Domain	Criteria for judging risk of bias
Random sequence generation relating to selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence	Judgement of 'low risk' if the trial authors described a random component in the sequence generation, e.g. referring to a random‐number table; using a computer random‐number generator; coin‐tossing; shuffling cards or envelopes; throwing dice; drawing of lots; minimisation Judgement of 'high risk' if the trial used a systematic non‐random method, e.g. date of admission; odd or even date of birth; case record number; clinician judgement; participant preference; patient risk factor score or test results; availability of intervention Judgement of 'unclear risk' if there is insufficient information about the sequence generation process to permit judgement of 'low risk' or 'high risk'.
Allocation concealment relating to selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment	Judgement of 'low risk' in studies using: individual randomisation if the trial described allocation concealment as by central allocation (telephone, internet‐based or pharmacy‐controlled randomisation); sequentially‐numbered identical drug containers; sequentially‐numbered, opaque, sealed envelopes cluster‐randomisation if allocation of all cluster units performed at the start of the study and individual participant recruitment was completed prior to assignment of the cluster, and the same participants were followed up over time or individual participants were recruited after cluster assignment, but recruitment carried out by a person unaware of group allocation and participant characteristics (e.g. fall history) or individual participants in intervention and control arms were invited by mail questionnaire with identical information Judgement of 'high risk' in studies using: individual randomisation if investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, e.g. using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes unsealed, non‐opaque, or not sequentially‐numbered; alternation or rotation; date of birth; case record number; or any other explicitly unconcealed procedure cluster‐randomisation if individual participant recruitment was undertaken after group allocation by a person who was unblinded and may have had knowledge of participant characteristics Judgement of 'unclear risk' if insufficient information to permit judgement of 'low risk' or 'high risk'. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definite judgement, e.g. if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed
Blinding of participants and personnel relating to performance bias due to knowledge of the allocated interventions by participants and personnel carrying out the interventions	Judgement of 'low risk' if blinding of participants and personnel implementing the interventions was ensured, and unlikely that the blinding could have been broken but the review authors judge that the outcomes (falls and fractures) are unlikely to be influenced by lack of blinding Judgement of 'high risk' if participants or intervention delivery personnel, or both, were not blinded to group allocation (e.g. exercise intervention), and the outcomes (falls and fractures) are likely to be influenced by lack of blinding Judgement of 'unclear risk' if there is insufficient information to make a judgement of 'low risk' or 'high risk'
Blinding of outcome assessment relating to detection bias due to knowledge of the allocated interventions by outcome assessors	Falls judgement of 'low risk' if outcomes were recorded/confirmed in all allocated groups using the same method and the personnel recording/confirming outcomes were blind to group allocation judgement of 'high risk' if outcomes were not recorded/confirmed in all allocated groups using the same method or the personnel recording/confirming outcomes were NOT blind to group allocation judgement of 'unclear risk' if there is insufficient information to make a judgement of 'low risk' or 'high risk' Fractures: judgement of 'low risk' if fractures were recorded/confirmed in all allocated groups using the same method and fractures were confirmed by the results of radiological examination or from primary‐care case records and the personnel recording/confirming fractures were blind to group allocation judgement of 'high risk' if fractures were not recorded/confirmed in all allocated groups using the same method or the only evidence for fractures was from self‐reports from participants or carers judgement of 'unclear risk' if there is insufficient information to make a judgement of 'low risk' or 'high risk' Hospital admission, medical attention and adverse events: judgement of 'low risk' if requiring hospital admission/medical attention as a result of a fall was recorded/confirmed in all allocated groups using the same method (e.g. from primary‐care records) judgement of 'high risk' if requiring hospital admission/medical attention as a result of a fall was not recorded/confirmed in all allocated groups using the same method (e.g. from primary‐care records) or the only evidence for requiring medical attention was from self‐reports from participants or carers judgement of 'unclear risk' if there is insufficient information to make a judgement of 'low risk' or 'high risk' Health‐related quality of life (self‐reported outcome): judgement of 'low risk' if trial participants were blind to group allocation judgement of 'high risk' if trial participants were not blind to group allocation judgement of 'unclear risk' if blinding was reported and thus trial participants may have been unaware of group
Incomplete outcome data relating to attrition bias due to amount, nature or handling of incomplete outcome data	Judgement of 'low risk' if there are no missing outcome data, or less than 20% of outcome data are missing and losses are balanced in numbers across intervention groups with similar reasons for missing data across groups or missing data have been imputed using appropriate methods Judgement of 'high risk' if greater than 20% of outcome data missing, or reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups, or ‘as‐treated’ analysis done with substantial departure of the intervention received from that assigned at randomisation or potentially inappropriate application of simple imputation Judgement of 'unclear risk' if there is insufficient information to make a judgement of 'low risk' or 'high risk'
Selective outcome reporting relating to bias due to the selective reporting or non‐reporting of findings	Judgement of 'low risk' if the trial reports rate of falls, risk of falls and adverse events (minimum set of expected outcomes) and the prospective trial registration or the study protocol are available and prespecify the same fall outcomes as those in the trial report Judgement of ‘high risk’ if there is evidence of selective outcome reporting, with important disparity between prespecified falls outcomes if the prospective trial registration or the study protocol are available; or the lack of appropriate data for both falls outcomes Judgement of 'unclear risk' if the trial does not report on one or more of the minimum set of expected outcomes or if there is insufficient information to make a judgement of ‘low risk’ or ‘high risk’
Method of ascertaining falls relating to bias in the recall of falls due to unreliable methods of ascertainment	Judgement of 'low risk' if the study used some form of concurrent collection of data about falling, e.g. participants given postcards to fill in daily and mail back monthly, calendar to mark monthly, or more frequent follow‐up by the researchers Judgement of 'high risk' if ascertainment relied on participant recall at longer intervals than one month during the study or at its conclusion Judgement of 'unclear risk' if there was retrospective recall over a short period only, or if the trial authors did not describe details of ascertainment, i.e. insufficient information was provided to allow a judgement of 'low risk' or 'high risk'
Cluster‐randomised trials relating to bias due to factors particular to cluster‐randomised trials	Judgement of ’low risk’ if the study predominantly had the following characteristics: i) individuals were recruited to the trial prior to randomisation of the clusters; ii) baseline comparability of clusters was reported or there was statistical adjustment for baseline characteristics; iii) no loss of clusters or missing outcomes for individuals within specific clusters; iv) clustering is accounted for in the analyses; v) results are comparable with individually‐randomised trials Judgement of ’high risk’ if the study predominantly had the following characteristics: i) individuals were recruited to the trial after the randomisation of the clusters; ii) baseline comparability of clusters was not reported and there was no statistical adjustment for baseline characteristics; iii) loss of entire clusters or missing outcomes for individuals within clusters; iv) no account for clustering in analyses; v) results not comparable with individually‐randomised trials Judgement of ’unclear risk’ if there is insufficient information to make a judgement of ’low risk’ or ’high risk’