[Summary text]
For more information, please see the following refernce:
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older peple in the community. Cochrane Database Syst. Rev. 2012 Sep 12;(9): CD007146.pub3.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: Individuals were included if they were aged 65 and above, were community dwelling, were ambulatory with or without a walking aid, and had visited an ED primarily because of a fall
Excluded criteria: Individuals who fell because of excess alcohol intake or sustained a sudden blow or loss of consciousness or sudden onset of paralysisdue to stroke or an epileptic seizure were excluded. Individuals with a telephone Mini-Mental State Exam-ination (MMSE)20score less than 15 and those who were unable or unwilling to provide consent were excluded, aswere those residing in nursing homes. Individuals who didnot speak Cantonese were excluded for practical reasons.
Pretreatment: Flere havde hip fracture i interventionsgruppen p=0.05, og flere udførte daglig exercise p=0.04
Intervention Characteristics
Intervention
Kontrol
Antal fald (uden bevidsthedstab)
Antal af personer som falder (uden bevidsthedstab)
Fald med fraktur (major injury)
Frygt for fald (FES-I)
Dagligt aktivitetsniveau (accellerometer/skridttæller, PROM)
Livskvalitet
Sponsorship source: This work was supported by a project grant (referencenumber 06070571) from the Health and Medical ResearchFund, Food and Health Bureau, Government of the HongKong Special Administrative Region, People’s Republic of China
Country: Kina
Setting: This was a single-blind, multicenter, randomized, con-trolled trial in three regional acute care hospitals in HongKong: Center A—Queen Mary Hospital, Center B—Prin-cess Margaret Hospital, and Center C—Prince of WalesHospital.
Comments:
Authors name: Mary Man-Lai Chu MBA, ROT
Institution: Department of Occupational Therapy, Queen Mary Hospital, Hong Kong
Email:
Address:
For more information, please see the following refernce:
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older peple in the community. Cochrane Database Syst. Rev. 2012 Sep 12;(9): CD007146.pub3.
For more information, please see the following refernce:
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older peple in the community. Cochrane Database Syst. Rev. 2012 Sep 12;(9): CD007146.pub3.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: community-dwelling people aged 70 andolder living in the City of Whitehorse local governmentarea in metropolitan Melbourne. Eligibility criteria includedliving in one’s own home or apartment or leasing similaraccommodation and permitted to make modifications.
Excluded criteria: Potential participants were excluded if they did not expect to remain in the area for two years (except for short absences); had participated in regular to moderate physical activity with a balance improvement component in the previous two months; could not walk 10-20 metres without rest, help, or having angina; had severe respiratory or cardiac disease; had a psychiatric illness prohibiting participation; had dysphasia; had had recent major home modifications; had an education and language adjusted score > 4 on the short portable mental status questionnaire5 ; or did not have the approval of their general practitioner.
Pretreatment: ingen angivelse af baseline værdier seperat for intervention og kontrol
Intervention Characteristics
Intervention
Kontrol
Antal fald (uden bevidsthedstab)
Antal af personer som falder (uden bevidsthedstab)
Fald med fraktur (major injury)
Frygt for fald (FES-I)
Dagligt aktivitetsniveau (accellerometer/skridttæller, PROM)
Livskvalitet
Sponsorship source: National Health and MedicalResearch Council (Commonwealth Department of Healthand Aged Care), Victorian Department of Human Services(Aged Care), City of Whitehorse, Victorian Health PromotionFoundation, Rotary and the National Safety Council.
Country: Australia
Setting: The study was conducted in the City of Whitehorse, amainly middle class area of Melbourne, the secondlargest city in Australia. Potential participants werepeople aged 70 years and over living in their ownhome.
Comments: Nogle data trukket fra: BMJ. 2002 Jul 20;325(7356):128.Randomised factorial trial of falls prevention among older people living in their own homes.Day L1, Fildes B, Gordon I, Fitzharris M, Flamer H, Lord S.
Authors name: MICHAELP. FITZHARRIS
Institution: Accident Research Centre, Monash University, Victoria 3800, Australia
Email: michael.fitzharris@monash.edu
Address:
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: The subjects were older adults aged 65 years and over recruited through posters, flyers, and websites from the Tokyo metropolitan region. The inclusion criteria were: first time participation in the program; allowed by their primary physician to undergo physical exercise; living in their own residence; and aged of 65 years or older.
Excluded criteria: low cognitive function; demen-tia; and/or poor physical condition such as inability to walk by themselves.
