, route of administration
of medication used
Management
information,
counselling
analgesia used (during/after)
contraceptive
use after (timing, type)
hospital vs home administration
side effects
Medical vs surgical
Methods
type,
dose, route of administration of medical methods
type of
surgical method (aspiration, D&C)
Management
anaesthesia
used
analgesia used (during/after)
side
effects
Surgical vs surgical
Methods
vacuum
aspiration
D&C
combined
manual vacuum
aspiration
ultrasound guided
evacuation
Management
information,
counselling
anaesthesia used
analgesia used
(during/after)
office/vs hospital
antibiotic use
(route/dose/type,/duration of antibiotic)
cervical
ripening (type/route of
administration/dose/timing)
oxytocics use
(during/after)
side effects
Second
trimester induced abortion
General
Methods
any
method vs any other method
Management issues related to
abortion
counselling and information
on abortion
methods
on contraceptive methods
surveillance and
care after the procedure (e.g. bath
routine antibiotic
use
contraceptive use (immediate vs delayed/type)
routine
counselling by eg psychiatrists
side effects
Medical
vs medical methods for abortion
Methods
type, dose,
route of administration of medication
used
Management
information, counselling
analgesia
used (during/after)
contraceptive use after (timing,
type)
hospital vs home administration
ultrasound
(routine/dates), (before/after)
side effects
Medical
vs surgical
Methods
type, dose, route of
administration of medical methods
type of surgical method
(aspiration ( ?), D&C)
Management
information,
counselling
anaesthesia used
analgesia used
(during/after)
side effects
Surgical vs
surgical
Methods
vacuum aspiration
D&C
combined
manual vacuum
aspiration
ultrasound guided
evacuation
Management
information,
counselling
anaesthesia used
analgesia used
(during/after)
office vs hospital
routine
antibiotics
route, dose, type, duration of
antibiotic
cervical ripening (type/route of
administration/dose)
side effects
Glossary
Abortion,
Incomplete
Abortion in which not all the products of
conception have been expelled.
Abortion, Induced
Abortion brought on intentionally.
Abortion,
Legal
Termination of pregnancy under conditions allowed
under local laws. (Popline Thesaurus,1991)
Adnexa
Uteri
Appendages of the uterus: the fallopian tubes,
ovaries and supporting ligaments of the uterus.
Aetiology/Etiology
Looking at the cause and nature of a disease or illness.
Amenorrhea
Abscence of menses for three months or more.
Anovulation
Suspension or cessation of ovulation.
Antibiotics
Chemical substances produced by micro-organisms, that
have the capacity, in dilute solutions, to inhibit the
growth of or to kill other organisms. Antibiotics that are
sufficiently nontoxic to the host are used as
chemotherapeutic agents in the treatment of infectious
diseases of man, animals and plants. (Dorland, 28th ed)
Antibiotic
Prophylaxis
Use of antibiotics before, during or after a
diagnostic, therapeutic or surgical procedure to prevent
infectious complications.
Ampulla
Middle portion of a woman's fallopian tube and in men
the upper end of the vas deferens tube where sperm is
stored.
Barrier
methods
Condoms and diaphragms/pessaries.
Body
Mass Index
One of the anthropometric measures of body
mass; the highest correlation with skinfold thickness or
body density.
Cervix
Bottom part of the uterus situated at the top of the
vagina which opens up to allow the birth of a baby.
Coitus
Sexual intercourse.
Culdoscopy
Endoscopic examination, therapy or surgery of the female
pelvic viscera by means of an endoscope introduced into the
pelvic cavity through the posterior vaginal fornix.
Desogestrel
Third generation progestin belonging to the distinct
class of gonane progestins like norgestrel, levenorgestrel,
gestodene and norgestimate.
Diaphragm
see
Pessaries.
Dilatation
and Curettage
Dilatation of the cervix uteri followed by
a scraping of the endometrium with a curette.
Ectopic
Pregnancy
Development of the fertilized ovum outside the
uterine cavity. (Dorland, 27th ed)
Emergency
Contraception
Contraceptive methods to be used after
coitus.
Endoscopy
Endoscopic examination, therapy or surgery performed on
interior parts of the body.
Ethynodiol
Diacetate
First generation progestin that belongs to the
distinct class of astranes that convert to the biologically
active component norethindrone. Other progestins of this
type include norethindrone, norethindrone acetate and
lynestrenol.
Ethinyl
Estradiol
Semisynthetic estrogen with high oral
estrogenic potency. Often used as the estrogenic component
in oral contraceptives.
Expulsion
IUD
Spontaneous loss of IUD from the uterus.
Fallopian
Tubes
Two long muscular tubes that transport ova from
the ovaries to the uterus. They extend from the horn of the
uterus to the ovaries and consist of an ampulla, an
infundibulum, an isthmus, two ostia and a pars uterina. The
walls of the tubes are composed of three layers: mucosal,
muscular and serosal.
Family
Planning
Programs or services designed to assist the
family in controlling reproduction by either improving or
diminishing fertility.
Female Condoms
Soft loose
fitting poly-urethane sheath, closed at one end with
flexible rings at both ends. The device is inserted into the
vagina by
compresing the inner ring and pushing it in.
Properly positioned, the ring at the closed end covers the
cervix and the sheath lines the walls of the vagina. The
outer ring remains outside the vagina, covering the
labia.(Med Lett Drugs Ther 1993 Dec 24;35(12):123)
Follicle
Stimulating Hormone
Hormone (glycoprotein) produced and
released from the pituitary gland. In women it stimulates
division of granulosa cells inside the follicle, which
produces oestrodiol. In men it stimulates the quality
(motility) of sperm.
FSH
Follicle
Stimulating Hormone.
Gestodene
A
third generation progestin belonging to the distinct class
of gonane progestins like norgestrel, levenorgestrel,
desogestrel and norgestimate.
Hemorrhage
A
significant loss of blood that if severe enough may require
a blood transfusion.
Iatrogenic
A
complication, problem or adverse reaction as a result of
medical treatment.
Intrauterine
Device
Contraceptive device placed high in the uterine
fundus with a string extending from the device through the
cervical as into the vagina. (UMDNS, 1999)
Intrauterine
Device, Copper
IUD with metallic copper.
Intrauterine
Device, Medicated
IUD that releases contraceptive agents.
Intrauterine
System
Medicated or hormone-releasing intrauterine
device.
IUD
Intrauterine
Device.
IUS
Intrauterine
System.
Injectable
Contraception
Long-acting injectable progestational
contraceptive. Originally, depot medroxyprogesterone
acetate. (DMPA)
Lactational
Amenorrhea Method
Method of family planning that provides
more than 98% protection from pregnancy in the first 6
months if a mother fully or nearly fully breastfeeds and
remains amenorrheic.
LAM
Lactational
Amenorrhea Method.
Laparotomy
Surgical incision made into the wall of the abdomen.
