human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: For more than 30 years , there have been concerted efforts internationally to develop the evidence base for brief interventions in general practice 1 . The choice of this setting reflected strategic judgements about where in health systems heavy drinking and alcohol problems were likely to be most encountered and thus where these interventions may be optimally delivered . This literature is usually interpreted along the lines that efficacy is now well established in general practice and that there is a need to extend study to new setting s 2,3 . This year has seen the publication of two large general practice cluster r and omised effectiveness trials that in different ways draw attention to a crucial limitation of the evidence base in this setting ; the lack of well-developed study of intervention content . Although both undertaken in the UK , they are likely to be seen internationally as important studies . The three-arm Screening and Intervention Programme for Sensible drinking ( SIPS ) trial compared a leaflet control condition against the same leaflet plus five minutes advice and the addition subsequently of 20 minutes counselling 4 . Preventing disease through opportunistic , rapid engagement by primary care teams using behaviour change counselling ( PRE-EMPT ) compared training practitioners to address behaviour change for the big four key lifestyle risk factors ( diet , exercise , smoking and alcohol ) versus delayed training , thus entailing a non-intervention control condition 5 . Both trials found no differences in alcohol outcomes for hazardous and harmful drinkers over a 12-month study period following interventions delivery by general practitioners and practice nurses . The authors of these studies identify contrary implication s for practice from these null findings . The SIPS authors conclude that the control condition : ‘ screening followed by simple feedback and written information may be the most appropriate strategy to reduce hazardous and harmful drinking in primary care ’ 4 . One commentator , however , is concerned that this provides : ‘ false reassurance that we have taken care of unhealthy alcohol use and will waste time and money ’ 6 by delivering more time consuming interventions . In contrast , the PRE-EMPT authors , including myself , conclude that : ‘ enduring behaviour change and improvements on biochemical and biometric measures are unlikely after a single routine consultation with a clinician trained in behaviour change counselling , without additional intervention ’ 5 . Attention to the detailed content of the evaluated interventions and consideration of their relationship to the existing general practice literature is necessary for interpreting study findings . Following screening in SIPS , leaflet delivery was accompanied by the st and ard script reproduced in Box 1 ( interested readers are strongly encouraged to examine the study website 7 for detailed information on all interventions ) . It will be seen that the feedback is very brief . The leaflet comprises content on health and social consequences , awareness of units ( st and ard drinks ) , recommendations on daily consumption and where to get help . The advice intervention covers similar material providing additional tips on planning and the benefits of cutting down after being shown that drinking exceeded the majority of the population , without having further dedicated content on decision making , i.e. whether one should cut down 7 . This was based on the Drink-Less material developed approximately 20 years ago , and in SIPS one hour training in delivery was given 7 . The counselling intervention provides quite different material , being influenced by motivational interviewing , and requiring some underst and ing of this approach , though not proficiency in it 7 . Counselling required a return visit to general practice , and just over half took this up 4 . Box 1 . The SIPS control condition ‘ Thank you for taking part in this project . Your screening test result shows that you 're drinking alcohol above safe levels , which may be harmful to you . This leaflet describes the recommended levels for sensible drinking and the consequences for excessive drinking . Take time to read the leaflet . There are contact details on the back [ Indicate where these are ] should you need further help or advice ’ . [ http://www.sips.iop.kcl.ac.uk/pil.php ] PRE-EMPT is a training trial that examined the effects of the ‘ Talking Lifestyle ’ training program on outcomes following a routine practice consultation . This program aims to enhance skills in undertaking behaviour change discussion s 5 . This intervention was thus not specific to alcohol , which may have been discussed only for those screening positive , most likely for those for whom this was their only positive screen . To see the detailed content of the training program visit http://www.3trials.net : login = ku.ca.fc@01tseug , password = guest10 , and then click on the Talking Lifestyles icon . Although there were good levels of engagement with the training