Pretreatment: ingen oplyste
Intervention Characteristics
Intervention
Kontrol
Antal fald (uden bevidsthedstab)
Antal af personer som falder (uden bevidsthedstab)
Fald med fraktur (major injury)
Frygt for fald (FES-I)
Dagligt aktivitetsniveau (accellerometer/skridttæller, PROM)
Livskvalitet
Sponsorship source: This study was funded by the St.Luke’s and TERUMO collaborative fund (2008–2011),Japan
Country: Japan
Setting: Urban community
Comments:
Authors name: Tomoko KAMEI
Institution: College of Nursing, St. Luke’s International Universit
Email:
Address:
Study design: Randomized controlled trial
Study grouping: Crossover
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: people living in the Taranaki region who had recently received government-subsidised home insulation that was retrofitted to their homes. Only individuals who said they intended to live at the house for at least the next 3 years were eligible to participate, because we sought to evaluate the safety benefits of home improvements over a 4-year period. Moreover, we only included owner-occupiers, because people renting houses are a very mobile population in New Zealand,
Excluded criteria: Ikke ekspliciteret.
Pretreatment: ikke angivet baseline værdier
Intervention Characteristics
Intervention
Kontrol
Antal fald (uden bevidsthedstab)
Antal af personer som falder (uden bevidsthedstab)
Fald med fraktur (major injury)
Frygt for fald (FES-I)
Dagligt aktivitetsniveau (accellerometer/skridttæller, PROM)
Livskvalitet
Sponsorship source: The HIPI study is funded by the Health Research Council of New Zealand (HRCNZ).
Country: New Zealand
Setting: The Taranaki region - owner-occupied dwelling constructed before 1980
Comments:
Authors name: Michael D Keall
Institution: Otago University, Wellington,
Email:
Address:
Mette Leth on 27/03/2017 22:32
Outcomes
Jeg er i tvivl om, hvilke outcomes, vi kan bruge her? 1) Data er opdelt i 60-69årige samt lig med/over 70år. Kan vi slå disse grupper sammen? 2) Jeg kan ikke se data opgjort ved henholdvis 6 og 12 mdr. ift. antal fald og antal af personer som falder. Til gengæld opgjort ved 36 måneder., ujusteret. 3) Hvad er antal fald og personer som falder i tabel 3?
Mette Leth on 27/03/2017 22:53
Study Design
Using an electronic coin toss with equalprobability to allocate households to either immediatehome modification (treatment group) or a delay of 3 yearsbefore home modifi cation (control group).
For more information, please see the following refernce:
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older peple in the community. Cochrane Database Syst. Rev. 2012 Sep 12;(9): CD007146.pub3.
For more information, please see the following refernce:
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older peple in the community. Cochrane Database Syst. Rev. 2012 Sep 12;(9): CD007146.pub3.
For more information, please see the following refernce:
Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older peple in the community. Cochrane Database Syst. Rev. 2012 Sep 12;(9): CD007146.pub3.
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: Community-dwelling peopleaged 70 and older residing in the catchment area who hadexperienced one or more falls in the preceding year (definedin this study as ‘‘an unexpected event in which the partic-ipants come to rest on the ground, floor or lower level’’)23could be included
Excluded criteria: People living in nursing or residential homes, thosecurrently receiving OT, or those who had received a falls-specific OT intervention in the preceding year were ex-cluded.
Pretreatment: ingen angivne
Intervention Characteristics
Intervention
Kontrol
Antal fald (uden bevidsthedstab)
Antal af personer som falder (uden bevidsthedstab)
Fald med fraktur (major injury)
Frygt for fald (FES-I)
Dagligt aktivitetsniveau (accellerometer/skridttæller, PROM)
Livskvalitet
Sponsorship source: The Department of Health Re-search Capacity Development Programme provided fellow-ship funding Alison C. Pighills.
Country: UK
Setting: Community-dwelling people - home
Comments:
Authors name: Alison C. Pighills, PhD
Institution: Rehabilita-tion, Bradford and Airedale Community Health Services, Douglas Mill,Bradford BD5 7JR, United Kingdom.
Email:
Address:
Study design: Randomized controlled trial
Study grouping: Crossover
Baseline Characteristics
Intervention
Kontrol
Overall
Included criteria: We recruited participants from a pool of individ-uals aged 65 and older who were currently receiving some form of agency service. All participants were known to the two local public agencies involved in the study and were community-dwelling sen-iors who had significant impairments in ADL.
Excluded criteria: Additional inclusion criteria included the ability to speak English, adequate mobility within the home, and sufficient cognitive capacity to participate in the intervention
Pretreatment: intet angivet
Intervention Characteristics
Intervention
Kontrol
Antal fald (uden bevidsthedstab)
Antal af personer som falder (uden bevidsthedstab)
Fald med fraktur (major injury)
Frygt for fald (FES-I)
Dagligt aktivitetsniveau (accellerometer/skridttæller, PROM)
Livskvalitet
Sponsorship source:
Country: USA
Setting: Community-dwelling - home
Comments:
Authors name: Chava Sheffield, PhD, OTR/L
Institution: Department of Public Policy, University of Maryland, Baltimore County, Baltimore
Email:
Address:
For more information, please see the following refernce:Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older peple in the community. Cochrane Database Syst. Rev. 2012 Sep 12;(9): CD007146.pub3.