Laparoscope
Tube with a light attached to it which is inserted
through a small incision in the abdomen so the outside
surface of the uterus and other parts of a woman's
reproductive system can be examined.
Levonorgestrel
A
second generation progestin that belongs to the distinct
class of gonane progestins like norgestrel, desogestrel,
gestodene, and norgestimate.
LH
Luteinizing
Hormone
A glycoprotein hormone secreted by the pituitary
gland. In women it is responsible for inducing the ovulation
process inside the follicle and thus producing progesterone.
In men it stimulates the production of testosterone and is
involved with the production of sperm cells.
Lynestrenol
A
first generation progestin that belongs to the distinct
class of estranes that convert to the biologically active
component norethindrone. Other progestins of this type
include norethindrone, norethindrone acetate, and ethynodiol
diacetate.
Menarche
The
start of menstrual periods in adolescence.
Menopause
Permanent
cessation of menstruation.
Mestranol
The
methyl ether of ethinyl estradiol. Mestranol must be
converted to the active estrogen, ethinyl estradiol. Data
indicate that 30% is lost in the conversion, making 50
microgram mestranol pills bioequivalent to 35 microgram
ethinyl estradiol. (Wallach and Grimes, Modern Oral
Contraception, 2000)
Midwifery
The
practice of assisting women in childbirth.
Mifepristone
Progesterone
and glucocorticoid antagonist with potential applications in
terminating pregnancy, controlling menstruation and
ovulation.
Myometrium
The
smooth muscle coat of the uterus, which forms the main mass
of the organ.
Norethindrone
A
distinct class of synthetic first generation progestins.
Progestins of this type include norethindrone, norethindrone
acetate, lynestrenol, and ethynodiol diacetate. These
progestins are estranes and convert to the biologically
active component norethindrone.
Norgestrel
A
second generation progestin that belongs to the distinct
class of gonane progestins like levenorgestrel, desogestrel,
gestodene, and norgestimate. Norgestrel is less potent than
levenorgestrel.
Norplant
Subdermal
implant system releasing levenorgestrel.
Oligomenorrhea
Abnormally irregular, less frequent menstruation,
associated with anovulation.
Oral
Contraceptives
Compounds, usually hormonal, taken orally
in order to prevent ovulation and thus the occurrence of
pregnancy. The hormones are primarily a progestogen,
generally combined with an estrogen.
Oral
Contraceptives, Combined
Fixed combination of
progestogens and estrogens.
Oral
Contraceptives, Sequential
Drugs administered orally and
sequentially for contraceptive purposes.
Oral
Contraceptives, Low-dose
Products containing less than
50 microgram ethinyl estradiol.
Oral
Contraceptives, First Generation
Products containing
generally progestogens as lynesterenol or norethisteron,
mostly combined with 50 microgram or more of ethinyl
estradiol.
Oral
Contraceptives, Second Generation
Products containing
progestogens as levenorgestrel, norgestimate, and other
members of the norethindrone family, mostly combined with 30
or 35 microgram ethinyl estradiol.
Oral
Contraceptives, Third Generation
Products containing
progestogens as desogestrel or gestodene mostly combined
with 30 microgram or less ethinyl estradiol.
Pearl
Index
Number of failures per 100 women-years of exposure.
The denominator is the total months or cycles of exposure
from the onset of a method until completion of the study, an
unintended pregnancy, or discontinuation of the method. The
quotient is multiplied by 1200 if the denominator consists
of months or by 1300 if the denominator consists of cycles.
Pelvic
Inflammatory Disease
Infection of the uterus and
fallopian tubes.
Pessary
Instrument placed in the vagina to support the uterus or
rectum or to serve as a contraceptive device. (Dorland, 28th
ed)
PID
Pelvic
inflammatory disease or salpingitis.
Placebos
Pills, injections or treatments missing the active
component of interest, administered to experimental control
groups to correct for nonspecific effects.
Pregnancy
in Adolescence
Pregnancy in women under 19.
Pregnancy
Rate
Ratio of the number of conceptions that occur
during a period to the mean number of women of reproductive
age. (POPLINE Thesaurus, 1991)
Progestasert
See
progesterone-IUD
Progesterone-IUD
Membrane
enclosed reservoir inserted in uterus containing
progesterone; once-a-year contraceptive.
Salpingitis
Inflammation
of the fallopian tubes.
Sepsis
Infection that has spread throughout the body.
Serum
screening
The systematic testing of blood to check for
exposure to disease or the presence of a disorder that can
be detected in the blood.
Spermatocides
/ Spermicides
Chemical substances that are destructive to
spermatozoa used as topically administered vaginal
contraceptives.
Sponge
The
vaginal contraceptive sponge is a sustained-release system
for a spermicide. The sponge also absorbs semen and blocks
the entrance to the cervical canal.
STD
Sexually
Transmitted Diseases.
Subdermal
implants
Long-acting, low-dose, reversible progestin-only
method of contraception for women, consisting of
implantable, subdermal capsules.
Synthetic
Progestational Hormones
Compounds obtained by chemical
synthesis that possess progestational activity, but differ
in structure from naturally occurring progestational
hormones.
Tubal
Patency
The fallopian tubes are intact and unblocked,
thus capable of transporting an ovum from the fimbriae to
the ampulla, sperm from the uterus to the ampulla and a
fertilised ovum to the uterus.
Tubal
Sterilization
Surgical interruption of the fallopian
tube.
Uterine
Cavity
The pelvic space where the uterus is situated.
Uterine
Perforation
Penetration through the uterine wall caused
by trauma, surgery or a weak spot.
Vas
Deferens
A thick-walled tube going from a man's testis
into the ejaculatory duct. This tube carries the sperm from
the epididymis (where sperm is stored and nurtured), to the
penis.
Vasectomy
Surgical
removal of the ductus deferens, or a portion of it. It is
done in association with prostatectomy, or to induce
infertility. (Dorland, 28th ed)
Specialised
register
Inclusion
criteria
A
trial should be included in the Register if, on the basis of
the best available information, it is judged that the
individuals ( or other units) followed in the trial were
definitely or possibly assigned prospectively to one of two
(or more) alternative forms of health care using, random
allocation or some quasi-random method of allocation (such
as alternation, date of birth, or case record number).
In
addition:
If one or more outcomes were assessed using
"double blinding" or "double masking"
such that neither the participant/patient nor the assessor
was aware of the intervention received, but randomization is
not mentioned explicitly in the text, a trial should be
included.
Crossover trials, in which patients have been
assigned to the first intervention using random or
quasi-random allocation, should be included.
Reports of
trials dealing only with animals should not be
included.
Units of randomization may be individuals,
groups (such as communities or hospitals), organs or other
parts of the body.
A report of a randomized trial should
be included even when no results are presented or when
results are limited to the analyses of baseline variables.
Each
trial report is downloaded from CENTRAL/Cochrane Controlled
Trials Register and is checked initially to assess whether
it falls into the scope of the Fertility Regulation Group.
