Methods

Randomized controlled trial (RCT), duration of treatment was for a year, followed by one year of follow‐up. Treatment integrity was done by written or recorded sessions, blinding of outcome evaluation was unclear, ITT was not included.

Participants

13 female patients with anorexia nervosa (DSM‐IV)
Mean age 18.1 years (SD 2.4). 5% of those screened were excluded.

Interventions

Self psychological treatment vs cognitive orientation. Both groups had nutritional counselling.

Outcomes

DSM Symptomatology Scare, Eating Attitudes Test (EAT 26), Global Severity Index (GSI) and Selves Questionnaire

Notes

Blinding of the outcome unclear, allocation of concealment not mentioned and specific outcome data was not avalable for anorexia nervosa participants.

Sequence Genereation: The bulimia group was divided into the control, self psychotherapy and cognitive orientation therapy groups, and the anorexia group was divided into the COT and SPT group such that both intervention groups had 17 people and the control group had 10 people: "The 31 bulimic patients were randomly assigned to the three groups in the following numbers: 10 in SPT, 11 in COT, and 10 in C/NC. The 13 anorexic patients were randomly assigned to the two psychological treatment groups: 7 in SPT and 6 in COT. Thus, the total number of patients in each group at the beginning of this study was 17 in SPT, 17 in COT, and 10 in C/NC." ‐ allocation sequence was adequately generated.

Incomplete Outcome Data: Specific outcome data was not made available for anorexia (only mentioned for bulimia). There was no explanation given as to why. Numbers were given for drop‐outs, but no explanations: "Finally, one of the inherent problems with treatment studies is dropout. We know that the dropouts in the present study did not differ on any of the sociodemographic data or on the baseline of any of the outcome measures. But we do not know whether they have gone elsewhere for therapy or whether they differed on a crucial and yet unquantifiable measure of willingness to be cured. The dropout rate in our sample was 25%." ‐ incomplete outcome data was not completely addressed.

Selective Outcome Reporting: Considerable attrition of data, no explanations given for drop‐outs. There was also no ITT. Also, as mentioned previously, specific outcome data was omitted for anorexia.There was no reporting of potential conflicts of interest: "We did not implement an intent‐to‐treat analysis because the dropouts in our study left within the first few sessions of the therapy, which lasted one year." There was also bias in the selection stradegy in that subjects were "from families belonging to the upper middle class" even though "The target population for this study consisted of all the bulimic and anorexic patients who were referred to the eating disorder units of the psychiatry departments of two general hospitals in Israel" (at least mentions the area from which subjects were selected. There were no inclusion and exclusion criteria for subjects detailed in this paper ‐ the lack of ITT in particular is indicative of selective outcome reporting. Also, the attrition of anorexia data could be indicative of this.

Risk of bias ‐ present

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

RCT of a treatment for 19 anorexia nervosa and 13 bulimia nervosa patients. Randomization by computer generation and allocations were kept in sealed envelopes. No comparative data of treatment outcome is presented for active and control groups in the published paper but this was supplied later by the authors. Cisapride was administered to seven anorexia nervosa patients. Four patients were treated as inpatients for between 8 and 30 days. It was unclear if outcome ratings were blind to group status.

Participants

19 patients with anorexia nervosa (DSM‐IV). Median age was 16 (range 10‐33). 19 of 47 screened (40%) participated.

Interventions

The treatment incorporated computer supported feedback to participants on satiety ratings. The approach was predomiantly nutritional and behavioural.Controls were placed on a wait‐list of variable duration (7.1‐21.6 months).

Outcomes

Remission (defined as no longer meeting criteria for an eating disorder). Body weight, psychiatric profile and laboratory tests were normal. Patients had to state food and dieting were no longer problems and they were back in school or professional activites.

Notes

Data as to the numbers of anorexia nervosa patients assigned to active treatment and control groups (10 and 8 respectively) was provided by the authors.

Sequence Generation: "We used a computer‐generated randomization list to assign patients to treatment or deferred treatment. Randomization was done in blocks of four consecutive patients at the time of the initial evaluation." ‐ the allocation sequence was adequately generated.

Allocation concealment: "Treatment allocations were kept in numbered sealed envelopes." ‐ allocation was adequately concealed.

Blinding: It was unclear if outcome ratings were blind to group status. ‐ Treatment allocation was adequately blinded but it was unclear whether outcome ratings were blind to group status.

Incomplete Outcome Data: No comparative data of traetment outcome is presented for active and control groups in the published paper: There was very little detail presented in this regard; only a graph comparing the control to the active treatment group only in terms of percentage of group in remission. ‐ incomplete outcome data was not adequately addressed.