Wrong study design
Wrong intervention
Wrong intervention
Wrong intervention
Wrong intervention
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Gillespie et al., 2012
Judgement Comment: Accounting for an estimated overall 30%attrition rate, it was assumed that the intervention andcontrol groups were equivalent in size after using blockrandomization with a random numbers table.
Gillespie et al, 2012
Gillespie et al, 2012
Judgement Comment: fra Day 2002: Participants were randomly assigned by an “adaptive biased coin” technique, rather than simple equiprobable randomisation, to ensure balance of group numbers.4 (computerprogram)
Quote: "Research assistants allocated participants randomly into either the HHMP group or the control group and without the presence of the researchers. Both"
Judgement Comment: ikke angivet hvordan
Quote: "After consent had been obtained, a statistician in the research team generated a randomisation schedule with R version 2.10.0, using an electronic coin toss with equal probability to allocate households to either immediate home modifi cation (treatment group) or a delay of 3 years before home modifi cation (control group)."
Gillespie et al, 2012
Gillespie et al., 2012
Gillespie et al., 2012
Quote: "The computer-generated outcome of randomization"
Quote: "a research assistant, who was not involved in data collection or analysis, randomized participants to immediate intervention or the delayed intervention control group using a Microsoft Excel random number generator."
Gillespie et al., 2012
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Gillespie et al., 2012
Judgement Comment: Central allocation:"Using block randomization (blocks of four), a memberof the research team (MMLC) who was blinded and notinvolved in the screening assessments or any subsequentinterventions or data collection randomized participants toan intervention group (IG) or a control group (CG)."
Gillespie et al, 2012
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Judgement Comment: Central allocation: Participants were then assigned (by computer generated randomisation) to an intervention group by an independent third party via telephone.
Judgement Comment: ikke angivet
Judgement Comment: ikke beskrevet
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Gillespie et al., 2012
Quote: "outcome of randomization was auto- matically e-mailed to an independent person who passed the participant’s case notes on to the contact person for the group to which they had been randomized."
Judgement Comment: Central allocation: Followingconsent to participate, a research assistant, whowas not involved in data collection or analysis,randomized participants to immediate interventionor the delayed intervention control group using aMicrosoft Excel random number generator. Uvist om personale + deltagere kan forudsige randomisering. We removed individuals assigned to the control group whowere in immediate need of services due to ethical considerations.
Gillespie et al., 2012
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Gillespie et al., 2012
Judgement Comment: inkluderede var blindet, men ikke muligt at blinde personale. CG participants received a single visit by a research assistant who had no professional training and no knowledge of fall prevention that lasted approximately 1.5 hours, equivalent to the duration of the home visit in the IG; the research assistants focused on showing concern for participants through conversation. The purpose of the well-wishing visit was to provide an attention control and to ensure that CG participants received the same amount of attention and social interaction as IG participants
Gillespie et al, 2012
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Judgement Comment: ikke muligt
Quote: "The same staff-educators were assigned to both morning and afternoon programs to ensure the same program consistency."
Judgement Comment: ikke muligt at blinde staff
Quote: "We could not achieve masking of the random allocation for household members in the treatment group because modifi cations were made immediately to their homes."
Gillespie et al, 2012
Gillespie et al., 2012
Gillespie et al., 2012
Judgement Comment: Deltagerne er ikke blindet og frygt for fald er primær outcome = meget subjektivt outcome
Judgement Comment: Deltagerne ved, hvilken gruppe de er randomiseret til.For individuals assigned to the delayed intervention control group, the therapists conducted a reassessment 3 months after the initial assessment, followed by the intervention. Therapists could not be blinded to group assignment because they wereboth the assessors and the interventionists.
Gillespie et al., 2012
Detection bias due to knowledge of the allocated interventions by outcome assessors
Gillespie et al., 2012
Judgement Comment: ikke beskrevet om blindet ved fald assessment
Gillespie et al, 2012
Gillespie et al, 2012
Judgement Comment: Fra Day 2002:Participants reported falls using a monthly postcard calendar system to record daily falls outcome. Participants not returning their calendar within five working days of the end of each month, and those recording a fall, were followed up by telephone by a research assistant blinded to group assignment.
