screening for physical dis - NCBI

prevalence of undetected abnormality, and the physical development of J. RAYMOND GILBERT,*t MD the babies in the two groups was WILLIAM FELDMAN4 MD, FRCP[C] almost identical. The mean scores of LINDA S. SIEGEL,§ PH D the two groups in assessments of DOROTHY-ANNE MILLS,* RN, M H SC mental development, maternal-child CHARLES DUNNETT,t D Sc relations, maternal anxiety and paGREG STODDART,t PH D rental satisfaction with health care were close. The results suggest that the recommended number of wellscientific no find Since we could basis for the 10 well-baby visits baby visits for healthy, low-risk newrecommended in the first 2 years of borns can be reduced to five for life in Ontario, we carried out a children of multiparas and six for randomized trial in 570 healthy, low- children of primiparas. Any additionrisk newborns to determine the effi- al well-baby visits should be schedcacy and safety of decreasing the uled according to the needs and number of scheduled well-baby visits experience of the parents. from 10 to 5. Among the 466 babies still in the trial at the end of the N'ayant pu trouver de fondement study period those in the 10-visit scientifique des 10 consultations group had had a mean of 7.63 sched- p.diatriques de d.pistage recommanuled and 0.26 unscheduled well-baby does en Ontario au cours des 2 visits and those in the 5-visit group premieres ann.es de la vie, nous a mean of 4.77 scheduled and 1.42 avons mend un essai randomis. chez unscheduled well-baby visits. Reduc- 570 nouveau-n.s en bonne sante et . ing the recommended number of vis- faible risque visant . .tablir la sflret. its did not result in an increased et l'efficacit. de r.duire le nombre incidence of illness or an increased des consultations p.diatriques de d.pistage pr.vues de 10 . 5. Parmi les 466 b.b.s qui faisaient encore From the departments of *family medicine, partie des effectifs ii la fin de l'.tude, tclinical epidemiology and biostatistics, and ceux du groupe de 10 consultations §psychiatry, McMaster University, Hamil- avaient eu en moyenne 7,63 consultaton, Ont. tions de d.pistage pr.vues et 0,26 .Head, pediatric medical ambulatory care, consultations de d.pistage non Children's Hospital of Eastern Ontario, Ottapr.vues; pour le groupe de 5 consulwa The following physicians participated in this tations les chiffres correspondants study: Max Beer, Benjamin Carruthers, .taient de 4,77 et 1,42 consultations Larry Cowan, J. Steven Cramer, David Da- respectivement. Le fait de r&luire le vis, Robert Dickson, Thomas Durcan, W. Ian nombre recommand. de consultations Hay, William Kellington, James Kramer, n'a pas entrain. une augmentation Edward Kwong, Mark' Levy, Michael Mills, James Morris, Edward Naganobu, Soo- de Pincidence des maladies ou de la bramani Naidoo, Sheila Paprica, Mostapha prevalence des anomalies passant R. Rifaat, Hendrick Scholtens, John Sellors, inaper.ues. De plus, le d6veloppeJack J. Shekter, Gary Sincerbox and G. ment physique des b6b.s des deux Patrick Sweeny. groupes a . presque identique. Les Reprint requests to: Dr. J. Raymond Gilbert, cotes moyennes chez les deux grouDepartment of family medicine, McMaster University, 1200 Main St. W, Hamilton, Ont. pes des mesures du d.veloppement mental, des relations m.re-enfant, L8N 3Z5

de l'anxi.t. maternelle et de la satisfaction des parents . l'6gard des soins de sante .taient semblables. Ces r.sultats 'montrent que le nombre recommand6 de consultations p6diatriques de d&pistage chez les nouveau-n.s en bonne sante et . faible risque pourrait .tre r.duit . cinq pour les enfants de multipares et ii six pour les enfants de primipares. Toute consultation additionnelle de d&pistage devrait .tre organis& en fonction des besoins et de l'exp&ience des parents.

Well-baby visits have four major purposes: screening for physical disease, screening for disturbances in child-parent relations, immunization and health counselling. The frequency of these visits (Table I), who provides them and what actually occurs during them all vary from country to country. In addition, recommendations as to frequency change over time. In 1977 the American Academy of Pediatrics recommended eight visits over 2 years,4 but it recently proposed a 50% increase in the number of visits for well children aged 1 month to 21 years.5 In Ontario in 1980 the pro-