Selective Outcome Reporting: Authors did not give comprehensive details on the selection strategy of subjects (specifically the area from which they were picked). Inclusion criteria was given as a reference to the Diagnostic and Statistical Manual of Mental Disorders(DSM)‐IV). No comparative data of traetment outcome is presented for active and control groups in the published paper: There was very little detail presented in this regard; only a graph comparing the control to the active treatment group only in terms of percentage of group in remission: ‐ it is possible that there was selective outcome reporting.

Risk of bias ‐ present

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized controlled trial (RCT), duration of treatment was 6 months and follow‐up was one year. All treatment sessions were audiotaped, outcome evaluation was not blind, ITT by withdrawals followed up and included in analysis.

Participants

24 female patients with anorexia nervosa (Russell's 1983 criteria) Mean age 23.84 years. 29% of those screened were excluded.

Interventions

Cognitive behavioural therapy vs behavioural therapy vs specialist eclectic therapy.

Outcomes

BMI, Morgan and Russell interview and Self report measures of Eating Disorders Inventory (EDI), Beck Depression Inventory (BDI), Maudsley Obsessive‐ Compulsive Inventory and preferred weight.

Notes

Sequence allocation: "Restricted randomisation was made in blocks of six, so that equal numbers of Ss were entered into each group after every six referrals." The sequence allocation was not adequately described.

Blinding: Outcome evaluation was not blind. No mention of any other blinding.

Incomplete Outcome Data: "There were no dropouts in the cognitive‐behavioural group. One subject in the behavioural group and two in the control treatment dropped out during the 12‐month follow‐up period, but were seen at the appropriate assessment intervals and included in the analysis." There was no reason given for this drop‐out. ITT by withdrawals followed up and included in analysis (information given by authors on request). Incomplete outcome data was adequately addressed.

Selective Outcome Reporting: Authors gave sufficient detail on where patients came from and the inclusion criteria for subjects in this study which reducing the risk of selective outcome reporting. "The Ss were a series of female outpatients from the Eating Disorders Clinic of the Maudsley Hospital, London, who were referred for the trial during the 15month intake period, and who met Russell's (1983) diagnostic criteria for anorexia nervosa. Patients with bulimic features were accepted only if they also met the diagnostic criteria for anorexia nervosa. There was no selection for the amount of treatment received prior to acceptance into the trial. Thirty‐four patients were referred for an initial assessment, and 24 of these met the admission criteria for the trial."
Transparency about sources of support (reduces risk of bias). "Acknowledgements‐The authors wish to express their gratitude to Professor Gerald Russell, in whose unit this study was carried out for his help and encouragement; and the Bethlem‐Maudsley Research Fund. for a generous grant that supported the study."
There is a very small risk of selective outcome reporting in this study.

Risk of bias ‐ present

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized controlled trial (RCT), duration of treatment was for a year, no follow‐up reported beyond this, treatment was closely supervised but integrity not formally assessed, outcome evaluation was not blind, ITT by estimation of outcome.

Participants

84 (two men) with anorexia nervosa (DSM‐IV) Mean age 26.3 years and all >18 years.

Interventions

Focal psychoanalytic psychotherapy (1 year) vs cognitive analytic therapy (7 months) vs Family therapy (1 year) vs routine treatment (1 year). 'Routine treatment' was a low‐contact management, the usual practice of an eating disorder service in which specialist treatments are not used. Therapist were mid‐level trainee psychiatrists who changed rotations each 6 months. Sessions were 30 minutes with weekly supervision over one year. Therapy included psycho‐education, supportive encouragement towards a more healthy diet, and regular monitoring of weight and physical state.

Outcomes

Morgan and Russell interview and BMI

Notes

The CAT was not 'purely' individual in that it included some contact between parents and/or the partner of the patient, and their relationship to the therapy and patient was a topic of treatment.

Sequence generation: “A stratified randomization procedure – the minimization method (Pocock 1983) was used to control for the age of onset and the duration of the illness, the presence of bulimic symptoms and marital status.” ‐ allocation sequence was adequately generated.

Allocation concealment: no method of allocation concealment mentioned.

Blinding: Subjects were blinded to which treatment group they would join, but at follow up the patients experiences of therapy were explored at the end of the interview, so they were no longer blinded (outcome evaluation not blind).: “The initial assessment was blind to the treatment to which the patients would be allocated. At the follow up assessments, the patients’ experiences of therapy were explored at the end of the interview, and therefore the follow‐up research clinician was not blind to the treatment.” ‐ Blinding was performed to the extent it could have been since the follow up involved an interview discussion of the patient's experiences.

Incomplete outcome data: All outcomes were followed up for 1 year, but only 73% of patients at the beginning were followed‐up after one year (with telephone follow up for a further 11%). Researchers were transparent in their reporting of data, especially drop‐outs, but did not give explanations for drop‐outs. ITT reported by estimation of outcome. ‐ Outcome follow up was incomplete in spite of best efforts.