The title and abstract of the trial report is retrieved and
assessed to ascertain whether it is identifiable as a
randomized or quasi-randomized controlled trial according to
the criteria described above. If it is, then it is included
in the Specialized Register. If the abstract is unclear or
unavailable, then the full report is obtained and assessed
for possible inclusion.
Search
strategies for the identification of studies
Electronic
searches
CENTRAL/Cochrane Controlled Trials
Register
CENTRAL is the Cochrane Collaboration's internal
register of studies, which may be relevant for inclusion in
Cochrane reviews. Its development is guided by the Trials
Registers Development Group and the first full version was
made available in issue 4 of The Cochrane Library in October
1997. CENTRAL aims to include all relevant reports that have
been identified through the work of the Cochrane
Collaboration. It can be searched by anyone within the
Collaboration needing to identify studies for a Cochrane
review. It is the source from which the Collaboration will
supply public domain databases of trial information such as
The Cochrane Controlled Trials Register and MEDLINE.
Responsibility for the development of CENTRAL/CCTR rests
with an Advisory Group, responsible to the Cochrane
Collaboration Steering Group, which is convened by Kay
Dickersin.
MEDLINE
(1966 - )
The
MEDLINE database is produced by the US National Library of
Medicine. The MEDLINE database is widely recognized as the
premier source for bibliographic and abstract coverage of
biomedical literature. MEDLINE encompasses information from
Index Medicus, Index to Dental Literature, and International
Nursing, as well as other sources of coverage in the areas
of allied health, biological and physical sciences,
humanities and information science as they relate to
medicine and health care, communication disorders,
population biology, and reproductive biology. More than
3,600 journals are indexed, plus selected monographs of
congresses and symposia (1976-1981). Abstracts are included
for about 67% of the records.
There
are several versions of MEDLINE - with different software
for searches - all based on the same database. Two different
search strategies are listed below: one using OVID (paid
access ), the other using PubMed (free access). The search
strategy for identifying possible randomized controlled
trials was initially devised for OVID by Carol Lefebvre and
Steve McDonald (UK Cochrane Centre) and is extended with the
search for 'volunteers' in abstract and title. The OVID
search strategy is still preferred to the search strategy
for PubMed. The PubMed search strategy is described in:
Nixon S, O'Brien K, Glazier RH, Wilkins AL. Aerobic exercise
interventions for people with HIV/AIDS (Cochrane Review).
In: The Cochrane Library, Issue 2, 2001. Oxford: Update
Software), and was adapted from Robinson (Robinson KA,
Hinegardner PG, Lansing P. Development of an optimal search
strategy for the retrieval of controlled trials using
PubMed. Poster presented at: 6th International Cochrane
Colloquium, Oct 22-26, 1998, Baltimore, MD. with minor
additions from Fraser (Fraser C, Thomson-O'Brien MA.
Identifying non-randomized studies in MEDLINE. Poster
presented at: 6th International Cochrane Colloquium, Oct
22-26, 1998, Baltimore, MD.)
Search
strategy for MEDLINE: generic part for randomized controlled
and controlled clinical trials
MEDLINE (OVID; paid
access)
1.randomized controlled trial.pt.
2.controlled
clinical trial.pt
3.randomized controlled
trials.sh
4.random allocation.sh
5.double-blind
method.sh
6.single-blind method.sh
7.clinical
trial.pt
8.exp clinical trials/
9.(clin$ adj25
trial$).ti,ab
10.((singl$ or doubl$ or trebl$ or tripl$)
adj25 (blind$ or
mask$)).ti,ab
11.placebos.sh
12.placebo$.ti,ab
13.random$.ti,ab
14.research
design.sh
15.volunteer$.ti,ab
16.latin
square.tw
17.cross-over
studies.sh
18.crossover.tw
19.cross-over.tw
20.animal.sh
21.human.sh
22.20
not 21
23.or/1-19
24.23 not 22
PubMed
(free:
http://www.ncbi.nlm.gov/PubMed/)
((((((((((((((((((((((((
"randomized
controlled trials"[MESH:noexp] OR
"random
allocation"[MESH:noexp]) OR
"double-blind
method"[MESH:noexp]) OR
"single-blind
method"[MESH:noexp]) OR
"clinical
trials"[MESH]) OR
"placebos"[MESH:noexp])
OR
"research design"[MESH:noexp])
OR
"comparative study"[MESH:noexpl])
OR
"evaluation studies"[MESH]) OR
"follow-up
studies"[MESH:noexpl]) OR
"prospective
studies"[MESH:noexpl]) OR
"cross-over
studies"[MESH:noexpl]) OR
"intervention
studies"[MESH:noexpl]) OR
"randomized
controlled trial"[pt]) OR
"controlled clinical
trial"[pt]) OR
"clinical trial"[pt])
OR
"clinic* trial*" [title/abstract word])
OR
(((("singl*"[title/abstract word] OR
"doubl*"[title/abstract word]) OR
"tripl*"[title/abstract word]) OR
"trebl*"[title/abstract word]) AND
("blind*"[title/abstract word] OR
"mask*"[title/abstract word])) OR
"placebo*"
[title/abstract word]) OR
"random*"[title/abstract
word]) OR
"latin square"[title/abstract word])
OR
"control*"[title/abstract word])
OR
"prospectiv*"[title/abstract word])
OR
"volunteer*"[title/abstract word]) NOT
("animal"[MESH] NOT "human"[MESH]))
EMBASE
(1980 - )
In addition to Central/CCTR and MEDLINE, EMBASE
(the Excerpta Medica database produced by Elsevier Science)
should be searched. EMBASE is a major biomedical and
pharmaceutical database indexing over 3,500 international
journals in the following fields: drug research,
pharmacology, pharmaceutics, toxicology, clinical and
experimental human medicine, health policy and management,
public health, occupational health, environmental health,
drug dependence and abuse, psychiatry, forensic medicine,
and biomedical engineering/instrumentation.
Search
strategy for EMBASE: Generic part for randomized controlled
and controlled clinical trials
EMBASE (Ovid)
1.clinical
article/
2.clinical study/
3.clinical
trial/
4.controlled study/
5.randomized controlled
trial/
6.major clinical study/
7.double blind
procedure/
8.multicenter study/
9.single blind
procedure/
10.phase 3 clinical study/
11.phase 4
clinical study/
12.crossover
procedure/
13.placebo/
14.or/1-13
15.allocat$.ti,ab
16.assign$.ti,ab
17.blind$.ti,ab
18.((clinic$
adj25 (study or
trial)).ti,ab
19.compar$.ti,ab
20.control$.ti,ab
21.cross?over.ti,ab
22.factorial$.ti,ab
23.follow?up.ti,ab
24.placebo$.ti,ab
25.prospectiv$.ti,ab
26.random$.ti,ab
27.((singl$
or doubl$ or trebl$ or tripl$) adj25 (blind$ or
mask$).ti,ab
28.trial.ti,ab
29.(versus or
vs).ti,ab
30.or/15-29
31.14 or
30
32.human/
33.nonhuman/
34.animal/
35.animal
experiment/
36.33 or 34 or 35
37.32 not 3
38.31 not
36
39.31 and 37
40.38 and 39
Additional
Electronic Databases
CINAHL
(1982 - )
The Cumulative Index to Nursing & Allied
Health (CINAHL) database provides authoritative coverage of
the literature related to nursing and allied health.
Virtually all English-language publications are indexed
along with the publications of the American Nurses
Association and the National League for Nursing.
HealthStar
(1975 - )
HealthSTAR contains citations to the published
literature on health services, technology, administration,
and research. It focuses on both the clinical and
non-clinical aspects of health care delivery.
PsycINFO
(1887 - )
The PsycINFO and PsycLIT databases cover the
professional and academic literature in psychology and
related disciplines including medicine, psychiatry, nursing,
sociology, education, pharmacology, physiology, linguistics,
and other areas. Coverage is worldwide, and includes
references and abstracts to over 1300 journals (and in
PsycINFO, to dissertations) in more than 30 languages, and
to book chapters and books in the English language. Over
50,000 references are added annually. Popular literature is
excluded.
POPLINE
(1970 - ), free access: http://igm.nlm.nih.gov/
POPulation
information onLINE provides worldwide coverage of
population, family planning, and related health issues,
including family planning technology and programs,
fertility, and population law and policy. In addition,
POPLINE focuses on particular developing-country issues
including demography, AIDS and other sexually transmitted
diseases, maternal and child health, primary health care
communication, and population and environment. POPLINE
citations are searchable with POPLINE keywords as well as
MESH headings. The file is produced by the Population
Information Program at the Johns Hopkins School of Public
Health. The database is funded primarily by the United
States Agency of International Development.
Search
strategies for the identification of studies
Electronic searches
The
following search strategy has been designed to search
CENTRAL/Cochrane Controlled Trials Register published in The
Cochrane Library to identify reports of randomized or
quasi-randomized controlled trials within the scope of
fertility regulation. This search will be run for the first
time in The Cochrane Library, Issue 2, 2001 and thereafter
for each release of The Cochrane Library. All languages will
be included for consideration. The terms in upper case
denote 'controlled vocabulary' or 'Thesaurus' terms, e.g.
MeSH (Medical Subject Headings) applied by indexers of
electronic databases such as MEDLINE and EMBASE to describe
the subject content of each record. The terms in lower case
denote 'free text' or 'textwords' which are used by the
author to describe the subject content of the study. Drug
classes and individual names for contraceptives, including
their proprietary names used in different countries where
known, will be included. This strategy will be
regularly revised
to include the annual revision of MeSH terms to allow for
new terms to be added and existing terms to be changed as
appropriate. Until the New Generation Cochrane Library
version is available, the MeSH terms which have been added
to MEDLINE since 1998 will be included as free text phrases.
#1explode
CONTRACEPTION
#2CONTRACEPTION-BEHAVIOR
#3contracept*
#4explode
FAMILY-PLANNING
#5family planning or planned parenthood
or birth control
#6birth regulat* or population regulat*
or fertility regulat* or birth spacing
#7population
control or fertility control or reproduct*
control
#8pregnan* near (prevent* or interrupt* or
terminat*)
#9POPULATION-CONTROL
#10FAMILY-PLANNING-POLICY
#11explode
CONTRACEPTIVE-DEVICES
#12intrauterine device* or
intra-uterine device* or IUD* or TCu380a or CuT-200 or
Gynefix
#13barrier method* or condom* or vaginal sponge*
or cervical cap*
#14explode
REPRODUCTIVE-CONTROL-AGENTS
#15algestone acetophenide or
neolutin depositum or chlormadinone acetate or luteran or
gestafortin or prostal or cyproterone acetate or andro-diane
or androcur or cyprone or cyprostat or demegestone or
lutionex or desogestrel or marvelon or mercilon or dienogest
or drospirenone or ethinyloestradiol or ethinylestradiol or
progynon-c or estigyn or primogyn-c or estinyl or turisteron
or lynoral or etifollin or ethynodiol diacetate or
lutometrodiol or luteonorm or femulen or etonogestrel or
gestodene or femodene or minulet or lynoestrenol or
orgametril or exluton or exlutona or exlutena or
medroxyprogesterone acetate or depo-provera or depocon or
farlutal or prodafem or provera or depo-ralovera or ralovera
or depo-prodasone or gestoral or prodasone or clinofem or
clinovir or depo-clinovir or g-farlutal or lutoral or
perlutex or petogen or depo-progevera or progevera or
cykrina or gestapuran or prodafem or amen or curretab or
cycrin or mestranol or ortho-novum or norinyl-1 or
mifepristone or mifegyne or nomegestrol acetate or lutenyl
or norethisterone or norethisterone acetate or
norethisterone enanthate or micronovum or primolut-nor or
locilan or micronor or noriday or primolut-n or norlutate or
milligynon or norfor or noristerat or norluten or gestakadin
or sovel or conludag or nur-isterate or mini-pe or menzol or
sh-420 or utovlan or aygestin or nor-qd or norgestimate or
norgestrel or levonorgestrel or dexnorgestrel or microlut or
microval or mirena or norplant or mikro-30 or 28-mini or
levonova or microluton or follistrel or neogest or norgeston
or postinor-2 or ovrette norgestrienone or ogyline or
ormeloxifene or centchroman or progesterone or gestagen or
proluton or progestogel or utrogestan or gesterol or
prometrium or progestasert or progestosol or utrogestan or
esolut or proluton or prontogest or progestan or cyclogest
or cutifitol or progeffik or crinone or testosterone
enanthate
#16ovulat* near (supress* or inhibit* or
prevent*)
#17ABORTION-APPLICANTS
#18explode
ABORTION-INDUCED
#19abortion or abortifacient*or
termination or morning after pill or RU-486 or Yuzpe
#20explode STERILIZATION-SEXUAL
#21(female or woman
or women or male or man or men) near sterili*
#22vasectom*
#23SEXUAL-ABSTINENCE
#24periodic*
abstinen* or sexual* abstinen* or coitus interruptus
The
above subject search strategy will be adapted to search
MEDLINE, EMBASE, HealthStar, PsycINFO, CINAHL and POPLINE in
the first instance and full details will be published in
future issues of the Fertility Regulation Group's Module.
Hand searching
The
following journals are being searched prospectively by hand:
Advances
in Contraception (1985-1997 completed by Dutch Cochrane
Centre; 1998- search ongoing)
The Journal of Family
Planning and Reproductive Health Care [formerly Journal of
Family Planning Doctors and British Journal of Family
Planning] (1975-1997 completed; 1998- search
ongoing)
Contraception (1970-1996 completed by Cochrane
Menstrual Disorders Group;1997- search ongoing)
European
Journal of Contraception and Reproductive Health Care (1996-
search ongoing)
The
following journals are newly registered for searching
prospectively by hand:
Family Planning Perspectives
(1969-)
Studies in Family Planning (1963-)
Population
Reports:
Series A Oral Contraceptives (1974-)
Series
B Intrauterine Devices (1973-)
Series C Female
Sterilization (1973-)
Series D Male Sterilization
(1973-)
Series F Pregnancy Termination (1973-)
Series
G Prostaglandins (1973-)
Series H Barrier Methods
(1973-)
Series I Periodic Abstinence (1973-)
Series J
Family Planning Programs (1973-)
Series K Injectables and
Implants (1975-)
Series M Special Topic Monographs
(1977-)
Other strategies
To
identify additional high yield journals to be searched by
hand the following strategies will be carried out:
Search
Ulrich's International Directory of Periodicals by subject
to generate a list of potential journals within the scope of
fertility regulation; search MEDLINE and EMBASE for
randomised controlled trials in these journals and rank them
according to yield to identify priority journals for
immediate searching.
Generate a list of journals
containing the trial reports in the Group's Specialized
Register. Check the Master List of journals being searched
by hand to see if any are not already being searched.
Search
POPLINE for randomised controlled trials and rank results by
journal title. Check the Master List to see if any are not
already being handsearched.
To
identify conference proceedings to be searched by hand the
following strategies will be carried out:
Generate a list
of relevant conferences by asking experts in the field at
which conferences they present their research and identify
the sources in which the meeting/conference abstracts are
published.
Search the British Library Inside (online
database includes information on over 100,000 conference
proceedings worldwide) by subject.
Ensure that all
sections of journals identified for handsearching,
especially supplements, are searched as these are likely to
contain abstracts of trials presented at conferences.
Planned searching
activities
The
above subject search strategy (designed to search the
CENTRAL/Cochrane Controlled Trials Register, published in
The Cochrane Library) will be adapted to search MEDLINE,
EMBASE, PsycINFO, CINAHL and POPLINE in the first instance.
Full details of the search strategies for these databases
will be published in future issues of the Fertility
Regulation Group's Module.
Methods
used in reviews
Search strategies
Access to specialised
register by reviewers
The
Fertility Regulation Group's Specialized Register has been
submitted for the first time for inclusion in The Cochrane
Library, Issue 3, 2001. The Group's Specialized Register
code SR-FERTILREG can be incorporated into a search. The
Trials Search Co-ordinator is happy to help design and run
search strategies for reviewers, particularly on electronic
databases which are not accessible to them. The search
strategy designed to generate the Group's Specialized
Register will be run on each release of The Cochrane Library
and it is intended that trial reports identified in this
way, which are potentially relevant to specific reviewers
undertaking reviews registered with the Fertility Regulation
Group, will be sent to the reviewers concerned.
Additional search
strategies
Reviewers
are advised to:
Search at least Central/ Cochrane
Controlled Trials Register (CCTR), MEDLINE, and EMBASE (for
generic search strategies see the section on Electronic
searches below;
Search any other specialist databases in
their topic area(s) as well as the bibliographies of papers
they acquire. Descriptions of possible valuable databases
are given in the section on electronic searches;
Contact
authors of all trials and/or reviews relevant to their
review topic to request information on any further trials of
which they may be aware, whether unpublished or "on-going";
Contact pharmaceutical industries to request information
on/data concerning trials conducted by them;
Visit our
web site, http://www.medfac.leidenuniv.nl/cochrane/, for
search strategies, useful links, examples of letters to
authors (in the near future);
Ask for help from the
Review Group Coordinator if there are any problems.
Study selection
Reviews should only
include evidence provided by randomised controlled trials
and controlled clinical trials until a new policy regarding
non-randomised evidence is developed. Two reviewers should
independently assess each potentially eligible trial for
inclusion in the review. A third reviewer should be used to
resolve any discrepancies regarding eligibility. Trial
publications should be assessed for eligibility with the
results section (and any other area where results may
appear) masked. Where necessary additional information
should be sought from the principal investigator of the
trial concerned.
Assessment of
methodological quality
Assessment
of methodological quality
Two independent reviewers
should independently assess the methodological quality of
all eligible studies and the level of agreement should be
reported in the review. Any disagreement will be resolved by
discussion with a third reviewer, and any differences in
opinion which can not easily resolved, will be referred to
the editorial team. To enhance the (future) quality of the
systematic reviews, reviewers are encouraged to first pilot
test the assessment of methodological quality on a set of
articles available from the Review Group Co-ordinator.
An
important dimension of study quality relates to the extent
to which systematic error or bias is minimised. In clinical
trials, potential biases fall into four categories, and
should be therefore assessed for all reviews:
Selection
bias: biased allocation to comparison groups
Method of
avoidance: randomisation
Generation of unbiased
allocation sequence:
Adequate: random numbers, drawing
of lots, tossing a coin, shuffling cards, etc.
Inadequate
(possibly related to prognosis): case record number,
date-of-birth, day, week, months of admission
Concealment
of allocation sequence
Adequate (cannot be foreseen):
central randomisation, coding of drugs in pharmacy,
numbered, sealed envelopes, etc
Inadequate (can be
foreseen): open allocation schedules, alternation, unsealed
or non-opaque envelopes, etc.
Performance
bias: unequal provision of care apart from the treatment
under evaluation
Method of avoidance: blinding of care
providers and patients
Adequate
Inadequate
Detection
bias
Method of avoidance: blinding of outcome
assessors
Adequate
Inadequate
Attrition
bias: biased occurrence & handling of protocol
deviations, withdrawals and losses to follow-up
Method of
avoidance: all randomised patients should be included in the
analyses, regardless of their study adherence ('Intention to
treat analysis')
Adequate
Inadequate
If
the article does not contain information to judge the
presence or absence of these biases, the reviewers are
recommended to contact the authors for additional
information. If the authors cannot be contacted or the
information is no longer available, the criteria should be
scored as 'Inadequate'.
The
use of summary scores from quality scales is problematic.
Results depend on the choice of the scale, and the
interpretation of findings is difficult. It is therefore
preferable to examine the influence of individual components
of methodological quality. This is best done using
sensitivity analysis.
For
further information on the assessment of methodological
quality, please refer to Section 6, page 39 - 50, of the
Cochrane Reviewers' Handbook, version 4.1 (updated December
2000), or to chapter 5, page 87 - 108, of Systematic Reviews
in Health Care by M. Egger, G.D. Smith, and D.G. Altman
(eds.), 2001, London: BMJ Publishing Group.
Crossover
and cluster randomised studies should in principle be
included in the systematic review. Standard quality criteria
also apply to these trials. However, reviewers should
consider whether there was a substantial possibility of
carryover between the subsequent conditions in crossover
studies in a sensitivity analysis.
Data collection
At
least two reviewers should independently extract the data.
Reviewers
are asked to record at least the following general data in
addition to the pre-specified variables of interest
(outcomes), using a structured data extraction form. If data
is missing from a trial report the reviewer is encouraged to
contact the original investigator in order to request
additional information.
Identification:
ID
Review
Article
ID database of references
First
author
Year
ID Reviewer
Study
design:
Randomised controlled trial (RCT)
Controlled
clinical trial (CCT)
Cross-over study
Cluster
randomised study
Intervention
Treatment groups
Participants:
Inclusion
criteria
Exclusion criteria
Number
Age
Parity
Social
economical status
Educational level
Ethnicity
Previous
contraceptive method
Health status
Smoking
Body
mass index
Setting:
Country
Location
of care
Methods:
Unit
of allocation
Unit of analysis
Loss to
follow-up
Quality
Generation of unbiased allocation
sequence:
Concealment of allocation sequence
Blinding
of care providers and patients
Blinding of outcome
assessors
Intention to treat analysis
Analysis
Statistical
guidelines are available from the Group's editorial base and
further guidance can be obtained from the statistical
editor.
Statistical guidelines are provided by the Group
and are as follows:
STATISTICAL
GUIDELINES FOR REVIEWERS IN THE FERTILITY REGULATION
GROUP
Introduction
With these guidelines we want to
assist reviewers in making decisions about which are the
most appropriate statistical methods to use. Reviewers
undertaking or updating a Cochrane Review will in future be
asked to follow the guidelines detailed below. If they
choose to use other options, then this must be explicitly
stated in the methods section of the review, and preferably
discussed with the editor. Reviewers should, wherever
possible, seek the advice or help of a statistician before
embarking on a review. They should also use caution when
extracting and interpreting their data, and should work
closely with the editorial group and/or statistician.
These
guidelines attempt to suggest practical strategies for an
initial review of an area. In some cases a fuller analysis
may then be required, perhaps warranting obtaining
individual patient data, or further statistical modelling
involving fairly strong assumptions. However a decision on
whether this effort is warranted can only really be taken
once the initial systematic review is complete.
For
more information on the statistical methods and definitions
of statistical terms used in Cochrane Reviews, please refer
to section eight of the Cochrane Collaboration Handbook for
reviewers
(http://www.cochrane.dk/cochrane/handbook/handbook.htm).
Please
note these guidelines are for assisting people in writing
the text of the review. Users of the Cochrane Library are
able to change the defaults and look at the data in
different ways.
Included
studies
Both RANDOMISED CONTROLLED TRIALS and CONTROLLED
CLINICAL TRIALS (also mentioned as quasi-randomised or
pseudo-randomised; Medline uses the term 'controlled
clinical trials') are eligible for inclusion in the
analyses. Although randomised controlled trials are superior
to controlled clinical trials, reviewers should realise that
they assess the quality of the report and that the
requirements from journals have been changed over time.
Furthermore, for an author who is familiar to the work of
the Cochrane Collaboration it might be better not to respond
to a request for information on randomisation and
concealment of allocation, if this would disqualify their
study. Reviewers should therefore investigate the influence
of this and other indicators of biases (i.e. generation of
unbiased allocation sequence, concealment of allocation
sequence, blinding of care providers and patients, blinding
of outcome assessors, intention-to-treat analysis) on their
outcome measures in sensitivity analyses, and incorporate
these findings in their discussion and conclusions.
Ref:
Meta-analyses involving cross-over trials: methodological
issues. Diana R, Elbourne DR, Altman DG, Higgins JPT, Curtin
F, Worthington HV, Vail A. Int J Epidemiol 2002 (in press).
It
is common in our group to consider discontinuation rates
and/or side effects that were reasons for discontinuation of
contraceptive method. Reviewers should be aware that this
kind of outcome measure is related to loss to follow-up, and
that studies with high loss to follow-up might be the ones
investigating methods with unfavourable user profiles.
Finally,
reviewers should conduct their analyses according to the
intention-to-treat principle by using the original number
randomised to each group, and not the sample size excluding
protocol deviations or those lost to follow-up.
Outcomes
with no data
It is important to state beforehand what
types of outcomes would answer the "real clinical
problem" and, if necessary, to draw attention to the
fact that they have not been measured.
Unit
of measurement problems
In our scope, outcomes may be
registered at the person level, but also at the level of
menstrual cycle. It is often very difficult to convert data
provide by number of menstrual cycles into number of women,
and vice versa.
Effect
measures
Event
data (Dichotomous Data)
Simple binary variables are
common in trials of fertility regulation. In MetaView
several options are available as effect measure. Reviewers
should either use the relative risk or the odds ratio as the
effect measure for dichotomous data:
The RELATIVE RISK
or RISK RATIO (RR): For a single trial, if the outcome in
each group is expressed as a rate, the relative risk is the
ratio of the rate in the experimental group to that in the
control group. RR are more easy to interpret than odds
ratio's, but it affects trial weights in meta-analysis
(independent of sample sizes) if event rates are very
variable across trials, or event rates are very high.
The
ODDS RATIO describes the odds of a patient in the
experimental group having the outcome relative to a patient
in the control group. For rare outcomes, the relative and
the odds ratio are virtually interchangeable, but for more
common outcomes they can be very different. OR are difficult
to interpret, and might be misinterpreted as RR,
consequently overestimates the benefits and harms of an
intervention. If the OR is used, special attention should be
paid to properly explaining any differences. Reviewers may
convert the OR into RR before interpretation of results, or
they may derive the relative odds reductions to use in the
presentation of results.
The PETO ODDS RATIO is an
approximation of the Odds Ratio (OR), and was initially the
only effect measure in MetaView. Now that other methods are
available, Peto-OR should not be used anymore, because the
Peto-OR becomes biased when treatment effects become larger,
or when randomisation is unbalanced.
Some
outcomes take the form of a count. Examples include number
of pregnancies, number of occurrences of a particular side
effect. These should always be defined with respect to a
time period. It may be helpful to specify particular periods
of interest e.g. one week, one month, three months, one year
etc. In practice papers are likely to vary, so it may be
helpful to record the nearest available measure, in the form
AVERAGE NUMBER OF EVENTS PER GROUP, (AVERAGE) PERIOD OF
FOLLOW UP, and then calculate a RATE by dividing the first
by the second. The difference between the groups can then be
summarised, for example by a ratio of rates.
Continuous
data
It is worth documenting (for each group in each
trial, for each time point of interest) the raw mean,
standard deviation and number of observations, eventually
both in women and in menstrual cycles, as well as the
change, standard deviation of the change and the number of
observations (in women as well as in menstrual cycles).
At
each time point of interest, for continuous data the
WEIGHTED MEAN DIFFERENCE should be used whenever outcomes
are measured in a standard way across studies (e.g.
operation time, biochemical parameters). This has the
advantage of summarising results in natural units that are
easily understood (e.g. the mean difference in operation
time between the treatment and control group). If there is
only one study for a particular outcome, then the WEIGHTED
MEAN DIFFERENCE should be used.
Occasionally, it may be
desirable or necessary to summarise results across studies
with outcomes that are conceptually the same but measured in
different ways (e.g. side effects, outcomes measured in
women and menstrual cycles). Under these circumstances
STANDARDISED MEAN DIFFERENCES can be used. However, because
this approach makes it possible to combine the results of
dissimilar studies, reviewers must be particularly cautious
in deciding whether such an analysis makes sense in
interpreting the results.
Reviewers
should be aware of the possibility of skewed data and the
potential problems it presents. To detect skew in
measurements that are always positive divide the mean by the
standard deviation. If the result is less than 1.64 there is
some positive skew. Where there is positive skew, reviewers
should perform sensitivity analyses including and excluding
these trials (see section below on sensitivity analysis).
In many cases, only means and standard errors are
reported. Reviewers can convert standard errors into
standard deviations by using the formula:
Standard
deviation = standard error x square root of n (where n =
group sample size)
Fixed
effect versus random effects
Both the FIXED EFFECT model
and the RANDOM EFFECTS model can be used to analyse the
data. The fixed-effect models assume that all the studies
are estimating the same "true" effect, and that
the variation in effects seen between trials is only due to
chance. The random-effects model assumes that the treatment
effects from individual studies are a random sample from a
"population" of different effect sizes that
follows a normal distribution. There will be almost always
being differences in baseline risk of patients in trials
carried out in different trials and at different times.
Initially, only fixed effect models were available in
MetaView (the estimation of the Peto-OR corresponds to the
fixed effect model). Whether or not to use the fixed or
random effect model is still a matter of ongoing debate.
Reviewers should make a documented choice in their protocol
for one of these. The random effects model will tend to give
a more conservative estimate, but the results from the two
models should basically agree where there is homogeneity
(between studies).
Heterogeneity
An
important component of a systematic review is the
investigation of the consistency of the treatment effect
across trials (heterogeneity). The fixed effect model does
not allow for between trial variations. In the presence of
significant heterogeneity (i.e. the test for homogeneity
results in a p value of 0.05/0.10 or less) the between trial
variation should be acknowledged and this corresponds to the
use of the random effect model. Even when stratifying
reduces heterogeneity, there still will be residual
variation between trials, and this should be included in the
model, although use of this model does not overcome the
problem of heterogeneity. A non-significant test cannot be
interpreted as evidence of homogeneity. Tests of
heterogeneity have low statistical power and may fail to
detect as statistically significant even a moderate degree
of genuine heterogeneity. All reviewers should therefore
consider possible resources of heterogeneity where possible,
through examining whether differences in study results are
related to characteristics of the studies (quality, year of
study, place of study etc.), or specific clinical or
demographic differences between studies. It is advisable to
do a sensitivity analysis, starting by excluding trials of
the poorest quality and see whether homogeneity improves. If
reviewers refrain from pooling, they still need to explore
the sources of heterogeneity as this yields information that
increase our understanding of influential conditions that
modify treatment effects.
Subgroup
analysis
Wherever possible, any hypotheses about
potential subgroups (i.e. different doses of a drug, age
groups) should be stated a priori (in the protocol for the
review). The number of planned subgroup analyses should be
kept to a minimum to avoid spurious findings. Where there is
significant heterogeneity in the results and no subgroup
analysis has been stated a priori, subgroup analysis may be
used, but the results interpreted with caution. Readers
should be informed that the subgroup analysis was done
because of the significant heterogeneity found, not because
of an a priori hypothesis.
Sensitivity
analysis
Once the data has been analysed, reviewers
should consider how sensitive the results are in relation to
the way the analysis was done. The following is a minimum
set of sensitivity analyses that reviewers should perform:
1. Repeat the analysis excluding unpublished studies (if
there were any).
2. Repeat the analysis excluding studies
of the lowest quality (which would have been done already if
there were a heterogeneity problem).
3. If there were one
or more very large studies, repeat the analysis excluding
them to look at how much they dominate the results.
4.
Repeat the analysis excluding other types of studies,
depending on the particular review and the degree to which
there were choices about the inclusion/exclusion criteria
(e.g. with/without trials that had different dosages).
If
there are a reasonable number of studies, a funnel plot
should be drawn to examine the possibility of publication
bias. A funnel plot is a graphical display of sample size
plotted against effect size. A gap on one side of the wide
part of the funnel indicates that some studies have not been
published or located.
These
guidelines were modified from the guidelines developed by
the Menstrual Disorders Group and the Cystic Fibrosis and
Genetic Disorders Group.
Useful
references
L'Abbe KA, Detsky AS, O'Rourke K.
Meta-analysis in clinical research. Annals of internal
medicine 1987; 10: 224-233.
Petitti DB. Meta-Analysis,
and Cost-Effectiveness Analysis. Monographs in Epidemiology
and Biostatistics 1994; 10.
Systematic Reviews in Health
Care by M. Egger, G.D. Smith, and D.G. Altman (eds.), 2001,
London: BMJ Publishing Group.
Reporting of reviews
Still
in progress
Editorial
process
Titles
Titles
must be registered with the editorial base using a standard
form (available at the Editorial Office in Leiden from the
Review Group Co-ordinator Anja Helmerhorst), to prevent
possible wasted time and duplication of effort if more than
one person unknowingly embarks on the same review. The FRG
encourages reviewers to collaborate with at least one other
person, so that there is a mix of content and methodological
expertise. In Leiden at the Editorial Office a database with
collaborators and their interests is maintained. It is also
advisable to involve people from more than one centre.
Reviews must have a nominated contact reviewer who is
responsible for liaising with the editorial team and other
reviewers. All titles will be reviewed by all members of the
editorial team and considered for their potential overlap,
mixture of expertise, feasibility and suitability for a
systematic review. This process should take no longer than
two weeks.Once a title has been approved, it will appear in
the module.
If more than one person proposes to do the
same review the Review Group Co-ordinator will attempt to
establish a collaboration between the parties and will
arbitrate in the case of disagreements.
Protocols must be
delivered within three months of a title being registered.
Titles which have been registered for more than twelve
months, for which protocols have not been forthcoming, are
'de-registered' and become generally available once more for
review by other Group members.
Protocols
The
Group encourages reviewers to attend a workshop on
'Developing a protocol', before commencing work. Reviewers
are also sent 'Practical guidelines for writing a protocol',
when their title is accepted.
At least two
editors/external referees evaluate the protocol using a
refereeing checklist and a form for providing comment. They
are asked to return completed assessments within four weeks.
Comments are forwarded by the review group co-ordinator to
the contact reviewer. Following any necessary revisions, and
after approval by the refereeing editor, protocols are
submitted to the CDSR. Once the protocol has been accepted,
it must be sent to the editorial base electronically (in
Revman).
