Development of a screening tool for the identification of psychooncological treatment need in breast cancer patients

May combine two claims.

In Fallowfield et al., for 36% of patients the GHQ-12 suggested psychiatric morbidity; sensitivity of physicians' ratings was 29% and specificity was 85%.

“For 36% of the patients, the GHQ-12 suggested psychiatric morbidity.Sensitivity of the physicians' ratings was 29%, specificity was 85%.”

• cites [14] 14. Fallowfield L, Ratcliffe D, Jenkins V, Saul J. Psychiatric morbidity and its recognition by doctors in patients with cancer. Br J Cancer 2001;84(8):1011-1015. sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In the screening pilot, 8 patients were allocated to the POT-group and 12 patients to the Non-POT-group using a cut-off score of 0.30.

“Owing to the screening results 8 patients were allocated to the POT-group and 12 patients to the Non-POT-group (cut-off score 5 0.30).”

May combine two claims.

The Role Functioning scale consists of two items and adds valuable information by addressing impairment in daily work and leisure activities.

“The Role Functioning scale, consisting of two items, adds valuable information since it addresses a quite different aspect, namely impairment in daily work and leisure activities.”

Probably not a substantial claim: may not pass S3 (load-bearing).

None of the questions were omitted.

“None of the questions were omitted.”

May combine two claims.

Best single predictions were derived from the QLQ-C30 Emotional Functioning and Social Functioning scales and from both HADS scales, but predictive power of these single scales was only moderate.

“Best single predictions were derived from the QLQ-C30 Emotional Functioning and Social Functioning scales and from both HADSscales, but predictive power of these single scales was only moderate.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Assistance in filling in the questionnaire on the touchscreen of a tablet-PC was not needed.

“Assistance in filling in the questionnaire on the touchscreen of a tablet-PC (Figure 2(a)) was not needed.”

May combine two claims.

The PO-screening tool achieved sensitivities and specificities of 0.79/0.79 and 0.71/0.85 at certain cut-offs.

“0.79 | 0.79 | 66.0% | 0.30”

• Also stated in: § Discussion · plain

  “0.71 | 0.85 | 71.4% | 0.46”

Probably not a substantial claim: may not pass S3 (load-bearing).

Two patients required information regarding the content of certain items.

“Two of the patients required information regarding the content of certain items.”

May combine two claims.

The computerized screening tool implemented in CHES revealed no problems regarding usability and proved good acceptance.

“As a result of the semi-structured interviews, the computerized screening tool implemented in CHES revealed no problems regarding usability and proved good acceptance.”

• AssumptionRests on an assumption: Short screening instruments require less resources and especially less time than training oncologists.

Probably not a substantial claim: may not pass S3 (load-bearing).

Using stepwise backward-elimination as the selection procedure yielded very similar results.

“Using stepwise backward-elimination as selection procedure yielded very similar results (not shown).”

May combine two claims.

All employed scales were able to discriminate between the POT-group and the non-POT-group, with the POT-group having significantly poorer QOL and functioning scores and significantly higher impairment and symptom scores than the non-POT-group.

“ROC-analyses showed that all employed scales were able to discriminate between the POT-group and the non-POT-group with the POT-group having significantly poorer QOL and functioning scores and significantly higher impairment and symptom scores than the non-POT-group.”

• AssumptionRests on an assumption: The clinical rating by psychooncologists based on semistructured interviews is a valid criterion for POT need.

May combine two claims.

Employment status and PPP-treatment differed significantly between the POT-group and the non-POT-group.

“Furthermore employment status and PPP-treatment differed significantly between these two groups.”

May combine two claims.

The PO-screening tool overlaps with the EORTC-QLQ-C30 and requires only one question (regarding PPP-treatment) to be added.

“A further advantage of the PO-screening tool developed in this study is that it overlaps with the EORTC-QLQ-C30 and requires only one question (regarding PPP-treatment) to be added.”

May combine two claims.

Computer-based testing is highly feasible in a clinical setting and well accepted by patients.

“Our pilot study and other trials [47,48] indicate that computer-based testing is highly feasible in a clinical setting and well accepted by the patients.”

• cites [47] 47. Carlson LE, Speca M, Hagen N, Taenzer P. Computer- ized quality-of-life screening in a cancer pain clinic. J Palliat Care 2001;17(1):46-52. sourceNot checked — no full text of the source
• cites [48] 48. Taenzer PA, Speca M, Atkinson MJ et al. Computer- ized quality-of-life screening in an oncology clinic. Cancer Pract 1997;5(3):168-175.Not checked — no full text of the source

Classified as probably not a substantial claim. May combine two claims.

The PPP-treatment item records lifetime information and does not only measure present condition.

“In contrast to the two other scales it records lifetime information and does not only measure present condition.”

May combine two claims.

The Computer-based Health Evaluation System (CHES) showed high applicability in the screening pilot and good acceptance by patients and medical staff.

“Our specially developed Computer-based Health Evaluation System (CHES) showed high applicability in the conducted screening pilot and good acceptance by patients and medical staff.”

May combine two claims.