Selective outcome reporting: Authors were transparent about numbers but not explanations on drop‐outs. There were no reports of potential conflicts of interest. Authors were transparent about power of the study and were also transparent about inclusion and exclusion criteria for subjects (reducing potential for bias: this is written in the "Patients" subheading in the study). The area the patients came from was mentioned ("psychiatric teaching hospital, the Maudsley) ‐ It is possible but unlikely that there was selective outcome reporting.

Risk of bias ‐ present

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized controlled trial (RCT), duration of treatment was 20 sessions over a minumum of 20 weeks. Treatment integrity was done and sessions were recorded, blinding of outcome evaluation was done, ITT was included (by carrying forward the last observation). Randomisation was computer generated and sealed envelopes were used for allocation concealment. Follow‐up is ongoing at 3,6,9,12 months and 2,3,5 years post‐treatment.

Participants

56 female patients with anorexia nervosa (DSM‐IV criteria) of EDNOS AN (lenient weight BMI 17.5‐19, DSM‐IV criteria) without amenorrheoa criteria being imposed. Age 17‐40 years. 42% of those screened were excluded.

Interventions

Cognitive behaviour therapy vs interpersonal psychotherapy vs nonspecific clinical management.

Outcomes

Primary outcome: clinician global rating: 4=full criteria for spectrum AN, 3=number of features of AN but not full criteria, 2= few features of an eating disorder, 1= no significant features of eating disorders
Secondary outcomes: self‐report EDI‐2, height, weight, %body fat, EDE subscale scores, GAF (DSM‐IV), Hamilton Depression Rating Scale.

Notes

Moderately high exclusion rate: 400 inquiries, 135 individuals interviewed, 78 deemed eligible.
Treatment relatively short. Nonspecific therapy incorporated CBT elements such as psychoeducation and had focus on nromalising eating. Authors provided further information on design of study.

Sequence Generation: randomization was computer generated (wrote to author to find out). ‐ allocation sequnce was adequate.

Allocation concealment: envelopes were used for allocation concealment (wrote to author to find this out). ‐ Allocation concealment was sufficient.

Blinding: Blinding of outcome evaluation was done (found out from author). ‐ Knowledge of the allocated interventions were adequately prevented during the study.

Incomplete outcome data: Outcome data was complete for all subjects who completed the study. There were many few drop‐outs, but these all well explained and well accounted for, and ITT analysis was performed by carrying last observation forward. ‐ Incomplete outcome data was properly addressed with ITT and through accountability.

Selective outcome reporting: authors were transparent about potential sources of support (therefore reducing sources of bias) (Supported by project (97/144) and program grants from the Health Research Council of New Zealand.) Furthermore there was a considerably high exclusion rate of subjects, suggesting that there is the possibility of selecting subjects with biased judgement. Authors were quite transparent about selection stradegy for patients: "The inclusion criteria for this study were female gender, an age of 17–40 years, and the presence of current primary anorexia nervosa; the participants included individuals diagnosed according to the DSM‐IV weight criterion (body mass index, <17.5), which was considered to be a strict definition of anorexia nervosa, andthose diagnosed according to a lenient weight criterion (body
mass index, 17.5–19.0) (20). Individuals with a body mass index below 14.5 were considered unsuitable for outpatient psychotherapy and were referred for assessment at an inpatient unit. In light of debate as to the necessity of amenorrhea in diagnosing anorexia nervosa (21), amenorrhea was not an inclusion requirement. The exclusion criteria were current severe major depression, psychoactive substance dependence, major medical or neurological illness, developmental learning disorder, cognitive impairment, bipolar I disorder, schizophrenia, or a chronic, refractory course of anorexia nervosa. Individuals receiving a stable dose of a psychotropic medication with no change in anorexia nervosa symptoms were included; however, only two individuals were taking an antidepressant medication. Recruitment was broad‐based and included referrals from health professionals, self‐referrals, and family referrals. The study received ethical approval from the Southern Regional Ethics Committee, and written informed consent was obtained." The area where the subjects came from was not mentioned.

Risk of bias ‐ low

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized controlled trial (RCT), duration of treatment was six months (20 weekly sessions) and no further follow‐up was reported, treatment integrity was assessed using audiotaped sessions, outcome evaluation was not blind, ITT by estimation of outcome.

Participants

35 (two men) with anorexia nervosa (DSM III‐R) over 16 years of age. None of those screened were excluded. Seven participants had a BMI of between 17.5 and 19 thus technically not meeting diagnostic criteria.

Interventions

Cognitive therapy vs dietary advice.

Outcomes

BMI, EDI, Dysfunctional Attitudes Scale(DAS), Locus of Control of Behaviour (LCB) and BDI

Notes

Sixth month data reported as "follow‐up" is presumed to be end of treatment data. Authors responded to inquiries.