CAN MED ASSOC J, VOL. 130, APRIL 1, 1984

857

vincial government paid for a maxi* The family was expected to mum of 10 well-baby visits during remain in the study area for at least the first 2 years of life; more recent- 2 years. ly this upper limit has been reMothers of eligible newborns were moved. The Canadian Paediatric informed about the trial and were Society recommends nine visits over invited to participate. 2 years.2 In 1980 we surveyed 180 randomly selected family physicians Maneuver in Ontario and found that they scheduled a mean of 9.3 visits over 2 Babies of consenting mothers years.6 were randomly assigned by a reIt is not known how many parents search assistant to one of two comply with these recommendations groups, one to have 5 well-baby or whether they need to do so. For visits in the first 2 years of life and example, Hoekelman7 reported no one to have 10. For the 5-visit group differences in outcome of three ver- the first visit could be paid when the sus six well-baby visits in the first baby was either 1 or 2 months of year of life. However, this study age, with the remaining 4 visits included two additional visits for scheduled at 4, 6, 13 and 19 months immunizations, and additional of age; the 10-visit group had wellscreening and counselling may have baby visits scheduled at 2 weeks of occurred during these visits. Thus, age and then at 1, 2, 4, 6, 10, 12, 15, Yankauer's8 plea for prospective 18 and 24 months of age. Both groups had free access to additional study of this question still stands. Since we could find no scientific visits for any reason. basis for the 10 well-baby visits allowed in Ontario in 1980 we car- Follow-up ried out a randomized trial to deter- 1' mine the efficacy and safety of deEach baby was followed up for 2 creasing the recommended number years, during which time the family of scheduled well-baby visits in the physician's chart was regularly refirst 2 years of life from 10 to 5. The viewed for well-baby visits, and utinumber 5 was chosen as the mini- lization of other health care services mum number of visits needed to was monitored. The charts were recomplete the necessary immuniza- viewed when the babies were 2, 12, 18 and 24 months of age by research tions. assistants who were unaware of the babies' group assignments and used Methods standardized criteria. Each visit was classified into one of four categories: Criteria for inclusion * Ill-baby visit (an intercurrent illness was diagnosed or treated, or A newborn from a participating both). * Scheduled well-baby visit (the family practice was eligible for the trial if the following criteria were timing of the visit coincided with the met: recommended schedule, and no in* The baby's weight at birth was tercurrent illness was diagnosed or over 2500 g. treated). * The baby was discharged from * Unscheduled well-baby visit hospital within 7 days of birth (ex- (the timing of the visit did not cept when the stay was extended for coincide with the recommended maternal reasons, such as cesarean schedule, yet no intercurrent illness section). was diagnosed or treated, nor was * The baby was signed out as any immunization given).. "normal" by the attending physi* Indeterminate visit (the visit cian. satisfied none of the foregoing crit* The mother's age was between eria). 18 and 40 years. The duration of each well-baby * The mother previously had de- visit to a subset of the family physilivered no more than five living cians was also recorded by the office babies. receptionists. In addition, all illness* The parents were living togeth- es and abnormalities noted in the er at the time of delivery. chart were recorded on a chart re858

CAN MED ASSOC J, VOL. 130, APRIL 1, 1984

view form, and two physicians unaware of the babies' group assignments independently classified each as "major" (if the condition was treatable and, if not diagnosed at an appropriate age, could lead to longterm physical and emotional sequelae) or "minors' (ifotherwise). Thus, strabismus diagnosed in a baby older than 6 months and deformities of the feet or hips that required the use of splints, braces or casts were considered major abnormalities.* Parent-initiated utilization was monitored to document total utilization of health care services by both the 5-visit and 10-visit groups: illbaby contacts (office visits, house calls, consultations, admission to hospital and emergency room visits) for a. babies, plus telephone calls from parents to a subset of the family physicians, were noted. An assessment of the babies was carried out when they were between 24 and 27 months of age. This assessment consisted of a standardized physical examination done by an independent pediatrician who was unaware of the babies' group assignments, and a battery of tests administered in a home visit by study staff who were unaware of the babies' group assignments. These tests included the following: * The Mental Development Index of the Bayley scales of infant development9 (to identify previously undetected developmental problems). * The Home Observation for Measurement of the Environment test'0 (to assess the physical organization and safety of the home, the availability of toys and other play materials, and the degree of maternal involvement with the child). * The Hulka Infancy Questionnaire1' (to assess maternal anxiety). * A standardized questionnaire developed by Hulka to assess parental satisfaction with health care.'2"3

Sample size and statistical analysis The number of babies to be included in this trial was determined on the basis of both pragmatic and scientific requirements; we took into consideration both the logistics of *A list of all the major and minor conditions is available from the authors.

Table Il-Baseline characteristics of 5-visit and 10-visit groups of newborns in southwestern Ontario Characteristic Sex, no. of newborns Male Female Mean weight at birth, kg Mean age of mother, yr Mean no. of living children in family Obstetric status, no. of mothers Primiparous Multiparous Socioeconomic status, no. of families Upper 50% Lower 50% Cesarean births, % Infants breast-fed, % Families visited by public health nurse, %

Table Ill-Reasons for withdrawal from the study* No. of withdrawals

Reason

5-visit group (n = 50)


Move of family from area 22 22 Unwillingness to continue 15 7 Change to pediatrician 6 8 Change of family physician 7 5 Death of infant 0 2 *Five patients in each group were lost to follow-up.