program , skill acquisition was sub-optimal even though it was not design ed for advanced practice . The listening skills that are a key feature of motivational interviewing were not included within the training program 5 . Approximately one-third of the trials included within the Cochrane primary care review compared a brief intervention with no intervention ( as in PRE-EMPT ) , and in the other two-thirds the control conditions were the provision of leaflets or usual care in the form of general practitioner ( GP ) advice to cut down ( as in SIPS ) 8 . This review incorporates some emergency room studies as well as those conducted in general practice . Overall evaluated brief interventions were found to be effective in reducing drinking by approximately 38 grams of alcohol per week more than the control conditions 8 . This means that the findings from both SIPS and PRE-EMPT differ from previous studies in ways that remains to be explained , though the existing literature is not straightforward to interpret 9 . Both trials were pragmatic , intended by design to measure real world effectiveness , for which detailed investigation of intervention conduct could have interfered . The slow development of process study 10,11 has previously been widely recognised as a key weakness of this literature ( see , e.g. 2 ) and the corollary to this is that we do not know as much about effective content as we should . As a result , there has been little or no evidence -based innovation in the design of advice interventions . In SIPS , there appears little difference in content between the evaluated leaflet and advice interventions other than in the extent of verbal interaction . Providing relatively patient-centred counselling after this type of advice 7 may not be optimal . As a training trial , the detailed content of the intervention was not the object of evaluation in PRE-EMPT , making it impossible to know how exactly these discussion s were conducted 5 . Counselling that simply calls upon the perspective of motivational interviewing , though does not implement it , as is the case in both trials , may simply not be helpful enough ; non-specific forms of counselling do not have a good track record in this field ( e.g. 12 ) . Brief intervention content research questions are difficult to answer rigorously in pragmatic trials where effects may not survive well the translation into routine practice 6 . This would be true even if the specific content has previously been established as efficacious , which it has not been for brief interventions . It is an interesting possibility that leaflets with SIPS content accompanied by minimal verbal interaction can be effective in their own right and as effective as lengthier discussion s , however unlikely this appears . Brief interventions in routine practice can be very brief 13 , and this SIPS intervention deserves to be evaluated in well- design ed r and omised controlled trials that overcome barriers to interpretation cited by the SIPS authors , such as assessment effects 14 . Saitz 6 suggests that the SIPS trial results are vulnerable to unhelpful interpretations and I suggest this is true of PRE-EMPT too . Applying findings from these studies directly to influence policy and practice is misguided , as they conflict with what was previously known in ways which call for better underst and ing of the literature as a whole . A leaflet and a few words about drinking may well be enough for some , though we have no idea who they are and this is not what the wider literature indicates . It would be inadvisable to expect that anything delivered briefly as an intervention should be effective . There is reason to be concerned that many who might value the opportunity to talk about their drinking , and benefit from so doing , should not be denied that opportunity . It remains to be established which skills practitioners need to have , or how they need to be applied and for how long , in order to be able to discuss drinking or other behaviours in ways which do help people . Brief intervention content matters and we should study it Objective To evaluate the effectiveness of different brief intervention strategies at reducing  hazardous or harmful drinking in primary care . The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking . Design Pragmatic cluster r and omised controlled trial . Setting Primary care practice s in the north east and south east of Engl and and in London . Participants 3562 patients aged 18 or more routinely presenting in primary care , of whom 2991 ( 84.0 % ) were eligible to enter the trial : 900 ( 30.1 % ) screened positive for hazardous or harmful drinking and 756 ( 84.0 % ) received a brief  intervention .  The sample was predominantly male ( 62 % ) and white ( 92 % ) , and 34 % were current smokers . Interventions Practice s were r and omised to three interventions , each of which built on the previous one : a patient information leaflet control group , five minutes of structured brief advice , and 20 minutes of brief lifestyle counselling . Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation . Main outcome measures The primary outcome was patients ’ self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test ( AUDIT ) at six months . A negative AUDIT result ( score < 8) indicated non-hazardous or non-harmful drinking . Secondary outcomes were a negative AUDIT result at 12 months , experience of alcohol related problems ( alcohol problems question naire ) , health utility ( EQ-5D ) , service utilisation , and patients ’ motivation to change drinking behaviour ( readiness to change ) as measured by a modified readiness ruler . Results Patient follow-up rates were 83 % at six months ( n=644 ) and 79 % at 12 months ( n=617 ) . At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions . Compared with the patient information leaflet group , the odds ratio of having a negative AUDIT result for brief advice was 0.85 ( 95 % confidence interval 0.52 to 1.39 ) and for brief lifestyle counselling was 0.78 ( 0.48 to 1.25 ) . A per protocol analysis confirmed these findings . Conclusions All patients received simple feedback on their screening outcome . Beyond this input , however , evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking . Trial registration Current Controlled Trials IS RCT N06145674 CMAJ • MAY 12 , 2009 • 180(10 ) © 2009 Canadian Medical Association or its licensors E47 R and omized trials have traditionally been broadly categorized as either an effectiveness trial or an efficacy trial , although we prefer the terms “ pragmatic ” and “ explanatory . ” Schwartz and Lellouch described these 2 approaches toward clinical trials in 1967 . These authors coined the term “ pragmatic ” to describe trials that help users choose between options for care , and “ explanatory ” to describe trials that test causal research hypotheses ( i.e. , that a given intervention causes a particular benefit ) . We take the view that , in general , pragmatic trials are primarily design ed to determine the effects of an intervention under the usual conditions in which it will be applied , whereas explanatory trials are primarily design ed to determine the effects of an intervention under ideal circumstances . Thus , these terms refer to a trial ’s purpose and , in turn , structure . The degree to which this purpose is met depends on decisions about how the trial is design ed and , ultimately , conducted . Very few trials are purely pragmatic or explanatory . For example , in an otherwise explanatory trial , there may be some aspect of the intervention that is beyond the investigator ’s control . Similarly , the act of conducting an otherwise pragmatic trial may impose some control result ing in the setting being not quite usual . For example , the very act of collecting data required for a trial that would not otherwise be collected in usual practice could be a sufficient trigger to modify participant behaviour in unanticipated ways . Further , several aspects of a trial are relevant , relating to choices of trial participants , health care practitioners , interventions , adherence to protocol and analysis . Thus , we are left with a multidimensional continuum rather than a dichotomy , and a particular trial may display varying levels of pragmatism across these dimensions . In this article , we describe an effort to develop a tool to assess and display the position of any given trial within the pragmatic – explanatory continuum . The primary aim of this tool is to help trialists assess the degree to which design decisions align with the trial ’s stated purpose ( decision-making v. explanation ) . Our tool differs , therefore , from that of Gartlehner and associates in that it is intended to inform trial design rather than provide a method of classifying trials for the purpose of systematic review s. It can , however , also be used by research funders , ethics committees , trial registers and journal editors to make the same assessment , provided trialists declare their intended purpose and adequately report their design decisions . Hence , reporting of pragmatic trials is addressed elsewhere BACKGROUND Some r and omised controlled trials ( RCTs ) done in German-speaking Europe are published in international English- language journals and others in national German- language journals . We assessed whether authors are more likely to report trials with statistically significant results in English than in German . METHODS We studied pairs of RCT reports , matched for first author and time of publication , with one report published in German and the other in English . Pairs were identified from reports round in a manual search of five leading German- language journals and from reports published by the same authors in English found on Medline .  