In logistic regression, PPP-treatment, QLQ-C30 Role Functioning, and QLQ-C30 Emotional Functioning were significant predictors of POT need.

“PPP-treatment | 2.1578 | 0.613 | 12.410 | 1 | 0.000 | 8.652”

• Also stated in: § Discussion · plain

  “QLQ-C30 Role Functioning | À0.0232 | 0.010 | 5.604 | 1 | 0.018 | 0.977”

• Also stated in: § Discussion · plain

  “QLQ-C30 Emotional Functioning | À0.0387 | 0.013 | 8.260 | 1 | 0.004 | 0.962”

Probably not a substantial claim: may not pass S3 (load-bearing).

In the sample, 34.3% of patients were in the POT group.

“69 (65.7%) | | 36 (34.3%) | | 105 (100.0%)”

Probably not a substantial claim: may not pass S3 (load-bearing).

Owing to missing test scores in some scales, only 88 patients could be used for the selection procedure.

“Owing to missing test scores in some scales only 88 patients could be used for the selection procedure.”

Probably not a substantial claim: may not pass S3 (load-bearing).

About 25-40% of breast cancer patients experience psychological problems and psychosocial distress related to the disease and its treatment.

“Patients diagnosed with breast cancer are confronted with a wide range of stressors related to the disease and its treatment and this results in psychological problems and psychosocial distress in about 25-40% of breast cancer patients [1,2].”

• cites [1] 1. Coyne JC, Palmer SC, Shapiro PJ, Thompson R, DeMichele A. Distress, psychiatric morbidity, and prescriptions for psychotropic medication in a breast cancer waiting room sample. Gen Hosp Psychiatry 2004;26(2):121-128. sourceNot checked — no full text of the source
• cites [2] 2. Hegel MT, Moore CP, Collins ED et al. Distress, psychiatric syndromes, and impairment of function in women with newly diagnosed breast cancer. Cancer 2006;107(12):2924-2931. sourceNot checked — no full text of the source

May combine two claims.

Identification of highly distressed patients is often insufficient in clinical oncology settings and the rate of referral to mental health professionals is low.

“Despite the fact that many patients suffer from high distress, identification of those is often insufficient in clinical oncology settings and the rate of referral to mental health professionals is low [12,13].”

• cites [12] 12. Carlson LE, Bultz BD. Cancer distress screening. Needs, models, and methods. J Psychosom Res 2003; 55(5):403-409. sourceNot checked — no full text of the source
• cites [13] 13. Newport DJ, Nemeroff CB. Assessment and treatment of depression in the cancer patient. J Psychosom Res 1998;45(3):215-237. sourceNot checked — no full text of the source

• AssumptionRests on an assumption: Physicians are often too pressed for time to adequately inquire about patients' psychological status, and patients do not spontaneously talk about their distress.

May combine two claims.

Existing scales can discriminate to some extent between patients in need of POT and patients not in need, but diagnostic accuracy is only moderate and there is no agreement on the most appropriate screening instrument.

“Research evaluating these scales has shown that all of them are able to discriminate to some extent between patients who are in need of POT and patients who are not.However, diagnostic accuracy is only moderate and there is no agreement on which is the most appropriate screening instrument.”

• AssumptionRests on an assumption: General classification schemes like the DSM-IV or the ICD-10 are not fully appropriate to assess the whole range of aspects relevant to the need of POT, and symptoms presented by oncological patients may not be classifiable with reference to mental disorders.

Probably not a substantial claim: may not pass S3 (load-bearing).

The HSI has been developed as a screening tool for POT needs in facial and skin cancer patients.

“The HSI has been developed as a screening tool for POT needs in facial and skin cancer patients.”

• cites [40] 40. Strittmatter G, Tilkorn M, Mawick R. How to identify patients in need of psychological intervention. Recent results. Cancer Res 2002;160:353-361. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

The high prevalence of psychosocial impairments in breast cancer patients is well documented in the literature.

“The high prevalence of psychosocial impairments in breast cancer patients is well documented in the literature [42].”

• cites [42] 42. Mehnert A, Koch U. Prevalence of acute and post- traumatic stress disorder and comorbid mental dis- orders in breast cancer patients during primary cancer care: a prospective study. Psycho-Oncology 2007;16(3):181-188. sourceNot checked — no full text of the source

Classified as probably not a substantial claim.

The psychooncologists were blinded to all variables used for the development of the screening tool.

“The psychooncologists were blinded to all variables used for the development of the screening tool (although demographic and clinical issues could of course be explored in the interview).”

Classified as probably not a substantial claim.

The clinical rating of POT need was based on extensive semistructured patient interviews conducted by two experienced psychooncologists.

“In a second stage of the assessment two experienced psychooncologists rated the patients as positive or negative cases depending on whether or not they were assessed as being in need of POT.This clinical rating was based on extensive semistructured patient interviews.”

• AssumptionRests on an assumption: The clinical rating by psychooncologists based on semistructured interviews is a valid criterion for POT need.
• AssumptionRests on an assumption: The semistructured interview schedule compiled by five experts covers the relevant issues for POT need.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The EORTC-QLQ-C30 is an internationally validated and widely used cancer-specific QOL instrument that assesses various facets of functioning, symptoms common in cancer patients and general QOL.

