***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: BACKGROUND Treatment-resistant depression ( TRD ) is an extremely prevalent clinical condition . Although Interpersonal Psychotherapy ( IPT ) is an established treatment for uncomplicated depression , its effectiveness has never before been studied in patients with TRD in real-world setting s. We investigate IPT as an adjunct strategy to treatment as usual ( TAU ) for TRD patients in a pragmatic , r and omized , controlled trial . METHODS A total of 40 adult patients with TRD ( satisfying the criteria for major depressive disorder despite adequate antidepressant treatment ) were recruited from a tertiary care facility for this pragmatic trial and blinded to the evaluator . Patients were r and omized to one of two treatment conditions : ( 1 ) TAU - pharmacotherapy freely chosen by the clinician ( n=23 ) and ( 2 ) TAU+IPT ( n=17 ) . Assessment s were performed at weeks 8 , 12 , 19 and 24 . Changes in the estimated means of the Hamilton Depression Rating Scale score were the primary outcome measure . Secondary outcomes included patient-rated scales and quality of life scales . We used a linear mixed model to compare changes over time between the two groups . RESULTS Both treatments lead to improvements in depressive symptoms from baseline to week 24 with no significant between group differences in either  primary : TAU ( mean difference : 4.57 ; CI95 % : 0.59 - 8.55 ; d=0.73 ) vs. IPT+TAU ( mean difference : 5.86 , CI95 % : 1.50 - 10.22 ; d=0.93 ) or secondary outcomes . LIMITATIONS Our relatively small sample limits our ability to detect differences between treatments . CONCLUSIONS Both treatments lead to equal improvements in depressive symptoms . We found no evidence to support adding IPT to pharmacotherapy in patients with TRD . TRIAL REGISTRATION Clinical Trials.gov-NCT01896349 Background The scale-up of antiretroviral treatment ( ART ) programmes has seen HIV/AIDS transition to a chronic condition characterised by high rates of comorbidity with tuberculosis , non-communicable diseases ( NCDs ) and mental health disorders . Depression is one such disorder that is associated with higher rates of non-adherence , progression to AIDS and greater mortality . Detection and treatment of comorbid depression is critical to achieve viral load suppression in more than 90 % of those on ART and is in line with the recent 90 - 90 - 90 Joint United Nations Programme on HIV/AIDS ( UNAIDS ) targets . The CobALT trial aims to provide evidence on the effectiveness and cost-effectiveness of scalable interventions to reduce the treatment gap posed by the growing burden of depression among adults on lifelong ART . Methods The study design is a pragmatic , parallel group , stratified , cluster r and omised trial in 40 clinics across two rural districts of the North West Province of South Africa . The unit of r and omisation is the clinic , with outcomes measured among 2000 patients on ART who screen positive for depression using the Patient Health Question  naire ( PHQ-9 ) . Control group clinics are implementing the South African Department of Health ’s Integrated Clinical Services Management model , which aims to reduce fragmentation of care in the context of rising multimorbidity , and which includes training in the Primary Care 101 ( PC101 ) guide covering communicable diseases , NCDs , women ’s health and mental disorders . In intervention clinics , we supplemented this with training specifically in the mental health components of PC101 and clinical communications skills training to support nurse-led chronic care . We strengthened the referral pathways through the introduction of a clinic-based behavioural health counsellor equipped to provide manualised depression counselling ( eight sessions , individual or group ) , as well as adherence counselling sessions ( one session , individual ) . The co- primary patient outcomes are a reduction in PHQ-9 scores of at least 50 % from baseline and viral load suppression rates measured at 6 and 12 months , respectively . Discussion The trial will provide real-world effectiveness of case detection and collaborative care for depression including facility-based counselling on the mental and physical outcomes for people on lifelong ART in re source -constrained setting s . Trial registration Clinical Trials.gov ( NCT02407691 ) registered on 19 March 2015 ; Pan African Clinical Trials Registry ( 201504001078347 ) registered on 19/03/2015 ; South African National Clinical Trials Register ( SANCTR ) ( DOH-27 - 0515 - 5048 ) NHREC number 4048 issued on 21/04/2015 OBJECTIVE This r and omized , placebo-controlled study evaluated the efficacy and safety of a fixed dose ( 3mg/day ) and flexible dose ( 3 - 15 mg/day ) schedule of aripiprazole as augmentation therapy in Japanese patients with inadequate response to antidepressant therapy ( ADT ) . METHOD During an 8-week prospect i ve treatment phase , patients experiencing a major depressive episode received clinicians ' choice of ADT . Subjects with inadequate response to ADT were r and omized to receive adjunctive treatment with placebo ( n=195 ) , fixed dose aripiprazole ( n=197 ) or flexible dose aripiprazole ( n=194 ) for 6 weeks . The primary efficacy endpoint was mean change in the Montgomery-Åsberg Depression Rating Scale ( MADRS ) total score from the end of prospect i ve treatment ( baseline ) to the end of r and omized treatment . RESULTS More than 90 % of patients in all treatment groups completed the 6-week double-blind treatment phase . Mean MADRS total score was improved to a significantly greater extent with fixed dose aripiprazole and flexible dose aripiprazole ( -10.5 and -9.6 , respectively ) than with placebo ( -7.4 ) . Aripiprazole was well tolerated . The incidence of akathisia observed in the flexible dose group may relate to a higher prevalence of the CYP2D6(*)10 allele in Asian population s. LIMITATIONS Six weeks of adjunctive treatment is insufficient to draw conclusions about the long-term benefits of aripiprazole . Exclusion of patients with established medical comorbidities does not reflect real-world practice . CONCLUSIONS Aripiprazole augmentation at a fixed or flexible dose was superior to ADT alone and was reasonably well tolerated in Japanese patients with inadequate response to ADT Background Most evidence on the effect of collaborative care for depression is derived in the selective environment of r and omised controlled trials . In collaborative care , practice nurses may act as case managers . The Primary Care Services Improvement Project ( PCSIP ) aim ed to assess the cost-effectiveness of alternative models of practice nurse involvement in a real world Australian setting . Previous analyses have demonstrated the value of high level practice nurse involvement in the management of diabetes and obesity . This paper reports on their value in the management of depression . Methods General practice s were assigned to a low or high model of care based on observed levels of practice nurse involvement in clinical -based activities for the management of depression ( i.e. percentage of depression patients seen , percentage of consultation time spent on clinical -based activities ) . Linked , routinely collected data was used to determine patient level depression outcomes ( proportion of depression-free days ) and health service usage costs . St and ardised depression assessment tools were not routinely used , therefore a classification framework to determine the patient ’s depressive state was developed using proxy measures ( e.g. symptoms , medications , referrals , hospitalisations and suicide attempts ) . Regression analyses of costs and depression outcomes were conducted , using propensity weighting to control for potential confounders . Results Capacity to determine depressive state using the classification framework was dependent upon the level of detail provided in medical records . While antidepressant medication prescriptions were a strong indicator of depressive state , they could not be relied upon as the sole measure . Propensity score weighted analyses of total depression-related costs and depression outcomes , found that the high level model of care cost more ( 95 % CI : -$314.76 to $ 584 ) and result ed in 5 % less depression-free days ( 95 % CI : -0.15 to 0.05 ) , compared to the low level model . However , this result was highly uncertain , as shown by the confidence intervals . Conclusions Classification of patients ’ depressive state was feasible , but time consuming , using the classification framework proposed . Further validation of the framework is required . Unlike the analyses of diabetes and obesity management , no significant differences in the proportion of depression-free days or health service costs were found between the alternative levels of practice nurse involvement Abstract Background Health guidelines are developed to improve patient care by ensuring the most recent and ‘ best available evidence ’ is used to guide treatment recommendations . The National Institute for Health and Care Excellence 's ( NICE 's ) guideline development methodology acknowledges that evidence needed to answer one question ( treatment efficacy ) may be different from evidence needed to answer another ( cost‐effectiveness , treatment acceptability to patients ) . This review uses  counselling in the treatment of depression as a case study , and interrogates the constructs of ‘ best ’ evidence and ‘ best ’ guideline