Sequence Generation: “Using cards randomly placed into sealed envelopes, patients were allocated to one of two groups; dietician control (D) or cognitive therapy (CT).” ‐ Allocation sequence was sufficiently generated.

Allocation Concealment: Cards which allocated subjects to their random group were placed in envelopes (wrote to authors to get this information. ‐ Allocation was adequately concealed.

Blinding: Outcome evaluation was not blind, but personnel and participants were blinded for allocation (information received later from authors). During the study, knowledge of the allocated interventions were sufficiently concealed.

Incomplete outcome data: In the dietary counselling group, all subjects dropped out. ITT analysis by estimation of outcome was used for clinical diagnosis and BMI for this group. No further follow up was reported. Authors were transparent about numbers and explanations of drop‐outs: "All the patients in the dietary advice group had dropped out within 3 months of entry into the study.""Although follow‐up of the dietary control group was attempted, by writing and telephoning all participants and their GPs, the dietary control group refused to allow data to be released." ‐ Incomplete outcome data were not sufficiently addressed (could have been followed up by a phone call rather than ITT estimation analysis).

Selective Outcome Reporting: Authors were transparent about their selection of subjects strategy suggesting limited bias in outcome reporting:"Participants were drawn from a consecutive group of new patient general practitioner referrals to a new Eating Disorders Service at the Royal Hallamshire Hospital serving a catchment area of approximately 500,000. Although it is possible that a very small number of patients were referred to therapists in the private sector, this practice is extremely rare and there were no other NHS disposal routes for referrals." Inclusion criteria was mentioned: "All patients were eligible for the study, providing they were 16 years old or more and had a DSM‐III‐R (American Psychiatric Association, 1987) diagnosis of anorexia nervosa."
No follow up reported after the 6 months of treatment. Authors were transparent about numbers and explanations of drop‐outs (mentioned in incomplete outcome data). No report of potential conflicts of interest (potential source of bias). ‐ It is possible but unlikely that there has been selective outcome reporting.

Risk of bias ‐ present

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized controlled trial (RCT), duration of treatment was 5 months with one year follow‐up, treatment integrity was not done, outcome of evaluation was not blind, ITT by withdrawals followed up and included in analysis

Participants

30 (one man) with anorexia nervosa (ICD‐10) All over 18 years in age. 21% of those screened were excluded.

Interventions

Educational Behavioural therapy (EDT) vs cognitive analytic therapy (CAT)

Outcomes

Morgan and Russell interview and BMI

Notes

End of Treatment data not reported. Authors responded to inquiries. They reported that the EBT group would be more like a "treatment as usual" than "dietary advice alone" treatment and the CAT was the same as in the Dare 2001 study.

Sequence Generation: Subjects were randomly number allocated to different treatment groups, but this was matched: “After assessment patients were randomised using random numbers to the two treatment groups, (1) educational behavioural therapy and (2) cognitive analytical therapy.= “The randomisation was successful in that the groups were well matched before treatment” ‐ Allocation generation was adequate.

Allocation Concealment: No mention of strategies of allocation concealment.

Blinding: Outcome evaluation was not blind. Apart from this, there was no other mention of the blinding stradegies ‐ Unclear as to blinding to personnel and participants was sufficient but outcome evaluation was not blinded.

Incomplete outcome data: Authors were transparent about drop‐out numbers and explanantions, but did not report use of ITT.: “Thirty eight patients were assessed and thirty two fulfilled these entry criteria. Of these one lost further weight after the assessment interview and was admitted before therapy began. One eligible patient refused the offer of treatment.”‐ Incomplete outcome data was properly explained, but unclear if it was accounted for (e.g. through ITT).

Selective Outcome Data: Transparency about short comings and potential conflicts of interest so unlikely to be selective reporting: “The size of the study was small and so the power to distinguish between two forms of treatment was limited. As this was a pilot study of a new approach the therapists were relatively inexperienced.” Authors gave sufficient details on the selection strategy of subjects including where they came from and also inclusion criteria: "The subjects were a consecutive series of outpatients from the Eating Disorder Clinic at the Maudsley Clinic who were referred for treatment during the eighteen month recruitment phase of the trial. All patients met ICD‐10 diagnosis for anorexia nervosa and were over 18 years in age. Patients with a mixed diagnosis of anorexia nervosa and bulimia nervosa were included (see Table 1 for details of how many binged or used the various weight control measures). Patients were excluded if the psychiatrist giving the assessment interview judged that inpatient treatment was necessary
because of extreme, rapid weight loss with additional symptoms and signs of severe emaciation such as proximal myopathy, marrow suppression or hypoglycaemia."‐ It is possible that the has been selective outcome reporting with the lack of detail given on drop‐outs (mentioned in the incomplete outcome data section).

Risk of bias ‐ present

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear