Intervensjonsstudien "Forebyggelse av lårhalsbrudd". Metode og praktisk gjennomføring

Abstract

<strong><span style="font-family: TimesNewRomanPS-BoldMT;"><span style="font-family: TimesNewRomanPS-BoldMT;"><p align="left"> </p><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Bakgrunn</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p><p align="left"><span style="font-size: xx-small; font-family: TimesNewRomanPSMT;"><span style="font-size: xx-small; font-family: TimesNewRomanPSMT;">3 </span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">kan forebygge brudd blant sykehjemsbeboere. Her beskrives<p align="left">metoden og den praktiske gjennomføringen av studien.</p></span></span></p><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Metode</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p><p align="left"><span style="font-size: x-small; font-family: Symbol;"><span style="font-size: x-small; font-family: Symbol;">m</span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">g vitamin D daglig som 5 ml tran og kontrollgruppa fikk 5 ml tran der vitamin D var fjernet. Endepunktene<p align="left">var lårhalsbrudd og alle ikke-vertebrale brudd. Et enkelt studieopplegg ble vektlagt. På bakgrunn</p><p align="left">av styrkeberegningen var målsetningen å inkludere ca. 2000 deltakere.</p></span></span></p><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Resultater</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Konklusjon</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p><p align="left"><strong><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;">The intervention study<strong><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;"><p align="left">”Prevention of hip fractures”.</p></span></span></strong></span><strong><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;"><p align="left"> </p></span></strong></span></strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-ItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-ItalicMT;">Nor J Epidemiol </span></span></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">2000; </span></span><strong><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;">10 </span></span></strong><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">(1): 79-85.</span></span></p><p align="left"> </p><strong><span style="font-family: TimesNewRomanPS-BoldMT;"><span style="font-family: TimesNewRomanPS-BoldMT;"><p align="left"> </p><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Background</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p><p align="left"><span style="font-size: xx-small; font-family: TimesNewRomanPSMT;"><span style="font-size: xx-small; font-family: TimesNewRomanPSMT;">3 </span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">can prevent such<p align="left">fractures. Here we present the method and the implementation of the study.</p></span></span></p><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Method</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p><p align="left"><span style="font-size: x-small; font-family: Symbol;"><span style="font-size: x-small; font-family: Symbol;">m</span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">g vitamin D daily in 5 ml cod liver oil for 2 years and the control group received 5 ml cod liver oil<p align="left">without vitamin D. The endpoints were hip fractures and all non-vertebral fractures. It was considered</p><p align="left">important to use a trial that the nursing homes would find easy to implement. According to power calculation</p><p align="left">the aim was to include about 2000 participants.</p></span></span></p><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Results</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left">Conclusion</p></span></span></em></strong></span><strong><em><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldItalicMT;"><p align="left"> </p></span></em></strong></span><p align="left"> </p></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: The participation was lower than expected as recruiting nursing homes and nursing home<p align="left">residents posed considerable difficulty. However, the great majority of the ward staff at the participating</p><p>wards did not find the intervention demanding. A total of 1144 was included in the study.</p></span></span></strong></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: A total of 1144 residents from 51 nursing homes (of 106 invited) in Oslo, Lier and Bergen participated.<p align="left">The participation rate at the individual nursing home varied from 3 to 57%. The participants were</p><p align="left">85 years old and 3/4 were women. Mean calcium intake from cheese and milk was 450 mg/day, more than</p><p align="left">40% used a vitamin D supplement while only 3% used a calcium supplement. 1/3 of the participants completed</p><p align="left">the 2 years intervention, about 1/3 finished the intervention before 2 years because of death and 1/3</p><p align="left">finished before 2 years of other causes. The great majority of the wards did not find the intervention</p><p align="left">demanding.</p></span></span></strong></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: A randomised, double-blinded, controlled trial in nursing homes. The intervention group received<span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left">10</p></span></span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left"> </p></span></span></strong></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: Vitamin D deficiency is a potential important risk factor for osteoporotic fractures. We have<span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left">carried out a trial in nursing homes residents to study if supplementation with vitamin D</p></span></span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left"> </p></span></span></span></span><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;">ENGLISH SUMMARY</span></span></strong></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: Deltakelsen var lavere enn forventet idet det var betydelige vansker med å rekruttere sykehjemsbeboere<p align="left">til studien, men de avdelinger som deltok fant gjennomføringen av studien lite arbeidskrevende.</p><p align="left">Totalt ble 1144 inkludert i studien.</p><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left">Kvaavik E, Meyer HE, Smedshaug GB, Falch JA, Tverdal A, Pedersen JI.</p></span></span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left"> </p></span></span></strong></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: I alt 1144 beboere ved 51 sykehjem (av 106 forespurte) i Oslo, Lier og Bergen deltok. Deltakelsen<p align="left">ved de enkelte sykehjem varierte fra 3 til 57% av beboerne. Deltakerne var i gjennomsnitt 85 år og</p><p align="left">3/4 var kvinner. Kalsiuminntak fra ost og melk var i gjennomsnitt 450 mg/dag, 40% brukte vitamin Dtilskudd</p><p align="left">daglig mens 3% brukte kalsiumtilskudd. 1/3 av deltakerne fullførte intervensjonen, ca. 1/3 avsluttet</p><p align="left">før 2 år pga. død og 1/3 avsluttet før 2 år av andre årsaker. De fleste avdelingslederne fant det lite</p><p align="left">arbeidskrevende å gjennomføre intervensjonen.</p></span></span></strong></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: En randomisert, dobbelt blindet, kontrollert studie på sykehjem. Intervensjonsgruppa fikk i 2 år<span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left">10</p></span></span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left"> </p></span></span></strong></em><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;">: Vitamin D-mangel er en potensielt viktig risikofaktor for osteoporotiske brudd. Vi har gjennomført<span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left">en studie for å teste om vitamin D</p></span></span></span><span style="font-size: x-small; font-family: TimesNewRomanPSMT;"><p align="left"> </p></span></span></span></span><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;"><span style="font-size: x-small; font-family: TimesNewRomanPS-BoldMT;">SAMMENDRAG</span></span></strong>

Leder

“…Kvaavik og medforfattere presenterer en intervensjonsstudie hvor hensikten var å studere hvorvidt vitamin D3 kunne forebygge brudd blant sykehjemsbeboere. Resultatene fra forsøket vil bli publisert internasjonalt, men her presenteres metode og erfaringer fra den praktiske gjennomføringen (17). Forfatterne konkluderer med at lederne av sykehjemsavdelingene som deltok i undersøkelsen, fant det lite arbeidskrevende å delta.…”