Judgement Comment: After random allocation into the groups and before thebeginning of the interventions, the participants receiveda questionnaire by mail to: (i) provide baseline informationon demographics, medical history, risk of falls,and history of falls; (ii) assess their fall preventionawareness; and (iii) assess their perception of homehazards such as features of their home that may causefalls, slips, and trips. Participants of both groups wereasked to keep a self-report falls calendar to record dailyactivities, exercise, food, and fall incidents.
Quote: "The ACC matched participants’ names, dates of birth, and addresses to their claim fi les for unintentional home injuries but was unaware of the random allocation. Coders employed by the study team analysed text descriptions of injuries and were also unaware of the random allocation."
Judgement Comment: ..men fald er selvrapporteret fald og deltagere er ikke blindede
Gillespie et al, 2012
Gillespie et al., 2012
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Judgement Comment: Those assessing the outcome of the trial were blinded togroup assignment.
Quote: "Therapists could not be blinded to group assignment because they were both the assessors and the interventionists."
Gillespie et al., 2012
Attrition bias due to amount, nature or handling of incomplete outcome data
Gillespie et al., 2012
Judgement Comment: højt dropout i fleste hospitaler +50%Selvom der er udført analyser med ITT er det problematis når så højt frafald
Gillespie et al, 2012
Gillespie et al, 2012
Quote: "A total of 1107 participants were randomised with 1090 remaining in the trial after group allocation."
Judgement Comment: lav drop out
Quote: "130 subjects were enrolled and randomly allocated to the HHMP (n = 67) and control (n = 63) groups. In the HHMP group, 11 did not attend sessions regularly and withdrew over the course of the study. From the control group, nine did not attend sessions regularly and withdrew over the course of the study."
Judgement Comment: noget højt drop-out og kun per protokol analyse
Judgement Comment: lille drop out n=78/950
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Quote: "withdrew; 0 lost to follow-up <b>Some follow-up data: 3 died; 1 withdrew; 1 lost to follow-up (provided 11m data)</b> Figure 1. Flow of participants"
Judgement Comment: lille drop out, ok. i øvrigt ITT analyse
Judgement Comment: kun 31 af 46 analyseret (dvs. højt dropout og ikke ITT)
Gillespie et al., 2012
Reporting bias due to selective outcome reporting
Gillespie et al., 2012
Judgement Comment: samme outcomes i method og results
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Judgement Comment: kun på fald, ok hvis ikke ønskes at måle på andet
Judgement Comment: kun ønske om at rapportere fald incidens
Judgement Comment: This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000779279.følger protokol
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Judgement Comment: samme outcomes i method og results.De oplyser ikke trail.gov nr. eller lign, men argumenterer for deres valg af primær og sekundært outcome. Because of a likely rate of 50% of participants falling ina year 24 and allowing for attrition, a sample of 960 peoplewould have been required to power the pilot study on falls.Therefore, falls were selected as a secondary outcome. Fearof falling was chosen as the primary outcome, because it is common in older people with and without a falls history and is reported to be an independent predictor of falls.Data sharing: technical appendix, statistical code,and dataset available from the corresponding authoralison_pighills@health.qld.gov.auAll authors, external and internal, had full access to allof the data in the study (including statistical reports andtables) and can take responsibility for the integrity of thedata and the accuracy of the data analysis.All authors declare that they have no competing interestsand have nothing to declare.The researchers were all independent from the funder.
Judgement Comment: vi skulle kontakte forfattere for at få endpoint, da kun var opgivet som regressionskoeffienter.. men ok, vi fik data..
Gillespie et al., 2012
Bias due to problems not covered elsewhere in the table
Gillespie et al., 2012
Judgement Comment: - recall bias, intet skema som faldoversigt
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Judgement Comment: intet åbenlyst
Judgement Comment: begge grupper får intervention med træning og kostændringer. Derfor ikke sikkert om effekten kun skyldes modifikationer af hjemmet eller interaktion med den anden intervention
Judgement Comment: intet åbenlyst
Gillespie et al, 2012
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Quote: "Yes 40 (63) 67 (84) <b>Participants who adhered to recommendations, n (%) None 12 (30) 8 (12) ÃÃ Partial adherence 18 (45) 39 (60) ÃÃ Full adherence 10 (25) 18 (28) Ã</b> Participants to whom no recommendations"
Judgement Comment: deltagere følger ikke anbefalingerne 100% vi ved derfor ikke om den manglende effekt skyldes dette eller at anbefalingerne ikke har effekt
Quote: "We removed individuals assigned to the control group who were in immediate need of services due to ethical considerations."
Judgement Comment: randomisering bliver brudt interventionsgruppen får dermed flere som har akut brug for intervention og kan have bedre effekt
Gillespie et al., 2012