method ologies . Method The review comprises six sections : ( i ) implication s of diverse definitions of counselling in research ; ( ii ) research findings from meta‐analyses and r and omised controlled trials ( RCTs ) ; ( iii ) limitations to trials‐based evidence ; ( iv ) findings from large routine outcome data sets ; ( v ) the inclusion of qualitative research that emphasises service‐user voices ; and ( vi ) conclusions and recommendations . Results Research from meta‐analyses and RCTs contained in the draft 2018 NICE Guideline is limited but positive in relation to the effectiveness of counselling  in the treatment for depression . The weight of evidence suggests little , if any , advantage to cognitive behaviour therapy ( CBT ) over counselling once risk of bias and research er allegiance are taken into account . A growing body of evidence from large NHS data sets also evidence s that , for depression , counselling is as effective as CBT and cost‐effective when delivered in NHS setting s. Conclusion Specifications in NICE 's up date d guideline procedures allow for data other than RCTs and meta‐analyses to be included . Accordingly , there is a need to include large st and ardised collected data sets from routine practice as well as the voice of patients via high‐ quality qualitative research A report of a r and omized , controlled trial ( RCT ) should convey to the reader , in a transparent manner , why the study was undertaken and how it was conducted and analyzed . For example , a lack of adequately reported r and omization has been associated with bias in estimating the effectiveness of interventions ( 1 , 2 ) . To assess the strengths and limitations of an RCT , readers need and deserve to know the quality of its methods . Despite several decades of educational efforts , RCTs still are not being reported adequately ( 3 - 6 ) . For example , a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin-reuptake inhibitors as first-line management strategy for depression found that only 1 ( 0.8 % ) paper described r and omization adequately ( 5 ) . Inadequate reporting makes the interpretation of RCT results difficult if not impossible . Moreover , inadequate reporting borders on unethical practice when biased results receive false credibility . History of CONSORT In the mid-1990s , two independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement ( 7 ) , which was developed by an international group of clinical trialists , statisticians , epidemiologists , and biomedical editors . CONSORT has been supported by a growing number of medical and health care journals ( 8 - 11 ) and editorial groups , including the International Committee of Medical Journal Editors ( ICMJE , also known as the Vancouver Group ) ( 12 ) , the Council of Science Editors ( CSE ) , and the World Association of Medical Editors ( WAME ) . CONSORT is also published in Dutch , English , French , German , Japanese , and Spanish . It can be accessed on the Internet , along with other information about the CONSORT group ( 13 ) . The CONSORT statement comprises a checklist and flow diagram for reporting an RCT . For convenience , the checklist and diagram together are called simply CONSORT . They are primarily intended for use in writing , review ing , or evaluating reports of simple two-group , parallel RCTs . Preliminary data indicate that the use of CONSORT does indeed help to improve the quality of reports of RCTs ( 14 , 15 ) . In an evaluation ( 14 ) of 71 RCTs published in three journals in 1994 , allocation concealment was not clearly reported in 43 ( 61 % ) of the RCTs . Four years later , after these three journals required that authors reporting an RCT use CONSORT , the proportion of papers in which allocation concealment was not clearly reported had dropped to 39 % ( 30 of 77 ; mean difference , 22 % [ 95 % CI of the difference , 38 % to 6 % ] ) . The usefulness of CONSORT is enhanced by continuous monitoring of the biomedical literature ; this monitoring allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items . For example , when Meinert ( 16 ) observed that the flow diagram did not provide important information about the number of participants who entered each phase of an RCT ( enrollment , treatment allocation , follow-up , and data analysis ) , the diagram could be modified to accommo date the information . The checklist is similarly flexible . This iterative process makes the CONSORT statement a continually evolving instrument . While participants in the CON 
    Output:
    
Efficacy and effectiveness research hypothetically use different method ologies , but the efficacy and effectiveness literature s in the treatment of depression were comparable for most of the coded characteristics .