Quality of methods and reporting were assessed with two different scales by two investigators who were unaware of authors ' identities , affiliations , and other characteristics of trial reports . Main study endpoints were selected by two investigators who were unaware of trial results . Our main outcome was the number of pairs of studies in which the levels of significance ( shown by p values ) were disc 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: For more than 30 years , there have been concerted efforts internationally to develop the evidence base for brief interventions in general practice 1 . The choice of this setting reflected strategic judgements about where in health systems heavy drinking and alcohol problems were likely to be most encountered and thus where these interventions may be optimally delivered . This literature is usually interpreted along the lines that efficacy is now well established in general practice and that there is a need to extend study to new setting s 2,3 . This year has seen the publication of two large general practice cluster r and omised effectiveness trials that in different ways draw attention to a crucial limitation of the evidence base in this setting ; the lack of well-developed study of intervention content . Although both undertaken in the UK , they are likely to be seen internationally as important studies . The three-arm Screening and Intervention Programme for Sensible drinking ( SIPS ) trial compared a leaflet control condition against the same leaflet plus five minutes advice and the addition subsequently of 20 minutes counselling 4 . Preventing disease through opportunistic , rapid engagement by primary care teams using behaviour change counselling ( PRE-EMPT ) compared training practitioners to address behaviour change for the big four key lifestyle risk factors ( diet , exercise , smoking and alcohol ) versus delayed training , thus entailing a non-intervention control condition 5 . Both trials found no differences in alcohol outcomes for hazardous and harmful drinkers over a 12-month study period following interventions delivery by general practitioners and practice nurses . The authors of these studies identify contrary implication s for practice from these null findings . The SIPS authors conclude that the control condition : ‘ screening followed by simple feedback and written information may be the most appropriate strategy to reduce hazardous and harmful drinking in primary care ’ 4 . One commentator , however , is concerned that this provides : ‘ false reassurance that we have taken care of unhealthy alcohol use and will waste time and money ’ 6 by delivering more time consuming interventions . In contrast , the PRE-EMPT authors , including myself , conclude that : ‘ enduring behaviour change and improvements on biochemical and biometric measures are unlikely after a single routine consultation with a clinician trained in behaviour change counselling , without additional intervention ’ 5 . Attention to the detailed content of the evaluated interventions and consideration of their relationship to the existing general practice literature is necessary for interpreting study findings . Following screening in SIPS , leaflet delivery was accompanied by the st and ard script reproduced in Box 1 ( interested readers are strongly encouraged to examine the study website 7 for detailed information on all interventions ) . It will be seen that the feedback is very brief . The leaflet comprises content on health and social consequences , awareness of units ( st and ard drinks ) , recommendations on daily consumption and where to get help . The advice intervention covers similar material providing additional tips on planning and the benefits of cutting down after being shown that drinking exceeded the majority of the population , without having further dedicated content on decision making , i.e. whether one should cut down 7 . This was based on the Drink-Less material developed approximately 20 years ago , and in SIPS one hour training in delivery was given 7 . The counselling intervention provides quite different material , being influenced by motivational interviewing , and requiring some underst and ing of this approach , though not proficiency in it 7 . Counselling required a return visit to general practice , and just over half took this up 4 . Box 1 . The SIPS control condition ‘ Thank you for taking part in this project . Your screening test result shows that you 're drinking alcohol above safe levels , which may be harmful to you . This leaflet describes the recommended levels for sensible drinking and the consequences for excessive drinking . Take time to read the leaflet . There are contact details on the back [ Indicate where these are ] should you need further help or advice ’ . [ http://www.sips.iop.kcl.ac.uk/pil.php ] PRE-EMPT is a training trial that examined the effects of the ‘ Talking Lifestyle ’ training program on outcomes following a routine practice consultation . This program aims to enhance skills in undertaking behaviour change discussion s 5 . This intervention was thus not specific to alcohol , which may have been discussed only for those screening positive , most likely for those for whom this was their only positive screen . To see the detailed content of the training program visit http://www.3trials.net : login = ku.ca.fc@01tseug , password = guest10 , and then click on the Talking Lifestyles icon . Although there were good levels of engagement with the training program , skill acquisition was sub-optimal even though it was not design ed for advanced practice . The listening skills that are a key feature of motivational interviewing were not included within the training program 5 . Approximately one-third of the trials included within the Cochrane primary care review compared a brief intervention with no intervention ( as in PRE-EMPT ) , and in the other two-thirds the control conditions were the provision of leaflets or usual care in the form of general practitioner ( GP ) advice to cut down ( as in SIPS ) 8 . This review incorporates some emergency room studies as well as those conducted in general practice . Overall evaluated brief interventions were found to be effective in reducing drinking by approximately 38 grams of alcohol per week more than the control conditions 8 . This means that the findings from both SIPS and PRE-EMPT differ from previous studies in ways that remains to be explained , though the existing literature is not straightforward to interpret 9 . Both trials were pragmatic , intended by design to measure real world effectiveness , for which detailed investigation of intervention conduct could have interfered . The slow development of process study 10,11 has previously been widely recognised as a key weakness of this literature ( see , e.g. 2 ) and the corollary to this is that we do not know as much about effective content as we should . As a result , there has been little or no evidence -based innovation in the design of advice interventions . In SIPS , there appears little difference in content between the evaluated leaflet and advice interventions other than in the extent of verbal interaction . Providing relatively patient-centred counselling after this type of advice 7 may not be optimal . As a training trial , the detailed content of the intervention was not the object of evaluation in PRE-EMPT , making it impossible to know how exactly these discussion s were conducted 5 . Counselling that simply calls upon the perspective of motivational interviewing , though does not implement it , as is the case in both trials , may simply not be helpful enough ; non-specific forms of counselling do not have a good track record in this field ( e.g. 12 ) . Brief intervention content research questions are difficult to answer rigorously in pragmatic trials where effects may not survive well the translation into routine practice 6 . This would be true even if the specific content has previously been established as efficacious , which it has not been for brief interventions . It is an interesting possibility that leaflets with SIPS content accompanied by minimal verbal interaction can be effective in their own right and as effective as lengthier discussion s , however unlikely this appears . Brief interventions in routine practice can be very brief 13 , and this SIPS intervention deserves to be evaluated in well- design ed r and omised controlled trials that overcome barriers to interpretation cited by the SIPS authors , such as assessment effects 14 . Saitz 6 suggests that the SIPS trial results are vulnerable to unhelpful interpretations and I suggest this is true of PRE-EMPT too . Applying findings from these studies directly to influence policy and practice is misguided , as they conflict with what was previously known in ways which call for better underst and ing of the literature as a whole . A leaflet and a few words about drinking may well be enough for some , though we have no idea who they are and this is not what the wider literature indicates . It would be inadvisable to expect that anything delivered briefly as an intervention should be effective . There is reason to be concerned that many who might value the opportunity to talk about their drinking , and benefit from so doing , should not be denied that opportunity . It remains to be established which skills practitioners need to have , or how they need to be applied and for how long , in order to be able to discuss drinking or other behaviours in ways which do help people . Brief intervention content matters and we should study it Objective To evaluate the effectiveness of different brief intervention strategies at reducing  hazardous or harmful drinking in primary care . The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking . Design Pragmatic cluster r and omised controlled trial . Setting Primary care practice s in the north east and south east of Engl and and in London . Participants 3562 patients aged 18 or more routinely presenting in primary care , of whom 2991 ( 84.0 % ) were eligible to enter the trial : 900 ( 30.1 % ) screened positive for hazardous or harmful drinking and 756 ( 84.0 % ) received a brief  intervention .  The sample was predominantly male ( 62 % ) and white ( 92 % ) , and 34 % were current smokers . Interventions Practice s were r and omised to three interventions , each of which built on the previous one : a patient information leaflet control group , five minutes of structured brief advice , and 20 minutes of brief lifestyle counselling . Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation . Main outcome measures The primary outcome was patients ’ self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test ( AUDIT ) at six months . A negative AUDIT result ( score < 8) indicated non-hazardous or non-harmful drinking . Secondary outcomes were a negative AUDIT result at 12 months , experience of alcohol related problems ( alcohol problems question naire ) , health utility ( EQ-5D ) , service utilisation , and patients ’ motivation to change drinking behaviour ( readiness to change ) as measured by a modified readiness ruler . Results Patient follow-up rates were 83 % at six months ( n=644 ) and 79 % at 12 months ( n=617 ) . At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions . Compared with the patient information leaflet group , the odds ratio of having a negative AUDIT result for brief advice was 0.85 ( 95 % confidence interval 0.52 to 1.39 ) and for brief lifestyle counselling was 0.78 ( 0.48 to 1.25 ) . A per protocol analysis confirmed these findings . Conclusions All patients received simple feedback on their screening outcome . Beyond this input , however , evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking . Trial registration Current Controlled Trials IS RCT N06145674 CMAJ • MAY 12 , 2009 • 180(10 ) © 2009 Canadian Medical Association or its licensors E47 R and omized trials have traditionally been broadly categorized as either an effectiveness trial or an efficacy trial , although we prefer the terms “ pragmatic ” and “ explanatory . ” Schwartz and Lellouch described these 2 approaches toward clinical trials in 1967 . These authors coined the term “ pragmatic ” to describe trials that help users choose between options for care , and “ explanatory ” to describe trials that test causal research hypotheses ( i.e. , that a given intervention causes a particular benefit ) . We take the view that , in general , pragmatic trials are primarily design ed to determine the effects of an intervention under the usual conditions in which it will be applied , whereas explanatory trials are primarily design ed to determine the effects of an intervention under ideal circumstances . Thus , these terms refer to a trial ’s purpose and , in turn , structure . The degree to which this purpose is met depends on decisions about how the trial is design ed and , ultimately , conducted . Very few trials are purely pragmatic or explanatory . For example , in an otherwise explanatory trial , there may be some aspect of the intervention that is beyond the investigator ’s control . Similarly , the act of conducting an otherwise pragmatic trial may impose some control result ing in the setting being not quite usual . For example , the very act of collecting data required for a trial that would not otherwise be collected in usual practice could be a sufficient trigger to modify participant behaviour in unanticipated ways . Further , several aspects of a trial are relevant , relating to choices of trial participants , health care practitioners , interventions , adherence to protocol and analysis . Thus , we are left with a multidimensional continuum rather than a dichotomy , and a particular trial may display varying levels of pragmatism across these dimensions . In this article , we describe an effort to develop a tool to assess and display the position of any given trial within the pragmatic – explanatory continuum . The primary aim of this tool is to help trialists assess the degree to which design decisions align with the trial ’s stated purpose ( decision-making v. explanation ) . Our tool differs , therefore , from that of Gartlehner and associates in that it is intended to inform trial design rather than provide a method of classifying trials for the purpose of systematic review s. It can , however , also be used by research funders , ethics committees , trial registers and journal editors to make the same assessment , provided trialists declare their intended purpose and adequately report their design decisions . Hence , reporting of pragmatic trials is addressed elsewhere BACKGROUND Some r and omised controlled trials ( RCTs ) done in German-speaking Europe are published in international English- language journals and others in national German- language journals . We assessed whether authors are more likely to report trials with statistically significant results in English than in German . METHODS We studied pairs of RCT reports , matched for first author and time of publication , with one report published in German and the other in English . Pairs were identified from reports round in a manual search of five leading German- language journals and from reports published by the same authors in English found on Medline .  Quality of methods and reporting were assessed with two different scales by two investigators who were unaware of authors ' identities , affiliations , and other characteristics of trial reports . Main study endpoints were selected by two investigators who were unaware of trial results . Our main outcome was the number of pairs of studies in which the levels of significance ( shown by p values ) were disc 
    Output:
    