“The EORTC-QLQ-C30, an internationally validated and widely used cancer-specific QOL-instrument, assesses various facets of functioning, symptoms common in cancer patients and general QOL.”

• cites [30] 30. Aaronson NK, Ahmedzai S, Bergman B et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85(5):365-376. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The HADS is one of the most common screening tools for anxiety and depression in clinical studies and has been developed for use in the physically ill.

“The HADS is one of the most common screening tools for anxiety and depression in clinical studies and has been developed for use in the physically ill.”

• cites [17] 17. Zigmond A, Snaith R. The hospital anxiety and depres- sion scale. Acta Psychiatr Scand 1983;67(6):361-370. sourceNot checked — no full text of the source

May combine two claims.

In the HSI pilot study, 85.7% of grouped cases were correctly classified and Cronbach's alpha for the HSI was 0.62.

“In this pilot study 85.7% of grouped cases were correctly classified.Cronbachs alpha for the HSI was 0.62 [40].”

• cites [40] 40. Strittmatter G, Tilkorn M, Mawick R. How to identify patients in need of psychological intervention. Recent results. Cancer Res 2002;160:353-361. sourceNot checked — no full text of the source

May combine two claims.

The EORTC-QLQ-C30 Emotional Functioning scale is composed of only four items and is significantly shorter than the HADS subscales, GHQ-12, and K10 scale.

“The EORTC-QLQ-C30 scale Emotional Functioning also has the advantage of being composed of only four items and is therefore significantly shorter than other fairly brief scales like the HADS subscales (each seven items), the GHQ-12 [45] or the K10 scale [46].”

• cites [45] 45. Goldberg DP, Gater R, Sartorius N et al. The validity of two versions of the GHQ in the WHO study of mental illness in general health care. Psychol Med 1997;27(1):191-197. sourceNot checked — no full text of the source
• cites [46] 46. Kessler RC, Andrews G, Colpe LJ et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med 2002;32(6):959-976. sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Of 115 breast cancer patients approached, 105 were available for analysis after 10 were excluded because rating of POT-need was not possible due to time constraints.

“All of the 115 patients approached as potential study participants met the inclusion criteria and signed informed consent, but 10 had to be excluded from analyses because rating of POT-need was not possible due to time constraints.Sociodemographic and clinical data for the remaining 105 patients are shown in Table 1.”

• Also stated in: § Abstract · plain

  “Data from 105 breast cancer patients (mean age 58.8, SD 12.3) were available for analysis.”

Probably not a substantial claim: may not pass S2 (checkable).

Specification of a cut-off score is a matter of balancing heightened resource use due to false-positive patients with the problem of neglecting patients with severe psychosocial impairments.

“Therefore, the specification of a certain cut-off score is a matter of balancing heightened use of resources due to false-positive patients with the problem of neglecting patients suffering from severe psychosocial impairments.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

Screening tools are of greater importance in outpatients than in inpatients because contact between patient and medical staff is less intensive in outpatients.

“However, screening tools are of greater importance in outpatients than in inpatients since contact between patient and medical staff is much less intensive in outpatients.”

Classified as probably not a substantial claim.

The sample size in the study was rather limited.

“Moreover, further validity testing of the screening tool is needed, since the sample size in our study was rather limited.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

The time and effort required to implement the tool into oncological routine can be reduced significantly by using a computerized version, which is well accepted by patients and offers real-time results.

“The time and effort required to implement the tool into oncological routine can be reduced significantly by using a computerized version, which is well accepted by patients and offers real-time results.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The proposed screening tool requires access to adequate hardware and software resources.

“Clearly, the proposed screening tool requires access to adequate hardware and software resources.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based). May combine two claims.

The single item assessing former PPP-treatment may reflect a general psychological vulnerability and/or the impact of stressful life events prior to disease onset.

“The single item assessing former PPP-treatment may reflect a general psychological vulnerability and/or the impact of stressful life events prior to disease onset.”

May combine two claims.

The higher the cut-off score, the more likely a patient scoring above is really in need of POT, but the proportion of undetected patients in need of POT increases.

“The higher the cut-off score, the more likely a patient scoring above is really in need of POT.But at the same time the proportion of undetected patients being in need of POT increases.”

Classified as probably not a substantial claim.

Computer-based testing provides real-time availability of screening results.

“Another major advantage of computer-based testing is the real-time availability of the screening results, which is of great importance in the context of the short patient contacts common in outpatient units.”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

The cut-off score can be adjusted to available POT capacities in daily oncological practice.

“In the context of implementation into daily oncological practice the cut-offs core can be adjusted to available POT capacities.”

Probably not a substantial claim: may not pass S4 (based).

The optimal combination of scales and items differs across tumour types and course of treatment and disease.

“It can be expected that the optimal combination of scales and items differs, e.g.across tumour types and course of treatment and disease, therefore the logistic regression equation described is presumed to be specific for breast cancer patients.”