129 140 3.47 27.3 1.88

146 155 3.53 26.9 1.75

110 159

135 166

137 132 15.2 70.9 65.6

146 155 9.6 71.1 64.4

Table tV-Mean number of visits to family physicians and other sources of health care Mean no. of visits Source of health care; category ofvisit



Family physician Scheduled well-baby Unscheduled well-baby Ill-baby Indeterminate Consultants Emergency room Hospital

12.49

14.48 4.77

7.63

1.42 6.09 0.21

0.26 6.54 0.05

1.25

1.15

0.88 0.08

0.93 0.11

Table V-Patients' scores in end-of-study assessments at their homes Mean score ± standard deviation Assessment tool Mental Development Index9 Home Observation for Measurement of the Environment test'0 Hulka Infancy Questionnaire" Questionnaire to assess parental satisfaction with health care'Z'3

5-visit group

10-visit group

124.1 ± 17.2

121.6 ± 17.8

40.0 ± 2.5 13.7 ± 1.2

40.5 ± 3.0 13.8 ± 1.6

1.25 ± 0.69

1.27 ± 0.65

Easytotake References I. HARRIS BT: Health care for young children in Holland, Belgium, and France. JR Coil Gen Pract 1974; 24:676,681-686

2. Report of the Canadian Paediatric Society Task Force on the Periodic Health Examination. Presented at the annual meeting of the Canadian Paediatric Society, Quebec, June 25-29, 1983 3. Great Health Fit for mittee

Britain Committee on Child Services, COURT SDM (chmn): the Future: Report of the Comon Child Health Services,

HMSO, London, 1976

4. American Academy of Pediatrics, committee on standards of child health care: Recommendations for Preventive Health Care of Children and Youth, 3rd ed, Am Acad Pediatr, Evanston, III, 1977

5. HOEKELMAN RA: Well-child visits revisited.AmJDisChildI983; 137: 17-20 6. GILBERT JR. FELDMAN W, MILLS DA, SIEGEL L, DUNNETT CW, STODDART G, DURCAN T: How many well baby visits? A randomized trial in progress. Can Fain Physician 1980; 26: 1178-1181

7. HOEKELMAN RA: What constitutes adequate well-baby care? Pediatrics 1975; 55: 313-326 8. YANKAUER A: Child health supervision

- is it worth it? Pediatrics 1973; 52: 272-279

(enteric-coated ketoprofen)

Piescribing information THERAPEUTIC CLASSIFICATION: Anti-inflammatory agent with analgesic properties. INDICATIONS: Treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis.

CONTRAINDICATIONS: Active peptic ulcers or active inflammatory diseases of the gastrointestinal tract; suppositories should not be used in patients with any inflammatory lesions of rectum or anus, or a recent history of rectal or anal bleeding. Hypersensitivity to the drug. Because of the existence of cross sensitivity, Orudis should not be given to patients in whom acetylsalicylic acid and other non-steroidal anti-inflammatory drugs induce symptoms of asthma, rhinitis or urticaria.

WARNINGS: In pmgnancy - Safety in pregnant or nursing women has not been determined and therefore is not recommended. Pregnant rats who received ketoprofen 6 and 9 mg/kg/day p.o. from day 15 of gestation, showed dystocia and increased pup mortality. In chIldren - The conditions for safe and effective use in children under 12 years of age have not been established and the drug is therefore not recommended in this age group. PRECAUTIONS: Use with caution in patients with a history of gastrointestinal inflammatory disorders or ulceration. Orudis tablets, capsules and suppositories can cause upper gastrointestinal toxicity, including hemorrhage. Suppositories should be given with caution to patients with any rectal or anal pathology. The drug should be given under close medical supervision in patients with impaired liver or kidney function& Orudis may mask signs of infectious diseases. This should be kept in mind so that any delay in diagnosing and treating infection may be avoided.

Use in patients takIng oral antI-

9. BAYLEY N: Bayley Scales of Infant Development, Psychol Corp, New York, 1979 10. BRADLEY RH, CALDWELL B, ELARDO R: Home environment and cognitive development in the first two years: a crosslagged panel analysis. Dev Psychol 1979; 15: 246-250 11. LIPTAK GS, HULKA BS, CASSEL JC:

Effectiveness of physician-mother interactions during infancy. Pediatrics 1977; 60: 186-192 12. ZYZANSKI SJ, HULKA BS, CASSEL JC: Scale for the measurement of "satisfac-

tion" with medical care: modifications in content, format and scoring. Med Care 1974; 12: 61 1-620 13. HULKA BS, KUPPER LL, DALY MB,

CASSEL IC, SCHOEN F: Correlates of satisfaction and dissatisfaction with medical care: a community perspective. Med

Care 1975; 13: 648-658

coagulants: Orudis has been shown to depress platelet aggregation in animals. However, in twenty patients undergoing therapy with coumarin, Orudis failed to demonstrate potentiation of anticoagulant effect. Nevertheless, caution is recommended when Orudis is given concomitantly with anticoagulants. The presence of Orudis and its metabolites in urine has been shown to interfere with certain tests which are used to detect albumin, bile salts, 1 7-ketosteroids or 17hydroxycorticosteroids in urine and which rely upon acid precipitation as an end point or upon color reactions of carbonyl groups. No interference was seen in the tests for proteinuria using Albustix, HemaCombistix or Labstix Reagent Strips.

ADVERSE REACTIONS: GastroIntestInal: they were the most frequently observed and were seen in approximately 22% of patients. Ulceration and gastrointestinal bleeding have been noted in a few patients (approximately 0.8%). Other adverse reactions in order of decreasing frequency were: gastrointestinal pain, nausea, constipation, vomiting, dyspepsia and flatulence, diarrhea, anorexia and bad taste in mouth. Rectal administration was associated with a lower incidence of upper gastrointestinal reactions (12%) with the exception of ulceration, the incidence of which was the same. However, anorectal reactions presenting as local pain, burning, pruritus, tenesmus and rare instances of rectal bleeding occurred in 16.5% of subjects. 5% of patients discontinued rectal therapy because

of these local reactions. Central Nervous System: headache, tatigue, dizziness, tension, anxiety, depression and drowsiness. Skin: rashes, pruritus, flushing, excessive perspiration and loss of hair. Aliergic: urticaria, an. loedema and asthma. Cardiovascular: mild peripheral edema, palpitation and bruising. Auditory system: tinnitus. Mouth: ulcers, sore tongue, inflammation of the mouth and gums.

Laboratory Tests: Abnormal alkaline phosphatase, lactic dehydrogenase, glutamic oxaloacetic transaminase and blood urea nitrogen values were found in some patients receiving Orudis therapy. The abnormalities did not lead to discontinuation of treatment and, in some cases, returned to normal while the drug was continued. There have been sporadic reports of decreased hematocrit and hemoglobin values without progressive deterioration on prolonged administration of the drug.

SYMPTOMS AND TREATMENT OF OVERDOSAGE: Symptoms: At this time, no overdosage has been reported. Treatment: Administer gastric lavage or an emetic and treat symptomatically: compensate for dehydration, monitor urinary excretion and correct acidosis if present.

DOSAGE AND ADMiNiSTRATION: Aduits: Orai: The usual dosage for enteric-coated tablets or capsules is 150 to 200 mg per day in 3 or 4 divided doses. Orudis-E tablets provide an alternative presentation for those who may prefer this dosage form. No difference in toxicity profile was documented. Rectai: Orudis suppositories offer an alternative route of administration for those patients who prefer it. Administer one suppository morning and evening or one suppository at bedtime supplemented as needed by divided oral doses. The total daily dose of Orudis (capsules, tablets and suppositories) should not exceed 200 mg. When the patient's response warrants it, the dose may be decreased to the minimum effective level. In severe cases, during a flare-up of rheumatic activity or if a satisfactory response cannot be obtained with the lower dose, a daily dosage in excess of 200 mg may be used. However, a dose of 300 mg per day should not be exceeded. Chiidren: Orudis is not indicated in children under 12 years of age because clinical experience in this group of patients is insufficient. Avaiiabiiity: Capsules of 50 mg, bottles of 100 and 500. Tablets (enteric-coated) of 50 mg, bottles of 100 and 500. Suppositories of 100 mg, boxes of 30. Store below 30'C. Product information as of Jan. 7,1983.

Product Monograph avaiiabie on request. References 1. Muller-Fassbender, H., et al., XV mt. Con gr. Rheumatol., Paris, 1981

2. Willans, M.J., et al., Curt. That. Res., 25, 1, 35,1979 3. Mitchell, W.S., et al., Curt. Med. Res. Opin., 3, 423,1975 4. Howard, D.L.G., Curt. Ther. Res., 23, 6, 678,1978 5. Russel, A.S., et al., Curt. Ther. Res., 33, 2,1983 6. Gomez, G., Proceedings, VIII Eur. Rheumatol. Congr., Helsinki, June 1975 7. Fujimori, I., et al., Shin Ryo to ShinYaki, 11,101,1974 8. Willans, M.J., et al., Curt. Ther. Res., 31, 6, 913, 1982 9. Fava, G., et al., J. mt. Med. Res., 5, 301, 1977 10. Quenneau, P., et al., Proceedings (Supp.), VIII Eur. Rheumatol. Congr., Helsinki, 1975 *

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