Reviewers are aware of the identity and contact
details of the editors who comment on their protocols and,
in the event of a difference in opinion, are free to engage
in discussion with them to establish a
solution.
Copy-editing of protocols is done at the
editorial base and reviewers sent are asked to approve the
final version prior to publication on CDSR.
Reviews
should be submitted within twelve months of the protocol
being accepted for publication on CDSR.
Reviews
Reviewers
are sent a copy of 'Practical guidelines for writing a
review', once their protocol has been accepted. Advice on
specific problems/queries is available from the editorial
base. The complete review is forwarded to the editorial team
and evaluated by the same editors/external referees (minimum
2). External referees might be requested for advice when
deemed necessary. The refereeing editor summarises the
comments of the referees and outlines expected revisions. At
this stage editors/external reviewers will randomly check a
sample of the included trials to ensure that data have been
extracted correctly and quality of the included /excluded
studies has been assessed adequately. Following any
necessary revisions and approval by the refereeing editor,
the completed review is submitted to the CDSR. The editorial
process to referee a review takes four weeks; the whole
process from the formal submission of a review, feedback of
comments, making revisions/addressing comments, to receiving
overall editorial approval will take approximately twelve
months. Reviewers are aware of the identity and contact
details of the editors who comment on their reviews and in
the event of a different opinion, are free to engage in
discussion with them to establish a solution. Copy-editing
of reviews is done at the editorial base and reviewers sent
are asked to approve the final version prior to publication
on CDSR.
Updating
Authors
are advised of appropriate trials and are asked to examine
reviews on bienual basis with a view to updating them. If no
new trials have been identified, and no changes are desired
by the editorial base or the reviewer, then the review will
be updated as it stands. If changes are required, reviewers
have nine months in which to update the review. Revised
reviews are edited by a minimum of two editors and a
statistician prior to re-publication. Reviews that include
preliminary data from on-going trials are required to take
subsequent data into account within nine months of the
publication of the data. Revised reviews will be edited by
two editors and a statistician as above.
Reviewers are
free to update reviews more often than once per two years if
they wish.
It is likely that, in the future, reviews will
need to be updated in the light of comments received through
the 'Comments and criticisms' facility on the Cochrane
Library. It is expected that reviewers will be obliged to
provide a response to criticism, and, if significant changes
were made to the review as a result, the revised review
would be subjected to the same editorial requirements as an
updated review.
Publications
The
Fertility Regulation Group publishes a newsletter once a
year for their reviewers, peer reviewers, handsearchers,
special advisers, their funding agencies and their editors.
Persons who are interested in receiving the newsletter
should contact the editorial office in Leiden.
References
Still
in progress
Additional information
LINKS
WITH OTHER COLLABORATIVE REVIEW GROUPS:
Menstrual
Disorders and Subfertility Group ( Paul O'Brien )
Pregnancy
and Childbirth Group ( Frans Helmerhorst )
CO-PUBLICATION
Reviewers
may wish to seek co-publication of Cochrane Reviews in
peer-reviewed medical journals, particularly in those
journals that have expressed enthusiasm for co-publication
of Cochrane Reviews.
For
the Cochrane Collaboration, there is one essential condition
of co-publication: Cochrane Reviews must remain free for
dissemination in any and all media, without restriction from
any of them. To ensure this, Cochrane reviewers grant the
Collaboration world-wide licences for these activities, and
do not sign over exclusive copyright to any journal or other
publisher. A journal is free to request a non-exclusive
copyright that permits it to publish and re-publish a
review, but this cannot restrict the publication of the
review by the Cochrane Collaboration in whatever form the
Collaboration feels appropriate.
Reviewers
are strongly discouraged from publishing Cochrane Reviews in
journals before they are ready for publication in CDSR. This
applies particularly to Centre directors and editors of
Review Groups. However, journals will sometimes insist that
the publication of the review in CDSR should not precede
publication in print. When this is the case, reviewers
should submit a review for publication in the journal after
agreement from their CRG editor and before publication in
CDSR. Publication in print should not be subject to lengthy
production times, and reviewers should not unduly delay
publication of a Cochrane Review either because of delays
from a journal or in order to resubmit their review to
another journal. Journals can also request revision of a
review for editorial or content reasons. External peer
review provided by journals may enhance the value of the
review and should be welcomed. Journals generally may
require shorter reviews than those published in CDSR.
Selective shortening of reviews may be appropriate, but
there should not be any substantive differences between the
review as published in the journal and CDSR.
If
a review is published in a journal, it should be noted that
a fuller and maintained version of the review is available
in CDSR. Typically, this should be done by including a
statement such as the following in the introduction: 'A more
detailed review will be published and updated in the
Cochrane Database of Systematic Reviews.Reference'.
The
reference should be to the protocol for the review published
in CDSR. A similar statement should be included in the
introduction if a review is published in CDSR prior to
publishing a version of the review in a journal. After a
version of a Cochrane Review has been published in a
journal, a reference to the journal publication must be
added under the heading.
'Other
published versions of this review'.
Reviewers are also
encouraged to add the following statement to versions of
Cochrane Reviews that are published in journals.
'A
version of this review has been published in The Cochrane
Library. Cochrane systematic reviews are regularly updated
to include new research, and in response to comments and
criticisms from readers. If you wish to comment on this, or
other Cochrane reviews of interventions for XXX, please send
it to XXX'.
Review
Groups may wish to establish a policy on the person to whom
comments should be sent. Reviewers whose primary affiliation
is a Cochrane entity should include the following sentence
when publishing an article that is not about the Cochrane
Collaboration or does not reflect official policy:
"The
views expressed in this article represent those of the
authors and are not necessarily the views or the official
policy of the Cochrane Collaboration".
In addition,
the following modification of the disclaimer published in
The Cochrane Library should be added to Cochrane Reviews
published in journals.
"The
results of a Cochrane Review can be interpreted differently,
depending on people's perspectives and circumstances. Please
consider the conclusions presented carefully. They are the
opinions of review authors, and are not necessarily shared
by the Cochrane Collaboration."
The passage
below can be provided to journal editors upon submission of
a review for publication, and the letter of submission
should be copied to the CRG editors for information. This
policy and procedure may be new to some journal editors and
may require direct discussion with the journal editor. The
CRG editors should be informed of any problems encountered
in this process. The following passage is suggested for
inclusion in letters of submission to journal editors:
"This systematic review has been prepared under the
aegis of the Cochrane Collaboration, an international
organisation that aims to help people make well-informed
decisions about healthcare by preparing, maintaining and
promoting the accessibility of systematic reviews of the
effects of healthcare interventions."
The
Collaboration's publication policy permits journals to
publish reviews, with priority if required, but permits the
Cochrane Collaboration also to publish and disseminate such
reviews. Cochrane Reviews cannot be subject to the exclusive
copyright requested by some journals.
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